System and method for treatment of pain related to limb joint replacement surgery

Patent metadata

Field	Value
Publication number	US-11116971-B2
Application number	US-201916391362-A
Country	US
Kind code	B2
Filing date	Apr 23, 2019
Priority date	Mar 8, 2012
Publication date	Sep 14, 2021
Grant date	Sep 14, 2021

Abstract

It has been discovered that pain felt in a given region of the body can be treated by stimulating a peripheral nerve at a therapeutically effective distance from the region where pain is felt to generate a comfortable sensation (i.e., paresthesia) overlapping the regions of pain. A method has been developed to reduce pain in a painful region following limb joint replacement by stimulating a peripheral nerve innervating the painful region with an electrode inserted into tissue and spaced from the peripheral nerve. This method may be used to help alleviate postoperative pain in patients following total knee arthroplasty surgery or other limb joint replacement surgeries.

First claim

The invention claimed is:

1. A method to alleviate pain post limb joint replacement surgery, the method comprising:
identifying a tissue region outside of an expected targeted region of pain resulting from the limb joint replacement surgery;
placing at least one percutaneous lead within the tissue region near a peripheral nerve innervating the expected targeted region of pain; and
applying electrical stimulation to the peripheral nerve after the limb joint replacement surgery using a pulse generator operatively coupled with the at least one lead; and
evoking a post-surgical area of paresthesia without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

2. The method of claim 1 , wherein the limb joint replacement surgery comprises a total knee arthroplasty.

3. The method of claim 1 , wherein the limb joint replacement surgery comprises, total and partial limb joint replacement, and is selected from a group consisting of: a shoulder, elbow, wrist, finger joint, hip, knee, ankle and toe joint.

4. The method of claim 1 , wherein the peripheral nerve is selected from a group consisting of a femoral nerve, a sciatic nerve, lateral femoral cutaneous nerve, and an obturator nerve.

5. The method of claim 1 , wherein the peripheral nerve includes the branches therefrom.

6. The method of claim 1 , wherein the application of the electrical stimulation will not block motor or sensory function of a limb.

7. The method of claim 1 further comprising the steps of:
evoking a pre-surgical area of paresthesia in the expected targeted region of pain without functional nerve stimulation at a motor point and without damaging the peripheral nerve, wherein the pre-surgical area of paresthesia is substantially identical with the post-surgical area of paresthesia.

8. The method of claim 7 further comprising the step of:
comparing the post-surgical area of paresthesia with a region of pain occurring after the limb joint replacement surgery.

9. The method of claim 8 , wherein if the post-surgical area of paresthesia does not substantially match the region of pain, the method further comprises the step of:
placing the at least one electrode within the tissue region near the peripheral nerve outside of the region of pain;
applying electrical stimulation through the at least one electrode;
evoking a third area of paresthesia without functional nerve stimulation at a motor point and without damaging the peripheral nerve, wherein the third area of paresthesia is different from the first area of paresthesia; and
comparing the third area of paresthesia caused by the electrical stimulation with the region of pain occurring after the limb joint replacement surgery.

10. The method of claim 7 , wherein applying electrical stimulation through the at least one electrode after the limb joint replacement surgery includes a first set of electrical stimulation parameters.

11. The method of claim 10 , wherein if the post-surgical area of paresthesia does not substantially match the region of pain, the method further comprises the step of:
applying a second electrical stimulation through the at least one electrode after the limb joint replacement surgery, wherein the second electrical stimulation includes a set of second electrical stimulation parameters, wherein at least one of the second electrical stimulation parameters is different from at least one of the first electrical stimulation parameters; and
comparing the third area of paresthesia caused by the electrical stimulation with the region of pain occurring after the limb joint replacement surgery.

12. The method of claim 11 , wherein the at least one of the second electrical stimulation parameters includes at least one of frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, a predetermined number of phases, and wave form shape.

13. The method of claim 1 , wherein the electrode is operatively coupled with a lead, whereby the lead enables movement of a joint during the evoking of the second area of paresthesia.

14. A method to alleviate pain post limb joint replacement surgery, the method comprising:
identifying a tissue region comprising a peripheral nerve innervating a targeted region, wherein the tissue region is outside of the targeted region;
placing at least one electrode within the tissue region near the peripheral nerve;
applying electrical stimulation to activate the peripheral nerve;
evoking a tingling sensation in the targeted region in advance of the limb joint replacement surgery;
applying electrical stimulation through the at least one electrode after the limb joint replacement surgery; and
evoking a second tingling sensation in an area of paresthesia without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

15. The method of claim 14 further comprising comparing the area of paresthesia caused by the electrical stimulation with a region of pain occurring after the limb joint replacement surgery.

16. The method of claim 14 , further comprising:
re-placing the at least one electrode within the tissue region near the peripheral nerve;
re-applying electrical stimulation;
causing a second area of paresthesia; and
re-comparing the second area of paresthesia caused by the electrical stimulation with the region of pain resulting from the limb joint replacement surgery.

17. The method of claim 14 , wherein applying electrical stimulation after the limb joint replacement surgery includes a first set of electrical stimulation parameters.

18. The method of claim 17 , further comprising:
applying electrical stimulation after the limb joint replacement surgery, wherein the reapplied electrical stimulation includes a set of second electrical stimulation parameters, wherein at least one of the second electrical stimulation parameters is different from at least one of the first electrical stimulation parameters.

19. The method of claim 18 , wherein the at least one of the second electrical stimulation parameters includes at least one of frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, a predetermined number of phases, and wave form shape.

20. The method of claim 14 , wherein the limb joint replacement surgery includes total knee arthroplasty.

21. The method of claim 20 , wherein the peripheral nerve includes the femoral nerve.

22. The method of claim 21 , wherein the electrode is located in tissue that is distal from the targeted region.

23. A method to alleviate pain post limb joint replacement surgery, the method comprising:
identifying a tissue region comprising a peripheral nerve innervating a targeted region, wherein the tissue region is outside of the targeted region;
placing at least one electrode within the tissue region near the peripheral nerve;
applying electrical stimulation to activate the peripheral nerve;
evoking a tingling sensation in the targeted region in advance of the limb joint replacement surgery;
applying electrical stimulation to the peripheral nerve after the limb joint replacement surgery using a pulse generator operatively coupled with the electrode; and
evoking a post-surgical area of paresthesia without functional nerve stimulation at a motor point and without damaging the peripheral nerve.

Assignees

• Spr Therapeutics Inc

Inventors

• Boggs Ii Joseph W
• Bennett Maria E
• Wongsarnpigoon Amorn
• Chae John
• Grill Warren M
• Stager Kathryn
• Zang Rosemary

Classifications

• A61N1/36021 Primary

  for treatment of pain · CPC title

• A61N1/0502

  Skin piercing electrodes · CPC title

• A61B17/3468

  for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069) · CPC title

• A61N1/36017

  with leads or electrodes penetrating the skin · CPC title

• A61N1/0558

  Anchoring or fixation means therefor · CPC title