Catheter insertion system with passive skin dilation

Abstract

In some embodiments, the catheters disclosed herein include a distal section of the catheter configured to enter a skin insertion site. The distal section includes a taper junction including one or more expansion structures configured to expand the skin insertion site. The distal section further includes a distal portion extending from the distal end of the taper junction. The distal portion has a smaller diameter than the proximal portion of the catheter. In combination, the taper junction, the one or more expansion structures, and specific user actions that urge the catheter into the skin insertion site can enhance the fit of the catheter at the insertion site.

Description

Technical Field

[0001] The present disclosure relates to a catheter insertion system involving passive skin dilation.

Background Art

[0002] In some catheter placement procedures, the dilation of the tissue around the insertion site is a central action that occurs during catheter placement. Appropriate dilation of the tissue can improve the fit of the catheter. Current dilation methods are performed manually using individual rigid components and skin incisions or individual rigid components or skin incisions to relieve skin tension while dilating the tissue. These techniques require the insertion and removal of various instruments, increase complexity and time, and increase the risk of infection. Also, these techniques can lead to unwanted tissue displacement and require increased pushing force, which may result in excessive dilation of the tissue around the insertion site. It would be beneficial to be able to dilate only the tissue necessary for catheter fit and reduce the need for skin incisions. What is disclosed herein is a system and method of use directed to the above matters.

Summary of the Invention

[0003] What is disclosed herein is a distal section of a catheter configured to enter a skin insertion site, including a tapered junction including one or more dilation structures configured to dilate the skin insertion site, and a distal portion extending from the distal end of the tapered junction, the distal portion having a smaller diameter than the proximal portion of the catheter.

[0004] In some embodiments, the one or more dilation structures include one or more protrusions or helices extending from the sidewall of the tapered junction. In some embodiments, the one or more dilation structures extend radially from the sidewall of the tapered junction.

[0005] In some embodiments, each projection includes a proximal margin and a distal margin. In some embodiments, each projection extends longitudinally from the proximal edge to the distal edge. In some embodiments, each projection extends laterally from the side wall to the apex.

[0006] In some embodiments, the vertex is located between the longitudinal midpoint and either the proximal or distal margin, including the proximal or distal margin. In some embodiments, each projection defines a proximal surface extending between the apex and the proximal margin.

[0007] In some embodiments, each projection defines a distal surface extending between the apex and the distal edge. In some embodiments, the proximal surface defines a cut edge that extends longitudinally through the median of the proximal surface.

[0008] In some embodiments, the distal surface defines an incisal margin that extends longitudinally through the median of the distal surface. In some embodiments, the protrusions are longitudinally aligned in a first line of two or more protrusions and a second line of two or more protrusions, which are located on both sides of the tapered joint.

[0009] In some embodiments, the proximal and distal surfaces of each projection harmonize to define a rounded shape. In some embodiments, each projection of the first line is aligned longitudinally with each projection of the second line.

[0010] In some embodiments, each projection of the first line is offset longitudinally from each projection of the second line. In some embodiments, the helical portion includes either a right-handed or left-handed helical portion.

[0011] In some embodiments, the helical portion includes a beveled edge or a chamfered edge. Further disclosed herein is a method for inserting a catheter, comprising inserting a distal section of a catheter into a skin insertion site, wherein the distal section has a tapered joint comprising one or more expansion structures configured to expand the skin insertion site, and a distal portion extending from the distal end of the tapered joint, the distal portion having a smaller diameter than the proximal portion of the catheter, the method comprising inserting, expanding the skin insertion site, and advancing the proximal portion of the catheter into the expanded skin site.

[0012] In some embodiments, one or more extension structures include one or more projections or helices extending from the sidewall of the tapered joint. In some embodiments, each projection includes a proximal surface and a distal surface.

[0013] In some embodiments, the proximal surface defines a cut edge that extends longitudinally through the median of the proximal surface. In some embodiments, the distal surface defines an incisal margin that extends longitudinally through the median of the distal surface.

[0014] In some embodiments, expanding the skin insertion site includes using the incision edge to expand the insertion site. In some embodiments, expanding the skin insertion site involves rotating a helical expansion structure with respect to the longitudinal axis to expand the insertion site.

[0015] In some embodiments, the helical portion includes either a right-handed or left-handed helical portion. In some embodiments, the helical portion includes a beveled edge or a chamfered edge.

[0016] In some embodiments, expanding the skin insertion site includes using an oblique cut edge or a chamfered edge to expand the insertion site. In some embodiments, expanding the skin insertion site includes rotating the distal section of the catheter clockwise or counterclockwise about a longitudinal axis.

[0017] In some embodiments, expanding the skin insertion site includes incrementally moving the distal section of the catheter relative to a transverse or lateral axis. These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description which set forth in more detail specific embodiments of such concepts.

[0018] A more specific description of the present disclosure is made with reference to the specific embodiments illustrated in the accompanying drawings. It is recognized that these drawings depict only representative embodiments of the invention and, accordingly, should not be regarded as limiting its scope. Exemplary embodiments of the invention are described and illustrated using the accompanying drawings to add specificity and detail. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] [Figure 1] A plan view of a catheter insertion system according to some embodiments is shown. [Figure 2] A perspective view of components of a catheter insertion system including a taper junction according to some embodiments is shown. [Figure 3A] A schematic diagram of an exemplary expansion structure according to some embodiments is shown. [Figure 3B-3I] A perspective view of various embodiments of one or more expansion structures according to some embodiments is shown. [Figure 4A-4D] Cross-sectional views of various embodiments of an expansion structure according to some embodiments are shown. [Figures 5A-5C] An exemplary method of inserting a catheter into an insertion site according to some embodiments is shown. [Figure 6] A flowchart of an exemplary method of inserting a catheter according to some embodiments is shown.

Best Mode for Carrying Out the Invention

[0020] 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. The specific embodiments disclosed herein can be easily separated from the specific embodiments and, optionally, can have features that can be combined with or replaced by any of the many other embodiments disclosed herein.

[0021] Regarding the terms used herein, it should also be understood that the terms are for the purpose of describing some 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 multiple features or multiple steps and do not provide consecutive limitations or numerical restrictions. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a specific embodiment including such features or steps does not necessarily have to be limited to three features or steps. Labels such as "left", "right", "front", "rear", "up", "down", and other similar terms are used for convenience and do not, for example, mean a specific fixed position, orientation, or direction. Instead, such notations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless the context clearly dictates otherwise.

[0022] With respect to “proximal,” for example, the “proximal portion” or “proximal end portion” of a catheter disclosed herein includes the portion of the catheter 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 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. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter, but does not necessarily include the proximal end of the catheter. That is, unless suggested by the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0023] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a catheter disclosed herein includes the portion 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 needle includes the 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 portion, or distal length of a catheter may include the distal end of the catheter, but the distal portion, distal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless suggested by the context, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art. Figure 1 shows a plan view of a catheter insertion system 100 according to several embodiments. In some embodiments, the catheter insertion system 100 includes a catheter 110 having a hub 112 positioned at the proximal end and including one or more extension legs extending proximal from the proximal end of the hub 112. In some embodiments, the catheter 110 includes a catheter tube 116 extending distally from the distal end of the hub 112. In some embodiments, the catheter tube 116 may be configured to slide on a guidewire 102. The catheter tube 116 includes a proximal end 119 and a distal section 121 terminating at a distal tip 118, where one or more catheter lumens can be defined. In some embodiments, the catheter 110 may include a Rapid Insertion Central Catheter ("RICC"), such as those described in U.S. Patent No. 1,0376675, U.S. Patent Application No. 17 / 031478, U.S. Patent Application No. 17 / 006553, U.S. Patent Application No. 17 / 074405, U.S. Patent Application No. 17 / 077728, and U.S. Patent Application No. 17 / 080578, each of which is incorporated herein by reference in whole. As used herein, the catheter insertion system 100 can be used to position the RICC to access the patient's vascular structure. However, it will be recognized that the embodiments disclosed herein can be used, without limitation, to implant various catheters, cannulas, single-lumen catheters, multi-lumen catheters, intravenous (IV) catheters, peripheral intravenous (PIV) line catheters, peripherally inserted central catheters (PICCs), central venous catheters (CVCs), dialysis catheters, drainage catheters, and the like.

[0025] Typically, the insertion site is smaller than the diameter of the catheter 110, so the tissue surrounding the insertion site needs to be expanded to position the catheter 110. Current expansion methods use hardening components that can cause tissue expansion and may result in excessive stretching of skin tissue when the hardening component is advanced into the insertion site. Less movement at the insertion site and less tissue expansion around the insertion site can lead to more precise placement of the catheter 110 within the body and a better fit of the catheter 110 within the insertion site.

[0026] In some embodiments, the cross-sectional shape of the catheter tube 116 may be cylindrical, triangular prism, rectangular prism, or similar, although other cross-sectional shapes are also conceivable. In some embodiments, the catheter tube 116 may be configured to have a tapered joint 122 between the proximal end 119 of the catheter tube 116 and the distal section 121 of the catheter tube 116. In some embodiments, the tapered joint 122 may be configured to include one or more extension structures 123 extending from the side wall 124 of the tapered joint 122, which are described in more detail herein.

[0027] Figure 2 shows perspective views of components of a catheter insertion system 100 including a tapered joint 122 according to several embodiments. In some embodiments, the catheter tube 116 includes a proximal portion 125, a tapered joint 122 including a side wall 124, and a distal portion 127 distal to the tapered joint 122. In some embodiments, the catheter tube 116 defines a central longitudinal axis 117. The proximal portion 125 has a second diameter 126, and 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 the portion of the catheter tube 116 that gradually tapers 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 from the proximal portion 125 to the distal portion 127, or it may taper non-uniformly. In some embodiments, the first diameter 128 and the second diameter 126 may be associated with a French catheter scale. In some embodiments, the tapered joint 122 may be configured to include one or more expansion structures 123 which may be configured to have a special shape for expanding the tissue around the insertion site, which will be described in more detail herein.

[0028] Figure 3A shows schematic diagrams of exemplary expansion structures according to several embodiments. In some embodiments, one or more expansion structures 123 may be configured to include a structure extending from the tapered joint 122 that expands tissue when the catheter 110 is inserted into the insertion site. In some embodiments, one or more expansion structures 123 include a projection 130 extending from the side wall 124. In some embodiments, one or more expansion structures extend radially from the side wall 124 or longitudinally from the proximal edge 135 to the distal edge 137. In some embodiments, the projection 130 may be configured to extend from the side wall 124 to a vertex 132. In some embodiments, the vertex 132 defines the point of the projection 130 furthest from the side wall 124. In some embodiments, the projection 130 further defines a proximal surface 134 extending laterally between the vertex 132 and the proximal margin 135, and a distal surface 136 extending between the vertex 132 and the distal margin 137. In some embodiments, the projection 130 includes a length 138 and a width 140. In some embodiments, as shown in Figures 3C to 3D, the length 138 may remain the same, but the vertex 132 may be located anywhere along the length 138, including the longitudinal midpoint, toward and including the proximal margin 135 or the distal margin 13.

[0029] In some embodiments, one or more extension structures 123 may include one or more projections 130 or helical portions 160, which are described in more detail herein. Figures 3B to 3I show perspective views of various embodiments of the projections 130 or helical portions 160 according to some embodiments. As can be seen, the projections 130 may extend radially from the sidewall 124. In some embodiments, as described in more detail herein, one or more projections 130 may extend from the sidewall 124 of the tapered joint 122 at the same or different distances from the sidewall 124. In some embodiments, as illustrated in Figures 3B to 3C, the projections 130 may include various geometric shapes. For example, as illustrated in Figure 3B, a proximal surface 134A or a distal surface 136A may define a cut edge extending longitudinally through the midline 139 of the proximal surface 134A or the distal surface 136A. In some embodiments, the incision edge may be configured to help the user expand the tissue around the insertion site and prevent tissue displacement. As shown in Figure 3D, the tapered joint 122 may include a plurality of projections 130A-C, defining a longitudinally rounded distal surface 136, a midline 139, and a longitudinally rounded proximal surface 134. The apex 132A of the first projection 130A may be longitudinally offset from the apex 132B of the second projection 130B.

[0030] Figure 3E shows a perspective view of one or more projections 130, each projection 130 comprising a plurality of ribs 150, the plurality of ribs 150 being a repeating round projection. In some embodiments, each rib 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 a proximal edge 156 to a distal edge 157, and a rib width 159. In some embodiments, the rib face 155 defines the round outer diameter of the projection 130. In some embodiments, the rib lengths 158 of the plurality of ribs 150 may be the same or vary. In some embodiments, the rib widths 159 of the plurality of ribs 150 may be the same or vary. In one embodiment, the rib width 159 gradually tapers from a larger rib width 159 proximal to a smaller rib width 159 distal.

[0031] In some embodiments, the ribs 150 may be randomly or uniformly distributed on the sidewall 124 of the tapered joint 122. In some embodiments, the ribs 150 may be longitudinally aligned with a first line 152 of two or more ribs and a second line 154 of two or more ribs. In one embodiment, each rib of the first line 152 may be longitudinally aligned with each rib of the second line 154. In one embodiment illustrated in Figure 3E, each rib of the first line 152 may be longitudinally offset from each rib of the second line 154. Each rib of the first line 152 may be spaced uniformly or unevenly from the other ribs of the first line 152, and each rib of the second line may be spaced uniformly or unevenly from the other ribs of the second line. The first line 152 and the second line 154 may be located on both sides of the tapered joint 122. In some embodiments, the first line 152 may be aligned along the side, and the second line 154 may be aligned along the side or at an angle between them.

[0032] In one embodiment, the first line of ribs 152 can be arranged in a helical pattern with respect to the longitudinal axis 117, and each rib in the first line of ribs 152 is rotated by a certain angle and vertically by a certain distance with respect to the longitudinal axis 117. In one embodiment, each rib in the first line of ribs 152 can be rotated by the same angle or by different angles. In one embodiment, each rib in the first line of ribs 152 can be vertically offset by the same distance or by different distances.

[0033] Figures 3F to 3I show perspective views of one or more extension structures 123, each extension structure 123 including a helical portion 160 extending radially from a side wall 124 with respect to a longitudinal axis 117. In some embodiments, the helical portion 160 may be a right-handed or left-handed helical portion. In some embodiments, as shown in Figure 3F, the helical portion 160 may have a longitudinal length 161. In some embodiments, for example in Figure 3F, the extension structure 123 may include a relatively high number of turns per longitudinal axis length 161, providing a relatively "tight" helical structure. In some embodiments, for example in Figure 3G, the extension structure 123 may include a relatively low number of turns per longitudinal axis length 161, providing a relatively "loose" helical structure.

[0034] In some embodiments, as shown in Figure 3G, each rotation of the helical portion 160 may extend the same radial distance from the sidewall 124, or each rotation may extend a different distance from the sidewall 124. For example, as shown in Figure 3H, the helical portion 160 may extend a greater distance from the sidewall 124 at the proximal end and a smaller distance at the distal end. Advantageously, by rotating the tapered joint 122 including the helical expansion structure 123, the mechanical action of the helical portion 160 pulls the tapered joint 122 towards the insertion site 104, preventing tissue displacement or strain. In some embodiments, as shown in Figure 3I, the helical portion 160 may be configured to have an oblique cut edge, a chamfered edge, a square edge, or a rounded edge. The oblique cut edge or chamfered edge may be configured to partially or completely cut the tissue around the insertion site 104 as the helical portion 160 rotates, further expanding the tissue. Figures 3A to 3I illustrate various embodiments of one or more extension structures 123 of the tapered joint 122, but other shapes or protrusions are also possible.

[0035] Figures 4A to 4D show cross-sections of one or more extension structures 123 including one or more projections 130 of a tapered joint 122, according to several embodiments. In some embodiments, the catheter tube 116 includes one or more lumens through which it passes. In some embodiments, the projection 130 includes a height 141. As used herein, “height” of the projection 130 is the distance from the side wall 124 to the outermost point of the projection 130 extending radially. In some embodiments, the projection 130 defines a width 140. As used herein, “width” is the distance extending parallel to the side wall 124. In some embodiments, the projection 130 may have the same width 140 and the same height 141, or it may have different widths 140 and different heights 141.

[0036] As shown in Figure 4A, the tapered joint 122 may include four projections 130A-D extending radially from the side wall 124 of the tapered joint 122. In some embodiments, the first projection 130A may be equidistant from the second projection 130B and the fourth projection 130D. In some embodiments, the fourth projection 130D may be equidistant from the first projection 130A and the third projection 130C. In short, the four projections 130A-D may be arranged radially at uniform intervals around the tapered joint 122. As shown in Figure 4B, in some embodiments, the tapered joint 122 may include eight projections 130A-H extending from the side wall of the tapered joint 122. In some embodiments, the eight protrusions 132A-H may be arranged at uniform intervals, uneven intervals, or clustered together around the tapered joint 122. Although eight protrusions are illustrated, more or fewer protrusions are also conceivable.

[0037] As shown in Figure 4C, in some embodiments, the tapered joint 122 may include two projections 130A and 130B extending from the side wall 124 of the catheter tube 116. In some embodiments, the first projection 130A and the second projection 130B define a lateral axis 129. In some embodiments, the first projection 130A may be longitudinally aligned with the second projection 130B, defining the lateral axis 129 on both sides of the tapered joint 122. In some embodiments, the first projection 130A may be longitudinally offset from the second projection 130B. In some embodiments, one or more projections 130 may include a plurality of ribs 150. In some embodiments, the plurality of ribs 150 may be aligned with a first line 152 and a second line 154. As shown in Figure 4D, in some embodiments, the first line 152 may be longitudinally aligned with the second line 154 on both sides of the catheter tube 116. In some embodiments, the first line 152 may be longitudinally offset from the second line 154. In some embodiments, the ribs 150 may extend radially uniformly or unevenly from the side wall 124, defining different distances from the side wall 124 of the tapered joint 122. In some embodiments, the ribs 150 located proximal may extend radially at a greater distance from the side wall 124 than the ribs located distally. In some embodiments, the ribs 150 may be aligned in lines that are uniformly spaced around the tapered joint 122. In some embodiments, the ribs 150 may be spaced apart in an aligned or random configuration around the catheter tube 116. In some embodiments, the ribs may be arranged in a helical line with respect to the longitudinal axis 117.

[0038] Figures 5A to 5C illustrate exemplary methods of use for inserting the catheter 110 into an insertion site 104. In some embodiments, the catheter insertion system 100 includes a guidewire 102. As shown in Figure 5A, the guidewire 102 may be inserted into the insertion site 104 in a target area 106. In some embodiments, the target area 106 may include a target vessel. In some embodiments, the user may be able to verify that the guidewire 102 is in the correct target position. In some embodiments, as shown in Figure 5B, the catheter insertion system 100 further includes a catheter 110 having a hub 112 positioned at its proximal end and including one or more extension legs extending proximal from the proximal end of the hub 112. The catheter 110 includes a catheter tube 116 extending distally from the distal end of the hub 112. The catheter tube 116 may be configured to slide on the guidewire 102. The catheter tube 116 includes a proximal end 119 and a distal section 121 terminating at a distal tip 118, where one or more catheter lumens 120 can be defined. The catheter tube 116 further includes a proximal portion 125, a tapered joint 122 having a side wall 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, with the second diameter 126 being greater than the first diameter 128. The tapered joint 122 may be configured to include one or more expansion structures 123 extending radially from the side wall 124 and configured to have a special shape that expands the tissue around the skin insertion site 104 while mitigating tissue displacement. The expansion structures 123 may include one or more projections 130 or helical portions 160.

[0039] Once the guidewire 102 is positioned correctly, the catheter 110 can be slid along the guidewire 102 and advanced into the skin insertion site 104, as shown in Figure 5B. The distal portion 127 defines a smaller first diameter 128, allowing it to enter the skin insertion site 104 more easily. The tapered junction 122, including one or more expansion structures 123, can then expand the skin insertion site 104 with respect to the larger second diameter 126 and the proximal portion 125. Once the catheter 110 is advanced into the skin insertion site 104, the one or more expansion structures 123 facilitate expansion by spreading the tissue around the skin insertion site 104 along the lateral axis. For example, a rotating helix 160 may be configured to use a mechanical advantage to allow the tapered junction 122 to pass through the insertion site 104 while minimizing tissue displacement. In some embodiments, the user may further twist the catheter 110 clockwise or counterclockwise with respect to the longitudinal axis 117 while guiding the catheter 110 into the skin insertion site 104 and further expanding the tissue around the insertion site 104.

[0040] In some embodiments, the user may "move" the catheter 110 in small increments left, right, up, and down along the lateral axis, transverse axis, or a combination thereof, while guiding the catheter 110 into the skin insertion site 104 and further expanding the tissue surrounding the insertion site 104. In some embodiments, for example in Figure 3D, the user may move the catheter 110 in small increments left, right, up, and down along the lateral axis or transverse axis. In some embodiments, for example in Figures 3E to 3I, the user may move and twist the catheter 110 in small increments while guiding the catheter 110 into the insertion site 104. In some embodiments, as shown in Figure 5C, the user may continue to move or twist the catheter 110 in small increments until the catheter 110 is fully inserted into the insertion site 104. Once the catheter 110 is fully inserted, the user can confirm its proper target position by imaging. In some embodiments, using the catheter 110 to expand the insertion site 104 leads to an improved fit of the catheter 110 into the insertion site 104 while minimizing tissue displacement around the insertion site 104.

[0041] Figure 6 shows a flowchart of an exemplary method 300 for inserting a catheter 110 into an insertion site 104 using a catheter insertion system 100, according to several embodiments. In some embodiments, method 300 includes inserting the distal section 121 of the catheter 110 into the insertion site 104 (block 302). In some embodiments, the distal section 121 includes a tapered joint 122 having one or more expansion structures 123 extending radially from the side wall 124, and a distal portion 127 extending from the distal end of the tapered joint having a first diameter 128.

[0042] Method 300 includes expanding the skin insertion site 104 (block 304). In some embodiments, expanding the insertion site 104 includes expanding from a smaller first diameter 128 to a larger second diameter 126. In some embodiments, expanding the skin insertion site 104 includes guiding the tapered joint 122 of the catheter 110 into the skin insertion site 104, the tapered joint 122 including one or more expansion structures 123 extending radially from the side wall 124. In some embodiments, the one or more expansion structures 123 include one or more projections 130 or helical portions 160. In some embodiments, expanding the insertion site 104 includes twisting the catheter 110 clockwise or counterclockwise around the central longitudinal axis 117. In some embodiments, expanding the insertion site 104 includes moving the catheter 110 in small increments along a transverse or lateral axis.

[0043] Method 300 further 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.

[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. Those skilled in the art will understand that in broader embodiments, additional adaptations or modifications may be made, and these adaptations or modifications are also included. Thus, it is possible to implement these embodiments outside of the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A distal section of a catheter configured to enter a skin insertion site, A tapered joint comprising one or more expansion structures configured to expand the skin insertion site, Including the distal portion extending from the distal end of the tapered joint, The distal portion has a smaller diameter than the proximal portion of the catheter. One or more expansion structures include a first projection and a second projection, the first projection being aligned longitudinally with the second projection, the first projection and the second projection defining a lateral axis on both sides of the tapered joint, and the first projection and the second projection defining an incision edge that expands the tissue around the skin insertion site along the lateral axis. The distal section of the catheter has projections that are longitudinally aligned with a first line of two or more projections and a second line of two or more projections, located on both sides of the tapered joint.

2. In the distal section of the catheter according to claim 1, One or more extension structures extend radially from the side wall of the tapered junction in the distal section of the catheter.

3. In the distal section of the catheter according to claim 1 or 2, Each projection is the distal section of the catheter, including the proximal and distal edges.

4. In the distal section of the catheter according to claim 3, Each projection is the distal section of the catheter, extending longitudinally from the proximal to the distal edge.

5. In the distal section of the catheter according to claim 4, Each projection is the distal section of the catheter, extending laterally from the side wall to the apex.

6. In the distal section of the catheter according to claim 5, The apex is the distal section of the catheter, located between the longitudinal midpoint and either the proximal or distal edge, including the proximal or distal edge.

7. In the distal section of the catheter according to claim 6, Each projection is the distal section of the catheter, defining the proximal surface extending between the apex and the proximal edge.

8. In the distal section of the catheter according to claim 6, Each projection is the distal section of the catheter, defining the distal surface extending between the apex and the distal edge.

9. In the distal section of the catheter according to claim 7, The proximal surface is the distal section of the catheter, defining the incision edge which extends longitudinally through the midline of the proximal surface.

10. In the distal section of the catheter according to claim 8, The distal surface is the distal section of the catheter that defines the incision edge, which extends longitudinally through the midline of the distal surface.

11. In the distal section of the catheter according to any one of claims 1 to 10, The proximal and distal surfaces of each projection harmonize to define a rounded outer shape, forming the distal section of the catheter.

12. In the distal section of the catheter according to any one of claims 1 to 11, The distal section of the catheter, in which each projection of the first line is aligned longitudinally with each projection of the second line.

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