WO1992007614A1

WO1992007614A1 - Check valve for disposable pressure infusion system

Info

Publication number: WO1992007614A1
Application number: PCT/US1990/006302
Authority: WO
Inventors: Floyd V. Edwards; Scott H. Dewitt
Original assignee: Harmac Medical Products, Inc.
Priority date: 1990-11-01
Filing date: 1990-11-01
Publication date: 1992-05-14

Abstract

A check valve (38) for disposable pressure infusion systems (10) having an inflation bulb (30) with a single open end (46) includes a valve body (40) with a pair of intake ports (42) and a discharge port (44). Disposed at such single open end (46) of the inflation bulb (30), one of the intake ports permits a flow of pressurizing air from the inflation bulb (30) when squeezed to a pressure cuff (14) through flexible tubing (34) coupled to the discharge port (44). A single flapper member (50) in conjunction with opposed valve seats (52, 54) disposed at the other intake port and at the discharge port (44) form a flapper valve, such that the discharge port (44) will be closed when inflation bulb (30) is not squeezed and that the other intake port will be closed during squeezes of the inflation bulb (30).

Description

CHECK VALVE FOR DISPOSABLE PRESSURE INFUSION SYSTEM

Cross-Reference to Related Applications

This application is related to two copending applications Serial No. , filed

(Attorney's Docket No. HMED-3) and Serial No. , filed (Attorney's Docket No. HMED-4) , which are assigned to the same assignee and are incorporated herein by reference.

Background of the Invention

Field of the Invention

This invention relates generally to a pressure infusion system, and more particularly to check valves which are used with inflation bulbs in such systems. Statement of the Prior Art

Liquids administered by intravenous injection, such as whole blood, plasma, saline and dextrose solutions, are typically supplied in disposable infusion bags which are most often made of a flexible, transparent plastic having an outlet port or delivery tube which is adapted to be punctured by a coupler of a recipient set. In use, the infusion bag is suspended above the patient and the liquid contained therein is permitted to flow by gravity into the patient's vein. There are many situations, particularly when the infusion bag is nearly empty or in cases of severe hemorrhage and shock, where the administration of fluid by gravity flow with conventionally employed infusion bags is unacceptably slow.

Various pressure infusion apparatus have been used in the past to overcome such problems of slow delivery. See, for example, U.S. Patent No. 2,766,907, issued October 16, 1956 to Wallace, Jr.; U.S. Patent No. 3,153,414, issued October 20, 1964 to Beall et al.; U.S. Patent No. 4,090,514, issued May 23, 1978 to Hinck et al. ; U.S. Patent No. 4,507,116, issued March 26, 1985 to Leibinsohn; and U.S. Patent No. 4,735,613, issued April 5, 1988 to Bellin et al. Such known pressure infusion apparatus characteristically comprises bladder means for maintaining a fluid under pressure, means forming a pocket with the bladder means for holding an infusion bag against the bladder means for pressurizing the infusion bag by transmission of pressure from the pressurized bladder means to the infusion bag, and pressurization means which is coupled to the bladder means for introducing a flow of the fluid into the bladder means and thereby pressurizing same. A conventional inflation, or "squeeze" bulb is typically used as a pressurization means to minimize manufacturing costs.

One problem with such inflation bulbs is their tendency to leak and, therefore, their inability to maintain

^'pressure during use of the pressure infusion apparatus. Typically, inflation bulbs used with pressure infusion apparatus are of a "double-ended" type, such as the inflation bulbs which are shown in the above-referenced patents of Beall et al., Hinck et al., Leibinsohn and Bellin et al. These double-ended inflation bulbs are so called because they have one check valve at the distal end of the inflation bulb and another check valve at the proximal end of the inflation bulb. A squeezing of this type of inflation bulb simultaneously closes the distal end check valve while opening the proximal end check valve, and thereby creates a positive pressure for pumping air into the bladder means. When such inflation bulbs are released, the distal end check valve opens and the proximal end check valve closes to create a negative pressure until the inflation bulb is reinflated. Since the distal end check valve in such double-ended inflation bulbs is exposed to the ambient, it can be readily appreciated that these check valves may leak.

Summary of the Invention

Accordingly, it is a general object of this invention to provide a disposable pressure cuff which may be used in a pressure infusion system. It is a more particular object of this invention to provide improved pressurizing means for the disposable pressure cuffs.

Another object of this invention is to provide disposable pressure cuffs which are inexpensively manufactured and safely, yet easily used.

Still another object of this invention to provide a check valve for single-ended inflation bulbs which are used in disposable pressure cuffs.

Briefly, these and other objects according to the present invention are directed to pressure infusion apparatus of the type having an infusion bag, bladder means for maintaining a fluid under pressure, a single-ended inflation bulb for pumping a flow of fluid into the bladder means, and a pocket for disposing the infusion bag in contact with the bladder means such that the pressurizing fluid contained in the infusion bag is deliverable by pressure infusion. In order to maintain the flow of pressurizing fluid in a direction towards the bladder means, and at the same time preventing leakage of such fluid from the inflation bulb, the invention provides check valve means coupled to the single open end of the inflation bulb. The bladder means and pocket may comprise a conventional pressure cuff. One suitable such pressure cuff which is disposable is disclosed in the above-referenced copending application Serial No. , filed (Attorney's Docket No. HMED-4) . Connected to such pressure cuffs by flexible tubing, the single-ended inflation bulb with check valve means according to the present invention further comprises gauge means to indicate a range of pressures within the bladder means for monitoring administration of the fluid. Detailed information regarding such gauge means used in pressure infusion apparatus according to this invention can also be found in the above-referenced copending application Serial No. , filed (Attorney*s Docket No. HMED-3) .

Generally comprising a valve body having a pair of intake ports and a discharge port, wherein one of the intake ports couples to the single open end of the inflation bulb, the check valve means further comprises a first valve coupled to the other intake port and adapted to permit a flow of the fluid in a direction through such other intake port to the inflation bulb, and a second valve coupled to the discharge port and adapted to permit a flow of the fluid in a direction through the discharge port from the inflation bulb. In accordance with a preferred embodiment of this invention, such first and second valves each comprise a conventional duckbill valve. According to another embodiment of the present invention, such first and second valves each comprise a flapper or reed-type valve. By providing a single-ended inflation bulb with such check valve means, problems of leakage which have been experienced with prior art double- ended inflation bulbs are avoided and a reliable, yet disposable pressure infusion system is assured.

Other objects, advantages and novel features according to the present invention will become apparent from the following detailed description of the preferred embodiment, when considered in conjunction with the accompanying drawings wherein:

Brief Description of the Drawings Fig. 1 illustrates pressure infusion apparatus having a disposable pressure cuff and check valve means in accordance with the present invention; Fig. 2 is a sectional view of the check valve means shown in Fig. 1, taken along the lines 2-2; and Fig. 3 is a sectional view of a presently preferred check valve means according to the present invention.

Detailed Description of the Invention Referring now to the drawings, wherein identical numbers designate like or corresponding parts throughout the several views, there is shown in Fig. 1 pressure infusion apparatus 10 for use in pressurizing an infusion bag 12 with a disposable pressure cuff 14 according to the present invention.

As is well known, the typical infusion bag 12 is fitted with an outlet port 16 adapted to be punctured by a coupler 18 of a recipient set. Liquids, such as whole blood, plasma, saline or dextrose solutions, contained in the infusion bag 12 are supplied to the patient through intravenous injection by way of a delivery tube 20. The infusion bag 12 also conventionally includes a slit 22 for hanging the pressure infusion apparatus 10 from a hook 24, by way of a hanger 26 that is threaded through such slit 22. For the purpose of injecting a drug into the administered liquid, the infusion bag 12 may also be fitted with an injection port 28. The pressure infusion apparatus 10, as is conventional, includes bladder means for maintaining a fluid under pressure and means for pumping a flow of the fluid into the bladder means. As shown in Fig. 1, the pumping means comprises an inflation bulb 30 which is coupled to a pressure gauge 32 by way of flexible tubing 34. The pressure gauge 32,. in turn, couples to the bladder means by way of a pressurization port 36. It should be noted that such inflation bulb 30, unlike inflation bulbs which have been used in the prior art pressure infusion apparatus, is of the single-ended type. Accordingly, in order to maintain a flow of a pressurizing fluid from the inflation bulb 30 to the bladder means of pressure cuff 14, the inflation bulb 30 includes a check valve means 38 as described in greater detail herein below. Referring now to Fig. 2, it will be seen that the check valve means 38 according to one embodiment of the present invention generally comprises a valve body 40 with a pair of intake ports 42 and a discharge port 44, wherein one of the intake ports 42 couples to the single open end 46 of the inflation bulb 30. A first valve 48 is coupled to the other intake port 42, and is adapted to permit a flow of the pressurizing fluid in a direction through such other intake port 42 to the inflation bulb 30. Such first valve 48 also comprises a flapper 50 with an open position and a closed position, a valve seat 52 against which the flapper 50 is disposed while at the closed position for closing the other intake port 42, and a web 54 formed in the valve body 40 which prevents the flapper 50 from flapping any further than its open position to open the other intake port 42.

In a similar manner, a second valve 56 is coupled to the discharge port 44 and adapted to permit a flow of the pressurizing fluid in a direction through the discharge.port 44, from inflation bulb 30. Such second valve 56 comprises a flapper 50 with an open position and a closed position, a valve seat 52 against which the flapper 50 is disposed while at its closed position to close the discharge port 44, and web 54 which prevents the flapper 50 from flapping any further than its open position to open the discharge port 44. Valve body 40 is suitably formed in two parts, as shown in Fig. 2, from lightweight, low-cost, easily-formed plastic such as nylon, and flappers 50 comprise any elastomeric material having the resiliency to flex between open and closed positions, attached at one end to a slot 58 which is formed in the valve body 40. The valve body 40 is also bonded, both to the inflation bulb 30 and to the flexible tubing 34, by any conventional means such as an epoxy. In accordance with another embodiment of this invention, check valve means 38 also generally comprises a valve body 60 with a pair of intake ports 62 and a discharge port 64, as shown in Fig. 3. One of the intake ports 62 is also coupled to single open end 46 of the inflation bulb 30 in a similar manner as the embodiment shown in Fig. 2, and first valve 66 is coupled to the other intake port 62, adapted to permit a flow of the pressurizing fluid in a direction through such other intake port 62 to the inflation bulb 30. First valve 66 suitably comprises a "duckbill" type resilient member 68 which is bonded to the other intake port 42.

In a similar manner, a second valve 70 is coupled to the discharge port 64 and adapted to permit a flow of the pressurizing fluid in a direction through the discharge port 64, from inflation bulb 30. Such second valve 70 also comprises a duckbill resilient member 68. Valve body 60 is also suitably formed in two parts, as shown in Fig. 3, from lightweight, low-cost, easily-formed plastic such as nylon, and both duckbill resilient members 68 comprise any elastomeric material having the resiliency to flex between open and closed positions, attached to a slot 72 that is formed in the valve body 60. Valve body 60 is also bonded to the inflation bulb 30 and to the flexible tubing 34 by any conventional means such as epoxy.

Having described the details of construction of various check valve means 38 according to the present invention, operating details thereof are as follows. In a steady state where inflation bulb 30 is not squeezed, both flappers 50 shown in Fig. 2 and both duckbill resilient members 68 shown in Fig. 3 remain in the closed position.

When the inflation bulb 30 is squeezed, however, air is forced

^• through the intake port 42 or 62 that is disposed at single open end 46 of the inflation bulb 30, and the seals of first valve means 48, 66 are intensified thereby preventing any leakage of the pressurizing air from the inflation bulb 30 to pressure cuff 14 of Fig. 1.

In the presently preferred embodiment shown in Fig. 2, the flapper 50 of second valve means 56 is deflected to its open position by the air that is squeezed out of the inflation bulb 30. The flapper 50 is prevented from reaching an outgoing seal by the web 54, thus enabling the pressurizing air to flow in a direction through the discharge port 44. Similarly, the duckbill resilient member 68 of second valve means 70 shown in Fig. 3 is deflected to its open position by the air squeezed out of the inflation bulb 30, and thereby permitting the pressurizing air to flow in a direction through the discharge port 64. Under either set of circumstances, the pressurizing air which is forced through the discharge port 44, 64 will be transmitted to the pressure cuff 14 through the flexible tubing 34.

When the flow of pressurizing air from the inflation bulb 30 ceases, elastomeric qualities of the flapper 50 and the duckbill resilient member 68 of second valve means 56 or 70 will cause those members to their original closed positions. In the case of flapper 50 of second valve means 56, flapper 50 will return to its position against the seat 52. Duckbill resilient member 68 of second valve means 70 will, on the other hand, reform and close, thereby closing the discharge port 64. Pressures in the pressurized pressure cuff 14 will assure that such second valve means 56, 70 will stay closed under these circumstances.

After inflation bulb 30 is released, however, elastomeric memory of the inflation bulb 30 will create a suction at the intake port 42, 62 disposed at its single open end 46. This will not only enable the second valve means 56, 70 to be further sealed, but will also cause the first valve means 48, 66 to be opened. For example, the flapper 50 of second valve means 56 will be deflected open by air that is sucked into inflation bulb 30. This flapper 50 is also prevented from reaching an outgoing seal by the web 54, enabling air to flow in a direction through the intake port 42. Similarly, the duckbill resilient member 68 of second valve means 70 shown in Fig. 3 will be deflected open by the air sucked into the inflation bulb 30, thereby permitting the air to flow in a direction through the intake port 62. Under either set of circumstances, inflation bulb 30 will return to its normal position ready to be squeezed to further pressurize the pressure cuff 14.

Each squeeze of inflation bulb 30 is adapted to increase pressure within the pressure cuff 14 in a range of about twenty to forty millimeters of mercury. Such pressure increase will further seal the second valve means 56 or 70. Obviously, many modifications and variations are possible in light of the foregoing teachings. It should be understood that, within the scope of the appended claims, the present invention may be practiced otherwise than is specifically described herein.

Claims

What is claimed as our invention:

1. Pressure infusion apparatus for use with an infusion bag, comprising: bladder means for maintaining a fluid under pressure; an inflation bulb having a single open end for pumping a flow of said fluid into said bladder means; check valve means, attached to said single open end of said inflation bulb, for maintaining said flow of said fluid in a direction towards said bladder means; and a pocket for disposing the infusion bag in contact with said bladder means during pressurization thereof by said inflation bulb.

2. The pressure infusion apparatus according to claim 1, wherein said check valve means comprises a valve body having a pair of intake ports and a discharge port, one of said pair of intake ports coupled to said single open end of said inflation bulb.

3. The pressure infusion apparatus according to claim 2, wherein said check valve means further comprises: a first valve coupled to the other of said pair of intake ports and adapted to permit said flow of said fluid in a direction through said other intake port to said inflation bulb; and a second valve coupled to said discharge port and adapted to permit said flow of said fluid in a direction through said discharge port from said inflation bulb.

4. The pressure infusion apparatus according to claim 3, wherein said first valve comprises a duckbill valve.

5. The pressure infusion apparatus according to claim 3, wherein said second valve comprises a duckbill valve.

6. The pressure infusion apparatus according to claim 3, wherein said first valve comprises a flapper valve.

7. The pressure infusion apparatus according to claim 3, wherein said second valve comprises a flapper valve.

8. A check valve for use with a single-ended inflation bulb of a pressure infusion device, comprising: a unitary member having a pair of intake ports and a discharge port, a first of said pair of intake ports coupled to the single-ended inflation bulb for receiving a pressurizing flow of fluid therefrom; first valve means, coupled to a second of said pair of intake ports, for pressurizing the single-ended inflation bulb; and second valve means, coupled to said discharge port, for preventing depressurization of the pressure infusion device.

9. The check valve according to claim 8, wherein said first and second valve means each comprise a duckbill valve.

10. The check valve according to claim 8, wherein said first and second valve means each comprise a flapper valve.

11. The check valve according to claim 8, wherein -said first valve means is adapted to close said second intake port when the single-ended inflation bulb is squeezed.

12. The check valve according to claim 11, wherein said second valve means is adapted to open said discharge port when the single-ended inflation bulb is squeezed.

13. The check valve according to claim 8, wherein said first valve means is adapted to open said second intake port when the single-ended inflation bulb is released.

14. The check valve according to claim 13, wherein said second valve means is adapted to close said discharge port when the single-ended inflation bulb is released.

15. In pressure infusion apparatus of the type having an infusion bag, a bladder for maintaining a fluid under pressure, a single-ended inflation bulb which is connected to the bladder to pump a flow of the fluid into the bladder and thereby pressurizing same, and a pocket for holding the infusion bag in contact with the bladder to pressurize the infusion bag by transmission of pressure from the bladder, the improvement comprising: a valve body having a first intake port coupled to receive the flow of fluid from the single-ended inflation bulb, a second intake port, and a discharge port coupled to the bladder; a first check valve at said second intake port; and a second check valve at said discharge port.

16. The improvement according to claim 15, wherein said first check valve comprises: a flapper having an open position and a closed position; a valve seat against which said flapper is disposed in its closed position to close said second intake port; and means for preventing said flapper from flapping any further than its open position to open said second intake port.

17. The improvement according to claim 15, wherein said second check valve comprises: a flapper having an open position and a closed position; a valve seat against which said flapper is disposed in its closed position to close said discharge port; and means for preventing said flapper from flapping any further than its open position to open said discharge port.

18. The improvement according to claim 15, wherein said first check valve comprises a duckbill valve that is adapted to be closed when the single-ended inflation bulb is squeezed and opened during release and subsequent repressurization of the single-ended inflation bulb.

19. The improvement according to claim 15, wherein said second check valve comprises a duckbill valve that is adapted to be opened when the single-ended inflation bulb is squeezed and closed during release and subsequent repressurization of the single-ended inflation bulb.