Needle for subcutaneous delivery of fluids

• US 6,261,272 B1
• Filed: 06/01/1999
• Issued: 07/17/2001
• 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:
  US09/202,176
• Time in Patent Office: 777 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 needle for the delivery of a liquid to a subject, said needle comprising a shaft having a central longitudinal axis, a tubular sidewall, a first end and a second end, and an internal bore extending along said central longitudinal axis between said first end of said shaft and said second end of said shaft, said internal bore having an internal surface and being open at said first end of said shaft to receive a liquid supply and being open at said second end of said shaft, said second end of said shaft being sharpened for penetration of the skin of the subject, said shaft having at least one aperture therein, said at least one aperture being in the form of a linear cut in said tubular sidewall of said shaft extending transversely to said longitudinal central axis, said linear cut being in communication with said external surface of said sidewall of said shaft to form an external opening of said at least one aperture at said external surface, said linear cut also being in communication with said internal surface of said internal bore to form an internal opening of said at least one aperture at said internal surface, said at least one aperture including an aperture wall between said internal opening and said external opening, at least one portion of said aperture wall being oriented at an angle non-parallel to the radius of said internal bore, said external opening having an area that is substantially greater than the area of said internal opening of said at least one aperture.

2. A needle according to claim 1, wherein said sharpened end of said needle is in the form of a bevelled 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 bevelled or conical surface and said longitudinal axis.

3. A needle according to claim 1, wherein said cut extends in a direction approximately perpendicular to said longitudinal axis.

4. A needle according to claim 1, wherein width of said cut on said external surface is greater than the width of said cut on said internal surface.

5. A needle according to claim 4, wherein width of said cut on said external surface is at least twice the width of said cut on said internal surface.

6. A needle according to claim 1, wherein said shaft 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 internal opening are coplanar.

7. A needle according to claim 1, wherein said shaft is provided with a plurality of apertures, each of which is located a different distance from said sharpened end of said needle.

8. A needle according to claim 1, wherein the ratio between the area of said external opening of said at least one aperture is greater than or equal to the ratio between the external width of said shaft and the internal width of said bore.

9. A needle according to claim 1, wherein the depth of said cut relative to said external surface varies along the length of said cut.

10. A needle according to claim 9, 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 of said shaft at that point.

11. A needle according to claim 1, wherein said external surface is curved and wherein the variation in said depth of said cut results from a planar cut surface machined across said curved external surface.

12. A needle according to claim 1, wherein said sharpened end is provided with a terminal orifice to assist in delivery of the liquid through said needle.

13. A needle according to claim 1, wherein said at least one aperture is formed by the operation of a grinder on said external surface of said shaft.

14. A needle according to claim 1, wherein said at least one aperture is formed by milling.

15. A needle according to claim 1, wherein said external and internal surfaces of said needle are defined generally in cross-section by two concentric circles.

16. A liquid delivery device for delivering a liquid to a subject, comprising a reservoir for the liquid, means for driving the liquid from said reservoir to an outlet, and a delivery needle according to claim 1 in communication with said outlet.

17. A device according to claim 16, wherein said reservoir and said driving means are located in a housing which is provided with means for attachment to the skin of the subject and wherein said delivery needle protrudes from said housing in use such that it penetrates the skin of the subject upon application of said device to allow delivery of the liquid through said needle.

18. A device according to claim 16, wherein said delivery rate of the device is determined according to the pressure exerted by said driving means.

19. A needle according to claim 1, wherein all portions of said aperture wall are oriented at an angle non-parallel to the radius of said internal bore.

20. A needle according to claim 1, wherein said needle, when inserted below the skin of the subject, extends approximately 5 mm below the exterior surface of the skin.

21. A needle according to claim 20, wherein said at least one aperture is located approximately 2.5 to 4.5 mm below the exterior surface of the skin.