Controlled release systems and methods for intervertebral discs

• US 8,642,059 B2
• Filed: 04/24/2006
• Issued: 02/04/2014
• Est. Priority Date: 04/24/2006
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: Trieu, Hai H.
• Primary Examiner(s): Fubara, Blessing M
• Assistant Examiner(s): Akhoon, Kauser M
• Application Number:
  US11/410,216
• Publication Number:
  US 20070250044A1
• Time in Patent Office: 2,843 Days
• Field of Search: 424/422, 424/423, 604/890.1, 604/891.1, 604/892.1, 623/17.12
• US Class Current: 424/422
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• CPC Class Codes: A61M 2210/02 Bones
• CPC Class Codes: A61M 2210/1003 Spinal column
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/3682 with a variable atrioventricular delay

Abstract

A device includes a sensor configured to determine a condition associated with a nucleus pulposus, a reservoir configured to include a first agent capable of affecting the condition associated with the nucleus pulposus, a control element configured to provide access to the reservoir, and a controller in communication with the sensor and the control element. The controller is configured to manipulate the control element to provide access to the reservoir in response to the condition determined by the sensor.

Claims

1. A device comprising:

a sensor configured to determine a condition associated with a nucleus pulposus;

a reservoir configured to include a first agent capable of affecting the condition associated with the nucleus pulposus;

a control element configured to provide access to the reservoir;

a reservoir driver to motivate the agent to exit the reservoir;

a controller in communication with the sensor, the control element, and the reservoir driver;

the controller configured to manipulate the control element to provide access to the reservoir and manipulate the reservoir driver in response to the condition determined by the sensor; and

a housing containing the sensor, reservoir, control element, reservoir driver and controller, such that the device is adapted to be implanted as a whole into the nucleus pulposus, wherein the housing has at least one dimension of less than 8 mm.

2. The device of claim 1, further comprising a second reservoir configured to include a second agent capable of affecting the condition associated with the nucleus pulposus.

3. The device of claim 2, wherein the first agent includes a stimulating agent and wherein the second agent includes a degrading agent.

4. The device of claim 1, wherein the first agent is a stimulating agent.

5. The device of claim 1, wherein the first agent includes a degrading agent.

6. The device of claim 5, wherein the degrading agent includes a nucleolytic agent.

7. The device of claim 6, wherein the nucleolytic agent includes chymopapain.

8. The device of claim 6, wherein the nucleolytic agent includes chondroitinase ABC.

9. The device of claim 1, wherein the control element includes a valve.

10. The device of claim 1, wherein the condition includes pressure.

11. The device of claim 1, wherein the condition includes hydration level.

12. The device of claim 1, further comprising a housing overlying the controller.

13. The device of claim 1, further comprising a remote access component in communication with the controller.

14. A device comprising:

a sensor configured to determine a condition associated with a nucleus pulposus;

a first reservoir configured to include a stimulating agent;

a second reservoir configured to include a degrading agent;

a first control element configured to provide access to the first reservoir;

a second control element configured to provide access to the second reservoir;

a first reservoir driver to motivate the stimulating agent to exit the reservoir;

a second reservoir driver to motivate the degrading agent to exit the reservoir;

a controller in communication with the sensor, the first reservoir driver, and the second reservoir driver, the controller configured to manipulate the first control element and the second control element to selectively initiate access to the first reservoir or the second reservoir and manipulate the first reservoir driver or second reservoir driver in response to the condition determined by the sensor; and

a housing containing the sensor, first reservoir, second reservoir, first control element, second control element, first reservoir driver, second reservoir driver and controller, such that the device is adapted to be implanted as a whole into the nucleus pulposus, wherein the housing has at least one dimension of less than 8 mm.

15. The device of claim 14, further comprising a control element configured to provide access to the first reservoir.

16. The device of claim 14, wherein the degrading agent includes a nucleolytic agent.

17. The device of claim 16, wherein the nucleolytic agent includes chymopapain.

18. The device of claim 14, further comprising a remote access component in communication with the controller.

19. A device comprising:

a sensor configured to determine a condition associated with a nucleus pulposus;

a first reservoir configured to include a first agent;

a first reservoir driver coupled to the first reservoir and configured to effect the release of the first agent from the first reservoir;

a control element configured to provide access to the reservoir;

a controller in communication with the sensor;

a remote access component in communication with the controller, wherein the controller is configured to manipulate the control element to provide access to the reservoir and configured to manipulate the first reservoir driver to effect the release of the first agent in response to the condition received from the sensor and a first signal received via the remote access component; and

a housing containing the sensor, first reservoir, control element, first reservoir driver, and controller, such that the device is adapted to be implanted as a whole into the nucleus pulposus, wherein the housing has at least one dimension of less than 8 mm.

20. The device of claim 19, wherein the controller is configured to manipulate the first reservoir driver to prevent release of the first agent in response to a second signal received via the remote access component.

21. The device of claim 19, further comprising a second reservoir configured to include a second agent.