Devices and methods for delivering drug depots to a site beneath the skin

• US 8,221,358 B2
• Filed: 11/20/2007
• Issued: 07/17/2012
• 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.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Scott, Brandy C
• Application Number:
  US11/942,820
• Publication Number:
  US 20090131908A1
• Time in Patent Office: 1,701 Days
• Field of Search: 604/187, 604/188, 604/164.12, 604/60, 604/158
• US Class Current: 604/187
• 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 diameter, and a proximal end and a distal end, the proximal end of the cannula having an opening and a drug depot chamber to receive the drug depot, the distal end of the cannula for insertion at or near the spinal column and having an opening for passage of the drug depot, and the drug depot having a proximal end configured for attaching to a plunger and a distal end configured to facilitate insertion into the site, is disposed within the drug depot chamber of the cannula, the drug depot chamber being immovably disposed to the cannula at the proximal end and has a diameter larger than the diameter of the cannula;

a plunger being slidably receivable within the opening of the proximal end of the cannula and the drug depot chamber, the plunger having a first end and a tip at a second end that is configured to fit within said proximal end of said drug depot, the first end moves 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 the tip of the plunger to push the drug depot out of the drug depot chamber and out of the distal end of the cannula and cause delivery of the drug depot from the distal end of the cannula to the site at or near the spinal column of the patient; and

a drug cartridge having a proximal end and distal end, the proximal end of the cartridge having an opening in the form of a channel for loading at least one drug depot and for slidably receiving the plunger tip over a longitudinal axis of the drug cartridge, wherein the drug pellets are slidably receivable over the longitudinal axis within the channel of the drug cartridge such that the plunger tip is configured for pushing one or more drug pellets along the channel and guiding the drug pellets out the distal end opening to release the drug pellets to the distal end of the cannula, wherein the drug cartridge will remain in the drug depot chamber.

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 push the drug depot out of the drug depot chamber to deliver the drug depot out of the distal end of the cannula and to the site at or near the spinal column.

3. A device for delivering a drug depot according to claim 1, wherein the drug depot chamber has more than one drug depot 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 causing the tip of the plunger to push the drug depot out of the drug depot chamber and out of the distal end of the cannula 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.

5. A device for delivering a drug depot according to claim 1, wherein the drug depot is at least a sterilizable drug depot and/or a biodegradable drug depot.

6. 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.

7. 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.

18. A device for delivering a drug depot according to claim 1, wherein the plunger is longer than the cannula and the tip of the plunger extends beyond the distal end of the cannula when the plunger is moved in the extended position.

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

a needle having a diameter, and 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;

wherein the drug depot has a proximal end configured for attaching to a plunger and a distal end configured to facilitate insertion into the site,

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 that is configured to fit within said proximal end of said drug depot, 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 causing the tip of the plunger to push the drug depot from the distal end of the needle to effect delivery of the drug depot to the site beneath the skin of the patient, 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 has a diameter larger than the diameter of the needle; and

a drug cartridge having a proximal end and distal end, the proximal end of the cartridge having an opening in the form of a channel for loading at least one drug depot and for slidablv receiving the plunger tip over a longitudinal axis of the drug cartridge, wherein the drug pellets are slidably receivable over the longitudinal axis within the channel of the drug cartridge such that the plunger tip is configured for pushing one or more drug pellets along the channel and guiding the drug pellets out the distal end opening to release the drug pellets to the distal end of the cannula, wherein the drug cartridge will remain in the drug depot chamber.

9. A device for delivering a drug depot according to claim 8, wherein the drug depot chamber receives one or more drug depots and the tip of the plunger.

10. A device for delivering a drug depot according to claim 8, wherein the drug depot is at least a sterilizable drug depot or a biodegradable drug depot.

11. A device for delivering a drug depot according to claim 8, 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 causing the tip of the plunger to push the drug depot out of the distal end of the needle 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.

12. A device for delivering a drug depot according to claim 8, 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.

19. A device for delivering a drug depot according to claim 8, wherein the plunger is longer than the needle and the tip of the plunger extends beyond the distal end of the needle when the plunger is moved in the extended position.

13. 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 diameter and 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 being immovably disposed to the cannula and having an opening to receive the drug depot, wherein the drug depot chamber has a diameter larger than the diameter of the cannula and contains the drug depot;

wherein the drug depot has a proximal end configured for attaching to a plunger and a distal end configured to facilitate insertion into the site;

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 that is configured to fit within said proximal end of said drug depot, 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 the tip of the plunger to push the drug depot out the drug depot chamber and out the distal end of the cannula to cause delivery of the drug depot to the site at or near the spinal column of the patient; and

a drug cartridge having a proximal end and distal end, the proximal end of the cartridge having an opening in the form of a channel for loading at least one drug depot and for slidably receiving the plunger tip over a longitudinal axis of the drug cartridge, wherein the drug pellets are slidably receivable over the longitudinal axis within the channel of the drug cartridge such that the plunger tip is configured for pushing one or more drug pellets along the channel and guiding the drug pellets out the distal end opening to release the drug pellets to the distal end of the cannula, wherein the drug cartridge will remain in the drug depot chamber.

14. A device for delivering a drug depot according to claim 13, wherein the plunger is capable of insertion to the site at or near the spinal column.

15. A device for delivering a drug depot according to claim 13, 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 causing the tip of the plunger to push the one or more drug pellets from the drug cartridge to the distal end of the cannula to deliver the one or more drug pellets to the site at or near the spinal column.

16. 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 diameter and a proximal end and a distal end, the proximal end of the cannula having an opening to receive the drug depot, the drug depot having a proximal end configured for attached to a plunger and a distal end configured to facilitate insertion into the site, 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;

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 that is configured to fit within said proximal end of said drug depot, the first end being capable of moving the tip of the plunger to an extended position; and

a drug cartridge having a proximal end and distal end, the proximal end of the cartridge having an opening in the form of a channel for loading at least one drug depot and for slidably receiving the plunger tip over a longitudinal axis of the drug cartridge, wherein the drug pellets are slidably receivable over the longitudinal axis within the channel of the drug cartridge such that the plunger tip is configured for pushing one or more drug pellets along the channel and guiding the drug pellets out the distal end opening to release the drug pellets to the distal end of the cannula, wherein the drug cartridge will remain in the drug depot chamber;

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 a drug depot chamber that is attached to the cannula and has a diameter larger than the diameter of the cannula; and

positioning the plunger within the cannula and moving the plunger in the extended position to cause only the tip of the plunger to push the drug depot from the distal end of the cannula to deliver the drug depot to the site beneath the skin of the patient.

17. A method for delivering a drug depot, according to claim 16, 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.