System for preventing needle displacement in subcutaneous venous access ports

• US 5,637,088 A
• Filed: 09/14/1995
• Issued: 06/10/1997
• Est. Priority Date: 09/14/1995
• Status: Expired due to Fees

• Current Assignee: Donald E. Wenner, George L. Scott III
• Original Assignee: Donald E. Wenner, George L. Scott III
• Inventors: Wenner, Donald E., Scott, George L. III
• Primary Examiner(s): YASKO JR, JOHN D
• Application Number:
  US08/528,319
• Time in Patent Office: 635 Days
• Field of Search: 604/93, 604/167, 604/175, 604/264, 604/256, 604/280, 604/283
• US Class Current: 604/93.01
• CPC Class Codes: A61M 2039/0081 Means for facilitating introduction of a needle in the septum, e.g. guides, special construction of septum
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• 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 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053

Abstract

A threaded, dual needle system is securely attached to a modified subcutaneous venous access port having an internal reservoir, used for intravenous drug therapy particularly in human cancer treatment. A hollow outer needle is paired with a removable, male-threaded solid inner point and inserted through the patient'"'"'s tissue and through the port'"'"'s protective, self-sealing silicon septum, and the solid inner needle is then removed, while the outer needle is left in place. Next, a hollow inner needle is threaded through the outer needle to a depth sufficient to interlock with a female-threaded port receptacle at the base of the port'"'"'s fluid reservoir and rotated to install. Optional additional threading can permit securing the outer needle to the two inner needles. A breakaway system prevents displacement from unintended pulling of the flow-line. The system thus provides additional protection against needle displacement from venous access ports, the resulting leakage, and the problems caused thereby.

Claims

1. A subcutaneous venous access port apparatus for intravenous drug therapy comprising:

(a) a port enclosing an interior reservoir that is coupled to a catheter extending from the reservoir outside the port;

(b) a threaded receptacle on an interior surface of the reservoir;

(c) a hollow outer needle extending through the port to the interior reservoir; and

(d) a hollow inner needle having threading configured to interlock with the threaded receptacle, and having at least one aperture extending from the hollow interior of the inner needle to the reservoir when the threads of the inner needle are interlocked with the threaded receptacle.

2. The apparatus of claim 1 wherein the reservoir has a concave surface surrounding the receptacle.

3. The apparatus of claim 1 wherein the port comprises a base and a self-sealing silicon septum, which are fitted together to enclose an interior reservoir, wherein the base supports the concave surface, and wherein the hollow outer needle extends through the septum.

4. The apparatus of claim 1 wherein the receptacle has female threading and the hollow inner needle has male threading substantially adjacent to the end of the inner needle on the interior of the port.

5. The apparatus of claim 4 wherein the female threading consists of approximately a single turn of screw threads.

6. The apparatus of claim 1 wherein the at least one aperture comprises a plurality of holes extending radially around a limited-length section of the hollow inner needle.

7. The apparatus of claim 1 wherein the outer needle further has a smooth exterior and internal threads, and wherein the inner needle has threads on its outer surface that interlock with the internal threads of the outer needle.

8. The apparatus of claim 1 further comprising a cap securing together the exterior ends of the outer needle and the inner needle and having a hole positioned to permit fluid flow into the inner needle through the cap.

9. The apparatus of claim 8 wherein the end of the inner needle passes through the hole in the cap.

10. The apparatus of claim 1 further comprising a flexible fluid flow-line coupled to the hollow inner needle, and further comprising a break-away section located along the fluid flow-line.

11. A subcutaneous venous access port system for intravenous drug therapy comprising:

(a) a port comprised of a base and a self-sealing silicon septum, which are fitted together to enclose an interior reservoir, wherein the base has a concave surface abutting the interior reservoir, and further comprising a hollow catheter coupled to the port so as to allow fluid to pass from the reservoir through the hollow catheter;

(b) a female-threaded receptacle on the center of the concave interior surface of the base;

(c) a hollow outer needle having internal threading;

(d) a first inner needle that is solid and has (i) external threading fitting the threading of the outer needle and (ii) a pointed end; and

(e) a second inner needle that is hollow and has (i) first external threading fitting the threading of the outer needle, (ii) second external male threading substantially adjacent to the end of the second inner needle and configured to interlock with the female-threaded receptacle, and (iii) at least one aperture extending out of the hollow second inner needle between the first and second external threading;

(f) wherein the aperture is positioned to permit fluid to pass from the hollow interior of the second inner needle to the reservoir when (i) the outer needle extends through the silicon septum to the interior reservoir, (ii) the second inner needle extends entirely through the hollow outer needle, (iii) the end of the second inner needle outside the port is coupled to a source of fluid, (iv) the first threading of the second inner needle is fitted with the threading of the outer needle, and (v) the second threading adjacent to the end of the second inner needle inside the port is interlocked with the threaded receptacle.

12. The apparatus of claim 11 wherein the first inner needle further has a plurality of fins adjacent to the pointed end.

13. The apparatus of claim 11 further comprising:

(a) a flexible fluid flow line coupled to the hollow second inner needle;

(b) a break-away section located along the fluid flow-line; and

(c) a ball valve along the flow-line adjacent to the break-away section on the side towards the second inner needle.

14. The apparatus of claim 13 further comprising a cap fitting over the exterior end of the hollow outer needle, and wherein the cap and outer needle are configured to permit secure attachment of the hollow second inner needle to the fluid flow-line through the cap.

15. A method of using a subcutaneous venous access port system for intravenous drug therapy comprising:

(a) implanting below the skin of a patient a port comprised of a base and a self-sealing silicon septum that are fitted together to enclose an interior reservoir, and a threaded receptacle on an interior surface of the base;

(b) coupling the reservoir to a hollow catheter surgically implanted into a vein of the patient;

(c) thereafter piercing the skin and the septum with, and extending into the reservoir, a unit substantially consisting of a hollow outer needle and a solid, pointed inner needle;

(d) thereafter removing the solid inner needle while leaving the hollow outer needle in place;

(e) thereafter placing entirely through the hollow outer needle a two-ended hollow inner needle that has (i) external threads substantially adjacent to a first end of the hollow inner needle, and (ii) at least one aperture extending out of the hollow inner needle between the two ends;

(f) thereafter interlocking the threads adjacent to the first end of the hollow inner needle with the threaded receptacle;

(g) coupling a source of fluid to the second end of the hollow inner needle; and

(h) thereafter causing fluid to flow from the source, through the hollow inner needle, out of the aperture, and into the reservoir, and to flow from the reservoir, through the catheter, and into the vein.

16. The method of claim 15 wherein the base has a concave surface abutting the interior reservoir, and wherein the threaded receptacle is on the concave interior surface.

17. The method of claim 16 wherein the receptacle is female-threaded and the hollow inner needle has male threads at the first end.

18. The method of claim 15 wherein the hollow inner needle has further external threads fitting internal threads of the hollow outer needle, and wherein (e) comprises screwing the hollow inner needle into the hollow outer needle.

19. The method of claim 18 wherein the solid inner needle has external threads fitting the internal threads of the hollow outer needle, further comprising assembling the unit by screwing the solid inner needle into the hollow outer needle, and wherein (d) comprises unscrewing the solid inner needle from the hollow outer needle.

20. The method of claim 15 further comprising thereafter ceasing the flow of fluid and removing the hollow inner needle and the hollow outer needle, while leaving the port and catheter in place in the patient, and wherein removing the needles causes the septum to self-seal the hole previously held open by the outer needle.