US5755762A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Medical lead and method of making and using
Assignee: Pacesetter Inc
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Filing: 1996-06-14
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Granted: 1998-05-26
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Expires: 2016-06-14
Abstract
Abstract A continuous sheath of open-celled porous plastic, preferably ePTFE, is used on the outside of an implantable lead, extending along the lead body and the electrodes, in such a way that the lead is isodiametric along its length, and is very strong in tension as is required for lead removal. Because the plastic is open-celled, when the pores are filled with saline, the lead can deliver defibrillation energy through the pores in the plastic. Pore size is chosen to discourage tissue ingrowth while allowing for defibrillation energy delivery through it.
Inventors
- 👤 M. Elizabeth Bush
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 17:44
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/056; A61N1/057
Claims Analysis
Total Claims: 38
Claim 1
Independent Claim
86 words
An implantable medical lead comprising: a lead subassembly comprising an electrode, a conductor electrically coupled to said electrode, and a connector electrically coupled to a proximal end of said conductor; and a porous tubular covering extending over at least a portion of said electrode and at least a portion of said conductor, wherein said porous tubular covering has an outer surface pore size such that said porous tubular covering substantially isolates said portion of said electrode and said portion of said conductor from ingrowth of tissue.
Claim 2
Dependent Claim
86 words
An implantable medical lead comprising: a lead subassembly comprising an electrode, a conductor electrically coupled to said electrode, and a connector electrically coupled to a proximal end of said conductor; and a porous tubular covering extending over at least a portion of said electrode and at least a portion of said conductor, wherein said porous tubular covering has an outer surface pore size such that said porous tubular covering substantially isolates said portion of said electrode and said portion of said conductor from ingrowth of tissue.
Claim 3
Dependent Claim
12 words
The lead of claim 1, wherein said tubular covering is substantially isodiametric.
Claim 4
Dependent Claim
40 words
The lead of claim 1, wherein said tubular covering is chosen from the group consisting of: fluoropolymer, polyester, polyurethane, cellulose acetate, mixed esters of cellulose, acrylic copolymer on nylon support, polyvinyl difluoride, polysulfone, polypropylene, cellulose nitrate, polycarbonate, nylon, and polyethylene.
Claim 5
Dependent Claim
22 words
The lead of claim 3, wherein said tubular covering comprises a fluoropolymer chosen from the group consisting of: FEP, PTFE, and PFA.
Claim 6
Dependent Claim
19 words
The lead of claim 1, wherein said tubular covering comprises a composite or laminate of at least two materials.
Claim 7
Dependent Claim
25 words
The lead of claim 1, wherein said porous tubular covering has a structure chosen from the group consisting of: expanded, woven, felt, and fused mesh.
Claim 8
Dependent Claim
22 words
The lead of claim 1, wherein said tubular covering has an inner surface pore size larger than said outer surface pore size.
Claim 9
Dependent Claim
22 words
The lead of claim 1, wherein said porous tubular covering has pores that are at least partially filled by a wet-out agent.
Claim 10
Dependent Claim
19 words
The lead of claim 1, wherein said lead is packaged in a sealed package, wherein said package contains saline.
Claim 11
Dependent Claim
12 words
The lead of claim 1, wherein said electrode is a defibrillation electrode.,
Claim 12
Dependent Claim
16 words
The lead of claim 10, wherein said defibrillation electrode has a length greater than 7.5 centimeters.
Claim 13
Dependent Claim
12 words
The lead of claim 1, wherein said electrode is a sensing electrode.
Claim 14
Dependent Claim
33 words
The lead of claim 1, wherein said electrode is a defibrillation electrode and said lead further comprises a second electrode and a second conductor at least partially covered by said porous tubular covering.
Claim 15
Dependent Claim
13 words
The lead of claim 13, wherein said second electrode is a sensing electrode.
Claim 16
Dependent Claim
34 words
The lead of claim 1, wherein said porous tubular covering has an inner diameter greater than an outer diameter of said electrode thereby forming a gap between said porous tubular covering and said electrode.
Claim 17
Dependent Claim
20 words
The lead of claim 1, and further comprising an electrically insulating layer between said conductor and said porous tubular covering.
Claim 18
Dependent Claim
38 words
The lead of claim 16, wherein said porous tubular covering has an inner diameter greater than an outer dimension of said electrically insulating layer thereby creating a gap between said porous tubular covering and said electrically insulating layer.
Claim 19
Dependent Claim
32 words
The lead of claim 1, said lead body further including a second conductor coupled between a second connector at said lead body proximal end and a second electrode on said lead body.
Claim 20
Dependent Claim
43 words
The lead of claim 1 wherein said lead subassembly is of a construction that, without said porous tubular covering, a 10 day, 37° C., 9 g/l saline soak and subsequent one minute, 5N tensile load application results in permanent elongation greater than 5%.
Claim 21
Dependent Claim
19 words
The lead of claim 1 wherein at least a portion of said electrode has a fragile high-surface area coating.
Claim 22
Dependent Claim
14 words
The lead of claim 1 wherein said lead subassembly has a low abrasion resistance.
Claim 23
Dependent Claim
11 words
The lead of claim 1 wherein said lead subassembly is nonbiocompatible.
Claim 24
Dependent Claim
29 words
The lead of claim 22 wherein at least a portion of said lead subassembly has rough edges that would irritate body tissue if implanted without said porous tubular covering.
Claim 25
Dependent Claim
22 words
The lead of claim 22 wherein said electrode has crevices that would encourage tissue ingrowth if implanted without said porous tubular covering.
Claim 26
Dependent Claim
81 words
An implantable medical lead comprising: a lead body having a proximal end and a distal end and including at least one conductor; an electrode positioned on said lead body and electrically coupled to said conductor; a connector positioned at said proximal end of said lead body and electrically coupled to said conductor; and a porous tubular covering having proximal and distal ends and extending over at least a portion of said electrode and at least a portion of said lead body.
Claim 27
Dependent Claim
81 words
An implantable medical lead comprising: a lead body having a proximal end and a distal end and including at least one conductor; an electrode positioned on said lead body and electrically coupled to said conductor; a connector positioned at said proximal end of said lead body and electrically coupled to said conductor; and a porous tubular covering having proximal and distal ends and extending over at least a portion of said electrode and at least a portion of said lead body.
Claim 28
Dependent Claim
59 words
The lead of claim 25 wherein said distal end of said tubular covering is mechanically coupled to said lead body near said distal end of said lead body, and said proximal end of said tubular covering, is mechanically coupled to said lead body near said proximal end of said lead body whereby said tubular covering completely covers said electrode.
Claim 29
Independent Claim
44 words
A method of making an implantable medical lead comprising the steps of: (a) electrically connecting a conductor to a connector; (b) electrically connecting said conductor to an electrode; and (c) inserting said electrode and conductor into a porous tube having proximal and distal ends.
Claim 30
Independent Claim
44 words
A method of making an implantable medical lead comprising the steps of: (a) electrically connecting a conductor to a connector; (b) electrically connecting said conductor to an electrode; and (c) inserting said electrode and conductor into a porous tube having proximal and distal ends.
Claim 31
Dependent Claim
22 words
The method of claim 27 and further comprising the step of: (d) mechanically attaching said porous tube proximal end to said connector.
Claim 32
Dependent Claim
26 words
The method of claim 27 and further comprising the step of: (e) mechanically attaching said porous tube distal end near a distal end of said lead.
Claim 33
Dependent Claim
24 words
The method of claim 29 wherein said step (e) comprises applying an adhesive to said porous tube and to a distal pacing electrode shank.
Claim 34
Dependent Claim
23 words
The method of claim 29 wherein said step (e) comprises tying a ligature around said porous tube and a distal pacing electrode shank.
Claim 35
Dependent Claim
39 words
The method of claim 27 and further comprising the steps of: (f) forming holes or slots in said distal end of said porous tube; and (g) inserting tines positioned on said lead distal end through said holes or slots.
Claim 36
Independent Claim
49 words
A method for implanting a lead having a porous tubular covering extending over at least a portion of an electrode and at least a portion of a lead body comprising the steps of: (a) applying a wet-out agent to said lead; and (b) positioning said lead within a patient.
Claim 37
Independent Claim
49 words
A method for implanting a lead having a porous tubular covering extending over at least a portion of an electrode and at least a portion of a lead body comprising the steps of: (a) applying a wet-out agent to said lead; and (b) positioning said lead within a patient.
Claim 38
Dependent Claim
29 words
The method of claim 33, and further including after said step (a) and before step (b), the step of: (c) soaking said lead with said wet-out agent in saline.
References Cited (Backward Citations)
US4033357A
Cited
US4442841A
Cited
US4573480A
Cited
US4557957A
Cited
US5330520A
Cited
US4743480A
Cited
US4840186A
Cited
US5007435A
Cited
US4972846A
Cited
US5020544A
Cited
US5090422A
Cited
US5261419A
Cited
US5231996A
Cited
US5269810A
Cited
US5466252A
Cited
US5358516A
Cited
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-05-25 | 2001-11-24 | 2002-05-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-05-25 | 2005-11-24 | 2006-05-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-05-25 | 2009-11-24 | 2010-05-26 | $7700.00 | Window Closed / Lapsed |