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US5871528A Expired / Lapsed US ⏱️ 0.0 years remaining

Temporary bipolar heart wire

Assignee: Medtronic Inc
•
Filing: 1997-03-14
•
Granted: 1999-02-16
•
Expires: 2017-03-14
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Abstract

Abstract The present invention includes within its scope a low-cost temporary lead for pacing, sensing, monitoring, or defibrillating at least a portion of a human or animal organ, and methods for implanting and making same. The lead has at least two electrodes and distal and proximal ends, and a novel weakened zone disposed between the blunt end of a needle and at least two electrical connectors attached to the proximal end of the lead body. The novel weakened zone permits the needle to be separated from the connectors by application of a sufficiently large bending moment or pulling force thereto. Following separation of the connectors from the needle, the connectors may be attached directly and quickly to an external electrical apparatus.

Inventors

  • 👤 Antoine Camps
  • 👤 Farid Moumane
  • 👤 Jean Robinet
  • 👤 Benoit Deruyver

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-24 15:41
CPC Classifications
A; A61; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/0587

Claims Analysis

Total Claims: 66
Claim 1
Independent Claim 314 words
A temporary medical lead having distal and proximal ends, the lead being suitable for pacing, sensing, monitory, or defibrillating at least a portion of a human or animal organ, comprising: (a) a lead body having distal and proximal ends and comprising at least first and second electrical conductors having proximal and distal ends, the first and second electrical conductors being electrically insulated from one another, at least portions of the first and second conductors being covered by electrically insulative material, the first and second conductors being formed of wires or stranded wires; (b) at least distal and proximal electrodes comprising uninsulated distal portions of the first and second electrical conductors, respectively; (c) a substantially rigid needle assembly having distal and proximal ends, the needle assembly comprising a first portion comprising proximal and distal ends, the first portion having a pointed end disposed at the proximal end thereof, a second distal portion comprising at least first and second connectors having distal and proximal ends, the distal ends of the connectors forming the distal end of the needle assembly, the first proximal portion and the second distal portion being substantially rigidly connected to one another, a weakened zone being disposed at least propinguant to the region disposed between the first proximal portion and the second distal portion, the needle assembly, prior to the first and second portions thereof being separated manually from one another, forming a single contiguous and substantially rigid assembly; the first connector being attached to the proximal end of the first electrical conductor, the second connector being attached to the proximal end of the second electrical conductor wherein the connectors may be separated from the first proximal portion by the application of one of a single sufficiently large bending force and a single sufficiently large pulling force to the weakened zone, and the connectors are configured for attachment to an external electrical apparatus.
Claim 2
Dependent Claim 314 words
A temporary medical lead having distal and proximal ends, the lead being suitable for pacing, sensing, monitory, or defibrillating at least a portion of a human or animal organ, comprising: (a) a lead body having distal and proximal ends and comprising at least first and second electrical conductors having proximal and distal ends, the first and second electrical conductors being electrically insulated from one another, at least portions of the first and second conductors being covered by electrically insulative material, the first and second conductors being formed of wires or stranded wires; (b) at least distal and proximal electrodes comprising uninsulated distal portions of the first and second electrical conductors, respectively; (c) a substantially rigid needle assembly having distal and proximal ends, the needle assembly comprising a first portion comprising proximal and distal ends, the first portion having a pointed end disposed at the proximal end thereof, a second distal portion comprising at least first and second connectors having distal and proximal ends, the distal ends of the connectors forming the distal end of the needle assembly, the first proximal portion and the second distal portion being substantially rigidly connected to one another, a weakened zone being disposed at least propinguant to the region disposed between the first proximal portion and the second distal portion, the needle assembly, prior to the first and second portions thereof being separated manually from one another, forming a single contiguous and substantially rigid assembly; the first connector being attached to the proximal end of the first electrical conductor, the second connector being attached to the proximal end of the second electrical conductor wherein the connectors may be separated from the first proximal portion by the application of one of a single sufficiently large bending force and a single sufficiently large pulling force to the weakened zone, and the connectors are configured for attachment to an external electrical apparatus.
Claim 3
Dependent Claim 26 words
The temporary lead of claim 1, wherein the proximal electrode is an at least partially bare wire wound around an insulated portion of the first conductor.
Claim 4
Dependent Claim 38 words
The temporary lead of claim 1, wherein the proximal electrode is an at least partially bare wire having a distal end, the distal end of the bare wire being affixed to an insulated portion of the first conductor.
Claim 5
Dependent Claim 56 words
The temporary lead of claim 1, wherein the proximal electrode is an at least partially bare wire having a distal end, the distal end of the bare wire being affixed to an insulated portion of the first conductor by one of an electrode attachment member, heat shrink tubing, electrically conductive heat shrink tubing, tape and glue.
Claim 6
Dependent Claim 22 words
The temporary lead of claim 4, wherein the electrode attachment member is formed of at least one of an adhesive or polyurethane.
Claim 7
Dependent Claim 17 words
The temporary lead of claim 5, wherein the adhesive is one of a UV-cured adhesive and epoxy.
Claim 8
Dependent Claim 12 words
The temporary lead of claim 6, wherein the UV-cured adhesive is POM.
Claim 9
Dependent Claim 44 words
The temporary lead of claim 1, wherein the first and second conductors are formed of at least one of helically wound strands of multifilament stainless steel, twisted strands of multifilament stainless steel, single strands of stainless steel, and strands of electrically conductive polymeric material.
Claim 10
Dependent Claim 22 words
The temporary lead of claim 1, wherein the at least first and second electrical conductors are inner and outer coaxial conductors, respectively.
Claim 11
Dependent Claim 53 words
The temporary lead of claim 9, wherein a layer of inner insulation separates and electrically insulates the first inner conductor from the second outer conductor, the inner insulation being formed from a material selected from the group consisting of fluorinated ethylene propylene (FEP), polytetrafluorethylene (PTFE), co-polymer polytetrafluorethylene, polyethylene, silastic, neoprene, polypropylene and polyurethane.
Claim 12
Dependent Claim 33 words
The temporary lead of claim 10, wherein the outer conductor is composed of between about 26 and 40 medical grade stainless steel strands or filaments wound helically over the layer of inner insulation.
Claim 13
Dependent Claim 28 words
The temporary lead of claim 10, wherein the inner conductor is composed of about 19 medical grade twisted, wound, or twisted and wound stainless steel filaments or strands.
Claim 14
Dependent Claim 49 words
The temporary lead of claim 1, wherein a layer of outer insulation is disposed over the outer surface of the second conductor, the outer insulation being electrically insulative and formed from a material selected from the group consisting of FEP, polyethylene, biocompatible PTFE, polyethylene, silastic, neoprene, polypropylene and polyurethane.
Claim 15
Dependent Claim 49 words
The temporary lead of claim 1, wherein a layer of outer insulation is disposed over the outer surface of the first conductor, the outer insulation being electrically insulative and formed from a material selected from the group consisting of FEP, polyethylene, biocompatible PTFE, polyethylene, silastic, neoprene, polypropylene and polyurethane.
Claim 16
Dependent Claim 19 words
The temporary lead of claim 1, wherein the at least first and second electrical conductors are zip cord conductors.
Claim 17
Dependent Claim 21 words
The temporary lead of claim 1, wherein the at least first and second electrodes are formed of medical grade stainless steel.
Claim 18
Dependent Claim 11 words
The temporary lead of claim 1, wherein the needle is atraumatic.
Claim 19
Dependent Claim 17 words
The temporary lead of claim 1, wherein the first portion of the needle assembly is substantially straight.
Claim 20
Dependent Claim 18 words
The temporary lead of claim 1, wherein the first portion of the needle assembly has a triangular cross-section.
Claim 21
Dependent Claim 18 words
The temporary lead of claim 1, wherein the first portion of the needle assembly is a Keith-type needle.
Claim 22
Dependent Claim 22 words
The temporary lead of claim 1, wherein the first portion of the needle assembly is formed of medical grade plastic or polymer.
Claim 23
Dependent Claim 16 words
The temporary lead of claim 1, wherein the first portion of the needle assembly is curved.
Claim 24
Dependent Claim 44 words
The temporary lead of claim 1, wherein the distal end of the proximal portion is attached by breaking means, snapping means, crimping means, compressional means, frictional means, adhesive means, glue means or elastic means to the proximal ends of the first and second connectors.
Claim 25
Dependent Claim 29 words
The temporary lead of claim 1, wherein the reduced diameter pins fit into corresponding individual recesses disposed within the distal end of the first portion of the needle assembly.
Claim 26
Dependent Claim 15 words
The temporary lead of claim 1, wherein the first and second connectors form reed-shaped connectors.
Claim 27
Dependent Claim 15 words
The temporary lead of claim 1, wherein the first and second connectors form flexible connectors.
Claim 28
Dependent Claim 22 words
The temporary lead of claim 1, wherein the first and second connectors have reduced diameter pins disposed at the proximal ends thereof.
Claim 29
Dependent Claim 27 words
The temporary lead of claim 27, wherein the first and second connectors each have a scored region disposed between the reduced diameter pin and its proximal end.
Claim 30
Dependent Claim 29 words
The temporary lead of claim 27, wherein the reduced diameter pins fit into corresponding individual recesses disposed within the distal end of the first portion of the needle assembly.
Claim 31
Dependent Claim 33 words
The temporary lead of claim 27, wherein the reduced diameter pins are frictionally engaged, adhered, glued, crimped, brazed, soldered or welded to the distal end of the first portion of the needle assembly.
Claim 32
Dependent Claim 53 words
The temporary lead of claim 1, wherein the proximal ends of the first and second conductors slide within recesses disposed in the distal ends of the first and second connectors, the conductors being crimped, brazed, soldered or welded in place therein to establish electrical and mechanical connections between the conductors and the connectors.
Claim 33
Dependent Claim 53 words
The temporary lead of claim 1, wherein the weakened zone is a crimp, score grave, portion of a grave, notch or portion of a notch, disposed on one or both sides of the needle assembly at a location propinquant to the region disposed between the first proximal portion and the second distal portion.
Claim 34
Dependent Claim 318 words
A temporary medical lead having distal and proximal ends, the lead being suitable for pacing, sensing, monitoring, or defibrillating at least a portion of human or animal organ, comprising: (a) a lead body having distal and proximal ends and comprising at least first and second means for conducting electricity, the first and second conducting means having proximal and distal ends being electrically insulated from one another, at least portions of the first and second conducting means being covered by means for electrically insulating; (b) at least distal and proximal electrodes comprising uninsulated distal portions of the first and second conducting means, respectively; (c) a substantially rigid means for piercing having distal and proximal ends, the piercing means comprising a first proximal portion comprising proximal and distal ends, the first portion having a pointed end disposed at the proximal end thereof, a second distal portion comprising at least first and second means for connecting having distal and proximal ends, the distal ends of the connecting means forming the distal end of the piercing means, the first proximal portion and the second distal portion being substantially rigidly connected to one another, a weakened zone being disposed at least propinquant to the region disposed between the first proximal portion and the second distal portion, the piercing means, prior to the first and second portions thereof being separated from one another, forming a single contiguous and substantially rigid assembly, the first connecting means being attached to the proximal end of the first conducting means, the second connecting means being attached to the proximal end of the second conducting means; wherein the first and second connecting means may be separated from the first proximal portion by the application of one of a single sufficiently large bending moment and a single sufficiently large pulling force to the weakened zone, the first and second connecting means being configured for attachment to an external electrical apparatus.
Claim 35
Dependent Claim 318 words
A temporary medical lead having distal and proximal ends, the lead being suitable for pacing, sensing, monitoring, or defibrillating at least a portion of human or animal organ, comprising: (a) a lead body having distal and proximal ends and comprising at least first and second means for conducting electricity, the first and second conducting means having proximal and distal ends being electrically insulated from one another, at least portions of the first and second conducting means being covered by means for electrically insulating; (b) at least distal and proximal electrodes comprising uninsulated distal portions of the first and second conducting means, respectively; (c) a substantially rigid means for piercing having distal and proximal ends, the piercing means comprising a first proximal portion comprising proximal and distal ends, the first portion having a pointed end disposed at the proximal end thereof, a second distal portion comprising at least first and second means for connecting having distal and proximal ends, the distal ends of the connecting means forming the distal end of the piercing means, the first proximal portion and the second distal portion being substantially rigidly connected to one another, a weakened zone being disposed at least propinquant to the region disposed between the first proximal portion and the second distal portion, the piercing means, prior to the first and second portions thereof being separated from one another, forming a single contiguous and substantially rigid assembly, the first connecting means being attached to the proximal end of the first conducting means, the second connecting means being attached to the proximal end of the second conducting means; wherein the first and second connecting means may be separated from the first proximal portion by the application of one of a single sufficiently large bending moment and a single sufficiently large pulling force to the weakened zone, the first and second connecting means being configured for attachment to an external electrical apparatus.
Claim 36
Dependent Claim 27 words
The temporary lead of claim 33, wherein the proximal electrode is an at least partially bare wire wound around an insulated portion of the first conducting means.
Claim 37
Dependent Claim 39 words
The temporary lead of claim 33, wherein the proximal electrode is an at least partially bare wire having a distal end, the distal end of the bare wire being affixed to an insulated portion of the first conducting means.
Claim 38
Dependent Claim 61 words
The temporary lead of claim 33, wherein the proximal electrode is an at least partially bare wire having a distal end, the distal end of the bare wire being affixed to an insulated portion of the first conducting means by one of an electrode attachment means, heat shrink tubing, electrically conductive heat shrink tubing, means for taping, and means for gluing.
Claim 39
Dependent Claim 22 words
The temporary lead of claim 36, wherein the electrode attachment means is formed of at least one of an adhesive or polyurethane.
Claim 40
Dependent Claim 13 words
The temporary lead of claim 37, wherein the adhesive is a UV-cured adhesive.
Claim 41
Dependent Claim 12 words
The temporary lead of claim 38, wherein the UV-cured adhesive is POM.
Claim 42
Dependent Claim 45 words
The temporary lead of claim 33, wherein the first and second conducting means are formed of at least one of helically wound strands of multifilament stainless steel, twisted strands of multifilament stainless steel, single strands of stainless steel, and strands of electrically conductive polymeric material.
Claim 43
Dependent Claim 22 words
The temporary lead of claim 33, wherein the at least first and second conducting means are inner and outer coaxial conductors, respectively.
Claim 44
Dependent Claim 55 words
The temporary lead of claim 41, wherein a layer of inner insulation separates and electrically insulates the first inner conducting means from the second outer conducting means, the inner insulation being formed from a material selected from the group consisting of fluorinated ethylene propylene (FEP), polytetrafluorethylene (PTFE), co-polymer polytetrafluorethylene, polyethylene, silastic, neoprene, polypropylene and polyurethane.
Claim 45
Dependent Claim 34 words
The temporary lead of claim 41, wherein the outer conducting means is composed of between about 26 and 40 medical grade stainless steel strands or filaments wound helically over the layer of inner insulation.
Claim 46
Dependent Claim 29 words
The temporary lead of claim 41, wherein the inner conducting means is composed of about 19 medical grade twisted, wound, or twisted and wound stainless steel filaments or strands.
Claim 47
Dependent Claim 50 words
The temporary lead of claim 33, wherein a layer of outer insulation is disposed over the outer surface of the second conducting means, the outer insulation being electrically insulative and formed from a material selected from the group consisting of FEP, polyethylene, biocompatible PTFE, polyethylene, silastic, neoprene, polypropylene and polyurethane.
Claim 48
Dependent Claim 50 words
The temporary lead of claim 33, wherein a layer of outer insulation is disposed over the outer surface of the first conducting means, the outer insulation being electrically insulative and formed from a material selected from the group consisting of FEP, polyethylene, biocompatible PTFE, polyethylene, silastic, neoprene, polypropylene and polyurethane.
Claim 49
Dependent Claim 19 words
The temporary lead of claim 33, wherein the at least first and second conducting means are zip cord conductors.
Claim 50
Dependent Claim 21 words
The temporary lead of claim 33, wherein the at least first and second electrodes are formed of medical grade stainless steel.
Claim 51
Dependent Claim 16 words
The temporary lead of claim 33, wherein the first portion of the piercing means is atraumatic.
Claim 52
Dependent Claim 17 words
The temporary lead of claim 33, wherein the first portion of the piercing means is substantially straight.
Claim 53
Dependent Claim 18 words
The temporary lead of claim 33, wherein the first portion of the piercing means has a triangular cross-section.
Claim 54
Dependent Claim 18 words
The temporary lead of claim 33, wherein the first portion of the piercing means is a Keith-type needle.
Claim 55
Dependent Claim 22 words
The temporary lead of claim 33, wherein the first portion of the piercing means is formed of medical grade plastic or polymer.
Claim 56
Dependent Claim 16 words
The temporary lead of claim 33, wherein the first portion of the piercing means is curved.
Claim 57
Dependent Claim 50 words
The temporary lead of claim 33, wherein the distal end of the first proximal portion of the piercing means is attached breakingly, snappingly, crimpingly, compressionally, frictionally, adhesively, gluingly, or elastically frictional means, adhesive means, glue means or elastic means to the proximal ends of the first and second connecting means.
Claim 58
Dependent Claim 37 words
The temporary lead of claim 33, wherein the first and second connecting means, upon being separated from the first proximal portion, form cylindrically-shaped pin connectors having at least one of circular cross-sections, rectangular cross-sections and square cross-sections.
Claim 59
Dependent Claim 16 words
The temporary lead of claim 33, wherein the first and second connecting means form reed-shaped connectors.
Claim 60
Dependent Claim 16 words
The temporary lead of claim 33, wherein the first and second connecting means form flexible connectors.
Claim 61
Dependent Claim 23 words
The temporary lead of claim 33, wherein the first and second connecting means have reduced diameter pins disposed at the proximal ends thereof.
Claim 62
Dependent Claim 28 words
The temporary lead of claim 59, wherein the first and second connecting means each have a scored region disposed between the reduced diameter pin and its proximal end.
Claim 63
Dependent Claim 29 words
The temporary lead of claim 59, wherein the reduced diameter pins fit into corresponding individual recesses disposed within the distal end of the first portion of the piercing means.
Claim 64
Dependent Claim 33 words
The temporary lead of claim 59, wherein the reduced diameter pins are frictionally engaged, adhered, glued, crimped, brazed, soldered or welded to the distal end of the first portion of the piercing means.
Claim 65
Dependent Claim 58 words
The temporary lead of claim 33, wherein the proximal ends of the first and second conducting means slide within recesses disposed in the distal ends of the first and second connecting means, the conducting means being crimped, brazed, soldered or welded in place therein to establish electrical and mechanical connections between the conducting means and the connecting means.
Claim 66
Dependent Claim 54 words
The temporary lead of claim 33, wherein the means for weakening is a crimp, score, grave, portion of a grave, notch or portion of a notch disposed formed by crimping, scoring, machining or cutting a groove, a portion of a on one or both sides of the connector means or the piercing assembly means.

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 2002-02-15 2002-08-17 2003-02-16 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2006-02-15 2006-08-17 2007-02-16 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2010-02-15 2010-08-17 2011-02-16 $7700.00 Window Closed / Lapsed

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