A distal section of a catheter configured to enter a skin insertion site

Abstract

Disclosed herein are distal sections of a catheter configured to enter a skin insertion site. In some embodiments, the distal section includes a tapered junction having one or more expansion structures configured to expand the skin insertion site. The distal section also includes a distal portion extending from a distal end of the tapered junction, the distal portion having a smaller diameter than a proximal portion of the catheter. In combination, the tapered junction, the one or more expansion structures, and a particular motion of a user pushing the catheter into the insertion site can result in improved fit of the catheter in the insertion site.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 121,761, filed December 4, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to the distal segment of a catheter configured for insertion into a skin site. Background Technology

[0004] In some catheter placement procedures, the expansion of the tissue surrounding the insertion site is a core activity that occurs during catheter placement. Proper tissue expansion allows for improved catheter fit. Current expansion techniques are performed manually, using separate rigid components and / or skin incisions to relieve tension in the skin while expanding the tissue. These techniques require the insertion and removal of various instruments, increasing complexity, time, and the risk of infection. Furthermore, these techniques can lead to undesirable tissue deflection and require increased thrust, resulting in over-expansion of the tissue surrounding the insertion site. It would be beneficial to be able to expand only the tissue needed to fit the catheter and reduce the need for skin incisions. This article discloses a system and method of use that addresses the aforementioned problems. Summary of the Invention

[0005] This document discloses a distal segment of a catheter configured to enter a skin insertion site, the distal segment of the catheter comprising: a tapered junction including one or more expansion structures configured to expand the skin insertion site; and a distal portion extending distal to the tapered junction, the distal portion having a smaller diameter than the proximal portion of the catheter.

[0006] In some embodiments, one or more expansion structures include a helix or one or more protrusions extending from the sidewall of the tapered joint.

[0007] In some implementations, one or more expansion structures extend radially from the sidewall of the tapered joint.

[0008] In some implementations, each protrusion includes a proximal edge and a distal edge.

[0009] In some implementations, each protrusion extends longitudinally from the proximal edge to the distal edge.

[0010] In some implementations, each protrusion extends laterally from the sidewall to the apex.

[0011] In some implementations, the vertex is located between the longitudinal midpoint and one of the proximal and distal edges, including the proximal or distal edge.

[0012] In some implementations, each protrusion is defined on a proximal side extending between the apex and the proximal edge.

[0013] In some implementations, each protrusion is defined on a distal side extending between the apex and the distal edge.

[0014] In some implementations, the proximal side defines a cutting edge that extends longitudinally through the midline of the proximal side.

[0015] In some implementations, the distal side defines a cutting edge that extends longitudinally through the midline of the distal side.

[0016] In some embodiments, the protrusions are longitudinally arranged as a first row of two or more protrusions and a second row of two or more protrusions on opposite sides of the tapered joint.

[0017] In some implementations, the proximal and distal sides of each protrusion cooperate to define a circular outer contour.

[0018] In some implementations, each protrusion in the first row is longitudinally aligned with each protrusion in the second row.

[0019] In some implementations, each protrusion in the first row is longitudinally offset from each protrusion in the second row.

[0020] In some implementations, the helical portion includes a right-handed helical portion or a left-handed helical portion.

[0021] In some implementations, the spiral portion includes a beveled edge or a chamfered edge.

[0022] This article also discloses a method for inserting a catheter, comprising: inserting a distal segment of the catheter into a skin insertion site, the distal segment having a tapered junction and a distal portion, the tapered junction including one or more expansion structures configured to expand the skin insertion site, the distal portion extending from a distal end of the tapered junction, the diameter of the distal portion being smaller than that of the proximal portion of the catheter; expanding the skin insertion site; and advancing the proximal portion of the catheter into the skin insertion site.

[0023] In some embodiments, one or more expansion structures include a spiral portion or one or more protrusions extending from the sidewall of the tapered joint.

[0024] In some implementations, each protrusion includes a proximal side and a distal side.

[0025] In some implementations, the proximal side defines a cutting edge that extends longitudinally through the midline of the proximal side.

[0026] In some implementations, the distal side defines a cutting edge that extends longitudinally through the midline of the distal side.

[0027] In some implementations, expanding the skin insertion site includes using a cutting edge to expand the insertion site.

[0028] In some implementations, expanding the skin insertion site includes rotating a spiral expansion structure about a longitudinal axis to expand the insertion site.

[0029] In some embodiments, the spiral portion includes a right-handed spiral portion or a left-handed spiral portion.

[0030] In some implementations, the spiral portion includes a beveled edge or a chamfered edge.

[0031] In some implementations, expanding the skin insertion site includes using beveled or chamfered edges to expand the insertion site.

[0032] In some implementations, expanding the skin insertion site involves twisting the distal segment of the catheter clockwise or counterclockwise around the longitudinal axis.

[0033] In some implementations, expanding the skin insertion site includes wiggles of the distal segment of the catheter around a transverse or lateral axis.

[0034] These and other features of the concepts provided herein will become clearer to those skilled in the art in light of the accompanying drawings and the following description, which describe specific embodiments of these concepts in more detail. Attached Figure Description

[0035] A more specific description of the invention will be presented with reference to specific embodiments of the invention illustrated in the accompanying drawings. It should be understood that these drawings illustrate only typical embodiments of the invention and should not be considered as limiting the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional features and details using the accompanying drawings, in which:

[0036] Figure 1 A plan view of a catheter insertion system according to some embodiments is shown.

[0037] Figure 2 A perspective view of components of a catheter insertion system including a tapered joint, according to some embodiments, is shown.

[0038] Figure 3A A schematic diagram of an exemplary expansion structure according to some implementation schemes is shown.

[0039] Figures 3B to 3IPerspective views are shown of various embodiments of one or more extended structures according to some implementation schemes.

[0040] Figures 4A to 4D Cross-sectional views of various embodiments of the expanded structure according to some implementation schemes are shown.

[0041] Figures 5A to 5C An exemplary method for inserting a catheter into an insertion site is shown according to some embodiments.

[0042] Figure 6 A flowchart illustrating an exemplary method for inserting a catheter according to some implementation schemes is shown. Detailed Implementation Plan

[0043] Before disclosing some specific embodiments 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 may have features that can be easily separated from the specific embodiments and optionally combined with or substituted for any of the various other embodiments disclosed herein.

[0044] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different components or steps within a group of parts or steps, and do not provide for a sequence or numerical limitation. For example, “first,” “second,” and “third” components or steps do not necessarily appear in that order, and a particular embodiment including such components or steps is not necessarily limited to these three components or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” and “back” are used for convenience and do not imply any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” include plural indicators.

[0045] Regarding "proximal," for example, the "proximal portion" or "proximal portion" of a catheter disclosed herein includes the portion of the catheter intended to be close to the clinician when used with a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be close to the clinician when used with a patient. For example, the "proximal end" of a catheter includes the tip of the catheter intended to be close to the clinician when used with a patient. The proximal portion, proximal portion, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal portion, or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal portion, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0046] Regarding "distal," for example, the "distal portion" or "distal part" of a catheter disclosed herein includes the portion of the catheter intended to be close to or within the patient when used in a patient. Similarly, the "distal length" of a catheter includes, for example, the length of the catheter intended to be close to or within the patient when used in a patient. For example, the "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when used in a patient. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of a catheter does not necessarily need to include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0047] 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.

[0048] Figure 1 A plan view of a catheter insertion system 100 according to some embodiments is shown. In some embodiments, the catheter insertion system 100 includes a catheter 110 having a bushing 112 disposed proximally and including one or more extension legs extending proximally from the proximal end of the bushing 112. In some embodiments, the catheter 110 includes a catheter fitting 116 extending distally from the distal end of the bushing 112. In some embodiments, the catheter fitting 116 may be configured to slide on a guidewire 102. The catheter fitting 116 includes a proximal end 119 and a distal segment 121 terminating at a distal end 118, and the catheter fitting may define one or more catheter lumens 120 therein. In some embodiments, catheter 110 may include a rapid insertion central catheter (“RICC”), such as those described in U.S. Patent Nos. 10,376,675; 17 / 031,478; 17 / 006,553; 17 / 074,405; 17 / 077,728; and 17 / 080,578, each of which is incorporated herein by reference in its entirety. As used herein, catheter insertion system 100 may be used to place an RICC to access a patient’s vascular system. However, it should be understood that the embodiments disclosed herein may be used to place various catheters, cannulas, single-lumen catheters, multi-lumen catheters, intravenous (IV) catheters, peripherally inserted venous (PIV) catheters, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), dialysis catheters, drainage catheters, etc., but are not intended to be limiting.

[0049] Placing catheter 110 requires dilating the tissue around the insertion site, as the insertion site is typically smaller than the diameter of catheter 110. Current dilation techniques use rigid components, which can cause tissue deflection and excessive stretching of the skin tissue when forced through the insertion site. Less movement at the insertion site and less tissue dilation around it allows for more accurate placement of catheter 110 within the body and better fit of catheter 110 within the insertion site.

[0050] In some embodiments, the cross-sectional shape of the catheter fitting 116 may be prism, triangular prism, rectangular prism, etc., but other cross-sectional shapes are also contemplated. In some embodiments, the catheter fitting 116 may be configured to have a tapered joint 122 between the proximal end 119 of the catheter fitting 116 and the distal section 121 of the catheter fitting 116. In some embodiments, the tapered joint 122 may be configured to include one or more expansion structures 123 extending from the sidewall 124 of the tapered joint 122, which will be described in more detail herein.

[0051] Figure 2 This diagram shows a perspective view of components of a catheter insertion system 100 including a tapered joint 122 according to some embodiments. In some embodiments, the catheter fitting 116 includes a proximal portion 125, a tapered joint 122 having sidewalls 124, and a distal portion 127 extending distally from the tapered joint 122. In some embodiments, the catheter fitting 116 defines a central longitudinal axis 117. The proximal portion 125 has a second diameter 126, while the distal portion 127 has a first diameter 128. In some embodiments, the second diameter 126 is larger than the first diameter 128. The tapered joint 122 is a portion of the catheter fitting 116 that tapers gradually from the proximal portion 125 to the distal portion 127 and from the second diameter 126 to the first diameter 128. In some embodiments, the tapered joint 122 may taper uniformly or non-uniformly from the proximal portion 125 to the distal portion 127. In some embodiments, the first diameter 128 and the second diameter 126 may be associated with the French catheter scale. In some embodiments, the tapered junction 122 may be configured to include one or more expansion structures 123, which may be configured to have a specific shape to expand the tissue around the insertion site, as will be described in more detail herein.

[0052] Figure 3AA schematic diagram of an exemplary expansion structure according to some embodiments is shown. In some embodiments, one or more expansion structures 123 may be configured to include a structure extending from a tapering junction 122 that expands tissue when a catheter 110 is inserted into an insertion site. In some embodiments, one or more expansion structures 123 include a protrusion 130 extending from a sidewall 124. In some embodiments, one or more expansion structures extend radially from the sidewall 124 or longitudinally from a proximal edge 135 to a distal edge 137. In some embodiments, the protrusion 130 may be configured to extend from the sidewall 124 to a apex 132. In some embodiments, the apex 132 defines the point of maximum distance of the protrusion 130 from the sidewall 124. In some embodiments, the protrusion 130 further defines a proximal side 134 extending laterally between the apex 132 and the proximal edge 135 and a distal side 136 extending between the apex 132 and the distal edge 137. In some embodiments, the protrusion 130 includes a length 138 and a width 140. In some implementation schemes, such as Figures 3C to 3D As shown, the length 138 can remain constant, while the vertex 132 can be arranged along the length 138 anywhere including the longitudinal midpoint, facing and including the proximal edge 135 or the distal edge 13.

[0053] In some embodiments, one or more expansion structures 123 may include one or more protrusions 130 or spirals 160, which will be described in more detail herein. Figures 3B to 3I Perspective views of various embodiments of the protrusion 130 or spiral portion 160 according to some embodiments are shown. As will be understood, the protrusion 130 may extend radially from the sidewall 124. In some embodiments, one or more protrusions 130 may extend from the sidewall 124 at the same or different distances from the sidewall 124 of the tapered joint 122, as will be described in more detail herein. In some embodiments, such as Figures 3B to 3C As shown, the protrusion 130 may include various geometries. For example, such as Figure 3B As shown, the proximal side 134A or the distal side 136A may define a cutting edge extending longitudinally through the midline 139 of the proximal side 134A or the distal side 136A. In some embodiments, the cutting edge may be configured to help the user expand the tissue around the insertion site and prevent tissue deflection. Figure 3D As shown, the tapered joint 122 may include a plurality of protrusions 130A-130C that define a distal side 136, a midline 139, and a proximal side 134 of a longitudinal circle. The apex 132A of the first protrusion 130A may be longitudinally offset from the apex 132B of the second protrusion 130B.

[0054] Figure 3EA perspective view of one or more protrusions 130 is shown, wherein the one or more protrusions 130 include a plurality of ribs 150, wherein the plurality of ribs 150 are repeating circular protrusions. In some embodiments, each of the plurality of ribs 150 includes a rib face 155 extending from a proximal edge 156 to a distal edge 157, a rib length 158 extending from the proximal edge 156 to the distal edge 157, and a rib width 159. In some embodiments, the rib face 155 defines a circular outer contour of the protrusion 130. In some embodiments, the rib length 158 of the plurality of ribs 150 may be the same or different. In some embodiments, the rib width 159 of the plurality of ribs 150 may be the same or different. In embodiments, the rib width 159 gradually tapers from a larger rib width 159 proximal to a smaller rib width 159 distal.

[0055] In some embodiments, a plurality of ribs 150 may be randomly or evenly distributed on the sidewall 124 of the tapered joint 122. In some embodiments, the plurality of ribs 150 may be longitudinally organized into a first row 152 of two or more ribs and a second row 154 of two or more ribs. In embodiments, each rib in the first row 152 may be longitudinally aligned with each rib in the second row 154. Figure 3E In the illustrated embodiment, each rib in the first row 152 may be longitudinally offset from each rib in the second row 154. Each rib in the first row 152 may be uniformly or unevenly spaced from the other ribs in the first row 152, and each rib in the second row may be uniformly or unevenly spaced from the other ribs in the second row. The first row 152 and the second row 154 may be arranged on opposite sides of the tapered joint 122. In some embodiments, the first row 152 may be aligned laterally, and the second row 154 may be aligned laterally, or have an angle between them.

[0056] In one embodiment, the first row of ribs 152 may be arranged in a spiral pattern around the longitudinal axis 117, wherein each rib in the first row of ribs 152 is rotated and offset by an angle and longitudinally offset by a distance around the longitudinal axis 117. In another embodiment, each rib in the first row of ribs 152 may be rotated and offset by the same angle or different angles. In yet another embodiment, each rib in the first row of ribs 152 may be longitudinally offset by the same distance or different distances.

[0057] Figures 3F to 3I A perspective view of one or more expansion structures 123 is shown, wherein the expansion structure 123 includes a helical portion 160 extending radially from a sidewall 124 about a longitudinal axis 117. In some embodiments, the helical portion 160 may be a right-handed helical portion or a left-handed helical portion. In some embodiments, such as Figure 3F As shown, the spiral portion 160 may have a longitudinal length 161.

[0058] In some implementations, for example Figure 3F The expansion structure 123 may include a relatively high number of revolutions per longitudinal length of 161, thereby providing a relatively "tighter" helical structure. In some embodiments, for example Figure 3G The expansion structure 123 may include a relatively low number of revolutions per longitudinal length of 161, thereby providing a relatively "loose" helical structure.

[0059] In some embodiments, each turn of the helix 160 may extend radially from the sidewall 124 by the same distance, such as Figure 3G As shown, or each ring can extend a different distance from the side wall 124. For example, as Figure 3H As shown, the helical portion 160 can extend a greater distance from the sidewall 124 proximally and a smaller distance from the sidewall 124 distally. Advantageously, by rotating the tapered joint 122, which includes the helical expansion structure 123, the mechanical action of the helical portion 160 pulls the tapered joint 122 past the insertion portion 104, thereby preventing tissue deflection or twisting. In some embodiments, such as Figure 3I As shown, the spiral portion 160 can be configured to have inclined, chamfered, square, or rounded edges. The inclined or chamfered edges can be configured to partially or completely cut the tissue surrounding the insertion site 104 as the spiral portion 160 rotates, thereby further expanding the tissue. Although Figures 3A to 3I Various embodiments of one or more expansion structures 123 of the tapered joint 122 are shown, but other shapes or protrusions may be considered.

[0060] Figures 4A to 4D The diagram shows a cross-section of one or more expansion structures 123 including one or more protrusions 130 with a tapered joint 122, according to some embodiments. In some embodiments, the conduit fitting 116 includes one or more lumens 120 extending therethrough.

[0061] In some embodiments, the protrusion 130 includes a height 141. As used herein, the “height” of the protrusion 130 is the distance from the outermost point of the radially extending protrusion 130 to the sidewall 124. In some embodiments, the protrusion 130 defines a width 140. As used herein, “width” is a distance extending parallel to the sidewall 124. In some embodiments, the protrusion 130 may have the same width 140 and the same height 141, or different widths 140 and different heights 141.

[0062] like Figure 4AAs shown, the tapered joint 122 may include four protrusions 130A-130D extending radially from the sidewall 124 of the tapered joint 122. In some embodiments, the first ridge 130A may be equidistant from the second ridge 130B and the fourth ridge 130D. In some embodiments, the fourth ridge 130D may be equidistant from the first ridge 130A and the third ridge 130C. In short, the four protrusions 130A-130D may be radially and evenly spaced around the tapered joint 122. Figure 4B As shown, in some embodiments, the tapered joint 122 may include eight ridges 130A-130H extending from the sidewall 124 of the tapered joint 122. In some embodiments, the eight ridges 132A-132H may be evenly spaced, unevenly spaced, or clustered together around the tapered joint 122. Although eight ridges are shown, more or fewer ridges are also conceivable.

[0063] like Figure 4C As shown, in some embodiments, the tapered joint 122 may include two protrusions 130A, 130B extending from the sidewall 124 of the catheter fitting 116. In some embodiments, the first protrusion 130A and the second protrusion 130B define a lateral axis 129. In some embodiments, the first protrusion 130A may be longitudinally aligned with the second protrusion 130B to define a lateral axis 129 on opposite sides of the tapered joint 122. In some embodiments, the first protrusion 130A may be longitudinally offset from the second protrusion 130B. In some embodiments, one or more protrusions 130 may include a plurality of ribs 150. In some embodiments, the plurality of ribs 150 may be organized in a first row 152 and a second row 154. Figure 4D As shown, in some embodiments, on opposite sides of the catheter fitting 116, the first row 152 may be longitudinally aligned with the second row 154. In some embodiments, the first row 152 may be longitudinally offset from the second row 154. In some embodiments, a plurality of ribs 150 may extend radially from the sidewall 124 uniformly or non-uniformly to define different distances from the sidewall 124 of the tapered joint 122. In some embodiments, the plurality of ribs 150 located proximally may extend radially a greater distance from the sidewall 124 compared to the ribs located distally. In some embodiments, the plurality of ribs 150 may be organized into a plurality of rows uniformly spaced around the tapered joint 122. In some embodiments, the plurality of ribs 150 may be spaced around the catheter fitting 116 in an organized or random configuration. In some embodiments, the plurality of ribs may be arranged in a spiral around the longitudinal axis 117.

[0064] Figures 5A to 5C An exemplary method of inserting catheter 110 into insertion site 104 is shown. In some embodiments, catheter insertion system 100 includes guidewire 102. Figure 5A As shown, the guidewire 102 can be inserted into the insertion site 104 in the target region 106. In some embodiments, the target region 106 may include a target blood vessel. In some embodiments, the user can confirm that the guidewire 102 is in the correct target position. In some embodiments, such as Figure 5B As shown, the catheter insertion system 100 also includes a catheter 110 having a bushing 112 disposed proximally and including one or more extension legs extending proximally from the proximal end of the bushing 112. The catheter 110 includes a catheter fitting 116 extending distally from the distal end of the bushing 112. The catheter fitting 116 is configured to slide on a guidewire 102. The catheter fitting 116 includes a proximal end 119 and a distal segment 121 terminating at a distal end 118, and the catheter fitting may define one or more catheter lumens 120 therein. The catheter fitting 116 also includes a proximal portion 125, a tapered joint 122 having sidewalls 124, and a distal portion 127. The proximal portion 125 has a second diameter 126 and the distal portion 127 has a first diameter 128, wherein the second diameter 126 is larger than the first diameter 128. The tapered joint 122 may be configured to include one or more expansion structures 123 that extend radially from the sidewall 124 and are configured to have a specific shape to expand the tissue around the skin insertion site 104 while mitigating tissue deflection. The expansion structure 123 may include one or more protrusions 130 or spiral portions 160.

[0065] Once the guidewire 102 is placed in the correct target position, the catheter 110 can slide on the guidewire 102 and be pushed into the skin insertion site 104, as... Figure 5B As shown. Because the distal portion 127 defines a smaller first diameter 128, the distal portion 127 can more easily enter the skin insertion site 104. The tapered joint 122, including one or more expansion structures 123, can then expand the skin insertion site 104 for the larger second diameter 126 and proximal portion 125. When the catheter 110 is pushed into the skin insertion site 104, the one or more expansion structures 123 facilitate tissue expansion around the skin insertion site 104 by stretching the tissue around the skin insertion site 104 along a lateral axis. For example, the rotating helix 160 can be configured to use mechanical advantage to pull the tapered joint 122 across the skin insertion site 104, thereby minimizing tissue deflection. In some embodiments, the user can further twist the catheter 110 clockwise or counterclockwise about the longitudinal axis 117 while pushing the catheter 110 into the skin insertion site 104 to further expand the tissue around the insertion site 104.

[0066] In some embodiments, the user can wiggle the catheter 110 back and forth along a lateral axis, a transverse axis, or a combination thereof, while simultaneously pushing the catheter 110 into the insertion site 104 to further dilate the tissue surrounding the insertion site 104. In some embodiments, for example... Figure 3D The user can swing the catheter 110 back and forth along the lateral or transverse axis. In some embodiments, for example... Figures 3E to 3I The user can swing and twist the catheter 110 while pushing it into the insertion site 104. In some embodiments, the user can continue to swing or twist the catheter 110 until it is fully inserted into the insertion site 104, such as... Figure 5C As shown. Once catheter 110 is fully inserted, the user can confirm the proper target placement of catheter 110 via imaging. In some embodiments, using catheter 110 to dilate insertion site 104 results in increased fit between catheter 110 and insertion site 104 while minimizing tissue deflection around insertion site 104.

[0067] Figure 6 A flowchart illustrating an exemplary method 300 for inserting a catheter 110 into an insertion site 104 using a catheter insertion system 100 according to some embodiments is shown. In some embodiments, method 300 includes inserting a distal segment 121 of the catheter 110 into the insertion site 104 (box 302). In some embodiments, the distal segment 121 includes a tapered joint 122 having one or more expansion structures 123 extending radially from a sidewall 124 and a distal portion 127 having a first diameter 128 extending from the distal end of the tapered joint.

[0068] Method 300 includes dilating the skin insertion site 104 (frame 304). In some embodiments, dilating the insertion site 104 includes dilating from a smaller first diameter 128 to a larger second diameter 126. In some embodiments, dilating the skin insertion site 104 includes pushing a tapered joint 122 of a catheter 110 into the skin insertion site 104, the tapered joint 122 including one or more expansion structures 123 extending radially from a sidewall 124. In some embodiments, the one or more expansion structures 123 include one or more protrusions 130 or helical portions 160. In some embodiments, dilating the insertion site 104 includes twisting the catheter 110 clockwise or counterclockwise about a central longitudinal axis 117. In some embodiments, dilating the insertion site 104 includes oscillating the catheter 110 along a transverse or lateral axis.

[0069] Method 300 also includes advancing the proximal portion 125 of the catheter 110 into the insertion site 104. In some embodiments, the proximal portion 125 includes a second diameter 126. In some embodiments, the second diameter 126 is larger than the first diameter 128.

[0070] While certain specific embodiments have been disclosed herein, and in detail, these specific embodiments are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will likely occur to those skilled in the art, and such adaptations and / or modifications will be included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are possible without departing from the scope of the concepts provided herein.

Claims

1. A catheter configured for insertion into a skin site, characterized in that, include: A bushing, which is arranged proximally and includes one or more extending legs extending proximally from the bushing; A catheter fitting extending distally from the bushing and defining a first catheter lumen and a second catheter lumen, each of the first and second catheter lumens being in fluid communication with an extension leg of one or more extension legs, the catheter fitting comprising: A tapering junction located between the distal and proximal portions of the catheter fitting, and including an expansion structure configured to expand the skin insertion site, the expansion structure comprising: A first protrusion extends along a longitudinal axis between a first distal edge and a first proximal edge and along a lateral axis to a first apex, the first apex being disposed near a first midpoint between the first distal edge and the first proximal edge, the first protrusion including a first cutting edge; and A second protrusion extends along the longitudinal axis between the second distal edge and the second proximal edge and along the lateral axis to a second apex, the second apex being disposed near a second midpoint between the second distal edge and the second proximal edge. The second protrusion includes a second cut edge. The distal portion of the catheter fitting extends from the distal end of the tapered joint to the distal end of the catheter fitting, the diameter of the distal portion is smaller than the diameter of the proximal portion of the catheter fitting, and the distal portion defines the distal portion of the first catheter lumen, the second catheter lumen terminating in a hole disposed in the sidewall of the tapered joint and adjacent to the expansion structure.

2. The catheter according to claim 1, characterized in that, The outermost lateral diameter extending between the first vertex and the second vertex is greater than the diameter of the conduit fitting.

3. The catheter according to claim 2, characterized in that, The outermost lateral diameter of the expansion structure, which extends perpendicularly to the lateral axis, is smaller than the diameter of the conduit fitting.

4. The catheter according to claim 1, characterized in that, The first protrusion defines a first proximal side extending between the first vertex and the first proximal edge, and the second protrusion defines a second proximal side extending between the second vertex and the second proximal edge.

5. The catheter according to claim 4, characterized in that, The first protrusion defines a first distal surface extending between the first vertex and the first distal edge, and the second protrusion defines a second distal surface extending between the second vertex and the second distal edge.

6. The catheter according to claim 4, characterized in that, The first proximal side defines a first cutting edge extending longitudinally through a first midline of the first proximal side, and the second proximal side defines a second cutting edge extending longitudinally through a second midline of the second proximal side.

7. The catheter according to claim 5, characterized in that, The first distal side defines a first cutting edge extending longitudinally through a first midline of the first distal side, and the second distal side defines a second cutting edge extending longitudinally through a second midline of the second distal side.

8. The catheter according to claim 1, characterized in that, The tapered joint and the distal portion of the catheter fitting are configured to be placed subcutaneously through the skin insertion site.

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