Title of Invention

FLUID FLOW CONTROL DEVICE

Abstract

A fluid flow control device for the transfer set for CAPD system comprising a main body (1) and a clamp cap (2) wherein the main body (1) at one end is having an internal threading (5) through central hole for the free passage of the flexible tubing, an external threading (7) on the bottom end of the said central hole and means for fully tightening and releasing the flexible tubing, the clamp cap (2) comprising a middle part and end cover, (9) inner threading provided into the middle part conforming to the corresponding threading provided onto the main body (1) , the clamp cap (2) is provided with inside tapering surface to enable it to close or open the legs of the main body (1).

Full Text

FIELD OF THE INVENTION The present invention is directed for controlling the flow of liquid through the flexible tubing. More particularly, present invention relates to a novel fluid flow control device having horizontally connected two components namely, main body and the clamp cap. The latter regulates the flow of fluid in the tubing. The device has application particularly in the field of dialysis as the transfer set is to be used in CAPD (Continuous Ambulatory Peritoneal Dialysis) system. BACKGROUND OF THE INVENTION Various methods have been known and proposed to control the flow of liquid from a source and the present invention is directed to provide means of controlling the flow of liquid through the flexible tubing. A disposable flexible tubing set namely, the transfer set is used in CAPD (Continuous Peritoneal Ambulatory Dialysis) system during the exchange procedure of dialysis. The dialysis fluid from dialysis bag is transferred to the peritoneal cavity of the patient and vice versa. In CAPD system dialysis fluid/solution is filled in the dialysis bag which is generally a double bag. The dialysis solution is introduced in the peritoneal cavity of the patient, allowed to remain there for few hours and then drained out from the patient's peritoneal cavity removing the toxic substances. This process is repeated for 3-4 times in a day. It is necessary to have substantially sterile conditions during introduction of the peritoneal dialysis fluid in the patient's peritoneal cavity. EP-B1-197 553 describes a system comprising a sterile connector having the possibility of obtaining the different flow conditions with the use of a Y-piece. 2 WO 88/06895 describes a device, which includes a valve as replacement for the Y-piece, whereby the valve can be operated into four distinct positions. A similar device is disclosed in EP-A1-715 860. The problem with these devices is mainly that they are difficult to operate since they require a substantial force for moving the valve member between the different positions. Moreover, the valve is incorporated in the tube set and increases the cost for the peritoneal dialysis set. US Patent no. 6755591 describes a device, which is composed of two horizontally aligned components parts, namely fixed spillway subtending an angle of 60 degree and a pivotal wedged-shaped module residing at a specific and constant distance parallel to the spillway face. The wedge-module is designed so that it rotates around a defined arc radius so maintaining both a constant distance between interfaces of the wedge-module and spillway and a constant angle of attach. This device has been demonstrated to accelerate that rate of fluid flow under either low or high head pressure by way of generating a negative pressure (venturi) effect in the device. The nature of the wedge-module is to present a "throat" configuration at the slit opening thereby tending to suck fluid into the device under such negative (venturi) pressures, while maintaining a laminar flow pattern ahead of the wedge-module/spillway arrangement US Patent application Ser.No 09/364,628 filed Jul. 29,1999 and US patent application Ser. No. 09/492,060 filed Jan 27,2000, describe the tubing set which includes multiple and separate flow control devices for controlling the flow of biological fluid (e g , blood) through the tubing set and to the sampling pouch and/or collection container. Flow control devices commonly used are the 3 Roberts-type clamps, which are well known in the art. The Roberts-type clamps are placed on the tubing line leading to the blood collection container and on the tubing line leading to the sampling pouch. A Roberts-type clamp generally comprises a single strip of plastic where the ends of the strip are curved towards each other to engage each other in a snap-fit, spring relation. The body of the clamp includes a pair of apertures through which the tubing passes. The clamp further includes a pair of projections which compress the tubing when the body of the clamp is depressed, thereby restricting flow thorough the tube Clamps of this type are generally describes in U.S.Pat. Nos., 3,942,228 and 6,089,527, both of which are incorporated herein by reference. In the prior art, the transfer sets are available with loose clamps provided on the catheter. In some other system a single clamp cap is provided with the locking arrangement This locking / unlocking system is too tight for easy operations by the patient. Many times the clamp cap shall break from the locking point, which is not easily noticeable by the patient as the clamp cap near the lock is very thin and brittle. In such eventuality, the clamping of the tube gets opened and peritoneal cavity is once again directly exposed to the ambient resulting into infection and peritonitis. The material of construction used in the existing devices do not have erosion resistance and with continual screwing and unscrewing of the patient connector, the threading gets damaged. Thus, a further improvement in selectively controlling the flow of biological and other fluids through the conventional designs of fluid flow control device is desired which can remove all the above mentioned drawbacks. Therefore, the object of the present invention is to provide a fluid control device, which is cost effective and economical 4 The object of the present invention is to provide a fluid control device in which clamp cap has been made from two separate components. Another object of the present invention is to provide a fluid control device that has easy and comfortable operation of clamp cap. Further object of the present invention is to provide fluid control device in which the clamp cap has been provided with outside projected knurling surfaces. Further other object of the present invention is to provide a fluid control device in which there is very negligible wear and tear of the threading of the fluid control device. SUMMARY OF THE INVENTION The present invention is directed to flow control device that includes two components parts namely a main body and the clamp cap. The main body has two especially designed clamp legs projecting away from it in the coaxial direction. The clamp cap has inner threading compatible with the corresponding main body and a central hole through which flexible tubing passes. While the flow of the fluid is to be controlled it is done by the controlled circular movement of the clamp cap. The clamp legs are so designed that when the clamping end cap is pushed inward by the clamp cap, these clamping legs shall come together securing clamp flexible tubing centrally between the two legs of the clamp cap. The clamping by these clamp legs is such that when the clamp cap is fully tightened, the flexible tubing is completely air tight and closed. When the clamp cap is loosened in the main body the clamping legs open and release the clamping of the flexible tubing resulting into the flow of fluid in the flexible tubing. Thus, the regulatory movement of the clamp cap on to the main body can control the flow of liquid. 5 Accordingly the present invention relates to a fluid flow control device for the transfer set for CAPD system comprising of (i) Main Body (ii) Clamp Cap. The main body at one end is having an internal threading and an external threading on the border. The main body is provided with central hole for the free passage of the silicon tubing. The external threaded end portion of the main body is provided with two resilient clamp legs.t^which are parallel to each other and are coaxial with the central hole. By means of these clamp legs the silicon tubing can be clamped or declamped. The clamp cap comprising a middle part and end cover, inner threading provided into the middle part in compatible to the corresponding threading provided onto the main body, the clamp cap is provided with inside tapering surface to enable it to close or open the resilient legs of the main body A more detailed invention is provided in the following description and claims and is illustrated in the accompanying drawings. According to the invention, A fluid flow control device for the transfer set for CAPD system comprises a main body and a clamp cap wherein the main body at one end is having an internal threading through central hole for the free passage of the flexible tubing, an external threading on the bottom end of the said central hole and means for fully tightening and releasing the flexible tubing, the clamp cap comprising a middle part and end cover, inner threading provided into the middle part conforming to the corresponding threading provided onto the main body, the clamp cap is provided with inside tapering surface to enable it to close or open the resilient legs of the mam body. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS Figure 1 shows the exploded view of the fluid control device Figure 2 shows the sectional view of the clamp cap. DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a novel fluid flow control device. Particularly fluid flowing through flexible tube such as tubes which are a part of a transfer set to be used in CAPD system for transfer of the dialysate from the dialysate bag to the peritoneal cavity of the patient and vice versa Figure 1 shows exploded view of the fluid flow control device of the present invention. The device includes two components namely the main body (1) and clamp cap (2). The main body has a central hole (3) from one end to the other end. The hole (3) is provided for free passage of the flexible tubing. One end of the main body (1) has internal threading (5) and the other end (6) has external threading (7). Near the external threading (6) outside the hole the main body (1) is provided with two specially designed clamp legs (4a, 4b) projecting away from the main body (1) in the coaxial direction. The clamp legs (4a, 4b) are configured to receive the flexible tubing between them. The ends of the clamp legs (4a, 4b) are protruded and are triangular in shape. Both the clamp legs (4a, 4b) are structurally identical and are placed opposite to each other with one's flat surface facing the other. The clamp cap (2) consists of middle part (8) and end cover (9). The clamp cap middle part (8) has inner threading compatible to the corresponding threading (7) provided on to the main body (1). The clamp cap end cover (9) has inside tapering surface. It shall help to close or open the clamp legs (4a, 4b) of the main body (1). The clamp cap end cover has a central hole (11) through which the flexible silicon rubber tubing passes. The clamp cap has a knurling on outside surface to provide easy circular movement of the cap. The components of fluid flow control device are made up of the material such as polypropylene or polyethylene so that with continuous screwing and unscrewing the threadings are not easily damaged. Figure 2 shows that the clamp cap (2) consists of middle part (8) and end cover (9). The clamp cap middle part (8) has inner threading (10) which is compatible with the corresponding threading (7) provided on to the main body (1). The clamp cap (2) has inside tapering surface. It shall help to close or open the clamp legs (4a, 4b) of the main body (1). Both the middle part (8) and the end cover (9) of 7 the clamp cap (2) are joined together by a press fit or glued on by an adhesive or by using press fit pins. Between the main body (1) and the clamp cap (2) a two side, diagonally opposite, locking system is provided. The thickness of the clamp cap (2) is so designed that it does not break on continual locking unlocking of the same. While the flow of the fluid is to be controlled it is done by the controlled circular movement of the clamp cap (2). The clamp legs (4a, 4b) are so designed that when the clamping end cap is pushed inward by screwing the clamp cap (2), these clamping legs (4a, 4b) shall come together resulting in clamping of silicon tubing centrally between the two legs of the clamp cap (2). The clamping by these clamp legs (4a, 4b) is such that when the clamp cap (2) is fully tightened, the silicon rubber tubing is completely, air tight and closed. When the clamp cap (2) is loosened in the main body (1) the clamping legs (4a, 4b) open because of their resilience and release the clamping of the flexible silicon tubing resulting into the flow of fluid in the flexible tubing. Thus, just by the regulatory movement of the clamp cap (2) on to the main body (1) the flow of liquid can be controlled. 8 I CLAIM: 1. A fluid flow control device for the transfer set for CAPD system comprising ; a main body (1) and a clamp cap (2) wherein the main body (1) at one end is having an internal threading (5) through central hole for the free passage of the flexible tubing, an external threading (7) on the bottom end of the said central hole and means for fully tightening and releasing the flexible tubing, the clamp cap (2) comprising a middle part and end cover, (9) inner threading provided into the middle part conforming to the corresponding threading provided onto the main body, the clamp cap is provided with inside tapering surface to enable it to close or open the resilient legs of the main body. 2. The fluid flow control device for the transfer set as claimed in claim 1. wherein the means for fully tightening and releasing the flexible tubing are a pair of resilient clamp legs provided at the bottom end of the central hole having protrusion at its top end, and a inside tapering surface provided in the clamp end cover, keeping the clamp legs of the central body in the closed or open position 3. The fluid flow control device for the transfer set as claimed in claim 1, wherein the middle part and end cover of the clamp cap are joined press fitted or glued by adhesive or by using press fit pins 4. The fluid flow control device for the transfer set as claimed in claim 1, wherein the damp cap is provided at the other end a knurling internal threading and the two projections on the main body, to provide easy circular movement of the cap. - q - 5. A fluid flow control device for transfer set such as hereinbefore described with reference to the accompanying drawings. A fluid flow control device for the transfer set for CAPD system comprising a main body (1) and a clamp cap (2) wherein the main body (1) at one end is having an internal threading (5) through central hole for the free passage of the flexible tubing, an external threading (7) on the bottom end of the said central hole and means for fully tightening and releasing the flexible tubing, the clamp cap (2) comprising a middle part and end cover, (9) inner threading provided into the middle part conforming to the corresponding threading provided onto the main body (1) , the clamp cap (2) is provided with inside tapering surface to enable it to close or open the legs of the main body (1).

Documents:

00482-kol-2004 abstract.pdf

00482-kol-2004 claims.pdf

00482-kol-2004 correspondence.pdf

00482-kol-2004 description(complete).pdf

00482-kol-2004 drawings.pdf

00482-kol-2004 form-1.pdf

00482-kol-2004 form-18.pdf

00482-kol-2004 form-2.pdf

00482-kol-2004 form-3.pdf

00482-kol-2004 letters patent.pdf

482-KOL-2004-CORRESPONDENCE 1.1.pdf

482-KOL-2004-FORM 13.pdf

482-KOL-2004-FORM-27.pdf

482-KOL-2004-PA.pdf