Hypodermic needle with weeping tip and method of use

• US 20010023349A1
• Filed: 04/09/2001
• Published: 09/20/2001
• Est. Priority Date: 12/20/1999
• Status: Active Grant

• Current Assignee: Tricardia Ventures LLC
• Original Assignee: Tricardia Ventures LLC
• Inventors: Schwartz, Robert S., Holmes, David R. Jr., VanTassel, Robert A.
• Granted Patent: US 6,547,769 B2
• Time in Patent Office: Days
• US Class Current: 606/53
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/0073 Tip designed for influencing the flow or the flow velocity of the fluid, e.g. inserts for twisted or vortex flow general flow characteristics A61M2206/10
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention provides surgical needles with a porous distal portion from which a liquid injectate will weep or ooze multidirectionally under injection pressure while the porous distal portion of the needle is inserted into a body surface. The porous distal portion of the needle can be fabricated from a porous carbon, metal, ceramic or polymer and preferably has a decreasing gradient of impedance to fluid flowing to the point of the needle to compensate for the falling off of injection pressure as fluid moves towards the point, thereby ensuring uniform weeping of the injectate along the injection course. The needle is adapted for attachment to a catheter or syringe. In another embodiment, a surgical assemblage is provided wherein a porous distal portion having similar fluid flow characteristics is located along the distal end of a catheter, and a needle point is attached to the distal end of the catheter (e.g., a steerable catheter) for piercing tissue. A guidance catheter can be used to direct the invention devices to a remote internal injection site. The invention devices and methods can be used to inject fluids (including those containing nucleic acids for gene therapy) into interior body walls or tissue, such as a beating heart, without substantial loss of fluid and without substantial damage to tissue caused by injectate.

Claims

1. A surgical needle comprising:

a nonporous hollow needle shaft having a proximal end adapted to mate with a surgical instrument,

a porous distal portion in fluid-tight connection to the needle shaft, and

a point that is open, closed, or has a solid partial plug,

wherein the porous distal portion is adapted to cause a liquid injectate to weep or ooze therefrom multidirectionally under injection pressure while the point and distal portion of the needle are inserted into a body surface.

2. The needle according to

claim 1

wherein the porous distal portion has pores with an average largest dimension in the range from about 1.0 micron to about 200 microns.

3. The needle according to

claim 1

wherein the porous distal portion creates a gradient of hydraulic impedance on injectate moving therethrough towards the point.

4. The needle according to

claim 3

wherein the gradient is linear, exponential or Gaussian in either longitudinal direction.

5. The needle according to

claim 3

wherein the gradient is a decreasing gradient.

6. The needle according to

claim 3

wherein the porous distal portion has a increasing interior diameter along the length thereof from the proximal end to the point.

7. The needle according to

claim 3

wherein the size and/or number of the pores in the porous distal portion increases along the length thereof from the proximal end to the point.

8. The needle according to

claim 1

wherein at least the porous distal portion is fabricated from a porous carbon, metal, ceramic, or polymer.

9. The needle according to

claim 8

wherein the porous distal portion is fabricated from a porous metal.

10. The needle according to

claim 8

wherein the porous distal portion is fabricated from a porous polymer.

11. The needle according to

claim 8

wherein the porous distal portion is fabricated from a porous carbon or ceramic.

12. The needle according to

claim 1

wherein the porous distal portion has a porosity of about 50% to about 85%.

13. The needle according to

claim 1

wherein flow of a liquid from the needle is in the range from about 0.1 cc/sec to about 2.0 cc/sec.

14. The needle according to

claim 1

wherein the surgical instrument is a catheter.

15. The needle according to

claim 14

wherein the catheter is a steerable endoscopic catheter.

16. The needle according to

claim 1

wherein the surgical instrument is a syringe.

17. The needle according to

claim 1

wherein the needle further comprises one or more connectors for electrical attachment to an electrocardiogram.

18. The needle according to

claim 17

wherein the exterior of the needle shaft is coated with an insulator and the connector is electrically connected to the proximal end of the needle shaft.

19. A method for injecting a medicament into tissue in a subject in need thereof, said method comprising:

inserting the distal portion of the needle according to

claim 1

into the tissue of the subject and causing a therapeutic amount of the medicament to ooze multidirectionally from the needle into the tissue without substantial leakage or loss of the medicament at the surface of the tissue.

20. The method according to

claim 19

wherein the amount is from about 0.5 cc to about 2.0 cc of the medicament.

21. The method according to

claim 19

wherein injection pressure is applied to the liquid medicament in fluid communication with the distal portion of the needle to cause a therapeutic amount of the medicament to ooze from the needle.

22. The method according to

claim 19

wherein flow of the medicament from the needle is in the range from about 0.1 cc/sec to about 2.0 cc/sec.

23. The method according to

claim 19

wherein the medicament comprises an isolated therapeutic nucleic acid sequence.

24. The method according to

claim 23

wherein the nucleic acid sequence is contained within a vector, a liposome, or a cell.

25. A method for injecting a medicament into a subject in need thereof, said method comprising:

inserting the distal portion of the needle of

claim 1

into an interior body wall or tissue of the subject and

applying sufficient pressure to a liquid medicament in fluid communication with the distal portion of the needle to expel the medicament,

whereby the medicament weeps multidirectionally from the pores in the distal portion into the interior body wall without substantial leakage or loss of the medicament at the surface of the tissue.

26. The method according to

claim 25

wherein the flow of the medicament into the surrounding tissue is substantially equal along the length of the porous distal portion of the needle.

27. The method according to

claim 25

wherein the needle is attached to a syringe.

28. The method according to

claim 25

wherein the needle is attached to the distal tip of a catheter and the body wall is within a body cavity.

29. The method according to

claim 28

wherein the catheter is a steerable catheter that is used to guide the needle to an injection site.

30. The method according to

claim 28

wherein a guidance catheter is used to guide the needle and catheter with porous distal portion to an injection site.

31. The method according to

claim 28

wherein the body cavity is surgically created.

32. The method according to

claim 28

wherein the body wall is subject to motion.

33. The method according to

claim 32

wherein the body wall is in a beating heart.

34. The method according to

claim 25

wherein the needle flirter comprises at least one sensor in electrical connection to an electrocardiogram and the method further comprises sensing electrical activity in the body wall.

35. The method according to

claim 34

wherein electrical activity is sensed prior to injection of the medicament.

36. The method according to

claim 34

wherein the needle comprises multiple sensors and wherein the multiple sensors are used to determine the depth of needle penetration into the tissue of the subject before, during and/or after the injection of medicament.

37. The method according to

claim 25

wherein the body wall is in a beating heart.

38. The method according to

claim 25

wherein the body wall is within an artery.

39. The method according to

claim 25

wherein the medicament comprises a isolated therapeutic nucleic acid sequence.

40. The method according to

claim 39

wherein the nucleic acid sequence is contained within a vector, liposome, or cell.

41. The method according to

claim 39

wherein the therapeutic nucleic acid sequence encodes bFGF, AFGF, EGF, VEGF, angiostatin, ecchystatin, or an IGF.

42. The method according to

claim 41

wherein the therapeutic nucleic acid is contained within a viral vector.

43. The method according to

claim 25

wherein the medicament comprises genetically engineered cells containing a isolated nucleic acid sequence that encodes a therapeutic gene product.

44. The method according to

claim 40

wherein the cell is heterologous.

45. The method according to

claim 39

wherein the cell is obtained from the subject.

50. The assemblage according to

claim 44

wherein the porous distal portion is made of a porous polymer.

55. A method for preventing substantial tissue damage when injecting a medicament, said method comprising injecting the medicament from the distal portion of the needle of

claim 1

into the subject so that the medicament weeps multidirectionally from the pores in the distal portion thereof without substantial damage to tissue of the subject caused by injectate.

46. A surgical assemblage comprising:

a hypodermic needle with a sharp distal point that is open, closed, or has a solid partial plug, and

a catheter with a porous distal portion attached to the distal end of the needle,

wherein the porous distal portion is adapted to cause a liquid injectate to weep or ooze multidirectionally therefrom into surrounding tissue under injection pressure while inserted into a body surface.

47. The assemblage according to

claim 46

wherein the porous distal portion creates a gradient of hydraulic impedance on injectate moving therethrough in order to preferentially deliver agent at any longitudinal point longitudinally along the distal portion.

48. The assemblage according to

claim 47

wherein the decrease in impedance is linear, exponential or Gaussian.

49. The assemblage according to

claim 46

wherein the needle has a length in the range from about 100 mm to about 1500 mm and the porous distal portion of the catheter has a length in the range from about 1 mm to about 20 mm.

51. A surgical assemblage comprising:

a nonporous needle with a sharp distal point, said needle being adapted at the proximal end for attachment to the distal end of a catheter, and

a catheter comprising a porous distal portion and a distal end that is adapted for attachment to the needle, wherein the porous distal portion is adapted to cause a liquid injectate to weep or ooze multidirectionally therefrom into surrounding tissue under injection pressure while the porous distal portion of the catheter is inserted into a body surface.

52. The assemblage according to

claim 51

wherein the needle has a length in the range from about 10 mm to about 1500 mm and the porous distal portion has a length in the range from about 1 mm to about 20 mm.

53. The assemblage according to

claim 51

wherein the catheter is a steerable catheter.

54. The assemblage according to

claim 51

further comprising a guidance catheter for receiving and steering the assembled needle and catheter with a porous distal portion to an injection site.