Devices and methods for delivering medical agents

• US 20060259006A1
• Filed: 04/29/2005
• Published: 11/16/2006
• Est. Priority Date: 04/29/2005
• Status: Active Grant

• Current Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Original Assignee: Warsaw Orthopedic Incorporated (Medtronic Plc)
• Inventors: McKay, William F., Drapeau, Susan J.
• Granted Patent: US 7,850,656 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00261 Discectomy
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2005/341 angularly adjustable or angled away from the axis of the injector
• CPC Class Codes: A61M 5/3148 Means for causing or aiding aspiration or plunger retraction
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel

Abstract

Described are novel methods for delivering a medical agent to a plurality of locations within a patient tissue volume such as the interior space of a spinal disc, and also for removing material therefrom during medical agent delivery to enhance the delivery. Also described are medical delivery devices such as needle assemblies configured to facilitate the regional delivery of medical agents to patient tissue.

Claims

1. A medical device useful in the regional delivery of a medical agent into tissue of a patient, the medical device comprising:

one or more medical agent supply reservoirs;

a plurality of elongate tissue-penetrating members each having a fluid channel;

each said tissue-penetrating member having a plurality of orifices in communication with the fluid channel of the tissue-penetrating member, for expelling medical agent delivered through said fluid channel;

the fluid channels of said tissue-penetrating members in fluid communication with said one or more medical agent supply reservoirs; and

a mechanism for delivering medical agent from said one or more supply reservoirs through said fluid channels and out of said plurality of orifices.

2. The medical device of claim 1, wherein:

said fluid channels are each in fluid communication with a common medical agent supply reservoir.

3. The medical device of claim 1, wherein:

at least one of said tissue-penetrating members has a curved portion when in a relaxed condition.

4. The medical device of claim 3, wherein:

each of said plurality of tissue-penetrating members has a curved portion when in a relaxed condition.

7. The medical device of claim 1, also comprising:

a cannulated element received about said plurality of tissue-penetrating members.

8. The medical device of claim 7, wherein the cannulated element has a tissue penetrating tip.

5. (canceled)

6. (canceled)

9. (canceled)

10. (canceled)

11. (canceled)

12. (canceled)

13. A method of delivering a medical agent to the interior disc space of a spinal disc, the method comprising:

providing a medical agent delivery device, said delivery device including a plurality of exit orifices, said plurality of exit orifices each in fluid communication with a supply of the medical agent;

manipulating the medical agent delivery device so as to position said plurality of exit orifices in non-vascularized disc nucleus tissue within the interior disc space; and

delivering the medical agent from said plurality of exit orifices to a plurality of locations within the non-vascularized disc nucleus tissue.

14. (canceled)

15. (canceled)

16. (canceled)

17. (canceled)

18. (canceled)

19. (canceled)

20. (canceled)

21. (canceled)

22. (canceled)

23. (canceled)

24. A medical needle device useful for regional delivery of a medical agent, the needle device comprising:

one or more medical agent supply reservoirs;

one or more elongate needles having a sidewall, a fluid channel extending longitudinally therethrough, and a non-coring, tissue-penetrating needle tip;

said one or more elongate needles each having a plurality of sidewall orifices in said sidewall in fluid communication with said channel for expelling medical agent delivered through said channel;

said channel of each said elongate needle in fluid communication with said one or more medical agent supply reservoirs; and

a mechanism for delivering amounts of medical agent from said one or more supply reservoirs through each said fluid channel and out of each said plurality of sidewall orifices.

25. The medical needle device of claim 24, wherein said needle tip is a closed tip.

26. The medical needle device of claim 24, wherein said needle tip is an open tip having an end orifice.

28. The medical needle device of claim 24, wherein said one or more elongate needles provide at least one such needle having a curve when in a relaxed condition.

29. The medical needle device of claim 24, comprising a plurality of said elongate needles.

30. The medical needle device of claim 29, wherein each of said plurality of elongate needles has a curve in a relaxed condition.

27. (canceled)

31. A medical device for delivery of a substance to tissue of a patient, the medical device comprising:

one or more elongate tissue-penetrating members for penetrating into a tissue region of the patient;

a first orifice located on said one or more tissue-penetrating members;

a first fluid path from said first orifice;

a delivery mechanism for delivering a medical agent, said delivery mechanism fluidly coupled to the first fluid path;

a second orifice on said one or more tissue penetrating members;

a second fluid path from said second orifice; and

a withdrawal mechanism for withdrawing material from tissue of the patient, said withdrawal mechanism fluidly coupled to said second fluid path.

32. The medical device of claim 31, comprising a plurality of said tissue-penetrating members.

33. The medical device of claim 32, wherein:

said first orifice is located on a first of said tissue-penetrating members, and said second orifice is located on a second of said tissue-penetrating members.

35. The medical device of claim 31, wherein:

said delivery mechanism includes a delivery plunger operatively associated with a medical agent supply chamber and adapted to deliver medical agent from the supply chamber through said first fluid path.

36. The medical device of claim 35, wherein:

said withdrawal mechanism includes a withdrawal plunger operatively associated with at least one tissue material receiving chamber and adapted to withdraw tissue material through said second fluid path.

37. The medical device of claim 36, wherein:

said delivery plunger and withdrawal plunger are the same plunger.

39. The medical device of claim 37, wherein:

said medical agent supply chamber is provided by a barrel;

said plunger and barrel are configured so that said plunger is traversable through the barrel so as to force medical agent forward of the plunger through said first fluid path and also create a reduced pressure zone rearward of the plunger in the barrel; and

said second fluid path is coupled to said reduced pressure zone such that traversal of the plunger through the barrel simultaneously delivers medical agent to the tissue region and withdraws tissue material from the tissue region.

34. (canceled)

38. (canceled)

40. A method for delivering a medical agent to the interior space of a spinal disc, the method comprising:

introducing amounts of the medical agent to the interior space of the spinal disc; and

removing amounts of tissue material from the interior space of the disc so as to decrease pressurization of the interior space caused by introduction of the medical agent.

41. (canceled)

42. (canceled)

43. (canceled)

44. A medical device useful for regional delivery of a medical agent, the device comprising:

a medical agent supply reservoir;

a plurality of elongate tissue-penetrating members each having a fluid channel, at least one delivery orifice in fluid communication with said fluid channel, and a tissue-penetrating tip;

said fluid channels of said elongate members in fluid communication with said medical agent supply reservoir; and

a mechanism for forcing medical agent from said supply reservoir through said fluid channels and out of said delivery orifices.

45. The medical device of claim 44, wherein:

said elongate tissue-penetrating members are substantially straight members.

46. The medical device of claim 44, wherein:

said elongate tissue-penetrating members each have at least one curved portion when in a relaxed condition.

47. A medical device useful for regional delivery of a medical agent, the device comprising:

a medical agent supply reservoir;

a plurality of elongate tissue-penetrating members each having a fluid channel, at least one delivery orifice in fluid communication with said fluid channel, and a tissue-penetrating tip;

said fluid channels of said elongate members in fluid communication with said medical agent supply reservoir;

a retraction sleeve having a plurality of internal cannulas, each said cannula configured to slidably receive one of said elongate tissue-penetrating members; and

a mechanism for forcing medical agent from said supply reservoir through said fluid channels and out of said delivery orifices.

48. The medical device of claim 47, wherein:

said internal cannulas of said retraction sleeve are substantially straight.

49. The medical device of claim 47, wherein:

one or more of said internal cannulas of said retraction sleeve extends at least partially in a curved configuration.

50. The medical device of claim 47, wherein:

said tissue penetrating members include at least one deflectable tissue-penetrating member; and

said retraction sleeve includes at least one internal cannula corresponding to and configured to deflect said at least one deflectable tissue-penetrating member.

51. The medical device of claim 50, wherein:

said tissue penetrating members include a plurality of deflectable tissue penetrating members; and

said retraction sleeve includes internal cannulas corresponding to and configured to deflect each of said deflectable tissue penetrating members.