Recoverable intravascular implantable device for fistula formation and maturation

Abstract

An intravascular implant device for forming a fistula includes a body including a wall defining a lumen having a distal opening and a proximal opening. An anchor is coupled to a distal end of the body adjacent the distal opening. The anchor can include a first anchor extending from a first side of the distal end of the body and a second, spaced apart anchor extending from a second side of the distal end of the body. A retrieval device can be coupled to a proximal end of the body adjacent the proximal opening.

Description

Technical Field

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 079,087, filed Sep. 16, 2020. This application relates to U.S. Provisional Patent Application No. 62 / 787,985, filed Jan. 3, 2019, and U.S. Patent Application No. 16 / 733,583, filed Jan. 3, 2020. The disclosure of each of these applications is incorporated herein by reference.

[0002]

[0001] This disclosure relates to medical devices, and more particularly, to a retrievable intravascular implant device for fistula creation and maturation.

Background Art

[0003]

[0002] Currently, the only option for creating an arteriovenous (AV) fistula in the United States for end-stage renal disease (ESRD) patients who require dialysis is to undergo an invasive surgery. In 2016, it was estimated that just over 70,000 AV fistulas were created.

[0004]

[0003] Fistula maturation is the process by which a fistula becomes suitable for cannulation, and the criteria are as follows: a blood flow rate greater than 600 ml / min, a diameter greater than 6 mm, a depth less than 0.6 cm subcutaneous, and the above criteria should be met 4 - 6 weeks after surgical creation. Fistula maturation continues to be a problem, and approximately 50% of fistulas fail to mature. The possible reasons for fistula maturation failure include insufficient dilation, collateral veins, stenosis, thrombosis, arterial / venous disease, and hypotension. Existing solutions include balloon angioplasty, removal of competing vessels, and biodegradable magnesium stents.

Summary of the Invention

Problems to be Solved by the Invention

[0005]

[0004] Therefore, there is a need for a device that helps to mature the fistula, widen the vascular space to allow for proper dilation, increase flow, and help prevent stenosis. The device should enable physicians to create AV fistulas by percutaneous, minimally invasive techniques, regardless of the distance between the vein and artery, greatly reducing surgical vascular trauma, eliminating variability that limits the frequency of re-interventions, achieving better maturation success, and presenting a wider range of anatomical fistula options. [Means for solving the problem]

[0006]

[0005] According to a first aspect of the present disclosure, an intravascular implantable device for forming a fistula is disclosed. The implantable device comprises a body including a wall portion that forms a lumen, the body including a distal end having a distal opening and a proximal end having a proximal opening. The implantable device further comprises a retaining device coupled to the distal end of the body adjacent to the distal opening, the retaining device including a first retaining device extending from a first side of the distal end of the body and a second retaining device extending from a second side of the distal end of the body, the second retaining device separated from the first retaining device.

[0007]

[0006] In one embodiment, the first mooring device and the second mooring device are separated by an inlet to a lumen. The implanted device may further include a retriever. The wall of the implanted device may comprise a material having thickness and further comprising a pair of interconnected hooks forming the retriever. Each hook of the pair comprises a first longitudinal portion extending from and integrally formed with the wall, and a second portion connected to the first longitudinal portion, and each hook of the interconnected hook is formed of the material of the wall having thickness.

[0008]

[0007] In one embodiment, a pair of hooks are at least partially connected to each other by a joint. The joint may include a welded portion.

[0008] A pair of interconnected hooks may include a radially innermost portion offset from the central axis of the body. The first longitudinal portion of each hook may be partially twisted, and the second portion may project radially inward from the first longitudinal portion.

[0009]

[0009] According to another aspect of the present disclosure, an intravascular implantable device for forming a fistula is provided. The implantable device comprises a body including a wall portion that forms a lumen. The body includes a distal end having a distal opening and a proximal end having a proximal opening. A retaining device is coupled to the distal end of the body adjacent to the distal opening, and a retrieval device is coupled to the proximal end of the body adjacent to the proximal opening.

[0010]

[0010] In one embodiment, the wall portion is made of a material having thickness. The embedded device may further include a pair of interconnected hooks that form a retrieval device. Each of the pair of hooks includes a first longitudinal portion that extends from and is formed integrally with the wall portion, and a second portion connected to the first longitudinal portion. The second portion of the interconnected hooks, each hook, is made of the material of the wall portion having thickness.

[0011]

[0011] In one embodiment, a pair of hooks are at least partially connected to each other by a joint such as a weld. The pair of interconnected hooks may include radially innermost portions offset from the central axis of the body. The first longitudinal portion of each hook may be partially twisted, and the second portion may project radially inward from the first longitudinal portion.

[0012]

[0012] The main body may be provided with a mesh having a coating. The mooring device may be provided with a first mooring device and a second mooring device separated by an inlet to the lumen.

[0013] According to another aspect of the present disclosure, an intravascular implantable device for forming a fistula is provided. The implantable device comprises a body including a wall portion that forms a lumen, the body including a distal end having a distal opening and a proximal end having a proximal opening. A retaining device is coupled to the distal end of the body adjacent to the distal opening. The retaining device includes a first retaining device extending from a first side of the distal end of the body and a second separated retaining device extending from a second side of the distal end of the body. The retrieval device comprises a pair of interconnected hooks, each hook of the pair having a first longitudinal portion extending from and integrally formed with the wall portion and a second portion coupled to the first longitudinal portion, the second portion of the interconnected hooks, and each hook is formed of the wall material having thickness. The retaining device may comprise a first retaining device and a second retaining device separated by an inlet to the lumen.

[0013]

[0014] In any of the embodiments described above, the main body may include a mesh having a coating. [Brief explanation of the drawing]

[0014] [Figure 1]

[0015] Figure 1 is a top view of an embedded device according to one embodiment of the present disclosure.

[0016] Figure 1a is a lateral cross-sectional view of the implantation device shown in Figure 1. [Figure 2]

[0017] This is a plan view of a precursor for forming an embedded device including a recovery device. [Figure 4]

[0018] This is a schematic diagram illustrating the possible use of an implantable device for fistula formation. [Figure 5] This is a schematic diagram illustrating the possible use of an implantable device for fistula formation. [Figure 6] This is a schematic diagram illustrating the possible use of an implantable device for fistula formation. [Modes for carrying out the invention]

[0015]

[0019] The following detailed description includes many specific details to enable a thorough understanding of the disclosed concepts. Those skilled in the art will know that the disclosed invention may be practiced without these specific details. In other cases, well-known methods, procedures, components, or structures may not be described in detail so as not to obscure the disclosed invention.

[0016]

[0020] The descriptions provided below, and in connection with the figures, apply to all embodiments unless otherwise stated, and features common to each embodiment are similarly shown and numbered.

[0017]

[0021] Referring to the drawings, an implantation device 10 for forming an AV fistula is provided, shown from both a top view (Figure 1) and a side view (Figure 1a). In the embodiment shown, the implantation device 10 comprises a single tubular material forming a tubular body 12. As shown in Figure 1a, the tubular body 12 may have walls formed of a mesh with wires or struts defining a plurality of closed cells 12a, thus giving the body considerable flexibility.

[0018]

[0022] The main body 12 may be at least partially covered with a coating or membrane made of a biocompatible material (e.g., ePTFE, polyurethane, etc.). This coating may be self-sealing after needle insertion. As can be seen from Figures 1 and 1a, the main body 12 thus coated, when inserted into the associated vascular vessel, thus forms a lumen L having a distal opening (inlet I) and a proximal opening (outlet O) for the flow of fluids such as blood to pass through together, while also assisting the corresponding vascular vessel in maintaining patency.

[0019]

[0023] The implant device 10 can further include one or more mooring tools 14, 16 for mooring the implant device in a desired location in place, such as for forming an AV fistula. The mooring tools 14, 16 are shown at the distal end of the implant device 10, which corresponds to the arterial side of the fistula site. The mooring tools 14, 16 may have an elliptical shape or different shapes, and their ends may be closed or open. The mooring tools 14, 16 can extend obliquely and in the reverse direction from a position adjacent to the open upper (inlet) end of the implant device 10. Although two mooring tools 14, 16 are shown, three or more may be provided. Optionally, a mooring tool (not shown) may be provided at the proximal end of the implant device 10 corresponding to the location within the vein during use.

[0020]

[0024] The implant device 10 can also include a retrieval device 18. In one embodiment, the retrieval device 18 is in the form of a hook, the details of which are further outlined in the following description. The hook forming the retrieval device 18 can be positioned adjacent to the proximal (exit O) end of the implant device 10.

[0021]

[0025] The hook forming the retrieval device 18 is connected to the body 12, such as directly connected to an elongated backbone portion 20 that extends longitudinally along one side (e.g., the lower side) of the implant device 10 in the shown orientation. The closed cell 12a defines the boundaries of both outer portions. This backbone portion 20 is formed of a material that is generally wider circumferentially than the wires or struts forming the closed cell 12a of the body 12, thus enhancing the ability to retrieve the implant device 10 using the associated retrieval device 18. Although only one backbone portion 20 is shown, two or more may be present as needed, or the backbone portion may be completely omitted.

[0022]

[0026] The formation of the implantation device 10 can be achieved by cutting the body 12 from a single tubular material. Looking at the plan view of FIG. 2, this process enables the direct cutting of two longitudinally extending J-shaped hooks 18a, 18b from a single-thickness material, which can be considered to create a preform for forming the implantation device 10 (thus the hooks have the same thickness as the wall of the body 12). Of each of the hooks 18a, 18b, the radially innermost portion is offset from the central axis X of the body. The hooks 18a, 18b may be thus folded, or bent / twisted, and arranged in an abutting relationship, and then joined to each other (by, for example, a welded portion) to form a double-thickness hook that functions as the retrieval device 18 of FIGS. 1 and 1a. In view of the above-described formation process, it can be understood that the height of the hooks 18a, 18b is substantially smaller than the diameter of the body 12 of the implantation device 10, thereby minimizing the impedance to fluid flow.

[0023]

[0027] Referring now to FIGS. 4-6, the use of the implantation device 10 for forming an AV fistula is described. The implantation device can be delivered using a sheath S, such as by delivering the sheath through the vein V to the fistula creation site, and a hole (puncture) can be created through the vein and artery walls W using a needle (not shown). A guide wire G is then used to pass through the needle into the artery A.

[0024]

[0028] The implantation device 10 can then be delivered to the tip of the sheath S. The sheath S is then retracted. As a result, the distal anchors 14, 16 of the implantation device 10 are left in place, followed by the tubular body 12.

[0025]

[0029] As a result, lumen L provides a conduit for arterial blood to flow into the vein, thus creating an AV fistula. Optionally, vein V may be dilated with a PTA balloon before implantation to roughly match the diameter of the implantation device. Alternatively, the balloon may be used to dilate the conduit created by the needle and sheath before implantation, or to dilate the implantation device after its placement.

[0026]

[0030] After a certain period of time (for example, several days or weeks), the implanted device 10 can be removed percutaneously. This may be done by using a snare (not shown) to pull the implanted device longitudinally into the sheath. Returning to Figure 1a, it can also be understood that at least the end associated with the retrieval device 18 may be inclined or tapered to form a second angle β with respect to the horizontal axis X. As can be understood, when the retrieval device 18 is pulled longitudinally for retrieval purposes, this tapering allows the narrower tapered portion of the implanted device 10 to enter the sheath first when it is pulled into the opening of the sheath. Thus, even if the inner diameter of the sheath is considerably smaller than the outer diameter of the implanted device 10, further longitudinal movement into the sheath can partially deform the implanted device 10 to ensure retrieval.

[0027]

[0031] The implantable device 10 can be made from a variety of materials. For example, the implantable device 10 may be made from a shape memory material such as nitinol, or from other metals / alloys such as steel (e.g., stainless steel), nickel-chromium, cobalt-chromium alloy, or titanium alloy. The implantable device 10 can also be formed from a polymer material, or even from a bioabsorbable material such as magnesium or other such materials, or from a composite of any material.

[0028]

[0032] As is known in the art, the implantable device 10 may be coated with a pharmaceutical or drug (e.g., paclitaxel) for therapeutic purposes. The implantable device 10 may also be made radiopaque for identification using fluoroscopy, or it may incorporate a radiopaque marker.

[0029]

[0033] In summary, this disclosure can be considered to relate to the following items: [Item 1] An intravascular implantable device for forming a fistula, A body including a wall portion that forms a lumen, wherein the body includes a distal end having a distal opening and a proximal end having a proximal opening, A mooring device coupled to the distal end of a main body adjacent to a distal opening, wherein the mooring device includes a first mooring device extending from a first side of the distal end of the main body and a second mooring device extending from a second side of the distal end of the main body, the second mooring device being separated from the first mooring device and An intravascular implantable device equipped with [specific features / features]. [Item 2] The intravascular implantable device described in item 1, wherein the first anchoring device and the second anchoring device are separated by an inlet into the lumen. [Item 3] An intravascular implantable device as described in item 1 or item 2, further including a retrieval device. [Item 4] An intravascular implantable device according to any one of items 1 to 3, wherein the wall portion is made of a material having thickness and further having a pair of interconnected hooks that form a retrieval device, and each hook of the pair of hooks has a first longitudinal portion extending from the wall portion and formed integrally with the wall portion, and a second portion connected to the first longitudinal portion, and the second portion of the interconnected hooks and each hook are made of the material of the wall portion having thickness. [Item 5] An intravascular implantable device as described in item 4, wherein a pair of hooks are at least partially connected to each other by a joint. [Item 6] An intravascular implantable device as described in item 5, wherein the joint portion is a welded portion. [Item 7] An intravascular implantable device according to any one of items 4 to 6, wherein a pair of interconnected hooks include the innermost radial portion offset from the central axis of the main body. [Item 8] An intravascular implantable device according to any one of items 4 to 7, wherein the first longitudinal portion of each hook is partially twisted and the second portion protrudes radially inward from the first longitudinal portion. [Item 9] An intravascular implantable device according to any one of items 1 to 8, wherein the main body comprises a mesh having a coating. [Item 10] An intravascular implantable device for forming a fistula, A body including a wall portion that forms a lumen, wherein the body includes a distal end having a distal opening and a proximal end having a proximal opening, A mooring device connected to the distal end of the main body adjacent to the distal opening, A recovery device is attached to the proximal end of the main body adjacent to the proximal opening. An intravascular implantable device equipped with [specific features / features]. [Item 11] The intravascular implantation device according to item 10, wherein the wall portion is made of a material having thickness and further having a pair of interconnected hooks that form a retrieval device, and each hook of the pair of hooks has a first longitudinal portion that extends from the wall portion and is formed integrally with the wall portion, and a second portion that is connected to the first longitudinal portion, and the second portion of the interconnected hooks and each hook are made of the material of the wall portion having thickness. [Item 12] An intravascular implantable device as described in item 11, wherein a pair of hooks are at least partially connected to each other by a joint. [Item 13] An intravascular implantable device as described in item 11, wherein the joint portion is a welded portion. [Item 14] An intravascular implantable device as described in item 11, wherein a pair of interconnected hooks include the innermost radial portion offset from the central axis of the main body. [Item 15] The intravascular implantation device described in item 11, wherein the first longitudinal portion of each hook is partially twisted, and the second portion protrudes radially inward from the first longitudinal portion. [Item 16] An intravascular implantable device according to any one of items 11 to 15, wherein the main body comprises a mesh having a coating. [Item 17] An intravascular implantable device according to any one of items 11 to 16, wherein the anchoring device comprises a first anchoring device and a second anchoring device separated by an inlet to the lumen. [Item 18] An intravascular implantable device for forming a fistula, A body including a wall portion that forms a lumen, wherein the body includes a distal end having a distal opening and a proximal end having a proximal opening, A mooring device coupled to the distal end of the main body adjacent to the distal opening, the mooring device comprising a first mooring device extending from a first side of the distal end of the main body and a second mooring device extending from a second side of the distal end of the main body, wherein the second mooring device is separated from the first mooring device, A retrieval device comprising a pair of interconnected hooks, wherein each hook of the pair has a first longitudinal portion extending from and integrally formed with the wall, and a second portion connected to the first longitudinal portion, and the second portion of the interconnected hooks, each hook, is formed of the wall material having thickness. An intravascular implantable device equipped with [specific features / features]. [Item 19] An intravascular implantable device as described in item 18, the main body of which is equipped with a mesh.

[0030]

[0034] As used herein, each of the following terms written in the singular grammatical form: “a,” “an,” and “the” means “at least one” or “one or more.” The use of the phrase “one or more” in this specification does not alter the intended meaning of “a,” “an,” or “the.” Thus, as used herein, the terms “a,” “an,” and “the” can refer to and encompass multiple stated subjects or objects unless it is specifically defined or stated herein that they are not, or unless the context clearly indicates otherwise. For example, as used herein, the phrases “a unit,” “an apparatus,” “an assembly,” “a mechanism,” “a component,” “an element,” and “a step or procedure” can refer to and encompass multiple units, multiple apparatuses, multiple assemblies, multiple mechanisms, multiple components, multiple elements, and multiple steps or procedures, respectively.

[0031]

[0035] As used herein, each of the following terms: “includes,” “including,” “has,” “having,” “comprises,” and “comprising,” as well as their linguistic / grammatical variations, derived forms, and / or conjugations, should be interpreted as meaning “including, but not limited to,” specifying the constituent elements, features, properties, parameters, integers, or steps being described, and not precluding the addition of one or more additional constituent elements, features, properties, parameters, integers, steps, or groups thereof. Each of these terms is considered to be semantically equivalent to the phrase “consisting essentially of.” As used herein, each of the phrases “consisting of” and “consists of” means “including and limited to.” The phrase "consisting essentially of" means that the described subject or item (system, system unit, system subunit equipment, assembly, subassembly, mechanism, structure, component, or peripheral equipment utility, accessory, or material, method or process, step or procedure, substep or subprocedure) which is all or part of an exemplary embodiment of the disclosed invention, or / or used to carry out an exemplary embodiment of the disclosed invention, may include at least one additional feature or characteristic which is a system unit, system subunit equipment, assembly, subassembly, mechanism, structure, component or element, or peripheral equipment utility, accessory, or material, step or procedure, substep or subprocedure, but only if each such additional feature or characteristic does not substantially alter the basic novel and inventive or special technical feature of the item.

[0032]

[0036] As used herein, the term “method” means steps, procedures, ways, means, or / and techniques for performing a given work, including but not limited to steps, procedures, ways, means, or / and techniques that are known to practitioners of the relevant art of the disclosed invention or that are readily developed from steps, procedures, ways, means, or / and techniques known by practitioners of the relevant art of the disclosed invention.

[0033]

[0037] As used herein, approximate terms such as "about," "substantially," and "approximately" refer to a range of ±10% of the stated value. The use of the terms "parallel" or "perpendicular" is intended to mean that the condition is approximately met unless otherwise specified.

[0034]

[0038] For clarity, some aspects, characteristics, and features of the Invention described and presented as examples in the context or form of multiple distinct embodiments may also be described and presented as examples in any suitable combination or subcombination in the context or form of a single embodiment. Conversely, various aspects, characteristics, and features of the Invention described and presented as examples in a combination or subcombination in the context or form of a single embodiment may also be described and presented as examples in the context or form of multiple distinct embodiments.

[0035]

[0039] While the present invention has been described and presented as an example of specific exemplary embodiments, it will be apparent to those skilled in the art that many alternative, modified, and / or variant forms will be evident. For example, although a pair of hooks has been described above, it may be understood that three or more hooks may be used to form a single hook, and thus the retrieval device 18. Similarly, if desired for a particular use, multiple single hooks, each formed with a double hook, may be provided in a single embedding device. Thus, all such alternative, modified, and / or variant forms are intended to be included in and encompassed by the broad scope set forth in the appended claims.

Claims

1. An intravascular implantable device for forming a fistula, A body including a wall portion that forms a lumen, wherein the body includes a distal end having a distal opening and a proximal end having a proximal opening, A mooring device coupled to the distal end of the main body adjacent to the distal opening, wherein the mooring device includes a first mooring device extending from a first side of the distal end of the main body and a second mooring device extending from a second side of the distal end of the main body, the second mooring device being separated from the first mooring device. Equipped with, Intravascular implantation device, wherein the wall portion has thickness and is provided with a pair of hooks, the pair of hooks are at least partially interconnected by a joint to form a retrieval device, and each hook of the pair of hooks has a first longitudinal portion extending from the wall portion and formed integrally with the wall portion, and a second portion connected to the first longitudinal portion, the first longitudinal portion being the portion to which each hook is connected to the other hook, and the second portion being the portion of the first longitudinal portion extending from the side opposite to the wall portion.

2. The intravascular implantation device according to claim 1, wherein the first anchoring device and the second anchoring device are separated by an inlet to the lumen.

3. The intravascular implantable device according to claim 1, wherein the joint portion comprises a welded portion.

4. The intravascular implantation device according to claim 1, wherein the pair of interconnected hooks include the innermost portion in the radial direction offset from the central axis of the main body.

5. The intravascular implantation device according to claim 1, wherein the first longitudinal portion of each hook is partially twisted and the second portion protrudes radially inward from the first longitudinal portion.

6. The intravascular implantable device according to any one of claims 1 to 5, wherein the main body comprises a mesh having a coating.

7. An intravascular implantable device for forming a fistula, A body including a wall portion that forms a lumen, wherein the body includes a distal end having a distal opening and a proximal end having a proximal opening, A mooring device connected to the distal end of the main body adjacent to the distal opening, A recovery device coupled to the proximal end of the main body adjacent to the proximal opening and Equipped with, The wall portion has thickness and comprises a pair of interconnected hooks forming the recovery device, each of the pair of interconnected hooks having a first longitudinal portion extending from the wall portion and formed integrally with the wall portion, and a second portion connected to the first longitudinal portion, the first longitudinal portion being the portion to which each hook is connected to the other hooks, and the second portion being the portion of the first longitudinal portion extending from the side opposite to the wall portion. An intravascular implantation device in which the first longitudinal portion of each hook is partially twisted, and the second portion protrudes radially inward from the first longitudinal portion.

8. The intravascular implantation device according to claim 7, wherein the pair of interconnected hooks are at least partially connected to one another by a joint.

9. The intravascular implantation device according to claim 8, wherein the joint portion comprises a welded portion.

10. The intravascular implantation device according to claim 7, wherein the pair of interconnected hooks includes the innermost portion in the radial direction offset from the central axis of the main body.

11. The intravascular implantation device according to claim 7, wherein the first longitudinal portion of each hook is partially twisted and the second portion protrudes radially inward from the first longitudinal portion.

12. The intravascular implantable device according to any one of claims 7 to 11, wherein the main body comprises a mesh having a coating.

13. The intravascular implantable device according to any one of claims 7 to 12, wherein the anchoring device comprises a first anchoring device and a second anchoring device separated by an inlet to the lumen.

14. An intravascular implantable device for forming a fistula, A body including a wall portion that forms a lumen, wherein the body includes a distal end having a distal opening and a proximal end having a proximal opening, A mooring device coupled to the distal end of the main body adjacent to the distal opening, wherein the mooring device includes a first mooring device extending from a first side of the distal end of the main body and a second mooring device extending from a second side of the distal end of the main body, the second mooring device being separated from the first mooring device, A retrieval device comprising a pair of hooks at least partially connected to each other by a joint, wherein each hook of the pair has a first longitudinal portion extending from and integrally formed with the wall, and a second portion connected to the first longitudinal portion, the first longitudinal portion being the portion to which each hook is connected to the other hook, and the second portion being the portion of the first longitudinal portion extending from the side opposite to the wall. An intravascular implantable device equipped with [specific features / features].

15. The intravascular implantable device according to claim 14, wherein the main body comprises a mesh having a coating.

16. The intravascular implantable device according to claim 14 or 15, wherein the anchoring device comprises a first anchoring device and a second anchoring device separated by an inlet to the lumen.

17. The intravascular implantable device according to claim 1, 7, or 14, wherein the proximal end of the main body is tapered.

18. The intravascular implantable device according to claim 1, 7, or 14, wherein arterial blood flows into the lumen.

Images