DEVICES AND METHODS FOR DELIVERING DRUG DEPOTS TO A SITE BENEATH THE SKIN

• US 20090131908A1
• Filed: 11/20/2007
• Published: 05/21/2009
• Est. Priority Date: 11/20/2007
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F.
• Granted Patent: US 8,221,358 B2
• Time in Patent Office: Days
• US Class Current: 604/511
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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

Devices and methods are provided for delivering a drug depot at or near the spinal column of a patient. In various embodiments, the drug depot comprises a drug cartridge containing drug pellets for delivery at or near the spinal column of a patient.

Claims

1. A device for delivering a drug depot to a site at or near a spinal column of a patient, the device comprising:

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 capable of insertion at or near the spinal column and having an opening for passage of the drug depot, and the drug depot is disposed within the cannula; and

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;

wherein the openings of the proximal and distal ends permit passage of the drug depot and wherein the movement of the tip of the plunger to the extended position causes delivery of the drug depot from the distal end of the cannula to the site at or near the spinal column of the patient.

2. A device for delivering a drug depot according to claim 1, wherein the cannula comprises a hub surrounding the opening of the proximal end of the cannula and the plunger engages the hub to move the tip of the plunger to the extended position to deliver the drug depot from the distal end of the cannula to the site at or near the spinal column.

3. A device for delivering a drug depot according to claim 1, wherein the proximal end of the cannula further comprises a drug depot chamber capable of receiving the drug depot and the tip of the plunger, the drug depot chamber having one or more drug depots disposed therein.

4. A device for delivering a drug depot according to claim 2, wherein the threading of the hub comprises internal threading and the threading of the first end comprises external threading that pair when:

(i) the first end is rotated in a clockwise direction causing the tip of the plunger to move in the extended position or (ii) the first end is rotated in a counterclockwise direction to secure the tip of the plunger in a retracted position in a direction toward the hub and away from the drug depot.

6. A device for delivering a drug depot according to claim 3, wherein the drug depot is contained within a drug cartridge and the drug cartridge contains one or more drug pellets.

7. A device for delivering a drug depot according to claim 3, wherein the drug depot is at least a sterilizable drug depot and/or a biodegradable drug depot.

8. A device for delivering a drug depot according to claim 1, wherein the site is at least one muscle, ligament, tendon, cartilage, spinal disc, spinal foraminal space, near the spinal nerve root, facet joint, or spinal canal.

9. A device for delivering a drug depot according to claim 2, wherein at least one of:

(i) a handle is fixed to at least the hub of the cannula, (ii) a handle is fixed to at least the hub of the cannula, and the handle, first end, plunger or hub includes dose indicator markings to indicate the number of drug depots delivered, or (iii) the plunger, cannula or drug depot include markings that indicate location at or near the site beneath the skin.

5. (canceled)

10. A device for delivering a drug depot to a site beneath the skin of a patient, the device comprising:

a needle having a proximal end and a distal end, the proximal end of the needle having an opening to receive the drug depot and a generally cylindrical hub surrounding the opening of the proximal end of the needle, the distal end of the needle having a tip capable of passage through the skin of the patient and an opening for passage of the drug depot; and

a plunger being slidably receivable within the opening of the proximal end of the needle and movable to an extended position, the plunger having a knob at a first end and a tip at a second end, the knob having threading for engaging the hub of the needle and the hub of the needle comprising threading for engaging the knob of the plunger, wherein rotation of the knob of the plunger along the threading of the hub moves the tip of the plunger to the extended position so as to effect deliver of the drug depot from the distal end of the needle to beneath the skin of the patient.

11. A device for delivering a drug depot according to claim 10, wherein the proximal end of the needle further comprises a drug depot chamber contacting the opening of the needle and the threading of the hub, and the drug depot chamber is capable of receiving one or more drug depots and the tip of the plunger.

12. A device for delivering a drug depot beneath the skin of a patient according to claim 11, wherein the drug depot is contained within a drug cartridge, which is disposed within the drug depot chamber.

13. A device for delivering a drug depot according to claim 12, wherein the drug depot is at least sterilizable drug depot or biodegradable drug depot.

14. A device for delivering a drug depot according to claim 10, wherein the threading of the hub comprises internal threading and the threading of the knob comprises external threading that pair when:

(i) the knob is rotated in a clockwise direction causing the tip of the plunger to move in the extended position or (ii) the knob is rotated in a counterclockwise direction to secure the tip of the plunger in a retracted position in a direction away from the drug depot.

15. A device for delivering a drug depot according to claim 12, wherein the drug depot comprises one or more drug pellets contained within a channel of the drug cartridge, wherein the channel of the drug cartridge receives the tip of the plunger and movement of the plunger to the extended position moves the one or more drug pellets from the cartridge out the distal end of the needle to deliver the drug pellet.

16. A device for delivering a drug depot according to claim 12, wherein at least one of:

(i) a handle is fixed to at least the hub of the needle;

(ii) the knob, plunger or hub includes dose indicator markings to indicate the number of drug depots delivered or (iii) the plunger, needle or drug depot include markings that indicate depth beneath the skin.

17. A device for delivering a drug depot to a site at or near a spinal column of a patient, the device comprising:

a cannula having a proximal end and a distal end, the distal end of the cannula having an opening for passage of the drug depot, the proximal end of the cannula attached to a depot chamber, the drug depot chamber having an opening to receive the drug depot, wherein the drug depot chamber contains the drug depot; and

a plunger being slidably receivable within the opening of the drug depot chamber and within the cannula, the plunger having a first end and a tip at a second end, the first end for moving the tip of the plunger to an extended position, wherein the openings of the drug depot chamber and distal end of the cannula permit passage of the drug depot and wherein the movement of the tip of the plunger to the extended position causes delivery of the drug depot from the distal end of the cannula to the site at or near the spinal column of the patient.

18. A device for delivering a drug depot according to claim 17, wherein the plunger is capable of insertion to the site at or near the spinal column.

19. A device for delivering a drug depot according to claim 17, wherein the drug depot chamber further comprises a drug cartridge containing one or more drug depots in the form of one or more drug pellets and movement of the tip of the plunger to the extended position causes delivery of the one or more drug pellets from the drug cartridge in the chamber to the distal end of the cannula to the site at or near the spinal column.

20. A device for delivering a drug depot according to claim 19, wherein the device further comprises a handle attached to the drug depot chamber, the handle having threading aligned with the opening of the chamber and for engaging the first end of the plunger, and the first end of the plunger comprising threading for engaging the threading of the handle, wherein rotation of the first end of the plunger along the threading of the handle moves the tip of the plunger to the extended position to deliver the one or more drug pellets from the drug cartridge to the distal end of the cannula to the site at or near the spinal column.

21. A drug cartridge for delivering a drug pellet to a site beneath the skin of a patient, the drug cartridge comprising:

one or more drug pellets contained within a channel of the drug cartridge, the drug cartridge having a proximal end and a distal end, the proximal end of the drug cartridge having an opening to receive the one or more drug pellets and a plunger, the distal end of the cartridge having an opening for receiving the plunger and passage of the drug depot, wherein movement of the plunger to an extended position moves the one or more drug pellets within the channel of the cartridge out the distal end of the drug cartridge.

22. A method for delivering a drug depot to a site beneath the skin of a patient, the method comprising:

providing a device for delivering a drug depot, the device comprising 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 capable of insertion to the site beneath the skin of the patient and having an opening for passage of the drug depot; and

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;

inserting the distal end of the cannula and/or the plunger to the site beneath the skin of the patient;

loading the drug depot for delivery in the cannula; and

positioning the plunger within the cannula and moving the plunger in the extended position thereby delivering the drug depot from the distal end of the cannula to the site beneath the skin of the patient.

23. A method for delivering a drug depot, according to claim 22, wherein (i) the site is at least one muscle, ligament, tendon, cartilage, synovial joint, spinal disc, spinal foraminal space, near the spinal nerve root, facet joint or spinal canal or (ii) the drug depot comprises at least one anti-inflammatory agent, analgesic agent, anabolic or anti-catabolic growth factor.