Bioresorbable medical devices

Abstract

Various aspects of the present disclosure relate to devices, systems and methods that include a plurality of absorbable filaments disposed in a support structure and configured to degrade over a defined period of time and a membrane disposed around the plurality of absorbable filaments, the membrane configured to retain debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of Provisional Patent Application No. 62 / 794,312, filed January 18, 2019, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] The present disclosure generally relates to implantable medical devices. More specifically, the present disclosure generally relates to fully or partially absorbable implantable medical devices for repairing cardiac and vascular defects or tissue openings, such as a patent foramen ovale (PFO) or shunt in the heart, vascular system, or other locations in a patient's body. Background Art

[0004] The implantation of occluding devices through open heart surgery has historically been used to treat heart defects or tissue openings. Recently, in order to avoid the trauma and complications associated with open heart surgery, a variety of transcatheter closure techniques have been developed. In such techniques, the occluding device is delivered to the opening or defect site through a catheter, where the occluding device is deployed. Summary of the invention

[0005] According to one example ("Example 1"), a device includes a support structure comprising: a plurality of absorbable filaments configured to support tissue and degrade over a defined period of time; and a diaphragm disposed around the plurality of absorbable filaments and configured to accommodate debris (fragments) of the plurality of absorbable filaments in response to breakage or degradation of the filaments and promote at least one of tissue encapsulation of tissue ingrowth into the diaphragm and at least a portion of the diaphragm.

[0006] According to another example ("Example 2") further to the device of Example 1, the membrane is configured to promote healthy tissue growth and remain with the tissue after the absorbable filaments degrade.

[0007] According to another example ("Example 3") further to the apparatus of any of Examples 1-2, the absorbable filaments are at least one of bioabsorbable and bioerodible.

[0008] According to another example ("Example 4") that is further than the device of any one of Examples 1-3, the device also includes a proximal hub-shaped portion disposed at the proximal end of the multiple absorbable filaments, a distal hub-shaped portion disposed at the distal end of the multiple absorbable filaments, a proximal disk-shaped portion configured to contact a first side of a tissue wall, and a distal disk-shaped portion configured to contact a second side of the tissue wall.

[0009] According to another example ("Example 5") that is further than the device of Example 4, the device also includes an elastic tensile member, which is configured to be connected to the proximal hub and the distal hub and is disposed within the supporting structure, and the elastic tensile member is configured to juxtapose the proximal disk-shaped portion with a first side of the tissue wall and to juxtapose the distal disk-shaped portion with a second side of the tissue wall.

[0010] According to another example ("Example 6") that is further than the device of Example 4, the device also includes a capture member that is configured to connect the proximal hub and the distal hub within the support structure when engaged, and the capture member is configured to juxtapose the proximal disk portion with a first side of the tissue wall and to juxtapose the distal disk portion with a second side of the tissue wall.

[0011] According to another example ("Example 7") further relative to the apparatus of Example 4, the proximal hub includes a proximal portion of the plurality of absorbable filaments, and the distal hub includes a distal portion of the plurality of absorbable filaments.

[0012] According to another example ("Example 8") that is further relative to the apparatus of Example 4, proximal portions of the plurality of absorbable filaments are formed together to form a proximal hub, and distal portions of the plurality of absorbable filaments are formed together to form a distal hub.

[0013] According to another example ("Example 9") that is further relative to the device of any of Examples 4-7, the proximal hub includes a material band arranged around the proximal portion of the multiple absorbable filaments, and the distal hub includes a material band around the distal portion of the multiple absorbable filaments.

[0014] According to another example ("Example 10") further to the device of any of Examples 4-9, the device further comprises an intermediate hub-shaped portion comprising a central portion of the plurality of absorbable filaments.

[0015] According to another example ("Example 11") further than the apparatus of Example 10, the intermediate hub comprises a band of material disposed around a central portion of the plurality of absorbable filaments.

[0016] According to another example ("Example 12") that is further relative to the device of any of Examples 4-11, the central portion of the plurality of absorbable filaments forms a waist configured to form an open central area within the plurality of absorbable filaments.

[0017] According to another example ("Example 13") further to the apparatus of Example 12, the waist can be configured to juxtapose the proximal disc portion with a first side of the tissue wall and to juxtapose the distal disc portion with a second side of the tissue wall.

[0018] According to another example ("Example 14") further than the device of any of Examples 1-13, the membrane is configured to allow contact with blood or moisture to promote degradation of the plurality of absorbable filaments.

[0019] According to another example ("Example 15") further than the apparatus of any of Examples 1-14, the membrane includes a gap configured to allow direct contact of the tissue with the absorbable filament.

[0020] According to another example ("Example 16") further relative to the apparatus of any of Examples 1-15, the diaphragm is discontinuous.

[0021] According to another example ("Example 17") further relative to the device of Example 16, the septum includes at least two pieces and is attached to accommodate (control / inhibit) a plurality of absorbable filaments.

[0022] According to another example ("Example 18") further than the apparatus of Example 17, the membrane is configured to facilitate movement of the plurality of absorbable filaments.

[0023] According to another example ("Example 19") further to the device of any of Examples 1-18, the plurality of absorbable filaments and the septum are configured to facilitate traversal of the atrial septum after implantation.

[0024] According to another example ("Example 20") further than the device of any of Examples 1-19, at least one of the plurality of absorbable filaments comprises a cross-section that is at least one of non-uniform (irregular / uneven / bumpy), jagged, star-shaped, and polygonal.

[0025] According to one example ("Example 21"), a medical implantable occlusive component includes: a braid of at least one absorbable filament, the braid having an expanded state and an elongated state and a proximal end and a distal end, and the braid includes a proximal hub, a proximal expanded diameter portion, a central portion, a distal expanded diameter portion, and a distal hub, which extends along a longitudinal axis in the expanded state and is configured to be stretched into a tubular shape in the elongated state; and a diaphragm, which is substantially disposed around the braid and is configured to contain (control / inhibit) debris of the braid and promote at least one of tissue ingrowth into the diaphragm and tissue encapsulation (tissue encapsulation) of at least a portion of the diaphragm.

[0026] According to another example ("Example 22"), a method of manufacturing a medical implantable occlusive component includes any of Examples 1-21.

[0027] According to one example ("Example 23"), a method for treating an opening in a patient's body comprises: delivering a medical device into an opening at a treatment site, the device framework (device stent) comprising a plurality of absorbable filaments disposed in a supporting structure and configured to support tissue and degrade within a defined period of time, and a septum disposed around the plurality of absorbable filaments; degrading the plurality of filaments within the septum; containing (confining / controlling) debris of the plurality of absorbable filaments within the septum in response to breakage or degradation of the plurality of filaments; and maintaining the septum within the opening after the plurality of filaments have degraded.

[0028] According to another example ("Example 24") further to the method of Example 23, containing (holding) the debris of the plurality of absorbable filaments includes reducing the risk of releasing particulate degradation products.

[0029] According to another example ("Example 25") further to the method of Example 23, containing (holding) the debris of the plurality of absorbable filaments includes reducing adverse events caused by embolism in a vascular system.

[0030] According to another example ("Example 26"), a device includes an absorbable support structure configured to support tissue and degrade over a defined period of time; and a diaphragm disposed around the absorbable structure and configured to accommodate (retain) debris of the absorbable structure in response to fracture or degradation of a portion of the absorbable structure and to promote at least one of tissue ingrowth into the diaphragm and tissue encapsulation of at least a portion of the diaphragm.

[0031] According to another example ("Example 27") further than the apparatus of Example 26, the absorbable structure is formed by cut tubes, cut sheets, filaments, injection molding or additive printing.

[0032] According to another example ("Example 28") that is further related to the apparatus of Example 26, the absorbable structure and the septum are configured to be implanted in the vasculature or appendages of a patient.

[0033] According to another example ("Example 29") further than the device of Example 26, the device also includes a plug (plug-shaped object) arranged at one end of the absorbable structure.

[0034] According to another example ("Example 30") further than the apparatus of Example 26, the membrane is at least partially absorbable and configured to promote healthy tissue ingrowth.

[0035] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by the present disclosure. Although a number of examples are disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the present invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] The accompanying drawings are used to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the present disclosure.

[0037] Figure 1 is an end view of an exemplary closure member according to an embodiment;

[0038] Figure 2 is a perspective view of an exemplary blocking member according to an embodiment;

[0039] Figure 3 is a side view of an exemplary closure member in an elongated configuration according to an embodiment;

[0040] Figure 4 is a side view of another exemplary blocking member according to an embodiment;

[0041] Figure 5 is a partial cross-sectional view of another exemplary occluder in a deployed configuration according to an embodiment;

[0042] Figure 6 is a side view of another exemplary closure member having a diaphragm according to an embodiment;

[0043] Figure 7 is an illustration of a tubular structure that may subsequently be formed into a medical device according to an embodiment;

[0044] Figure 8 According to an embodiment, Figure 7 An exemplary medical device formed of a tubular structure as shown in;

[0045] Fig. 9 is an expanded medical device formed by a cut tube according to an embodiment;

[0046] Fig.10 is a cross-sectional view of an exemplary stent according to an embodiment;

[0047] Figures 11A-11C is an illustration of an example filament cross section according to an embodiment;

[0048] Fig.12is a side view of another exemplary closure member having a diaphragm according to an embodiment;

[0049] Fig.13A is a side view of another exemplary closure member having a septum and a capture member in a first configuration according to an embodiment;

[0050] Fig. 13B According to an embodiment, the second configuration Fig.13A The blocking member shown in ;

[0051] Fig.14A is a view of another exemplary closure member having a diaphragm according to an embodiment;

[0052] Fig. 14B According to an embodiment Fig.14A The occluding pieces with different waist configurations shown in ;

[0053] Fig.15 is a perspective view of another exemplary closure member having a diaphragm according to an embodiment;

[0054] Fig.16 is a side view of another exemplary blocking member according to an embodiment;

[0055] Fig.17 is a side view of another exemplary closure member having a diaphragm according to an embodiment;

[0056] Fig.18 is a side view of another exemplary closure member having a diaphragm according to an embodiment;

[0057] Fig.19 is a perspective view of an exemplary frame that can be used for a blocking member according to an embodiment;

[0058] Fig. 20A is a first perspective view of an exemplary frame that may be used for a blocking member according to an embodiment;

[0059] Fig. 20B According to an embodiment Fig. 20A A second perspective view of the frame shown in ;

[0060] Fig.21 is a perspective view of an exemplary frame that can be used for a blocking member according to an embodiment;

[0061] Fig. 22 is a perspective view of an exemplary frame that can be used for a blocking member according to an embodiment;

[0062] Fig.23 is a perspective view of an exemplary frame that can be used for a blocking member according to an embodiment;

[0063] Fig.24 An exemplary medical device according to an embodiment is shown;

[0064] Fig.25 An exemplary medical device according to an embodiment is shown; and

[0065] Fig.26 An exemplary stabilization of debris of an exemplary filament according to an embodiment is shown. DETAILED DESCRIPTION

[0066] Definitions and terminology

[0067] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0068] This disclosure is not intended to be read in a limiting manner. For example, the terms used in this application should be read broadly in the context of the meanings that those skilled in the art would attribute to such terms.

[0069] With respect to imprecise terms, the terms "about" and "approximately (approximately)" are used interchangeably to refer to measurements that include the stated measurement, and also include any measurements that are reasonably close to the stated measurement. As understood and readily determined by one of ordinary skill in the relevant art, measurements that are reasonably close to the stated measurement deviate from the stated measurement by a relatively small amount. For example, such deviations may be due to measurement error or minor adjustments made to optimize performance. If it is determined that a person of ordinary skill in the relevant art would not easily determine the value of such a reasonably minor difference, the terms "about" and "approximately" may be understood to be plus or minus 10% of the stated value.

[0070] Description of various embodiments

[0071] Various aspects of the present disclosure relate to a medical device having one or more absorbable filaments (e.g., biodegradable or biocorrodible) arranged to form a medical device. The absorbable filaments can be biocorrodible, biodegradable, or both (e.g., a combination thereof) of biocorrodible and biodegradable. The absorbable filaments (which can be struts, fibers, braided fibers, woven fibers, composite fibers, or other structural elements) can be degraded or dissolved by one or more chemical and / or biological mechanisms, which results in a tissue reaction suitable for the intended implant application. The diaphragm can be arranged together with at least a portion of the one or more filaments or attached to at least a portion of the one or more filaments. The diaphragm can be configured to structurally enhance and / or maintain the integrity of the filaments during degradation or fracture. The medical device can include, for example, a stent or stent graft, a closure piece for being placed in a tissue opening and closing a tissue opening (e.g., a patent foramen ovale (PFO) or atrial septal defect (ASD)), a vascular closure device, or other similar devices. In some cases, the absorbable filaments are configured to structurally reinforce or support the space (opening) in which the medical device is implanted. In some cases, the biodegradable or bioerodible filaments degrade and the membrane promotes healthy tissue ingrowth or regrowth, such that the structure provided by the biodegradable or bioerodible filaments may become unnecessary.

[0072] Absorbable refers to materials that can be absorbed by the body in this article, whether directly absorbed by dissolving or indirectly absorbed by degrading the implant into smaller components that are subsequently absorbed. The term "absorbable" used herein also encompasses various alternative terms that have been used interchangeably (but sometimes with introduced differences) within and across surgical disciplines in history. These terms include, for example, absorbable and derivatives thereof, degradable and derivatives thereof, biodegradable and derivatives thereof, resorbable and derivatives thereof, bioabsorbable and derivatives thereof, and biocorrodible and derivatives thereof. As used herein, the term "absorbable" may include a variety of degradation mechanisms, including but not limited to corrosion and ester hydrolysis. Other terms related to absorbable may further refer to Appendix X4 of ASTM F2902-16.

[0073] In addition, the filaments discussed herein may include monofilaments, which may also be described as a single fiber, strand, wire, rod, bead, or other non-rigid, elongated, substantially cylindrical embodiment having a longitudinal dimension exceeding 100 times its cross-section. The monofilament may optionally have one or more covering coatings or other surface modifications to provide characteristics not inherent to the underlying base structure. Further, while the devices described herein are described as including and formed from one or more filaments, these devices may be formed by other means, such as cutting a tube (e.g., laser cutting and subsequent expansion and shape setting of a polymer or metal tube), as described with reference to Fig. 9 described.

[0074] Figure 1 is an end view of an exemplary occluder 100 according to an embodiment. The occluder 100 may be formed of at least one absorbable filament 102. The at least one absorbable filament 102 may be woven into a framework that forms the occluder 100. In some cases, the at least one absorbable filament 102 may include a substantially circular perimeter 104. The at least one absorbable filament 102 may have an overlapping arrangement (structure) (e.g., formed via braiding, weaving, winding or other processing techniques). In some cases, the (one or more) absorbable filaments 102 may overlap each other in a balanced tubular arrangement (tubular structure) (e.g., Figure 7 ). The tubular arrangement may then be shaped into a desired shape, such as a plugging piece. The shape setting process may also be performed using a solvent, and may also be performed in other ways, such as by absorption (impregnation) of a polymer with an appropriate fluid or heat setting. In addition, at least one absorbable filament 102 may create open cells 106 between overlapping filaments 102 within a substantially circular perimeter 104.

[0075] In some cases, the open cells 106 within the substantially circular perimeter 104 are formed by weaving (braiding) at least one absorbable filament 102. In addition, at least one absorbable filament 102 can be interwoven or braided into a tubular structure and formed into an occluder 100 having a substantially circular perimeter 104. At least one absorbable filament 102 can be formed into a device including one or more disc-shaped portions, such as two disc-shaped portions as shown (e.g., a proximal disc-shaped portion and a distal disc-shaped portion or a diameter expansion portion). Figure 1 The end view shown in shows a single disk.

[0076] like Figure 1 As shown, at least one absorbable filament 102 may converge at the end of the occluder 100 to form a hub 108. The hub 108 may include additional bands, eyelets, or materials that curl (crimp) or hold the ends of at least one absorbable filament 102 together. In some cases, the ends of at least one absorbable filament 102 may be bonded (bonded), melted, or otherwise formed together to form the hub 108. As explained in further detail below, the septum may be substantially disposed around the braid and configured to contain (hold) or limit braid debris and promote tissue attachment and / or tissue ingrowth.

[0077] Figure 2 is a perspective view of an exemplary occluder 100 according to an embodiment. The occluder 100 may include a plurality of absorbable filaments 102 disposed in a support structure. The plurality of absorbable filaments 102 are configured to support tissue and degrade within a defined period of time. As shown, the plurality of absorbable filaments 102 are interwoven to form a support structure.

[0078] like Figure 2 As shown, the occluder 100 includes a proximal hub 108 disposed at the proximal end of a plurality of absorbable filaments 102 and a distal hub 110 disposed at the distal end of the plurality of absorbable filaments 102. In some cases, the proximal hub 108 includes the proximal portion of the plurality of absorbable filaments 102, and the distal hub 110 includes the distal portion of the plurality of absorbable filaments 102. The proximal portion of the plurality of absorbable filaments 102 and the distal portion of the plurality of absorbable filaments 102 can be molded, woven or disposed together and held in place, respectively, wherein the proximal hub 108 and the distal hub 110 are material bands disposed around the proximal portion of the plurality of absorbable filaments 102.

[0079] In addition, the occluder may include a proximal disc 212 configured to contact a first side of a tissue wall and a distal disc 214 configured to contact a second side of the tissue wall. The proximal disc 212 and the distal disc 214 are formed by braiding a plurality of absorbable filaments 102. The plurality of absorbable filaments 102 may be interwoven or braided together and shaped in a structure including the proximal disc 212, the distal disc 214, the proximal hub 108, and the distal hub 110.

[0080] In certain cases and as hereinafter referred to Figure 6 For further discussion, Figure 2 The occluder 100 may include a septum disposed around a plurality of absorbable filaments 102. The septum (not shown) is configured to contain (retain) or limit debris of the plurality of absorbable filaments 102 in response to breakage or degradation of the filaments, and to promote tissue ingrowth into the septum. In addition, and as discussed in detail below, the absorbable filaments 102 prevent embolization of the device through the opening (e.g., PFO) in which it is implanted, and are configured to apply apposition forces against the septum so that the septum can promote tissue attachment, tissue ingrowth, and / or tissue encapsulation to close the opening.

[0081] Figure 3 is a side view of an exemplary occluder 100 in an elongated configuration according to an embodiment. The occluder 100 may include a plurality of absorbable filaments 102, comprising a braid having a proximal hub 108, a proximal expanded diameter portion (e.g., a proximal disk) 212, an intermediate hub or central hub 316, a distal expanded diameter portion (e.g., a distal disk) 214, and a distal hub 110. Each element extends along a longitudinal axis (between the hubs 108, 110) in an expanded state, and the braid formed by the plurality of absorbable filaments 102 is configured to stretch into a tubular shape in a loaded state (or elongated configuration), such as Figure 3As shown. The braided multiple absorbable filaments 102 can be retracted or retracted to form a disc-shaped portion that conforms to the patient's anatomical structure. In some cases, the braided multiple absorbable filaments 102 are configured to maintain contact with the tissue in response to the physiological movement of the patient's heart.

[0082] In some cases, the proximal portions of the plurality of absorbable filaments 102 are formed together to form a proximal hub 108, and the distal portions of the plurality of absorbable filaments 102 are formed together to form a distal hub 110. In some cases, the respective ends may be bonded (glued), melted, or otherwise formed together to form the hubs 108, 110. Figure 3 As shown, the occluder may also have a central hub 316 that includes a central portion of the plurality of absorbable filaments 102. The central hub 316 may include a band of material disposed around the central portion of the plurality of absorbable filaments 102, or as shown in FIG. Figure 3 As shown, the central portion of the plurality of absorbable filaments 102 may be bonded (glued), melted or otherwise formed together to form an intermediate hub 316. In some cases, the hubs 108, 110 (and / or the hub 316) may be formed of or include a radiopaque material (e.g., gold, tantalum, platinum iridium, tungsten) to facilitate deployment of the device 100.

[0083] In some cases, the device 100 (and other devices discussed herein) can be formed of absorbable and non-absorbable filaments 102. In these cases, the scaffold 102 of the device 100 formed of non-absorbable filaments 100 can remain in place. In the case where the device 100 (and other devices discussed herein) includes absorbable and non-absorbable filaments 102, in addition to maintaining the septum 520 in the body by the non-absorbable filaments 102 remaining in the body, the structural integrity of the tissue can also be supported.

[0084] Figure 4 is a side view of another exemplary occluder 100 according to an embodiment. The occluder 100 may include a plurality of absorbable filaments 102 disposed in a support structure. The plurality of absorbable filaments 102 are configured to support tissue and degrade within a defined period of time. As shown, the plurality of absorbable filaments 102 are interwoven to form a support structure.

[0085] The occluder 100 includes a proximal hub 108 disposed at the proximal end of a plurality of absorbable filaments 102 and a distal hub 110 disposed at the distal end of the plurality of absorbable filaments 102. In some cases, the proximal end 108 includes a proximal portion of the plurality of absorbable filaments 102, and the distal hub 110 includes a distal portion of the plurality of absorbable filaments 102. The proximal portion of the plurality of absorbable filaments 102 and the distal portion of the plurality of absorbable filaments 102 can be woven so that the ends or hubs 108, 110 are flat (in a plane) with the end of the device or do not substantially protrude beyond the end of the device (e.g., a closed loop braided disc).

[0086] The end of the occluding member 100 may include a proximal disc-shaped portion 212 configured to contact a first side of a tissue wall and a distal disc-shaped portion 214 configured to contact a second side of the tissue wall. The proximal disc-shaped portion 212 and the distal disc-shaped portion 214 are formed by braiding a plurality of absorbable filaments 102. The plurality of absorbable filaments 102 may be interwoven or braided together and shaped in a structure including the proximal disc-shaped portion 212, the distal disc-shaped portion 214, the proximal hub-shaped portion 108, and the distal hub-shaped portion 110. In the elongated structure, as shown in FIG. Figure 4 As shown, the proximal disk 212 and the distal disk 214 can be spherical. In the expanded configuration, the end sides of the proximal disk 212 and the distal disk 214 (and the hubs 108, 110) are substantially flat and include a thickness in the range of about 0.5 mm to 2 mm or twice the diameter of the filament 102. The interior of the proximal disk 212 and the distal disk 214 can taper into a waist 418.

[0087] The waist 418 can be formed by a central portion of the plurality of absorbable filaments 102. Furthermore, the waist 418 can be configured to form an open central region within the plurality of absorbable filaments 102 in each of the expanded and elongated configurations. The waist 418 can be configured to juxtapose the proximal disk 212 with a first side of a tissue wall and juxtapose the distal disk 214 with a second side of a tissue wall.

[0088] Figure 5 is a partial cross-sectional view of another exemplary occluder 100 in an expanded configuration according to an embodiment. The occluder 100 may include a plurality of absorbable filaments 102 disposed in a support structure. The plurality of absorbable filaments 102 are configured to support tissue and degrade within a defined period of time and may be interwoven to form a support structure.

[0089] The occluder 100 includes a distal hub 110 disposed at the distal ends of a plurality of absorbable filaments 102. As discussed in detail above, the distal hub 110 includes the distal end portions of the plurality of absorbable filaments 102. Figure 5As shown, the proximal end 508 of the occluding member 100 is an integral part of the proximal disc 212. The proximal portion of the plurality of absorbable filaments 102 is braided so that the ends or hubs 108, 110 are in a plane (flush) with the ends of the occluding member 100 or do not substantially protrude beyond the ends of the occluding member 100. In some cases, the proximal disc 212 can be a closed-loop braided disc so that there are no outgrowth (protruding) features. The distal disc 214 can be similarly formed so that the distal disc 214 does not include the distal hub 110. In this case, the proximal and distal designations do not indicate the direction of implantation in the body. For example, the proximal end 508, which is an integral part of the proximal disc 212, can be implanted in the left atrium to minimize thrombus formation.

[0090] The end of the occluding member 100 may include a proximal disc-shaped portion 212 configured to contact a first side of a tissue wall and a distal disc-shaped portion 214 configured to contact a second side of the tissue wall. The proximal disc-shaped portion 212 and the distal disc-shaped portion 214 are formed by braiding a plurality of absorbable filaments 102. The plurality of absorbable filaments 102 may be interwoven or braided together and shaped in a structure including the proximal disc-shaped portion 212, the distal disc-shaped portion 214, the proximal hub-shaped portion 108, and the distal hub-shaped portion 110. The proximal disc-shaped portion 212 and the distal disc-shaped portion 214 may be formed in different shapes, such as Figure 5 In addition, the interior of the proximal disk portion 212 and the distal disk portion 214 can be tapered into a waist portion 418.

[0091] The waist 418 can be formed by a central portion of the plurality of absorbable filaments 102. Furthermore, the waist 418 can be configured to form an open central region within the plurality of absorbable filaments 102 in each of the expanded and elongated configurations. The waist 418 can be configured to juxtapose the proximal disk 212 with a first side of a tissue wall and juxtapose the distal disk 214 with a second side of a tissue wall.

[0092] As shown, absorbable filaments 102 can be braided to form a framework (stent), and absorbable filaments 102 are configured to degrade over time. In some cases, the braid provides a stent structure that is essentially flexible and compliant, allowing the device 100 to conform naturally to tissue and anatomical structures. The braided structure is also balanced with the filaments 102 that are spirally wound and interwoven with an even number of numbers in multiple directions. The balance of the braid allows the device 100 to expand naturally into its expected shape by reducing internal restraint distortion or bending forces.

[0093] In addition, the membrane 520 can be attached (e.g., using a medical adhesive) to the perimeter of the absorbable filament 102. The medical adhesive can also be absorbable. In some cases, the membrane 520 can be porous so that fluid or moisture exchange is carried out through the pores of the membrane 520, thereby allowing degradation of the absorbable filament 102. In other cases, the absorbable filament 102 can naturally degrade within a non-porous membrane.

[0094] In some cases, the membrane 520 may be configured to promote healthy tissue ingrowth or re-growth. Such tissue attachment to the membrane 520 ensures fixation within the anatomical structure, making the structure provided by the absorbable filaments 102 unnecessary. The membrane 520 may have a surface structure that can stabilize the device 100, thereby limiting the movement of debris of the absorbable filaments 102 from the treatment site (movement away from the treatment site). In some cases, the membrane 520 can promote tissue ingrowth or encapsulate or attach the structure of the absorbable filaments 102.

[0095] In addition, the membrane 520 can be completely encapsulated and provide a porous jacket material around the filament 102. The membrane 520 surrounding the filament 102 can include tensile strength and toughness to provide continuous structural integrity while allowing degradation and fluid or moisture exchange to the filament 102 through the open pores of the membrane 520 (allowing fluid or moisture exchange to the filament 102 through the open pores of the membrane 520). In some cases, the filament 102 as a temporary support is configured to provide sufficient outward force and / or pressure to allow the membrane 520 to support against the tissue to maintain the framework (scaffold) structure of the tissue during an initial period of time (e.g., 30-60 days) and after the degradation of the filament 102. The membrane 520 can be arranged around the filament 102 and is configured to accommodate (hold) or limit the debris of the filament 102, and maintain the structure of the device 100 in response to the breakage or degradation of the filament 102. In some cases, the filament 102 degrades within the scope of the membrane 520.

[0096] Compared with uncovered absorbable filaments, containing or limiting the debris of the plurality of absorbable filaments 102 reduces the risk of releasing particulate degradation products. In addition, containing (maintaining) the debris of the absorbable filaments 102 can reduce the possibility of migration and potential adverse events caused by thrombosis or the generation of emboli in the vascular system.

[0097] As described above, the diaphragm 520 can be porous. The porosity of the diaphragm 520 can control or affect the rate at which the filaments 102 degrade. The filaments 102 and diaphragm 520 can be implanted in a patient to enhance or repair unhealthy or poorly formed tissue. As described above, the device 100 can be implanted in a PFO or ASD opening. The device 100 can seal the opening or otherwise prevent or reduce shunting through the septum. Microvascularized tissue grows inward and through or on the diaphragm 520 to promote healthier overall tissue growth and restore the structural integrity of the tissue to seal the opening. In some cases, unlike metal or semi-metal filaments, the degradable filaments 102 allow the opening to be closed while the generally more biocompatible diaphragm 520 remains in place.

[0098] In some cases, one or more filaments 102 may be coated or imbibed with a therapeutic agent. The membrane 520 will have an engineered porosity that controls the release of the therapeutic agent, contains (holds) degradation products until their physical or chemical size is reduced to a size that allows them to pass through the pores and / or the resulting membrane / tissue complex. In some cases, the membrane 520 may be configured to retain debris from moving away from the treatment site until the debris is reduced to a size small enough to enable benign absorption by the patient.

[0099] In addition, one or more of the filaments 102 can be an absorbable metal (such as magnesium) and the membrane 520 can be a non-degradable polymer (such as ePTFE). If one or more filaments 102 are formed of a metal degradable material, the device can also provide radiopacity and initial strength due to the metal frame of the one or more filaments 102, or if the membrane 520 is absorbed with a radiopaque material, the device can include radiopacity.

[0100] In some cases, the membrane 520 may be absorbable or partially absorbable. If the membrane 520 is absorbable, the membrane may have the same or shorter lifespan as the absorbable filament 102. In these cases, the membrane 520 may enhance / reinforce the tissue coverage on the underlying (underlying) absorbable filament 102. In these cases, the membrane 520 may effectively inhibit or contain (retain) the migration of debris or particles that may be emitted from the absorbable filament 102 during degradation or breakage of the absorbable filament 102. Similar to a non-absorbable membrane, the degradable membrane 520 may allow for tissue attachment and / or ingrowth that stabilizes the overlying (superjacent) tissue so that it may contain (hold / control / inhibit) or substantially inhibit the migration of debris and particulate matter emitted by the degrading filaments. Preferred is a porous absorbable membrane 520 that may maintain strength and / or provide the ability to stabilize and reinforce the overlying tissue for a longer period of time than the degrading filaments 102. The membrane 520 may include an absorbable portion and a non-absorbable portion (e.g., a partially absorbable membrane 520).

[0101] Figure 6 5 is a side view of another exemplary occluder 100 having a septum 520 according to one embodiment. The septum 520 may be disposed around a plurality of absorbable filaments (as discussed in detail above) and configured to accommodate (retain) debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments and promote tissue ingrowth into the septum. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after the absorbable filaments are degraded. The absorbable filaments 102 are configured to structurally enhance or maintain an open space in which the occluder is implanted. The absorbable filaments 102 prevent embolism of the device through the opening (e.g., PFO) in which it is implanted and are configured to resist the septum from applying juxtaposition forces so that the septum 520 can promote tissue ingrowth near the opening. During degradation of the biodegradable or bioerodible filaments, the septum 520 promotes healthy tissue ingrowth or regrowth, such that the structure provided by the biodegradable or bioerodible filaments may become unnecessary. The membrane 520 remains within the patient's body and provides structure, without the metallic structure remaining that would occur with a non-degradable stent.

[0102] In some cases, the septum 520 is configured to allow contact with blood without debris of the filament 102 escaping from the septum 520. The septum 520 may allow fluid or moisture to pass through without allowing debris or fragments of the filament to escape (which could cause embolism).

[0103] In some cases, the septum 520 includes a gap 622 and is configured to allow direct tissue contact and encapsulation of the absorbable filaments 102. The gap 622 may face the septum to promote tissue attachment or in-growth to further stabilize the occluder 100. In addition, the septum 520 may be discontinuous. Further, the septum 520 may also be formed as a two-piece (separated by the gap 622) and attached to multiple filaments. In these cases, the septum 520 may be configured to promote the movement of multiple absorbable filaments 102. The septum 520 may be attached to the filaments at one or more locations.

[0104] The plurality of absorbable filaments 102 and the septum 520 may be configured to facilitate penetration of the (atrial) septum after implantation. Degradation of the filaments may leave access points in the tissue so that the (atrial) septum may be re-pierced after implantation for other procedures (surgery).

[0105] In some cases, the filaments absorb or degrade within a year and, when implanted in the atrial septum, may also preserve access to the left atrium for future transseptal procedures. The absorbable frame construction helps eliminate the uncertainty caused by metal frame fracture. In addition, an internal film patch (not shown) may be used inside the braided disc to facilitate the formation of a closed seal.

[0106] Figure 7 is an illustration of a tubular arrangement 700 that can subsequently be formed into a medical device according to an embodiment. The tubular arrangement 700 can include filaments 102 that are braided together. The filaments 102 can be absorbable filaments, as discussed in detail above, or the filaments 102 can be formed of a non-absorbable polymer (e.g., polyester, nylon, polyetheretherketone (PEEK)).

[0107] Whether absorbable or non-absorbable, the filaments 102 can be braided to form a tubular arrangement 700. The filaments 102 can be helically woven together into the tubular arrangement 700. In some cases, the braid provides a structure that is inherently flexible and compliant, thereby allowing the device formed by the tubular arrangement 700 to naturally conform to tissue and anatomical structures. The braided construction is also balanced with the filaments 102 helically wound and interwoven in an even number of directions. The balance of the braid can allow the device formed by the tubular arrangement 700 to naturally expand into its intended shape by reducing internal restraining distortion (forces) or bending forces. The tubular arrangement can then be shaped into a desired shape, such as, for example, Figure 8 The tubular arrangement 700 can also be molded into Figure 1-6 Device shown.

[0108] Figure 8 According to an embodiment, Figure 7 The exemplary medical device 100 is formed by the tubular arrangement 700 shown in FIG. Figure 8 The illustrated medical device 100 may be formed by molding a tubular arrangement (tubular structure) 700 into the shape and shape setting shown.

[0109] The medical device 100 can be similarly constructed as described in detail above. For example, the medical device 100 may include filaments 102 that are braided together. The filaments 102 may be absorbable filaments, as discussed in detail above, or the filaments 102 may be formed of non-absorbable polymers. As discussed in detail above in the case where the filaments 102 are absorbable filaments 102, the absorbable filaments 102 are configured to support tissue and degrade within a limited period of time, and may be interwoven to form a support structure.

[0110] The device 100 includes a distal hub 110 disposed at the distal end of the filament 102. As discussed in detail above, the distal hub 110 includes the distal portion of the filament 102. In addition, the proximal hub 108 includes the proximal portion of the filament 102. In some cases, the proximal portion or the distal portion of the filament 102 is braided so that the end or hub 108, 110 is flush with the end of the device 100 (flat / in a plane relative to the end of the device) or does not substantially protrude beyond the end of the device 100. In some cases, the proximal disk 212 or the distal disk 214 can be a closed loop braided disk so that there are no protruding features.

[0111] The end of the occluder 100 may include a proximal disc 212 configured to contact a first side of a tissue wall and a distal disc 214 configured to contact a second side of the tissue wall. The proximal disc 212 and the distal disc 214 are formed by braiding of the filaments 102. The filaments 102 may be interwoven or braided together and shaped in a structure that includes the proximal disc 212, the distal disc 214, the proximal hub 108, and the distal hub 110. In addition, the interior of the proximal disc 212 and the distal disc 214 may taper to a waist 418.

[0112] The waist 418 can be formed by a central portion of the filament 102. Furthermore, the waist 418 can be configured to form an open central region within the filament 102 in each of the expanded and elongated configurations. The waist 418 can be configured to juxtapose the proximal disk 212 with a first side of the tissue wall and juxtapose the distal disk 214 with a second side of the tissue wall.

[0113] In some cases, device 100 may include an elastic tensile member 830 disposed between hubs 108, 110 and within waist 418. In some cases, elastic tensile member 830 may be configured to snap device 100 together when stretched or elongated, or otherwise return distal hub 108 and proximal hub 110 together. Elastic tensile member 830 may facilitate maintaining device 100 in a secure position. Figure 8 The desired deployed configuration is shown. Elastic tensile member 830 may be adhered or coupled to hubs 108, 110. Additionally, elastic tensile member 830 may be stretched and maintained at an elastic limit.

[0114] Resilient tensile member 830 may be configured to generate an apposition force between disks 212, 214 of device 100 when device 100 is deployed. The apposition force may be increased relative to device 100 that does not include resilient tensile member 830. Resilient tensile member 830 may be placed under tension when device 100 is deployed. As device 100 is elongated, the tension in resilient tensile member 830 increases, but remains below the tensile limit of resilient tensile member 830. When device 100 is released from its elongated state, the tension in resilient tensile member 830 serves to draw disks 212, 214 together with additional force.

[0115] In some cases, waist 418 may include a central hub 316 that surrounds a central portion of filament 102. Central hub 316 may include a band of material (e.g., ePTFE) disposed around the central portion of filament 102. The band of material surrounding central hub 316 may maintain the diameter of waist 418 during stretching of device 100 and elastic tensile member 830.

[0116] In addition, a membrane (not shown) may be attached (e.g., using a medical adhesive) to the perimeter of the filament 102. In some cases, the membrane may be porous so that fluid or moisture exchange occurs through the pores of the membrane, thereby allowing degradation of the filament 102. In some cases, the membrane 520 may be configured to promote encapsulation of the membrane 520 by healthy tissue, tissue ingrowth into the membrane 520, and / or re-growth of tissue. The elastic tensile member 830 may also be formed of an absorbable material so that only the membrane is left as discussed in detail above.

[0117] Fig. 9 is an expanded medical device 100 formed by cutting a tube according to one embodiment. The tube or structure of material can be laser cut or cut to form Fig. 9 The medical device 100 shown. In some cases, such as Fig. 9 As shown, the medical device 100 may include frame elements 102a that spread outwardly in an expanded configuration. The medical device 100 may include a disc as described in detail above.

[0118] Fig.10 is a cross-sectional view of an exemplary stent according to an embodiment. The stent may include a frame element 102a (which may be a filament 102 or a cut tube element) that may be formed from a filament or may be formed from a cut tube. For example, the stent may be as follows Figure 7The septum layers 520a, 520b may be tubular as shown, or may include a helical pattern of struts or discrete stent rings. A stent or other medical device discussed herein may be disposed between the membrane layers 520a, 520b. The membrane layers 520a, 520b (the properties of which are discussed in detail above) may be sandwiched between the frame elements 102a. The frame elements 102a may be absorbable.

[0119] Fig.11A -C is a diagram of an example filament 102 cross section according to an embodiment. As shown and discussed in detail above, the filament 102 may include a substantially circular cross section. In other cases and as Fig.11A As shown in -C, filament 102 may include a cross-section that is not substantially circular in cross-section.

[0120] For example, the filament 102 may be formed or drawn to include a star-shaped cross section. Compared to a filament 102 having a substantially circular cross section, the filament 102 may be formed or drawn to include a star-shaped cross section. Fig.11A -C can increase the surface area of ​​the filament 102. As a result, the degradation curve of the filament 102 formed by a polymer that is susceptible to enzymatic degradation at its surface can be customized based on the cross-section of the filament 102. For example, the filament 102 may have a faster degradation curve or rate with a larger surface area. Conversely, in a large number of hydrolyzable polymers, the higher cross-sectional surface area to volume ratio of the star or polygon can relatively slow down the hydrolytic degradation by effectively reducing the distance from the core to the outer surface of the filament 102, by reducing the acid catalysis risk presented by the concentration of low molar mass acidic degradation products within the core of the filament 102. Although Fig.11A -C includes a particular shape, but the filaments 102 discussed herein may include uneven (irregular / uneven / bumpy), jagged or polygonal edges, or include edges that are larger than Fig.11A - More or fewer sides than shown in C (eg, triangle, square, pentagon, hexagon). In some cases, the filament 102 as discussed herein can be hollow (eg, micro-tubing).

[0121] Fig.12 is a side view of another exemplary occluder 1200 with a septum according to an embodiment. According to one embodiment, the occluder 1200 has a septum 520. The septum 520 can be arranged around a plurality of absorbable filaments (as discussed in detail above) and is configured to accommodate (retain) debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments and promote tissue ingrowth into the septum or tissue encapsulation of the septum. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after the absorbable filaments are degraded. The filaments can form a proximal disc 212 and a distal disc 214.

[0122] The absorbable filaments (discussed and shown in detail above) are configured to structurally enhance or maintain open (or closed) the space in which the occluder is implanted. The absorbable filaments 102 prevent the device from embolizing through the opening (e.g., PFO) in which it is implanted and are configured to apply a juxtaposition force to the interval so that the septum 520 can promote tissue ingrowth near the opening or tissue encapsulation of the septum 520. During the degradation of the biodegradable or bioerodible filaments, the septum 520 promotes healthy tissue ingrowth into the septum 520, tissue regrowth, and / or tissue encapsulation of the septum 520, so that the structure provided by the biodegradable or bioerodible filaments may become unnecessary. The septum 520 remains in the patient's body and provides structure, unlike the metal structure residue that would occur when using a non-degradable stent.

[0123] The waist 418 can be formed by the central portion of the plurality of absorbable filaments. In addition, the waist 418 can be configured to form an open central region within the plurality of absorbable filaments in each of the expanded configuration and the elongated configuration. The waist 418 can be configured to juxtapose the proximal disk 212 with a first side of the tissue wall and juxtapose the distal disk 214 with a second side of the tissue wall.

[0124] The occluder 1200 may also include hubs 108, 110. The hubs 108, 110 may be formed from filaments or may include additional bands, eyelets, or materials that crimp or hold the ends of the filaments together. In some cases, the ends of the filaments may be bonded, melted, or otherwise formed together to form the hubs 108, 110. Optionally, the diaphragm 520 may be attached during the formation of the hubs.

[0125] In some cases, the occluder 1200 may include a capture member 1220 disposed between the hubs 108 and 110. The capture member 1220 may be configured to be connected to a delivery catheter or delivery system. In some cases, the capture member 1220 may include a threaded end configured to be threadedly connected to a corresponding threaded member on the delivery catheter or delivery system. The capture member 1220 may facilitate the deployment of the discs 212 and 214. In some cases, the capture member 1220 includes a joint component attached to the hubs 108 and 110. When the occluder 1200 is deployed, the capture member 1220 may pull the discs 212 and 214 together and maintain apposition with the tissue. The capture member 1220 may be formed of an absorbable material or other material (e.g., nitinol). The apposition member 1220 may be flexible in the middle body portion to allow consistency of the discs 212 and 214. In some cases, capturing member 1220 can be resiliently (spring) loaded to maintain apposition of discs 212, 214 to tissue. Capturing member 1200 can include a lumen therethrough to allow for recrossing.

[0126] Fig.13A 1 is a side view of another exemplary occluder 1300 having a septum 520 and a capture member 1220 in a first configuration according to an embodiment. According to an embodiment, the occluder 1300 has a septum 520. The septum 520 may be disposed around a plurality of absorbable filaments (as discussed in detail above) and configured to contain (retain) debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments and to promote tissue ingrowth into the septum 520 and / or tissue encapsulation of the septum 520. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after degradation of the absorbable filaments. The filaments may form a proximal disc 212 and a distal disc 214.

[0127] The absorbable filaments (discussed and shown in detail above) are configured to structurally enhance or maintain an open or closed space in which the occluder is implanted. The absorbable filaments 102 prevent the device from embolizing through the opening (e.g., PFO) in which it is implanted and are configured to apply a juxtaposition force to the interval so that the septum 520 can promote tissue ingrowth near the opening or tissue encapsulation of the septum 520. During the degradation of the biodegradable or bioerodible filaments, the septum 520 promotes healthy tissue ingrowth or regrowth (or tissue encapsulation of the septum 520) so that the structure provided by the biodegradable or bioerodible filaments may become unnecessary. The septum 520 remains in the patient's body and provides structure, unlike the metal structure residue that would occur when using a non-degradable stent.

[0128] The ends 108, 110 of the closure member may be formed from filaments or may include additional bands, eyelets, or materials that crimp (crimp) or hold the ends of the filaments together. Fig. 13B As shown, the distal end 110 of the occluding member 1330 is turned (inverted) so that the filament 102 extends inwardly and returns toward the proximal end 108. Fig.13A As shown, the occluder 1300 can include a capture member 1220 disposed within the proximal end 108 for coupling to a delivery catheter or delivery system.

[0129] like Fig. 13B As shown, the proximal end 108 may include a ball 1330. The ball 1330 may be absorbable (or may be a barbed feature). The ball 1330 may help capture the occluder 1300 or otherwise block a passage through the occluder 1300 after delivery.

[0130] Fig.14A is a diagram of another exemplary closure member 1400 having a septum 520 according to one embodiment. Fig. 14B According to an embodiment Fig.14A4. The occlusion piece 1400 shown in FIG. 4 has a different waist configuration 418. The different waist 418 diameters may be related to the target location of the occlusion piece 1400. For example, when placed in an atrial septal defect (ASD), the occlusion piece 1400 may include a larger waist, such as Fig.14A When placed in a patent foramen ovale (PFO), the occluder 1400 may include a smaller waist, such as Fig. 14B shown.

[0131] As discussed in detail above, the occluder 1400 includes a septum 520 that can be disposed around a plurality of absorbable filaments (as discussed in detail above) and configured to contain (retain) debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments and promote tissue ingrowth into the septum and / or tissue encapsulation of the septum 520 and / or re-growth of healthy tissue. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after degradation of the absorbable filaments. The filaments can form a proximal disc 212 and a distal disc 214.

[0132] The absorbable filaments (discussed and shown in detail above) are configured to structurally enhance or maintain open the space in which the occluder is implanted. The absorbable filaments 102 prevent the device from embolizing through the opening (e.g., PFO) in which it is implanted and are configured to apply a juxtaposition force to the interval so that the septum 520 can promote tissue ingrowth near the opening and / or tissue encapsulation of the septum 520 and / or re-growth of healthy tissue. During the degradation of the biodegradable or biocorrodible filaments, the septum 520 promotes healthy tissue ingrowth or re-growth, so that the structure provided by the biodegradable or biocorrodible filaments may become unnecessary. The septum 520 remains in the patient's body and provides structure, unlike the residual metal structure that would occur when using a non-degradable stent.

[0133] The occluder 1400 may also include hubs 108, 110. The hubs 108, 110 may be formed from filaments or may include additional bands, eyelets, or materials that crimp or hold the ends of the filaments together. In some cases, the ends of the filaments may be bonded, melted, or otherwise formed together to form the hubs 108, 110. Optionally, the diaphragm 520 may be attached during the formation of the hubs.

[0134] Fig.15is a perspective view of another exemplary occluder 1500 having a septum 520 according to an embodiment. As discussed in detail above, the occluder 1500 includes a septum 520 that can be disposed around a plurality of absorbable filaments (as discussed in detail above) and configured to contain (retain) debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments and to promote tissue ingrowth into the septum or tissue encapsulation of the septum 520. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after degradation of the absorbable filaments. The filaments can form a proximal disc 212 and a distal disc 214.

[0135] The absorbable filaments (discussed and shown in detail above) are configured to structurally enhance or maintain open the space in which the occluder is implanted. The absorbable filaments prevent embolism of the device through the opening (e.g., PFO) in which it is implanted and are configured to apply apposition forces against the septum so that the septum 520 can promote tissue ingrowth near the opening. During the degradation of the biodegradable or biocorrodible filaments, the septum 520 promotes healthy tissue ingrowth or regrowth (and / or tissue encapsulation of the septum 520), so that the structure provided by the biodegradable or biocorrodible filaments may become unnecessary. The septum 520 remains in the patient's body and provides structure, unlike the residual metal structure that would occur when using a non-degradable stent.

[0136] The occluder 1500 may also include hubs 108, 110. The hubs 108, 110 may be formed from filaments or may include additional bands, eyelets, or materials that crimp or hold the ends of the filaments together. In some cases, the ends of the filaments may be bonded, melted, or otherwise formed together to form the hubs 108, 110. Optionally, the diaphragm 520 may be attached during the formation of the hubs.

[0137] In some cases and as shown, the occluder 1500 may include radiopaque elements 1550, 1552. The radiopaque elements 1550, 1552 may be disposed within the disc-shaped portions 212, 214. In some cases, the radiopaque elements 1550, 1552 extend from the hub-shaped portions 108, 110 to the perimeter of the disc-shaped portions 212, 214. The radiopaque elements 1550, 1552 may be formed of or include a radiopaque material (e.g., gold, tantalum, iodine, or a combination thereof). In some cases, the radiopaque elements 1550, 1552 may be filaments wrapped in the septum 520 material. The radiopaque elements 1550, 1552 may be sputter-coated or spray-coated to encapsulate the radiopaque material within the septum 520 material.

[0138] Fig.16is a side view of another exemplary occluder 1600 according to an embodiment. As discussed in detail above, the occluder 1600 includes a septum 520 that can be individually disposed around each of the plurality of absorbable filaments 102 (as discussed in detail above) and configured to accommodate (retain) debris of the plurality of absorbable filaments 102 in response to breakage or degradation of the filaments and to promote tissue ingrowth into the septum or tissue encapsulation of the septum 520. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after degradation of the absorbable filaments. The filaments 102 can form a proximal disc 212 and a distal disc 214.

[0139] The absorbable filament 102 is configured to structurally enhance or maintain open the space in which the occluder 1600 is implanted. The absorbable filament 102 prevents the device from embolizing through the opening (e.g., PFO) in which it is implanted and is configured to resist the septal application of apposition forces. In some cases, a septum component 520 is also disposed within the discs 212, 214 to promote tissue ingrowth near the opening. During the degradation of the biodegradable or biocorrodible filament 102, the septum component 520 within the discs 212, 214 promotes healthy tissue ingrowth or regrowth, so that the structure provided by the biodegradable or biocorrodible filament may become unnecessary. The septum 520 disposed separately around the filament 102 and the septum component 520 within the discs 212, 214 remain in the patient's body and provide structure, without residual metal structure as with the use of non-degradable stents.

[0140] The occluder 1600 may also include hubs 108, 110. The hubs 108, 110 may be formed from filaments or may include additional bands, eyelets, or materials that crimp or hold the ends of the filaments together. In some cases, the ends of the filaments may be bonded, melted, or otherwise formed together to form the hubs 108, 110. Optionally, the diaphragm 520 may be attached during the formation of the hubs.

[0141] Fig.17 is a side view of another exemplary occluder 1700 having a septum 520 according to an embodiment. As discussed in detail above, the occluder 1700 includes a septum 520 that can be disposed around a plurality of absorbable filaments 102 (as discussed in detail above) and configured to contain (retain) debris of the plurality of absorbable filaments 102 in response to breakage or degradation of the filaments 102 and to promote tissue ingrowth into the septum 520 or tissue encapsulation of the septum 520. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after degradation of the absorbable filaments 102. The filaments 102 can form a proximal disc 212 and a distal disc 214.

[0142] The absorbable filaments 102 (discussed and shown in detail above) are configured to structurally enhance or maintain open the space in which the occluder is implanted. The absorbable filaments 102 prevent the device from embolizing through the opening (e.g., PFO) in which it is implanted and are configured to apply a juxtaposition force to the interval so that the septum 520 can promote tissue ingrowth near the opening. During the degradation of the biodegradable or bioerodible filaments 102, the septum 520 promotes healthy tissue ingrowth or regrowth (or tissue encapsulation of the septum 520), so that the structure provided by the biodegradable or bioerodible filaments 102 may become unnecessary. The septum 520 remains in the patient's body and provides structure, unlike the metal structure residue that would occur when using a non-degradable stent.

[0143] The occluder 1700 may also include hubs 108, 110. The hubs 108, 110 may be formed by the filaments 102 or may include additional bands, eyelets, or materials that curl (crimp) or hold the ends of the filaments 102 together. In some cases, the ends of the filaments 102 may be bonded (bonded), melted, or otherwise formed together to form the hubs 108, 110. Optionally, the diaphragm 520 may be attached during the formation of the hubs. In some cases, one or more of the hubs 108, 110 and the waist 418 may be formed by a ring (as shown in the hub 108) or a winding of the filament 102 (as shown in the waist 4189 and the hub 110).

[0144] Fig.18 is a side view of another exemplary occluder with a septum according to an embodiment. As discussed in detail above, the occluder 1800 includes a septum 520 that can be disposed around a plurality of absorbable filaments 102 (as discussed in detail above) and configured to accommodate (retain) debris of the plurality of absorbable filaments 102 in response to breakage or degradation of the filaments and to promote tissue ingrowth into the septum. In some cases, the septum 520 is configured to promote healthy tissue growth and remain with the tissue after the absorbable filaments 102 degrade. The filaments 102 can form a proximal disc 212 and a distal disc 214.

[0145] The absorbable filaments 102 (discussed and shown in detail above) are configured to structurally reinforce or maintain open the space in which the occluder is implanted. The absorbable filaments prevent the device from embolizing through the opening (e.g., PFO) in which it is implanted and are configured to apply a juxtaposition force to the septum so that the septum 520 can promote tissue ingrowth near the opening or tissue encapsulation of the septum 520. During the degradation of the biodegradable or bioerodible filaments 102, the septum promotes healthy tissue ingrowth or regrowth, so that the structure provided by the biodegradable or bioerodible filaments 102 may become unnecessary. The septum 520 remains in the patient's body and provides structure, unlike the metal structure residue that would occur when using a non-degradable stent.

[0146] The occluder 1800 may include a proximal end 108 and a distal end 110. The ends 108, 110 may be formed by the filament 102 or may include additional bands, eyelets, or materials that curl (crimp) or hold the ends of the filament 102 together. In some cases, the ends of the filament 102 may be bonded (bonded), melted, or otherwise formed together to form the hubs 108, 110. Optionally, the diaphragm 520 may be attached during the formation of the hub. The filament 102 may be helically wound and one or more of the discs 212, 214 may be closed loops, as shown in the disc 214, and thus there is no hub at the distal end 110. In addition, the waist 418 may include a ring to constrain the waist 418 portion.

[0147] Fig.19 1 is a perspective view of an exemplary frame 1900 that can be used for an occluder according to an embodiment. As shown, the frame 1900 includes discs 212, 214 and hubs 108, 110. Each of the discs 212, 214 may include a plurality of petals 1950 that converge at the hubs 212, 214. The hubs 108, 110 may be cylindrical. The frame 1900 is formed by a cut pattern (tube or sheath) of an absorbable material. The frame 1900 may be extruded and quenched to set the frame 1900 shape to the pattern shown. The frame 1900 may be considered to include a plurality of struts (struts) or filaments formed by the cut pattern. The frame 1900 may be considered to include a plurality of struts (struts) or filaments formed by the cut pattern.

[0148] Fig. 20A is a first perspective view of an exemplary frame 2000 that may be used for a closure member according to an embodiment, and Fig. 20B yes Fig. 20A 2000 is a second stereoscopic view of the framework 2000 shown in FIG. As shown, the framework 2000 forms a plug structure formed by a cut pattern (tube or sheath) of an absorbable material. The plug structure may include a plurality of cells 2002, which may include a polygonal shape. The framework 2000 may be a bioabsorbable support structure and include a diaphragm (not shown) disposed around the support structure as described in detail above. The plug 2004 may be disposed at one or both ends within the framework 2000. The plug 2004 may be degradable and interface with a delivery catheter or system. In some cases, the framework 2000 may be used as a vascular plug or as a closure such as an appendage in other parts of the body (e.g., left atrial appendage). The framework 2000 may be used to seal cardiac and vascular defects or tissue openings, vascular systems, or other locations in a patient's body. The framework 2000 (and other frameworks discussed herein) is a framework (stent) or a bioabsorbable support structure. The framework 2000 may be considered to include a plurality of struts (struts) or filaments formed by a cut pattern.

[0149] Fig.21 2 is a perspective view of an exemplary frame that can be used for a plugging member according to an embodiment. As shown, the frame 2100 includes a disc 212, 214 and a hub 108, 110. Each of the discs 212, 214 may include a plurality of petals 1950 that converge at the hub 212, 214. The hubs 108, 110 may be cylindrical. The frame 2100 is formed by a cut pattern (tube or sheath) of an absorbable material. The frame 2100 may be extruded and quenched to set the frame 2100 shape (shape) to the pattern shown. In other cases, the frame 2100 may be formed by additive printing or additive manufacturing. The frame 2100 may be considered to include a plurality of pillars (struts) or filaments formed by the cut pattern. The frame 2100 may be considered to include a plurality of pillars (struts) or filaments formed by the cut pattern. The frame 2100 may be injection molded or formed by additive printing.

[0150] Fig. 22 2 is a perspective view of an exemplary frame 2200 that can be used for a plugging member according to an embodiment. As shown, the frame 2100 includes a disc 212, 214 and a hub 108, 110. Each of the discs 212, 214 may include a plurality of petals 1950 that converge at the hub 212, 214. The hubs 108, 110 may be cylindrical. The frame 2100 is formed by a cut pattern (tube or sheath) of an absorbable material. The frame 2100 may be extruded and quenched to set the frame 2100 shape (shape) to the pattern shown. In other cases, the frame 2200 may be formed by additive printing or additive manufacturing. The frame 2200 may be considered to include a plurality of pillars (struts) or filaments formed by the cut pattern. The frame 2200 may be considered to include a plurality of pillars (struts) or filaments formed by the cut pattern. The frame 2200 may be injection molded or formed by additive printing.

[0151] Fig.23 2 is a perspective view of an exemplary frame 2300 that can be used in a medical device according to an embodiment. As shown in the figure, the frame 2100 includes a disc portion 212 and a hub portion 108. Fig.24An exemplary frame 2400 is shown, which includes two discs 212, 214 formed by a frame 2300. Each of one or both discs 212, 214 may include a plurality of petals 1950 that converge at the hub 212, 214. The hubs 108, 110 may be cylindrical. The frames 2200, 2300 may be formed by a cut pattern (tube or sheath) of an absorbable material. The frames 2200, 2300 may be extruded and quenched to shape the frames 2200, 2300 (shaped) to the pattern shown. In other cases, the frames 2200, 2300 may be formed by additive printing or additive manufacturing. The frame 2300 may be considered to include a plurality of struts (struts) or filaments formed by the cut pattern. The frame 2300 may be considered to include a plurality of struts (struts) or filaments formed by the cut pattern. The frame 2300 may be injection molded or formed by additive printing.

[0152] Fig.24 An exemplary medical device 2400 according to an embodiment is shown. The medical device 2400 can be a fistula device 2400. The fistula device 2400 is formed by an absorbable filament 102 and can include a flange 2402 at one or both ends. As shown, the flange 2402 is disposed at one end of the fistula device 2400. The fistula device 2400 provides support as the fistula matures and becomes loose over time, as described in detail above with respect to the occluders discussed herein. The fistula device 2400 can include a septum (not shown) disposed around the filament 102.

[0153] Fig.25 An exemplary medical device 2500 according to an embodiment is shown. The medical device 2500 can be a shunt device 2500. The shunt device 2500 can be composed of an absorbable filament 102 and a septum 520, as described in detail above. The shunt device 2500 may include a channel 2502 centrally disposed between the discs 212, 214. Each disc may include a flap 950 that can conform to a tissue wall. In some cases, the shunt device 2500 can be implanted into an access site or tissue and promote tissue healing.

[0154] As described above, the membrane 520 can be disposed around the filaments 102 and configured to contain (retain) debris of the plurality of absorbable filaments 102 in response to breakage or degradation of the filaments and to promote tissue ingrowth into the membrane 520 or tissue encapsulation of the membrane 520. In some cases, the membrane 520 is configured to promote healthy tissue growth or tissue encapsulation of the membrane 520 and remain with the tissue after degradation of the absorbable filaments 102. If desired, tissue ingrowth or encapsulation (encapsulation) and the membrane 520 left behind after degradation of the filaments 102 can allow for recrossability for further procedures.

[0155] Fig.26 FIG. 1 shows an exemplary stabilization of debris of an exemplary filament 102 according to an embodiment. Fig.26 As shown, the diaphragm 520 can be formed by a framework (stent) structure (e.g., woven, knitted, non-woven, absorbable or non-absorbable) component 1122, 1124. As the filament 102 degrades, the components 1122, 1124 can accommodate structural components and debris. In some cases, the components 1122, 1124 can also include porosity to stabilize the debris and / or particles that may be generated due to the degradation of the filament 102 100 and / or the diaphragm 520. In some cases, for example, the bottom component (underlying component) 1122 can degrade, and the covering component 1124 can stabilize the underlying component 1122. In this way, the diaphragm 520 can also degrade and promote stability, as described in detail above.

[0156] The bottom component (underlying component) 1122 can stabilize the filaments 102 and the upper component 1124 when degrading. The physical reduction of the overall structure can promote the degradation of the filaments 102 and the parts of the diaphragm 520 while integrating the diaphragm 520 into the tissue. The upper component 1124 can be degraded and the lower component 1122 can be integrated into the tissue. The degraded upper component 1124 (or only the filament 102 degrades, while the entirety of the diaphragm 520 is not degradable) can promote continuous tissue coverage and maturation. The upper component 1124 and the lower component 1122 can form a continuous diaphragm 520, or the upper component 1124 and the lower component 1122 can be separate structures. In the case where the upper component 1124 and the lower component 1122 are separate structures, the upper component 1124 can be the diaphragm 1202, and the lower component 1122 can be an absorbable layer.

[0157] Examples of absorbable filaments include, but are not limited to, absorbable metals such as magnesium and magnesium alloys, ferrous materials such as iron, aluminum, and aluminum alloys, and other similar materials.

[0158] Examples of absorbable polymers that can be used in the filament or diaphragm component include, but are not limited to, polymers, copolymers (including terpolymers), and blends that can include, in whole or in part, polyesteramides, polyhydroxyalkanoates (PHAs), poly(3-hydroxyalkanoates), such as poly(3-hydroxypropionate), poly(3-hydroxybutyrate), poly(3-hydroxyvalerate), poly(3-hydroxyhexanoate), poly(3-hydroxyheptanoate), and poly(3-hydroxyoctanoate), poly(4-hydroxyoctanoate), poly(4-hydroxyhexanoate), poly(3-hydroxyheptanoate), and poly(3-hydroxyoctanoate). 4-hydroxybutyrate), poly(4-hydroxyvalerate), poly(4-hydroxyhexanoate), poly(4-hydroxyheptanoate), poly(4-hydroxyoctanoate), poly(L-lactide-co-glycolide) and copolymer variants, poly(D,L-lactide), poly(L-lactide), polyglycolide, poly(D,L-lactide-co-glycolide), poly(L-lactide-co-glycolide), polycaprolactone, poly(lactide-co-caprolactone) , poly(glycolide-caprolactone), poly(dioxanone), poly(orthoesters), poly(trimethylene carbonate), polyphosphazenes, poly(anhydrides), poly(tyrosine carbonate) and derivatives thereof, poly(tyrosine esters) and derivatives thereof, poly(imino carbonates), poly(lactic acid-trimethylene carbonate), poly(glycolic acid-trimethylene carbonate), polyphosphates, polyphosphate urethanes, poly(amino acids), poly(ethylene glycol) (PEG), copoly(ether esters) (e.g., PEO / PLA), polyalkylene oxides such as poly(ethylene oxide), poly(propylene oxide), poly(ether esters), polyalkylene oxalates, poly(aspirin), biomolecules such as collagen, chitosan, alginate, fibrin, fibrinogen, cellulose, starch, collagen, dextran, dextrin, fragments and derivatives of hyaluronic acid, heparin, fragments and derivatives of heparin, glycosaminoglycans (GAGs), GAG derivatives, polysaccharides, elastin, chitosan, alginate, or combinations thereof.

[0159] Examples of synthetic polymers suitable as membrane materials (which can be used as membranes) include, but are not limited to, nylon, polyacrylamide, polycarbonate, polyoxymethylene, polymethyl methacrylate, polytetrafluoroethylene, polychlorotrifluoroethylene, polyvinyl chloride, polyurethane, elastomeric silicone polymers, polyethylene, polyurethane, polyglycolic acids, polyesters, polyamides, and mixtures, blends, and copolymers thereof. In one embodiment, the membrane is made of (a class of) polyesters, polyfluorocarbons, and porous or non-porous polyurethanes, such as polyethylene terephthalate, including and and polyaramids, such as The above-mentioned polyfluorocarbons are hexafluoropropylene ( or ) of polytetrafluoroethylene (PTFE). In some cases, the diaphragm includes an expanded fluorocarbon polymer (particularly ePTFE) material. Included in this class of preferred fluoropolymers are polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), tetrafluoroethylene (TFE) and perfluoro (propyl vinyl ether) copolymers (PFA), homopolymers of polytrifluorochloroethylene (PCTFE), and copolymers thereof with TFE, ethylene-trifluorochloroethylene (ECTFE), copolymers of ethylene-tetrafluoroethylene (ETFE), polyvinylidene fluoride (PVDF) and polyvinyl fluoride (PVF). ePTFE is particularly preferred due to its widespread use in vascular prostheses. In some embodiments, the diaphragm includes a combination of the materials listed above. In some cases, the diaphragm is substantially impermeable to body fluids. The substantially impermeable diaphragm can be made of a material that is substantially impermeable to body fluids, or can be constructed of a permeable material that is processed or manufactured (e.g., by laminating different types of materials described above or known in the art) that is substantially impermeable to body fluids.

[0160] Other examples of diaphragm materials include, but are not limited to, vinylidene fluoride / hexafluoropropylene hexafluoropropylene (HFP), tetrafluoroethylene (TFE), vinylidene fluoride, 1-hydropentafluoropropylene, perfluoro(methyl vinyl ether), chlorotrifluoroethylene (CTFE), pentafluoropropylene, trifluoroethylene, hexafluoroacetone, hexafluoroisobutylene, fluorinated poly(ethylene-co-propylene) (FPEP), poly(hexafluoropropylene) (PHFP), poly(chlorotrifluoroethylene) (PCTFE), poly(vinylidene fluoride) (PVDF), poly(vinylidene fluoride-co-tetrafluoroethylene) (PVDF-TFE), poly(vinylidene fluoride-co-hexafluoropropylene) (PVDF-HFP), poly(tetrafluoroethylene-co-hexafluoropropylene) Poly(PTFE-HFP), poly(tetrafluoroethylene-co-vinyl alcohol) (PTFE-VAL), poly(tetrafluoroethylene-co-vinyl acetate) (PTFE-VAC), poly(tetrafluoroethylene-co-propylene) (PTFEP), poly(hexafluoropropylene-co-vinyl alcohol) (PHFP-VAL), poly(ethylene-co-tetrafluoroethylene) (PETFE), poly(ethylene-co-hexafluoropropylene) (PEHFP), poly(vinylidene fluoride-co-chlorotrifluoroethylene-ethylene) (PVDF-CTFE) and combinations thereof, and other polymers and copolymers described in U.S. Publication No. 2004 / 0063805, the entire contents of which are incorporated herein by reference for all purposes. Other polyfluoropolymers include tetrafluoroethylene (TFE) / perfluoroalkyl vinyl ether (PAVE). PAVE can be perfluoromethyl vinyl ether (PMVE), perfluoroethyl vinyl ether (PEVE) or perfluoropropyl vinyl ether (PPVE). Other polymers and copolymers include: polylactide, polycaprolactone-glycolide, polyorthoesters, polyanhydrides; polyamino acids; polysaccharides; polyphosphazenes; poly(ether-ester) copolymers such as PEO-PLLA or blends thereof, polydimethylsiloxane; poly(ethylene-vinyl acetate); acrylate-based polymers or copolymers such as poly(hydroxyethyl methyl methacrylate), polyvinylpyrrolidone; fluorinated polymers such as polytetrafluoroethylene; cellulose esters and any polymers and copolymers.

[0161] The invention of the present application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and changes may be made to the embodiments without departing from the scope of the present disclosure. Therefore, the embodiments are intended to cover modifications and changes of the present invention as long as they fall within the scope of the appended claims and their equivalents.

Claims

1. A device comprising: a support structure having a proximal end and a distal end and comprising a plurality of absorbable filaments configured to support tissue and degrade over a defined period of time; as well as A diaphragm disposed entirely around the support structure to completely encapsulate the plurality of absorbable filaments and disposed entirely around at least one of the proximal end and the distal end, the diaphragm being configured to accommodate debris of the plurality of absorbable filaments in response to breakage or degradation of the filaments and to promote at least one of tissue ingrowth into the diaphragm and tissue encapsulation of at least a portion of the diaphragm, wherein the proximal end is an integral part of the proximal disc-shaped portion such that the proximal end does not protrude beyond the proximal end of the device, wherein the diaphragm defines a first layer and a second layer, the plurality of absorbable filaments being arranged between the layers of the diaphragm such that the first layer and the second layer of the diaphragm sandwich the plurality of absorbable filaments therebetween.

2. The device according to claim 1, characterized in that The membrane is configured to promote healthy tissue growth and remain with the tissue after the absorbable filaments degrade.

3. The device according to any one of claims 1 to 2, characterized in that The absorbable filaments are at least one of bioabsorbable and bioerodible.

4. The device according to claim 1, characterized in that It also includes a proximal hub portion disposed at the proximal ends of the multiple absorbable filaments, a distal hub portion disposed at the distal ends of the multiple absorbable filaments, the proximal disc portion configured to contact a first side of a tissue wall, and a distal disc portion configured to contact a second side of the tissue wall.

5. The device according to claim 4, characterized in that Also included is an elastic tensile member, which is configured to be connected to the proximal hub and the distal hub and disposed within the support structure, and the elastic tensile member is configured to juxtapose the proximal disk with the first side of the tissue wall and juxtapose the distal disk with the second side of the tissue wall.

6. The device according to claim 4, characterized in that Also included is a capture member configured to connect the proximal hub and the distal hub within the support structure when engaged, the capture member being configured to juxtapose the proximal disk with the first side of the tissue wall and to juxtapose the distal disk with the second side of the tissue wall.

7. The device according to claim 4, characterized in that The proximal hub includes a proximal portion of the plurality of absorbable filaments, and the distal hub includes a distal portion of the plurality of absorbable filaments.

8. The device according to claim 7, characterized in that The proximal portions of the plurality of absorbable filaments are formed together to form the proximal hub, and the distal portions of the plurality of absorbable filaments are formed together to form the distal hub.

9. The device according to any one of claims 4 to 7, characterized in that The proximal hub includes a band of material disposed about proximal portions of the plurality of absorbable filaments, and the distal hub includes a band of material surrounding distal portions of the plurality of absorbable filaments.

10. The device according to any one of claims 4 to 7, characterized in that Also included is a central hub comprising a central portion of the plurality of absorbable filaments.

11. The device according to claim 10, characterized in that The intermediate hub includes a band of material disposed about a central portion of the plurality of absorbable filaments.

12. The device according to any one of claims 1 to 2, characterized in that The membrane is configured to allow contact between the plurality of filaments and blood or moisture to promote degradation of the plurality of absorbable filaments.

13. The device according to any one of claims 1 to 2, characterized in that The membrane includes a gap configured to allow direct tissue contact with the absorbable filament.

14. The device according to any one of claims 1 to 2, characterized in that The diaphragm is discontinuous.

15. The device according to claim 14, characterized in that The septum includes at least two pieces and is attached to house the plurality of absorbable filaments.

16. The device according to any one of claims 1 to 2, characterized in that At least one of the plurality of absorbable filaments includes a cross-section that is at least one of irregular, jagged, star-shaped, and polygonal.

17. The device according to any one of claims 1 to 2, characterized in that The membrane includes a biodegradable upper component and a lower component that is configured to integrate into tissue.

18. The device according to any one of claims 1 to 2, characterized in that The device includes a first layer and a second layer, each of the first layer and the second layer including a biodegradable overlying component and an underlying component configured to integrate into tissue.

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