WO2009144599A1

WO2009144599A1 - Luer tip activated flow control device

Info

Publication number: WO2009144599A1
Application number: PCT/IB2009/051544
Authority: WO
Inventors: Amit Shlezinger
Original assignee: Elcam Medical A.C.S. Ltd
Priority date: 2008-04-14
Filing date: 2009-04-14
Publication date: 2009-12-03

Abstract

A fluid flow control device having a cutoff means activated/deactivated by a Luer tip comprising 1- a housing, having an inlet and an outlet forming a continuum with a lumen of the housing, and 2 - an elastomeric FCM (flow control member), characterized by having (a) an antenor apical portion terminated by a frustum, forming a plane anterior face, (b) a wedged opening, in the anterior portion, which is capable to allow the flow to pass therethrough, from the antenor face to an exterior surface of the FCM, (c) a posterior stubby portion, an annular suspension portion, disposed in a groove within the housing, (d) an interconnecting portion, connecting the annular suspension portion with the posterior stubby portion, and (e) at least one slot, within the interconnecting portion, which allows the flow to pass therethrough, from the exteπor surface of the FCM into the interior of the housing

Description

LUER TIP ACTIVATED FLOW CONTROL DEVICE

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority to US Provisional Patent Application Ser. No. 61/044,523, filed 14 April 2008 entitled "LUER TIP ACTIVATED FLOW CONTROL DEVICE"; the aforementioned Provisional Patent Application is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to medical devices in general and more particularly, to a swabbable device for the control of fluid flow having a cutoff means deactivated by a Luer tip.

BACKGROUND ART

It is a common medical practice to intravenously infuse various fluids into the blood vessels of a patient. The standard practice up until a few years ago was the use of hypodermic needles to inject or withdraw medical fluids from a medical access device. The needle was used to puncture the injection site in order to administer the fluid, and the injection site sealed the opening to prevent leakage and entry of bacteria into the system. The use of hypodermic needles leads to needle-stick accidents and contamination of the patient, in cases in which the needle had been infected. To overcome such drawbacks, various needleless fluid flow control devices were introdicedinvented; in particular Luer tip activated fluid flow control devices.

An important aspect of a fluid flow control device is to provide an anti-bacterial barrier, thus avoiding entry of bacteria into the device and as result contamination of the patient which could result in a serious infection. The most likely area of entry for bacteria resides at the interface between the movable elastomeric plug which constitutes the moving element of the valve mechanism and the entry to the female Luer portion of the static portion of the valve. There is an ongoing need in the market for a fluid flow control device which would improve the existing products or provide a needleless medical valve which would facilitate injecting or withdrawing medical fluids without the use of a needle. Such a device would also have to use the engagement of a Luer tip to the valve and maintain an aseptic leak-free system while being low cost and easy to manufacture. There were numerous devices developed to find a solution for the above mentioned need, as will be described further, but the current invention shows important improvements over existing prior art. With regards to all known prior art, there is still a need for an improved device, particularly for a device having better performance, such as a greater flow rate and reduced dead space, better piston functioning, increased swabbability and lower cost. Furtheremore, most devices of the prior art consist of at least three parts, which results in high production costs. Additionally, most of the prior art devices contain an internal flow path of medical fluid which increases the possibility of contamination and trapped fluid within the flow path.

Prior art designs have provided for an elastomeric seal attached to, or integral with, the movable piston. As the piston is urged toward the inside of the valve body by the Luer tip of a syringe or IV connector, this seal acts as a wiper seal against the inside surface. There are also devices in the prior art which show an external flow path of the fluid between the housing and the movable element, e.g. WO20041 12866, however these devices do not provide an efficient swabbable surface and thus fail to provide an effective anti-bacterial barrier. This problem occurs as the device contains a flexible spring member which does not conform to linear behavior and after multiple engagements with the Luer tip it fails to return to its position and provide an efficiently swabbale surface.

The present invention aims to provide a device which is to overcome the disadvantages referenced herein above.

SUMMARY OF THE INVENTION

There is provided in accordance with some embodiments of the present invention a needleless access device for fluid flow control, which is activated by an engagement of a Luer tip thereto.

There is provided in accordance with some embodiments of the present invention a needleless access device for fluid flow control, in which the piston member seals the inlet to prevent leakage and entry of bacteria and the piston head can be easily swabbed prior to actuation.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the appended drawings in which:

Fig. 1 is a cross-sectional view of the fluid flow control device, showing the following structural characteristics thereof: confirming engagement that allows positive displacement of fluid, the annular suspension member for an enhanced attachment of the flow member device to the housing and a rib of the housing;

Figs 2 A and B are a cross-sectional view of the fluid flow control device, in which Fig. 2B showing a rib of the housing aligned with the corresponding arcuate slot in the flow control member, for centering, as well as the arcuate slots which present a part of the fluid path when the flow member in its open conformation;

Figs 3 A-E are respectively perspective-top, perspective- bottom, side, bottom and top views of a preferred embodiment of the flow control member of the invention; Figs 3 F-J are respectively perspective-top, perspective-bottom, side, bottom and top views of another preferred embodiment the flow control member of the invention;

Fig. 4 is a cross-sectional view showing a preferred embodiment of the fluid flow control device; Fig. 5 is a cross-sectional view showing yet another preferred embodiment of the fluid flow control device configured as a Wye-hose connector;

Fig. 6 is an isometric view showing still yet another preferred embodiment of the fluid flow control device, incorporating a faucet . While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the invention.

DISCLOSURE OF THE INVENTION Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

In accordance with some embodiments of the present invention, a flow control device includes the following parts: a housing made from a substantially hard plastic material having an aperture therein, and a flow control member (FCM) produced of a substantially flexible material, preferably an elastomer, which retracts into the aperture in the housing. The FCM is designed to be disposed at the proximal portion of the fluid flow control device, at the inlet thereof.

In some embodiments, the circumference of the head of the elastomeric FCM has a somewhat elliptical cross-section, whereas the inlet of the housing has a circular cross-section, so that when the FCM retracts into the housing, a force is exerted onto the poles of the head which are formed about the major axis of the elliptical cross-section; whereby the head of the FCM is distorted and forcibly engaged with to the housing, sealing the inlet and preventing the flow through the housing.

In yet some other embodiments the head of the elastomeric FCM has a widening conical shape terminated by a frustum, forming a plane anterior face thereof. The FCM may have a circular cross-section, in which the outer diameter at the edge of the frustum is bigger than the inner diameter of the inlet of the housing, so that when the FCM is retracted into the housing, the head of the FCM is forced into against the interior surface of the inlet, thereby sealing it and preventing flow through the housing.

It is further disclosed that the head of the FCM has a wedged opening which allows flow through to the exterior surface of the FCM, when in the open conformation. The fluid flow control device provides for a needless access with a cutoff means, which is deactivated by engaging a Luer tip to anterior face of the FCM thereof.

Reference is now made to Figs 1 and 2A-B, in which some preferred embodiment of the fluid flow control device 10 is shown. Fluid flow control device 10 consists and assembled from two constituents, essentially cylindrical elongated housing 12, formed by anterior part 14 and posterior part

16, which are preferably welded together, and elastomeric FCM 20.

Housing 12 has inlet 22 formed by the proximal portion of anterior part 14 and an outlet (not shown) formed by the distal portion of posterior part 16. The inlet and the outlet form a continuum with the lumen of the housing. Substantially flexible FCM 20 is disposed within housing 12, typically in the manufacture assembly process thereof.

FCM control member 20 has anterior apical portion 2OA terminated by a frustum forming essentially plane anterior face A, which facilitates an enhanced swabbability thereof, and posterior stubby portion 2OP forming posterior face P. FCM control member 20 is further structurally characterized by that posterior portion 2OP thereof is connected by means of relatively thin interconnecting portion 2Ol to annular suspension portion 2OS, which occupies the circumferential groove formed between anterior part 14 and posterior part 16. Interconnecting portion mainly 2Ol serves as an energy accumulating means, which has no sealing properties, employed for a reversible operation of fluid flow control device 10.

Interconnecting portion 2Ol has arcuate slots 24 therein which are aligned vis-a-vis corresponding longitudinal ribs 26 on the interior surface of posterior part 16. This alignment provides for a more concentric displacement of FCM 20 into housing 12 upon physical pressure applied to anterior face A thereof and for linearity of such displacement, thereby enhancing the reversibly of the alteration of control member 20 between the open and closed conformations thereof, as will be elaborated infra.

This particular structure of FCM 20 provides for a more stable reversible alternating of conformation from a closed one to an open one, thereby facilitating a more efficient multiple reversible operation of fluid flow control device 10, as will be elaborated infra.

FCM 20 has an open conformation (not shown) and a closed conformation, shown in Figs 1 - 2. By engaging a Luer tip (not shown) to anterior face A of FCM 20 the conformation thereof is altered from the closed conformation, in which the FCM control member seals the inlet, to the open conformation, in which the flow is permitted. At the open conformation, anterior face A of FCM control member 20 is concavely deformed by being pressed-in by the Luer tip whereas posterior face P thereof is convexly stretched-out.

The exterior surface of FCM 20, in its closed conformation, adjoins in conforming engagement 28 to the interior surface of anterior part 14, thereby providing for positive displacement of fluid from fluid flow control device 10 upon alternation from open to closed conformation and reducing the risk of microbiological contamination of flow control device 10.

FCM 20 is further characterized by having wedged opening 30, which allows the flow to pass therethrough, from anterior face A, to the exterior surface of the FCM control member 20, in the open conformation of FCM 20, and further through arcuate slots 24 into the interior of posterior part 16. Wedged opening 30, in the closed conformation of FCM 20, collapses to form essentially plane, continuous, anterior face A; providing for en enhanced swabbability across inlet 22 and thereby reducing the risk of microbiological contamination thereof.

It is further disclosed that annular suspension portion 2OS has top portion 201 S and bottom portion 202S, in which the latter has chamfered edge 203S. Such formation of annular suspension portion 2OS enhances the resiliency of member 20 and facilitates a more premeditated stretching-out action of interconnecting portion 201 at the open conformation.

It is yet further disclosed that member 20 on posterior face P thereof comprises V-shaped groove 2OG. Groove 2OG enhances the resiliency of member 20 thereby facilitating a more premeditated stretching- out action of posterior portion 2OP at the open conformation.

To elaborate the aforementioned structural characteristics of the FCM 20, reference is now made to Figs 3A-E.

Reference is now made to Figs 3F-J, showing another preferred embodiment of FCM 250, which is adapted to retain higher pressures within the flow control device of the invention. FCM 250 is essentially similar to FCM 20 but contradistinctively thereto comprises radial protrusions 252. Protrusions 252 of FCM 250 facilitate retaining of higher pressures within the flow control device of the invention. Since under substantial pressure within the flow control device of the invention the FCM is forced out of the inlet of the housing and can be suboptimally deformed thereupon, radial protrusions 252 are pressed against the interior surface of the housing, more particularly against the interior surface of the anterior part thereof, wherein the housing acts as an abutment, thereby effectively and suboptimal deformation thereof. FCM 250 is typically made of an elastomer, preferably silicone, which is characterized by an ability of being considerably stretched but nonetheless is not efficiently compressed; whereby radial protrusions 252 can sustain a sufficient counterforce without being substantially deformed and provide for effectively preventing a displacement of the FCM out of the inlet of the housing.

Furthermore, interconnecting portion 2501 is oriented upwards from annular suspension portion 250S, i.e. towards the anterior portion of FCM 250; whereas in FCM 20 interconnecting portion 201 is oriented downwards from annular suspension portion 2OS, i.e. away from anterior portion 2OA of FCM 20. When interconnecting portion 2501 is oriented upwards, it exerts a force, due to intrinsic bias thereof, onto FCM 250 thereby forcing it into the inlet of the housing and sealing the flow control device. This configuration of FCM 250 establishes a distinct alternation mechanism therefor. Upon engagement of a male Luer tip to the anterior face of FCM 250, initially, interconnecting portion 2501 inversely reciprocates to assume a downward orientation, i.e. away from anterior portion of FCM 250, and thence stretched downwards as the male Luer tip is onwardly advanced into the inlet of the housing. Such configuration of FCM 250 facilitates a more premeditated, reversible and reliable alteration of FCM from open to closed conformation. Reference is now made to Fig. 4, in which another preferred embodiment the fluid flow control device 300 is shown. Fluid flow control device 310 includes essentially cylindrical elongated housing 312, formed by anterior part 314 and posterior part 316, which are preferably welded to each other, and elastomeric FCM 320, having wedged opening 320W therein. The function of fluid flow control device 300 is essentially similar to the function of fluid flow control device 10, as shown in Figs 1 and 2A-B, but control device 300 has several structural differences enhancing some aspects of the function thereof.

Interconnecting portion 320I is bevelled, what enhances the reversibly of the alteration of FCM 320 between the open and closed conformations and facilitates a more premeditated stretching-out action thereof.

The exterior surface of FCM 320, in its closed conformation, adjoins in an extended conforming engagement 328 with the interior surface of anterior part 314, thereby providing for an enhanced positive displacement of fluid from fluid flow control device 300 upon alteration from open to closed conformation and reducing the risk of microbiological contamination flow control device 300. Anterior part 314 has protrusions 340 matching standard screw-threading of Luer lock connectors. BEST MODE OF CARRYING OUT AND USING THE INVENTION

Reference is now made to Fig. 5, in which yet another preferred embodiment of the fluid flow control device 500 is shown. Posterior part 510 fluid flow control device 500 is configured as a Wye-hose connector having main tubular portion 520 and bifurcating therefrom portion 530 in fluid communication therebetween.

In accordance with yet some other preferred embodiments of the present invention, a plurality of fluid flow control devices can be configured as a multi-line connector (not shown), assembled form a single posterior part shaped as manifold, furnished with an anterior part and a FCM on each furcation thereof.

Reference is now made to Fig. 6, in which still yet another preferred embodiment of the fluid flow control device 700 is shown. Posterior part 710 of fluid flow control device 700, having a non-valved female Luer fitting portion 720, non-valved male Luer fitting portion 730 and fluid flow control device having with cutoff means deactivated by a Luer tip 740, as disclosed supra; wherein the fluid communication between the aforementioned portions is controlled by a faucet incorporated therein, operated via handle 750.

It will be appreciated that the present invention is not limited by what has been particularly described and shown hereinabove and that numerous modifications, all of which fall within the scope of the present invention, exist. Rather the scope of the invention is defined by the claims which follow:

Claims

1. A fluid flow control device having a cutoff means activated/deactivated by a Luer tip, said device comprising: - a housing, having an inlet and an outlet forming a continuum with a lumen of said housing, and

^■ an elastomeric FCM (flow control member), characterized by having: i. an anterior apical portion terminated by a frustum, forming an essentially plane anterior face; ii. a wedged opening, in said anterior portion, which is capable to allow said flow to pass therethrough, from said anterior face to an exterior surface of said FCM; iii. a posterior stubby portion; iv. an annular suspension portion, disposed in a groove within said housing; v. an interconnecting portion, connecting said annular suspension portion with said posterior stubby portion, and vi. at least one slot, within said interconnecting portion, which allows said flow to pass therethrough, from said exterior surface of said FCM into the interior of said housing; wherein said FCM is suspended within said housing from said annular suspension portion by said interconnecting portion, and is capable of efficiently sealing said inlet; and wherein upon insertion of a male Luer tip into said inlet, said anterior face of said FCM is concavely pressed-in, whereas a posterior face of said posterior portion is convexly stretched-out; whereby a passage for said flow is formed from anterior face into said interiorof said hous, via said wedged opening and said at least one slot.

2. The fluid flow control device as in claim 1 , wherein said housing comprising anterior and posterior parts.

3. The fluid flow control device as in claim 1 , wherein said anterior face of said FCM is essentially planar and characterized by an enhanced swabbability thereof.

4. The fluid flow control device as in claim 1 , wherein said anterior portion of said FCM has an ellipsoidal cross-section.

5. The fluid flow control device as in claim 1 , wherein said housing comprises at least one rib longitudinally disposed at the interior thereof.

6. The fluid flow control device as in claim 5, wherein said at least one rib is positioned vis-a-vis said at least one slot.

7. The fluid flow control device as in claim 1 , wherein said FCM comprises radial protrusions and whereby said the flow control device is adapted to retain higher pressures.

8. A fluid flow control device having a cutoff means activated/deactivated by a Luer tip, said device comprising:

^■ a housing, having an inlet and an outlet forming a continuum with a lumen of said housing, and

^■ an elastomeric FCM (flow control member), characterized by having: i. a wedged opening, which allows said flow to pass therethrough, from the anterior face thereof to the exterior surface thereof, and ii. at least one slot therein, which allows said flow to pass therethrough, from said exterior surface thereof into the interior of said housing; wherein said FCM disposed at the proximal portion of said housing and is capable of efficiently sealing said inlet thereof.

9. The fluid flow control device as in claim 8, wherein said anterior face of said FCM is essentially planar and characterized by an enhanced swabbability thereof.

10. The fluid flow control device as in claim 8, wherein said FCM comprises an annular suspension portion, affixed to said housing, and wherein the posterior portion thereof is connected by means of an interconnecting portion to said annular suspension portion.

1 1. The fluid flow control device as in claim 8, wherein said housing comprises at least one rib longitudinally disposed at the interior thereof.

12. The fluid flow control device as in claim 1 1 , wherein said at least one rib is positioned vis-a-vis said at least one slot.