Stent graft device having anchor members with adjustable geometric structure

Abstract

A stent graft device is provided, which includes a frame, a cover material that covers the frame, and an anchor member having an adjustable geometric structure. [Solution] The anchor member may be incorporated as part of the frame or bonded to it. The anchor member may be formed from a material having tensile strength such that it can be bent, straightened, or otherwise reshaped. The tissue that grows on and / or around the anchor member secures the stent graft device within the lumen. During removal of the stent graft device, the geometry of the anchor member changes to allow the anchor member to be removed from the grown tissue along the removal path with minimal trauma. The design and / or shape of the anchor member is not particularly limited, as long as the anchor member has an adjustable geometry that allows for tissue overgrowth and subsequent removal from the overgrowth tissue with minimal trauma.

Description

Technical Field

[0001] The present disclosure generally relates to implantable medical devices, and more particularly to a stent graft device having an anchor member with an adjustable geometry that enables non-invasive removal of the stent graft device.

Background Art

[0002] A wide variety of known medical devices can be implanted in a patient's body to provide an intervention or treatment procedure. Stent graft devices can be implanted in a patient to treat various medical conditions or weaknesses known as aneurysms within the patient's vasculature. For example, a stent graft device is implanted within a patient to treat an aneurysm within a blood vessel. In other examples, a stent graft device is implanted within a patient to seal an opening within a body lumen (e.g., the gastrointestinal (GI) tract), or within the wall of an organ. In a further example, a stent graft device is implanted within a patient to treat a body lumen having a stenosis such that the device opens or expands the fluid flow path through the body lumen.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Once deployed at a desired location within a patient, in many cases, the continued effectiveness of an implantable device can depend on its ability to remain in a substantially fixed position relative to the surrounding tissue. For example, an occlusion device implanted to occlude or close an opening should maintain its proper position relative to the tissue surrounding the opening, or else it may fail to close the opening. Similarly, a stent graft device deployed at a location of stenosis should remain at the location of the lumen stenosis and create or expand an open passage for fluid flow.

[0004] Furthermore, once the intended treatment or procedure is complete, it is sometimes desirable for the medical device to be removed. Removal of such a device can be difficult due to tissue growth within and around the device. Therefore, in this art, there is a need for a medical device that can be used intravascular or transluminal for the entire intended treatment period and, once the treatment is complete, can be removed with minimal trauma to the surrounding tissue and the patient. [Means for solving the problem]

[0005] One embodiment of the present invention relates to a stent graft apparatus comprising (1) an expandable frame, (2) a cover extending over the expandable frame, and (3) an anchor member coupled to the expandable frame and extending along the length of the expandable frame. The anchor member moves axially to remove the anchor member from the expandable frame, with minimal movement of tissue grown around the anchor member. In at least one embodiment, the anchor member generally has a meandering or "cork-screw" shape. The anchor member may be coupled to the expandable frame by a plurality of coupling members (e.g., loops) arranged on the outer surface of the expandable frame. Mechanical force may be applied to one end of the anchor member to separate the anchor member from the overgrown tissue and move the anchor member along a removal path defined by the anchor member along the length of the stent with minimal or no trauma to the tissue. The geometry of the anchor member changes to remove the anchor member from the grown tissue along the removal path.

[0006] A second embodiment of the present invention relates to a stent graft device comprising (1) an expandable frame, (2) a cover extending over the expandable frame, and (3) at least one anchor member coupled to the outside of the expandable frame. The anchor members may be coupled to the stent at separate, spaced locations. The coupling members form a raised portion that extends away from the frame and may generally have a "U" shape or curved form. The geometry of the anchor members defines a removal path for the anchor members. Each anchor member extends along the expandable frame in the implanted state over a certain distance. The anchor members are suitable for removal from overgrown tissue along the removal path for the anchor members. Overgrown tissue on and / or around the anchor members fixes the stent graft device within the lumen. Removal of the anchor members from the overgrown tissue is non-traumatic. The anchor members may be coupled to the expandable frame at an attachment area located on the outer surface of the expandable frame.

[0007] A third embodiment of the present invention relates to a stent graft device comprising (1) an expandable support frame incorporating an anchor member for fixing a stent graft device within a lumen, and (2) a cover extending over the expandable support frame. In one embodiment, the anchor member is a coiled wire extending outward from the expandable support frame. The geometry of the anchor member changes to remove the anchor member from tissue that has grown around it. For example, the anchor member takes a non-coiled form to remove the anchor member from the overgrown tissue and subsequently remove the stent graft device from the lumen. In another embodiment, the anchor member comprises a first member and an opposing second member, the first and second members engaging with each other in the implanted state. The first and second members separate to remove the stent graft device from the lumen. The geometry of the engaged first and second members changes to a separated form to remove the anchor member from the overgrown tissue. The anchor member is removed from the overgrown tissue along a removal path defined by the geometry of the anchor member. Overgrown tissue on top of the anchor member fixes the stent graft device within the lumen.

[0008] A fourth embodiment of the present invention relates to a method for removing a stent graft device from a lumen, the method comprising (1) providing a stent graft device having an expandable frame and an anchor member coupled thereto, and (2) applying mechanical force to the anchor member to remove the anchor member from the stent graft device along a removal path. The anchor member extends along the length of the expandable frame and defines the removal path of the anchor member. The expandable frame has a cover that extends over the expandable frame. The anchor member is coupled to the frame by a coupling member, for example, via a loop located on the outer surface of the expandable frame. Once the anchor member is detached and removed from the stent graft device, the stent graft device may be removed from the lumen.

[0009] A fifth embodiment of the present invention relates to a method for removing a stent graft device from a lumen, the method comprising (1) providing a stent graft device having an anchor member extending outward from the stent graft device and therein incorporated therein, and (2) applying mechanical force to alter the geometry of the anchor member and remove the anchor member along a removal path defined by the anchor member. The stent graft device comprises an expandable support frame having an anchor member therein incorporated therein, and a cover extending over the expandable support frame. In one embodiment, the anchor member has a coiled form, and altering the geometry involves uncoiling the anchor member. In a further embodiment, the anchor member comprises a first member and an opposing second member, the first member and the second member engaging with each other. In this embodiment, altering the geometry involves separating the first member and the second member. Once the anchor member is separated and / or removed from the overgrown tissue, the stent graft device may be removed from the lumen. [Brief explanation of the drawing]

[0010] The accompanying drawings are included to provide a further understanding of this disclosure, are incorporated into this specification and constitute part thereof, illustrate embodiments, and, together with the description, help to illustrate the principles of this disclosure.

[0011] [Figure 1] Figure 1 is a schematic diagram of a stent graft device according to at least one embodiment of the present invention.

[0012] [Figure 2] Figure 2 is a schematic diagram of a stent graft device having an anchor member that extends along the length of the stent graft device, according to one embodiment of the present invention.

[0013] [Figure 3A] Figure 3A is a schematic diagram of an overgrown tissue embedded in the lumen wall of the raised portion of the anchor member shown in Figure 2, according to one embodiment of the present invention.

[0014] [Figure 3B] Figure 3B is a schematic diagram of removing the anchor member of Figure 3A from overgrown tissue along a removal path according to at least one embodiment of the present invention.

[0015] [Figure 4A] Figure 4A is a schematic diagram of a stent graft device having a plurality of anchor members attached at one end thereof to a stent frame at individually spaced locations according to at least one embodiment of the present invention.

[0016] [Figure 4B] Figure 4B is a schematic diagram of removing the anchor member of Figure 4A along a removal path according to at least one embodiment of the present invention.

[0017] [Figure 5] Figure 5 is a schematic diagram of an anchor member in the form of opposing fins integrated with a stent frame according to at least one embodiment of the present invention.

[0018] [Figure 5A] Figure 5A is a top schematic view of the anchor member of Figure 5.

[0019] [Figure 5B] Figure 5B is a schematic diagram of overgrown tissue embedding the raised portion of the anchor member of Figure 5 in the inner lumen wall according to one embodiment of the present invention.

[0020] [Figure 5C] Figure 5C is a schematic diagram of the engaging form of the anchor member of Figure 5 according to one exemplary embodiment of the present invention.

[0021] [Figure 5D] Figure 5D is a schematic diagram of removing the fins of the anchor member of Figure 5 along a removal path according to at least one embodiment of the present invention.

[0022] [Figure 6] Figure 6 is a schematic diagram of an anchor member, including a stent graft device in the form of a flexible coiled wire, according to one embodiment of the present invention.

[0023] [Figure 6A] Figure 6A is a schematic diagram of the stent graft device of Figure 6, which has an anchor member embedded in overgrown tissue.

[0024] [Figure 6B] Figure 6B is an enlarged schematic diagram of the anchor member of Figure 6 embedded in overgrown tissue according to an embodiment of the present invention.

[0025] [Figure 6C] Figure 6C is an enlarged schematic diagram showing the removal of the anchor member shown in Figure 6B along the removal path according to at least one embodiment of the present invention. [Modes for carrying out the invention]

[0026] term As used herein, the terms “tissue growth” and “tissue overgrowth” include any tissue that is attached to, adheres to, located within, periphery of, touching, or otherwise in contact with any part of the lumen or with an anchor member that secures the medical device transluminally.

[0027] As used herein, the term "adjustable geometry" means that the shape or position of the anchor member relative to the stent can be changed to allow the anchor member to be removed from overgrown tissue.

[0028] As used herein, the term "macroscopic" refers to overgrown tissue at the cellular level.

[0029] As used herein, the term "non-traumatic" means that, as a result of removing the anchor member from overgrown tissue, there is little to no tissue damage.

[0030] As used herein, the term "minimum trauma" means an injury that does not result in a negative outcome for the patient.

[0031] As used herein, the term "lumen" means the inside of a tubular structure, such as an artery, intestine, conduit, or tube.

[0032] Those skilled in the art will readily recognize that various aspects of this disclosure can be realized by any method and apparatus configured to perform the intended function. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to a fixed proportion and may be exaggerated to illustrate various aspects of this disclosure; in this respect, the drawings should not be interpreted restrictively. It should be understood that the terms “stent graft apparatus” and “stent” are used interchangeably herein. It should also be understood that the terms “frame” and “stent frame” are used interchangeably herein.

[0033] The present invention relates to a stent graft device comprising a frame, a cover material covering the frame, and at least one anchor member bonded to or integrated with the frame. The tissue grown on and / or around the anchor member secures the stent graft device within the lumen. The geometry of the anchor member is varied to allow for removal of the anchor member from the growing tissue with minimal trauma. It is recognized that the stent graft devices and anchor members described herein are measurable to a wide range of sizes and geometric structures so that the stents and anchor members can be used in a wide variety of different tissues, implant sites, e.g., body lumens, organs and cavities, and types of implementation.

[0034] While the present invention is described herein in relation to stent graft devices, it should be noted that any medical device including cover material and anchor members may be used, which can be geometrically modified for non-traumatic removal of the stent from the lumen and are considered to be within the scope of the present invention.

[0035] Referring to Figure 1, a schematic diagram of an exemplary stent graft device is shown. The stent graft device 10 may be used for intraluminal or transluminal applications. The stent graft device 10 includes a stent frame 20 and a cover material 30. The stent graft device 10 is generally cylindrical and defines a long axis 25. In some embodiments, the ends of the stent graft device 10 may be corrugated or follow the shape of the stent frame. Furthermore, the stent graft device 10 may include one or more fenestrations and / or side branches. The stent graft device 10 provides a compressive force to the lumen so that the anchor member, which will be described in detail below, contacts the tissue of the body lumen and allows tissue to grow on and / or around the anchor member.

[0036] The frame 20 may be formed from one or more elongated members (e.g., wires) that are spirally wound into a tubular shape. In an exemplary embodiment, the stent frame 20 is formed from a single spirally wound elongated member. In the embodiment shown in Figure 1, the elongated members are wound around a tubular member such that each stent ring 45 within the frame 20 generally has a meandering shape (e.g., a sinusoidal or zigzag shape). However, it should be understood that the shown stent frame 20 is not the only form of stent frame envisioned within the scope of the invention. For example, but not limited to, the stent frame 20 can differ from the embodiment shown in Figure 1 in many ways, such as the number of stent rings, the shape of the stent rings, the diameter of the stent rings, the geometry of the stent rings, the pitch of the stent rings, the number of wires, and / or the diameter of the wires (e.g., elongated members). For example, the elongated members may be wound to form other geometric structures, and such other geometric structures are considered within the scope of the invention. In other embodiments, part or all of the stent frame 20 is formed from stent rings having interconnecting elements. Furthermore, the stent frame 20 may be formed from braided or mixed elongated members.

[0037] In alternative embodiments, the frame 20 is formed from a tube or sheet of material that has been cut according to a pattern and then stretched (and, in some embodiments, heat-set). For example, the frame 20 may be made from tubular material and form ring and / or cellular / lattice structures. In some embodiments, the frame is cut from a sheet of material and then formed into ring or tubular cellular structures. Such cutting may be performed by laser cutting, chemical etching, machining, or waterjet cutting. In at least one embodiment, part or all of the stent frame 20 has a cellular structure.

[0038] The stent frame 20 may be molded from various materials and / or combinations of materials. In an exemplary embodiment, nitinol (NiTi) is used as the material for the stent frame 20. Other materials, such as stainless steel, polymer materials, polyamides, polyesters, polyimides, bioabsorbable polymers, cobalt, chromium, nickel alloys, or any other suitable biocompatible materials, and combinations thereof, may be used as the material for the stent frame 20. The stent frame 20 is generally conformable, fatigue-resistant, elastic, and extensible so that it can conform to the topography of the surrounding tissue when the stent graft device 10 is deployed in the lumen.

[0039] The stent frame 20 provides structure and shape to the stent graft device 10. In the embodiment shown in Figure 1, the cover material 30 is attached to the stent frame 20 to create a tubular fluid conduit. This provides the stent frame 20 with a supporting structural framework for the otherwise relatively loose and flexible cover material 30. The cover material 30 is attached to at least a portion of the outer surface of the stent frame 20. As used herein, “outer portion” means the surface of the cover material 30 facing and optionally in contact with the wall of the lumen. In some embodiments, the cover material 30 is attached to the frame 20 with an adhesive, such as silicone, polyurethane, or fluoroethylene propylene (FEP). For example, silicone functions as an adhesive to bond the cover material 30 to the stent frame 20. The adhesive may be applied to a portion of the stent frame 20 or to the entire stent frame 20.

[0040] In one or more embodiments, part or all of the cover material 30 is positioned on both the inner and outer portions of the stent frame 20, and the portions of the cover material 30 are bonded to each other to enclose part or all of the stent frame 20. The cover material 30 may be attached to the stent frame 20 by means of sutures, fastening, binding and / or clips. In some embodiments, a combination of techniques is used to attach the cover material 30 to the stent frame 20.

[0041] The cover material 30 may be molded from a membrane material that inhibits or reduces the passage of blood, bile, and other bodily fluids and substances through the cover material 30. In exemplary embodiments, the cover material 30 is a polymer material, such as a fluoropolymer material. In at least one embodiment, the cover material 30 is a stretched polytetrafluoroethylene membrane. The cover material 30 may also be molded from other materials, such as, but not limited to, silicone, urethane, polyester (e.g., DACRON®), and combinations thereof.

[0042] The stent graft device 10 may be delivered to an in vivo deployment site using various minimally invasive transcatheter deployment techniques and deployed there. In such embodiments, the stent 10 may have a delivery form and a deployed form. For example, while the stent is delivered to the deployment site within the delivery sheath, the stent may constitute a small-contour delivery form folded within the delivery sheath. After the stent emerges from the delivery sheath, the stent may take on an expanded or deployed form. In some embodiments, the stent may self-expand into an expanded or deployed form. In other embodiments, the stent may expand in response to the application of supplemental force from another device (e.g., an inflatable balloon). In some embodiments, the stent may be expanded into its deployed form using a combination of self-expansion and forced expansion. The stent may be implanted, for example, at the site of luminal stenosis in a patient to create an open passage for fluid flow or to expand. In some embodiments, the stent may be inflated by an external force beyond its nominal diameter for treatment. Once treatment is complete, the stent returns to its nominal diameter by the removal of the external force.

[0043] It should be understood that stent graft devices may expand to conform to the topography of the surrounding tissue when implanted in a patient. As a result, the in-situ deployment form of the stent graft device may be a fully expanded form or not. That is, when the stent graft device is deployed, the stent may take one or more partially expanded or partially deployed forms, allowing at least the anchor members of the stent graft device to make contact with the body tissue.

[0044] As described above, the stent graft device 10 also includes at least one anchor member incorporated as part of the frame 20 or bonded to the frame 20. The design and / or shape of the anchor member is not particularly limited, as long as the anchor member has an adjustable geometry that allows for tissue overgrowth and subsequent removal of the overgrowth with minimal trauma. As used herein, tissue overgrowth and tissue growth may include any tissue that is attached to or bonded to, located inside, periphery-located, touching, or otherwise in contact with the anchor member that fixes the stent graft device to any part of the lumen or transluminally. The anchor member may be formed from a material having tensile strength such that it can be bent, straightened, or otherwise reshaped. Non-limiting examples of suitable materials for the anchor member include, but are not limited to, nitinol wire, Platinol®, cobalt-chromium, various stainless steel alloys, polypropylene, polyamide, and / or other implantable metal or polymer materials.

[0045] Figure 2 is a schematic diagram of an exemplary anchor member 50 extending along the length of the stent graft device 10. The anchor member 50 may extend along the entire length or along a portion of the stent graft device 10. The stent graft device 10 may have a connecting member 40 (e.g., a loop) integrated with or coupled to the frame 20, through which the anchor member 50 passes. The connecting member 40 shown in Figure 2 is actually exemplary and may have any shape or design that can be used, as long as the anchor member 50 can pass through it. The anchor member 50 may have a form that forms a raised portion 55 between consecutive connecting members 40 (e.g., a meandering or helical form). In an exemplary embodiment, the raised portion 55 is in contact with the inner surface of the body lumen 70. As shown in Figure 3A, tissue may grow on and / or around the anchor member 50, particularly at the raised portion 55, embedding the anchor member 50 into the lumen wall 70. The overgrown tissue on the anchor member 50 fixes and / or assists in fixing the stent graft device 10 within the lumen.

[0046] To remove the anchor member 50 from the overgrown tissue, a mechanical force (e.g., longitudinal) may be applied to one end of the anchor member 50 to separate it from the overgrown tissue, and the anchor member 50 may be moved along the length of the stent 10 along a removal path defined by the geometry of the anchor member, with minimal or no trauma to the tissue. For example, one end of the anchor member 50 may be grasped and pulled to separate it from the tissue, as well as to pull the anchor member 50 along the removal path. The stent graft apparatus 10 without the anchor member 50 may then be removed by any conventional method.

[0047] The removal of the anchor member 50 is illustrated in Figures 3A and 3B. As shown in Figure 3A, the overgrown tissue may embed the raised portion 55 of the anchor member 50 into the lumen wall 70. To remove the anchor member 50, it may be pulled in the direction of arrow 65. When pulled, as schematically shown in Figure 3B, the anchor member 50 moves axially with minimal movement within the enclosed tissue along the removal path 85 formed by the anchor member 50, and is removed from the expandable frame 20. During removal, the geometry (i.e., shape) of the anchor member 50 changes so that it can follow the removal path 55 with minimal tissue damage to the surrounding tissue.

[0048] In another exemplary embodiment generally shown in Figure 4A, the stent graft apparatus 10 has a plurality of anchor members 80 that connect to the stent frame 20 at separate intervals. The connection region of the anchor member 80 to the stent frame 20 is identified by reference numeral 100. Each anchor member extends along the length of the expandable frame in the implanted state. The anchor member 80 is attached to one end of the frame 20 and forms a raised portion 95 that extends from the frame 20. The raised portion 95 of the anchor member 80 shown in Figure 4A is actually exemplary, and it is recognized that the anchor member 80 may have alternative shapes, lengths, and / or dimensions, as long as tissue overgrowth occurs over at least a portion of the anchor member 80 and the anchor member 80 is embedded at least temporarily within the wall of the lumen 70. For example, the anchor member 80 may have a less curvilinear shape or may include one or more raised regions (not shown). Similar to the embodiment shown in Figure 2, tissue growth occurs on and / or around the anchor member 80 of the raised portion 95, fixing the stent graft device 10 within the lumen 70.

[0049] Referring to Figure 4B, the anchor member 80 may be removed non-traumatically by applying a longitudinal force to the stent graft device 10 (for example, in the direction of arrow 85). When a force is applied to the stent graft device 10, the anchor member 80 is pulled through the tissue growth along the removal path 90 defined by the anchor member 80 with minimal movement of the overgrown tissue and minimal trauma to the overgrown tissue. When the stent graft device 10 is removed, the anchor member 80 changes its geometric structure (i.e., shape) so that it can follow the removal path 90 with minimal trauma to the surrounding tissue.

[0050] Further embodiments of exemplary anchor members are shown in Figure 5. In this embodiment, the anchor member 110 takes the form of opposing fins 120(a) and 120(b) integrated into the frame 20 of the stent graft device 10. In another embodiment, the anchor member 110 may be coupled to the frame 20 via a coupling member (not shown). Furthermore, the fins 120(a) and 120(b) may be molded to be substantially mirror images of each other. The fins 120(a) and 120(b) extend away from the frame 20 and engage with each other in the implantation state. For example, the fins 120(a) and 120(b) may be molded to form raised portions that extend outward at an angle from the frame 20 in the engaged implantation state. The angle at which the fins 120(a) and 120(b) extend from the frame 20 may be approximately 90°, or it may be in the range of approximately 10° to approximately 90°, approximately 20° to approximately 80°, or approximately 30° to approximately 70°. It is recognized that the angle of the fins 120(a) and 120(b) relative to the stent graft device 10 is not particularly limited, as long as tissue grows around and / or on the fins 120(a) and 120(b) to fix the stent graft device 10 in the lumen. A top view showing the position of the anchor member 110 is shown in Figure 5A. Tissue grows on and / or around the fins 120(a) and 120(b) as generally shown in Figure 5B. Figure 5C shows an enlarged view of the anchor member 110 showing the fins 120(a) and 120(b) together with the overgrown tissue 140 in the engagement configuration. The fins 120(a) and 120(b) are actually illustrative and may have alternative shapes, lengths, and / or dimensions, insofar as tissue overgrowth occurs on at least a portion of the anchor member 80 and the geometry of the anchor member changes for non-traumatic removal along the removal path.

[0051] To remove the stent graft device 10 from the overgrown tissue 140, a mechanical force (e.g., longitudinal) may be applied to the stent graft device 10, for example, in the direction of arrow 130. Pulling, or otherwise moving, the opposing fins 120(a) and 120(b) of the anchor member 110 separate, and as generally shown in Figure 5D, they move through the overgrown tissue 140 along removal paths 145(a) and 145(b), respectively, defined by the geometry of the fins 120(a) and 120(b), with minimal movement of the tissue 140. Once the fins 120(a) and 120(b) are separated from the overgrown tissue 140, the stent graft device 10 may then be removed by any conventional method.

[0052] Figure 6 is a schematic diagram showing yet another exemplary anchor member. As shown in Figure 6, the stent graft apparatus 10 includes a plurality of anchor members 140 in the form of flexible, coiled wires that extend away from the frame 20. The anchor members 140 may be located at at least one end of the stent graft apparatus 10. In the implantation configuration commonly shown in Figure 6A, the anchor member 150 engages with the lumen wall 70 and fixes the stent graft apparatus 10 within the lumen 70 until tissue growth occurs on and / or around the coil 150 of the anchor member 140 and the stent graft apparatus 10 is removed. When a longitudinal force is applied to the stent graft apparatus 10 in the direction of arrow 160, the coil of the anchor member 140 unwinds and is pulled through the overgrown tissue along a removal path defined by the geometry of the anchor member 140, with minimal movement of the overgrown tissue. A magnified schematic diagram of the anchor member 10 embedded in the overgrown tissue 170 is shown in Figure 6B. As the anchor member 140 moves in the direction of arrow 160, the anchor member 140 changes its geometric structure (for example, the coil unravels or becomes straight), and the stent graft device 10 is removed. As shown in Figure 6C, the anchor member 140 follows the removal path 175 and separates from the surrounding tissue 170. The stent graft device 10 may then be removed by any conventional method.

[0053] To prevent movement of the stent graft device as it deploys, the radial force provided by the stent frame temporarily fixes and / or holds the stent graft device in place within the lumen. In at least one embodiment, to prevent movement of the stent graft device as it deploys, the stent graft device includes bioabsorbable fixation members (e.g., hooks, spines, sutures, or clips) to temporarily fix and / or hold the stent graft device in place within the lumen. Once sufficient tissue growth occurs on and / or around the anchor member, the grown tissue will fix and / or assist in fixing the stent graft device within the lumen until it is to be removed.

[0054] In some embodiments, once the overgrown tissue is separated from one or more anchor members, the stent graft device 10 can be drawn into a retrieval sheath (not shown). Once the gripping device is further retracted, the entire stent graft device 10 can be drawn into the lumen of the retrieval sheath. The retrieval sheath containing the stent graft device 10 can then be removed from the patient.

[0055] The present invention has been described above in terms of both general and specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in embodiments without departing from the scope of this disclosure. Accordingly, the embodiments are intended to encompass modifications and variations of the present invention, insofar as they remain within the scope of the appended claims and equivalents. Examples of embodiments of the present invention are listed in the following sections [1] to

[21] . [1] Expandable frame and; A cover extending over the aforementioned expandable frame; An anchor member connected to the expandable frame and extending along the length of the expandable frame A stent graft apparatus including, A stent graft apparatus wherein the anchor member moves axially with minimal movement of tissue grown on the anchor member in order to remove the anchor member from the expandable frame. [2] The stent graft device according to item 1, wherein the tissue grown on the anchor member fixes the stent within the lumen. [3] The stent graft apparatus according to item 1, wherein the anchor member has a meandering or helical shape. [4] The stent graft apparatus according to item 3, wherein the wire is connected to the expandable frame by a plurality of connecting members arranged on the outer surface of the expandable frame. [5] Expandable frame and; A cover extending over the aforementioned expandable frame; An anchor member connected to the expandable frame and extending along the length of the expandable frame in the transplanted state. A stent graft apparatus including, A stent graft device wherein the length defines a removal path for the anchor member, and the anchor member is suitable for removal from the expandable frame along the removal path of the anchor member. [6] The stent graft device according to item 5, wherein overgrown tissue on the anchor member fixes the stent within its lumen. [7] The stent graft device described in item 6, wherein the removal of the anchor member is non-traumatic. [8] The stent graft apparatus according to item 5, wherein the anchor member has a meandering or helical shape. [9] The stent graft apparatus according to item 8, wherein the anchor member is connected to the expandable frame by a plurality of connecting members arranged on the outer surface of the expandable frame.

[10] An expandable support frame incorporating anchor members for fixing the stent graft device within the lumen; A cover extending over the aforementioned expandable support frame and A stent graft apparatus including, A stent graft apparatus in which the geometric structure of the anchor member is altered in order to remove the anchor member from tissue that has grown on the anchor member.

[11] The stent graft apparatus according to item 10, wherein the anchor member is a coiled wire extending outward from the expandable support frame in the implanted state, and the anchor member takes a non-coiled form for removing the stent graft apparatus from the lumen.

[12] The stent graft apparatus according to item 10, wherein the anchor member comprises a first member and an opposing second member, the first member and the second member engage with each other in the implanted state, and the first member and the second member separate to remove the stent graft apparatus from the lumen.

[13] The stent graft device according to item 10, wherein the grown tissue fixes the stent within the lumen.

[14] A method for removing a stent graft device from the lumen, the method being: The present invention provides a stent graft device having an anchor member coupled thereto, wherein the anchor member extends along the length of the expandable frame, and the length defines a removal path for the anchor member; By applying mechanical force to the anchor member, the anchor member is removed from the stent graft device along the removal path. Methods that include...

[15] The method according to item 14, further comprising removing the stent graft device from the lumen.

[16] The stent graft device, Expandable frame and; A cover extending on the aforementioned expandable frame and Includes, The method according to item 14, wherein the anchor member is connected to the expandable frame.

[17] A method for removing a stent graft device from the lumen, the method being: To provide a stent graft device that incorporates an anchor member extending outward from the stent graft device, The method involves applying mechanical force to change the geometric structure of the anchor member and removing the anchor member along the removal path defined by the anchor member. Methods that include...

[18] The method according to item 17, further comprising removing the stent graft device from the lumen.

[19] The stent graft device, An expandable support frame incorporating the aforementioned anchor member; A cover extending over the aforementioned expandable support frame and The method described in item 17, including the method described in item 17.

[20] The method according to item 17, wherein the anchor member is a coiled wire, and changing the geometry includes uncoiling the coil of the anchor member. [twenty one] The method according to item 17, wherein the anchor member includes a first member and an opposing second member, the first member and the second member engage with each other, and changing the geometric structure includes separating the first member and the second member.

Claims

1. A transplantable device comprising an expandable support frame including an anchor comprising a wire extending outward from the expandable support frame, wherein the anchor has a first form in which the wire is coiled, the first form allowing tissue adjacent to the expandable support frame to grow on the anchor to form overgrown tissue when transplanted, and the first form defines a removal path in the overgrown tissue, and the anchor is configured such that the end of the wire changes from the first form to a second form along the removal path, thereby facilitating the removal of the anchor from the overgrown tissue on the anchor.

2. The portable device according to claim 1, wherein the anchor becomes straight when changing from the first form to the second form.

3. The implantable device according to claim 1, wherein the anchor is configured to be removed from the overgrown tissue on the anchor when the expandable support frame is in an expanded state.

4. The implantable device according to claim 1, wherein the anchor is configured such that the removal of the anchor from the overgrown tissue is non-traumatic.

5. The portable device according to claim 1, further comprising a cover positioned on the expandable support frame.

6. The transplantable device according to claim 5, wherein the anchor is positioned on the outside of the cover as a whole.

7. The portable device according to claim 1, wherein the anchor is configured to adapt from the first to the second form when a longitudinal force is applied to the anchor.

8. The portable device according to claim 1, wherein the anchor is located at at least one end of the expandable support frame.

9. The implantable device according to claim 1, wherein the expandable support frame comprises a stent.

10. The transplantable device according to claim 1, wherein the coiled wire includes a long member having a first end spaced apart from the expandable support frame and a second end connected to the expandable support frame, the first end being curved toward the second end in the first embodiment.

11. The transplantable device according to claim 10, wherein, in the second embodiment, the coiled wire becomes straight.

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