Catheter assembly with seal member

0001The present invention relates to over-the-needle catheters, such as peripheral intravascular catheters (PIVCs), and more specifically includes seals placed within the catheter hub for enhanced blood control. It relates to a catheter assembly used with such a catheter.

0002As a background technique, conventional PIVCs include a catheter assembly, which typically comprises a catheter hub and a catheter tube extending apical from the catheter hub in an over-the-needle manner. It has an attached needle assembly. The needle assembly typically comprises a needle hub or support and a needle cannula that extends distally from the needle hub. The needle cannula extends through the catheter tube in the PIVC standby position, exposing the sharp tip of the needle cannula from the tip of the cannula tube. The tip of the needle cannula is used to penetrate the tissue during insertion of the catheter tube into the patient's vascular system. After the catheter tube is placed in the vessel, the needle cannula is withdrawn from the catheter assembly in the proximal direction and the catheter assembly remains fluid-operated with respect to the vessel. The PIVC can also be equipped with a protector to enclose at least the tip of the needle cannula after use rather than the entire needle cannula. PIVCs with protectors are referred to as safety catheters and can be preferred.

0003The catheter hub typically has an open proximal end configured to receive a male luer taper into the internal cavity of the catheter. This makes it possible to establish fluid communication between the patient's vasculature and the luer taper. An external ear or the like can be further provided at the base end portion. This allows the luer taper to be secured within the catheter hub, for example when the luer taper is connected to a male luer lock collar or nut. This makes it possible to form a part of a processing set such as a syringe, that is, a male luer lock such as a connector at an end. Under normal conditions, blood begins to flow immediately through the catheter tube and into the internal cavity of the catheter hub after withdrawal of the needle cannula and before the luer taper is inserted into the catheter hub. .. In a typical catheter hub configuration, the proximal end of the catheter hub opens and communicates with the catheter tube through an internal cavity. This allows blood to flow into the catheter hub and out into the surrounding environment if care is not taken in a timely manner. To limit the influx of blood into the catheter hub, healthcare professionals typically apply digital pressure to the vicinity of the insertion site. As a result, the inflow of blood into the catheter tube can be blocked. The processing set or syringe is then connected to the catheter assembly. This allows fluid to be introduced into the patient and / or blood to be drawn from the patient.

0004By providing a hemostatic seal in the internal cavity at the proximal opening of the catheter hub so that different configurations of catheter assembly can block fluid flow between the proximal end of the catheter hub and the catheter tube. It has been proposed to control or limit blood flow. In such a configuration, the hemostatic seal allows the passage of the needle cannula in the PIVC standby position. However, the hemostatic seal seals the blood flow to or from the proximal end of the catheter hub when the needle cannula is pulled out toward the proximal end. The hemostatic seal is adapted to be opened by inserting a luer taper into the catheter hub. This allows fluid communication between the luer taper and the catheter tube.

<p num="0005"><patcit num="1"><text>U.S. Patent Application Publication No. 2007/0191775</text></patcit></p>

<p num="0006"> Although various configurations of catheter assemblies with hemostatic seals have been proposed, no commercially acceptable one has yet been presented. Therefore, there is a demand for improvements that can overcome the shortcomings of existing configurations.</p>

<p num="0007"> The present invention provides a catheter assembly with an improved hemostatic seal configuration, and an object of the present invention is to overcome various drawbacks in the conventional catheter assembly configuration. To this end, in one feature of the invention, a rigid actuator is oriented in the internal cavity from the tip of the catheter hub to the free end with an enlarged base flange. It is postponed. The increased diameter base end flange can advantageously define the barb. In a further feature of the invention, the seal member is located within the internal cavity of the catheter hub and comprises a membrane and a tip extending distally from the membrane to the seal outlet hole. The tip comprises an actuator cavity formed between the membrane and the seal outlet hole. As a result, the free end of the actuator is received inside the actuator cavity through the seal outlet hole. The actuator cavity can advantageously have a reduced diameter portion that imparts a constricted shape to the actuator cavity. As a result, the surface of the proximal flange can be engaged with the reduced diameter portion of the actuator cavity when the actuator extends into the actuator cavity through the seal outlet hole. The above features provide a reliable seal between the seal member and the actuator, and in addition provide a reliable hold of the seal member to the actuator.</p><p num="0008"> The sealing member advantageously comprises a proximal end. The base end portion is, for example, a cylinder, and extends from the membrane to the base end defining the impact surface in the direction of the base end. When inserting the male luer taper into the internal cavity of the catheter hub, the free end of the male luer taper impacts the impact surface. As a result, the seal member can be slid in the axial direction along the actuator. The membrane is, after all, forcibly released as the free end of the actuator moves through the membrane. The membrane can advantageously be slit so that the membrane can be easily opened. The seal member is advantageously an integral member.</p><p num="0009"> In another feature of the invention, the actuator for the catheter assembly can include an eyelet portion configured to assist in fixing the catheter tube to the catheter hub. As a result, the actuator integrally has an eyelet portion. For this purpose, the actuator was provided at one end of the actuator with a main shaft having a first cross-sectional dimension and an eyelet shaft having a second cross-sectional dimension, and at the other end of the actuator. A barb having a third cross-sectional dimension can be provided. The third cross-sectional dimension is made larger than the first and second cross-sectional dimensions, and the second cross-sectional dimension is the same as or smaller than the first cross-sectional dimension, which is advantageous. The second cross-sectional dimension is the size associated with the number of gauges on the needle cannula used with the catheter hub. Thus, the actuator provides both the function of fixing the catheter tube to the catheter hub and, if desired, opening the seal member.</p><p num="0010"> In yet another feature of the invention, when the gauge number of the needle cannula is small, for example 16 or 18, the diameter of the needle cannula is quite large and the cross-sectional dimensions of the eyelet shaft. Can be approximately the same size or slightly smaller than the cross-sectional dimensions of the actuator main shaft. The actuator is advantageously provided with surface features in the form of radially outwardly extending annular ribs to enhance the fixation of the actuator to the catheter hub. The annular rib can be provided at the connecting portion between the main shaft and the eyelet shaft. When the gauge number of the needle cannula is large, for example 20, 22, 24, 26, the diameter of the needle cannula is relatively small, and the cross-sectional dimension of the eyelet shaft is the cross-sectional dimension of the actuator main shaft. It can be made substantially smaller than the above. If desired, the actuator may be provided with surface features to enhance the fixation of the actuator to the catheter hub. Surface features can be annular ribs, or one or more dimples, such as those provided on the main shaft adjacent to the eyelet shaft, or one or more axial grooves or annular grooves. Can be.</p><p num="0011"> The seal member can be supported on the actuator. The outer surface of the sealing member partially engages the inner surface or inner wall of the catheter hub around the periphery. As a result, it is secured between the region of the internal cavity on the distal end side of the seal member and the region of the internal cavity on the proximal end side of the seal member. Thus, the seal member is held without causing unnecessary lateral or tilting movements, yet allows air or other fluids to escape while easily sliding the seal member along the actuator in the axial direction. be able to. The air path, or at least a portion of the air path that functions to limit engagement around the perimeter because it is a partial engagement around the perimeter, is advantageously an axis within the outer surface of the seal member. It can be defined at least partially by a directional channel or groove. In this case, the sealing member is not engaged with the inner wall of the catheter hub in the area of the groove. The shape of the sealing member on the proximal end side and the distal end side with respect to the region of partial engagement around the peripheral edge can be a smaller cross-sectional dimension as compared with the cross-sectional dimension of the facing region of the catheter hub. Thereby, an annular gap can be formed between the opposing surfaces in the opposing region, and this annular gap can be a part of the air path.</p><p num="0012"> The catheter assembly can be configured for use with a needle cannula and nose that project into the internal cavity of the catheter hub. The nose advantageously extends into a standard luer taper base end for engaging with the inner wall of the catheter hub adjacent to the base end opening of the catheter hub and into the base end cylindrical portion of the seal member. It has a tip-shaped portion that is smaller than the standard lure portion so that it can protrude. The tip of the nose is adjacent to the membrane of the sealing member. The membrane can be provided with a slit that penetrates the membrane. The slit defines multiple flaps. The tip of the nose can advantageously be provided with a recess that overlaps the slit in the membrane. The recess can accommodate the flap of the slit when the needle cannula is withdrawn from the catheter hub.</p><p num="0013"> From a further point of view of the present invention, the sealing member can be placed within the catheter hub. In this case, the tip of the seal member having the seal outlet hole is separated from the tip of the catheter hub by the first distance, and the impact end of the seal member is the second distance from the base end of the catheter hub. Is only separated. For example, by inserting the male luer taper into the catheter hub, the seal member is driven axially by a third distance. As a result, the membrane is driven beyond the free end of the actuator, thereby opening the seal member. Advantageously, the third distance is set to be smaller than the first distance, whereby the seal member is driven axially by the third distance to open the seal member and then compressed in the axial direction. There is no. In any case, the base end portion of the seal member is not compressed in the axial direction after the seal member is driven to the open state. More advantageously, each of the first distance and the second distance is made larger than the axial thickness of the membrane of the sealing member.</p><p num="0014"> Membrane slits, if provided, are advantageously trislits. The trislit forms a Y-shape in a plan view. In yet another embodiment of the invention, the perforation tool for forming a trislit on the membrane of the sealing member has a three-sided base with three corners at one end and a sharp tip at the other end. It comprises a pyramid of molds and a shaft extending from the base, the shaft comprising three straight sharp edges and a flat surface located between the edges, each of which has a base. It is aligned in the axial direction with respect to the three corners of. In a related method, a sealing member is placed in the hole of the fixture and the drilling tool is inserted into the fixture to engage the sharp tip with the membrane and the drilling tool into the fixture. By continuing to insert, at least part of the pyramid of the drilling tool is pushed in with the membrane inserted.</p><p num="0015"> From a further point of view of the present invention, the seal member can be configured as a multiple use type seal and includes an urging member between the seal outlet hole and the tip of the catheter hub. In this embodiment, the seal member can slide axially along the actuator towards the tip. As a result, the membrane can be moved beyond the free end of the actuator, and the membrane can be opened. The urging member can slide the seal member along the actuator toward the proximal end. This allows the membrane to move back beyond the free end of the actuator, thereby closing the membrane. For example, when the male luer taper is removed from the catheter hub, the urging member can drive the sealing member axially towards the occlusion position. Therefore, the urging member can repeatedly open and close the seal member.</p><p num="0016"> In one embodiment, the urging member may include a tubular extension member. The tubular extension member can be compressed when the seal member is opened. This makes it possible to provide a return driving force that slides the seal member in the axial direction toward the closed position. Alternatively, the urging member may include one or more legs with similar properties. In another aspect of the invention, the urging member can be partially compressed when the membrane is closed. As a result, it is possible to increase the return driving force acting on the seal member when the membrane returns and moves beyond the free end of the actuator. In other respects, the urging member may include a flange configured to cooperate with an annular rib formed in the catheter hub. Thereby, the sealing member can be fixed in the catheter hub. The above provides catheter assemblies with improved hemostatic seal configurations for the purpose of overcoming various shortcomings of the configurations of conventional catheter assemblies, individually or in combination. The above and other objects and advantages of the present invention will be clarified by the accompanying drawings and the following description.</p><p num="0017"> The accompanying drawings that form part of this specification illustrate various embodiments of the present invention, along with a general description described above and a detailed description of embodiments described below. It serves to illustrate the principles of the invention.</p>

0018<figref num="1">FIG. 5 is a cross-sectional view showing an embodiment of a catheter assembly including an actuator and a sealing member based on various features of the present invention.</figref><figref num="2">FIG. 1 is a cross-sectional view showing a portion of a PIVC with the catheter assembly of FIG. 1 in a standby position for purposes of explaining various features of the invention.</figref><figref num="3">It is a perspective view which shows the actuator in FIG. 1 and FIG.</figref><figref num="3A">It is a partial perspective view which shows the alternative embodiment of the actuator in FIGS. 1 and 2 for the purpose of explaining still other features of this invention.</figref><figref num="3B">It is a partial perspective view which shows the alternative embodiment of the actuator in FIGS. 1 and 2 for the purpose of explaining still other features of this invention.</figref><figref num="3C">It is a partial perspective view which shows the alternative embodiment of the actuator in FIGS. 1 and 2 for the purpose of explaining still other features of this invention.</figref><figref num="4">FIG. 3 is a partial perspective view showing alternative embodiments of actuators in the catheter assemblies of FIGS. 1 and 2.</figref><figref num="4A">It is a cross-sectional view taken along the line 4A-4A of FIG.</figref><figref num="5">It is a perspective view which shows the seal member in FIG. 1 and FIG.</figref><figref num="6">It is a cross-sectional view which shows the seal member of FIG. 5, and is the cross-sectional view taken along the arrow 6-6 in FIG.</figref><figref num="7">It is a cross-sectional view which shows the seal member of FIG. 5, and is the cross-sectional view taken along the arrow 7-7 in FIG.</figref><figref num="8">Although the drawing is similar to that of FIG. 2, in this case, the needle cannula is retracted toward the proximal end in order to explain the features of the present invention.</figref><figref num="9">It is a cross-sectional view partially showing the catheter assembly of FIG. 1, and when the seal member is driven, it slides in the axial direction along the actuator by inserting a male luer taper into the catheter hub. Is shown.</figref><figref num="10">FIG. 1 is a cross-sectional view partially showing the catheter assembly of FIG. 1, where the sealing member has finished sliding axially onto the free end of the actuator and is completely opened by inserting a male luer taper into the catheter hub. It shows how it was done.</figref><figref num="11">FIG. 1 is a diagram showing a seal member in FIG. 1 showing a fixture in cross section and a perforation tool used together to form a trislit on the membrane of the seal member.</figref><figref num="11A">It is a figure showing an alternative embodiment, showing the sealing member in FIG. 1, the fixture in the cross section, and the diameter expansion tool used together to form a trislit in the membrane. ..</figref><figref num="11B">Similar to FIG. 11A, but in this case the diameter expansion tool is engaged with the seal member.</figref><figref num="12">It is a cross-sectional view which shows the end part of the drilling tool in FIG. 11, and is the cross-sectional view taken along the line 12-12 in FIG.</figref><figref num="13">It is a perspective view which shows the multi-purpose seal member based on the further feature point of this invention.</figref><figref num="14">FIG. 13 is a cross-sectional view partially showing a catheter assembly with a multi-use seal member of FIG. 13 showing a state before driving by inserting a male luer taper into a catheter hub.</figref><figref num="15">FIG. 14 is a cross-sectional view showing a partial view of the catheter assembly of FIG. 14, where the seal member finishes sliding axially on the free end of the actuator and is completely opened by inserting a male luer taper into the catheter hub. This shows that the urging member of the seal member is being pressed.</figref><figref num="16">It is a perspective view which shows the alternative seal member for a plurality of uses.</figref><figref num="17">FIG. 14 is a cross-sectional view partially showing a catheter assembly similar to FIG. 14, comprising a partially pressed urging member when the sealing member is in the closed position.</figref><figref num="18">It is a perspective view which shows the other multi-purpose seal member.</figref><figref num="19">FIG. 18 is a cross-sectional view partially showing a catheter assembly with a multi-use seal member of FIG. 18 before being driven by insertion of a male luer taper into a catheter hub.</figref>

0019As shown in FIG. 1, a catheter assembly 10 based on the various features of the invention is a catheter hub 12 and a catheter that is anchored to the catheter hub 12 and extends distally from the catheter hub 12. A tube 14, an actuator 16 that is fixed to the catheter hub 12 and extends axially along with the catheter hub 12, and is located within the catheter hub 12 and is movable on the actuator 16. It comprises a supported sealing member 18. The seal member 18 can be axially shifted with respect to the actuator 16. The seal member 18 slides axially along the actuator 16, for example, between the closed position or seal position shown in FIG. 1 and the open position or drive position (eg, shown in FIG. 10). Thereby, it is possible to shift in the axial direction with respect to the actuator 16. In the occlusion position, the catheter hub 12 is substantially sealed to the catheter tube 14. As a result, blood inflow into the catheter hub 12 is prohibited. However, in the open position, as will be described in detail later, the seal member 18 is pushed onto the actuator 16, and the catheter hub 12 and the catheter tube 14 are in an open fluid communication state.

0020The catheter hub 12 comprises a proximal end 20 with an unobstructed opening 21, a distal end 22, and an internal cavity 24 extending between the proximal end 20 and the distal end 22. The inner cavity 24 is defined by the inner surface or wall 25. The internal cavity 24 includes a proximal end portion 26 extending from a location adjacent to the proximal end portion 20 to the vicinity of the distal end portion 22, and a distal end cavity 28 located in the vicinity of the distal end portion 22. Proximal end component 26 has a first upper 29 formed on the basis of the luer taper standards to the luer taper 30 therein (FIGS. 9 and 10) can receive engaging manner, at least the minimum of the first portion 29 It includes a second lower portion 31 having a relatively constant cross-sectional dimension (eg, diameter) that is larger than the tapered cross-sectional dimension. A transition area 32 is provided between the first upper part 29 and the second lower part 31.

0021The catheter tube 14 includes a proximal end 34, a tapered tip 35, and an opening passage 36 extending between the proximal end 34 and the distal end 35. The proximal end 34 of the catheter tube 14 is secured within the distal cavity 28 of the catheter hub 12 using the actuator 16. As a result, the catheter tube 14 extends from the tip end 22 of the catheter hub toward the tip end. Therefore, not only does the actuator 16 support the seal member 18 and allow the seal member 18 to open, but the actuator 16 also functions to secure the catheter tube 14 to the catheter hub 12.

0022Catheter assembly 10 is advantageously utilized as part of PIVC38. A part of PIVC38 is shown in FIG. 2 in the standby position of PIVC38. For this purpose, the needle cannula 40 has a shaft 41 and extends distally from the nose 42 to the sharp tip 43. The nose 42 extends within the upper 29 of the internal cavity 24 of the catheter hub 12. In the standby position shown in FIG. 2, the needle cannula 40 extends through the seal member 18, the actuator 16, and the catheter tube 14. As a result, the sharp tip 43 is exposed beyond the tip 35 of the catheter tube 14. In the embodiment of FIG. 2, the needle cannula 40 is slidable in the axial direction through the nose 42. As a result, the needle cannula 40 can be pulled out from the catheter hub 14 and the sealing member 18 toward the proximal end without having to pull the nose 42 from the catheter hub 12 toward the proximal end, and finally, the needle cannula 40 can be pulled out toward the proximal end. It can be completely removed from the catheter assembly 10. The nose 42 can extend from the protector cap or flange 44. An example of a protector is Smiths Medical ASD, Inc. ProtectIV® PIVC Needle Guard Housing 45 (only part of which is illustrated with a virtual line in FIG. 2) commercially available from the company. Other types of protectors (not shown) can be used with PIVC38, as will be readily appreciated by those skilled in the art. As shown in FIG. 2, the flange 44 can abut against the proximal end 20 of the catheter hub 12. In addition, the flange 44 can have an annular tip overhang (not shown) that abuts around the proximal end 20 of the catheter hub 12. This allows the PIVC38 to be secured to the proximal end of the catheter hub. For example, such an annular tip overhang can interact with the retention ear 112 of the catheter hub 12. In other embodiments (not shown), the nose and needle cannula are fixed to each other so that they can move integrally. As a result, the nose is inevitably retracted from the catheter hub 12 by retracting the needle cannula toward the proximal end. In this embodiment, the nose functions as a needle hub or support for the needle cannula, as embodied in JELCO® PIVC commercially available from Smiths Medical ASD, Inc. Other examples of needle cannula and nose combinations are disclosed in US Patent Application Publication No. 2007/0191775. The contents of this document are incorporated herein by reference. It functions as a needle hub or support for the needle cannula, as embodied in JELCO® PIVC, which is commercially available from the company. Other examples of needle cannula and nose combinations are disclosed in US Patent Application Publication No. 2007/0191775. The contents of this document are incorporated herein by reference. It functions as a needle hub or support for the needle cannula, as embodied in JELCO® PIVC, which is commercially available from the company. Other examples of needle cannula and nose combinations are disclosed in US Patent Application Publication No. 2007/0191775. The contents of this document are incorporated herein by reference.

0023Further, as shown in FIG. 3, the actuator 16 is generally rigid, and has an overall cylindrical main shaft 46 having an outer surface 47, and a tip eyelet portion 48 at the tip 49. It is provided with a proximal barb 50 at a free end 51 on the proximal side. The open passage 52 extends between the free end 51 and the eyelet portion 48 so that the needle cannula 40 can be received through such passage 52 and the seal member 18 is in the open position. When done, the fluid can be circulated through the passage 52. The tip eyelet portion 48 is similar to a normal eyelet and is for a large gauge needle cannula 40, for example, for a gauge needle cannula 40 of 20,22,24,26. It has an eyelet shaft 53 and a head 54 that couples to the main shaft 46 at the coupling point 55. The eyelet shaft 53 has a cross-sectional dimension that is substantially smaller than the cross-sectional dimension of the main shaft 46. As a result, the size of the eyelet shaft can be made close to the diameter of the needle cannula 40. The barb (or reverse spine) 50 at the free end 51 on the proximal side is the largest cross section that is generally larger than the cross section of the main shaft 46 (and thus the cross section of the eyelet shaft 53). It can be characterized by having dimensions and can include a diameter-expanding flange 56 that is bent over a portion of the main shaft 46. The diameter-expanding flange 56 expands in diameter toward the tip end, and defines a truncated cone-shaped outer surface 57 on the radial outer side of the main shaft 46.

0024As shown in FIG. 1, the tip eyelet portion 48 of the actuator 16 is frictionally engaged in the tip portion 22 of the catheter hub, for example, in the tip cavity 28. As a result, the catheter tube 14 can be fixed to the catheter hub 12. However, unlike conventional eyelets, the main shaft 46 of the actuator 16 extends from the tip 22 of the catheter hub toward the proximal end. As a result, the tip 60 of the main shaft 46 frictionally engages the portion 62 of the tip cavity 28 at region 63. Thereby, it is possible to assist in fixing the actuator 16 to the catheter hub 12. Further, the proximal free end 51 is located within the internal cavity 24 of the catheter hub 12, although it may be separated from the distal end 22. More specifically, the main shaft 46 of the actuator 16 may extend from the distal cavity 28 into the proximal end 26 of the internal cavity 24, whereas the proximal free end 51 of the actuator 16 is of the catheter hub 12. It does not extend to the proximal end 20, but rather terminates on the distal end side of the proximal end 20. In the illustrated embodiment, for example, the free end 51 on the proximal end side terminates within the second portion 31 of the internal cavity 24. In addition, the radial cross-sectional dimension of the actuator 16, including the barb 50, is set to be smaller than the cross-sectional dimension of the second portion 31 of the internal cavity 24 on the proximal side of the tip cavity 28. There is. As a result, an annular space 64 can be formed between the inner wall 25 of the catheter hub 12 and the actuator 16. As will be described in detail later, the annular space 64 is configured to be able to receive the seal member 18 when transitioning to the opening position.

0025The actuator 16 can include surface features formed on the surface so that the fixation of the actuator 16 to the tip 22 of the catheter hub can be enhanced. The surface feature can be, for example, one or more dimples 65a provided on the outer surface 47 at the tip 60 of the main shaft 46, away from the head 54 of the eyelet portion (FIG. 3A). ), Or one or more notch lines or grooves 65b formed on the outer surface 47 extending along the tip 60 of the main shaft 46, preferably into the eyelet portion 54. (Fig. 3B), or one or more annular grooves 65c provided on the outer surface 47 at the tip 60 of the main shaft 46 (Fig. 3C). The surface feature is configured to be able to interact with part 62 of the catheter hub at region 63. This makes it possible to enhance the frictional engagement between them.

0026As shown in FIG. 3, the actuator 16 is advantageously configured for a small diameter needle cannula 40, for example a gauge of 20-26. If the needle cannula 40 has a large diameter, for example a gauge of 16 or 18, then an alternative embodiment of the actuator 16a can be as shown in FIG. 4 (similar reference numerals). Shows the same feature points as in the case of actuator 16). For this purpose, the eyelet shaft 53a of the eyelet portion 48a can have approximately the same cross-sectional dimensions as compared to the cross-sectional dimensions of the main shaft 46 (eg, for a 16 gauge needle cannula 40). Alternatively, it can have a slightly smaller cross-sectional dimension (eg, 18 gauge needle cannula 40). In this situation, the fixation of the actuator 16a can be enhanced by providing the actuator 16a with a surface feature in the form of an annular rib 65d extending radially outward. The annular rib 65d can provide a cross-sectional dimension that is approximately 12% greater than the cross-sectional dimension of the main shaft 46. Advantageously, the rib 65d is in the form of a saw tooth in cross-sectional view (Fig. 4A). However, the rib 65d can have a more rounded shape. The annular rib 65d is advantageously located on the tip 60 of the main shaft 46 and can overlap the eyelet portion 48a at the intersection 55a. When the actuator 16a is used, the catheter hub 12 in region 62 may be provided with a notch (not shown) extending radially outward. The notch can have a cross-sectional dimension of a size that is smaller than the cross-sectional dimension of the annular rib 65d. This allows a tight fit to be formed between the notch and the annular rib. Instead, the notch has a cross-sectional dimension slightly larger than the cross-sectional dimension of the annular rib 65d. Can be. This allows the rib 65d to be more easily located in the notch. However, the actuator 16a can be more effectively fixed to the catheter hub 12.

0027Actuators 16, 16a can be formed from suitable materials, including various metals and plastics, and can be formed as an integral member. However, in an alternative embodiment, the actuators 16, 16a can be formed by joining a plurality of individual members. The bond can be welded or glued. In one exemplary embodiment, actuators 16, 16a can be formed from medical grade stainless steel (eg, 410 stainless steel, 17-7 stainless steel, etc.) by a process known in the art. ..

0028As shown in FIG. 1, the sealing member 18 is located in the internal cavity 24 of the catheter hub 12 and is at least partially supported by the actuator 16 in the internal cavity 24. As will be described later, the sealing member 18 can also be partially supported by the inner wall 25 of the catheter hub 12. As shown in FIGS. 5 to 7, the sealing member 18 extends from the membrane 72 toward the tip and terminates at the tip 75, and the overall cylindrical body 70 having the outer surface 71 and the central membrane 72. It includes a tip portion 74 and a base end portion 76 that extends from the cylinder 72 toward the base end and terminates at the base end, that is, the impact end 77. The membrane 72 extends substantially perpendicular to the central axis 78 and extends along a plane located midway between the base end 77 and the tip end 75 of the seal member 18. In one embodiment, the membrane 72 has an overall planar upper surface 79 and an overall planar lower surface 80, and has an overall constant axial thickness. The membrane 72 includes a normally closed slit 82 that extends completely through the axial thickness of the membrane 72. In an alternative embodiment, the upper surface 79 and the lower surface 80 of the membrane 72 may have a shape other than a flat surface, may have other shapes, and may be concave or convex, for example.

0029The slit 82 can be of various aspects known in the art, for example, a single linear slit (not shown) penetrating the membrane 72. Advantageously, in the embodiment illustrated herein, the slit 82 is a trislit extending to three radial outermost ends 83 that exhibit a Y-shape in plan view as shown in FIG. It has a structure (a structure consisting of three slits). The slit 82 forms a plurality of membrane flaps 84. The number of membrane flaps depends on the shape of the slit 82 (eg, three flaps 84 in the case of a trislit configuration). In addition, the length of the slit 82 (eg, radial length) is preferably smaller than the cross-sectional dimension (eg, diameter) of the membrane 72. As a result, the radial outermost end 83 of the slit 82 is separated from the inner surface 85 of the cylindrical body 70 of the seal member 18, and the slit 82 enters the inner surface 85 of the cylindrical body 70 of the seal member 18. Not done. In the standby position of PIVC38, the slit 82 in the membrane 72 and the needle shaft 41 can cooperate with each other. As a result, when the needle shaft 41 penetrates the membrane 72, a substantial fluid sealing seal can be formed around the needle shaft 41 (FIG. 2). However, the slit 82 and the needle shaft 41 may not be fluid sealed. However, even then, advantageously, when the needle shaft 41 penetrates the membrane 72, it can result in significant restrictions on blood flow through the membrane 72. This allows, for example, when the catheter hub 14 is inserted into the patient's vascular system (not shown), only the smallest amount of blood is exuded through the slit 82 of the membrane 72.

0030The tip portion 74 of the seal member 18 is located between the seal outlet hole 86 defined by the annular seal lip 87 extending inward from the tip 75 toward the base end, and between the seal outlet hole 86 and the lower surface 80 of the membrane 72. It comprises a located actuator cavity 88. The free end 51 of the actuator 16 is received into the actuator cavity 88 through the seal outlet hole 86, and the barb 50 is housed in the actuator cavity 88 (FIG. 1). The actuator cavity 88 advantageously comprises a reduced diameter portion 89 that imparts a constricted shape (FIG. 6) to the actuator cavity 88. For example, the reduced diameter portion 89 can be provided by the annular rib 90. The annular rib 90 projects radially inward from the portion 93 of the inner wall 85 that defines the actuator cavity 88. At the closed position of the seal member 18 as shown in FIG. 1, the truncated cone-shaped surface 57 of the actuator 16 engages with the annular rib 90.

0031The proximal portion 76 of the sealing member 18 is advantageously cylindrical in shape and comprises an overall cylindrical hole 92 extending between the membrane 72 and the opening 94 at the proximal 77. The hole 92 can have an overall constant cross-sectional shape along the longitudinal direction. The opening 94 and, preferably the cylindrical hole 92, prevent the nose of standard luer dimensions and the luer taper 30 of standard dimensions (Fig. 9) from entering the hole 92, yet are maximal. However, it is configured so that it only impacts the base end 77. For this purpose, as shown in FIG. 2, the nose 42, used with the catheter assembly 10 illustrated herein, engages the wall 25 that constitutes the proximal end 20 of the catheter hub. A reduced diameter with a base end shape 42a that defines a standard luer taper cross-sectional dimension to obtain and a uniform cross-sectional dimension sized to allow entry into the hole 92 along the axial direction. It has a tip shape of 95 and. However, the length of the tip shape 95 is selected so that the tip 96 of the tip shape 95 does not excessively press the upper surface 79 of the membrane 72 in the standby position. This makes it possible to avoid deformation of the membrane 72 that could adversely affect all seals between the slit 82 and the shaft 41 of the needle cannula 40. A recess 97 can be formed in the tip 96 for that purpose.

0032The normal length of the nose that will extend into the luer-tapered proximal portion 26 of the catheter hub 12 provides a reasonably reliable frictional engagement between the proximal portion and the nose. It is said that. As a result, the nose does not deviate from the catheter hub 12, and the nose can be easily removed from the catheter hub by a slight force by the operator (not shown). Based on the reduced diameter tip shape 95, there is no excessive engagement between the nose base end shape 42a and the inner wall 25 of the catheter hub 12. To prevent too loose engagement, the tip shape 95 can advantageously be sized to allow frictional engagement within the hole 92. Alternatively or additionally, radial inward ribs or protrusions (not shown) can be formed on portion 98 of the inner wall 85 of the hole 92. As a result, a stronger engagement with the tip shape 95 of the nose 42 can be obtained.

0033The membrane 72 that closes the seal member 18 is arranged between the base end 77 and the tip end 75 of the seal member 18 (that is, neither near the base end nor near the tip end). In this respect, the seal member 18 has an axial length l of the proximal end portion 76._p Substantially thinner than, and the axial length of the tip 74 l_d It can be characterized by a membrane 72 with a substantially thinner axial thickness t. Although not limited, for example, axial length l_pAnd l_dCan be in the range of 7 to 15 times the thickness t. In one exemplary embodiment, the thickness t of the membrane 72 can be approximately 0.381 to 0.508 mm (0.015 to 0.020 inches) and the length l._p Can be approximately 5.996 mm (0.235 inches) and length l_d Can be approximately 3.937 to 4.064 mm (0.155 to 0.16 inches).

0034As shown in FIG. 1, in the closed position of the seal member 18, the actuator 16 can extend through the seal outlet hole 86. As a result, the barb 50 is arranged in the actuator cavity 88. More specifically, the seal lip 87 of the seal outlet hole 86 engages hermetically with the outer surface 47 of the actuator shaft 46. As a result, the actuator cavity 88 can be substantially sealed from the atmosphere on the tip side. The main shaft 46 of the actuator 16 is advantageously cross-sectionally sized to receive the needle cannula of the largest diameter that can be used with the catheter assembly 10, and the eyelet portions 48,48a of the actuator 16 are specific. The cross-sectional dimensions are such that it fits snugly against the needle cannula 40. As a result, the seal outlet hole 86 can be of normal size for a series of needle cannulas. Thus, the same sealing member 18 can be used for multiple needle cannulas of gauges in the expected range. This eliminates the need to use different sealing members for the needle cannulas of each gauge or for the needle cannulas of different gauges.

0035In addition to this, the barb 50 is fully contained within the actuator cavity 88 and can be engaged with the reduced diameter portion 89 as described above. The barb 50 has an outermost cross-sectional dimension that is larger than the cross-sectional dimension of the seal outlet hole 86, and is further configured to be able to slide the seal outlet hole 86 toward the tip beyond the barb 50. Moreover, the barb 50 prohibits the movement of the seal member 18 toward the proximal end on the barb 50.

0036In the occlusion position, the seal member 18 is completely located within the internal cavity 24 of the catheter hub 12. As a result, the sealing member 18 is separated from both the proximal end 20 and the distal end 22 of the catheter hub. For this purpose, the base end 77 of the seal member 18 is at a distance d._p It is separated from the opening 21 at the proximal end 20 of the catheter hub 12 by the amount of. As a result, a space P1 is formed on the base end side of the seal member 18. Further, the tip 75 of the seal member 18 has a distance d._d It is separated from the tip cavity 28 of the catheter hub 12 by the amount of. As a result, a space D1 is formed on the tip end side of the seal member 18. In one embodiment as an example, d_p Can be approximately 1.143 mm (0.045 inch), d_d Can be approximately 2.159 to 4.318 mm (0.085 to 0.17 inches). In addition to this, the membrane 72 is located closer to the proximal end than the free end 51 of the actuator 16. As a result, the normally closed slit 82 formed in the membrane 72 substantially seals the actuator cavity 88 from the proximal end side. Therefore, as will be described in detail later, when blood flows into the actuator cavity 88 of the seal member 18 when the catheter assembly 10 is inserted, for example, the actuator cavity 88 engages with the seal lip 87 and the actuator wall 47. Is fluid-insulated (eg, sealed) from the distal end side, and fluid-insulated (eg, sealed) from the proximal end side by a normally closed slit 82 of the membrane 72. This prevents blood from flowing beyond the membrane into the internal cavity 24 of the catheter hub 12.

0037In some prior art configurations, a long member extends within the catheter hub and the sealing member is pressed against the long member in order to open the sealing member. However, the seal members in those configurations typically float freely on the elongated members. Therefore, it is separated from the wall of the catheter hub along the entire periphery. Alternatively, the sealing member engages the wall of the catheter hub over the entire perimeter. Each approach is considered to have drawbacks. The free-floating sealing member lacks sufficient support within the catheter hub and is subject to unreasonable lateral movement and similar movement and tilt. The sealing member that engages the wall of the catheter hub over its entire periphery inevitably has a relatively large frictional force at the boundary between the sealing member and the wall of the catheter hub, thus pushing the sealing member into the open position when driven. The force required to move it becomes large. This type of sealing member also has other drawbacks. For example, pressure buildup can occur when the seal member is driven due to engagement on all edges. This is because, for example, air cannot escape from such a space when the sealing member moves into the space on the distal end side of the sealing member in the catheter hub. Accumulation of such pressure is undesirable and requires an unreasonably large driving force for operation.

0038In another feature of the invention, the seal member 18 is supported by both the actuator 16 and the catheter hub 12. However, in the closed position, the outer surface 71 of the seal member 18 is only partially around the periphery of the inner wall 25 of the catheter hub 12 along the outer contact area 100 (FIG. 1) of the seal member 18. Engage. Thereby, at least one air path 102 (illustrated by an arrow 102 in FIG. 1) can be maintained between the space P1 on the proximal end side and the space D1 on the distal end side of the seal member 18. .. Advantageously, two such air paths 102 are provided. For this purpose, the outer surface 71 of the seal member 18 can include at least one axial channel or groove 104 along at least the contact area 100 of the seal member 18. The groove 104 extends inward from the outer surface 71 and forms a part of the air path 102, if not the entire air path 102, along the axial direction. If two or more axial grooves 104 are provided, each groove forms part or all of the respective air path 102. Advantageously, only the short axial portion of the outer surface 71 is engaged in the abutment region 100. As a result, as illustrated in FIG. 1, the region on the proximal end side and the region on the distal end side with respect to the contact region 100 are separated from the inner wall 25 of the inner cavity 24 in the regions 105 and 106. Area 105, The 106 also has the advantage of forming part of the air passage 102 and reducing friction between the sealing member 18 and the catheter hub 12. As a result, the seal member 18 can slide more easily in the catheter hub 12 when the seal member is opened as described later. By providing the air path 102, the outer surface 71 of the seal member 18 can be engaged with the inner wall 25 of the catheter hub 12 around the periphery in the engagement region 100. This makes it possible to form a partial peripheral engagement. As a result, the seal member 18 is held in a stable position on the actuator 16, and the region P1 on the proximal end side of the internal cavity 24 of the seal member 18 and the region D1 on the distal end side of the internal cavity 24 of the seal member 18 And can facilitate fluid communication between This can prevent pressure buildup during drive of the seal member 18 and reduce the contact surface area between the seal member 18 and the inner wall 25 of the catheter hub 12, thereby sealing during such drive. The frictional force applied to the member 18 can be minimized.

0039The tip region 106 is adjacent to the tip 74 of the seal member 18 by reducing the outer diameter dimension of the seal member 18 along the tip 74 of the seal member 18 and / or in the internal cavity 24. It can be obtained by increasing the external dimensions of the second portion 31. Similarly, the proximal region 105 is the base of the seal member 18 by reducing the outer diameter dimension of the seal member 18 along the proximal portion 76 of the seal member 18 and / or of the internal cavities 24. It can be obtained by increasing the external dimensions of the first portion 29 adjacent to the end 76. For example, the proximal region 105 can be the result of the luer taper of the first portion 29 of the proximal portion 26 of the internal cavity 24, the outer diameter of the proximal portion 76 of the sealing member 18, as shown in FIG. Can be kept relatively constant.

0040The contact area 100 between the sealing member 18 and the catheter hub 12 can occur along the membrane 72 and along the cutting edge area of the proximal end 76 of the sealing member 18. However, in particular, the axial groove 104 extends at least from the region on the distal end side of the contact region 100 to the region on the proximal end side of the contact region 100. Thus, depending on the particular size of the contact area 100, the axial groove 104 can extend over the entire length of the sealing member 18, or only part of the length of the sealing member. It can (in this case, the axial groove 104 extends axially long enough to form part of the associated air path 102 through the engagement region 100. The groove 104 does not have to extend beyond the engagement area 100, but it is advantageous to extend beyond the engagement area 100). In one embodiment, each axial groove 104 opens at the tip 75 of the seal member 18 and terminates without reaching the proximal end 77 of the seal member 18 (FIG. 6). Further, the depth of the axial groove 104 is such that it does not penetrate the inner surface 85 of the seal member 18 at the seal outlet hole 86 and the actuator cavity 88, and preferably at the hole 92.

0041As shown in FIG. 2, the cap 44 is sized so that it does not fit within the proximal opening 20 of the catheter hub 12. Instead, the cap 44 can abut against the proximal surface 110 of the catheter hub 12 when the PIVC38 is in the standby position. The cap 44 can also be provided with a continuous or segmented collar or rim (not shown). The collar or rim shall engage with the external luer lock receiving ear 112 of the catheter hub 12, which defines the end surface 110, and, if possible, detachably. Can be done. A step (not shown) can be formed on the tip of the receiving ear 112, which can facilitate the assembly of the catheter assembly 10. Advantageously, in the standby position, the cap 44 is in contact with the end surface 110, the nose 42 extends into the internal cavity 24, and the proximal shape 42a of the nose 42 is a catheter. It fits tightly to the inner wall 25 of the hub 12. The tip segment 95 is sized to fit within the hole 92. Thereby, the tip 96 can be adjacent to or engaged with the side surface 79 on the proximal end side of the membrane 72. When the tip 96 comes into contact with the membrane 72, the tip 96 does not penetrate through the slit 82 of the membrane 72. In addition, the hole 97 at the tip 96 is arranged so as to be aligned with the slit 82 of the membrane 72.

0042During use, the sharp tip 43 of the PIVC38 is inserted into the artery or vein of the patient (not shown) in a conventional manner from the standby position shown in FIG. The needle shaft 41 may have a slot 114 adjacent to the sharp tip 43 and through the needle shaft. This can provide a flashback of blood. The use of slot 114 in the needle cannula 40 can be partially advantageous with respect to the larger gauge number of needle cannulas 40 (ie, the smaller diameter needle cannula 40). In addition to or in place of the cannula slot 114, for the needle cannula 40, adjacent to the proximal end (not shown) of the needle cannula 40 for conventional blood flashback. Flash chambers (not shown) can be connected.

0043After insertion of the catheter tube 14 into the patient, the needle cannula 40 is withdrawn from the catheter tube 14 and the catheter hub 12 in the proximal direction. In that case, the catheter assembly 10 is left as fluid communication to the patient's vascular system. When the needle cannula 40 is pulled out, the drag force applied onto the seal member 18 based on the proximal movement of the needle cannula 40 (eg, the drag force applied onto the slit 82 of the membrane 72) is the catheter. It is insufficient to overcome the force holding the seal member 18 in the hub 12. Therefore, the sealing member 18 can stay in the catheter hub 12 when the needle cannula 40 is pulled out toward the proximal end. More specifically, the force applied on the actuator 16 by the seal lip 87 (the actuator 16 is fixedly fixed to the catheter hub 12 as described above) and the catheter along the contact area 100. The frictional force of the sealing member 18 that engages with the inner wall 25 of the hub 12 is the proximal movement of the sealing member 18 with respect to the catheter hub 12 individually or collectively when the needle cannula 40 is withdrawn. Can resist against. The barb 50 of the actuator 16 is said to be larger than the seal exit hole 86 of the seal member 18, even if some initial proximal movement of the seal member 18 with respect to the catheter hub 12 occurs. As a result, the initial axial movement of the seal member 18 can be restrained.

0044Further, when the needle cannula 40 is pulled out toward the proximal end, the drag force acting on the slit 82 of the membrane 72 causes one or more flaps 84 formed by the slit 82 to be slightly flexed toward the proximal end. Can be inflated. More specifically, the slot 114 can engage with the flap 84 as it penetrates through the slit 82 towards the proximal end and flexes the flap 84. At the time of such withdrawal, the nose 42 remains within the catheter hub 12. As a result, as shown in FIG. 8, the deflection of the flap 84 toward the base end stays in the recess 97 instead of abutting the tip 96 of the nose 42. This reduces the risk of damage to the flap 84 and the risk of adverse effects that could affect the sealing capacity of the slit 82. If the nose 42 and the needle cannula 40 are fixed so that the nose 42 can move with the proximal movement of the needle cannula 40, the recess 97 can be omitted.

0045In addition to the above, the drag force on the sealing member 18 as generated by pulling out the nose 42 from the catheter hub 12 also overcomes the force holding the sealing member 18 within the catheter hub 12. It is inadequate. Thus, for example, the slip engagement between the reduced diameter tip shape 95 of the nose 42 and the hole 92 of the base end 76 of the seal member is the seal member when the nose 42 is pulled out from the catheter hub 12 toward the base end. Not tight enough to pull 18 out of catheter hub 12. Similar to the above, the barb 50 of the actuator 16 is larger than the seal exit hole 86 of the seal member 18 even if some initial proximal movement of the seal member 18 with respect to the catheter hub 12 occurs. This makes it possible to constrain all initial proximal movements of the seal member 18.

0046After the needle cannula 40 has been withdrawn and the nose 42 separated from the catheter assembly 10, the seal member 18 within the catheter hub 12 is in the occlusion position or seal position. This can prevent blood from the patient from flowing into the internal cavity 24 of the catheter hub 12 (FIG. 1). More specifically, during and after insertion of the catheter tube 14 into the patient's vasculature (eg, during proximal withdrawal of the needle cannula 40, or when the needle cannula 40 and, if possible, the nose 42 catheterize. After being withdrawn from the hub 12 towards the proximal end), blood from the patient passes through the catheter tube 14, the actuator 16, and the actuator of the seal member 18 where the proximal free end 51 of the actuator 16 is located. It can flow into the cavity 88. In other words, an unobstructed fluid flow path exists between the tip 35 of the catheter tube 14 and the proximal free end 51 of the actuator 16. This allows blood to flow between them. However, advantageously, the blood flowing into the actuator cavity 88 is substantially prevented from flowing out of the actuator cavity 88. As a result, hemostasis is obtained or hemostasis is maintained.

0047For this purpose, the seal lip 87 of the outlet hole 86 forms a substantial fluid seal to the outer surface 47 of the actuator main shaft 46. This can prevent blood from flowing out of the actuator cavity 88 along the interface (eg, the actuator cavity 88 provides effective sealing from the tip side). In addition to this, after the needle cannula 40 is removed from the membrane 72, the slit 82 is closed based on the elasticity of the material forming the membrane 72 (ie, the slit 82 is normally closed). The obstruction of the slit 82 substantially prevents blood from flowing out of the actuator cavity 88 through the membrane 72. Advantageously, the slit 82 is substantially occluded so that blood does not leak through the slit 82 of the membrane 72 due to the pressure normally observed during use.

0048As mentioned above, even if there is any leakage through the slit 82 of the membrane 72, the blood volume is minimal and hemostasis during and after insertion of the catheter tube 14 (and before driving the seal member 18). Hemostasis) is still well maintained. Therefore, when blood flows into the actuator cavity 88 of the seal member 18, the cavity 88 is provided by the engagement of the seal lip 87 with the actuator surface 47 on the distal end side and on the proximal end side. The slit 82 of the membrane 72 provides a substantially fluid insulation (eg, seal). This effectively prevents blood from flowing beyond the membrane. This allows the healthcare professional to solve other pressing problems for the time being without worrying about blood trying to drain from the catheter hub 12.

0049Not only is the sealing member 18 configured to be able to control blood flow during use, but the sealing member 18 is also configured to be able to be driven to open the fluid flow path from the catheter tube 14. .. Advantageously, as shown in FIGS. 9 and 10, the seal member 18 can be configured to be axially movable. As a result, the seal member 18 can slide along the main shaft 46 of the actuator 16 in the axial direction, and can slide to the open position. Such axial movement can be performed by inserting the male luer taper 30 into the proximal end 20 of the catheter hub 12. As a result, the free end of the male luer taper 30, that is, the tip 120, impacts the base end 77 of the seal member 18 and seals with sufficient force to overcome the frictional force holding the seal member 18 in place. Push the member 18 toward the tip. For this purpose, the luer taper 30 can work with a luer lock collar or luer lock nut 122 configured to be able to engage screw-wise with the catheter hub ear 112. As a result, the luer taper 30 can be propelled toward the base end 77. As a result, the luer taper 30 is pushed toward the tip by the amount of movement distance. As a result, the seal member 18 is slid-driven in the axial direction, the membrane 72 is driven onto the actuator barb 50, the flap 84 is expanded, and the seal member is opened. The catheter assembly 10 is configured such that the entire sealing member 18 can slide axially distally within the catheter hub 12.

0050As the sealing member 18 slides axially within the catheter hub 12, the free end 51 on the proximal end side of the actuator 16 contacts the tip surface 80 of the membrane 72 and begins to enter through the slit 82, by the slit 82. The flap 84 formed is spread out toward the proximal end and slid along the barb 50, eg, along the truncated cone surface 57 of the barb 50. As a result, the slit 82 is gradually opened. By further inserting the luer taper 30 toward the tip, the sealing member 18 is further slid toward the tip, and finally, the luer taper 30 is completely extended into the internal cavity 24. As a result, the tip 75 of the seal member 18 is driven toward the tip cavity 28. As a result, as shown in FIG. 10, the open position of the seal member 18 is achieved. In one embodiment, the membrane 72 is made sufficiently elastic and the barb 50 can enter the slit 82 without tearing or destroying the membrane 72. The slit 82 can reclose the periphery of the actuator main shaft 46 after the barb 50 has passed. In an alternative embodiment, the membrane 72 can be deformed, or torn or destroyed as the barb 50 enters through the slit 82. This is illustrated, for example, by the corrugated appearance of the membrane 72 in FIG.

0051In the open position of the sealing member 18, an unobstructed fluid path is established between the catheter tube 14 and the luer taper 30 via the actuator 16. This allows, for example, the catheter assembly 10 to supply fluid to the patient, or the catheter assembly 10 to extract blood from the patient. Advantageously, the seal member 18 and the catheter hub 12 are such that the seal member 18 is not compressed in the axial direction in the open position, that is, the seal member 18 is formed between the luer taper 30 and the tip portion 22 of the catheter hub 12. The size is set so that it is not compressed in the axial direction between them. At this point, the moving distance d of the seal member 18 between the closed position and the open position._t Is the distance d between the tip 75 of the seal member 18 and the tip cavity 28 of the catheter hub 12._d It is configured to be smaller than. In one embodiment as an example, d_d Is approximately 4.318 mm (0.17 inch) and travel distance d_t Can be approximately 3.302 mm (0.163 inches). However, the present invention is not limited to such an embodiment in the alternative embodiment, and the sealing member 18 can be slightly compressed in the axial direction in the open position.

0052In the illustrated embodiment, as described above, the seal member 18 is a seal that is used only once. In this respect, after removing the luer taper 30 from the catheter hub 12, the seal member 18 does not move back toward the proximal end towards the occlusion position, but remains in the open position. More specifically, the barb 50 allows the seal member 18 to move toward the tip, but prevents the seal member 18 from moving toward the proximal end. Thereby, in the illustrated embodiment, the membrane 72 does not automatically return and move onto the barb 50, but blocks the fluid flow path established using the catheter tube 14. In this case, the catheter tube 14 provides an unobstructed fluid flow path between the catheter tube 14 and the internal cavity 24 and / or between the catheter tube 14 and the open proximal end 20 of the catheter hub 12. doing. However, in other embodiments, the catheter assembly may be provided with a mechanism such as a spring, an elastic member or a bellows. As a result, it is possible to provide a driving force for returning and moving the seal member 18 toward the proximal end in the axial direction, whereby the seal member 18 can be reclosed. An exemplary embodiment of such a multi-use type seal will be described in detail below. However, in the embodiments shown in FIGS. 1, 2, 5 to 10, the seal member 18 is a single-use type seal, which is intended to provide hemostasis and re-occlude after opening. Not done.

0053The sealing member 18 can be generally flexible and can be formed from a suitable material such as silicone or polyisoprene. In one embodiment, the seal member 18 can be formed as an integral member by various molding processes, such as the injection molding process, as is known in the art. The slit 82 is not molded in the membrane 72, but is formed after the molding process. In this regard, a punch tool or slit tool 160 can be used, as shown in FIGS. 11 and 12. As a result, a trislit (slit having three notch lines) 82 can be formed on the membrane 72. A conventional tool (not shown) for forming a trislit is a flat heating punch having a shape corresponding to the shape of the trislit. However, such tools, when used against elastic materials, often stretch the material during the drilling operation. Therefore, the material under which the slit should be formed must be directly and sufficiently supported below the material in which the slit should be formed so as not to tear or damage the material.

0054To overcome such drawbacks, the slit tool 160 has a tip 161 formed from a pyramid 162 with three faces. The base 164 of the pyramid 162 has three corners 165 at one end 166. The pyramid 162 terminates at the sharp tip 168 at the other end 169. This forms the three divergent surfaces 170 of the pyramid 162. The tool 160 also has a shaft 172. The shaft 172 has a sharp edge 173 that is generally straight and a flat surface 174 located between these sharp edges 173. The pyramid 162 is connected to the shaft 172. As a result, the edge 173 is aligned in the axial direction as a whole with respect to each corner 165 of the base 164. As shown in FIG. 12, in order to form the trislit 82, the molded seal member 18 is placed in a fixture 180 having a hole 182 internally sized to receive the seal member 18. can do. The hole 182 has a bottom wall 184 configured to engage the tip 75 of the seal member 18 within the fixture 180. The tool 160 is inserted through the proximal opening 94 of the hole 92 of the seal member 18. As a result, the sharp tip 168 can be engaged with the base end surface 79 of the membrane 72. As the insertion of the tool 160 continues, the sharp tip 168 and the divergent surface 170 cut the seal member 18 at least partially, thereby gradually increasing the length of the slit 82 until the desired trislit configuration is obtained. Increase.

0055In an alternative embodiment, the seal member 18 can be inverted within the fixture 180, as shown in FIGS. 11A and 11B. As a result, the base end 77 of the seal member 18 engages with the bottom wall 184, and the tool 160 is inserted through the seal outlet hole 86 and the actuator cavity 88. As a result, it can be engaged with the tip surface 80 of the membrane 72. When the slit 82 is formed in the seal member 18 in this orientation, the diameter expansion tool 186 can be provided to increase the size of the seal outlet hole 86. As a result, the slit tool 160 can be inserted through the seal outlet hole 86 without contacting the seal member 18 and without damaging the seal member 18. In this regard, the diameter expansion tool 186 includes an annular flange 188 and three tabs 190. The three tabs 190 extend toward the tip and are arranged in a triangular configuration corresponding to the three surfaces of the pyramid 162 and the shaft 172 of the slit tool 186. The outer surface 192 of the tab 190 has a shape having a thin-walled portion 194 at the tip of the tab 190 and a thick-walled portion 196 extending from the thin-walled portion 194 toward the base end. The thin portion 194 smoothly shifts to the thick portion 196 (for example, taper). The tab 190 is sized so that the thin portion 194 of the tab 190 can fit into the shape of the seal exit hole 86. However, as shown in FIG. 11B, when the diameter expansion tool 186 moves towards the fixture 180, the outer surface shape of the outer surface 192 of the tab 190 is such that the seal exit hole 86 is the peripheral edge of the triangular configuration of the tab 190. Increase the diameter to the outside around. This increases the size of the seal outlet hole 86. The fixture 180 can have an annular notch 198. The notch 198 can accommodate the enlarged portion of the seal member 18 when the diameter expansion tool 186 is inserted inside. Tip orientation of diameter expansion tool 186 towards fixture 180 The motion can be stopped by engaging the flange 188 with the base end 199 of the fixture 180. When the diameter expansion tool 186 is inserted so as to increase the size of the seal outlet hole 86, the slit tool 160 can insert the diameter expansion tool 186 and the seal outlet hole 86. As a result, the slit 82 can be formed in the membrane 72 without contacting the seal member 18 and without damaging the seal member 18.

0056Regardless of the orientation of the sealing member 18 within the fixture 180, the membrane 72 does not need to be directly supported. However, if desired, it can be placed directly under the membrane 72. This configuration of the tool 160 can result in a well-shaped slit 82, reducing the risk of damage to the sealing member 18 during the slit forming process.

0057The catheter assembly 10 can be assembled as follows. The actuator 16 can be inserted through the proximal opening 21 of the catheter hub 12. As a result, the distal eyelet portion 48 or 48a captures the proximal end 34 of the catheter tube 14 within the distal cavity 28 of the catheter hub 12. Instead, the proximal end 34 of the catheter tube 14 can be connected to the eyelet portions 48, 48a of the actuators 16, 16a, and the proximal end 34 and the eyelet portion 48, thus formed. A subassembly consisting of 48a can be inserted through the proximal opening 21 of the catheter hub 12. Thereby, the proximal end 34 of the catheter tube 14 can be captured in the distal cavity 28. In any of the embodiments, the actuator 16, The 16a projects from the tip 22 of the catheter hub 12 toward the proximal end and is located in the internal cavity 24. The needle cannula 40 is inserted through the seal member 18 which can be formed by the method described above. In one embodiment, the sharp tip 43 of the needle cannula 40 can simply be inserted through the slit 82 of the membrane 72. The seal member 18 is located on the needle shaft 41. In an alternative embodiment, the needle cannula 40 can be extended through the membrane 72 in a manner that reduces potential damage to the membrane 72. For this purpose, first of all, a small tube (not shown) can be inserted through the slit 82. The small tubes can be constructed as generally smooth (eg, no sharp edges, no burrs, etc.) and relatively soft, and can be formed from suitable plastic materials. After positioning the tube through the slit 82, the needle cannula 40 can be inserted through the tube. As a result, the sharp tip 43 cannot directly engage the membrane 72 when extending the needle cannula 40 through the slit 82. The tube is then pulled from the slit 82 onto the needle cannula 40, eg, onto the sharp tip 43 of the needle cannula 40. As a result, the slit 82 and the needle shaft 41 are engaged with each other. Can be done. In this way, the tube acts as a barrier between the membrane 72 and the needle cannula 40 when the needle cannula 40 is inserted through the slit 82. This makes it possible to avoid or reduce the tendency of damage during assembly.

0058After placement on the needle shaft 40, the seal member 18 can be slidably positioned on the nose 42. In that case, the tip shape received in the hole 92 in the proximal end 76 of the seal member 18 is slip-fitted. The slip fit can range from a just fit to provide engagement to one that frictionally holds the seal member 18 onto the nose 42. The tip shape 95 of the nose 42 can be inserted into the hole 92, and finally the base end 77 of the seal member 18 abuts against the annular shoulder 190 at the intersection of the nose 42a, 95. It becomes. When this happens, the tip shape 95 of the nose 42 can be engaged with or slightly separated from the proximal surface 79 of the membrane 72. In an alternative embodiment, the tip shape 95 can be inserted into the hole 92. Eventually, the tip 96 of the nose comes into contact with the base end surface 79 of the membrane 72. When this happens, the base end 77 of the sealing member 18 can be slightly separated from the annular shoulder 190. It is readily understood that the needle cannula 40 can be retracted and, as described above, the seal member 18 can be placed on the nose 42 before the needle cannula 40 is placed on the seal member 18. Let's go.

0059After the seal member 18 is located on the nose 42 and the needle cannula 40 extends distally to the nose, the catheter assembly 10 is placed such that the seal member 18 is located within the catheter hub 12. Can be installed on the nose 42. In this regard, when the catheter assembly 10 and the nose 42 move together, the seal outlet hole 86 abuts against the barb 50 and the seal lip 87 bends outward (seal lip 87 and flange). Based on cam-like engagement between 56 conical trapezoidal surfaces 57). This allows the barb 50 to enter the actuator cavity 88 through the seal outlet hole 86. When the seal outlet hole 86 moves beyond the barb 50, the seal lip 87 elastically returns inward in the radial direction based on the elasticity of the seal member 18 and returns to the outer surface 47 of the actuator 16 on the tip side of the barb 50. Engage against, thereby forming a fluid seal along the outer surface.

0060The catheter assembly 10 and nose 42 can move together further. Eventually, the cap 44 abuts against the proximal surface 110 of the catheter hub 12. During such movement, the seal lip 87 of the seal outlet hole 86 slides along the outer surface 47 of the actuator 16 to maintain a fluid sealed seal along the outer surface 47. When the cap 44 and the catheter hub 12 are engaged, the sealing member 18 is configured to be properly seated on the actuator 16 within the catheter hub 12 in the standby position. In this standby position, the barb 50 can engage the reduced diameter portion 89 of the actuator cavity 88. As a result, a certain degree of resistance can be imparted to the further movement of the tip of the seal member 18 with respect to the actuator 16. During assembly, this resistance can provide a clear indication that the seal member 18 is fully seated on the actuator 16.

0061As described above, in an alternative embodiment, the sealing member of the catheter assembly can be configured as a multiple use type seal rather than a single use type seal. In this case, the driving force can move the seal member towards the proximal end, thereby reclosing the seal member and reestablishing hemostasis when the male luer taper is removed from the catheter hub. be able to. In this regard, FIG. 13 shows an exemplary multi-use type seal member 200. In FIG. 13, the same reference numerals are given to the same members as those in FIGS. 1 to 12. The seal member 200 includes a base end portion 202. The base end portion 202 is substantially the same as the base end portion of the seal member 18 in FIGS. 5 to 7, and is as described in detail above. For example, the proximal end 202 can comprise the details of the sealing member 18 and can be shortened in the longitudinal direction (ie, in the proximal end direction). Thereby, a mechanism for providing a return driving force can be provided in the catheter hub. Therefore, further description of the base end portion 202 will be omitted. However, unlike the above embodiment, the seal member 200 includes an urging member 204 extending from the base end portion 202 toward the tip end. In the illustrated embodiment, the urging member 204 can include a peripherally continuous tubular extension member 206 that is generally thin. The extending member 206 forms an open passage 208 and is integrally formed with the base end portion 202. As a result, the seal member 200 forms an integral member. Similar to the above embodiments, the sealing member 200 can be generally flexible and can be formed from a suitable material such as silicone or polyisoprene. In addition to this, the seal member 200 can be formed by various molding processes such as injection molding processes known in the art.

0062As will be easily understood by those skilled in the art, the seal member 200 operates in the same manner as the seal member 18 described above when in use. Therefore, only the operational differences will be described in detail. In this respect, the primary difference is the drive of the seal member 200 by the male luer taper 30. As shown in FIGS. 14 and 15, the seal member 200 can be configured to be slidable in the axial direction. As a result, the seal member 200 can be slid in the axial direction along the main shaft 46 of the actuator 16 toward the open position. This slide is performed by inserting a male luer taper 30 into the proximal end 20 through the proximal end 20 of the catheter hub 12. As a result, the free end of the luer taper 30, that is, the tip 120, impacts the base end surface 77 of the seal member 200, and the seal member 200 has a sufficient force to overcome the frictional force holding the seal member 200 in a predetermined position. Can be pushed toward the tip. Similar to the above, the male luer taper 30 can work with a luer lock collar or luer lock nut 122 configured to be screwed into the catheter hub ear 112. As a result, the luer taper 30 can be propelled toward the base end 77. As a result, the luer taper 30 can be pressed against the base end 77 by a predetermined distance. As a result, the seal member 200 can be slid in the axial direction, the membrane 72 can be driven onto the actuator barb 50, and the seal member can be opened.

0063When the sealing member 200 slides axially within the catheter hub 12, the proximal free end 51 of the actuator 16 contacts the proximal surface 80 of the membrane 72 and begins to penetrate the slit 82. As a result, the flap 84 formed by the slit 82 is expanded toward the proximal end and slides along the barb 50, for example, along the conical trapezoidal surface 57 of the barb 50. As a result, the slit 82 is gradually opened. Further continuation of the tip-facing insertion of the luer taper 30 further advances the sealing member 200 in the axial direction, and finally the luer taper 30 extends completely into the internal cavity 24. In this case, the seal member 200 is moving toward the tip cavity 28, whereby the open position of the seal member 200 is achieved, as shown in FIG. In this embodiment, the membrane 72 is sufficiently elastic. This allows the barb 50 to penetrate the slit 82 without tearing or destroying the membrane 72. The slit 82 can close the periphery of the main shaft 46 of the actuator after the barb 50 has passed through the slit 82.

0064Before or during an axial slide of the sealing member 200 within the catheter hub 12, the tip 210 of the tubular extension member 206 relative to the inner wall 25 of the catheter hub 12 in the vicinity of the tip cavity 28. And abut. As a result, the tubular extension member 206 begins to be pressed by the further tip-facing slide of the seal member 200. When the seal member 200 is in the open position, the tubular extension member 206 is in a pressed state and is configured to be able to generate a restoring force. This restoring force urges the seal member 200 to push it back toward the base end toward the closed position. In this respect, the tubular extension member 206 operates similarly to a coil spring in that the pressing of the tubular extension member 206 produces a restoring force opposite to the compression. However, such proximal return movement of the seal member 200 towards the occlusion position is blocked by the presence of the luer taper 30 with respect to the catheter hub 12. Similar to the above embodiment, in the open position of the seal member 200, an unobstructed fluid path is established between the catheter tube 14 and the luer taper 30 via the actuator 16. This allows, for example, a catheter assembly to supply fluid to the patient, or a catheter assembly to extract blood from the patient.

0065In this embodiment, the seal member 200 is configured as a multiple use type seal and is therefore configured to be able to return and move from the open position to the reclosed position. In this regard, when the male luer taper 30 is removed from the catheter hub 12, the urging force generated by the compression of the tubular extension member 206 slides the seal member 200 towards the proximal end. For this purpose, the urging force provided by the tubular extension member 206 is the frictional force between the sealing member 200 and the actuator 16 and the frictional force between the sealing member 200 and the inner wall 25 of the catheter hub 12. And, it is enough to overcome. More specifically, when the seal member 200 is driven toward the proximal end based on the urging force, the tip 212 of the barb 50 abuts against the proximal surface 79 of the membrane 72. As a result, the flap 84 formed by the slit 82 is expanded toward the tip, whereby the barb 50 can pass through the slit 82 and move back.

0066After the barb 50 is removed from the membrane 72, the slit 82 is closed based on the elasticity of the material forming the membrane 72 (ie, the slit 82 is normally closed). The obstruction of the slit 82 substantially prevents blood from flowing out of the actuator cavity 88 through the membrane 72. Advantageously, the slit 82 is substantially closed. As a result, substantially no blood leaks through the slit 82, that is, through the membrane 72. As mentioned above, even if there is some leakage through slit 82 of the membrane 72, the amount of leaked blood is minimal and hemostasis is well established. Therefore, even if blood flows into the actuator cavity 88 of the seal member 200, the actuator cavity 88 is provided by the engagement between the seal lip 87 and the actuator surface 47 on the distal end side and on the proximal end side. The closed slit 82 of the membrane 72 provides substantial fluid insulation (eg, sealing). As a result, blood cannot circulate beyond Membrane 72. As a matter of course, the seal member 200 can move in the axial direction toward the open position in the above-described manner. The urging member 204 is configured to allow the sealing member 200 to be repeatedly and repeatedly moved between the open and closed positions. This makes it possible to provide a multi-use type configuration.

0067FIG. 16 shows a multi-use type seal member 220 according to an alternative embodiment. Like the seal member 200, the seal member 220 includes a proximal end 222 that is substantially similar to the case of the seal member 18 illustrated and described in detail in FIGS. 5-7. Similarly, the proximal end 222 may comprise the details of the sealing member 18. However, the proximal end 222 can be shortened in the longitudinal direction. Thereby, a mechanism for providing the return driving force can be provided in the catheter hub. Therefore, further description of the details of the proximal end 222 will be omitted. In addition to this, the seal member 220 includes an urging member 204 extending from the base end 222 toward the tip. In the illustrated embodiment, the urging member 204 may include a pair of thin-walled legs 224 that are generally opposed. The leg 224 is formed integrally with the proximal end 222. As a result, the seal member 220 forms an integral member. In one embodiment, for example, the leg 224 can be entirely arc-shaped and can be in the form of a tubular segment with a constant radius of curvature. In the illustrated embodiment, such two legs are exemplified, but because the seal member 220 generates a driving force to move the seal member 220 back toward the proximal end to reclose the seal member 220. It will be appreciated that it may be equipped with fewer or additional legs 224. The operation of a catheter assembly with a sealing member 220 will be readily understood by those skilled in the art. Therefore, detailed description of such an operation will be omitted. However, it should be noted that the spacing or gap 226 between the legs 224 can cooperate with the groove 104, which may provide an air escape path when driving the seal member 220.

0068In the embodiment shown in FIG. 14, when the seal member 200 is in the closed position, the urging member 204 is not compressed. As a result, the urging force toward the proximal end based on the urging member 204 is not applied to the sealing member 200. In an alternative embodiment, as shown in FIG. 17, the seal member 230 is configured such that the urging member 204 can be partially compressed when the seal member 230 is in the closed position. Therefore, it is possible to provide a urging force toward the proximal end. In FIG. 17, the same feature points as in FIG. 14 are designated by the same reference numerals. Such partial compression effectively exerts a force applied to the seal member 230 as the barb 50 returns and moves through the membrane 72 as the seal member 230 moves from the open position to the closed position. Increase.

0069In one embodiment, partial compression of the urging member 204 can be obtained by increasing the length of the urging member 204 as compared to the length shown in FIG. For example, in one embodiment, the seal member 230 can be substantially the same as the seal member 200. However, it differs in that the length of the tubular extension member 206 is increased. Instead, the seal member (not shown) can be substantially identical to the seal member 200, yet the leg 224 can be increased in length. In order to keep the urging member 204 in a partially compressed state in the closed position, the proximal movement of the sealing member 230 is resisted by the engagement between the barb 50 of the actuator 16 and the actuator cavity 88. To. More specifically, the barb 50 is made larger than the seal outlet hole 86 of the seal member 230. As a result, the movement of the seal member 230 toward the proximal end is prevented by the barb 50 coming into contact with the tip wall 232 of the actuator cavity 88. Although the difference is that the urging member 204 is partially compressed, those skilled in the art will appreciate that the operation of the catheter assembly with the sealing member 230 is similar to the above, and thus such operation. It will be understood that no more detailed explanation of is needed.

0070In the previous embodiment, the proximal free end 51 of the actuator 16 comprises a barb 50. The barb 50 provides a seal for the seal member on the actuator 16 and also prevents the seal member from being pulled out of the catheter hub 12 in the proximal direction. Such withdrawal can occur, for example, when the needle cannula 40 is withdrawn or when the nose 42 is withdrawn from the catheter hub 12. However, the barb 50 exhibits resistance to the free movement of the seal member from the open position to the closed position in the multiple use type embodiment. In an alternative embodiment, the barb 50 can be omitted from the proximal free end 51 of the actuator. This makes it possible to reduce the resistance with respect to the movement of the seal member between the open position and the closed position. Therefore, the seal member and the catheter hub can work together in an alternative manner to hold the seal member inside during use.

0071In this regard, as shown in FIGS. 18 and 19, the multi-use type seal member 240 according to an alternative embodiment comprises a base end portion 242. The base end portion 242 is substantially the same as the base end portion of the seal member 18 in FIGS. 5 to 7, and is as described in detail above. In FIGS. 18 and 19, the same feature points as in the previous embodiment are designated by the same reference numerals. Therefore, further description of the base end portion 242 will be omitted. In addition to this, the seal member 240 includes an urging member 204. The urging member 204 extends from the base end portion 242 toward the tip end portion 242 and is integrally formed with the base end portion 242. As a result, the seal member 240 forms an integral member. In the illustrated embodiment, the urging member 204 is a leg 248 defined by a proximal tube-shaped extension portion 244 and a pair of opposed slots 252 extending towards the proximal end from the distal end 210 of the urging member 204. It is provided with a tip separation tubular portion 246 and the like. In this illustrated embodiment, the slot 252 extends along only a portion of the length of the urging member 204, whereas in an alternative embodiment, the slot 252 is the urging member 204. Can extend over the entire length of. Thereby, the urging member 204 can be made similar to the leg 224 of the seal member 220. In a further alternative embodiment, slot 252 can be omitted, which allows the urging member to be similar to the tubular extension member 206 of the seal member 200.

0072In these embodiments, the tip 210 of the urging member 204 is provided with a radially outward flange 254 on each of the legs 248. Flange 254 defines a proximally oriented ridge or shoulder 256. As shown in FIG. 19, the flange 254 is configured to be able to cooperate with the annular groove 258 formed on the inner wall 25 of the catheter hub 12. When the sealing member 240 is properly positioned within the catheter hub 12, the flange 254 on each leg 248 is configured to be located within the annular groove 258 or engages with the annular groove 258. It is configured to get. Thereby, the sealing member 240 can be held in the catheter hub 12. For example, in one embodiment, the leg 248 can be urged radially outward so that it can engage the annular groove 258 (eg, as in a duck building). The holding force generated between the flange 254 and the annular groove 258 is applied to the sealing member 240, for example, when the needle cannula 40 is withdrawn from the catheter assembly 10 or when the nose 42 is withdrawn from the catheter hub 12. It is said that it is larger than the driving force toward the base end. Therefore, the seal member 240 stays in place within the catheter hub 12 during use.

0073Those skilled in the art will appreciate that the urging member 204 shown in FIGS. 18 and 19 is compressed when the male luer taper 30 is inserted into the catheter hub 12, as in the case of the sealing member 200 shown in FIG. It will be understood that it will be. Those skilled in the art will also be able to remove the sealing member 240 from the open position when the compression of the urging member 204 produces a return urging force, whereby the male luer taper 30 is removed from the catheter hub 12. It will be appreciated that hemostasis is reestablished by sliding axially towards the occlusion position. Without the barb 50 on the actuator 16, it is expected that the force required to return the seal member 240 towards the closed position will be reduced. It will be appreciated that although the seal member 240 can be used if the barb 50 on the actuator 16 is omitted, the barb 50 can be used in combination with the flange 254 and the annular groove 258. It will also be appreciated that in such an alternative embodiment, the urging member 204 can be partially compressed, as shown in FIG.

0074Although some embodiments of the present invention have been described with respect to the present invention, and some embodiments have been described in detail, it is intended to limit the claims of the present invention to those details. It has not been. Additional benefits and changes will be apparent to those skilled in the art. For example, in some applications it may be desirable to enhance the fixation of the sealing member 18 within the catheter hub 12. It can be done, for example, using a holding mechanism. The holding mechanism can be in the form of a radially inward annular rib (not shown) provided on the inner wall 25 of the catheter hub. Such annular ribs engage with the corresponding annular groove (not shown) of the sealing member 18 in the closed position. However, when the male luer taper 30 is inserted into the catheter hub 12, this engagement can overcome the force that slides the seal member 18 axially towards the open position, as described above. In addition, a variety of alternative assembly processes can be used. An example of such an alternative assembly process is the use of a tool (not shown) having a shape similar to the nose 42 to insert the seal member 18 into the catheter hub 12. After the tool has placed the sealing member 18 within the catheter hub 12, the tool can be removed. In another example, the slit 82 may be preformed in the membrane 72 by a cut, but the membrane 72 may also have no slit preformed. In that case, the perforation can be formed by the sharp tip 43 of the needle cannula 40 during assembly. When the needle cannula 40 is withdrawn from the membrane 72, the holes formed by the perforations (not shown) can be reclosed based on the elasticity of the membrane 72. This can result in hemostasis. However, even if the hole is not completely occluded, the hole can adequately restrict blood flow through the membrane. .. This allows, for example, during normal use, only the smallest amount of blood to pass through the membrane 72. The degree of force required to drive the seal member 18 can be slightly greater, and when the seal member 18 moves towards the open position, the membrane 72 is permanently deformed or damaged. Can cause That will be understood. Such deformation or damage is not a problem if the seal member is a single-use type seal, as is advantageous here. Further, although the seal member 18 is described as an integral member in one embodiment of the illustration, the seal member may have a configuration of a plurality of members in an alternative embodiment. .. For example, the seal member may include a rigid holding member that is connected to an elastic seal portion. The rigid holding member is similar to the base end 76 of the seal member 18 described above in that it can be generally cylindrical and has a nose receiving hole such as the hole 92. Can be. The elastic seal portion can be the same as the membrane 72 and the tip portion 74 of the seal member 18 described above. The elastic seal portion can be connected to the tip of the holding portion, and together with the holding portion, can have the same shape as the seal member 18 described above. The rigid holding member is configured to be able to receive the stress and force applied by the impact from the male luer taper 30. On the other hand, the elastic seal portion is configured to provide a hemostatic function, and is configured to allow the barb 50 of the actuator 16 to pass through the membrane 72 when driven. Therefore, in a broad sense, the present invention is not limited to the specific details, devices, methods and examples illustrated and described above. Therefore, changes can be made to such details without departing from the spirit or scope of the general concept of the invention.

007510 Catheter assembly 12 Catheter hub 14 Catheter tube 16 Rigid actuator 18 Seal member 20 Open base 22 tip 24 Internal cavity 25 inner surface 30 luer taper 40 Needle Cannula 42 nose 42a base end shape part 43 Sharp tip 46 shaft 48 eyelet part 49 One end 50 barbs 51 Free end, base end Free end 56 Expanded base flange 65a dimples (surface features) 65b Axial groove (surface feature) 65c Circular groove (surface feature) 65d annular rib (surface feature) 71 outer surface 72 Membran 74 tip 76 base end 77 Impact surface 84 flaps 86 Seal outlet hole 88 Actuator cavity 89 Reduced diameter part 92 Nose receiving space 94 Base end opening 95 Tip shape part 96 tip 97 recess 102 air path 104 Groove 120 free end 160 Drilling tool 162 Pyramid 164 base 165 corner 166 One end 168 Sharp tip 169 other end 172 shaft 173 Sharp edge 174 Flat surface 180 Fixture 182 holes 204 urging member 206 Tube-shaped extension member 224 legs 244 Base tube-shaped extension 246 Tip 248 legs 254 flange 258 groove