US20060276757A1 - Medical valve with positive flow characteristics - Google Patents

Abstract

A valve for selectively permitting a fluid flow between first and second medical implements is disclosed. The valve has a housing with an interface suitable for receiving a connector portion of a first medical device such as a catheter, and a seal made of a flexible material. The seal has a first end in fluid communication with the interface, a second end suitable for receiving the second medical device, and at least one slit in fluid communication with the first end and the second end. The slit defines a restricted fluid flow path and a relatively small interior volume when in an undisturbed state, defines an expanded fluid flow path and a larger interior volume upon the introduction of the second medical instrument into the slit, and retracts to define a restricted flow path and a small interior volume upon the withdrawal of the second medical device from the seal.

Description

RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 11/157,216, filed Jun. 20, 2005, pending, which is a continuation of U.S. patent application Ser. No. 10/636,163, filed Aug. 7, 2003, now U.S. Pat. No. 6,916,309, which is a continuation of U.S. patent application Ser. No. 09/614,001, filed Jul. 11, 2000, now U.S. Pat. No. 6,695,817, all of which are incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention relates generally to a medical valve, and in particular to a valve which, when connected between a first medical device, such as a fluid source, and a second medical device, such as a catheter, facilitates fluid flow therebetween, and when the first medical device is disconnected therefrom, induces a positive flow of fluid through the valve in the direction of the second medical device.
• 2. Description of the Related Art
• The manipulation of fluids for parenteral administration in hospitals and medical settings routinely involves the use of connectors and valves for selectively facilitating the movement of fluids between two points. These valves are typically placed along a fluid flow line leading to a patient or other destination. For example, the tube may lead to a catheter having its tip positioned within a patient.
• The valve is arranged so that a fluid source or other line may be connected thereto for providing a fluid flow from the source to the patient. When the fluid source or line is removed, the valve closes, sealing the line leading to the patient.
• The element which is connected to the valve may comprise a tube or other medical device such as a conduit, syringe, IV set (both peripheral and central lines), piggyback line, or similar component which is adapted for connection to the medical valve. Unfortunately, prior art valves suffer from a problem arising from the disconnection of these medical devices from the valve.
• These valves define a space within them through which a fluid or other material may flow from the device to the line on which the valve is mounted. When the medical device is connected to the valve, it typically occupies a portion of this internal valve space, displacing the fluid (whether it be a liquid or air) within the valve.
• A problem arises when the medical device is disconnected from the valve. When the device is disconnected, it no longer occupies a portion of the space in the valve. The increase in space within the valve causes the fluid in the valve and line to which the valve is connected, to move to fill the space. In effect, the removal of the device creates a suction force which draws fluid into the valve.
• In the medical setting, this movement of fluid is very undesirable. When the valve is connected to a fluid line leading to a patient, the movement of fluid through the line towards the space in the valve has the effect of drawing blood from the patient in the direction of the valve. A serious problem may result in that this blood may clot and clog the catheter near its tip, rendering it inoperable, and may even result in a clot of blood in the patient, which may prove fatal.
• One attempt at overcoming this clogging problem has been to coat the inner surface of the catheter near its tip in order to prevent blood from sticking to its interior surfaces. This method has generally been unsuccessful in preventing clogging of the catheter.
• The risk of blood clogging of the catheter is significantly heightened where the inner diameter of the catheter is small (e.g., 27 gauge). These small catheters have the advantage, however, in that they reduce the trauma and discomfort caused by insertion into a patient. Because these catheters have a very small passage therethrough, even a small suction force may draw sufficient amount of fluid back through a catheter toward the valve to introduce blood into the catheter tip, which blood may clog the catheter's passage.
• Overcoming the above-stated problem is made more difficult when considering other criteria which the valve must satisfy. For example, the valve should be arranged to so that it does not have any fluid stagnation points. If the fluid is allowed to stagnate in one or more areas of the valve, bacteria growth and other problems may occur.
• In addition, the valve should have an internal flow path which is smooth. Sharp edges and corners may damage blood cells and cause hemolysis.
• A valve that overcomes the above-stated problems is desired.
SUMMARY OF THE INVENTION
• In accordance with one preferred embodiment, a medical valve for selectively permitting fluid to flow between a first medical device and a second medical device comprises a housing that has an interface suitable for receiving a connector portion of the first medical device, and a seal. The seal is made of a flexible material and has a downstream end in fluid communication with the interface, an upstream end suitable for receiving the second medical device, and a normally substantially closed passage in fluid communication with the downstream end and the upstream end. The passage has a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of the second medical instrument into the upstream end of the passage. The passage retracts to define a restricted flow path and a relatively small interior volume upon the withdrawal of the second medical device from the seal (the upstream end initially being sealed as the second medical device is withdrawn) so that a fluid occupying the interior volume is forced toward the downstream end as the passage walls collapse.
• In accordance with another preferred embodiment there is provided a valve seal for use in a medical valve having an interface for fluid communication with a first medical device. The seal comprises a first end in fluid communication with the interface, a second end suitable for receiving a second medical device, and at least one slit in fluid communication with the first end and the second end. The slit defines a restricted fluid flow path and a relatively small interior volume when in an undisturbed state, and defines an expanded fluid flow path and a larger interior volume upon the introduction of the second medical device into the slit. The slit retracts to define a restricted flow path and a relatively small interior volume upon the withdrawal of the second medical device from the seal.
• In accordance with another preferred embodiment a method is provided for causing a positive flow in the direction of a first medical device from a valve that connects the first medical device to a second medical device and has an associated seal. The seal is adapted to receive at least a portion of the second medical device and provide fluid communication between the first and second medical devices. The method comprises the steps of withdrawing the second medical device from the seal and
• permitting the seal to retract from a large interior volume to a relatively small interior volume so as to displace any fluid within the seal in the direction of the first medical device.
• In accordance with another preferred embodiment there is provided a method of preventing blood from flowing out of a patient into a catheter when a syringe is withdrawn from a valve between the syringe and the catheter. The method comprises the steps of connecting the downstream end of the valve to the catheter and inserting the end of the syringe into a slit forming the upstream end of a normally substantially closed seal passage that is located in a resilient seal and is in fluid communication with the downstream end of the valve. This causes the seal passage to open while providing sealing contact between the syringe and the upstream end of the seal passage. The method further comprises the steps of injecting fluid from the syringe through the seal passage to the catheter and into the patient, and withdrawing the syringe, allowing the walls of the seal passage to return to their substantially closed position while initially maintaining sealing contact between the upstream end and the syringe. This provides a force urging fluid in the passage toward the catheter.
• In accordance with another preferred embodiment there is provided a medical valve for selectively permitting fluid to flow between a first medical device and a second medical device through an associated seal. The valve comprises an interface suitable for receiving a connector portion of the first medical device, and a seal holder in fluid communication with the interface.
• In accordance with another preferred embodiment a system for administering fluid to a blood vessel of a patient comprises a catheter having an upstream end and a downstream end that is suitable for placement in fluid communication with the blood vessel, and a syringe suitable for expelling fluid into the catheter. The system further comprises a valve having a fitting suitable for connection to the upstream end of the catheter and providing selective fluid communication between the syringe and the catheter. The valve further comprises a seal made of a flexible material. The seal has a downstream end in fluid communication with the fitting, an upstream end suitable for receiving the syringe, and a normally substantially closed passage in fluid communication with the downstream end and the upstream end. The passage has a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of the syringe into the upstream end of the passage. The passage retracts to define a restricted flow path and a relatively small interior volume upon the withdrawal of the second medical device from the seal (the upstream end initially being sealed as the syringe is withdrawn), so that a fluid occupying the interior volume is forced toward the downstream end as the passage walls collapse.
• In accordance with another preferred embodiment there is provided a method of making a medical valve seal of the type having a body made of a flexible material and at least one slit formed within the body between adjacent first and second slit walls. The method comprises molding first and second preforms, each preform comprising one of the first and second slit walls and a perimeter edge portion, and pressing the first and second preforms together so that the first and second slit walls face each other. The method further comprises molding an additional amount of a flexible material to at least part of the perimeter edge portions of the first and second preforms so that the first and second preforms and the additional material form a unitary mass with the slit formed therein.
• For purposes of summarizing the invention and the advantages achieved over the prior art, certain objects and advantages of the invention have been described herein above. Of course, it is to be understood that not necessarily all such objects or advantages may be achieved in accordance with any particular embodiment of the invention. Thus, for example, those skilled in the art will recognize that the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein.
• All of these embodiments are intended to be within the scope of the invention herein disclosed. These and other embodiments of the present invention will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments having reference to the attached figures, the invention not being limited to any particular preferred embodiment(s) disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
• Having thus summarized the general nature of the invention and its essential features and advantages, certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
• FIG. 1 is a schematic view of the use of a valve in accordance with the invention to interconnect a catheter with a fluid source such a syringe;
• FIG. 2 is a perspective view of the valve;
• FIG. 3 is a front elevation view of the valve;
• FIG. 4 is a side elevation view of the valve;
• FIG. 5 is a perspective view of a seal for use in the valve;
• FIG. 6A is a front elevation view of the seal;
• FIG. 6B is a front cross-sectional view of the seal;
• FIG. 7A is a side elevation view of the seal;
• FIG. 7B is a side cross-sectional view of the seal;
• FIG. 8A is a front elevation view of the seal;
• FIGS. 8B-8D are cross-sectional schematic views of the insertion of a medical device into the seal taken throughlines8B-8B,8C-8C and8D-8D ofFIG. 8A, respectively;
• FIG. 9 is a front cross-sectional view of a housing for use in the valve;
• FIG. 10 is a side cross-sectional view of the valve and the syringe before insertion of the syringe into the valve;
• FIG. 11 is a side cross-sectional view of the valve with the syringe fully inserted;
• FIG. 12 is a front cross-sectional view of the valve with the syringe fully inserted;
• FIG. 13 is a side cross-sectional view of the valve with the syringe partly withdrawn;
• FIG. 14 a side cross-sectional view of the valve with the syringe further withdrawn in comparison toFIG. 13;
• FIG. 15 is a side elevation view of an alternative embodiment of the valve, with the syringe partly inserted;
• FIG. 16 is a side elevation view of an alternative embodiment of the valve, with the syringe fully inserted;
• FIG. 17 is a front elevation view of the valve as used with a syringe having a Luer lock;
• FIG. 18 is a side elevation view of an alternative embodiment of the valve housing;
• FIGS. 19A-19E are schematic views of a process of making the seal; and
• FIG. 20 is a plan view of an overmold plate used in making the seal.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
• FIGS. 1-9 depict avalve20 in accordance with a preferred embodiment of the invention.FIG. 1 illustrates a particular use of thevalve20 to which it is well suited. Of course, thevalve20 may be used in a variety of other manners.
• As illustrated inFIG. 1, thevalve20 may advantageously be used to selectively control the flow of fluid to a first medical device (such as acatheter22 shown here) from a second medical device (generally comprising a fluid source such as an ISO standard syringe24). In this arrangement, thecatheter22 is connected to one end of thevalve20 and has atip26 inserted into the arm of a patient. Thesyringe24 has a cannula tip orLuer28 that is inserted into the other end of thevalve20, which is designed to accept theLuer28 of thesyringe24 without a needle installed on the Luer.
• When so connected, thevalve20 permits fluid to flow from thesyringe24 to thecatheter22 and into the patient. Thevalve20 is also arranged so that when thesyringe24 is disconnected, fluid flow through thevalve20 is prevented. In addition, when thesyringe24 is disconnected, thevalve20 generates a “positive” fluid flow, i.e. flow of fluid in the direction of the patient, thereby preventing blood from entering thecatheter22 and causing the associated adverse effects.
• FIGS. 2-4 depict one preferred embodiment of avalve20 in accordance with the invention. Thevalve20 comprises a relativelyrigid housing30 and a relatively flexible andresilient seal32 disposed on or within thehousing30. Thehousing30 has aLuer lock interface34 at its lower end to facilitate connecting thevalve20 to a variety of medical devices. One skilled in the art will readily appreciate that a number of other interface or connection types are suitable for use in place of theLuer lock34, such as a Luer slip connection or a barbed hose fitting.
• Theseal32 has a slit opening36 (best seen inFIG. 2) which is configured to permit theLuer28 of a syringe24 (seeFIG. 1) to enter theseal32 upon application of moderate pressure by the user. Thesyringe Luer28 thus enters a slit38 (seeFIG. 3) formed in the interior of theseal32. With thesyringe Luer28 thus inserted, the seal permits fluid ejected from thesyringe24 through theLuer28 to flow through theslit38 and Luer lock34 and into thecatheter22 or other medical device attached to theLuer lock34.
• FIGS. 5-7B show theseal32 removed from the housing for purposes of clarity. Theseal32 has abody40 which may take the form of a slab having a flat, generally rectangular shape. Like the entirety of theseal32, thebody40 is preferably formed of molded, 50 durometer silicone rubber, or is alternatively formed of synthetic polyisoprene. At one end of thebody40 is formed a flat, generallyrectangular neck42 and a generally circulartransverse flange44. Theneck42 is situated between first and secondlateral extensions43a,43bwhich haveshoulders43c,43dcomprising those portions of the lateral extensions nearest theflange44. Thebody40,neck42 andflange44 thus form an integral unit, inside of which is formed the (preferably substantially planar) slit38. Theslit38 extends from the slit opening36 (best seen inFIG. 2) in theflange44 to alead lumen46 formed in an end of thebody40 opposite theflange44. Thelead lumen46 is preferably substantially cylindrical and centered about an axis that is substantially parallel to or collinear with the longitudinal axis of the seal. Theslit38 is preferably substantially planar and of virtually no thickness unless a Luer is connected. Theslit38 thus forms (in its undisturbed state, i.e. when thesyringe Luer28 has not been inserted into the seal32) a highly restricted fluid flow path from the slit opening36 to thelead lumen46. As used herein in reference to a flow path, “restricted” means a flow path that permits either no fluid, or a clinically negligible amount of fluid, to pass.
• The preferred configuration of theslit38 andlead lumen46 is best seen inFIGS. 6A-7B. Theslit38 has abody portion48 within thebody40 of theseal32. Advantageously, thebody portion48 is a region of maximum width, preferably about 0.228″, of theslit38. Theslit38 tapers to a point orregion50 of minimum width, which is preferably located within theneck42. Advantageously, at theregion50 of minimum width theslit38 is preferably about 0.120″ wide. In other words, the width of theslit38 in thebody portion48 is almost twice that of theregion50 of minimum width. From theregion50 of minimum width theslit38 tapers outward to the slit opening36, where it attains a preferred width of about 0.200″. This tapered configuration acts as lead-in for insertion of thesyringe Luer28 into theslit38. Theslit38 may also have beveledcorners52 at its lower end, opposite theneck42. At its lower end theslit38 connects to thelead lumen46 to facilitate fluid communication between theslit38 and thelead lumen46. Thelead lumen46 preferably has a lead-inchamfer54 and abeveled transition56 to theslit38. The preferred inside diameter of thelead lumen46 is about 0.040″.
• In the side views ofFIGS. 7A and 7B, it may be seen that theseal32 has a T-shaped cross section before installation in thehousing30, with theflange44 forming the cross portion of the “T”. Viewed from the side, theslit38 is uniformly thin, i.e. of no or virtually no thickness, as it runs from the top of theseal32 to thelead lumen46. However, upon installation in thehousing30, the thickness of the slit38 (when viewed from the side) will vary somewhat as will be explained in greater detail below.
• FIGS. 8A-8D show the effects, in terms of sealing performance, of the varying width of theslit38 after introduction of asyringe Luer28 into theslit38. (Thesyringe Luer28 is not shown inFIG. 8A for purposes of clarity.)FIG. 8B shows the arrangement of theslit38 and thesyringe Luer28 at theregion50 of minimum width, when theLuer28 has been fully inserted into theslit38. Due to the relative narrowness of theslit38 at theregion50, theslit38 draws up against substantially the entire perimeter of thesyringe Luer28 at that location, creating a relatively tight perimeter seal between theslit38 and theLuer28. In other words, the perimeter of theopen slit38 at theregion50 is less than the circumference of theLuer28.
• FIGS. 8C and 8D show that where theslit38 is wider (i.e., in thebody portion48 of the slit and the transition from the region50) the slit no longer contacts the entire perimeter of thesyringe Luer28, leavinggaps57 on one or both sides and the end of theLuer28. In other words, the perimeter of the open slit in thebody portion48 is greater than the circumference of theLuer28. As will be discussed in greater detail below, this arrangement of a slit-Luer seal near the top of theslit38 and a fluid-occupiable volume (in the form of the gaps57) below the slit-Luer seal, promotes a positive-flow function for thevalve20 when thesyringe Luer28 is withdrawn.
• FIGS. 3, 4, and9 show a preferred configuration of thehousing30 and the installation of theseal32 therein. Thehousing30 is preferably formed of molded polycarbonate, or alternatively formed from any suitable thermoplastic. Thehousing30 has aseal holder58 attached to theLuer lock34; the seal holder preferably has a cylindrical configuration, but may comprise any shape or construction sufficient to hold theseal32 on or in thehousing30 without interfering with operation of thevalve20. The seal holder has anaxial opening60 opposite theLuer lock34, and first andsecond side openings62a,62bwhich have first and secondtop edges63a,63bthat comprise the edges of the side openings nearest theaxial opening60. A lead cannula64 (best seen inFIG. 9) extends from theLuer lock34 toward theaxial opening60 and contains aninternal lumen66 which is in fluid communication with alumen68 in theLuer lock34. Thelead cannula64 is preferably substantially cylindrical or frusto-conical in shape and centered about an axis that is substantially parallel to or collinear with the longitudinal axis of thehousing30. A pair oflugs70 are positioned on the end of theseal holder58 near theaxial opening60, to permit a Luer lock or other threaded connection (not shown) to threadably engage thehousing30 at theaxial opening60.
• As best seen inFIGS. 3 and 4, most of theseal32 is situated within theseal holder58, with the first and secondlateral extensions43a,43bof theseal32 protruding from the first andsecond side openings62a,62b. Thelead lumen46 of theseal32 is situated so that thelead cannula64 extends at least partway into the lead lumen, facilitating fluid communication between theseal32 and theLuer lock34. Theflange44 covers theaxial opening60 and contacts the adjacent edges of the opening. Preferably, the distance between theaxial opening60 and thetop edges63a,63bof theside openings62a,62bis slightly larger than the distance between theflange44 and theshoulders43c,43dof thelateral extensions43a,43b. This arrangement results in the application of a tensile force or preload to theseal32 between theflange44 and thelateral extensions43a,43b. The preload arises as theshoulders43c,43dbear against thetop edges63a,63band theflange44 bears against the edges of theaxial opening60. The preload causes theflange44 to assume a slightly bowl-shaped or concave configuration as the edges of theaxial opening60 bear against the underside of theflange44. The bowl-shapedflange44 thus serves as a lead-in for the insertion of thesyringe Luer28 into the slit opening36 (best seen inFIG. 2), and tends to pinch closed theslit opening36 and thus enhances the ability of theseal32 to prevent fluid flow. The preload also prevents buckling of the seal along its longitudinal axis and maintains the sides of theslit38 in close proximity along their entire length. The preload thus promotes a relatively thin slit below theflange44, which enhances the sealing performance of theslit38.
• FIGS. 10-14 illustrate the function of thevalve20 as asyringe Luer28 is inserted into and withdrawn from theslit38.FIG. 10 shows thevalve20 prior to insertion of thesyringe Luer28; at this point theslit38 defines a substantially closed or highly restricted flow path through theseal32, marked by a very thin (or substantially nonexistent) path thickness T_minbetweenslit walls72a,72b. This thin or nonexistent path thickness T_minprevails along most or substantially all of the length of theslit38 below theflange44. This condition restricts fluid flow through theseal32 so as to seal off the catheter22 (seeFIG. 1) or other medical device connected to theLuer lock34. At this point theslit38 also defines a relatively small interior volume V_minwithin theseal32, between theslit walls72a,72b. (As used herein in reference to an interior volume of the seal, “relatively small” means a volume that is either nonexistent or clinically negligible in size.) In this initial state, theseal32 is situated upon thelead cannula64 such that substantially none of thelead cannula64 extends into theslit38.
• FIGS. 11 and 12 show thevalve20 after thesyringe Luer28 has been completely inserted into theslit38. Theseal32 has also been stretched or forced downward onto thelead cannula64, at least part of which penetrates into theslit38 itself. At this point theslit38 defines an expanded flow path through theseal32, in that theslit walls72a,72bhave spread to a path width T_max. Theseal32 thus permits fluid to flow between thesyringe24 and thecatheter22. In addition, theslit38 now defines a larger or maximum interior volume V_max. V_maxcomprises the entire space between theslit walls72a,72bless the volume taken up by the cannula (but not the internal lumen) of thesyringe Luer28 and less that portion of thelead cannula64 which has penetrated into theslit38. Accordingly, under pressure exerted via thesyringe24 an amount of fluid substantially equivalent to V_maxnow fills theslit38 between theslit walls72a,72b. This is also shown asgaps57 inFIGS. 8C and 8D.
• FIGS. 13 and 14 show the function of theslit38 as thesyringe Luer28 is withdrawn from thevalve20. As thesyringe Luer28 andlead cannula64 exit the slit, theslit walls72a,72bretract to substantially their original configuration to once again define a narrow path width (approaching T_min) between them. This retraction of theslit walls72a,72breduces the volume between the walls; that is, the internal volume within theslit38 is decreasing from V_max. Thus the amount of fluid within the slit must also decrease from V_max. Accordingly, the retractingslit walls72a,72bdisplace the fluid from theslit38 as thesyringe Luer28 is withdrawn.
• The fluid thus displaced cannot flow out of theslit38 through the top of theseal32. As detailed above with regard toFIGS. 8A-8B, theslit38 maintains a tight seal against thesyringe Luer28 at theregion50 of minimum width as thesyringe Luer28 is withdrawn. In addition, the displaced fluid cannot flow into the interior of thesyringe24 at all times relevant to the use of thevalve20. Therefore, substantially all of the displaced fluid must exit theslit38 through thelead cannula64 andLuer lock34, resulting in positive flow from thevalve20 upon withdrawal of thesyringe Luer28.
• FIGS. 15-18 show variations on thevalve20 disclosed above, which variations may be desirable under certain operating conditions. For example, as seen inFIGS. 15 and 16 thehousing30 may have abreak74 running vertically between theaxial opening60 and one or both of theside openings62a,62b. Thebreak74 permits theseal holder58 to spread open as a Luer slip28 (as opposed to aLuer lock76 shown inFIG. 17) is inserted into theseal32. This spreading action has been found to be advantageous for using thevalve20 with aLuer slip28, as thevalve20 becomes less likely to squeeze or pinch theLuer28 out of theseal32.
• FIG. 18 shows an alternative configuration of thehousing30, with a curved or streamlined appearance in comparison to the housing disclosed above. Both this type of housing or the type disclosed above, may have an external coating or layer of a relatively soft, pliant material such as a thermoplastic elastomer to enhance operator comfort and to promote the theme of avalve20 that provides a connection without the use of sharp, puncturing elements such as needles or blades.
• FIGS. 19A-21 depict a preferred method of making theseal32. First, a pair ofpreforms202a,202bare molded between first and second mold pairs204a,204band206a,206brespectively. Each preform202 has a generallyplanar portion208 that, in the completedseal32, forms a wall of the slit38 (seeFIGS. 6A-7B). Aflange portion210 is also integrally molded into both preforms202. The sides of theflange portion210 are preferably set back from the upper face of theplanar portion208, to provide a space for overmold material (discussed in further detail below) to flow between and connect theflange portions210. The molding of the preforms202 is accomplished using conventional techniques and equipment, preferably by injecting a thermoset material into the cavity formed between the mold pairs204a,204band206a,206band heating the molds and/or material to the set temperature of the specific material used. Pressure may be applied as needed to prevent material from leaking between the halves of the mold.
• After this initial molding step, the mold halves204a,206a, with thepreforms202a,202bstill positioned in them, are pressed together with anovermold plate212 positioned between the mold halves, as depicted inFIGS. 19B-19C. Theovermold plate212, best seen inFIG. 20 (with the outline of the preforms202 also shown in phantom), comprises a generallyplanar plate body214 with anovermold opening216 cut into thebody214. Theovermold opening216 has a plan perimeter that conforms to the outer edges of the completedseal32, and may include amandrel218 that projects from the lower portion of theopening216 and forms the lead lumen46 (seeFIGS. 6A-7B) during the overmold process, as will be discussed in greater detail below. The contacting faces of the mold halves204a,206aand theovermold plate212 are advantageously substantially planar. Thus the mold halves204a,206a,plate212, and preforms202a,202bdefine a mold cavity orvolume220 between the walls of theovermold opening216 and the outer edges of thepreforms202a,202b, and between the faces of the mold halves204a,206a.
• With the mold apparatus (mold halves204a,206aand overmold plate212) arranged as shown inFIG. 19C, additional thermoset material is injected into the mold apparatus to fill themold cavity220 and form the remainder of theseal32. Preferably, the additional material is injected soon (i.e., a few seconds) after the preforms202 are molded and while they are still somewhat hot from the initial molding. The additional material injected into themold cavity220 bonds to the edges of the preforms202 and forms the edges of theslit38 in the completedseal32. In other words, the remainder of the seal is overmolded onto the “sandwich” of preforms202. Preferably, the preforms202 are pressed together with sufficient force during the overmolding process to prevent the additional material from migrating between the contacting surfaces of the preforms202. This preserves the patency of theslit38 by preventing the contacting faces of the preforms202 from bonding to each other during the overmold step.
• Theovermold plate212 may be made with a thickness approximately the same as that of the “sandwich” ofpreforms202a,202bto define amold cavity220 that, as described above, comprises the open space between the walls of theovermold opening216 and the outer edges of thepreforms202a,202b, and between the faces of the mold halves204a,206a. This overmold opening thus also has a thickness approximately equal to that of the preform sandwich, and all or nearly all of the overmold material injected therein bonds only to the edges of thepreforms202a,202b. In an alternative embodiment, theovermold plate212 may have a thickness greater than the preform sandwich. This thicker, alternative overmold plate thereby defines a mold cavity that also includes open space that is created between the mold halves204a,206aand the outer (i.e., facing away from the slit in the completed seal) faces of thepreforms202a,202b. The mold halves204a,206aare preferably configured with projections, ridges, channels, gaps or the like to create such space during this alternative overmold step while pressing the preforms together as may be needed during the overmold. Accordingly, in this embodiment the overmold material bonds to both the edges and to the outer faces of thepreforms202a,202b. In other words this alternative overmold step involves injecting the overmold material into a mold cavity that surrounds most or all of the preform sandwich, rather than overmolding to the only the edges of the preforms.
• It is preferred that the material added in the overmold step is similar to that utilized in molding the preforms202; however, in other embodiments the preform material and the overmold material may comprise different but nonetheless suitable materials for manufacturing the seal, as discussed above. Therefore as used herein “a flexible material” refers to any material selected from the class of suitable seal materials as disclosed.
• After the overmolding is complete, the mold halves204a,206aare removed from theseal plate212, which now contains a substantially completedseal32, as seen inFIGS. 19D-19E. The completedseal32 is easily removed from theseal plate212, and the seal thus formed comprises, as discussed above, a unitary mass of molded material with the slit arranged within it.
• Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims (1)

1. A seal element for a medical valve, the seal element comprising:

a seal body made of a flexible material, the seal body having a downstream end configured to fluidly communicate with a housing of the medical valve, an upstream end suitable for receiving a medical device, and a normally substantially closed planar passage in fluid communication with the downstream end and the upstream end, the seal body having a generally rectangular shape;

a neck formed at the upstream end of the seal body; and

a transverse flange at an end of the neck opposite the body, the transverse flange having at least one opening in fluid communication with the passage; and

wherein the passage has a relatively small interior volume when in an undisturbed state and a larger interior volume upon the introduction of a medical device into the upstream end of the passage, the passage retracting to define a restricted flow path and a relatively small interior volume upon the withdrawal of the medical device from the seal element, the upstream end initially being sealed as the medical device is withdrawn, so that a fluid occupying the interior volume is forced toward the downstream end as the passage walls collapse.

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