CA2185146C - Catheter having shaft of varying stiffness - Google Patents
Catheter having shaft of varying stiffnessInfo
- Publication number
- CA2185146C CA2185146C CA002185146A CA2185146A CA2185146C CA 2185146 C CA2185146 C CA 2185146C CA 002185146 A CA002185146 A CA 002185146A CA 2185146 A CA2185146 A CA 2185146A CA 2185146 C CA2185146 C CA 2185146C
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- Canada
- Prior art keywords
- section
- proximal
- flexibility
- distal
- catheter
- 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.)
- Expired - Fee Related
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- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 2
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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
- A61M25/10—Balloon catheters
- A61M25/104—Balloon catheters used for angioplasty
-
- 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
- A61M25/06—Body-piercing guide needles or the like
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
-
- 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
- A61M2025/0183—Rapid exchange or monorail catheters
-
- 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
Abstract
A medical device such as a catheter (10) is described having a stiff, preferably metallic, proximal tube (21). The distal portion of the proximal tube may have a plurality of perforations or slots formed therein to increase its flexibility. This provides a smooth transition between the relatively stiff proximal tube and a more flexible distal polymeric tube (22).
Description
wo 95/24236 PCT/IB9S/00075 CATHETER HAVING SHAFT OF VARYING STIFFNESS
Background of the Invention This invention relates to an improved catheter, more particularly a balloon catheter for use in angioplasty. This invention is even more particularly adapted for use as a balloon d;~ tion catheter in percutaneous transluminal coronary an~,:Qplq~ty (PTCA). A PTCA procedure is used to dilate the stenosed region of a ~ise~eed coronary blood vessel. In a typical PTCA procedure, a guide catheter is introduced in a peripheral artery, such as the femoral artery, and advanced through the aorta until the distal end of the guide catheter is engaged with the coronary ostium for the coronary artery to be treated. Next a balloon r~ tA~ion catheter is introduced over a guidewire which has been introduced through the guide catheter. The gu;c~cwire is advanced past the distal end of the guide catheter within the lumen of the diseased vessel andmanipulated across the region of the slenosis. The balloon dilatation catheter is then advanced past the distal end of the guide catheter over the guidewire until the balloon is positioned across the sler,olic lesion. The balloon is inflated by supplying a fluid under pressure to the balloon through an inflation lumen in the catheter. Inflating the balloon stretches the d,~oas0d artery to ree~ I sh acceptable blood flow through the artery.
A typical over the wire balloon dilatation catheter has two lumens extending through substantially the entire length of the catheter. One lumen is used to pass the guidewire through the catheter and extends from a proximal guidewire port to a distal gl~ ~eu~i,e port located distal of the balloon. The other lumen is used to inflate and deflate the balloon and extends from a proximal inflation port adjacent to the proximal end of the catheter to a distal inflation port which is in communication with the balloon cavity.
A typical rapid exchange balloon dilatation catheter has a single inflation lumen extending from the proximal end of the catheter to the distal inflation port which is in communication with the balloon cavity. The guidewire lumen extends through only the most distal portion of the catheter from a proximal gu;c'ewire port, which is proximal of the balloon but distal to the proximal end of the calheler, to a distal guidewire port in 35 the distal end of the catheter. This configuration facilitates the maintenance of the location of the guidewire across the stenosis during catheter exchange.
21 ~51 46 A typical fixed-wire balloon dilatation catl,eter has a single lumen shaft that extends from the proximal end of the catheter to the proximal end of the balloon. A
wire is fixed in the catheter and extends past the distal end of the balloon which is connected thereto. The fixed-wire acts as the 9~ JeYI . a to steer the catheter so that 5 a separate gu ~ev.;.e is not needed.
In order for a balloon ~ tAtion call,eter optimally to perform Hs function in anangioplasty procedure, the catheter should have a small profile, a flexible distal portion and a stiff proximal portion. The small profile allows the catheter to be inserted into small arteries. A flexible distal portion allows that part of the catheter to pass through 10 the tortuous, tight curvatures of the vasculature. In addition, a stiff proximal portion gives the catheter ~pushability~, i.e. transr"ission of longitudinal force along the catheter, so a physician can push the catheter through the vascular system and the stenosis.
Finally the transition between the stiff proximal portion and the flexible distal portion should be smooth and should avoid areas of high stress concer,l,aliGn.
Balloon dilatation catheters currently on the market attempt to achieve these goals with varying degrees of success. I lowevcr, none has heretofore provided such an optimum combination of features.
Therefore it would be desirable to provide a balloon d;'~tAtion catheter that has a small profile. It would also be desi,able to provide a balloon dilatation call,eter 20 having a flexible distal portion.
It would be further desirable to provide a balloon dilatation catheter having a stiff proximal portion.
It would be yet further desirable to provide a balloon dilatation catheter that has a smooth transition from a stiff proximal portion to a flexible distal portion which avoids 25 areas of high stress concentration.
Summary of the Invention These and other objects of the invention are achieved by a balloon dilatation catheter having a stiff proximal tube preferably formed from metal. The use of metal helps to provide a balloon dilatation catheter with a small profile. The metal used for 30 the proximal tube can be made from, for example, stainless steel hypotube, a superelastic alloy such as nitinol, nickel and its alloys, or titanium and its alloys or any other biocompatible metal. The distal portion or transition zone of the metallic proxirnal tube has one or more perforations or slots formed therein to increase the flexibility of the distal portion. This increased flexibility of the distal porrtion of the proximal tube facilitates the transition from the relatively stiff poniOn to a more flexible portion and avoids a region of high stress concenl.z,lion. Pleferably the transition zone is formed with a plurality of discrete peiforalions a.,anged generally in rows. The perforations in 5 one row are offset from the perforations in an adjacent row. In addition, preferably the perforations in one row extend at least partially into the space between the perforations in an adjacent row.
Although the present invention has particular applicability to balloon dilatalion catheters, it is also applic~ to other medical devices having the same requirements 10 of a stiff proximal portion, a flexible distal pOnion and a smooth l,ansilion between the stffl proximal portion and the flexible distal portion to avoid areas of high stress concer,l,~lion. For example, this invention could be used as part of a stent delivery catheter, guide catheter or diagnostic catheter.
Brief Descri~tion of the Drawinas The above and other objects and advantages of this invention will become apparent upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which like referel)ce characters refer to like parts throughout and in which:
FIG. 1 is a partial section side elevation view of one embodiment of an over the20 wire balloon dilatation catheter of this invention;
FIG. 2 is a partial section side elevation view of a second embodiment of an over the wire balloon dilatation catheter of this invention;
FIG. 3 is a partial section side elevation view of a third embodiment of a rapidexchange balloon dilatation catheter of this invention;
FIG. 4 is a sectional view taken along line 44 of FIG. 3;
FIG. 5 is a sectional view taken along line 5-5 of FIG. 3;
FIG. 6 is an enlarged per~pecti~/e view of the transition zone of the proximal inner tube of FIG. 1;
FIG. 7 is a perspective view of the proximal inner tube of FIG. 1.
FIG. 8. is a side elevation view of a portion of the transition zone of FIG. 6;
FIG. 9 is a partial section side elevation view of a fourth embodiment of a fixed-wire balloon dilatation catheter of this invention; and ~l 851 46 FIGS.10 through 14 are per~pe~,ti~e views of variations of the stiff proximal tube of this invention.
Detailed Deser~ iGn of the Invention The balloon dilatation catheter 10 depict~ ' in FIG. 1 has a coaxial tube designwith an inner gu!~2~;,e tube 20 surrounded by an outer i,lllation tube 30. The lumen defined by gu ~3~ .æ tube 20 is the gu ~ev~:.e Iumen 25. The annular space formed between guidew:.æ tube 20 and i.~llalion tube 30 defines the inflation lumen 35. The proximal end of guidewire tube 20 and inflation tube 30 are mounted in a standard manifold 15. A balloon 40 is mounted to the distal end of guidewire tube 20 and inflation tube 30. A soft bumper tip 50 can be affixed to the distal end of g~ ~ de-~,;. e tube 20. Bumper tip 50 can be formed from a relatively soft polymeric material such as polyethylene with a flex modulus of between 5000 psi and 100,000 psi (34.47 MPa and 689.48 MPa). (It is to be understood that all of the values for pressure and dimension provided herein relate to the use of the subject invention in a balloon dilatation catheter adapted for use in PTCA procedures. It is also to be understood that these values can vary depending on the particular application for the invention without deviating from the scope and spirit of the invention.) Bumper tip 50 minimizes the chances of vascular trauma when balloon catheter 10 is maneuvered through the vascular system to thetreatment site.
Inflation tube 30 may be a single tube piece or may be formed from multiple pieces as shown in FIG. 1. Using a single tube piece for inflation tube 30 facilitates manufacturability, improves reliability and masks the transition point of gu!~;aJ.i.æ tube 20 where multiple tube pieces are used for 9~ v-;.e tube 20. If multiple tube pieces are used for inflation tube 30, a proximal inflation tube 31 and a distal inflation tube 32 connected at its proximal end to the distal end of proximal inflation tube 31 are used.
By using multiple sections, the cha,acteri~lics of proximal inflation tube 31 and distal inflation tube 32 can be tailored to the requirements of catheter 10. Of course, where multiple sections are used for both inflation tube 30 and guidewire tube 20, distal inflation tube 32 could be formed from a single tube having a bilumen configuration, where the lumens are side by side ratherthan coaxial. In addition, the relative locations between the bonds in inflation tube 30 and guidewire tube 20 could vary so that they are radially aligned or one is proximal or distal to the other. As shown in FIG. 1, the wo 9s/24236 2 1 8 5 1 4 6 PCT/IB9S/00075 bond connecting the multiple pieces of inflation tube 30 is proximal to the area of the bond connectil,g the multiple pieces of g~ 'awire tube 20.
hlndliGn tube 30 should be flexible and lubricous and should be able to urithsland pressures in the range ot up to about 20 atmospheres (294 psi) (2.03 MPa) 5 ~,vhich is the maximum i~ltlaliGn pressure that may be used to inflate balloon 40.
Suitable nlal~r;&ls for i"n~t;on tube 30 include high density polyethylene, polyimide, and various other polymeric ~"ate,ials. These mat~ ls prefer~bly have a flex modulus in the range of 10,000 psi to 500,000 psi (68.95 MPa to 3447.36 MPa). In addition, a wall thickness in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and an 10 outer diameter in the range of 0.030 inches to 0.050 inches (0.76 mm to 1.27 mm) should be used for i"fldlion tube 30 to minimize the profile of catheter 10.
If multiple tube pieces are used for inflation tube 30, proximal i,ltlalion tube 31 should have the characterislics of inflation tube 30 described above. Distal i"flation tube 32, like proximal inflation tube 31, should be able to v~,ilhslal1cl pressures of up to 15 20 al" ,os~c heres (294 psi) (2.03 MPa). i lowever, distal inflation tube 32 should be more flexible than proximal i"tlat;on tube 31 to allow the distal portion of catheter 10 to be guided through the tortuous passages of the v~scul~tu~e. Suitable material for distal inflation tube 32 includes polyethylene or other polymers having a flex modulus in the range of 10,000 psi to 500,000 psi (68.94 MPa to 3447.4 MPa). Again the wall 20 thickness of distal i.ltlation tube 32 should be in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and distal inflation tube 32 should have an outer diameter in the range of 0.030 inches to 0.050 inches (0.76 mm to 1.27 mm) to minimize the profile of c~li,eter 10.
Where multiple tube pieces are used for inflation tube 30, the distal end of 25 proximal inflation tube 31 is bonded to the proximal end of distal inflation tube 32 by heat. Although heat bonding is preferred, any suitable bonding technique, such as the use of a chemical adhesive, could also be used.
The proximal neck of balloon 40 is bonded adjacent the distal end of distal inflation tube 32. Altematively, if a single tube piece is used, the proximal neck of 30 balloon 40 is bonded adjacent the distal end of inflation tube 30. Again, heat bonding is preferred although other suitable bonding techniques can be used.
Although 9~ ~ dw;. e tube 20 may be a single tube piece, it is preferably formed from multiple pieces. ~leferclbly a proximal guidewire tube 21 and a distal guidewire WO 9S/24236 PCT/IB9~/00075 tube 22, having its proximal end connected to the distal end of proximal gu d~ii. e tube 21, are used. This m~tisection arrangement allows the characteristics of proximal al~ ~'cw;.e tube 21 and distal guidewire tube 22 to vary to meet the needs of catheter 10. Proximal g~ eJIi.e tube 21 is preferGbly stiff while distal guidewire tube 22 is 5 preferably flexible.
In order to provide sufficient stiffness to proximal 9~ ~:~'e .~i. e tube 21 so that the resulting catheter 10 has adequate pushability, proximal 9~ sw;.e tube 21 is formed from a metal such as stai.,less steel hypotube, a superelastic alloy such as nitinol, nickel and its alloys or titanium and its alloys or any other biocompatible metal. This 10 material provides proximal guidewire tube 21 with longitudinal stir~"ess, yet allows proximal guidewire tube 21 to have a wall thickness in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and an outer diameter in the range of 0.018 inches to 0.035 inches (0.46 mm to 0.89 mm) which minimizes the profile of catheter 10, maximizes the size of inflation lumen 35 and still allows a guidew;. e to pass through 15 gu~ w;.e lumen 25. Other stiff materials could also be used for proximal gu ~J,~;.e tube 21. Other suitably stiff materials include polyimide and polyether ether ketone (PEEK).
On the other hand, distal gl~tde~ri.e tube 22 should be flexible to track a guide~:.e through the tortuous v~sc~ tl~e. Distal gu dew;.e tube 22 may be made 20 from polyethylene and other polymers having a flex modulus in the range of 10,000 psi to 500,000 psi (68.94 MPa to 3447.3 MPa). In addition, the wall thickness of distal guidewire tube 22 should be in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and an outer diameter in the range of 0.018 inches to 0.03 inches (0.046 mm to 0.076 mm). As discussed above, distal 9~ ~ devl:. e tube 22 could be formed from 25 a tube having a bilumen configuration rather than being part of a coaxia1 tube arrangement where multiple tube pieces are used for inflation tube 30. The proximal end of distal guidewire tube 22 is preferably placed against the distal end of proximal guidewire tube 21 in abutting relationship. A sleeve formed of the same material as distal gu ~ev:;.e tube 22 is placed over the distal portion of proximal guidewire tube 21 30 and the proximal portion of distal gu de~ e tube 22. This sleeve is adhered to the outer surface of proximal guidewire tube 21 and distal guidewire tube 22 by a chemical adhesive and/or heat bonding. Altematively, the proximal portion of distal gui~e~;~e wo 95J24236 2 1 ~ ~ 1 4 6 PCT/IB95100075 tube 22 can be placed over or inside the distal portion of proximal guidewire tube 21 and adhered to the outer or inner surface of proximal gu;dewi,e tube 21.
Although balloon dilatation call.eter 10 is described above as having a stffl proximal gu'dev::.e tube 21, preferably formed from metal, it is also possible to have 5 p,oxi",al inflation tube 31 formed from a stiff material, preferably metal. See FIG. 2. In such a case, proximal i,llldtion tube 31 would have the properties and characteristics described above for proximal g~u ~ev~ tube 21 and, conversely, proximal guo~e~ri.e tube 21 would have the properties and characteristics described above for proximal inflation tube 31. It is important to note, however, that if proximal inflation tube 31 is 10 formed from metal, the stiffness of the resulting catheter will be substantially greater than where proximal 9~ iewi.a tube 21 is formed from metal. This results from the increased size of the metal tube used. In certain circ~ tances, this substantialincrease in stiffness would be undesirable.
In addition, the balloon dilatation catheter could have a rapid exchange 15 configuration as shown in FIG. 3. Such a rapid exchange balloon dilatation call,eter 100 has a proximal single lumen shaft 110 and a stem 120 affixed to the distal end of proximal shaft 110, which together define the inflation lumen. In addition, a short ~ de~vi,e tube 130 which has a coaxial ar,angen,ent with stem 120 can be heat bonded to stem 120 to provide the configuration shown. Altematively, the stem and 20 gu odew:. e tube could be formed from a single bilumen tube piece that defines both the distal portion of the inflation lumen and the entire g~J .~'Wi. e lumen that extends through the balloon 140. The proximal neck of balloon 140 is bonded to stem 120 and the distal neck of balloon 140 is bonded to guidewire tube 130. As with balloon catheter 10, a soft bumper tip can be affixed to the distal end of gu ~w;re tube 130. In a 25 balloon dilatation cc~ ter of this configuration, proximal shaft 110 is formed of a stiff material, preferably metal.
Alternatively, the balloon ~ t~tion catheter could be of the fixed-wire type. See FIG. 9. Such a fixed-wire catheter 200 has a proximal single lumen shaft 210 and a stem 220 afffixed to the distal end of proximal shaft 210, which together define the 30 inflation lumen. A wire 230 is fixedly attached to catheter 200 and extends through the balloon 240. In the embodiment shown, wire 230 is bonded to proximal shaft 210. The proximal neck of balloon 240 is bonded to stem 220 and the distal neck of balloon 240 is bonded to wire 230. In the balloon dilatation catheter of.this configuration, proximal shaft 210 is formed from a stiff mate,ial, pr~ferably metal.
Although the pleseNl invention has particular ~plic~bility to balloon Ji~ t;on oalhetera, it is also ~FF'ic~ to other medical devices having the same requirements 5 of a stm proximal portion, a flexible distal portion and a smooth transition between the stiff proximal portion and the flexible distal portion to avoid areas of high stress concentlalion. For example, this invention could be used as part of a stent delivery catheter, guide catheter or diagnostic catheter.
Regardless of whether the stiff, preferably metallic, tube is used as proximal 10 inflation tube 31 or proximal guidewire tube 21 in an over the wire catheter 10, as proximal shaft 110 in a rapid exchange catheter 100, as proximal shaft 210 in a fixed-wire catheter 200 or as a proximal tube in some other medical device, the l,ansilion between the stiff, preferably metallic, tube and the distal more flexible tube presents an abrupt change in the hardness and flexibility of the assembly. Unless properly 15 designed, this transition could become the location for kinking or other catastrophic failure of the device. A smoother transition can be provided by designing the distal portion of the stiff, preferably metallic, tube so that the flexibility of the stiff, preferably metallic, tube increases toward its distal end.
The ~liscussion that follows focuses on proximal 9~ ~IPw:re tube 21. However, 20 it is to be understood that the discussion applies equally well to proximal inflation tube 31, proximal shaft 110, proximal shaft 210 and any stiff tube in a medical device where it is desirable for one end of that tube to be more flexible than the other end.One means of increasing the flexibility of the distal portion of proximal guidewire tube 21 is to perforate the distal portion of proximal guidewire tube 21 as seen in FIG.
25 1 to create a transition zone that is more flexible than the proximal portion of proximal guidewire tube 21. The perforations preferably extend along the distal most two to three inches (5.08 to 7.62 cm) of proximal guidewire tube 21. Of course, the transition zone could be longer or shorter as desired. The exact shape, size, depth, spacing and pattern of these perforations should be chosen to increase the flexibility and minimize 30 stress and material fatigue of the distal portion of proximal guidewire tube 21 without comprolni~i"g its structural integrity or promoting kinking in that region.
One important factor that helps to identify whether these characteristics are met is by analyzing the area moments of inertia of incremental cross sections of proximal WO 95/24236 PCT~9S/00075 ~- 21 851 46 gu ~w;re tube 21 perpendicular to its longitudinal axis. The area moment of inertia is d~fi"ed as I y2 dA
where Y is the di~t~nce to the longitudinal axis and A is the area. This area moment 5 of inertia can be reduced by reducing the cross-se~ tional area of proximal guidewire tube 21. Reducing the area moment of inertia decreases the stiffness of proximal9,, 1ew:. e tube 21 at that point. rl ~ferably the area moments of inertia should decrease gradually, not abruptly. In addition, the area moments of inertia taken through substantially the entire iength of the transition zone should be less than the area 10 moments of inertia taken along the proximal portion of proximal guidewire tube 21.
This ensures that the slin"ess of proximal guidewire tube 21 gradually decreases to approach the stfflness of distal guidewire tube 22.
Another important factor to help identify whether proximal guidewire tube 21 hasthe appropriate characteristics to be used in a balloon dilatation catheter is the location 15 of the cenl,, d for the cross-section defined above in connection with the area moment of inertia. Preferably this centroid should be at or close to the longitudinal axis of proximal gu dev~i,e tube 21.
One particularly prefer,ed configuration for the bans;tion zone of proximal guidewire tube 21 is to have the peifo~lions arranged in rows with two pei ~ordtions in 20 each row. One perforation in each row should be located 180O from the other perforation in that row. Each pe,~r~lion in one row is offset from the perforations in the adjacent rows by 90O and extend at least partially into the space between the pe,~or~lions in an adjacent row. P,ef~lably the center to center distance between perforations in adjacent rows is 0.005 inches to 0.080 inches (0.13 mm to 2.03 mm).
25 This configuration ensures that throughout the majority of the length of the transition zone there are no complete annular bands of proximal gu ~ J~ire tube 21 defining a region with an area moment of inertia equal to the area moment of inertia of a cross section of proximal guidewire tube 21 taken along the proximal portion of proximal guidewire tube 21. Preferably an annular band is left at the very distal end of proximal 30 guidewire tube 21 for structural integrity. The perforations in every other row are aligned with each other along the longitudinal axis of proximal guidewire tube 21.
Where proximal 9~ Qwire tube 21 has an outer diameter of 0.025 inches (0.64 mm) each perforation preferably has a length (L) of 0.010 inches to 0.090 inches (0.25 mm WO 95/24236 PCT/IB95/0007~
21 ~51 46 ,~
to 2.29 mm). In addition, the ~islance (D) between the centers of each longitudinally aligned perforation is preferably 0.010 inches to 0.090 inches (0.25 mm to 2.29 mm).
Distance D could also vary along the rows of the perforations.
Each perforation is formed by electrodischarge machining. In this procedure, 5 guidnw:.e tube 21 is held in place and positioned with respect to the electrodischarge machine electrode to form the perforations. The ele_tlode moves toward gu i~v~i.e tube 21 at an angle of 30O to 60O to the longitudinal axis of proximal guidewire tube 21. The elect,ode extends to a depth ~Y) of 0.001 inches to 0.012 inches (0.025 mm to 0.30 mm) before being pulled away from the longitudinal axis of gu dew;.e tube 21 10 at an angle of 30O to 600. The resulting perforation has a beveled edge. Guidewire tube 21 is then rotated or moved along its longitudinal axis so another perforation can be formed. The perforations in the distal-most row are formed by pulling the ele_t.ode in the electrodischarge machine away from proximal gu d~w:. e tube 21 at a 90o angle to the longitudinal axis of proximal gu;dewi.e tube 21. The depth (Y) of the 15 perforations is less along the most proximal eight rows of perforations.
It is also possible to form the perforations into shapes, such as ovals, circles, rectangles or triangles which do not have beveled edges. These shapes may be formed by only moving the elect.G-Jischarge machine ele_tlode toward and away from proximal guidew:.e tube 21 at an angle of 90o to the longitudinal axis. These 20 perforations can be ar,Gnged in rows as shown in FIG. 10. Each row contains two perforations on opposite sides of proximal g~ v:. e tube 21, i.e. they are 180 degrees apart. Each peilora~ion in one row is offset from the perforations in the adjacent row by 90o. The perforations in every other row are aligned with each other along the longitudinal axis of guidewire tube 21. In addition, the spacing between adjacent rows 25 of perforations gradually decreases in the distal direction. Thus proximal gllideuli.e tube 21 increases in flexibility in the distal direction. Although not shown, it is to be understood that these perforations could also be arranged as shown in FIG. 7.
Another embodiment of this invention includes the use of one or more slots cut into the distal portion of proximal guidewire tube 21. See FIGS. 10-14. Any number 30 of slots could be located around the circumference of guidewire tube 21. These slots can also be tapered so that they increase in the distal direction. For ex~",ple, the embodiment shown in FIG. 11 uses two slots on opposite sides of the distal portion of guidewire tube 21 that gradually increase in size to a point just proximal of the distal end of guidewire tube 21. This leaves an annular ring at the distal end of gu!iev,/;re tube. Alternatively, the slots could extend to the very distal end of gl ~ d~ J.~i.e tube 21 so there would be no annular ring. See FIG. 13. In addition, instead of being tapered, the slots could have a uniform width or could be wavy. Again these slots could extend 5 to the very distal end of gu;dsw;.~ tube 21 as in FIG. 14, or could terminate just short of the distal end to leave an annular ring as in FIG. 13. The embodiment of FIG. 13 also shows a different number of slots. Moreover the slots could each have various lengths.
The perforations and slots described above can be formed by any standard 10 method. For example, electrodischarge machining, chemical etching, mechanicalcutting or grinding, or the use of an eximer laser could provide the desired configuration for the stiff, pr~ferably metallic, tube.
It is to be understood that the above description conceming the distal portion of proximal g~lide~:.e tube 21 can be applied to the entire length of proximal gl~l~rw:.e 15 tube 21 or any other length to increase the flexibility of that portion of pr~xi",al guidewire tube 21. This descl i~tion can also apply to any stiff, preferably metallic, tube of any type of medical device where a smooth l,ansition is needed between a stffl portion and a more flexible portion.
The proximal portion of distal guidewire tube 22 is connected to the distal end 20 of proximal g~ c~i,e tube 21. In order to make guDdeu;.e tube 20 fluid tight, a tube must cover the pe, f~,rd~iGns formed in the distal portion of proximal guidewire tube 21.
The proximal end of distal guidewire tube 22 is placed against the distal end of proximal guidewire tube 21. A sleeve that is formed of the same material used to form distal guidewire tube 22 is placed over the ~,ansilion zone of proximal guidewire tube 21 and 25 the proximal portion of distal guidewire tube 22. The sleeve is chemically bonded to proximal guidewire tube 21. In addition, the polymeric tube is heated to bond it to distal guidewire tube 22. This heating also melts the plastic of the sleeve so it extends into the depth of the perforations for a stronger bond between the sleeve and proximal guidewire tube 21. The plastic filled perforations facilitate guidewire movement through 30 proximal gu dew;~e tube 21 because the guidewire would not extend into any of the perforations. In addition, the fatigue resistance and stiffness of the transition zone increases when the perforations are filled with the plastic.
Thus it is seen that a catheter is provided that has a small profile, a flexible distal portion, a stffl proximal portion and a smooth tlansition from a stiff proximal portion to a flexible distal portion which avoids areas of high stress concent,~liGn. One skilled in the art will appreciate that the descril.ed embodiments are presented for purposes of 5 illu~lr~lion and not of limitation and the present invention is only limited by the claims which follow.
Background of the Invention This invention relates to an improved catheter, more particularly a balloon catheter for use in angioplasty. This invention is even more particularly adapted for use as a balloon d;~ tion catheter in percutaneous transluminal coronary an~,:Qplq~ty (PTCA). A PTCA procedure is used to dilate the stenosed region of a ~ise~eed coronary blood vessel. In a typical PTCA procedure, a guide catheter is introduced in a peripheral artery, such as the femoral artery, and advanced through the aorta until the distal end of the guide catheter is engaged with the coronary ostium for the coronary artery to be treated. Next a balloon r~ tA~ion catheter is introduced over a guidewire which has been introduced through the guide catheter. The gu;c~cwire is advanced past the distal end of the guide catheter within the lumen of the diseased vessel andmanipulated across the region of the slenosis. The balloon dilatation catheter is then advanced past the distal end of the guide catheter over the guidewire until the balloon is positioned across the sler,olic lesion. The balloon is inflated by supplying a fluid under pressure to the balloon through an inflation lumen in the catheter. Inflating the balloon stretches the d,~oas0d artery to ree~ I sh acceptable blood flow through the artery.
A typical over the wire balloon dilatation catheter has two lumens extending through substantially the entire length of the catheter. One lumen is used to pass the guidewire through the catheter and extends from a proximal guidewire port to a distal gl~ ~eu~i,e port located distal of the balloon. The other lumen is used to inflate and deflate the balloon and extends from a proximal inflation port adjacent to the proximal end of the catheter to a distal inflation port which is in communication with the balloon cavity.
A typical rapid exchange balloon dilatation catheter has a single inflation lumen extending from the proximal end of the catheter to the distal inflation port which is in communication with the balloon cavity. The guidewire lumen extends through only the most distal portion of the catheter from a proximal gu;c'ewire port, which is proximal of the balloon but distal to the proximal end of the calheler, to a distal guidewire port in 35 the distal end of the catheter. This configuration facilitates the maintenance of the location of the guidewire across the stenosis during catheter exchange.
21 ~51 46 A typical fixed-wire balloon dilatation catl,eter has a single lumen shaft that extends from the proximal end of the catheter to the proximal end of the balloon. A
wire is fixed in the catheter and extends past the distal end of the balloon which is connected thereto. The fixed-wire acts as the 9~ JeYI . a to steer the catheter so that 5 a separate gu ~ev.;.e is not needed.
In order for a balloon ~ tAtion call,eter optimally to perform Hs function in anangioplasty procedure, the catheter should have a small profile, a flexible distal portion and a stiff proximal portion. The small profile allows the catheter to be inserted into small arteries. A flexible distal portion allows that part of the catheter to pass through 10 the tortuous, tight curvatures of the vasculature. In addition, a stiff proximal portion gives the catheter ~pushability~, i.e. transr"ission of longitudinal force along the catheter, so a physician can push the catheter through the vascular system and the stenosis.
Finally the transition between the stiff proximal portion and the flexible distal portion should be smooth and should avoid areas of high stress concer,l,aliGn.
Balloon dilatation catheters currently on the market attempt to achieve these goals with varying degrees of success. I lowevcr, none has heretofore provided such an optimum combination of features.
Therefore it would be desirable to provide a balloon d;'~tAtion catheter that has a small profile. It would also be desi,able to provide a balloon dilatation call,eter 20 having a flexible distal portion.
It would be further desirable to provide a balloon dilatation catheter having a stiff proximal portion.
It would be yet further desirable to provide a balloon dilatation catheter that has a smooth transition from a stiff proximal portion to a flexible distal portion which avoids 25 areas of high stress concentration.
Summary of the Invention These and other objects of the invention are achieved by a balloon dilatation catheter having a stiff proximal tube preferably formed from metal. The use of metal helps to provide a balloon dilatation catheter with a small profile. The metal used for 30 the proximal tube can be made from, for example, stainless steel hypotube, a superelastic alloy such as nitinol, nickel and its alloys, or titanium and its alloys or any other biocompatible metal. The distal portion or transition zone of the metallic proxirnal tube has one or more perforations or slots formed therein to increase the flexibility of the distal portion. This increased flexibility of the distal porrtion of the proximal tube facilitates the transition from the relatively stiff poniOn to a more flexible portion and avoids a region of high stress concenl.z,lion. Pleferably the transition zone is formed with a plurality of discrete peiforalions a.,anged generally in rows. The perforations in 5 one row are offset from the perforations in an adjacent row. In addition, preferably the perforations in one row extend at least partially into the space between the perforations in an adjacent row.
Although the present invention has particular applicability to balloon dilatalion catheters, it is also applic~ to other medical devices having the same requirements 10 of a stiff proximal portion, a flexible distal pOnion and a smooth l,ansilion between the stffl proximal portion and the flexible distal portion to avoid areas of high stress concer,l,~lion. For example, this invention could be used as part of a stent delivery catheter, guide catheter or diagnostic catheter.
Brief Descri~tion of the Drawinas The above and other objects and advantages of this invention will become apparent upon consideration of the following detailed description taken in conjunction with the accompanying drawings, in which like referel)ce characters refer to like parts throughout and in which:
FIG. 1 is a partial section side elevation view of one embodiment of an over the20 wire balloon dilatation catheter of this invention;
FIG. 2 is a partial section side elevation view of a second embodiment of an over the wire balloon dilatation catheter of this invention;
FIG. 3 is a partial section side elevation view of a third embodiment of a rapidexchange balloon dilatation catheter of this invention;
FIG. 4 is a sectional view taken along line 44 of FIG. 3;
FIG. 5 is a sectional view taken along line 5-5 of FIG. 3;
FIG. 6 is an enlarged per~pecti~/e view of the transition zone of the proximal inner tube of FIG. 1;
FIG. 7 is a perspective view of the proximal inner tube of FIG. 1.
FIG. 8. is a side elevation view of a portion of the transition zone of FIG. 6;
FIG. 9 is a partial section side elevation view of a fourth embodiment of a fixed-wire balloon dilatation catheter of this invention; and ~l 851 46 FIGS.10 through 14 are per~pe~,ti~e views of variations of the stiff proximal tube of this invention.
Detailed Deser~ iGn of the Invention The balloon dilatation catheter 10 depict~ ' in FIG. 1 has a coaxial tube designwith an inner gu!~2~;,e tube 20 surrounded by an outer i,lllation tube 30. The lumen defined by gu ~3~ .æ tube 20 is the gu ~ev~:.e Iumen 25. The annular space formed between guidew:.æ tube 20 and i.~llalion tube 30 defines the inflation lumen 35. The proximal end of guidewire tube 20 and inflation tube 30 are mounted in a standard manifold 15. A balloon 40 is mounted to the distal end of guidewire tube 20 and inflation tube 30. A soft bumper tip 50 can be affixed to the distal end of g~ ~ de-~,;. e tube 20. Bumper tip 50 can be formed from a relatively soft polymeric material such as polyethylene with a flex modulus of between 5000 psi and 100,000 psi (34.47 MPa and 689.48 MPa). (It is to be understood that all of the values for pressure and dimension provided herein relate to the use of the subject invention in a balloon dilatation catheter adapted for use in PTCA procedures. It is also to be understood that these values can vary depending on the particular application for the invention without deviating from the scope and spirit of the invention.) Bumper tip 50 minimizes the chances of vascular trauma when balloon catheter 10 is maneuvered through the vascular system to thetreatment site.
Inflation tube 30 may be a single tube piece or may be formed from multiple pieces as shown in FIG. 1. Using a single tube piece for inflation tube 30 facilitates manufacturability, improves reliability and masks the transition point of gu!~;aJ.i.æ tube 20 where multiple tube pieces are used for 9~ v-;.e tube 20. If multiple tube pieces are used for inflation tube 30, a proximal inflation tube 31 and a distal inflation tube 32 connected at its proximal end to the distal end of proximal inflation tube 31 are used.
By using multiple sections, the cha,acteri~lics of proximal inflation tube 31 and distal inflation tube 32 can be tailored to the requirements of catheter 10. Of course, where multiple sections are used for both inflation tube 30 and guidewire tube 20, distal inflation tube 32 could be formed from a single tube having a bilumen configuration, where the lumens are side by side ratherthan coaxial. In addition, the relative locations between the bonds in inflation tube 30 and guidewire tube 20 could vary so that they are radially aligned or one is proximal or distal to the other. As shown in FIG. 1, the wo 9s/24236 2 1 8 5 1 4 6 PCT/IB9S/00075 bond connecting the multiple pieces of inflation tube 30 is proximal to the area of the bond connectil,g the multiple pieces of g~ 'awire tube 20.
hlndliGn tube 30 should be flexible and lubricous and should be able to urithsland pressures in the range ot up to about 20 atmospheres (294 psi) (2.03 MPa) 5 ~,vhich is the maximum i~ltlaliGn pressure that may be used to inflate balloon 40.
Suitable nlal~r;&ls for i"n~t;on tube 30 include high density polyethylene, polyimide, and various other polymeric ~"ate,ials. These mat~ ls prefer~bly have a flex modulus in the range of 10,000 psi to 500,000 psi (68.95 MPa to 3447.36 MPa). In addition, a wall thickness in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and an 10 outer diameter in the range of 0.030 inches to 0.050 inches (0.76 mm to 1.27 mm) should be used for i"fldlion tube 30 to minimize the profile of catheter 10.
If multiple tube pieces are used for inflation tube 30, proximal i,ltlalion tube 31 should have the characterislics of inflation tube 30 described above. Distal i"flation tube 32, like proximal inflation tube 31, should be able to v~,ilhslal1cl pressures of up to 15 20 al" ,os~c heres (294 psi) (2.03 MPa). i lowever, distal inflation tube 32 should be more flexible than proximal i"tlat;on tube 31 to allow the distal portion of catheter 10 to be guided through the tortuous passages of the v~scul~tu~e. Suitable material for distal inflation tube 32 includes polyethylene or other polymers having a flex modulus in the range of 10,000 psi to 500,000 psi (68.94 MPa to 3447.4 MPa). Again the wall 20 thickness of distal i.ltlation tube 32 should be in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and distal inflation tube 32 should have an outer diameter in the range of 0.030 inches to 0.050 inches (0.76 mm to 1.27 mm) to minimize the profile of c~li,eter 10.
Where multiple tube pieces are used for inflation tube 30, the distal end of 25 proximal inflation tube 31 is bonded to the proximal end of distal inflation tube 32 by heat. Although heat bonding is preferred, any suitable bonding technique, such as the use of a chemical adhesive, could also be used.
The proximal neck of balloon 40 is bonded adjacent the distal end of distal inflation tube 32. Altematively, if a single tube piece is used, the proximal neck of 30 balloon 40 is bonded adjacent the distal end of inflation tube 30. Again, heat bonding is preferred although other suitable bonding techniques can be used.
Although 9~ ~ dw;. e tube 20 may be a single tube piece, it is preferably formed from multiple pieces. ~leferclbly a proximal guidewire tube 21 and a distal guidewire WO 9S/24236 PCT/IB9~/00075 tube 22, having its proximal end connected to the distal end of proximal gu d~ii. e tube 21, are used. This m~tisection arrangement allows the characteristics of proximal al~ ~'cw;.e tube 21 and distal guidewire tube 22 to vary to meet the needs of catheter 10. Proximal g~ eJIi.e tube 21 is preferGbly stiff while distal guidewire tube 22 is 5 preferably flexible.
In order to provide sufficient stiffness to proximal 9~ ~:~'e .~i. e tube 21 so that the resulting catheter 10 has adequate pushability, proximal 9~ sw;.e tube 21 is formed from a metal such as stai.,less steel hypotube, a superelastic alloy such as nitinol, nickel and its alloys or titanium and its alloys or any other biocompatible metal. This 10 material provides proximal guidewire tube 21 with longitudinal stir~"ess, yet allows proximal guidewire tube 21 to have a wall thickness in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and an outer diameter in the range of 0.018 inches to 0.035 inches (0.46 mm to 0.89 mm) which minimizes the profile of catheter 10, maximizes the size of inflation lumen 35 and still allows a guidew;. e to pass through 15 gu~ w;.e lumen 25. Other stiff materials could also be used for proximal gu ~J,~;.e tube 21. Other suitably stiff materials include polyimide and polyether ether ketone (PEEK).
On the other hand, distal gl~tde~ri.e tube 22 should be flexible to track a guide~:.e through the tortuous v~sc~ tl~e. Distal gu dew;.e tube 22 may be made 20 from polyethylene and other polymers having a flex modulus in the range of 10,000 psi to 500,000 psi (68.94 MPa to 3447.3 MPa). In addition, the wall thickness of distal guidewire tube 22 should be in the range of 0.001 inches to 0.005 inches (0.025 mm to 0.13 mm) and an outer diameter in the range of 0.018 inches to 0.03 inches (0.046 mm to 0.076 mm). As discussed above, distal 9~ ~ devl:. e tube 22 could be formed from 25 a tube having a bilumen configuration rather than being part of a coaxia1 tube arrangement where multiple tube pieces are used for inflation tube 30. The proximal end of distal guidewire tube 22 is preferably placed against the distal end of proximal guidewire tube 21 in abutting relationship. A sleeve formed of the same material as distal gu ~ev:;.e tube 22 is placed over the distal portion of proximal guidewire tube 21 30 and the proximal portion of distal gu de~ e tube 22. This sleeve is adhered to the outer surface of proximal guidewire tube 21 and distal guidewire tube 22 by a chemical adhesive and/or heat bonding. Altematively, the proximal portion of distal gui~e~;~e wo 95J24236 2 1 ~ ~ 1 4 6 PCT/IB95100075 tube 22 can be placed over or inside the distal portion of proximal guidewire tube 21 and adhered to the outer or inner surface of proximal gu;dewi,e tube 21.
Although balloon dilatation call.eter 10 is described above as having a stffl proximal gu'dev::.e tube 21, preferably formed from metal, it is also possible to have 5 p,oxi",al inflation tube 31 formed from a stiff material, preferably metal. See FIG. 2. In such a case, proximal i,llldtion tube 31 would have the properties and characteristics described above for proximal g~u ~ev~ tube 21 and, conversely, proximal guo~e~ri.e tube 21 would have the properties and characteristics described above for proximal inflation tube 31. It is important to note, however, that if proximal inflation tube 31 is 10 formed from metal, the stiffness of the resulting catheter will be substantially greater than where proximal 9~ iewi.a tube 21 is formed from metal. This results from the increased size of the metal tube used. In certain circ~ tances, this substantialincrease in stiffness would be undesirable.
In addition, the balloon dilatation catheter could have a rapid exchange 15 configuration as shown in FIG. 3. Such a rapid exchange balloon dilatation call,eter 100 has a proximal single lumen shaft 110 and a stem 120 affixed to the distal end of proximal shaft 110, which together define the inflation lumen. In addition, a short ~ de~vi,e tube 130 which has a coaxial ar,angen,ent with stem 120 can be heat bonded to stem 120 to provide the configuration shown. Altematively, the stem and 20 gu odew:. e tube could be formed from a single bilumen tube piece that defines both the distal portion of the inflation lumen and the entire g~J .~'Wi. e lumen that extends through the balloon 140. The proximal neck of balloon 140 is bonded to stem 120 and the distal neck of balloon 140 is bonded to guidewire tube 130. As with balloon catheter 10, a soft bumper tip can be affixed to the distal end of gu ~w;re tube 130. In a 25 balloon dilatation cc~ ter of this configuration, proximal shaft 110 is formed of a stiff material, preferably metal.
Alternatively, the balloon ~ t~tion catheter could be of the fixed-wire type. See FIG. 9. Such a fixed-wire catheter 200 has a proximal single lumen shaft 210 and a stem 220 afffixed to the distal end of proximal shaft 210, which together define the 30 inflation lumen. A wire 230 is fixedly attached to catheter 200 and extends through the balloon 240. In the embodiment shown, wire 230 is bonded to proximal shaft 210. The proximal neck of balloon 240 is bonded to stem 220 and the distal neck of balloon 240 is bonded to wire 230. In the balloon dilatation catheter of.this configuration, proximal shaft 210 is formed from a stiff mate,ial, pr~ferably metal.
Although the pleseNl invention has particular ~plic~bility to balloon Ji~ t;on oalhetera, it is also ~FF'ic~ to other medical devices having the same requirements 5 of a stm proximal portion, a flexible distal portion and a smooth transition between the stiff proximal portion and the flexible distal portion to avoid areas of high stress concentlalion. For example, this invention could be used as part of a stent delivery catheter, guide catheter or diagnostic catheter.
Regardless of whether the stiff, preferably metallic, tube is used as proximal 10 inflation tube 31 or proximal guidewire tube 21 in an over the wire catheter 10, as proximal shaft 110 in a rapid exchange catheter 100, as proximal shaft 210 in a fixed-wire catheter 200 or as a proximal tube in some other medical device, the l,ansilion between the stiff, preferably metallic, tube and the distal more flexible tube presents an abrupt change in the hardness and flexibility of the assembly. Unless properly 15 designed, this transition could become the location for kinking or other catastrophic failure of the device. A smoother transition can be provided by designing the distal portion of the stiff, preferably metallic, tube so that the flexibility of the stiff, preferably metallic, tube increases toward its distal end.
The ~liscussion that follows focuses on proximal 9~ ~IPw:re tube 21. However, 20 it is to be understood that the discussion applies equally well to proximal inflation tube 31, proximal shaft 110, proximal shaft 210 and any stiff tube in a medical device where it is desirable for one end of that tube to be more flexible than the other end.One means of increasing the flexibility of the distal portion of proximal guidewire tube 21 is to perforate the distal portion of proximal guidewire tube 21 as seen in FIG.
25 1 to create a transition zone that is more flexible than the proximal portion of proximal guidewire tube 21. The perforations preferably extend along the distal most two to three inches (5.08 to 7.62 cm) of proximal guidewire tube 21. Of course, the transition zone could be longer or shorter as desired. The exact shape, size, depth, spacing and pattern of these perforations should be chosen to increase the flexibility and minimize 30 stress and material fatigue of the distal portion of proximal guidewire tube 21 without comprolni~i"g its structural integrity or promoting kinking in that region.
One important factor that helps to identify whether these characteristics are met is by analyzing the area moments of inertia of incremental cross sections of proximal WO 95/24236 PCT~9S/00075 ~- 21 851 46 gu ~w;re tube 21 perpendicular to its longitudinal axis. The area moment of inertia is d~fi"ed as I y2 dA
where Y is the di~t~nce to the longitudinal axis and A is the area. This area moment 5 of inertia can be reduced by reducing the cross-se~ tional area of proximal guidewire tube 21. Reducing the area moment of inertia decreases the stiffness of proximal9,, 1ew:. e tube 21 at that point. rl ~ferably the area moments of inertia should decrease gradually, not abruptly. In addition, the area moments of inertia taken through substantially the entire iength of the transition zone should be less than the area 10 moments of inertia taken along the proximal portion of proximal guidewire tube 21.
This ensures that the slin"ess of proximal guidewire tube 21 gradually decreases to approach the stfflness of distal guidewire tube 22.
Another important factor to help identify whether proximal guidewire tube 21 hasthe appropriate characteristics to be used in a balloon dilatation catheter is the location 15 of the cenl,, d for the cross-section defined above in connection with the area moment of inertia. Preferably this centroid should be at or close to the longitudinal axis of proximal gu dev~i,e tube 21.
One particularly prefer,ed configuration for the bans;tion zone of proximal guidewire tube 21 is to have the peifo~lions arranged in rows with two pei ~ordtions in 20 each row. One perforation in each row should be located 180O from the other perforation in that row. Each pe,~r~lion in one row is offset from the perforations in the adjacent rows by 90O and extend at least partially into the space between the pe,~or~lions in an adjacent row. P,ef~lably the center to center distance between perforations in adjacent rows is 0.005 inches to 0.080 inches (0.13 mm to 2.03 mm).
25 This configuration ensures that throughout the majority of the length of the transition zone there are no complete annular bands of proximal gu ~ J~ire tube 21 defining a region with an area moment of inertia equal to the area moment of inertia of a cross section of proximal guidewire tube 21 taken along the proximal portion of proximal guidewire tube 21. Preferably an annular band is left at the very distal end of proximal 30 guidewire tube 21 for structural integrity. The perforations in every other row are aligned with each other along the longitudinal axis of proximal guidewire tube 21.
Where proximal 9~ Qwire tube 21 has an outer diameter of 0.025 inches (0.64 mm) each perforation preferably has a length (L) of 0.010 inches to 0.090 inches (0.25 mm WO 95/24236 PCT/IB95/0007~
21 ~51 46 ,~
to 2.29 mm). In addition, the ~islance (D) between the centers of each longitudinally aligned perforation is preferably 0.010 inches to 0.090 inches (0.25 mm to 2.29 mm).
Distance D could also vary along the rows of the perforations.
Each perforation is formed by electrodischarge machining. In this procedure, 5 guidnw:.e tube 21 is held in place and positioned with respect to the electrodischarge machine electrode to form the perforations. The ele_tlode moves toward gu i~v~i.e tube 21 at an angle of 30O to 60O to the longitudinal axis of proximal guidewire tube 21. The elect,ode extends to a depth ~Y) of 0.001 inches to 0.012 inches (0.025 mm to 0.30 mm) before being pulled away from the longitudinal axis of gu dew;.e tube 21 10 at an angle of 30O to 600. The resulting perforation has a beveled edge. Guidewire tube 21 is then rotated or moved along its longitudinal axis so another perforation can be formed. The perforations in the distal-most row are formed by pulling the ele_t.ode in the electrodischarge machine away from proximal gu d~w:. e tube 21 at a 90o angle to the longitudinal axis of proximal gu;dewi.e tube 21. The depth (Y) of the 15 perforations is less along the most proximal eight rows of perforations.
It is also possible to form the perforations into shapes, such as ovals, circles, rectangles or triangles which do not have beveled edges. These shapes may be formed by only moving the elect.G-Jischarge machine ele_tlode toward and away from proximal guidew:.e tube 21 at an angle of 90o to the longitudinal axis. These 20 perforations can be ar,Gnged in rows as shown in FIG. 10. Each row contains two perforations on opposite sides of proximal g~ v:. e tube 21, i.e. they are 180 degrees apart. Each peilora~ion in one row is offset from the perforations in the adjacent row by 90o. The perforations in every other row are aligned with each other along the longitudinal axis of guidewire tube 21. In addition, the spacing between adjacent rows 25 of perforations gradually decreases in the distal direction. Thus proximal gllideuli.e tube 21 increases in flexibility in the distal direction. Although not shown, it is to be understood that these perforations could also be arranged as shown in FIG. 7.
Another embodiment of this invention includes the use of one or more slots cut into the distal portion of proximal guidewire tube 21. See FIGS. 10-14. Any number 30 of slots could be located around the circumference of guidewire tube 21. These slots can also be tapered so that they increase in the distal direction. For ex~",ple, the embodiment shown in FIG. 11 uses two slots on opposite sides of the distal portion of guidewire tube 21 that gradually increase in size to a point just proximal of the distal end of guidewire tube 21. This leaves an annular ring at the distal end of gu!iev,/;re tube. Alternatively, the slots could extend to the very distal end of gl ~ d~ J.~i.e tube 21 so there would be no annular ring. See FIG. 13. In addition, instead of being tapered, the slots could have a uniform width or could be wavy. Again these slots could extend 5 to the very distal end of gu;dsw;.~ tube 21 as in FIG. 14, or could terminate just short of the distal end to leave an annular ring as in FIG. 13. The embodiment of FIG. 13 also shows a different number of slots. Moreover the slots could each have various lengths.
The perforations and slots described above can be formed by any standard 10 method. For example, electrodischarge machining, chemical etching, mechanicalcutting or grinding, or the use of an eximer laser could provide the desired configuration for the stiff, pr~ferably metallic, tube.
It is to be understood that the above description conceming the distal portion of proximal g~lide~:.e tube 21 can be applied to the entire length of proximal gl~l~rw:.e 15 tube 21 or any other length to increase the flexibility of that portion of pr~xi",al guidewire tube 21. This descl i~tion can also apply to any stiff, preferably metallic, tube of any type of medical device where a smooth l,ansition is needed between a stffl portion and a more flexible portion.
The proximal portion of distal guidewire tube 22 is connected to the distal end 20 of proximal g~ c~i,e tube 21. In order to make guDdeu;.e tube 20 fluid tight, a tube must cover the pe, f~,rd~iGns formed in the distal portion of proximal guidewire tube 21.
The proximal end of distal guidewire tube 22 is placed against the distal end of proximal guidewire tube 21. A sleeve that is formed of the same material used to form distal guidewire tube 22 is placed over the ~,ansilion zone of proximal guidewire tube 21 and 25 the proximal portion of distal guidewire tube 22. The sleeve is chemically bonded to proximal guidewire tube 21. In addition, the polymeric tube is heated to bond it to distal guidewire tube 22. This heating also melts the plastic of the sleeve so it extends into the depth of the perforations for a stronger bond between the sleeve and proximal guidewire tube 21. The plastic filled perforations facilitate guidewire movement through 30 proximal gu dew;~e tube 21 because the guidewire would not extend into any of the perforations. In addition, the fatigue resistance and stiffness of the transition zone increases when the perforations are filled with the plastic.
Thus it is seen that a catheter is provided that has a small profile, a flexible distal portion, a stffl proximal portion and a smooth tlansition from a stiff proximal portion to a flexible distal portion which avoids areas of high stress concent,~liGn. One skilled in the art will appreciate that the descril.ed embodiments are presented for purposes of 5 illu~lr~lion and not of limitation and the present invention is only limited by the claims which follow.
Claims (31)
1. A catheter (10) comprising:
(a) an inner tube comprising (i) a proximal section having a distal end, the distal end having a substantially circular cross-section throughout its length and a first flexibility;
(ii) a distal section having a proximal end, the proximal end having a substantially circular cross-section throughout its length and a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (b) an outer tube positioned around the inner tube.
(a) an inner tube comprising (i) a proximal section having a distal end, the distal end having a substantially circular cross-section throughout its length and a first flexibility;
(ii) a distal section having a proximal end, the proximal end having a substantially circular cross-section throughout its length and a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (b) an outer tube positioned around the inner tube.
2. The catheter (10) of claim 1 wherein the transition section is metallic.
3. The catheter (10) of claim 1 wherein one or more of the openings have beveled edges.
4. The catheter (10) of claim 2 wherein one or more of the openings have beveled edges.
5. A catheter (10) comprising:
(a) an inner tube comprising;
(i) a non-perforated proximal section having a distal end with a first flexibility;
(ii) a non-perforated distal section having a proximal end with a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, b) an outer tube having a continuous surface positioned in co-axial relation about and bonded to the transition section.
(a) an inner tube comprising;
(i) a non-perforated proximal section having a distal end with a first flexibility;
(ii) a non-perforated distal section having a proximal end with a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, b) an outer tube having a continuous surface positioned in co-axial relation about and bonded to the transition section.
6. The catheter (10) of claim 5 wherein the transition section is metallic.
7. The catheter (10) of claim 5 wherein one or more of the openings have beveled edges.
8. The catheter (10) of claim 6 wherein one or more of the openings have beveled edges.
9. The catheter (10) of claim 5 wherein the outer tube is chemically bonded to the transition section.
10. The catheter (10) of claim 5 wherein the outer tube is plastic and extends into a depth of the one or more openings.
11. A balloon dilatation catheter (10) comprising:
(a) an inner tube comprising;
(i) a proximal section having a distal end with a first flexibility;
(ii) a distal section having a proximal end with a second flexibility; and, (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section;
(b) an outer tube positioned around and attached to the inner tube; and, (c) a balloon connected to the outer tube distal to the transition section.
(a) an inner tube comprising;
(i) a proximal section having a distal end with a first flexibility;
(ii) a distal section having a proximal end with a second flexibility; and, (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section;
(b) an outer tube positioned around and attached to the inner tube; and, (c) a balloon connected to the outer tube distal to the transition section.
12. The catheter (10) of claim 11 wherein the transition section is metallic.
13. The catheter (10) of claim 11 wherein one or more of the openings have beveled edges.
14. The catheter (10) of claim 12 wherein one or more of the openings have beveled edges.
15. A catheter (10) comprising:
(a) an inner tube comprising (i) a proximal section having a distal end, the distal end having a substantially circular and uninterrupted cross-section throughout its length and a first flexibility;
(ii) a distal section having a proximal end, the proximal end having a substantially circular and uninterrupted cross-section throughout its length and a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (b) an outer tube positioned around the inner tube and forming a lumen between the inner tube and outer tube.
(a) an inner tube comprising (i) a proximal section having a distal end, the distal end having a substantially circular and uninterrupted cross-section throughout its length and a first flexibility;
(ii) a distal section having a proximal end, the proximal end having a substantially circular and uninterrupted cross-section throughout its length and a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (b) an outer tube positioned around the inner tube and forming a lumen between the inner tube and outer tube.
16. The catheter (10) of claim 15 wherein the transition section is metallic.
17. The catheter (10) of claim 15 wherein one or more of the openings have beveled edges.
18. A catheter (10) comprising:
(a) an inner tube comprising;
(i) a non-perforated proximal section having a distal end with a first flexibility;
(ii) a non-perforated distal section having a proximal end with a second flexibility;
(iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (iv) a sleeve bonded to the transition section; and b) an outer tube positioned around the inner tube and forming a lumen between the inner tube and outer tube.
(a) an inner tube comprising;
(i) a non-perforated proximal section having a distal end with a first flexibility;
(ii) a non-perforated distal section having a proximal end with a second flexibility;
(iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (iv) a sleeve bonded to the transition section; and b) an outer tube positioned around the inner tube and forming a lumen between the inner tube and outer tube.
19. The catheter (10) of claim 18 wherein the transition section is metallic.
20. The catheter (10) of claim 18 wherein the sleeve is chemically bonded to the transition section.
21. The catheter (10) of claim 18 wherein the sleeve is plastic and extends into a depth of the one or more openings.
22. A balloon dilatation catheter (10) comprising:
(a) an inner tube comprising;
(i) a proximal section having a distal end with a first flexibility;
(ii) a distal section having a proximal end with a second flexibility; and, (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section;
(b) an outer tube positioned around the inner tube and forming a lumen between the inner tube and outer tube; and (c) a balloon connected to the outer tube distal to the transition section of the inner tube.
(a) an inner tube comprising;
(i) a proximal section having a distal end with a first flexibility;
(ii) a distal section having a proximal end with a second flexibility; and, (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section;
(b) an outer tube positioned around the inner tube and forming a lumen between the inner tube and outer tube; and (c) a balloon connected to the outer tube distal to the transition section of the inner tube.
23. The catheter (10) of claim 22 wherein the transition section is metallic.
24. A catheter (10) comprising:
(a) an inner tube; and (b) an outer tube positioned around the inner tube and forming a lumen between the outer tube and inner tube, the outer tube comprising:
(i) a proximal section having a distal end, the distal end having a substantially circular and uninterrupted cross-section throughout its length and a first flexibility;
(ii) a distal section having a proximal end, the proximal end having a substantially circular and uninterrupted cross-section throughout its length and a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section.
(a) an inner tube; and (b) an outer tube positioned around the inner tube and forming a lumen between the outer tube and inner tube, the outer tube comprising:
(i) a proximal section having a distal end, the distal end having a substantially circular and uninterrupted cross-section throughout its length and a first flexibility;
(ii) a distal section having a proximal end, the proximal end having a substantially circular and uninterrupted cross-section throughout its length and a second flexibility; and (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section.
25. The catheter (10) of claim 24 wherein the transition section is metallic.
26. A catheter (10) comprising:
(a) an inner tube; and (b) an outer tube positioned around the inner tube and forming a lumen between the outer tube and inner tube, the outer tube comprising:
(i) a non-perforated proximal section having a distal end with a first flexibility;
(ii) a non-perforated distal section having a proximal end with a second flexibility;
(iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (iv) a sleeve bonded to the transition section.
(a) an inner tube; and (b) an outer tube positioned around the inner tube and forming a lumen between the outer tube and inner tube, the outer tube comprising:
(i) a non-perforated proximal section having a distal end with a first flexibility;
(ii) a non-perforated distal section having a proximal end with a second flexibility;
(iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and, (iv) a sleeve bonded to the transition section.
27. The catheter (10) of claim 26 wherein the transition section is metallic.
28. The catheter (10) of claim 26 wherein the sleeve is chemically bonded to the transition section.
29. The catheter (10) of claim 26 wherein the sleeve is plastic and extends into a depth of the one or more openings.
30. A balloon dilatation catheter (10) comprising:
(a) an inner tube; and (b) an outer tube positioned around the inner tube and forming a lumen between the outer tube and inner tube, the outer tube comprising:
(i) a proximal section having a distal end with a first flexibility;
(ii) a distal section having a proximal end with a second flexibility; and, (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and (b) a balloon connected to the outer tube distal to the transition section of the outer tube.
(a) an inner tube; and (b) an outer tube positioned around the inner tube and forming a lumen between the outer tube and inner tube, the outer tube comprising:
(i) a proximal section having a distal end with a first flexibility;
(ii) a distal section having a proximal end with a second flexibility; and, (iii) a transition section intermediate the proximal section and the distal section, the transition section having one or more openings therein, with the transition section being configured to provide a flexibility which is greater than the first flexibility of the distal end of the proximal section and which flexibility is less than the second flexibility of the proximal end of the distal section; and (b) a balloon connected to the outer tube distal to the transition section of the outer tube.
31. The catheter (10) of claim 30 wherein the transition section is metallic.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US20934294A | 1994-03-10 | 1994-03-10 | |
| US08/209,342 | 1994-03-10 | ||
| PCT/IB1995/000075 WO1995024236A1 (en) | 1994-03-10 | 1995-02-02 | Catheter having shaft of varying stiffness |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2185146A1 CA2185146A1 (en) | 1995-09-14 |
| CA2185146C true CA2185146C (en) | 1999-08-17 |
Family
ID=22778387
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002185146A Expired - Fee Related CA2185146C (en) | 1994-03-10 | 1995-02-02 | Catheter having shaft of varying stiffness |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US5605543A (en) |
| EP (1) | EP0749333A1 (en) |
| JP (1) | JPH09504980A (en) |
| KR (1) | KR100186950B1 (en) |
| AU (1) | AU685575B2 (en) |
| BR (1) | BR9507017A (en) |
| CA (1) | CA2185146C (en) |
| FI (1) | FI963537A0 (en) |
| NO (1) | NO963777L (en) |
| WO (1) | WO1995024236A1 (en) |
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1995
- 1995-02-02 BR BR9507017A patent/BR9507017A/en not_active Application Discontinuation
- 1995-02-02 WO PCT/IB1995/000075 patent/WO1995024236A1/en not_active Application Discontinuation
- 1995-02-02 CA CA002185146A patent/CA2185146C/en not_active Expired - Fee Related
- 1995-02-02 AU AU14646/95A patent/AU685575B2/en not_active Ceased
- 1995-02-02 EP EP95906456A patent/EP0749333A1/en not_active Withdrawn
- 1995-02-02 KR KR1019960705009A patent/KR100186950B1/en not_active IP Right Cessation
- 1995-02-02 JP JP7523328A patent/JPH09504980A/en active Pending
-
1996
- 1996-01-30 US US08/594,355 patent/US5605543A/en not_active Expired - Lifetime
- 1996-09-09 NO NO963777A patent/NO963777L/en unknown
- 1996-09-09 FI FI963537A patent/FI963537A0/en unknown
- 1996-11-07 US US08/745,073 patent/US5743876A/en not_active Expired - Lifetime
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| KR100186950B1 (en) | 1999-04-01 |
| NO963777D0 (en) | 1996-09-09 |
| AU1464695A (en) | 1995-09-25 |
| FI963537A (en) | 1996-09-09 |
| US5605543A (en) | 1997-02-25 |
| BR9507017A (en) | 1997-09-09 |
| MX9603977A (en) | 1997-09-30 |
| JPH09504980A (en) | 1997-05-20 |
| US5743876A (en) | 1998-04-28 |
| WO1995024236A1 (en) | 1995-09-14 |
| KR970701574A (en) | 1997-04-12 |
| NO963777L (en) | 1996-11-04 |
| FI963537A0 (en) | 1996-09-09 |
| AU685575B2 (en) | 1998-01-22 |
| EP0749333A1 (en) | 1996-12-27 |
| CA2185146A1 (en) | 1995-09-14 |
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