CA2233898A1 - Steerable catheter - Google Patents
Steerable catheter Download PDFInfo
- Publication number
- CA2233898A1 CA2233898A1 CA002233898A CA2233898A CA2233898A1 CA 2233898 A1 CA2233898 A1 CA 2233898A1 CA 002233898 A CA002233898 A CA 002233898A CA 2233898 A CA2233898 A CA 2233898A CA 2233898 A1 CA2233898 A1 CA 2233898A1
- Authority
- CA
- Canada
- Prior art keywords
- steerable catheter
- catheter
- outer jacket
- deflection
- center tube
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0136—Handles therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0141—Tip steering devices having flexible regions as a result of using materials with different mechanical properties
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0144—Tip steering devices having flexible regions as a result of inner reinforcement means, e.g. struts or rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0152—Tip steering devices with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0158—Tip steering devices with magnetic or electrical means, e.g. by using piezo materials, electroactive polymers, magnetic materials or by heating of shape memory materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/00336—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00392—Transmyocardial revascularisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00738—Depth, e.g. depth of ablation
Abstract
An elongated steerable catheter for placement within a heart chamber, organ aperture or other body opening and having at least one center tube with hollow passageway for guiding a laser delivery means or other functional device to selected surfaces of a heart chamber, organ aperture or other body cavity for laser or other treatment thereon, particularly adapted for laser-assisted percutaneous transmyocardial revascularization (TMR), is disclosed herein. The steerable catheter has a handle portion at its proximal end and a controllably deflectable end portion at its distal end. The elongated center tube has a distal end, in the region where a curvature is to be formed, and a shim anchor sleeve is slidably disposed over the center tube. The shim anchor sleeve is attached to the inside wall of the outer jacket and coupled to the distal end of the center tube with a bendable shim member which extends between the distal tip of the steerable catheter and the sleeve over the center tube. Opposite the shim is a guide for a pull cable, the pull cable attached to the distal end of the steerable catheter and extending through the guide to the handle. Thus, the shim is maintained radially opposite the pull cable with the center tube in between. An outer jacket has, in a preferred embodiment, distinct sections of different stiffness or durometer. A distal, more flexible portion is coupled to a proximal, stiffer portion. The shim anchor sleeve is positioned at or near the junction of two portions of the outer jacket. Thus, the center tube moves freely through the shim anchor sleeve. Adjacent the handle, the outer jacket terminates at the catheter base. The pull cable extends past the catheter base, through a deflection housing tube, and terminates in a cable stop. Rotation of a deflection knob threadably mounted onto the deflection housing tube will cause the pull cable to be pulled backward, or the outer jacket to be pushed forward, relative to each other, thereby inducing deflection of the distal end of the steerable catheter.
Description
Title: STEERABLE CATHETER
FIELD OF THE INVLNTION
The present invention relates generally to c~th~ens and ~I,~,t~,. p, u~lw ~ involving laser energy delivery using fiber optic and other laser delivery systems. More particularly, the invention relates to a steerable catheter and method of use, particularly adapted for laser-assisted lla Ls",yo~niial revascul~i~ion (TMR). The distal tip of a central, hollow flexible center tube for guiding a laser delivery means or other filnrtil~n~l device eYt~m1~ble therethrough is ~efl~ ble utilizing a semi rigid shim, the shim acted upon by a pull cable for controllably d~flr~ting the distal tip ofthe ~ le catheter in at least one given plane.
The steerable catheter can be used in conju"ilion with a fiber or other laser delivery means advance .--f- h~ .., optionally using a depth control .~e~h~ as well.
BACKGROUND OF THE INVEN~ION
In the ll~l "~i"t of heart disease, one method of illl~ Villg ~--yo~dial blood supply is called 1, u,~,.yocardial revascularizaffon (TMR), the creation of ~ .. .el~ in the myocardium ofthe heart. The pr~lult; using needles in a form of surgical "l"yoca~ . . . e" has been used clinically since the 1960s. Dec~e1,bal~m L.I., Cardiovascular Applications of Laser Te-' -'cgy, Lasers in Surgery and Medicine 15 :315-341 (1994). The ~ihni1ue relieves i~-~h~mi~ by allowing bloodto pass fromthe ventricle throughthech~nnelseitherdirectlyintoothervesselsco.. "i-;c~ gwiththecl~ll-l-fl~orintomyocardial sinn~o ~ which connect to the myocardial l-~icr~ci~ ti~n In the reptilian hcart, p~ n occurs via c~ ti~ c~ f l ~ bctween the left ~ tl icle and the co,~ ~y arteries. Frazier, O.H., Myocal lial Rev~ccul~ri7~tion with Laser - Plt;lillllllaly Findings, Circulat~on, 1995; 92 [suppl IIl :II-58-II-65. There is evidence of these c ~ ~tj~ C.~ .lf lS in the dcvelo~--.g human embryo. In the human heart, Illyoc~u~dial m ~ nmy involves the p-esellce of IllyfK~ Q;n~leo:~ These ~inlleo:1~l communications vary in size and structure, but It~ t a network of direct arterial-luminal, arterial-arterial, arterial-venous, and venous-luminal cl~nn~~ti~ns This vascular mesh forms an il-~ source of Illy(Jwdial blood supply in reptiles but its role in humans is poorly u~ lood.
Nul~c.~us surgical TMR studies have been pe~ 'f~, in.~lntling early studies using needles to perform ~yo~ lial ac~ or boring7 to mprh~ni~ ly displace andlor remove tissue Such studies have involved surgically ~ osing the heart and sc~ lly i,~sc;l~ g needles to form a number of .~h~nn~~le through the epicardium, Illy~wdiul~l, and endoc~uJiul-- to allow blood from the vtilltli~,lc to perfuse the ~ nl- ~f l c. The early studies using needles showed that the newly created ~,l~ -f l i were subject to acute l~l-ul~lbo~,is followed by org~ni7~tion and fibrosis of clots resulting in channel closure. Interest in TMR using needles waned with the knowledge that such .~,h~nn~le did not remain open. II(~wtivt;l, interest in TMR pl ~lul ~s has recurred with the advent of medical lasers used to create TMR cl ~z ~ "cl s .
Hietologi.~, l evidence of patent, ~~.n-lf~t~h~ m-lined tracts within laser-created cl~ flc shows t-h-at the lumenoflaserchannelscanbecomehf~n~~4.. l.dl;hl~andresistsoc.~ll-~;rln At-hinzoneofcl~hlillgoccurs on the pe, il,he, y of the laser-created .~h~nnel e through the well-known thermal effects of optical radiation on cardiovascular tissue. ~ditif)n~lly~ recent hi~oe .~~l evidence shows probable new vessel form-ti~f n aAj~--~ent collagen o~~hlded ~ llly~dial ch~ flc~ thereby sn~Geting benefits from TMR with or without the form~til~n of ~ n~lele which remain patent.
Surgical TMR p- ~lul ~s using laser energy have been described in the prior art. U. S . Patent No.
4,6~8,817 issued Apr. 21, 1987 to Hardy teaches a method and al~ps~ t,-C for surgical TMR using a CO2 laser cn~ d to an arti.~,nl,t~fd arm having a I~J~,ir~A5 ,tt~-~hf-d thereto. The h~-nflri~~~ emits laser energy from a single aperture and is moved around the surface ofthe heart to create the desired number of c,~ f.le, u~s~ Patent No. 5,380,316 issued Jan. 10, 1995 to Aita et al. ~,u-~ to teach the use of a flexible lasing ~pp~us which is inserted into the open chest cavity in a surgical p-u~huti. A lens at the distal end of the flexible a~,l,al~us is used to focus laser energy, and the aypal~lus is moved about the surface of the heart to create the desired number of c~ c.
The roregoillg ~liccll c~ir n relates to surgical ~,locc~iules, i.e. p-oce lu-~ which access the heart surgically, either via open heart surgery, or perhaps by ~ ~ -lly invasive surgical (MIS) methods if the design and size of the distal ends ofthe hand pieees are suitable for use in an MIS site. II~Jwt;v~, since TMR most often involves creating ch~ -f l c through the endoca~diul.. into the lower left ~l~..bel of the heart, it is desirable to create TMR ch~ rlc in a per~u~ -~..c procedure, i.e. by t;.~ .g a catheter appali~us through the v~ccul~lre into the ventricle and creating the ch~nl-flc through endocardial surfaces and into ~--yocal~ ' Pt;- rc,.. ~.g such pe-~ f-Ou~; TMR is desirable for a number of reasons.
F.,lc~ ~uc catheter p-~lu-~;s are typically less tl~llalic to the patient c~lllpalt;d to surgical proce(lu.~s. ~tlhecionc between the pericardial sac and epicardium are el;~ ,l~ Fel~ u~ TMR
with a catheter à~)pal ~lus also offers an alternative solution to persons who are not c~nA~ tes for surgical ploc~lul~is.
Because TMR procedures generally involve creating a plurality of ~ nl~lc within the Illyoc~diwll, p~lro~..fi.lg the pr~lul~ per~ -f-ou~ly- rc~uires the ability to steer a cathcter appal~lus through the v~cc~ h-re and l~ cuv~;r the app~tus within the ventricle of the beating heart as rapidly as possible to create the ch~nn~lc without ~cting the heart to the undue stress of a lengthy pl(~lUI~:.
~d~ -n~lly, the ability to control and stabilize the catheter app~ ~lus against the beating heart wall while creating ch~nn~lc with a laser is desirable for pe~;u~neu~s pl~iUltiS to ensure creation of channels as desired and to ensure that the laser is fircd only within the Illyu~u lial tissue. TMR C~ lC should be spaced and grouped applup-i~tely to achieve the desired res-wt without ~ r~ or lUl)tUlillg the heart muscle.
The early l~yc~ pluG~]ultiS were not p~ ru~ d peL~ r~ ~.ly. The Hardy CO2 laser delivery system de~scribed above is rigid, l~ ,ly large, and not adaptable for pel.. ' v~us use. The Aita '316 patent does not suggest a method for pc.~ f~uc use ofthe laser delivery deviee ~nbed therein for surgical use.
U.S. Patent No. 5, 389,096 issued Feb. 14, 1995 to Aita et al. lJUllJUll:i to teach one method of uus TMR using an e1ong~ted flexible lasing appaldlus with control lines and a focusing lens i,LI u~ at the distal tip. However, the method uses plCi:i:iUlti applied manually to attempt to stabilize the a~)pal~us against the wall of the heart, and no central, hollow passageway is ~sc~ ;1~ No handle :~tl U~lUlt;, modular or OllICI wise, is l1P~nbe~ nor are dçflecti~ n dPflP~ion cc,- ~ .1~e. .1 ~; or a floating center tube.
Several prior art patents describe the use of catheters within the ventricle for pel-iu~
tl~l",~ t of ventricular tacl-y~ lia. Such devices have a means to locate an a .hyl~ a site and ablate the site, at or just below the ventricle surface, using an electrode device or laser energy. U.S. Patent No.
5,104,393 issued Apr. 14, 1992 to Isner teaches a catheter app~tus having a guiding Y-shaped sheath and guide catheter assembly for introducing an optical fiber into the Vt;lltl i~lc. Positioni~ is dP~ ;bP~ to enable a single burst of laser energy from a single aperture to ablate the site. However, positioning or specific steering means snffi~ nt to create one or more TMR .1.~ is not 1Ps~ ~ ;~d or s,Jgg~l~
U.S. Patent Nos. 5,255,679 issued Oct. 26, 1993 and 5,465,717 issued Nov. 14, 1995 to, l~e.,liv~ly, Imran and Imran et al., disclose non-laser, basket-shaped catheter a~Jp~lus for l"appi,g and/or ablation of a-,l.ylh",-a sites -within the ventricle. A pull cable is used to expand the basket portiûn within the ventricle, and a plurality of electrodes on the arms of the basket are used for ablation. The basket device is desi~led to place the electrodes on the ventricle wall. Although the device allows for a fairly e~ llSiv~ ",apping procedure without repQsitioni~ no positir)ni~ means is provided for a laser delivery system to allow creation of TMR .',1~.",~1~
U.S. Patent No. 5,114,402 issued May 19, 1992 to McCoy teaches a ~ lGu~,. ble distal al)pal~lus with a lG~ rGl~lu-e ~tiv~d material of co~llu~ilioll which, upon heating to a p~GdG1tllllined po~itinn~ will assume a plG~Il.lined, ~ d shape, and which upon cooling, will assume a di~r~ t shape by action of a spring eleme;nt urging the appan~tus into the di~e~ t shape.
S U.S. Patent No. 5,190,050 issued Mar. 2, 1993 to Nil~ teaches a ~1~ b'c catheter with a handle and a tube, the dist. l tip of which may be selectively curved by controllably moving one of three flat, sandwiched shims relative to the others by mq-niplllqtic~n of a handle portion. However, ~fl~o~tif n control requires the use of multiple shims, and no ,~ ", for hlt~l~lGd or otherwise fiber advance meaos is taught.
U.S. Patent No. 5,358,479 issued Oct. 25, 1994 to Wilson, hereby h~col~l~l~d herein in its entirety by IGrGl~ ce, teaches another ~leG-~blc catheter with a handle and a center tube, the a~paldtus having a single ~lon~qt~A~ b~ 1 ;qlly flat shim spring ....~ ~1 within the tip of the catheter tube, the shim having at least one tl~u~vGI~e or lateral twist which causes the tip of the catheter tube to assume a desired curvature. I IOWGVG1, Wilson does not teach the use of a hollow catheter for delivery of laser energy or any other fim~ti- n~q,l device, nor does it c~ .plnlt; the use of a floating center tube.
Theuseof~ul,G~ icand/orshapememorymqtPliql~iswidelyknown. StructureandPropertiesof Ti-NI Alloys: Nitinol Devices & Co~ ollGIlt~ Duerig et al., In Press, Titanium Handbook, ASM
(1994) In general, binary col~ tions of Nickel (Ni) and Titanium (Ti), yield alloys with shape memory and supG-~ lic properties. These alloys are c~.. -.~ly referred to as Ni-Ti, nitinol, and other industry names. Their precise physical and other PIO~)GI lies of interest are ~ ,,llely s~,.~ilivG to the precise NilTi ratio used. Generally, alloys with 49.0 to 50.7 atomic % of Ti are c<~llllllGI-,;ally available, with ~lic alloys in the range of 49.0 to 49.4%, and shape memory alloys in the range of 49.7 to 50.7%.
Due to a rapid declGase in the ductility of the material, binary alloys with less than 49.4 at.% Ti are generally unstable. In general, these types of m~tf~n~ls exhibit hysteresis, defined as a ph~
exhibited by a system whose statc depends on its previous history, and illu~llalcd dia~,~ lly by the familiar upper and lower curves which meet at the ends and define an area under the curves. In the case of solid m~teri~lc ul~cl~,oh~g elastic Ly~clc~is (as opposed to ma~Ptic or P,lectric~l Ly~lclc~;s), the curves are related to stress n~ssaly to cause dcrull~iol~ or otherwise overcome existing stress in pre-stressed materials.
Plupcllies of these mAteri~lc change cigllifil~ntly as their respective "phase ~ rv..-~;O., Iclll~ldui~" are approached. In general, at lower t~ el~ul~,s, these alloys will exist in a ~ ~t~ ile state c~ ;7J~d as hard and easily d~rv- ,..~ IIvwcvcl, in austenite, the high l~ clature phase, the alloys have a much higher yield and flow stresses. The addition of small ~..o~ ofthird elemPntc in the alloy can also have very cignific~nt effects on pel rv~ "~Ance of the m~ten~lc. Flementc inc ludi~ but not limitedto oxygen (O), nitrogen (N), iron (Fe), a~ (Al), cl~ ~uuu~ (Cr), cobalt (Co) ~ - ' (V), ~irCOniUIII (Zr) and copper (Cu), though having various effects on the Ni-Ti matrix, can have the l~ cll~iy to increase strength, increase 5tiffnPcc, control L~lclc~;s and/or decrease or increase phase trancition ICIII~CIalUI~.
Ni-Ti products are c~mmonly used in the form of cold drawn wire or as barstock. Tubing is also available. The toxicity ofthe alloy or the solubility or other comrAtibility with the biclogic~l envi,vlll"c,l~
in which catheter e~ ~ ;r.. . -~. .1 is used is an illl~JOI ~11 consideration. The alloys are c~ ~ Iy used in a cold worked and partially AnnP~IP,d u n~liti- n The partial anneal does not recrystallize the material but does bring about the onset of recovery processes. The extent of the post-cold worked recovery depends upon many aspects ofthe appli~til~n such as the desired stiffnPcc, fatigue life, ductility, lecovcly stress, etc.
Ni-Tiisdifficulttojoinsincemostmatingm~tPnAlccannottoleratethelargestrains~ lbyNi-Ti.
Most c~ nnp~cl;ons will rely on crimped bonds. Although Ni-Ti can be brazed or welded to itself with relative ease, such as by Ic~ ce and with TIG mPth-Y1c, brazing or welding to other materials is difficult though proprietary methods do exist and are pr~tir~d in large volumes, for ~ , I in the pr~l~ction of ~_~lass frames.
For the l,ul~,oses of this ~I;sclo~ c, a rlietincti~n bet~-veen superelashc m~tciqle and shape memory m~tcri~le is made. Superelashcity refers to the highly exaggerated elasticity, or s~ ~a~
S obsc- vcd in many Ni-Ti alloys ~cr5,. ~.. ~ at a specific t~ )clalulc. The function of the material in many of such cases is to store ~ ' I energy. Though limited to a rather small Ic~ c range, these alloys can deliver over 15 times the elastic motion of a spring steel, i.e., withstand a force up to 15 times greater without pe~ ",~ rv~ n Shape memory m~tciq-lc will refer to those mq-t~ri,q-le which can be ~lcru. ,"eA but which will freely recover their original shapes during heating, often utilizing çlectnc-q-l resistivity, or which will develop a large recovery stress when recovery is p-cvc ~Icd. With regard to the present invention, it wvill be ul~dc-~od that the transition tclll~Jclalulc of mq-t~riqle must, in general, be SOllk~Ldl above body tclllpclalulc.
U.S. Patent No. 3,890,977 issued June 24, 1975 to Wilson teaches kinetic memory ele~1lodes~
catheters and c-q-nmllq-e. These devices incorporate a ~ -1, such as a Ni-Ti alloy, having heat-acli~,al~l me~h~;c~l memory properties. The device is formed into an opclalive shape at a high tClnlJCl~lUlC. Then, at a low ~ --I)c-~lu-c below its tr-q-nc ition~l Icllll)cla~ulc, it is ~cro--llcd into a shape for ease of insertion into a guide catheter or the like or othen-vise through a portion of a patient's vq-ecul~t lre or other body lumen. When located in the organ or other desired region, those portions ofthe device constructed using such shape memory mqt~ri~ls are heated to above their trq-n~itionq-l ICIll~JClalulcs, using electrically resistive e~ nts~ thereby Iclwllillg the catheter to its original ~q,nne~q,led ~ .,, ;n~ or proper locating shape. An illl~X~I ~It drawback of the Wilson app~lus is that heat must be applied to the catheter tip.
Complicated construction and t~lectric-q-l power ~ l~ ;b~ n must be considered.
As can be seen from a des~ription ofthe prior art above, pe~ v~c TMR steerable r ~.th~ere are virtually unknown with the eY~eption ofthe catheter briefly desc ;bed in the '096 Aita patent. There is a need in the art for a pe.~,v~ ~ouc TMR ~ e catheter which has means for easily st~r n~, positio~;ng and repositi--ni~ the steerable catheter on the ventricle wall, and having a port for a laser delivery means to enable rapid creation of one or more d~ ia~ly grouped and spaced TMR c ADVANTAGES AND SUMMARY OF THE INVEN~ON
Thus, it is an advantage of the present invention to provide a steerable catheter and method of use for pel.,~ c and other intra-vascular p~lu-~, ;"rlu~l ~g TMR, or any stim~ tinn plu~lu-t;, which ov~-w .~s the limit~ti-)n.c ofthe prior art.
It is a further advantage ofthe present invention to provide a steerable catheter capable of being guided into a heart chamber and used therein for creating a plurality of TMR c~ f l~ wntrollably and .ffi~ ntly.
It is a further advantage of the present invention to provide an clo~ A steerable catheter for pl~-~Pn~nt within a heart cl~llbel, organ aperture or other body opening, the steerable catheter having at least one center tube with hollow pass~;way ~e~ p. thel~l-ough, the center tube for gluding a laser delivery means or other filn~ )n~l device to selected surfaces ofthe heart ~ be~, organ aperture or other body opening for lacer or other ll~allllt;lll thereon, particularly adapted for laser-assisted yucardial rev~cc-ll~ri7~tion (TMR).
It is yet a further advantage ofthe present invention to provide a pel.;~ eQ~c sleelab!~ catheter which can be po~itit~ned securely into a selected position within the left ventricle, or other body opening or cavity.
A fiurther advantage ofthe present invention is to provide a steerable catheter to enable creation of a plurality of applu~lialely grouped and spaced TMR c~ on a selected surface within a body cavity or organ quickly and safely.
Yet an a~ tinlnql advantage of the present invention is to provide a modular .,t~. ''- catheter system capable of b~eing as~."blod and ope~d as desired, ~"~ one or more modular ~A~s~blies which can be coupled together for Op~,~atiOn in unison, ~ h ' ~ but not limited to a central, modular steerable catheter with a ~lrA-fl~At~hlA end portion, a modular fiber advance h~ndr~ unit, and other rV.. ~i~;O~ul devices inrhl~li~ fiber advance depth control .. ~h~ .. , vic~li7ztic-n means, etc.
Therefore, to sul~ c, an e1on~a~Ad s~k catheter for p~ Pm~nt within a heart cl~
organ apel lult; or other body opening and having at least one center tube with hollow passageway for guiding a laser delivery means or other r,l.,. .1 ;. n~l device to selected surfaces of a heart chz ..hf -, organ aperture or other body cavity for laser or other l~ ,nt thereon, particularly adapted for laser ~si~led pe~ rouc transmyocardial revasculari_ation (TMR), is r~ie~Alose~d herein. The steerable catheter has a _andle portion at its proximal end and a controllably ~eflect~hle portion at its distal end.
The ek~n~ted center tube has a distal end, in the region where a ~iUI VatUI~; is to be formed, and a shim anchor sleeve is slidably di~,~,osed over the center tube. The shim anchor sleeve is ~t~Ahed to the inside wall of the outer jacket and coupled to the distal end of the center tube with a ber~ e shim member which extends between the distal tip ofthe steerable catheter and the sleeve over the center tube.
Opposite the shim is a guide for a pull cable, the pull cable a~A-hed to the distal end of the steerable catheter and ~ g through the guide to the handle. Thus, the shim is ~ .~1 radially opposite the pull cable with the center tube in between.
An outer jacket has, in a plerelled embo~ nt~ distinct sections of dirr.;ltil~t stiffness or dulolllctel. One or more distinct sections of material of .1;~-;.~ stiffness or dulc~lllc;l~l can be used.
JllnAti-~ne between the sections of different stiffness or ~lulolll~l can be discrete and clearly defined, or they can blend smoothly or get more or less flexible gradually. A distal, more flexible portion is coupled to a proximal, stiffer portion. The shim anchor sleeve is coupled to the outer jacket at or near the junction of two portions of the outer jacket. Thus, the center tube moves freely through the shim anchor sleeve.
g Adjacent the handle, the proximal outer jacket portion terminates at the catheter base. The pull cable extends through the catheter base, through a ~efl~o~ctinn housing tube, and ~ in a cable stop.
Rotation of a ~efl~ctil~n knob threadably ~ d onto the ~lloflection housing tube will cause the pull cable to be pulled backward, or the outer jacket to be pushed forward, relative to each other, thereby in~ defl~ti~n ofthe distal end ofthe steerable catheter.
The el~u~ted ~tcclabl~ catheter is ~le~ d to be placed into the v~Qcnl~tllre ofthe patient and steered thc-c~.lvugh until the distal tip is a~ nt a selected portion oftissue, such as on an ~ doc~udial surface within the left ventricle. Thus, the distal tip of a laser delivery means, such as an optical fiber or fiber bundle or other filncti~ n~l device, can be eYtl-n~led through the center tube of the steerable catheter such that its distal tip comes into contact with the selected surface structure for llcaLIIIe.lt thereon. With regard to TMR IL~,~er~,lc, the laser delivery means can be controllably alv~ulced through the s~rakle catheterforcreatingoneormoreTMRcl~nn~l~ Fullllcll~ore,withregardtonon-laserTMR,acannula or trocar assembly may be ~ ~ Ir~ ed through the steerable catheter into the tissue ofthe left ventricle, with or without use of a m~h~n;~l piercing tool.
In a plcrcllcd cl~bo~ l, the invention is a modular steerable catheter system capable of being assel--b!~ and O~clalcd as desired, COIll~ illg one or more modular assemblies which can be coupled together for operation in unison, incln-li~ but not limited to a central, modular steerable catheter with a ~l~fle~ble end portion, a modular fiber advance hanJ~iece unit, and other filnctil~n~l devices ~ ~h ' E.
fiber advance depth control ",~1~ , vi~ li7~tic~n means, drug delivery app~alus, etc.
Numerous other advantages and features of the present invention will become readily appal~ t from the following detailed description of the invention and the c.--l~ 1: ~ . -r- 11 ~i thereof, from the claims and fromthea~ p~yilg~aw IgS.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a lG~IG~Gllt~livG i~ . ;c view ofthe steerable catheter ofthe present invention showing a modular handle having a ~leflecti~n c~ "lt and fiber advance co""~on~,lt.
FIG. 2 is a lep,~ t~ivG isometric view ofthe d~flPrt~hl~ end portion of the steerable catheter with the shim anchor sleeve in a bl~a~.ay view of a plGrGIlGd Glllbodi llGllt of the steerable catheter of the present invention and shown without the ~fl~cti..n knob.
FIG. 3 is a IG~JIG iGllt~lliVe ~;ulaway i~o...~l ~ ;c view of detail 3 showing the distal tip of a plGrGllGd emh~im~o.nt of the steerable catheter of the present invention.
FIG. 4 is a IG~)lGsGll~live i~....~t. ic view of detail 4 showing shim anchor sleeve keyed to inside ofthe outer jacket and located adjacent the junction between dirrGrGlll types of outer jacket construction ofthe steerable catheter ofthe present invention.
FIG. 5 is a l~)lGsGIllalive isometric view of the distal end of a laser delivery means of the present invention.
FIG. 6 is a IGl~G~G~ltalive end view of a ~)IGrGllGd ~.mbo~irm~.nt of the shim anchor sleeve ofthe steerable catheter of the present invention.
FIG. 7 is a IG~lGsG~live section view of a plGrG,,Gd embodiment ofthe distal tip ofthe . ~- ___Ll _ catheter of the present invention.
FIG. 8A is a I~lGsGlltaliVG section view of a plGrG~Gd embodiment of a piercing means in a retracted position in the distal tip of the steerable catheter of the present invention.
FIG. 8B is a lG~s~l,~live section view of a plGrGIled embodiment of a piercing means in a protracted position in the distal tip of the steerable catheter of the present invention.
FIG. 8C is a IG~JlGsGlllalive end view of a plGrGIIGd l""bodi-"Glll of a piercing means in the distal tip ofthe steerable catheter ofthe present invention.
FIG. 9A is a re~"Gse,lt~ive section view of another plGrGlled ~ ho~ ..e-~1 of a piercing means in a l~d position in the distal tip of the ~ blc catheter of the present invention.FIG. 9B is a ,~i~)les~ tdli~e section view of another plerelIcd ~ 1 of a piercing means in a pl~ position in the distal tip ofthe steerable catheter ofthe present invention.
FIG. 10 is a I~ s~ iv~i~qm~tric view ofthe distal end and shim a~chor sleeve of a prerel~ed S~mho~lirnent of the steerable catheter of the present inve~
FIG. I l is another ~ s~llt~live i~m~tric view of the distal end and shim anchor sleeve of another pl~rtill~id e-l-bodil--~llt of the ~ldble catheter of the present invention.
FM. 12 is a l~les~.ltdliv-e partially cut-away and partially exploded view ofthe modular handle showing a fiber advance means ~l..~n~ and a ~leflecti~n compon~nt FIG. 13A is a l~lt;s~ dlive exploded view of the internal assembly of a d~flecti-~n means --~ol elll of a pl~re~ d embodiment of the steerable catheter of the present invention.
FIG. 13B is a ~e~ sellldliv-e section view ofthe dçflection means of a p,~r~ ..e~l of the steerable catheter of the present invention shown removably coupled to the distal end of a fiber advance component.
FIG. 14Aisarel.. t;se"ldlivt;sectionviewofaproximalendofthesteerablecatheterofthepresent invention.
FIG. 14B is a lti~l~c;llldlive eYplo~cd view of the depth stop means of the steerable catheter of the present invention.
FIG. 15 is a lc~ illldliv-e isometric view of a drug delivery appdld~us coupled to the proxim~l 20end of the modular handle of a steerable catheter of the present invention.
FIG. 16 is a l~l~se"ldliv-e p i~;liv-e view of the steerable catheter of the present invention within the left ventricle.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Preferred Apparatus FIG. 1 is a ~ tivt; i~nm~trir view of the ~t~, Ll~ catheter 100 of the present invention showing a modular handle having a ~n~;.., c~""p~ ~d and a fiber advance co~ o~ A p.cr~
~ of the steerable catheter 100 has a modular handle 102 at its proximal end 104 and a controllably defl~ end portion 106 at its distal end 108. The elo~ d central tol~un~g portion 110 is s~ cwl at flexible and enables tol~uil~g and steering. The ~leflect~ end portion 106 is more flexible than the el~ted central torquing portion 110, allowing the defl~ ble end portion 106 to develop a controlled bend with a smaller radius of ~,iUl VdtUl~.
FIG. 2 is a l~l~s~ ive isometric view of the ~lefl.~ ble end portion 106 of the s~ra~'-catheter 100 in breakaway view and shown without the ~leflection knob 180. FIG. 3 is a cutaway view of detail3showingthedistaltipll8ofapl~rt;ll~idembodimentofthe~lwlab!ecatheterlooandFIG.4is a view of detail 4 showing a shim anchor sleeve 112 keyed to inside of the outer jacket and located ~dj~r~nt the junction 113 between the ~leflect~ble end portion 106 and the ~lon~ed central torquing portion 110 of the steerable catheter 100 of the present invention. The proximal outer jacket portion 126 extends from the distal end of the modular handle 102 to the junction 113 and distal outer jacket portion 127 extends frorn the junction 113 to distal tip 118 ofthe steerable catheter 100.
A center tube 114 extends at least partially through the sk~ ~' catheter, and is att~hed at one end to the distal tip 118 of the s~eerable catheter. The proximal end of the center tube 114 is free and floats within the modular handle, thereby allowing the center tube 114 to slide and move during ~fl~tion of the distal tip 118 of the steerable catheter 100. The center tube 114 defines a hollow, central paSSagt;wa~ 115 through the center tube 114 for insertion of a tool such as an optical fiber for moflaserenergy~orotherfimcti<~n~ldevice.Thetubularmaterialofconstructionofthecenter tube 114, such as, but not limited to, Polyl,lopyl~c or other polymeric material will resist collapse during bending and twisting, and will resist collapse by external forces. At the distal end ofthe center tube 114 the distal tip 118 is contoured andlor polished to minimize any adverse effect, such as trauma caused by motion of the tip through a body lumen, cavity or opening, or by loss of m~leuve.~ility and control thereo~
As best shown in FIGS. 3 and 4, the center tube 114 slidably extends through the shim anchor slwve 112 which is ~tt~rh~d to the innerwall ofthe outer jacket. The shim anchor sleeve 112 is coupled to the distal tip 118 of the ~twl~blc catheter with~ and provides support for, a flat, semi-rigid shim 120 which extends betwwn the distal tip 118 and the shim anchor sleeve 112. The flat shim 120 defines a plane out of which the shim 120 can be ~leflect~ upon the application of lateral force, but back into which the shim 120 will re~rn with spring-like action on release ofthe ~rO, ...;-.~ force. A tang 121 at the distal end ofthe shim 120 serves to anchor the shim 120, such as by sold~ ;..g to the distal tip 118. As will be nl~d later in greater detail, the purpose ofthe shim anchor slwve 112 is to allow frw Il~ ,.llhll of the center tube 114 within the outer jackets 126 and 127, to support and position the center tube 114, as well as to serve as an anchor point for shim 120 and a guide for a pull cable 122.
Proximal outer jacket portion 126 covers the center tube 114 ariiac~nt the ~ n~t~ central tor.luil.g portion 110 and distal outer jacket portion 127 covers the as~ll,bly a~ c~,nt the ~flect~ble end portion 106. Further, it will be un~l~lood that laser delivery means 116, or other fim~.tinn~l device, can be slidably dis~,osed inside center tube 114 such that a distal tip 128 of laser delivery means 116 can be advancedthroughthedistaltip118Ofcentertube114tosurfacesorstructuresforlaserl-t;dlu-~lltthereon.
Optionally, the proximal outer jacket portion 126 can be made of a braided or "laid-up" type of construction. The braidedconstructionwill enhance l~";s~ eto sidewall collapse, f~.ilit~te tc,l~luillg and twisting, and provide ~nh~n~d col~mn~r support during deflection The shim anchor sleeve 112 is proximal the joint 113, and in a p~ d e~ the entire shim anchor sleeve 112 is bonded to the inside wall within the proximal outer jacket portion 126 ~dj,q-r~.nt the junction 113 with the distal outer jacket portion 127. It will be Ull~ luod that the precise length and point of cnnnActinn between the shim anchor sleeve 112 and the outer j. ckets is s -l~qh'~ as desired, but that the design must not interfere with or .JtL~ .;se impair normal operqfl.~n ofthe junction 113.
Pull cable 122 extends from the distal tip 118, where it is fixedly att~~ht-A through pull cable guide 124 or other l~ lf~lg aperture in shim anchor sleeve 112. By positinni~g pull cab1e guide 124 axially opposite shim 120, the pull cable 122 is caused to deflect distal tip 118, thereby bending shim 120.
The pull cable 122 passes through pull cable guide 124 and extends to modular handle 102 where it c. n be controllably pulled . nd released by a ~l~flectinn co~ o~e,lt, as desired, to cause selective .1~ r.J. "".I;nn of the defl~ qble end portion 106 of the steerable catheter 100 of the present invention.
FIG. 6 is a l~ s~ t~tive end view of a plt~ d embodiment of the shim anchor sleeve 112 of the steerable catheter 100 of the present invention. The shim 120 is linked to shim . nchor sleeve 112 at shim q~ttqehment point 136, radially opposite or otherwise ope,~tively spaced relative to pull cable guide 124.
As best shown in FIGS. 3 and 4, a helical coil spring 130 preferably is w,~ped around at least portions ofthe center tube 114. Helical coil spring 130 h. s several fi-n~tinn~, one of which is to provide enhq-n~l vi~ qli7-qtinn By constructing helical coil spring 130 of platinum or other radiopaque mqt~riql, the precise angle of ~efl~tion as well as gec""~llic po~itinnin~ ofthe (~PfleGtqble end portion 106 can be deienninedusing fluoroscol~y. Another fiunction of helical coil spring 130 is to impart ~ul~1iti~n~l sidewall strength to the tubing material of center tube 114, esperiqlly illlpOl ~" in the ~fl~~ble end portion 106 portion of the steerable catheter 100 during t~ JUl~ly steering, twisting, and bending ~l~r.. -~1 ;nn~ to prevent sidewall collapse. Proper slolection ofthe stiffness and number and plqcem~-nt of individual coils Will~A~ the bend r. dius ofthe dpflp~q-hle end portion 106 and its distance from the dwstal tip 118 ofthecentertubell4.Furthermore,byusingsu~ icorshapememorym~eriq-lsofcol~llu~ion~as will be further '~ SfJ;l below, the APflPrtqh!P end portion 106 can be given some pla~;lll~ined ~,w v~lw~.
In an ~IA:~innql prer~ d e~.. hoA ~ the centertube 114, shim 120, proximal and distal outer jacket portions 126 and 127 andlor the helical coil spring 130 are preferably made at least partially of, or otherwise C'J"'I";~:~ a s.l~l~,laslic material which can be given a selected shape. Other suitable m~~eriqlc include plqflnllm spring steel, shqin1P-c.~ steel, shape memory or ~u~ ic/shape memory alloys. Once a ~u~el~ ic material has been shaped, it has a memory for the shape. Upon APro..~
from the plt;r~,ll"ed shape, the material will tend to ;.. -1~ A.~ y return to its pltirc,.-"ed shape with spring-like action. Thus, the AeflP,ctvkle end portion 106 ofthe steerable catheter 100 can be l~."~.~ily ~ ~.",~A or otherwise curved so as to steer and position the AeflP~qble end portion 106 ofthe steerable catheter 100 through the va~Clll~q-hlre and inside the left ventricle or other body opening, and against the heart wall.
In the case of shape memory materials, a "memory" for a pl~rc,--"ed shape can be It;lll~l~IUlti set in the ~AeflP,ctqble end portion 106 of the ~ blc catheter 100. The pe~ Pu~e steerable catheter can be ~ uily and r ~- ~.AeA through the vq-c clllq-hlre. Once the steerable catheter is in position, memory recall of the original pltir~,ll"~ shape can be produced by any of a number of W~FCI~illl ways. These include heating using electrically resistive material, electrically s~ ilive m~~~isl, radio fre~u~ P~ circulatingheatedfluid,etc.Itwillalsobeunderstoodthatthecenter~hube114Ofthesteerable catheter 100 can also act as a type of "hypo" hube, and an additional hube inside the center hube or annularly inside or outside the center hube for delivery of fluids, other tools, etc. can be used. Furthermore, by providing di~lin~live cross section gec""~llies, c~ po~e~ ; can be "keyed" together as desired, to prevent ulldeshcd rotation of one or the other COl~ llcllt, as well as to provide rot~tir~l ql control to the physician.
FIG.5 is a ~ c~c"~i~e isometric view ofthe distal tip 128 and distal end 132 of a laser delivery means 116 ofthe present invention. The distal end 132 ofthe laser delivery means 116 optirn~lly may be S provided with a slight d~-flt~tion or ~,wvdtulc. It will be undc~ od that the slight ~iulvahuc ofthe distal end 132 of laser delivery means l l6 can be made in any of several Ji~clclll ways~ in~lu~l;~ a pf ~
~UIV~UIC formed by heat, ~!' g l~ ot~ construction, etc., or a ~""~,~y ~;u,v~uc formed c~th~, w;se.
npaque marker 134 adj~,Pnt the distal tip 128 of laser delivery means 116 is particularly useful in vic~ 7~ti~n via fluoroscopy or other methr~c Such marker 134 can be made of platinum or other suitable radio-opaque material. Thus, the precise location of the distal tip 128 of laser delivery mean_l16canbedcl~i~...;.~ Itwillbeunderstoodthatvicll~li7~ti--neul~l~ aids,inclu-' gbutnot limited to r~liopa~ue markers, t~nt~ m andlor platinum bands, foils, strips may be placed on the various ~ Jonc~ ofthe present invention, inrl~ ~' g on the defl~t~lc end portion 106, helical coil spring 130, and other parts of the steerable catheter 100, or at any position on laser delivery means 116, such as optical fiber or fiber bundle, or other fimcti~n~l device, will be very helpfiul in vic~ i7~tion of the per.,u~n~.uc ploc~lulc.
It will be understood hereby, with particular regard to FIGS. 7-9B as well as IL~ugl~uL this that various emboflimentc of various aspects of the present invention will be referred to by c~. u . . . ~1- reference numerals, for convenience and to indicate similar general purpose, despite the dec~rihed structural variations and others in~ ded within the scope of the present invention.
FIG. 7 is a ~c~resc~ /e section view of a plc~cllcd embodiment of the distal tip 118 of the steerable catheter 100 ofthe present invention. First att~r,hm~nt point 138 and second a~t~rh..~ d point 140 are o~. ~Li~ ~,ly positil~n~d radially opposite each other on the distal tip 118, serving to couple the shim 120 and pull cable 122 to shim anchor sleeve 112. Proximal end 142 attaches to center tube 114 and forms the distal end of ~l~ofl~ ble end portion 106. As shown, spaced radial barbs 178 serve to anchor the distal tip 118 into the center tube 114 FIG. 8A is a r~l~llt~live section view of a p~Gft;~ bCY~ of a piercing means in a rt;l.~d position in the distal tip 118 ofthe st bl~ catheter 100 ofthe present invention. FIG. 8B is a l~r~se.lL~Live section view of a p~,f~,llcd c .-1~l;."~ of a piercing means in an e~ -~1 position in the distal tip 118 ofthe ~lecl~blc catheter 100 ofthe present invention. FIG. 8C is a l~l.,se.lt~Liv~i end view of a plt;r~ d ~.mbodirnf-.nt of a piercing means in the distal tip 118 ofthe st~rable catheter 100 of the present invention. Pressure plate 200 is retained by threadable end cap 202 threaded onto or otherwise coupled to the distal tip 118 of the ~L~.~ble catheter 100. When a force is applied to plC;:iSUlt; plate 200 in direction 204, and~olillg teeth 206 will be e ~ ed as shown in FIG. 8B. When the force is released, biasing spring 208 will reposition pl ~ssul e plate 200 as shown in FIG.8A and retract al~chol illg teeth 206.
As shown in FIG. 8C, the operative spacing and shape of anchoring teeth 206 can be selected as desired. The piercing tip is especially useful for merh:~n;c~lly piercing the endocardial surface of the left ventricle, when il~luced thereinto percut~neoucly. M.orh~nir~lly piercing the surface of openings, body cavities or othertissue structures will also serve to anchorthe defl~ble end portion 106 ofthe b~e catheterlooinagivenpositionforlaserorotherlltiallll~lltthereon~effectedviathesteerablecatheter such as through the center tube 114.
FIG. 9A is a ~ s~lltalive section view of another l)f efel led embodiment of a piercing means in a lc~acl~d position in the distal tip 118 of the steerable catheter of the present invention. FIG. 9B is a c~Jl.,s~ tiv~ section view of another pler~ d ~I"bodi ll~,.d of a piercing means in an e~ d position in the distal tip 118 of the steerable catheter of the present invention. As in FIGS. 8A-8C, helical coil biasing spring 208 and pl~UlCi plate 200 are retained ~ dj ~ ~t distal tip 118 ofthe ste~,~!e catheter 100 by end cap 202. As plti~i~iUlti plate 200 is moved in direction 204, as by internal pl~;~ul~; or foroe created by fluid, rods or other biasing means, piercing tube 214 will be ~ U1~ as shown in FIG.
9B. When the ~ ul~ or foroe is l~ uv~d, biasing spring 208 will return piercing tube 214 to within the S distal end ofthe piercing means assembly. Ad~ means designs, including multiple individual solid or hollow needles, flat blades, curvedblades, etc. will be in~ Aed withinthe scope ofthe present invention. Therefore, it is ~ od that piercing tips may be a~tivate~ by applying plC~Ul~ to plt;~i:iUlt~ plate, using flushing fluids as an e~u~lc, through center tube 114, or the piercing means may be ~tt~chcd tû a tube which extends t~ the handle for contrûl at the proximal end. In such emboAirnent the plessule plate may be omitted, and the spring is useful but opti~nz~l FM. 10 is a ~ taliveis~jlllt;llic view ûfthe dçflect~hle end portion 106 and shim anchor sleeve 112 of a plcr~ lubo lilll~ of the steerable catheter 100 of the present invention. FIG. 11 is another l~lltalive ic~ mf~tric view ofthe d~fl~ble end portion 106 and shim anchor sleeve 112 of anotherple~llcdembodimentofthesteerablecatheterlOOofthepresentillvt;llti~ .Aswillbe..~ lood by the dlawhlgs and description herein, the curvature in the ~l~flect~ble end portion 106 of the oenter tube 114 can be positi~nçd as desired at any pûint. The helical coil spring 130 canbe ~ u~d with varying degrees of flexibility, and with any number ûf coils, such that the CUIValUI~ can be moved closer to the distal tip 118 of the center tube 114 or closer tû the shim anchor sleeve 112, as desired as shown, respectively, in FIGS. 10 and 11. As will be understood, hlw~illg the tension in pull cable 122 by retraction thereof will cause dçflection of the distal tip 118 and the deflect~le end portion 106 in a direction çc~Pnt~ y out of, and into and toward a position pel~ r to, the plane of the shim 120.
C-...fl~ ed retraction of the pull cable 122 will cause c~ ntimlçd d~flection of the distal tip 118 of the steerable catheter, with useful ranges of d~flecti~ n between about 0 and about 180 degrees (U shape) to about 270 degrees (pig-tail shape), or more or less d~ upon construction. ~dAitinn~lly, by allowing thecentertubell4toremainfreeatitsproximalend,.. ~x;.. ~lPflP~.tinnispossiblewithoutundostrain on the center tube 114 which can slide forward within the handle.
~AA;t;~n ~IIY, as AFYj- ;1~d above, by utilizing materials with varying dul~J~ and by varying S the number and density of coils and by varying the stiffness ofthe helical coil spring used, the center tube 114 can be ~s;gl~Fd to bend at a pl~d~,l,~ined or selected point within the dPflP~a~le end portion 106.
Suchpointcanbei~ e~yadjacentthedistaltipll8,betweenthedistaltipll8andtheshimanchor sleeve 112, and or a~j~cPnt the shim anchor sleeve 112 itsel~
FIG. 12 is a ,eplest;"lalive partially cut-away and partially exploded view ofthe modularhandle 102 showing a fiber advance means C~J~q)~ and a dPflPctinn colnl)ol,cllt. FIG. 13A is a ~ st;,d~ive eYplo~lP~l view of the internal assembly of the APflection co npone ~l and FIG. 13B is a ~ ~,e It~live section view ofthe deflP,ctic n component coupled to a fiber advance handle ofthe steerable catheter 100 of the present invention shown removably coupled to the distal end of a fiber advance l~F~ FIG.
14A is a ~e~.,ell~ive section view of a proximal end of the steerable catheter 100 of the present invention. FIG. 14B is a r~ iv~ exploded view of the depth stop means of the fiber advance ,", of the steerable catheter 100 of the present invention. It will be understood that structural cl~".~"l~; with like ~ere~ ce n-lmer~l~, as Apsrrih-pd herein with ,~r~ "~e to the d,~ s, are idPnti~
or similar to each other.
Referring now to FIGS. 12-13B, proximal outer jacket portion 126 t ~ ~ at its proximal end and is coupled to a distal, inside stepped portion 165 of catheter base 162 by set~c,~w 167, or by other means in~luAin~ adhesive, etc. An optional strain relief 164 is fastened to either or both the proximal catheter jacket 126 or to the distal, stepped portion 165 and/or the catheter base 162, or is ~lL~Iw;se coupled thereabouts, such as by setscrew 167, and serves to minimi7P, the effect of ~lçflP~tinn or other I~"n~lli~ of the elo~g?ted central tc~r~uillg portion 110 and ~flP~tqb!c end portion 106 on the modular handle 102 and ~fl~o.ction ,..~ ". A ~cl~inll~ collar 166 is provided aroundthe strain relief 164 and distal, stepped portion 165. A hollow, tubular defl~tion housing tube 150 houses the catheter base 162 and has a first one or more external helical ~lcd portion 152 loca~ed at the distal end ofthe d~fl~i- n S housing tube 150. Defl~c-ti-n knob 156 with cc--c;,~l-d~g helical threads located on an inner, annular surface is threadably coupled to threaded portion 152 at the distal end of ~1efl~ctinn member 150. Thus, ~flecti~-n knob 156 is able to rotate on Illr~ded portion 152 above catheter base 162, retained in place by Ic~i~fillg collar 166, thus ~A;'~ ;'';''g the axial position of the catheter base 162 relative to the d~o.fl~ n knob 156.
Pullcable122extendsfromthedistaltip118Ofthe~1w~_~'~cathcterpastcatheterbase162and through d~flection housing tube 150, and t~ ...;,.~les at pull cable stop 168, with pull cable stop 168 fixed into position relative to cl~flection housing tube 150 by SCI~CI~W 169. It will be understood that slot 171 in pull cable stop 168 will permit att~hm~ nt of setscrew 169 in several loc~ti- n~ thereby enabling adj~ nt ofthe tension of pull cable 122 to effect the overall s~ ivlly ofthe fl~flecti~n ass."llbly. As best shown in FIG. 13A, pull cable 122 may pass through pull cable stop 168 through aperture 192 to be retained thereby, or will le~ at pull cable stop 168 by bond other means . Furthermore, center tube 114 will pass through pull cable stop 168 through aperture 194., as shown, or pull cable stop 168 can be pos~ n~ to one side ofthe proximal end of ~leflecti~n housing 150 (not shown) for lateral cle~O~ of center tube 114 thclclllrough. As ~lefl~ n knob 156 is rotated in one direction towards the distal end of dPflP~tion housing tube lS0, the distance betwecn the axial position of the defl~ction knob 156 and the proximal end of the ~flection housing tube 150 will be incl ~sed, resulting in ~.I~,r~ased tension in the pull cable 122, dPflection of the flat shim 120 out of its own plane, and advance of the proximal outer jacket portion 126 relative to the pull cable 122. As the ~leflection knob 156 is rotated in the opposite direction, the distance between the axial position ofthe ~fle~tinn knob 156 and the d~fl~~tisn housing tube 150 is decr~d, thereby resulting in a ~~ .ol~ g deel~sc in tension of the pull cable 122 and a return to an un~lefl~t~d position. The ~leflto,ctinn module may be used alone for applir~tions ~u~uilu~g only ~n~ ofthe distal tip 118.
S For appli~tion~ such as TMR, fiber advance means module is rernovably coupled to the defle~tinn module as shown in a pl~ir,.ltid embodim~t, by second one or more helical threads 181. It will be ~ od that the fiber advance . ~ . . can be coupled to the steerable catheter 100 0fthe present invention utilizing other collpling means, including varying pitch threaded systems, bayonet mount systems, adhesives, etc.
Referring nowto FIGS. 1, 12, 13B and 14B, a "Tuohy-Borst" type con,~ ion adapter 170 for releasably coupling to a fiber optic bundle or other laser delivery means 116 (see FIG. 1) is located at the proximal end of the steerable catheter 100. Collll,l t;~sion nut 173 tightens around laser delivery means 116 and retains it fixed therein. A depth-stop control nut 180, or other manually or otherwise controllable depth stop means, is provided distal to the adapter 170. F.YI, -, 0l~ 182 extends proximally to t ~ ~l at luer fitting 185 and extends dis~ally to advance slider 184 with fluid seal 188. Center tube 114, coupled to distal tip 118 and ~ proximally, floats freely through catheter base 162, deflectinn housing tube 150 and through fluid seal 188, and It;~ es within ~ l- 182.
Referring now to FIG. 12, depth stop control nut 180 can be po~itisn~ as desired on ~
182 so as to limit ~n~ of laser delivery means 116. Thus, as control nut 180 is moved along e ~ :on 182, ~e ~ x;.. distance A can be traveled in precise il,clel"~ , optinn~lly by use of a calibrated depth scale 187 threaded over eYten~ n 182 and/or ~ g from nut 180. In the pl~
embodiment used for TMR, such travel could be limited to between about O and about 3 c~ , or more or less. Advance housing 172 has a slot 174 on one side for retaining thumb advance button 175 eoupled to advanee slider 184. Forward tr~n~ n of thumb advanee button 175,11 c~cro-c, results in unison forward t~nQ~ )n of adapter 170, depth eontrol nut 180, eytf n~ion 182, advanee slider 184 and fluid seal 188 along with laser delivery means 116 (not sho~-vn), as pc~... 'l~ through distanee A.
C~-4,-~;on spring 176 or other biasing means .~ advanee button 175 biased b~.w~, in a proximally ~ctl~k;d position. As will be ul~c-~od, ;.. "~ ,ly p~c~iing operational a~lv _ . ~ent and/or operational ret~ti~ n, as in retro-lasing whieh will be more fully c~p~ -fd in the following, of a laser delivery means 116, the spring 176-biased advanee slider 184 will retraet the distal end 128 ofthe laser delivery means 116 sueh as an optieal fiber or fiber bundle baek inside the ~lf flfxt~hle end portion 106 so as to prevent injury to the patient during derr"~ n of the ~Ifflf~Able end portion 106 for p~ c~iv-eoperativepl~mfntofdistaltip 118.
A saline flush, drug solnti~n~ vi~u~li7~ti~n or other th~ culie agent ~..'~ fluid ean be provided to the steerable eatheter via one branehed arm 190 of adapter 170. Saline sohltion7 drug or sueh other fluid will fill adapter 170. Proximal fluid seal such as co~ .lc~ion nut 173, or other sealing means, will create a seal around optieal fiber or other laser delivery means 116. Such sealing means include o-rings, as shown, rubberdiaphragrns, otherelasticmember, etc. Salineorotherfluidwillbeplevc .lcdfrom f ~ r;~ past adapter 170 around laser delivery means 116. Fur~hermore, by ~'A;~ the plCS:iU-~i of said flush or other fluids soll~cv~lldt above that developed in the left ventricle, in the ease of TMR, sueh will flow around laser delivery means 116, and through the pas~cwa~ 115 through eenter tube 114, thus p-cvc~ling back flow of blood from the left ventricle into the steerable eatheter. ,A~111iti~n~11y, fluid seal 188,asdeseribedintherulcg~",.g,preventsfluidfloworbaekflusharoundtheproximalend117Ofeenter tube 114. In a p-crc-lcd clnl)o~ .t, it will be ul~del~luod that any backflow preventer, cheek valve, blood seal, etc. with the neeessary operative funetion and suitability ean be employed els~,~.hclc on the steerable eatheter 100 and will be inchldfd within the seope ofthe present invention. Saline solution or other fluid can also be used to activate ~ of the piercing means 206 and 214, as shown in FIGS.
8A-9B.
It will be ul~del~od, and ~ -crol~ inr,l~lded within the scope ofthis invention, that the manually v~l~L~d fiber optic or other laser delivery means advance ...~ ... can be replaced with a wide range of diIrcil~llt m~h~nieme or devices, inf.~ i~ indexed or l~L~d .. ~Yl~n~ , electric drives with ~ l~llvlfic controllers, etc., ~vl~ J;d advance and retract controllers, etc.
FIG. 15 is a l~le~ ive i~m-,tric view of a drug delivery ~p~lus 196 coupled to the proximal end 104 of steerable catheter 100 of the present invention. As shown, other tools may be ~tt~hed to the modular handle 102 of the steerable catheter 100 of the present invention for operation through the center tube 114 in addition to the drug delivery or f~ g al)pcu~tus 196. It will be ul~el~lood, therefore, that such drug delivery or ~ al)l)al~tus 196 can be m~n--~lly or a~t-m~t~ lly activated, can be adjustable or piogl~lul-able to ~~ e individual aliquots of a preA~ d volume, at a pre~ ed or sperified rate, as desired.
Fr~f~red Method FIG. 16 is a le~ sell~ive p~ ;ve view ofthe steerable catheter 100 Ofthe present invention within the left ventricle 230. As inflir~t~ above with regard to FIGS. 1-15, the present invention is directed to "stand alone systems", in other words, to catheter systems which are guided into and through parts ofthe body, such as into the left venhicle, optif)n~lly withoutthe use of a guide catheter 232 or other guide system. Such guide catheters are well known and may be used with the present invention, and therefore are inch~ded within the scope of this invention. Typically, entry into the v~e~ hlre is made through the femoral artery. If used, the physician steers an optional guide wire (not shown) into the left ventricle 230, and slides the guide catheter 232 over the guide wire, over the aortic arch 234 and across the aortic valve 236.
IIvwt;vel, as a "stand alone system", the 1~ ;o~ guide wire or guide catheter 232 need not be used. The distal tip 118 and drfl~-q-hle end portion 106 ofthe ~l b',e catheter 100 is e~ 1~ overthe S aortic arch 234 and p,~Jl~sed through the aortic valve 236 into the left vt;~ icle 230. The st~r~hle catheter lQ0 can be guided into a selected position 3~ q,r~nt a selected surface 238, in this case a portion of .,ndoc~ liulll. Thus, by s~ H~ y deflecti~ the ~1~fl~ e end portion lo6 of the ~ rq-~s catheter 100 and/or by rotating the steerable catheter 100, e ~ the distal end 128 of a laser delivery means 116 or other fimcti-nql device therethrough, delivering laser energy or ~ru~ ng other therapy, vicu-q-li7-q-ti--n or ~ q-~ostic, and retracting the distal end 128 of the laser delivery means 116 or other fim~.tionql device back into the ~flectqble end portion 106, the steerable catheter 100 can treat a series of individual, selected ~ llcllt points 240 of endoc~-iiulll. Such ~ points 240 would typically be TMR ~hqnn~l~ or stim~llqti~n sites. Another feature ofthe present invention is the ability to ac~iul~ly position and stabili_e the distal tip 118 of steerable catheter 100 in the apex 242 ofthe left ~e~dli~le 230 for treating therein.
AI~Il~Lively, retro-lasing can be pi~ r~,....~ This novel method includes the steps of adval Cillg thedistaltip 128Oflaserdeliverymeans 116aselecteddistanceintothen,yocdldiull,andthendelivelillg laser energy to create a TMR channel or other ~ llt;ld site while simllltq-n~4ucly retracting the fiber, laser delivery means 116 or other fimc~i~Lql device. With this pl~dUl~, with regard to TMR e~ qlly7 ;.. ~c.. ~ as laser energy is only deli~ e.c;d during retraction ofthe fiber, the possibility of a lval~cil~g the fiber too far and lasing through an epi~ dial surface is ~ . .1 ~ and the risks of cQnlplit~-qtionc arising from such epicardial pelrul~lions, includi~ but not lirnitedto cardiac tamponade (a buildup of plCS:iUl~i in the pericardial sac caused by the plesence of n excess of fluid such as blood), prolirel~iol~ of ci~nc between the ~ ic diu,,, and the p~,.i~u lial sac (thereby plCVClltil~g normal, r, ~-cl cl~u-c of the heart muscle within the pc~ dial sac), etc. are minimized.
Furthermore, adjunct use of aypl~ iate drug delivery al)pa.~tus, blood seal means, depth stop appau~us such as clamps, b,.~ , etc., vicu~li7~tirln means, marker means as well as other ha,.lw~c and methf '~1~ ,y will be considered within the scope of the present invention. ~A~1ition~11y, use of el~llopL~: s~ (EP) rcadings from the distal tip 118 for ~ ...r.. . :~ tissue contact will be particularly useful.
The present invention is inten~ for use with any medical laser. In particular, the Holmium or excimer laser is particularly suited to the present invention. However, any suitable laser source, pulsed or otherwise, could provide laser energy to the laser delivery means ofthe present invention for p ,- 1~.. : ~ ~
the method ofthe present invention. Likewise, the steerable catheter and surgical e~ ;p~r~1, including laser delivery means, referred to in the present ~loc~.u~ as well a~s that known and used in m~iritl~ and other disciplines today and in the future, will be inr~h~c1~ in the scope of this tlisrlosl~re. Such laser delivery means include, but are not limited to, individual optical fibers as well as bundles of fibers with and without piercing tips and with or without firing tips or fiber ends having shaped or contoured end faces for selectively diverging the laser beam or other laser energy livcl~lg means, rods, mirrors configurations and other laser delivery means with and without ~us-ng len~s and the like. It will also be undc~od that the steerable catheter and method of the present invention as described herein inelllc1i~
the novel cc"nbil~Lion or use with of any conventional ",~l~n;~.," or method which are known to those skilled in the art, are in~h~ded within the scope of this i~VC~tiOll. Furthermore, with regard to non-laser TMR, a cannula or trocar assembly may be eYt~lll?d into the tissue ofthe le~ ventricle, with or without use of a, ~ ' ~-1 piercing tool.
It will further be ull~cl~lood that while the present invention has been described for pclrulllung TMR on endocardial surfaces in the left ventricle, the ap~ us and methods ~lescrihed herein are equally ir~ended for use in any suitable pr~u.e, inr~ ~ but not limited to pl(M~IUlC~ where any device need be ~ Pd through a guide catheter to an opening or other point within the body for o~her medical p ~u-cs inr~ ing laser lr~llllCIIl, viC~ 7~til~n~ biopsy, etc. ''stim~ tion~ for ~ , is pc by using laser energy to create zones or pockets, optil~n~lly i-llc~ d at least initially by small S cl"- ~Ic ablated through the tissue, for the introduction of blood bom growth and healing factors and stim~ te~ capilla~y growth ~ul~undi~g the lased zones or pockets to create an ~,-c-eased supply of oxygen to the tissue and thus a revit~li7~tion of the heart muscle Methods and apparatus for causing stim~ ti~n are more fully des~;-ibed in co-pending U S Patent Application Serial No 08/664,956 filed June 13, 1996 While the principles ofthe invention have been made clear in illu~ ive embo~ Pntc~ there will be ;..~ ell~tely obvious to those skilled in the art many morlific~ti- ns of structure, a--~
proportions, the elpm-pntc~ materials, and components used inthe practice ofthe invention, and otherwise, which are particularly adapted to specific envi.ol-lllcllls and opcl~live IC4UilClllClltS without d~li lg from those principles The appended claims are intended to cover and embrace any and all such m~ifir~tionc with the limits only of the true spirit and scope of the invention
FIELD OF THE INVLNTION
The present invention relates generally to c~th~ens and ~I,~,t~,. p, u~lw ~ involving laser energy delivery using fiber optic and other laser delivery systems. More particularly, the invention relates to a steerable catheter and method of use, particularly adapted for laser-assisted lla Ls",yo~niial revascul~i~ion (TMR). The distal tip of a central, hollow flexible center tube for guiding a laser delivery means or other filnrtil~n~l device eYt~m1~ble therethrough is ~efl~ ble utilizing a semi rigid shim, the shim acted upon by a pull cable for controllably d~flr~ting the distal tip ofthe ~ le catheter in at least one given plane.
The steerable catheter can be used in conju"ilion with a fiber or other laser delivery means advance .--f- h~ .., optionally using a depth control .~e~h~ as well.
BACKGROUND OF THE INVEN~ION
In the ll~l "~i"t of heart disease, one method of illl~ Villg ~--yo~dial blood supply is called 1, u,~,.yocardial revascularizaffon (TMR), the creation of ~ .. .el~ in the myocardium ofthe heart. The pr~lult; using needles in a form of surgical "l"yoca~ . . . e" has been used clinically since the 1960s. Dec~e1,bal~m L.I., Cardiovascular Applications of Laser Te-' -'cgy, Lasers in Surgery and Medicine 15 :315-341 (1994). The ~ihni1ue relieves i~-~h~mi~ by allowing bloodto pass fromthe ventricle throughthech~nnelseitherdirectlyintoothervesselsco.. "i-;c~ gwiththecl~ll-l-fl~orintomyocardial sinn~o ~ which connect to the myocardial l-~icr~ci~ ti~n In the reptilian hcart, p~ n occurs via c~ ti~ c~ f l ~ bctween the left ~ tl icle and the co,~ ~y arteries. Frazier, O.H., Myocal lial Rev~ccul~ri7~tion with Laser - Plt;lillllllaly Findings, Circulat~on, 1995; 92 [suppl IIl :II-58-II-65. There is evidence of these c ~ ~tj~ C.~ .lf lS in the dcvelo~--.g human embryo. In the human heart, Illyoc~u~dial m ~ nmy involves the p-esellce of IllyfK~ Q;n~leo:~ These ~inlleo:1~l communications vary in size and structure, but It~ t a network of direct arterial-luminal, arterial-arterial, arterial-venous, and venous-luminal cl~nn~~ti~ns This vascular mesh forms an il-~ source of Illy(Jwdial blood supply in reptiles but its role in humans is poorly u~ lood.
Nul~c.~us surgical TMR studies have been pe~ 'f~, in.~lntling early studies using needles to perform ~yo~ lial ac~ or boring7 to mprh~ni~ ly displace andlor remove tissue Such studies have involved surgically ~ osing the heart and sc~ lly i,~sc;l~ g needles to form a number of .~h~nn~~le through the epicardium, Illy~wdiul~l, and endoc~uJiul-- to allow blood from the vtilltli~,lc to perfuse the ~ nl- ~f l c. The early studies using needles showed that the newly created ~,l~ -f l i were subject to acute l~l-ul~lbo~,is followed by org~ni7~tion and fibrosis of clots resulting in channel closure. Interest in TMR using needles waned with the knowledge that such .~,h~nn~le did not remain open. II(~wtivt;l, interest in TMR pl ~lul ~s has recurred with the advent of medical lasers used to create TMR cl ~z ~ "cl s .
Hietologi.~, l evidence of patent, ~~.n-lf~t~h~ m-lined tracts within laser-created cl~ flc shows t-h-at the lumenoflaserchannelscanbecomehf~n~~4.. l.dl;hl~andresistsoc.~ll-~;rln At-hinzoneofcl~hlillgoccurs on the pe, il,he, y of the laser-created .~h~nnel e through the well-known thermal effects of optical radiation on cardiovascular tissue. ~ditif)n~lly~ recent hi~oe .~~l evidence shows probable new vessel form-ti~f n aAj~--~ent collagen o~~hlded ~ llly~dial ch~ flc~ thereby sn~Geting benefits from TMR with or without the form~til~n of ~ n~lele which remain patent.
Surgical TMR p- ~lul ~s using laser energy have been described in the prior art. U. S . Patent No.
4,6~8,817 issued Apr. 21, 1987 to Hardy teaches a method and al~ps~ t,-C for surgical TMR using a CO2 laser cn~ d to an arti.~,nl,t~fd arm having a I~J~,ir~A5 ,tt~-~hf-d thereto. The h~-nflri~~~ emits laser energy from a single aperture and is moved around the surface ofthe heart to create the desired number of c,~ f.le, u~s~ Patent No. 5,380,316 issued Jan. 10, 1995 to Aita et al. ~,u-~ to teach the use of a flexible lasing ~pp~us which is inserted into the open chest cavity in a surgical p-u~huti. A lens at the distal end of the flexible a~,l,al~us is used to focus laser energy, and the aypal~lus is moved about the surface of the heart to create the desired number of c~ c.
The roregoillg ~liccll c~ir n relates to surgical ~,locc~iules, i.e. p-oce lu-~ which access the heart surgically, either via open heart surgery, or perhaps by ~ ~ -lly invasive surgical (MIS) methods if the design and size of the distal ends ofthe hand pieees are suitable for use in an MIS site. II~Jwt;v~, since TMR most often involves creating ch~ -f l c through the endoca~diul.. into the lower left ~l~..bel of the heart, it is desirable to create TMR ch~ rlc in a per~u~ -~..c procedure, i.e. by t;.~ .g a catheter appali~us through the v~ccul~lre into the ventricle and creating the ch~nl-flc through endocardial surfaces and into ~--yocal~ ' Pt;- rc,.. ~.g such pe-~ f-Ou~; TMR is desirable for a number of reasons.
F.,lc~ ~uc catheter p-~lu-~;s are typically less tl~llalic to the patient c~lllpalt;d to surgical proce(lu.~s. ~tlhecionc between the pericardial sac and epicardium are el;~ ,l~ Fel~ u~ TMR
with a catheter à~)pal ~lus also offers an alternative solution to persons who are not c~nA~ tes for surgical ploc~lul~is.
Because TMR procedures generally involve creating a plurality of ~ nl~lc within the Illyoc~diwll, p~lro~..fi.lg the pr~lul~ per~ -f-ou~ly- rc~uires the ability to steer a cathcter appal~lus through the v~cc~ h-re and l~ cuv~;r the app~tus within the ventricle of the beating heart as rapidly as possible to create the ch~nn~lc without ~cting the heart to the undue stress of a lengthy pl(~lUI~:.
~d~ -n~lly, the ability to control and stabilize the catheter app~ ~lus against the beating heart wall while creating ch~nn~lc with a laser is desirable for pe~;u~neu~s pl~iUltiS to ensure creation of channels as desired and to ensure that the laser is fircd only within the Illyu~u lial tissue. TMR C~ lC should be spaced and grouped applup-i~tely to achieve the desired res-wt without ~ r~ or lUl)tUlillg the heart muscle.
The early l~yc~ pluG~]ultiS were not p~ ru~ d peL~ r~ ~.ly. The Hardy CO2 laser delivery system de~scribed above is rigid, l~ ,ly large, and not adaptable for pel.. ' v~us use. The Aita '316 patent does not suggest a method for pc.~ f~uc use ofthe laser delivery deviee ~nbed therein for surgical use.
U.S. Patent No. 5, 389,096 issued Feb. 14, 1995 to Aita et al. lJUllJUll:i to teach one method of uus TMR using an e1ong~ted flexible lasing appaldlus with control lines and a focusing lens i,LI u~ at the distal tip. However, the method uses plCi:i:iUlti applied manually to attempt to stabilize the a~)pal~us against the wall of the heart, and no central, hollow passageway is ~sc~ ;1~ No handle :~tl U~lUlt;, modular or OllICI wise, is l1P~nbe~ nor are dçflecti~ n dPflP~ion cc,- ~ .1~e. .1 ~; or a floating center tube.
Several prior art patents describe the use of catheters within the ventricle for pel-iu~
tl~l",~ t of ventricular tacl-y~ lia. Such devices have a means to locate an a .hyl~ a site and ablate the site, at or just below the ventricle surface, using an electrode device or laser energy. U.S. Patent No.
5,104,393 issued Apr. 14, 1992 to Isner teaches a catheter app~tus having a guiding Y-shaped sheath and guide catheter assembly for introducing an optical fiber into the Vt;lltl i~lc. Positioni~ is dP~ ;bP~ to enable a single burst of laser energy from a single aperture to ablate the site. However, positioning or specific steering means snffi~ nt to create one or more TMR .1.~ is not 1Ps~ ~ ;~d or s,Jgg~l~
U.S. Patent Nos. 5,255,679 issued Oct. 26, 1993 and 5,465,717 issued Nov. 14, 1995 to, l~e.,liv~ly, Imran and Imran et al., disclose non-laser, basket-shaped catheter a~Jp~lus for l"appi,g and/or ablation of a-,l.ylh",-a sites -within the ventricle. A pull cable is used to expand the basket portiûn within the ventricle, and a plurality of electrodes on the arms of the basket are used for ablation. The basket device is desi~led to place the electrodes on the ventricle wall. Although the device allows for a fairly e~ llSiv~ ",apping procedure without repQsitioni~ no positir)ni~ means is provided for a laser delivery system to allow creation of TMR .',1~.",~1~
U.S. Patent No. 5,114,402 issued May 19, 1992 to McCoy teaches a ~ lGu~,. ble distal al)pal~lus with a lG~ rGl~lu-e ~tiv~d material of co~llu~ilioll which, upon heating to a p~GdG1tllllined po~itinn~ will assume a plG~Il.lined, ~ d shape, and which upon cooling, will assume a di~r~ t shape by action of a spring eleme;nt urging the appan~tus into the di~e~ t shape.
S U.S. Patent No. 5,190,050 issued Mar. 2, 1993 to Nil~ teaches a ~1~ b'c catheter with a handle and a tube, the dist. l tip of which may be selectively curved by controllably moving one of three flat, sandwiched shims relative to the others by mq-niplllqtic~n of a handle portion. However, ~fl~o~tif n control requires the use of multiple shims, and no ,~ ", for hlt~l~lGd or otherwise fiber advance meaos is taught.
U.S. Patent No. 5,358,479 issued Oct. 25, 1994 to Wilson, hereby h~col~l~l~d herein in its entirety by IGrGl~ ce, teaches another ~leG-~blc catheter with a handle and a center tube, the a~paldtus having a single ~lon~qt~A~ b~ 1 ;qlly flat shim spring ....~ ~1 within the tip of the catheter tube, the shim having at least one tl~u~vGI~e or lateral twist which causes the tip of the catheter tube to assume a desired curvature. I IOWGVG1, Wilson does not teach the use of a hollow catheter for delivery of laser energy or any other fim~ti- n~q,l device, nor does it c~ .plnlt; the use of a floating center tube.
Theuseof~ul,G~ icand/orshapememorymqtPliql~iswidelyknown. StructureandPropertiesof Ti-NI Alloys: Nitinol Devices & Co~ ollGIlt~ Duerig et al., In Press, Titanium Handbook, ASM
(1994) In general, binary col~ tions of Nickel (Ni) and Titanium (Ti), yield alloys with shape memory and supG-~ lic properties. These alloys are c~.. -.~ly referred to as Ni-Ti, nitinol, and other industry names. Their precise physical and other PIO~)GI lies of interest are ~ ,,llely s~,.~ilivG to the precise NilTi ratio used. Generally, alloys with 49.0 to 50.7 atomic % of Ti are c<~llllllGI-,;ally available, with ~lic alloys in the range of 49.0 to 49.4%, and shape memory alloys in the range of 49.7 to 50.7%.
Due to a rapid declGase in the ductility of the material, binary alloys with less than 49.4 at.% Ti are generally unstable. In general, these types of m~tf~n~ls exhibit hysteresis, defined as a ph~
exhibited by a system whose statc depends on its previous history, and illu~llalcd dia~,~ lly by the familiar upper and lower curves which meet at the ends and define an area under the curves. In the case of solid m~teri~lc ul~cl~,oh~g elastic Ly~clc~is (as opposed to ma~Ptic or P,lectric~l Ly~lclc~;s), the curves are related to stress n~ssaly to cause dcrull~iol~ or otherwise overcome existing stress in pre-stressed materials.
Plupcllies of these mAteri~lc change cigllifil~ntly as their respective "phase ~ rv..-~;O., Iclll~ldui~" are approached. In general, at lower t~ el~ul~,s, these alloys will exist in a ~ ~t~ ile state c~ ;7J~d as hard and easily d~rv- ,..~ IIvwcvcl, in austenite, the high l~ clature phase, the alloys have a much higher yield and flow stresses. The addition of small ~..o~ ofthird elemPntc in the alloy can also have very cignific~nt effects on pel rv~ "~Ance of the m~ten~lc. Flementc inc ludi~ but not limitedto oxygen (O), nitrogen (N), iron (Fe), a~ (Al), cl~ ~uuu~ (Cr), cobalt (Co) ~ - ' (V), ~irCOniUIII (Zr) and copper (Cu), though having various effects on the Ni-Ti matrix, can have the l~ cll~iy to increase strength, increase 5tiffnPcc, control L~lclc~;s and/or decrease or increase phase trancition ICIII~CIalUI~.
Ni-Ti products are c~mmonly used in the form of cold drawn wire or as barstock. Tubing is also available. The toxicity ofthe alloy or the solubility or other comrAtibility with the biclogic~l envi,vlll"c,l~
in which catheter e~ ~ ;r.. . -~. .1 is used is an illl~JOI ~11 consideration. The alloys are c~ ~ Iy used in a cold worked and partially AnnP~IP,d u n~liti- n The partial anneal does not recrystallize the material but does bring about the onset of recovery processes. The extent of the post-cold worked recovery depends upon many aspects ofthe appli~til~n such as the desired stiffnPcc, fatigue life, ductility, lecovcly stress, etc.
Ni-Tiisdifficulttojoinsincemostmatingm~tPnAlccannottoleratethelargestrains~ lbyNi-Ti.
Most c~ nnp~cl;ons will rely on crimped bonds. Although Ni-Ti can be brazed or welded to itself with relative ease, such as by Ic~ ce and with TIG mPth-Y1c, brazing or welding to other materials is difficult though proprietary methods do exist and are pr~tir~d in large volumes, for ~ , I in the pr~l~ction of ~_~lass frames.
For the l,ul~,oses of this ~I;sclo~ c, a rlietincti~n bet~-veen superelashc m~tciqle and shape memory m~tcri~le is made. Superelashcity refers to the highly exaggerated elasticity, or s~ ~a~
S obsc- vcd in many Ni-Ti alloys ~cr5,. ~.. ~ at a specific t~ )clalulc. The function of the material in many of such cases is to store ~ ' I energy. Though limited to a rather small Ic~ c range, these alloys can deliver over 15 times the elastic motion of a spring steel, i.e., withstand a force up to 15 times greater without pe~ ",~ rv~ n Shape memory m~tciq-lc will refer to those mq-t~ri,q-le which can be ~lcru. ,"eA but which will freely recover their original shapes during heating, often utilizing çlectnc-q-l resistivity, or which will develop a large recovery stress when recovery is p-cvc ~Icd. With regard to the present invention, it wvill be ul~dc-~od that the transition tclll~Jclalulc of mq-t~riqle must, in general, be SOllk~Ldl above body tclllpclalulc.
U.S. Patent No. 3,890,977 issued June 24, 1975 to Wilson teaches kinetic memory ele~1lodes~
catheters and c-q-nmllq-e. These devices incorporate a ~ -1, such as a Ni-Ti alloy, having heat-acli~,al~l me~h~;c~l memory properties. The device is formed into an opclalive shape at a high tClnlJCl~lUlC. Then, at a low ~ --I)c-~lu-c below its tr-q-nc ition~l Icllll)cla~ulc, it is ~cro--llcd into a shape for ease of insertion into a guide catheter or the like or othen-vise through a portion of a patient's vq-ecul~t lre or other body lumen. When located in the organ or other desired region, those portions ofthe device constructed using such shape memory mqt~ri~ls are heated to above their trq-n~itionq-l ICIll~JClalulcs, using electrically resistive e~ nts~ thereby Iclwllillg the catheter to its original ~q,nne~q,led ~ .,, ;n~ or proper locating shape. An illl~X~I ~It drawback of the Wilson app~lus is that heat must be applied to the catheter tip.
Complicated construction and t~lectric-q-l power ~ l~ ;b~ n must be considered.
As can be seen from a des~ription ofthe prior art above, pe~ v~c TMR steerable r ~.th~ere are virtually unknown with the eY~eption ofthe catheter briefly desc ;bed in the '096 Aita patent. There is a need in the art for a pe.~,v~ ~ouc TMR ~ e catheter which has means for easily st~r n~, positio~;ng and repositi--ni~ the steerable catheter on the ventricle wall, and having a port for a laser delivery means to enable rapid creation of one or more d~ ia~ly grouped and spaced TMR c ADVANTAGES AND SUMMARY OF THE INVEN~ON
Thus, it is an advantage of the present invention to provide a steerable catheter and method of use for pel.,~ c and other intra-vascular p~lu-~, ;"rlu~l ~g TMR, or any stim~ tinn plu~lu-t;, which ov~-w .~s the limit~ti-)n.c ofthe prior art.
It is a further advantage ofthe present invention to provide a steerable catheter capable of being guided into a heart chamber and used therein for creating a plurality of TMR c~ f l~ wntrollably and .ffi~ ntly.
It is a further advantage of the present invention to provide an clo~ A steerable catheter for pl~-~Pn~nt within a heart cl~llbel, organ aperture or other body opening, the steerable catheter having at least one center tube with hollow pass~;way ~e~ p. thel~l-ough, the center tube for gluding a laser delivery means or other filn~ )n~l device to selected surfaces ofthe heart ~ be~, organ aperture or other body opening for lacer or other ll~allllt;lll thereon, particularly adapted for laser-assisted yucardial rev~cc-ll~ri7~tion (TMR).
It is yet a further advantage ofthe present invention to provide a pel.;~ eQ~c sleelab!~ catheter which can be po~itit~ned securely into a selected position within the left ventricle, or other body opening or cavity.
A fiurther advantage ofthe present invention is to provide a steerable catheter to enable creation of a plurality of applu~lialely grouped and spaced TMR c~ on a selected surface within a body cavity or organ quickly and safely.
Yet an a~ tinlnql advantage of the present invention is to provide a modular .,t~. ''- catheter system capable of b~eing as~."blod and ope~d as desired, ~"~ one or more modular ~A~s~blies which can be coupled together for Op~,~atiOn in unison, ~ h ' ~ but not limited to a central, modular steerable catheter with a ~lrA-fl~At~hlA end portion, a modular fiber advance h~ndr~ unit, and other rV.. ~i~;O~ul devices inrhl~li~ fiber advance depth control .. ~h~ .. , vic~li7ztic-n means, etc.
Therefore, to sul~ c, an e1on~a~Ad s~k catheter for p~ Pm~nt within a heart cl~
organ apel lult; or other body opening and having at least one center tube with hollow passageway for guiding a laser delivery means or other r,l.,. .1 ;. n~l device to selected surfaces of a heart chz ..hf -, organ aperture or other body cavity for laser or other l~ ,nt thereon, particularly adapted for laser ~si~led pe~ rouc transmyocardial revasculari_ation (TMR), is r~ie~Alose~d herein. The steerable catheter has a _andle portion at its proximal end and a controllably ~eflect~hle portion at its distal end.
The ek~n~ted center tube has a distal end, in the region where a ~iUI VatUI~; is to be formed, and a shim anchor sleeve is slidably di~,~,osed over the center tube. The shim anchor sleeve is ~t~Ahed to the inside wall of the outer jacket and coupled to the distal end of the center tube with a ber~ e shim member which extends between the distal tip ofthe steerable catheter and the sleeve over the center tube.
Opposite the shim is a guide for a pull cable, the pull cable a~A-hed to the distal end of the steerable catheter and ~ g through the guide to the handle. Thus, the shim is ~ .~1 radially opposite the pull cable with the center tube in between.
An outer jacket has, in a plerelled embo~ nt~ distinct sections of dirr.;ltil~t stiffness or dulolllctel. One or more distinct sections of material of .1;~-;.~ stiffness or dulc~lllc;l~l can be used.
JllnAti-~ne between the sections of different stiffness or ~lulolll~l can be discrete and clearly defined, or they can blend smoothly or get more or less flexible gradually. A distal, more flexible portion is coupled to a proximal, stiffer portion. The shim anchor sleeve is coupled to the outer jacket at or near the junction of two portions of the outer jacket. Thus, the center tube moves freely through the shim anchor sleeve.
g Adjacent the handle, the proximal outer jacket portion terminates at the catheter base. The pull cable extends through the catheter base, through a ~efl~o~ctinn housing tube, and ~ in a cable stop.
Rotation of a ~efl~ctil~n knob threadably ~ d onto the ~lloflection housing tube will cause the pull cable to be pulled backward, or the outer jacket to be pushed forward, relative to each other, thereby in~ defl~ti~n ofthe distal end ofthe steerable catheter.
The el~u~ted ~tcclabl~ catheter is ~le~ d to be placed into the v~Qcnl~tllre ofthe patient and steered thc-c~.lvugh until the distal tip is a~ nt a selected portion oftissue, such as on an ~ doc~udial surface within the left ventricle. Thus, the distal tip of a laser delivery means, such as an optical fiber or fiber bundle or other filncti~ n~l device, can be eYtl-n~led through the center tube of the steerable catheter such that its distal tip comes into contact with the selected surface structure for llcaLIIIe.lt thereon. With regard to TMR IL~,~er~,lc, the laser delivery means can be controllably alv~ulced through the s~rakle catheterforcreatingoneormoreTMRcl~nn~l~ Fullllcll~ore,withregardtonon-laserTMR,acannula or trocar assembly may be ~ ~ Ir~ ed through the steerable catheter into the tissue ofthe left ventricle, with or without use of a m~h~n;~l piercing tool.
In a plcrcllcd cl~bo~ l, the invention is a modular steerable catheter system capable of being assel--b!~ and O~clalcd as desired, COIll~ illg one or more modular assemblies which can be coupled together for operation in unison, incln-li~ but not limited to a central, modular steerable catheter with a ~l~fle~ble end portion, a modular fiber advance hanJ~iece unit, and other filnctil~n~l devices ~ ~h ' E.
fiber advance depth control ",~1~ , vi~ li7~tic~n means, drug delivery app~alus, etc.
Numerous other advantages and features of the present invention will become readily appal~ t from the following detailed description of the invention and the c.--l~ 1: ~ . -r- 11 ~i thereof, from the claims and fromthea~ p~yilg~aw IgS.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a lG~IG~Gllt~livG i~ . ;c view ofthe steerable catheter ofthe present invention showing a modular handle having a ~leflecti~n c~ "lt and fiber advance co""~on~,lt.
FIG. 2 is a lep,~ t~ivG isometric view ofthe d~flPrt~hl~ end portion of the steerable catheter with the shim anchor sleeve in a bl~a~.ay view of a plGrGIlGd Glllbodi llGllt of the steerable catheter of the present invention and shown without the ~fl~cti..n knob.
FIG. 3 is a IG~JIG iGllt~lliVe ~;ulaway i~o...~l ~ ;c view of detail 3 showing the distal tip of a plGrGllGd emh~im~o.nt of the steerable catheter of the present invention.
FIG. 4 is a IG~)lGsGll~live i~....~t. ic view of detail 4 showing shim anchor sleeve keyed to inside ofthe outer jacket and located adjacent the junction between dirrGrGlll types of outer jacket construction ofthe steerable catheter ofthe present invention.
FIG. 5 is a l~)lGsGIllalive isometric view of the distal end of a laser delivery means of the present invention.
FIG. 6 is a IGl~G~G~ltalive end view of a ~)IGrGllGd ~.mbo~irm~.nt of the shim anchor sleeve ofthe steerable catheter of the present invention.
FIG. 7 is a IG~lGsG~live section view of a plGrG,,Gd embodiment ofthe distal tip ofthe . ~- ___Ll _ catheter of the present invention.
FIG. 8A is a I~lGsGlltaliVG section view of a plGrG~Gd embodiment of a piercing means in a retracted position in the distal tip of the steerable catheter of the present invention.
FIG. 8B is a lG~s~l,~live section view of a plGrGIled embodiment of a piercing means in a protracted position in the distal tip of the steerable catheter of the present invention.
FIG. 8C is a IG~JlGsGlllalive end view of a plGrGIIGd l""bodi-"Glll of a piercing means in the distal tip ofthe steerable catheter ofthe present invention.
FIG. 9A is a re~"Gse,lt~ive section view of another plGrGlled ~ ho~ ..e-~1 of a piercing means in a l~d position in the distal tip of the ~ blc catheter of the present invention.FIG. 9B is a ,~i~)les~ tdli~e section view of another plerelIcd ~ 1 of a piercing means in a pl~ position in the distal tip ofthe steerable catheter ofthe present invention.
FIG. 10 is a I~ s~ iv~i~qm~tric view ofthe distal end and shim a~chor sleeve of a prerel~ed S~mho~lirnent of the steerable catheter of the present inve~
FIG. I l is another ~ s~llt~live i~m~tric view of the distal end and shim anchor sleeve of another pl~rtill~id e-l-bodil--~llt of the ~ldble catheter of the present invention.
FM. 12 is a l~les~.ltdliv-e partially cut-away and partially exploded view ofthe modular handle showing a fiber advance means ~l..~n~ and a ~leflecti~n compon~nt FIG. 13A is a l~lt;s~ dlive exploded view of the internal assembly of a d~flecti-~n means --~ol elll of a pl~re~ d embodiment of the steerable catheter of the present invention.
FIG. 13B is a ~e~ sellldliv-e section view ofthe dçflection means of a p,~r~ ..e~l of the steerable catheter of the present invention shown removably coupled to the distal end of a fiber advance component.
FIG. 14Aisarel.. t;se"ldlivt;sectionviewofaproximalendofthesteerablecatheterofthepresent invention.
FIG. 14B is a lti~l~c;llldlive eYplo~cd view of the depth stop means of the steerable catheter of the present invention.
FIG. 15 is a lc~ illldliv-e isometric view of a drug delivery appdld~us coupled to the proxim~l 20end of the modular handle of a steerable catheter of the present invention.
FIG. 16 is a l~l~se"ldliv-e p i~;liv-e view of the steerable catheter of the present invention within the left ventricle.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Preferred Apparatus FIG. 1 is a ~ tivt; i~nm~trir view of the ~t~, Ll~ catheter 100 of the present invention showing a modular handle having a ~n~;.., c~""p~ ~d and a fiber advance co~ o~ A p.cr~
~ of the steerable catheter 100 has a modular handle 102 at its proximal end 104 and a controllably defl~ end portion 106 at its distal end 108. The elo~ d central tol~un~g portion 110 is s~ cwl at flexible and enables tol~uil~g and steering. The ~leflect~ end portion 106 is more flexible than the el~ted central torquing portion 110, allowing the defl~ ble end portion 106 to develop a controlled bend with a smaller radius of ~,iUl VdtUl~.
FIG. 2 is a l~l~s~ ive isometric view of the ~lefl.~ ble end portion 106 of the s~ra~'-catheter 100 in breakaway view and shown without the ~leflection knob 180. FIG. 3 is a cutaway view of detail3showingthedistaltipll8ofapl~rt;ll~idembodimentofthe~lwlab!ecatheterlooandFIG.4is a view of detail 4 showing a shim anchor sleeve 112 keyed to inside of the outer jacket and located ~dj~r~nt the junction 113 between the ~leflect~ble end portion 106 and the ~lon~ed central torquing portion 110 of the steerable catheter 100 of the present invention. The proximal outer jacket portion 126 extends from the distal end of the modular handle 102 to the junction 113 and distal outer jacket portion 127 extends frorn the junction 113 to distal tip 118 ofthe steerable catheter 100.
A center tube 114 extends at least partially through the sk~ ~' catheter, and is att~hed at one end to the distal tip 118 of the s~eerable catheter. The proximal end of the center tube 114 is free and floats within the modular handle, thereby allowing the center tube 114 to slide and move during ~fl~tion of the distal tip 118 of the steerable catheter 100. The center tube 114 defines a hollow, central paSSagt;wa~ 115 through the center tube 114 for insertion of a tool such as an optical fiber for moflaserenergy~orotherfimcti<~n~ldevice.Thetubularmaterialofconstructionofthecenter tube 114, such as, but not limited to, Polyl,lopyl~c or other polymeric material will resist collapse during bending and twisting, and will resist collapse by external forces. At the distal end ofthe center tube 114 the distal tip 118 is contoured andlor polished to minimize any adverse effect, such as trauma caused by motion of the tip through a body lumen, cavity or opening, or by loss of m~leuve.~ility and control thereo~
As best shown in FIGS. 3 and 4, the center tube 114 slidably extends through the shim anchor slwve 112 which is ~tt~rh~d to the innerwall ofthe outer jacket. The shim anchor sleeve 112 is coupled to the distal tip 118 of the ~twl~blc catheter with~ and provides support for, a flat, semi-rigid shim 120 which extends betwwn the distal tip 118 and the shim anchor sleeve 112. The flat shim 120 defines a plane out of which the shim 120 can be ~leflect~ upon the application of lateral force, but back into which the shim 120 will re~rn with spring-like action on release ofthe ~rO, ...;-.~ force. A tang 121 at the distal end ofthe shim 120 serves to anchor the shim 120, such as by sold~ ;..g to the distal tip 118. As will be nl~d later in greater detail, the purpose ofthe shim anchor slwve 112 is to allow frw Il~ ,.llhll of the center tube 114 within the outer jackets 126 and 127, to support and position the center tube 114, as well as to serve as an anchor point for shim 120 and a guide for a pull cable 122.
Proximal outer jacket portion 126 covers the center tube 114 ariiac~nt the ~ n~t~ central tor.luil.g portion 110 and distal outer jacket portion 127 covers the as~ll,bly a~ c~,nt the ~flect~ble end portion 106. Further, it will be un~l~lood that laser delivery means 116, or other fim~.tinn~l device, can be slidably dis~,osed inside center tube 114 such that a distal tip 128 of laser delivery means 116 can be advancedthroughthedistaltip118Ofcentertube114tosurfacesorstructuresforlaserl-t;dlu-~lltthereon.
Optionally, the proximal outer jacket portion 126 can be made of a braided or "laid-up" type of construction. The braidedconstructionwill enhance l~";s~ eto sidewall collapse, f~.ilit~te tc,l~luillg and twisting, and provide ~nh~n~d col~mn~r support during deflection The shim anchor sleeve 112 is proximal the joint 113, and in a p~ d e~ the entire shim anchor sleeve 112 is bonded to the inside wall within the proximal outer jacket portion 126 ~dj,q-r~.nt the junction 113 with the distal outer jacket portion 127. It will be Ull~ luod that the precise length and point of cnnnActinn between the shim anchor sleeve 112 and the outer j. ckets is s -l~qh'~ as desired, but that the design must not interfere with or .JtL~ .;se impair normal operqfl.~n ofthe junction 113.
Pull cable 122 extends from the distal tip 118, where it is fixedly att~~ht-A through pull cable guide 124 or other l~ lf~lg aperture in shim anchor sleeve 112. By positinni~g pull cab1e guide 124 axially opposite shim 120, the pull cable 122 is caused to deflect distal tip 118, thereby bending shim 120.
The pull cable 122 passes through pull cable guide 124 and extends to modular handle 102 where it c. n be controllably pulled . nd released by a ~l~flectinn co~ o~e,lt, as desired, to cause selective .1~ r.J. "".I;nn of the defl~ qble end portion 106 of the steerable catheter 100 of the present invention.
FIG. 6 is a l~ s~ t~tive end view of a plt~ d embodiment of the shim anchor sleeve 112 of the steerable catheter 100 of the present invention. The shim 120 is linked to shim . nchor sleeve 112 at shim q~ttqehment point 136, radially opposite or otherwise ope,~tively spaced relative to pull cable guide 124.
As best shown in FIGS. 3 and 4, a helical coil spring 130 preferably is w,~ped around at least portions ofthe center tube 114. Helical coil spring 130 h. s several fi-n~tinn~, one of which is to provide enhq-n~l vi~ qli7-qtinn By constructing helical coil spring 130 of platinum or other radiopaque mqt~riql, the precise angle of ~efl~tion as well as gec""~llic po~itinnin~ ofthe (~PfleGtqble end portion 106 can be deienninedusing fluoroscol~y. Another fiunction of helical coil spring 130 is to impart ~ul~1iti~n~l sidewall strength to the tubing material of center tube 114, esperiqlly illlpOl ~" in the ~fl~~ble end portion 106 portion of the steerable catheter 100 during t~ JUl~ly steering, twisting, and bending ~l~r.. -~1 ;nn~ to prevent sidewall collapse. Proper slolection ofthe stiffness and number and plqcem~-nt of individual coils Will~A~ the bend r. dius ofthe dpflp~q-hle end portion 106 and its distance from the dwstal tip 118 ofthecentertubell4.Furthermore,byusingsu~ icorshapememorym~eriq-lsofcol~llu~ion~as will be further '~ SfJ;l below, the APflPrtqh!P end portion 106 can be given some pla~;lll~ined ~,w v~lw~.
In an ~IA:~innql prer~ d e~.. hoA ~ the centertube 114, shim 120, proximal and distal outer jacket portions 126 and 127 andlor the helical coil spring 130 are preferably made at least partially of, or otherwise C'J"'I";~:~ a s.l~l~,laslic material which can be given a selected shape. Other suitable m~~eriqlc include plqflnllm spring steel, shqin1P-c.~ steel, shape memory or ~u~ ic/shape memory alloys. Once a ~u~el~ ic material has been shaped, it has a memory for the shape. Upon APro..~
from the plt;r~,ll"ed shape, the material will tend to ;.. -1~ A.~ y return to its pltirc,.-"ed shape with spring-like action. Thus, the AeflP,ctvkle end portion 106 ofthe steerable catheter 100 can be l~."~.~ily ~ ~.",~A or otherwise curved so as to steer and position the AeflP~qble end portion 106 ofthe steerable catheter 100 through the va~Clll~q-hlre and inside the left ventricle or other body opening, and against the heart wall.
In the case of shape memory materials, a "memory" for a pl~rc,--"ed shape can be It;lll~l~IUlti set in the ~AeflP,ctqble end portion 106 of the ~ blc catheter 100. The pe~ Pu~e steerable catheter can be ~ uily and r ~- ~.AeA through the vq-c clllq-hlre. Once the steerable catheter is in position, memory recall of the original pltir~,ll"~ shape can be produced by any of a number of W~FCI~illl ways. These include heating using electrically resistive material, electrically s~ ilive m~~~isl, radio fre~u~ P~ circulatingheatedfluid,etc.Itwillalsobeunderstoodthatthecenter~hube114Ofthesteerable catheter 100 can also act as a type of "hypo" hube, and an additional hube inside the center hube or annularly inside or outside the center hube for delivery of fluids, other tools, etc. can be used. Furthermore, by providing di~lin~live cross section gec""~llies, c~ po~e~ ; can be "keyed" together as desired, to prevent ulldeshcd rotation of one or the other COl~ llcllt, as well as to provide rot~tir~l ql control to the physician.
FIG.5 is a ~ c~c"~i~e isometric view ofthe distal tip 128 and distal end 132 of a laser delivery means 116 ofthe present invention. The distal end 132 ofthe laser delivery means 116 optirn~lly may be S provided with a slight d~-flt~tion or ~,wvdtulc. It will be undc~ od that the slight ~iulvahuc ofthe distal end 132 of laser delivery means l l6 can be made in any of several Ji~clclll ways~ in~lu~l;~ a pf ~
~UIV~UIC formed by heat, ~!' g l~ ot~ construction, etc., or a ~""~,~y ~;u,v~uc formed c~th~, w;se.
npaque marker 134 adj~,Pnt the distal tip 128 of laser delivery means 116 is particularly useful in vic~ 7~ti~n via fluoroscopy or other methr~c Such marker 134 can be made of platinum or other suitable radio-opaque material. Thus, the precise location of the distal tip 128 of laser delivery mean_l16canbedcl~i~...;.~ Itwillbeunderstoodthatvicll~li7~ti--neul~l~ aids,inclu-' gbutnot limited to r~liopa~ue markers, t~nt~ m andlor platinum bands, foils, strips may be placed on the various ~ Jonc~ ofthe present invention, inrl~ ~' g on the defl~t~lc end portion 106, helical coil spring 130, and other parts of the steerable catheter 100, or at any position on laser delivery means 116, such as optical fiber or fiber bundle, or other fimcti~n~l device, will be very helpfiul in vic~ i7~tion of the per.,u~n~.uc ploc~lulc.
It will be understood hereby, with particular regard to FIGS. 7-9B as well as IL~ugl~uL this that various emboflimentc of various aspects of the present invention will be referred to by c~. u . . . ~1- reference numerals, for convenience and to indicate similar general purpose, despite the dec~rihed structural variations and others in~ ded within the scope of the present invention.
FIG. 7 is a ~c~resc~ /e section view of a plc~cllcd embodiment of the distal tip 118 of the steerable catheter 100 ofthe present invention. First att~r,hm~nt point 138 and second a~t~rh..~ d point 140 are o~. ~Li~ ~,ly positil~n~d radially opposite each other on the distal tip 118, serving to couple the shim 120 and pull cable 122 to shim anchor sleeve 112. Proximal end 142 attaches to center tube 114 and forms the distal end of ~l~ofl~ ble end portion 106. As shown, spaced radial barbs 178 serve to anchor the distal tip 118 into the center tube 114 FIG. 8A is a r~l~llt~live section view of a p~Gft;~ bCY~ of a piercing means in a rt;l.~d position in the distal tip 118 ofthe st bl~ catheter 100 ofthe present invention. FIG. 8B is a l~r~se.lL~Live section view of a p~,f~,llcd c .-1~l;."~ of a piercing means in an e~ -~1 position in the distal tip 118 ofthe ~lecl~blc catheter 100 ofthe present invention. FIG. 8C is a l~l.,se.lt~Liv~i end view of a plt;r~ d ~.mbodirnf-.nt of a piercing means in the distal tip 118 ofthe st~rable catheter 100 of the present invention. Pressure plate 200 is retained by threadable end cap 202 threaded onto or otherwise coupled to the distal tip 118 of the ~L~.~ble catheter 100. When a force is applied to plC;:iSUlt; plate 200 in direction 204, and~olillg teeth 206 will be e ~ ed as shown in FIG. 8B. When the force is released, biasing spring 208 will reposition pl ~ssul e plate 200 as shown in FIG.8A and retract al~chol illg teeth 206.
As shown in FIG. 8C, the operative spacing and shape of anchoring teeth 206 can be selected as desired. The piercing tip is especially useful for merh:~n;c~lly piercing the endocardial surface of the left ventricle, when il~luced thereinto percut~neoucly. M.orh~nir~lly piercing the surface of openings, body cavities or othertissue structures will also serve to anchorthe defl~ble end portion 106 ofthe b~e catheterlooinagivenpositionforlaserorotherlltiallll~lltthereon~effectedviathesteerablecatheter such as through the center tube 114.
FIG. 9A is a ~ s~lltalive section view of another l)f efel led embodiment of a piercing means in a lc~acl~d position in the distal tip 118 of the steerable catheter of the present invention. FIG. 9B is a c~Jl.,s~ tiv~ section view of another pler~ d ~I"bodi ll~,.d of a piercing means in an e~ d position in the distal tip 118 of the steerable catheter of the present invention. As in FIGS. 8A-8C, helical coil biasing spring 208 and pl~UlCi plate 200 are retained ~ dj ~ ~t distal tip 118 ofthe ste~,~!e catheter 100 by end cap 202. As plti~i~iUlti plate 200 is moved in direction 204, as by internal pl~;~ul~; or foroe created by fluid, rods or other biasing means, piercing tube 214 will be ~ U1~ as shown in FIG.
9B. When the ~ ul~ or foroe is l~ uv~d, biasing spring 208 will return piercing tube 214 to within the S distal end ofthe piercing means assembly. Ad~ means designs, including multiple individual solid or hollow needles, flat blades, curvedblades, etc. will be in~ Aed withinthe scope ofthe present invention. Therefore, it is ~ od that piercing tips may be a~tivate~ by applying plC~Ul~ to plt;~i:iUlt~ plate, using flushing fluids as an e~u~lc, through center tube 114, or the piercing means may be ~tt~chcd tû a tube which extends t~ the handle for contrûl at the proximal end. In such emboAirnent the plessule plate may be omitted, and the spring is useful but opti~nz~l FM. 10 is a ~ taliveis~jlllt;llic view ûfthe dçflect~hle end portion 106 and shim anchor sleeve 112 of a plcr~ lubo lilll~ of the steerable catheter 100 of the present invention. FIG. 11 is another l~lltalive ic~ mf~tric view ofthe d~fl~ble end portion 106 and shim anchor sleeve 112 of anotherple~llcdembodimentofthesteerablecatheterlOOofthepresentillvt;llti~ .Aswillbe..~ lood by the dlawhlgs and description herein, the curvature in the ~l~flect~ble end portion 106 of the oenter tube 114 can be positi~nçd as desired at any pûint. The helical coil spring 130 canbe ~ u~d with varying degrees of flexibility, and with any number ûf coils, such that the CUIValUI~ can be moved closer to the distal tip 118 of the center tube 114 or closer tû the shim anchor sleeve 112, as desired as shown, respectively, in FIGS. 10 and 11. As will be understood, hlw~illg the tension in pull cable 122 by retraction thereof will cause dçflection of the distal tip 118 and the deflect~le end portion 106 in a direction çc~Pnt~ y out of, and into and toward a position pel~ r to, the plane of the shim 120.
C-...fl~ ed retraction of the pull cable 122 will cause c~ ntimlçd d~flection of the distal tip 118 of the steerable catheter, with useful ranges of d~flecti~ n between about 0 and about 180 degrees (U shape) to about 270 degrees (pig-tail shape), or more or less d~ upon construction. ~dAitinn~lly, by allowing thecentertubell4toremainfreeatitsproximalend,.. ~x;.. ~lPflP~.tinnispossiblewithoutundostrain on the center tube 114 which can slide forward within the handle.
~AA;t;~n ~IIY, as AFYj- ;1~d above, by utilizing materials with varying dul~J~ and by varying S the number and density of coils and by varying the stiffness ofthe helical coil spring used, the center tube 114 can be ~s;gl~Fd to bend at a pl~d~,l,~ined or selected point within the dPflP~a~le end portion 106.
Suchpointcanbei~ e~yadjacentthedistaltipll8,betweenthedistaltipll8andtheshimanchor sleeve 112, and or a~j~cPnt the shim anchor sleeve 112 itsel~
FIG. 12 is a ,eplest;"lalive partially cut-away and partially exploded view ofthe modularhandle 102 showing a fiber advance means C~J~q)~ and a dPflPctinn colnl)ol,cllt. FIG. 13A is a ~ st;,d~ive eYplo~lP~l view of the internal assembly of the APflection co npone ~l and FIG. 13B is a ~ ~,e It~live section view ofthe deflP,ctic n component coupled to a fiber advance handle ofthe steerable catheter 100 of the present invention shown removably coupled to the distal end of a fiber advance l~F~ FIG.
14A is a ~e~.,ell~ive section view of a proximal end of the steerable catheter 100 of the present invention. FIG. 14B is a r~ iv~ exploded view of the depth stop means of the fiber advance ,", of the steerable catheter 100 of the present invention. It will be understood that structural cl~".~"l~; with like ~ere~ ce n-lmer~l~, as Apsrrih-pd herein with ,~r~ "~e to the d,~ s, are idPnti~
or similar to each other.
Referring now to FIGS. 12-13B, proximal outer jacket portion 126 t ~ ~ at its proximal end and is coupled to a distal, inside stepped portion 165 of catheter base 162 by set~c,~w 167, or by other means in~luAin~ adhesive, etc. An optional strain relief 164 is fastened to either or both the proximal catheter jacket 126 or to the distal, stepped portion 165 and/or the catheter base 162, or is ~lL~Iw;se coupled thereabouts, such as by setscrew 167, and serves to minimi7P, the effect of ~lçflP~tinn or other I~"n~lli~ of the elo~g?ted central tc~r~uillg portion 110 and ~flP~tqb!c end portion 106 on the modular handle 102 and ~fl~o.ction ,..~ ". A ~cl~inll~ collar 166 is provided aroundthe strain relief 164 and distal, stepped portion 165. A hollow, tubular defl~tion housing tube 150 houses the catheter base 162 and has a first one or more external helical ~lcd portion 152 loca~ed at the distal end ofthe d~fl~i- n S housing tube 150. Defl~c-ti-n knob 156 with cc--c;,~l-d~g helical threads located on an inner, annular surface is threadably coupled to threaded portion 152 at the distal end of ~1efl~ctinn member 150. Thus, ~flecti~-n knob 156 is able to rotate on Illr~ded portion 152 above catheter base 162, retained in place by Ic~i~fillg collar 166, thus ~A;'~ ;'';''g the axial position of the catheter base 162 relative to the d~o.fl~ n knob 156.
Pullcable122extendsfromthedistaltip118Ofthe~1w~_~'~cathcterpastcatheterbase162and through d~flection housing tube 150, and t~ ...;,.~les at pull cable stop 168, with pull cable stop 168 fixed into position relative to cl~flection housing tube 150 by SCI~CI~W 169. It will be understood that slot 171 in pull cable stop 168 will permit att~hm~ nt of setscrew 169 in several loc~ti- n~ thereby enabling adj~ nt ofthe tension of pull cable 122 to effect the overall s~ ivlly ofthe fl~flecti~n ass."llbly. As best shown in FIG. 13A, pull cable 122 may pass through pull cable stop 168 through aperture 192 to be retained thereby, or will le~ at pull cable stop 168 by bond other means . Furthermore, center tube 114 will pass through pull cable stop 168 through aperture 194., as shown, or pull cable stop 168 can be pos~ n~ to one side ofthe proximal end of ~leflecti~n housing 150 (not shown) for lateral cle~O~ of center tube 114 thclclllrough. As ~lefl~ n knob 156 is rotated in one direction towards the distal end of dPflP~tion housing tube lS0, the distance betwecn the axial position of the defl~ction knob 156 and the proximal end of the ~flection housing tube 150 will be incl ~sed, resulting in ~.I~,r~ased tension in the pull cable 122, dPflection of the flat shim 120 out of its own plane, and advance of the proximal outer jacket portion 126 relative to the pull cable 122. As the ~leflection knob 156 is rotated in the opposite direction, the distance between the axial position ofthe ~fle~tinn knob 156 and the d~fl~~tisn housing tube 150 is decr~d, thereby resulting in a ~~ .ol~ g deel~sc in tension of the pull cable 122 and a return to an un~lefl~t~d position. The ~leflto,ctinn module may be used alone for applir~tions ~u~uilu~g only ~n~ ofthe distal tip 118.
S For appli~tion~ such as TMR, fiber advance means module is rernovably coupled to the defle~tinn module as shown in a pl~ir,.ltid embodim~t, by second one or more helical threads 181. It will be ~ od that the fiber advance . ~ . . can be coupled to the steerable catheter 100 0fthe present invention utilizing other collpling means, including varying pitch threaded systems, bayonet mount systems, adhesives, etc.
Referring nowto FIGS. 1, 12, 13B and 14B, a "Tuohy-Borst" type con,~ ion adapter 170 for releasably coupling to a fiber optic bundle or other laser delivery means 116 (see FIG. 1) is located at the proximal end of the steerable catheter 100. Collll,l t;~sion nut 173 tightens around laser delivery means 116 and retains it fixed therein. A depth-stop control nut 180, or other manually or otherwise controllable depth stop means, is provided distal to the adapter 170. F.YI, -, 0l~ 182 extends proximally to t ~ ~l at luer fitting 185 and extends dis~ally to advance slider 184 with fluid seal 188. Center tube 114, coupled to distal tip 118 and ~ proximally, floats freely through catheter base 162, deflectinn housing tube 150 and through fluid seal 188, and It;~ es within ~ l- 182.
Referring now to FIG. 12, depth stop control nut 180 can be po~itisn~ as desired on ~
182 so as to limit ~n~ of laser delivery means 116. Thus, as control nut 180 is moved along e ~ :on 182, ~e ~ x;.. distance A can be traveled in precise il,clel"~ , optinn~lly by use of a calibrated depth scale 187 threaded over eYten~ n 182 and/or ~ g from nut 180. In the pl~
embodiment used for TMR, such travel could be limited to between about O and about 3 c~ , or more or less. Advance housing 172 has a slot 174 on one side for retaining thumb advance button 175 eoupled to advanee slider 184. Forward tr~n~ n of thumb advanee button 175,11 c~cro-c, results in unison forward t~nQ~ )n of adapter 170, depth eontrol nut 180, eytf n~ion 182, advanee slider 184 and fluid seal 188 along with laser delivery means 116 (not sho~-vn), as pc~... 'l~ through distanee A.
C~-4,-~;on spring 176 or other biasing means .~ advanee button 175 biased b~.w~, in a proximally ~ctl~k;d position. As will be ul~c-~od, ;.. "~ ,ly p~c~iing operational a~lv _ . ~ent and/or operational ret~ti~ n, as in retro-lasing whieh will be more fully c~p~ -fd in the following, of a laser delivery means 116, the spring 176-biased advanee slider 184 will retraet the distal end 128 ofthe laser delivery means 116 sueh as an optieal fiber or fiber bundle baek inside the ~lf flfxt~hle end portion 106 so as to prevent injury to the patient during derr"~ n of the ~Ifflf~Able end portion 106 for p~ c~iv-eoperativepl~mfntofdistaltip 118.
A saline flush, drug solnti~n~ vi~u~li7~ti~n or other th~ culie agent ~..'~ fluid ean be provided to the steerable eatheter via one branehed arm 190 of adapter 170. Saline sohltion7 drug or sueh other fluid will fill adapter 170. Proximal fluid seal such as co~ .lc~ion nut 173, or other sealing means, will create a seal around optieal fiber or other laser delivery means 116. Such sealing means include o-rings, as shown, rubberdiaphragrns, otherelasticmember, etc. Salineorotherfluidwillbeplevc .lcdfrom f ~ r;~ past adapter 170 around laser delivery means 116. Fur~hermore, by ~'A;~ the plCS:iU-~i of said flush or other fluids soll~cv~lldt above that developed in the left ventricle, in the ease of TMR, sueh will flow around laser delivery means 116, and through the pas~cwa~ 115 through eenter tube 114, thus p-cvc~ling back flow of blood from the left ventricle into the steerable eatheter. ,A~111iti~n~11y, fluid seal 188,asdeseribedintherulcg~",.g,preventsfluidfloworbaekflusharoundtheproximalend117Ofeenter tube 114. In a p-crc-lcd clnl)o~ .t, it will be ul~del~luod that any backflow preventer, cheek valve, blood seal, etc. with the neeessary operative funetion and suitability ean be employed els~,~.hclc on the steerable eatheter 100 and will be inchldfd within the seope ofthe present invention. Saline solution or other fluid can also be used to activate ~ of the piercing means 206 and 214, as shown in FIGS.
8A-9B.
It will be ul~del~od, and ~ -crol~ inr,l~lded within the scope ofthis invention, that the manually v~l~L~d fiber optic or other laser delivery means advance ...~ ... can be replaced with a wide range of diIrcil~llt m~h~nieme or devices, inf.~ i~ indexed or l~L~d .. ~Yl~n~ , electric drives with ~ l~llvlfic controllers, etc., ~vl~ J;d advance and retract controllers, etc.
FIG. 15 is a l~le~ ive i~m-,tric view of a drug delivery ~p~lus 196 coupled to the proximal end 104 of steerable catheter 100 of the present invention. As shown, other tools may be ~tt~hed to the modular handle 102 of the steerable catheter 100 of the present invention for operation through the center tube 114 in addition to the drug delivery or f~ g al)pcu~tus 196. It will be ul~el~lood, therefore, that such drug delivery or ~ al)l)al~tus 196 can be m~n--~lly or a~t-m~t~ lly activated, can be adjustable or piogl~lul-able to ~~ e individual aliquots of a preA~ d volume, at a pre~ ed or sperified rate, as desired.
Fr~f~red Method FIG. 16 is a le~ sell~ive p~ ;ve view ofthe steerable catheter 100 Ofthe present invention within the left ventricle 230. As inflir~t~ above with regard to FIGS. 1-15, the present invention is directed to "stand alone systems", in other words, to catheter systems which are guided into and through parts ofthe body, such as into the left venhicle, optif)n~lly withoutthe use of a guide catheter 232 or other guide system. Such guide catheters are well known and may be used with the present invention, and therefore are inch~ded within the scope of this invention. Typically, entry into the v~e~ hlre is made through the femoral artery. If used, the physician steers an optional guide wire (not shown) into the left ventricle 230, and slides the guide catheter 232 over the guide wire, over the aortic arch 234 and across the aortic valve 236.
IIvwt;vel, as a "stand alone system", the 1~ ;o~ guide wire or guide catheter 232 need not be used. The distal tip 118 and drfl~-q-hle end portion 106 ofthe ~l b',e catheter 100 is e~ 1~ overthe S aortic arch 234 and p,~Jl~sed through the aortic valve 236 into the left vt;~ icle 230. The st~r~hle catheter lQ0 can be guided into a selected position 3~ q,r~nt a selected surface 238, in this case a portion of .,ndoc~ liulll. Thus, by s~ H~ y deflecti~ the ~1~fl~ e end portion lo6 of the ~ rq-~s catheter 100 and/or by rotating the steerable catheter 100, e ~ the distal end 128 of a laser delivery means 116 or other fimcti-nql device therethrough, delivering laser energy or ~ru~ ng other therapy, vicu-q-li7-q-ti--n or ~ q-~ostic, and retracting the distal end 128 of the laser delivery means 116 or other fim~.tionql device back into the ~flectqble end portion 106, the steerable catheter 100 can treat a series of individual, selected ~ llcllt points 240 of endoc~-iiulll. Such ~ points 240 would typically be TMR ~hqnn~l~ or stim~llqti~n sites. Another feature ofthe present invention is the ability to ac~iul~ly position and stabili_e the distal tip 118 of steerable catheter 100 in the apex 242 ofthe left ~e~dli~le 230 for treating therein.
AI~Il~Lively, retro-lasing can be pi~ r~,....~ This novel method includes the steps of adval Cillg thedistaltip 128Oflaserdeliverymeans 116aselecteddistanceintothen,yocdldiull,andthendelivelillg laser energy to create a TMR channel or other ~ llt;ld site while simllltq-n~4ucly retracting the fiber, laser delivery means 116 or other fimc~i~Lql device. With this pl~dUl~, with regard to TMR e~ qlly7 ;.. ~c.. ~ as laser energy is only deli~ e.c;d during retraction ofthe fiber, the possibility of a lval~cil~g the fiber too far and lasing through an epi~ dial surface is ~ . .1 ~ and the risks of cQnlplit~-qtionc arising from such epicardial pelrul~lions, includi~ but not lirnitedto cardiac tamponade (a buildup of plCS:iUl~i in the pericardial sac caused by the plesence of n excess of fluid such as blood), prolirel~iol~ of ci~nc between the ~ ic diu,,, and the p~,.i~u lial sac (thereby plCVClltil~g normal, r, ~-cl cl~u-c of the heart muscle within the pc~ dial sac), etc. are minimized.
Furthermore, adjunct use of aypl~ iate drug delivery al)pa.~tus, blood seal means, depth stop appau~us such as clamps, b,.~ , etc., vicu~li7~tirln means, marker means as well as other ha,.lw~c and methf '~1~ ,y will be considered within the scope of the present invention. ~A~1ition~11y, use of el~llopL~: s~ (EP) rcadings from the distal tip 118 for ~ ...r.. . :~ tissue contact will be particularly useful.
The present invention is inten~ for use with any medical laser. In particular, the Holmium or excimer laser is particularly suited to the present invention. However, any suitable laser source, pulsed or otherwise, could provide laser energy to the laser delivery means ofthe present invention for p ,- 1~.. : ~ ~
the method ofthe present invention. Likewise, the steerable catheter and surgical e~ ;p~r~1, including laser delivery means, referred to in the present ~loc~.u~ as well a~s that known and used in m~iritl~ and other disciplines today and in the future, will be inr~h~c1~ in the scope of this tlisrlosl~re. Such laser delivery means include, but are not limited to, individual optical fibers as well as bundles of fibers with and without piercing tips and with or without firing tips or fiber ends having shaped or contoured end faces for selectively diverging the laser beam or other laser energy livcl~lg means, rods, mirrors configurations and other laser delivery means with and without ~us-ng len~s and the like. It will also be undc~od that the steerable catheter and method of the present invention as described herein inelllc1i~
the novel cc"nbil~Lion or use with of any conventional ",~l~n;~.," or method which are known to those skilled in the art, are in~h~ded within the scope of this i~VC~tiOll. Furthermore, with regard to non-laser TMR, a cannula or trocar assembly may be eYt~lll?d into the tissue ofthe le~ ventricle, with or without use of a, ~ ' ~-1 piercing tool.
It will further be ull~cl~lood that while the present invention has been described for pclrulllung TMR on endocardial surfaces in the left ventricle, the ap~ us and methods ~lescrihed herein are equally ir~ended for use in any suitable pr~u.e, inr~ ~ but not limited to pl(M~IUlC~ where any device need be ~ Pd through a guide catheter to an opening or other point within the body for o~her medical p ~u-cs inr~ ing laser lr~llllCIIl, viC~ 7~til~n~ biopsy, etc. ''stim~ tion~ for ~ , is pc by using laser energy to create zones or pockets, optil~n~lly i-llc~ d at least initially by small S cl"- ~Ic ablated through the tissue, for the introduction of blood bom growth and healing factors and stim~ te~ capilla~y growth ~ul~undi~g the lased zones or pockets to create an ~,-c-eased supply of oxygen to the tissue and thus a revit~li7~tion of the heart muscle Methods and apparatus for causing stim~ ti~n are more fully des~;-ibed in co-pending U S Patent Application Serial No 08/664,956 filed June 13, 1996 While the principles ofthe invention have been made clear in illu~ ive embo~ Pntc~ there will be ;..~ ell~tely obvious to those skilled in the art many morlific~ti- ns of structure, a--~
proportions, the elpm-pntc~ materials, and components used inthe practice ofthe invention, and otherwise, which are particularly adapted to specific envi.ol-lllcllls and opcl~live IC4UilClllClltS without d~li lg from those principles The appended claims are intended to cover and embrace any and all such m~ifir~tionc with the limits only of the true spirit and scope of the invention
Claims (42)
1. A deflectable, steerable catheter comprising a modular handle at a proximal end and a deflectable tip at a distal end, the modular handle comprising at least a deflection component and a connector for attaching other components; the distal end having an outer jacket extending therefrom to at least a distal portion of the modular handle and a center tube attached to the distal tip and extending inside the outer jacket to terminate within the modular handle, the center tube having a proximal end free floating within the modular handle; the steerable catheter further comprising a deflection mechanism extending between the distal tip and the deflection component.
2. The steerable catheter of claim 1 further comprising a shim anchor sleeve over a portion of the center tube and allowing the center tube to slide therein, the shim anchor sleeve attached to an inside wall of the outer jacket.
3. The steerable catheter of claim 2, wherein the shim anchor sleeve anchors the deflection mechanism.
4. The steerable catheter of claim 3 wherein the deflection mechanism is a shim mounted to the distal tip and to one side of the shim anchor sleeve and further comprises a cable mounted to the distal tip and extending through the shim anchor sleeve to the deflection component.
5. The steerable catheter of claim 4 in which the shim anchor sleeve is disposed around the center tube a selected distance from the distal end of the center tube thereby defining and distinguishing a deflectable end portion from an elongated central torquing portion of the steerable catheter, the shim extending along the deflectable end portion of the steerable catheter between the distal tip and the shim anchor sleeve.
6. The steerable catheter of claim 1 in which the center tube has a proximal end and a distal end and at least one passageway extending therethrough, the center tube for providing access to an internal region of the body by a functional device extended through the at least one passageway.
7. The steerable catheter of claim 1, in which the outer jacket has a proximal end and a distal end and the deflection component comprises:
a catheter base, the catheter base having a proximal end and a distal end, the distal end fixedly coupled to the proximal end of the outer jacket; and a deflection housing tube having a proximal end and a distal end, the pull cable fixedly attached to the proximal end of the deflection housing tube, the distal end of the deflection housing tube operatively coupled to the proximal end of the catheter base to allow selective, axial translation of the deflection housing tube relative to the catheter base.
a catheter base, the catheter base having a proximal end and a distal end, the distal end fixedly coupled to the proximal end of the outer jacket; and a deflection housing tube having a proximal end and a distal end, the pull cable fixedly attached to the proximal end of the deflection housing tube, the distal end of the deflection housing tube operatively coupled to the proximal end of the catheter base to allow selective, axial translation of the deflection housing tube relative to the catheter base.
8. The steerable catheter of claim 7, further comprising:
a deflection knob rotatably mounted to the catheter base and having one or more helical grooves on an inner annular region of an opening extending therethrough; and one or more helical grooves on the distal end of the deflection housing tube, the helical grooves of the deflection knob corresponding in shape and dimension to the one or more helical grooves of the deflection housing tube such that rotation of the deflector knob causes axial translation of the deflection housing tube.
a deflection knob rotatably mounted to the catheter base and having one or more helical grooves on an inner annular region of an opening extending therethrough; and one or more helical grooves on the distal end of the deflection housing tube, the helical grooves of the deflection knob corresponding in shape and dimension to the one or more helical grooves of the deflection housing tube such that rotation of the deflector knob causes axial translation of the deflection housing tube.
9. The steerable catheter of claim 1 further comprising fiber advance means.
10. The steerable catheter of claim 9, wherein fiber advance means is a modular assembly detachably coupled to the connector means.
11. The steerable catheter of claim 9, wherein the fiber advance means comprises:
a hollow housing defining mating connector means attachable to the connector means of the deflection component, the housing having an elongated slot therein;
an advance slider member coupled to laser delivery means, the advance slider member disposed within the housing;
advance button extending into the elongated slot, the advance button coupled to the advance slider member such that directed translation of the advance button within the elongated slot will cause simultaneous advance of the laser delivery means through the center tube of the steerable catheter as well as advance of a distal tip of the laser delivery means out the distal tip of the steerable catheter; and fiber retraction means for biasing the advance slider member in a normally proximal-most position.
a hollow housing defining mating connector means attachable to the connector means of the deflection component, the housing having an elongated slot therein;
an advance slider member coupled to laser delivery means, the advance slider member disposed within the housing;
advance button extending into the elongated slot, the advance button coupled to the advance slider member such that directed translation of the advance button within the elongated slot will cause simultaneous advance of the laser delivery means through the center tube of the steerable catheter as well as advance of a distal tip of the laser delivery means out the distal tip of the steerable catheter; and fiber retraction means for biasing the advance slider member in a normally proximal-most position.
12. The steerable catheter of claim 11, in which the fiber retraction means is a biasing spring.
13. The steerable catheter of claim 1, further comprising a depth stop means for delimiting the advance of the distal end of a laser delivery means or other functional device through the center tube and out the distal tip of the steerable catheter.
14. The steerable catheter of claim 1 in which the shim anchor sleeve is coupled to the outer jacket.
15. The steerable catheter of claim 1 in which the shim anchor sleeve is keyed to the outer jacket.
16. The steerable catheter of claim 1, further comprising a helical coil spring disposed between at least a portion of the outer jacket and the center tube.
17. The steerable catheter of claim 16, in which the helical coil spring is made at least in part of a radiopaque material to enhance visualization.
18. The steerable catheter of claim 1, in which the distal tip is made at least in part of a radiopaque material to enhance visualization.
19. The steerable catheter of claim 1, in which the distal tip further comprises a piercing tool.
20. The steerable catheter of claim 19, in which the piercing tool comprises a plurality of individual teeth.
21. The steerable catheter of claim 19, in which the piercing tool comprises a tubular blade.
22. The steerable catheter of claim 19, in which the piercing tool defines an activation mechanism for causing the piercing tool to be extended distally from the distal tip when desired.
23. The steerable catheter of claim 20, in which the activation mechanism comprises a pressure plate and retraction spring.
24. The steerable catheter of claim 20, in which the activation mechanism comprises at least one push rod.
25. The steerable catheter of claim 1 in which the outer jacket has at least two portions, a distal, more flexible, deflectable end portion and a proximal, less flexible, steerable and torqueable portion.
26. The steerable catheter of claim 25 further comprising an helical coil spring encircling at least a portion of the center tube.
27. The steerable catheter of claim 26 in which the helical coil supports the center tube.
28. The steerable catheter of claim 26 in which the helical coil defines a bend radius during deflection.
29. The steerable catheter of claim 26 in which the helical coil is formed of a radiopaque material to enhance visualization.
30. A modular handle for guiding a deflectable steerable catheter through the vasculature of an individual for treatment or therapy, the handle comprising a detachable and interchangeable deflection module, a detachable and interchangeable functional device module, and conventional tubing and catheter introducer and fluid seal attachment connectors.
31. The modular handle of claim 30 in which the functional device module comprises a fiber optic laser delivery means.
32. The modular handle of claim 30 in which the functional device module comprises mechanical piercing means.
33. The modular handle of claim 30 in which the functional device module comprises a drug delivery apparatus.
34. A steerable catheter for transmyocardial revascularization having a proximal end with a modular handle and a distal end with a deflection mechanism therein coupled to a distal tip, the modular handle comprising a deflection module for activating the deflection mechanism for causing deflection of the distal tip, the steerable catheter further comprising an outer jacket and an inner, center tube, the center tube attached at a distal end to the distal tip, the steerable catheter further comprising an optical fiber laser delivery means disposed within the center tube for extending therethrough for creating TMR channels.
35. The steerable catheter of claim 34 in which the distal tip comprises retractable piercing means.
36. A steerable catheter insertable through the vasculature comprising:
a hollow outer jacket having proximal and distal ends;
at least one inner tube within the hollow outer jacket, the inner tube having a distal end attached to the distal end of the hollow outer jacket, the inner tube further having a proximal end free floating within the hollow outer jacket, the inner tube adapted for insertion therethrough of at least one tool slidably disposed therein; and a deflection mechanism comprising an actuating assembly at the proximal end of the hollow outer jacket, the actuating assemble operatively attached to a deflector device at the distal end of the hollow outer jacket, the free floating inner tube sliding within the outer jacket during activation of the deflector device by the actuating assembly to deflect the distal end of the hollow outer jacket.
a hollow outer jacket having proximal and distal ends;
at least one inner tube within the hollow outer jacket, the inner tube having a distal end attached to the distal end of the hollow outer jacket, the inner tube further having a proximal end free floating within the hollow outer jacket, the inner tube adapted for insertion therethrough of at least one tool slidably disposed therein; and a deflection mechanism comprising an actuating assembly at the proximal end of the hollow outer jacket, the actuating assemble operatively attached to a deflector device at the distal end of the hollow outer jacket, the free floating inner tube sliding within the outer jacket during activation of the deflector device by the actuating assembly to deflect the distal end of the hollow outer jacket.
37. The steerable catheter of claim 36 further comprising a retractable piercing tip proximal the distal ends of both the outer jacket and the inner tube.
38. The steerable catheter of claim 36 further comprising a coil spring wrapped around at least a portion of the inner tube for providing structural support and for enhancing controllable deflection of the distal end of the hollow outer jacket.
39. The steerable catheter of claim 36 in which at least portions of the inner tube and/or the outer jacket comprise shape memory and/or superelaslic materials of construction.
40. The steerable catheter of claim 36 in which the actuating assembly is disposed within a modular handle positioned adjacent the proximal end of the hollow outer jacket.
41. The steerable catheter of claim 40 in which the modular handle further comprises a fiber advance mechanism for advancing an optical fiber or other functional device through the center tube.
42. The steerable catheter of claim 41 in which the fiber advance mechanism further comprises a depth stop adjustment means for controlling the advance distance of the optical fiber or other functional device.
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US08/833,352 | 1997-04-04 | ||
US08/833,352 US5876373A (en) | 1997-04-04 | 1997-04-04 | Steerable catheter |
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CA2233898A1 true CA2233898A1 (en) | 1998-10-04 |
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CA002233898A Abandoned CA2233898A1 (en) | 1997-04-04 | 1998-04-02 | Steerable catheter |
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US (3) | US5876373A (en) |
EP (1) | EP0868923A3 (en) |
JP (1) | JPH10295822A (en) |
AU (1) | AU5845398A (en) |
CA (1) | CA2233898A1 (en) |
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- 1998-03-26 EP EP98302316A patent/EP0868923A3/en not_active Withdrawn
- 1998-04-02 CA CA002233898A patent/CA2233898A1/en not_active Abandoned
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2000
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EP0868923A2 (en) | 1998-10-07 |
US5876373A (en) | 1999-03-02 |
US6530913B1 (en) | 2003-03-11 |
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Date | Code | Title | Description |
---|---|---|---|
FZDE | Discontinued |