Trial stimulation systems

• US 9,707,405 B2
• Filed: 03/06/2013
• Issued: 07/18/2017
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Mairs, Nicholas S., Shishilla, John, Pederson, Kathryn A., Jain, Mukul
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US14/396,667
• Publication Number:
  US 20150094790A1
• Time in Patent Office: 1,595 Days
• 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, a portion of the holster configured to be disposed at least partially around a perimeter of the trial stimulator to hold the trial stimulator within the holster, wherein the holster comprises;

a first planar major wall having one or more edges;

one or more minor walls, each of which protrudes perpendicular to the first major planar wall from a respective edge of the one or more edges, wherein at least one minor wall of the one or more minor walls defines one or more slots; and

a second planar major wall defining one or more grooves corresponding to respective slots of the one or more slots, wherein the second planar major wall is connected to and offset from the first planar major wall by the one or more minor walls, and wherein the second planar major wall is parallel to the first planar major wall and perpendicular to the one or more minor walls.

2. The system of claim 1, wherein:

the first planar major wall comprises four linear edges, the four linear edges comprising the one or more edges;

the one or more minor walls comprises four minor walls, each of which protrudes perpendicular to the first planar major wall from one of the four linear edges;

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

a first aperture is defined by one of the first planar major wall, the second planar major wall, 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 one of the four minor walls defines a second aperture configured to provide access to an input/output (I/O) device of the trial stimulator.

4. The system of claim 3, further comprising the trial stimulator that comprises the I/O device, 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 or a receptacle configured to receive a computer readable storage medium.

5. The system of claim 1, wherein:

the first planar major wall comprises four linear edges, the four linear edges comprising the one or more edges; and

the one or more minor walls comprises three minor walls, each of which protrudes perpendicular to the first planar major wall from one of the four linear edges, wherein the holster is configured to receive the trial stimulator such that one of the three minor walls and the second planar 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, further comprising the trial stimulator that comprises the I/O device, and wherein the I/O device comprises a user interface component.

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 further comprises a double-sided tape, wherein the holster is connected to the second major surface of the patch with the 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 a first side of the polyester film carrier; and

a layer of acrylic adhesive on a second side of the polyester film 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 via the pouch.

14. The system of claim 1, wherein the one or more grooves are configured to channel liquids off of the trial stimulator and through the one or more slots.

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. The system of claim 1, wherein each groove of the one or more grooves terminates at at least one slot of the one or more slots.

18. 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 so that a portion of the holster is disposed at least partially around a perimeter of the trial stimulator to hold the trial stimulator within the holster, wherein the holster comprises;

a first planar wall having one or more edges;

one or more minor walls, each of which protrudes perpendicular to the first major planar wall from a respective edge of the one or more edges, wherein at least one minor wall of the one or more minor walls defines one or more slots; and

a second planar major wall defining one or more grooves corresponding to respective slots of the one or more slots, wherein the second planar major wall is connected to and offset from the first planar major wall by the one or more minor walls, and wherein the second planar major wall is parallel to the first planar major wall and perpendicular to the one or more minor walls; and

connecting the stimulation lead to the trial stimulator.

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

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

5 durometer hardness.

21. The method of claim 18, wherein the adhesive at least partially covering the first major surface of the patch comprises an acrylic pressure-sensitive adhesive.

22. The method of claim 21, 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.

23. The method of claim 18, wherein the holster is connected to the second major surface of the patch with a double-sided tape.

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

a polyester film carrier;

a layer of silicone pressure sensitive adhesive on a first side of the polyester film carrier; and

a layer of acrylic adhesive on a second side of the polyester film carrier.

25. The method of claim 18, wherein each groove of the one or more grooves terminates at at least one slot of the one or more slots.