Central catheter, central catheter assembly and central catheter hub

Abstract

The central catheter (100) includes a catheter tube (104) coupled to a plurality of extension legs (110) and a needle hub (106) coupled to the catheter tube (104), the needle hub configured to receive a needle (150) therethrough such that the needle is disposed within the primary catheter tube lumen. The central catheter includes a manifold hub (108) for coupling the extension legs to the catheter tube. The manifold hub (108) may be integral with the needle hub (106). The needle hub (106) includes a septum within the needle hub lumen, the septum configured to define a fluid-tight seal with the needle (150) and prevent fluid flow through a proximal portion of the needle hub lumen when the needle is withdrawn from the needle hub lumen.

Description

[Background technology]

[0001] Several steps and medical devices (e.g., needles, scalpels, guidewires, introducer sheaths, dilators, etc.) are utilized to introduce a central catheter, such as a central venous catheter (CVC), into a patient and advance such catheter through the patient's vasculature. Although the Seldinger technique is effective, many of the steps are time consuming and the handling of numerous medical devices is cumbersome, all of which may be traumatic for the patient. In addition, due to the large number of medical devices that must be replaced during the multiple steps of the Seldinger technique, the potential for contamination through contact is relatively high. Thus, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient's body and advancing the catheter through its vasculature.

[0002] In some cases, the needle may be unnecessarily long, extending between the luer connector of the extension leg and the distal end of the catheter tube. The long length of the needle requires extensive care in handling the needle to prevent bending or other damage to the needle. Also, a long needle length may cause a significant delay in obtaining a blood flush, and in some instances, a long needle length may cause intraluminal blood clots.

[0003] Disclosed herein are central catheters and related devices, assemblies for providing shorteners, and methods for inserting a central catheter having a shortener. Summary of the Invention

[0004] Disclosed herein is a central catheter including a catheter tube configured for advancement along a patient's vascular system, the catheter tube including (i) a plurality of catheter tube lumens extending along the catheter tube, (ii) a number of extension legs equal to the number of catheter tube lumens, each extension leg being in fluid communication with a corresponding catheter tube lumen, and (iii) a needle hub coupled to the catheter tube, the needle hub including a needle hub lumen configured for advancement of a needle therethrough. The needle hub further includes a septum disposed across a proximal portion of the needle hub lumen, the septum configured to define a fluid-tight seal with the needle when the needle is disposed within the needle hub lumen and to prevent fluid flow through the proximal portion of the needle hub lumen when the needle is not disposed within the needle hub lumen. The needle hub is coupled to the catheter tube such that the needle hub lumen is in fluid communication with one of the catheter tube lumens.

[0005] In some embodiments, the needle hub lumen is parallel to the catheter tube along the distal portion of the needle hub, and the needle hub lumen may be collinear with one of the catheter tube lumens along the distal portion of the needle hub.

[0006] In some embodiments, the needle hub further includes one or more suture wings for securing the needle hub to a patient. The one or more suture wings may define a patient-contacting surface of the hub, and in some embodiments, the patient-contacting surface is parallel to the needle hub lumen.

[0007] In some embodiments, the catheter includes a manifold hub that defines fluid communication between each extension leg and its corresponding catheter tube lumen, the extension legs being attached to the manifold hub.

[0008] In some embodiments, the needle hub includes a manifold hub integrated therein such that the extension legs are attached to the needle hub, hi some embodiments, each extension leg includes a luer connector at its proximal end.

[0009] In some embodiments, each extension leg may be attached to the needle hub at an angle relative to the needle hub lumen. Each extension leg may also be attached to the needle hub at an angle relative to the patient-contacting surface. In further embodiments, the extension legs are attached to the needle hub in one plane.

[0010] In some embodiments, the several lumens may include (i) a primary lumen extending distally to a distal end of the catheter tube, (ii) a secondary lumen extending distally to a first side port of the catheter tube, and (iii) a tertiary lumen extending distally to a second side port, the second side port being disposed proximal to the first side port.

[0011] In some embodiments, the material of the septum is one of silicone rubber, ethylene propylene diene terpolymer (EPDM), or polyurethane, and in some embodiments, the hub and the septum are constructed of the same material.

[0012] In some embodiments, the septum is formed integrally with the hub during the hub formation process, and in some embodiments, the septum includes a pre-formed slit configured for insertion of a needle therethrough.

[0013] Also disclosed herein is a central catheter assembly including any of the central catheter embodiments summarized above and a needle preloaded within the central catheter, the needle being disposed within the needle hub lumen and the primary catheter tube lumen, the needle being capable of being positioned within the primary catheter tube lumen such that the needle extends beyond the distal end of the catheter tube to facilitate percutaneous puncture by the needle.

[0014] In some embodiments, the needle includes a lubricant disposed on an exterior surface of the needle to promote sliding engagement between the needle and the septum. In some embodiments, the plurality of extension legs includes a primary extension leg in fluid communication with the primary lumen, and the assembly further includes a pre-loaded guidewire disposed within the primary extension leg.

[0015] Also disclosed herein is a method for introducing a central catheter into a patient's blood vessel. The method includes providing a central catheter including a catheter tube having a catheter tube lumen extending therethrough to a distal end of the catheter tube and a needle hub coupled to the catheter tube. The needle hub includes a needle hub lumen configured for advancement of a needle therethrough and a septum disposed over a proximal portion of the needle hub lumen. The septum is configured to (i) define a fluid-tight seal with the needle when the needle is disposed within the needle hub lumen and (ii) prevent fluid flow through the proximal portion of the needle hub lumen when the needle is not disposed within the needle hub lumen. The needle hub is coupled to the catheter tube such that the needle hub lumen is in fluid communication with the catheter tube lumen. The method further includes (i) inserting the catheter tube through the patient's skin and into the blood vessel such that a distal end of the catheter is disposed within the blood vessel, the catheter tube lumen including a needle disposed therein; (ii) advancing the catheter tube over the needle to advance the catheter tube further into the blood vessel lumen; and (iii) withdrawing the needle from the catheter tube lumen.

[0016] In some embodiments, the method further comprises inserting a needle through the needle hub lumen and into the catheter tube lumen. In some embodiments, the method further includes verifying that the distal tip of the needle is disposed within the blood vessel lumen by aspirating blood with a syringe connected to the needle prior to withdrawing the needle from the catheter tube lumen.

[0017] Also disclosed herein is a central catheter hub including a hub body defining a proximal end and a distal end, the hub body configured to mate with a central catheter tube having a number of catheter tube lumens extending therethrough. The central catheter hub further includes a needle hub lumen extending therethrough configured for advancement of a needle therethrough, the needle hub lumen being in fluid communication with one of the number of catheter tube lumens. The central catheter hub further includes a septum disposed across a proximal portion of the needle hub lumen, the septum configured to (i) define a fluid-tight seal with the needle when the needle is disposed within the needle hub lumen, and (ii) prevent fluid flow through the proximal portion of the needle hub lumen when the needle is not disposed within the needle hub lumen. The central catheter hub further includes one or more suture wings extending from the hub body for securing the needle hub to a patient.

[0018] In some embodiments, the one or more suture wings define a patient-contacting surface of the hub, the patient-contacting surface being parallel to the needle hub lumen. In some embodiments, the hub body is configured to mate with the catheter tube such that the needle hub lumen is parallel to the catheter tube along a distal portion of the hub body, hi some embodiments, the hub body is configured to mate with the catheter tube such that the needle hub lumen is collinear with one of several catheter tube lumens along a distal portion of the hub body.

[0019] In some embodiments, the hub body is configured to couple to a number of extension legs equal to the number of catheter tube lumens, such that each extension leg is in fluid communication with a corresponding catheter tube lumen.

[0020] In some embodiments, the hub body is configured to couple to the extension legs such that each extension leg extends from the proximal end at an angle relative to the needle hub lumen. In some embodiments, the hub body is configured to couple to the extension legs such that each extension leg extends from the proximal end at an angle relative to the patient contacting surface.

[0021] In some embodiments, the material of the septum is one of silicone rubber, ethylene propylene diene terpolymer (EPDM), or polyurethane, and in some embodiments, the hub body and the septum are constructed of the same material, in some embodiments, the septum is integrally formed with the hub body during the hub body forming process, and in some embodiments, the septum includes a pre-formed slit configured for insertion of a needle therethrough.

[0022] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail certain embodiments of such concepts.

[0023] A more particular description of the present disclosure will be made by reference to specific embodiments that are illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and should not be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief description of the drawings]

[0024] [Figure 1] FIG. 1 illustrates a central catheter assembly assembled and ready to be introduced, according to some embodiments. [Diagram 2] FIG. 1 illustrates a central catheter assembly in a disassembled state, according to some embodiments. [Diagram 3] FIG. 1 illustrates a central catheter in a disassembled state, according to some embodiments. [Figure 4] FIG. 4 is a perspective view of the needle hub of the catheter of FIGS. 1-3 including a needle inserted therethrough, according to some embodiments. [Diagram 5]5 is a cross-sectional view of the needle hub of FIG. 4 in accordance with some embodiments. [Figure 6A] FIG. 6 is a front view of the septum of the needle hub of FIGS. 4-5, according to some embodiments. [Figure 6B] 6B is a cross-sectional view of the bulkhead of FIG. 6A taken along section line 6B-6B, according to some embodiments. [Figure 7] FIG. 4 illustrates a distal portion of the catheter tube of the central catheter of FIG. 3, according to some embodiments. [Figure 8A] FIG. 2 is a cross-sectional view showing a first section of a catheter tube according to some embodiments. [Figure 8B] FIG. 2 is a cross-sectional view showing a transition between a first section and a second section of a catheter tube, according to some embodiments. [Figure 8C] 11 is another cross-section showing a transition between the first and second sections of the catheter tube, according to some embodiments. [Figure 8D] 11 is a cross-section showing a second section of a catheter tube, according to some embodiments. [Figure 9] FIG. 1 illustrates another embodiment of a central catheter, in accordance with some embodiments. [Figure 10A] 13A-13C illustrate portions of yet another embodiment of a central catheter, in accordance with some embodiments. [Figure 10B] 10B is a cross-sectional view showing the needle hub of the central catheter of FIG. 10A in accordance with some embodiments. [Figure 11] FIG. 1C illustrates another embodiment of the needle hub of FIGS. 10A and 10B, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other numerous embodiments disclosed herein.

[0026] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as "left", "right", "upper", "lower", "front", "rear", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[0027] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a catheter includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, a "proximal length" of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the "proximal end" of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. Although a proximal portion, proximal end portion, or proximal length of a catheter can include the proximal end of the catheter, a proximal portion, proximal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a proximal portion, proximal end portion, or proximal length of a catheter is not a terminal portion or terminal length of a catheter.

[0028] With respect to "distal," for example, a "distal portion" or "distal end portion" of a catheter includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, the "distal end" of a needle includes the end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Although a distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. The phrases "connected" and "coupled" refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, signal, communication (including wireless), and thermal interaction. Two components may be connected or coupled to one another even if they are not in direct contact with one another. For example, two components may be coupled to one another through an intermediate component.

[0030] Any method disclosed herein includes one or more steps or acts of performing the described method. Method steps and / or acts may be interchanged with one another. In other words, the order and / or use of certain steps and / or acts may be changed unless a certain order of steps or acts is required for proper operation of the embodiment. Furthermore, only subroutines or portions of the methods described herein may be separate methods within the scope of the present disclosure. In other words, some methods may include only some of the steps described in a more detailed method.

[0031] As discussed above, there is a need to reduce the number of steps and medical devices involved in introducing a catheter into a patient's body and advancing the catheter through its vasculature. Disclosed herein are central catheters, central catheter assemblies, and methods that address the above.

[0032] 1 and 2 show a central catheter assembly 102 in a ready-to-insert assembled state and an unassembled state, respectively, according to some embodiments. The catheter assembly 102 generally includes a catheter 100 (e.g., a central venous catheter or a rapid insertion central catheter) and a needle 150 disposed within the catheter 100.

[0033] Optionally, in the ready-to-inject state of the central catheter assembly 102, the central catheter assembly 102 includes a guidewire 152 preloaded in the catheter 100, a syringe 154 coupled to the hub of the needle 150, or both the guidewire 152 and the syringe 154. In the packaged state of the central catheter assembly 102, the central catheter assembly 102 is similar to the ready-to-inject state of the central catheter assembly 102. However, if the syringe 154 is present in the package including the central catheter assembly 102, the syringe 154 does not have to be coupled to the hub of the needle 150. In fact, the syringe 154 may be packaged beside the rest of the central catheter assembly 102 in the packaged state of the central catheter assembly 102.

[0034] The catheter 100 generally includes a catheter tube 104 coupled to a number of extension legs 110 via a manifold hub 108, with each extension leg including an extension leg lumen 111. The catheter tube 104 includes a number of catheter tube lumens 105 extending along the catheter tube 104, with the number of catheter tube lumens 105 equal to the number of extension legs 110. As the extension legs 110 are coupled to the catheter tube 104, each extension leg lumen 111 is in fluid communication with a corresponding catheter tube lumen 105. Each extension leg 110 includes a luer connector 124 at a proximal end of each extension leg 110.

[0035] The catheter 100 includes a needle hub 106 coupled to a catheter tube 104. The needle hub 106 includes one or more suture wings 120 having one or more through holes 122. The needle 150 is inserted into the catheter 100 through the needle hub 106 and along the catheter tube 104 to the distal end of the catheter tube 104. More specifically, the needle 150 is inserted into the catheter tube lumen 105 (e.g., the primary catheter tube lumen) such that the distal tip of the needle 150 extends beyond the distal end of the catheter tube 104. The needle hub 106 includes a septum 118 through which the needle 150 is inserted. The needle 150 may optionally include a lubricant 151 disposed along an outer surface of the needle 150 to promote sliding engagement between the needle 150 and the septum 118. That is, the lubricant 151 may reduce friction between the needle 150 and the septum 118.

[0036] The guidewire 152 may be inserted into the catheter 100 via the extension leg lumen 111 through a corresponding luer connector 124 in the optional ready-to-introduce state of the central catheter assembly 102. More specifically, the guidewire 152 is inserted into the extension leg lumen 111, which is coupled with the primary catheter tube lumen. Such an arrangement of the guidewire 152 in the ready-to-introduce state of the central catheter assembly 102 allows the guidewire 152 to be immediately advanced into the patient's vascular lumen after percutaneous puncture by the needle 150 and withdrawal of the needle 150 from the catheter 100. The above-described arrangement of the guidewire 152 in the ready-to-introduce state of the central catheter assembly 102 is advantageous over the arrangement of the guidewire 152 in the needle 150, because it allows the guidewire 152 to have a larger diameter than that allowed by the needle 150, which provides greater stability for the catheter tube 104 when maneuvering through the guidewire 152.

[0037] The catheter 100 may be a single lumen catheter or a multi-lumen catheter, such as a two-lumen catheter, a three-lumen catheter, a four-lumen catheter, a five-lumen catheter, or a six-lumen catheter. Thus, the manifold hub 108 is either unbifurcated for a single lumen catheter or bifurcated for the number of lumens extending through the catheter 100. For example, the manifold hub 108 may be bifurcated for a two-lumen catheter or trifurcated for a three-lumen catheter. Depending on the fabrication method selected, the manifold hub 108 may be molded over several core pins for several fluid paths extending longitudinally through the manifold hub 108 configured to fluidly connect each catheter tube lumen 105 to a corresponding extension leg lumen 111. Alternatively, the manifold hub 108 may be molded over several cannulas extending longitudinally through the manifold hub 108 configured to fluidly connect each catheter tube lumen 105 to a corresponding extension leg lumen 111.

[0038] A number of extension legs 110 extend from the manifold hub 108 via their distal portions. The number of extension legs 110 is equal to the number of lumens extending through the catheter 100. For example, if the catheter 100 is a single lumen catheter, one extension leg extends from the manifold hub 108. If the catheter 100 is a dual lumen catheter, two extension legs extend from the manifold hub 108. If the catheter 100 is a triple lumen catheter, three extension legs extend from the manifold hub 108.

[0039] 3 illustrates a catheter 100 in a disassembled state according to some embodiments. In the illustrated embodiment, the catheter 100 is a tri-lumen catheter including a primary catheter tube lumen 305A coupled to a primary extension leg 310A, a secondary catheter tube lumen 305B coupled to a secondary extension leg 310B, and a tertiary catheter tube lumen 305C coupled to a tertiary extension leg 310C.

[0040] In the assembled state of the central catheter assembly 102, the needle 150 is inserted into the primary catheter tube lumen 305A of the catheter 100 via the needle hub 106 with the central catheter assembly 102 ready for introduction so that the distal tip of the needle 150, including the bevel, extends beyond the distal end of the catheter tube 104 for percutaneous puncture by the needle 150.

[0041] The catheter tube 104 is shown having a first section 326, a second section 328 proximal to the first section 326, and a third section 336 proximal to the second section 326. In some embodiments, the second section 328 may be larger in diameter than the first section 326 and the third section 336 may be larger in diameter than the second section 328. The catheter tube 104 may include a first tapered transition portion 330 disposed between the first section 326 and the second section 328. The catheter tube 104 may further include a second tapered transition portion 331 disposed between the second section 328 and the third section 336.

[0042] The primary catheter tube lumen 305A extends from the proximal end 308 of the catheter tube 104 to the distal end 309 of the catheter tube 104. The secondary catheter tube lumen 305B extends from the proximal end 308 to a secondary side port 306, and the tertiary catheter tube lumen 305B extends from the proximal end 308 to a tertiary side port 307. In some embodiments, the secondary side port 306 can be disposed distal to the tertiary side port 307. A needle side port 340 provides needle access to the primary catheter tube lumen 305A. In some embodiments, the needle side port 340 can be disposed along the second tapered transition portion 331.

[0043] 4-5 show the needle hub 106 including the catheter tube 104 and the needle 150. FIG. 4 is a top perspective view, and FIG. 5 is a top cross-sectional view. The needle hub 106 includes a hub body 407 and one or more suture wings 120 extending from the hub body 407. The suture wings 120 include a number of wing through holes 122 for suturing the needle hub 106 to a patient. Each wing of the one or more suture wings 120 may include a number of through holes 122 (e.g., one, two, three, four, or more) for suturing the needle hub 106 to a patient. The hub body 407 and the suture wings 120 may define a patient-contacting surface 416 of the needle hub 106, the patient-contacting surface 416 being disposed along a lower surface of the needle hub 106. The catheter tube 104 and needle 150 enter the hub body 407 at a proximal end 408 of the hub body 407 and exit the hub body 407 at a distal end 409 of the hub body 407. The needle hub may be formed of any suitable moldable material, such as, for example, a thermoplastic or elastomeric material.

[0044] 5, the hub body 407 includes a needle hub lumen 550 extending between the proximal end 408 and the distal end 409. The hub body 407 further includes a catheter tube passage 540 extending between the proximal end 408 and the distal end 409. The needle hub lumen 550 and the catheter tube passage 540 enter the hub body separately and combine to exit the hub body 407. More specifically, the needle hub lumen 550 and the catheter tube passage 540 combine (converge) within the hub body 407 to form a combined passage at the distal end 409. The needle 150 is inserted through the needle hub lumen 550. The needle 150 is inserted into the primary catheter tube lumen 305A via the needle port 340. The needle 150 exits the hub body 407 with the needle disposed within the primary catheter tube lumen 305A.

[0045] The needle hub lumen 550 and the catheter tube passage 540 are positioned at the proximal end 408 such that the needle 150 and the catheter tube 104 extend proximally from the needle hub 106 at an angle 513 relative to one another such that the needle 150 and the catheter tube 104 move away from one another as they extend proximally from the needle hub 106. More specifically, the catheter tube 104 extends proximally from the needle hub 106 at an angle 513 relative to a longitudinal axis 519 of the needle hub lumen 550. In some embodiments, the needle 150 and the catheter tube 104 may move away from one another laterally relative to the patient contacting surface 416, e.g., in a direction parallel to the patient contacting surface 416. In some embodiments, the needle 150 and the catheter tube 104 may move away from one another perpendicularly relative to the patient contacting surface 416, e.g., in a direction perpendicular to the patient contacting surface 416. In further embodiments, the needle 150 and the catheter tube 104 may be spaced both laterally and vertically from one another.

[0046] In some embodiments, the needle hub lumen 550 is disposed parallel to the catheter tube 104 along a distal portion of the needle hub 106. In other words, the catheter tube 104 disposed parallel to the distal portion of the needle hub 106 may define a longitudinal axis 514, and the longitudinal axis 519 may be parallel to the longitudinal axis 514. In further embodiments, the primary catheter tube lumen 305A may define a longitudinal axis 514, and the longitudinal axis 514 may be collinear with the longitudinal axis 519.

[0047] The needle hub 106 further includes a septum 118 disposed within the needle hub lumen 550. The septum 118 is configured to define a fluid-tight seal with the needle 150 when the needle 150 is disposed within the needle hub lumen 550 and to prevent fluid flow through the needle hub lumen when the needle 150 is withdrawn from (i.e., not disposed within) the needle hub lumen 550. In some embodiments, the septum 118 is positioned at the proximal end 408 of the hub body 407. Positioning the septum 118 at the proximal end 408 may facilitate wiping of the septum 118 by a clinician to disinfect the septum 118 and prevent microbial entry into a patient's vasculature during insertion of the needle 150.

[0048] 6A-6B show an exemplary embodiment of septum 118, with FIG. 6A being a front view of septum 118 and FIG. 6B being a cross-sectional side view taken along section line 6B-6B. The septum 118 may take any shape or form consistent with the function of the septum 118. Thus, the illustrated form of the septum 118 is merely one exemplary form of many that may be contemplated by one of ordinary skill in the art. The septum 118 includes a top wall 605 coupled with a surrounding side wall 606. The side wall 606 is configured to define a fluid-tight seal with the hub body 407 when disposed within the needle hub lumen 550. The side wall 606 may secure the septum 118 to the needle hub 106 and define an interference fit with the needle hub lumen 550 to define a fluid-tight seal with the hub body 407. In some embodiments, the side wall 606 may include an interference element 607, such as a protruding rib, an annular grove, and the like. In some embodiments, the sidewall 606 may be adhesively bonded to the needle hub 407. The septum 118 may be formed of any suitable elastomeric material, such as, for example, silicone rubber, ethylene propylene diene terpolymer (EPDM), or polyurethane.

[0049] The septum 118 includes a slit 610 extending through the top wall 605. The slit 610 is configured to receive the needle 150 therethrough and provide a fluid-tight seal with the needle 150. The slit 610 is also configured to sealably close upon withdrawal of the needle 150 to prevent fluid flow across the top wall 605 when the needle 150 is not disposed within the slit 610. In some embodiments, the slit 610 may be formed in the top wall 605 by cutting during the fabrication process of the septum 118. In other embodiments, the slit 610 may be formed in the top wall 605 by insertion of the needle 150 during assembly of the central catheter assembly 102.

[0050] As an alternative to coupling the septum 118 to the hub body 407 as a separate component, the septum 118 may be integral with the hub body 407. For example, the hub body 407 and the septum 118 may be formed of the same material, and the hub body 407 and the septum 118 may be formed simultaneously by the same process, such as, for example, a molding process.

[0051] Figure 7 further illustrates the distal portion of the catheter tube 104 of the catheter 100 and its components, according to some embodiments. Figures 8A-8D illustrate various cross-sections of the catheter tube 104, according to some embodiments. The first tapered transition section 330 and the second section 328 of the catheter tube 104 include an outer layer 832 (see Figures 8B-8D) of the catheter tube 104 that is extruded onto an inner layer 834 (see Figures 8A-8D) of the catheter tube 104, such that the outer diameter of the catheter tube 104 is larger in the second section 328 than in the first section 326 of the catheter tube 104 beginning at the first tapered transition section 330 between the first section 326 and the second section 328 of the catheter tube 104.

[0052] The first section 326 of the catheter tube 104 and the inner layer 834 of both the first tapered transition section 330 and the second section 328 of the catheter tube 104 may be formed of a first polymeric material (e.g., polytetrafluoroethylene, polypropylene, or polyurethane) having a first durometer hardness, while the remaining portions, i.e., the outer layer 832, of the first tapered transition section 330 and the second section 328 of the catheter tube 104 may be formed of a second polymeric material (e.g., polyvinyl chloride, polyethylene, polyurethane, or silicone) having a second durometer hardness that is less than, greater than, or substantially equal to the first durometer hardness. For example, each layer of the inner layer 834 and the outer layer 832 of the catheter tube 104 may be made from different polyurethanes having different durometer hardnesses (e.g., the same or different diisocyanates or triisocyanates reacted with different diols or triols, different diisocyanates or triisocyanates reacted with the same or different diols or triols, etc.). Polyurethanes are advantageous for the catheter tube 104 in that they are relatively stiff at room temperature, but may become more flexible in vivo at body temperature, thereby reducing irritation to the vessel wall and phlebitis. Polyurethanes are also advantageous in that they may be less thrombogenic than some other polymers.

[0053] Notwithstanding the above, the first tapered transition portion 330 and the second section 328 of the catheter tube 104, including both the inner layer 834 and the outer layer 832 of the catheter tube 104, may be formed of the same polymeric material (e.g., polyurethane) having the same durometer hardness, provided that the column strength of the catheter tube 104 is sufficient to prevent buckling of the catheter tube 104 as it is inserted into the insertion site and advanced through the patient's vasculature. The column strength of the catheter tube 104 in any given embodiment is noteworthy in that it allows for the catheter tube 104 to be rapidly inserted into the insertion site and advanced through the patient's vasculature without the use of the Seldinger technique.

[0054] The catheter tube 104 includes a third section 336 proximal to the second section 328 of the catheter tube 104 that includes an increased diameter bounded by a second tapered transition section 331 in an intermediate portion of the catheter tube 104. The third section 336 of the catheter tube 104 has a larger outer diameter than both the first section 326 and the second section 328 of the catheter tube 104. The needle hub 106 may be disposed over the second tapered transition section 331 such that the second tapered transition section 331, including the needle side port 340, is disposed within the hub body 407 (see FIG. 4 ). Thus, the catheter tube 104 proximal to the needle hub 106 has a larger outer diameter than the catheter tube 104 distal to the needle hub 106. The larger outer diameter of the third section 336 of the catheter tube 104 proximal to the needle hub 106 provides a thicker, more kink resistant catheter tube wall useful for bending the manifold hub 108 and the multiple extension legs 110 away from the patient's head or neck while the catheter 100 is in use. In addition, any lumens present within the catheter tube 104 may have a larger diameter within the third section 336 of the catheter tube 104 proximal to the needle hub 106 than distal to the needle hub 106. This prevents flow reduction, particularly when the third section 336 of the catheter tube 104 proximal to the needle hub 106 is bent away from the patient's head or neck.

[0055] The catheter tube 104 between the needle hub 106 and the manifold hub 108 may include a taper where the larger outer diameter of the catheter tube 104 continues to increase from the needle hub 106 to the manifold hub 108. In other words, the catheter tube 104 tapers from the manifold hub 108 to the needle hub 106, but continues to have a larger outer diameter than the catheter tube 104 distal to the needle hub 106. As the outer diameter of the catheter tube 104 continues to increase from the needle hub 106 to the manifold hub 108, the catheter tube wall may continue to increase in thickness, any lumen of the catheter tube 104 may continue to increase in cross-sectional area, or a combination thereof. As a result, the catheter tube 104 between the needle hub 106 and the manifold hub 108 may be more resistant to kinking and reduced flow, especially when the catheter tube 104 proximal to the needle hub 106 is bent away from the patient's head or neck. Notwithstanding the above, the catheter tube 104 between the needle hub 106 and the manifold hub 108 may alternatively have a constant diameter from the needle hub 106 to the manifold hub 108.

[0056] Advantageously, the catheter tube 104 between the needle hub 106 and the manifold hub 108, i.e., the third section 336 of the catheter tube 104, is a unitary catheter tube configured to reduce bacterial ingress between a dressing applied over the needle hub 106 and the patient's skin. Existing central venous catheters (CVCs) or peripherally inserted central catheters ("PICCs") have multiple extension legs that extend from a sutured wing-hub combination common to CVCs and PICCs. The multiple extension legs in a CVC or PICC provide multiple paths under the dressing for microbial ingress. By having the catheter tube 104 be a unitary catheter tube at least between the needle hub 106 and the manifold hub 108, the dressing can be clamped more tightly around the catheter tube 104 than is possible due to the multiple extension legs of existing CVCs or PICCs. For example, the dressing can easily be wrapped around the entire catheter tube 104 and sandwiched together underneath the catheter tube 104 between the catheter tube 104 and the patient. In contrast, even if a dressing is wrapped around multiple extension legs of an existing CVC or PICC as described for the catheter tube extensions, it leaves gaps between adjacent extension tubes for bacterial ingress. Therefore, the catheter tube 104 being a single catheter tube inhibits bacterial ingress between a dressing applied over the needle hub 106 and the patient's skin.

[0057] The catheter tube 104 between the needle hub 106 and the manifold hub 108, and again the third section 136 of the catheter tube 104, or the catheter tube extension, is also configured to alleviate patient discomfort due to the proximity of some or the extension legs 110 to the patient's head or neck. As discussed above, the third section 336 of the catheter tube 104 proximal to the needle hub 106 provides a thicker, more kink resistant catheter tube wall. However, the third section 336 of the catheter tube 104 has sufficient flexibility to allow the catheter tube 104 to bend away from the patient's head or neck and be secured to the patient for patient comfort.

[0058] FIG. 9 illustrates another embodiment of a catheter 900 that may be similar in some respects to the catheter components described with respect to FIGS. 1-8D. It will be understood that all of the illustrated embodiments may have similar features. Thus, the relevant disclosures set forth above with respect to similarly identified features may not be repeated below. Furthermore, certain features of the catheter and related components shown in FIGS. 1-8D may not be indicated or identified by reference numbers in the drawings or specifically described in the following description. However, such features may be clearly the same or substantially the same as features shown in other embodiments and / or described with respect to such embodiments. Thus, the relevant discussion of such features applies equally to the features of the catheter of FIG. 9. Any suitable combination of features and variations thereof described with respect to the catheter and components shown in FIGS. 1-8D may be used with the catheter and components of FIG. 9, and vice versa. This pattern of disclosure applies equally to further embodiments shown in subsequent figures and described below.

[0059] The catheter 900 generally includes a catheter tube 904 having several catheter tube lumens extending therethrough and an equal number of extension legs 910 having Luer connectors 924 disposed at their proximal ends. Each catheter tube lumen is in fluid communication with a corresponding extension leg lumen. Similar to the catheter 100, the catheter 900 includes a needle hub 906 and a manifold hub 908. The catheter 900 generally differs from the catheter 100 in that the needle hub 906 is disposed proximal to the manifold hub 908.

[0060] The manifold hub 908 includes one or more suture wings 920. The needle hub 906 is disposed in line with a primary extension leg 910A. The primary extension leg 910A includes a primary extension leg lumen 911A extending from the luer connector 924 through the needle hub 906 to the manifold hub 908. The needle hub 906 includes a needle hub lumen 950 having a septum 918 disposed therein, the needle hub lumen 950 configured to receive a needle 150. The primary extension leg 910A includes a needle side port 940 extending through a side wall of the primary extension leg 910A. The needle side port 940 is configured to receive a needle therethrough such that the needle 150 may be advanced along the distal primary extension leg lumen 911A of the needle hub 906. Similar to catheter 100, catheter 900 can be combined with a needle 150 to define a central catheter assembly similar to central catheter assembly 102 of FIGS. 1-2, in which needle 150 is disposed within extension leg lumen 911A through septum 918 and then advanced along primary catheter tube lumen 905A.

[0061] 10A-10B show portions of a third embodiment of a catheter 1000. Like catheter 900, catheter 1000 may be similar in some respects to the components and functionality of catheter 100 described with respect to FIGS. 1-8D. Catheter 1000 includes a combination hub 1006 that incorporates the functionality of needle hub 106 and manifold hub 108 of catheter 100 into a single hub. Catheter 1000 includes a number of extension legs 1010 coupled to combination hub 1000 at a proximal end 1008, and a catheter tube 1004 coupled to combination hub 1006 at a distal end 1009. A number of flow lumens 1012 extending through combination hub 1006 fluidly couple extension leg lumens 1011 to catheter tube lumens 1005 such that each extension leg lumen 1011 is in fluid communication with a corresponding catheter tube lumen 1005. Specifically, the primary extension leg lumen 1011A of the primary extension leg 1010A is coupled to the primary catheter tube lumen 1005A via the primary flow lumen 1012A. The needle hub lumen 1050 is coupled to the primary flow lumen 1012A to facilitate passage of the needle 150 through the needle hub lumen 1050 and further into the primary catheter tube lumen 1005A. A septum 1018 is disposed in conjunction with the needle hub lumen 1050.

[0062] The extension leg 1010 extends proximally from the combination hub 10060 at an angle 1013 relative to a such that, in use, the extension leg 1010 is disposed at an angle relative to the needle 150 extending proximally from the combination hub 1006.

[0063] One or more suture wings 1020 extend laterally from the combination hub 1000. In the illustrated embodiment, the suture wings 1020 are disposed parallel to the extension leg 1010. In alternative embodiments, the suture wings 1020 may be disposed parallel to the longitudinal axis 1019 of the needle hub lumen 1050.

[0064] The catheter tube 1004 extends distally from the combination hub 1006 longitudinal axis 1014, and in some embodiments, the longitudinal axis 1019 of the needle hub lumen 1050 and the longitudinal axis 1014 are parallel to one another. In further embodiments, the primary catheter tube lumen 1005A may define a longitudinal axis 1014, and the longitudinal axis 1014 may be collinear with the longitudinal axis 1019.

[0065] 11 illustrates a second embodiment of a combination hub. The combination hub 1106 may be similar in some respects to the components and functionality of the combination hub 1006. The combination hub 1106 generally includes a flat shape that defines a plane 1130. Thus, the extension leg 1110 and the needle 150 extend proximally from the combination hub 1106 in the plane 1130 when the needle is disposed within the needle hub lumen. That is, the portion of the extension leg 1110 adjacent the combination hub 1106, the needle 150, is disposed within the plane 1130. Similarly, the catheter tube 1104 extends distally from the combination hub 1106 in the plane 1130. The suture wings 1120 may also be disposed within or extend along the plane 1130. To provide access to (ie, grasping of) the needle 150 , the extension leg 1110 , when present, extends proximally from the combination hub 1106 at an angle relative to the needle 150 .

[0066] A method for introducing a central catheter into a patient's blood vessel may include providing a central catheter including a catheter tube having a catheter tube lumen extending therethrough to a distal end of the catheter tube and a needle hub coupled to the catheter tube. The needle hub includes a needle hub lumen configured for advancement of a needle therethrough and a septum disposed over a proximal portion of the needle hub lumen, the septum configured to (i) define a fluid-tight seal with the needle when the needle is disposed within the needle hub lumen and (ii) prevent fluid flow through the proximal portion of the needle hub lumen when the needle is not disposed within the needle hub lumen. The needle hub is coupled to the catheter tube such that the needle hub lumen is in fluid communication with the catheter tube lumen.

[0067] The method further includes inserting the catheter tube through the patient's skin and into the blood vessel such that a distal end of the catheter is disposed within the blood vessel, the catheter tube lumen including a needle disposed therein. The method may further include advancing the catheter tube over the needle to advance the catheter tube further into the blood vessel lumen. The method may further include withdrawing the needle from the catheter tube lumen.

[0068] In some embodiments, the method may include inserting a needle through the needle hub lumen and into the catheter tube lumen. In some embodiments, the method may include aspirating blood from the blood vessel with a syringe connected to the needle prior to withdrawing the needle from the catheter tube lumen. Aspirating blood may confirm that the distal tip of the needle is disposed within the blood vessel lumen.

[0069] Although some specific embodiments have been disclosed herein, and those specific embodiments have been disclosed in some detail, those specific embodiments are not intended to limit the scope of the concepts provided herein. Further adaptations and / or modifications may become apparent to those skilled in the art, and are likewise encompassed in the broader aspects. Thus, departures from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A central catheter comprising: a catheter tube configured for advancement along a patient's vascular system, the catheter tube including a plurality of catheter tube lumens extending therealong; a number of extension legs equal to the number of catheter tube lumens, each extension leg being in fluid communication with a corresponding catheter tube lumen; a needle hub coupled to the catheter tube, a needle hub lumen configured for advancement of a needle therethrough; a septum disposed across a proximal portion of the needle hub lumen, the septum comprising: defining a fluid-tight seal with the needle when the needle is disposed within the needle hub lumen; Preventing fluid flow through the proximal portion of the needle hub lumen when the needle is not disposed within the needle hub lumen. A bulkhead configured as follows: Includes needle hub and Equipped with The central catheter, wherein the needle hub is coupled to the catheter tube such that the needle hub lumen is in fluid communication with one of the catheter tube lumens.

2. The catheter of claim 1 , wherein the needle hub lumen is parallel to the catheter tube along a distal portion of the needle hub.

3. The catheter of claim 1 , wherein the needle hub lumen is collinear with the one of the catheter tube lumens along a distal portion of the needle hub.

4. The catheter of claim 1 , wherein the needle hub further comprises one or more suture wings for securing the needle hub to a patient.

5. 5. The catheter of claim 4, the one or more suture wings define a patient-contacting surface of the needle hub; The catheter, wherein the patient-contacting surface is parallel to the needle hub lumen.

6. The catheter of claim 1 , further comprising a manifold hub defining fluid communication between each extension leg and a corresponding catheter tube lumen.

7. The catheter of claim 6 , wherein the extension leg is attached to the manifold hub.

8. The catheter of claim 6 , wherein the needle hub includes the manifold hub integrated therein such that the extension leg is attached to the needle hub.

9. The catheter of claim 8 , wherein each extension leg is attached to the needle hub at an angle relative to the needle hub lumen.

10. The catheter of claim 5 , wherein each extension leg is attached to the needle hub at an angle relative to the patient-contacting surface.

11. The catheter of claim 8 , wherein the extension leg is attached to the needle hub in one plane.

12. 12. The catheter of claim 1, wherein each extension leg includes a luer connector at a proximal end of the extension leg.

13. 12. The catheter of claim 1, wherein the plurality of catheter tube lumens are: a primary lumen extending distally to the distal end of the catheter tube; a secondary lumen extending distally to a first side port of the catheter tube; a tertiary lumen extending distally to a second side port of the catheter tube, the second side port being disposed proximal to the first side port; a catheter.

14. 12. The catheter of claim 1, wherein the septum material is one of silicone rubber, ethylene propylene diene terpolymer, or polyurethane.

15. The catheter of claim 1 , wherein the needle hub and the septum are constructed from the same material.

16. 12. The catheter of claim 1, wherein the septum is integrally formed with the needle hub during the needle hub formation process.

17. 12. The catheter of claim 1, wherein the septum includes a preformed slit configured for insertion of the needle therethrough.

18. 1. A central catheter assembly comprising: A central catheter according to any one of claims 1 to 11; a needle preloaded within the central catheter, the needle disposed within the needle hub lumen and the primary lumen of the catheter tube; A central catheter assembly comprising:

19. 19. The catheter assembly of claim 18, wherein the needle extends beyond the distal end of the catheter tube to facilitate percutaneous penetration by the needle.

20. 20. The catheter assembly of claim 18, wherein the needle includes a lubricant disposed on an outer surface of the needle to promote sliding engagement between the needle and the septum.

21. 20. The catheter assembly of claim 18, wherein the plurality of extension legs includes a primary extension leg in fluid communication with the primary lumen, and the central catheter assembly further includes a pre-loaded guidewire disposed within the primary extension leg.

22. A central catheter hub comprising: a hub body defining a proximal end and a distal end, the hub body configured to couple to a catheter tube having a plurality of catheter tube lumens; a needle hub lumen extending through the hub body configured for advancement of a needle therethrough and in fluid communication with one of the plurality of catheter tube lumens; a septum disposed across a proximal portion of the needle hub lumen, the septum comprising: defining a fluid-tight seal with the needle when the needle is disposed within the needle hub lumen; Preventing fluid flow through the proximal portion of the needle hub lumen when the needle is not disposed within the needle hub lumen. A partition wall configured as follows: one or more suture wings extending from the hub body for securing the needle hub to a patient; A central catheter hub comprising:

23. 23. The catheter hub of claim 22, the one or more suture wings define a patient-contacting surface of the needle hub; The catheter hub, wherein the patient contacting surface is parallel to the needle hub lumen.

24. 23. The catheter hub of claim 22, wherein the hub body is configured to couple to the catheter tube such that the needle hub lumen is parallel to the catheter tube along a distal portion of the hub body.

25. 23. The catheter hub of claim 22, wherein the hub body is configured to mate with the catheter tube such that the needle hub lumen is collinear with one of multiple catheter tube lumens along a distal portion of the hub body.

26. 23. The catheter hub of claim 22, wherein the hub body is configured to couple to a number of extension legs equal to the number of catheter tube lumens, such that each extension leg is in fluid communication with a corresponding catheter tube lumen.

27. 27. The catheter hub of claim 26, wherein the hub body is configured to couple to the extension legs such that each extension leg extends from the proximal end at an angle relative to the needle hub lumen.

28. 24. The catheter hub of claim 23, wherein the hub body is configured to couple to extension legs such that each extension leg extends from the proximal end at an angle relative to the patient-contacting surface.

29. 29. The catheter hub of any one of claims 22 to 28, wherein the septum material is one of silicone rubber, ethylene propylene diene terpolymer, or polyurethane.

30. 29. The catheter hub of any one of claims 22-28, wherein the hub body and the septum are constructed from the same material.

31. 29. The catheter hub of any one of claims 22-28, wherein the septum is integrally formed with the hub body during the hub body forming process.

32. 29. The catheter hub of any one of claims 22 to 28, wherein the septum includes a pre-formed slit configured for insertion of the needle.

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