Valved connector and method of use

• US 6,360,784 B1
• Filed: 12/22/1999
• Issued: 03/26/2002
• Est. Priority Date: 12/22/1999
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Johnson, Patrick, Pierce, Joanna, Hauch, Tim, Guimont, Jill, Spencer, Robert, Borchard, Craig F., Sheehan, Dan, Robischon, Mary, Philippens, Frans
• Primary Examiner(s): Huson, Gregory L.
• Assistant Examiner(s): DEVORE, PETER T
• Application Number:
  US09/470,020
• Time in Patent Office: 825 Days
• Field of Search: 141/2, 141/21, 141/25, 141/26, 141/27, 141/98, 141/18, 604/7, 604/9, 604/187, 604/247, 604/323, 604/407, 604/409, 604/246, 137/511
• US Class Current: 141/2
• 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 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances

Abstract

A device and method for aseptically filling high pressure reservoirs in medicament pumps is disclosed. The device preferably includes a filter, a connector having a one-way valve and a filling tube with a terminal needle. The filter is connectable to a pharmacy prepared syringe containing a drug to be transferred to the reservoir of the IDIP. The filter is connected to the connector. The connector has a first and a second inlet port fluidly connected to an outlet port. A one-way valve is located in the connector “upstream” of the point where the two inlet ports connect to the outlet port. The filling tube is connectable to the outlet port. In use, a pharmacy syringe is connected to the first inlet port. A filling syringe is connected to the second inlet port. The filling tube is connected to the outlet port. The terminal needle of the filling tube is passed through the patient'"'"'s skin and into the IDIP. The practioner draws the drug into the filling syringe from the pharmacy syringe through the connector. When the filling syringe is full, the practioner pushes the filling syringe plunger in thereby forcing the drug out of the outlet port, through the filling tube and terminal needle into the reservoir of the IDIP. The one-way valve prevents the drug from re-entering the pharmacy syringe.

Claims

1. An implantable pump filling system comprising:

a connector having a central lumen, a first inlet port, a second inlet port and an outlet port, the first and second inlet ports and the outlet port being fluidly connected to the central lumen, the connector having a one-way valve located in the central lumen between the first inlet port an d the point where the second inlet port connects to the central lumen, the one-way valve biased to allow fluid to pass only from the first inlet port to the central lumen, the one-way valve being selected from the group consisting of a flexible disk valve, a duck-billed valve, a slit valve and an umbrella valve;

a filling tube having a proximal and a distal end, the proximal end connected to the outlet port; and

a clamp disposed between the filling tube distal end and the outlet port to prevent fluid flow between the distal end and the outlet port when the clamp is activated.

2. The implantable pump filling system of claim 1 further comprising a filter, the filter connected to the first inlet port.

3. The implantable pump filling system of claim 2 wherein the filter is integrally connected to the first inlet port.

4. The implantable pump filling system of claim 1 wherein the filling tube is integrally connected to the outlet port.

5. The implantable pump filling system of claim 1 wherein the filling tube includes a terminal needle.

6. The implantable pump filling system of claim 1 wherein the first inlet port has a luer lock connection.

7. The implantable pump filling system of claim 1 wherein the second inlet port has a luer lock connection.

8. The implantable pump filling system of claim 1 wherein the outlet port has a luer lock connection.

9. The implantable pump filling system of claim 1 wherein the one-way valve comprises a flexible disk valve.

10. The implantable pump filling system of claim 1 wherein the clamp is manually actuatable between an open position in which the clamp does not prevent flow between the distal end and the outlet port, and an activated position in the clamp prevents flow between the distal end and the outlet port.

11. The implantable pump filling system of claim 1 wherein the first and second inlet ports and the outlet port each have luer lock connections, the connector comprising a Y-type connector.

12. A method of transferring fluid from a first syringe to a second syringe and from the second syringe to a reservoir of an implantable pump, the second syringe having a plunger, comprising the steps of:

providing an implantable pump filling system comprising;

a connector having a central lumen, a first inlet port, a second inlet port and an outlet port, the first and second inlet ports and the outlet port being fluidly connected to the central lumen, the connector having a one-way valve located in the central lumen between the first inlet port and the point where the second inlet lumen connects to the central lumen, the one-way valve biased to allow fluid to pass only from the first inlet port to the central lumen; and

a filling tube connected to the outlet port, the filling tube having a terminal needle;

connecting the first syringe to the first inlet port;

connecting the second syringe to the second inlet port, the plunger of the second syringe being fully depressed;

placing the terminal needle in an implantable pump in fluid communication with the reservoir of the implantable pump;

drawing fluid from the first syringe into the second syringe by drawing out the plunger of the second syringe;

depressing the plunger of the second syringe whereby fluid is expelled from the second syringe out of the connector and through the filling tube into the implantable pump reservoir.

13. The method of claim 12 wherein the implantable pump filling system further comprises a filter, the filter connected to the first inlet port.

14. The method of claim 13 wherein the filter is integrally connected to the first inlet port.

15. The method of claim 12 wherein the filling tube is integrally connected to the outlet port.

16. The method of claim 12 wherein the first inlet port has a luer lock connection.

17. The method of claim 12 wherein the second inlet port has a luer lock connection.

18. The method of claim 12 wherein the out let port has a luer lock connection.

19. The method of claim 12 wherein the one-way valve is chosen from the group consisting of a flexible disk valve, a ball valve, a duck-billed valve, a slit valve and an umbrella valve.

20. The method of claim 12 further comprising activating a clamp disposed along the filling tube between the outlet port and terminal needle to prevent fluid flow between the terminal needle and the outlet port.

21. A combination comprising:

an implantable drug pump having a reservoir and a refill port; and

an implantable pump filling system comprising

a connector having a central lumen, a first inlet port, a second inlet port and an outlet past, the first and second inlet ports and the outlet port being fluidly connected to the central lumen, the connector having a one-way valve located in the central lumen between the first inlet port and the point where the second inlet port connects to the central lumen, the one-way valve biased to allow fluid to pass only from the first inlet port to the central lumen; and

a filling tube having a proximal and a distal end, the proximal end connected to the outlet port and the distal end adapted for fluid communication with the reservoir of the implantable, drug pump for filling the reservoir.

22. The combination of claim 21 wherein the implantable pump filling system further comprises a filter, the filter connected to the first inlet port.

23. The combination of claim 22 wherein the filter is integrally connected to the first inlet port.

24. The combination of claim 21 wherein the filling tube is integrally connected to the outlet port.

25. The combination of claim 21 wherein the filling tube includes a terminal needle.

26. The combination of claim 21 wherein the one-way valve is selected from the group consisting of a flexible disk valve, a ball valve, a duck-billed valve, a slit valve and an umbrella valve.

27. The combination of claim 21 wherein the one-way valve is selected from the group consisting of a flexible disk valve, a duck-billed valve, a slit valve and an umbrella valve.

28. The combination of claim 21 wherein the reservoir of the implantable drug pump has a pressure bias against which the reservoir is refilled by a drug or other agent, the combination further comprising:

a pharmacy syringe containing a drug or other agent to be transferred to the reservoir, the pharmacy syringe being connected to the first inlet port; and

a filling syringe of a size that facilitates applying sufficient force to the drug or other agent to overcome the pressure bias of the reservoir and allow the drug or other agent to be admitted to the reservoir to refill the reservoir.

29. The combination of claim 28 wherein the first and second inlet ports and the outlet port each have luer lock connections, the connector comprising a Y-type connector.

30. The combination of claim 28 wherein the one-way valve is chosen from the group consisting of a flexible disk valve, a duck-billed valve, a slit valve and an umbrella valve.

31. The combination of claim 30 wherein the one-way valve comprises a flexible disk valve.

32. The combination of claim 28 wherein the filling tube includes a terminal needle.

33. The combination of claim 28 wherein the implantable pump filling system further comprises a clamp disposed between the filling tube distal end and the outlet port to prevent fluid flow between the distal end and the outlet port when the clamp is activated.

34. The combination of claim 33 where the clamp is manually actuatable between an open position in which the clamp does not prevent flow between the distal end and the outlet port, and an activated position in the clamp prevents flow between the distal end and the outlet port.

35. An implantable pump filling system for filling a pressurized reservoir of an implantable pump, the system comprising:

a connector having a central lumen, a first inlet port, a second inlet port and an outlet port, the first and second inlet ports and the outlet port being fluidly connected to the central lumen, the connector having a one-way valve located in the central lumen between the first inlet port and the point where the second inlet port connects to the central lumen, the one-way valve biased to allow fluid to pass only from the first inlet port to the central lumen such that fluid entering from the second inlet port is prevented from passing to the first inlet port;

a filling tube having a proximal and a distal end, the proximal end connected to the outlet port;

a pharmacy syringe containing a drug or other agent to be transferred to the reservoir, the pharmacy syringe being connected to the first inlet port; and

a filling syringe of a size that facilitates applying sufficient force to the drug or other agent to overcome the pressure bias of the reservoir and allow the drug or other agent to be admitted to the reservoir to refill the reservoir.

36. The implantable pump filling system of claim 35 wherein the first and second inlet ports and the outlet port each have luer lock connections, the connector comprising a Y-type connector.

37. The implantable pump filling system of claim 36 wherein the one-way valve is chosen from the group consisting of a flexible disk valve, a duck-billed valve, a slit valve and an umbrella valve.

38. The implantable pump filling system of claim 37 wherein the one-way valve comprises a flexible disk valve.

39. The implantable pump filling system of claim 35 the filling tube includes a terminal needle.

40. The implantable pump filling system of claim 35 wherein the implantable pump filling system further comprises a clamp disposed between the filling tube distal end and the outlet port to prevent fluid flow between the distal end and the outlet port when the clamp is activated.

41. The implantable pump filling system of claim 40 wherein the clamp is manually actuatable between an open position in which the clamp does not prevent flow between the distal end and the outlet port, and an activated position in the clamp prevents flow between the distal end and the outlet port.