Troubleshooting accelerator system for implantable drug delivery pumps

• US 20040143242A1
• Filed: 01/22/2003
• Published: 07/22/2004
• Est. Priority Date: 01/22/2003
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Codman & Shurtleff Incorporated (Johnson & Johnson)
• Inventors: Ludin, Lev, Beardsley, Tim, Mastrorio, Brooke
• Granted Patent: US 6,902,544 B2
• Time in Patent Office: Days
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14586 pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/16827 controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16831 Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16881 Regulating valves on-off valves, e.g. clamps A61M39/28

Abstract

An implantable pump and methods for detecting leaks in an implantable pump are provided. In one embodiment, the implantable drug pump includes a housing having at least one inlet port and an outlet port formed therein. The outlet port is adapted to communicate with a catheter for delivering fluid to a patient'"'"'s body, and the inlet port(s) are effective to deliver fluid into the housing. The housing further includes at least one reservoir disposed therein and effective to contain a fluid. In use, the pump preferably includes a fluid having one or more drugs disposed in at least one of the reservoirs, and a radiolucent fluid disposed in one of the reservoirs. A user programmable control mechanism is coupled to the drug pump and is effective to selectively control movement of the valves between the open and closed positions.

Claims

1. A method for detecting a leak in an implantable drug pump, comprising:

providing an implantable drug pump having a housing having a first reservoir disposed therein and containing a fluid having one or more drugs, and a second reservoir disposed therein and containing a radiolucent fluid,

at least one inlet port formed in the housing and in communication with at least one of the first and second reservoirs,

an outlet port formed in the housing and adapted to deliver a fluid to a patient'"'"'s body,

a first programmable valve in fluid communication with the first reservoir and the outlet port, the first valve being movable between a closed position, in which fluid is prevented from flowing from the first reservoir to the outlet port, and an open position, in which fluid is free to flow from the first reservoir to the outlet port,

a second programmable valve in fluid communication with the second reservoir and the outlet port, the second valve being movable between a closed position, in which fluid is prevented from flowing from the second reservoir to the outlet port, and an open position, in which fluid is free to flow from the second reservoir to the outlet port, and

a driver mechanism effective to drive fluid from the first and second reservoirs to the outlet port for delivering fluid to a patient'"'"'s body;

causing the first valve to move to the closed position;

causing the second valve to move to the open position; and

actuating the driver mechanism to cause the radiolucent fluid disposed within the second reservoir to flow through the valve and into the outlet port to be delivered to a patient'"'"'s body;

wherein the flow of radiolucent fluid through the pump can be radiographically viewed to determine if any leaks exist in the implantable drug pump and structures connected to the implantable drug pump.

2. The method of claim 1, wherein the implantable drug pump includes a first inlet port in communication with the first reservoir, and a second inlet port in communication with the second reservoir.

3. The method of claim 1, further comprising a catheter connected to the outlet port and adapted to deliver a fluid to a patient'"'"'s body, wherein the flow of radiolucent fluid through the pump and the catheter can be radiographically viewed to determine if any leaks exist in the implantable drug pump and the catheter.

4. The method of claim 2, wherein, prior to the steps of programming the first and second valves and actuating the driver mechanism, the radiolucent fluid is introduced into the second reservoir through the second inlet port.

5. The method of claim 4, wherein the radiolucent fluid comprises a marking agent.

6. The method of claim 1, wherein the driver mechanism of the implantable drug pump is selected from the group consisting of a compression spring, a propellant gas, and an electromechanical actuator.

7. The implantable drug pump of claim 1, wherein the driver mechanism of the implantable drug pump is adapted to apply a force to at least one of the first and second reservoirs to cause fluid disposed within the reservoir to be forced through one of the first and second valves and at least one of the at least one outlet ports.

8. The method of claim 1, wherein the inlet port of the implantable drug pump comprises a bolus port adapted to allow a drug to be delivered directly to the outlet port.

9. The method of claim 1, wherein the radiolucent fluid comprises a mixture of a marking agent and sodium chloride.

10. The method of claim 1, wherein the implantable drug pump further comprises a user programmable control mechanism coupled to the drug pump and effective to selectively control movement of each of the first and second valves between the open and closed positions.

11. An implantable drug pump, comprising:

a housing having an inlet port and an outlet port formed therein, the outlet port being adapted to communicate with a catheter for delivering fluid to a patient'"'"'s body, and the inlet port being effective to deliver fluid into the housing;

a plurality of reservoirs disposed within the housing and effective to contain a fluid therein, the plurality of reservoirs being selectively rotatable within the housing such that any one of the plurality of reservoirs can be positioned to be in fluid communication with the outlet port, and any one of the plurality of reservoirs can be positioned to be in fluid communication with the inlet port;

a valve disposed between the plurality of reservoirs and the outlet port, the valve being effective to control the flow of fluid from the plurality of reservoirs to the outlet port; and

a driver mechanism effective to selectively drive fluid from the plurality of reservoirs to the outlet port.

12. The implantable drug pump of claim 11, wherein the driver mechanism is selected from the group consisting of a spring, a propellant gas, and an electromechanical actuator.

14. The implantable drug pump of claim 11, further comprising a plurality of valves, each valve being in fluid communication with the outlet port and one of the plurality of reservoirs.

15. The implantable drug pump of claim 14, further comprising a controller in communication with the plurality of valves for selectively moving each of the plurality of valves between an open position and a closed position, and an external programmer effective to actuate the controller.

16. The implantable drug pump of claim 11, wherein the valve comprises a plunger movable between an open and closed position, and an actuator mechanism effective to move the plunger between the open and closed positions.

17. The implantable drug pump of claim 16, wherein the actuator mechanism comprises a piezoelectric actuator.

18. The implantable drug pump of claim 11, further comprising a fluid having one or more drugs disposed in at least one of the plurality of reservoirs, and a radiolucent fluid disposed in one of the plurality of reservoirs.

19. The implantable drug pump of claim 11, further comprising a user programmable control mechanism coupled to the drug pump and effective to selectively control movement of the valve between the open and closed positions.

13. The implantable drug pump of claim I 1, wherein the driver mechanism is adapted to selectively apply a force to at least one of the plurality of reservoirs to cause fluid disposed within the reservoir to be forced through the valve and the outlet port.

20. An implantable drug pump, comprising:

a housing having an inlet port and a plurality of outlet ports formed therein, the plurality of outlet ports being adapted to communicate with at least one catheter for delivering fluid to a patient'"'"'s body, and the inlet port being effective to deliver fluid into the housing;

a plurality of reservoirs disposed within the housing and effective to contain a fluid therein, each of the plurality of reservoirs being in fluid communication with at least one of the plurality of outlet ports and with the inlet port;

a plurality of valves, each valve being disposed between one of the plurality of reservoirs and one of the plurality of outlet ports, the plurality of valves being effective to control the flow of fluid from the plurality of reservoirs to the plurality of outlet ports; and

a driver mechanism effective to selectively drive fluid from the plurality of reservoirs to the plurality of outlet ports.

21. The implantable drug pump of claim 20, wherein the driver mechanism is selected from the group consisting of a spring, a propellant gas, and an electromechanical actuator.

22. The implantable drug pump of claim 20, wherein the driver mechanism is adapted to selectively apply a force to at least one of the plurality of reservoirs to cause fluid disposed within the reservoir to be forced through the valve and the outlet port coupled to the reservoir.

23. The implantable drug pump of claim 20, further comprising a controller in communication with the plurality of valves for selectively moving each of the plurality of valves between an open position and a closed position, and an external programmer effective to actuate the controller.

24. The implantable drug pump of claim 20, further comprising a fluid having one or more drugs disposed in at least one of the plurality of reservoirs, and a radiolucent fluid disposed in one of the plurality of reservoirs.

25. The implantable drug pump of claim 20, further comprising a user programmable control mechanism coupled to the drug pump and effective to selectively control movement of each of the plurality of valves between the open and closed positions.