WO1995021641A1

WO1995021641A1 - Valve apparatus

Info

Publication number: WO1995021641A1
Application number: PCT/US1995/001953
Authority: WO
Inventors: Daniel A. Summers; Howard Levy
Original assignee: Summers Daniel A; Howard Levy
Priority date: 1994-02-14
Filing date: 1995-02-14
Publication date: 1995-08-17
Also published as: EP0808186A4; EP0808186A1; AU1845295A

Abstract

The valve (10) comprises a valve body (12) having three apertures (14), (16), (18) and a bypass passageway (20). Furthermore, the valve (10) has a movable valve member (24) with truncated end portions (24''), (24''') that move linearly within the valve body (12).

Description

VAIiVE APPARATUS

BACKGROUND OF THE INVENTION

Field of the Invention (Technical Field) :

The invention relates to paracentesis and lavage valves operable solely by mechanical (including magnetic) and hydraulic forces; and a method for using such valves.

Background Art:

Previously, the medical procedure for irrigation or lavage of organs, joints or cavities required manual manipulation of a three-way valve. Together, with the requisite needle, syringe, vacuum source and tubing, the three-way valve would first be manually manipulated to direct the laving fluid into the patient; then again manually manipulated to allow expulsion of the fluid from the patient. The disadvantages of this procedure include patient discomfort, improper valve manipulation, valve jamming (as with gloves, etc.) and the risk of torn gloves and subsequent infection.

The medical procedure known as paracentesis is tedious and potentially dangerous. The procedure normally entails insertion of a syringe or trocar into a body cavity, for example the thoracic or abdominal cavities and subsequent fluid removal or drainage from such cavity.

Paracentesis procedures in the past normally required a manually operated three-way valve. Moving the valve lever in a predetermined direction enabled withdrawal of fluid into a syringe barrel; moving the lever in another direction enabled voiding and expulsion of fluid from the syringe barrel into a receptacle. The disadvantages of this procedure include patient discomfort, improper valve manipulation, valve jamming, and the risk of torn gloves and subsequent infection.

The following U.S. patents are exemplary of the prior art valves and procedure: U.S. Patent No. 4,844,087 to Garg, entitled First Method for Using Cannula Including a Valve Structure and Associated Instrument Element; U.S. Patent No. 4,447,235 to Clarke, entitled Thoracentesis Device; U.S. Patent No. 4,784,156 to Garg, entitled Cannula Including a Valve Structure and Associated Instrument Elements and Method for Using Same; U.S. Patent No. 4,840,184 to Garg, entitled Second Method for Using Cannula Including a Valve Structure and Associated Instrument Elements; and U.S. Patent No. 4,832,044 to Garg, entitled Cannula Including a Valve Structure and Associated Instrument Elements . U.S. Patent No. 3,957,052, to Topham, entitled Pumping-Syringe , discloses a T-passageway valve configuration for withdrawing and pumping fluids. Ball check valves are used. Similarly, U.S. Patent No. 4,051,852, to Villari, entitled Aspirating Device, discloses ball, flap and cylindrical check valve member embodiments for withdrawing body fluids and thereafter pumping them into suitable collection bags. U.S. Patent No. 657,440 to McCaw, entitled Aspirator, discloses similar structure.

U.S. Patent No. 3,515,163 to Freeman, entitled Respiratory

Apparatus does disclose a respiratory valve with a sliding valve member. The sliding valve member, however, is magnetically biased, and flow occurs through centrally located orifices in the sliding valve member. U.S. Patent No. 3,877,616, to Stevens, entitled Pump With Unitary Valve Member, discloses a reciprocating valve member with upper and lower resilient check valves. U.S. Patent No. 4,592,382, to Rubin, et al . , entitled Anti-SipΛon Nozzle, discloses an unbiased slidable valve member.

U.S. Patent No. 4,246,932, to Raines, entitled Multiple

Additive Valve Assembly; and U.S. Patent No. 4,729,401, to Raines, entitled Aspiration Assembly Having Dual Co-Axial Check Valves, both disclose pumping devices for medical fluids employing resilient disk check valves. U.S. Patent No. 2,567,391 to Mead, entitled Exhaust Valve Structure also discloses a resilient valve member.

It is seen that none of the above references disclose a biased slidable valve member operable solely by mechanical (or magnetic) and hydraulic force to first direct laving or irrigating fluid into the patient, then automatically withdrawing such fluid. Likewise, it is seen that none of the above references disclose a biased slidable valve member operable solely by hydraulic force to first withdraw fluid from the patient, then allow such fluid to be automatically voided into a receptacle.

SUMMARY OF THE INVENTION (DISCLOSURE OF THE INVENTION)

In accordance with the present invention there is provided a valve apparatus. The valve apparatus comprises a valve body. The valve body comprises first, second and third orifices and a bypass passageway. A valve member comprising first and second end portions is movable within the valve body.

For the paracentesis valve, application of negative hydraulic pressure to the first end portion of the moveable valve member causes fluid flow through the first and second orifices and the bypass passageway while closing the third orifice. Application of positive hydraulic pressure to the first end portion of the valve member causes fluid flow through the first and third orifices while closing the second orifice and the bypass passageway. The bypass passageway comprises an aperture and a pressure relief valve is disposed in the aperture. A check valve is disposed in the aperture. A check valve is disposed in the third orifice.

In accordance with the present invention there is provided a method for using a valve comprising the steps of providing a valve body comprising first, second and third orifices and a bypass passageway; providing a valve member comprising first and second end portions, and moveable in the valve body. For the paracentesis valve, the method moves the valve member solely by hydraulic pressure. Applying negative hydraulic pressure to the first end of the movable valve member forces fluid through the first and second orifices while closing the third orifice. Applying positive hydraulic pressure to the first end of the movable valve member forces fluid through the first and third orifices while closing the second orifice and the bypass passageway.

For the lavage valve, the method further comprises a cylindrical center portion, and the first and second end portion comprise first and second truncated cone end portions. The valve body comprises a hollow central portion complementary in configuration to the valve member.

For the lavage valve, the structure for biasing the valve member comprises structure for biasing the valve member into occluding the first orifice and bypass passageway while opening the second and third orifices. The biasing structure may comprise a helical spring, an annular spring or magnets structure. Applying pressure to the first end portion opens the first orifice and bypass passageway while occluding the third orifice. The structure for applying pressure comprises structure for applying hydraulic pressure, thereby directing fluid flow through the first and second orifices and the bypass passageway. The bypass passageway comprises an aperture and a pressure relief valve or a pressure gauge is disposed in the aperture.

A primary object of the present invention is the provision of a hydraulically operated paracentesis valve.

Another primary object of the present invention is the provision of a hydraulically and mechanically operated lavage valve. Yet another object of the invention is the provision of paracentesis valves which reduce patient discomfort and the possibility of operator error.

Still another object of the invention is the provision of improved methods for valve procedures.

An advantage of the present invention is the elimination of manual manipulation of a three-way valve.

Another advantage of the present invention is the lessening of time, effort and fatigue in performing paracentesis and lavage procedures.

Still another advantage of the present invention is the provision of safe and efficient valve methods.

Other objects, advantages and novel features, and further scope of applicability of the present invention will be set forth in part in the detailed description to follow, taken in conjunction with the accompanying drawings, and in part will become apparent to those skilled in the art upon examination of the following, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and attained by means of the instrumentalities and combinations particularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and form a part of the specification, illustrate several embodiments of the present invention and, together with the description, serve to explain the principles of the invention. The drawings are only for the purpose of illustrating a preferred embodiment of the invention and are not to be construed as limiting the invention. In the drawings:

Fig. 1 is a cross-section of the preferred paracentesis embodiment of the invention with negative hydraulic pressure applied;

Fig. 2 is a cross-section of the preferred paracentesis embodiment of the invention with positive hydraulic pressure applied; Fig. 3 is a perspective view of a pressure relief valve usable in combination with the preferred paracentesis embodiment;

Fig. 4 is a perspective view of a pressure gauge usable in combination with the preferred paracentesis embodiment;

Fig. 5 is a cross-section of the preferred lavage embodiment of the invention with hydraulic pressure applied;

Fig. 6 is a cross-section of the preferred lavage embodiment of the invention with mechanical force applied;

Fig. 7 is a cross-section of another lavage embodiment of the invention;

Fig. 8 is a cross-section of yet another lavage embodiment of the invention;

Fig. 9 is a cross-section of still another lavage embodiment of the invention;

Fig. 10 is a perspective view of a pressure relief valve usable in combination with the Fig. 9 embodiment; and

Fig. 11 is a perspective view of a pressure gauge usable in combination with the Fig. 9 embodiment.

DESCRIPTION OF THE PREFERRED EMBODIMENTS (BEST MODES FOR CARRYING OUT THE INVENTION)

PARACENTESIS VALVE

Reference is now made to Figs. 1 and 2 which show the preferred paracentesis embodiment of the invention. Paracentesis valve 10 comprises valve body 12. Valve body 12 further comprises first, second and third orifices 14, 16 and 18, as well as orifice extensions 14', 16', and 18', respectively. Valve body 12 further comprises bypass passageway 20 which bypasses central cavity 22 and interconnects orifices 14 and 16.

Valve member 24 is positioned within central cavity 22, complementary in configuration to valve member 24 for linear movement therein. Valve member 24, complementary in shape to central cavity 22, comprises cylindrical center portion 24' and truncated cone end portions 24'' and 24''', respectively. End portions 24'' and 24''' seat within orifices 14 and 16, respectively, of valve body 12, thereby occluding such orifices. Further, when valve member 24 is in position to occlude orifice 14, orifice 18 is also sealed. Concomitantly, orifice 16 and bypass passageway 20 are also simultaneously occluded when valve member 24 is in its leftmost position (see Fig. 2).

Orifice 18 (and orifice extension 18') are coupled to a receptacle or sump (not shown).

Valve 10 may comprise any suitable material compatible with its contemplated medical use. Accordingly, valve 10 may comprise any suitable plastic, stainless steel, aluminum and other such materials known to those ordinarily skilled in the art. If plastics are used, self-lubricating plastics such as nylon or PTFE are preferred in order to facilitate movement of valve member 24 in valve body 12.

Typically, orifice extension 16' is coupled to a hypodermic needle or trocar and cannula for withdrawing fluid from the affected body cavity of the patient. Orifice extension 14' is similarly coupled to a syringe barrel or the like, and is initially empty. Orifice extension 18' is coupled to a receptacle (not shown) .

The preferred couplings comprise the well known International Standard Luer conical male or female couplings. In such case, orifice extension 14', 16' and 18' will comprise a 6° taper, and may also comprise the well known "Luer-Loks™" coupling. Other couplings well known in the art may be employed.

In normal operation, a hypodermic needle or trocar is coupled to orifice extension 16' , while an empty syringe is coupled to orifice extension 14'. After insertion of the needle into the body cavity to be drained, the fluid is withdrawn through orifice 14 by manual withdrawal of the syringe piston. The negative hydraulic pressure thereby created moves valve member 24 to the right, as shown in Fig. 1. The entrance to bypass passageway 20 is opened allowing fluid to flow therethrough, as well as through orifices 16 and 14, to the empty syringe. Withdrawal of fluid continues until the syringe barrel is full; at this point, positive pressure is manually applied to the syringe, thereby evacuating the fluid therefrom. As shown in Fig. 2, positive hydraulic pressure moves valve member 24 to the left and fluid then flows through open orifices 14 and 18 to an appropriate receptacle or sump. The paracentesis procedure is repeated until body cavity drainage is considered complete. Another embodiment of the invention is depicted in Figs. 3 and 4. These embodiments comprises threaded aperture 34 in valve body 12. Threaded aperture 34 provides communication between bypass passageway 20 and the ambient atmosphere, and primarily serves as a training or monitoring device.

Fig. 3 depicts a threaded attachment 60 used in combination with aperture 34. Attachment 60 comprises a "pop off" or pressure relief valve with stem adapted to be screwed or otherwise secured into aperture 34. Pressure relief valve 60 is set to open at a predetermined pressure, for example 21 mm Hg or 20 cm H₂0. In operation, medical personnel manually applying pressure to the irrigating syringe would thus be encouraged to apply steady, constant pressure (less than a predetermined pressure) to the irrigating syringe; exceeding the predetermined pressure would open the valve and vent the irrigating fluid.

Similarly, attachment 70 shown in Fig. 4 also serves as a training or monitoring aid. Attachment 70 is a pressure gauge with stem; gauge 70 screws or is otherwise secured into aperture 34, thus affording a visual indication of actual pressure applied to the irrigating syringe. Such visual indication of pressure applied would also tend to encourage steady, uniform application of manual pressure upon the irrigating syringe.

Those skilled in the art will recognize that any known means of securement or attachment may be used to secure valve 60 and gauge 70 in valve body 12, including the threaded means depicted.

In order to ensure that re-injection of fluid does not occur, a simple check valve may be positioned in orifice 18. Such check valve would only permit flow to the receptacle and would preclude flow from the receptacle. The check valve may be of any construction known to the art including, but not limited to ball, flap or cylinder-type valves.

The paracentesis valve of the present invention is useful whenever fluid removal or drainage of a body space is required. It is particularly useful for thoracentesis procedures.

LAVAGE VALVE

Reference is now made to Figs. 5 and 6 which show the preferred lavage embodiment of the invention. Lavage valve 110 comprises valve body 112. Valve body 112 further comprises first, second and third orifices 114, 116 and 118, as well as orifice extensions 114', 116', and 118', respectively. Valve body 112 further comprises bypass passageway 120 which bypasses central cavity 122 and interconnects orifices 114 and 116.

Valve member 124 is positioned within central cavity 122, complementary in configuration to valve member 124 for linear movement therein. Valve member 124 comprises cylindrical center portion 124' and truncated cone end portions 124'' and 124''', respectively. End portions 124'' and 124''' seat within orifices 114 and 116, respectively, of valve body 112, thereby occluding such orifices. Further, when valve member 124 is in position to occlude orifice 114, bypass passageway 120 is also occluded by end portion 124'', as depicted in Fig. 6.

Orifice 118 (and orifice extension 118') are coupled to a vacuum source and receptacle or sump (not shown) . As will be detailed later, the vacuum source sucks the irrigating fluid out of the patient, after completion of the procedure, and into the receptacle.

Valve 110 may comprise any suitable material compatible with its contemplated medical use. Accordingly, valve 110 may comprise any suitable plastic, stainless steel, aluminum and other such materials known to those ordinarily skilled in the art.

Typically, orifice extension 116' is coupled to a hypodermic needle or trocar and cannula for injecting irrigating or laving, fluid into and around the affected body parts of the patient. Orifice extension 114' is similarly coupled to a syringe barrel or the like initially containing the irrigating fluid, while orifice extension 118' is coupled to a vacuum source and receptacle (not shown) .

The preferred couplings comprise the well known International Standard Luer conical male or female couplings. In such case, orifice extension 114', 116' and 118' will comprise a 6° taper, and may also comprise the well known "Luer-Loks""' coupling. Other couplings well known in the art may be employed.

The preferred embodiment of the invention further comprises biasing means such as, a helical or coil spring 126 positioned between end portion 124''' of valve member 124 and valve body 112. Spring 126 normally forces valve member 124 to the right as shown in Fig. 6, thereby occluding and sealing orifice 114 and bypass passageway 120. In normal operation, a hypodermic syringe or trocar is coupled to orifice extension 116', while a syringe barrel charged with irrigating fluid is coupled to orifice extension 114'. After insertion of the needle into the patient proximate the body part to be washed, the irrigating fluid is injected through orifice 114.

The hydraulic pressure exerted by injection of the irrigating fluid overcomes the bias of spring 126, compressing spring 126, and moving valve member 124 to the left, as shown in Fig. 5. The entrance to bypass passageway 120 is opened allowing fluid to flow therethrough, as well as through orifice 116, to the body part to be washed. Flow continues until the irrigating fluid is totally injected or the hydraulic pressure exerted falls below the force required to compress spring 126. At such point, biasing spring 126 moves valve member 124 to the right, as shown in Fig. 6.

Such movement of valve member 124 to the right again (see Fig. 6) occludes orifice 114 and bypass passageway 120. Concomitantly, orifice 118 is opened, thereby permitting vacuum-induced flow of irrigating fluid out of the body into an appropriate receptacle or sump.

The lavage operation may be repeated as often as required by merely refilling the attached syringe barrel or replacing the empty syringe with a charged syringe. No manual manipulation of the valve itself is required, and leakage will not occur.

Nevertheless, in order to ensure against reverse flow through orifice 118, a check valve (not shown) may be positioned therein. Such check valve would only permit flow of fluid to the receptacle and would preclude flow from the receptacle. Those ordinarily skilled in the art recognize that a simple ball, flap or cylinder-type check valve could be used, as well as any other check valve known to the art.

Fig. 7 shows another embodiment of the invention. The Fig. 7 embodiment is otherwise identical in structure and operation to the preferred embodiment of Figs. 5 and 6 and components are identically numbered. Fig. 7 illustrates the provision of annular projection 126' as a biasing spring. Projection 126' is centrally mounted and attached to valve member 124. Projection 126' resembles a Belleville washer-type spring in function and configuration, and is lodged within annular recess 128 of valve body 112 for coaction therewith. As in the preferred embodiment of the invention of Figs. 5 and 6, annular spring 126' normally biases valve member 124 into occlusion and sealing engagement with orifice 114. The advantage of biasing spring 126' of the Fig. 7 embodiment over the spring employed in the Figs. 5 and 6 embodiment is that annular spring 126' inherently prevents fluid passage around it by virtue of its configuration. On the other hand, use of annular spring 126' also entails possible reduced cycle life of the valve assembly.

Fig. 8 illustrates yet another embodiment of the invention. The Fig. 8 lavage valve embodiment utilizes magnetic biasing to occlude orifice 114. As illustrated, annular permanent magnet 130 attracts magnetic slug 132 resulting in occlusion of orifice 114. Those ordinarily skilled in the art will recognize that the relative positions of magnet 130 and magnetic slug 132 may be reversed with slug 132 on valve body 112 and magnet 130 on valve member 124, and, additionally, that magnetic slug 132 may also be polarized (with unlike poles adjacent to poles of magnet 130). In order to avoid magnetic stiction, both magnet 130 and slug 132 should have nonmagnetic layering, such as plastic or stainless steel valve material or other material such as Stellite™, brass or the like, well known to those skilled in the art. Operation of the Fig. 8 embodiment otherwise is similar to the Figs. 5 and 6 preferred embodiment: Permanent magnet 130 and magnetic slug 132 bias valve member 124 into sealing engagement with orifice 114, thereby occluding orifice 114, until such bias is overcome by hydraulic pressure from an attached syringe barrel.

Still another embodiment of the invention iβ depicted in Fig. 9. The Fig. 9 embodiment comprises threaded aperture 134 in valve body 112. Threaded aperture 134 provides communication between bypass passageway 120 and the ambient atmosphere, and primarily serves as a training or monitoring device.

Fig. 10 depicts a threaded attachment 160 used in combination with aperture 134. Attachment 160 comprises a "pop off" or pressure relief valve with stem adapted to be screwed or otherwise secured into aperture 134. Pressure relief valve 160 is set to open at a predetermined pressure, for example 21 mm Hg or 20 cm H₂0. In operation, medical personnel manually applying pressure to the irrigating syringe would thus be encouraged to apply steady, constant pressure (less than a predetermined pressure) to the irrigating syringe; exceeding the predetermined pressure would open the valve and vent the irrigating fluid.

Similarly, attachment 170 shown in Fig. 11 also serves as a training or monitoring aid. Attachment 170 is a pressure gauge with stem; gauge 170 screws or is otherwise secured into aperture 134, thus affording a visual indication of actual pressure applied to the irrigating syringe. Such visual indication of pressure applied would also tend to encourage steady, uniform application of manual pressure upon the irrigating syringe.

Those skilled in the art will recognize that any known means of securement or attachment may be used to secure valve 160 and gauge 170 in valve body 112, including the threaded means depicted.

The lavage valve of the present invention is useful whenever irrigation of an organ, joint or cavity is required, e.g. attachment to bronchoalveolar lavage catheters, for irrigating the urinary bladder, thoracic cavity, gastric cavity, joints, abscesses, cavities and other infected or fluidized body spaces.

Although the invention has been described in detail with particular reference to these preferred embodiments, other embodiments can achieve the same results. Variations and modifications of the present invention will be obvious to those skilled in the art and it is intended to cover in the appended claims all such modifications and equivalents. The entire disclosures of all references, applications, patents, and publications cited above, and of the corresponding application(s), are hereby incorporated by reference.

Claims

CLAIMSWhat is claimed is:

1. Valve apparatus comprising: a valve body comprising first, second and third orifices and a bypass passageway; and a valve member comprising first and second truncated cone end portions; and said valve member movable within said valve body solely by hydraulic pressure.

2. The invention of claim 1 wherein said valve member comprises cylindrical center portion means.

3. The invention of claim 1 wherein said first and second end portions comprise first and second truncated cone end portions.

4. The invention of claim 1 wherein said valve body comprises a hollow central portion complementary in configuration to said valve member.

5. The invention of claim 1 wherein application of negative hydraulic pressure to said first end portion of said moveable valve member causes fluid flow through said first and second orifices and said bypass passageway while closing said third orifice.

6. The invention of claim 1 wherein application of positive hydraulic pressure to said first end portion of said valve member causes fluid flow through said first and third orifices while closing said second orifice and said bypass passageway.

7. The invention of claim 1 wherein bypass passageway comprises an aperture.

8. The invention of claim 7 further comprising a pressure relief valve disposed in said aperture.

9. The invention of claim 7 further comprising a pressure gauge disposed in said aperture.

10. The invention of claim 1 wherein said third orifice comprises a check valve disposed therein.

11. A method for using a valve comprising the steps of: providing a valve body comprising first, second and third orifices and a bypass passageway; providing a valve member comprising first and second truncated cone end portions, and movable in the valve body; and moving the valve member solely by hydraulic pressure.

12. The method of claim 11 comprising the step of applying negative hydraulic pressure to the first end of the movable valve member, thereby forcing .fluid through the first and second orifices while closing the third orifice.

13. The invention of claim 11 comprising the step of applying positive hydraulic pressure to the first end of the movable valve member, thereby forcing fluid through the first and third orifices while closing the second orifice and the bypass passageway.

14. Valve apparatus comprising: a valve body comprising first, second and third orifices and a bypass passageway; a valve member comprising first and second end portions and movable within said valve body; means for biasing said valve member and means for applying pressure to said first end portion, thereby opening said first orifice and said bypass passageway while occluding said third orifice; wherein said means for biasing said valve member comprises means for biasing said valve member into occluding said first orifice and said bypass passageway while opening said second and third orifices.

15. The invention of claim 14 wherein said valve member comprises cylindrical center portion means.

16. The invention of claim 14 wherein said first and second end portions comprise first and second truncated cone end portions.

17. The invention of claim 14 wherein said valve body comprises a hollow central portion complimentary in configuration too said valve member.

18. The invention of claim 14 wherein said biasing means comprises helical spring means.

19. The invention of claim 14 wherein said means for applying pressure comprises means for applying hydraulic pressure, thereby directing fluid flow through said first and second orifices and said bypass passageway.

20. The invention of claim 14 wherein said bypass passageway comprises an aperture.

21. The invention of claim 20 further comprising pressure relief valve disposed in said aperture.

22. The invention of claim 20 further comprising a pressure gauge disposed in said aperture.

23. A method for using a valve comprising the steps of: providing a valve body comprising first, second and third orifices and bypass passageway; providing a valve member comprising first and second end portions, and movable in the valve body; biasing the valve member; and applying pressure to the first end portion thereby opening the first orifice and bypass passageway and occluding the second and third orifices; wherein the step of biasing the valve member comprises the steps of occluding the first orifice and bypass passageway while opening the second and third orifices.

24. The method of claim 23 wherein the step of applying pressure further comprises the step of applying hydraulic pressure and thereby directing fluid flow through the first and second orifices and the bypass passageway.