Large volume bolus device and method

• US 6,981,967 B2
• Filed: 06/03/2002
• Issued: 01/03/2006
• 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): Lucchesi, Nicholas D.
• Assistant Examiner(s): Maiorino, Roz
• Application Number:
  US10/162,089
• Publication Number:
  US 20030040722A1
• Time in Patent Office: 1,310 Days
• Field of Search: 604 80-518, 606/236, 215 111- 116, 215/12.2
• US Class Current: 604/174
• 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 first reservoir configured to provide 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 and configured to receive fluid from said first reservoir, said bolus reservoir being configured to elastically expand to pressurize fluid, store the pressurized fluid and dispense the pressurized fluid; and

a patient operable actuator to release fluid from the bolus reservoir, said actuator being configured such that it does not require effort to force the fluid out of the bolus reservoir and that when actuated by the patient, fluid is permitted to flow out of the bolus 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.

18. The device of claim 1, wherein said bolus reservoir comprises a spring-biased piston.

9. A device for dispensing fluid to a patient, comprising:

a fluid pump configured to supply a source of fluid under pressure;

a continuous flow path in communication with the fluid pump, the continuous flow path configured to deliver a continuous dose of fluid;

a manually-adjustable flow regulator configured to regulate a flow rate within the continuous flow path;

a bolus flow path in communication with the fluid pump, the bolus flow path configured to deliver a bolus dose of fluid;

a bolus reservoir in communication with the bolus flow path, the bolus reservoir configured to receive and store fluid from said fluid pump and selectively permit fluid to be dispensed; and

a patient operable actuator configured to dispense fluid from the bolus reservoir.

10. The device of claim 9, wherein the flow regulator is a valve including a dial to permit adjustment of a flow rate through the flow regulator.

11. The device of claim 10, wherein the flow regulator includes a display configured to indicate a flow rate of fluid through the flow regulator.

12. The device of claim 9, wherein the flow regulator permits adjustment of a flow rate through the flow regulator of between about 1 and 5 cc'"'"'s of fluid per hour.

13. The device of claim 9, wherein the bolus reservoir comprises an expandable, elastomeric reservoir member.

14. The device of claim 9, wherein the bolus reservoir comprises a spring-biased piston.

15. The device of claim 9, wherein the actuator comprises a valve.

16. The device of claim 9, wherein the actuator comprises a syringe.

17. The device of claim 16, additionally comprising a check valve within the bolus flow path, between the syringe and the bolus reservoir.