Large volume bolus device and method

• US 20030040722A1
• Filed: 06/03/2002
• Published: 02/27/2003
• Est. Priority Date: 06/01/2001
• Status: Active Grant

• Current Assignee: Avent Incorporated (Avanos Medical, Inc.)
• Original Assignee: I-Flow Corporation (Kimberly-Clark Corporation)
• Inventors: Massengale, Roger Dillard, Rake, Kenneth W., Mabry, Eric
• Granted Patent: US 6,981,967 B2
• Time in Patent Office: Days
• US Class Current: 604/255
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 5/1424 Manually operated pumps
• CPC Class Codes: A61M 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061

Abstract

A device and method for the infusion of medicinal fluid at a controlled flow rate to a wound site or the blood stream of a patient is disclosed. A pump delivers fluid under pressure from a fluid source through a continuous and substantially constant flow path and through a supplemental bolus dose flow path. A large volume bolus dose reservoir accumulates a large quantity of fluid from the bolus dose flow path and holds the fluid under pressure. A flow regulator controls the fill rate of the large volume bolus reservoir. The large volume supplemental bolus dose is released from the bolus reservoir upon patient activation of a valve. The release rate of the bolus dose is controlled by the decompression of an elastomeric sphere or spring chamber, by the pressure gradient at the valve and/or by optional flow control tubing. In one embodiment, a source of fluid under pressure is pumped at a continuous and substantially constant rate to a wound site or the blood stream of a patient and into a bolus syringe, which is capable of holding a large quantity of fluid under pressure. A plunger on the bolus syringe may be depressed to release a bolus dose of fluid into a chamber accumulator and then to the patient at a controlled release rate.

Claims

1. A device for dispensing fluid to a patient comprising:

a source of fluid under pressure;

a bolus flow path for the delivery of a bolus dose of fluid;

a large volume bolus reservoir in fluid communication with said bolus flow path, said reservoir being configured to expand, store and dispense fluid under pressure; and

a patient operable actuator to release fluid from the reservoir, said actuator being configured such that it does not require effort to force the fluid out of the reservoir and that when actuated by the patient, fluid is permitted to flow out of the reservoir to the patient without further action by the patient.

2. The device of claim 1, including a continuous flow path from the source providing a continuous and substantially constant flow rate of fluid, and wherein the continuous flow path and bolus flow path are in fluid communication with the source of fluid.

3. The device of claim 2, including a flow regulator which sets the flow rate through the continuous flow path into the patient.

4. The device of claim 2, wherein said paths converge into a single path downstream from said valve.

5. The actuator of claim 2, wherein the continuous flow path further comprises an adjustable flow regulator.

6. The device of claim 2, wherein the continuous flow path further comprises an adjustable flow regulator for the manual adjustment to 1-5 cc'"'"'s of fluid per hour.

7. The device of claim 1, including a flow regulator which sets the flow rate of fluid through the bolus flow path.

8. The device of claim 1, wherein said bolus reservoir comprises an elastomeric chamber for holding a bolus volume of fluid under pressure to be delivered on demand at a controlled rate to a patient.

9. The device of claim 1, wherein said reservoir includes a spring which provides the pressure delivering fluid to the patient.

10. The device of claim 1, wherein said reservoir includes a chamber and a spring urging a back plate to keep the fluid in the chamber under pressure.

11. The device of claim 1, wherein said actuator comprises a patient operated valve downstream from said chamber.

12. A device for dispensing fluid to a patient comprising:

a source of fluid under pressure;

a large volume bolus chamber in fluid communication with said source;

a plunger for forcing fluid out of said chamber; and

an accumulator downstream from said chamber to accumulate fluid forced out of said chamber by said plunger, said accumulator being configured to expand to receive fluid and to dispense fluid to the patient.

13. The device of claim 12, further comprising a lockout orifice for preventing the backflow of fluid from traveling upstream from said syringe.

14. The device of claim 12, further comprising a valve between the accumulator and the bolus chamber for allowing a flow of fluid downstream at a continuous and substantially constant rate to the patient and for channeling a flow of fluid into said bolus chamber,

15. The device of claim 12, further comprising a check valve between the accumulator and the bolus chamber which will not open until a predetermined pressure is applied to it, and which prevents the flow of fluid upstream from said accumulator.

16. The device of claim 15, wherein said predetermined pressure is greater than the pressure of the fluid filling said bolus chamber.

17. The device of claim 12, further comprising flow control tubing downstream from the accumulator.

18. The device of claim 12, wherein the accumulator is housed in a container which limits expansion of the elastomeric chamber.

19. The device of claim 12, wherein the bolus chamber is capable of holding approximately 10 cc'"'"'s of fluid.

20. A method of introducing fluid to a nerve bundle or the blood stream of a patient, comprising the step of:

providing a catheter to a nerve bundle or the blood stream of a patient;

providing a bolus flow path for delivering a large volume bolus dose of fluid to the patient;

providing a bolus reservoir in fluid communication with said bolus flow path, said bolus reservoir being configured to expand, store and dispense fluid under pressure; and

providing a patient operable actuator to release the large volume bolus dose to the patient without the patient applying pressure to the fluid.

21. The method of claim 20, including the step of providing a flow path for a continuous flow of fluid to the nerve bundle or the blood stream of a patient.

22. The method of claim 21, including the step of providing a flow regulator in the bolus dose flow path leading to the bolus regulator.

23. The method of claim 21, including the step of providing an adjustable flow regulator in the continuous and substantially constant flow path.

24. The method of claim 20, including the step of providing a bolus reservoir in the form of an elastomeric chamber for holding fluid under pressure.

25. The method of claim 20, including the step of providing a spring configured to provide a pressurized bolus volume from said reservoir to be delivered at a controlled rate to a patient.

26. The method of claim 20, further including the step of providing a wall of the bolus reservoir and a spring urging a back plate to keep the fluid in the chamber under pressure.

27. The method of claims 20, wherein said actuator providing step includes providing a patient operable valve downstream of said reservoir for releasing said bolus dose without further effort by the patient.

29. The method of claim 27, including the step of providing a lockout orifice for preventing the flow of fluid from the chamber to the source of fluid.

30. The method of claim 27, including the step of providing flow control tubing downstream from the accumulator.

31. The method of claim 27, including the step of providing a valve downstream from the bolus chamber that will not open until fluid is dispensed from the chamber.

33. The method of claim 27, wherein the chamber is capable of holding 10 cc'"'"'s of fluid.

34. The method of claim 27, wherein the chamber is capable of holding 30 cc'"'"'s of fluid.

35. The method of claim 27, wherein the chamber is capable of holding about 20 cc'"'"'s of fluid.

28. A method of introducing fluid to a patient, comprising the steps of:

providing a source of fluid under pressure;

providing a large volume bolus chamber;

providing a plunger in said chamber for dispensing the fluid in the syringe; and

providing an expandable accumulator for controlling the release rate of fluid from the chamber to the patient.

32. The method of claim 28, including the step of providing a container for housing the accumulator and limiting its expansion.