WO2001012258A9 - Cardiac stimulation lead with dual pitch fixation apparatus - Google Patents
Cardiac stimulation lead with dual pitch fixation apparatusInfo
- Publication number
- WO2001012258A9 WO2001012258A9 PCT/US2000/040562 US0040562W WO0112258A9 WO 2001012258 A9 WO2001012258 A9 WO 2001012258A9 US 0040562 W US0040562 W US 0040562W WO 0112258 A9 WO0112258 A9 WO 0112258A9
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- corkscrew
- lead
- electrode
- pitch
- sleeve
- Prior art date
Links
- 230000000747 cardiac effect Effects 0.000 title abstract description 36
- 230000000638 stimulation Effects 0.000 title description 5
- 230000009977 dual effect Effects 0.000 title description 2
- 239000004020 conductor Substances 0.000 claims description 34
- 238000000034 method Methods 0.000 claims description 15
- 239000000463 material Substances 0.000 description 18
- 239000011295 pitch Substances 0.000 description 17
- 239000000853 adhesive Substances 0.000 description 12
- 230000001070 adhesive effect Effects 0.000 description 12
- 238000003466 welding Methods 0.000 description 12
- 210000001124 body fluid Anatomy 0.000 description 5
- 239000010839 body fluid Substances 0.000 description 5
- 229920001296 polysiloxane Polymers 0.000 description 5
- 238000002513 implantation Methods 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 230000007246 mechanism Effects 0.000 description 4
- 239000010935 stainless steel Substances 0.000 description 4
- 229910001220 stainless steel Inorganic materials 0.000 description 4
- 239000011800 void material Substances 0.000 description 4
- 239000007799 cork Substances 0.000 description 3
- 238000002788 crimping Methods 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 210000001174 endocardium Anatomy 0.000 description 3
- 229920002635 polyurethane Polymers 0.000 description 3
- 239000004814 polyurethane Substances 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 238000012795 verification Methods 0.000 description 3
- IMNFDUFMRHMDMM-UHFFFAOYSA-N N-Heptane Chemical compound CCCCCCC IMNFDUFMRHMDMM-UHFFFAOYSA-N 0.000 description 2
- 239000004642 Polyimide Substances 0.000 description 2
- -1 for example Substances 0.000 description 2
- 230000004941 influx Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 230000002107 myocardial effect Effects 0.000 description 2
- 210000002445 nipple Anatomy 0.000 description 2
- 230000037361 pathway Effects 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 229920001721 polyimide Polymers 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000004065 semiconductor Substances 0.000 description 2
- 241000237858 Gastropoda Species 0.000 description 1
- 229910000566 Platinum-iridium alloy Inorganic materials 0.000 description 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000006227 byproduct Substances 0.000 description 1
- 210000000038 chest Anatomy 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- HTXDPTMKBJXEOW-UHFFFAOYSA-N dioxoiridium Chemical compound O=[Ir]=O HTXDPTMKBJXEOW-UHFFFAOYSA-N 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000010292 electrical insulation Methods 0.000 description 1
- 239000012777 electrically insulating material Substances 0.000 description 1
- 238000002594 fluoroscopy Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 239000011810 insulating material Substances 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 229910052741 iridium Inorganic materials 0.000 description 1
- GKOZUEZYRPOHIO-UHFFFAOYSA-N iridium atom Chemical compound [Ir] GKOZUEZYRPOHIO-UHFFFAOYSA-N 0.000 description 1
- 229910000457 iridium oxide Inorganic materials 0.000 description 1
- 238000002955 isolation Methods 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229910052697 platinum Inorganic materials 0.000 description 1
- HWLDNSXPUQTBOD-UHFFFAOYSA-N platinum-iridium alloy Chemical class [Ir].[Pt] HWLDNSXPUQTBOD-UHFFFAOYSA-N 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 230000007480 spreading Effects 0.000 description 1
- 239000010936 titanium Substances 0.000 description 1
- 229910052719 titanium Inorganic materials 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N1/0573—Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N1/057—Anchoring means; Means for fixing the head inside the heart
- A61N2001/058—Fixing tools
Definitions
- This invention relates generally to cardiac stimulator leads, and more particularly to a cardiac stimulator lead having an extendable and retractable screw-in fixation mechanism.
- Conventional cardiac stimulator systems consist of a cardiac stimulator and at least one elongated flexible cardiac lead that is connected proximally to a header structure on the cardiac stimulator and is implanted distally at one or more sites within the heart requiring cardiac stimulation or sensing.
- the cardiac stimulator is normally a pacemaker, a cardioverter/defibrillator, a sensing instrument, or some combination of these devices.
- the distal end of a cardiac lead is inserted through an incision in the chest and manipulated by the physician to the site requiring electrical stimulation with the aid of a flexible stylet that is removed prior to closure.
- the distal end of the lead is anchored to the endocardium by an active mechanism, such as a screw-in electrode tip, or alternatively, by a passive mechanism, such as one or more radially spaced tines.
- the proximal end of the lead is then connected to the cardiac stimulator and the incision is closed.
- the implantation route and site are usually imaged in real time by fluoroscopy to confirm proper manipulation and placement of the lead.
- a conventional cardiac stimulator lead normally consists of an elongated, flexible, tubular, electrically insulating sleeve that is connected proximally to a connector that is adapted to couple to the header of a cardiac stimulator, and distally to a tubular tip electrode.
- One or more ring-type electrodes may be secured to the sleeve at various positions along the length of the sleeve.
- the proximal end of the lead sleeve is connected to the connector by application of various biocompatible adhesives to various portions of the connector and the sleeve.
- the tip electrode ordinarily consists of a tubular structure that has an increased diameter portion that forms an annular shoulder against which the distal end of the lead sleeve abuts.
- the exterior surface of the tubular structure is normally smooth, as is the interior surface of the distal end of the lead sleeve.
- the most common method of verifying a proper engagement of the endocardium by the corkscrew is by touch. Following deployment of the corkscrew, the physician applies a gentle, axial, tensile force on the lead connector. An absence of appreciable longitudinal movement of the lead is ah indication that the corkscrew has successfully penetrated and engaged the tissue. However, a sudden longitudinal movement of the lead is an indication that the corkscrew either did not engage enough tissue or did not engage any tissue at all. In such circumstances, the physician must retract the corkscrew, reposition the tip of the lead proximate the targeted tissue, and redeploy the corkscrew.
- the corkscrew may deploy and either not engage any tissue at all or only penetrate a small distance into the tissue. In the former situation, the corkscrew will have to be retracted and second attempt made. In the latter scenario, two undesirable outcomes may result. First, a less than optimum amount of tissue penetration may result.
- minimal tissue penetration by a fully extended corkscrew may resu t n t e con uc ng p o e e ec ro e av ng on y nterm en p ys ca contact with the targeted tissue or no contact at all.
- the present invention is directed to overcoming or reducing the effects of one or more of the foregoing disadvantages.
- a cardiac stimulator lead in accordance with one aspect of the present invention, includes a connector for connecting to a cardiac stimulator and a tubular insulating sleeve that has a first end coupled to the connector and a second end.
- An electrode is coupled to the second end and has a longitudinal bore.
- a washer is disposed in the bore for restricting the influx of body fluids into the sleeve.
- a conductor wire is disposed in the sleeve and coupled between the connector and the electrode for transmitting electric signals between the cardiac stimulator and the electrode.
- a corkscrew is coupled to the electrode and is extendable from and retractable into the bore.
- the lead includes means for transmitting torque from the pin member to the corkscrew.
- the cork screw has a selected pitch and is mounted on a threaded shaft. Threads on the shaft have a different pitch from the pitch of the cork screw, preferably a pitch less than that of the cork screw, and most preferably a pitch about half that of the corkscrew.
- the corkscrew When the corkscrew is advanced out of the lead, it engages the cardiac wall. Because of the larger pitch of the corkscrew, the corkscrew drives into the heart wall faster than the corkscrew is exposed outside the tip of the lead. This pulls the lead tip securely against the heart wall. If the tip is also an electrode, a better electrical connection is made between the electrode and the heart.
- FIG. 1 is a pictorial view of an exemplary embodiment of a cardiac stimulator lead and a cardiac stimulator in accordance with the present invention
- FIG. 2 is a cross-sectional view of the cardiac lead of FIG. 1 taken at section 2-2 in accordance with the present invention
- FIG. 4 is a cross-sectional view of FIGS. 2 and 3 taken at section 4-4 in accordance with the present invention
- FIG. 5 is a close-in view of a portion of the lead shown in FIG. 2 depicting another portion of the connector in accordance with the present invention
- FIG. 6 is a cross-sectional view of FIG. 1 taken at section 6-6 in accordance with the present invention.
- FIG. 1 there ft shown an exemplary cardiac stimulator lead 10 that includes a flexible insulating sleeve 12 that has a proximal end 14 coupled to a connector 16, and a distal end 18 coupled to a tip electrode 20.
- the connector 16 is designed to be inserted into a cardiac stimulator 24, and is shown highly exaggerated in size relative to the cardiac stimulator 24.
- the cardiac stimulator 24 may be a pacemaker, a cardioverter/defibrillator, or other type of stimulator or a sensing instrument.
- the tip electrode 20 includes a tip 25 and a corkscrew 26 projectable therefrom to engage and actively secure the lead 10 to myocardial tissue.
- the illustrated embodiment of the lead 10 is bipolar. Accordingly, the distal end 18 is provided with an electrode 27 located proximal to the tip electrode 20. However, unipolar or other multi-polar arrangements are possible as well.
- a suture sleeve 28 is slipped over the sleeve 12. During implantation, the suture sleeve 28 is sewn to body tissue at the site of transvenous entry.
- the sleeve 12 is a flexible tubular member that provides a robust, electrically insulating coupling between the connector 16 and the electrode 20.
- the sleeve 12 protects one or more fine gage conductor wires enclosed therein from body fluids and tissues, and is advantageously composed of a biocompatible, electrically insulating material, such as silicone, polyurethane, or like materials.
- the connector 16 includes a connector pin assembly 30 coupled to a connector sleeve assembly 32.
- the connector pin assembly 30 includes a tubular pin member 34 that has an elongated proximal end 36 designed to make electrical contact with one or more electrical contacts inside the cardiac stimulator 24 depicted in FIG. 1, and serves as a handle for twisting the pin 34 to manipulate the corkscrew 26 as described below.
- the distal end of the pin 34 consists of an intermediate shank 38 that tapers down from the proximal end 36 to establish an annular shoulder 37, an intermediate shank 39, and a distal shank 40.
- the intermediate shank 39 is suitably sized to accommodate the nested coils of a conductor wire 42 and another conductor wire 44.
- the distal shank 40 is sized to receive the coils of a torque coil 48.
- the wire 42 is electrically connected distally to the tip electrode 20 depicted in FIG. 1, and the wire 44 is electrically connected distally to the annular electrode 27 depicted in FIG. 1.
- a lumen 46 extends through the pin member 34.
- a first insulating sleeve 50 is coupled to the exterior of the pin member 34.
- the first insulating sleeve 50 includes longitudinally spaced-apart O-rings 52 and 54 that are designed to engage structures within the cardiac stimulator 24 shown in FIG. 1 and to provide a seal for the pin member 34 against the intrusion of body fluids following implantation.
- a single O-ring may be used in place of the pair 52 and 54.
- the first insulating sleeve 50 is provided with a proximally facing chamfer surface 56 that is principally designed to provide a tapered surface to facilitate easy insertion of the connector 16 into the cardiac stimulator 24 shown in FIG. 1.
- the distal end of the first insulating sleeve 50 includes a distally facing annular surface 58 against which the conductor sleeve assembly 32 is abutted when the connector 16 is assembled.
- the first insulating sleeve 50 is advantageously composed of a biocompatible flexible material that may be advantageously injection molded around the pin member 34.
- the material may be silicone, polyurethane, or like materials.
- the O-rings 52 and 54 may be formed integrally with the first insulating sleeve 50.
- the first insulating sleeve 50 may be provided with external grooves and the O-rings 52 and 54 secured to the first insulating sleeve 50 as separate members.
- annular member 62 is disposed around a reduced diameter portion the conductor wire 44 is attached and which provides an electrical pathway between the wire 44 and a contact (not shown) within the cardiac stimulator 24 shown in FIG. 1.
- the annular member 62 includes a proximally projecting reduced diameter nipple 68 that projects into the first insulating sleeve 50.
- the nipple has two or more circumferentially spaced ports 70 and 72 that enable molded structure to harden therein and provide a secure mechanical engagement between the first insulating sleeve 50 and the annular member 62.
- the flag 66 is provided with an external circumferential groove 74 that is dimensioned to receive the stripped end 76 of the conductor wire 44. The stripped end 76 is secured to the flag 66 by laser welding or like welding techniques.
- the sleeve 12 is provided with a longitudinally extending slot 77 that is slightly wider than the outer diameter of the wire 44.
- the slot 77 provides a space to accommodate the wire 44 so that the sleeve 12 may be pushed past the wire 44 and abutted against the reduced diameter portion 64.
- Electrical connection between the conductor wire 42 and the pin member 34 is established by a cylindrical contact sleeve 78 through which the pin member 34 is journalled and which is disposed partially within the annular member 62.
- the contact sleeve 78 abuts proximally against the reduced diameter portion 64 and is provided distally with an inwardly tapering portion 80 that engages a notch in the pin member 34 at 82.
- the engagement between the tapered portion 80 and the notch 82 serves to retain the pin member 34 within the connector pin assembly 30.
- the pin member 34 is rotated to extend and/or retract the corkscrew 26 depicted in FIG. 1.
- the fit provided between the tapered portion 80 and the notch 82 is such that the pin member 34 may readily be rotated relative to the fixed contact sleeve 78 while still mamtaining sufficient contact between the pin member 34 and the contact sleeve 80 such that electrical conductivity between the conductor wire 42 and the pin member 34 is retained.
- the wire 42 is stripped at 84 and secured to the contact sleeve 78 by laser welding or like techniques.
- Electrical isolation between the annular member 62 and the contact sleeve 78 is provided by an annular bushing 86 that includes distally disposed annular flange 88 shoulders against the distal end of the annular member 62.
- the flange is not coextensive with the entire circumference of the bushing 86.
- the flange 78 includes a cutout, best seen in FIG. 4, extending from the surface 90 to the surface 92. The cutout is provided to accommodate the flag 66.
- the embodiment depicted in FIGS. 1, 2, 3, and 4, is bipolar.
- a unipolar arrangement may be implemented by incorporating a single conductor wire, such as the wire 42, that is coupled to either the pin member 34 or to the flag 66.
- the conductor wires 42 and 44 are depicted as single individually insulated wires with insulation stripped prior to welding to contact sleeve 68 and the flag 66.
- the skilled artisan will appreciate that the conductor wires 42 and 44 may not be individually insulated if the lead 10 is unipolar or if the various conductor wires in the lead 10 are coaxially arranged or arranged in a nested configuration.
- the torque coil 48 is secured to the distal shank 40 by laser welding or like welding techniques.
- the pitch of the individual coils in the torque coil 48 is largely a matter of design discretion. The skilled artisan will appreciate that as the pitch of the coils is increased, the torque carrying capabilities of the coil 48 will decrease unless the stiffness of the material used to fabricate the coil 48 is proportionally increased.
- the torque coil 48 is advantageously composed of a biocompatible material with sufficient stiffness to readily transmit torque from the pin member 34 to the corkscrew 26 depicted in FIG. 1. Exemplary materials include MP35N alloy, 316L stainless steel, or like materials.
- the torque coil 48 and the wires 42 and 44 extend longitudinally through the lumen 93 of the sleeve 12 to the tip electrode 20.
- first insulating sleeve 50 and particularly the reduced diameter portion 64, as well as the bushing 86. It is anticipated that the material used to fabricate the first insulating sleeve 50 will readily fill the space, and provide a complete electrically insulating separation between the annular member 62 and the pin member 34. However, the skilled artisan will appreciate that there is the possibility of void formation during the molding process due to air bubbles or other mechanisms.
- an insulating annular member 94 may be slipped over the intermediate shank 38 and abutted proximally against the shoulder 37 prior to molding of the first insulating sleeve 50.
- the insulating annular member 94 may be composed of a variety of biocompatible insulating materials such as, for example, polyimide, polyurethane, or like materials.
- the connector sleeve assembly 32 includes a conductor sleeve 96 that is coupled to a second insulating sleeve 98.
- the second insulating sleeve 98 is a tubular member of such length and the scale of FIG. 2 is such that the second insulating sleeve 98 is shown broken.
- the conductor sleeve 96 includes a proximally disposed bore 100 that is dimensioned so that the conductor sleeve 96 may be readily slipped over the annular member 62 until the annular surface 102 of the conductor sleeve 96 abuts the annular shoulder 58 of the first insulating sleeve 50.
- the conductor sleeve 96 is designed to establish an electrical pathway between the annular member 62 and a conducting structure inside the cardiac stimulator 24 shown in FIG. 1. Accordingly, the fit between the internal diameter of the conductor sleeve 96 and the outer diameter of the annular member 62 should be close enough to provide good electrical contact.
- the conductor sleeve 96 is coupled to the annular member 62 by laser welding or like techniques.
- the proximal end 103 of the second insulating sleeve 98 is provided with two longitudinally spaced-apart O-rings 104 and 106 that serve to seal the conductor sleeve 96 against the intrusion of body fluids after the lead 10 is coupled to the cardiac stimulator 24 shown in FIG. 1.
- the O-rings 104 and 106 may be integrally molded into the second insulating sleeve 98 or attached as separate members.
- the second insulating sleeve 98 expands in diameter and defines a chamfer surface 108 that provides the same functionality as the chamfer surface 56, albeit in conjunction with a different portion of the internal structure of the cardiac stimulator 24 shown in FIG. 1.
- the internal diameter of the second insulating sleeve 98 is generally dimensioned to provide a sliding fit with the outer surface of the sleeve 12 to permit easy assembly.
- the second insulating sleeve 98 is secured to the sleeve 12 by a suitable biocompatible medical grade adhesive, such as silicone, or any of a variety of two s age a es ves. o ac a e e n ro uc on an sprea ng o e a es ve, t e secon insulating sleeve 98 is provided with a port 110. Adhesive is introduced into the port 110 under slight pressure to encourage the rapid and uniform spreading of the adhesive around the sleeve 12. The flow characteristics of the adhesive may be enhanced by thinning with a suitable diluent, such as heptane, prior to injection through the port 110. In addition, adhesive is back filled between the second insulating sleeve 98 and the sleeve 12 by injection under slight pressure at the interface designated 112.
- a suitable biocompatible medical grade adhesive such as silicone
- FIG. 5 is a magnified view of the portion of FIG. 2 circumscribed by the dashed oval 114. Note that in FIG. 5, the sleeve 12 is not shown for clarity of illustration.
- a central portion 116 of the conductor sleeve 96 is provided with a plurality of circumferentially spaced bores, six of which are depicted at 118, 120, 122, 124, 126, and 128.
- the bores 118, 120, 122, 124, 126, and 128 are designed to enable the material used to mold the second insulating sleeve 98 to flow into the bores 118, 129, 122, 124, 126, and 128 and harden into buttons 130, 132, 134, 136, 138, and 140.
- the engagement between the buttons 130, 132, 134, 136, 138, and 140 and the central portion 116 of the conductor sleeve 96 establishes a secure mechanical engagement between the conductor sleeve 96 and the second insulating sleeve 98.
- 98 is advantageously composed of the same types of materials used to fabricate the first insulating sleeve 50 shown in FIG. 2, and is advantageously injection molded.
- the pin member 34, the annular member 62, and the conductor sleeve 96 are advantageously composed of a biocompatible conducting material that may be welded via laser or like techniques.
- Exemplary materials include 316L stainless steel, other suitable types of stainless steel, MP35N, or like materials.
- the connector 16 depicted in FIGS. 1, 2, 3, 4, and 5, eliminates the necessity for the conventionally used tubular crimping members and the attendant difficulties in establishing consistent and reliable crimped connections between the conductor wires of the lead and the various crimping members. Reliable electrical and mechanical connection between the conductor wires 42 and 44 and the connector 16 are established by welding.
- FIG. 6 is a cross-sectional view of FIG. 1 taken at section 6-6, and to FIG. 7, which is a detailed view of a portion of FIG. 6.
- the electrode 20 consists of a tubular shank 141 coupled to another tubular shank 142 and sharing a common, centrally disposed bore 143.
- the shank 141 includes a proximally disposed flange 144 and a distally positioned flange
- the flange 145 abuts the proximal end 146 of the shank 142, and terminates short of the distal end of the shank 141 so that a distally facing annular shoulder 147 projects into the shank 142.
- the structure of the shanks 141 and 142 may be incorporated into a single piece.
- the distal coils 148 of the conductor wire 42 are spiraled around the shank 141 so that at least one coil 148 is disposed between the flange 144 and the flange 145. This provides a mechanical capture of the coil or coils 148 to secure the wire 42 to the shank 141.
- the wire 42 is stripped distally to establish a conductive path to the shank 141.
- the wire 42 is stripped distally to establish a conductive path to the shank 141.
- the corkscrew 26 is shown in a partially extended position in FIG. 6. The corkscrew
- the threaded shaft 160 is itself connected proximally to the torque coil 48 in a similar fashion. Rotation of the torque coil 48 causes the threaded shaft 160 to rotate. As the shaft 160 rotates, threads 162 on the shaft urge the corkscrew 26 to extend from or retract into the bore 143, depending on the direction of rotation and the type of threads, i.e., left or right handed.
- the threaded shaft 160 comprises a central core 164 with threads 162 on a central portion thereof.
- a distal end 166 of the core extends beyond the threads and passes through an annular washer 156, described below, the length of the distal end is sufficient to allow the corkscrew to be exposed outside the tip of the lead without the threads 162 encountering the washer 156.
- a proximal portion 168 of the central core may be provided proximal from the threads for securing the torque coil to the threaded shaft. The threads 162 on the threaded shaft engage female threads 170 on the inside of the bore 143.
- the pitch of the corkscrew be different from the pitch of the threads 162, more specifically, that the pitch of the corkscrew be greater than that of the threads 162. Because of this difference in pitch, the corkscrew will be exposed outside of the distal end of the lead at a slower rate than the rate at which the corkscrew will try to embed itself into an adjacent cardiac wall. The result will be that the distal end of the lead will be pulled into close contact with the cardiac wall, even if the corkscrew does not immediately pierce the wall as the corkscrew is exposed outside the distal tip of the lead. This results in an improved physical and electrical contact between the distal tip and the heart wall and makes it unlikely that the lead will need to be re-positioned.
- the pitch of the corkscrew should be no more than twice the pitch of the threads 162.
- annular washer 156 having a central aperture 158 is disposed inside the shank 142 and abutted against the annular shoulder 147 of the shank 141.
- the washer 156 is designed to provide some restriction to the influx of body fluids into the lumen 93 of the sleeve 12.
- the washer 156 may be composed of a variety of biocompatible flexible materials, such as, silicone, polyimide, or like materials.
- the aperture 158 is provided and sized to accommodate the torque coil 48.
- the shanks 141 and 142 are inserted into the distal end 18 of the sleeve 12.
- the tip 25 of the shank 142 is provided with an expanded diameter to establish a proximally facing annular shoulder 159 against which the distal end 18 is abutted.
- a biocompatible adhesive is applied to the exterior of the shanks 141 and 142 prior to insertion into the distal end 18 of the sleeve 12.
- the adhesive may be a suitable medical grade adhesive, such as silicone based adhesive, a two-part adhesive, or similar adhesives.
- the electrical transmission capability of the tip 25 is enhanced by increasing the surface thereof exposed to myocardial tissue.
- one or more slots 172 are provided in the face of the tip 25.
- e s an may e a ca e om a va e y o ocompa e con uct ng materials, such as iridium oxide coated titanium, MP35N, stainless steel, platinum-iridium alloy consisting of approximately 90% platinum and 10% iridium, or some other biocompatible conducting metal, or a semiconductor material, such as silicon, or other semiconductor material.
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU18181/01A AU1818101A (en) | 1999-08-03 | 2000-08-03 | Cardiac pacemaker lead with dual pitch fixation apparatus |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/366,401 | 1999-08-03 | ||
US09/366,401 US6269272B1 (en) | 1999-08-03 | 1999-08-03 | Cardiac pacemaker lead with dual pitch fixation apparatus |
Publications (3)
Publication Number | Publication Date |
---|---|
WO2001012258A2 WO2001012258A2 (en) | 2001-02-22 |
WO2001012258A3 WO2001012258A3 (en) | 2001-09-13 |
WO2001012258A9 true WO2001012258A9 (en) | 2001-10-04 |
Family
ID=23442858
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/040562 WO2001012258A2 (en) | 1999-08-03 | 2000-08-03 | Cardiac stimulation lead with dual pitch fixation apparatus |
Country Status (3)
Country | Link |
---|---|
US (1) | US6269272B1 (en) |
AU (1) | AU1818101A (en) |
WO (1) | WO2001012258A2 (en) |
Families Citing this family (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7027876B2 (en) | 2001-10-12 | 2006-04-11 | Medtronic, Inc. | Lead system for providing electrical stimulation to the Bundle of His |
US8000802B2 (en) * | 2002-04-22 | 2011-08-16 | Medtronic, Inc. | Implantable lead with coplanar contact coupling |
US7158838B2 (en) * | 2003-01-31 | 2007-01-02 | Medtronic, Inc. | Arrangement for implanting a miniaturized cardiac lead having a fixation helix |
US7286882B2 (en) * | 2003-10-03 | 2007-10-23 | Medtronic, Inc. | Implantable electrical connector system |
US7657326B2 (en) * | 2006-11-08 | 2010-02-02 | Cardiac Pacemakers, Inc. | Cardiac lead with a retractable helix |
US8112160B2 (en) * | 2007-12-14 | 2012-02-07 | Cardiac Pacemakers, Inc. | Fixation helix and multipolar medical electrode |
US20140018892A1 (en) * | 2012-07-16 | 2014-01-16 | St. Jude Medical Ab | Implantable medical lead |
WO2017180832A1 (en) * | 2016-04-15 | 2017-10-19 | Medtronic, Inc. | Medical device lead assembly with variable pitch coil |
US20220265998A1 (en) * | 2019-06-25 | 2022-08-25 | Verily Life Sciences Llc | Connectors For High Density Neural Interfaces |
Family Cites Families (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4106512A (en) | 1976-12-16 | 1978-08-15 | Medtronic, Inc. | Transvenously implantable lead |
DE2732547A1 (en) | 1977-07-19 | 1979-02-01 | Bisping Hans Juergen | IMPLANTABLE ELECTRODE |
US4538623A (en) | 1984-04-09 | 1985-09-03 | Medtronic, Inc. | Thread electrode assembly |
FR2575925B1 (en) * | 1985-01-16 | 1988-12-09 | Roudy Gil | ELECTRODE FOR HEART STIMULATION AND DETECTION PROBE |
EP0261582B1 (en) * | 1986-09-23 | 1992-12-16 | Siemens-Elema AB | Heart pacemaker electrode |
DE3712082A1 (en) * | 1987-04-09 | 1988-10-20 | Bisping Hans Juergen | Implantable electrode probe with extendable and retractable screwing electrode |
US5282845A (en) | 1990-10-01 | 1994-02-01 | Ventritex, Inc. | Multiple electrode deployable lead |
US5246014A (en) | 1991-11-08 | 1993-09-21 | Medtronic, Inc. | Implantable lead system |
US5324327A (en) | 1991-12-17 | 1994-06-28 | Cohen Donald M | Low threshold cardiac pacing lead |
US5300108A (en) | 1993-01-05 | 1994-04-05 | Telectronics Pacing Systems, Inc. | Active fixation lead with a dual-pitch, free spinning compound screw |
US5385579A (en) | 1993-03-30 | 1995-01-31 | Siemens Pacesetter, Inc. | Myocardial body implantable lead |
US5840031A (en) | 1993-07-01 | 1998-11-24 | Boston Scientific Corporation | Catheters for imaging, sensing electrical potentials and ablating tissue |
US5593433A (en) | 1994-12-19 | 1997-01-14 | Intermedics, Inc. | Implantable endocardial lead with self-healing retractable fixation apparatus |
SE9500273D0 (en) | 1995-01-26 | 1995-01-26 | Pacesetter Ab | Locking |
US5769858A (en) | 1995-10-20 | 1998-06-23 | Medtronic, Inc. | Locking stylet for extracting implantable lead or catheter |
US5851226A (en) | 1996-10-22 | 1998-12-22 | Medtronic, Inc. | Temporary transvenous endocardial lead |
-
1999
- 1999-08-03 US US09/366,401 patent/US6269272B1/en not_active Expired - Lifetime
-
2000
- 2000-08-03 AU AU18181/01A patent/AU1818101A/en not_active Abandoned
- 2000-08-03 WO PCT/US2000/040562 patent/WO2001012258A2/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
AU1818101A (en) | 2001-03-13 |
WO2001012258A2 (en) | 2001-02-22 |
US6269272B1 (en) | 2001-07-31 |
WO2001012258A3 (en) | 2001-09-13 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6108582A (en) | Cardiac pacemaker lead with extendable/retractable fixation | |
US6083216A (en) | Bent cardiac lead with shape memory torque coil | |
US4026303A (en) | Endocardial pacing electrode | |
US4142530A (en) | Epicardial lead | |
US5876431A (en) | Small cable endocardial lead with exposed guide tube | |
US5851227A (en) | Cardiac pacemaker cable lead | |
US7162310B2 (en) | Flat wire helix electrode used in screw-in cardiac stimulation leads | |
US5800496A (en) | Medical electrical lead having a crush resistant lead body | |
EP2424613B1 (en) | Implantable electric lead | |
US5716390A (en) | Reduced diameter active fixation pacing lead using concentric interleaved coils | |
US6370434B1 (en) | Cardiac lead and method for lead implantation | |
US8112160B2 (en) | Fixation helix and multipolar medical electrode | |
US6167314A (en) | Cardiac pacemaker lead with pacemaker connector | |
US9114251B2 (en) | Medical implantable lead and a method for attaching the same | |
US6038463A (en) | Medical electrical lead | |
US7983764B2 (en) | Co-radial lead with extendable/retractable fixation mechanism and apparatus therefor | |
JP2006507086A (en) | System for delivering implantable medical devices intravenously | |
US6016436A (en) | Medical electrical lead | |
US7031774B1 (en) | Switch for electrode selections in Single-pass Atrial/Ventricular leads | |
US6269272B1 (en) | Cardiac pacemaker lead with dual pitch fixation apparatus | |
JP5688469B2 (en) | Implantable medical electrical lead | |
US20140114387A1 (en) | Chatter-free active fixation lead | |
EP1017445B1 (en) | Medical electrical lead | |
WO2000027470A1 (en) | Cardiac lead with reduced inner crimp sleeve |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AK | Designated states |
Kind code of ref document: A2 Designated state(s): AU CA JP |
|
AL | Designated countries for regional patents |
Kind code of ref document: A2 Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE |
|
121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
AK | Designated states |
Kind code of ref document: A3 Designated state(s): AU CA JP |
|
AL | Designated countries for regional patents |
Kind code of ref document: A3 Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE |
|
AK | Designated states |
Kind code of ref document: C2 Designated state(s): AU CA JP |
|
AL | Designated countries for regional patents |
Kind code of ref document: C2 Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE |
|
COP | Corrected version of pamphlet |
Free format text: PAGES 1/4-4/4, DRAWINGS, REPLACED BY NEW PAGES 1/4-4/4; DUE TO LATE TRANSMITTAL BY THE RECEIVING OFFICE |
|
32PN | Ep: public notification in the ep bulletin as address of the adressee cannot be established |
Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 69(1)EPC-EPO FORM 1205 OF 23.12.02 |
|
122 | Ep: pct application non-entry in european phase | ||
NENP | Non-entry into the national phase |
Ref country code: JP |