TRIAL STIMULATION SYSTEMS

• US 20150094790A1
• Filed: 03/06/2013
• Published: 04/02/2015
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shishilla, John, Pederson, Kathryn A., Jain, Mukul, Mairs, Nicholas S.
• Granted Patent: US 9,707,405 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/37241 providing test stimulations

Abstract

A trial stimulation system includes a disposable trial electrical stimulator that, in some examples, is sterilized for a single use in a stimulation trial of one patient. Additionally, systems for securing a disposable trial stimulator to the body of a patient are described, which may function to improve the durability of the system during the trial period and reduce the risk of damage or malfunction to the system due to lead/electrode dislocation and/or off-label uses like showering or bathing with the trial stimulator still secured to the body

Claims

1. A system for securing a disposable trial stimulator to a body of a patient, the system comprising:

a patch comprising a first major surface at least partially covered with an adhesive configured to adhere the patch to the body of the patient; and

a holster connected to a second major surface of the patch, wherein the holster is configured to receive the trial stimulator.

2. The system of claim 1, wherein the holster comprises:

a planar major wall comprising four linear edges;

four minor walls, each of which protrudes perpendicular to the major wall from one of the four edges;

a second planar major wall connected to and offset from the first major wall by the four minor walls, wherein the second major wall is parallel to the first major wall and perpendicular to the four minor walls; and

a first aperture in at least one of the first or second major walls, or one of the four minor walls and through which the holster is configured to receive the trial stimulator.

3. The system of claim 2, wherein at least one of the four minor walls comprises a second aperture configured to provide access to an input/output (I/O) device of the trial stimulator.

4. The system of claim 3, wherein the I/O device comprises at least one of a receptacle configured to receive a plug for connecting a stimulation lead to the trial stimulator, a user interface component, and a receptacle configured to receive a computer readable storage medium.

5. The system of claim 1, wherein the holster comprises:

a planar major wall comprising four linear edges;

three minor walls, each of which protrudes perpendicular to the major wall from one of the four edges, and

wherein the holster is configured to receive the trial stimulator such that one minor wall and one major wall of the trial stimulator are not covered by the holster.

6. The system of claim 5, wherein at least one of the three minor walls comprises at least one aperture configured to provide access to an input/output (I/O) device of the trial stimulator.

7. The system of claim 6, wherein the I/O device comprises at least one of a receptacle configured to receive a plug for connecting a stimulation lead to the trial stimulator, a user interface component, and a receptacle configured to receive a computer readable storage medium.

8. The system of claim 1, wherein the holster comprises at least one of a plastic or an elastomer.

9. The system of claim 8, wherein the holster comprises a Class VI silicone comprising a 40 +/−

5 durometer hardness.

10. The system of claim 1, wherein the adhesive at least partially covering the first major surface of the patch comprises an acrylic pressure-sensitive adhesive.

11. The system of claim 1, wherein the holster is connected to the second major surface of the patch with a double-sided tape.

12. The system of claim 11, wherein the double-sided tape comprises:

a polyester film carrier;

a layer of silicone pressure sensitive adhesive on one side of the carrier, and

a layer of acrylic adhesive on the other side of the carrier.

13. The system of claim 1, further comprising:

a pouch,

wherein the pouch is adhered to the second major surface of the patch, and

wherein the pouch is configured to receive the holster to connect the holster to the patch.

14. The system of claim 1, wherein the holster comprises one or more grooves configured to channel liquids off of the trial stimulator.

15. The system of claim 1, wherein the patch comprises a polyethylene terephthalate non-woven material.

16. The system of claim 1, further comprising the disposable trial stimulator configured to be received by the holster.

17. A method of securing a disposable trial stimulator to a body of a patient, the method comprising:

implanting a stimulation lead to deliver stimulation to a target tissue location;

adhering a first major surface of a patch at least partially covered with an adhesive to the body of the patient, wherein a holster is connected to a second major surface of the patch, and wherein the holster is configured to receive the trial stimulator,

inserting the trial stimulator into the holster; and

connecting the stimulation lead to the trial stimulator.

18. The method of claim 17, wherein the holster comprises at least one of a plastic or an elastomer.

19. The method of claim 18, wherein the holster comprises a Class VI silicone comprising a 40 +/−

5 durometer hardness.

20. The method of claim 17, wherein the adhesive at least partially covering the first major surface of the patch comprises an acrylic pressure-sensitive adhesive.

21. The method of claim 20, further comprising removing a film covering the first major surface of the patch to expose the first major surface, and wherein adhering the first major surface of the patch to the body of the patient comprises pressing the exposed first major surface against the body of the patient.

22. The method of claim 17, wherein the holster is connected to the second major surface of the patch with a double-sided tape.

23. The method of claim 22, wherein the double-sided tape comprises:

a polyester film carrier;

a layer of silicone pressure sensitive adhesive on one side of the carrier, and

a layer of acrylic adhesive on the other side of the carrier.