Non-invasive septal stent

Abstract

A stent includes a tubular body formed from one or more interwoven wires, the tubular body having opposite first and second open ends and a lumen extending therebetween. The stent further includes a first anchoring member disposed proximate the first open end and a second anchoring member disposed proximate the second open end, the first and second anchoring members each extending radially outward from the tubular body, the first and second anchoring members each having an outer diameter that is greater than an outer diameter of the tubular body disposed between the first and second anchoring members. A plurality of spacing members are disposed about the first open end and extend longitudinally beyond the first open end, wherein the outer diameter of the tubular body does not decrease when a pulling force is applied to the spacing members.

Description

[0001] This application is a divisional application of invention patent number 201880069606.7.

[0002] Cross-reference to related applications

[0003] This application claims priority to U.S. Provisional Patent Application No. 62 / 576,890, filed October 25, 2017, which is incorporated herein by reference in its entirety. Technical Field

[0004] This invention relates to apparatus, methods, and systems for implanting stents. More specifically, this invention relates to implantable stents having non-invasive septal components. Background Technology

[0005] Endoluminal prostheses are medical devices used to treat body cavities. One type of endoluminal prosthesis used to repair and / or treat various diseases in the body's blood vessels is a stent. A stent is a generally longitudinally tubular device formed of biocompatible material that can be used to open and support various cavities within the body. For example, stents can be used in the vascular system, genitourinary tract, gastrointestinal tract, esophagus, trachea / bronchus, and bile ducts, as well as a variety of other applications within the body.

[0006] Parallel metallic stents to the lumen are also used to drain pancreatic fluid and provide direct gallbladder and gallbladder drainage. Placement of a metallic stent adjacent to the cyst wall can lead to acute post-hemorrhage because the distal surface of the stent and the cyst wall come into contact due to the reduction in cyst volume caused by drainage. Repetitive interactions may be required between the stent tip (e.g., the tip of a multi-pointed stent) and the cyst wall. Therefore, when intraluminal prostheses (e.g., stents) are used for drainage, there is a continuous need to mitigate or eliminate this tissue interaction and to stop bleeding. Summary of the Invention

[0007] The present invention relates to various embodiments of a support (e.g., a braided support) having a complete spacer mechanism.

[0008] A first exemplary support includes a tubular body formed by one or more interlaced lines, the tubular body having opposing first and second open ends and a cavity extending therebetween, the tubular body defining a longitudinal axis extending between the first and second open ends. A first anchoring member is disposed adjacent to the first open end, and a second anchoring member is disposed adjacent to the second open end. The first and second anchoring members each extend radially outward from the tubular body and each has an outer diameter larger than the outer diameter of the tubular body disposed between the first and second anchoring members. A plurality of spacer members are disposed around the periphery of the first open end and extend longitudinally beyond the first open end, wherein the outer diameter of the tubular body does not decrease when a tensile force is applied to the spacer members.

[0009] Alternatively or additionally for any of the examples above, each spacer member has first and second legs extending along a portion of the tubular body toward the second open end.

[0010] Alternatively or additionally for any of the above examples, the spacer extends radially outward beyond the outer diameter of the tubular body.

[0011] Alternatively or additionally for any of the examples above, each spacer member is formed by a single loop of wire.

[0012] Alternatively or additionally for any of the above examples, the spacer is formed separately from the tubular body and is connected to the inner wall of the tubular body.

[0013] Alternatively or additionally, in any of the above examples, the spacer members are interwoven with the tubular body.

[0014] Alternatively or additionally, for any of the examples above, the spacer is less flexible than the tubular body.

[0015] Alternatively or additionally for any of the above examples, the plurality of spacer members include a first set of spacer members having a first length and a second set of spacer members having a second length shorter than the first length.

[0016] For any of the examples above, alternatively or additionally, the first set of spacers is more flexible than the second set of spacers.

[0017] Alternatively or additionally for any of the above examples, the stent may further include a covering that extends over the entire tubular body, the first and second anchoring members, and the plurality of spacer members.

[0018] Alternatively or additionally for any of the above examples, at least one spacer member has variable flexibility along its length.

[0019] Alternatively or additionally for any of the above examples, at least one spacer member is formed by a tapered line having a first thickness in a first region adjacent to the tubular body and a second thickness in a second region disposed away from the tubular body.

[0020] For any of the examples above, alternatively or additionally, the second thickness is less than the first thickness, resulting in greater flexibility in the second region.

[0021] Alternatively or additionally for any of the examples above, the first and second anchoring members extend perpendicular to the longitudinal axis.

[0022] Alternatively or additionally for any of the examples above, the support may further include a retrieval element disposed at the second opening end.

[0023] Another exemplary support includes a tubular body formed by one or more interlaced lines, the tubular body having opposing first and second open ends and a cavity extending therebetween, the tubular body defining a longitudinal axis extending between the first and second open ends. A first spacer group is disposed around the periphery of the first open end and extends longitudinally beyond the first open end and radially outward beyond the outer diameter of the tubular body, the first spacer group having a first length. A second spacer group is disposed around the periphery of the first open end and extends longitudinally beyond the first open end and radially outward beyond the outer diameter of the tubular body, the second spacer group having a second length shorter than the first length, and wherein, when a tensile force is applied to the first and / or second spacer group, the outer diameter of the tubular body does not decrease.

[0024] Alternatively or additionally for any of the above examples, a first anchoring member is disposed adjacent to the first opening end and a second anchoring member is disposed adjacent to the second opening end. Each of the first and second anchoring members extends radially outward from the tubular body and each has an outer diameter larger than the outer diameter of the tubular body disposed between the first and second anchoring members.

[0025] For any of the examples above, alternatively or additionally, the first set of spacers is more flexible than the second set of spacers.

[0026] Alternatively or additionally for any of the above examples, at least one spacer in the first or second spacer group is formed by a tapered line having a first thickness in a first region adjacent to the tubular body and a second thickness in a second region disposed away from the tubular body, wherein the second thickness is less than the first thickness, resulting in greater flexibility in the second region.

[0027] Another example is a method for draining fluid from a cyst, which involves implanting a stent through a tissue wall, wherein a first open end of the stent is disposed within the cyst, and a second open end of the stent is disposed outside the cyst. The stent includes a tubular body formed by one or more interlaced lines defining a lumen extending between the first and second open ends. The stent includes a plurality of spacer members disposed peripherally to the first open end and extending longitudinally beyond it. Fluid is drained from the cyst through the lumen of the stent, wherein when the cyst drains, the cyst wall contacts one or more of the plurality of spacer members, which prevent the cyst wall from contacting the first open end of the stent.

[0028] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of the invention. The following drawings and detailed description illustrate some of these embodiments in more specific terms. Attached Figure Description

[0029] In the accompanying drawings, which are not necessarily drawn to scale, similar figures may describe similar components in different views. The drawings generally illustrate various embodiments discussed in the invention by way of example and not limitation.

[0030] Figure 1 is a side view of a stent disposed adjacent to the bladder wall in the prior art;

[0031] Figure 2 This is a side view of a hollow tubular body adjacent to the cyst wall according to an embodiment of the present invention;

[0032] Figure 3 for Figure 2 End view of the bracket;

[0033] Figure 4 An end view of a bracket according to another embodiment of the present invention;

[0034] Figure 5 for Figure 2 A perspective view of the stent end placed in the tissue structure;

[0035] Figure 6A and 6B A partial sectional side view of a scaffold implanted in a target tissue structure according to another embodiment of the present invention;

[0036] Figure 7 This is a side view of a bracket according to another embodiment of the present invention;

[0037] Figure 8 for Figure 7 A perspective view of the scaffold tip within the tissue structure; and

[0038] Figure 9 This is a side view of a bracket according to another embodiment of the present invention.

[0039] While the invention can be modified and alternatively implemented in various ways, its details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the invention to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0040] The terms defined below shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0041] Whether explicitly stated or not, all numerical values ​​herein are assumed to be modified by the term "about". The term "about" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the referenced value (e.g., having the same function or result). In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0042] A description of a range of numbers represented by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0043] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include a plural of indicators unless the content expressly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless the content expressly indicates otherwise.

[0044] It should be noted that the embodiments described by references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification may include a particular feature, structure, or characteristic. However, such description does not necessarily mean that all embodiments include the specific feature, structure, and / or characteristic. Furthermore, when a particular feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that, unless expressly stated otherwise, these features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether explicitly described or not.

[0045] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily drawn to scale, depict exemplary embodiments and are not intended to limit the scope of this disclosure.

[0046] Figure 1 illustrates a prior art braided scaffold 5 placed adjacent to a tissue wall (e.g., cyst wall 40). Due to the reduction in cyst volume caused by drainage through the scaffold lumen, the distal end 7 of the scaffold 5 may come into contact with the cyst wall 40, potentially leading to tissue inflammation and thus bleeding and / or vascular infection. Furthermore, premature contact between the scaffold end and the tissue wall may leave residual cystic fluid that cannot be effectively drained due to obstruction of the scaffold lumen.

[0047] Figure 2 A stent 10 is shown, comprising a tubular body 20 and a plurality of non-invasive septal members 30 extending beyond the ends of the tubular body 20. The tubular body 20 is a hollow tubular structure having an open first end 22, an open second end 24, and a lumen extending therebetween. The tubular body 20 may be formed from one or more threads 15. The threads 15 may be woven, braided, wound, knitted, and combinations thereof to form the tubular body 20.

[0048] The support 10 may include multiple wires 15 of a metallic material, such as nitinol or a nitinol-containing material, or other nickel-titanium alloys. For example, in some cases, the wires 15 may have a diameter of approximately 0.11 inches. The number and diameter of the wires 15 may be the same or different. Figure 2 The description herein is not limiting; other numbers of wires 15 and other wire diameters may be used as appropriate. Ideally, an even number of wires 15 may be used, for example, approximately 10 to approximately 36 wires 15.

[0049] Ideally, line 15 is made of any suitable portable material, including but not limited to nitinol, stainless steel, and nonmagnetic alloys such as Elgilo. Cobalt-based alloys, platinum, gold, titanium, tantalum, niobium, polymer materials, and combinations thereof. Useful, non-limiting examples of polymeric scaffold materials include poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolic acid (PGA), poly(L-lactide-co-D,L-lactide) (PLLA / PLA), poly(L-lactide-co-glycolic acid) (PLLA / PGA), poly(D,L-lactide-co-glycolic acid) (PLA / PGA), poly(glycolic acid-co-trimethylene carbonate) (PGA / PTMC), polydioxanone (PDS), polycaprolactone (PCL), polyhydroxybutyrate (PHBT), polyphosphazene, poly(D,L-lactide-co-caprolactone) (PLA / PLC), poly(lactide-co-caprolactone) (PGA / PCL), polyphosphates, etc. The wires made of polymeric materials may also include radiopaque materials, such as metal-based powders, granules, or pastes that can be part of the polymeric material. For example, the radiopaque material may be mixed with the polymeric component forming the polymeric wire and subsequently shaped into the scaffold 10 as described herein. Alternatively, the radiopaque material may be used on the surface of the metal or polymeric wires 15 of the scaffold 10. In any embodiment, a variety of radiopaque materials and their salts and derivatives may be used, including, but not limited to, bismuth, barium and its salts (such as barium sulfate), tantalum, tungsten, gold, platinum, and titanium. Other useful radiopaque materials can be found in U.S. Patent No. 6,626,936, the contents of which are incorporated herein by reference. Metal composites as radiopaque materials are also contemplated. The scaffold may be selectively radiopaque at desired locations along the wire, or it may be completely radiopaque.

[0050] In some cases, line 15 may have a composite structure having a core of tantalum, gold, platinum, tungsten, iridium, or a combination thereof, and an outer layer or component of nitinol to provide a composite line for improving transmissivity or visibility. In one example, the core may be platinum and the outer layer may be nitinol. Based on the percentage of the entire cross-section, the platinum core may represent at least about 10% of line 15. Furthermore, nitinol without shape memory treatment (such as nitinol in martensitic and austenitic phases through heating, forming, and cooling) as the outer layer is also useful. Further details of such composite lines can be found in U.S. Patent 7,101,392, the contents of which are incorporated herein by reference. Line 15 may be made of nitinol or a composite line having a platinum core and a nitinol outer layer. Further, if required by a welding process (such as MIG welding), the filler weld material may also be made of nitinol, stainless steel, chromium-based alloys (such as Elgiloyl nonmagnetic alloys), platinum, gold, titanium, tantalum, niobium, and combinations thereof.

[0051] The tubular body 20 may have one or more anchoring members 26, 28 respectively adjacent to the first and second ends. The anchoring members 26, 28 may be regions extending radially outward from the tubular body 20 to form flanges. Figure 2 In the example shown, anchoring members 26 and 28 extend circumferentially and radially outward from the tubular body 20, substantially perpendicular to the longitudinal axis X of the support 10. The outer diameter of anchoring members 26 and 28 may be larger than the outer diameter of the support body portion disposed between anchoring members 26 and 28.

[0052] The stent 10 may include a plurality of non-invasive septal members 30 disposed around the first end 22 of the tubular body, such as Figure 2As shown. In other examples, multiple spacer members 30 may be provided around both the first end 22 and the second end 24. The spacer members 30 are configured to hold the first end 22 of the stent away from the cyst wall 40 as the cyst is drained and the cyst wall 40 advances toward the first end 22. The spacer members 30 prevent the cyst wall 40 of the cyst from contacting the first end 22 of the tubular body 20 of the stent 10. Even when the cyst is completely drained, the spacer members 30 can prevent contact between the cyst wall and the first end 22 of the tubular body 20, thereby preventing damage to the tissue wall by contact with the exposed first end 22 of the stent. In some cases, the spacer members 30 may be formed by a thread 15 defining the tubular body 20. For example, the spacer members 30 may be formed by extending one or more threads 15 from the first end 22 of the tubular body 20 and then weaving the threads back into the tubular body 20. In other examples, the spacer members 30 may be formed by additional threads added to the previously formed tubular body 20. The spacer member 30 may have a first region 36 disposed adjacent to the first end 22 of the tubular body 20, and an end 38, which is the point on the spacer member 30 furthest from the first end 22 of the tubular body 20 as measured along the length of the spacer member 30. The spacer member 30 may be formed of a biocompatible material, such as the metal and polymeric materials listed above for the wire 15 of the tubular body 20. The spacer member 30 may be self-supporting, such that the spacer member 30 may be cantilevered and / or extend from the first end 22 of the tubular body 20 while maintaining its shape. However, when the spacer member 30 engages the cavity wall, the radial resistance provided by the spacer member 30 may be insufficient to anchor the stent 10.

[0053] exist Figure 2 In the example shown, each spacer member 30 is formed from a single thread 35, formed in a loop and attached to a previously formed tubular body 20, the ends of which define legs 32, 34 attached to the inner surface of the tubular body 20. In other examples, multiple spacer members 30 may be formed from a single thread. Legs 32, 34 may be welded to the interior of the tubular body 20. Alternatively, legs 32, 34 may be attached by adhesive, thread wrapping, or other suitable permanent connection. In some cases, legs 32, 34 may be woven into the thread 15 of the tubular body 20. Legs 32, 34 may extend from the first end 22 to the second end 24 for 25% or more, 50% or more, or 75% or more of the length of the tubular body 20. In some examples, legs 32, 34 extend from the first end 22 to the second end 24 over the entire length of the tubular body 20. Legs 32, 34 may extend substantially parallel to or at an angle relative to the longitudinal axis along the inner surface of the tubular body 20, and thus extend in a helical direction. In some examples, legs 32 and 34 can be juxtaposed along the path of line 15 in the weave pattern of the support 10.

[0054] In some cases, legs 32, 34 from one spacer member 30 may overlap with legs 32, 34 of another spacer member 30. For example, in some embodiments, legs 32, 34 of the first spacer member 30 may extend along the inner surface of the tubular body 20 in a first helical direction, while legs 32, 34 of the second spacer member 30 may extend along the inner surface of the tubular body 20 in the opposite second helical direction and intersect with legs 32, 34 of the first spacer member 30. In other examples, all legs 32, 34 of all spacer members 30 extend along the interior of the tubular body 20 without contacting legs 32, 34 of another spacer member 30. For example, legs 32, 34 of each spacer member 30 may extend along the interior of the tubular body 20 in the same helical direction.

[0055] The wire 35 forming the spacer 30 may have the same or different properties as the wire 15 forming the tubular body 20. For example, the wire 35 may have the same or different stiffness or flexibility, all of which may be tailored to a specific application. In some embodiments, the wire 35 forming the spacer 30 may be stiffer than the support wire 15 forming the tubular body 20 of the support 10. In some cases, the wire 35 forming the spacer 30 may be made of a different material and / or may have a different diameter than the support wire 15. In some cases, the wire 35 forming the spacer 30 may be stainless steel, while the support wire 15 may be formed of a nickel-titanium alloy (such as nitinol). The material forming the spacer wire 35 may have a stiffness greater than, equal to, or less than that of the material forming the tubular body 20 and / or the material forming the spacer wire 35 may have a modulus of elasticity (Young's modulus) greater than, equal to, or less than that of the material forming the tubular body 20. The materials, diameters, and pretreatment choices of the lines 35, 15, and the support structure are factors that can be varied to achieve specific support properties. Additionally, at least one of the spacer members 30 can be made radiopaque by various methods, such as with a coating or surface material, with a strip, or as part of the support material. Colors or different surface materials can also be added to the spacer members 30 to visually distinguish them from the remaining support lines 15.

[0056] The spacer member 30 is configured such that applying tensile or compressive forces to the spacer member 30 does not reduce the outer diameter of the tubular body 20. In an example, the spacer member 30 is formed by additional thread attached to the preceding tubular body 20. This attachment ensures that pulling on the spacer member 30 does not reduce the outer diameter of the tubular body 20. For example, welding the spacer member 30 or using an adhesive to attach the spacer member 30 to one or more thread intersections on the inner surface of the tubular body 20 can prevent the spacer member 30 from interacting with the woven or braided structure of the tubular body 20 to reduce its diameter when the spacer member 30 is pulled or compressed. In an example, the spacer member 30 is made of one or more threads used to form the tubular body 20, and portions of the threads forming the spacer member 30 can be stabilized relative to the tubular body 20 so that pulling on the spacer member 30 does not reduce the outer diameter of the tubular body 20. In one example, stabilization may include welding one or more final thread intersections at the first end 22 of the tubular body, where the threads forming the spacer member 30 exit the tubular body 20. In other examples, adhesive or additional thread wrapping can be used to stabilize the spacer member 30 relative to the tubular body 20. Therefore, the spacer member 30 does not function as a retrieval element to reduce the diameter of the support 10 used for removal. In some examples, a separate retrieval element 80 may be provided at the second end 24 and / or the first end 22 of the tubular body 20. Figure 2 In the example shown, the stent 10 includes a retrieval element 80 attached to the second end 24 of the tubular body 20. In some cases, the retrieval element 80 may be a thread or suture woven through the thread 15 of the tubular body 20 at the second end of the tubular body 20.

[0057] The spacer member 30 extends longitudinally beyond the first end 22 of the tubular body 20. The spacer member 30 may extend beyond the first end 22 of the tubular body 20 by a distance D. In some cases, for example, the distance D may be 5% to 50%, 10% to 50%, 10% to 30%, or 5% to 30% of the total length of the tubular body 20. In some examples, the spacer member 30 may extend beyond the first end by 8 mm to 15 mm. The spacer member 30 may also extend radially away from the tubular body 20, exceeding the outer diameter of the tubular body 20 as measured at the first end 22. Figure 2 and 3As shown in the example, the spacer member 30 also extends radially beyond the outer diameter of the anchor members 26, 28. For example, the spacer member 30 may extend radially outward from the longitudinal axis of the support 10 at an angle of approximately 20 degrees to approximately 85 degrees, approximately 25 degrees to approximately 75 degrees, approximately 30 degrees to approximately 60 degrees, or approximately 45 degrees to approximately 75 degrees. The angle of the spacer member 30 relative to the longitudinal axis X may be, for example, 25 degrees or more, 30 degrees or more, 35 degrees or more, 40 degrees or more, 45 degrees or more, 50 degrees or more, 55 degrees or more, 60 degrees or more, 65 degrees or more, 70 degrees or more, 75 degrees or more, 80 degrees or more, or 85 degrees or more, or other desired angles. The spacer member 30 shown in the figure is shaped as an elongated ring. In other examples, the spacer member 30 may be any desired shape, including circular, elliptical, teardrop-shaped, etc. The end 38 of the spacer member 30 may be rounded, such as... Figure 3 As shown, this provides a non-traumatic end that engages with the cyst wall 40.

[0058] The spacer member 30 can provide a structure with the required stiffness to hold the stent 10 away from the spacer orientation of the capsule wall 40, thereby preventing damage to the tissue wall due to contact with the first end 22 of the tubular body 20. In some examples, the flexibility of the spacer member 30 varies along its length. The spacer member 30 can be formed of a line having a variable thickness along its length. In one example, such as Figure 4 As shown, the stent 100 includes at least one spacer member 130, which is formed of a wire having a first thickness in a first region 136 adjacent to the tubular body 120, and the wire gradually tapers and / or transitions to a second thickness at an end 138. Figure 4 As shown, the second thickness can be less than the first thickness to achieve a more flexible septum member 130 at the end 138. The more flexible end 138 allows the septum member 130 to bend slightly at the end 138, reducing the possibility of tissue damage when it contacts the capsule wall 40.

[0059] In some embodiments, the stents 10, 100 may include covers 70, 170 disposed over at least a portion of the tubular bodies 20, 120 of the stents 10, 100. For example, covers 70, 170 may completely cover the entire length of the stents 10, 100, forming fully covered stents, wherein all gaps defined in the braided or woven pattern are covered by covers 70, 170 to prevent tissue ingrown growth and fluid leakage into the lumens of the tubular bodies 20, 120. In other examples, covers 70, 170 may cover only a portion of the length of the tubular bodies 20, 120 of the stents 10, 100, forming partially covered stents, wherein a portion of the gaps defined in the braided or woven pattern remains exposed to allow tissue ingrown growth. In some cases, spacer members 30, 130 may be covered by covers 70, 170, so that the entire stents 10, 100, including the entire tubular bodies 20, 120 and spacer members 30, 130, may be covered by covers 70, 170. For example, covers 70, 170 may extend through and fill the space between adjacent sides of the ring formed by the lines forming spacers 30, 130, while the gap between adjacent spacers 30, 130 may be without any covering material, allowing liquid to flow between spacers 30, 130 around the ends of supports 10, 100 and into the cavities of supports 10, 100. In some cases, supports 10, 100 may be immersed in a solution of silicone resin or other polymers to form covers 70, 170. In other cases, polymer sheets or tubes may be placed around and / or within tubular bodies 20, 120 to form covers 70, 170. Covers 70, 170 may be disposed on the outer or inner surface of tubular bodies 20, 120, or on both the inner and outer surfaces of tubular bodies 20, 120, thereby embedding supports 10, 100 into the polymer material. The coating or covering can be a polymeric covering, such as polytetrafluoroethylene (PTFE) or silicone covering; however, other coverings, specifically, can use elastic polymers. Non-limiting examples of useful polymeric materials include polyesters, polypropylene, polyethylene, polyurethane, polynaphthalene, polytetrafluoroethylene, expanded polytetrafluoroethylene, silicone resins, and combinations and copolymers thereof.

[0060] Figure 5 It shows Figure 2The stent 10 is implanted at one end representing the tissue portion of the cyst. In the method of cyst drainage, the first end of the stent 10 can be implanted through an opening in the tissue wall using a first anchoring member 26, the first end 22 of a tubular body 20, and three spacer members 30, all of which protrude through the tissue wall 46 into the cavity representing the cyst. A second anchoring member 28 can be disposed on the other side of the tissue wall to secure the stent 10 through the tissue wall 46. The larger diameter of the first anchoring member 26 holds the stent 10 in place, and the spacer members 30 are disposed within the cyst. As the cyst volume decreases due to drainage through the cavity of the stent 10, the lower cyst wall (see Figure 2 The septum member 30, rather than the first end 22 of the tubular body 20, will contact the cyst wall. The septum member 30 prevents the cyst wall from contacting the first end 22 of the tubular body 20. The septum member 30 keeps the first end 22 of the tubular body 20 away from the cyst wall and allows fluid to bypass the first end 22 of the tubular body 20 between adjacent septum members 30 and enter the lumen of the tubular body 20 to drain fluid from the cyst. Even when all fluid has been drained from the cyst, the cyst wall is separated from the first end 22 of the tubular body 20 by the septum member 30. This separation can reduce or eliminate tissue irritation and / or resulting bleeding.

[0061] Figure 6A and 6B Another example is shown, in which a stent 200 is disposed through a tissue wall 46, positioned within the lumen of a cyst 242 via a first end 222 of the stent 200. The stent 200 includes a tubular body 220, and a first set of spacer members 230 having a first length extending from a first region 236 adjacent to the first end 222 of the tubular body 220 to a distal end 238 of the spacer member 230. The stent 200 includes a second set of spacer members 231 extending from a first region 237 adjacent to the first end 222 of the tubular body 220 to a distal end 239 of the spacer member 231. A second length of the second set of spacer members 231 is shorter than the first length of the first set of spacer members 230, such that the distal end 239 of the second set of spacer members 231 is positioned closer to the first end 222 of the tubular body 220 than the distal end 238 of the first set of spacer members 230. Figure 6A As shown, when fluid in cyst 242 drains through the lumen of stent 200 in the direction of arrow 260, cyst wall 40 collapses and engages with the end 238 of the first set of spacer members 230. Subsequently, as... Figure 6B As shown, as the cyst continues to drain and the cyst wall 40 advances toward the first end 222 of the tubular body 220, the first set of spacers 230 can be bent or folded back toward the second end 224 of the tubular body 220 in the direction of arrow 250, thereby allowing the end 239 of the second set of spacers 231 to engage with the cyst wall 40.

[0062] The first set of spacers 230 may be more flexible than the second set of spacers 231, thereby allowing the first set of spacers 230 to bend, buckle, or partially collapse as the capsule wall 40 advances toward the first end 222 of the tubular body 220. Like the spacers 30 described above, the first and second sets of spacers 230, 231 may have variable flexibility along their length. In particular, one or both of the first and second sets of spacers 230, 231 may have an end 238 that is more flexible than the first region 236 adjacent to the tubular body 320. Similar to the stent 10 described above, when the first and second sets of spacers 230, 231 engage with the cavity wall, the radial resistance provided by the spacers 230, 231 is insufficient to anchor the stent 200. Similar to the spacers 30 described above, the spacers 230, 231 are configured such that applying tensile or compressive forces to the spacers 230, 231 will not reduce the outer diameter of the tubular body 220.

[0063] exist Figure 7 Another example of a support 300 having a tubular body 320 and a plurality of spacer members 330 is shown. In this example, the tubular body 320 is formed by one or more support wires 315 and has substantially the same diameter along its length, without anchoring members. The plurality of spacer members 330 may be attached to a first end 322, a second end 324, or both of the tubular body 320. The spacer members 330 may be formed by the wires 315 forming the tubular body 320, or by wires 335 attached to the tubular body 320 after its formation. As with the support 10 discussed above, the wires 335 may be attached to the tubular body 320 by welding, adhesive, wire wrapping, or other suitable permanent connection. Likewise, as with the support 10 described above, the spacer members 330 are configured such that applying tensile or compressive forces to the spacer members 330 does not reduce the outer diameter of the tubular body 320.

[0064] The line 335 may be tapered to provide variable flexibility along the spacer member 330. For example, the line 335 may have a first thickness in a first region 336 adjacent to the tubular body 320 and gradually decrease to a second smaller thickness in the region at the end 338 of the spacer member 330, resulting in the end 338 being more flexible than the first region 336. This allows the end 338 of the spacer member 330 to bend or fold back toward the other end of the tubular body 320 once it contacts the tissue wall. The stiffer first region 336 keeps the end of the tubular body 320 away from the tissue wall, thereby allowing fluid to drain around the first end 322 of the tubular body 320 into the lumen of the stent 300. The flexibility of the end 338 of the spacer member 330 allows the spacer member 330 to engage gently with the tissue wall beneath the stent 300, but the radial resistance provided by the spacer member 330 is insufficient to anchor the stent 300 to the lumen wall extending substantially parallel to the longitudinal axis. The relatively rigid first region 336 can provide sufficient resistance in the longitudinal direction to anchor the scaffold 300, which is positioned perpendicular to the tissue wall. Figure 8 The first end 322 of the tubular body 320 is shown extending through an opening in the tissue wall 46. In this example of the stent 300, the spacer member 330 has a dual function: holding the stent 300 within the opening in the tissue, and spaced the first end 322 of the tubular body 320 of the stent 300 from the tissue wall when the cyst drains.

[0065] Figure 9Another example of a support 400 is shown, which has a tubular body 420 formed by weaving, braiding, or knitting one or more threads 415, or wound into a tubular body 420. The support 400 includes a first set of spacers having a first length extending from a first region 436 adjacent to a first end 422 of the tubular body 420 to an end 438 of the spacers 430. The tubular body 400 includes a second set of spacers 431 extending from a first region 437 adjacent to the first end 422 of the tubular body 420 to an end 439 of the spacers 431. A second length of the second set of spacers 431 is shorter than the first length of the first set of spacers 430, thereby positioning the end 439 of the second set of spacers 431 closer to the first end 422 of the tubular body 420 than the end 438 of the first set of spacers 430. The first set of spacers 430 may be more flexible than the second set of spacers 431, allowing the first set of spacers 430 to bend, fold, or partially collapse as the cyst drains and the tissue wall advances toward the first end 422 of the tubular body 420. In this example, the tubular body 420 has substantially the same diameter along its length and has no anchoring members. The first and second sets of spacers 430, 431 may be attached to the first end 422 of the tubular body 420, the second end 424 of the tubular body 420, or both. The spacers 430, 431 may be formed by the line 415 forming the tubular body 420 or by the line 435 attached to the tubular body 420 after its formation. As with the stent 10 discussed above, the spacers 430, 431 are configured such that applying tensile or compressive forces to the spacers 430, 431 does not reduce the outer diameter of the tubular body 420. The line 435 may be gradually tapered to provide variable flexibility along the spacers 430, 431. For example, the line 435 may have a first thickness in a first region 436, 437 adjacent to the tubular body 420, and gradually decrease or transition to a second, smaller thickness in the region of the ends 438, 439, such that the ends 438, 439 are more flexible than the first region 436, 437. Once the tubular body 420 contacts the tissue wall, this allows the ends 438, 439 of the spacers 430, 431 to bend back toward the second end 424 of the tubular body 420. The stiffer first region 436, 437 keeps the ends of the tubular body 420 away from the tissue wall. The flexibility of the ends 438, 439 of the spacers 430, 431 allows the spacers 430, 431 to gently engage with the tissue wall beneath the stent 400, but provides insufficient radial resistance to anchor the stent 400 to the cavity wall extending substantially parallel to the longitudinal axis. The relatively rigid first regions 436 and 437 can provide sufficient resistance in the longitudinal direction to anchor the scaffold 400 arranged perpendicular to the tissue wall.

[0066] Similar to scaffold 10, scaffolds 100, 200, 300, and 400 may include a covering, similar to the coverings 70 and 170 described above, which is disposed over at least a portion of the tubular body of scaffolds 100, 200, and 300. For example, the covering may completely cover the entire length of the tubular body of scaffolds 100, 200, 300, and 400, thereby forming a fully covered scaffold, wherein all gaps defined in the woven or braided pattern are covered by the covering to prevent tissue inward growth and to prevent fluid from seeping into the lumen of the tubular body. In other examples, the covering may only cover a portion of the length of the tubular body of scaffolds 100, 200, 300, and 400, thereby forming a partially covered scaffold, wherein a portion of the gaps defined in the woven or braided pattern remain uncovered, thereby allowing tissue inward growth. In some cases, spacers 130, 230, 330, and 430 may be covered with a covering, so that the entire stent 100, 200, 300, and 400, including both the entire tubular body and the spacers 130, 230, 330, and 430, may be covered with a covering. For example, the covering may extend and fill the space between adjacent sides of a ring formed by the lines forming the spacers 130, 230, 330, and 430, while the gaps between adjacent spacers 130, 230, 330, and 430 may not have any covering material, thereby allowing liquid to flow between the spacers 130, 230, 330, and 430 around the ends of the stent members 100, 200, 300, and 400 and into the cavities of the stent 100, 200, 300, and 400.

[0067] Various stent types and stent configurations are available for stents 10, 100, 200, 300, and 400. For example, stents 10, 100, 200, 300, and 400 can be self-expanding stents or expandable balloon stents. Stents 10, 100, 200, 300, and 400 can be radially contracted into a compressed or collapsed configuration for delivery, and then expandable into an expandable configuration during intracavitary deployment. Therefore, stents 10, 100, 200, 300, and 400 can be described as radially expandable or deformable. Self-expanding stents include those that have a spring-like effect that causes the stent to expand radially, or stents that expand due to the memory properties of the stent material for a specific configuration at a specific temperature. The stent configuration can also be selected from a variety of geometries. For example, a wire stent can be fixed in a continuous spiral pattern, with or without wavy or serrated edges in the wire, to form a radially deformable stent. Individual rings or circular components can be joined together (e.g., by struts, stitches, welding, or interlacing or locking of rings) to form a tubular support. In other embodiments, supports 10, 100, 200, 300, 400 can be formed as an integral tubular component by etching or cutting a pattern of interconnected struts from the tubular body.

[0068] It should be understood that the present invention is illustrative in many respects only. Changes in detail may be made, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of the invention. To the appropriate extent, this may include the use of any feature of an exemplary embodiment used in other embodiments. The scope of the invention is, of course, defined by the language expressed in the appended claims.

Claims

1. A stent comprising: A tubular body formed by one or more interlaced lines, the tubular body having opposing first and second open ends and a cavity extending therebetween; A first anchoring member is disposed near the first opening end and a second anchoring member is disposed near the second opening end. The first anchoring member and the second anchoring member each extend circumferentially and radially outward from the tubular body. The outer diameter of the first anchoring member and the second anchoring member is larger than the outer diameter of the tubular body disposed between the first anchoring member and the second anchoring member. as well as A plurality of spacer members are disposed around the first opening end and extend longitudinally beyond the first opening end, wherein the plurality of spacer members are formed by lines separate from the interlacing lines forming the tubular body, the lines forming the spacer members being attached to the previously formed tubular body, wherein each of the spacer members has a first leg and a second leg extending along a portion of the tubular body toward the second opening end, and each spacer member is formed by a single line formed in a loop and extending from the interior of the tubular body; The plurality of spacer members are configured to keep the first opening end away from the capsule wall.

2. The support as claimed in claim 1, wherein the first leg and the second leg of the spacer member are interwoven with the tubular body.

3. The support as claimed in claim 1 or 2, wherein the spacer extends radially outward beyond the outer diameter of the tubular body.

4. The support as claimed in claim 1 or 2, wherein the spacer extends radially outward beyond the outer diameter of the tubular body, wherein the spacer is longitudinally spaced from the first anchoring member and the second anchoring member.

5. The stent of claim 1 or 2, wherein the wire forming the spacer member is less flexible than the wire forming the tubular body.

6. The support as claimed in claim 1 or 2, wherein the plurality of spacers comprises a first set of spacers having a first length and a second set of spacers having a second length shorter than the first length.

7. The support as claimed in claim 6, wherein the first set of spacers is more flexible than the second set of spacers.

8. The support as claimed in claim 1 or 2, further comprising a cover extending over the entire tubular body, the first anchoring member and the second anchoring member, and the plurality of spacer members.

9. The stent of claim 8, wherein the gap between adjacent spacers is not covered, thereby allowing liquid to flow between adjacent spacers and into the cavity of the tubular body.

10. A stent comprising: A tubular body formed by one or more interlaced lines, the tubular body having opposing first and second open ends and a cavity extending therebetween; A first anchoring member is disposed near the first opening end and a second anchoring member is disposed near the second opening end. The first anchoring member and the second anchoring member each extend circumferentially and radially outward from the tubular body. The outer diameter of the first anchoring member and the second anchoring member is larger than the outer diameter of the tubular body disposed between the first anchoring member and the second anchoring member. as well as A plurality of spacer members are disposed around the first opening end and extend longitudinally beyond the first opening end, each spacer member having a first leg and a second leg extending along a portion of the tubular body toward the second opening end, and each spacer member being formed by a single line formed in a ring shape and extending from the interior of the tubular body; At least a portion of the spacer member is longitudinally spaced from the first anchor member and the second anchor member, and extends radially outward beyond the outer diameter of the first anchor member and the second anchor member.

11. The support of claim 10, further comprising a cover extending over the entire tubular body, the first anchoring member and the second anchoring member, and the plurality of spacer members.

12. The stent of claim 11, wherein the gap between adjacent spacers is not covered, thereby allowing liquid to flow between adjacent spacers and into the cavity of the tubular body.

13. The stent of claim 10 or 11, wherein the spacer member is formed by a line separate from the interlacing lines forming the tubular body, the line forming the spacer member being attached to the inner wall of the previously formed tubular body.

14. The support as claimed in claim 10 or 11, wherein the first leg and the second leg are welded to the tubular body.

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