CATHETER HUB ADAPTED FOR USE WITH A MULTI-PURPOSE BLOOD CONTROL VALVE - Patent application

Abstract

The catheter hub of the safety needle assembly including the multi-purpose valve uses the proximal portion of the catheter as an actuator to open the compartment membrane of the valve when the valve is subjected to an external biasing force. In another embodiment, the actuator is formed as an integral component of the catheter hub.

Description

[Technical Field]

[0001] The present invention relates to intravenous catheter assemblies and other vascular access devices, including peripheral intravenous catheter (PIVC) assemblies, and more particularly to an improved catheter hub adapted for use with a resealable valve to control blood flow in the catheter assembly. [Background technology]

[0002] A catheter assembly typically includes a catheter hub with a catheter tube extending from the distal end of the catheter hub. A needle cannula, or simply a needle, slidably extends through the lumen of the catheter such that the sharp tip of the needle extends beyond the distal end of the catheter. The catheter is guided into the appropriate vascular system, e.g., a vein or artery of the patient, with the sharp tip of the needle inserted into the patient's vascular system. Once the catheter is in place, the needle is removed from the catheter and catheter hub. A fluid containment device, such as a syringe or pump, is then coupled to the catheter hub so that a fluid pathway is established between the patient's vascular system, e.g., a vein, and the fluid containment device through the interior space of the catheter and catheter hub.

[0003] To ensure that the catheter is properly positioned within a patient's vein or artery, the needle may have a side opening to allow blood to leak into the space between the interior surface of the catheter and the exterior circumferential surface of the needle. This blood along the catheter may serve as an indication to the clinician that the catheter is properly placed. However, after removing the needle from the catheter, but before coupling the fluid containment device to the catheter hub, pressurized blood may undesirably backflow into the catheter through the unobstructed lumen of the catheter.

[0004] To prevent backflow of blood, the prior art discloses a resilient septum or seal provided within the catheter hub. The static seal responds to the insertion movement of a probe, e.g., a male luer taper, into the cavity of the catheter hub and opens when the luer lock or end connector of the fluid containment device is securely coupled to the luer end of the catheter hub. The fluid containment device may be, for example, a syringe, administration set, or pump.

[0005] Commonly assigned patents and applications describe a compressible valve that is biased by an inserted luer taper against an actuator that is fixedly mounted inside a catheter hub. The actuator is a separate component that has an eyelet portion. The eyelet portion is inserted into the catheter hub to attach the actuator and catheter to the catheter hub. Hub The actuator is press-fit into an aperture at the distal end of the catheter along the proximal end of the actuator. To enable it to be press-fit into the aperture, at least the eyelet portion of the actuator is made of a metallic material. Therefore, in addition to requiring separate components, a catheter assembly having an actuator press-fit into a catheter hub may not be safe for use in magnetic resonance imaging (MRI). Patents and applications assigned to the assignee of the present application that describe catheter hubs with compressible valves and fixedly attached actuators include U.S. Patent Nos. 8,652,104, 9,399,116, 9,545,495, and 10,080,867, and U.S. Application Nos. 16 / 110051 and 16 / 110111. The disclosures of each of the '104, '116, '495, and '867 patents, and the '051 and '111 applications, are incorporated herein by reference in their entirety. Summary of the Invention

[0006] The present invention is directed to an improved catheter hub for use with a catheter assembly. In a first embodiment of the invention, a catheter is used to form both the catheter and the actuator of the catheter hub, instead of a separate actuator. As such, the catheter is suitably threaded through an aperture at the distal end of the catheter hub, such that the distal portion extends distally away from the catheter hub and the proximal portion extends proximally into the interior cavity of the catheter hub. The portion of the catheter sandwiched between the distal and proximal portions is fixedly bonded to the aperture by any conventional method, including, for example, chemical adhesive bonding, melt bonding, plastic insert molding, among others. The proximal portion of the catheter can be configured to be structurally rigid, and its probe end can be configured to include a resealable multi-purpose valve. bulkhead or membrane opening. This can be achieved by injection molding the catheter so that the circumferential wall thickness of the proximal section is greater than the circumferential wall thickness of the distal section. Alternatively, the proximal and distal sections of the catheter can be extruded using different materials, or particles can be added to the proximal section to add columnar strength and rigidity. The proximal section of the catheter that extends into the cavity of the catheter hub can be referred to as the catheter actuator, or simply the actuator.

[0007] Separating the valve into proximal and distal portions bulkhead Alternatively, a resilient resealable multi-purpose valve having a membrane is slidably and non-removably inserted into a cavity of a catheter hub with its membrane proximal to an actuator when the valve is in its natural, unbiased state. The membrane has at least one slit to assist in its opening. Multiple slits can be provided in the membrane to provide flaps when the membrane is open. In the unbiased position, the flexibility of the membrane is such that it remains closed to prevent fluid leakage from the portion of the catheter hub blocked by the valve, even when the catheter is positioned in a patient's artery and blood in the catheter lumen is pressurized.

[0008] When an external fluid containment device is coupled to the catheter hub, the membrane is biased to an open position within the catheter hub relative to the actuator when the contact end of the connector (the luer taper of a luer lock connector) of the external device, e.g., the fluid containment device, contacts the proximal end of the valve. With the membrane open, an open fluid communication path is established between a chamber in the proximal portion of the valve, a cavity in the proximal portion of the catheter hub, and the lumen of the catheter so that fluid can be collected from or infused into the patient. When the external fluid containment device is removed from the catheter hub, it is no longer biased and, due to its inherent resiliency, the valve returns to its natural state, with the membrane repositioned proximal to the probe end of the actuator in the closed position.

[0009] Another embodiment of the present invention has the actuator integrally formed as part of the catheter hub. In this embodiment, the actuator is internally disposed within the catheter hub as a tubular structure having an internal passageway that aligns with an aperture at the distal end of the catheter hub. side The actuator extends integrally from the distal end wall. The actuator can have a frusto-conical probe tip to assist in opening the membrane. The proximal portion of the catheter can extend into and be fixedly attached to an aperture in the distal end of the catheter hub. Alternatively, the proximal portion of the catheter can extend through a passage in the actuator such that the lumen of the catheter provides a through passage between the interior cavity of the catheter hub and the patient's vein or artery.

[0010] Various embodiments of the present invention eliminate the need for a separate actuator component and the additional process of installing the separate actuator component in the catheter hub. Therefore, fewer components and less manufacturing are required to produce the catheter hub assembly, resulting in reduced costs. Furthermore, the elimination of a metal actuator allows the catheter assemblies of the present invention to be safely used in MRI scans.

[0011] The invention will become apparent and may be best understood by referring to the following description of the invention taken in conjunction with the accompanying drawings, in which: FIG. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a semi-transparent perspective rear view of a first embodiment of a catheter hub assembly of the present invention. [Figure 2] FIG. 1 is a semi-transparent perspective front view of a first embodiment of a catheter hub assembly of the present invention. [Figure 3] FIG. 1 is an exploded view showing a catheter hub assembly in a first embodiment of the present invention. [Figure 4] 1 is a cross-sectional cutaway view showing a catheter hub according to a first embodiment of the present invention. FIG. [Figure 5] 1 is a partially cutaway cross-sectional view showing a catheter hub assembly according to a first embodiment of the present invention. [Figure 6] FIG. 1 is a partially cutaway perspective view of the outer wall showing the catheter hub assembly of the first embodiment. [Figure 7] FIG. 1 is a perspective semi-transparent view showing a catheter hub assembly and a multi-purpose valve positioned therein. [Figure 8] FIG. 1 is a cross-sectional view showing the catheter hub assembly of the present invention and its relationship to the multi-purpose valve in the unbiased position. [Figure 9] 1 is a cross-sectional view of a first embodiment of a catheter hub assembly of the present invention and illustrating the positioning of a multi-purpose valve relative to an actuator portion of a catheter when the valve is in a biased position. [Figure 10A] FIG. 1 is a cross-sectional view of a catheter hub assembly of the present invention showing the membrane of the multipurpose valve in its natural closed position. [Figure 10B] FIG. 1 is a cross-sectional view of a catheter hub assembly of the present invention showing the membrane of the multipurpose valve in its natural open position. [Figure 11]FIG. 10 is a cross-sectional view illustrating another embodiment in which the actuator portion of the catheter within the cavity of the catheter hub is flared or enlarged and positioned distal to the closed membrane of the multipurpose valve. [Figure 12] FIG. 12 is a cross-sectional view of the catheter hub of FIG. 11 showing the multi-purpose valve biased to its open position by the flared catheter actuator. [Figure 13A] FIG. 10 illustrates the positioning of the multipurpose valve relative to a flared catheter actuator with the membrane in the closed position. [Figure 13B] FIG. 10 illustrates the positioning of the multipurpose valve relative to a flared catheter actuator with the membrane in the open position. [Figure 14A] 10A-10C are cross-sectional views illustrating different exemplary multi-purpose valves adapted for use in the catheter hub assemblies of the present invention. [Figure 14B] 10A-10C are cross-sectional views illustrating different exemplary multi-purpose valves adapted for use in the catheter hub assemblies of the present invention. [Figure 14C] 10A-10C are cross-sectional views illustrating different exemplary multi-purpose valves adapted for use in the catheter hub assemblies of the present invention. [Figure 15] FIG. 10 is a cutaway view showing a further embodiment of a catheter hub of the present invention. [Figure 16] FIG. 16 is a cross-sectional view of the catheter hub of FIG. 15 with a catheter. [Figure 17] FIG. 10 is a cross-sectional view illustrating an embodiment in which a proximal portion of the catheter extends through an internal passageway of an integrated actuator of the catheter hub. DETAILED DESCRIPTION OF THE INVENTION

[0013] In the following description, the terms proximal and non-patient, and distal and patient, are interchangeable when used to refer to directions in the catheter assemblies of the present invention. For example, the terms distal end and patient end refer to the same direction, and the terms proximal end and non-patient end refer to the same opposite direction.

[0014] 1-5, a first embodiment of a catheter hub assembly 2 of the present invention is shown having an elongated cylindrical body 4 with an open proximal end 6, a distal end 8, and an internal cavity 10 that opens to an opening 4o. The cavity 10 has a proximal section 4p and a slightly larger diameter distal section 4d separated by a transition section 4s. An aperture 12 extends through the distal end 8. Although not required for the embodiment, the aperture 12 is shown to have a distal portion 12a and a proximal portion 12b, with portion 12b having a larger cross-section than portion 12a. The proximal end 6 has two other portions 6a and 6b that enable the proximal end 6 to be lockingly coupled to a luer connector 14c of an external device 14, shown in FIG. 5 and represented by arrow 14 in other figures. The external device may be a fluid storage device, including, for example, a syringe, administration set, or pump. When so coupled, the luer taper cone, or simply luer taper 14t, of the external device enters the cavity 10 of the catheter hub and contacts the proximal end 16b of the multipurpose valve 16 positioned within the catheter hub, as described in more detail below. The luer taper 14t is sometimes referred to as the connector end of the external device.

[0015] A catheter 18 extends from the distal end 8 of the catheter hub. As best shown in FIG. 3, the catheter 18 has a proximal portion 18p and a distal portion 18d having a distal tip 18t. As shown in FIG. 5, the proximal portion 18p of the catheter 18 extends into the interior cavity 10 of the catheter hub 4 through an aperture 12. As the catheter 18 slidably passes through the aperture 12, a portion of the proximal portion 18p is fixedly attached to the interior wall defining the aperture 12 at the distal end 8 of the catheter hub 4 by any of a number of conventional attachment methods, including, for example, adhesive bonding, glue bonding, melt bonding, ultrasonic bonding, etc. The aperture 12 can be configured into two sections 12a and 12b, with the catheter 18 slidably passing through section 12a and adhesive provided in section 12b to fixedly attach the catheter 18 to the catheter hub. The length of the portion of catheter 18 that extends proximally into cavity 10 is designated 18i in FIG. 6 and may be referred to as the actuator portion of the catheter, the catheter actuator, or simply the actuator. Actuator 18i can be configured with a frusto-conical probe end 18e to assist in opening the membrane within valve 16. The length of actuator 18i within cavity 10 is determined by the length of the proximal end of the catheter 18 that extends proximally into cavity 10, as described further below. bulkhead The stiffness and columnar strength of at least that portion of the catheter necessary to act as an actuator to open the valve 16, as well as the length and cross-sectional dimensions of the portion of the valve 16 that prevents fluid leakage from the catheter actuator.

[0016] The catheter 18 can be extruded to have a different material or blend of materials so that the actuator section has greater stiffness and columnar strength than the remainder of the catheter. The catheter 18 can also be formed by injection molding using a material forming the actuator section that has greater stiffness than the material forming the patient end of the catheter. Materials that can be used to extrude or mold the catheter 18 include polyurethane or nylon, as well as other conventionally known materials. Air bubbles and other non-metallic particles can also be added to the actuator section during the extrusion or molding process to provide different columnar strengths in different portions of the catheter. The walls of the actuator section can also be formed to have a greater thickness than the walls of the patient section of the catheter.

[0017] The valve 16, sometimes referred to as a sealing member, is an elongated cylindrical member made of a resilient material, such as silicone or polyisoprene, or other similar material having the necessary flexibility and compressibility characteristics. As shown in Figures 5-7, one exemplary multi-purpose valve 16 has a proximal portion 16p and a distal portion 16d. The valve 16 has cross-sectional dimensions that allow it to slide through the catheter hub cavity 10. A through passage 16o extends between the proximal end 16b and the distal end 16e of the valve 16 to form a chamber within the valve 16. A notch 16n in the outer surface of the proximal portion 16p provides an outlet for air to escape from the internal cavity 10 when the distal portion 16d is compressed within the catheter hub. The notch 16n also provides an inlet for passing sterilizing gas into the distal portion of the catheter hub cavity to sterilize the catheter hub assembly. The inherent resilience properties of the elastic material allow the valve to compress within cavity 10 when it encounters a biasing force along its longitudinal axis and return to its natural state when the biasing force is removed. It should be appreciated that distal portion 16d can further function as a compressible biasing member for valve 16, as it is more easily compressible in response to the biasing force due to the space surrounding valve 16 within cavity 10 and can then decompress to return the valve to its natural state when the biasing force is removed.

[0018] Integral membrane of valve 16 or bulkhead The distal end 16e of the valve 16 is located within the catheter hub 4. side The distal wall 4w is in contact with the distal wall 4w. The distal wall 4w defines the distal end of the internal cavity 10 of the catheter hub 4. As best shown in FIG. 4 , the wall 4w surrounds the aperture 12. In the illustrated embodiment, the wall 4w is shown as flat, but it should be understood that the wall 4w has a corresponding configuration adapted to reflect the particular or given configuration of the distal end 16e of the valve 16 to ensure a maximum contact area is provided between the wall 4w and the distal end 16e to allow optimal compression by the valve 16 under a biasing force and to return the valve 16 to its natural position when the biasing force is removed. For example, if the distal end 16e has a rounded configuration, the wall 4w will have a corresponding grooved configuration to receive the distal end 16e. Alternatively, if the distal end 16e is flat, the distal wall 4w will be flat as well. In the illustrated valve embodiments, even though the distal portion is considered the biasing member, it should be understood that, as previously mentioned, due to the inherent resilience of the elastic material, the entire valve can act as a biasing member, as will be described below in connection with the embodiment shown in FIG. 14B.

[0019] 7, the valve 16 is slidably inserted into the cavity 10 of the catheter hub 4 through an opening 4o in the proximal end 6 of the catheter hub 4. To maintain but allow the valve 16 to slide within the catheter hub 4, cooperating means, not shown, such as cooperating grooves and flanges, can be provided on the exterior surface of the valve 16 and the interior circumferential surface of the catheter hub 4, respectively.

[0020] Referring to FIG. 1 , a ready-to-use needle cannula, or simply needle 20, extending from a needle hub or needle insertion device or assembly 22 is inserted through membrane 16m of valve 16 into cavity 10 of catheter hub 4 and slidably extends through lumen 18a of catheter 18, with sharp tip 20a extending beyond distal end 18t of catheter 18.

[0021] 8 and 9 are illustrations of another exemplary multi-purpose valve adapted for use with the catheter assembly of the present invention. Components identical to those in the exemplary valves described above are labeled with the same reference numerals. As shown, the distal section 16d of the multi-purpose valve 16 of the embodiment of FIGS. 8-9 has an outer circumferential surface that substantially follows the outer circumferential surface of the proximal section 16p, but its inner surface is unevenly shaped to define a chamber 16f that accommodates a catheter actuator 18i. The distal portion 16d is compressible inwardly into the chamber 16f and is therefore the bias portion of the exemplary valve 16. The valve 16 shown in FIGS. 8-9 is similar to the seal members described in the aforementioned patents and publications incorporated by reference, e.g., U.S. Pat. No. 8,652,104. FIG. 8 illustrates the seal member 16m, which is positioned at the probe end 16f of the actuator 18i. 8 The valve 16 in its native state is shown proximal to e.

[0022] 9 shows an external device, designated by arrow 14, coupled or connected to the proximal Luer end 6 of the catheter hub 4. When the external device is connected to the proximal end 6 using its Luer lock, its Luer taper 14t is inserted into the catheter hub cavity 10 and its distal connector end 14e contacts the proximal end 16b of the valve 16. Due to its resiliency, the valve 16, particularly its distal portion 16d, compresses against the distal end wall 4w inside the catheter hub 4 when biased by the Luer taper 14t, as described in more detail in the aforementioned patents and publications incorporated by reference, such as the '104 patent associated with FIGS. 9, 10, and 19. Further distal movement of the distal connector end 14e moves the valve 16 distally relative to the catheter hub 4 toward the actuator 18i, and more specifically, toward its biasing membrane 16m relative to its probe end 18e, until the opening in the probe end 18e is positioned within the through passage 16o, which may also be referred to as the chamber or proximal chamber 16o of the valve 16. As a result, an open fluid communication path is established between an external fluid containment device and the patient's vein via the lumen 18a of the catheter 18, the chamber 16o of the valve 16, and the cavity 10 within the catheter hub 4. Because both the chamber 16o and the cavity 10 are internal to the catheter hub 4, it should be understood that the term cavity may also define the interior space or cavity of the catheter hub that is open relative to the proximal probe end 18e of the actuator 18i. When the external device is removed from the catheter hub 4, thereby removing the force biasing the membrane 16m against the actuator 18i, the valve 1 6 returns to its natural or unbiased position with membrane 16m closed and proximal to probe end 18e, as shown in Figure 8. As previously mentioned, one or more slits can be formed in membrane 16m to assist in opening and closing membrane 16m.

[0023] 10A and 10B illustrate distal movement of valve 16, showing membrane 16m in closed and open positions, respectively.

[0024] Referring to FIG. 1, to use the catheter assembly of the present invention, a clinician uses the sharp tip 20a of the needle 20 to pierce a patient's vascular system, e.g., a vein or blood vessel. The needle 20 is then moved to position the catheter 18 over the needle 20 within the vein. After the catheter 18 is properly positioned, the needle is removed, and the catheter assembly becomes as shown in cross section in FIG. 8. The clinician can use several suture securement rings 24 on the exterior surface of the catheter hub 4 and tape to attach the catheter hub assembly to the patient's skin. A fluid storage device, e.g., a syringe, can then be connected to the catheter assembly by mating the luer connector of the fluid storage device to the luer end 6 of the catheter hub 4.

[0025] After removing the needle 20 from the catheter hub assembly 2, but prior to coupling of an external device to the catheter hub 4, the catheter assembly 2 is as shown in FIG. 8, with the valve 16 in its natural state. As shown, the membrane 16m is closed and positioned proximal to the probe end 18e of the catheter actuator 18i. In this position, the membrane 16m separates a proximal chamber 16o in the proximal portion 16p from a distal chamber 16f in the distal portion 16d of the valve 16. With the membrane closed, blood is prevented from flowing back from the patient through the lumen 18a of the catheter 18 and out of the chamber 16f.

[0026] Figures 11 and 12 illustrate another embodiment using a one-piece catheter, with both the actuator and the patient's vascular conduit shown. The same reference numerals from Figures 1 through 10 are repeated to identify the same components within the figures under consideration. As shown, the actuator 18i' of the catheter 18' is enlarged by a flaring device such that the flared cylindrical catheter actuator 18i' has a bore 26 that tapers to match the lumen 18a' via a tapered section 26t. By having a flared actuator, the membrane 16m has a larger opening when biased against the probe end 18e'. This results in more fluid flow through the catheter assembly. Additionally, the tapered section 26t is retentively supported by the circumferential protrusion 16h, while the flared portion 18i' is retentively supported by the circular protrusion 16g of the valve 16 to provide a more stable actuator. The operation and function of the catheter assembly shown in Figures 11 and 12 is similar to that discussed above for the embodiment shown in Figures 1 through 10. Figures 13A-13B show movement of the valve relative to the catheter hub when the membrane is unbiased against the flared actuator and in its unbiased closed position, and when the membrane is biased against the flared actuator and in its open position.

[0027] Referring to Figures 14A-14C, three embodiments of a multi-purpose valve adapted for use with an actuator within a catheter hub are shown. The different multi-purpose valves are shown in their unbiased positions. Components that are the same as those described in the previous figures are labeled with the same reference numbers. The multi-purpose valve 16 shown in Figure 14A is the same valve as that described in the incorporated-by-reference '104 patent. A cavity 28 in the distal portion 16d of the valve 16 allows the distal portion 16d to be easily compressed against the distal end wall 4w when the valve 16 is biased distally relative to the catheter hub 4. A circumferential protrusion 16h provides support for the catheter actuator 18i.

[0028] FIG. 14B shows a multipurpose valve 16′ having a distal portion 16d′ formed with a substantially solid elastic portion 30 supporting an actuator 18i. In this embodiment, the elastic material forming portion 30 can be a more resilient and flexible material, such as Elastosil, which allows portion 30 to be more easily compressed. For the embodiment of FIG. 14B, even though shown as having the same length as the catheter actuators of FIGS. 14A and 14B, the length of the catheter actuator 18i within the catheter hub can be varied (shorter or longer) as described above, and the length of the valve's distal portion 30 can also be varied to balance its resiliency against the distance to the end wall 4w where the actuator 18i is required to open the valve membrane under a biasing force. Additionally, the valve's proximal portion 16p′ can be reinforced with additives or, for example, reinforced or replaced by a cylindrical ring having a higher Shore hardness than the elastic material from which the valve is made.

[0029] FIG. 14C illustrates the multipurpose valve 16″ shown in FIGS. 5-7. The valve 16″ has a distal portion 16d″ that tapers from the distal end of the proximal portion 16p″ such that the distal portion 16d″ has a diameter smaller than the diameter of the proximal portion 16p″. Thus, there is a circumferential space 32 surrounding the elongated cylinder 34 of the valve's distal portion 16d″. In this embodiment, Long and slender Cylinder 34 provides support for the entire length of catheter actuator 18i, and space 32 provides room for cylinder 34 to collapse or compress when the valve is moved distally by a biasing force.

[0030] Another embodiment of the catheter hub of the present invention is shown in Figures 15-17. As shown in the figures, the catheter hub 36 has an elongated cylindrical body, a distal end 40 that tapers from the body 38, and a proximal end 39 configured to receive a luer connector from an external device, as previously described. Similar to the previously discussed embodiment, the catheter hub 36 has a proximal end 42 that is open to an internal cavity 44, with a smaller diameter proximal section 46 and a larger diameter distal section 48 connected by a tapered transition 50. Instead of utilizing the proximal portion of the catheter as the actuator, the actuator 52 in this embodiment is located within the catheter hub. sideThe actuator 52 extends integrally from the distal end wall 54. In other words, the actuator 52 is an integral component of the one-piece catheter hub 36, which may be formed from the same mold. As shown, the actuator 52 is a cylindrical extension having a frusto-conical probe tip 56 and a passageway 58 that aligns with an aperture 60 in the distal end 40 of the catheter hub 36. The passageway 58 and aperture 60 collectively form a through passageway from the distal end 62 to the interior cavity 10. Although not shown with a multi-purpose valve, it should be understood that the multi-purpose valve 16 described in the previous embodiment can be provided within the cavity 44 of the catheter hub 36 and applied in the same manner, i.e., a distal force designated by arrow 14 can be applied to move the valve distally relative to the catheter hub so that the valve membrane 16m is biased to its open position relative to the probe end 56 of the actuator 52, and when the external distal force is removed, the valve returns to its natural state so that its membrane is in its closed position, proximal to the actuator 52 to prevent blood leakage. By having an integrated actuator, no support of the type that may be required for a catheter actuator as described in the previous embodiment is required. Because the actuator and catheter hub are molded as a one-piece component, manufacturing costs can also be reduced due to fewer manufacturing steps.

[0031] 16 shows the catheter 18 slidably threaded within the aperture 60. A step 64 joining the aperture 60 and the passageway 58 acts as a stop for the proximal end of the catheter. The portion of the catheter 18 within the aperture 60 is fixedly attached to the interior circumferential surface of the aperture by any of the conventional adhesive methods previously described. When the catheter is attached to the catheter hub 36, a fluid communication path is established from the distal end of the catheter to the cavity 44 and to an external fluid containment coupled to the proximal end of the catheter hub.

[0032] 17 illustrates one embodiment in which a through aperture 66 extends from the distal end 62 of the catheter hub 36 to the probe end 56 of the actuator 52. The proximal portion of the catheter 18 slidably passes through the aperture 60′ to the probe end 56 of the actuator 52. The catheter can be adhesively attached to the aperture 66 as described above, or it can be press-fit into the aperture 66. By extending the catheter through to the probe end 56 of the actuator 52, a continuous lumen of the same diameter is provided.

[0033] The invention disclosed above is subject to many detailed variations, modifications, and changes. Accordingly, it is intended that all matter set forth throughout this specification and shown in the accompanying drawings be interpreted as illustrative only and not in a limiting sense. It is therefore intended that the invention be limited only by the spirit and scope of the appended claims.

Claims

1. A catheter hub comprising a body, a catheter, and an actuator, a catheter hub, the catheter having a proximal end and a proximal end, the body having a cavity that opens from the proximal end to an inner distal wall surrounding an aperture at the distal end, the catheter having a proximal portion, a distal portion, and a through lumen extending along the aperture, the through lumen of the catheter providing a through passageway between the cavity of the catheter hub and a distal tip of the distal portion of the catheter, the catheter being fixedly attached to the inner distal wall of the aperture such that the distal portion of the catheter extends distally from the distal end of the catheter hub, the proximal portion of the catheter extending proximally within the cavity of the catheter hub, the proximal portion of the catheter having greater stiffness and columnar strength than the remainder of the catheter such that the proximal portion acts as an actuator within the cavity.

2. 10. The catheter hub of claim 1, wherein the actuator of the catheter within the cavity has the probe end for opening the resealable septum of the valve positioned within the cavity when the valve is biased distally relative to the catheter hub such that the septum contacts the probe end and is thereby opened, the through lumen establishing a through passage between the proximal end of the catheter hub and the distal end of the catheter, and the wall of the proximal portion of the catheter having a greater thickness than the wall of the distal portion of the catheter.

3. 10. The catheter hub of claim 1, wherein the catheter is formed by injection molding a material that forms the proximal portion of the catheter that defines the actuator, the actuator being configured to have a greater stiffness than a material that forms the distal portion of the catheter.

4. 3. The catheter hub of claim 2, wherein the cavity is cylindrical and the inner distal wall forming the distal end of the cavity surrounding the aperture has a configuration that mirrors the shape of the distal end of the valve that contacts the inner distal wall.

5. The catheter hub of claim 1 , wherein the proximal portion of the catheter within the cavity has a flared cylindrical portion that includes a probe end.

6. further comprising a valve positioned within the cavity; 2. The catheter hub of claim 1, wherein the valve has a resealable septum, a proximal valve end, and a distal valve end, the distal valve end contacting the inner distal wall and the proximal valve end adapted to be biased by a contact end of an external device, the resealable septum being disposed proximal to a probe end of the actuator when the valve is in an unbiased state, and the proximal portion defining the actuator has sufficient stiffness and columnar strength to open the resealable septum of the valve located within the cavity when the resealable septum is urged toward the actuator by a contact end of an external device.

7. 7. The catheter hub of claim 6, wherein when the contact end of the external device contacts the proximal valve end and moves the valve distally relative to the catheter hub, the resealable septum is opened by the probe end of the actuator such that an open passage is established through the through lumen of the catheter between the probe end of the proximal section and the distal end of the catheter within the catheter hub.

8. a needle that passes through the resealable septum and slidably extends through the through lumen of the catheter such that a distal tip of the needle extends beyond the distal end of the catheter when the catheter hub is in use; The catheter hub of claim 6 further comprising:

9. A catheter hub comprising a body and an actuator, The catheter hub, wherein the body has a distal end, a proximal end, and an internal cavity between the proximal end and a distal end wall surrounding an aperture at the distal end, the proximal portion of the catheter having an internal lumen that is appropriately received in the aperture, and a cylindrical extension extending integrally from the distal end wall into the internal cavity to define the actuator, the cylindrical extension having an internal passage and a proximal probe end, the internal passage being aligned with the aperture so as to be fluidly connected with the internal lumen of the catheter.

10. a valve positioned within the internal cavity, the valve having a proximal valve end, a distal valve end, and a resealable septum, the distal valve end contacting the distal end wall, the resealable septum being proximal to the probe end of the actuator when the valve is in an unbiased state; 10. The catheter hub of claim 9.

11. 11. The catheter hub of claim 10, wherein the internal cavity is cylindrical except for the actuator extending from the distal end wall into the internal cavity, and the distal end of the valve has a configuration that ensures a maximum contact area is provided between the distal end of the valve and the distal end wall.

12. 11. The catheter hub of claim 10, wherein when an external device is coupled to the catheter hub, the valve is moved distally by the external device to bias the resealable septum against the probe end of the actuator to establish an open passage between the proximal end of the catheter hub and the lumen of the catheter through the internal passage of the actuator.

13. a needle slidably extending through the resealable septum, the interior passageway of the actuator, and the lumen of the catheter such that a distal tip of the needle extends beyond the distal end of the catheter when the catheter hub is ready for use. The catheter hub of claim 11.

14. 1. An apparatus comprising: a catheter hub having an elongate body with an open proximal end, a distal end, and an internal cavity, the proximal end adapted to receive an extension of an external device into the internal cavity, the internal cavity extending along the elongate body from the proximal end to a distal end wall within the catheter hub, the distal end wall having an aperture; a catheter having an internal lumen suitably extending through the aperture, the catheter having a patient end of a patient portion of the catheter extending distally from the distal end of the catheter hub and a non-patient end of a non-patient portion of the catheter having greater stiffness and columnar strength than the patient portion extending proximally into the internal cavity, the catheter being fixedly attached to the aperture; a valve having a distal section and a proximal section separated by a resealable septum, the valve being fixedly mounted within the interior cavity with a distal end of the distal section in contact with the distal end wall, the resealable septum being in a closed position separating the non-patient end of the catheter from the open proximal end of the catheter hub when the valve is in an unbiased state; Equipped with when the extension is inserted into the internal cavity through the open proximal end and contacts the proximal section, the valve is biased by the extension to open the resealable septum toward the non-patient end of the catheter to establish a fluid communication path between the external device and the lumen of the catheter; the lumen of the catheter providing a through passageway between the interior cavity of the catheter hub and the patient end of the patient portion of the catheter; When the extension is removed from the open proximal end, the valve returns to its unbiased state and the resealable septum returns to its closed position. Device.

15. 15. The device of claim 14, wherein the non-patient end of the catheter has a flared cylindrical end portion with a distal end that tapers distally toward the patient end of the catheter.

16. 15. The device of claim 14, wherein the non-patient end of the catheter has sufficient stiffness and columnar strength to open the resealable septum when the patient is biased against the resealable septum, and the stiffness and columnar strength of the non-patient portion of the catheter is achieved by either the catheter being a different material or a blend of different materials such that the stiffness and columnar strength of the non-patient portion is greater than that of the patient portion, or the material forming the non-patient portion is injection molded to have a greater stiffness than the material forming the patient portion of the catheter, or the wall of the non-patient portion is formed to have a greater thickness than the wall of the patient portion of the catheter.

17. a needle that passes through the resealable septum and slidably extends through the lumen of the catheter such that a distal tip of the needle extends beyond the distal end of the catheter when the catheter hub is ready for use.

15. The apparatus of claim 14.

18. 1. An apparatus comprising: a catheter hub having an elongate body with open proximal and distal ends and an internal cavity, the proximal end adapted to receive an extension of an external device into the internal cavity, the internal cavity extending along the elongate body from the proximal end to a distal end wall internal to the catheter hub, the distal end wall having an aperture, a catheter having an internal lumen fixedly attached to the aperture with a patient end extending distally from the catheter hub, an actuator having an internal passage aligned with the aperture extending integrally away from the distal end wall into the internal cavity, the internal passage of the actuator fluidly communicating with the internal lumen of the catheter such that the lumen of the catheter and the internal passage of the actuator provide a through passage between the patient end of the catheter and the internal cavity of the catheter hub; a valve having a distal section and a proximal section separated by a resealable septum, the valve being fixedly mounted within the interior cavity with a distal end of the distal section in contact with the distal end wall, the resealable septum being in a closed position separating the non-patient end of the catheter from the open proximal end of the catheter hub when the valve is in an unbiased state; Equipped with when the extension portion is inserted into the internal cavity through the open proximal end and contacts the proximal section, the valve is biased by the extension portion to open the resealable septum to the actuator to establish a fluid communication path between the external device and the lumen of the catheter through the internal passage of the actuator; When the extension is removed from the open proximal end, the valve returns to its unbiased state and the resealable septum returns to its closed position. Device.

19. a needle that passes through the septum and slidably extends through the interior passageway of the actuator and the lumen of the catheter such that a distal tip of the needle extends beyond the distal end of the catheter when the catheter hub is ready for use.

20. The apparatus of claim 18.

20. 20. The device of claim 18, wherein the internal cavity is cylindrical and the distal end of the valve has a configuration that ensures maximum contact area between the distal end of the valve and a distal wall.

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