Controlled release systems and methods for osteal growth

• US 8,642,060 B2
• Filed: 09/08/2006
• 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:
  US11/517,693
• Publication Number:
  US 20070250045A1
• Time in Patent Office: 2,706 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: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 17/7061 for stabilising vertebrae or discs by improving the condition of their tissues, e.g. using implanted medication or fluid exchange intraosseous injection devices A61B17/3472
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• 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: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/604 Biodegradation
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• 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 first reservoir configured to include a degradation agent, a second reservoir configured to include an osteogenerative agent, and a controller configured to selectively initiate access to the first reservoir or the second reservoir.

Claims

1. A device comprising:

a first reservoir configured to include a degradation agent;

a second reservoir configured to include a osteogenerative agent;

a controller configured to selectively initiate release of the degradation agent from the first reservoir and the osteogenerative agent from the second reservoir;

a sensor in communication with the controller and configured to measure a condition of a soft tissue, wherein the controller selectively initiates access to the first reservoir or the second reservoir based at least in part on the condition measured by the sensor; and

a housing overlying the controller and sensor and having an expandable mechanism with an expandable element for moving first and second portions between expanded and unexpanded configurations, wherein the housing has at least one dimension of less than 8 mm.

2. The device of claim 1, wherein the controller is configured to initiate release of the degradation agent prior to initiating release of the osteogenerative agent, and the expandable element comprises a balloon.

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

4. The device of claim 1, wherein the condition includes hydration level, and further comprising a delivery instrument that moves the expandable mechanism between the expanded and unexpanded configurations.

5. The device of claim 4, further comprising a control element configured to provide access to the first reservoir, and the delivery instrument comprises a shaft with a lumen for transporting fluid relative to the expandable element.

6. The device of claim 5, wherein the controller is configured to manipulate the control element in response to a signal from a sensor, and the lumen comprises multiple lumens.

7. The device of claim 5, wherein the control element includes a valve.

8. The device of claim 5, wherein the control element includes a removable barrier.

9. The device of claim 5, wherein the control element includes a pump, and the expandable mechanism provides bi-directional expansion such that the expandable element applies a uniform expansion force between the first and second portions between leading and trailing ends thereof along a length of the expandable mechanism.

10. The device of claim 1, wherein the osteogenerative agent is an osteoinductive agent.

11. The device of claim 1, further comprising a reservoir driver configured to motivate at least one of the degradation agent to exit the first reservoir or the osteogenerative agent to exit the second reservoir.

12. An implantable medical device comprising:

a first reservoir configured to include a degradation agent;

a second reservoir configured to include a osteogenerative agent;

a controller configured to selectively initiate release of the degradation agent from the first reservoir prior to initiating release of the osteogenerative agent from the second reservoir;

a sensor in communication with the controller and configured to sense a condition of a soft tissue, wherein the controller selectively initiates access to the first reservoir or the second reservoir in response to a signal from the sensor; and

a housing overlying the controller and sensor and having an expandable mechanism having first and second portions, linkages for movably coupling the first and second portions to each other and moving the first and second portions between expanded and unexpanded configurations, wherein the housing has at least one dimension of less than 8 mm.

13. The device of claim 12, further comprising a control element configured to provide access to the first reservoir, first and second members pivotally coupled to each other with first ends positioned in respective receptacles of the first portion, and opposite second ends positioned in respective receptacles the second portion, and ends of the first and second members interdigitate with a ratchet surface formed along the respective receptacles.

14. The device of claim 13, wherein the controller is configured to manipulate the control element in response to a condition determined by a sensor.

15. The device of claim 13, further comprising a remote access component in communication with the controller, and in the unexpanded configuration, the ends of the first and second members are positioned at outer ends of the respective receptacles, the first and second portions move bi-directionally away from each other, the ends of first and second members move longitudinally toward each other along the receptacles, the first and second members move the first and second portions away from each other and engage ratchet surfaces along the receptacles to maintain the expanded or unexpanded configurations, such that the expandable mechanism is collapsible to facilitate insertion in a collapsed disc space with a delivery instrument, and thereafter expandable to distract the disc space and maintain distraction post-operatively.

16. An implantable medical device comprising:

a first reservoir configured to include a degradation agent;

a second reservoir configured to include a osteogenerative agent;

a sensor configured to sense a condition of a soft tissue;

a controller in communication with the sensor, wherein the controller selectively initiates release of the degradation agent from the first reservoir and the osteogenerative agent from the second reservoir based on a signal from the sensor; and

a housing overlying the controller and sensor and having an expandable mechanism having first and second portions with expanded and unexpanded configurations, the first and second portions having respective sidewalls, arms, receptacles formed on ends of the arms and engagement surfaces extending along the receptacles, wherein the housing has at least one dimension of less than 8 mm.

17. The device of claim 16, wherein the controller is configured to initiate release of the degradation agent prior to initiating release of the osteogenerative agent, and the arms have respective engagement surfaces that are engageable, and the engagement surfaces interdigitate and engage each other to maintain the expanded configuration.