System and apparatus for the patient-controlled delivery of a beneficial agent, and set therefor

• US 5,061,243 A
• Filed: 02/08/1989
• Issued: 10/29/1991
• Est. Priority Date: 08/06/1985
• Status: Expired due to Term

• Current Assignee: Baxter International Inc.
• Original Assignee: Baxter International Inc.
• Inventors: Mitchell, Richard, Fowles, Thomas A., Winchell, David A.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US07/308,972
• Time in Patent Office: 993 Days
• Field of Search: 604/93, 604/132, 604/185, 604/891.1, 604/892.1, 604/153, 604/246
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 5/1424 Manually operated pumps
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body

Abstract

An apparatus (60) and system (20) are disclosed for the patient-controlled delivery of an analgesic or other beneficial agent 142, while preventing administration of a toxic quantity of the beneficial agent. The invention permits delivery of fractional doses to a patient in quantities which are directly proportional to the time period since the last dose or fraction thereof was delivered to the patient. In the preferred embodiments the apparatus includes a housing (58) including a casing (88) and a back plate (86), the housing containing a control switch (84) for opening and closing downstream conduit (62) and for depressing a floating plate (100) that thereby compresses a dose reservoir (90) with the beneficial agent (142) therein. A spring (124) biases the control switch (84).

Claims

1. A system for the patient-controlled delivery of a beneficial agent, comprising:

(a) supply means for storing the beneficial agent;

(b) conduit means for transporting the beneficial agent from the supply means to a dose reservoir;

(c) pump means for expressing the beneficial agent out of the supply means through the conduit means and into a dose reservoir at a controlled rate;

(d) a dose reservoir for receiving a dose of beneficial agent from the supply means;

(e) control means operative by the patient for selectively expressing the beneficial agent out of said dose reservoir, through an outlet thereof, in at least one of discrete dose volumes or fractional dose volumes, as selected by the patient; and

(f) excess dose prevention means for supplying the beneficial agent to the dose reservoir at a predetermined flow rate that fills the volume of the dose reservoir substantially linearly with time up to the discrete dose volume;

(g) wherein said system is patient-wearable and permits the patient to be ambulatory.

2. The system in accordance with claim 1, wherein said supply means and said pump means comprise an expandable, elastomeric, self-pressurized bladder for storing and pumping the beneficial agent.

3. An apparatus for the patient-controlled delivery of a beneficial agent comprising:

(a) a dose reservoir for receiving and storing a dose of beneficial agent;

(b) an inlet to said dose reservoir, for receiving the beneficial agent under pressure;

(c) an outlet to said dose reservoir, through which beneficial agent in said dose reservoir exits said dose reservoir;

(d) downstream passageway means having a proximal end in communication with said outlet; and

(e) control means operative by the patient for selectively expressing the beneficial agent out of said dose reservoir, through said outlet, said control means comprising

(i) valve means having a closed mode of operation whereby said downstream passageway means is closed and an open mode of operation whereby said downstream passageway means is open, permitting flow of the beneficial agent therethrough;

(ii) biasing means for biasing said valve means in said closed operating mode;

(iii) dose reservoir compression means for compressing said dose reservoir; and

(iv) a control switch operatively connected to said valve means, said biasing means, and said compression means, such that the force of actuation of said control switch by the patient overcomes said biasing means and places said valve means in said open mode of operation, the force of actuation of said control switch also causing said control switch to operatively engage said compression means to reduce the volume of said dose reservoir and express the beneficial agent out of said dose reservoir and said outlet while said valve means is in said open mode of operation;

(f) wherein said apparatus may be worn by the patient and permits the patient to be ambulatory.

4. The apparatus in accordance with claim 3, wherein said dose reservoir comprises an upper volume limit substantially equal to a dose volume.

5. The apparatus in accordance with claim 3, including downstream conduit secured at one end to said outlet and having a distal end adaptable for securement to an intravenous catheter.

6. The apparatus in accordance with claim 3, wherein said control means may be repeatedly actuated by the patient, said control means permitting the delivery of multiple doses of the beneficial agent to the patient at a controlled delivery rate.

7. The apparatus in accordance with claim 3, further comprising a housing for said dose reservoir and said control means.

8. The apparatus in accordance with claim 3, wherein said control switch overcomes said biasing means and urges said valve means into said open mode before said control switch actuates said compression means, so that said compression means does not urge the beneficial agent out of said drug reservoir until after said valve means is in said open mode of operation.

9. The apparatus in accordance with claim 3, wherein said biasing means comprises a spring.

10. The apparatus in accordance with claim 3, wherein said downstream passageway means includes a downstream apparatus conduit having a flexible wall portion and wherein said valve means comprises a conduit occlusion bar which in said closed mode of operation is urged by said biasing means against said flexible wall portion, compressing said wall together to occlude said conduit.

11. The apparatus in accordance with claim 10, wherein said conduit occlusion bar and said control switch form an integral, rigid part.

12. The apparatus in accordance with claim 3, wherein said dose reservoir compression means comprises:

(a) a floating plate;

(b) a stop engaged by said floating plate upon expansion of said dose reservoir to a certain, predetermined maximum volume, said stop and said floating plate together preventing further expansion of said dose reservoir;

(c) whereby patient-actuation of said control switch engages said floating plate and, when said drug reservoir is filled to its maximum volume, also disengages said floating plate from said stop.

13. The apparatus in accordance with claim 12, further comprising:

(a) at least one volume indicator peg extending from said floating plate on said control switch side thereof; and

(b) a housing for said dose reservoir and said control means, said housing defining an opening for said control switch, wherein said peg is visible through said opening when said dose reservoir is full.

14. The apparatus in accordance with claim 13, wherein a portion of said peg is external of said housing when said dose reservoir is full.

15. The apparatus in accordance with claim 13, said defined opening defining a slot for each peg wherein said slot guides the travel of said floating plate to maintain said floating plate parallel to said back plate.

16. The apparatus in accordance with claim 3, further comprising a housing for said dose reservoir and said control means.

17. The apparatus in accordance with claim 3, wherein:

(a) said dose reservoir has one wall defined by said housing and further includes a flexible sheet;

(b) said dose reservoir further comprising pressure seal structure in said housing for pressing said flexible sheet adjacent its periphery against said reservoir-defining wall of said housing, creating a liquid-tight seal therebetween.

18. The apparatus in accordance with claim 3, wherein said dose reservoir comprises chamber-defining sidewalls forming a chamber closed except for said inlet and said outlet, wherein at least a portion of one of said sidewalls may be pressed against the opposite sidewall by said compression means.

19. The apparatus in accordance with claim 18 wherein said apparatus permits said dose reservoir to be removed from said housing and replaced with another one of said dose reservoirs.

20. The apparatus in accordance with claim 3, further comprising upstream passageway means having a distal end in communication with said inlet.

21. The apparatus in accordance with claim 3, further comprising said control means for permitting delivery of fractional doses of the beneficial agent to the patient.

22. The apparatus in accordance with claim 3, further comprising said control means for preventing delivery of a quantity of beneficial agent to the patient in excess of the dose volume within a preselected time period.

23. An apparatus for patient controlled delivery of an agent comprising:

a dose reservoir in fluid communications with an outlet and an inlet, the dose reservoir having a maximum capacity which represents the discrete dose limit to be administered to the patient;

excessive dose prevention means for supplying a predetermined flow rate of the agent to the dose reservoir such that after a predetermined fill time the dose reservoir is filled to maximum capacity;

valve means having a closed mode of operation whereby the outlet is closed and an open mode of operation whereby the outlet is open, permitting flow of the beneficial agent therethrough;

biasing means for biasing the valve means in the closed operating mode;

dose reservoir compression means for compressing the dose reservoir; and

a control switch operatively connected to the valve means, the biasing means, and the dose reservoir means such that the force of actuation of the control switch overcomes the biasing means and places the valve means in the open mode of operation, the force of actuation of the control switch also causing the control switch to operatively engage the compression means to reduce the volume of the dose reservoir and express the beneficial agent out of the dose reservoir and the outlet while the valve means is in the open mode of operation;

whereby operation of the valve means prior to the fill time results in an amount of agent less than the discrete dose maximum being administered to the patient.

24. The apparatus of claim 23 wherein the predetermined flow rate causes the volume of agent in the dose reservoir to increase substantially linearly with time up to the maximum capacity of the dose reservoir.

25. The apparatus of claim 23, further including a supply means for storing the beneficial agent and pump means in fluid communications with the supply means and the inlet for expressing the agent from the supply means to the dose reservoir.

26. The apparatus of claim 25 wherein the supply means and the pump means comprise on expandable, elastomeric, self pressurized bladder for storing and pumping the agent.

27. The apparatus of claim 25, wherein the supply means and the pump means comprises a source of pressurized fluid for storing and pumping the agent.

28. The apparatus of claim 23, further including a downstream conduit secured at one end to the outlet and having a distal end adaptable for securement into an intravenous catheter.

29. The apparatus of claim 23, wherein the dose reservoir is removable.

30. The apparatus of claim 23, further including housing containing the apparatus and wrist band portions connected to the housing so that the apparatus can be worn in the manner of a watch.