METHOD AND SYSTEM FOR TREATMENT OF INTRACTABLE SCROTAL AND/OR TESTICULAR PAIN
First Claim
1. A device used for implanting an implantable lead into a patient, the implantable lead having a distal lead end and a proximal end wherein the proximal end of the implantable lead is operatively associated with an implantable pulse generator, the implantable lead including at least one electrode wherein the electrode is for placement into body tissue fo the patient, the system comprising:
- a sheath comprising a distal end having a blunt tip in proximity to a distal aperture, the sheath further comprising a longitudinally oriented bore adapted for receiving temporarily at least a portion of the implantable lead including the electrode, the longitudinally oriented bore extending between the distal aperture of the sheath and a proximal aperture at a proximal end of the sheath, the sheath having at least one electrode exposure aperture corresponding to a longitudinal position of the electrode;
wherein the distal lead end of the implantable lead cooperates with the blunt tip of the sheath for allowing advancement of the electrode into the tissue of the patient.
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Accused Products
Abstract
A system and method is provided for the implantation and treatment of pain, such as scrotal and/or testicular pain, using electrical stimulation. The implanted portion of the system includes an implantable pulse generator that provides an electrical current through an implantable lead that extends to at least one electrode or an electrode array. The electrode is implanted into the relatively fragile tissue of the scrotal sac using a method that eliminates or otherwise minimizes damage to the tissue of the scrotal sac during the implantation procedure. An embodiment of the invention allows in-place testing of the electrode while the sheath still covers the implantable lead.
74 Citations
33 Claims
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1. A device used for implanting an implantable lead into a patient, the implantable lead having a distal lead end and a proximal end wherein the proximal end of the implantable lead is operatively associated with an implantable pulse generator, the implantable lead including at least one electrode wherein the electrode is for placement into body tissue fo the patient, the system comprising:
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a sheath comprising a distal end having a blunt tip in proximity to a distal aperture, the sheath further comprising a longitudinally oriented bore adapted for receiving temporarily at least a portion of the implantable lead including the electrode, the longitudinally oriented bore extending between the distal aperture of the sheath and a proximal aperture at a proximal end of the sheath, the sheath having at least one electrode exposure aperture corresponding to a longitudinal position of the electrode; wherein the distal lead end of the implantable lead cooperates with the blunt tip of the sheath for allowing advancement of the electrode into the tissue of the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A system for implantation and electrical stimulation of a patient having a scrotal sac, the system comprising:
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an implantable pulse generator; an implantable lead operatively associated with the pulse generator; at least one implantable electrode operatively associated with the implantable lead; and means for introducing the implantable electrode subcutaneously into the scrotal sac. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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18. A method for implanting at least a portion of an electrical stimulation system in a patient, the method comprising:
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(a) causing an incision to be made in the patient, the incision spaced apart from an implant target location; (b) inserting a distal end of a sheath through the incision, the sheath holding at least a portion of an implantable lead having an electrode; (c) advancing a blunt tip of the sheath subcutaneously to and into a tissue of the patient to the implant target location, the sheath having a longitudinally oriented bore for holding and selectively positioning the electrode into the tissue, wherein the sheath and electrode are advanced together during the advancing step; and (d) withdrawing the sheath from the tissue while maintaining the electrode within the tissue. - View Dependent Claims (19, 20, 21, 22, 23)
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24. A method for treating intractable scrotal and/or testicular pain in a patient having a scrotal sac, the method comprising:
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causing an incision to be made in the patient, the incision spaced apart from the scrotal sac; inserting a sheath and an electrode lead having at least one electrode through the incision, the sheath comprising a distal end that includes a blunt tip, the sheath having a longitudinally oriented bore holding at least a portion of the electrode lead, wherein the sheath extends longitudinally in a distal direction beyond the electrode; advancing the blunt tip of the sheath subcutaneously to and into the scrotal sac; positioning the distal end of the electrode lead within the scrotal sac; withdrawing the sheath from covering the electrode while maintaining the electrode within the scrotal sac; implanting a pulse generator into the patient; connecting a proximate end of the electrode lead to the pulse generator; and causing an electrical pulse to be generated by the pulse generator, wherein the electrical pulse passes through the electrode lead and to the electrode located in the scrotal sac. - View Dependent Claims (25, 26, 27, 29)
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30. A method of assembling an implantable electrical stimulation system, the method comprising:
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providing an implantable pulse generator; providing an electrical lead comprising at least one electrode; and providing a sheath for holding the lead, wherein the sheath comprises a diameter sized for receiving the lead; wherein a distal end of the lead is adapted for residing within a distal end of the sheath. - View Dependent Claims (31, 32, 33)
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Specification