Minimally invasive implantable neurostimulation system
A neuromodulation therapy is delivered via at least one electrode implanted subcutaneously and superficially to a fascia layer superficial to a nerve of a patient. In one example, an implantable medical device is deployed along a superficial surface of a deep fascia tissue layer superficial to a nerve of a patient. Electrical stimulation energy is delivered to the nerve through the deep fascia tissue layer via implantable medical device electrodes.
1. An implantable medical device, comprising:
a hermetically sealed housing constructed of at least one of a biocompatible titanium or stainless steel and
formed as an elongated tube having a circular cross-section
with an overall length of less than about thirty millimeters to enable minimally invasive implantation of the housing within a body of a patient;
a pulse generating circuit at least partially housed within the hermetically sealed housing;
an insulated lead tethered to one end of the hermetically sealed housing by way of an electrically insulated, sealed feedthrough, the insulated lead including:
two or more spaced apart electrodes in electrical communication with the pulse generating circuit, the two or more spaced apart electrodes carried near a distal end of the insulated lead and constructed of at least one of a conductive platinum or platinum iridium material,
the two or more spaced apart electrodes are configured to be positioned such that at least one electrode is in proximity to a tibial nerve of a patient for the delivery of a neurostimulation therapy to the tibial nerve of the patient as a treatment for symptoms related to an overactive bladder; and
a protective, resilient polymer enclosure at least partially surrounding the hermetically sealed housing; and
a fixation member arranged between the hermetically sealed housing and the two or more spaced apart electrodes, the fixation member configured to anchor the implantable medical device at an implant site.
2. The implantable medical device of claim 1 , wherein the hermetically sealed housing has a total volume of about one cubic centimeter.
3. The implantable medical device of claim 1 , wherein the hermetically sealed housing has a total volume of between about one cubic centimeter and about one tenth of a cubic centimeter.
4. The implantable medical device of claim 1 , wherein the shape and profile of the hermetically sealed housing is adapted for implantation at a particular implant site.
5. The implantable medical device of claim 1 , wherein the hermetically sealed housing is configured for implantation in a region of the medial malleolus of a patient for delivering a neurostimulation therapy to a tibial nerve of the patient.
6. The implantable medical device of claim 1 , further comprising a power supply, comprising at least one of a primary battery cell, rechargeable battery cell, or an inductively coupled power source.
7. The implantable medical device of claim 1 , wherein the polymer enclosure includes one or more fixation elements in the form of a tab defining an aperture through which a suture can be threaded to enable stable fixation of the tibial nerve stimulation device at an implant site.
8. The implantable medical device of claim 1 , wherein the lead includes a passive fixation member enabling tissue growth to anchor the at least one electrode at a targeted site.
9. The implantable medical device of claim 1 , further comprising a telemetry module configured to enable communication with at least one external programming device.
10. The implantable medical device of claim 9 , wherein the telemetry module is configured to establish a wireless telemetry link over a distance of at least two-feet.
11. The implantable medical device of claim 9 , wherein the telemetry module is configured to enable a user to control therapy output parameters, including at least one of a pulse amplitude, a pulse width, pulse shape, pulse frequency, duty cycle, or therapy on and off times.
12. The implantable medical device of claim 9 , wherein the telemetry module of the implantable medical device is configured to provide confirmation to the external programming device upon receipt of a communication from the external programming device.
13. The implantable medical device of claim 1 , wherein an output of the pulse generating circuit is selectively adjustable via an external magnetic field.
14. The implantable medical device of claim 13 , wherein a decrease in the output of the pulse generating circuit results in a reduced power requirement.
15. The implantable medical device of claim 13 , wherein the external magnetic field is configured to cease the neurostimulation therapy.
16. An implantable medical device, comprising:
a hermetically sealed housing constructed of at least one of a biocompatible titanium or stainless steel and
formed as an elongated tube having a circular cross-section
with an overall length of less than about thirty millimeters to enable minimally invasive implantation of the housing within a body of a patient;
a pulse generating circuit at least partially housed within the hermetically sealed housing;
an insulated lead tethered to one end of the hermetically sealed housing by way of an electrically insulated, sealed feedthrough, the insulated lead including:
two or more spaced apart electrodes in electrical communication with the pulse generating circuit, the two or more spaced apart electrodes carried near a distal end of the insulated lead and constructed of at least one of a conductive platinum or platinum iridium material,
the two or more spaced apart electrodes are configured to be positioned such that at least one electrode is in proximity to a tibial nerve of a patient for the delivery of a neurostimulation therapy to the tibial nerve of the patient as a treatment for symptoms related to an overactive bladder;
a protective, resilient polymer enclosure at least partially surrounding the hermetically sealed housing; and
a telemetry module configured to enable communication with an external programming device, wherein communication with the external programming device via the telemetry module enables receipt of a command to adjust an intensity or strength of the therapy up or down.