CA2091761A1 - Implantable defibrillation electrode and method of manufacture - Google Patents
Implantable defibrillation electrode and method of manufactureInfo
- Publication number
- CA2091761A1 CA2091761A1 CA002091761A CA2091761A CA2091761A1 CA 2091761 A1 CA2091761 A1 CA 2091761A1 CA 002091761 A CA002091761 A CA 002091761A CA 2091761 A CA2091761 A CA 2091761A CA 2091761 A1 CA2091761 A1 CA 2091761A1
- Authority
- CA
- Canada
- Prior art keywords
- electrode
- core
- segments
- coil
- elongated
- 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.)
- Abandoned
Links
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
- A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
Abstract
A defibrillation electrode fabricated by molding an elongated electrode core taking the form of two parallel segments each defining several sigmoidal curves (12, 14), sliding a conductor coil (20) over and along the electrode core, coupling the electrode coil (20) to an elongated conductor (24), molding bridging members (18) to connect the two segments of the core at spaced loca-tions along the segments and molding a transition member (22) to the electrode assembly (10) at the junction of the electrode coil (20) and the elongated conductor (24). The resulting electrode is particularly adapted for use as an epicardial defibrillation elec-trode, and displays flexibility within the plane defined by the electrode body as well as for twisting and other deformation to fol-low the changing surface of the heart during contractions.
Description
wo ~/0~616 PCT/US91/06~
IMPLAN~AB~E DEFI~TT~'TION EL~ ~DE
AND ~ OF MANUFACTURE
'.
BACXGROUND OF THE 1N V ~ ~ ~ ION
r . -This invention relates generally to electrical 5 medlcal leads and more particularly to epicardial defibrillation electrode leads.
Early epicardial defibrillation electrodes typically took the form of a wire mesh mounted in an insulative -~ ; ng . Such electrodes are illustrated in design ~-10 patent 274,262 jrs~ to ~eil -tl, U.S. Patent No.
4,548,203 iss~ to Tacker et al and U.S. Patent No.
4,827,932 issued to Ide~er et al.
The above cited ele~L.~de~, while workable, do not exhibit the degree o~ fleYlhility that might be desired 15 in con~unction with a large surface area defibrillation ele_L~ode. The surface of the heart undeLyo_s a complex wringing motion characterized by longitl~inal and - ~
circumferential dimensional cha~ 6 and by angular shear - --deformation with each heartbeat.- The heart, therefore, ~ ;
20 displays an actual ~-har elin surface area, with individual areas of the surface of the heart moving relative to one another during each cvl.~.action. Large surface area el__~r-'-F of fixed configuration cannot both maintain intimate cont~ct with the surface of the 25 h-art and follow the surface of the heart as the heart beats.
A number of de~ibrillation eleoLrodes do display ~r-' flexibility and an ability to re~hApe the~s-lv s to confor~ to the çhA~g;ng surface of the 30 h-art. For example, the electrodes illustrated in U.S.
Patent No. 4,641,656 ~~le' to Smits, figs. 6A, 7 and 10 ~1~plry _~ J ~lly planar ~o~ tive el~ e bodies with a plurality of individual oondu,~ive areas. These ~o~.~u~-~ive areas may move relative to one another because . ... ., . , . , " , . , ~
W092/076l6 PCT/US91/~
IMPLAN~AB~E DEFI~TT~'TION EL~ ~DE
AND ~ OF MANUFACTURE
'.
BACXGROUND OF THE 1N V ~ ~ ~ ION
r . -This invention relates generally to electrical 5 medlcal leads and more particularly to epicardial defibrillation electrode leads.
Early epicardial defibrillation electrodes typically took the form of a wire mesh mounted in an insulative -~ ; ng . Such electrodes are illustrated in design ~-10 patent 274,262 jrs~ to ~eil -tl, U.S. Patent No.
4,548,203 iss~ to Tacker et al and U.S. Patent No.
4,827,932 issued to Ide~er et al.
The above cited ele~L.~de~, while workable, do not exhibit the degree o~ fleYlhility that might be desired 15 in con~unction with a large surface area defibrillation ele_L~ode. The surface of the heart undeLyo_s a complex wringing motion characterized by longitl~inal and - ~
circumferential dimensional cha~ 6 and by angular shear - --deformation with each heartbeat.- The heart, therefore, ~ ;
20 displays an actual ~-har elin surface area, with individual areas of the surface of the heart moving relative to one another during each cvl.~.action. Large surface area el__~r-'-F of fixed configuration cannot both maintain intimate cont~ct with the surface of the 25 h-art and follow the surface of the heart as the heart beats.
A number of de~ibrillation eleoLrodes do display ~r-' flexibility and an ability to re~hApe the~s-lv s to confor~ to the çhA~g;ng surface of the 30 h-art. For example, the electrodes illustrated in U.S.
Patent No. 4,641,656 ~~le' to Smits, figs. 6A, 7 and 10 ~1~plry _~ J ~lly planar ~o~ tive el~ e bodies with a plurality of individual oondu,~ive areas. These ~o~.~u~-~ive areas may move relative to one another because . ... ., . , . , " , . , ~
W092/076l6 PCT/US91/~
2 o 9 ~ ~ 6 ~
of the provision of perforations extending through the lead body which allow relative v. nt of the electrodes within the plane defined by the lead body. This allows the individual electrode surfaces of the lead to remain 5 adjacent heart tissue while it moves during contraction of the heart.
The form of the conductive surfaces employed in defibrillation electrodes has also changed in recent history. U.S. Patent No. 4,817,634 ;RS~ to Holleman et 10 al discloses a flexible electrode patch which employs an elongated electrode coil, rather than a wire mesh. The coil follows an elongated convoluted path along the ele~LLode head and, in conjunction with the elasticity of the head provides some ability to conform to the heart as 15 it changes shape during contractions. A similar ele~Lode design, but lAr~ing an in~ tive backing, is disclosed in U.S. Patent No. 4,860,769 issued to Fogarty et al. In this lead, the electrode comprises a multifilar coil . ~ed~e~ in the surface of an elongated 20 defibrillation electrode which displays a spiral configuration at its distal end. This spiral portion define6 a generally planar insulative lead body with provision for allowing mvv ~~~ of individual con~ctive _rea~ (turns of the elec~Lode coil) relative to one 25 another within the plane defined by the electrode body, and should he able to follow ~hAng~5 in configuration of the he~rt surface during contraction of the heart.
sr ~ ~Y OF ~ INV~rIQ~ - -The ~f F~ invention i8 also a defibrillation 30 ~leo~6de lead which includes a gener_lly planar, fl~Y~hle inC~ tive ele~,ode body. In the present ~nvention, the ele_L~de body takes the form of an .
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2~91 761
of the provision of perforations extending through the lead body which allow relative v. nt of the electrodes within the plane defined by the lead body. This allows the individual electrode surfaces of the lead to remain 5 adjacent heart tissue while it moves during contraction of the heart.
The form of the conductive surfaces employed in defibrillation electrodes has also changed in recent history. U.S. Patent No. 4,817,634 ;RS~ to Holleman et 10 al discloses a flexible electrode patch which employs an elongated electrode coil, rather than a wire mesh. The coil follows an elongated convoluted path along the ele~LLode head and, in conjunction with the elasticity of the head provides some ability to conform to the heart as 15 it changes shape during contractions. A similar ele~Lode design, but lAr~ing an in~ tive backing, is disclosed in U.S. Patent No. 4,860,769 issued to Fogarty et al. In this lead, the electrode comprises a multifilar coil . ~ed~e~ in the surface of an elongated 20 defibrillation electrode which displays a spiral configuration at its distal end. This spiral portion define6 a generally planar insulative lead body with provision for allowing mvv ~~~ of individual con~ctive _rea~ (turns of the elec~Lode coil) relative to one 25 another within the plane defined by the electrode body, and should he able to follow ~hAng~5 in configuration of the he~rt surface during contraction of the heart.
sr ~ ~Y OF ~ INV~rIQ~ - -The ~f F~ invention i8 also a defibrillation 30 ~leo~6de lead which includes a gener_lly planar, fl~Y~hle inC~ tive ele~,ode body. In the present ~nvention, the ele_L~de body takes the form of an .
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2~91 761
-3-elongated electrode core formed of silicone rubber or other non-creeping polymer reinforced by a metal wire coil or coil electrode. The core takes the form of one or more sigmoidally curved segments. The curved s- nts S are connected at proximal and/or distal ends and may be provided with bridging means connecting adjacent inwardly curved portions of the electrode core to one another. As such, the electrode body may be considered to display a series of perforations. The electrode surfaces mounted lO to the electrode body take the form of individual turns of an elongated monofilar or multifilar, conductive coil mounted around the cylindrical silicone rubber lead core. -As in the Smits ele~ode described above, individual electrode surfaces (turns of the coil)`may move with lS respect to one another within the plane defined by the eleeL,ode body.
The structure of the lead that is pro~ e~ is particularly beneficial in that it is readily elastically ext~n~ed ~n a longitu~inAl direction, is stretchable to ~;.
20 some degree laterally, and may be twisted to follow virtually any three ~i - cional contour. The bridges co.~.e~Ling adjacent inwardly directed ~,væs on the eleiL.ode body serve as convenient locations for su~uLes, staples or other mechanisms for anchoring the lead to the 25 heart. In addition, leads according to the present invention may also be employed as subcutaneous ele~ odes, if desired.
The lead is particularly simple and convenient to manufacture, yet displays a high resistance to fatigue or 30 fracture due to repeated flexing which is especially desirable in the context of an epicardial defibrillation ele~L~ode. The lead is formed by molding an elongated convoluted silicone rubber core displaying a ~UL ved configuration, 51 i~ing the ele_~ode coil over the core, ,: . .
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The structure of the lead that is pro~ e~ is particularly beneficial in that it is readily elastically ext~n~ed ~n a longitu~inAl direction, is stretchable to ~;.
20 some degree laterally, and may be twisted to follow virtually any three ~i - cional contour. The bridges co.~.e~Ling adjacent inwardly directed ~,væs on the eleiL.ode body serve as convenient locations for su~uLes, staples or other mechanisms for anchoring the lead to the 25 heart. In addition, leads according to the present invention may also be employed as subcutaneous ele~ odes, if desired.
The lead is particularly simple and convenient to manufacture, yet displays a high resistance to fatigue or 30 fracture due to repeated flexing which is especially desirable in the context of an epicardial defibrillation ele~L~ode. The lead is formed by molding an elongated convoluted silicone rubber core displaying a ~UL ved configuration, 51 i~ing the ele_~ode coil over the core, ,: . .
. . .
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.: . . ~ . -,~ - -: : . - :
:: . - ,, ., . j , : .: :
~. : ; . : . . , WO 92/0~6]6 Pcl/vS9l/o6388 209~ 6~
-4-along its length, crimping both electrode coil ends to the elongated conductor, molding bridging h~rs around the electrode coil and underlying electrode core in areas of adjacent inwardly directed curves, and molding the two
5 open ends of the core and crimp a~sembly into a transition member, from which an elongated lead body extends. This process is substantially simplified as compared to the process for manufacturing t~e electrode described in the above-cited Fogarty application, and is 10 believed to provide a substantial imp ov~ --L in flexibility due to the fact that the electrode coil is not required to be emhed~ed or otherwise molded into the surface of the lead body.
R~TFF DF~ TPTION OF T~ DRAWINGS
Fig. 1 shows a top, plan view of the distal end of a defibrillation lead according to the present invention, including the ele~t~ode body and Acsociated ele~L.ode coil.
Figs. 2 and 2a show the configuration of the 20 elongated sjl icQne rubber elecLlode core, prior to assembly of the lead.
Fig. 3 6hows a cross section th~uyh the ele~ode body in the vicinity of the bridges co~P~Ling ad~acent ~UL~ portions of the electrode core.
Fig. 4 shows the molded transition '-1, and the cG--~e_~ion of the ele~Lode coil to an elongated insulated cvr.~l..-,Lor. .~
Fig. 5 s~ows an alternAte embodiment-of the: -lecL.ode body of:a lead according to the present 30 invention. ~
Figs. 6a, b, c and d show additional alternate ~oAi ~ of the ele~.ode body.
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.~. . .
R~TFF DF~ TPTION OF T~ DRAWINGS
Fig. 1 shows a top, plan view of the distal end of a defibrillation lead according to the present invention, including the ele~t~ode body and Acsociated ele~L.ode coil.
Figs. 2 and 2a show the configuration of the 20 elongated sjl icQne rubber elecLlode core, prior to assembly of the lead.
Fig. 3 6hows a cross section th~uyh the ele~ode body in the vicinity of the bridges co~P~Ling ad~acent ~UL~ portions of the electrode core.
Fig. 4 shows the molded transition '-1, and the cG--~e_~ion of the ele~Lode coil to an elongated insulated cvr.~l..-,Lor. .~
Fig. 5 s~ows an alternAte embodiment-of the: -lecL.ode body of:a lead according to the present 30 invention. ~
Figs. 6a, b, c and d show additional alternate ~oAi ~ of the ele~.ode body.
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DETAILED DESCRIPTION OF THE lNv~Nl~ON
Fig. 1 shows a top, plan view of the distal end of an electrode lead according to the present invention. As illustrated, the distal end of the electrode is provided 5 with an electrode body 10, which takes the form of two generally parallel s-, -~ts, each segment defining a plurality of sigmoidal curves. As illustrated, certain portions 12 of the electrode body have curves directed outwardly from the electrode body, whereas other portions 10 14 define curves which are directed inwardly toward the central axis 16 of the lead body. The lead body is constructed so that the inwardly directed curves 14 are ~-located adjacent to one another and are co~cted by means of flexible insulative bridge ~ hers 18, which are 15 molded to and around the elongated electrode coil 20, which extends the length of the ele~-.ode body. These bridge - ~rg 18 are convenient locations for sutures, staples, or other apparatus for att~ ng the lead to the surface of the heart. The sigmoidal ~Ul ~es allow for 20 substantial elo~g~tion of the ele~ode body, twisting of the electrode body around its axis and h~n~ i ~g around its - axis in the plane of and perpendicular to the plane of the electrode body. The curves also allow for some eYr~ncion of the ele~L-ode body perpendicular to the 25 ~xis.
At the proximal end of the ele~-.ode body is a transition~member 22, which contains the junction between the ele~ '- coil 20 and an elongated insulated c~n~uctor 24. This is illustrated in more detail in Fig.
30 4. Also-provided on the transition - h~r are su~e tabs 26, which are typically pFovided with a Dacron mesh reinfo.. ~ for ~.e~r.Ling tearing and holes 27 for F-aF~ of ~ul u.~s.
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WO92/07616 PCT/US91/~
209~ 6-In use, it is expected that two or more of these electrodes will be attached the surface of the heart by staples, surgical sutures or other means, and used to apply defibrillation pulses. The electrode may be 5 applied perpendicular to or parallel to the axis of the heart. However, it is anticipated that in most cases two or more electrodes will be applied parallel to the axis of the heart, located primarily on the ventricles of the heart.
Fig. 2 shows an elongated silicone rubber electrode core 30, from which the electrode body aæs~ hly illustrated in Fig. 1 is fabricated. This electrode core is molded to display the curved sigmoidal configuration illustrated, and is provided with two open ends 32,34.
15 During ~ss~ hly, a quadrifilar platinum coil, or a coil of other suitable material is pARseA along ele~L~ode core 30 until it extends Along the coil from open end 32 to open end 34. The proYi -1 ends of the multifilar coil are coupled to an elongated ~nc~ ted con~ctor 24, and 20 the assembly is placed into a mold. Bridges 18 and transition member 22 are then provided by a separate molding operation. Bridges 18 and transition member 22 may be fabricated of silicone rubber or other suitable material.
Fig. 2a illustrates that the ~Ul ~ed radius of core 30 is smaller and the curve angle of the core is larger than for the electrode head A~s~-`ly. This is because the elec~ode coil tends to straighten out the ele~L ode core, after mounting, resulting in a curve angle-as -30 illustrated of approximately 180 after mounting, compared to approY~ -~ely 200 prior to mounting. This -also results in some elongation of the elecL-ode-head.
The specific form of the core curvature ~ep~nAC upon the stiffness of the material rhosen for the core, the ... . . .... ... . - -, .;: ~- : ., .:, ,. . ~:
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W092/07616 PCT/US91/o~
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DETAILED DESCRIPTION OF THE lNv~Nl~ON
Fig. 1 shows a top, plan view of the distal end of an electrode lead according to the present invention. As illustrated, the distal end of the electrode is provided 5 with an electrode body 10, which takes the form of two generally parallel s-, -~ts, each segment defining a plurality of sigmoidal curves. As illustrated, certain portions 12 of the electrode body have curves directed outwardly from the electrode body, whereas other portions 10 14 define curves which are directed inwardly toward the central axis 16 of the lead body. The lead body is constructed so that the inwardly directed curves 14 are ~-located adjacent to one another and are co~cted by means of flexible insulative bridge ~ hers 18, which are 15 molded to and around the elongated electrode coil 20, which extends the length of the ele~-.ode body. These bridge - ~rg 18 are convenient locations for sutures, staples, or other apparatus for att~ ng the lead to the surface of the heart. The sigmoidal ~Ul ~es allow for 20 substantial elo~g~tion of the ele~ode body, twisting of the electrode body around its axis and h~n~ i ~g around its - axis in the plane of and perpendicular to the plane of the electrode body. The curves also allow for some eYr~ncion of the ele~L-ode body perpendicular to the 25 ~xis.
At the proximal end of the ele~-.ode body is a transition~member 22, which contains the junction between the ele~ '- coil 20 and an elongated insulated c~n~uctor 24. This is illustrated in more detail in Fig.
30 4. Also-provided on the transition - h~r are su~e tabs 26, which are typically pFovided with a Dacron mesh reinfo.. ~ for ~.e~r.Ling tearing and holes 27 for F-aF~ of ~ul u.~s.
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209~ 6-In use, it is expected that two or more of these electrodes will be attached the surface of the heart by staples, surgical sutures or other means, and used to apply defibrillation pulses. The electrode may be 5 applied perpendicular to or parallel to the axis of the heart. However, it is anticipated that in most cases two or more electrodes will be applied parallel to the axis of the heart, located primarily on the ventricles of the heart.
Fig. 2 shows an elongated silicone rubber electrode core 30, from which the electrode body aæs~ hly illustrated in Fig. 1 is fabricated. This electrode core is molded to display the curved sigmoidal configuration illustrated, and is provided with two open ends 32,34.
15 During ~ss~ hly, a quadrifilar platinum coil, or a coil of other suitable material is pARseA along ele~L~ode core 30 until it extends Along the coil from open end 32 to open end 34. The proYi -1 ends of the multifilar coil are coupled to an elongated ~nc~ ted con~ctor 24, and 20 the assembly is placed into a mold. Bridges 18 and transition member 22 are then provided by a separate molding operation. Bridges 18 and transition member 22 may be fabricated of silicone rubber or other suitable material.
Fig. 2a illustrates that the ~Ul ~ed radius of core 30 is smaller and the curve angle of the core is larger than for the electrode head A~s~-`ly. This is because the elec~ode coil tends to straighten out the ele~L ode core, after mounting, resulting in a curve angle-as -30 illustrated of approximately 180 after mounting, compared to approY~ -~ely 200 prior to mounting. This -also results in some elongation of the elecL-ode-head.
The specific form of the core curvature ~ep~nAC upon the stiffness of the material rhosen for the core, the ... . . .... ... . - -, .;: ~- : ., .:, ,. . ~:
~ : . . :: . - . , .. . : :
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-7-stiffness of the electrode coil, and the final curve angle and curve radius desired for the electrode head AS8~ hly.
Fig. 3 illustrates a cross section through the lead S in the area of one of the bridges 18. In this figure, it can be seen that the bridges are molded to the electrode core 30, and around the individual conductors 20A, 20~, 20C and 2OD. The core wire 31 is also visible in this view. Core wire 31 serves to reinforce the core or to 10 cor.L,~l its stiffness. It may take the form of a flexible metal or polymer wire or coil molded into core 30. If core wire 31 is manufactured of a con~uctive material, it may optionally be coupled to the electrode coil 20 at its pro~i -1 and distal ends. This serves to 15 reduce the overall electrical resistance of the electrode head.
Fig. 4 shows a cutaway view in the vicinity of the transition her 22. In this view, it can be seen that the insulated con~uctor 24 includes an elongated 20 con~uctor coil 38 crimped within a metal cylinder 40.
The proximal ends of ele~ode coil 20 are wrapped around metal cylinder 40, and are crimped to metal cylinder 40 by means of crimping sleeves 42 and 44 which the hold the ends of the coil in contact with metal cylinder 40.
25 These CQ~ ions are made pri,or to the molding of transition ~ ~~ 22. Coupled to the proximal end of elongated ~n~lAted cond~ctor 24 is a conne~or assembly-not ~llus~L~ed, which may be any commonly used medical electrical c~nn~or, and ho-1~ co,.~ ~ '-generally to 30 those electrical conr~_Lors used in conjunction-with~
prior art p~cing and de~ibrillation ele~Lodes. One o~.iate con r~or is disclosed in U.S. Patent No.
4,258,725, is~ed to O'Neill, incu ~uLa-ed herein by ref~l~.,ce in its entirety.
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WO92/07616 PCT/US91/~
209~ 6~
Fig. 5 shows an alternate ~ho~i -nt of the invention, which covers a greater surface area than the - ho~i -nt illustrated in Fig. 1 and displays a substantial increased ability to be s~retched 5 horizontally, perpendicular to the axis of the electrode body. In this case, the electrode structures correspond to those illustrated in Fig. 1, with the exception that two of the bridge members 46 take the form of silicone rubber loops, allowing for substantial lateral expansion 10 of the electrode body 50 perpendicular to the axis 52 of the electrode body.
Fig. 6a shows an alternative :, ho~; -nt of the electrode body of a lead according to the present invention, wherein the main axis 60 of the electrode body 15 is perpendicular to the axis of the elongated conductor 62. The relationship of the sigmoidally ~lved segments 64 and 66, however, is similar to that illustrated in Figs. 1-5, above.
Fig' 6b shows an additional alternative ~. ho~
20 of an electrode body according to the present invention, with -~U-U~` tabs 68 and 70 located at the distal and proYi -~ ends of the electrode. A a~L~e groove 72 is also illustrated as an alternative suturing means.
Fig. 6c illustrates yet another alternative 25 embodiment of a lead body according to the present invention. In this embodiment, the distal ends of the signoidally ~u-v~d segments 74 and 76 are not coupled to one another, and there are no bridging h~rs conn~cting the adjacent portions of the curved segments, with the 30 ex~epLion of the transition ~~ 78.- Suturing tabs 80, 82, 84 and 86 are provided at proximal and distal ends of the ele~L~ode head. This ~ hodi~ent allows for placement of the ele~ode body between coronary arteries. The el~ ode is particularly valuable in the context of a ~,.. ",, ,: ;.: .: .-.. . . .
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2~91 761 patient who has had one or more coronary bypasses, as it avoids applying defibrillation energy adjacent the bypass sites.
Figure 6d illustrates an ~ hoAi -nt of the lead 5 particularly adapted for subcutA~eouc implantation. The lead is provided with three sigmoidal s~ -nts 90, 92 and 94 extending from an elongated transition member 102.
Each sigmoidal se~ -~t is provided with a suture tab, 96, 98, lO0. The transition member 102 is similarly provided lO with s~L~le tabs 104, 106 and 108. The electrode coils located on the sigmoidal S_ -nts are all coupled to a single insulated con~uctor llO. In use, the sigmoidal 90, 92 and 94 are placed subcutAneo~cly between the ribs, so that the ribs do not interfere with delivery of 15 defibrillation energy to the heart. The sigmoidal configuration of the electrode body s- --~s allows for stretching and ~onAing of the leads during respiration, as the rib cage eYra~ and contracts.
The above ~ ~o t -nts all disclose electrode 20 configurations employing two generally parallel ~_ -nts of sigmoidal curves. u~/evcr, it is believed that some 3 ' ' - benefit of the invention may also be obtain~d by employing individual electrodes, each taking the form of one segment defining _ plurality of sigmoidal ~u~vcs.
25 The electrodes may be located ad~acent one another to a~oximate the s~,u~u,e illustrAted in Fig. 2, or might be located spaced from one another and co~r,~cLed at oppo~;te polarities, ' ~p~ ; n~ upon the particular defibrillation pulse regime and el.~L,ode configuration 30 desired. Althou~h sp-c;fically adapted for use on the ! ~r~ ~Ardium, tbe leads might also be employed as subcu~An-o~c ele_L~.:es, if desired.
Further, although not illustrated above, one side of the ele~,ode coil and the electrode body may be coated .,., ,, '~,.. .
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209~ 6~ -with silicone rubber, Tefzel0 polymer, parylene, polyurethane, PTFE or other insulative material to limit the exposed conductive area to only the portion of the electrode coil located adjacent the~heart tissue.
As such, the above disclosed ~ ho~i ?nts should be considered exemplary, rather than limiting with regard to - the scope of the following claims. In conjunction with the above specification, we claim:
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Fig. 3 illustrates a cross section through the lead S in the area of one of the bridges 18. In this figure, it can be seen that the bridges are molded to the electrode core 30, and around the individual conductors 20A, 20~, 20C and 2OD. The core wire 31 is also visible in this view. Core wire 31 serves to reinforce the core or to 10 cor.L,~l its stiffness. It may take the form of a flexible metal or polymer wire or coil molded into core 30. If core wire 31 is manufactured of a con~uctive material, it may optionally be coupled to the electrode coil 20 at its pro~i -1 and distal ends. This serves to 15 reduce the overall electrical resistance of the electrode head.
Fig. 4 shows a cutaway view in the vicinity of the transition her 22. In this view, it can be seen that the insulated con~uctor 24 includes an elongated 20 con~uctor coil 38 crimped within a metal cylinder 40.
The proximal ends of ele~ode coil 20 are wrapped around metal cylinder 40, and are crimped to metal cylinder 40 by means of crimping sleeves 42 and 44 which the hold the ends of the coil in contact with metal cylinder 40.
25 These CQ~ ions are made pri,or to the molding of transition ~ ~~ 22. Coupled to the proximal end of elongated ~n~lAted cond~ctor 24 is a conne~or assembly-not ~llus~L~ed, which may be any commonly used medical electrical c~nn~or, and ho-1~ co,.~ ~ '-generally to 30 those electrical conr~_Lors used in conjunction-with~
prior art p~cing and de~ibrillation ele~Lodes. One o~.iate con r~or is disclosed in U.S. Patent No.
4,258,725, is~ed to O'Neill, incu ~uLa-ed herein by ref~l~.,ce in its entirety.
' .
., .. - . .. . .. . . . . . .
WO92/07616 PCT/US91/~
209~ 6~
Fig. 5 shows an alternate ~ho~i -nt of the invention, which covers a greater surface area than the - ho~i -nt illustrated in Fig. 1 and displays a substantial increased ability to be s~retched 5 horizontally, perpendicular to the axis of the electrode body. In this case, the electrode structures correspond to those illustrated in Fig. 1, with the exception that two of the bridge members 46 take the form of silicone rubber loops, allowing for substantial lateral expansion 10 of the electrode body 50 perpendicular to the axis 52 of the electrode body.
Fig. 6a shows an alternative :, ho~; -nt of the electrode body of a lead according to the present invention, wherein the main axis 60 of the electrode body 15 is perpendicular to the axis of the elongated conductor 62. The relationship of the sigmoidally ~lved segments 64 and 66, however, is similar to that illustrated in Figs. 1-5, above.
Fig' 6b shows an additional alternative ~. ho~
20 of an electrode body according to the present invention, with -~U-U~` tabs 68 and 70 located at the distal and proYi -~ ends of the electrode. A a~L~e groove 72 is also illustrated as an alternative suturing means.
Fig. 6c illustrates yet another alternative 25 embodiment of a lead body according to the present invention. In this embodiment, the distal ends of the signoidally ~u-v~d segments 74 and 76 are not coupled to one another, and there are no bridging h~rs conn~cting the adjacent portions of the curved segments, with the 30 ex~epLion of the transition ~~ 78.- Suturing tabs 80, 82, 84 and 86 are provided at proximal and distal ends of the ele~L~ode head. This ~ hodi~ent allows for placement of the ele~ode body between coronary arteries. The el~ ode is particularly valuable in the context of a ~,.. ",, ,: ;.: .: .-.. . . .
.. . . .
~. , . - , ... . . . . .
, . .
.. . . .
: - , , , ' ' : -WO92/07616 PCTrUS91/~
2~91 761 patient who has had one or more coronary bypasses, as it avoids applying defibrillation energy adjacent the bypass sites.
Figure 6d illustrates an ~ hoAi -nt of the lead 5 particularly adapted for subcutA~eouc implantation. The lead is provided with three sigmoidal s~ -nts 90, 92 and 94 extending from an elongated transition member 102.
Each sigmoidal se~ -~t is provided with a suture tab, 96, 98, lO0. The transition member 102 is similarly provided lO with s~L~le tabs 104, 106 and 108. The electrode coils located on the sigmoidal S_ -nts are all coupled to a single insulated con~uctor llO. In use, the sigmoidal 90, 92 and 94 are placed subcutAneo~cly between the ribs, so that the ribs do not interfere with delivery of 15 defibrillation energy to the heart. The sigmoidal configuration of the electrode body s- --~s allows for stretching and ~onAing of the leads during respiration, as the rib cage eYra~ and contracts.
The above ~ ~o t -nts all disclose electrode 20 configurations employing two generally parallel ~_ -nts of sigmoidal curves. u~/evcr, it is believed that some 3 ' ' - benefit of the invention may also be obtain~d by employing individual electrodes, each taking the form of one segment defining _ plurality of sigmoidal ~u~vcs.
25 The electrodes may be located ad~acent one another to a~oximate the s~,u~u,e illustrAted in Fig. 2, or might be located spaced from one another and co~r,~cLed at oppo~;te polarities, ' ~p~ ; n~ upon the particular defibrillation pulse regime and el.~L,ode configuration 30 desired. Althou~h sp-c;fically adapted for use on the ! ~r~ ~Ardium, tbe leads might also be employed as subcu~An-o~c ele_L~.:es, if desired.
Further, although not illustrated above, one side of the ele~,ode coil and the electrode body may be coated .,., ,, '~,.. .
.. . .
~; ',, ,' :.' " ' '' ; ' . ,.~ ' ",.' ' ', .
' ''' ' ' ' ' ' ' ' ' ' : ' .
''~.i. '' . ' . ' " ', ' ~, ' ;- . , ' ' ." ' ' . . . ' .' ' ., WO92/07616 PCTtUS91/06~
209~ 6~ -with silicone rubber, Tefzel0 polymer, parylene, polyurethane, PTFE or other insulative material to limit the exposed conductive area to only the portion of the electrode coil located adjacent the~heart tissue.
As such, the above disclosed ~ ho~i ?nts should be considered exemplary, rather than limiting with regard to - the scope of the following claims. In conjunction with the above specification, we claim:
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. ~ ~
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Claims (9)
1. An implantable defibrillation electrode lead comprising an elongated insulated conductor (24) coupled to an electrode body assembly (10), said electrode body assembly including a generally planar, flexible, elongated electrode core (30) and an electrode coil mounted (20) around said electrode core and extending along said electrode core, coupled to said elongated insulated conductor, characterized in that;
said electrode core (30) defines two generally parallel elongated segments, each of said elongated segments defining a plurality of sigmoidal curves located in the plane of said electrode body (10), wherein said sigmoidal curves defined by said segments of said electrode core are arranged such that inwardly curved portions (14) of said segments are located adjacent to one another, and in that said electrode body (10) further comprises means for connecting said segments of said electrode core (30) to one another only at said adjacent, inwardly curved portions (14) of said segments of said electrode core (30)
said electrode core (30) defines two generally parallel elongated segments, each of said elongated segments defining a plurality of sigmoidal curves located in the plane of said electrode body (10), wherein said sigmoidal curves defined by said segments of said electrode core are arranged such that inwardly curved portions (14) of said segments are located adjacent to one another, and in that said electrode body (10) further comprises means for connecting said segments of said electrode core (30) to one another only at said adjacent, inwardly curved portions (14) of said segments of said electrode core (30)
2 An implantable defibrillation electrode lead according to claim 1 wherein said electrode coil (20) comprises a multifilar coil.
3 An implantable defibrillation electrode lead according to claim 2 wherein said electrode core (30) comprises a molded, cylindrical silicone rubber core
4 An implantable defibrillation electrode according to claim 1 or claim 2 further comprising means (31) for reinforcing said electrode body, located within said electrode core (30) An implantable defibrillation electrode lead according to claim 4 wherein said reinforcing means (31) comprises a metallic wire or coil.
1 6
6. A method of fabrication of an implantable defibrillation electrode lead comprising an electrode coil mounted over an elongated insulated electrode core characterized in that: said method of manufacturing comprises the steps of molding a flexible, insulated electrode core (30) defining a plurality of sigmoidal curves, sliding said electrode coil (20) over said core, along the length of said core (30), coupling an elongated, insulated conductor (24) to said electrode coil, and molding an insulative transition member (22) over the junction of said electrode coil and said elongated coiled conductor.
7. A method according to claim 6 wherein said step of molding said electrode core (30) comprises molding two generally parallel elongated segments, each of said elongated segments defining a plurality of coplanar sigmoidal curves, and wherein said step of sliding said electrode coil (20) over said core comprises sliding an electrode coil (20) over each of said elongated segments.
8. A method according to claim 7 further comprising the step of molding bridging (18) members to said assembly of said core segments (30) and said electrode coil (20), said bridging members (18) connecting said first and second segments to one another at locations (14) spaced along said first and second segments.
9. A method to according to claim 7 further comprising step of arranging first and second segments (30) such that such sigmoidal curves defined by said segments are located such that inwardly curved portions (14) of said segments are located adjacent to one another and wherein said step of molding said bridging members (18) comprises molding said bridging members (18) to said first and second segments, in the vicinity of adjacent ones of said inwardly curved portions (14).
.
.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/604,686 | 1990-10-26 | ||
US07/604,686 US5105826A (en) | 1990-10-26 | 1990-10-26 | Implantable defibrillation electrode and method of manufacture |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2091761A1 true CA2091761A1 (en) | 1992-04-27 |
Family
ID=24420598
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002091761A Abandoned CA2091761A1 (en) | 1990-10-26 | 1991-09-06 | Implantable defibrillation electrode and method of manufacture |
Country Status (7)
Country | Link |
---|---|
US (1) | US5105826A (en) |
EP (1) | EP0556229B1 (en) |
JP (1) | JPH06504214A (en) |
AU (1) | AU8765191A (en) |
CA (1) | CA2091761A1 (en) |
DE (1) | DE69102142T2 (en) |
WO (1) | WO1992007616A1 (en) |
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US10391299B2 (en) | 2017-03-30 | 2019-08-27 | Medtronic, Inc. | Interventional medical systems for therapy delivery in extracardiovascular spaces and associated tools and methods |
US11291833B2 (en) | 2018-05-09 | 2022-04-05 | Medtronic, Inc. | Bonding strip for fixing an electrode coil to a lead body |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4026303A (en) * | 1975-11-17 | 1977-05-31 | Vitatron Medical B.V. | Endocardial pacing electrode |
DE3412950A1 (en) * | 1984-04-06 | 1985-10-17 | Peter Dr.-Ing. 7889 Grenzach-Wyhlen Osypka | SURGICAL ELECTRODE |
US4817634A (en) * | 1987-06-18 | 1989-04-04 | Medtronic, Inc. | Epicardial patch electrode |
US4860769A (en) * | 1987-11-12 | 1989-08-29 | Thomas J. Fogarty | Implantable defibrillation electrode |
-
1990
- 1990-10-26 US US07/604,686 patent/US5105826A/en not_active Expired - Lifetime
-
1991
- 1991-09-06 EP EP91918913A patent/EP0556229B1/en not_active Revoked
- 1991-09-06 JP JP3517841A patent/JPH06504214A/en active Pending
- 1991-09-06 AU AU87651/91A patent/AU8765191A/en not_active Abandoned
- 1991-09-06 CA CA002091761A patent/CA2091761A1/en not_active Abandoned
- 1991-09-06 WO PCT/US1991/006388 patent/WO1992007616A1/en not_active Application Discontinuation
- 1991-09-06 DE DE69102142T patent/DE69102142T2/en not_active Revoked
Also Published As
Publication number | Publication date |
---|---|
DE69102142D1 (en) | 1994-06-30 |
DE69102142T2 (en) | 1994-09-08 |
AU8765191A (en) | 1992-05-26 |
US5105826A (en) | 1992-04-21 |
EP0556229A1 (en) | 1993-08-25 |
EP0556229B1 (en) | 1994-05-25 |
JPH06504214A (en) | 1994-05-19 |
WO1992007616A1 (en) | 1992-05-14 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
FZDE | Discontinued |