Access graft system and method

Abstract

A device for supporting an elongated tubular member, the device including a support member having an inner surface defining a receiving cavity, the support member further defining a peripheral opening, the receiving cavity operable to receive the elongated tubular member therein, and the support member operable to place the elongated tubular member in compression about its periphery.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the benefit of Provisional Application No. 63 / 320,386, filed on March 16, 2022, and incorporates by reference in its entirety the provisional application for all purposes.

[0002] Field The present disclosure generally relates to implantable conduits. More specifically, the present disclosure relates to devices, systems, and methods for providing a self - sealing graft, including an implantable graft.

Background Art

[0003] Background Vascular access grafts are used in patients in conditions that require regular intravascular access. For example, patients undergoing dialysis treatment require regular cannulation of the graft through the graft wall with a dialysis needle inserted through the graft lumen into a system of blood lines that circulate blood between the patient and the dialysis machine. Vascular access grafts are operable to self - seal, but repeated insertions can break the graft and cause blood leakage from the graft.

[0004] Another difficulty related to repeated access is the process of accessing the lumen of the graft with a needle. Often, the graft presents a relatively small target or surface area through which a medical professional or a patient trained in self - care treatment must insert a needle to access the graft. Failure to access requires re - insertion of the needle, causing further discomfort to the patient.

[0005] When the needle advances too far and completely penetrates the access graft, another difficulty arises. It is relatively difficult to determine the depth of the access graft, and thus it is difficult to discern the appropriate depth at which to insert the needle into the lumen of the access graft.

[0006] Home self-managed dialysis is currently under development and in progress. Home and nocturnal dialysis has the potential to significantly improve the quality of life for people undergoing dialysis, but safe and easy-to-use equipment is necessary for patients to safely self-treat.

[0007] What is needed is an improvement in providing and / or supporting tubular structures for medical procedures. [Overview of the Initiative]

[0008] Abstract According to one example ("Example 1"), a device for supporting a long tubular member, the device comprising a support member having an inner surface defining a receiving cavity, the support member further defining a periphery opening, the receiving cavity being operable to receive a long tubular member therein, and the support member being operable to compress the long tubular member around its periphery.

[0009] In another example ("Example 2"), in addition to the features of Example 1, the receiving cavity is adhesively bonded to the elongated tubular member.

[0010] In another example ("Example 3"), in addition to Example 1 or 2, the support member includes a material that is resistant to needle punctures with typical force applied manually by the user.

[0011] In another example ("Example 4"), in addition to the features of Example 3, the support member includes a bioabsorbable material.

[0012] In another example ("Example 5"), in addition to any of Examples 1 to 4, the peripheral opening of the support member is approximately 10% to approximately 90% of the circumference of the elongated tubular member.

[0013] In another example ("Example 6"), in addition to any of Examples 1 to 4, the inner surface of the support member has an elliptical cross-section.

[0014] In another example ("Example 7"), in addition to any of Examples 1 to 4, the inner surface of the support member has a circular cross-section.

[0015] In another example ("Example 8"), in addition to any of Examples 6-7, the support member is operable to maintain the same cross-sectional area of ​​the elongated tubular member inside the receiving cavity and outside the receiving cavity.

[0016] In another example ("Example 9"), in addition to any of Examples 1 to 8, the support member has two opposing arms defining a periphery opening, the two opposing arms being interconnected by a body, and comprising a material having a durometer hardness lower than the durometer hardness of the body.

[0017] In another example ("Example 10"), in addition to any of Examples 8-9, the two opposing arms apply a compressive force to the elongated tubular member.

[0018] In another example ("Example 11"), in addition to any of Examples 9-10, the two opposing arms are formed from a shape memory material.

[0019] In another example ("Example 12"), in addition to the example in Example 11, the shape memory material is nitinol.

[0020] In another example ("Example 13"), in addition to any of Examples 9-12, the body is thicker than the two opposing arms.

[0021] In another example ("Example 14"), in addition to any of Examples 1 to 13, the support member includes a plurality of segments along the longitudinal length that are operable to facilitate the bending of the elongated tubular member when positioned together with the support member.

[0022] In another example ("Example 15"), in addition to Example 14, the multiple segments are individual elements.

[0023] According to another example ("Example 16"), in addition to Example 14, the plurality of segments are an integral member forming the support member, the support member includes an extension portion extending between adjacent segments, and the extension portion includes a thin profile operable to facilitate bending.

[0024] According to another example ("Example 17"), in addition to any one of Examples 14 to 16, the plurality of segments facilitate bending of the long tubular member.

[0025] According to another example ("Example 18"), the support member is resistant to puncture.

[0026] According to another example ("Example 19"), in addition to any one of Examples 1 to 17, the support member is operable to compress the tubular member.

[0027] According to another example ("Example 20"), in addition to any one of Examples 1 to 5, the support member further includes a positioning device operable to magnetically couple to the support member, and the positioning device forms a donut hole into which a needle can be inserted.

[0028] According to another example ("Example 21"), in addition to Example 20, the positioning device includes an indicator around the donut hole, and the indicator indicates different positions of needle insertion.

[0029] According to another example ("Example 22"), a method of assembling a support member according to any one of Examples 1 to 7 onto a long tubular member includes overlapping the support member and the long tubular member and applying a compressive force to the tubular member, and the diameter of the support member within the overlap is smaller than the diameter of the support member before applying the overlap.

[0030] According to another example ("Example 23"), the overlap is performed after applying an adhesive coupling to the support member and the long tubular member and curing the adhesive.

[0031] According to another example ("Example 24"), a method for assembling any of the support members of Examples 1 to 7 on a long tubular member includes stretching the tubular member to narrow its outer diameter so that it is received within a receiving cavity of the support member, the receiving cavity of the support member having a diameter smaller than the outer diameter of the tubular member when the tubular member is not compressed.

[0032] In another example ("Example 25"), the method for assembling the support member of Example 24 onto an elastomer tubular member includes deflecting the arm away from the body to enlarge a periphery opening that is operable to receive the tubular member into a receiving cavity.

[0033] In another example ("Example 26"), the AV access graft includes an elongated tubular member defining a lumen and an elongated support member defining a receiving cavity and a periphery opening, wherein the receiving cavity is operable to receive the elongated tubular member therein, and the elongated support member is operable to compress the tubular member periphery.

[0034] In another example ("Example 27"), in addition to Example 26, the receiving cavity is operable to receive an adhesive for bonding the elongated tubular members within the receiving cavity.

[0035] In another example ("Example 28"), in addition to any of Examples 25-26, the elongated tubular member is an artery or a vein.

[0036] According to another example ("Example 29"), in addition to any of Examples 25-26, the elongated tubular member is a biological material, a synthetic material, or a combination thereof.

[0037] According to another example ("Example 30"), in addition to any of Examples 25-28, the elongated tubular member in a circumferentially compressed state is operable to recover and seal after being punctured with a 14-gauge, 15-gauge, 16-gauge, or 17-gauge needle.

[0038] According to another example ("Example 31"), in addition to any of Examples 25 to 28, the outer dimensions of the long tubular member when it is in a state of ambient compression are in the range of approximately 1% to approximately 10% of the outer dimensions of the long tubular member when it is not in a state of ambient compression.

[0039] In another example ("Example 32"), in addition to any of Examples 25-28, the elongated tubular member includes an elliptical cross-section along at least a portion of the elongated tubular member, and the elongated tubular member is supported by the support member.

[0040] In another example ("Example 33"), in addition to any of Examples 25-31, the support member is a long C-shaped clip.

[0041] In another example ("Example 34"), the AV access graft comprises an elastomer tubular member including a first longitudinal portion having an elliptical cross-section, which resists deformation along the first longitudinal portion, thereby maintaining the elliptical cross-section of the first longitudinal portion when subjected to biological forces when implanted in the body.

[0042] In another example ("Example 35"), in addition to Example 34, the elastomer tubular member includes a rigidifying layer in the first longitudinal portion.

[0043] In another example ("Example 36"), in addition to Example 34, the elastomer tubular member includes a shape memory layer in the first longitudinal portion.

[0044] In another example ("Example 37"), in addition to Example 34, the elastomer tubular member is processed to include an elliptical cross-section in the first longitudinal portion.

[0045] In another example ("Example 38"), in addition to Example 37, the elastomer tubular member is heat-set such that the first longitudinal portion includes an elliptical cross-section.

[0046] In another example ("Example 39"), in addition to Example 34, the elastomer tubular member includes an integrated brace member in the first longitudinal portion, the brace member having an elliptical cross-section.

[0047] In another example ("Example 40"), in addition to Examples 34-39, the elastomer tubular member in the first longitudinal portion includes a first elongated portion and a second elongated portion, defining an elliptical cross-section, and the first elongated portion is operable to self-seal after puncture.

[0048] In another example ("Example 41"), in addition to the examples 34-39, the second elongated portion is reinforced to withstand punctures.

[0049] In another example ("Example 42"), the AV access graft includes an elongated tubular member including a first longitudinal portion, the first longitudinal portion having an integrated support member on part of the periphery of the elastomer elongated tubular member of the first longitudinal portion.

[0050] In another example ("Example 43"), in addition to Example 42, the integrated support member has a higher durometer hardness in the first longitudinal portion than the rest of the elongated tubular member.

[0051] In another example ("Example 44"), in addition to any of Examples 42-43, the elongated tubular member is a fluoropolymer.

[0052] According to another example ("Example 45"), in addition to any of Examples 42-44, the elongated tubular member includes a circular profile.

[0053] According to another example ("Example 46"), in addition to any of Examples 42-45, the elongated tubular member includes an elliptical profile.

[0054] In another example ("Example 47"), in addition to Example 46, the integrated support member provides the elongated tubular member with at least a partial elliptical profile.

[0055] In another example ("Example 48"), in addition to any of Examples 42-47, the long tubular member is self-sealing.

[0056] In another example ("Example 49"), in addition to any of Examples 42-48, the support member is bonded or joined to the long tubular member.

[0057] In another example ("Example 50"), in addition to any of Examples 42-49, the elongated tubular member is formed from a single layer of material.

[0058] In another example ("Example 51"), in addition to Example 50, the support member is a densified region of the long tubular member.

[0059] In another example ("Example 52"), in addition to any of Examples 42-50, the support member is positioned at the first longitudinal position, covering approximately 25% of the circumference of the elongated tubular member.

[0060] According to another example ("Example 53"), in addition to any of Examples 42 to 51, the elongated tubular member lacks the support members at each end of the elastomer elongated tubular member.

[0061] In another example ("Example 54"), in addition to any of Examples 42-53, the integrated support member is a rigidifying layer.

[0062] In another example ("Example 55"), in addition to any of Examples 42-54, the integrated support member is a tubular member and supports most of the length of the long tubular member.

[0063] Another example ("Example 56") provides a device for supporting a tubular member, the device comprising a segmented support member having a plurality of longitudinal segments, the segmented support member having an inner surface defining a receiving cavity, the receiving cavity being operable to engage with a tubular member therein, and each of the plurality of longitudinal segments at least partially encloses a portion of the tubular member.

[0064] In another example ("Example 57"), in addition to Example 56, each of the longitudinal segments of the plurality of longitudinal segments is a separate element and is spaced apart from one another.

[0065] In another example ("Example 58"), in addition to Example 57, the segmented support member is substantially rigid, and the tubular member can be bent because the longitudinal segments are spaced apart.

[0066] In another example ("Example 59"), in addition to Example 58, the distance between each longitudinal segment within the plurality of longitudinal segments determines the degree of bending of the tubular member.

[0067] In another example ("Example 60"), in addition to Example 58, each longitudinal segment within the plurality of longitudinal segments comes into contact with an adjacent longitudinal segment along the inner curve when the tubular member is bent.

[0068] In another example ("Example 61"), in addition to any of Examples 56-60, the tubular member is bonded or joined within the receiving cavity.

[0069] In another example ("Example 62"), in addition to any of Examples 56-61, the tubular member bends along its length when it engages with the segmented support member.

[0070] According to another example ("Example 63"), in addition to any of Examples 56-62, segmented support segments are resistant to puncture.

[0071] In another example ("Example 64"), in addition to any of Examples 56-63, each longitudinal segment within the plurality of longitudinal segments is connected to one another by extensions.

[0072] In another example ("Example 65"), in addition to Example 64, the extension portion is integrated with the segmented support member.

[0073] In another example ("Example 66"), in addition to Example 64, the extension is joined or bonded to the segmented support member.

[0074] In another example ("Example 67"), in addition to any of Examples 64-66, the extension, when in a neutral orientation, causes each longitudinal segment within the plurality of longitudinal segments to be at a certain distance from adjacent longitudinal segments.

[0075] In another example ("Example 68"), in addition to any of Examples 64-67, the extension portion is operable to bend or deflect in order to facilitate the curvature of the tubular member.

[0076] In another example ("Example 69"), in addition to any of Examples 64-68, the extension is made from a shape memory material containing nitinol.

[0077] According to another example ("Example 70"), in addition to any of Examples 64-69, the extension portion has a thin profile to facilitate the bending of the tubular member.

[0078] In another example ("Example 71"), in addition to any one of Examples 64-70, the segmented support member is operable to compress the tubular member in the longitudinal direction.

[0079] The examples described herein are merely embodiments and should not be construed as limiting or narrowing any scope of the inventive concepts provided herein. Although several examples are disclosed, further embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates exemplary examples. Accordingly, the drawings and detailed description should be considered illustrative and not restrictive in nature. [Brief explanation of the drawing]

[0080] Brief explanation of the drawing The accompanying drawings are included to provide a further understanding of this disclosure, are incorporated herein and constitute part thereof, illustrate embodiments, and help to explain the principles of this disclosure together with the description.

[0081] [Figure 1] Figure 1 is a diagram of a device according to an embodiment, which includes a tubular member supported by a support member.

[0082] [Figure 2] Figure 2 is an end view of a support member having an elliptical profile according to an embodiment.

[0083] [Figure 3] Figure 3 is a perspective view of a support member having an elliptical profile according to an embodiment.

[0084] [Figure 4] Figure 4 is an end view of a support member having a circular profile according to an embodiment.

[0085] [Figure 5] Figure 5 is an end view of a support member according to an embodiment, which has a body that is thicker than the arms of the support member.

[0086] [Figure 6] Figure 6 is an end view of a needle access to the lumen of a tubular member supported by a support member, according to an embodiment.

[0087] [Figure 7] Figure 7 is a top view of the needle access to the lumen of a tubular member supported by a segmented support member, according to an embodiment.

[0088] [Figure 8] Figure 8 is a perspective view of a tubular member supported by a segmented support member according to an embodiment.

[0089] [Figure 9]Figure 9 is a top view of a support member according to an embodiment, in which a tubular member is supported by a segmented support member and includes a bend.

[0090] [Figure 10A] Figure 10A is a side view of a support member, according to an embodiment, which includes segments connected to each other by extensions.

[0091] [Figure 10B] Figure 10B is a perspective view of a support member, including segments connected to each other by extensions, according to an embodiment.

[0092] [Figure 10C] Figure 10C is a bottom view of a support member including segments with a chevron shape according to an embodiment.

[0093] [Figure 11] Figure 11 is a perspective view of a tubular member including an integrated support member according to an embodiment.

[0094] [Figure 12] Figure 12 is a cross-sectional view of a tubular member having an integrated support member according to an embodiment.

[0095] [Figure 13] Figure 13 is a cross-sectional view of a tubular member in which an integrated support member is arranged on the outer surface of the tubular member, according to an embodiment.

[0096] [Figure 14] Figure 14 is a cross-sectional view of a tubular member according to an embodiment, in which an integrated support member is arranged on the inner surface of the tubular member.

[0097] [Figure 15] Figure 15 is a perspective view of a tubular member having an integrated support member positioned at a first longitudinal location according to an embodiment, wherein the tubular member lacks a support member along at least a portion of the tubular member.

[0098] [Figure 16] Figure 16 is a cross-sectional view of a tubular member having an integrated support member positioned within less than 50% of the tubular member's circumference, according to an embodiment.

[0099] [Figure 17] Figures 17A and 17B are cross-sectional views of overlapping devices according to an embodiment.

[0100] [Figure 18] Figure 18 shows an exemplary method for manufacturing a device according to an embodiment.

[0101] [Figure 19] Figure 19 shows a diagram of a positioning device according to an embodiment, which helps to locate the implantable device when it has been implanted in a patient. [Modes for carrying out the invention]

[0102] Detailed explanation Definitions and Terms This disclosure should not be constrained. For example, terms used in this application should be interpreted broadly in the context of the meaning that a person skilled in the art would give to such terms.

[0103] With regard to the terminology of inaccuracy, the terms “about” and “approximately” may be used interchangeably to refer to measurements including the stated measurement and measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates by a reasonably small amount from the stated measurement, as can be understood and readily verified by a person skilled in the art. Such deviations may result from, for example, measurement errors, differences in the calibration of measurement and / or manufacturing equipment, human error in reading and / or setting of measurement values, small adjustments made to optimize performance and / or structural parameters to account for differences in measurement values ​​related to other components, specific implementation scenarios, inaccurate adjustment and / or handling of the object by a person or machine, and / or similar. Where a person skilled in the art determines that the value of such a reasonably small difference cannot be readily determined, the terms “about” and “approximately” may be understood to mean plus or minus 10% of the stated value.

[0104] Description of various embodiments Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of this disclosure; in this respect, the drawings should not be construed as limiting.

[0105] The device shown in Figure 1 is provided as an example of various features of one embodiment of the device, and while combinations of these illustrated features are clearly within the scope of the invention, the example and the figure do not suggest that the inventive concept provided herein is limited to one or more features shown in Figure 1, from fewer features, additional features, or alternative features.

[0106] Referring to Figure 1, device 10 is provided for repetitive and repeatable intraluminal access. For example, intravenous access may be required for procedures such as dialysis that require repeated access to the access site. Device 10 supports the access site to limit leakage after one or more punctures and facilitates access by providing an increased surface area that can be implemented in some embodiments to provide intraluminal access.

[0107] In some embodiments, the device 10 includes a support member 12 and a tubular member 14. The support member 12 is operable to support the tubular member 14 in a specific configuration and / or compressed state to increase the surface area of ​​the target site and / or limit leakage of the tubular member 14 during and after puncture. The support member 12 may be separate from the tubular member 14 so as to be mounted on the tubular member 14 (e.g., removable, mounted after manufacture), or it may be provided integrated with the tubular member 14 (formed together, inseparably fixed, etc.). Each embodiment (i.e., where the support member 12 and the tubular member 14 are separate and integrated) is described in more detail herein.

[0108] Continuing to refer to Figure 1, the illustrated embodiment shows a support member 12 that partially surrounds a tubular member 14 and provides structural support to the tubular member 14. The tubular member 14 can take various forms, such as a graft, synthetic blood vessel, or natural blood vessel. The support member 12 can be used to support the tubular member 14 for various purposes, including, but not limited to, arterial and venous access ("AV access"), such as repeated access for dialysis. Although device 10 is described in detail in relation to AV access, device 10 will also be considered and discussed in relation to other purposes.

[0109] In some embodiments, including the embodiment shown in Figure 1, the support member 12 is an elongated C-shaped clip (see also Figure 3, which shows the elongated nature of the support member 12). The support member 12 has an inner surface 22 and an outer surface 26 that define a receiving cavity 24. The inner surface 22 includes a concave profile, and the outer surface includes a convex profile. As shown, the inner surface 22 and outer surface 22 are curved to have a concave and convex profile, but it is also within the scope of this disclosure that the inner surface and outer surface are not curved, or are not curved overall to generally provide a concave and convex profile (for example, formed from straight segments instead). The receiving cavity 24 is operable to receive a tubular member 14, thereby positioning and holding the tubular member 14 within the receiving cavity 24 and positioning it relative to the inner surface 22 of the support member 12.

[0110] Referring to Figure 3, the support member 12 includes a periphery opening 28 that provides access to the receiving cavity 24 of the support member 12. In some embodiments, the periphery opening 28 extends along the entire longitudinal length of the support member 12, allowing the tubular member 14 to be advanced into the receiving cavity 24 by passing it through the periphery opening 28. This ensures that the tubular member 14 remains intact while installed with the support member 12. This can be important if the tubular member 14 is a natural blood vessel or an implanted graft, thus eliminating the need to pass the end of the tubular member 14 through the support member 12. Passing the end of the tubular member 14 through the support member 12 would require dividing the tubular member 14 in half.

[0111] The width 30 of the peripheral opening 28 of the support member 12 is smaller than the inner dimensions 32 of the receiving cavity 24 (for example, the widest part of the inner diameter of a non-circular profile, here representing the distance between opposing inner surfaces; see Figure 2). This allows the support member 12 to surround the tubular member 14 for more than 180 degrees but less than 360 degrees when the tubular member 14 is placed in the receiving cavity 24. For example, when the tubular member 14 is mounted inside the support member 12, the support member 12 can surround the tubular member 14 from about 190 degrees to about 215 degrees, from about 215 degrees to about 240 degrees, from about 240 degrees to about 265 degrees, from about 265 degrees to about 290 degrees, and from about 290 degrees to about 325 degrees. The width 30 of the peripheral opening 28 may be larger in some embodiments and smaller in other embodiments. The gripping force (and compressive force described later) of the support member 12 may be greater when the width 30 of the surrounding opening 28 is relatively small than in embodiments where the width 30 of the surrounding opening 28 is large. For example, the gripping force can be increased by increasing the width of the surrounding opening 28, or decreased by increasing the width of the surrounding opening 28.

[0112] In some embodiments, the support member 12 is sized such that its inner circumference (including the width 30 of the periphery opening 28) is smaller than the outer circumference of the tubular member 14. By sizing the inner circumference of the support member 12 smaller than the outer circumference of the tubular member 14, the tubular member 14 is placed in a compressed state (e.g., compression around the tubular member 14) when it is engaged with the support member 12. Compression reduces leakage of the tubular member 14 during and after puncture (e.g., needle puncture for dialysis) and facilitates resealing. Compression also helps prevent or reduce fluid leakage from the puncture by returning the surfaces of the opening formed by the puncture to contact each other. The amount of compression can be changed by adjusting the relative periphery of the support member 12 and the tubular member 14. Greater compression can be achieved by narrowing the width 30 of the peripheral opening 28, thereby bringing the tubular member 14 into stronger contact with the inner surface 22 of the support member 12 (for example, compression can be increased by narrowing the width of the peripheral opening 28). A narrower width 30 of the peripheral opening 28 limits the tubular member 14 from protruding from the support member 12 at the peripheral opening 28, thereby reducing the compression of the tubular member 14, including the portion that protrudes outward from the peripheral opening 28. Therefore, a narrower width 30 allows for the use of a tubular member 14 with a larger outer diameter to increase the compression of the tubular member 14.

[0113] In some embodiments, the periphery opening 28 of the elongated support member 12 is about 10% to about 90% of the circumference of the support member 12. In some embodiments, the periphery opening 28 of the elongated support member 12 is about 25% to about 75% of the circumference of the support member 12. In embodiments where the periphery opening 28 is greater than 50% of the circumference of the support member 12, the compression of the elongated support member 12 can be localized. For example, the elongated support member 12 may contain compressed holes (e.g., microscopic holes), but the elongated tubular member 14 is not compressed around its entire circumference. In embodiments where the periphery opening 28 is less than 50% of the circumference of the support member 12, the compression of the elongated support member 12 can be overall compression. For example, the elongated support member 12 may be compressed around its entire circumference. In some embodiments, the width 30 of the periphery opening 28 defines the cannula insertion area of ​​the device 12 (e.g., in embodiments used for cannula insertion such as hemodialysis). This also defines the cannula insertion angle 31 of the device 10, which is the angle at which cannula insertion access to the tubular member 14 is achieved (see Figure 1).

[0114] In some embodiments, the support member 12 includes a material that is substantially resistant to needle puncture under typical force manually applied by the user. This restricts the movement of the needle through the device 10. For example, the tubular member 14 can be punctured for lumen access through the peripheral opening 28 of the support member 12, but the body of the support member 12 is not penetrated by the needle, thus restricting movement through the opposite side of the tubular member. This limits the possibility of the user fully extending the needle through the tubular member 14, resulting in excessive bleeding, delivery of fluid to the lumen of the tubular member 14, and inefficient absorption of fluid from the lumen of the tubular member 14. One embodiment showing a needle 1000 whose movement through the support member 12 is restricted is shown in Figure 6. The support member 12 includes a material that is resistant to needle puncture (e.g., nitinol). Note that the needle 1000 can puncture the rear portion of the tubular member 14, but is restricted from moving beyond it by the support member 12. Therefore, the lumen or hole of the needle 1000 is in fluid communication with the lumen of the tubular member 14, and the fluid is delivered to and / or received by the lumen of the tubular member 14. To construct the support member 12 to be resistant to needle puncture, various materials can be implemented, but are not limited to, biocompatible metals, alloys, polymers, etc.

[0115] In some embodiments, the typical circular cross-section of the tubular member 14 can be compressed and constrained to an elliptical or oblong shape to improve cannula insertion access. Increasing the major axis of the ellipse increases the area that the user (e.g., clinician, blood collector, or patient) can target and penetrate. Increasing the major axis decreases the minor axis. The smaller minor axis reduces the distance that the needle 1000 can insert and remain in the lumen of the tubular member 14. Adding a relatively puncture-resistant area (e.g., support member 12) on the opposite side of the cannula insertion zone limits the possibility of the user passing through the back of the tubular member 14. Combining ellipsification (to increase the cannula insertion zone) with the addition of a puncture-resistant back wall zone improves the graft structure.

[0116] In some embodiments, the support member 12 comprises at least partially radiopaque material so that the support member 12 can be visible during delivery, deployment, and use. For example, the support member 12 can be visible during radiography so that a user attempting to access an artery or vein can visualize the location of the support member 12 and thus successfully obtain access with fewer punctures. Various radiopaque markers may be placed around the support member 12 and / or tubular member 14 to assist in the delivery and implantation of the device 10.

[0117] Referring to Figure 19, in some embodiments, a positioning device 54 may be implemented in conjunction with device 10 to assist in the positioning, alignment, and / or stable retention of device 10. In one embodiment, device 10 includes a portion 58 (e.g., adjacent to the peripheral opening 28 of the support member 12) that has magnetic properties (e.g., is magnetized) or is attracted to a magnet (e.g., is ferromagnetic). The positioning device 54 may include a donut-shaped magnetic or ferromagnetic material on the outside of the patient adjacent to the device (e.g., the arm in the case of dialysis) to magnetically attract (e.g., magnetically couple) the positioning device 54 and device 10. Once the user (e.g., a professional or a patient receiving home dialysis treatment) positions a "target" for inserting the cannula insertion needle 1000 into the donut hole of the positioning device 54, device 10 is positioned, aligned, and / or stably held. In some embodiments, the donut hole of the positioning device 54 may have indicators 56 (e.g., number / letter marks) around the donut hole of the positioning device 54 (e.g., similar to an analog clock). The indicators 56 may be provided daily, and the user may find a different indicator each day (e.g., a mark for Tuesday) and insert the hand 1000 next to that indicator 56, without reinserting it in the same place every day.

[0118] In some embodiments, the support member 12 may be formed from a bioabsorbable or bioreabsorbable material. This allows the support member to be implemented in the user's body for a limited time without requiring a second surgery to remove it. For example, periodic IV access may be required for a limited period. The support member 12 is implemented for that limited time and can be slowly reabsorbed by the patient. The reabsorption period is adjusted to ensure that the support member 12 remains structurally sound throughout its expected lifespan.

[0119] Referring to Figures 2 and 3, the inner surface 22 of the support member 12 has a substantially elliptical cross-section. In other embodiments, such as shown in Figure 4, the inner surface 22 of the support member 12 has a circular cross-section. It is understood that various other cross-sections can be implemented for various purposes. The inner surface 22 of the support member 12 having the above-described cross-sections is operable to maintain the same cross-sectional area of ​​the tubular member 14 inside and outside the receiving cavity 24. In other words, the inner surface 22 of the support member 12 determines the configuration in which the tubular member 14 is held when engaged with the support member 12. Various configurations can provide various functions.

[0120] For example, referring to Figure 1, the support member 12 has an inner surface 22 having an elliptical cross-section, which gives the tubular member 14 an elliptical shape in which the tubular member 14 engages with the support member 12. The elliptical shape of the tubular member 14 exhibits a relatively flat surface (compared to a circular cross-section) along the length of the support member at the periphery opening 28 of the support member 12, as the periphery opening 28 is defined along the elongated portion of the ellipse. The relatively flat surface of the tubular member 14 provides an access area for the tubular member 14 and makes it easier to implement (for example, with respect to IV access, including dialysis). The relatively flat profile of the tubular member 14 reduces the possibility of the access needle going off the side of the tubular member 14 (i.e., the needle is less likely to penetrate the curved surface of the tubular member 14 unless it is radially aligned with the circular profile). The flat sidewalls of the tubular member 14 ensure and easy access. In other embodiments, a circular profile may be desirable to support the tubular member 14 in a circular profile configuration. For example, natural blood vessels may need to be supported by a circular profile (see Figure 4). In some embodiments, maintaining the circular profile of the tubular member 14 can provide appropriate hydrodynamics and degradation resistance. For example, in some applications such as dialysis, the tubular member 14 is positioned at a high pressure, high velocity relative to the blood flow, and the hemodynamics can be such that the circular profile of the tubular member 14 reduces or completely eliminates hemodynamic disturbances in the blood vessels. The circular profile of the tubular member 14 can also extend the lifespan of the tubular member 14 in use.

[0121] The support member 12 will be described in more detail with reference to Figures 2 to 5. The support member 12 includes a body portion 40 and arm portions 42. The arm portions 42 extend from the body portion 40. The arm portions 42 extend from each side portion of the body portion 40 such that each arm portion 42 faces the other. The arm portions 42 define a perimeter opening 28 so that access to the receiving cavity 24 is provided between the opposing arm portions 42. The arm portions 42 are curved, thereby defining the receiving cavity 24 with respect to the arm portions 42 and the body portion 40. In some embodiments, the body portion 40 may also be curved (see Figures 2 and 3), and in some embodiments, the body portion 40 is substantially flat (see Figure 6). In some embodiments, the arm portions 42 include a material having a durometer hardness lower than the durometer hardness of the body portion 40. This allows the arm portion 42 to have a flexible function to facilitate insertion of the tubular member 14 into the receiving cavity 24. Once the tubular member 14 is positioned in the receiving cavity 24, the arm portion 42 returns to an unflexed configuration, even if it flexed during the insertion of the tubular member 14. The arm portion 42 can apply compressive force to the tubular member 14 (for example, for the compression described above). In some embodiments, at least the arm portion 42 is formed from a shape memory material such as nitinol. By including a shape memory material, the arm portion 42 can apply a greater compressive force. In some embodiments, the entire support member 12 is formed from a shape memory material and applies compressive force to the tubular member 14 over most of its circumference.

[0122] Referring to Figure 5, in some embodiments, the main body portion 40 is thicker than the arm portion 42. This allows for greater bending of the arm portion 42, while simultaneously enabling the main body portion 40 to more reliably maintain the shape of the support member 12. Furthermore, the relatively thicker main body portion 40 allows it to have enhanced durability as a needle backstop. In some embodiments, the bending of the arm portion 42 can facilitate bending at multiple bending surfaces.

[0123] It is understood that the support member 12 can further support the tubular member 14, thereby reducing twisting of the tubular member 14 during implant treatment. Twisting of the tubular member 14 during implant treatment can lead to undesirable hemodynamics and may also cause the tubular member 14 to kink. By supporting the tubular member 14 with the support member 12, the tubular member 14 is held in a manner that reduces the risk of twisting of the tubular member 14.

[0124] Referring to Figures 7 to 10, in some embodiments, the support member 12 is segmented to include a plurality of longitudinal segments 50. Each of the longitudinal segments 50 is operable to at least partially surround a portion of the tubular member 14. When positioned with the support member 12, the longitudinal segments 50 are operable to facilitate the bending of the elongated tubular member 14. When mounted on the tubular member 14, each of the longitudinal segments 50 is spaced apart from one another. The inclusion of a plurality of longitudinal segments 50, and the spacing of the longitudinal segments 50 from one another, allows the tubular member 14 to bend at least partially along the length to which it engages with the support member 12. This allows the support member 12 to be implanted in a location where there is a bend or curve in the patient's anatomical structure. Figure 8 shows a tubular member 14 to which the support member 12 is attached, the support member 12 is segmented, and the tubular member 14 is positioned in a bent configuration. Because the various longitudinal segments 50 are spaced apart from one another, the support member 12 can be manipulated to bend the tubular member 14 even if the support member 12 is substantially rigid. In some embodiments, as described above, the support member 12 may include a shape memory material (e.g., nitinol) that gives the support member 12 flexibility and also makes the support member 12 resistant to puncture (e.g., rigid in at least one plane to be resistant to puncture by a needle 1000). The bending of the support member 12 may be performed in a single bending plane or in multiple bending planes. As seen in Figure 8, the concave surface of the curved portion of the bent tubular member 14 positions the arm portion 42 on the concave surface closer to adjacent segments than a convex arm portion 42 would be positioned on adjacent segments. The spacing of the various longitudinal segments 50 may be slightly smaller than the outer diameter of a 12, 13, 14, 15, 16, 17, 18, 19, or 20 gauge needle. This limits the ability of the needle to pass through the space between the longitudinal segments.

[0125] Referring to Figures 8 and 9, the longitudinal segments 50 can be separated from each other (for example, the longitudinal segments 50 are separate elements). In this embodiment, each of the longitudinal segments can be individually attached to the tubular member 14. The longitudinal segments 50 can be spaced apart from each other at any distance determined by the user. The distance between each longitudinal segment 50 can be sufficient to give the tubular member 14 a specific curvature when the support member 12 is attached to the tubular member 14. When the tubular member 14 contains a larger curvature or is implanted with a larger curvature, the longitudinal segments 50 can be spaced apart from each other at a greater distance than when a smaller curvature is desired, and a smaller curvature allows the longitudinal segments 50 to be placed closer together. In some embodiments, when the tubular member 14 contains a curvature or is given a curvature, some of the adjacent longitudinal segments 50 are in contact with each other inside the curve, while the longitudinal segments 50 are spaced apart from each other outside the curve.

[0126] In other embodiments, such as those shown in Figures 10A and 10B, the longitudinal segments 50 may be connected to one another by extensions 52 (for example, a plurality of longitudinal segments 50 may be a single unit forming a support member 12, which includes extensions extending between adjacent longitudinal segments). The extensions 52 may be formed integrally with each longitudinal segment 50, or the extensions 52 may be connected to the longitudinal segments 50 (e.g., by welding, bonding, or being operable to receive). The extensions 52 position the longitudinal segments 50 at a certain distance from each other when in a neutral orientation. The extensions 52 are operable to bend or flex to facilitate the curvature of the tubular member 14. In some embodiments, the bending or flexing of the extensions 52 is along a single bending surface (e.g., bending along the extensions 52). The extensions 52 may be formed from a variety of materials, including materials that are capable of both plastic and elastic deformation. For example, the extension portion 52 may be formed from nitinol to facilitate bending of the support member 12. By using nitinol or other sufficiently elastic and / or rigid material, the extension portion 52 may also be made resistant to puncture (e.g., puncture by a needle 1000). In some embodiments, the thickness of the material of the extension portion 52 is thinner than the thickness of the longitudinal segment 50, and therefore the support member 12 can bend or flex at the extension portion 52 (e.g., the extension portion 52 includes a thin profile that is operable to facilitate bending). As shown in Figures 10A and 10B, the extension portion 52 may extend from the body portion 40 of an adjacent longitudinal segment, and therefore the arm portion 42 remains free from the extension portion 52. In some embodiments, the support member 12 is operable to compress the tubular member 14 in the longitudinal direction. In some embodiments, the support member 12 may be manufactured by densifying an expandable material such as ePE or ePTFE, 3D printing (e.g., PE), or by machining, casting, or molding.

[0127] Various configurations of the longitudinal segment 50 can be provided, including those shown in Figure 10C. These configurations can be implemented to accommodate various functions, including bending profiles (e.g., curve radius or curvature in a single plane). For example, Figure 10B shows a longitudinal segment 50 with a nesting pattern in which the longitudinal segment 50 has a chevron shape. Extensions may or may not be implemented to connect each of the longitudinal segments 50 having this configuration. In some embodiments, the support member 12 can include different gap widths between the longitudinal segments 50. This may be along the length of the body of the support member 12, or it may be on certain sides in particular (e.g., to facilitate bending in one direction).

[0128] A method for assembling the support member 12 onto the tubular member 14 includes narrowing the outer diameter of the tubular member 14 and extending the tubular member 14 so that it is received within a receiving cavity 24 (e.g., a C-shaped clip) of the support member 12, where the receiving cavity 24 of the support member 12 has a diameter smaller than the outer diameter of the tubular member 14 when it is not compressed. In some embodiments, the outer dimensions of the tubular member 14 when compressed are in the range of 0.1% to about 10% of the outer dimensions of the elongated tubular member when it is not compressed. In some embodiments, this method includes deflecting the arm portion 42 away from the body portion 40 and enlarging the periphery opening 28 so that the tubular member 14 is received in the receiving cavity 24.

[0129] In some embodiments, the tubular member 14 can be a natural blood vessel (e.g., a patient's artery or vein), and the support member is positioned around the natural blood vessel to support it. In some embodiments, the tubular member 14 is formed from a biological material (e.g., an autograft, a cadaver graft, etc.). In some embodiments, the tubular member 14 is formed from a synthetic material. Any of the materials used can be capable of acting to seal after needle puncture. The resilience and resealability of the tubular member 14 can be improved by the support member 12, which holds the tubular member 14 in a compressed state to recover from needle puncture (e.g., a 12-gauge needle).

[0130] Referring to Figure 11, in some embodiments, an AV access graft 100 is provided, which includes an elongated tubular member 102 of elastomer having a first longitudinal portion 104 having an elliptical cross-section, and is resistant to deformation along the first longitudinal portion 104, thereby maintaining the elliptical cross-section of the first longitudinal portion 104 when subjected to biological forces when implanted in the body. In some embodiments, the tubular member 102 is processed to include the elliptical cross-section in the first longitudinal portion 104. In some embodiments, the elongated tubular member 102 is heat-set to include the elliptical cross-section in the first longitudinal portion 104.

[0131] Referring to Figure 12, in some embodiments, the tubular member 102 includes an integrated support member 106 in the first longitudinal portion 104. In some embodiments, the tubular member 102 is processed to include an elliptical cross-section. In some embodiments, the elongated tubular member 102 is heat-set to include an elliptical cross-section in the first longitudinal portion 104. In some embodiments, the integrated support member 106 is a stiffening layer. The stiffening layer can be operable to provide support for maintaining a predetermined shape, and can also be operable to provide a stopper to resist needle puncture when a needle is placed in the lumen of the elongated tubular member 102, and / or to provide tactile feedback. The stiffening layer contains a durometer hardness (e.g., the maximum value of Shore D or Mohs hardness about 10) sufficient to prevent needle puncture from the back side of the tubular member 102. In some embodiments, the integrated support member 106 is a layer attached to the tubular member 102 by heat bonding, chemical bonding, bonding, or other means. This layer may be on the outer surface (see Figure 13), the inner surface (see Figure 14), or it may be positioned along a portion of the perimeter of the tubular member 102 (see Figure 12) to cover the entire thickness of the tubular member 102.

[0132] Figure 15 shows a tubular member 102 with an integrated support member 106 in a first longitudinal portion 104 (for example, the tubular member 102 may include a support portion for needle access and a non-support portion), where the integrated support member 106 is absent in at least the second and third longitudinal portions 108, 109 of the tubular member 102. In some embodiments, the first longitudinal portion 104 in which the integrated support member 106 supports the tubular member 102 may include most of the length of the tubular member. For example, the integrated support member 106 may include about 40 cm of a 45 cm tubular member. However, the integrated support member 106 can be provided along any portion or the entire length of the tubular member 102. In some embodiments, the tubular member 102 is without support members 106 at both ends. This allows the surgeon to cut the tubular member 102 to the desired length and angle without having to cut the support members 12. In a scenario where device 10 is implemented for cannula insertion, the support member 12 can be implemented in the cannula insertion zone, but its implementation in other areas can be considered optional.

[0133] The support member 106 can be provided with at least a partially elliptical cross-section. In some embodiments, the tubular member 102 includes a first elongated portion 110 and a second elongated portion 112 in a first longitudinal portion 104, defining an elliptical cross-section, with the first elongated portion operable to self-seal after puncture. In some embodiments, the second elongated portion 112 is reinforced to be resistant to puncture. It is understood that various other cross-sectional profiles can be implemented. For example, a circular cross-section can be implemented, which is at least partially provided and maintained by the integrated support member 106. As shown in Figure 15, the support member 106 is positioned around approximately 75% or 270 degrees of the tubular member 102. It is understood that in various embodiments, the support member 106 can be positioned around various portions of the tubular member 102. For example, the support member 102 can be positioned around the tubular member 102 over a range of 180 to 350 degrees (e.g., approximately 180 to 225 degrees, approximately 225 to 270 degrees, approximately 270 to 315 degrees, and approximately 315 to 350 degrees). By providing a larger support area on the tubular member 102, the likelihood of the needle passing behind the tubular member 102 during puncture is reduced. The elliptical configuration allows for easy access to unsupported areas, as described above.

[0134] The device 10 can transition from substantially circular to substantially elliptical at multiple longitudinal positions along its length. For example, a tubular member 102 can be circular at one end, then gradually transition to a first elliptical shape, then transition back to a circular shape, then gradually transition to a second elliptical shape, and then transition back to a circular shape at the other end. The two elliptical regions are cannula insertion regions (e.g., in the case of AV access). The user can feel these regions (through the skin) to know where the elliptical portions of the device 10 are located. In some embodiments, the internal cross-sectional area of ​​the device 10 (e.g., the cross-sectional area of ​​the lumen) remains constant as the device 10 transitions between different cross-sectional shapes. This limits flow interruption and thrombus formation in the transition regions.

[0135] Referring to Figure 16, another embodiment of the tubular member 102 is provided, in which the support member 106 is positioned around less than approximately 50% of the perimeter of the tubular member 102. Although the perimeter profile of the tubular member 102 is shown, it is understood that any number of configurations can be implemented in which the support member 106 is positioned around less than approximately 50% of the perimeter of the tubular member 102. It is also understood that the various configurations described above, in which the integrated support member 106 is positioned in a portion of the perimeter of the tubular member 102, including the inner surface, outer surface, or full thickness of the tubular member, can be implemented in which the support member 106 is positioned around less than approximately 50% of the perimeter of the tubular member 102. For example, the support member 102 can be positioned around the tubular member 102 over a range of 10 to 180 degrees (e.g., approximately 10 to approximately 45 degrees, approximately 45 to approximately 90 degrees, approximately 90 to approximately 135 degrees, and approximately 135 to approximately 180 degrees). By providing the support member over less than 50% of the circumference of the tubular member 102, the surface area for accessing the lumen of the tubular member 102 is increased, while a backstop is still provided to reduce needle puncture from the back side of the tubular member 102.

[0136] Referring to Figures 17A and 17B, a device 10 is shown comprising a tubular member (e.g., tubular member 14 or tubular member 102) according to any of the embodiments discussed herein and a support member (e.g., support member 12 or integrated support member 106) according to any of the embodiments discussed herein. The support member 12 and the tubular member 14 are bonded to each other via adhesive 200. An overlap 202 can be applied to the assembly. The overlap 202 can impart a compressive force to the tubular member (indicated by arrows in Figure 17B) (in some embodiments, the compressive force is increased in addition to the compressive force provided by the support member). Before applying the overlap 202, the device 12 may include a first diameter 204 along its long axis. After applying the overlap 202, the device 12 may include a second diameter 206 along its long axis. In this case, the second diameter 206 is smaller than the first diameter 204. This is due to the compressive force applied by the overlap 202.

[0137] As stated above, the embodiments discussed herein can be implemented in a variety of situations and are not limited to the specific embodiments described herein. For example, the use of device 10 for cannula insertion (e.g., hemodialysis) has been described at length. However, since other applications, such as use at anastomotic surfaces, are also applicable, the description herein is not limited to cannula insertion. For example, increasing the stiffness of the device at the anastomotic site increases the durometer stiffness, which reduces bleeding at the suture. Another example is the attachment of the support member 12 to a natural blood vessel. For example, the support member 12 can be attached to a location where a blood vessel is compressed by other anatomical structures in the body that are competing for the same space. This occurs, for example, in Mayserner syndrome, where the left iliac vein is compressed by the right iliac artery. Compression of the left iliac vein can cause deep vein thrombosis. The support member 12 can be implanted outside the blood vessel (e.g., the left iliac vein) to restore blood flow and / or function to the vessel.

[0138] Referring to Figure 18, a method for manufacturing the device 10 is provided. This method includes manufacturing a lumen graft component (e.g., a long tubular member 14), manufacturing a support component (e.g., a support member 12), assembling the graft component and support component with an adhesive (e.g., any suitable elastomer adhesive), curing the adhesive, overlapping the subassembly with a film (e.g., a film suitable for extraluminal use), and trimming, sterilizing, and packaging the device.

[0139] In any embodiment described herein, the tubular member 102 may include a variety of materials and compositions, including biocompatible materials capable of acting to self-seal after puncture. Such materials may be implemented, for example, when intravenous access is required immediately after the tubular member 102 has been implanted. Other biocompatible materials capable of acting to promote internal tissue growth may be implemented so that the tissue provides sealing ability after sufficient tissue has been incorporated into the material. Materials can be selected for various properties such as durability, durometer hardness, and thickness, and the tubular member can be optimized for its application (e.g., high-speed flow, implant lifespan, low implant profile, etc.). In some embodiments, the tubular member 102 is formed from a single layer of material.

[0140] Biocompatible materials for tubular member components as described herein may be used. In certain cases, the graft may include fluoropolymers such as polytetrafluoroethylene (PTFE) polymer or stretched polytetrafluoroethylene (ePTFE) polymer. In some examples, the graft may be formed from, but are not limited to, polyester, silicone, urethane, polyethylene terephthalate, fluorinated ethylene propylene, polyethylene (PE), expanded polyethylene (ePE), or other biocompatible polymers, or combinations thereof. In some examples, bioreabsorbable or bioabsorbable materials such as bioreabsorbable or bioabsorbable polymers may be used. In some examples, the graft may include Dacron, polyolefin, carboxymethylcellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers. Biological grafts are also implemented, which include, but are not limited to, bovine carotid arteries or laboratory-cultured blood vessels.

[0141] In some embodiments, it is understood that the support member may include a surface texture for either promoting internal tissue growth or preventing tissue incorporation. This can be achieved in a variety of ways, including, but not limited to, providing a smooth surface, a textured surface, a porous surface, a treated surface, and the like.

[0142] In some embodiments, the tubular members and support members of any embodiment described herein may be provided in a straight or curved configuration. A curved configuration can provide a stress-free state at implantation when the device is positioned along at least one curve (for example, as an arteriovenous graft).

[0143] Furthermore, while nitinol (NiTi) can be used as the material for the frame or stent (and any of the frames described herein), other materials, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymer materials, Pyhnox, Elgiloy, or other suitable biocompatible materials and combinations thereof, can be used as the material for the frame. The superelastic properties and flexibility of NiTi can improve the adaptability of the stent. In addition, NiTi can be shaped to a desired form; that is, NiTi can be shaped so that the frame tends to self-expand to a desired shape when the frame is unconstrained, such as when the frame is deployed from a delivery system.

[0144] The invention of this application has been described above in general terms and in reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes can be made to the embodiments without departing from the scope of the disclosure. Accordingly, the embodiments are intended to cover modifications and changes to the invention, insofar as they fall within the scope of the appended claims and their equivalents. (Appearance) (Aspect 1) A device for supporting a long tubular member, the device comprising a support member having an inner surface defining a receiving cavity, the support member further defining a periphery opening, the receiving cavity being operable to receive a long tubular member therein, and the support member being operable to compress the long tubular member around its periphery. (Aspect 2) The device according to embodiment 1, wherein the receiving cavity is adhesively bonded to the long tubular member. (Aspect 3) The device according to embodiment 1, wherein the support member comprises a material that is resistant to needle punctures with typical force applied manually by a user. (Aspect 4) The device according to embodiment 3, wherein the support member includes a bioabsorbable material. (Aspect 5) The device according to any one of embodiments 1 to 4, wherein the peripheral opening of the support member is approximately 10% to approximately 90% of the circumference of the long tubular member. (Aspect 6) The device according to any one of embodiments 1 to 4, wherein the inner surface of the support member has an elliptical cross-section. (Aspect 7) The device according to any one of embodiments 1 to 4, wherein the inner surface of the support member has a circular cross-section. (Pattern 8) The device according to any one of embodiments 6 to 7, wherein the support member is operable to maintain the same cross-sectional area of ​​the elongated tubular member inside the receiving cavity and outside the receiving cavity. (Aspect 9) The device according to any one of embodiments 1 to 8, wherein the support member has two opposing arms defining a periphery opening, the two opposing arms are interconnected by a main body, and the support member comprises a material having a durometer hardness lower than the durometer hardness of the main body. (Aspect 10) The device according to embodiment 8, wherein the two opposing arms apply a compressive force to the elongated tubular member. (Aspect 11) The device according to any one of embodiments 9 to 10, wherein the two opposing arm portions are formed from a shape memory material. (Aspect 12) The device according to embodiment 11, wherein the shape memory material is nitinol. (Aspect 13) The device according to any one of embodiments 9 to 12, wherein the main body is thicker than the two opposing arms. (Aspect 14) The device according to any one of embodiments 1 to 10, wherein the support member includes a plurality of segments along the longitudinal length that are operable to facilitate the bending of the elongated tubular member when placed together with the support member. (Aspect 15) The device according to embodiment 14, wherein the plurality of segments are individual elements. (Aspect 16) The device according to embodiment 14, wherein the plurality of segments are an integral member forming the support member, the support member includes an extension portion extending between adjacent segments, the extension portion includes a thin profile that is operable to facilitate bending. (Aspect 17) The device according to any one of embodiments 14 to 16, wherein the plurality of segments facilitate the bending of the long tubular member. (Aspect 18) The support member is puncture-resistant, the device according to any one of embodiments 14 to 17. (Aspect 19) The device according to any one of embodiments 1 to 17, wherein the support member is operable to compress the tubular member. (Aspect 20) The device according to any one of embodiments 1 to 5, further comprising a positioning device operable to magnetically couple to the support member, wherein the positioning device forms a donut hole into which a needle can be inserted. (Aspect 21) The device according to embodiment 15, wherein the positioning device includes an indicator around the donut hole, and the indicator indicates different positions for needle insertion. (Aspect 22) A method for assembling a support member according to any one of embodiments 1 to 7 onto a long tubular member, comprising overlapping the support member and the long tubular member to apply a compressive force to the tubular member, wherein the diameter of the support member within the overlap is smaller than the diameter of the support member before the overlap is applied. (Aspect 23) The method for assembling a support member according to embodiment 17, wherein the overlap is performed after applying an adhesive coupling to the support member and the long tubular member and allowing the adhesive to harden. (Aspect 24) A method for assembling a support member according to any one of embodiments 1 to 7 onto a long tubular member, comprising extending the tubular member to narrow the outer diameter of the long tubular member so that it is received within a receiving cavity of the support member, wherein the receiving cavity of the support member has a diameter smaller than the outer diameter of the tubular member when the tubular member is not in a compressed state. (Aspect 25) A method for assembling the support member described in embodiment 23 onto an elastomer tubular member, comprising deflecting the arm away from the main body to enlarge a periphery opening that is operable to receive the tubular member into a receiving cavity. (Aspect 26) A long tubular member that defines the lumen, and A long support member that defines the receiving cavity and defines the surrounding opening, Includes, An AV access graft in which the receiving cavity is operable to receive the long tubular member therein, and the long support member is operable to compress the tubular member in its surroundings. (Aspect 27) The AV access graft according to embodiment 25, wherein the receiving cavity is operable to receive an adhesive for bonding the elongated tubular member within the receiving cavity. (Aspect 28) The AV access graft according to any one of embodiments 25 to 26, wherein the long tubular member is an artery or a vein. (Aspect 29) The AV access graft according to any one of embodiments 25 to 26, wherein the long tubular member is a biological material, a synthetic material, or a combination thereof. (Aspect 30) An AV access graft according to any one of embodiments 25 to 28, wherein the elongated tubular member, which is in a state of circumferential compression, is operable to recover and seal after being punctured with a 14-gauge, 15-gauge, 16-gauge, or 17-gauge needle. (Aspect 31) An AV access graft according to any one of embodiments 25 to 28, wherein the outer dimensions of the long tubular member when it is in a state of ambient compression are in the range of approximately 1% to approximately 10% of the outer dimensions of the long tubular member when it is not in a state of ambient compression. (Aspect 32) The AV access graft according to any one of embodiments 25 to 28, wherein the elongated tubular member includes an elliptical cross-section along at least a portion of the elongated tubular member, and the elongated tubular member is supported by the support member. (Aspect 33) The support member is a long C-shaped clip, as described in any one of embodiments 25 to 31 of the AV access graft. (Aspect 34) AV access graft comprising an elastomer elongated tubular member having a first longitudinal portion having an elliptical cross-section, resisting deformation along the first longitudinal portion, thereby maintaining the elliptical cross-section of the first longitudinal portion when subjected to biological forces when implanted in the body. (Aspect 35) The AV access graft according to embodiment 34, wherein the elastomer tubular member includes a rigidifying layer in the first longitudinal portion. (Aspect 36) The AV access graft according to embodiment 34, wherein the elastomer tubular member includes a shape memory layer in the first longitudinal portion. (Aspect 37) The AV access graft according to embodiment 34, wherein the elastomer tubular member is processed to include an elliptical cross-section in the first longitudinal portion. (Aspect 38) The AV access graft according to embodiment 37, wherein the elastomer tubular member is heat-set so as to include an elliptical cross-section in the first longitudinal portion. (Aspect 39) The AV access graft according to embodiment 34, wherein the elastomer tubular member includes an integrated brace member in the first longitudinal portion, and the brace member gives an elliptical cross-section. (Approach 40) The AV access graft according to any one of embodiments 34 to 39, wherein the elastomer tubular member in the first longitudinal portion includes a first longitudinal portion and a second longitudinal portion, defining an elliptical cross-section, and the first longitudinal portion is operable to self-seal after puncture. (Aspect 41) The AV access graft according to any one of embodiments 34 to 39, wherein the second elongated portion is reinforced to withstand punctures. (Aspect 42) An AV access graft comprising a long tubular member including a first longitudinal portion, wherein the first longitudinal portion has an integrated support member on a portion of the periphery of the elastomer long tubular member of the first longitudinal portion. (Aspect 43) The AV access graft according to embodiment 42, wherein the integrated support member has a durometer hardness higher than the rest of the elongated tubular member in the first longitudinal portion. (Aspect 44) The AV access graft according to any one of embodiments 42 to 43, wherein the long tubular member is a fluoropolymer. (Aspect 45) The AV access graft according to any one of embodiments 42 to 44, wherein the long tubular member includes a circular profile. (Aspect 46) The AV access graft according to any one of embodiments 42 to 45, wherein the long tubular member includes an elliptical profile. (Aspect 47) The AV access graft according to embodiment 45, wherein the integrated support member provides the long tubular member with at least a partial elliptical profile. (Aspect 48) The AV access graft according to any one of embodiments 42 to 47, wherein the long tubular member is self-sealing. (Aspect 49) The AV access graft according to any one of embodiments 42 to 48, wherein the support member is bonded or connected to the long tubular member. (Appearance 50) The AV access graft according to any one of embodiments 42 to 48, wherein the long tubular member is formed from a single layer of material. (Aspect 51) The AV access graft according to embodiment 50, wherein the support member is a densified region of the long tubular member. (Appearance 52) The AV access graft according to any one of embodiments 42 to 50, wherein the support member is positioned at a first longitudinal position and covers approximately 25% of the circumference of the elongated tubular member. (Aspect 53) The AV access graft according to any one of embodiments 42 to 51, wherein the long tubular member is an elastomer long tubular member and the support member is absent at each end of the elastomer long tubular member. (Aspect 54) The AV access graft according to any one of embodiments 42 to 53, wherein the integrated support member is a rigidifying layer. (Aspect 55) The AV access graft according to any one of embodiments 42 to 54, wherein the integrated support member is a tubular member and supports most of the length of the long tubular member. (Aspect 56) A device for supporting a tubular member, wherein the device is A device comprising a segmented support member having a plurality of longitudinal segments, wherein the segmented support member has an inner surface defining a receiving cavity, the receiving cavity being operable to engage with a tubular member therein, and each of the plurality of longitudinal segments at least partially encloses a portion of the tubular member. (Aspect 57) The device according to embodiment 56, wherein each of the plurality of longitudinal segments is an individual element and is spaced apart from one another. (Pattern 58) The device according to embodiment 57, wherein the segmented support member is substantially rigid, and the tubular member can be bent because the longitudinal segments are spaced apart. (Aspect 59) The device according to embodiment 58, wherein the distance between each longitudinal segment within the plurality of longitudinal segments determines the degree of bending of the tubular member. (Appendix 60) The device according to embodiment 58, wherein each longitudinal segment within the plurality of longitudinal segments comes into contact with an adjacent longitudinal segment along the inner curve when the tubular member is bent. (Aspect 61) The device according to any one of embodiments 56 to 60, wherein the tubular member is bonded or connected within the receiving cavity. (Aspect 62) The device according to any one of embodiments 56 to 61, wherein the tubular member bends along the length of the tubular member when it engages with the segmented support member. (Aspect 63) The device according to any one of embodiments 56 to 62, wherein the segmented support segments are puncture-resistant. (Personal aspect 64) The device according to any one of embodiments 56 to 63, wherein each of the longitudinal segments within the plurality of longitudinal segments is connected to one another by an extension portion. (Patent 65) The device according to embodiment 64, wherein the extended portion is integrated with the segmented support member. (Aspect 66) The device according to embodiment 64, wherein the extended portion is coupled to or bonded to the segmented support member. (Personal aspect 67) The device according to any one of embodiments 64 to 66, wherein the extension portion, when in a neutral orientation, positions each longitudinal segment within the plurality of longitudinal segments at a certain distance from adjacent longitudinal segments. (Pattern 68) The device according to any one of embodiments 64 to 67, wherein the extension portion is operable to bend or deflect in order to facilitate the curvature of the tubular member. (Patent 69) The device according to any one of embodiments 64 to 68, wherein the extension portion is made from a shape memory material containing nitinol. (Aspect 70) The device according to any one of embodiments 64 to 69, wherein the extended portion has a thin profile to facilitate bending of the tubular member. (Aspect 71) The device according to any one of embodiments 64 to 70, wherein the segmented support member is operable to compress the tubular member in the longitudinal direction.

Claims

1. A device for supporting a long tubular member, the device comprising a support member including a main body and two opposing arm portions extending from the main body, the support member having an inner surface defining a receiving cavity, the two opposing arm portions of the support member further defining a perimeter opening between them, the receiving cavity being operable to receive a long tubular member therein, and the two opposing arm portions being operable to surround a portion of the long tubular member and apply compressive force to compress the long tubular member around its perimeter.

2. The device according to claim 1, wherein the receiving cavity is adhesively bonded to the long tubular member.

3. The device according to claim 1, wherein the support member comprises a material that is resistant to needle punctures with typical force applied manually by a user.

4. The device according to claim 3, wherein the support member includes a bioabsorbable material.

5. The device according to any one of claims 1 to 4, wherein the peripheral opening of the support member is 10% to 90% of the circumference of the long tubular member.

6. The device according to any one of claims 1 to 4, wherein the inner surface of the support member has an elliptical cross-section.

7. The device according to any one of claims 1 to 4, wherein the inner surface of the support member has a circular cross-section.

8. The device according to claim 6, wherein the support member is operable to maintain the same cross-sectional area of ​​the elongated tubular member inside the receiving cavity and outside the receiving cavity.

9. The device according to any one of claims 1 to 4, wherein the two opposing arm portions include a material having a durometer hardness lower than the durometer hardness of the main body portion.

10. The device according to claim 9, wherein the two opposing arms apply a compressive force to the long tubular member.

11. The device according to claim 9, wherein the two opposing arms are formed from a shape memory material.

12. The device according to claim 11, wherein the shape memory material is nitinol.

13. The device according to claim 9, wherein the main body portion is thicker than the two opposing arm portions.

14. The device according to any one of claims 1 to 4, wherein the support member includes a plurality of segments along the longitudinal length that are operable to facilitate the bending of the elongated tubular member when placed together with the support member.

15. The device according to claim 14, wherein the plurality of segments are individual elements.

16. The device according to claim 14, wherein the plurality of segments are an integral member forming the support member, the support member includes an extension portion extending between adjacent segments, and the extension portion includes a thin profile that is operable to facilitate bending.

17. The device according to claim 14, wherein the plurality of segments facilitate the bending of the long tubular member.

18. The device according to claim 14, wherein the support member is resistant to puncture.

19. The device according to any one of claims 1 to 4, wherein the support member is operable to compress the long tubular member.

20. The device according to any one of claims 1 to 4, further comprising a positioning device operable to magnetically couple to the support member, wherein the positioning device has a donut-shaped hole into which a needle can be inserted.

21. The device according to claim 20, wherein the positioning device includes an indicator around the donut hole, the indicator indicating different positions for needle insertion.

22. The device according to any one of claims 1 to 4, wherein the two opposing arm portions are movable to a non-flexible state in order to put the long tubular member into a second uncompressed state.

23. The device according to any one of claims 1 to 4, wherein, when compressed, the long axis of the cross-section of the long tubular member extends with respect to the short axis of the cross-section of the long tubular member.

24. The device according to any one of claims 1 to 4, wherein the elongated tubular member includes an elliptical cross-section along at least a portion of the elongated tubular member that is supported by the support member.

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