Implantable therapeutic substance delivery system with catheter access port block and method of use

• US 8,444,609 B2
• Filed: 04/28/2006
• Issued: 05/21/2013
• Est. Priority Date: 04/28/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Christenson, Steven R., Ali, Irfan Z.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): CARPENTER, WILLIAM R
• Application Number:
  US11/413,835
• Publication Number:
  US 20070255236A1
• Time in Patent Office: 2,580 Days
• Field of Search: 604/93.01, 604119-125, 604131-134, 604/140, 604/149, 604150-152, 604/154, 604/156, 604/159, 60428801-28803, 604/288.06, 604/891.1
• US Class Current: 604/288.02
• CPC Class Codes: A61M 39/04 having pierceable self-sealing members
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

A system including an implantable delivery device having a housing, a reservoir, fill and catheter access ports, and a denial device. The housing maintains the fill port in fluid communication with the reservoir. The catheter access port includes a septum between an inlet and a well. The denial device includes a pin, a biasing element, and a solenoid. The pin is arranged to be movable between a first position in which the pin blocks passage of a needle into the well and a second position, with the biasing element biasing the pin to the first position. The solenoid is operatively coupled to the pin and provides an energized and de-energized states; in the energized state, the solenoid moves the pin from the first position to the second position to permit access to the well. An external controller effectuating clinician control over operation of the denial device is also provided.

Claims

1. A liquid therapeutic substance delivery system comprising:

an implantable medical device for delivering a liquid therapeutic substance to a delivery site within a patient, the delivery device including;

a housing defining a catheter outlet;

a reservoir maintained by the housing for containing the therapeutic substance, the reservoir forming a reservoir outlet;

a reservoir fill port fluidly connected to the reservoir;

a catheter access port apart from the reservoir fill port and including a needle inlet defining a passage, a well fluidly coupled to the catheter outlet via a fluid pathway, and a septum disposed between the well and the needle inlet; and

a denial device associated with the catheter access port and including;

a pin arranged to be movable between a first position in which the pin blocks passage of a needle into the well and a second position in which the pin does not prevent passage of a needle into the well,

a biasing element biasing the pin to the first position,

a solenoid operatively coupled to the pin and providing an energized state and a de-energized state, the solenoid being adapted and arranged such that in the energized state, the solenoid operates to move the pin from the first position to the second position,

wherein the well is not fluidly sealed relative to an exterior of the medical device by the pin in the first position.

2. The system of claim 1, wherein the needle inlet passage defines a central axis, and further wherein the denial device is positioned such that the pin moves laterally relative to the central axis in transitioning between the first and second positions.

3. The system of claim 1, wherein the needle inlet passage defines a central axis, and further wherein the denial device is positioned such that the pin move co-axially relative to the central axis in transitioning between the first and second positions.

4. The system of claim 1, wherein the septum defines an outer surface and an inner surface, the outer surface facing the needle inlet passage and the inner surface facing the well, and further wherein the denial device is positioned such that the pin is associated with the inner surface to block passage of a needle through the septum and into the well.

5. The system of claim 4, wherein the solenoid is vertically below the septum, opposite the needle inlet passage.

6. The system of claim 1, wherein the septum defines an outer surface and an inner surface, the outer surface facing the needle inlet passage and the inner surface facing the well, and further wherein the denial device is position such that the pin is associated with the outer surface to block passage of a needle through the needle inlet passage and into the septum.

7. The system of claim 1, wherein the denial device further includes an elastomeric seal between the pin and the solenoid to prevent passage of liquid into the solenoid.

8. The system of claim 1, wherein the denial device further includes a bellows forming a hermetic seal between the pin and the solenoid to prevent passage of liquid into the solenoid.

9. The system of claim 1, wherein the denial device further includes a welded barrier hermetically separating the pin from the solenoid.

10. The system of claim 1, wherein the implantable medical device further includes a metering device coupled to the reservoir outlet, the metering device having a metered outlet fluidly connected to the catheter outlet along a fluid pathway, and further wherein the well is fluidly coupled to the fluid pathway between the metered outlet and the catheter outlet.

11. The system of claim 1, wherein the implantable medical device further includes a device controller electronically coupled to the solenoid for selectively prompting operation of the solenoid in the energized state and the de-energized state.

12. The system of claim 11, wherein the implantable medical device further includes a telemetry device, the system further comprising:

an external controller including a user interface and a telemetry device for communicating information to the medical device telemetry device, the external controller adapted to;

receive information from the user interface indicative of a user intention to insert a needle into the catheter access port, and

prompt signaling of information to the device controller indicative of the user intent;

wherein the device controller is adapted to prompt operation of the solenoid in the energized state in response to the user intent information.

13. The system of claim 12, wherein the device controller includes a microprocessor programmed with software adapted to act upon the user intent information in controlling operation of the solenoid.

14. The system of claim 12, wherein the device controller includes a hardware based state machine adapted to act upon the user intent information in controlling operation of the solenoid.

15. The system of claim 12, wherein the implantable medical device further includes:

a detection device associated with the catheter access port and adapted to detect presence of a needle in the catheter access port;

wherein at least one of the device controller and the external controller is adapted to prompt operation of the solenoid based upon information from the detection device.

16. The system of claim 15, wherein the device controller is adapted to perform a catheter access port insertion routine including:

prompting the solenoid to operate in the energized state for a predetermined time period upon receiving the user intent information; and

prompting the solenoid to operate in the de-energized state upon expiration of the predetermined time period if the detection device information is indicative of a needle not being present in the catheter access port.

17. The system of claim 12, wherein the device controller stores a predetermined time period value and is adapted to further prompt operation of the solenoid based upon the predetermined time period value.

18. The system of claim 17, wherein the device controller is adapted to alter the stored predetermined time period value in response to instructions delivered from the external controller, the instructions being generated in response to information entered at the user interface.

19. The system of claim 12, wherein the external controller stores a predetermined time period value based upon which the solenoid is operated, the external controller being further adapted to transmit the predetermined time period value to the device controller with the user intention information.

20. The system of claim 19, wherein the external controller is adapted to alter the stored predetermined time period value in response to user instructions entered at the user interface.

21. The system of claim 12, further comprising:

a detection device associated with the catheter access port and adapted to detect presence of a needle in the catheter access port;

wherein at least one of the device controller and the external controller is adapted to log information relating to activities occurring relative to the catheter access port assembly, the activities including;

the denial device in an open state and a needle insertion event is detected,

the denial device in an open state and no needle insertion event is detected, and

the denial device in a closed state and an attempted needle insertion event is detected.

22. The system of claim 1, wherein the pin terminates at a leading end opposite the solenoid, and further wherein relative to a central axis of the passage, the leading end is spaced from the central axis in a first direction in the first position and is spaced from the central axis in a second direction in the second position, the first and second directions being opposite of one another.

23. The system of claim 22, wherein the leading end does not physically contact the catheter access port in the first position.