CA1145315A - Roller clamp having conduit insert with low compression set properties - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE

A flow regulating device and specifically an improved roller clamp with a length of conduit exhibiting low compression set properties disposed therein. The clamp includes an elongated box-like body having a fluid inlet at one end with a fluid outlet at the opposite end which are joined by the conduit to provide a flow lumen through the clamp. The roller is captured within a track in the body to selectively compress or release the conduit towards or away from a compression surface disposed at an angular variance to the track. The flow rate is regu-lated by appropriately positioning the roller. The conduit is captured within the body so as to be unaffected by external pulling or tugging forces.

Description

53~S

~AC~GROUND OF l~E INVENTIt~N

This invention relates generally to clamps for use in regulatin~ fluid flow rate through Plastic tubing and more specifically to a self-contained device for regulating the fluid flow therethrough.
Plastic tubing, generally of a PVC, or vinyl material is ex~ensively employed in hospital~ as a fluid conduit in numerous applications. Vinyl tubing is inexpensive and generally inert so as to be advantageous for administering fluids to a patient such as in parenteral solution admini-stration sets. Numerous devices such as cam, screw and roller type clamps are available for regulating the fluid flow rate of the solution reaching the patient by selectively compressing the tubing to Yary ~he size of the fluid lumen. These flow regul~ting devices are positioned along the leng~h o~ tubing to permit the operator to regulate the flow rate and the volume per unit time of liguid administered to a particular patient.
When vinyl tubing is compressed, its inheren~
rigidity produces a high intern~ strain to resist com- -pression for the first several minutes after being clamped.
Eventually, the tubing will begin to relieve its internal strain or undergo the phenomen~ of Wcold flcw~ causing ~
progressive ~hange in the cross-sectional area of the con-stA cted tubing producing a potentially dangerous fluc-tua~ion in the desired flow r~te. Consequently, these prior devices must be frequently monitored and re-adjusted to maintain a pre~cribsd flow ra~e.
Although all of the types of clamps referred to above re-gula~e flow by compressing the tubing, they are entirely dissimilar in operation and effectiveness. Cam-type clamps generally employ a transaxial c~m to compress ~ particular transverse section of tubing~ but are generally difficult 35 for the attendant or nurse to manipulate and their configu-rations do not readily lend themselves to variable settings of flow regulation. Screw clamps have a threaded plunger to selectively compress the tubing benea~h the plunger by which ~o regulate fl~w. However, screw clamps are noto-riously unreliable in maintaining a set flow rate due tothe formation of secondary lumens around the pl~nger caused by cold flow. Generally, the plunger cannot completely crimp the tubing closed to block flow for any length of time due to the increased tendency for the formation of 10 secondary lumens on either side of the plunger.
Roller clamps have heretofore generally had a U-shaped body to ~it over the tubing with a roller mounted ~herein to selectively compress ~he tubing against the base o~ the body. The early roller clamps~ such as shown in ~.S. patent 3,189,038, suffered a severe drawback from cold flow by ~-providing a flat-inclined clamping surface relative to the mQvement of the-roller'to progressively compress the tu-bing-in a uniform transverse cross-section against the co~pression surface which lead to secondary lumen formation.
In an attempt to overcome the difficulties with cold flow produced by a flat compression surface several roller clamps have been proposed with ~ grsoved clamping surface. One such clamp compresses the transverse edges of the tubing by ~ roller mounted uniformly above ~ com-pression surface whi~h has a channel of varying cross-section to control the lumen size. For example, U.S.
patent 3,685,7~7 discloses a cla~p having a roller spaced uniformly above a compression surface to squeeze the trans--verse edges of the tubing while permitting the central 30 portion of ~he tube to flow into a longitudinal channel in the compre~ision surface to form a lumen. The channel varies in depth ~rom large to small ~o regulate lumen size.
Although that deYice W215 an impro-vement over ezlrlier roller clamps, the configuration and cxoss-sectional area of the channel still permitted ~cold flowW migration of the compressed tubing wall into the excess channel space causing s fluctuations in the desired flow rat~.. U.S. patents 4,031,263 and 4,047,694 disclose improvements to the embodiment of the 3,685,787 patent in an attempt to direct the cold flow away from the excess space i~ the channel and 5 a recessed roller to permit migration of the tubing during cold flow into this additional space and away from flow-rate defining lumen. ~owever, these and the other prior art roller clamps haYe not adequ~tely overcome the disad-vantages ~ttributed to cold flow making the currently available roller clamps l~ss than satis~actory.
Tv overcome some of these difficulties~ the use of a cam-type clamp with an expensive and complicated multi-lumen insert of resilient material which does not exhibit the phenomena of cold 1OW when compressed, has been sug-gested in U.S. Patent 3,805,830 to alleviate flow ratefluctuations attributed to cold flow and capillary action encountered with standard vinyl tubing. The patentee of U.SO Patent 3,948,977 has proposed that ~he multi-lumen insert described therein may be employed with the screw clamp disclosed in U~S. Patent.3,805,830.. This screw cl~mp device suffers from the disadvantages of limited control r~nge and difficulty ~f complete shut-off inheren~
with that type of Clamp9 Both of ~hese clamps employing the resilient insert are subject to flow xate variations produced by tugging or stretching of ~he aaministration tubiny by extern~l forces. For example, moYement by the patient which produced a pulling force would tend to change the flow rate due to the resilient, easily stretched insert maXing these devices unreliable for maintainins consistent flow rates.
Heretofore, the prior tubing clamps have failed to overcome flow rate fluctuations attributed to cold flow and/or external stretching forces causing them to be un-satisfactorily unreliable for failing to maintain ~ pre-scribed flow r~te.
oBJEc~rs OF ~E INVENTION
A primary object of the present invention is to 5~
4 --provide an adjustable flow regulating device over an ex-panded control range which eliminates fluctuations from a desired flow rate setting by eliminating the phenomena of cold flow and preventing flow variations attributed ~o external forces.
A further object of the present flow regulating invention is to provide an improved roller clamp having a self-contained fluid conduit of material exhibiting small compression set properties constrained therein pro-viding a clamp which is readily adaptable for use withconventional vinyl tubing administration sets.

~UMMARY OF THE I~NTIO~
A fluid regulating device and particularly an im-provided roller clamp, fluid regulating device is disclosed which proviaes a solution to the recurring problems of accurately regulating flow rate ~hrough plastic tubing attributed to cold flow and external stretching forces.
The present invention provides a roller clamp having an elongated two piece, box-like body provided with ~ fluid inlet at one end and a fluid outlet at ~he opposite end. A cylindrical roller is mounted within a track in the body for longitudinal movement. A length of conduit having low compression set characteristics i8 disposed between the bottom of the roller and a compression surface i~ the base providing a fluid passageway through the interior of the 2S body from the inlet to the outlet. m e compression surface has ~ minimal angular varian~e to the path of the roller.
The flow rate through the conduit is regul~ted by longi-tudinally moving ~he roller along the length of the body ~hich varies the area between the rolIer and~compression surface-to permit the conduit to be fully open at one end of the clamp and fully closed at t~e other end of the clamp.
~ he conduit is captured within the body and pre-ferably, is captured in a slightly stretched configuration bet~een the fluid inlet and the fluid outlet. In use, the present invention is readily adapted to receive a leng~h of conventional,plastic tubing leading from a source of s fluid at the fluid inlet and to receive a length of conYen-tional tubing at it~ fluid outlet. The elongate~ body provides an improved control range to permit slight adjust-ments in the ~low lumen size of the conduit, which when set, will not vary aue to cold flow nor be affectea by external forces.
DESCRIPTION OF ~rHE DRAWINGS
.
Fig. 1 is a perspective view of the roller clamp of this invention shown in use with a schematic representa-tion of a conventional fluid administration set.
Fig. 2 is a vertical cross-sectional view of the roller clamp taken along lines 2-2 of Fig. 4.
- Fig. 3 is ~ vertical cross-section~l view of the clamp taken along lines 3-3 of Fig. 47 Fig. 4 is a longitudin~l cross-sectional view, partially broken away of the clamp illustrated in Fig~ 1.
DETAILED ~ESCRIPq'II~N OF THE PREFERRED EMBODIMENTS
Referring to Eig. 1~ ~ roller clamp 10 embodying various aspect~ of the present invention is shown in operative association with a con~ention~l fluid solution administr~tion set. A length of conventional flexible tubing 12, such as P~C or vinyl tubing, connects a source of fluid to ~ fluid inlet end 14 of the clamp lo ~nd another length of conventional tubing 16 is joined to ~ fluid out-let 18 and is suit~bly ~oined to the patient. In the illustrated embodiment of our flow regulating invention shown generally in Figs. 1-4 an elong~ted box-like body 20 is longitudinally divided to provide ~wo pieces shown 30 generally ~s an uppex meJbber 22 and a lower member 24. me upper 22 and lower 24 members each include two end walls 26, 28 a~d 30, 32 and longitudinal side walls 34, 36 and 38, 40 which are cooper~ti~tely joined at juncture 42. l~e upper member 22 of the body 20 further includes an elongated opening 49 boardered 21t both ends by horizontal top walls 46 and 48 to provide ~ ~assageway and ready access to a rol-ler 50, the box-like body 20 is cooperatively joined by any 3~
- 6 ~
suitable means at the juncture 42. The roller ~0 and upper 22 and lower 24 members are preferably molded from an essentially rigid plastic material to maintain close toleran-ces in the finishea clamp~
Referring to Figs. 2 and 4, the roller 50 -s ~ormed with a circumferential outer surface 54, which is preferably knurled as shown, with a centrally disposed axle 55. It will be understood that the roller 50 will generally be of a unitary construction and may include hub-like projections to serve as the axle 55.
Re~erring now tD Figs. 4 and 2, ~ length of conduit 56 is disposed within the boay 20 and is connected at one end 58 to a means for defining a fluid inlet ~uch as a nipple 62a, and with the other end 60 connected to a means for defining a fluid outlet, or a second nipple 62b. The conduit 56 provides a flow lume~ 64 for defining a fluid passageway between ~he inlet 14 and outlet 18 enas of the clamp 10. Any suitable iner~ material exhibiting low compression set properties, such as silicone or latex, may be employed.for the conduit 56 whïch virtually eliminates the pro~lems attributed to cold flow. Prefer~bly, the conduit 56 is an elastic silicone conduit, which is sub-stan~ially inert to chemical leaching.
As 8hown in the orien~ations of Figs. 2 ana 4, the base wall 52 is provided wi~h ~ conduit receiving channel 66~ As shown, the ~hannel 66 is defined ~y an elongated compression ~urface 70 joined by vertical shoulders 68 to roller bearing surfaces or ledges 72 projecting towards the center of the body 20 along the length o~ both walls 38 and 40. As shown in ~ig. 2, the compression surface 70 of the channel 66 is suitably dimensioned to recei~e the conduit 56.
~ eferring to Figs. 2 and 3, the lower member 24 of the body 20 is provided with horizontal walls 74 pro-jecting outwardly which are suitably joined ~t ~he juncture 42 with the vertical sidewalls 34 and 3S of ~he upper member 22 of the body 20. The sidewalls 34 and 36 are provided 53~5 with inwardly projecting horizontal lips 76 board~ring the length of the passageway 44 to the top walls 46 and 48. As shown, the lower portion of the lips 76 are provided with flat hub bearing surfaces 7B which extend substantially along the longitudinal length of the ~ody 20~
Turning momentarily to Fig. 4, the ledges 72 are spaced uniformly below the hub bearing surfaces-78 along the length of the body 20 beginning at a point A.near the inlet end 14,to the outle~ end 18 of clamp lOo As shown in Figs. 2, 3 and 4, the roller 50 is appropriately di-mensioned ana unted within a longitudinal track in the body 20 defined by ledge3 72 and surfaces 76. Beginning at point A of the body 20, the uniform vertical distance between the hub bearing surfaces 78 and the ledges 72 is slightly 15 less than the distance between the uppermost point of the ~~
axle 55 and the lowermost outer surface 54 of the roller 50 to create a slightly biased fit, but still permitting longitudinal movement of the roller 50 within the track.
As shown gener~lly, the outer surface 54 of the roller 50 diametrically projects through the passageway 44 and compresses the conduit 56 towards the surface 70 of the channel 66.
Starting near the inlet end 18 of the cl~mp 10.
insliczlted by A~ the compression surface 70 is angled to converge ~oward the plane of the ledges 72 by providing a decreasing height of the shoulders 68 as the roller is moved longitudinally toward the fluid outlet end 18 of ~he body 20. Longitudinal movement of the roller 50 toward the outlet end 18 selectively compresses the c~nduit 56 toward 30 the surface 70 to v~ry the size of the lumen 64 from a fully open position near the inlet end 14 to 21 :Eully closed pos ition at the oppos i te end of the body as shown in Fi g . 4 .
Alternat~ly, opposite vement of the roller 50 spens the lumen 64 as a result o~ the low compression set properties 35 of conduit 56. l~e b~se wall 52 and s:hannel 66 slightly diverges away frs:)m the surfaces 78 to insure ~ completely ~S3~

open position when the roller 50 is positioned near the inlet end 14 of the clamp 10 as shown.
Referring now to Figure 4, the nipple 62a is provided with a centrally disposed retainer ring 80 of larger diameter separating an inner tubular coupling 82 from an outer tubular coupling 84. As shown, the couplings 82 and 84 are preferably provided with tapered ends per-mitting ease of insertion of the conduit 56 to coupling B2 and the conventional vinyl tubing 12 to the coupling 84.
The nipple 62b is similar in configuration and ~imension to nipple 62a and is also provided with couplings to receive the conduit 56 and the conventional tubing 18 having a retaining ring 86 therebetween. As shown, the couplings of nipples 62a and 62b are dimensioned to be snugly received within the interior diameter of the inlet 12 and outlet 18 tubing and the conduit 56. Other embodiments for the nipples not shown, may be provided with variable sized couplings on either side of suitable clips or retainer rings and do not necessarily have to be identical.
21 As shown in Fig. 4~ the retainer rings 80 and 82 of the nipples 62a and 62b are captured within similarly configured retaining spaces 88 and 90. The lower member 24 of the-body 20 is provided with notches 92 and 94 for receiving the retainer rings B0 and 86 respectively. The space ga is defined on ~he side towards the interior of the body 20 by a vertical lower yoXe 96 upwardly extending from the lower member 24 and a downwardly projecting upper yoke 98 shown in Fig. 3. As shown in Fig~ 4, the exterior side of space 90 is defined by the end wall 32 of the lower member 24 cooperatively joined with the end wall 2B of the upper member 22. Fig. 3 illustrates the co-action of the lower yoke 96 with the upper yoke 98 to circumferentially collar the retainer rings 80 and 86. Preferably, the lower 96 and upper 98 yokes are suitably dimensioned to avoid snugly compressing the conduit 56 against the inner coupling 100 of nipple 62b. In the preferred dimensions of ~he yokes, ~ ~ ~53~5 g the possibility of leakage due to slight manufacturing variations causing an uneven compression by the yokes is avoided. If desired, a suitable binaer material may be provided to glue the conduit 56 to the nipples to insure leakproof integrity. As illustrated in Figs. 1 and 4, the space 88 is similar defined by an upper yoke 102, a lower yoke (not shown) and by the end wall 26 of the upper member 22 and end wall 30 of the lower member.
Alternatively, the upper and lower yokes may be dimensioned to snugly compress the conduit 56 against the inner couplings of the nipples 62a and 62b. Care must be ta~en to avoid an uneven compression causin~ the conduit 56 to bind, providing a potential source of leakage.
The wall 26 is provided with a vertically project- --ing retainer wall 106 dimensioned to cooperate with a notchprovided in the lowr wall 30 of the lower member 2~. The retainer wall 106 may be dimensioned to snugly circum-ferentially compress or collar the tubing 12 to the outer coupling 84 of the nipple 62a to assist in insuring fluid-tight integrity. ~ similar retaininy wall ana notch maybe provided at the outlet end 18 of the clamp 10.
The yokes insure that the nipples 62a and 62b of conduit 56 are snugly captured within the retainer spaces 88 and 90. The conduit 56 is fur~her captured within the body 20 by fitti~g the retainer rings 80 and ~6 within the notches 92 and 94. The captured conduit is thereby unaffected by external forces such as pulling tugging or stretching of either tubing 12 or 18. Stretch-ing of the conduit 56 would vary the flow lumen size and therPby undesirably affect the flow rate. Additionally, the walls 26, 30 and 28, 32 may be more vertically angled than is shown in Fig. 4 to reduce the size of spaces 88 and 90 and to moxe snugly secure the nipples within the retaining spaces if desired.
In a preferred form of the present invention, the length of conduit 56, provided with nipples 62a and 62b, or suitable securing means, is slightly shorter by a s - lG -predetermined amount than the distance between the yokes.
When the retaining rings are placed within the retaining spaces on either side of the yokes, the shorter conduit is slightly elongated or stretched by a pre-determined S amount. We have found that this elongation optimizes flow rate stability and substantially prevents the conduit from binding or bunching together on the forward side during movement of the roller. We have found that a range of approximately 4 to 8 percent elongation of the con-duit is optimum ~or flow rate stability and to alleviatebunching of the conduit. The body 20 of the clamp 10 is preferably sig-nificantly longer compared to other roller clamp bodies to permit a gradual angular variance of the compression ~-surface 70 to the path of the roller 50 along its track.
The range of flow control sensitivity is thereby enhanced to provide a clamp which is accurately regulatabl~ over small incremental changes in flow rate.
The clamp 10 o~ the present invention may be an integral part of a standard fluid administration set, such as a parenteral set, in which the conven~ional vinyl inlet and outlet tubes may be solvent bonded to the outer couplings of the fluidinlet and outlet. Additionally, ~he clamp may be employed with any fluid administration system by appro-priately removins a length of tubing or severing the sameand inserting the flow regulating clamp of the present inven-tion. When it is desired to set a particular fl~w rate setting, the cperator grips the clamp and longitudinally positions ~he roller within the passageway until the flow lumen of the conduit obtains an internal area corres-ponding to the desired flow rate.
The present invention is more readily assembled when the preferred two piece clam-shell like body 20 is employed. The conduit 56 having suitable clips or nipples 62a and 62b at both ends i5 readily inserted into appropriate retainer spaces in the lower member of the body 24, followed 5~5 by insertion of the roller 50 and the assembly of the upper member 22 at the juncture 42 to the lower member 24.
Numerous methods of bonding the upper and lower members together may be employed, such as, for example, solvent or heat bonding.
From the foregoing description of the specific structure of the preferred embodiments, it will be apparent to one skilled in the art that numerous modifica-tions may be made without departing from the spirit of the invention, nor from the scope of the appended claims.
All such modifications and alterations are intended to be included within the scope of the invention as defined by the appended claims.

Claims (5)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A roller clamp for regulating the rate of fluid flow from a supply source to a desired delivery point through plastic tubing comprising:
an elongated, box-like body having a base por-tion with an internal compression surface, a top portion with an elongated, open passageway, elon-gated side walls, and end walls;
a centrally disposed passageway in said end walls defined by a fluid inlet means at one end wall for receiving the plastic tubing from said supply source, and a fluid outlet at the opposite end wall for receiving the plastic tubing leading to the delivery point;
a length of conduit fabricated from silicone rubber having a lumen for the passage of fluid through the body from the inlet to the outlet, said conduit being disposed and captured within the body in stretched condition between said inlet and said outlet means so as not to be affected by external stretching and tugging forces;
a roller having a circumferential outer sur-face and centrally disposed axle hubs;
a track within the body for capturing said roller for longitudinal movement within said body, said compression surface having an angular variance to the track to provide a variable distance between the outer surface of the roller in contact with the conduit and the base;
whereby the fluid flow may be varied by appli-cation of a manual force to the roller, thereby altering the diameter of the lumen from fully open to completely closed as defined by the area between the roller and compression surface.

2. The roller clamp of claim 1 in which said body is longitudinally divided into two cooperating pieces including an upper member and a lower member.

3. The roller clamp according to claim 2 wherein the track further includes:
a roller bearing surface in the lower member adjacent and joined to the compression surface by a shoulder of varying height defining a variable area below the plane of the roller bearing surface;
and axle hub bearing surfaces formed in the upper member and uniformly spaced above the roller bearing surfaces so that when said upper and lower body mem-bers are secured together the outer surface of the roller is maintained in slightly biased engagement with the roller bearing surface.

4. The roller clamp according to claim 1 wherein the fluid inlet means and fluid-outlet means further includes:
a short, rigid coupling dimensioned to snugly hold the conduit in fluid-tight engagement to the coupling within the interior of the body;
a retainer of slightly larger diameter than the coupling; and means for securing the retainer within the body to internally trap the conduit therein so as to protect the conduit from external stretching and tugging forces.

5. The roller clamp according to claim 4 wherein the body and means for securing the retainer further includes:
a first set of projecting means within the body adjacent to the end walls defining a retainer space dimensioned so as to secure the retainer of the coupling in said space thereby preventing external forces from affecting the conduit.