Applying fiber material to medical device rotation

Abstract

A method of applying a fibrous material to a medical device component involves: connecting the medical device component with a holder device; rotating a reservoir device containing a liquid polymer solution to expel at least a portion of the liquid polymer solution from an orifice of the reservoir device, the expelled at least a portion of the liquid polymer solution forming one or more streams of fibrous material in a deposition plane; and rotating the holder device at least partially within the deposition plane to apply at least a first portion of the one or more streams of fibrous material to one or more surfaces of the medical device component to form a fibrous covering on the one or more surfaces of the medical device component.

Description

[0001] Related applications

[0002] This application claims priority to U.S. Provisional Application No. 62 / 882,352, filed August 2, 2019, entitled ROTARY FIBROUS MATERIAL APPLICATION TO MEDICAL DEVICES, the disclosure of which is incorporated herein by reference in its entirety. Background Technology Technical Field

[0003] This disclosure generally relates to the field of medical implant devices.

[0004] Description of Related Art

[0005] Various medical devices include components (one or more) with fabric or other fibrous features. Manufacturing such devices according to various application processes can be cumbersome. Furthermore, the material properties of such fabric / fiber features can affect the efficacy of the associated medical device. Summary of the Invention

[0006] This document describes methods and apparatus for facilitating the application of fibrous materials and / or features to a medical device. In some embodiments, this disclosure relates to a method of applying fibrous material to a component of a medical device. The method includes: coupling a medical device component to a retainer device; rotating a reservoir device containing a liquid polymer solution to discharge at least a portion of the liquid polymer solution from an orifice of the reservoir device, the discharged at least a portion of the liquid polymer solution forming one or more strands of fibrous material in a deposition plane; and rotating the retainer device at least partially within the deposition plane to apply at least a first portion of the one or more strands of fibrous material to one or more surfaces of the medical device component, thereby forming a fibrous covering on the one or more surfaces of the medical device component.

[0007] In some embodiments, the retainer device is a component of the collection assembly, which further includes a rotary motor and a mandrel mechanically coupled to the retainer device and the rotary motor. For example, the method may further include translating the collection assembly along a vertical axis while discharging at least a portion of the liquid polymer solution.

[0008] The retainer device can advantageously have a spacer form that is at least partially cylindrical. For example, the method may further include applying at least a second portion of the one or more strands of fibrous material to the surface of the retainer device, thereby forming an excess fibrous covering portion on the surface of the retainer device. The method may further include: decoupling the medical device component from the retainer device; and folding the excess fibrous covering portion over at least one edge of the medical device component to cover at least a portion of the inner surface of the medical device component. As an alternative to folding the excess material, the mandrel may be coated first, followed by the mounting of the support, and then the outer skirt may be coated. After completion, the support and fibrous material sandwiched in between can be removed from the retainer. In some embodiments, any excess fibrous material can be cut / removed using a laser (e.g., a CO2 laser).

[0009] In some embodiments, the retainer device includes a plurality of arms configured to be coupled to a medical device component. For example, coupling a medical device component to the retainer device may include suturing the medical device component to the plurality of arms of the retainer device. In some embodiments, rotation of the reservoir device and the retainer device is performed using control circuitry at least in part communicatively coupled to a collection assembly associated with the retainer device and a deposition assembly associated with the reservoir device.

[0010] In some embodiments, the medical device component includes a stent for a transcatheter prosthetic heart valve implantation device, a retainer device including a spacer type that is at least partially cylindrical, and coupling the medical device component to the retainer involves arranging the stent around the spacer type. For example, the stent may have a non-uniform longitudinal diameter. In some embodiments, the medical device component includes a frame for a surgical prosthetic heart valve implantation device, the retainer device including a plurality of arms, and coupling the medical device component to the retainer involves coupling the frame to the plurality of arms. For example, the frame may include a wireform type defining a plurality of connecting columns and an anchoring skirt coupled to a sealing ring portion of the surgical prosthetic heart valve implantation device.

[0011] The method may further include applying at least a second portion of the one or more strands of fibrous material to the anchoring skirt to form a skirt cover, wherein the skirt cover is coarser than the fibrous cover. For example, in some embodiments, the frame includes a body portion and an anchor feature portion, and applying the at least first portion of the one or more strands of fibrous material to the one or more surfaces of the medical device component involves covering at least a portion of the anchor feature portion of the frame with the fibrous material. Covering at least a portion of the anchor feature portion can be performed when the anchor feature portion is in a straightened-out configuration.

[0012] In some embodiments, the medical device component includes a valve leaflet spacer device. For example, a rotation retainer device can be performed with the valve leaflet spacer device configured in at least a partially straightened configuration, wherein the method further includes changing the valve leaflet spacer device from the at least partially straightened configuration to a folded configuration after forming a fibrous covering on one or more surfaces of the medical device component.

[0013] In some embodiments, this disclosure relates to a method of applying a fibrous material to a component of a medical device. The method includes: coupling a retainer device to a rotatable mandrel, the retainer device including a spacer type; rotating a reservoir device containing a liquid polymer solution to discharge at least a portion of the liquid polymer solution from an orifice of the reservoir device, the discharged at least a portion of the liquid polymer solution forming one or more strands of fibrous material in a deposition plane; rotating the retainer device at least partially in the deposition plane to apply at least a first portion of the one or more strands of fibrous material to a surface of the retainer device, thereby forming a fibrous covering on the surface of the retainer device; and arranging a medical device component on the retainer device on the fibrous covering.

[0014] The method may further include: applying a layer of fibrous material from the reservoir to at least a portion of the outer surface of the medical device component; and removing the medical device component, along with the fibrous covering and the layer of fibrous material, from the retainer device. As an alternative to folding excess material, the mandrel may be coated first, followed by the mounting of the support, and then the outer skirt may be coated. After completion, the support and fibrous material sandwiched in between can be removed from the retainer. In some embodiments, any excess fibrous material can be cut / removed using a laser (e.g., a CO2 laser). The method may further include folding a portion of the fibrous covering onto the outer surface of the medical device component. In some embodiments, the spacer is cylindrical.

[0015] For the purpose of summarizing this disclosure, certain aspects, advantages, and novel features are described herein. It should be understood that not all of these advantages can necessarily be achieved according to any particular embodiment. Therefore, the disclosed embodiments may be implemented in a manner that achieves or optimizes one or more advantages as taught herein without necessarily achieving other advantages as taught or implied herein. Attached Figure Description

[0016] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be construed as limiting the scope of the invention. Furthermore, various features of different disclosed embodiments can be combined to form other embodiments, which are part of this disclosure. Throughout the drawings, reference numerals are repeatedly used to indicate correspondences between reference elements. However, it should be understood that the use of similar reference numerals with respect to multiple drawings does not necessarily imply similarity between the corresponding embodiments associated with them. Moreover, it should be understood that the features in the various drawings are not necessarily drawn to scale, and the illustrative dimensions are presented for the purpose of illustrating their inventive aspects. In general, some of the illustrated features may be smaller than those illustrated in some embodiments or configurations.

[0017] Figure 1 A support frame for a surgical heart valve is shown according to one or more embodiments.

[0018] Figure 2 Examples illustrate at least partially covered with fabric according to one or more embodiments. Figure 1 The framework.

[0019] Figure 3 and Figure 4 Another example assembly of a prosthetic heart valve implantation device, at least partially covered by fabric according to one or more embodiments, is shown.

[0020] Figure 5 An operator is illustrated who performs operations on a prosthetic human implant device according to one or more embodiments.

[0021] Figure 6 A close-up view of a prosthetic implant device having a fabric / woven component placed thereon and held and sewn together manually, according to one or more embodiments, is shown.

[0022] Figure 7 An electrospinning system for applying fibrous material to components of a medical implant device according to one or more embodiments is shown.

[0023] Figure 8A A rotary jet spinning system for applying fibrous material to components of a medical implant device according to one or more embodiments is shown.

[0024] Figure 8B It is based on one or more embodiments. Figure 8A A close-up view of the savings component of the system shown.

[0025] Figure 9 and Figure 10Side views of examples of collection assemblies including spacer-type retainers and arm-type retainers according to one or more embodiments are shown.

[0026] Figure 11 An exemplary stent, according to one or more embodiments, is illustrated for use in a prosthetic heart valve implantation device.

[0027] Figure 12 A bracket arranged around a spacer-type retainer according to one or more embodiments is shown.

[0028] Figure 13 The illustration shows a support structure arranged around a retainer and at least partially covered with fibrous material using a rotary jet spinning deposition system, according to one or more embodiments.

[0029] Figure 14 Examples are provided for frames incorporated into implantable prosthetic valves according to one or more embodiments.

[0030] Figure 15 An exemplary heart valve implantation device including a stent is shown, having fibrous material applied to one or more portions thereof using a rotary jet spinning process according to one or more embodiments.

[0031] Figure 16 Examples of heart valve implant devices with uneven stent diameters are shown, which have fibrous material applied to one or more portions thereof using a rotary jet spinning process according to one or more embodiments.

[0032] Figure 17 This is a perspective view of a prosthetic heart valve implantation device according to one or more embodiments.

[0033] Figure 18 A heart valve assembly arranged on a retainer according to one or more embodiments is shown.

[0034] Figure 19 A surgical heart valve is shown, which has a fibrous material applied to a portion thereof using rotary jet spinning according to one or more embodiments.

[0035] Figure 20 This is a side view of a prosthetic spacer device according to one or more embodiments.

[0036] Figure 21 A spacer device arranged on a retainer according to one or more embodiments is shown.

[0037] Figure 22 A spacer device is shown, having fibrous material applied to a portion thereof by rotary jet spinning according to one or more embodiments.

[0038] Figure 23 A prosthetic heart valve device is shown, which can be at least partially covered by fibrous material using rotary jet spinning according to one or more embodiments.

[0039] Figure 24 A heart valve frame arranged on a retainer according to one or more embodiments is shown.

[0040] Figure 25 A heart valve device is shown, which has fibrous material applied to a portion thereof by rotary jet spinning according to one or more embodiments.

[0041] Figure 26 This is a perspective view of a valve annuloplasty repair device according to one or more embodiments.

[0042] Figure 27 An annular repair device arranged on a retainer according to one or more embodiments is shown.

[0043] Figure 28 A perspective view of a valve annuloplasty repair device is shown, which has fibrous material applied thereto by rotary jet spinning according to one or more embodiments.

[0044] Figure 29 This is a perspective view of a frame for a docking device according to one or more embodiments of the present disclosure.

[0045] Figure 30 A docking device frame arranged on a retainer according to one or more embodiments is shown.

[0046] Figure 31 A perspective view of the docking device is shown, which has fibrous material applied to at least a portion thereof according to an embodiment of the present disclosure.

[0047] Figure 32 An example type of docking device is shown, which can be at least partially covered by fibrous material using a rotary jet spinning solution according to one or more embodiments.

[0048] Figure 33 A docking device frame arranged on a retainer according to one or more embodiments is shown.

[0049] Figure 34 A docking device is shown, which has fibrous material applied to a portion thereof by rotary jet spinning according to one or more embodiments.

[0050] Figure 35 A docking device is shown, which can be at least partially covered by fibrous material using a rotary jet spinning solution according to one or more embodiments.

[0051] Figure 36 A valved conduit assembly according to one or more embodiments is shown.

[0052] Figure 37 An example of a spacer closure device is provided, which has fibrous material applied to one or more portions thereof by rotary jet spinning according to one or more embodiments.

[0053] Figure 38 An example of a docking device is provided, which has fibrous material applied to one or more portions thereof by rotary jet spinning according to one or more embodiments.

[0054] Figure 39 An example of a tissue anchoring device is provided, which has fibrous material applied to one or more portions thereof by rotary jet spinning according to one or more embodiments.

[0055] Figure 40 An example of a valve annulus repair device is provided, which has fibrous material applied to one or more portions thereof by rotary jet spinning according to one or more embodiments.

[0056] Figure 41 This is a flowchart of a process for applying fibrous material to a component of a medical device according to one or more embodiments.

[0057] To further clarify various aspects of the embodiments of this disclosure, certain embodiments will be described in more detail with reference to various aspects of the accompanying drawings. It should be understood that these drawings depict only typical embodiments of this disclosure and should therefore not be considered as limiting the scope of this disclosure. Furthermore, while the drawings may be drawn to scale for some embodiments, they are not necessarily drawn to scale for all embodiments. Embodiments of this disclosure will be described and explained with additional specificity and detail using the accompanying drawings. Detailed Implementation

[0058] The embodiments of the technology disclosed herein relate to methods and apparatus for facilitating the application of fibrous materials / features to medical devices. More specifically, various embodiments of the technology disclosed herein relate to methods for applying rotary jet-spun fibrous materials to one or more surfaces of a medical device, such as a filament-type frame or stent.

[0059] Various medical devices include components that are advantageously at least partially covered by cloth or other fibrous materials. The terms “fiber” and “fibrous material” are used herein in their broad and general sense and can refer to any type of natural or synthetic substance or material significantly longer than its width, including any elongated or relatively thin, fine, and / or linear elements, filaments, cords, yarns, piles, strands, threads, ropes, or portions thereof. Furthermore, “fiber” or “fibrous material” can refer to a single filament or collectively to multiple filaments. Examples of fibrous materials according to embodiments of this disclosure include any type of cloth, fabric, or textile. While some of the following descriptions refer to the characteristics of “cloth” and / or “cloth-covered,” it should be understood that such descriptions apply to any type of fibrous material, including any type of cloth, fabric, textile, or interlocking fibrous material or form.

[0060] Examples of medical device components that may be covered with or otherwise associated with cloth or other fibrous materials include certain stents, which typically may include a conduit configuration configured for placement within the body to create or maintain a channel, or to provide a relatively stable anchoring structure for supporting one or more other devices or anatomical structures. Stents that are at least partially covered with cloth can be used for a variety of purposes, such as for dilating certain blood vessels, including blood vessels, catheters, or other conduits, whether vascular, coronary, bile duct, or other types. In the context of prosthetic heart valve devices, stents can serve as structural components for anchoring the prosthetic heart valve to the heart valve annulus. Such stents may have varying shapes and / or diameters.

[0061] It should be understood that prosthetic heart valve implants, as well as many other types of prosthetic implant devices and other types of devices, may include various fabric-covered components and / or portions. For example, sealing portions of medical implant devices, such as the skirt component / part of a prosthetic heart valve, may be sewn to its frame to help prevent blood leakage around the outer edge or periphery of the device.

[0062] In some implementations, sutures can be used to secure fabric coverings for medical device components. For example, in some implementations, a human operator can handle the implant device component and perform sutures thereon to secure the fabric to it. However, in some cases, suturing performed by a human operator can be relatively difficult and / or tedious. For example, in situations where small stitches need to be made with relatively high precision, the complexity and / or associated operator burden can lead to injury / exhaustion and / or undesirably low product quality. Furthermore, medical implant devices, such as certain heart valve implants, may require thousands of sutures, or more, which can involve numerous labor-intensive and error-prone suturing procedures. Therefore, reducing collaborative human involvement in applying fibrous materials to medical device components would be desirable, thereby improving quality and efficiency and / or reducing operator strain.

[0063] Certain embodiments disclosed herein provide methods for applying fibrous materials to components (one or more) of a medical implant device using rotary jet spinning apparatus, systems, processes, and mechanisms. Various embodiments relating to rotary jet fabric application are applicable to medical implant devices and heart valves having any type of structural configuration or style. Examples of medical implant device and heart valve structures applicable to certain embodiments presented herein are disclosed in WIPO Publication No. WO2015 / 070249—the entire contents of which are expressly incorporated herein by reference for all purposes.

[0064] Some exemplary medical implant devices incorporating fabric coverings include prosthetic heart valve implants with fabric coverings and / or wire frames that can provide sealing, structural support, and / or anchoring functionality. Figure 1 A frame 92 for a support stent for a surgical heart valve is shown according to some embodiments. The frame 92 may include a plurality of cusps curved toward an axial inflow end, alternating with a plurality of ferrules 22 projecting toward an axial outflow end, the support stent 92 defining an undulating outflow edge. The support stent 92 may include a filament type 20 having three upright ferrules 22 alternating with three cusps 24 generally circumferentially tangential. A reinforcing band 26 may be disposed within or outside the filament type 20. The inflow edge of the band 26 may be at least partially conformal to the cusps 24 of the filament type 20 and may be curved in the outflow direction between regions of the filament type ferrules 22. In some embodiments, the support stent 92 provides a support structure for a unidirectional surgical prosthetic heart valve, as disclosed in more detail with respect to some embodiments described below.

[0065] Figure 2 An example is shown with 40% of fabric covering. Figure 1The frame 92 includes a fabric 40 that can be sewn into one or more sections to secure the fabric 40 as a cover for the frame 92. The fabric-covered support 42 may be generally tubular and may include a plurality of protrusions 44 curved toward an axial inflow end, alternating with a plurality of ferrules 46 projecting toward an axial outflow end. The support 42 may include undulating outflow edges around which the fabric 40 is secured or held. In some embodiments, a seam 50 may be sewn adjacent to an inflow edge 52 that secures the fabric 40 around the support. For clarity, although the seam 50 is shown slightly axially above the inflow edge 52, it may be located directly above the inflow edge or even within the support. In one embodiment, one or more seams may be located in other locations on the fabric. As described in detail below, the support 42 and / or one or more other components of the associated implant device may also have leaflets and / or other materials sewn to them.

[0066] Figure 3 and Figure 4 An exploded view of another exemplary assembly of a prosthetic heart valve implant device, at least partially covered by fabric, is shown. This exploded view is presented to provide additional context related to the incorporation of fabric coverings into medical implant devices. Specifically, Figure 3 and Figure 4 Examples may generally relate to valve implant devices having an associated fabric-covered anchoring skirt 26. For example, a self-expanding stent or balloon-expanding stent may be used as part of a prosthetic heart valve with a single-stage implantation, in which the surgeon attaches a hybrid heart valve with an anchoring skirt and valve components as a unit or piece to the heart valve annulus. Several relevant solutions specifically for aortic valve replacement are provided in U.S. Patent No. 8,641,757, the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, with Figure 3 and Figure 4 The implantation process related to the assembly may require as few as three sutures, unlike the more time-consuming process that requires placing a dozen or more sutures and tying each of the multiple parts / sections of the assembly.

[0067] Figure 3 and Figure 4 Valve implant assemblies can be incorporated in one or more aspects similar to Figure 1 and Figure 2The valve frame shown and described above. Anchor skirt 26 may include an internal malleable expansion stent covered with fabric (e.g., polymer fabric). Anchor skirt 26 may include an internal stent frame 80, a fabric cover 82, and a strip-shaped lower sealing flange 84. Internal stent frame 80 may include a tubular malleable expansion member having an undulating or fan-shaped upper end 86 that conforms to the contour of the inflow portion of the heart valve.

[0068] In some embodiments, fabric 82 may be sewn to the support frame 80. For example, tubular sections of fabric 82 may be stretched around the support frame 80 inside and / or outside the support frame 80 and sewn thereto to form an intermediate fabric-covered frame 88. After the support frame 80 is surrounded with fabric 82, a series of longitudinal stitches may be performed to secure the two components together. Furthermore, a series of stitches may be performed along the undulating upper end 86 of the support frame 80 to complete the fabric enclosure.

[0069] In general, the fabric 82 attached to the stent 80 can be used to reduce friction between the stent and the associated body orifice, to secure the prosthetic heart valve in the orifice location, to fill gaps through which fluid can pass, and / or to provide a location for tissue to grow inward. However, applying and sewing the fabric 82 can be a relatively time-consuming and laborious process.

[0070] Apart from Figures 1-4 Beyond the fabric / woven components exemplified in the examples, medical device implants can include a variety of other fabric-covered and / or sutured components and / or portions. In some embodiments, applying fibrous material to one or more medical device components by an operator can be relatively difficult and / or cumbersome. For example, in cases where small stitches need to be fabricated with relatively high precision, the complexity and / or associated operator burden can lead to injury and / or undesirably low product quality. Furthermore, some heart valve implants may require thousands of sutures, which can involve numerous labor-intensive and error-prone suturing procedures. Therefore, simplifying the application of fabric / woven materials to medical device implants could potentially improve quality and / or reduce operator involvement, such as requiring less handling to position the fabric / woven portions and / or hold them in place for suturing.

[0071] In general, the application of fabric to medical implant devices can be performed in various ways. For example, certain handheld processes for applying and suturing fibrous material to prosthetic human implant devices can be implemented, in which the operator uses both hands to hold, secure, and / or sew the fabric / woven portion of the implant device. As an example, Figure 5An example is illustrated where an operator 405 performs operations on a prosthetic human implant device 410. In some embodiments, as described above, the operator 405 may hold the outer suture frame of the device 410 and / or sew it to an inner skirt or fabric. Figure 5 In one example, implant device 410 may be a transcatheter heart valve device or other implant device.

[0072] like Figure 5 As shown in the figure, in some procedures, operator 405 may need to use his or her hands to attach the fibrous material / fabric to the medical implant device. For example, a first hand 406 may be used to hold the cloth / fabric and / or secure it to the implant device 410 in the desired position, while a second hand 407 may be used to manually manipulate suture needles and the like. Furthermore, in order for operator 405 to effectively perform the associated fabric application operations, it may be necessary or desirable to magnify or otherwise enhance the field of view of the implant device 410 in some way. For example, as shown, operator 405 may further utilize a magnification system 460, such as a microscope, which may include an eyepiece component 461 and one or more lenses and / or refractive elements 463. In some embodiments, the magnification system 460 may be designed such that operator 405 can have a first angle of view 409, wherein the magnification system 460 is configured to reflect light therein at least partially at a downward angle 408 to provide depth of field at a target distance from the refractive element 463. By keeping the implant device 410 or its target portion within the depth of field of the magnification system 460, the operator 405 is able to observe an enhanced view of the implant device 410 or its target portion, which may be desired or necessary for performing precise fabric application and / or suturing operations.

[0073] Figure 6A close-up view of a prosthetic implant device 440, as described above, having a fabric / fabric component placed thereon and manually held and sutured. As shown, for a handheld suturing solution, a first hand 406 may be needed to hold the fabric / fabric component in place on the implant device 440, while a second hand 507 may be needed to manipulate the suture needle 409 and the like. Depending on the procedure, the operator may need to hold one or more hands in a substantially constant position for an extended period of time to maintain the fabric / fabric portion in the desired position while performing suturing. This may require the operator to squeeze, push, pull, or otherwise apply hand force to one or more portions of the implant device 510, resulting in strain on the muscles, joints, etc., of the operator's hands and / or other anatomical structures. In some embodiments, the implant device 440 may be supported on a retainer 401. In some embodiments, handheld retainers and tools may require the operator to hold the retainer or tool with one hand, thus limiting the operator's ability to use such a holding hand to adjust the tension and / or realign the fabric / fabric component(s).

[0074] In some embodiments, this disclosure relates to systems, apparatus, and methods for applying fibrous materials to the surface of medical implant devices, such as stents or the like, in a manner that reduces labor time and production costs. The embodiments disclosed herein address this and other needs.

[0075] In some implementations, fibrous materials can be applied to medical implant devices using an electrospinning process. For example, for certain prosthetic heart valve implant devices, fibrous materials can be applied to a metallic scaffold structure, where the applied fibrous material can be used to reduce friction between the scaffold and an anatomical structure (e.g., a blood vessel / orifice) at the implantation site, thereby securing the implant device to the implantation site, filling gaps through which fluid may pass, and / or providing a surface for inward tissue growth.

[0076] Polymer fibers, such as nanofibers, possess the desired utility for medical implant device coverings due to their high surface area-to-mass ratio, high porosity, tissue-in-place growth properties, and their ability to be easily wound into various shapes. Electrospinning represents one method for producing such nanofibers. As detailed below, the electrospinning process typically employs a high voltage to generate an electric field between a polymer solution droplet at the needle tip and a collector plate. One electrode of the voltage source is placed in the solution, while the other is connected to the collector. This generates an electrostatic force. As the voltage increases, the electric field strengthens, causing a force to accumulate on the suspended droplet of polymer solution at the needle tip. This force acts in the opposite direction to the surface tension of the droplet. The increased electrostatic force causes the droplet to elongate, forming a conical shape. When the electrostatic force overcomes the surface tension of the droplet, a charged, continuous jet of solution is ejected from the cone. The jet of solution accelerates toward the collector, whipping and bending violently. As the solution moves away from the needle and toward the collector, the jet rapidly thins and dries as the solvent evaporates. On the surface of the ground collector, a nonwoven mat of randomly oriented solid nanofibers was deposited.

[0077] As described in detail above, for some fabric application processes, applying and sewing the fabric can be a time-consuming and labor-intensive process. Electrospinning application of fibrous materials represents one example of an alternative method for applying fabric or fibrous materials (e.g., polymer fiber materials) to the surface of a stent or other medical implant device component in a manner that reduces labor time and production costs. As an example, electrospinning polymer materials can be applied to a medical device implant (e.g., a metal stent) while the implant and supporting mandrel / retainer are rotated using a rotating tool. Over time, the electrospinning process produces a layer of polymer threads or fibers covering the exterior of the target surface. Certain methods, apparatuses, and systems relating to the electrospinning concept applicable to embodiments of this disclosure are disclosed in U.S. Publication No. 2017 / 0325976, the disclosure of which is incorporated herein by reference in its entirety.

[0078] Figure 7 A system 100 for applying electrospun material 102 to a component 104 of a stent or other medical implant device is shown. System 100 includes an electrospun material source 106, a collector 108, and a controller 110. The electrospun material source is any suitable device, such as a device including a spinneret electrically coupled to a voltage source. The source may include, for example, one or more infusion pumps, one or more syringes mounted on the infusion pump(s), and one or more syringe needles fluidly coupled to the syringe(s). In some embodiments, a spinneret-type syringe(s) is implemented. In some embodiments, a voltage source is electrically coupled to the syringe needle(s).

[0079] In some embodiments, the electrospun material 102 is a solution of polyethylene terephthalate (PET). A PET solution can be produced by mixing PET (e.g., about 10% to 20% by weight) with a suitable solvent or mixture of solvents (e.g., about 80% to 90% by weight of hexafluoroisopropanol (HFIP)) and allowing the PET to dissolve completely. In a specific embodiment, the PET solution is produced by mixing about 15% to 18% by weight of PET with about 82% to 85% by weight of a solvent such as HFIP. Instead of PET or other than PET, another polymer, such as a polymer selected from polytetrafluoroethylene (PTFE), polycaprolactone (PCL), polydioxanone (PDO), polyglycolic acid (PGA), and polyurethane (PU), can be used alone or in combination. Furthermore, one or more pharmaceutical and / or bioactive ingredients can be added to the solution. Similarly, other solvents or mixtures thereof are used in other embodiments.

[0080] In some embodiments, the medical device implant 104 includes a prosthetic heart valve such as the Edwards valve disclosed in U.S. Patent No. 8,641,757 to Pintor et al. Valve system or Edwards A stent for a portion of a transcatheter heart valve. Stent 104 can be an expandable stainless steel stent. However, the material is not limited to stainless steel, and other materials such as cobalt-chromium alloys and nitinol can also be used.

[0081] Injection pump 106 serves as the source of the electrospun material 102 applied to the support 104. Some embodiments include multiple injection pumps. Typically, electrospinning utilizes electrical charge to draw very fine (typically micron or nanometer-scale) fibers from a liquid, such as a polymer solution or polymer melt. In some embodiments, the polymer is discharged toward a target through a charged orifice, wherein the orifice and the target have opposite charges. A voltage source is provided to generate a first charge at the charged orifice and an opposite charge at the target. The polymer becomes electrostatically charged by contacting the charged orifice. The electrostatically charged polymer is then collected at the target. Electrospun PTFE is described in U.S. Patent Publication No. 2010 / 0193999, which is incorporated herein by reference.

[0082] The syringe pump 106 can be used with a syringe, which typically includes a cylinder defining a reservoir in which a quantity of electrospun material 102 is placed. After the reservoir is filled, the syringe can be placed on the syringe holder unit (block) of the syringe pump 106. After the syringe pump 106 is adapted to the loaded syringe, the syringe orifice can be connected to a tube coupled to a spinneret, which includes, for example, a stainless steel needle. The electrospun material 102 can be electrostatically drawn from the spinneret tip by applying a relatively high voltage or potential difference between the spinneret tip and the collector 108 using a high-voltage power supply 130 connected by cable 132 to the spinneret and the collector 108. In some embodiments, the high-voltage power supply 130 provides a direct current (DC) power supply of approximately 5 kV to 50 kV.

[0083] In some implementations, a rotary jet spinning process can be used to apply fibrous materials to medical implant devices. For example, for certain prosthetic heart valve implant devices, fibrous materials can be applied to a metallic scaffold structure, where the applied fibrous material can be used to reduce friction between the scaffold and an anatomical structure (e.g., a vessel / orifice) at the implantation site, thereby securing the implant device to the implantation site, filling gaps through which fluids may pass, and / or providing a surface for inward tissue growth. As described in detail above, for some fabric application processes, applying and suturing the fabric can be a time-consuming and labor-intensive process. Rotary jet spinning of fibrous materials represents another example of a method for applying fabric or fibrous materials (e.g., polymeric fibrous materials) to the surface of a scaffold or other medical device implant component in a manner that reduces labor time and production costs. As an example, rotary jet spinning material can be applied to a medical device implant (e.g., a metallic scaffold) while the implant and support retainer are rotated by a rotary tool. Over time, the rotary jet spinning process can produce a layer of polymer threads or fibers covering the exterior of the target surface. Unlike electrospinning, rotary jet spinning typically does not require the use of any electric field. As described in more detail below, rotary jet spinning can involve converting a material (e.g., a polymer) dissolved in a solvent into continuous strands / fibers by centrifugally ejecting the material / solvent at high speed, such that the ejected strands / fibers at least partially coat or otherwise apply to a target surface. For example, the target surface may include the surface of a medical device component (e.g., a stent / frame), which may also be rotated to cover varying surface areas. Certain methods, apparatuses, and systems relating to the rotary jet spinning concept applicable to embodiments of this disclosure are disclosed in U.S. Patent No. 9,410,267, the entire disclosure of which is incorporated herein by reference.

[0084] Rotary jet spinning systems and processes may involve imparting rotational motion to a reservoir containing a polymer solution, causing the polymer to be ejected from one or more orifices in the reservoir. Such processes may further involve collecting the formed fibers on a retainer having a desired shape to form micron, submicron, or nano-sized polymer fibers as a cover for one or more components of a medical implant device. Figure 8A A system 800 is shown for applying a rotary jet-spun material 85 to a stent or other medical implant device component 73, which is coupled to a retainer component 70 associated with a rotating mandrel 75. The system 800 may include a rotary motor (e.g., a pneumatic motor) 86, which can be configured to drive the rotation of a reservoir 80. The reservoir 80 is in... Figure 8B The image is shown in nearsightedness. In some embodiments, the polymer solution is extruded through a small orifice 89. The extrusion of the solution can create a plane 81 of fibers 85, which, during collection, translates the rotating retainer 70 in and out of plane 81 in a desired translational sequence.

[0085] The rotation of the spindle 75 and retainer 70 can be driven by the motor 11. Furthermore, the spindle 75 and retainer 70 can be mounted on a linear motor 12 configured to achieve vertical translation of the spindle 75 and retainer 70. The motor 12 can be considered a fiber planar translation motor and can include, for example, a single-axis high-precision linear drive, configured to translate the collector assembly 79 along an axis 13 parallel to the rotation axis 83 of the rotating reservoir 80, corresponding to the translation relative to the rotation axis 83 of the rotating reservoir 80. Figure 8A The example is a vertical translation of the orientation. Axis 83 may be referred to as the deposition rotation axis. In some embodiments, one or more additional linear actuators may be used to translate the rotating mandrel 75 and the retainer 70 along one or more axes perpendicular to the rotation axis 83 of the rotating reservoir (one or more) (e.g., movement toward and away from the deposition rotation axis 83). In some embodiments, multi-axis actuators or robotic arms may be used to provide increased flexibility in translation and / or changing the angular alignment of the retainer 70.

[0086] The mandrel 75 and retainer 70 may represent components of the collecting assembly 79, which can at least partially be inserted into the path / plane 81 of the polymer fiber 85. The axis 14 around which the mandrel / retainer 70 rotates may be referred to as the collecting rotation axis or the mandrel / retainer rotation axis. As the retainer 70 is translated along axis 13, when the retainer 70 is in the path / plane 81 of the polymer fiber 85 ejected from the rotating reservoir 80, the polymer fiber 85 is able to wind around the retainer 70 via rotation of the retainer 70 about the collecting rotation axis 14.

[0087] In some embodiments, the method of depositing fibrous material on a medical implant device component involves feeding a polymer into a rotary reservoir 80 and generating rotational motion at a speed and time sufficient to form polymer fibers of micron, submicron, or nanoscale, and depositing the material on the medical implant device (not shown in detail; see also...). Figures 10-40 For example, fibers formed may be collected on a medical implant device (which may be mounted on or otherwise secured to or held by the retainer 70) to form a polymer fiber cover of a desired shape / configuration at the micron, submicron, or nanometer scale. In some embodiments, fiber strands are produced by subjecting the polymer solution to a sufficient amount of pressure / stress to form a fiber cover of the desired shape and / or configuration on one or more components of the medical implant device. For example, sufficient pressure / stress to produce fiber strands from the polymer solution may be about 3,000 Pascals or greater.

[0088] In some embodiments, the system 800 is at least partially automated by a control circuit 5 configured to control one or more of the following by generating electrical signals and / or sending electrical signals to one or more components of the system 800: the rotational rate of the reservoir 80, the rotational rate of the holder 70, and the linear and / or multidimensional translation of the holder 70 along an axis 13 parallel to the rotational axis 83 of the rotating reservoir and / or one or more other axes.

[0089] Control over the translational rate of the retainer 70 along axis 13 and / or the orientation of the collection axis 14 relative to the reservoir rotation axis 83 can provide at least partial control over the orientation of the fibers deposited on the collection retainer 70. For example, fibers can be collected on the retainer 70, which is substantially parallel to the reservoir rotation axis 83 and slowly translated along the collection rotation axis 14. In some embodiments, the rotation of the collection device (e.g., retainer 70) can be opposite to the rotation of the reservoir 80 (e.g., counterclockwise and clockwise, respectively) or the rotation of the collection device 70 can be the same as the rotation of the reservoir 80 (e.g., both counterclockwise). In some embodiments, complete alignment coverage of the retainer and / or medical device components is maintained by slowly moving the collection device (e.g., retainer 70) along axis 13 through the path of the polymer fibers 85 while rotating the collection device / assembly 70.

[0090] like Figure 8AAs shown, the collection rotation axis 14 can be oriented at an angle θ relative to the deposition rotation axis 83. This configuration results in the collection of fibers in a cross-shaped polymer fiber arrangement on the collection assembly 70. Cross-shaped weaves can be produced by increasing the translational speed and / or rotating the retainer 70 at a non-zero angle θ relative to the deposition rotation axis 83. The collection assembly 79 can be moved manually or mechanically.

[0091] In some embodiments, system 800 includes a platform 10 for supporting the deposition of fibrous material, wherein deposition assemblies (80, 86) and collection assemblies (70, 71, 73, 76, 11) are vertically arranged on platform 10 and / or spaced apart from platform 10 along a vertical axis 13. Sufficient rotational speed and time for operating the rotating structure 80 to form fibers may depend on the concentration of the material / solution and the desired characteristics of the fibers formed. Exemplary rotational speeds of the rotating structure may range from about 100 rpm to about 500,000 rpm, but are not limited to this exemplary range. Furthermore, the rotating structure 80 may be rotated to impact the liquid material for a time sufficient to form the desired fibers, such as, for example, a time between about 1 and 100 minutes, or other intermediate times or ranges, which are also intended to be part of the invention. The force or energy imparted by the rotating structure 80 advantageously overcomes the surface tension of the solution and causes a portion of the liquid material to separate and fling away from the platform (not shown) that contacts and holds the liquid with the rotating structure, thereby forming fibers (one or more). The fibers (one or more) can be collected on the collecting device 70. In some embodiments, the direction in which the liquid material is flung can be substantially the same as the tangential direction of the rotational movement of the reservoir 80 in contact with the liquid material. In some embodiments, the rotating structure can impart a force to the liquid material in a direction substantially parallel to the top surface of the liquid material.

[0092] Retainers 80 or collectors 70 of any suitable size or geometry can be used to manufacture / collect polymer fibers. For example, reservoir 80 can be tubular, conical, crescent-shaped, bicuspid, circular, rectangular, or elliptical. Retainers 70 can be circular, elliptical, rectangular, or hemispherical. Retainers 70 can also be shaped into any living organ, such as the heart, kidney, liver lobes (one or more), bladder, uterus, intestine, skeletal muscle, or lung, or a portion thereof. Retainers 70 can be further shaped into any hollow cavity, organ, or tissue, such as circular muscle structures, such as valves, sphincter muscles, or irises.

[0093] The collecting device 70 may be a retainer configured in a desired shape and positioned in the path of the polymer ejected from the one or more orifices or in the path of the fibers thrown from the rotating structure 80. In some embodiments, the collecting device 70 may be positioned at a distance of approximately 2 inches (approximately 5 cm) to approximately 12 inches (approximately 30 cm) from the reservoir 80 from which the ejected polymer is deposited. Certain exemplary distances may include, but are not limited to, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 inches (5, 7.6, 10.2, 12.7, 15.2, 17.8, 20.3, 22.9, 25.4, 27.9, 30 cm) and all intermediate numbers. This distance may be selected and / or configured to avoid the formation of fiber beads (which may occur if the collecting device 70 is too close to the reservoir 80) and to obtain sufficient fiber quality (which may not occur if the collecting device is too far from the reservoir). In some embodiments, the formation of fiber beads is intentionally implemented to provide desired fiber properties.

[0094] Figure 9 and Figure 10 A side view is shown of an example of a collection assembly comprising a spacer-type (e.g., cylindrical) retainer and an arm-type retainer coupled to a rotating mandrel (973, 1073), which may be coupled to one or more motion generators to impart rotational and / or linear motion to the mandrel and retainer. The collection device according to embodiments of this disclosure can rotate at speeds ranging from, for example, about 1,000 rpm to about 80,000 rpm, but not limited to this exemplary range. For example, the rotational speed of the collection device may range from about 1,000 rpm to 50,000 rpm, about 1,000 rpm to about 40,000 rpm, about 1,000 rpm to about 20,000 rpm, about 5,000 rpm to about 20,000 rpm, about 5,000 rpm to about 15,000 rpm, or about 50,000 rpm to about 400,000 rpm, and / or intermediate ranges and values ​​of the foregoing.

[0095] Exemplary collection devices (e.g., retainers) can be linearly translated relative to the axis of rotation 83 of the rotating reservoir 80 of the fiber forming system 800 at linear speeds ranging from about 1 mm / s to about 300 mm / s (e.g., translating up and down along axis 13 parallel to the axis of rotation 83 of the rotating structure / reservoir 80 of the fiber forming system 800 or translating back and forth along an axis angled to the axis of rotation of the rotating structure / reservoir). The invention also contemplates ranges and speeds between these ranges and speeds. In some embodiments, the rotating reservoir 80 of the fiber forming system 800 can also, or optionally, translate relative to the collection assembly 79 during fiber collection. Translation of the collection assembly 79 relative to the rotating reservoir 80 allows the collection assembly 79 to enter and exit the plane 81 (i.e., the fiber plane 81) through which the thrown or ejected fibers 85 travel, to facilitate complete fiber coverage.

[0096] Further reference Figure 9 and Figure 10 As described in detail herein, exemplary stents 910 and 1010 are shown on spacer-type (e.g., cylindrical type) 977 retainers and arm-type 1077 retainers, respectively, which allow for the application / deposition of fibrous material onto stents 910 and 1010 using rotary jet spinning. In some embodiments, the stents may be formed from a biocompatible metal frame, such as stainless steel, cobalt-chromium alloy, or nickel-titanium.

[0097] about Figure 9The medical implant device 910 (e.g., a stent) can be placed on a retainer 977 having any suitable or desired type or shape. In some embodiments, the device 910 is placed around a cylindrical retainer having a length L1 equal to or greater than the axial length L2 of the implant device 910. In some embodiments, the length L1 of the cylindrical retainer is equal to or greater than twice the length L2 of the implant device 910. Such a length of the cylindrical portion 977 allows a reversible portion (not shown) of the fiber covering to extend beyond the implant device 910 by an amount sufficient to allow excess portions of the fiber covering to fold back onto the inner or outer surface of the implant device. That is, when fibers are applied to the implant device 910, the fibers can also be layered on at least a portion of the retainer 977 supporting the implant device 910. In some embodiments, the retainer 977 and / or mandrel 973 may be shaped and configured such that the axial extension of the fibrous covering beyond at least a portion of the implant device 910 forms a layer of fibrous material in a cylindrical or conical shape / type. This cylindrical / conical shape of the polymer material can then be used as an inner material layer of the implant device 910 (e.g., a stent) by folding or placing the material inside the stent. In some embodiments, the folding / placement of excess fibrous material within the implant device can be achieved by moving the stent 910 relative to the retainer 977, which may at least partially flip the cylindrical / conical shape of the fibrous material and wrap it toward the inner surface of the implant device. In this way, both the inner and outer surfaces of the implant device can be completely surrounded by fibrous material without the need for applying and sewing pre-fabricated polymer fabric.

[0098] The retainer 977 can be screwed onto the mandrel 973. For example, the retainer 977 may have an inner bore (not shown) through which the mandrel 973 can be screwed. The retainer 977 may comprise any suitable material, including but not limited to metals such as stainless steel, ceramics, or polymers. In some embodiments, the retainer 977 comprises a 3D-printed polymer clamp or balloon. The diameter of the retainer 977 is advantageously smaller than the diameter of the implant device 910. For example, the retainer 977 may be cylindrical in shape, having a diameter larger than that of the mandrel 973 and slightly smaller than the inner diameter of the implant device 910. In some embodiments, the retainer 977 includes a lubricating coating that facilitates axial movement of the implant device 910 on the retainer 977.

[0099] In some embodiments, the cylindrical form of the retainer 977 may be coated with a fibrous layer applied by rotary jet spinning, extending beyond the implant device 910 on the cylinder by a sufficient amount to allow excess portions of the fibrous layer to fold back onto the outer surface of the implant device 910, thereby creating a second fibrous material layer covering the outer surface of the implant device 910 in the embodiments described below. For example, the fibrous layer may be applied to the cylinder 977, after which the implant device 910 may be placed on the cylinder. Subsequently folding the fibrous layer over the outer portion of the implant device 910 results in at least a portion of both the inner and outer portions of the implant device 910 being covered by the fibrous material. In some embodiments, the retainer 977 is integral with the mandrel 973. For example, the retainer 977 and the mandrel 973 may be embodied as a single unit.

[0100] exist Figure 10 In this configuration, retainer 1077 is attached to spindle 1073 in such a way that the rotation of spindle 1073 is converted into rotation of retainer 1077. Regarding... Figure 9 and Figure 10 Mandrels 973 and 1073 may include stainless steel rods. The diameter of the rod may be approximately 3 mm, but mandrels of different diameters and materials may also be used optionally. The diameter of mandrels 973 and 1073 is advantageously smaller than the diameter of supports 910 and 1010.

[0101] The retainer 1077 may include any number of arms 1079 or other attachment members, which can be secured to the implant device 1010 (e.g., a stent) in any suitable or desired manner. Figure 9 and Figure 10 In the example implementation, the medical implant devices 910, 1010 may include a stent having first ends 986, 1086, which follow a generally circular undulating path with alternating arcuate grooves and peaks, the alternating arcuate grooves and peaks generally corresponding to the undulating profile of the underside of a sewing ring (not shown) that serves as part of a prosthetic heart valve. The second ends 994, 1094 of the stent may form a substantially smooth circle. The intermediate section of the stent may consist of one or more rows of expandable struts 998, 1098, which extend circumferentially between axially extending struts in a zigzag or herringbone pattern.

[0102] Retainer 1077 is used to retain an implanted device (e.g., a stent) 1010. In some embodiments, the retainer includes a central hub portion 1066, which may have a generally tubular form, and a plurality of stabilizing arms 1079 projecting axially and radially outward therefrom. In the illustrated embodiment, retainer 1077 has three stabilizing arms 1079, but retainers with more or fewer stabilizing arms may also be used. The central hub portion 1066 may have an inner bore 1070. Retainer 1077 may be made of a rigid polymer, such as acetal ( Formed from materials such as DuPont, nylon, polypropylene, or the like. In some embodiments, the retainer 1077 is integral with the mandrel 1073. For example, the retainer 1077 and the mandrel 1073 may be embodied as a single unit. In some embodiments, the medical implant device 910 is directly attached to the stabilizing arm 1079 of the retainer 1077 at the joint end or other attachment feature 1072 of the medical implant device 1010 using sutures or other attachment means or mechanisms. Exemplary attachment means or mechanisms for attaching / coupling the implant device 1010 to the retainer 1077 include, but are not limited to, one or more pins, clips, clamps, tabs, adhesive elements, hooks, or other structural or friction-based attachment features.

[0103] The retainer 1077 can be screwed onto the mandrel 1073 via, for example, an inner bore 1070 of the retainer 1077. In some embodiments, the retainer 1077 (and the medical implant device 1010) can be freely translated along the axis of the mandrel 1073. In some embodiments, the retainer 1077 can be mechanically or adhesively secured to the mandrel 1073, for example, using adhesive elements or other attachment means as described herein. Examples of suitable adhesive elements according to this disclosure may include epoxy resin, adhesive tape, and / or the like. Although Figure 10 A single retainer device 1077 is shown, but other embodiments may include additional / secondary retainers and / or other support frames.

[0104] As described herein, various medical device components can advantageously be at least partially covered by fibrous material. For example, in the case of prosthetic heart valve implants, fibrous sealing portions and / or skirt portions can be sutured to the frame of the prosthetic heart valve to help prevent blood leakage at or around the outer edge of the prosthetic heart valve. Figure 11An exemplary stent 210 is illustrated that can be used in a prosthetic heart valve implantation device according to one or more embodiments of the present disclosure. The stent 210 may be made from a laser-cut tubing of a malleable expandable metal or other at least partially rigid material. In some embodiments, the stent frame 210 may be further processed to be at least partially self-expanding. Although a laser-cut stent is shown, it should be understood that the fiber application process and apparatus disclosed herein are also applicable to other types of stents, including stents comprising a rigid ring adapted within, for example, a heart valve annulus and defining orifices for blood passage therethrough, helically wound tubing, and other tubes / channels.

[0105] The stent 210 may be at least partially self-expanding and / or mechanically expandable (e.g., balloon-expandable). For example, a self-expanding stent may be folded or otherwise compressed into a tube and may have sufficient elasticity to spring outward on its own when restraints (such as an outer sheath / catheter) are removed. In contrast, a balloon-expandable stent may comprise a relatively less elastic material and is capable of plastic expansion from the inside out when the stent is changed from a constricted diameter / configuration to an expanded diameter / configuration. Plastic expansion can be accomplished with a balloon or other devices, such as devices with mechanical fingers. With such a balloon-expandable stent, the stent frame can plastically deform upon application of a deforming force, such as an inflating balloon or expanding mechanical fingers.

[0106] Stent 210 (e.g., a self-expanding stent or a balloon-expandable stent) can be used as part of a prosthetic heart valve with single-stage implantation, in which a surgeon attaches the heart valve, having a fibrous anchoring skirt and valve components, as a unit or piece to the heart valve annulus. Certain stent solutions for aortic valve replacement according to some embodiments of this disclosure are disclosed in U.S. Patent No. 8,641,757, which is incorporated herein by reference in its entirety. In some embodiments, an exemplary delivery system advances the stent at the lead end or distal end of the valve implant device until it is located within the valve annulus and / or left ventricular outflow tract, where a balloon can inflate to expand the stent against the aortic valve annulus and / or ventricular tissue.

[0107] exist Figure 11In the example implementation, the support frame 210 is generally annular and / or cylindrical in shape and includes a plurality of angled, vertically extending, connected attachment posts or supports 218. The posts 218 may be interconnected at least by a lower row of circumferentially extending posts 220 and one or more upper row of circumferentially extending posts 222 and 224, respectively. As shown, the posts in each row may be arranged in a zigzag or generally zigzag pattern extending along the circumference of the frame. Adjacent posts in the same row may be interconnected to form an angle between approximately 90 and 110 degrees. The angle between adjacent posts can be selected to optimize the radial strength of the frame 210 when expanded, while still allowing the frame 210 to be crimped and expanded uniformly.

[0108] In the example implementation, pairs of adjacent circumferential struts in the same row are connected to each other by corresponding generally U-shaped crown structures or portions 226. Each crown structure 26 may include a horizontal portion extending between and connecting adjacent ends of the struts, such that a gap is defined between the adjacent ends and the crown structure connects the adjacent ends at a location offset from the natural intersection of the struts. During creases and expansions of the frame 210, the crown structure 226 can significantly reduce residual strain on the frame 210 at the locations of struts 220, 222, 224. Each pair of struts 222 connected at the common crown structure 226 can generally form a unit with an adjacent pair of struts 224 in the upper row. Each unit can connect to an adjacent unit at a node 232. Each node 232 can interconnect with the lower row struts via corresponding vertical (axial) struts 230 connected to the corresponding node 232 and the lower row strut 220 at locations where two struts connect at their ends opposite the crown structure 226, and extending between the corresponding node 232 and the location.

[0109] In some embodiments, the lower support 220 has a greater thickness or diameter than the upper supports 222, 224. In one embodiment, for example, the lower support 220 has a thickness of about 0.42 mm and the upper supports 222, 224 have a thickness of about 0.38 mm. Figure 11 In specific embodiments, because there is only one row of lower struts 220 and two rows of upper struts 222, 224, expanding the lower struts 220 relative to the upper struts 222, 224 can advantageously enhance the radial strength of the frame 210 in the lower region of the frame and / or allow the frame to expand more uniformly. The columns of the frame 210 may be defined by adjacent pairs of struts 220, 222, 224 extending between two axially extending struts 230. In some embodiments, the frame 210 comprises three 120-degree segments, each segment being defined by two posts 218. Therefore, Figure 11The frame 210 of the specific implementation includes a total of 9 columns. In some implementations, the number of columns and rows may be minimized to reduce the overall crease profile of the frame 210 and / or the associated valve.

[0110] Figure 12 A cardiac valve stent 210, as described herein, is shown arranged around a spacer-type retainer 277. Although in Figure 12 The spacer type retainer is shown, but it should be understood that any type of retainer can be used to retain the support 210, including retainers with arms or other attachment features, as described herein. As detailed herein, the spindle 273 and retainer 277 can be part of the collector assembly 270.

[0111] With the support 210 arranged on the retainer 277, the spindle 273 and the coupled retainer 277 can rotate about the axis 274 defined by the spindle 273. For example, the collector assembly 270 may include a rotor motor configured to rotate the spindle 273. Various components of the collector assembly 270 can be controlled at least in part by the control circuitry of a local and / or remote controller system.

[0112] Fiber material can be applied to the scaffold 210 and / or retainer 277 using a rotary jet spinning deposition system, which in some respects can be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and 8B As shown. Figure 13 As shown, fiber strands (one or more strands) may be applied to at least a portion of the outer surface of the support 210 and at least a portion of the retainer 277 to form a layer of fiber material 202.

[0113] The application of rotary jet spinning fiber material can create a first portion 201 of a layer of fiber material 202 on the outer surface of the support 210 and a second portion 203 of a layer of fiber material on the outer surface of the retainer 277. In some embodiments, a conical shape (not shown) of the fiber material 202 is formed and extends between the proximal end 209 of the retainer 277 and the mandrel 273.

[0114] After the fibrous material 202 is applied to the stent 210, the stent 210 and / or additional fibrous material deposited on the retainer can be removed from the collection assembly 270. Removal of excess portions 203 of the fibrous material 202 layer can be achieved, for example, by cutting the fibrous material layer at or near the mandrel 273. At least a portion of the second portion 203 of the fibrous material may be folded under the stent 210 to provide double-sided coverage of the stent 210. In some embodiments, the application of excess fibrous material can be achieved simply by moving the stent 210 relative to the retainer 277 and allowing excess portions to flip between the stent 210 and the retainer 277. In some embodiments, the application of excess fibrous material to the interior of the stent 210 is performed manually and / or using one or more tools. The process of depositing fibrous material on a medical device can be performed as many times as desired and / or for a desired amount of time to produce fibrous material of a desired thickness.

[0115] Figure 14 An example is illustrated in one or more embodiments of an implantable prosthetic valve 260. Figures 11-13 The frame 210. As assembled, the valve 260 in the example embodiment includes a leaflet structure 264 supported by the support frame 210, which includes a fabric skirt 201 applied to the support frame 210 using the rotary jet spinning technique described above. The valve implant device 260 can be adapted for implantation in, for example, the annulus of a natural aortic valve, but can also be adapted for implantation in other natural annulus of the heart or various other catheters or orifices of the body. The valve implant device 260 has a “lower” end 280 and an “upper” end 282. In the context of this application, in some cases, the terms “lower” and “upper” are used interchangeably with the terms “inflow” and “outflow,” respectively. Thus, for example, the lower end 280 of the valve can be considered the inflow end and the upper end 282 of the valve can be considered the outflow end.

[0116] The valve implant device 260 and stent frame 210 are configured to radially fold into a folded or creased state for introduction into the body within a delivery catheter, and are configured to radially expand into an expanded state to implant the valve 260 into a desired location in the body (e.g., a natural aortic valve). For example, the stent frame 210 may be made of a malleably expandable material that allows the valve to be folded into a smaller profile for delivery and expansion using an expansion device (such as a balloon in a balloon catheter). Alternatively, the valve implant device 260 may be a self-expanding valve, wherein the frame is made of a self-expanding material such as a shape memory metal (e.g., nitinol). The self-expanding valve can be folded into a smaller profile and held in the folded state by a restraint device (such as a sheath covering the valve). When the valve is positioned at or near the target site, the restraint device can be removed to allow the valve to self-expand to its functional expanded size.

[0117] although Figures 11-14 Components for transcatheter heart valves and associated stents with specific types and features are shown, but it should be understood that the rotary jet spinning process and system described herein are suitable for applying fibrous material to stents and / or valve devices with any suitable or desired type and / or features. Figure 15 An exemplary heart valve implant device 291 including a stent 295 according to an embodiment of the present invention is shown. The stent 295 has fibrous material applied to a portion thereof using a rotary jet spinning process. Figures 11-14 Unlike bracket 210, bracket 295 does not have a uniform cross-sectional shape or diameter along its length. For example, as shown, bracket 295 includes a lower end with a diameter D1 smaller than the diameter D2 at the upper end. In some embodiments, as exemplified, bracket 295 may have one or more tapered longitudinal portions 294, 293, and / or 292. The tapered portions (one or more) may bridge between the smaller and larger diameters of bracket 295.

[0118] Due to the tapered (e.g., hourglass) shape of the support 295, the retainer for applying the fibrous material 297 to the support 295 can advantageously be configured to at least partially adapt to this shape. For example, a retainer device having a non-cylindrical shape in at least a portion of its longitudinal region can be used. In some embodiments, a retainer with one or more arm support members can be used, or alternatively, a spacer-type retainer device having at least a partially tapered shape or portion to match or adapt to at least a portion 294 of the support 295 that will be covered by the fibrous material can be used. In some embodiments, a retainer with at least a partially tapered shape can be used similar to... Figure 15 The device 291. In some embodiments, fibrous material may be applied to one or more longitudinal portions of the support 295, while one or more portions (e.g., 292, 293) may be left uncovered.

[0119] Figure 16 Another example of a cardiac valve implantation device with a stent component 245 having a non-uniform stent diameter is shown. As illustrated, as described in detail herein, at least a portion 243 of the stent 245 can advantageously be covered with a fibrous material using a rotary jet spinning method. In some embodiments, the stent 245 may have one or more protruding features 242, which can be advantageously configured to adapt to certain cardiac anatomy structures associated with the target implantation site. The valve device 241 further includes a plurality of leaflets 244. In some embodiments, the valve device 241 is an aortic valve replacement implantation device.

[0120] The support 245 can be attached to any type of retainer for applying fibrous material 247 using a rotary jet spinning system and / or process. For example, a retainer with one or more arm support members can be used, or alternatively, a spacer-type retainer device with at least a partially angled or tapered shape or portion can be used to match or adapt to at least a portion 243 of the support 245 that will be covered by fibrous material.

[0121] In addition to transcatheter heart valve and stent components, other types of prosthetic heart valve implants may also include components (one or more) that are desiccated to be at least partially covered with fibrous material using a rotary jet spinning process as described herein. For example, Figure 17 This is a perspective view of a prosthetic heart valve implant device 410 according to one or more embodiments. The heart valve 410 may include a peripheral sealing ring structure 491 configured to provide support for nesting the heart valve 410 within a heart valve cavity and / or placing it on or attaching it to a valve annulus or other cardiac structure / anatomy. The valve 410 further includes a frame member 492 (e.g., a metal frame) providing support for a plurality of flexible leaflets 493 and defining three upright commissural posts 494, wherein the leaflets 493 are supported between the commissural posts 494. The heart valve 410 is shown in a closed position where fluid flow through the valve is inhibited; when in a state of at least partial opening, fluid (e.g., blood) can flow in one direction through an internal channel of the valve, which is formed when the leaflets 493 are separated.

[0122] The leaflet 493 may include three separate tissue flaps, such as xenograft tissue (e.g., bovine pericardium), or all three leaflets may originate from a single xenograft valve (e.g., a porcine valve). The leaflet 493 may be secured and supported by syndesmosis posts 494 and arched tips 495 of the frame members between the syndesmosis posts. In some embodiments, the leaflets 493 are matched in thickness and / or elasticity to desirably block fluid flow through the valve 410. The leaflet 493 extends inwardly from the surrounding frame 492 into the flow orifice thus defined. In some embodiments, the leaflet 493 is curved in the outflow direction and "mates" at the center of the valve orifice to facilitate unidirectional flow through the valve 410.

[0123] The frame member 492 may comprise at least partially flexible wires made of a metal alloy or other metal or at least partially rigid material. In some embodiments, the frame member 492 is configured to reduce loading shock on the leaflets 493 during the cardiac cycle. A sealing ring 491 may be attached around the outer periphery of the frame member 492 at the inflow end of the valve, wherein the commissural post 494 protrudes in the outflow direction. The frame member 492 may be generally rigid and / or anti-distension to substantially maintain a specific shape and diameter of the valve orifice and also maintain proper alignment of the valve leaflets 493 for proper valve closure and opening. Although Figure 17 The invention depicts a generally circular implementation, but other shapes are also within the scope of the invention, depending on the specific application (e.g., a specific natural valve to be replaced).

[0124] The valve device 410 may further include a support structure 497 designed to fit over the sealing ring 491. In some embodiments, the support structure 497 is made of one or more metal and / or plastic (e.g., polyester, polyethylene terephthalate (PET), or biaxially oriented PET, such as Mylar PET, DuPont Teijin Films) components, wherein the leaflet 493 may be sewn or otherwise attached to, for example, a plastic strip component of the support structure 497. The support structure 497 may include a rigid reinforcing strip, which may be made of, for example, metal or other rigid materials. The support structure 497 may include, regarding Figure 17 The example has a vertically extending connecting support portion that can at least partially fit within the upwardly projecting connecting region 494 of the frame member 492.

[0125] The sealing ring 491 of the heart valve implant device 410 may be configured to, for example, prevent backflow by maintaining occlusion and valve integrity, while allowing good hemodynamics during forward flow to at least partially stabilize the annulus and support functional changes that occur during the cardiac cycle. The sealing ring 491 may include an internally at least partially rigid substrate (e.g., a metal such as stainless steel or titanium, or a flexible material such as silicone rubber or PET cable). The sealing ring 491 may be rigid or flexible, may be discrete or continuous, and may have various shapes, including circular, D-shaped, kidney-shaped, or C-shaped. In some embodiments, when implanted, suture fasteners (not shown) may be distributed around the sealing ring 491, which binds the sealing ring to the patient's attachment tissue.

[0126] In some embodiments, valve 410 further includes a sub-annular frame 404. When implanted, for example, into an aortic valve annulus, frame 404 can provide improved support and / or sealing functionality. Frame 410 may be made from a laser-cut tubing of malleable expandable metal or other at least partially rigid material. In some embodiments, frame 410 may be further processed to be at least partially self-expanding. Although a laser-cut sub-annular frame has been shown, it should be understood that the fiber application process and apparatus disclosed herein are also applicable to other types of frames, including frames comprising rigid rings adapted to fit within, for example, a cardiac valve annulus and defining orifices for blood passage therethrough, helically wound tubing, and other tubing.

[0127] Figure 18 A heart valve assembly 410 is shown arranged on a stent 479, as described herein, on an arm-type retainer. Although the arm retainer is... Figure 18 As shown herein, however it should be understood that any type of retainer can be used to retain valve 410, including cylindrical or other shaped spacer-type retainers or other attachment features as described herein. As detailed herein, spindle 473 and retainer 479 may be part of collector assembly 470.

[0128] With the valve assembly 410 arranged on the retainer 479, the spindle 473 and the coupled retainer 479 can rotate about an axis defined by the spindle 473. For example, the collector assembly 470 may include a rotor motor configured to rotate the spindle 473. Various components of the collector assembly 470 may be controlled at least in part by control circuitry of a local and / or remote controller system.

[0129] The fibrous material can be applied to the valve assembly 410 using a rotary jet spinning deposition system, which in some respects can be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and Figure 8B As shown. Figure 19 As shown, fiber strands (one or more strands) may be applied to at least a portion of the outer surfaces of the frame 492, sealing ring 491, and skirt frame 404 to form one or more layers of fiber material. Although Figure 18Leaflets 493 attached to valve assembly 410 are shown, but in some embodiments, fibrous material may be applied to valve frame assembly 410 prior to the application of leaflets 493. In some preferred embodiments, the leaflets are applied / attached after one or more associated rotary jet spinning processes for applying the fibrous material. In some embodiments, some and / or each component (e.g., 404, 494, 491) requiring fibrous material coating / application may be treated using rotary jet spinning to individually apply the fibrous material to them.

[0130] Figure 19 A surgical heart valve is shown, having a fibrous material applied to a portion thereof using rotary jet spinning according to one or more embodiments of the present disclosure. A fibrous-covered peripheral sealing ring structure 491 may be configured to provide support for nesting a heart valve 410 within a heart valve cavity and / or placing it on or attaching it to a valve annulus or other structure of the heart. A fibrous-covered frame member 492 provides support for a plurality of flexible leaflets 493 and defines an upright commissural post 494, wherein the leaflets 493 may be supported between the commissural posts 494. The sealing ring 491 may be attached to the periphery of the frame member 494 toward the inflow end of the valve 410, wherein the commissural post 494 protrudes in the outflow direction. The leaflets 493 may be formed from individual material or tissue valves, such as, for example, xenograft tissue (e.g., bovine pericardium), or the leaflets 493 may be derived from a single xenograft valve (e.g., a porcine valve). Leaflet 493 can be fixed and supported by connecting column 494 and the arched protrusions of the frame members along the connecting columns.

[0131] Rotary jet spinning can be used to apply a fibrous material 401 having a first set of properties to a first portion 411 of the valve assembly 410, such as to the connecting column 494 and / or sealing ring 491, while a fibrous material 402 having a second set of properties is applied to a second portion 412 of the valve assembly 410. For example, the fibrous material 401 may be relatively smooth, while the fibrous material 402 may be relatively textured to provide a strong fit in the valve annulus to aid sealing. Fiber material 401 and / or fiber material 402 may comprise polymeric fibrous materials, as described in detail herein. The process of depositing fibrous material 401 and / or 402 can be performed as many times as desired and / or for a desired amount of time to produce fibrous material of a desired thickness.

[0132] Frame 494 may be covered with fibrous material 401 using a rotary jet spinning process (one or more). In some embodiments, as shown, the fibrous material 401 may be sewn into one or more sections after its rotary jet spinning application to secure the fibrous material 401 as a cover for frame 492. In some embodiments, one or more seams may be sewn adjacent to an inflow edge that secures the fibrous material 401 around the support and / or in other locations (one or more). Frame 492 and / or one or more other components of the valve implant device 410 may also have leaflets 493 sewn thereto and / or other materials.

[0133] Anchor skirt 412 is shown as associated with the inlet end of valve assembly 410. The frame 404 of anchor skirt 412 may be expandable (e.g., self-expanding) to advantageously provide secure attachment to the valve annulus and / or other anatomical structures associated with the target cardiac valve. For example, in some embodiments, valve frame 492 and / or sealing ring 491 are non-expandable, while anchor skirt frame 404 can be expanded from... Figures 17-19 The contracted state expands to an expanded state. The size of the anchoring skirt 412 can vary depending on the overall size of the heart valve 410. As shown, the frame 404 of the valve 410 may include a generally tubular, malleable expansion structure with an undulating or fan-shaped lower end 409. The coarse fibrous material 402 may allow the skirt 412 to be sutured to adjacent cardiac tissue.

[0134] Besides prosthetic heart valves and stent devices, other types of medical implant devices may also include components (one or more) that are desiccated, at least partially, by a rotary jet spinning process to be covered with fibrous material, as described herein. For example, Figure 20This is a side view of a prosthetic spacer device 500 according to one or more embodiments, configured to reduce or prevent valvular regurgitation when attached to one or more leaflets, such as a natural mitral valve. Optionally, the spacer device 500 may be implanted in the aortic, tricuspid, or pulmonary valve region of a human heart according to a suitable implantation procedure. The prosthetic spacer device 500 can be used to help restore and / or improve the function of defective natural valves. For example, in some embodiments, the prosthetic spacer device 500 may include a central body or body 510 and one or more movable elements 540 configured to capture the leaflets of the natural valve between elements 540 and body 510. The natural leaflets may thus form a seal against body 510. Body 510 may then be configured to prevent blood flow through the prosthetic device, resulting in a sharp reduction in regurgitation (e.g., functional mitral regurgitation) after implantation. This would be advantageous in patients without severe degeneration of left ventricular function. Examples of other prosthetic spacer devices are further described in U.S. Patent Publication No. 2018 / 0325661 (which is incorporated herein by reference).

[0135] In addition to the spacer member 510, the prosthetic spacer device 500 may include a plurality of anchors or paddles 540 (e.g., two in the example embodiment), a plurality of fasteners 506 (e.g., two in the example embodiment), a first collar or hub member 508, and a second collar or hub member 509. A first end 512 of the anchor 540 may be coupled to and extend from a first end 514 of the spacer member 510, and a second end 516 of the anchor 540 may be coupled to the first collar 508. The second collar 509 may be coupled to the second end 518 of the spacer member 510.

[0136] Figure 21 A spacer assembly 500 coupled to retainer 579, as described herein, is shown. Although in Figure 21 A clip / arm retainer is shown, but it should be understood that any type of retainer can be used to retain the spacer assembly 500, including cylindrical or other shaped spacer-type retainers or other attachment features as described herein. As detailed herein, the spindle 573 and retainer 579 can be part of the collector assembly 570.

[0137] When fibrous material is applied to the spacer assembly using rotary jet spinning, the spacer assembly can be in a configuration that is at least partially straightened. For example, in some embodiments, when the anchor 540 is in a straightened configuration, the angle between the first portion 520 of the anchor 540 and the spacer member 510 can be approximately 180 degrees, while when the anchor 540 is in a straightened configuration... Figure 20In the fully folded configuration shown, the angle between the first portion 520 of the anchor 540 and the spacer member 510 can be approximately 0 degrees. In some embodiments, some and / or each component (one or more) (e.g., spacers, paddles) can be individually coated and then assembled.

[0138] With the spacer assembly 500 arranged on the retainer 579, the spindle 573 and the coupled retainer 579 can rotate about an axis defined by the spindle 573. For example, the collector assembly 570 may include or be mechanically coupled to a rotor motor, which is configured to rotate the spindle 573. Various components of the collector assembly 570 may be controlled at least in part by control circuitry of a local and / or remote controller system.

[0139] Fiber material can be applied to the spacer device 570 using a rotary jet spinning deposition system, which in some respects can be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and Figure 8B As shown. Figure 21 As shown, fiber strands (one or more strands) may be applied to at least a portion of the spacer member 510, fastener 520, anchor member 540, and / or distal collar 508 to form one or more layers of fiber material.

[0140] Figure 22 A spacer device 500 is shown, having fibrous material 550 applied to a portion thereof according to one or more embodiments of the present disclosure using rotary jet spinning. The spacer device 500 in... Figure 22As shown, a fibrous material cover 550 is arranged around the spacer member 510 and the anchor member 540. In some instances, the fibrous material cover 550 may be porous, allowing at least partial permeability to blood flow. For example, the fibrous material cover 550 may be an openwork fabric or mesh defining an opening of any suitable or desired size. In some instances, the fibrous material cover 550 may comprise a low-density rotary-jet spun polymer fibrous material having, for example, 60-120 weft loops (courses) / inch (courses per inch) and / or 20-60 warp loops (wales) / inch (wales per inch). To produce the desired fibrous cover 550, the rotational rate of the rotary-jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fibrous material.

[0141] In some embodiments, the spacer device 500 may be configured to axially move the first collar 508 relative to the spacer member 510 along a longitudinal axis extending between the first end 514 and the second end 518 of the spacer member 510, thereby axially moving the anchor 540. Figure 21 configuration and Figure 22 The anchor 540 can be positioned in a straight configuration by moving the first ring 508 away from the spacer member 510, thereby making the anchor 540 more taut / open.

[0142] The anchor 540 can be moved from the spacer member 510 by moving the first ring 508 toward the spacer member 510. Figure 21 The straightened configuration moved to Figure 22 The folded configuration. Initially, as the first collar 508 moves toward the spacer member 510, the anchor 540 can bend at the joint portion 524, and the joint portion 524 moves radially outward and axially toward the first end 514 of the spacer member 510 relative to its longitudinal axis. As the collar 508 continues to move toward the spacer member 510, the joint portion 524 can move radially inward and axially toward the second end 518 of the spacer member 510 relative to its longitudinal axis, until the folded configuration is achieved. Figure 22 The folded configuration.

[0143] Figures 23-25 The accompanying description relates to an embodiment of another example type of prosthetic heart valve device, which can be at least partially covered with a fibrous material using a rotary jet spinning solution as described herein. In some embodiments, Figure 23 and Figure 24The heart valve device frame 600 is suitable as a heart valve device 601 for implantation as a replacement mitral valve (see [link]). Figure 25 The frame 600 includes a frame body 602 having an upper region 610, a middle region 620, and a lower region 630. The frame 600 may include a first type of anchoring feature 640 and a second type of anchoring feature 650, either of which may serve as a proximal or distal anchoring feature.

[0144] One or both of anchoring features 640 and 650 may contact or engage the natural mitral valve annulus, such as the natural mitral valve annulus, tissue extending beyond the natural valve annulus, natural leaflets, and / or other tissue at or around the implantation site. For example, when frame 600 is used to replace a mitral valve prosthesis, during at least the systolic phase of the cardiac cycle, the second anchoring feature 650 may be sized to contact or engage the natural mitral valve annulus, while the first anchoring feature 640 may be sized to be spaced from the natural mitral valve annulus.

[0145] As shown in the figure, the frame body 602 may have a bulbous or slightly bulbous shape, wherein the middle region 620 is larger than the upper region 610 and / or the lower region 630. The bulbous shape of the frame body 602 advantageously allows it to engage with a natural valve annulus or other body cavity while separating the inlet and outlet from the heart or blood vessel walls. This can advantageously reduce undesirable contact between the prosthesis and the heart or blood vessels (such as the atrial and ventricular walls of the heart).

[0146] The intermediate region 620 may be generally cylindrical in shape, such that the diameter of the upper end of the intermediate region 620 and / or the diameter of the lower end of the intermediate region 620 are equal to or generally equal to the diameter of the middle portion of the intermediate region 620. The overall uniformity of the diameter of the intermediate region 620 from the upper to the lower end, together with the axial dimension between the upper and lower ends (i.e., the “height” of the intermediate region 620), provides a considerable circumferential area on which the natural valve annulus or other body cavity can engage. This can advantageously improve the fixation of the frame 600 to the natural valve annulus or other body cavity. This can also improve the seal between the frame 600 and the natural valve annulus or other body cavity, thereby reducing paravalvular leakage.

[0147] In some embodiments, the frame body 602, when in an expanded configuration, may have a diameter at its widest portion between about 30 mm and about 60 mm, between about 65 mm and about 55 mm, about 40 mm, any subrange within these ranges, or any other diameter as desired. In some embodiments, the frame body 602 in an expanded configuration may have a diameter at its narrowest portion between about 20 mm and about 40 mm, any subrange within these ranges, or any other diameter as desired. In the expanded configuration, the axial dimension of the frame body 602 between its upper and lower ends (i.e., the "height" of the frame body 602) may be between about 10 mm and about 40 mm, between about 18 mm and about 60 mm, about 20 mm, any subrange within these ranges, or any other height as desired.

[0148] At the junction between the intermediate region 620 and the upper region 610, the frame body 602 may include a bend 612. The bend 612 may be a bend that is radially inward toward the longitudinal axis of the frame 600, such that a portion of the upper region 610—extending upward from the beginning of the bend 612 adjacent to the intermediate region 620—is inclined or curved toward the longitudinal axis of the frame 600. The inclined or curved portion of the upper region 610 facilitates the fixation of the supplementary prosthesis within the frame 600.

[0149] At the junction between the intermediate region 620 and the lower region 630, the frame body 602 may include a bend 632 toward the longitudinal axis of the frame 600. The bend 632 may be a bend that is radially inward toward the longitudinal axis of the frame 600, such that a portion of the lower region 630—extending downward from the beginning of the bend 632 adjacent to the intermediate region 620—is inclined or curved toward the longitudinal axis of the frame 600. The bend 632 may generally form an arc with an angle between about 20 degrees and about 90 degrees. The lower region 630 may include a bend 634 below the bend 632. The orientation of the bend 634 may be opposite to that of the bend 632, such that a portion of the lower region 630—extending downward from the beginning of the bend 634—is inclined or curved toward the longitudinal axis of the frame 600 at an angle smaller than the portion above the beginning of the bend 634, generally parallel to the longitudinal axis, or inclined or curved at an angle away from the longitudinal axis of the frame 600. The diameters of the upper end of the upper region 610 and the lower end of the lower region 630 may be approximately the same or different.

[0150] The frame body 602 may include a plurality of pillars, wherein at least some of the pillars form units 660a, 660b, and 660c. Any number of pillar configurations may be used, such as rings forming undulating pillars in elliptical, oval, rounded polygonal, teardrop, herringbone, rhomboid, curved, and / or various other shapes. In some embodiments, the frame body 602 may include three rows of units 660a, 660b, and 660c.

[0151] Units 660a, 660b, and 660c can have any suitable or desired shape and can advantageously be self-expanding or otherwise expandable. For example, any row of units can have hexagonal or generally hexagonal, rhomboid, or similar shapes. Circumferentially expandable struts 665 can be inclined or curved toward the longitudinal axis of frame 600, such that the upper portion of strut 665 is positioned closer to the longitudinal axis of frame 600 than the lower portion of strut 665. Strut 670 can extend generally longitudinally and can incorporate bends 612, such that the upper portion of strut 670 is inclined or curved toward the longitudinal axis of frame 600.

[0152] The lower part of unit 660a may be formed by a set of circumferentially expandable struts 675 having a serrated or undulating shape forming a repeating "V" shape. The struts 675 may form an overall cylindrical portion of frame 600, wherein the radial dimension of the upper part of strut 675 is approximately the same as the radial dimension of the lower part of strut 675.

[0153] Units 660b and 660c may provide shortened portions of frame 600. The example rhomboid or generally rhomboid shape can be formed by combining supports. The upper portion of unit 660b may be formed by a set of circumferentially expandable supports 675, such that unit 660b shares supports with unit 660a. The lower portion of unit 660b may be formed by a set of circumferentially expandable supports 680. The circumferentially expandable supports 680 may incorporate bends 632, such that the upper portion of the supports 680 forms a generally cylindrical portion of frame 600 and the lower portion of the supports 680 may be inclined or curved towards the longitudinal axis of frame 600. The upper portion of unit 660c may be formed by a set of circumferentially expandable supports 680, such that unit 660c shares supports with unit 660b. The lower portion of unit 660c may be formed by a set of circumferentially expandable supports 685. The circumferentially expandable supports 685 may be inclined or curved towards the longitudinal axis of frame 600.

[0154] Anchoring feature 640 may include one or more anchors. For example, as shown in the example embodiment, anchoring feature 640 may include twelve anchors. Each anchor may include one or more struts 642 extending from the upper region 610 of the frame body 602. As shown, struts 642 extend into unit 660a. In some embodiments, struts 642 extend from the upper intersection of two segments of unit 660a, for example, from the uppermost corner of unit 660a between struts 665. Struts 642 may extend generally downward into unit 660a while curving outward away from the frame body 602. Anchoring feature 640 extends radially outward from the frame body 602 because it generally extends downward toward tip 644.

[0155] Anchoring feature 640 may include one or more eye openings forming a portion of tip 644 of anchoring feature 640, which can be used to attach other components of a prosthesis in which frame 600 is used. Anchoring feature 650 may include one or more anchor members. Each anchor member may include one or more struts 652 extending from lower region 630 of frame 600.

[0156] The strut 652 may extend generally downwards while curving inwards from the frame 600 toward the longitudinal axis. The strut 652 may incorporate a bend 654 to orient it radially outwards away from the longitudinal axis of the frame 600. The bend 654 may be generally semi-circular or semi-elliptical, providing space for the distal end of the natural valve leaflet for retention / storage. The anchor may then extend radially outwards and upwards within the linear segment. The strut 652 may include a second bend 656 along the linear segment, which orients the strut 652 such that it extends generally parallel to the longitudinal axis of the frame 600. In some embodiments, each of the anchor features 640, 650 is positioned or extends generally radially outwards from the frame 600 such that the anchor tips 644, 658 are generally spaced apart from or radially outwards from the rest of the frame body 602 and from the location where the base of the anchor connects to the frame body 602.

[0157] Individual anchors may extend radially outward from the frame at their base and terminate at their tip. Individual anchors may be attached to the frame at one of many different locations, including apex, joint, other parts of the support, etc. Further details that may be incorporated into and / or interchanged with the features described herein are disclosed in U.S. Publications 2014 / 0277422, 2014 / 0277427, 2014 / 0277390, and 2015 / 0328000 (which are incorporated herein by reference). Although Figures 23 to 25The document illustrates a specific implementation of a mitral valve frame, but it should be understood that the fiber application process and apparatus disclosed herein are also applicable to other types of frames, including frames comprising rigid rings adapted within, for example, cardiac valve annulus and defining orifices for blood to pass through, spirally wound tubes, and other tubes.

[0158] Figure 24 A heart valve frame 600 is shown arranged on a retainer 679, as described herein, on an arm-type retainer. Although the arm retainer is... Figure 24 As shown herein, but it should be understood that any type of retainer can be used to retain the valve frame 600, including cylindrical or other shaped spacer-type retainers or other attachment features as described herein. As detailed herein, the spindle 673 and retainer 679 can be part of the collector assembly 670.

[0159] With the valve frame 600 arranged on the retainer 679, the spindle 673 and the coupled retainer 679 can rotate about an axis defined by the spindle 673. For example, the collector assembly 670 may include a rotor motor configured to rotate the spindle 673. Various components of the collector assembly 670 may be controlled at least in part by control circuitry of a local and / or remote controller system.

[0160] Fiber material can be applied to the valve frame 600 using a rotary jet spinning deposition system, which in some respects can be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and 8B As shown. Figure 25 As shown, fiber strands (one or more strands) can be applied to at least a portion of the outer surface of the frame 600 to form one or more layers of fiber material.

[0161] Fiber material can be applied to at least a portion of frame 600 to provide a covering and / or cushioning for the valve implant device. In some embodiments, rotary jet spinning can be used to apply the fiber material around or partially around or covering at least a portion of the first anchoring feature 640 and / or the second anchoring feature 650—such as the tip or end 644 of the first anchoring feature 640 and / or the tip or end 658 of the second anchoring feature 650 and / or the strut to which the tip or end 644, 658 is attached.

[0162] In some implementations, one or more features of frame 600 can be straightened at one or more points during the application of the fiber material. For example, as Figure 24As shown, one or more anchor features, such as anchor feature 650, can be straightened to apply fibrous material to the back side of the anchor feature using rotary jet spinning.

[0163] In some embodiments, additional cushioning may be applied to one or more features of frame 600, such that the applied fibrous material forms a layer covering the cushioning. For example, the cushioning may be formed of a foam material (such as polymer foam), such that the cushioning is at least partially compliant. In some embodiments, the cushioning may be formed as a polymer-molded insert. In some embodiments, the cushioning may be loosely coupled to anchoring features (one or more). In some embodiments, all anchors of the second anchoring feature 650 have cushioning applied to them.

[0164] The upper end of the strut 692 may include an enlarged head 694 feature, which may have a semi-circular or semi-elliptical shape, or any other type or shape. The end 694 and / or the strut 692 may function as a locking protrusion and may include one or more eyeholes at one or more locations. The locking protrusion feature can be advantageously used with various types of delivery systems. For example, the shape of the strut 692 and the enlarged head 694 can be used to secure the frame 600 to a slot-based delivery system. In some embodiments, the head portion (e.g., eyeholes) 694 can be used to secure the frame 600 to a tether-type delivery system, which can utilize sutures, threads, or fingers to control the delivery of the frame 600. Such a feature can advantageously facilitate in-situ recapture and repositioning of the frame 600. In addition to functioning as a locking protrusion feature, or as an alternative to functioning as a locking protrusion feature, the strut end 694 can be used to secure the frame 600 to a retainer 679. For example, the support head 694 can be used to sew, clamp, snap, hook, or otherwise secure the support head (one or more) 694 to the arm (one or more) 679 or other features (one or more) of the retainer 679.

[0165] Figure 25 A heart valve device 601 is shown, having fibrous material applied to portions thereof using rotary jet spinning according to one or more embodiments of the present disclosure. The valve body preferably includes a plurality of valve leaflets 662. The plurality of valve leaflets 662 may function as needed in a manner similar to a natural mitral valve or any other valve in the vascular system.

[0166] As described herein, fibrous material 660 can be applied to one or more portions or components using rotary jet spinning. For example, fibrous material 660 can be applied to the exterior (and / or interior) of frame 600. In some embodiments, fibrous material 660 extends from an upper region of frame 600 toward a lower region of frame. In some embodiments, rotary jet spinning is used to apply fibrous material to frame 600 between radial feature 640 and the base of frame. In some embodiments, fibrous material is applied to one or more sides of the anchoring element of anchoring feature 650. The application of fibrous material 660 can advantageously enhance the seal along the lower region of frame 600. Fiber material 660 can be applied such that a portion of the fibrous material positioned around the middle portion of frame 600 is loose relative to the exterior of frame. Variations in the rotational and / or translational speeds of the fiber solution reservoir and / or collection assembly can be implemented to produce a desired thickness, looseness, and / or other properties (one or more) of the fibrous material applied to frame 600. In some implementations, the stitch 6630 may be wrapped around the posts of certain anchoring features and / or the posts of the frame body to couple the anchoring / frame features to the fiber material 660.

[0167] Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different parts of a frame. For example, fibrous materials with a first set of properties can be applied to the frame body 612, while fibrous materials with a second set of properties can be applied to the anchor feature 650. The process of depositing the fibrous material can be performed as many times as desired and / or for a desired amount of time to produce the desired thickness and / or other properties of the fibrous material. To produce the desired fibrous cover 660, the rotational speed of the rotary jet spinning reservoir and / or mandrel / retainer, the translational speed of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fibrous material.

[0168] Figures 26-28 The accompanying description relates to an embodiment of another example type of medical implant device, which can be at least partially covered with a fibrous material using a rotary jet spinning solution as described herein. Specifically, Figures 26-28 An example of a valve annulusoplasty repair device 700 is provided, which includes one or more components or portions that are desiccated at least partially with a fibrous material using a rotary jet spinning process, as described herein.

[0169] Figure 26This is a perspective view of an annulusoplasty repair device 720 according to one or more embodiments. The annulusoplasty repair device 720 can be used to help restore and / or improve the function of defective natural valves. For example, the annulusoplasty repair device 720 can be designed for use with procedures for tightening or strengthening natural heart valve annulus (such as the mitral valve annulus). Typically, due to cardiac enlargement and / or valvular regurgitation conditions, heart valve annulus can widen and deviate from its normal shape. Widening or deformity of the annulus can cause the valve leaflets to fail to align properly. To repair deformed or defective valve annulus, the annulusoplasty repair device 720 can be attached to the annulus to reshape, strengthen, or tighten it.

[0170] An exemplary annulusoplasty repair device 720 may include annulusoplasty structure 722, which includes a body portion 724, a flexible contractile longitudinal member 730 (referred to herein as a “contraction member” or “flexible member”), and / or an adjustment mechanism 740. At least a portion of the body portion 724 may include a compressible material (such as a coiled element), as shown by way of example and not limitation. For example, the body portion 724 may include a support-like strut or a braided mesh. The body portion 724 may define an inner cavity along the longitudinal axis of the annulusoplasty structure 722, which advantageously accommodates the adjustable contractile member 730. The flexible contractile member 730 may include a thread, strip, rope, or belt. The flexible contractile member 730 may be coupled at its first end to the adjustment mechanism 740, which is coupled to a first end 721 of the structure 722. A second end of the flexible contractile member 730 may be coupled to a second end 723 of the annulusoplasty structure 722. In some embodiments, the flexible contractile member 730 has at least one free end. The flexible contractile member 730, together with the compressible elements of the main body 724 and the woven mesh surrounding the main body 24, imparts flexibility to the annulus valgus structure.

[0171] The body portion 724 may include relatively flexible biocompatible materials such as nitinol, stainless steel, platinum-iridium alloy, titanium, expanded polytetrafluoroethylene (ePTFE), cobalt-chromium alloy, and / or braided polyester sutures (e.g., Ticron). In some embodiments, the body portion 724 is coated with PTFE (polytetrafluoroethylene) or other materials. In some embodiments, the body portion 724 includes an accordion-like compressible structure that promotes proper tightening of the annulus when the annulusoplasty structure 722 contracts. When the body portion 724 is compressed around the annulus implantation, it enables a portion of the annulusoplasty structure 722 to contract and / or conform to the configuration of the annulus. Therefore, the compressibility of the body portion 724 can promote annulus contraction in response to the contraction of the annulusoplasty structure 722.

[0172] exist Figure 26In this configuration, the annulusoplasty structure 722 is shown in a partially contracted state, such that the axis of structure 722 is at least partially non-linear. For example, in response to rotation or other actuation of the adjusting member 740, a portion of the contraction member 730 may be wound around a winding shaft (not shown) or otherwise adjusted to effectively shorten a portion of the flexible member disposed within the annulusoplasty structure 722. Thus, the second end of the flexible contraction member 730 may be pulled toward the adjusting mechanism 740, thereby pulling the second end 723 of structure 722 toward the first end 721 of structure 722.

[0173] Figure 27 A valve annulusoplasty repair device 720 is shown arranged on a retainer 779, such as an arm-type or clip-type retainer as described herein. Although in Figure 27 The clip / arm retainer is shown, but it should be understood that any type of retainer can be used to retain the annulusoplasty repair device 720, including cylindrical or other shaped spacer-type retainers or other attachment features as described herein. As detailed herein, the spindle 773 and retainer 779 can be part of the collector assembly 770.

[0174] like Figure 27 As shown, when fibrous material is applied to the annulus repair device 720 using rotary jet spinning, the annulus repair device 720 can be in a configuration that is at least partially straightened. When the annulus repair device 720 is arranged on the retainer 779, the mandrel 773 and the coupled retainer 779 can rotate about an axis defined by the mandrel 773. For example, the collector assembly 770 may include or be mechanically coupled to a rotor motor, which is configured to rotate the mandrel 773. Various components of the collector assembly 770 can be at least partially controlled by control circuitry of a local and / or remote controller system.

[0175] The fibrous material can be applied to the annulus repair device 720 using a rotary jet spinning deposition system, which in some respects can be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and Figure 8B As shown in the diagram, fiber strands (one or more strands) may be applied to at least a portion of the annulusoplasty structure 722 (e.g., coil 724) to form one or more layers of fiber material.

[0176] Figure 28A perspective view of a valve annulusoplasty repair device 710 is shown, having a fibrous material 701 applied thereto by rotary jet spinning according to one or more embodiments of the present disclosure. In some instances, the fibrous material 701 may be porous, such that the fibrous material is at least partially permeable to blood flow. For example, the fibrous material 701 may include openings of any suitable or desired size. To produce the desired fibrous covering 701, the rotational rate of the rotary jet spinning reservoir and / or the translational rate of the mandrel / retainer, the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fibrous material.

[0177] exist Figure 28 In the process, the annulusoplasty repair device is shown to be in a state of at least partial contraction / rounding. In some embodiments, the annulusoplasty repair device 710 can be configured to [perform a specific function] by shortening the internal cable or other suture or device connecting one end 702 of the device 710 and the opposite end 702 of the device 710. Figure 27 The straightened configuration and Figure 28 The contraction configurations move between each other.

[0178] Figures 29-31 The accompanying description relates to an embodiment of another example type of medical implant device, which may be at least partially covered with a fibrous material using a rotary jet spinning solution as described herein. Specifically, Figures 29-31 An example of a docking device 820 is provided, which includes one or more components or portions that may be at least partially covered with fibrous material using a rotary jet spinning process, as described herein.

[0179] According to embodiments of this disclosure, a docking device utilizing rotary jet spinning to cover a fibrous material can be configured for implantation into the body or a circulatory vessel / chamber of the body (e.g., heart, natural heart valves, blood vessels, vascular system, arteries, veins, aorta, inferior vena cava (IVC), superior vena cava (SVC), pulmonary artery, aortic valve, pulmonary valve, mitral valve, tricuspid valve, etc.). Such a device may include at least one sealing portion, a frame, and / or a valve seat. Docking device 820 (see...) Figure 31 The docking device and its frame 810 can be configured or shaped to conform to the shape of the part of the body to which it will be implanted, such as conforming to the shape of the aorta, pulmonary artery, IVC, or SVC. Furthermore, regardless of whether the anatomical structure is variable or more homogeneous, the docking device and / or associated frame suitable for the embodiments disclosed herein can be configured such that, when dilated within the target blood vessel, a majority of the docking station contacts the inner surface of the blood vessel and distributes the pressure and force applied by the docking device over the portion or length of the docking station in contact with the inner surface. This can aid, for example, in treating aortic regurgitation caused by aortic valve and / or aortic dilatation.

[0180] Figure 29 This is a perspective view of a frame 810 for a docking device according to one or more embodiments of the present disclosure. The frame includes legs 850 for supporting a valve seat 818 or forming part of a valve seat. The valve seat 818 may include separate components attached to or integrally formed with the legs 850. In some embodiments, the valve seat 818 is replaced with / integrated with a valve device, and the docking device 820 and the valve device are configured and deployed as a single unit.

[0181] Advantageously, the at least partially expandable frame 810 can provide the shape of the sealing portion 811, the valve seat 818, and / or the retaining portion 814. The frame 810 can take many different forms. In some embodiments, the frame 810 has an end 862 having an inner diameter defined by the valve seat 818 and an outer diameter defined by the annular or cylindrical outer wall 868 of the retaining portion 814.

[0182] The valve seat 818 may be formed by an annular wall 18 extending radially downward from the inner side of the sealing portion 811. As shown, the frame 810 may be formed from an expandable mesh. The expandable mesh may be made in a variety of ways, such as by connecting individual threads to form a mesh. In some embodiments, the mesh is formed by weaving a suitable material. Alternatively, the mesh may be cut from a sheet and then rolled or otherwise shaped into the form of the expandable frame, molded, cut from a cylindrical tube, or formed by other methods (one or more) or combinations of the listed processes.

[0183] In some embodiments, frame 810 is made of a relatively flexible metal, metal alloy, or polymer. Examples of metals and metal alloys that can be used include, but are not limited to, nitinol and other shape memory alloys, Elgiloy nonmagnetic alloys, and stainless steel, but other metals and elastic or compliant nonmetallic materials may also be used to manufacture frame 810. These materials allow the frame to be compressed to a small size and then, when the compressive force is released, the frame can self-expand back to its pre-compression diameter and / or the frame can be expanded by the expansion of a device / balloon positioned within the frame. Frame 850 may also be made of other materials and / or may be expandable and collapsible by various methods, including but not limited to mechanically expandable, balloon-expandable, self-expandable, or combinations thereof.

[0184] The sealing portion 811 may have a fibrous material applied thereto by means of a process disclosed herein, such as rotary jet spinning. The sealing portion 811 may take any form that prevents or inhibits blood flow around the outer surface of the valve mounted to the docking device. In some embodiments, the fibrous material applied to the sealing portion 811 may extend to the valve seat 818 and / or extend over the valve seat 818. The fibrous material 821 may extend radially outward to cover the end 862 of the frame 810 and / or may extend longitudinally to cover at least a portion of the annular outer surface or wall 814. The sealing portion 811 may provide a seal between the docking device 820 and the inner surface of the target blood vessel. That is, the sealing portion 811 and the associated valve (when closed) may substantially prevent or inhibit blood flow in the inflow direction.

[0185] The valve seat 818 may be formed part of the frame 810 or may be formed separately from the frame 810. The valve seat 818 may take any form that provides a supporting surface for implantation or deployment of a valve implant device in the docking device 800 when the docking device is expanded. The valve seat may optionally be reinforced with a reinforcing material (e.g., fibrous material from a rotary jet spinning system, sutures, threads, bands, collars, etc., which may surround the valve seat or a portion thereof).

[0186] The retaining portion(s) 814 can take many different forms. For example, the retaining portion(s) 814 can include any structure that positions the docking device 800 within the target vessel or chamber. For example, the retaining portion(s) 814 can press against or be pressed into internal tissue surfaces and / or outline / extend around the anatomical structures of the target vessel(s) to position and maintain the docking device 800. The retaining portion(s) 814 can be part of the body and / or a portion defining the body and / or a sealing portion of the docking station 820, or it can be a separate component attached to the body of the docking device.

[0187] The retaining portion 814 may have an elongated form to allow relatively small forces to be applied to a large area of ​​the target tissue, while the valve mounted to the docking device 800 can apply relatively large forces to the valve seat 818. Applying small radially outward forces over a larger area is sufficient to hold the docking station firmly in place, which allows the docking station to conform to the unique shape / size of the anatomical structure and avoids / reduces the possibility of damage to relatively fragile natural tissue. The frame 810 (e.g., the retaining portion 814) may be formed from a strut 801 that may have a variable thickness. For example, reduced thickness in certain areas can advantageously allow for easier bending or deflection. In some embodiments, the frame 810 is configured such that, upon implantation, all or most of the outer surface of the docking station or frame contacts the inner surface of the target blood vessel (even when the shape is irregular or varied). This also helps to avoid / reduce the possibility of damage to relatively fragile natural tissue (e.g., by excessive local forces and / or pressures at one, two, or more specific locations).

[0188] Figure 30 A docking device frame 810 is shown arranged on a retainer 879, as described herein, in the form of a cylindrical spacer. Although Figure 30 A cylindrical retainer is shown, but it should be understood that any type of retainer can be used to retain the valve frame 810, including arm-type retainers or other attachment features as described herein. As detailed herein, the spindle 873 and retainer 879 can be part of the collector assembly 870.

[0189] With the valve frame 810 arranged on the retainer 879, the spindle 873 and the coupled retainer 879 can rotate about an axis defined by the spindle 873. For example, the collector assembly 870 may include a rotor motor configured to rotate the spindle 873. Various components of the collector assembly 870 may be controlled at least in part by control circuitry of a local and / or remote controller system.

[0190] The fibrous material can be applied to the frame 810 using a rotary jet spinning deposition system, which in some respects can be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and Figure 8B As shown. Figure 31 As shown, fiber strands (one or more strands) can be applied to at least a portion of the outer surface of the frame 810 to form one or more layers of fiber material.

[0191] Fiber material can be applied to at least a portion of the frame 810 to provide a sealing cover for the docking device 820. In some embodiments, rotary jet spinning can be used to apply the fiber material in a manner that covers at least a portion of the end post 862 (such as the tip or end 844)—which can act as a valve seat when the post 862 bends inward—such as... Figure 31 As shown in the image.

[0192] In some implementations, one or more features of frame 810 can be straightened at one or more points during the application of the fiber material. For example, as... Figure 30 As shown, the end post 862 can be straightened to apply fibrous material using rotary jet spinning.

[0193] Figure 31 A perspective view of the docking device 820 is shown, which has fibrous material 821 applied to at least a portion thereof according to an embodiment of the present disclosure. The frame 810 may have the rotary jet-spun fibrous material 821 applied to its end 862 to achieve a seal between the valve and the inner surface of the target blood vessel when the valve is arranged in the valve seat 818 of the frame 810 and the frame 810 is radially expanded and placed in the target blood vessel. As applied, the fibrous material 821 may be formed into a cylinder that appears to roll on the end 862 of the frame 810.

[0194] In some embodiments, after the fibrous material 821 is applied, it can be secured to the frame 810 in some way. For example, the fibrous material 821 can be attached to the frame 810 by sutures, adhesive, binding, fusion, or similar methods. The fibrous material 821 can be deposited onto the end 862 of the frame 810. In some embodiments, the end of the fibrous material 821 is adjacent to the end 862 of the frame 810. The inner diameter of the fibrous material 821 can advantageously be radially inside and adjacent to the inner diameter of the frame 810. The outer diameter of the fibrous material 821 can be radially outside and adjacent to the outer diameter of the frame 810. The proximal surface of the fibrous material 821 can extend around a portion of the retaining portion 814 of the frame 810. In some embodiments, the outer diameter of the fibrous material covering provides a secure fit and / or seal between the frame 810 and the internal tissue surface of the target blood vessel.

[0195] The fibrous material 821 can be applied completely around the end 862 of the frame 810 using rotary jet spinning. The fibrous material 821 may have a contour or otherwise undulate between the struts 801 of the frame 810, or the fibrous material 821 may be flush with the end 862 of the frame 810. The valve seat 818 may be defined by the inner diameter of the frame 810 and the inner diameter of the fibrous material 821. In such a configuration, the fibrous material 821 can achieve a continuous seal between the outer diameter of the frame 810 and the inner surface of the target blood vessel, and between the inner diameter of the frame 810 and the prosthetic valve device. As described above, the docking device 820 can be adapted to various locations in the circulatory system, such as the aorta. To produce the desired fibrous covering 821, the rotational rate of the rotary jet spinning reservoir and / or the translational rate of the spindle / retainer, the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fibrous material.

[0196] Figures 32-34 The accompanying description relates to an embodiment of another example type of docking device 1000, which can be at least partially covered by a fibrous material using a rotary jet spinning solution as described herein. In some embodiments, Figure 32 and Figure 33 The docking device frame 1010 is suitable for use as a docking device for prosthetic heart valves, such as transcatheter heart valves (e.g., aortic heart valve implants).

[0197] Figures 32-34 The docking device includes a frame 1010, which may be at least partially made of a self-expanding shape memory metal (e.g., nitinol). The assembled / manufactured docking device 1000 (see...) Figure 34 The docking device 1000 can be configured to be secured within a target blood vessel or chamber (such as the aortic root) of the heart / circulatory system to assist in the circumferential fixation of medical implant devices (such as transcatheter heart valves). The docking device 1000 can be advantageously combined with a stent or other component of a heart valve implant to entrap the natural valve leaflet associated with the target blood vessel / chamber. The docking device 1000 can be used to anchor a self-expanding and / or balloon-expanding implant device therein.

[0198] The docking device 1000 can be implanted in any suitable or desired medical procedure—such as median sternotomy and left ventricular puncture followed by snaring and externalization of the suture from the femoral artery, wherein the docking device 1000 and the anchored heart valve can be introduced from the femoral artery and the apex of the suture. Alternatively, the docking device 1000 can be implanted via a completely percutaneous approach through one or more femoral arteries.

[0199] The docking device 1000 can be used to secure a prosthetic heart valve within a natural heart valve. Although the use of the docking device according to this disclosure is described as for securing a transcatheter heart valve in the aortic or mitral valve of the heart, it should be understood that the disclosed docking device can also be configured for any other heart valve. The frame 1010 includes a plurality of forks / arms 1028 (three in the example embodiment) of the respective peaks of the struts (one or more) 1020 attached to the frame 1010.

[0200] Figure 33 A docking device frame 1010 is shown arranged on a bracket 1018, as described herein, on an arm-type retainer. Although the arm retainer is... Figure 33 As shown herein, however it should be understood that any type of retainer can be used to retain the docking device frame 1010, including cylindrical or other shaped spacer-type retainers or other attachment features as described herein. As detailed herein, the mandrel 1019 and retainer 1018 may be part of the collector assembly 1017.

[0201] With the docking device frame 1010 arranged on the retainer 1018, the spindle 1019 and the coupled retainer 1018 can rotate about an axis defined by the spindle 673. For example, the collector assembly 1017 may include a rotor motor configured to rotate the spindle 1019. Various components of the collector assembly 1017 may be controlled at least in part by control circuitry of a local and / or remote controller system.

[0202] A rotary jet spinning deposition system can be used to apply fiber material to the docking device frame 1010. This rotary jet spinning deposition system can, in some respects, be similar to... Figure 8A and Figure 8B The system 800 shown. For example, a rotary reservoir containing a solution can rotate at a sufficient speed to eject / discharge a plane of fiber strands (one or more strands), such as... Figure 8A and Figure 8B As shown. Figure 25 As shown, fiber strands (one or more strands) may be applied to at least a portion of the outer surface of the frame 1010 to form one or more layers of fiber material.

[0203] Fiber material may be applied to at least a portion of the frame 1010 to provide coverage for the docking device implant 1000. In some embodiments, rotary jet spinning may be used to apply the fiber material in a manner that surrounds or partially surrounds or covers at least a portion of the strut 1020 of the frame 1010.

[0204] The retaining arm 1028 can be used to assist in positioning and deploying the docking device 1000 to its proper position relative to the natural aortic valve. As shown, the retaining arm 1028 has an eyehole / hole therein. The upper / proximal / peak of one or more of the struts 1020 can be attached to and / or integrated with the retaining arm 1028. The retaining arm 1028 can be advantageously used with various types of delivery systems. For example, the arm 1028 may be shaped to have an enlarged head for securing the frame 1010 to a slot-based delivery system. In some embodiments, the head portion of the arm 1028 (e.g., the eyehole) can be used to secure the frame 1010 to a tethered delivery system, which may utilize sutures, threads, or fingers to control the delivery of the frame 1010. Such features can advantageously facilitate in-situ recapture and repositioning of the frame 1010. Additionally, or as an alternative, arm feature 1028 may be used to secure frame 1010 to collector assembly 1017 of rotary jet spinning system. For example, head 1029 may be used to sew, clamp, snap, hook, or otherwise secure post head(s) 1029 to arm(s) or other features(s) of retainer 1018.

[0205] Figure 34 A docking device 1000 is shown, having a fibrous material 1022 applied to portions thereof using rotary jet spinning according to one or more embodiments of the present disclosure. The fibrous material 1022 can be applied to one or more portions or components of the device 1000 using rotary jet spinning in any suitable or desired manner. For example, the fibrous material 1022 can be applied to the exterior (and / or interior) of a frame 1010. In some embodiments, the fibrous material 1022 extends from the upper end to the lower end of the frame support 1020. The application of the fibrous material can advantageously enhance the sealing properties of the device 1000. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of the frame 1010. The process of depositing the fibrous material can be performed as many times as desired and / or for a desired amount of time to produce a desired thickness and / or other properties of the fibrous material. In order to produce the desired fiber cover 1022, the rotational rate of the rotary jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fiber material.

[0206] Figure 35 and Figure 36 The accompanying description relates to embodiments of other exemplary types of docking devices, which may use a rotary jet spinning solution as described herein that is at least partially covered by a fibrous material. In some embodiments, Figure 35 and Figure 36The docking devices 930 and 940 can be used as docking devices for prosthetic heart valves, such as transcatheter heart valves (e.g., aortic valves).

[0207] Figure 35 The docking device 930 includes a support frame or frame 931, which can be used to help secure a heart valve implant into the interior of a natural heart valve (such as an aortic valve). The frame 931 may have a generally annular or hypertoroidal body formed of a suitable shape memory metal or alloy (such as spring steel, Elgyro nonmagnetic alloy, or nitinol). The frame 931 is radially compressible to a smaller profile and can self-expand when deployed to its functional size and shape. In some embodiments, the frame 931 is not self-expanding.

[0208] The support frame 931 includes a generally cylindrical body portion 932 and an edge portion 933. The frame 931 can be a grid structure, which may be formed, for example, by a plurality of pillars, with approximately half of the pillars angled in a first direction and approximately half of the pillars angled in a second direction, thus creating a cross or diamond pattern. In an example embodiment, the edge portion 933 has a larger diameter than the body portion 932 and is formed as an extension at the bottom region of the body portion, the extension folding outward from the body portion and returning towards the top region of the body portion. The edge portion 933 can therefore form a U-shaped edge or lip around the bottom region of the frame 910. Generally, the edge portion 933 can be designed to have a diameter slightly larger than the wall of the aortic arch surrounding the aortic valve. Therefore, when the frame 910 is delivered to the aortic valve and deployed at the aorta, the edge portion 933 can expand to engage the surrounding aortic wall and frictionally secure the frame 910. Meanwhile, the main body 932 can define the interior into which an expandable heart valve implant (not shown) can expand and further engage (e.g., the natural leaflet of an aortic valve).

[0209] The frame 931 may further include a retaining arm 934, which can be used to assist in positioning and deploying the frame 910 in its proper position relative to the natural valve. The retaining arm 934 may have associated apertures that can be used for various purposes, including coupling the frame 931 to a retainer device for a rotary jet spinning system, as described in detail herein.

[0210] Frame 931 may have fibrous material 935 applied to its portions according to one or more embodiments of this disclosure using rotary jet spinning. Fiber material 935 may be applied to one or more portions or components of device 930 using rotary jet spinning in any suitable or desired manner. For example, fibrous material 935 may be applied to the exterior (and / or interior) of frame 931. In some embodiments, fibrous material 935 extends from the upper end of the frame strut of body portion 932 to the end of edge portion 933. The application of fibrous material may advantageously enhance the sealing properties of device 930. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of frame 931. The process of depositing fibrous material 935 may be performed as many times as desired and / or for a desired amount of time to produce the desired thickness and / or other properties of the fibrous material. To produce the desired fibrous cover 935, the rotational rate of the rotary jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly may be controlled to produce the desired application of fibrous material.

[0211] Figure 36 The valved conduit 940 is shown, which includes a conduit graft 942 integrated with a prosthetic valve implant device 941 (partially obscured). Figure 36 (Within the conduit graft 942). The conduit 942 and the valve device 941 together form a two-piece valved conduit assembly. The conduit graft 942 can be configured to facilitate the replacement of a previously implanted prosthetic valve implant. That is, the heart valve 941 within the valved conduit 940 may sometimes become calcified and must be replaced. The assembly 940 provides relatively easy valve removal.

[0212] In some embodiments, the conduit graft 942 can be used, for example, as an aortic conduit graft. As shown, a prosthetic heart valve 941 can be at least partially positioned within one end of the conduit graft 942. The valved conduit 940 can be used to replace the natural aortic valve and / or the ascending aorta. However, it should be understood that some of the principles disclosed herein are also applicable to the replacement of the pulmonary valve and the pulmonary artery.

[0213] The heart valve 941 may include a rigid or semi-rigid stent supporting a plurality of flexible leaflets (not shown), which are mounted to a peripheral stent structure and form a fluid-blocking surface within the valve orifice to form a one-way valve. As described in detail above, the frame structure may include a plurality of generally axially extending assemblies distributed circumferentially around the valve among the leaflets and in the same number as the leaflets. The valve orifice may be oriented about an axis along the inflow-outflow direction through the valve 941. Figure 36The sewn ring component of valve 941, exposed at its inflow end outside conduit graft 942, is shown. It may conform to the undulating profile of the valve tip or define a generally circular planar ring.

[0214] The conduit graft 942 may define an overall tubular structure extending from the inlet end 943 to the outlet end (not shown). In the illustrated embodiment, the valve 941 is associated with the conduit graft 941 in such a way that the valve leaflets control blood flow through the conduit by allowing blood to flow into the conduit (e.g., when the conduit is used for aortic replacement, blood flows into the aorta) while preventing blood from flowing out of the conduit in the opposite direction (i.e., when the conduit is used for aortic replacement, blood flows back into the patient's left ventricle).

[0215] The illustrated conduit graft 942 is particularly suitable for attachment within the aortic valve annulus and ascending aorta, thus allowing for close conformation to the aortic root anatomy and including an enlarged region or protrusion 944 near the inflow end 943, which conforms precisely to the Valsalva sinus on the aortic valve annulus. The conduit graft 942 may have a fibrous material 945 applied thereto using rotary jet spinning according to embodiments of this disclosure. In some embodiments, the fibrous material 945 may be sealed with a bioabsorbable medium such as gelatin or collagen. At least a portion of the conduit graft 942 may include circumferentially wavy (i.e., grooved) or pleated sidewall portions (one or more) providing longitudinal flexibility and / or radial compressibility while ensuring that the graft does not excessively expand radially under the pressure of blood flowing through it. The enlarged region or protrusion 944 may be configured with longitudinal corrugations that expand radially more than circumferential pleats to allow expansion into the Valsalva sinus at that location. The tube graft 942 can be expected to have a length ranging from a few centimeters to 10 to 12 centimeters.

[0216] The conduit graft 942 may have a fibrous material 945 applied to its portions according to one or more embodiments of the present disclosure using rotary jet spinning. The fibrous material 945 may be applied to one or more portions or components of the device 940 in any suitable or desired manner using rotary jet spinning. For example, the fibrous material 945 may be applied to one or more portions of the exterior of the conduit graft 942. In some embodiments, the fibrous material 945 extends from the outlet end of the conduit graft 942 to the end of the protrusion 944. The application of the fibrous material 945 may advantageously enhance the sealing properties of the device 940. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of the conduit graft 942. The process of depositing the fibrous material 945 may be performed as many times as desired and / or for a desired amount of time to produce a desired thickness and / or other properties of the fibrous material. In order to produce the desired fiber coating 945, the rotational rate of the rotary jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fiber material.

[0217] Figure 37 An example is provided of a septal closure device 160 including a blood-blocking portion 161, at least partially formed of fibrous material 165 applied to a frame 162 by a rotary jet spinning process (one or more) according to one or more embodiments of the present disclosure. The septal closure device 160 may be configured to be implanted in or to a septal wall to at least partially close the septal orifice. In some embodiments, the septal closure device 160 allows subsequent re-entry through the septum at the same orifice location while other therapeutic interventions are being performed. In some embodiments, the closure device 160 is configured to provide an access port for accessing the left side of the heart via a catheter or other medical device. In some embodiments, the closure device 160 may be implanted in an orifice formed in the ventricular septum, the apex of the heart, or other segments, or in an orifice formed in other organs of the body (surgical or congenital).

[0218] The spacer closure device 160 may include a frame 162 configured to support a blood-blocking fibrous material 165. The frame 162 in the illustrated configuration may include a generally flat body comprising a central portion 166 and a plurality of anchoring arms 163 extending radially outward from the central portion 166. For example, as shown in the illustrated embodiment, at least four arms may extend from the central portion 166, but in other embodiments the frame may have more than four arms or fewer than four arms.

[0219] As exemplified, the four arms 163 may include a first set of opposing distal arms 168 and a second set of opposing proximal arms 169 extending from the central portion 166. The closure device desirably (though not necessarily) has the same number of arms in the first and second sets, such that when the device is implanted, the clamping force exerted by the arms is uniformly distributed against the septum. In a deployment or expansion configuration, the arms 163 may extend radially outward from the central portion 166. The arms 163 may extend perpendicularly or substantially perpendicularly to the central axis of the device 160 (which extends orthogonally to the page plane), such that when the device 160 is implanted in the interatrial septum, the septum wall can be compressed or clamped between the first set of arms 168 and the second set of arms 169. In other words, when the device 160 is implanted, the first set of arms 168 may be on one side of the interatrial septum, the second set of arms 169 may be on the other side of the interatrial septum, and the central portion 166 may be arranged within an orifice or defect or offset to one side of the septum.

[0220] Frame 162 may have a relatively thin and flat profile to avoid or minimize the risk of thrombosis. Therefore, for this purpose, arms 163 may be attached to central portion 166 at angledly spaced locations on the central portion, wherein the attachment locations intersect a common plane perpendicular to the central axis; in other words, all arms 163 in the example embodiment may be attached to the central portion along the same circumferential path defined by the central portion 166.

[0221] Furthermore, the arms 163 and connecting frame portions 167 (covered by fiber material 165 in the example configuration) of the example frame 162 can together form a simple closed-loop structure, wherein a single continuous frame member forms each of the arms and connecting portions. Each of the arms 163 can have various shapes. For example, embodiments of the plurality of arms 163 can be mushroom-shaped, rhomboid, or circular.

[0222] The central portion 166 of frame 162 may have a fibrous material 165 applied to it using rotary jet spinning according to one or more embodiments of the present disclosure. The fibrous material 165 may be applied to one or more portions or components of device 160 in any suitable or desired manner using rotary jet spinning. For example, the fibrous material 165 may be applied to one or both sides of the central portion 166 using rotary jet spinning. In some embodiments, the fibrous material 165 substantially covers the entire central portion 166, as shown, or optionally only covers one or more strips or portions thereof. The application of the fibrous material can advantageously enhance the blocking characteristics of device 160. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of device 160. Furthermore, the process of depositing the fibrous material 165 can be performed as many times as desired and / or for a desired amount of time to produce the desired thickness and / or other properties of the fibrous material. In order to produce the desired fiber coating 165, the rotational rate of the rotary jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fiber material.

[0223] Figure 38 Another embodiment of the docking device 1100 is illustrated, comprising fibrous material 1180 applied to a portion thereof using rotary jet spinning according to one or more embodiments. The docking device 1100 can be configured for use with an expandable transcatheter heart valve at a natural valve annulus (e.g., a mitral or tricuspid annulus) to more securely implant and retain the prosthetic valve at the implantation site. Anchoring / docking devices according to embodiments of this disclosure can provide or form a more rounded and / or more stable valve annulus at the implantation site, wherein a prosthetic valve having a circular or cylindrical valve frame or stent can be expanded or otherwise implanted.

[0224] In addition to providing an anchoring point for the prosthetic valve, the anchoring / docking device 1100 can be sized and shaped to radially tighten or pull the anatomy of the natural valve (e.g., mitral, tricuspid, etc.). In this way, one of the main causes of valvular regurgitation (e.g., functional mitral regurgitation)—specifically, the dilation of the heart (e.g., left ventricle) and / or valve annulus, and the resulting stretching of the natural valve (e.g., mitral) annulus—can be at least partially compensated for or offset. Some embodiments of the anchoring or docking device 1100 further include features that are shaped and / or modified, for example, during and / or after the prosthetic valve is dilated therein, to better maintain the position or shape of the docking device. By providing such an anchoring or docking device, the replacement valve can be more securely implanted and held at various valve annulus locations, including implantation and holding at mitral valve annulus locations that do not have a natural circular cross-section.

[0225] The docking device 1100 may include a central region 1110, a lower region 1120, an upper region 1130, and an extension region 1140. In some embodiments, the lower region 1120 and the upper region 1130 may have a larger coil diameter than the central region 1110, and the extension region 1140 may vertically separate the upper region 1130 from the central region 1110.

[0226] The central coil / turn 1110 of the docking device 1100 provides the primary docking site for the prosthetic valve that expands therein. The central turn 1110 can be generally positioned in the left ventricle, while a small distal portion, if present, can extend through the natural valve annulus into the left atrium. The central turn 1110 can be configured to hold the expanded valve implant stably within the docking device 1100 with sufficient force and prevent the valve from dislodging from the docking device 1100—even during severe mitral valve pressure.

[0227] The lower region 1120 of the docking device 1100 can serve as a lead coil / turn (e.g., a ventricular encircling turn). The lower region 1120 includes the distal tip of the docking device 1100 and flares radially outward from the central turn 1100 to capture some or all of the natural valvular leaflets, chordae tendineae, and / or other mitral valve anatomy as the docking device 1100 is advanced into the left atrium.

[0228] The upper region 1130 of the docking device 1100 can act as a stabilizing coil / turn (e.g., an atrial coil / turn) that provides a self-holding mechanism for the docking device 1100 during the transition phase after it is deployed at the native valve and before THV delivery. For example, the diameter of the upper region 1130 can be selected to allow it to fit at approximately the desired height in the left atrium and to prevent it from sliding or falling further toward the native mitral valve annulus after reaching the desired position.

[0229] The extension region 1140 provides a vertical extension and spacer between the central region 1110 and the upper region 1130 of the docking device 1100. The position of the docking device 1100 across the mitral valve plane is important in maintaining the integrity of the natural valve anatomy—specifically, the leaflets and commissures—thus serving as a suitable docking site for the final implantation of the valve implant. In docking devices without such an extension or ascending region 1140, the docking device is more likely to sit or abut against the mitral valve plane and be clamped against the natural leaflets, and the relative movement or friction of the docking device against the natural leaflets could potentially damage the natural leaflets from the atrial side. Having the extension region 1140 allows the portion of the docking device 1100 positioned in the left atrium to ascend away from and spaced apart from the mitral valve plane.

[0230] The docking device 1100 may include a low-friction (e.g., ePTFE) covering layer 1170, which can improve the interaction between the distal end of the docking device 1100 and the natural cardiac anatomy. For example, additional friction on at least a portion of the central region 1110—which provides the functional coils of the docking device 1100 for docking with a valve implant—would be more desirable. Therefore, fibrous material 1180 may be applied to the central region 1110 of the docking device 1100 using a rotary jet spinning process (one or more) according to embodiments of this disclosure. The fibrous material 1180 can provide additional friction between adjacent coils and to the natural leaflet and / or the valve implant device docked in the docking device 1100. The friction provided by the fibrous material 1180 at the interfaces between coils and between the inner surface of the central region 1110 of the docking device 1100, the natural mitral valve, and / or the outer surface of the valve implant can create a more robust locking mechanism, thereby more firmly anchoring the valve device and the docking device 1100 to the natural valve. Since the functional coil / turn or central region 1110 of the docking device 1100, i.e. the region where the docking device interacts with the valve implant device, may be the only region where high-friction fiber material / layers are desired, the fiber material 1180 can be selectively applied only to a portion (one or more) of the central region 1110 using rotary jet spinning, so that other regions remain low-friction to facilitate less invasive interaction with the natural valve and other cardiac anatomy structures.

[0231] The docking device 1100 may have a fibrous material 1180 applied to its portions according to one or more embodiments of the present disclosure using rotary jet spinning. The fibrous material 1180 may be applied to one or more portions or components of the device 1100 using rotary jet spinning in any suitable or desired manner. For example, the fibrous material 1180 may be applied to one or more portions of the exterior and / or interior of the coil 1110 and / or other portions of the docking device 1100. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of the docking device 1100. The process of depositing the fibrous material 1180 may be performed as many times as desired and / or for a desired amount of time to produce a desired thickness and / or other properties of the fibrous material. To produce the desired fibrous coating 1180, the rotational rate of the rotary jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly may be controlled to produce the desired application of the fibrous material.

[0232] Figure 39An example of a tissue anchoring device 1200 is provided, comprising a fibrous material 1245 applied to a portion thereof using rotary jet spinning according to one or more embodiments. Device 1200 can be used for medical treatment and / or therapy of cardiac conditions, including, for example, dilation (including dilated left ventricle), valvular insufficiency (including mitral regurgitation), and other similar heart failure conditions. In some embodiments, device 1200 functions to assist in the juxtaposition of heart valve leaflets to improve valvular function. Furthermore, device 1200 can be placed in conjunction with other devices configured to locally and / or globally alter the shape or geometry of the heart, thereby further increasing cardiac efficiency. That is, device 1200 can act alone or in synergy with one or more other implantable devices to promote improved cardiac pumping efficiency by altering the shape or geometry of the heart and consequently reducing stress on the heart walls and by improving valvular function.

[0233] In some embodiments, the anchoring device 1200 is adapted to secure a mitral valve clip device within the heart and / or left atrium. The anchoring device 1200 may be self-expanding and may include a ring 1252 that can support a cover portion 1256 peripherally, the cover portion 1256 being at least partially covered with a fibrous material 1245 using rotary jet spinning according to embodiments of the present disclosure. After tightening a centrally located tension member or cord 1260, for example, when the inner end of the protrusion 1288 is pulled toward the center, the cover 1256 may take on a circular, flat, disc-shaped, or pie-shaped configuration, as shown, or it may take on a tapered configuration if the end of the protrusion 1288 is pulled in a direction perpendicular to a plane aligned with the ring 1252, such as when the tension member pulls the anchoring device 1200 toward another anchoring device.

[0234] The deployment or expansion configuration of the self-expanding anchor 1200 (e.g., circular / disc / pie / conical configuration) is suitable for anchoring the tension member within the heart (such as the left atrium) and for withstanding forces encountered when the heart's shape changes. Generally, the larger surface area of ​​the cover portion 1256 helps the anchor 1200 withstand greater forces. For example, the relatively large surface area of ​​the cover 1256 coupled to the centrally located tension member 1260 can provide an inherently stable configuration for the anchor 1200, thereby eliminating or reducing the risk of mechanical failure and migration into tissue when encountering certain other anchors. Furthermore, with the cover 1256 having a relatively large surface area and the tension member 1260 associated with the center of the device, as shown, the device 1200 can function as a closure device sealing perforations in the walls of the heart or other anatomical structures. In some embodiments, the fibrous material 1245 is applied in a manner that forms an overall conical configuration when placed under tension to inhibit anchor migration during cardiac pulsation.

[0235] Anchoring device 12100 may have fibrous material 1245 applied to its portions according to one or more embodiments of the present disclosure using rotary jet spinning. Fiber material 1245 may be applied to one or more portions or components of device 1200 using rotary jet spinning in any suitable or desired manner. For example, fibrous material 1245 may be applied to one or more portions of cover 1256 and / or ring 1252. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of anchoring device 1200. The process of depositing fibrous material 1245 may be performed as many times as desired and / or for a desired amount of time to produce a desired thickness and / or other properties of the fibrous material. To produce the desired fibrous material 1245, the rotational rate of the rotary jet spinning reservoir and / or mandrel / support, the translational rate of the mandrel / support, and the angle and / or angular variation of the support assembly may be controlled to produce the desired application of the fibrous material.

[0236] Figure 40 Another embodiment of the annulusoplasty repair device 1300 is illustrated, which includes fibrous material 1245 applied to a portion thereof using rotary jet spinning according to one or more embodiments. The annulusoplasty repair device 1300 can be configured to restore the specific morphology and dynamic characteristics of a heart valve damaged by various degenerative valvular diseases, overcoming some limitations of the currently available rings described.

[0237] The annulus remodeling repair device 1300 may be a semi-rigid ring device. The device 1300 may include a relatively rigid front side and a gradually becoming more flexible rear side to provide the ring with a degree of flexibility while retaining its annulus remodeling effect. The annulus remodeling repair device 1300 may have a fibrous material 1345 applied to portions thereof according to one or more embodiments of the present disclosure using rotary jet spinning. The fibrous material 1345 may be applied to one or more portions or components of the device 1300 in any suitable or desired manner using rotary jet spinning. For example, the fibrous material 1345 may be applied to one or more interiors or exteriors of the ring type of the device. Rotary jet spinning can be used to apply fibrous materials with different sets of properties to different portions of the annulus remodeling repair device 1300. The process of depositing the fibrous material 1345 may be performed as many times as desired and / or for a desired amount of time to produce the desired thickness and / or other properties of the fibrous material. In order to produce the desired fiber coating 1345, the rotational rate of the rotary jet spinning reservoir and / or mandrel / retainer, the translational rate of the mandrel / retainer, and the angle and / or angular variation of the retainer assembly can be controlled to produce the desired application of the fiber material.

[0238] Figure 41This is a flowchart of process 1400 for applying fibrous material to a component of a medical device. At block 1402, process 1400 involves coupling the medical device component to a retainer associated with a rotating mandrel. As described herein, the retainer and / or mandrel may be part of a collection assembly. Furthermore, as detailed herein, the retainer may be a spacer-type or arm-type retainer.

[0239] At box 1404, process 1400 involves rotating a reservoir of a rotary jet spinning system to eject a plane of fibrous material, as described herein. For example, the reservoir may contain a volume of polymer solution that is ejected from one or more orifices in the reservoir when the reservoir rotates at a sufficient speed. The reservoir device may be part of a deposition assembly.

[0240] At block 1406, process 1400 involves using a mandrel and / or one or more other components of the collection assembly to rotate and / or translate the retainer in the plane of the ejected fibrous material. The retainer advantageously rotates simultaneously with the rotation of the reservoir. At block 1408, process 1400 involves continuing to rotate and / or translate the retainer to produce a desired fibrous material coating on one or more portions of the medical device component.

[0241] Process 1400 can be performed at least in part by control circuitry coupled to the collection assembly and / or deposition assembly.

[0242] Additional Embodiments

[0243] Depending on the implementation described herein, certain actions, events, or functions of any process or algorithm may be performed in different orders, added, combined, or omitted entirely. Therefore, in some implementations, not all described actions or events are necessary for the practice of the process.

[0244] Unless otherwise specifically stated or understood in the context, the conditional language used herein, such as “can,” “may,” “possibly,” “may,” “for example,” etc., is intended to have its general meaning and is generally intended to express that certain embodiments include certain features, elements, and / or steps, while other embodiments do not. Therefore, such conditional language is generally not intended to imply that one or more embodiments require features, elements, and / or steps in any way, or that one or more embodiments must include logic for determining (whether or not the author has entered or prompted) whether such features, elements, and / or steps are included in any particular embodiment or will be performed in any particular embodiment. The terms “comprising,” “including,” “having,” etc., are synonymous, used in their general meaning, and used inclusively in an open-ended manner, without excluding other elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive meaning (not in its unique meaning) such that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the listed elements. Unless otherwise specifically stated, connective language such as the phrase "at least one of X, Y, and Z" should be understood in the context in which items, terms, elements, etc., can be X, Y, or Z. Therefore, such connective language is generally intended to imply that certain implementations require the presence of at least one of X, at least one of Y, and at least one of Z.

[0245] It should be understood that in the above description of the embodiments, various features are sometimes combined in a single embodiment, drawing, or description thereof in order to simplify this disclosure and aid in understanding one or more aspects of the invention. However, this method of disclosure should not be construed as reflecting an intention that any claim requires more features than are expressly recited in that claim. Furthermore, any component, feature, or step exemplified and / or described in the specific embodiments herein may be applied to or used with any other embodiment(s). Additionally, a component, feature, step, or group of components, features, or steps is not essential or indispensable to each embodiment. Therefore, the scope of the invention intended to be disclosed herein and claimed hereinafter should not be limited by the specific embodiments described above, but should be determined solely by a reasonable reading of the appended claims.

[0246] It should be understood that certain ordinal terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Therefore, as used herein, ordinal terms used to modify elements such as structure, component, operation, etc. (e.g., "first," "second," "third," etc.) do not necessarily indicate the priority or order of the element relative to any other element, but can generally distinguish the element from another element with a similar or identical name (if the ordinal term were not used). Furthermore, as used herein, indefinite articles ("a" and "an") can mean "one or more" rather than "one." Moreover, an operation performed "based on" a condition or event can also be performed based on one or more other unstated conditions or events.

[0247] Unless otherwise defined, all terms used herein (including technical and scientific terms) shall have the same meaning as commonly understood by one of ordinary skill in the art to which the exemplary embodiments pertain. It should further be understood that terms, such as those defined in common dictionaries, shall be interpreted as having meaning consistent with their meaning in the context of the relevant field and shall not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

[0248] The spatially relative terms “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” and similar terms are used herein to describe the relationship between one element or component and another, as exemplified in the accompanying drawings. It should be understood that, in addition to the orientations depicted in the drawings, the spatially relative terms are intended to cover different orientations of the device during use or operation. For example, in the case where the device shown in the drawings is flipped, a device positioned “below” or “below” another device can be placed “above” another device. Thus, the exemplary term “below” can include both a lower position and an upper position. The device may also be oriented in another direction, and therefore the spatially relative terms can be interpreted differently depending on the orientation.

[0249] Unless otherwise expressly stated, comparative and / or quantitative terms such as “less,” “more,” “greater,” etc., are intended to encompass the concept of equality. For example, “less” can mean not only “less” in the strictest mathematical sense, but also “less than or equal to.”

Claims

1. A method for applying a fibrous material to a medical device, the method comprising: A medical device is coupled to a retainer device, wherein the medical device is a surgical heart valve device comprising: Non-expandable sealing ring; Multiple connecting posts protruding along the outflow direction on the outflow side of the sealing ring; and An expandable skirt frame extending on the inflow side of the sealing ring; A rotating reservoir device is used to discharge at least a portion of a first liquid polymer solution from the orifice of the reservoir device, wherein the discharged at least a portion of the first liquid polymer solution forms a first strand or multiple strands of fibrous material in a first deposition plane; The retainer device is rotated at least partially within the first deposition plane to apply at least a first portion of the first strand or multiple strands of fibrous material to the sealing ring and the plurality of connecting posts of the surgical heart valve device, thereby forming a first fibrous covering on the sealing ring and the plurality of connecting posts, the first fibrous covering having a first set of characteristics; The reservoir device is rotated to discharge at least a portion of the second liquid polymer solution from the orifice of the reservoir device, and the discharged at least a portion of the second liquid polymer solution forms a second strand or multiple strands of fiber material in the second deposition plane; and The retainer device is rotated at least partially within the second deposition plane to apply at least a portion of the second single or multiple strands of fibrous material to the skirt frame of the surgical heart valve device, thereby forming a second fibrous covering on the skirt frame, the second fibrous covering having a second set of characteristics.

2. The method of claim 1, wherein the retainer device is a component of a collection assembly, the collection assembly further comprising: Rotary motor; and A spindle, which is mechanically coupled to the retainer device and the rotary motor.

3. The method of claim 2, further comprising translating the collection assembly along a vertical axis while discharging at least a portion of the first liquid polymer solution.

4. The method of claim 1, wherein the retainer device is at least partially cylindrical in shape and is of the type of spacer.

5. The method of claim 4, further comprising applying another portion of the second strand or multiple strands of fiber material to the surface of the retainer device, thereby forming an excess fiber covering portion on the surface of the retainer device.

6. The method of claim 5, further comprising: Decouple the medical device from the retainer device; and The excess fiber covering is folded over the inflow edge of the skirt frame to cover at least a portion of the inner surface of the skirt frame.

7. The method of claim 1, wherein the retainer device comprises a plurality of arms configured to be coupled to the medical device.

8. The method of claim 7, wherein coupling the medical device to the retainer device comprises suturing the medical device to the plurality of arms of the retainer device.

9. The method of claim 1, wherein the rotation of the reservoir device and the retainer device is performed using control circuitry at least partially communicatively coupled to a collection assembly associated with the retainer device and a deposition assembly associated with the reservoir device.

10. The method according to claim 1, wherein: The retainer device includes at least a partially cylindrical spacer type.

11. The method of claim 10, wherein the spacer type has a non-uniform longitudinal diameter.

12. The method according to claim 1, wherein: The retainer device includes multiple arms; and The coupling of the medical device to the retainer involves coupling the frame to the plurality of arms.

13. A method of applying fibrous material to a leaflet spacer device, the method comprising: The leaflet spacer assembly is coupled to the retainer assembly, the leaflet spacer assembly comprising: Spacer body; and Multiple clamping components are configured to be movable to capture one or more leaflets of a heart valve between the multiple clamping components and the spacer body; The plurality of clamp components are opened to a straightened configuration, exposing the spacer body and the inner surfaces of the plurality of clamp components; The reservoir device is rotated to discharge the first portion of fibrous material into the first deposition plane; and The retainer device is rotated at least partially within the first deposition plane to apply the first portion of the fibrous material to the inner surfaces of the spacer body and the plurality of clip members of the leaflet spacer device, thereby forming a fibrous covering on the inner surfaces of the spacer body and the plurality of clip members.

14. The method of claim 13, further comprising: Close the plurality of clamp components; And when the plurality of clip components are in a closed configuration, at least a portion of the outer surface of the plurality of clip components is covered with fibrous material discharged from the second portion of the reservoir device.

15. The method of claim 13, further comprising, after forming the fiber covering on the inner surfaces of the spacer body and the plurality of clip members, changing the leaflet spacer assembly from the straightened configuration to a folded configuration.

16. A method of applying fibrous material to a prosthetic heart valve, the method comprising: Couple the retainer assembly to the rotatable mandrel; A prosthetic heart valve is coupled to the retainer device, the prosthetic heart valve comprising: Sealing ring; A first frame, the first frame comprising a plurality of connecting columns; and The second frame extends on the inflow side of the sealing ring; A rotating reservoir device is used to discharge a first portion of the liquid polymer solution into the first deposition plane; The retainer device is rotated at least partially within the first deposition plane to apply the first portion of the liquid polymer solution to the sealing ring, thereby forming a first fiber cover on the sealing ring, the first fiber cover having a first set of characteristics; Rotate the reservoir device to discharge the second portion of the liquid polymer solution into the second deposition plane; and The retainer device is rotated at least partially within the second deposition plane to apply the second portion of the liquid polymer solution to the second frame, thereby forming a second fiber cover on the second frame, the second fiber cover having a second set of properties that are different from the first set of properties.

17. The method of claim 16, further comprising: The prosthetic heart valve is removed from the retainer device.

18. The method of claim 16, further comprising folding a portion of the second fibrous covering over the inflow edge of the prosthetic heart valve.

19. The method of claim 16, wherein the retainer device comprises a spacer type.

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