DEVICE AND METHOD FOR DELIVERY OF THERAPEUTIC AGENTS VIA ARTIFICIAL INTERNAL IMPLANTS

• US 20100130959A1
• Filed: 10/15/2009
• Published: 05/27/2010
• Est. Priority Date: 10/15/2008
• Status: Abandoned Application

• Current Assignee: Orthoclip LLC
• Original Assignee: Palmetto Biomedical, Inc.
• Inventors: Boyd, Lawrence M., Penny, Matthew R., Adams, Samuel B. JR.
• Application Number:
  US12/580,190
• Publication Number:
  US 20100130959A1
• Time in Patent Office: Days
• US Class Current: 604/513
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 17/70 Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• 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 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 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A device is provided for use with a medical implant for delivering an agent to a designated site of action in a body of a patient. The agent-delivery device comprises a body member adapted to be secured to the medical implant and an agent-delivery component associated with the body member. The agent-delivery component includes a therapeutic agent for treating the body of the patient. The agent-delivery component is configured to release the therapeutic agent after implantation in the body of the patient.

Claims

1. An device for use with a medical implant for delivering an agent to a designated site of action in a body of a patient, the agent-delivery device comprising:

a body member adapted to be secured to the medical implant; and

an agent-delivery component associated with the body member, the agent-delivery component including a therapeutic agent for treating the body of the patient,

wherein the agent-delivery component is configured to release the therapeutic agent after implantation in the body of the patient.

2. An agent-delivery device as recited in claim 1, wherein the body member comprises

a base portion terminating in longitudinal edges;

and

legs extending from the longitudinal edges of the base portion and terminating in longitudinal edges, the legs extending from the base portion at an acute angle such that the base portion and the legs define an open longitudinal channel narrower at the edges of the legs than at the base portion,

wherein the longitudinal channel is adapted to slidably receive the medical implant.

3. An agent-delivery device as recited in claim 1, wherein the body member comprises

a base portion terminating in longitudinal edges;

legs extending from the longitudinal edges of the base portion and terminating in longitudinal edges, the base portion and the legs defining an open longitudinal channel; and

a flange integral with the longitudinal edges of each leg, the flanges extending inwardly such that the base portion, legs, and flanges define opposed longitudinal slots,

wherein the longitudinal channel and slots are adapted to receive the medical implant.

4. An agent-delivery device as recited in claim 1, wherein the body member comprises a bio-absorbable polymer.

5. An agent-delivery device as recited in claim 1, wherein the body member comprises a non-bio-absorbable polymer.

6. An agent-delivery device as recited in claim 1, wherein the agent-delivery comprises a carrier for the therapeutic agent.

7. An agent-delivery device as recited in claim 6, wherein the carrier comprises a sponge.

8. An agent-delivery device as recited in claim 1, wherein the agent-delivery component comprises at least a portion of the surface of the body member having the therapeutic agent impregnated thereon or adsorbed thereon or otherwise contained therein, and wherein the agent desorbs, elutes, or is otherwise delivered from the body member to a site of action.

9. An agent-delivery device as recited in claim 1, further comprising an insert having an axis defined in a direction of insertion, the insert comprising:

a plurality of legs depending from the inner surface of the body member and along the insert axis, the outer dimensions of the legs having a profile adapted to be received in a hole in the medical implant, the length of the legs adapted to be longer than the thickness of the area of the medical implant defining the hole; and

outwardly extending flanges at a distal end of the legs, the outer dimensions of the flanges having a wider profile than the legs relative to the insertion axis,

wherein the insert is adapted to be received in the hole in the medical implant, the flanges adapted for contacting the implant adjacent the hole during insertion for flexing the legs resiliently inwardly for reducing the outer dimensions of the flanges such that the flanges pass through the hole and the flanges contact the opposite side of the medical implant adjacent the hole for a snap-fit securing the agent-delivery device relative to the medical implant.

10. An agent-delivery device as recited in claim 1, further comprising:

opposed arcuate walls depending from a surface of the body member, the walls defining a partial tube and a longitudinal slot extending between the length of the terminal edges of the walls,

wherein the walls are adapted to receive a cylindrical medical implant, the walls flexing resiliently outwardly when pressed against the medical implant for enlarging the slot and receiving the medical implant between the walls such that the agent-delivery device is secured relative to the medical implant.

11. An agent-delivery device as recited in claim 1, wherein the body member comprises

a first base portion and a second base portion, each base portion terminating in longitudinal edges defining a transverse slot in one edge, and including

at least one leg extending from the edge of each base portion opposite the slot and terminating in a longitudinal edge,

a flange integral with the longitudinal edge of the at least one leg, the flange extending inwardly such that each base portion, the at least one leg, and the flange define a longitudinal slot for receiving a medical implant,

a tongue integral with each base portion, and

means operatively associated with each slot for securing the tongue at a plurality of relative positions of the base portions,

wherein the tongues are configured to be received in a respective slot for securing together the first base portion and the second base portion such that the first and second base portions and the legs define an open longitudinal channel adaptable to the width of the medical implant.

13. An agent-delivery device as recited in claim 1, further comprising an agent-delivery system including at least one reservoir and having a valve in fluid communication with an orifice opening into the reservoir.

14. An agent-delivery device as recited in claim 13, further comprising a magnetic element associated with the valve, wherein when the device has been placed within the body of a patient, the location of the valve can be located from outside the body of the patient using a triangulation technique for introducing the agent to the reservoir via the valve by a tubular member.

15. An agent-delivery device as recited in claim 13, wherein the tubular member is selected from a cannula, a rod, a shaft, and a needle.

16. A system for use as a medical implant, the medical implant system comprising:

a medical implant;

a device for delivering an agent to a designated site of action in a body of a patient, the agent-delivery device comprising;

a body member configured to be secured to the medical implant, and

an agent-delivery component associated with the body member, the agent-delivery component including a therapeutic agent for treating the body of the patient,

wherein the agent-delivery component is configured to release the therapeutic agent after implantation in the body of the patient.

17. A medical implant system as recited in claim 16, wherein the medical implant comprises a bone fixation element adapted to be secured to a bone portion in the body of a patient.

18. A medical implant system as recited in claim 16, wherein the agent-delivery device is attached to the medical implant with an adhesive.

19. A medical implant system as recited in claim 16, wherein the body member comprises

a base portion terminating in longitudinal edges;

and

legs extending from the longitudinal edges of the base portion and terminating in longitudinal edges, the legs extending from the base portion at an acute angle such that the base portion and the legs define an open longitudinal channel narrower at the edges of the legs than at the base portion,

wherein the longitudinal channel is configured to slidably receive at least a portion of the medical implant.

20. A medical implant system as recited in claim 16, wherein the body member comprises

a base portion terminating in longitudinal edges;

legs extending from the longitudinal edges of the base portion and terminating in longitudinal edges, the base portion and the legs defining an open longitudinal channel; and

a flange integral with the longitudinal edges of each leg, the flanges extending inwardly such that the base portion, legs, and flanges define opposed longitudinal slots,

wherein the longitudinal channel and slots are configured to slidably receive the medical implant.

21. A medical implant system as recited in claim 20, wherein the flanges terminate in pointed longitudinal edges, and wherein the medical implant has V-shaped grooves in exterior surfaces for receiving the edges of the flanges.

22. A medical implant system as recited in claim 20, wherein the body member further comprises a projection extending into the channel, and the medical implant defines an opening for receiving the projection for securing the agent-delivery device relative to the implant.

23. A medical implant system as recited in claim 16, wherein the body member comprises a bio-absorbable polymer.

24. A medical implant system as recited in claim 16, wherein the body member comprises a non-bio-absorbable polymer.

25. A medical implant system as recited in claim 16, wherein the agent-delivery comprises a carrier for the therapeutic agent.

26. A medical implant system as recited in claim 25, wherein the carrier comprises a sponge.

27. A medical implant system as recited in claim 16, wherein the agent-delivery component comprises at least a portion of the surface of the body member having the therapeutic agent impregnated thereon or adsorbed thereon or otherwise contained therein, and wherein the agent desorbs, elutes, or is otherwise delivered from the body member to a site of action.

28. A medical implant system as recited in claim 16, wherein the medical implant has at least one hole, and further comprising an insert having an axis defined in a direction of insertion, the insert comprising:

a plurality of legs depending from the inner surface of the body member and along the insert axis, the outer dimensions of the legs having a profile adapted to be received in a hole in the medical implant, the length of the legs adapted to be longer than the thickness of the area of the medical implant defining the hole; and

outwardly extending flanges at a distal end of the legs, the outer dimensions of the flanges having a wider profile than the legs relative to the insertion axis,

wherein the insert is configured to be received in the at least one hole in the medical implant, the flanges contacting the implant adjacent the hole during insertion for flexing the legs resiliently inwardly for reducing the outer dimensions of the flanges such that the flanges pass through the hole and the flanges contact the opposite side of the medical implant adjacent the hole for a snap-fit securing the agent-delivery device relative to the medical implant.

29. A medical implant system as recited in claim 28, wherein the medical implant comprises a bone fixation member defining a plurality of holes spaced longitudinally along the member and adapted for receiving fasteners for securing the member to bone.

30. A medical implant system as recited in claim 16, wherein the medical implant comprises a rod portion, and the body member further comprises opposed arcuate walls depending from a surface of the body member, the walls defining a partial tube and a longitudinal slot extending between the length of the terminal edges of the walls, wherein the walls are adapted to receive the rod, the walls flexing resiliently outwardly when pressed against the rod for enlarging the slot and receiving the rod between the walls such that the agent-delivery device is secured relative to the medical implant.

31. A medical implant system as recited in claim 16, wherein the body member comprises

a first base portion and a second base portion, each base portion terminating in longitudinal edges defining a transverse slot in one edge, and including

at least one leg extending from the edge of each base portion opposite the slot and terminating in a longitudinal edge,

a flange integral with the longitudinal edge of the at least one leg, the flange extending inwardly such that each base portion, the at least one leg, and the flange define a longitudinal slot for receiving the medical implant,

a tongue integral with each base portion, and

means operatively associated with each slot for securing the tongue at a plurality of relative positions of the base portions,

wherein the tongues are configured to be received in a respective slot for securing together the first base portion and the second base portion such that the first and second base portions and the legs define an open longitudinal channel adjustable to the width of the medical implant.

32. A medical implant system as recited in claim 16, further comprising an agent-delivery system including at least one reservoir for accommodating a therapeutic agent, and a valve in fluid communication with an orifice opening into the reservoir.

33. A medical implant system as recited in claim 32, further comprising a magnetic element associated with the valve, wherein when the device has been placed within the body of a patient, the location of the valve can be located from outside the body of the patient using a triangulation technique for introducing the agent to the reservoir via the valve by a tubular member.

34. A medical implant system as recited in claim 33, wherein the tubular member is selected from a cannula, a rod, a shaft, and a needle.

35. A method of delivering a therapeutic agent to a site within the body of a patient adjacent to a medical implant, the method comprising the steps of:

providing a medical implant;

providing a therapeutic agent to be delivered to a site of action within the body of a patient;

providing an agent-delivery device;

operatively associating the therapeutic agent with the agent-delivery device such that the therapeutic agent is arranged to delivery a therapeutically effective amount of the agent to the site;

securing the agent-delivery device to the medical implant; and

surgically implanting the medical implant.

36. A method of delivering a therapeutic agent as recited in claim 35, wherein the step of providing an agent-delivery device comprises providing an agent-delivery device including a body member comprising a base portion terminating in longitudinal edges, and legs extending from the longitudinal edges of the base portion and terminating in longitudinal edges, the legs extending from the base portion at an acute angle such that the base portion and the legs define an open longitudinal channel narrower at the edges of the legs than at the base portion;

and

wherein the securing step comprises sliding the agent-delivery device onto the medical implant such that the longitudinal channel receives at least a portion of the medical implant.

37. A method of delivering a therapeutic agent as recited in claim 35, wherein the step of providing an agent-delivery device comprises providing an agent-delivery device including a body member comprising a base portion terminating in longitudinal edges, legs extending from the longitudinal edges of the base portion and terminating in longitudinal edges, the base portion and the legs defining an open longitudinal channel, and a flange integral with the longitudinal edges of each leg, the flanges extending inwardly such that the base portion, legs, and flanges define opposed longitudinal slots;

and

wherein the securing step comprises sliding the agent-delivery device onto the medical implant such that the longitudinal channel and slots slidably receive at least a portion of the medical implant.

38. A method of delivering a therapeutic agent as recited in claim 35, wherein the step of providing an agent-delivery device comprises providing an agent-delivery device including an insert having an axis defined in a direction of insertion, the insert comprising a plurality of legs depending from the inner surface of the body member and along the insert axis, the outer dimensions of the legs having a profile adapted to be received in a hole in the medical implant, the length of the legs adapted to be longer than the thickness of the area of the medical implant defining the hole, and outwardly extending flanges at a distal end of the legs, the outer dimensions of the flanges having a wider profile than the legs relative to the insertion axis;

and

wherein the securing step comprises directing the insert into a hole in the medical implant, the flanges contacting the implant adjacent the hole during insertion for flexing the legs resiliently inwardly for reducing the outer dimensions of the flanges such that the flanges pass through the hole and the flanges contact the opposite side of the medical implant adjacent the hole for a snap-fit.

39. A method of delivering a therapeutic agent as recited in claim 35, wherein the securing step comprises attaching the agent-delivery device to the medical implant with an adhesive.

40. A method of delivering a therapeutic agent as recited in claim 35, wherein the step of providing a medical implant comprises providing a bone fixation member defining a plurality of holes spaced along the member and adapted for receiving fasteners for securing the member to bone.

41. A method of delivering a therapeutic agent as recited in claim 35, further comprising the step of providing an agent-delivery system including at least one reservoir for accommodating a therapeutic agent, and a valve in fluid communication with an orifice opening into the reservoir;

and

delivering therapeutic agent to the reservoir post-implantation.

42. A method of delivering a therapeutic agent as recited in claim 35, further comprising the step of providing a magnetic element associated with the valve, and

locating the valve from outside the body of the patient using a triangulation technique for introducing the agent to the reservoir via the valve by a tubular member.