Implantable therapeutic substance infusion device with active longevity projection

• US 7,001,359 B2
• Filed: 03/16/2001
• Issued: 02/21/2006
• Est. Priority Date: 03/16/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rogers, Charles R.
• Primary Examiner(s): Le, Long V.
• Assistant Examiner(s): Lam, Ann Y
• Application Number:
  US09/809,809
• Publication Number:
  US 20020161328A1
• Time in Patent Office: 1,803 Days
• Field of Search: 604/65, 604/66, 604/67, 604118-123, 604131-155, 604/890.1, 604/891.1, 604/30, 604/500, 604/502, 604/503, 604/288.01
• US Class Current: 604/118
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades

Abstract

A medical device known as an implantable therapeutic substance delivery device is configured for implanting in humans to deliver a therapeutic substance such as pharmaceutical compositions, genetic materials, and biologics to treat a variety of medical conditions such as pain, spastisity, cancer, and many other conditions. The infusion device embodiment has active longevity projection that more accurately predicts an elective replacement period for the infusion device to increase the infusion device'"'"'s effective life, reduce the need for a clinician to perform static longevity forecasts for therapy changes, facilitate elective replacement scheduling for the convenience of the patient and clinician, and many other improvements. The infusion device has a housing, a power source, a therapeutic substance reservoir, a therapeutic substance pump, and electronics. Many embodiments of the therapeutic substance delivery device with active longevity projection and its methods of operation are possible.

Claims

1. An implantable therapeutic substance infusion device with active longevity projection, comprising:

a housing;

a power source carried in the housing;

a therapeutic substance reservoir carried in the housing, the therapeutic substance reservoir configured for containing a therapeutic substance and being refilled with the therapeutic substance while implanted;

a therapeutic substance pump carried in the housing, the therapeutic substance pump fluidly coupled to the therapeutic substance reservoir, and electrically coupled to the power source;

electronics carried in the housing, the electronics coupled to the therapeutic substance pump and the power source, the electronics including,

a processor,

a memory coupled to the processor,

an infusion program residing in the memory, the infusion program capable of being modified once the therapeutic substance infusion device is implanted;

transceiver circuitry coupled to the processor for externally receiving and transmitting therapeutic substance infusion device information;

at least one preset longevity parameter residing in the memory indicative of longevity of the implantable therapeutic substance infusion device;

a monitor for sensing at least one sensed longevity parameter accessible by the processor and indicative of longevity of the implantable therapeutic substance infusion device wherein the sensed longevity parameter comprises therapeutic substance pump cycles,

a longevity prediction program contained in the memory, the longevity prediction program correlating the preset parameter to the sensed parameter and calculating an elective replacement period for the implantable therapeutic substance infusion device; and

a longevity extension program contained in the memory, the longevity extension program selectively implementing predetermined functional limitations to the implantable therapeutic substance infusion device based on the correlation of the sensed longevity parameter to the preset longevity parameter, to extend critical functionality of the implantable therapeutic substance infusion device beyond a calculated end-of-life period for the implantable therapeutic substance infusion device, wherein the predetermined functional limitations are selected from the group consisting of limit pump flow rate, and limit pump bolus rate.

2. A method for calculating an elective replacement period for an implantable therapeutic substance infusion device, comprising:

storing at least one preset parameter accessible by a processor indicative of longevity for the implantable therapeutic substance infusion device;

operating the therapeutic substance infusion device to infuse therapeutic substance into a patient;

sensing at least one sensed parameter indicative of longevity for the implantable therapeutic substance infusion device wherein the sensed parameter comprises therapeutic substance pump cycles;

calculating an elective replacement period for the implantable therapeutic substance infusion device by correlating the preset parameter with the sensed parameter; and

,

selectively implementing predetermined functional limitations based on the correlation of the preset parameter with the sensed parameter, to extend critical therapeutic substance infusion device functionality beyond a calculated end-of-life period for the implantable therapeutic substance infusion device, wherein the predetermined functional limitations are selected from the group consisting of limit pump flow rate, and limit pump bolus rate.