Needle for Subcutaneous Port

• US 20100010413A1
• Filed: 07/09/2009
• Published: 01/14/2010
• Est. Priority Date: 07/09/2008
• Status: Abandoned Application

• Current Assignee: Grantadler Corporation
• Original Assignee: Grantadler Corporation
• Inventors: Loiterman, David A., Loiterman, Michael G.
• Application Number:
  US12/500,436
• Publication Number:
  US 20100010413A1
• Time in Patent Office: Days
• US Class Current: 604/6.160
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2206/11 Laminar flow
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft
• CPC Class Codes: A61M 5/3291 Shafts with additional lateral openings

Abstract

This disclosure relates to a new type of needed for a subcutaneous port or for any use where blood is recycled, and more precisely to a needle with reduced friction openings for easing blood and its elements along a passageway made of a through bore in the body of a needle. The needle includes an oval shape opening for increased mechanical resistance of the needle while allowing a greater passage curvature of the blood cells at the greatest zone of passage. In other embodiments, a plurality of staggered openings is used to reduce the flow through any single opening where damage occurs, the openings can be made in a curved area, or a plurality of smaller openings or a grid made of openings can be used to further reduce the interference of the needle tip and the needle openings on blood.

Claims

1. A needle for a subcutaneous port adapted to reduce the damage to a biological or physiological fluid at the inlet of the needle, comprising:

a needle shaft with a bore along a longitudinal axis of the needle shaft and a proximal end and a distal end in opposition thereof;

a pointed tip at the distal end with a pointed end tip for the entry of at least a portion of the needle shaft into a biological or physiological fluid reservoir in the subcutaneous port; and

at least an inlet orifice along the needle shaft between the proximal end and the distal end and in fluidic contact with the biological or physiological fluid reservoir and adjacent to the pointed tip, wherein said inlet orifice communicates with the bore for the passage of the fluid from the biological or physiological fluid reservoir through the inlet orifice and through the bore, and wherein the inlet orifice has at least a rounded edge.

2. The needle of claim 1, wherein the inlet orifice is of oval shape.

3. The needle of claim 2, wherein the oval shape has a long axe along the longitudinal axis.

4. The needle of claim 3, wherein the pointed end tip at the pointed tip is a 20 degree cone.

5. The needle of claim 1, wherein the needle shaft has an exterior diameter in the range of 0.0645 to 0.0655 inch, and a bore of an internal diameter in the range of 0.0525 inch to 0.0545 inch.

6. The needle of claim 1, wherein the needle shaft has a thickness in the range of 0.001 to 0.003 inch.

7. The needle of claim 1, wherein the inlet orifice is a circular opening with a diameter in the range of 0.042 inch and is offset from the pointed end tip by approximately 0.035 inch.

8. The needle of claim 1, wherein at least two inlet orifices are along the needle shaft between the primal end and the distal end and in fluidic contact with the biological or physiological fluid reservoir and adjacent to the pointed tip, wherein each of the at least two inlet orifices communicate with the bore for the passage of the biological or physiological fluid from the biological or physiological fluid reservoir through the inlet orifice and through the bore, and wherein the inlet orifice has at least a rounded edge, and wherein each of the at least two inlet orifices are staggered at approximately 180 degree along the needle shaft.

9. The needle of claim 8, wherein the needle shaft wherein the longitudinal axis of is curved adjacent to the pointed tip.

10. The needle of claim 1, wherein a plurality of orifices are along the needle shaft between the proximal end and the distal end and in fluidic contact with the biological or physiological fluid reservoir and adjacent to the pointed tip, and wherein each of the plurality of inlet orifices communicate with the bore for the passage of fluid from the biological or physiological fluid reservoir through the inlet orifice and through the bore.

11. The needle of claim 10, wherein the plurality of orifices is a mesh.

12. The needle of claim 1, wherein a surface of the bore is coated with an anti-clotting.

13. The needle of claim 12, wherein the anti-clotting is heparin.

14. The needle of claim 1, wherein a surface of the bore includes a bio-compatible coating selected from a group consisting of polished titanium oxide, and polymer coating.

15. The needle of claim 14, wherein the polymer coating is selected from a group consisting of Teflon or PTFE.

16. The needle of claim 1, wherein an external surface of the needle shaft is coated with an anti-clotting.

21. The needle of claim 1, wherein the biological or physiological fluid is blood.

17. A method of protecting blood cells from damage during a medical treatment with a subcutaneous port, where blood is circulated through a needle, the method comprising the steps of:

connecting a needle to a medical treatment device for conducting a treatment using multiple circulation of blood through the needle, the needle having a needle shaft having a bore along a longitudinal axis of the needle shaft and a proximal end and a distal end in opposition thereof, a pointed tip at the distal end with a pointed end tip, and at least an inlet orifice along the needle shaft between the proximal end and the distal end, and wherein the inlet orifice has at least a rounded edge for the protection of blood cells;

puncturing a plenum surface of a subcutaneous port for entry of at least a portion of the needle shaft and the inlet orifice into a fluid reservoir in the subcutaneous port;

placing the inlet orifice in fluidic contact with blood in the fluid reservoir for the passage of the blood from the fluid reservoir through the inlet orifice and through the bore; and

circulating the blood so the flow of blood circulates around the rounded edge to protect the blood cells during the circulation to the medical treatment device.

18. The method of claim 17, wherein the medical treatment is hemodialysis.

19. The method of claim 17, wherein a diameter of the rounded edge is at least 5 to 10 times the total cross-section of blood cells in the blood.

20. The method of claim 17, wherein the inlet orifice is an oval has a long axe along the longitudinal axis