Filling methods and apparatus for implanted medical therapy delivery devices

• US 9,381,039 B2
• Filed: 03/15/2013
• Issued: 07/05/2016
• Est. Priority Date: 03/21/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Miesel, Keith A., Sarkinen, Scott A., Akpan, Emem D., Hentges, Douglas E., Dunlap, Mark E., Schauble, Darrin, Konen, Cindy, Bilitz, Mark R.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US13/840,718
• Publication Number:
  US 20140276573A1
• Time in Patent Office: 1,208 Days
• Field of Search: 604/22, 604 65- 67, 604/131, 604/93.01, 60428801-28804
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2039/0244 having means for detecting an inserted needle
• 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 5/329 characterised by features of the needle shaft
• CPC Class Codes: A61M 5/46 having means for controlling depth of insertion

Abstract

Transdermal insertion of a transcutaneous filling apparatus, for the purpose of filling a fill chamber of an implanted therapy delivery device, is monitored by measuring each impedance between pairs of electrodes of a needle of the apparatus, and comparing each to a threshold impedance; the electrodes, preferably at least three in number, are isolated and spaced apart from one another along a length of the needle. A confirmation signal is generated when at least one of the measured impedances is greater than the threshold impedance, and another is less than the threshold, the condition indicating that one of the electrodes is located within a non-conductive septum, through which the apparatus must pass to access the fill chamber. A detection circuit, which may be located in a housing of the apparatus that is attached to a proximal end of the needle, measures and compares the impedances.

Claims

1. A filling apparatus for use by an operator in delivering a liquid therapeutic agent into a refill chamber of a therapy delivery device through a non-conductive septum of the refill chamber wherein the septum, refill chamber and therapy delivery device are implanted subcutaneously in a patient, the apparatus comprising:

a needle comprising a proximal end, a distal portion, a distal-most end having a piercing distal tip, a conduit extending along the needle, from a proximal opening at the proximal end to a distal opening located in proximity to the distal-most end, and a connector at the proximal end configured to connect to a syringe containing the liquid therapeutic agent, first, second and third electrodes located on the distal portion of the needle so that when the distal-most end of the needle is inserted through the septum and in the refill chamber the second electrode is located within the septum and wherein each of the first electrode is spaced distally or proximally from the septum and the third electrode is spaced proximally from the septum;

a detection circuit attached to the proximal end of the needle and electrically coupled to the first, second and third electrodes of the needle, the circuit configured to measure a first impedance between the first and second electrodes, a second impedance between the second and third electrodes, and a third impedance between the first and third electrodes, and to compare each of the measured impedances to a threshold impedance as the needle is being guided through the patient'"'"'s tissue to the refill chamber, and the circuit is further configured to generate a confirmation signal when the first and second measured impedances are greater than the threshold impedance and the third measured impedance is less than the threshold impedance, the signal indicating to the operator that the second electrode is within the septum and the distal-most end of the needle is in the refill chamber and the liquid therapeutic agent can be delivered.

2. The apparatus of claim 1, wherein the detection circuit is further configured to continuously measure the first, second, and third impedances after the confirmation signal is generated and if either first or second measured impedance is less than the threshold impedance or the third measured impedance is greater than the threshold impedance indicating dislodgment of the second electrode from the septum the confirmation signal is stopped and a warning signal is generated.

3. The apparatus of claim 2, further comprising:

a pair of redundant conductors electrically coupling the second electrode to the detection circuit; and

the detection circuit is further configured to test electrical continuity through the pair of redundant conductors.

4. The apparatus of claim 2, wherein the needle further comprises:

a conductive wall extending around the conduit from the proximal end of the needle to the piercing distal tip of the needle, the wall having an uninsulated portion extending proximally from the distal-most end to form the first electrode;

at least one nonconductive layer overlaying the conductive wall, the second and third electrodes being formed on the at least one nonconductive layer;

a first conductive trace formed on the at least one nonconductive layer, the first conductive trace coupling the second electrode to the detection circuit;

a second conductive trace formed on the at least one nonconductive layer and being electrically isolated from the first conductive trace, the second conductive trace coupling the third electrode to the detection circuit; and

an outer insulation layer overlaying the first and second conductive traces.

5. The apparatus of claim 2, wherein the second electrode of the needle comprises a pair of redundant second electrodes;

and the needle further comprises;

a conductive wall extending around the conduit from the proximal end of the needle to the piercing distal tip of the needle, the wall having an uninsulated portion extending proximally from the distal-most end to form the first electrode;

at least one nonconductive layer overlaying the conductive wall, the pair of second redundant electrodes and the third electrode being formed on the at least one nonconductive layer;

a first conductive trace formed on the at least one nonconductive layer, the first conductive trace coupling one of the pair of redundant second electrodes to the detection circuit;

a second conductive trace formed on the at least one nonconductive layer, the second conductive trace coupling the other of the pair of redundant second electrodes to the detection circuit;

a third conductive trace formed on the at least one nonconductive layer and being electrically isolated from the first and second conductive traces, the third conductive trace coupling the third electrode to the detection circuit; and

an outer insulation layer overlaying the first, second and third conductive traces.

6. The apparatus of claim 5, wherein each of the first and second conductive traces comprises a pair of redundant conductive traces;

and the detection circuit is further configured to test electrical continuity through each pair of redundant conductive traces.

7. The apparatus of claim 2, wherein the needle further comprises:

a conductive wall extending around the conduit from the proximal end of the needle to the piercing distal tip of the needle, the wall having an uninsulated portion extending proximally from the distal-most end to form the first electrode;

a first conductive wire including insulated first and second segments that extend between the proximal end and the distal-most end of the needle, and an uninsulated third segment that extends between the first and second insulated segments to form the second electrode; and

a second conductive wire including insulated first and second segments that extend between the proximal end and the distal-most end of the needle, and an uninsulated third segment that extends between the first and second insulated segments of the second wire to form the third electrode.

8. The apparatus of claim 2, further comprising:

a power source;

an electrical interconnect assembly configured to electrically couple the power source to the detection circuit;

a housing containing the proximal end of the needle, the detection circuit, the power source, and the interconnect assembly; and

a cap covering an opening into the housing, the cap having a hub in which a port is formed, the port being in fluid communication with the conduit of the needle, and the hub being configured for attachment to a syringe.

9. The apparatus of claim 8, wherein the cap is secured to the housing by one or more of:

a snap-fit, a crush feature, adhesive bonding, and ultrasonic welding.

10. The apparatus of claim 8, wherein the confirmation signal and warning signal generated by the detection circuit each comprises a light signal, the confirmation signal being a different color light signal than the warning signal;

and at least a portion of the cap is translucent to allow projection of the light signals therethrough.

11. The apparatus of claim 8, further comprising a needle guard, the needle guard including a shaft configured to contain the distal portion of the needle, and a battery tab protruding from a proximal end of the shaft;

and wherein;

the interconnect assembly includes a receptacle formed therein and a battery connector, the battery connector including a tab member located within the receptacle; and

when the shaft of the needle guard is fitted around the distal portion of the needle, the battery tab of the needle guard extends into the receptacle of the housing and engages the tab member of the battery connector, the engagement preventing contact arms of the battery connector from making electrical contact with the detection circuit, and, when the fitted needle guard is removed from around the needle, the battery tab is pulled from the receptacle and disengages from the tab member, thereby allowing the contact arms to make electrical contact with the detection circuit.

12. The apparatus of claim 11, wherein the tab member of the battery connector includes an end configured to prevent reengagement of the battery tab of the needle guard after the needle guard has been removed from around the needle.

13. A transcutaneous filling apparatus for an implantable therapy delivery device, the apparatus comprising:

a needle comprising a proximal end, a distal portion, a distal-most end, a piercing distal tip terminated by the distal-most end, a conduit extending along a length of the needle, from a proximal opening at the proximal end to a distal opening located in proximity to the distal-most end, a plurality of electrodes isolated from one another and spaced apart from one another along the distal portion of the needle; and

a detection circuit electrically coupled to each electrode and configured to measure an impedance between each combination of pairs of the plurality of electrodes, to compare each measured impedance to a threshold impedance, and to generate a confirmation signal if at least one of the measured impedances is greater than the threshold impedance.

14. The apparatus of claim 13, wherein the plurality of electrodes comprises three electrodes;

and the detection circuit generates a confirmation signal if two of the measured impedances is greater than the threshold impedance and the other of the measured impedances is less than the threshold impedance.

15. The apparatus of claim 14, wherein:

the therapy delivery device includes a fill chamber defined between a non-conductive septum of the device and a floor of the chamber, the septum having a first side and a second side defining a thickness thereof, the first side facing away from the chamber and the second side facing toward the floor of the chamber and being spaced apart from the floor by a distance; and

the second electrode includes a distal edge and a proximal edge, the proximal edge being spaced apart from the distal edge by a distance that is less than the thickness of the septum of the device, and the distal edge of the second electrode being spaced apart from the distal-most end of the needle by a distance that is greater than the distance by which the second side of the septum is spaced from the floor of the fill chamber of the device.

16. The apparatus of claim 13, wherein the therapy delivery device includes a fill chamber defined between a non-conductive septum of the device and a floor of the chamber, the septum having a first side and a second side defining a thickness thereof, the first side facing away from the chamber and the second side facing toward the floor of the chamber and being spaced apart from the floor by a distance;

and wherein;

the needle further comprises a first insulative zone and a second insulative zone;

the plurality of electrodes of the needle comprise a first electrode located in proximity to the distal-most end, the first insulative zone extending proximally therefrom, a second electrode extending proximally from the first insulative zone, the second insulative zone extending proximally therefrom;

the second electrode includes a distal edge located adjacent the first insulative zone and a proximal edge located adjacent the second insulative zone, the proximal edge being spaced apart from the distal edge by a distance that is less than the thickness of the septum of the device, and the distal edge of the second electrode being spaced apart from the distal-most end of the needle by a distance that is greater than the distance by which the second side of the septum is spaced from the floor of the fill chamber of the device.

17. The apparatus of claim 13, further comprising:

a pair of redundant conductors electrically coupling a corresponding electrode to the detection circuit; and

the detection circuit is further configured to test electrical continuity through the pair of redundant conductors.

18. The apparatus of claim 13, wherein the needle further comprises:

a conductive wall extending around the conduit from the proximal end of the needle to the piercing distal tip of the needle, the wall having an uninsulated portion extending proximally from the distal-most end to form a first of the plurality of electrodes;

a nonconductive layer directly overlaying the inner wall;

a conductive layer deposited on the nonconductive layer, the conductive layer forming a second of the plurality of electrodes and a corresponding conductive trace that electrically couples the electrode to the detection circuit; and

an outer insulation layer overlaying the conductive trace.

19. The apparatus of claim 18, wherein the nonconductive layer overlaying the conductive wall is formed from a heat shrinkable material.

20. The apparatus of claim 13, further comprising:

a power source;

an electrical interconnect assembly configured to electrically couple the power source to the detection circuit;

a housing containing the proximal end of the needle, the detection circuit, the power source, and the interconnect assembly; and

a cap covering an opening into the housing, the cap having a hub in which a port is formed, the port being in fluid communication with the conduit of the needle, and the hub being configured for attachment to a syringe.

21. The apparatus of claim 20, wherein the signal generated by the detection circuit comprises a light signal;

and at least a portion of the cap is translucent to allow projection of the light signal therethrough.

22. The apparatus of claim 20, wherein the cap is secured to the housing by one or more of:

a snap-fit, a crush feature, adhesive bonding, and ultrasonic welding.

23. The apparatus of claim 20, further comprising a needle guard, the needle guard including a shaft configured to contain the distal portion of the needle, and a battery tab protruding from a proximal end of the shaft;

and wherein;

the interconnect assembly includes a receptacle formed therein and a battery connector, the battery connector including a tab member located within the receptacle; and

when the shaft of the needle guard is fitted around the distal portion of the needle, the battery tab of the needle guard extends into the receptacle of the housing and engages the tab member of the battery connector, the engagement preventing contact arms of the battery connector from making electrical contact with the detection circuit, and, when the fitted needle guard is removed from around the needle, the battery tab is pulled from the receptacle and disengages from the tab member, thereby allowing the contact arms to make electrical contact with the detection circuit.

24. The apparatus of claim 23, wherein the tab member of the battery connector includes an end configured to prevent reengagement of the battery tab of the needle guard after the needle guard has been removed from around the needle.