Systems and methods to place one or more leads in muscle for providing electrical stimulation to treat pain

• US 20100036454A1
• Filed: 08/03/2009
• Published: 02/11/2010
• Est. Priority Date: 06/03/1998
• Status: Active Grant

• Current Assignee: SPR Therapeutics, Inc.
• Original Assignee: NDI Medical, LLC
• Inventors: Boggs, Joseph W. III, Inmann, Andreas, Bennett, Maria E., Thrope, Geoffrey B.
• Granted Patent: US 8,626,302 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• 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 1/36071 Pain

Abstract

Systems and methods are adapted to provide the relief of pain. The systems and methods make possible the percutaneous placement of one or more intramuscular leads, without the need for fluoroscopy, for providing electrical stimulation to activate a motor point innervating the muscle, to provide the therapeutic relief of pain. The one or more intramuscular leads may be placed in muscle(s) to resist migration. The target nerves and their motor points innervate the muscles in which the one or more leads are placed. The systems and methods can include a two-stage solution. The first stage may include temporary systems and methods, including the use of an external pulse generator. The second stage may include more permanent systems and methods, including the use of an implanted pulse generator.

Claims

1. A method to reduce and/or relieve pain comprising:

percutaneously placing an intramuscular lead into a muscle in a region where pain is felt, such that the lead is in electrical proximity, but not touching, a motor point within the muscle, and

electrically stimulating the motor point within the muscle where the lead is placed to reduce and/or relieve the pain in the region where the pain is felt.

2. A method according to claim 1:

wherein the intramuscular lead includes at least one anchoring member to anchor the lead in the muscle.

3. A method according to claim 1:

wherein electrically stimulating the motor point reduces and/or relieves the pain without any functional movement or response.

4. A method according to claim 1:

wherein the region where the pain is felt comprises the muscle where the intramuscular lead is placed.

5. A method to alleviate pain, the method comprising:

identifying a tissue region where pain is perceived including skeletal muscle innervated by a peripheral nerve and including a motor point,

placing at least one intramuscular lead having at least one electrode within the skeletal muscle in electrical proximity, but not touching, the motor point, and

applying therapeutic electrical stimulation to the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and/or efferent nerve stimulation within the skeletal muscle and to provide the therapeutic electrical stimulation to the motor point to alleviate pain without any functional nerve stimulation involving the skeletal muscle.

6. A method according to claim 5:

wherein identifying the tissue region includes locating the motor point by percutaneously placing a first lead and applying the therapeutic electrical stimulation to the first lead and adjusting the position of the first lead until a muscle twitch is observed in the skeletal muscle.

7. A method according to claim 6:

wherein the motor point is located without any feedback from the patient.

8. A method of therapeutically stimulating a motor point of a peripheral nerve to reduce the perception of pain in a muscle region innervated by the peripheral nerve, without stimulating the motor point to produce a functional response, the method comprising:

percutaneously placing at least one intramuscular lead having at least one electrode in the muscle region where the perception of pain is experienced, and

electrically stimulating the motor point with the at least one electrode to reduce the perception of pain in the muscle region.

9. A method according to claim 8:

wherein electrically stimulating the motor point requires evoking a muscle contraction in the muscle to confirm correct lead placement.

10. A method according to claim 8:

wherein the steps to place the IM lead percutaneously near the motor point and to evoke a muscle contraction are accomplished between about one minute and about thirty minutes.

11. A method comprising:

placing a first lead in electrical proximity to a first motor point of a first muscle,

placing a second lead in electrical proximity to a second motor point of a second muscle,

placing a third lead in electrical proximity to a point generally in-between the first lead in electrical proximity to the first motor point of the first muscle and the second lead in electrical proximity to the second motor point of the second muscle, and

providing electrical stimulation to the third lead to activate the motor point of the first muscle and the motor point of the second muscle.

12. A method according to claim 11:

wherein the first muscle and the second muscle are activated simultaneously.

13. A method according to claim 11:

wherein the first lead and the second lead are a different configuration than the third lead.

14. A method according to claim 13:

wherein the third lead is an intramuscular lead and the first lead and the second lead are EMG leads.

15. A method according to claim 11:

further including recording electrical stimulation parameters used to activate the motor point of the first muscle and/or the motor point of the second muscle.

16. A method according to claim 11:

further including recording electrical stimulation parameters provided to the third lead to activate the motor point of the first muscle and the motor point of the second muscle.

17. A method according to claim 11:

wherein the first muscle comprises the middle deltoid muscle, and the second muscle comprises the posterior deltoid muscle, and the electrical stimulation applied to the third lead provides relief of shoulder pain.

18. A method according to claim 11:

further including removing the first lead and the second lead after placing the third lead.

19. A method according to claim 18:

wherein the electrical stimulation applied to the third lead provides relief of pain to both the first muscle and the second muscle.

20. A system for providing therapeutic electrical stimulation to a muscle region where pain is felt to reduce the perception of pain in a muscle region, the system comprising:

an intramuscular lead having at least one electrode, the lead and electrode adapted to be placed between motor points of at least two muscles, and

a pulse generator adapted to provide the therapeutic electrical stimulation to the lead and electrode to therapeutically stimulate the motor points of the at least two muscles to reduce the perception of pain in the muscle region.

21. A system according to claim 20:

wherein the intramuscular lead includes at least one anchoring member to anchor the lead in the muscle.

22. A system according to claim 20:

wherein the muscle region where pain is felt comprises the at least two muscle where the intramuscular lead is placed.

23. A system for providing therapeutic electrical stimulation to a region of pain to reduce the perception of pain, the system comprising:

an intramuscular lead having at least one electrode, the lead and electrode adapted to be placed in electrical proximity but not touching a motor point of a muscle, and

a pulse generator adapted to provide the therapeutic electrical stimulation to the lead and electrode to therapeutically stimulate the motor point of the muscle to reduce the perception of pain in the region of pain.

24. A system according to claim 23:

wherein the intramuscular lead includes at least one anchoring member to anchor the lead in the muscle.

25. A system according to claim 23:

wherein the therapeutic electrical stimulation is adapted to provide a therapeutic stimulation function, the therapeutic stimulation function including a function selected from a group comprising the treatment of (i) shoulder pain, (ii) arm pain, (iii) calf pain, (iv) leg pain, (v) neck pain, (vi) head pain, and (vii) back pain.

26. A method of reducing the perception of pain in a muscle region, the method comprising:

placing an intramuscular lead in muscle near but not touching a motor point of the muscle,

providing therapeutic electrical stimulation via the intramuscular lead to the motor point of the muscle,

activating the motor point of the muscle with the therapeutic electrical stimulation, and

causing the reduction of the perception of pain in the muscle region where the lead is placed.

27. A method according to claim 26:

wherein the intramuscular lead is placed percutaneously via an introducer.

28. A method according to claim 26:

wherein therapeutic electrical stimulation may be applied to target motor points in muscles, the muscles comprising the posterior, anterior, and/or middle dletoid, trapezius, erector spinae, gastrocnemius, occipitailis, gluteus maximus, gluteus medius, iliotibial band, biceps femoris, adductor magnus, semitendinosus, gracilis, semimembranosus, sartorius, pectineus, adductor longus, vastus medialis, vastus lateralis, and rectus femoris.

29. A method according to claim 26:

wherein the muscle region where the pain is perceived comprises the muscle where the intramuscular lead is placed.