Implantable infusion device

• US 4,360,019 A
• Filed: 03/31/1980
• Issued: 11/23/1982
• Est. Priority Date: 02/28/1979
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Andros, Inc. (Advanced Energy Industries, Inc. (China))
• Inventors: Jassawalla, Jal S., Portner, Peer M.
• Primary Examiner(s): Marlo, George J.
• Application Number:
  US06/135,219
• Time in Patent Office: 967 Days
• Field of Search: 128/260, 128/214 F, 128/213 R
• US Class Current: 604/131
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation

Abstract

An infusion system is disclosed for delivering precisely regulated and variable dosages of drugs. The device includes a reservoir for containing the drug, a catheter for delivering drug to the body, and actuating means responsive to a signal applied externally of the body for initiating delivery of a precisely regulated dosage. The actuating means include; a solenoid driven miniature pump which is controlled by an implanted controller and driven by an implanted power source. The implanted controller provides a basal dosage rate which itself may be variable or constant and which may be altered by telemetry signals delivered from outside the body. In addition, the internal device is operable by an external unit which may be set at a different rate from that which the internal or implanted controller is set and which, in addition, provides power for operating the implanted device. The reservoir is maintained at zero gauge or slightly negative gauge pressure to prevent loss of the contents of the reservoir into the body in which the device is implanted in the event of a failure. A tube communicating between the reservoir and the catheter is bent around on itself in such a way as to prevent bubbles from entering the tube. The implanted power and control electronics may be overridden to provide power from an extra corporeal unit and is also programmable from the extra corporeal unit to adjust dosage rates. A bellows is used to maintain a constant pressure within the reservoir, and suitable plates are utilized to produce a capacitive signal indicating the volume remaining of the contents of the reservoir.

Claims

1. An implantable drug infusion device for delivering precisely regulated dosages of drugs into the body of a patient, comprising

a housing for the infusion device which is implantable within the body of the patient,

a reservoir for containing a selected drug,

cathether means for connecting said reservoir with a portion of the body to which the drug is to be delivered,

first actuating means including power means and control means internally contained within said infusion device housing for causing flow of the selected drug from said reservoir through said catheter means at a first dosage rate, and

second actuating means responsive to non-invasive extracorporeal control means for causing flow of the selected drug from said reservoir through said catheter means at a second dosage rate determined by the extracorporeal control means, said second actuating means including means contained within said housing for receiving power from the extracorporeal control means through intact skin.

2. The implantable drug infusion device of claim 1 wherein said first actuating means is adapted for being overridden during the operation of said second actuating means in response to the extracorporeal control means.

3. The implantable drug infusion device of claim 2 wherein said internal control means for said first actuating means is responsive to the extracorporeal control means for adjusting the drug dosage delivered by said first actuating means.

4. The implantable drug infusion device of claim 1 wherein said internal control means for said first actuating means is responsive to the extracorporeal control means for adjusting the drug dosage delivered by said first actuating means.

5. The implantable drug infusion device of claim 1 wherein said reservoir includes means for maintaining a generally constant pressure within said reservoir which is less than atmospheric pressure, and further comprising pump means for supplying the drug from said reservoir to said catheter under control of said first and second actuating means.

6. The implantable drug infusion device of claim 5 wherein said pump means includes a reciprocating pump element and solenoid means for operating said pump element in response to said first and second actuating means, movement of said pump element in one direction drawing a drug supply from said reservoir into a pump chamber and movement of the pump element in the opposite direction causing the drug supply in the pump chamber to be delivered through said catheter means.

7. The implantable drug infusion device of claim 6 wherein said uniform pressurizing means within said reservoir means comprises an extensible and collapsible bellows forming a separate gas pressure chamber, said bellows including capacitive means for producing a signal corresponding to the volume of said reservoir.

8. The implantable drug infusion device of claim 1 further comprising drug outlet means arranged within said reservoir means for permitting the drug to flow from said reservoirs means while trapping bubbles within said reservoir means.

9. The implantable drug infusion device of claim 8 wherein said drug outlet means comprises a tube extending into said reservoir means and having an open end within said reservoir means spaced a distance from a surface within said reservoir means selected to prevent bubbles from entering the tube.

10. The implantable drug infusion device of claim 8 wherein said tube is bent back upon itself so that the open end of the tube is spaced slightly apart from a surface portion of the tube.

11. The implantable drug infusion device of claim 1 further comprising inlet means for permitting injection of a drug supply into said reservoir means while said infusion device is implanted within the body of the patient.

12. The implantable drug infusion device of claim 11 wherein said inlet means includes a penetrable, self-sealing membrane for allowing injection of a drug supply into said reservoir means and further comprising a redundant check valve means in series with said membrane for preventing escape of the drug supply from said reservoir through said inlet means.

13. The implantable drug infusion device of claim 1 wherein said reservoir means includes expansible and retractable means arranged therein for maintaining a generally uniform pressure within said reservoir when the drug supply within said reservoir is increased or decreased, said pressurizing means further being adapted to produce a sharp pressure rise within said reservoir when it is properly filled with a drug supply in order to produce a detectable pressure rise signal indicating that said reservoir is full.

14. The implantable drug infusion device of claim 1 wherein said first actuating means is adapted for delivery of the drug from said reservoir through said catheter at a basal rate, said second actuating means being responsive to the extracorporeal means for delivery of the drug from said reservoir through said catheter means at a bolus rate, said first actuating means being adapted to be overridden during operation of said second actuating means.

15. A drug infusion system for delivering precisely regulated dosages of drugs into the body of a patient, comprising

an implantable component including a housing which is implantable within the body of a patient, a reservoir for containing a selected drug, catheter means for connecting said reservoir with a portion of the body to which the drug is to be delivered, first actuating means including control means internally contained within said housing for causing flow of the selected drug from said reservoir through said catheter means at a first dosage rate, power receiving means, and second actuating means operable with power from said power receiving means for causing flow of the selected drug from said reservoir through said catheter means at a second dosage rate, and

an extracorporeal component including control means adapted for communication with the second actuating means when the infusion device is implanted within the body of a patient for establishing the second selected rate of drug flow and further including means for supplying power to said power receiving means.

16. The implantable drug infusion device of claim 15 wherein said extracorporeal control means further includes means for monitoring the drug supply level within said reservoir, means for monitoring the condition of said power source within said first actuating means, and means for monitoring delivery of said drug supply through said catheter means.

17. The drug infusion system of claim 15 wherein said extracorporeal component further comprises means for overriding said first actuating means during operation of said second actuating means in response to said extracorporeal control means.

18. The drug infusion system of claim 17 wherein said extracorporeal component further comprises means for adjusting the drug dosage rate established by said first actuating means.

19. The drug infusion system of claim 15 wherein said extracorporeal component further comprises means for adjusting the drug dosage rate established by said first actuating means.

20. The drug infusion system of claim 15 wherein said implantable component further comprises pump means for supplying the drug from said reservoir to said catheter under control of one of said first and second actuating means, said pump means including a reciprocating pump element operated by solenoid means in response to one of said first and second actuating means, movement of said pump element in one direction drawing a drug supply from said reservoir into a pump chamber and movement of the pump element in the opposite direction causing the drug supply in the pump chamber to be delivered through said catheter means.

21. The drug infusion system of claim 20 wherein said extracorporeal component further comprises means for monitoring operation of said pump means.

22. The drug infusion system of claim 15 wherein said reservoir means includes means for maintaining a generally constant pressure within said reservoir regardless of the amount of drug supply within said reservoir, said extracorporeal component including means for monitoring the drug supply within said reservoir.

23. The drug infusion system of claim 22 wherein said uniform pressurizing means within said reservoir comprises an extensible and collapsible bellows, said bellows including capacitive means for producing a signal corresponding to the volume of said reservoir, said monitoring means in said extracorporeal component being adapted for receiving said signal.

24. The drug infusion system of claim 15 further comprising a drug outlet means arranged within said reservoir for permitting the drug to flow from the reservoir while trapping bubbles within said reservoir.

25. The drug infusion system of claim 24 wherein said drug outlet means comprises a tube extending into said reservoir and having an open end within said reservoir spaced slightly apart from a surface to prevent bubbles from entering said tube.

26. The drug infusion system of claim 25 wherein said tube is bent back upon itself so that the open end of the tube is spaced slightly apart from a surface portion of the tube.

27. The drug infusion system of claim 15 wherein said implantable component further comprises inlet means for permitting injection of a drug supply into said reservoir while the implantable component is within the body of the patient.

28. The drug infusion system of claim 27 wherein said inlet means includes a penetrable, self-sealing membrane for allowing injection of a drug supply into said reservoir and further comprising a check valve means in series with said membrane for preventing escape of the drug supply from said reservoir through said inlet means.

29. The drug infusion system of claim 15 wherein said reservoir means includes expansible and retractable means arranged therein for maintaining a generally uniform pressure within said reservoir when the drug supply within said reservoir is increased or decreased, said pressurizing means further being adapted to produce a sharp pressure rise within said reservoir when it is properly filled with a drug supply in order to produce a detectable pressure rise signal indicating that said reservoir is full.

30. The drug infusion system of claim 15 wherein said first actuating means is adapted for delivery of the drug from said reservoir means through said catheter at a basal rate, said second actuating means being responsive to said extracorporeal means for delivery of the drug from said reservoir through said catheter means at a bolus rate, said extracorporeal control means including means for overriding said first actuating means during operation of said second actuating means.