Multiple function lead assembly and method for inserting assembly into an implantable tissue stimulator

Abstract

Apparatus and methods are provided for manually altering the function of the distal electrodes of a body implantable tissue stimulator assembly. In one exemplary embodiment, the polarity of distal electrodes may be reversed by axially repositioning the proximal connectors within the female connector assembly of a tissue stimulator.

What is claimed is: 
     
       1. Apparatus for connecting a body implantable tissue stimulator and lead assembly, comprising at least two distal electrodes on said lead assembly for electrical stimulation or sensing,   at least .[.two.]. .Iadd.three .Iaddend.coaxial proximal connectors on said lead assembly spaced apart and .[.electrically.]. .Iadd.conductively .Iaddend.connected to said distal electrodes for connecting said distal electrodes with said .Iadd.implantable .Iaddend.tissue .[.stimulation means.]. .Iadd.stimulator, two of said three proximal connectors conductively connected to one of said two distal electrodes and the remaining one of said three proximal connectors conductively connected to the other of said two distal electrodes.Iaddend.,   a female connector assembly .[.on.]. .Iadd.of .Iaddend.said body implantable tissue stimulator .[.adapted to electrically connect.]. .Iadd.for conductively connecting at least two of .Iaddend.said proximal connector.Iadd.s .Iaddend.to said stimulator,   insulator means intermediate adjacent ones of said coaxial proximal connectors .[.having fluid sealing ribs cooperating with said female connector assembly.]. for maintaining fluid isolation between said connectors. .[.2. The apparatus described in claim 1, wherein said at least two distal electrodes comprises two electrodes, and said at least two proximal connectors comprises two connectors..]. .[.3. The apparatus described in claim 1, wherein said at least two distal electrodes are two distal electrodes; and   said at least two proximal connectors are three proximal connectors;   two of said three proximal connectors being connected to a first of said two distal electrodes, and the remaining one of said three proximal connectors being connected to a second of said two distal electrodes..].   
     
     
           The apparatus described in claim .[.3.]..Iadd.1.Iaddend., wherein said 
     
     
        two proximal connectors bracket said remaining one proximal connector. 5. The apparatus described in claim 1, wherein said tissue .[.stimulation means.]. .Iadd.stimulator .Iaddend.comprises a female connector assembly having connection means for removably securing .[.said at least two.]. .Iadd.at least two of said .Iaddend.proximal connectors in electrical contact with said tissue .[.stimulation means.]. 
     
     
        .Iadd.stimulator.Iaddend.. 6. The apparatus described in claim 5, wherein said connection means are located to align with two of said .[.at least two.]. proximal connectors when .[.said at least.]. .Iadd.the .Iaddend.two 
     
     
        proximal connectors are inserted therein. 7. A body .[.implantable lead assembly,.]. .Iadd.function assistance device, comprising: .Iaddend. .Iadd.a body implantable tissue stimulator including a female connector assembly, .[.comprising.].   .Iadd.a lead assembly for conductively engaging said female connector assembly, .Iaddend.   at least two distal electrodes .[.on.]. .Iadd.of .Iaddend.said lead assembly for electrical stimulation or sensing,   at least .[.two.]. .Iadd.three .Iaddend.coaxial proximal connectors .[.on.]. .Iadd.of .Iaddend.said lead assembly axially spaced apart and .[.electrically.]. .Iadd.conductively .Iaddend.connected with said distal electrodes, .Iadd.two of said three proximal connectors being connected to a first of said two distal electrodes, and the remaining one of said three proximal connectors being connected to a second of said two distal electrodes, .Iaddend.and   insulator means intermediate adjacent ones of said at least .[.two.]. .Iadd.three .Iaddend.coaxial proximal connectors and having at least a portion with a diameter greater than the diameter of said adjacent electrodes.Iadd., said at least a portion of the insulator means configured and adapted to act as a fluid sealing rib and to cooperate with the female connector assembly of the body implantable tissue stimulator to maintain fluid isolation between said proximal connectors. .Iaddend. .[.8. The apparatus described in claim 7, wherein said at least two distal electrodes comprises two electrodes and said at least two proximal connectors each comprises two connectors..]. .[.9. The apparatus described in claim 7, wherein   said at least two distal electrodes are two distal electrodes; and   said at least two proximal connectors are three proximal connectors;   two of said three proximal connectors being connected to a first of said two distal electrodes, and the remaining one of said three proximal connectors being connected to a second of said two distal electrodes..].   
     
     
        .Iadd.10.  A body implantable tissue stimulation system comprising: a body implantable lead comprising: first and second distal electrodes;   a proximal electrode assembly; and   first and second conductors extending between the proximal electrode assembly and the first and second distal electrodes, respectively;     a body implantable stimulator comprising: first and second stimulator electrodes; and   means for defining a channel in the stimulator adjacent the stimulator electrodes, said channel dimensioned to receive the proximal electrode assembly such that the proximal electrode assembly is movable axially between first and second axial positions without removing the proximal electrode assembly from the channel; and   means for interconnecting the first and second stimulator electrodes with the first and second conductors in accordance with the axial position of the proximal electrode assembly in the channel, said interconnecting means operative to interconnect the first stimulator electrode with the first conductor and the second stimulator electrode with the second conductor when the proximal electrode assembly is in the first axial position, and to interconnect the first stimulator electrode with the second conductor and the second stimulator electrode with the first conductor when the proximal electrode assembly is in the second axial position;     said lead, stimulator, and connecting means cooperating to allow an interchange of the functions of the distal electrodes without removing the proximal electrode assembly from the channel..Iaddend. .Iadd.11. The invention of claim 10 wherein the interconnecting means comprises:   first, second, and third coaxial, axially spaced proximal electrodes mounted on the proximal electrode assembly;   means for interconnecting the first and third proximal electrodes with the first conductor;   means for interconnecting the second proximal electrode with the second conductor; and   means for insulating the second proximal electrode from the first and third proximal electrodes;   said second proximal electrode situated intermediate of said first and third proximal electrodes. .Iaddend. .Iadd.12. The invention of claim 11 wherein the insulating means comprises:   a first sealing rib situated between the first and second proximal electrodes; and   a second sealing rib situated between the second and third proximal electrodes;   said first and second sealing ribs extending radially outwardly between the first, second, and third proximal electrodes and dimensioned and adapted to seal the channel between adjacent proximal electrodes in order to maintain fluid isolation between adjacent proximal electrodes. .Iaddend. .Iadd.13. A body implantable stimulation system comprising:   a body implantable lead comprising: first and second distal electrodes;     a proximal electrode assembly comprising first, second, and third coaxial, axially spaced proximal electrodes;   means for electrically connecting the first and third proximal electrodes with the first distal electrode;   means for electrically connecting the second proximal electrode with the second distal electrode; and   means for insulating the first and third proximal electrodes from the second proximal electrode;   said second proximal electrode situated intermediate of the first and third proximal electrodes;   a body implantable stimulator comprising: first and second stimulator connectors; and     means for receiving the proximal electrode assembly adjacent the first and second connectors;   said receiving means configured such that the proximal electrode assembly is movable along an axis between a first portion, in which the first connector is electrically connected with the first distal electrode via the first proximal electrode and the second connector is electrically connected with the second distal electrode via the second proximal electrode, and a second axial position, in which the first connector is electrically connected with the second distal electrode and the second connector is electrically connected with the first distal electrode via   
     
     
        the third proximal electrode. .Iaddend. .Iadd.14.  The invention of claim 13 wherein the receiving means comprises means for defining a bore and wherein the lead comprises at least two sealing ribs, each disposed between a respective adjacent pair of the proximal electrodes, said sealing ribs each extending radially outwardly from the proximal electrodes and dimensioned to create a seal against the means for defining the bore so as to maintain fluid isolation of the three proximal electrodes from one another when the proximal electrode assembly is positioned within the bore. .Iaddend. .Iadd.15. A method for coupling a body implantable lead to a body implantable stimulator comprising the following steps: (a) providing a body implantable lead comprising: first and second distal electrodes;   a proximal electrode assembly comprising first and second coaxial, axially spaced proximal electrodes;   means for electrically connecting the first proximal electrode with the first distal electrode and the second proximal electrode with the second distal electrode; and   means for electrically insulating the first and second proximal electrodes;     (b) providing a body implantable stimulator comprising: first and second stimulator connectors; and   means for receiving the proximal electrode assembly adjacent the first and second stimulator connectors, said receiving means defining a channel having first and second ends;     (c) inserting the proximal electrode assembly into the first end of the channel and positioning the proximal electrode assembly in the channel such that the first stimulator connector is electrically connected to the first distal electrode via the first proximal electrode and the second stimulator connector is electrically connected to the second distal electrode via the second proximal electrode; then   (d) removing the proximal electrode assembly from the channel; and then   (e) inserting the proximal electrode assembly into the second end of the channel and positioning the electrode assembly in the channel such that the first stimulator connector is electrically connected to the second distal electrode via the second proximal electrode and the second stimulator connector is electrically connected to the first distal electrode via the first proximal electrode, thereby reversing the connections of the first and second distal electrodes. .Iaddend.   
     
     
        .Iadd.     The invention of claim 15 wherein the insulating means further comprises: at least one sealing rib positioned between the first and second proximal electrodes to extend radially outwardly from the proximal electrodes, said sealing rib dimensioned and adapted to contact the channel to create a seal against the channel between the first and second proximal electrodes in order to maintain fluid isolation therebetween. .Iaddend. .Iadd.17. A body implantable tissue stimulation system comprising:   a body implantable lead comprising: first and second distal electrodes;     a proximal electrode assembly which comprises at least first and second coaxial, axially spaced proximal electrodes, each of which is electrically connected with a respective one of the distal electrodes, a third coaxial axially spaced proximal electrode electrically connected with the first proximal electrode and situated such that the second proximal electrode is interposed between the first and third proximal electrodes; and   means for electrically insulating the first proximal electrode from the second proximal electrode and the second proximal electrode from the third proximal electrode;   a body implantable tissue stimulator comprising: first and second stimulator electrodes; and   means for defining a channel in the stimulator adjacent the stimulator electrodes to receive the proximal electrode assembly in order to establish electrical contact between the stimulator electrodes and respective ones of the proximal electrodes; and   means for creating a fluid seal in the channel between the tissue stimulator and the proximal electrode assembly in order to maintain fluid isolation between at least two of the proximal electrodes. .Iaddend.     
     
     
        .Iadd.8.  The invention of claim 17 wherein the means for creating a seal comprises a fluid sealing rib mounted on the insulating means to extend radially outwardly from the proximal electrodes to contact and seal 
     
     
        against the channel defining means. .Iaddend. .Iadd.19.  The invention of claim 17 wherein the means for creating a seal comprises a first fluid sealing rib mounted on the means for insulating the first proximal electrode from the second proximal electrode to extend outwardly from the proximal electrodes to contact and seal against the channel defining means, and wherein the invention further comprises a second fluid sealing rib mounted on the means for insulating the third proximal electrode from the second proximal electrode to extend outwardly from the proximal electrodes to contact and seal against the channel defining means in order to maintain fluid isolation between the second and third proximal 
     
     
        electrodes. .Iaddend. .Iadd.20.  A body tissue stimulation apparatus, comprising: a body implantable tissue stimulator for generating electrical stimulation signals;   a body implantable lead assembly for sealingly and conductively engaging said tissue stimulator and for applying said stimulation signals to a predetermined site of the body;   said lead assembly including, two distal electrodes positioned at said site for applying said stimulation signals;   three spaced coaxially aligned proximal connectors;   means for conductively connecting one of the distal electrodes to two of the proximal connectors; and   means for conductively connecting the other of the distal electrodes to the third proximal connector;   said tissue stimulator including two terminals for adjustably conductively contacting proximal connectors and means for changing the pattern of conductive contact between said proximal connectors and said terminals to conductively connect said terminals to selected distal electrodes.     
     
     
        .Iaddend. .Iadd.21.  A body tissue stimulation apparatus, comprising: a body implantable tissue stimulator for generating electrical stimulation signals;   a body implantable lead assembly for sealingly and conductively engaging said tissue stimulator and for applying said stimulation signals to a predetermined site of the body;   said lead assembly including, at least two distal electrodes positioned at said site for applying said stimulation signals;   at least two spaced coaxially aligned proximal connectors; and   means for conductively connecting one of said distal electrodes to two of said proximal connectors and the other of said distal electrodes to the third proximal connector;     said tissue stimulator including at least two terminals for conductively contacting proximal connectors and means for changing the position of the proximal connectors with respect to said terminals to conductively connect   
     
     
        said terminals to selected distal electrodes. .Iaddend. .Iadd.22.  The apparatus of claim 21, wherein said third proximal connector is positioned between said two proximal connectors. .Iaddend. .Iadd.23. A body implantable tissue stimulation system comprising: a body implantable lead comprising: first and second distal electrodes;   a proximal electrode assembly which comprises first and second coaxial, axially spaced proximal electrodes, each of which is electrically connected with a respective one of the distal electrodes;   first insulating means for electrically insulating the first proximal electrode from the second proximal electrode;   a third coaxial axially spaced proximal electrode electrically connected with the first proximal electrode and situated such that the second proximal electrode is interposed between the first and third proximal electrodes;   second insulating means for electrically insulating the third proximal electrode from the second proximal electrode; and     a body implantable tissue stimulator comprising: first and second stimulator electrodes; and   means for defining a channel in the stimulator adjacent the stimulator electrodes to receive the proximal electrode assembly in order to establish electrical contact between the stimulator electrodes and respective ones of the proximal electrodes; and   means for sealing the proximal electrode assembly in said channel, said means for sealing including means disposed between the first and second proximal electrodes for maintaining fluid isolation between the first and second proximal electrodes. .Iaddend. .Iadd.24. The system of claim 23, wherein said means for sealing includes at least one fluid sealing rib formed on at least one of the insulating means and extending radially outwardly from the proximal electrodes for contacting and sealing against the channel defining means. .Iaddend. .Iadd.25. The system of claim 23, wherein said sealing means comprises at least one fluid sealing rib mounted on said insulating means and extending outwardly from the proximal electrodes for contacting and sealing against the channel defining means, and wherein the system further comprises at least one fluid sealing rib mounted on the second insulating means and extending outwardly from the proximal electrodes for contacting and sealing against the channel defining means. .Iaddend.