Large volume bolus device and method

• US 7,815,604 B2
• Filed: 12/29/2005
• Issued: 10/19/2010
• Est. Priority Date: 06/01/2001
• Status: Expired due to Term

• Current Assignee: Avent Incorporated (Avanos Medical, Inc.)
• Original Assignee: I-Flow Corporation (Kimberly-Clark Corporation)
• Inventors: Massengale, Roger Dillard, Rake, Kenneth W., Mabry, Eric
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew M
• Application Number:
  US11/321,197
• Publication Number:
  US 20060106367A1
• Time in Patent Office: 1,755 Days
• Field of Search: 604131-135, 604151-153, 604 65- 67, 604/6.11, 604/892.1
• US Class Current: 604/132
• 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 method of introducing fluid to a nerve bundle or the blood stream of a patient, comprising:

positioning a catheter adjacent a nerve bundle or into the blood stream of a patient;

delivering a continuous flow of fluid to the catheter from a first reservoir, said first reservoir comprising a source of fluid under pressure;

delivering fluid from the first reservoir to an expandable bolus reservoir, which is in the form of an elastomeric chamber for holding fluid under pressure, using pressure from said first reservoir to expand and fill the bolus reservoir, the bolus reservoir being in fluid communication with a bolus flow path, the bolus flow path comprising a flow path from the bolus reservoir to the patient; and

releasing a large volume bolus dose from the bolus reservoir in response to actuation of a patient operable mechanical actuator utilizing the stored energy of the expanded bolus reservoir such that the large volume bolus dose is delivered to the patient without requiring manual effort to force the fluid out of the bolus reservoir, said actuation of said actuator and release of said large volume bolus dose being accomplished in a purely mechanical manner;

wherein said actuator is configured such that, once actuated, said large volume bolus dose is released without requiring further effort to keep releasing the large volume bolus dose from the bolus reservoir until said bolus reservoir is substantially empty.

2. The method of claim 1, further comprising providing a flow regulator in the bolus flow path upstream from the bolus reservoir, wherein the bolus flow path further comprises a flow path from the first reservoir to the bolus reservoir.

3. The method of claim 1, further comprising providing an adjustable flow regulator in the continuous flow path.

4. The method of claim 1, further comprising providing a spring configured to provide a pressurized bolus volume from the bolus reservoir to be delivered at a controlled rate to a patient.

5. The method of claim 1, further providing a movable wall within the bolus reservoir and a spring urging the movable wall to keep the fluid in the bolus reservoir under pressure.

6. The method of claim 1, wherein the patient operable actuator is a patient operable valve downstream of the bolus reservoir for releasing the large volume bolus dose without further effort by the patient.

7. The method of claim 1, further comprising stopping said release of said bolus dose following said actuation to allow said bolus reservoir to refill.

8. The method of claim 1, wherein said actuator is configured to stop said release of said bolus dose automatically following said actuation.

9. The method of claim 8, wherein said actuator comprises a valve configured to provide a timed release of said large volume bolus dose.

10. The method of claim 8, wherein said actuator comprises a pressure responsive valve, said valve configured to remain open following actuation until a pressure of fluid in the bolus reservoir drops to a predetermined level, said valve configured to close when said pressure reaches said predetermined level.

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

positioning a catheter adjacent a nerve bundle or into the blood stream of a patient;

delivering a continuous flow of fluid to the catheter from a first reservoir, said first reservoir comprising a source of fluid under pressure;

delivering fluid from the first reservoir to an expandable bolus reservoir using pressure from said first reservoir to expand and fill the bolus reservoir, the bolus reservoir being in fluid communication with a bolus flow path, the bolus flow path comprising a flow path from the bolus reservoir to the patient; and

releasing a large volume bolus dose from the bolus reservoir in response to actuation of a patient operable mechanical actuator utilizing the stored energy of the expanded bolus reservoir such that the large volume bolus dose is delivered to the patient without requiring manual effort to force the fluid out of the bolus reservoir, said actuation of said actuator and release of said large volume bolus dose being accomplished in a purely mechanical manner;

wherein the patient operable mechanical actuator is a patient operable valve downstream of the bolus reservoir for releasing the large volume bolus dose without further effort by the patient; and

wherein said actuator is configured such that, once actuated, said large volume bolus dose is released without requiring further effort to keep releasing the large volume bolus dose from the bolus reservoir until said bolus reservoir is substantially empty.

12. The method of claim 11, further comprising providing a flow regulator in the bolus flow path upstream from the bolus reservoir, wherein the bolus flow path further comprises a flow path from the first reservoir to the bolus reservoir.

13. The method of claim 11, further comprising providing an adjustable flow regulator in the continuous flow path.

14. The method of claim 11, further comprising providing the bolus reservoir in the form of an elastomeric chamber for holding fluid under pressure.

15. The method of claim 11, further comprising providing a spring configured to provide a pressurized bolus volume from the bolus reservoir to be delivered at a controlled rate to a patient.

16. The method of claim 11, further providing a movable wall within the bolus reservoir and a spring urging the movable wall to keep the fluid in the bolus reservoir under pressure.

17. The method of claim 11, further comprising stopping said release of said bolus dose following said actuation to allow said bolus reservoir to refill.

18. The method of claim 11, wherein said actuator is configured to stop said release of said bolus dose automatically following said actuation.

19. The method of claim 18, wherein said actuator comprises a valve configured to provide a timed release of said large volume bolus dose.

20. The method of claim 18, wherein said actuator comprises a pressure responsive valve, said valve configured to remain open following actuation until a pressure of fluid in the bolus reservoir drops to a predetermined level, said valve configured to close when said pressure reaches said predetermined level.