US 3329391 A
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Description (OCR text may contain errors)
July 4, 1967 w. v. DEANE SURGICAL PINCH VALVE Filed Sept. 28, 1964 United States Patent O 3,329,391 SURGICAL PINCH VALVE William V. Deane, 105 S. Commonwealth, Apt. 9, Los Angeles, Calif. 90004 Filed Sept. 28, 1964, Ser. No. 399,434 6 Claims. (Cl. 251-7) This invention relates in general to miniature valves for administering the ilow of medical fluids from a sterile reservoir to the patient, and more particularly the invention is directed to inexpensive plastic valves which may be readily reused or discarded after a single use.
A great number of daily utilizations of fluid handling of medicinal agents which must be achieved in the most sterile manner possible are included in the modern medical procedures in most hospitals. Typical examples of this type of iiuid handling are intravenous feedings and blood transfusions wherein the medical fluid is contained in a flask and administered through tubing and a flow control valve to a means such as a hypodermic needle which may be inserted into the vascular system of the patient. A primary object of the present invention is to provide such a valve which is improved in certain respects, hereinafter set forth, as compared with those valves heretofore available for these and other utilizations of like character.
In the past it has typically been the practice to use valves made of heat sterilizable material such as brass, stainless steel, or pyrex glass, Such valves can be repeatedly sterilized and reused. However, they are initially expensive and their resterilization and sterile storage for future use constitutes additional responsibility for hospital personnel who are normally already overburdened with other duties. Furthermore, the cleaning and resterilization of valves which have lbeen used is inherently diflicult and at best imperfect because of the small scale rotary joints and ports and channels or passageways in which dried residue of the iluid state substance may remain undetected. Such residue causes a valve to be difcult to operate and more importantly, may cause serious pyrogenic reactions in the patient.
An additional disadvantage inherent in metallic valves is their chemical activity which may be manifest either in deleterious reaction with the fluid medicinal agents or with the caustic cleansing solutions used in preparing them for reuse.
One general prior art attempt to provide a simple low cost solution to the sterilization problem is the pinched tube type valve wherein a spring clip or more elaborate clamp is applied over a flexible tube. Although such valve arrangements may be linexpensive and may be readily resterilized since the clip mechanism need not directly contact the medical fluid, the flexible tulbing being discarded, they are less than totally satisfactory in their forms heretofore known Kbecause of their lack of positive action either in opening a previously pinched tube or in closing a previously open one. In addition, their action is not usually reliably variable between the limits of full flow and shut-olf. Furthermore, it may be seen that generally their action and reliablity depends upon the relationship between the strength of the spring and the resiliency of the flexible tube which relationship, in throw-away materials, is not consistently dependable.
Other attempts in the prior art to provide plastic valves inexpensive enough to be discarded after single or short use have typically resulted in apparatus which is either unwieldy and unreliable as regards leakage or flow control or is so complex as to be not adequately inexpensive for practical throw-away use.
Accordingly, it is another object to provide a surgical or medical fluid valve which is not subject to these and other disadvantages to the prior art.
It is another object to provide such a medical or surgical valve which is exceedingly inexpensive to manulfacture, with repeatability and reliability.
It is another object to provide such a valve which is chemically substantially inert, easily factory sterilized, non-breakable, light weight, and exceedingly compact.
It is another object to provide such a valve which does not require sealing the gaskets or O-rings or other sealing means and which is adaptable to slip over standard flexible tubing.
It is another object to provide such a valve which provides positive control of the ow therethrough in discrete steps of magnitude between full ow and shut-olf.
Briey, these and other objects are achieved in one example of the invention in which a small plastic valve body member is provided with a Ibore for slidingly receiving a length flexible tubing therethrough transversely to the bore. A body member is formed to include a slot which communicates with the bore and which has serrated sides. An elongated valve sliding member one end of which engages the flexible tube within the bore is disposed within the slot and is provided with serrated sides which cooperatively engage with the serrated side surfaces of the slot to secure, longitudinally, the elongated valve sliding member within the slot.
The composition of one or both the valve sliding and body members is of a deformable or semi-rigid plastic substance whereby with longitudinal force applied to the valve sliding member, it may move in discrete but small steps along the length of the slot toward or away from the bore within which the tubing is disposed. In a presently preferred example of the invention, a thumb engaging lateral extension is provided on one side of the sliding member which extends outside of the body member and against which such longitudinal force may be applied as by the thumb or other digit of the user. A snap-on cover for the body member may be provided for retaining the sliding member within the slot of the body member.
Thus by inserting the flexible tube through the bore, fluid flow through the tubing may be controlled in positive discrete steps by deforming the tubing within the bore through force applied transversely thereto through the end of the valve sliding member.
The resulting valve assembly may be exceedingly cornpact and inexpensive to manufacture and may be blow molded as a three piece unit, sterilized, packaged, and stored until desired for use. When the valve is to be used, it may be unpa-ckaged and set together to form, in cooperation with a length of flexible tubing, a complete medical fluid or a surgical valve system.
Further details of these and other novel features and their operation as well as additional objects and advantages of the invention will become apparent and be best understood from a consideration of the followng description taken in connection with the accompanying drawing which is presented by way of an illustrative example only and in which:
FIG. l is a perspective view of an example of a surgical valve constructed in accordance with the principles of the present invention;
FIG. 2 is la sectional view of a structure of FIG. 1 taken along the lines 2-2 thereof;
FIG. 3 is a frontal elevational view of the structure of the previous iigures with the cover plate removed; and
FIG. 4 is a perspective view of an internal element of the assembly illustrated in the previous-figures.
With specific reference now to the figures in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative -discussion only and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and structural concepts of the invention. In this regard, no attempt is made to show structural details of the apparatus in more detail than is necessary for a fundamental understanding of the invention, the description, taken ywith the drawing, making apparent to those skilled particularly in the art of plastics manufacture how the several forms of the invention may 'be embodied in practice, Specifically, the detailed showing is not to be taken as a limitation upon the scope of the invention which is ydened by the appended claims forming, along with the drawing, a part of the specification.
The example of the surgical valve illustrated in FIG. 1 includes a body member 12 having a flexible tube receiving lbore 14 formed therethrough Ialong an axis parallel to the `back surface 116 and the top and bottom surfaces 18, respectively of the body member 12.
The body member 12 is also formed with a channel 22 (see the subsequent figures) which is also disposed parallel to the #back surface 16 but perpendicular to and in communication with the bore 14. A valve sliding member 24 having a laterally extending thumb engaging portion 26 is -disposed slidingly within the channel 22 with the thumb engaging portion 26 protruding out of the body member 12 through a slot 28 formed through a cover plate 30 which grips the lbody member 12 and retains the valve sliding member 24 in a manner s-hown more clearly in the subsequent figures.
Referring to FIG. 2 the representation is a longitudinal sectional view taken through the channel 22 in a manner to show the valve sliding member 24 in elevation. Disposed snugly within the bore 14 is shown, in this view, :a length of flexible surgical tubing 30 the outer diamete-r of which is approximately equa-l to the diameter of the ibore 14. The communication of the channel 22 with the bore 14 is shown in this view as permitting the pinch closure engaging relationship of the round bottom portion 32 of the valve sliding member 24 with the surgical tubing 30. Thusly, by tnanslating force applied 4by the thumb of the user through the thumb engaging portion 26, the valve sli-ding mem'ber 24 may fbe moved :longitudinally along the channel 22 in a manner to open or close the tubing 30 therebyv to control the flow of medicinal fluids therethrough.
The valve sliding member 24 is held in discrete, selected positions by engagement of a series of longitudinal displacement control serrations 34 which engage rnatingly with similar serrations formed in the body member 12 along the sides of the channel 22. Individual ones of the serrations are oriented perpendicularly with respect to the direction of longitudinal freedom of displacement of the valve sliding member 24 within the channel 22. In this example both ythe valve members are formed of a semirigid, somewhat deformable plastic material so as to permit the indicator gripping relationship between the sliding and body members of the valve. The lateral amplitude of the serrations 34, 36 is readily determined by experimentation with the particular plastic materials chosen and with regard to the diameter and wall rigidity of the length of surgical tubing 30 `to determine an optimum gripping effect whereby the valve sliding member may be readily moved longitudinally Within its channel by force exerted by the thumb of the user while at the same time securely holding the tubing engaging round bottom portion 32 of the valve sliding member 24 in its desired pinch closure relationship with the tubing 30. For example, for holding and controlling the flow of intravenous nourishment through typical exible plastic tubing, the .amplitude of the serrations was chosen to be several thousandths of 1an inch and readily held the tubing in any desired degree of closure from full ilow to total shut-olf in any one of a very large number of discrete positions, providing in effect, a substantially infinite control between the indicated limits.
The cover plate member 29 is shown in FIG. 2 as bein juxtaposed over the face portion 38 of the valve body member 12 in a manner to retain the valve sliding member 24 within the channel 22 of the body member 12; the slot 28 being provided as indicated above to provide extension therethrough of the -thumb engaging portion 26 of the valve sliding member 24 whereby the thumb or other digit of the user may exert a force with respect t-o the remainder of the valve assembly for controlling the longitudinal displacement of the valve sliding member therewithin. As shown also in FIG. 3 the sides and top and bottom of the body member 12 are provided with a shoulder 40 which extends above the perimeter of the body member 12 contiguously to its face portion 38. The continuation of the edge surfaces of the sides and top and bottom of the body member toward the face portion 38 from the shoulder 40 is provided with a lip engaging retaining channel 42 which in this example eX- tends above the entire periphery of the ibody member 12 contiguously to the face portion 38. Similarly, the periphery of the cover plate member 29 is formed with a retaining lip 44 which includes a peripheral retaining land 46 which, in a snap-on relationship, engages with the retaining channel 42.
It should be noted that the View of FIG. 3 is of the valve `assembly with the cover plate member 29 removed and with the length of surgical tubing 30 inserted therethrough in a partially pinched closure relationship with the round bottom tubing engaging portion 26 of the valve sliding member 24. The holding serrati-ons, shown somewhat exaggerated in amplitude, 34 of the valve sliding member 24 and the mating serrations 36 on the sides of the channel 22 are represented in frontal elevation in the view of FIG. 3.
Referring to FIG. 4 the valve sliding member 24 is illustrated removed from the channel 22 of the valve body member 12 to show more clearly its side serrations 34, its thumb engaging portion 26, and its flexible tube engaging round bottom portion 32. It should be noted that the serrations need not necessarily be formed on the surfaces as shown in this example of the invention. They may, for example, be formed on only one surface which may be one of the sides as shown or on the front or back of the valve sliding member 24. It is contemplated however, that the individual serrations shall be oriented substantially perpendicularly to the direction of the freedom of movement of the valve sliding member 24 toward or away from the pinch closure engaging relation with the flexible surgical tubing within the bore 14.
In typical manufacture of the surgical valve 10 it has been found to be particularly expedient and otherwise advantageous to blow mold the three members of the valve assembly, not including the length of exible tubing, in one interconnected molding. The portions may then be broken away, snapped together, and then placed along the length of flexible medical tubing 14. In any point of time in their manufacture, assembly, or storage for use, the valve or its components may when desired, be sterilized `as for example by radiation within their package. Although the units are marketed for a few cents each, they may, when desired, be exceedingly readily cleaned, resterilized and reused since the medical fluid never comes in contact with the valve materials themselves. There has thus been disclosed and described, an example of a medical-surgical valve exhibiting the advantages and achieving the objects set forth hereinabove.
What is claimed is: l.'
' 1. Surgical valve assembly comprising:r
plastic valve body member having a bore formed therethrough with a diameter for snugly receiving a length of flexible tubing,
said body being formed furthe-r to include a slot therein having sides disposed transversely to and in intersecting communication with said bore, at least one of said sides having serrations formed therealong, individual ones thereof being oriented substantially parallel to said bore;
valve sliding member disposed slidingly within said slot and having an end portion extending into engageable relation with the side walls and with said flexible tubing within said bore and having a side surface for engaging at least one serrated side of said slot, said valve sliding member having a width dimension parallel with said bore such as to rest snugly within said slot, said side surface of said valve sliding member being serrated like at least one serrated side of said slot land being adapted to be matingly engaged therewith for holding said sliding member selectively in discrete, longitudinal positions along said slot and providing for movement of said sliding member either toward or away from said tubing, at least one of said body and sliding members being fabricated of deformable, semi-rigid plastic material and of suicient resilience that said sliding member may be shifted in either direction between different ones of said discrete positions when longitudinally directed force is applied to said sliding member with respect to said body member and held in the desired position by the interaction of said serrated surfaces.
2. The invention according to claim 1 in which said body member has -a face portion parallel to said bore and to the direction of travel of said sliding member and which is interrupted by said slot, the invention further including sliding member retaining means disposed over at least a portion of said slot and said face portion for securing said sliding member within said slot with a longitudinal freedom of movement therewithin.
3. Surgical valve assembly comprising:
plastic valve body having a face portion, sides perpendicular thereto, and a flexible tubing receiving bore formed therethrough parallel to the said face portion and being relieved to form a channel exposed through said face portion and extending from a region of intersection with said bore along at least a portion of said body parallel to said face portion;
a length of flexible tubing disposed through said bore and having an outer diameter substantially equal to that of said bore;
valve sliding member disposed at least substantially within said channel with a freedom of longitudinal displacement along the length thereof toward and away from pinch closure engagement with said ilexible tubing, said sliding member including a thumb engaging lateral extension protruding through said face portion of said body and adapted for translating force from the hand of a user to longitudinal displacement of said sliding member,
said sliding member and said channel having at least one pair of juxtaposed contacting surfaces disposed substantially parallel to the direction of said longitudinal displacement, said juxtaposed surfaces being matingly serrated with individual serr-ations being oriented substantally perpendicularly to said direction, at least one of said body and sliding members being formed of a material having snficient resilience that said sliding member may be shifted toward or away from said tubing and held in a desired position by the interaction of said serrated surfaces.
4. The invention according to claim 3 which further includes a retaining plate member juxtaposed over at least a portion of said face portion of said body and over at least a portion of said channel for retaining said valve sliding member therewithin, said retaining plate member being apertured to form a slot for passing said thumb engaging extension and for permitting said longitudinal displacement thereof.
5. The invention according to claim 4 which further includes pressure actuated, mated lip and lip engaging means disposed along the peripheral edges of said juxtaposed retaining plate member and said face portion of said valve body.
6. The invention according to claim 5 in which said lip engaging means comprises a retaining channel relieved from said sides of said body contiguously to said face portion and said lip means comprises a lip extension formed integrally with and about the periphery of said retaining plate member and having a terminating shoulder portion protruding into pressure actuated retaining engagement with said retaining channel.
References Cited UNITED STATES PATENTS 1,238,521 8/1917 Janish 251--7 2,455,236 11/1948 Darvie et al. 34-263 X 2,595,511 5/ 1952 Butler 251-6 2,865,591 12/195 8 Holinshead 251--8 3,086,544 4/ 1963 Yost 137-315 3,167,085 l/ 1965 Redmer 251-8 X WILLIAM F. ODEA, Primary Examiner.
R. GERARD, Assistant Examiner.