Device and method for delivery of a drug depot near the nerve

• US 8,715,223 B2
• Filed: 07/22/2009
• Issued: 05/06/2014
• Est. Priority Date: 07/22/2009
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US12/507,197
• Publication Number:
  US 20110022028A1
• Time in Patent Office: 1,749 Days
• Field of Search: 604/57, 604/16, 604/59
• US Class Current: 604/57
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4893 Nerves
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

Drug depot delivery devices and methods are provided for delivering one or more drug depots in close proximity to the nerve of a patient with or without repositioning the cannula. The device includes an electronic monitor for detecting the proximity of the tip of the cannula to a nerve. In some embodiments, a method of delivering a drug depot is provided by detecting the nerve and delivering the drug depot near the nerve.

Claims

1. A method of delivering a drug depot to a delivery site near a nerve of a patient, the method comprising:

detecting the nerve of the patient; and

positioning near the nerve of a patient a cannula having a proximal end and a distal end, the proximal end of the cannula having an opening to receive the drug depot, the distal end of the cannula having a side port containing an opening for passage of the drug depot on a shaft of said distal end of the cannula configured for delivery of said drug depot to the delivery site near the nerve of the patient;

positioning the side port to deliver said drug depot to the delivery site near the nerve by orientating the position of said side port using an index marker configured to indicate the relative position of said side port when inserted into the skin of a patient; and

delivering the drug depot at the delivery site near the nerve by sliding a plunger having a handle and a tip adapted for dispensing the drug depot, wherein the tip of the plunger is slidably receivable within the cannula to deliver the drug depot out the side port opening of the cannula to the delivery site near the nerve of the patient and the drug depot being in pellet form and comprising a biodegradable polymer.

2. A method of delivering a drug depot according to claim 1, wherein said detecting the nerve of the patient is performed using a cannula coupled to a nerve sensing unit comprising an electrical contact and an alarm coupled to the nerve sensing unit such that when the cannula is in close proximity to the nerve or contacts the nerve, the alarm is activated.

3. A method of delivering a drug depot according to claim 2, wherein the alarm is audible or visible or audible and visible.

4. A method of delivering a drug depot according to claim 1, wherein the detecting of the nerve of the patient and delivery of the drug depot is performed by the same cannula.

5. A method of delivering a drug depot according to claim 1, wherein the nerve comprises the sciatic nerve.

6. A method of delivering a drug depot according to claim 1, wherein the delivery site near the nerve comprises at least one muscle, ligament, tendon, cartilage, synovial joint, spinal disc, spinal foraminal space, near the spinal nerve root, facet joint or spinal canal.

7. A method of delivering a drug depot according to claim 1, wherein the distal end of the cannula comprises a blunt tip.

8. A method of delivering a drug depot according to claim 1, wherein the drug depot is delivered within 1 cm of the nerve site.

9. A method of delivering a drug depot to a delivery site near a nerve of a patient, the method comprising:

positioning a first cannula having a nerve sensing unit comprising an electrical contact and an alarm coupled to the nerve sensing unit, wherein the cannula contacts the nerve or is in close proximity to the nerve, the alarm is activated to indicate a location of the nerve;

positioning near the nerve of the patient a second cannula having a proximal end and a distal end, the proximal end of the second cannula having an opening to receive the drug depot, the distal end of the second cannula having a side port containing an opening for passage of the drug depot on a shaft of said distal end of the second cannula configured for delivery of said drug depot to the delivery site near the nerve of the patient;

positioning the side port to deliver said drug depot to the delivery site near the nerve by orientating the position of said side port using an index marker configured to indicate the relative position of said side port when inserted into the skin of a patient; and

delivering the drug depot at the delivery site near the nerve by sliding a plunger having a handle and a tip adapted for dispensing the drug depot, wherein the tip of the plunger is slidably receivable within the second cannula to deliver the drug depot out of the side port opening of the second canal to the delivery site near the nerve of the patient and the drug depot being in pellet form and comprising a biodegradable polymer.

10. A method of delivering a drug depot according to claim 9, wherein the alarm is audible or visible or audible and visible.

11. A method of delivering a drug depot according to claim 9, wherein the nerve comprises the sciatic nerve.

12. A method of delivering a drug depot according to claim 9 wherein the delivery site near the nerve comprises at least one muscle, ligament, tendon, cartilage, synovial joint, spinal disc, spinal foraminal space, near the spinal nerve root, facet joint or spinal canal.

13. A method of delivering a drug depot according to claim 9, wherein the first and second cannulas each comprise a blunt tip.

14. A device for delivering a drug depot at or near a nerve site beneath the skin of a patient, the device comprising:

a cannula having a proximal end and a distal end, the proximal end of the cannula having a side port containing an opening to receive the drug depot, the distal end of the cannula capable of insertion at or near the nerve site beneath the skin of the patient and having an opening for passage of the drug depot and an index marker at the proximal end of the cannula, the index marker parallel to and aligned with the opening for passage of the drug depot;

a plunger being slidably receivable within the opening of the proximal end of the cannula, the plunger having a first end and a tip at a second end, the first end being capable of moving the tip of the plunger to an extended position;

a nerve sensing unit disposed on or within the device, the nerve sensing unit comprising an electrical contact material configured to receive electrical impulses from the nerve site so as to detect the nerve.

15. A device for delivering a drug depot according to claim 14, wherein the electrical contact material is disposed at or in a tip of the distal end of the cannula.

16. A device for delivering a drug depot according to claim 14, wherein the nerve site comprises the sciatic nerve.

17. A device for delivering a drug depot, according to claim 14, wherein the nerve site comprises at least one muscle, ligament, tendon, cartilage, synovial joint, spinal disc, spinal foraminal space, near the spinal nerve root, facet joint or spinal canal.

18. A device for delivering a drug depot to a delivery site near a nerve of a patient, the device comprising:

a first cannula having a nerve sensing unit comprising an electrical contact and an alarm coupled to the nerve sensing unit, wherein the cannula contacts the nerve or is in close proximity to the nerve, the alarm is activated to indicate a location of the nerve;

a second cannula having a proximal end and a distal end, the proximal end of the second cannula having a side port containing an opening to receive the drug depot, the distal end of the second cannula having an opening for the passage of the drug depot from the distal end of the second cannula to the delivery site near the nerve of the patient and an index marker at the proximal end of the second cannula, the index marker parallel to and aligned with the opening for passage of the drug depot; and

a plunger having a handle and a tip adapted for dispensing the drug depot, wherein the tip of the plunger is slidably receivable within the second cannula to deliver the drug depot out of the opening of the second cannula to the delivery site near the nerve of the patient.

19. A device for delivering a drug depot according to claim 18, wherein the electrical contact material is disposed at or in a tip of a distal end of the first cannula and the second cannula is positioned near the first cannula after the nerve is located to deliver the drug depot near the nerve of the patient.

20. A device for delivering a drug depot according to claim 18, wherein the alarm is audible or visible or audible and visible.