Upper arm port

Abstract

[0005] Embodiments disclosed herein relate to a vascular access system including a port assembly and an expansion kit. The port assembly includes a port coupled to a catheter. The port can include a septum aligned with the catheter lumen configured to receive a guidewire therethrough. The expansion kit can include a dilator disposed within the sheath. The expansion kit can be advanced subcutaneously to separate tissue, with the tissue pocket being sized to receive the port assembly therein. The dilator can be removed and the port assembly can be disposed within the sheath. The port can include a splitter device configured to engage an opening disposed within the sheath. As the sheath is advanced proximally, the splitter can direct the sheath over the blade to facilitate separation of the sheath along the longitudinal axis.

Description

Technical Field

[0001] Briefly summarized, the embodiments disclosed herein relate to a vascular access system configured to place an assembly of a port and a catheter, for example, subcutaneously within a limb or upper arm region, and related methods.

Background Art

[0002] Placing an assembly of a catheter and a port often requires multiple steps, including connecting the catheter to the port and forming multiple incision sites.

Summary of the Invention

Problems to be Solved by the Invention

[0003] This is particularly difficult for clinicians operating in the restricted, moist environment of a subcutaneous tissue pocket and can cause discomfort to the patient. Miniaturization of the port and catheter assembly can improve patient comfort and facilitate access to smaller blood vessels, such as those located within the patient's limbs, for example, the ulnar cutaneous vein within the upper arm region. However, these smaller systems can make certain steps of the placement, such as connecting the catheter to the port, impossible to perform.

Means for Solving the Problems

[0004] Disclosed herein is a vascular access system comprising a catheter extending longitudinally and defining a catheter lumen, a port connected to the proximal end of the catheter and defining a reservoir in fluid communication with the catheter lumen, an expansion kit including a sheath defining a sheath lumen configured to receive one or both of the catheter and the port therein, and a splitter disposed on the port configured to separate the sheath along the longitudinal axis as the sheath is advanced proximally thereon.

[0005] In some embodiments, the sheath includes a tab extending from the proximal edge of the sheath, perpendicular to the longitudinal axis, and configured to facilitate gripping the sheath. In some embodiments, the sheath includes a tear line extending longitudinally from the proximal edge to the distal end of the sheath, configured to facilitate separation of the sheath along this tear line. In some embodiments, the port further includes a strain relief, and a splitter is positioned on the outer surface of the strain relief. In some embodiments, the splitter includes a guide extending longitudinally from the surface of the port and a blade positioned between the inner surface of the guide and the outer surface opposite the port.

[0006] In some embodiments, the sheath includes an opening that extends through its wall and communicates with the sheath lumen, the opening configured to receive a portion of the guide through it and to orient a portion of the sheath toward the blade. In some embodiments, the opening has a rhomboid shape. In some embodiments, the port placement system further includes a second opening located on the sheath opposite the first opening, and a second splitter located across the central longitudinal axis opposite the first splitter and configured to engage with the second opening. In some embodiments, the expansion kit further includes an expander configured to fit into the sheath lumen, the expander including a sharp tip.

[0007] In some embodiments, the dilator is formed from a rigid or elastic material and includes a guidewire lumen that penetrates the dilator longitudinally. In some embodiments, the dilator includes a longitudinally extending elongated body and a wedge located at its proximal end, the wedge having an outer contour that matches the outer contour of the port. In some embodiments, the port defines an upper, lower, proximal, and distal end face, and the catheter includes a first needle-penetrating septum extending from the distal end face, the proximal end face configured to provide access to a reservoir.

[0008] In some embodiments, the port body further includes a second needle-penetrating partition positioned on the upper surface and configured to provide access to the reservoir. In some embodiments, the port placement system further includes a guidewire configured to extend through the first needle-penetrating partition, through the reservoir, and into the catheter lumen.

[0009] Also disclosed is a method for positioning a port assembly having a port and a catheter, the method comprising the steps of: accessing the patient's vascular system; advancing a guidewire into the patient's vascular system; advancing a dilation kit, including a sheath positioned on a dilator, subcutaneously on the guidewire; forming a subcutaneous tissue pocket using the dilation kit; proximal removal of the dilator; positioning the port assembly within the lumen of the sheath; splitting the sheath along its longitudinal axis using a splitter positioned on the port; and proximal withdrawal of the sheath.

[0010] In some embodiments, the step of positioning the port assembly further includes positioning a portion of the catheter within the shaft of the sheath and positioning the port within the funnel of the sheath. In some embodiments, the dilator includes a longitudinally extending elongated body and a wedge positioned at its proximal end. In some embodiments, the elongated body defines a diameter equal to the outer diameter of the catheter. In some embodiments, the wedge defines an outer contour equal to the outer contour of the port.

[0011] In some embodiments, the step of advancing the dilation kit subcutaneously is defined by the dilator and further includes passing a guidewire through a guidewire lumen that extends longitudinally between the proximal and distal ends of the dilator. In some embodiments, the step of splitting the sheath includes separating the sheath along a tear line that extends longitudinally. In some embodiments, the step of splitting the sheath includes engaging a splitter with an opening in the sheath to guide the sheath onto the blade.

[0012] Also disclosed is a method for subcutaneously positioning a port assembly, comprising the steps of: pushing an expansion kit subcutaneously; positioning the port assembly within the lumen of the expansion kit's sheath; pushing the sheath proximal over the port of the port assembly; engaging a portion of the sheath with a splitter positioned over the port; and dividing the sheath along its longitudinal axis.

[0013] In some embodiments, the step of engaging a portion of the sheath with the splitter further includes extending the guide portion of the splitter through the opening and orienting that portion of the sheath toward the blade. In some embodiments, the opening is rhomboid in shape. In some embodiments, advancing the dilation kit subcutaneously includes advancing the distal tip into the patient's vascular system. In some embodiments, advancing the dilation kit subcutaneously includes advancing the wedge positioned at the proximal end of the dilator of the dilation kit subcutaneously to form a tissue pocket configured to receive the port of the port assembly. In some embodiments, the splitter is positioned on the strain relief of the port assembly.

[0014] A more detailed description of this disclosure is given by reference to the specific embodiments shown in the accompanying drawings. It is understood that these drawings show only typical embodiments of the invention and should therefore not be considered to limit the scope of the invention. Exemplary embodiments of the invention are described and explained in more specific and detail by using the accompanying drawings. [Brief explanation of the drawing]

[0015] [Figure 1] A perspective view of an assembly of a port and catheter in a vascular access system according to embodiments disclosed herein. [Figure 2] A perspective view of the port of Figure 1 according to an embodiment disclosed herein. [Figure 3]Cross-sectional view of a port of a vascular access system according to an embodiment disclosed herein. [Figure 4] Perspective view of a port of a vascular access system according to an embodiment disclosed herein. [Figure 5] A is a perspective view of an extension kit of a vascular access system according to an embodiment disclosed herein, and B is an enlarged detailed view of the extension kit of FIG. 5A according to an embodiment disclosed herein. [Figure 6] Exploded view of an extension kit of a vascular access system according to an embodiment disclosed herein. [Figure 7] Enlarged detailed view of a port disposed within a sheath of an extension kit according to an embodiment disclosed herein. [Figure 8A] Diagram showing an exemplary method of use for a vascular access system according to an embodiment disclosed herein. [Figure 8B] Same as above. [Figure 8C] Same as above. [Figure 8D] Same as above. [Figure 8E] Same as above. [Figure 8F] Same as above.

Mode for Carrying Out the Invention

[0016] 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. Also, it should be understood that the specific embodiments disclosed herein can have features that are easily separable from a particular embodiment and optionally combined with or replaced by features of any of several other embodiments disclosed herein.

[0017] With regard to the terms used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and 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 a sequential or numerical limitation. For example, the “first,” “second,” and “third” features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” and “rear” are used for convenience and are not intended, for example, to imply any particular fixed position, orientation, or direction. Instead, such labels are used, for example, to reflect relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise.

[0018] With respect to “proximal,” for example, the “proximal portion” or “proximal end” of a catheter disclosed herein includes the portion of the catheter that is intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the “proximal length” of a catheter includes the length of the catheter that is intended to be near the clinician when the catheter is used on a patient. For example, the “proximal end” of a catheter includes the end of the catheter that is intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end, or proximal length of a catheter may include the proximal end of the catheter. However, the proximal portion, proximal end, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless specifically indicated by the context, the proximal portion, proximal end, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0019] Regarding "distal", for example, the "distal portion" or "distal end" of a catheter as disclosed herein includes the part of the catheter that is intended to be near or within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be near or within the patient when the catheter is used in a patient. For example, the "distal end" of a catheter includes one end of the catheter that is intended to be near or within the patient when the catheter is used in a patient. The distal portion, distal end, or distal length of a catheter can include the distal end of the catheter. However, the distal portion, distal end, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal end, or distal length of a catheter is not the distal end portion or distal end length of the catheter.

[0020] To assist in the description of the embodiments described herein, as shown in FIG. 1, the longitudinal axis extends substantially parallel to the axial length of the catheter. The transverse axis extends perpendicular to the longitudinal axis, and the lateral axis extends perpendicular to both the longitudinal axis and the transverse axis. As used herein, the horizontal plane extends along the transverse axis and the longitudinal axis. The vertical plane extends perpendicular to the horizontal plane.

[0021] 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. Embodiments described herein relate to a vascular access system ("System") 100 configured to provide access to a patient's vascular system. In one embodiment, System 100 can provide vascular access in a limb, such as in the arm or leg region. More specifically, the vascular access system can be configured to access the ulnar cutaneous vein in the brachial region. However, it will be understood that System 100 can provide vascular access to other areas of the patient's body, without limitation. As shown in Figures 1 to 6, System 100 may generally include a port-catheter assembly ("Port Assembly") 108 or similar subcutaneous access device (Figure 1) comprising a catheter 110 connected to a port 120, and an expansion kit 158 ​​(Figure 5A) comprising a sheath 160 and a dilator 180.

[0022] The catheter 110 of the port assembly 108 may include a catheter body 116 that defines the catheter lumen 118 and extends between the distal tip 112 and the proximal end 114. In one embodiment, the proximal end 114 of the catheter 110 may be integrally formed with the port 120. In one embodiment, the port assembly 108 may further include a strain relief 130 that may be positioned above the connection between the catheter 110 and the port 120, or positioned between the catheter 110 and the port 120 and integrally formed with them. In one embodiment, the proximal end 114 of the catheter 110 may be selectively connected to the port 120. Optionally, a cathlock or similar device may further secure the catheter 110 to the port 120. Optionally, the proximal end 114 of the catheter 110 may be trimmed before connecting the catheter 110 to the port 120. In one embodiment, the catheter 110 can be made of a flexible material configured to pass through a winding vascular pathway. In one embodiment, the catheter 110 can be made of plastic, polymer, elastomer, rubber, silicone rubber, etc.

[0023] In one embodiment, the port 120 may generally include a body 122 that defines a reservoir 124 that is in fluid communication with the lumen 118 of the catheter 110. The port 120 may further include one or more needle-penetrating partitions 126 configured to provide access to one or both of the reservoir 124 and the catheter lumen 118. In one embodiment, an access needle may extend percutaneously into the reservoir 124 through the needle-penetrating partition 126 to provide fluid communication with it. In one embodiment, the port body 122 may be 20 mm long along its longitudinal axis, 10 mm high along its transverse axis, and 10 mm wide along its transverse axis. However, these dimensions are illustrative and not intended to be limiting, and it will be understood that dimensions larger or smaller than the port body 122 are also considered to be within the scope of the invention.

[0024] In one embodiment, the port assembly 108 may further include a splitter device ("splitter") 140 positioned on the strain relief 130. However, it will be understood that the splitter 140 may be positioned on other parts of the port assembly 108, for example, on a part of the port body 122 or the catheter 110. The splitter 140 may be configured to facilitate the separation of the sheath 160 of the expansion kit 158, as will be described in more detail herein.

[0025] In one embodiment, as shown in Figures 2-3, the splitter 140 may include a guide 142 and a blade 144. The guide 142 may extend substantially parallel to the longitudinal axis from the outer surface of the strain relief 130 and may include a chamfered or inclined distal end. In one embodiment, the guide 142 may be formed from the same material as one of the catheter 110, port 120, or strain relief 130. In one embodiment, the guide may be formed from a flexible (compliant) or pliable material. In one embodiment, the guide 142 may be formed from plastic, polymer, elastomer, rubber, silicone rubber, etc.

[0026] In one embodiment, the blade 144 may extend radially from the outer surface of the strain relief 130 and may extend parallel to the longitudinal axis. The distal edge of the blade 144 may be sharpened to facilitate the separation of the sheath 160 as the sheath 160 is advanced thereon, as will be described in more detail herein. In one embodiment, the blade 144 may be positioned between the outer surface of the strain relief 130 and the inner surface of the guide 142. The guide 142 may support the blade 144 positioned in this manner. In one embodiment, the blade 144 may be formed from a substantially rigid or elastic material such as plastic, polymer, metal, alloy, or composite material.

[0027] In one embodiment, the port assembly 108 may include one or more splitters 140. For example, as shown in Figures 2-3, the system 100 may include a first splitter 140A located on the upper surface of the strain relief 130 and a second splitter 140B located on the lower surface of the strain relief 130. It will be understood that other numbers or configurations of splitters 140 are also considered to fall within the scope of the present invention.

[0028] In one embodiment, as shown in Figures 2 to 4, the port 120 may include a partition 126 located on one or both of the upper and proximal surfaces of the port body 122 and configured to provide access to one or both of the reservoir 124 and the catheter lumen 118. In one embodiment, the port 120 may include a first partition 126A located on the upper surface of the port body 122 and a second partition 126B located on the proximal surface of the port body 122. As used herein, “partition” may include needle-penetrating partitions, valves, slit valves, etc., formed from silicone rubber or a similar material and configured to receive a slender medical device, needle, guidewire, or similar device through it, while also controlling the fluid flow through it.

[0029] As shown in Figures 3 and 4, in one embodiment, a second septum 126B positioned on the proximal surface can be aligned with the central longitudinal axis 80 of the catheter lumen 118. In one embodiment, the vascular access system 100 may further include a guidewire 150. The guidewire 150 may be configured to extend through the second septum 126B, through the reservoir 124, and into the catheter lumen 118, as will be described in more detail herein. In one embodiment, an access needle may be configured to extend through either the first septum 126A or the second septum 126B and to provide fluid communication with the reservoir 124.

[0030] Figures 5A to 6 show further details of the dilation kit 158 ​​of the vascular access system 100. The dilation kit 158 ​​may generally include a sheath 160 having a longitudinally extending shaft 162 and a funnel 170 positioned at its proximal end. The sheath 160 may be formed from a flexible or pliable material including plastic, polymer, elastomer, rubber, silicone rubber, etc. The sheath 160 may define a lumen 166 extending from the distal end 164 to the proximal end 168 of the sheath 160. The shaft 162 may define a substantially cylindrical shape and may be configured to receive a portion of either a dilator 180 or a catheter 110. In one embodiment, the distal end 164 of the sheath 160 may be open. Therefore, the distal tip 112 of the catheter 110 or the distal tip 184 of the dilator 180 may extend distal to the distal end 164 of the sheath 160, as will be described in more detail herein. In one embodiment, the distal tip 164 of the sheath 160 may be closed.

[0031] In one embodiment, the sheath 160 includes a funnel 170 connected to the proximal end of the shaft 162. The funnel 170 can define a substantially tapered portion of the lumen 166 and may be configured to receive a portion of the port 120 therein. In one embodiment, the inner contour of the funnel 170 may coincide with the outer contour of the port body 122. In one embodiment, the funnel 170 may be elastically or flexibly deformable to coincide with the outer contour of the port body 122. In one embodiment, the funnel 170 may be formed from the same material as the shaft 132. In one embodiment, the funnel 170 may be formed from a different material and may exhibit different mechanical properties than the shaft 132.

[0032] In one embodiment, the sheath 160 may include a tear line 178 extending longitudinally along at least a portion of it. In one embodiment, the tear line 178 may extend between the distal end 164 and the proximal end 168 of the sheath 160. In one embodiment, the tear line 178 may be a groove, a notch, a perforation, a laser cut line, or a similar brittle line configured to facilitate separation of the sheath 160 along it. In one embodiment, the sheath 160 may include a first tear line 178 extending along the upper surface of the sheath 160 and a second tear line 178 extending along the bottom surface of the sheath 160. However, it will be understood that other numbers and configurations of the tear line 178 are intended to fall within the scope of the present invention.

[0033] In one embodiment, the sheath 160 may include one or more pull tabs 172, for example, a first pull tab 172A and a second pull tab 172B. The one or more pull tabs 172 may be configured to grip the sheath 160 and facilitate pushing the first portion radially outward from the second portion, and to facilitate separating the sheath 160 along the longitudinal axis, for example, along the tear line 178. In one embodiment, the first pull tab 172A and the second pull tab 172B may extend radially from the sheath 160. In one embodiment, the first pull tab 172A and the second pull tab 172B may be positioned on opposite sides of the central longitudinal axis 80. For example, the first pull tab 172A and the second pull tab 172B may extend in the short direction from the proximal portion of the sheath 160, for example, the proximal end 168.

[0034] In one embodiment, the sheath 160 may include an opening 174 that extends through its wall and communicates with the sheath lumen 166. The opening 174 may define a substantially rhomboid shape, but it will be understood that other regular or irregular closed curve shapes are also intended. In one embodiment, as shown in Figure 5B, the opening 174 may be aligned with a tear line 178. In one embodiment, one or more inflection points of the opening 174 may be aligned with the tear line 178.

[0035] In one embodiment, as shown in Figure 7, the port assembly 108 can be advanced distally into the sheath lumen 166. The catheter 110 can extend through a portion of the lumen 166 defined by the shaft 162. Optionally, its distal tip 112 can extend distal to the distal end 164 of the sheath 166. When the port 120 is received in the funnel 170, the guide 142 of the splitter 140 can align with and extend through the opening 174. In one embodiment, the sheath 160 can be advanced proximal to the port assembly 108. Thus, the distal end of the opening 174 can be directed onto the blade 144 by the guide 142. When the shaft 162 is advanced proximal beyond the splitter 140, the blade 144 can facilitate the separation of the shaft 162 along its longitudinal axis, allowing a separate portion of the shaft 162 to be advanced proximal beyond the port 120.

[0036] As shown in Figures 5A to 6, the dilation kit 158 ​​may further include a dilator 180. The dilator 180 may be formed from a substantially rigid or elastic material, including plastics, polymers, metals, alloys, composite materials, and combinations thereof. The dilator 180 may include an elongated body 182 configured to extend through the sheath lumen 166. In one embodiment, the distal tip 184 of the dilator 180 may extend distal to the distal end 164 of the sheath 160. In one embodiment, the distal tip 184 of the dilator 180 may define a tapered shape and / or a sharp tip configured to facilitate tissue separation when the dilation kit 158 ​​is advanced subcutaneously.

[0037] In one embodiment, the dilator 180 may include a wedge 168 positioned at its proximal end. The wedge 180 can define a substantially tapered shape. In one embodiment, the wedge 186 can define an outer contour that coincides with either or both the outer contour of the port 120 and the inner contour of a portion of the lumen 166 defined by the funnel 170. As understood, the wedge 186 can define a variety of regular or irregular three-dimensional shapes without departing from the spirit of the invention. In one embodiment, the outer contour of the dilator 180 can substantially coincide with either or both the inner contour of the sheath lumen 166 and the outer contour of the port assembly 108. Thus, by advancing the dilation kit 158 ​​subcutaneously, a tissue pocket can be defined that is configured to isolate tissue and receive the port assembly 108 therein. In one embodiment, the dilator 180 may include a guidewire lumen 190 that extends between the proximal end 188 and the distal end 184 of the dilator 180 and is configured to receive the guidewire 150 through it.

[0038] In an exemplary use, referring to Figures 8A–8F, a vascular access system 100 is provided as described herein. As shown in Figure 8A, a user can form an insertion site 94 using a scalpel or by advancing a needle 70 distally to puncture the skin surface. In one embodiment, the user can advance the needle 70 to access the patient's vascular system 92, for example, the ulnar cutaneous vein 92 of the brachia 90. However, it will be understood that other areas of the body may be intended. In one embodiment, the user can be guided under ultrasound imaging or similar medical imaging techniques to access the vascular system 92 using the needle 70. As shown in Figure 8B, the user can then advance a guidewire 150 into the vascular system 92 through the needle lumen to maintain patency of the access site. The needle 70 can then be withdrawn proximal on the guidewire 150.

[0039] Next, as shown in Figure 8C, the user can advance the dilation kit 158 ​​into the vascular system 92 through the insertion site 94 on the guidewire 150. Optionally, the user can widen the insertion site 94 on the skin surface using a scalpel or the like before inserting the dilation kit 158. The distal tip 184 of the dilator can be defined as a sharp tip. Furthermore, the shaft 162 can be tightly fitted around a portion of the dilator body 182. The outer diameter of the shaft 162 positioned on the dilator 180 can be larger than the outer diameter of one or both of the needle 70 and the catheter body 116. Thus, the dilation kit 158 ​​can widen one or more of the access sites—the insertion site 94, the subcutaneous tissue surrounding the blood vessel 92, and the blood vessel 92 itself—to receive the catheter 110, as will be described in more detail herein. In one embodiment, the dilator 180 can provide increased rigidity to facilitate the subcutaneous advancement of the dilation kit 158 ​​and the formation of a pathway for the port assembly 108.

[0040] As shown in Figure 8D, the dilation kit 158 ​​can be continued to be advanced subcutaneously until one or both of the funnel 170 and wedge 186 portions of the dilation kit 158 ​​are subcutaneously positioned. As understood, the outer diameter of the funnel 170 can be larger than the outer diameter of one or both of the port 120 and shaft 162. Thus, advancing the funnel 170 subcutaneously can form a tissue pocket configured to receive the port 120 therein. With the sheath 160 subcutaneously positioned, the dilator 180 and guidewire 150 can be withdrawn proximal to the sheath 160 simultaneously or sequentially. The sheath 160 can be configured to maintain patency of the tissue pocket and the access site to the vascular system 92.

[0041] Next, as shown in Figure 8E, the port assembly 108 can be advanced into the lumen 166 of the sheath 160. In one embodiment, the diameter of the sheath lumen 166 defined by the shaft 162 can be equal to or slightly larger than the outer diameter of the catheter 110. Similarly, the diameter of the sheath lumen 166 defined by the funnel 170 can be greater than or equal to the outer diameter of the port 120. Thus, the port assembly 108 can be received into the sheath lumen 166 with little or no resistance.

[0042] With the port assembly 108 positioned subcutaneously, a user can grasp the sheath 160 using one or more tabs 172 and push the sheath 160 proximal to the port assembly 108. In one embodiment, a user can push the tabs 172 radially outward relative to the central longitudinal axis 80 to separate the funnel 170 along the longitudinal axis. In one embodiment, a tear line 178 can facilitate the separation of the funnel 170 into a first and second part along the longitudinal axis, and the first and second parts can then be pushed proximal to either side of the port 120.

[0043] In one embodiment, the guide 142 can engage with the opening 174 and orient a portion of the expander shaft 162 toward the blade 144 to facilitate separation of the shaft along its longitudinal axis. In one embodiment, the tear line 178 can be aligned with the blade 144 to facilitate separation of the shaft 162 into a first portion and a second portion, which can then be advanced proximal to either side of the port 120. The sheath 160 can then pass proximal to the port 120 and be removed. As shown in Figure 8F, with the port assembly positioned subcutaneously and the distal tip 112 of the catheter positioned within the vascular system 92, the insertion site 94 can be closed and the port 120 can be accessed percutaneously by an access needle.

[0044] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be obvious to those skilled in the art, and in broader embodiments, these adaptations and / or modifications are also included. Thus, deviations from specific embodiments disclosed herein can be made without departing from the scope of the concepts provided herein.

Claims

1. A catheter that extends longitudinally and defines the catheter lumen, A port connected to the proximal end of the catheter, comprising a port defining a reservoir that is in fluid communication with the catheter lumen, An expansion kit comprising a sheath defining a sheath lumen configured to receive one or both of the catheter and the port therein, The device comprises a splitter positioned on the port, configured to separate the sheath along its longitudinal axis when the sheath is pushed proximal on the port, A vascular access system comprising a first needle-penetrating septum configured such that the port defines an upper, bottom, proximal, and distal end face, the catheter extends from the distal end face, and the proximal end face provides access to the reservoir.

2. The vascular access system according to claim 1, wherein the sheath includes a tab extending from the proximal edge of the sheath, perpendicular to the longitudinal axis, and configured to facilitate grasping the sheath.

3. The vascular access system according to claim 1 or 2, wherein the sheath includes a tear line extending longitudinally from the proximal edge to the distal end of the sheath, the tear line being configured to facilitate separation of the sheath along the tear line.

4. The vascular access system according to any one of claims 1 to 3, wherein the port further includes a strain relief, and the splitter is disposed on the outer surface of the strain relief.

5. The vascular access system according to any one of claims 1 to 4, wherein the splitter includes a guide extending longitudinally from the surface of the port and a blade positioned between the inner surface of the guide and the outer surface opposite to the port.

6. The vascular access system according to claim 5, wherein the sheath extends through its wall and includes an opening that communicates with the sheath lumen, the opening being configured to receive a portion of the guide through it and to direct a portion of the sheath onto the blade.

7. The vascular access system according to claim 6, wherein the opening has a rhomboid shape.

8. The opening is a first opening, and the sheath further includes a second opening located on the sheath opposite the first opening. The vascular access system according to claim 6 or 7, wherein the splitter is a first splitter, and the port further comprises a second splitter positioned on the opposite side of the first splitter across the central longitudinal axis and configured to engage with the second opening.

9. The vascular access system according to any one of claims 1 to 8, further comprising a dilator configured to fit into a sheath lumen, wherein the dilator includes a sharp tip.

10. The vascular access system according to claim 9, wherein the dilator is formed from a rigid or elastic material and includes a guidewire lumen that penetrates the dilator in the longitudinal direction.

11. The vascular access system according to claim 9 or 10, wherein the expander comprises a longitudinally extending elongated body and a wedge positioned at its proximal end, the wedge having an outer contour that matches the outer contour of the port.

12. The vascular access system according to any one of claims 1 to 11, wherein the port further comprises a second needle-penetrating partition disposed on the upper surface of the port and configured to provide access to the reservoir.

13. A vascular access system according to any one of claims 1 to 12, further comprising a guidewire configured to extend through the first needle-penetrating partition, through the reservoir, and into the catheter lumen.

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