Implantable component with socket

Abstract

To provide implantable devices.SOLUTION: Implantable devices may include a single, first component or a plurality of components such as first and second components, the second component being flexibly coupled to the first component. A socket extends over one or more of the components, the socket being configured to enhance an inter-component interaction and / or including one or more exposed surfaces configured to exhibit one or more stages of foreign body responses within a range of possible foreign body responses.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 62 / 778,654, filed on Dec. 12, 2018, and claims the priority of U.S. Patent Application No. 16 / 710,637, filed on Dec. 11, 2019, both of which are hereby incorporated by reference in their entirety for all purposes.

[0002] The present disclosure generally relates to covers, receptacles, shrouds, couplers, constrictors, etc. (collectively referred to as sockets) for implantable medical devices, and more specifically to sockets configured to improve the interaction between and / or among components of an implantable device and / or environments.

Background Art

[0003] Components of implantable devices are implemented in various situations such as trans - catheter mitral valve chordal repair devices. Improvement in the interaction between multiple device components in vivo, as well as the interaction between multiple device components and the body environment, still needs to be achieved.

Summary of the Invention

[0004] Various examples relate to implantable medical devices (e.g., transcatheter mitral valve chordae tendineae devices) that include a first component (e.g., an anchor component) and a second component (e.g., a tether component) coupled to the first component. The interaction between the first and second components (e.g., relative motion, bending, abrasion, or other mechanical interactions) can be controlled (e.g., minimized), and the interaction between the first and / or second components and the bodily environment can be improved (e.g., by promoting internal tissue growth and / or minimizing thrombus formation). In further examples, the interaction between the first and / or second components and a third component (e.g., a tetherlock component) can be improved (e.g., by reducing relative motion and / or facilitating docking between components), and the interaction between the third component and the bodily environment can be improved (e.g., by promoting internal tissue growth and / or minimizing thrombus formation). The various examples provided herein relate to covers, receptacles, shrouds, couplers, constraints, retaining members, etc. (collectively referred to herein as “sockets”) for improving the interaction between such components and between the environment of an implantable device.

[0005] According to the first example ("Example 1"), the implantable device includes a first component, a second component flexibly coupled to the first component, and a socket extending over the first component and the second component, configured to improve the intercomponent interaction between the first component and the second component of the implantable device by reducing the relative motion between the first component and the second component, the socket including one or more outer exposed surfaces configured to exhibit one or more stages of a foreign body reaction within a range of possible foreign body reactions.

[0006] In another example ("Example 2"), in addition to Example 1, the one or more outer exposed surfaces are configured to exhibit a xenobiotic reaction, including extracellular matrix integration.

[0007] According to another example ("Example 3"), in addition to any of the preceding examples, the socket includes one or more layers of material that are impermeable to cell integration.

[0008] According to another example ("Example 4"), in addition to any of the preceding examples, the socket comprises one or more layers of material having a microstructure oriented to provide longitudinal strength to one or more portions of the socket.

[0009] According to another example ("Example 5"), in addition to any of the preceding examples, the socket comprises one or more layers of material having a microstructure oriented to provide circumferential strength to one or more portions of the socket.

[0010] In another example ("Example 6"), in addition to any of the preceding examples, the socket includes one or more reinforcing rings.

[0011] In another example ("Example 7"), in addition to Example 6, at least one of the one or more reinforcing rings is elastically deformable up to an enlarged diameter, and the one or more reinforcing rings elastically recover from the enlarged diameter.

[0012] In another example ("Example 8"), in addition to Example 6 or 7, the one or more reinforcing rings define a continuous helical undulating pattern.

[0013] In another example ("Example 9"), in addition to any of the preceding examples, the socket includes an outwardly flared end.

[0014] In another example ("Example 10"), in addition to any of the preceding examples, the socket includes a reinforced end.

[0015] In another example ("Example 11"), in addition to either of the preceding examples, the first component is an anchor component and the second component is a tether component.

[0016] In another example ("Example 12"), in addition to any of the prior examples, the implantable device of a prior claim further comprises a third and a fourth component, the socket being configured to receive the third and fourth components to improve the interaction between the components between the first and third components of the implantable device.

[0017] In another example ("Example 13"), in addition to Example 12, the third component is a tether lock component, and the fourth component is a tether component.

[0018] According to another example ("Example 14"), in addition to any of the preceding examples, at least one of the outer and inner surfaces of the socket includes a material configured to promote internal growth of tissue.

[0019] In another example ("Example 15"), in addition to any of the preceding examples, the socket is formed from one or more layers of a material comprising a film microstructure in which the fibril orientation is aligned with the longitudinal axis of the socket.

[0020] According to another example ("Example 16"), in addition to any of the preceding examples, the socket is formed from a set of materials including ePTFE graft material, elastomer material, other polymer material, or a combination of two or more such materials.

[0021] According to another example ("Example 17"), in addition to any of the preceding examples, the socket includes an ePTFE stretch graft material.

[0022] According to another example ("Example 18"), in addition to any of the preceding examples, the socket comprises a material that is partially or completely bioreabsorbable and / or partially or completely bioreabsorbable.

[0023] According to another example (“Example 19”), in addition to any of the previous examples, the socket is configured to provide a temporary fixation to body tissue that partially or completely degrades over time.

[0024] According to another example (“Example 20”), in addition to any of the previous examples, the socket includes one or more layers configured as a mesh or network of material adapted to improve biocompatibility and fibrosis formation after implantation.

[0025] According to another example (“Example 21”), in addition to Example 20, the mesh or network of material is formed by intersecting strands of material or by intermittent voids or openings in one or more layers of the material.

[0026] According to another example (“Example 22”), in addition to any of the previous examples, the implantable device is configured as a transcatheter mitral valve chordal repair device or a blood pump device.

[0027] According to another example (“Example **************”), a treatment method using an implantable device of any of the previous examples includes delivering the implantable device to a location within a patient's body.

[0028] According to another example (“Example 24”), in addition to Example 23, the method further includes inserting another component, such as the third component of Example 12, into the socket in vivo.

[0029] It should be noted that there seems to be an incomplete number in . I have translated it as best as possible based on the context. If you can provide the complete and correct information, it will be possible to give a more accurate translation.According to another example ("Example 25"), an implantable device includes a first component having a first outer profile defining a first radial variation along the first component, and a socket extending on the first outer profile of the first component and defining a second outer profile having a reduced second radial variation as compared to the first radial variation, wherein the socket includes one or more outer exposed surfaces configured to exhibit one or more stages of a foreign body reaction within a possible foreign body reaction range. Any of the features of Examples 1 to 24 can be applied to Example 25 as appropriate.

[0030] According to another example ("Example 26"), the socket is configured to extend on a first outer profile of a first component of an implantable device and define a second outer profile having a reduced second radial variation as compared to a first radial variation of the first component, and the socket includes one or more outer exposed surfaces configured to exhibit one or more stages of a foreign body reaction within a possible foreign body reaction range.

[0031] According to another example ("Example 27"), a socket is configured to extend over a first component and a second component of an implantable device, and the socket is configured to improve the interaction between the components of the implantable device by reducing the relative movement between the first component and the second component, and the socket includes one or more outer exposed surfaces configured to exhibit one or more stages of a foreign body reaction within a possible foreign body reaction range.

[0032] In another example ("Example 28"), the method includes delivering a multi-component device to a location in the body of a patient, wherein the multi-component device includes a first component having a first outer profile defining a first radial variation along a first component, and a socket extending on the first outer profile of the first component and defining a second outer profile having a second radial variation reduced compared to the first radial variation, and the socket includes one or more outer exposed surfaces configured to exhibit one or more stages of foreign body reaction within a range of possible foreign body reactions, and inserting a third component into the socket to improve the interaction between the components of the implantable device between the first component and the third component.

[0033] In another example ("Example 25"), in addition to the method of Example 24, the third component is a tetherlock component.

[0034] The examples described above are merely embodiments and should not be read to limit or otherwise narrow any scope of the concepts of the invention provided otherwise by this disclosure. While several examples are disclosed, further embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates illustrative examples. Various additional or alternative features and advantages are conceivable and will become apparent with reference to the following disclosure and drawings. Therefore, the drawings and detailed description should be considered illustrative, not restrictive, in nature. [Brief explanation of the drawing]

[0035] The accompanying drawings are included to provide a further understanding of this disclosure, are incorporated herein, constitute part thereof, illustrate embodiments, and, together with the description, illustrate the principles of this disclosure.

[0036] [Figure 1] Figure 1 shows several examples of implantable devices.

[0037] [Figure 2A] Figure 2A shows several examples of implantable devices. [Figure 2B] Figure 2B shows several examples of implantable devices.

[0038] [Figure 3] Figure 3 illustrates several methods, by example, of forming a socket and connecting the socket to a first component of an implantable device. [Figure 4] Figure 4 illustrates several methods, by example, of forming a socket and connecting the socket to a first component of an implantable device. [Figure 5] Figure 5 illustrates several methods, by example, of forming a socket and connecting the socket to a first component of an implantable device. [Figure 6] Figure 6 illustrates several methods, by example, of forming a socket and connecting the socket to a first component of an implantable device.

[0039] [Figure 7] Figure 7 shows the characteristics of sockets for implantable devices, using several examples.

[0040] [Figure 8] Figure 8 shows the characteristics and manufacturing methods of sockets for implantable devices, using several examples. [Figure 9] Figure 9 shows the characteristics and manufacturing methods of sockets for implantable devices, using several examples.

[0041] [Figure 10] Figure 10 shows how a socket is assembled to the first component of an implantable device, using several examples.

[0042] [Figure 11]Figure 11 shows several examples of implantable devices that utilize sockets.

[0043] [Figure 12] Figure 12 shows several examples of implantable devices that utilize sockets.

[0044] Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to a fixed scale and may be exaggerated to illustrate various aspects of this disclosure; in this respect, the drawings should not be construed as limiting. [Modes for carrying out the invention]

[0045] Definitions and Terms This disclosure is not intended to be read in a restrictive manner. For example, terms used in this application should be read broadly in the context of the meanings to which the terms of the art belong.

[0046] The terms “substantially” and “generally” are used in this disclosure to convey an degree of inaccuracy that would be understood and readily apparent to those skilled in the art.

[0047] With regard to the terminology of inaccuracy with respect to measurements, “approximately” and “nearly” are interchangeable and used to refer to measurements that include the stated measurement and / or measurements that are reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount that can be understood and readily verified by a person skilled in the art. Such deviations may result, for example, from measurement errors or small adjustments made to optimize performance. If it is determined that a person skilled in the art cannot readily verify the value of such a reasonably small difference, the terms “approximately” and “nearly” may be understood to mean ±10% of the stated value.

[0048] As used herein, the term “tube” does not necessarily have to be a component having a continuous wall unless otherwise specified, and may include meshes, frameworks, perforated structures, annular or ring structures, and the like.

[0049] As used herein, the term “socket” includes, and may be used interchangeably with, any of the following terms: cover, receptacle, shroud, coupler, constraint, retaining member, etc.

[0050] Description of various embodiments Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to a fixed scale and may be exaggerated to illustrate various aspects of this disclosure; in this respect, the drawings should not be construed as limiting.

[0051] Figure 1 shows an implantable device 10 in several examples. As shown, the implantable device 10 includes a plurality of components 20, such as a first component 22 and a second component 24, and a socket 30 extending over the first component 22 and the second component 24. The socket 30 is generally configured to improve the interaction between the components of the implantable device and with the environment. To facilitate the illustration and visualization of the components below, the socket 30 is shown in perspective, indicated by dashed lines. As shown, the socket 30 is generally in the form of a continuous tube or cylinder of material, but discontinuous tubes, annular tubes, and other tube variations are possible.

[0052] The implantable device 10 is then described with respect to components that may be related to a transcatheter mitral valve chordae tendineae repair device (for example, those disclosed in U.S. Patent Application Publication No. 2018 / 0185151, "Method for Transvascular Implantation of Neo Chordae Tendinae"), but similar principles can be applied to any of the various implantable devices as desired (see, for example, Figure 11 and related descriptions).

[0053] As illustrated, in some examples, the first component 22 is configured as an anchor component having a body 40 and barbs 42. In some examples, the body component is configured to be delivered into a lumen (e.g., via transcatheter technology) and is formed from, for example, a biocompatible metal or polymer material. The barbs 42 can be formed from the same, similar, or different material as the body 40 and are configured to be rotated or screwed into tissue (e.g., cardiac tissue, such as that associated with the ventricular wall of the heart). Next, the second component 24 may be configured as a tether component formed from a relatively flexible elongated material (e.g., monofilament, multifilament, braid, or other material). In some examples, the second component is formed from stretched polytetrafluoroethylene (ePTFE), but any of the various materials can be used as desired. The barbs 42 are shown as helical screw-type anchors, but it should be understood that any of the various anchor or engagement features can substitute for or be added to the barbs 42. For example, needles, arrow-shaped spines, expanded coils or umbrella-shaped anchors, cotton-spun tissue anchors, or any other variety of tissue anchor designs are possible.

[0054] As shown in Figure 1, the second component 24 is coupled to and extends from the first component 22. During use, the second component 24 may naturally bend or deflect after implantation. As shown in Figure 1, the socket 30 extends over a plurality of components 20, including the first component 22 and the second component 24. The socket 30 may extend partially or completely over the plurality of components 20.

[0055] As shown in Figure 1, the socket 30 is configured to minimize bending / deflection of the second component 24 adjacent to the location where the second component 24 extends from the first component 22. In particular, the socket 30 may be configured to hold the second component 24 (tether component) in place by compressing, clamping, guiding, and / or pressing the second component 24 near the body 40 of the first component 22 (anchor component). By minimizing relative movement at the interface between the first component 22 and the second component 24, and possible wear / friction / concentrated bending, the socket 30 helps improve the component-to-component interaction between the first component 22 and the second component 24 of the implantable device 10.

[0056] Additionally or alternatively, as described later, the socket 30 may be adapted to improve the inter-environmental interaction between the first component 22 and the second component 24 and the bodily environment (not shown). For example, the socket 30 may include one or more coatings, layers, surface treatments or other enhancers configured to promote or improve a desired interaction between the implantable device 10 and the bodily environment in which the implantable device 10 is implanted, by promoting internal tissue growth, inhibiting internal tissue growth, reducing thrombus formation, and a combination thereof.

[0057] Figures 2A and 2B show further optional features of the implantable device 10. As shown, the plurality of components 20 include a third component 26 and a fourth component 28. The third component 26 may be configured as an adjustable tether lock component, and the fourth component 28 may be configured as a second tether component. The third component 26 may slide along the second component 24 (first tether component) and the fourth component 28 (second tether component) and be configured to lock or prevent further sliding as desired once positioned. An example of a suitable tether lock component is described in U.S. Patent Application Publication No. 2018 / 0185151 “METHOD FOR TRANSVASCULAR IMPLANTATION OF NEO CHORDAE TENDINAE” above, but various arbitrary configurations are possible. As shown in Figures 2A and 2B, the third component 26 is configured to slide longitudinally within the socket 30 as part of the delivery of the implantable device 10.

[0058] As shown in Figure 2B, the socket 30 is configured to minimize bending / deflection of the second component 24 adjacent to the location where the second component 24 extends from the first component 22, as described above. Furthermore, the socket 30 may also be configured to help minimize bending between the third component (tether lock) and the fourth component (second tether component) by clamping one or more portions of the fourth component 28 against the third component 26. In addition, the socket 30 can help reduce relative movement (e.g., bending and / or longitudinal movement) between the first component 22 (anchor component) and the third component 26 (tether lock component). In particular, the socket 30 may be configured to hold the third component 26 in place relative to the first component 22 (e.g., generally axially aligned and longitudinally proximal and / or engaged), and to reduce the amount of bending or movement between the two. By minimizing relative motion and possible wear / friction / intensive bending between the multiple components 20, the socket 30 also helps to improve the interaction between the components of the implantable device 10. Additionally or alternatively, as described above and subsequently in detail below, the socket 30 may be adapted to improve the inter-environmental interaction between one or more of the multiple components 20 and the patient's body or bodily environment.

[0059] Figures 3-6 illustrate several methods for forming a socket 30 and connecting the socket 30 to the first component 22, as shown in some examples.

[0060] Several methods involve forming a precursor tube 100 which will then be processed into a socket 30. Thus, some manufacturing methods involve first providing the precursor tube 100. The precursor tube 100 is formed using winding techniques (e.g., tape material helically wound onto a mandrel and / or sheet material cigarette-wound onto a mandrel to form the precursor tube 100), extrusion techniques, molding techniques, combinations thereof, or other manufacturing techniques as desired. The precursor tube can be formed as a single-layer or multi-layer structure as desired. The precursor tube 100 can be formed from any of a variety of materials using any of the various methods, including any of those described above. In one example, the precursor tube 100 includes one or more layers of fluoropolymer (e.g., ePTFE) material. The precursor tube 100 can generally be in the form of a hollow straight column, may include tapers or steps, or may have any various additional or alternative features. As shown in Figure 3, the precursor tube 100 is generally elongated and has a defined length and includes an open lumen that can receive the first component 22.

[0061] Several methods for forming a socket 30 and connecting the socket 30 to the first component 22 can be understood by referring to Figure 3. As shown in Figure 3, the precursor tube 100 is received on the body 40 of the first component 22. Next, as shown in Figure 4, the retainer 102 is received on the precursor tube and the body 40, and the retainer 102 is received in a complementary feature (e.g., a recess) formed in the body 40. The retainer 102 can be a ring or wrap of material. In some examples, the retainer 102 can be formed as a continuous or partial ring of fluorinated ethylene propylene (FEP), but a variety of materials and physical configurations are possible.

[0062] As shown in Figure 5, one end of the precursor tube 100 can be folded over itself to invert the precursor tube 100. The inverted precursor tube 100 is then doubled to form an inner portion 104 which can contain one or more layers of material and an outer portion 106 which can contain one or more layers of material. The outer portion covers the inner portion, and the retainer 102 is received between the inner and outer portions.

[0063] Next, as shown in Figure 6, the precursor tube 100 can then be bonded to itself and / or to the retainer 102 (e.g., by compression, adhesion, sintering, bonding, or a combination thereof). In any case, Figure 6 shows the precursor tube 100 and other materials (i.e., the retainer 102) assembled to form the socket 30, which is bonded to the first component 22. In some examples, the inversion process and the formation of the double layer help to achieve a radially adaptable structure and longitudinal rigidity (e.g., relatively high column strength) compared to a single-layer structure, which helps to prevent buckling of the socket 30 in examples where the third component 26 is inserted into the socket 30 (e.g., in vivo). Radial adaptability can also help to retain the third component 26 within the socket 30 (e.g., after the third component 26 has been inserted into the socket 30).

[0064] Figure 7 shows additional or alternative features of the socket 30 in several examples. For reference, the formation of the socket 30 according to Figure 7 does not require the use of the manufacturing methods described above with respect to Figures 3-6, but such methods can certainly be used if desired. In any case, as shown in Figure 7, the socket 30 includes a reinforced and / or outwardly flared end 200, which may facilitate the acceptance of components (e.g., a third component 26) into the socket 30. The end 200 may be reinforced and / or flared with a reinforcing member 202 such as a ring or wrap of material. In some examples, the reinforcing member 202 is a ring of material (e.g., FEP) bonded to the inside and bonded or embedded to the outside of the tubular material of the socket 30. The outwardly flared and / or reinforced end portion 200 helps, for example, guide the third component 26 into the socket 30, keep the end portion 200 open, and ensure that the end portion 200 is robust enough to engage with the third component 26 without any unwanted deflection, buckling, and / or folding.

[0065] Figures 8 and 9 show alternative or additional features of the socket 30, and further, alternative manufacturing methods that can be combined with any of the above features or manufacturing techniques.

[0066] As shown in Figure 8, the socket 30 can be formed using a winding technique with a mandrel 300 below a desired diameter. In some examples, the inner portion 302 is placed on the mandrel 300. The inner portion 302 can be formed by winding (e.g., tape winding), extrusion, molding or by other means. The inner portion 302 may optionally include one or more layers (e.g., one or more passes or layers of material). Reinforcing rings 304 of one or more optional elements (e.g., formed as a continuous helical structure or as individual ring structures) may optionally be applied to the inner portion 302.

[0067] The reinforcing rings 304 can be formed from an elastically deformable (e.g., expandable) material, whether continuous (e.g., a continuous helical pattern) or discontinuous (e.g., a discrete pattern), so that when an external radial force is removed from the reinforcing rings 304, one or more of the reinforcing rings 304 return to their original diameter. One or more of the reinforcing rings 304 can be formed from any suitable material, such as a metallic material (e.g., nitinol or stainless steel) or a polymer material (e.g., elastomer), as desired.

[0068] As shown, the outer portion 306 may then be positioned on top of the inner portion 202 and one or more reinforcing rings 304. The outer portion 306 may be formed by winding (e.g., tape winding), extrusion, molding or otherwise, and may be one or more layers as desired. Figure 9 is an illustration of an example of a finished socket 30 constructed to include one or more reinforcing rings 304 (multiple reinforcing rings along the length of the socket 30, as shown).

[0069] In the above example, the socket 30 is configured to have the ability for one or more portions of the socket 30 to expand to an expanded diameter and then elastically recover from such expansion. Such examples address this feature by incorporating an elastically recoverable stent-like structure, but the socket 30 may incorporate additional or alternative features to achieve such elastic contraction following diametrical expansion. For example, the material of the socket 30 may include elastomer material in one or more layers of the material forming the socket 30 so that the socket 30 exhibits the ability to expand diametrically and then elastically recover. One option involves forming one or more layers of the socket 30 of elastomer material (e.g., FEP). Another option involves incorporating elastomer material into one or more layers of the socket 30 (e.g., by coating or absorbing elastomer material with an expandable substrate material such as ePTFE).

[0070] Regarding the potential advantages of incorporating assembly and elastic recovery properties, Figure 10 shows how the socket 30 can be assembled to the first component 22 by utilizing such elastic recovery properties. As shown, the socket 30 can expand or enlarge as it passes over the first component 22. The portion of the socket 30 on the first component 22 with a larger diameter then actively engages with or is biased against the first component 22. Additionally or alternatively, portions of the socket 30 that can return to a smaller diameter after expansion help to hold or secure the socket 30 to the first component. In particular, one or more portions of the socket 30 neck down or recover to a diameter smaller than adjacent portions of the first component 22, thereby securing the socket 30 in place.

[0071] The material implemented for any of the above-described examples of the socket 30 may be configured to exhibit desired mechanical properties and / or to produce a desired response from the body environment. In some examples, the socket 30 includes one or more layers of material oriented longitudinally for axial or columnar strength. For example, the layers may include a stretched fluoropolymer having a microstructure oriented to provide longitudinal strength. One such material may include a stretched fluoropolymer (e.g., ePTFE) having a fibril structure oriented longitudinally with respect to the socket 30 to improve the longitudinal or columnar strength of the socket 30. The material of the socket may also include one or more layers of material oriented circumferentially to obtain radial or hoop strength. For example, the socket 30 may include one or more layers of material oriented circumferentially to obtain radial or hoop strength. For example, the layers may include a stretched fluoropolymer having a microstructure oriented to provide radial or hoop strength. One such material may include a stretched fluoropolymer (e.g., ePTFE) having a fibril structure oriented circumferentially with respect to the socket 30 to improve the radial or hoop strength of the socket 30. Additionally or alternatively, multiple orientations (e.g., both longitudinal and circumferential) can be combined or included to achieve the desired properties.

[0072] Additionally or alternatively, the microstructure of one or more inner or outer layers may be oriented to enhance wear resistance and abrasion resistance. For example, if wear is likely to be encountered longitudinally with respect to the socket 30, a stretched fluoropolymer such as ePTFE with a fibril microstructure may have fibrils oriented longitudinally, i.e., in the direction of wear or friction. This can be particularly advantageous in the case of a uniaxially oriented fibril microstructure. Furthermore, the overall wear resistance and abrasion resistance of the inner or outer layers of the socket 30 can be improved by using a relatively dense (e.g., low porosity) microstructure. The wear resistance and abrasion resistance of the socket 30 may be enhanced by other additional or alternative features. For example, an wear-resistant coating may be applied to the outer or inner surface of the socket 30. One such coating may be a copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE). Another example of a wear-resistant / abrasion-resistant coating is the use of hydrophilic and / or lubricating materials such as hydrogel coatings. These are just a few examples, and other wear-resistant features can be used in addition to or instead of wear-resistant or abrasion-resistant microstructures.

[0073] From at least the above-described viewpoint, various examples include materials that form a socket 30 to promote internal tissue growth (e.g., to reduce thrombus formation or to assist in fixing a multi-component implantable device 10 to a desired implantation site). Furthermore, in some embodiments, the material forming the socket 30 includes a film microstructure in which the fibril orientation is substantially parallel to the longitudinal axis of the socket 30. Such a configuration can certainly help to align the longitudinal motion of one or more of the multiple components 20 (e.g., anchor components, tether components and / or tetherlock components) with the fibril orientation, thereby helping to reduce friction and / or wear of the components.

[0074] In various examples, the socket 30 may be formed from a set of materials including ePTFE graft material, elastomer material, other polymer material, or a combination of such materials. In some embodiments, the socket 30 is constructed from ePTFE stretch graft material, such as material similar to that available from WL Gore & Associates, Inc. under the "GORE-TEX®" brand "Stretch Vascular Grafts" trade name. The socket 30 may include material that has been modified to improve column strength (e.g., by including one or more layers of relatively high-density or low-porosity material). The socket 30 may also include material that is partially or completely bioreabsorbable or bioabsorbable. In such examples, the socket 30 may be configured to provide temporary fixation (e.g., between components and / or with the body) that partially or completely decomposes over time.

[0075] In some embodiments, the socket 30 includes one or more layers configured as a mesh or network of material adapted to improve biocompatibility and fibrosis after implantation. Such a mesh or network can be formed by intersecting strands of material or by forming intermittent voids or openings in the layers of material. Such a mesh or network configuration may be implemented to promote tissue growth on and / or through the mesh or network surface. In some examples, tissue growth may be promoted by incorporating a relatively rough and / or porous outer and / or inner surface into the socket 30. If desired, one or more holes may be formed in or through the socket material, which can promote the formation of scar tissue fibrous cells (for example, to promote strong fixation to tissue).

[0076] It should be understood that other components of the implantable device 10 may utilize similar features to improve the wear resistance or abrasion resistance of those components. For example, as described above, the second component 24 may be configured as a tether component formed from a relatively flexible elongated material (e.g., monofilament, multifilament, braid, or other material). Where longitudinal wear is likely to occur relative to the socket 30, a stretched fluoropolymer such as ePTFE with a fibril microstructure may have fibrils oriented longitudinally, i.e., in the direction of wear or friction. Again, this can be particularly advantageous in the case of a uniaxially oriented fibril microstructure. Again, the overall wear resistance and abrasion resistance of the second component 24 can be improved by using a relatively dense (e.g., less porous) microstructure (e.g., relatively dense ePTFE or stretched (fluoro)polymer).

[0077] Similar to the socket 30, wear resistance and abrasion resistance can also be enhanced through other additional or alternative features. For example, an wear-resistant coating can be applied to the second component 24. One such coating could be a copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE). Another example of a wear-resistant / abrasion-resistant coating is the use of hydrophilic and / or lubricating materials such as hydrogel coatings. Again, these are just a few examples, and other wear-resistant features can be used in addition to or instead of wear-resistant or abrasion-resistant microstructures. It should also be understood that a similar principle can be applied to other components of the implantable device 10, such as the fourth component 28.

[0078] In some examples, one or more layers of the socket 30 may be formed from a material having a desired permeability. For example, in some examples, the socket includes one or more layers that are impermeable to cell integration or to bodily fluids such as blood or serum, and that improve the overall mechanical properties and / or biological response as desired.

[0079] In some cases, the outermost layer may have internode distances or spacings of 6 micrometers or more.

[0080] In some cases, the outermost layer or exposed surface layer may be configured to achieve one or more steps within the range of biological or foreign body reactions.

[0081] The first stage of the foreign body reaction (for example, with the porosity of the first relative material) would involve impermeability to plasma and serum.

[0082] The second stage of the foreign body reaction (for example, due to the porosity of the second relative material) would involve the infiltration of plasma and / or serum onto the exposed surface.

[0083] A third stage of the foreign body reaction (for example, with the porosity of a third, higher relative material) would involve minimal or some level of extracellular matrix integration.

[0084] A fourth stage of the foreign body reaction (for example, with a fourth, even higher relative porosity of the material) would involve cellular integration.

[0085] The fifth stage of the foreign body reaction (for example, at the fifth highest relative porosity of the material) would involve complete internal growth of the tissue and vascular integration, including blood vessels supplying the tissue. The outermost or exposed surfaces can be adjusted to exhibit these relative stages of the foreign body reaction as desired, for example, by selecting the microstructure of the material, coatings, and / or surface treatments.

[0086] The evaluation of whether a material exhibits a specific stage of foreign body reaction can be performed using various techniques. Measurement techniques for assessing the presence of one or more stages of foreign body reaction may include permeability tests, as described in ASTM standards. In various cases, histological evaluation can be a suitable tool for evaluating foreign body reaction under the various stages described above.

[0087] The foreign body reaction of the outermost layer or surface can be additionally or alternatively modified through the use of coatings and / or surface treatments. For example, the outermost layer can be treated with heparin binding (including, for example, the product marketed under the trade name "CBAS" by WL Gore & Associates, Inc. and Carmeda AB, which is a heparin binding technology for sustained thrombotic resistance). As another example, the socket 30 can be modified to include one or more dissolution technologies, such as drug dissolution technologies. Any of the various biological coatings can be incorporated onto the outer and / or inner surfaces of the socket 30 to achieve desired biological responses, such as promoting healing and / or tissue growth.

[0088] As described above, the socket 30 and any of the features and examples described above can be applied in a variety of device environments. For example, Figure 11 shows another implantable device 410 that utilizes the socket 30, according to some examples. As shown, the implantable device 410 includes a plurality of components 420, such as a first component 422 and a second component 424, and a socket 30 extending over the first component 422 and the second component 424. The socket 30 is, again, generally configured to improve interaction between components of the implantable device and / or between environments. To facilitate the illustration and visualization of the components below, the socket 30 is, again, generally shown in a perspective style indicated by dashed lines.

[0089] The implantable device 410 in the example in Figure 11 is an implantable blood pump, such as a left ventricular assist device (LVAD), configured to be implanted in the body of a patient (not shown). As shown, the first component 422 is optionally the pump device, and the second component 424 is a lead (e.g., an electrical or mechanical connector) extending from the first component 422 (e.g., to power or control the pump device). The first component 422 includes a body 440 and an impeller and motor subassembly 442 housed or maintained by the body 440. The implantable device 410 can be any of the various blood pump designs commonly shown in Figure 11, with any of the various components that would benefit from the use of the socket 30. As shown, the socket 30 can help maintain the physical position of the second component 424 relative to the first component 422 (e.g., to avoid unwanted bending or movement at the interface between the first component 422 and the second component 424). Socket 30 can additionally or alternatively promote any of the environmental interactions mentioned in relation to any of the other examples described herein (e.g., impermeability, reduction of thrombus formation, intratissue growth, prevention of intratissue growth, and combinations thereof or others).

[0090] Various treatment methods using any of the implantable devices in the examples above involve delivering the implantable device to a location on the patient's body (e.g., the patient's heart). In various examples, another component (e.g., a third component 26) is received in vivo into the socket 30 (e.g., by sliding it into the socket 30 as part of tension or other processes associated with transcatheter mitral valve chordae tendineae repair).

[0091] While the various examples above are cast in relation to implantable devices, the various concepts and features above can also be applied in relation to single components, as desired. To avoid doubt, the scope of the present invention is not limited to multi-component implantable devices. Specifically, in some examples, the socket 30 can be implemented in relation to a single component and is configured to accept and / or does not actually need to accept additional individual components. For example, the socket 30 can be used to help smooth or reduce radial profile variations. Transverse elements of components protruding from the peripheral portion of the outer profile can, for example, lead to thrombus formation or damage to surrounding tissue.

[0092] Figure 12 shows an implantable device 510 including a first component 522 having a first outer profile that defines a first radial variation along the first component. The first component 522 also includes a radial projection 524 of an optional element that is integrated with the first component (e.g., an integrated anchor, antenna, or other feature) and projects transversely, defining a portion of the first outer profile and the associated radial variation of the first outer profile. The first component 522 may optionally be an implantable sensor, blood pump, or other device. As shown, the implantable device 510 includes a socket 30 extending over the first outer profile 524 of the first component, defining a second outer profile having a second radial variation that is reduced compared to the first radial variation. In other words, the outer profile 524 of the first component, including the radial projection 524 of the optional element, is smoothed by the socket 30, resulting in a reduced radial variation of the first outer profile. As in other examples, the socket 30 may include one or more outer exposed surfaces configured to exhibit one or more stages of foreign matter reaction within a range of possible foreign matter reactions.

[0093] The concept of the invention of this application has been described above with respect to both general and specific embodiments / examples. It will be apparent to those skilled in the art that various changes and modifications can be made in embodiments without departing from the scope of this disclosure. Accordingly, the embodiments are intended to cover changes and modifications of the invention, insofar as they fall within the scope of the appended claims and their equivalents. The embodiments of the present invention are listed below. [Aspect 1] A first component having a first outer profile that defines a first radial variation along the first component, and A socket extending on the first outer profile of the first component defines a second outer profile having a second radial variation that is reduced compared to the first radial variation. An implantable device comprising, The socket is an implantable device comprising one or more externally exposed surfaces configured to exhibit one or more stages of a foreign body reaction within a range of possible foreign body reactions. [Aspect 2] The first component, A second component flexibly connected to the first component, and Sockets extending over the first and second components An implantable device comprising, An implantable device wherein the socket is configured to improve the inter-component interaction between the first and second components of the implantable device by reducing the relative motion between the first and second components, and the socket includes one or more externally exposed surfaces configured to exhibit one or more stages of a foreign body reaction within a range of possible foreign body reactions. [Aspect 3] The implantable device according to embodiment 1 or 2, wherein one or more of the outer exposed surfaces are configured to exhibit a foreign body reaction including extracellular matrix integration. [Aspect 4] The implantable device according to any one of embodiments 1 to 3, wherein the socket comprises one or more layers of material that is impermeable to cell integration. [Aspect 5] The implantable device according to any one of embodiments 1 to 4, wherein the socket comprises one or more layers of a material having a microstructure oriented to provide longitudinal strength to one or more portions of the socket. [Aspect 6] The implantable device according to any one of embodiments 1 to 5, wherein the socket comprises one or more layers of a material having a microstructure oriented to provide circumferential strength to one or more portions of the socket. [Aspect 7] The implantable device according to any one of embodiments 1 to 6, wherein the socket includes one or more reinforcing rings. [Aspect 8] The implantable device according to embodiment 7, wherein at least one of the one or more reinforcing rings is elastically deformable with respect to the expanded diameter, and the one or more reinforcing rings elastically recover from the expanded diameter. [Aspect 9] The implantable device according to embodiment 7 or 8, wherein the one or more reinforcing rings define a continuous helical undulating pattern. [Aspect 10] The implantable device according to any one of embodiments 1 to 9, wherein the socket includes an outwardly flared end. [Aspect 11] The implantable device according to any one of embodiments 1 to 10, wherein the socket includes a reinforced end. [Aspect 12] An implantable device according to any one of embodiments 2 to 11, wherein the first component is an anchor component and the second component is a tether component. [Aspect 13] An implantable device according to any one of embodiments 2 to 12, further comprising a third component and a fourth component, wherein the socket is configured to receive the third component and the fourth component to improve the intercomponent interaction between the first component and the third component of the implantable device. [Aspect 14] The implantable device according to embodiment 13, wherein the third component is a tether lock component and the fourth component is a tether component. [Aspect 15] An implantable device according to any one of embodiments 1 to 14, wherein at least one of the outer and inner surfaces of the socket includes a material configured to promote internal tissue growth. [Aspect 16] The implantable device according to any one of embodiments 1 to 15, wherein the socket is formed from one or more layers of a material containing a film microstructure in which the fibril orientation is aligned with the longitudinal axis of the socket. [Aspect 17] The implantable device according to any one of embodiments 1 to 16, wherein the socket is formed from a set of materials including ePTFE graft material, elastomer material, other polymer material, or a combination of two or more such materials. [Aspect 18] The socket is an implantable device according to any one of embodiments 1 to 17, comprising ePTFE stretch graft material. [Aspect 19] The implantable device according to any one of embodiments 1 to 18, wherein the socket comprises a material that is partially or completely bioreabsorbable and / or partially or completely bioreabsorbable. [Aspect 20] The implantable device according to any one of embodiments 1 to 19, wherein the socket is configured to provide temporary fixation to body tissue, partially or completely disintegrating over time. [Aspect 21] The implantable device according to any one of embodiments 1 to 20, wherein the socket comprises one or more layers configured as a mesh or network of materials adapted to improve biocompatibility and fibrosis after implantation. [Aspect 22] The implantable device according to embodiment 21, wherein the mesh or network of the material is formed by intersecting strands of the material or by intermittent voids or openings in one or more layers of the material. [Aspect 23] An implantable device according to any one of embodiments 1 to 22, configured as a transcatheter mitral valve chordae tendineae repair device or a blood pump device.

Claims

1. A first component having a first outer profile that defines a first radial variation along the first component, and A socket extending on the first outer profile defines a second outer profile having a second radial variation that is reduced compared to the first radial variation. An implantable device comprising, An implantable device wherein the socket includes an outer portion and an inner portion supported by at least one reinforcing member, the at least one reinforcing member being coupled to the inner portion and positioned between the inner portion and the outer portion, the entire at least one reinforcing member being embedded by the inner portion and the outer portion.

2. The implantable device according to claim 1, wherein the inner portion comprises a plurality of layers.

3. The implantable device according to claim 1, wherein the aforementioned inner portion is wrapped around it.

4. The implantable device according to claim 1, wherein the reinforcing member has a continuous helical pattern.

5. The implantable device according to claim 1, wherein the reinforcing member includes a plurality of discontinuous rings.

6. The implantable device according to claim 1, wherein the reinforcing member is elastically deformable.

7. The implantable device according to claim 1, wherein the outer portion comprises a plurality of layers.

8. The implantable device according to claim 1, wherein the aforementioned outer portion is wrapped around it.

9. A first component having a first outer profile that defines a first radial variation along the first component, and A socket extending on the first outer profile defines a second outer profile having a second radial variation that is reduced compared to the first radial variation. An implantable device comprising, An implantable device wherein the socket includes an inner portion coupled to at least one reinforcing member, the at least one reinforcing member being coupled to the inner portion and positioned between the inner portion and the outer portion, so that the entirety of the at least one reinforcing member is embedded by the inner portion and the outer portion.

10. The implantable device according to claim 9, wherein the inner portion comprises a plurality of layers.

11. The implantable device according to claim 9, wherein the aforementioned inner portion is wrapped around it.

12. The implantable device according to claim 9, wherein the reinforcing member has a continuous helical pattern.

13. The implantable device according to claim 9, wherein the reinforcing member includes a plurality of discontinuous rings.

14. The implantable device according to claim 9, wherein the reinforcing member is elastically deformable.

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