Lumenless pervenous electrical lead and method of implantation

• US 4,585,013 A
• Filed: 05/18/1983
• Issued: 04/29/1986
• Est. Priority Date: 04/20/1981
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Harris, Donald L.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US06/495,636
• Time in Patent Office: 1,077 Days
• Field of Search: 128/784-786, 128/419 P, 128/640, 128/642
• US Class Current: 607/126
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

Abstract

A lead for connecting an electrical stimulation generator to an internal organ of the body via the vascular system includes a small diameter nonhollow multifilament lead body surrounded by a guide sleeve. The guide sleeve pushes against a sleeve stop at the distal end of the lead to impart axial motion to the lead with stylet-like action. After the lead electrode is properly positioned, the sleeve is removed by severing it longitudinally as it is pulled off of the lead. A plurality of radially deployable folding fins are arranged on the distal portion of the lead so that they can be wrapped around the lead body without overlap even though the combined length of the fins in one embodiment is greater than the circumference of the lead body. The electrically conductive core of the lead is preferably comprised of thousands of carbon filaments embedded in a resin matrix.

Claims

1. A pervenous lead system for establishing electrical contact between an electrical stimulation generator and an internal organ, comprising

an implantable lead with proximal and distal ends having a flexible substantially solid insulated lead body carrying at least one electrical conductor, said proximal end having means for electrically connecting the electrical stimulation generator to the electrical conductor, said lead having a portion of enlarged diameter toward the distal end and an electrode connected thereto in electrical contact with said conductor,

removable sleeve means slidably mounted on said lead body for applying axial force directly to the enlarged distal portion of said lead including a flexible guide sleeve disposed coaxially and slidably over substantially the entire length of said lead body with a uniform inner diameter between those of said lead body and the enlarged distal portion of said lead such that said sleeve is slidable into abutment with the enlarged distal portion of said lead so as to drive it forward when the sleeve is advanced from the proximal end,

said enlarged distal portion including guide sleeve stop means proximally spaced along said lead body from said electrode for blocking independent forward movement of the abutting end of the guide sleeve, and

a plurality of deployable flexible tissue-engaging projections extending outwardly from said lead body between said sleeve stop means and said electrode.

2. The lead system or claim 1, wherein said guide sleeve stop means includes a sleeve stop, and said projections fold against and conform to the adjacent circumference of the lead body between said sleeve stop and electrode without overlapping when said projections are bent in the same sense around said lead body.

3. The lead system of claim 2, wherein the outer diameter of said guide sleeve, sleeve stop means and electrode are approximately the same,

whereby the overall diameter of the lead with the guide sleeve in place and the projections wrapped around the circumference of the lead body is substantially uniform to accommodate a minimum size introducer sheath.

4. A pervenous lead system for establishing electrical contact between an electrical stimulation generator and an internal organ, comprising

an implantable lead with proximal and distal ends having a flexible insulated substantially solid lead body containing a plurality of electrically conductive flexible parallel carbon filaments embedded in a resin matrix longitudinally extending from the proximal to the distal end of said lead, said lead having a portion of enlarged diameter toward the distal end and an organ-contacting electrode electrically connected to said carbon filaments,

removable flexible sleeve means slidably mounted on said lead body for applying axial force directly to the enlarged distal portion of said lead while traveling through a blood vessel, and means at the proximal end for electrically connecting said carbon filaments to the generator, whereby the lead can be urged flexibly through a blood vessel with stylet-like action by externally manipulating said sleeve means.

5. The lead of claim 4, wherein said organ-contacting electrode has a larger diameter than said lead body.

6. The lead of claim 5, wherein said enlarged diameter portion comprises a raised, ring-like, circumferential projection on said lead body at the distal end axially spaced in the proximal direction from said organ-contacting electrode.

7. The lead of claim 6, further comprising a plurality of tissue-engaging, deployable flexible projections extending from plural locations on the lead body between said organ-contacting electrode and said ring-like projection.

8. The lead of claim 7, wherein the diameters of the ring-like projection and the organ-contacting electrode are substantially the same and said tissue-engaging projections are positioned and sufficiently flexible to fold against and conform to the circumference of the lead body, said projections having a maximum thickness less than the difference between the diameter of the organ-contacting electrode and ring-like projection on the one hand and the intermediate lead body on the other hand.

9. A method of implanting a lumenless electrical lead through the vascular system of the body, comprising the steps of

providing a lead system comprising a lead having a flexible, substantially solid, insulated, electrically conductive lead body with a proximal and distal end, said lead including a connector electrically connected to the proximal end of said lead body and an electrode assembly electrically connected to its distal end, said lead system further including a removable guide sleeve covering said lead body, the distal end portion of said lead having an enlargement acting as a guide sleeve stop,

introducing said lead system, distal end first, into a blood vessel through a removable introducer sheath,

removing the introducer sheath by severing it longitudinally while peeling it off of the lead system after a portion of the lead system has been inserted into the blood vessel,

driving the lead through the vascular system by pushing on the proximal end of the sleeve so that the distal end of the sleeve abuts against the sleeve stop and forces the distal end portion of the lead forward, and

after attaining the desired location for the distal portion of the lead, removing the guide sleeve from the lead body by severing the guide sleeve longitudinally while pulling it off of the lead body.

10. The method of claim 9, wherein said lead body has a resilient, preformed distal bend proximally spaced from said enlargement and the method further comprises the steps

covering and thereby straightening the bend with the guide sleeve while advancing the lead through the vascular system to a predetermined point therein,

partially retracting said guide sleeve to uncover and thereby deploy said preformed bend to assist in navigating a particular portion of the vascular system, and

resuming the advancing of said lead by sliding the sleeve into engagement with said sleeve stop thereby covering and restraightening the bend.

11. The method of claim 9, wherein the distal portion of said lead carries a plurality of flexible fins and the method further comprises the step of

twisting the lead axially while advancing the distal end of the lead through the introducer sheath to wrap the fins around the circumference of the lead without overlapping the fins.