Needle and method for delivery of fluids

• US 6,346,095 B1
• Filed: 02/06/2001
• Issued: 02/12/2002
• Est. Priority Date: 06/10/1996
• Status: Expired due to Term

• Current Assignee: Alkermes Pharma Ireland Limited (Alkermes plc)
• Original Assignee: Elan Corporation PLC (Perrigo Company PLC)
• Inventors: Danon, Haim, Gross, Joseph
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US09/778,332
• Time in Patent Office: 371 Days
• Field of Search: 604/272, 604/274, 604/264, 604/131, 604/132, 604/523
• US Class Current: 604/272
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

A needle (10) for the delivery of a liquid to a subject comprises a shaft (11) having an internal surface defining a longitudinally extending internal bore open at one end (15) to receive a liquid supply, the other end (16) being sharpened for penetration of the skin of the subject. A plurality of apertures (18) are provided, each in the form of a cut extending across the external surface of the side of the shaft (11) at a sufficient depth to establish communication with the bore. The external aperture area is approximately three times greater than the internal aperture area, thereby ensuring that the liquid is delivered to a large surface area of tissue to improve absorption and eliminate fluctuations in the delivery rate. The needle (10) can be mass-produced by aligning a batch of shafts alongside one another and running a grinder across the surfaces of the shafts to create the apertures (18) in the entire batch of needles simultaneously.

Claims

1. A method for the delivery of a liquid into or through the skin of a subject, comprising:

(A) providing a needle comprising a tubular sidewall and a sharpened end for penetrating the skin of the subject, said tubular sidewall having a longitudinal axis, a bore extending along said longitudinal axis, an exterior surface and at least one aperture in the form of a cut in said sidewall extending transversely to said longitudinal axis and in communication with said bore, said aperture having an inlet at said bore and an outlet at said exterior surface, said outlet being substantially larger than said inlet and shaped to be resistant to clogging;

(B) causing said needle to penetrate at least into the skin of the subject; and

(C) introducing the liquid into said bore and out through said at least one aperture, whereupon the liquid passes through said at least one aperture and out of said outlet for absorption into an area in the skin or beneath the skin contiguous said at least one aperture to facilitate the transfer of the liquid to the area.

2. The method of claim 1 wherein the liquid is delivered at a rate resistant to variation and/or fluctuation.

3. The method of claim 1 additionally comprising the step of providing the liquid from a reservoir coupled to said bore.

4. The method of claim 3, wherein said needle and said reservoir are located within a housing and wherein said method additionally comprises the step of securing said housing on the body of the subject, whereupon said needle penetrates the skin of the subject so that the liquid may pass into said bore and out of said outlet.

5. The method of claim 4, wherein said housing additionally comprises a driving means for driving the liquid into said bore and out of said outlet.

6. The method of claim 1, wherein said needle includes a plurality of apertures, each of which is located a different distance from said sharpened end of said needle, and wherein the liquid is delivered to contiguous internal tissue from said plurality of apertures.

7. A needle for delivery of a liquid into or through the skin of a subject, said needle comprising a tubular sidewall and a sharpened end for penetrating the skin of the subject to enable said needle to be located in the skin or beneath the skin, said tubular sidewall having a longitudinal axis, a bore extending along said longitudinal axis, an exterior surface and at least one aperture in the form of a cut in said sidewall extending transversely to said longitudinal axis and in communication with said bore, said aperture having an inlet at said bore and an outlet at said exterior surface, said outlet being substantially larger than said inlet and shaped to be resistant to clogging to facilitate the delivery of the liquid to an area in the skin or beneath the skin contiguous said at least one aperture.

8. The needle of claim 7, wherein said cut is linear.

9. The needle of claim 7, wherein said at least one aperture includes an aperture wall, and wherein at least one portion of said aperture wall is oriented at an angle non-parallel to the radius of said internal bore.

10. The needle of claim 7, wherein said sharpened end of said needle is in the form of a beveled or conical tip and said cut extends in a direction at an angle to said longitudinal axis which is greater than or equal to the angle between the beveled or conical surface and said longitudinal axis.

11. The needle of claim 7, wherein said cut extends in a direction approximately perpendicular to said longitudinal axis.

12. The needle of claim 7, wherein width of said cut at said outlet is greater than the width of said cut at said inlet.

13. The needle of claim 12, wherein width of said cut at said outlet is at least twice the width of said cut at said inlet.

14. The needle of claim 7, wherein said at least one aperture includes an aperture wall, wherein said sidewall has a C-shaped cross section at the locus of said at least one aperture, and wherein portions of said aperture wall contiguous with said inlet are coplanar.

15. The needle of claim 7, wherein said needle includes a plurality of apertures, each of which is located a different distance from said sharpened end of said needle.

16. The needle of claim 7, wherein said cut has a pair of ends and wherein said depth of said cut increases from zero at either end of said cut to a maximum depth towards the center of said cut which is greater than or equal to the thickness of said sidewall at that point.

17. A needle for the delivery of a liquid to internal tissue of a subject, said needle comprising a tubular sidewall and a sharpened end for penetrating the skin of the subject to enable said needle to be located in the skin or beneath the skin, said sidewall having a longitudinal axis, a bore extending along said longitudinal axis, an exterior surface and at least one aperture in the form of a cut in said tubular sidewall extending transversely to said longitudinal axis and in communication with said central bore, said aperture having an inlet at said central bore and an outlet at said exterior surface, said outlet being substantially larger than said inlet so that the liquid passes through said at least one aperture and out of said outlet to engage a relatively large area in the skin or beneath the skin contiguous said at least one aperture to facilitate the transfer of the liquid to that area at a flow rate that is resistant to variations and/or fluctuations.

18. The needle of claim 17, wherein said cut is linear.

19. The needle of claim 17, wherein said at least one aperture includes an aperture wall, and wherein at least one portion of said aperture wall is oriented at an angle non-parallel to the radius of said internal bore.

20. The needle of claim 17, wherein said sharpened end of said needle is in the form of a beveled or conical tip and said cut extends in a direction at an angle to said longitudinal axis which is greater than or equal to the angle between the beveled or conical surface and said longitudinal axis.

21. The needle of claim 17, wherein said cut extends in a direction approximately perpendicular to said longitudinal axis.

22. The needle of claim 17, wherein width of said cut at said outlet is greater than the width of said cut at said inlet.

23. The needle of claim 22, wherein width of said cut at said outlet is at least twice the width of said cut at said inlet.

24. The needle of claim 17, wherein said at least one aperture includes an aperture wall, wherein said sidewall has a C-shaped cross section at the locus of said at least one aperture, and wherein portions of said aperture wall contiguous with said inlet are coplanar.

25. The needle of claim 17, wherein said needle includes a plurality of apertures, each of which is located a different distance from said sharpened end of said needle.

26. The needle of claim 17, wherein said cut has a pair of ends and wherein said depth of said cut increases from zero at either end of said cut to a maximum depth towards the center of said cut which is greater than or equal to the thickness of said sidewall at that point.