WO2025101177A1

WO2025101177A1 - Implantable devices and methods for treating defective venous valves

Info

Publication number: WO2025101177A1
Application number: PCT/US2023/037032
Authority: WO
Inventors: Andrzej J. Chanduszko; Peter M. CRAPO; Alexander G. Lastovich
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2023-11-08
Filing date: 2023-11-08
Publication date: 2025-05-15
Anticipated expiration: 2026-05-08

Abstract

An implantable device includes a stent that is configured to transition between a free state, a collapsed state smaller than the free state, and an expanded state larger than the free state. The stent includes an adhesive layer configured to bond the stent to the vein wall so that structure strength of the stent can upon contraction from the expanded state toward the free state reduce the diameter of the vein. The device may include a sheath covering the stent. Some adhesives may bond to bodily tissue but avoid bonding to polymeric materials. A protective layer over the adhesive layer may upon placement of the device within the vein become degraded, thereby activating the adhesive. A balloon disposed within the device may expand the device toward the expanded state. The stent may include a resorbable material.

Description

IMPLANTABLE DEVICES AND METHODS

FOR TREATING DEFECTIVE VENOUS VALVES

BACKGROUND

[0001] Varicose veins are swollen, twisted, and often painful veins that typically appear in the legs. They occur when the one-way valves in the veins, which are responsible for ensuring blood flows upwards towards the heart, become weakened or damaged. As a result, blood can pool in the veins, causing them to enlarge and become visible under the skin. Varicose veins are primarily caused by hereditary factors, prolonged standing or sitting, obesity, pregnancy, and aging. Compression stockings can provide relief by improving blood flow. In more severe cases, medical interventions like endovenous laser treatment (EVLT), radiofrequency closure, or invasive procedures like sclerotherapy and ambulatory phlebectomy may be utilized to close off or remove affected veins. Surgery is often required for severe cases.

[0002] Disclosed herein are devices and methods that can help restore operation to defective one-way valves within veins.

SUMMARY

[0003] Briefly summarized, embodiments disclosed herein are directed to devices and methods for treating the inoperable one-way valves within veins. Disclosed herein is an implantable device that, according to some embodiments, includes a stent having a hollow cylindrical shape configured for placement with a bodily conduit of a patient. The stent is configured to transition between a free state defining a first diameter, a collapsed state defining a second diameter that is less than the first diameter, and an expanded state defining a third diameter that is greater than the first diameter. The stent is biased away from the third diameter toward the first diameter. The device further includes an adhesive layer coupled with the stent across an outside circumferential surface thereof. The adhesive layer is configured to (i) allow the outside circumferential surface to slide with respect to at least a catheter wall and (ii) prevent at least an inside surface of the bodily conduit from separating away from the outside circumferential surface. In some embodiments, the bodily conduit is a blood vessel or further a vein. In some embodiments, a length of the device is less than four times the first diameter.

[0004] In some embodiments, the third diameter is sized to define a circumferential contact between the outside circumferential surface and an inside surface of an expanded portion of the vein, where the expanded portion includes a valve, and where the larger diameter of the expanded portion causes the valve to be at least partially inoperable according to a first degree of operability. In some embodiments, the first diameter is sized such that when the inside surface is in circumferential contact with the outside circumferential surface, the valve is at least partially operable according to a second degree of operability that is greater than the first degree of operability.

[0005] In some embodiments, the implantable device further includes a sheath covering the outside circumferential surface of the stent, thereby forming a stent graft. In such embodiments, the adhesive layer is disposed on an outside circumferential surface of the sheath. The sheath may include one or more of a collagen film or a polymeric film.

[0006] In some embodiments, the adhesive layer includes an adhesive configured (i) to bind to protein based materials and (ii) to not bind to polymeric materials. The adhesive may include at least one of a microbial transglutaminases (mTG), lysine, or fibrin based adhesive. The adhesive layer may be configured to transition from a deactivated state to an activated state such that (i) the outside circumferential surface is allowed to slide with respect to the at least a catheter wall in the deactivated state, and (ii) the at least an inside surface is prevented from separating away from the outside circumferential surface in the activated state.

[0007] In some embodiments, transitioning from the deactivated state to the activated state includes (i) removal of a protective layer disposed across an outside surface of the adhesive layer or (ii) exposure of the adhesive layer to a specific wavelength of light. The protective layer may be configured to degrade due to exposure to cellulase or due to hydrolysis.

[0008] In some embodiments, the protective layer includes one or more of cellulose, methylcellulose, carboxymethylcellulose (CMC), or hydroxypropyl methylcellulose (HPMC), and/or one or more of polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyethylene oxide (PEO), gelatin, pectin, pullulan, maltodextrin, or alginate.

[0009] In some embodiments, a material the stent includes one or more of NITINOL®, stainless steel, cobalt chromium, polylactide, or a metal alloy including at least one of magnesium, iron, or zinc, and in some embodiments, the material of the stent includes a resorbable material including one or more of polyglycolide, or polyhydroxybutyrate (PHB). [0010] Also disclosed herein is a medical device assembly that, according to some embodiments, includes (i) a catheter defining a lumen and a distal end; (ii) the implantable device according to any of the embodiments described above, where the implantable device is disposed within the lumen of the catheter adjacent the distal end; and (ii) a balloon catheter disposed with the lumen proximal the implantable device, where the balloon is configured for placement within an interior of the implantable device when the implantable device is transitioned to the collapsed state, and where the balloon is further configured to expand the implantable device from at least the free state to the expanded state via inflation of the balloon.

[0011] Also disclosed herein is a method that, according to some embodiments, includes (i) contracting an implantable device including a stent from a free state to a collapsed state, where the free state defines a first diameter of the device, and where the collapsed state defines a second diameter that is less than the first diameter; (ii) placing the device within a bodily conduit with the device in the collapsed state, where the conduit defines a first conduit diameter; (iii) expanding the device from the collapsed state to an expanded state such that an outside circumferential surface of the device is in circumferential contact with an inside surface of the conduit, where the expanded state of the device defines a third diameter that is greater than the first diameter; (iv) bonding the outside circumferential surface to the inside surface of the conduit via an adhesive layer disposed across the outside circumferential surface; and (v) contracting the device from the expanded state toward the free state to define a second conduit diameter that is less than the first conduit diameter.

[0012] In some embodiments of the method, the conduit is a vein, and in some embodiments, placing the device within the bodily conduit includes positioning the device adjacent a valve of the vein.

[0013] In some embodiments of the method, the device includes a sheath that covers the outside circumferential surface of the stent.

[0014] In some embodiments, the method further includes inserting the device into a lumen of a catheter and removing the device from the lumen of the catheter.

[0015] In some embodiments of the method, the adhesive layer is configured to (i) allow the outside circumferential surface to slide with respect to at least a catheter wall and (ii) prevent at least the inside surface from separating away from the outside circumferential surface. [0016] In some embodiments of the method, bonding the outside circumferential surface to the inside surface includes transitioning an adhesive of the adhesive layer from a deactivated state to an activated state. In some embodiments of the method, the adhesive layer includes a protective layer disposed across an outside surface thereof, and transitioning the adhesive from the deactivated state to the activated state includes removing the protective layer.

[0017] In some embodiments, the method further includes receiving a balloon within an interior of the device. In some embodiments, expanding the device from the collapsed state to the expanded state includes inflating the balloon and contracting the device from the expanded state toward the free state includes deflating the balloon.

[0018] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which disclose particular embodiments of such concepts in greater detail.

DRAWINGS

[0019] FIG. 1 A illustrates a portion of a vein of a patient in a healthy state where the vein includes an operable one-way valve.

[0020] FIG. IB illustrates the portion of the vein of FIG. 1 A in an unhealthy state, where the vein is expanded such that the valve is inoperable.

[0021] FIG. 1C illustrates the portion of the vein of FIGS. 1 A, IB further including an implantable device positioned within the vein adjacent the valve, according to some embodiments disclosed herein.

[0022] FIG. 2 is a detailed illustration of the implantable device of FIG. 1C , according to some embodiments disclosed herein.

[0023] FIGS. 3A-3D illustrate the implantable device of FIG. 2 disposed within the vein according to sequential states of deployment of the implantable device, according to some embodiments disclosed herein.

[0024] FIG. 4 illustrates a vein having two of the implantable devices of FIG. 2 implanted therein, according to some embodiments disclosed herein. [0025] FIG. 5 is a block diagram of a method of treating an inoperable valve within a vein using the implantable device of FIG. 2, according to some embodiments disclosed herein.

DETAILED DESCRIPTION

[0026] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0027] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0028] The terms “proximal” and “distal” refer to opposite ends or portions of a medical device, including the devices or components disclosed herein. As used herein, the proximal portion of a medical device is the portion nearest a clinician during use, while the distal portion is the portion at the opposite end. For example, the proximal portion of a catheter is defined as the portion closest to the clinician or extending away from the patient, and the distal portion is the portion opposite the proximal portion, e.g., the portion disposed within the vasculature of the patient. In a similar fashion, a proximal end of a stent disposed within a vein as described herein, is the end directed away from the heart, i.e., upstream with respect to the direction of the blood flow within the vein, and the distal end is the end directed toward the heart, i.e., downstream. [0029] References to approximations may be made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” or “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. Unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. They are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0030] The phrases “connected to” or “coupled with,” refer to any form of interaction between two or more entities, including but not limited to mechanical and fluid interaction. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.

[0031] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and/or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0032] This disclosure is directed to an implantable device for use in restoring operation to non-operating one-way valves within a vein. Causes for defective (non-operating) one-way valves include radial expansion of the vein (increase in diameter) sufficiently to prevent the one-way valve from operating, i.e., preventing backflow of blood. As such, a treatment may include restoring the diameter of the vein, i.e., reducing the diameter of an expanded portion of the vein, adjacent the valve so that the valve can prevent backflow. Embodiments disclosed herein include devices configured for placement within the vein adjacent the defective valve, i.e., directly upstream and/or directly downstream of the valve. Such devices are configured to attach to the inside surface of the vein wall and draw the vein wall radially inward to effectively reduce the diameter of the vein to a diameter consistent with reliable operation of the valve, such as a diameter that is similar a diameter of the vein at other locations, i.e., an original diameter of the vein before expansion. Although, embodiments described herein are related to implantation within a vein, such embodiments are not restricted for implantation only within a vein, such embodiments may be configured for implantation within other bodily conduits, such as an artery, a urethra, an esophagus, or a trachea, for example.

[0033] FIG. 1A is a cross-sectional illustration of a portion of a vein 10 in a normal healthy state including an operating one-way valve 14 A. In FIG. 1 A, the operating valve 14 A is shown in an open state allowing blood 12 to flow in the distal direction 13A (i.e., toward the heart). As shown, the vein 10 includes a normal diameter 11A such that flaps 16 of the operating valve 14A have sufficient length to extended across the diameter 11 A of the vein 10 and engage each other to effectively close the operating valve 14A and prevent backflow (flow of blood in the proximal direction) of blood 12.

[0034] FIG. IB illustrates the cross-sectional portion of the vein 10 in an unhealthy expanded state including a defective valve 14B having a first degree of operability. As shown, the vein 10 includes an expanded diameter 1 IB that is sufficiently expanded such that the flaps 16 of the defective valve 14B have insufficient length to extended across the expanded diameter 1 IB and to operably engage each other. As such, the defective valve 14B allows an unhealthy amount of blood 12 to flow in the proximal direction 13B, i.e., is incapable of preventing flow of blood 12 in the proximal direction 13B, i.e., away from the heart, according to a sufficiently healthy valve.

[0035] FIG. 1C illustrates the cross-sectional portion of the vein 10 in a restored state including a restored valve 14C having a second degree of operability that is greater than (i.e., an improvement over) that first degree of operability. In some instances, the second degree of operability may be effectively similar to the operability of the operating valve 14A of FIG. 1A. An implantable device (ID) 100 (described in detail below) has been implanted into the vein 10 to effectively restore the vein 10 toward a normal healthy state of operability as illustrated in FIG. 1A and described therewith. As shown, the vein 10 includes a restored diameter 11C that is sufficiently similar to the normal diameter 11A such that the flaps 16 of the restored valve 14C have insufficient length to extended across the restored diameter 11C and operatively engage each other. As such, the restored valve 14C allows the blood 12 to flow in a distal direction 13A and also sufficiently prevents flow of the blood 12 in the proximal direction 13B (see FIG. IB). The ID 100 is coupled with the inside surface 18 of the vein wall 17 such that the vein wall 17 is prevented from separating from the ID 100. In other words, the ID 100 contains the vein 10 in the non-expanded state.

[0036] FIG. 2 is a side cross-sectional illustration of the ID 100 including various components thereof. The ID 100 is configured for placement within a vein of a patient a shown in FIG. 1C. Although, the ID 100 is not restricted to placement within a vein. Indeed, the ID may be configured for placement within any bodily conduit of the patient as discussed above. The ID 100 is configured for insertion into the vein utilizing typical vascular device insertion techniques, such as via a catheter, for example. The ID 100 is formed of biocompatible materials, such that the ID 100 may be disposed within the patient for an extended period of time, including a number of years or permanently.

[0037] The ID 100 preferably includes a hollow cylindrical shape so as to be consistent with a cylindrical shape of the vein. Although the ID 100 may include other shapes, such as oval or polygonal for example. The ID 100 defines a length 205 and a diameter 206. The diameter 206 is the diameter of the ID 100 in a free state, i.e., absent any external forces acting thereon. In the illustrated embodiment, the diameter 206 may be sized to be consistent with a normal healthy diameter of the vein within which the ID 100 is to be placed. Although in other embodiments, the diameter 206 may be larger or smaller than the normal healthy diameter of the vein.

[0038] In some embodiments, the length 205 may be related to the diameter 206. One intended functionality of the ID 100 is to reduce a diameter of the vein adjacent a valve as described above in relation to FIG. 1C. As such, the length 205 may not need to be longer than one, two, three or four times the diameter 206 in order to reduce a diameter of the vein adjacent the valve. Indeed a length that is longer than needed to reduce a diameter of the vein adjacent the valve may be disadvantageous to the patient, such as restricting flexibility of the vein, for example. Further, a length that is longer than needed may be more costly than necessary and/or more difficult than necessary to insert into the vein. As such, in the illustrated embodiment, the length 205 may be less than four times, three times, or twice the diameter 206. [0039] The ID 100 includes a number of components that define various functionalities of the ID 100, such as a stent 210, a sheath 220, an adhesive layer 250, and a protective layer 260. In some embodiments, the sheath 220 and/or the protective layer 260 may be optional as further described below.

[0040] The stent 210 is configured to define the structural functionality of the ID 100 which primarily includes drawing the vein wall radially inward to reduce an expanded diameter of the vein and establish a desired diameter of the vein. The structural functionalities of the stent 210 may also include supporting and reinforcing the vessel wall, so as to prevent or inhibit the vein from collapsing or narrowing due to atherosclerosis, plaque buildup, or other factors. The stent 210 includes structural elements that are designed to establish the structural functionalities of the ID 100, which primarily include drawing or pulling the vein wall radially inward to reduce the diameter of the vein. The stent 210 includes a series of interlacing struts or wires that create a lattice-like structure resembling a tube-like framework. The series of interlacing struts or wires define the structure functionality of the sent 210 including strength and flexibility of the stent 210 and the ID 100 as a whole. These struts are specifically designed to enable the stent to expand and contact during deployment of the ID 100. In some embodiments, the stent may define one or more radiopaque markers (not shown) to aid in precise placement under fluoroscopy, i.e., to ensure accurate placement of the ID 100 within the vein specifically relative to the defective valve 14B (see FIGS IB, 1C).

[0041] The stent 210 is constructed of biocompatible materials. The material of the stent may include a permanent (i.e., non-resorbable) material, such NITINOL®, stainless steel, cobalt chromium, polylactide, or a metal alloy including at least one of magnesium, iron, or zinc. Alternatively or in addition to the permanent material, the material of the stent 210 may include a resorbable material such as polyglycolide, polyhydroxybutyrate (PHB), or a combination thereof, for example. The stent 210 may be formed of a combination of permanent and resorbable materials. For example, a first portion of the stent 210 may be formed of a permanent material and a second portion of the stent may be formed of a resorbable material.

[0042] The sheath 220 is coupled with an outside circumferential surface of the stent 210. In some embodiments, the sheath 220 coupled with the stent 210 may be define a stent graft. The sheath 220 covers the stent 210 and may in some embodiments, include a fabric tube. In some embodiments, The sheath 220 may include polymeric materials, such as polyester or expanded polytetrafluoroethylene (ePTFE), for example. In further embodiments, the sheath 220 may include a collagen film, such as an amnion (amniotic membrane), a medical grade collagen casing, or a thin polymeric film including a poly-L-lactic acid (PLLA), a poly (lactic- co-gly colic acid) (PLGA), and/or the like. The sheath 220 may enable the ID 100 to slide with respect to a catheter wall during deployment of the ID 100. In some embodiments, the sheath 220 may be omitted from the ID 100.

[0043] The adhesive layer 250 is coupled with an outside circumferential surface of the sheath 220. However, it is noted that in embodiments where the sheath 220 is omitted, the adhesive layer 250 may be coupled directly with the outside circumferential surface of the stent 210. The adhesive layer 250 is configured to bond the stent 210 to the vein wall 17 or, more specifically, the inside surface 18 of the vein wall 17 so that the structure of the stent 210 may affect the shape or size of the vein 10 or the vein wall 17.

[0044] In some embodiments, the adhesive layer 250 may be configured to form a bond with specific materials and avoid forming a bond with other specific materials. In the context of this disclosure, the term “bond” may be defined such that when two components are bonded together at least physical separation of the two components is prevented. Further, when two components are not bonded together at least sliding displacement of one component with respect to the other component is allowed. According to one embodiment, the adhesive layer 250 may be applied to the outside circumferential surface during the manufacturing process of the ID 100. Applying the adhesive layer 250 during the manufacturing process may be advantageous at least because the adhesive layer 250 may be applied before sterilization. According to another embodiment, the adhesive layer 250 may be applied to the outside circumferential surface by a medical clinician prior to implantation. Applying the adhesive layer 250 by the medical clinician prior to implantation may be advantageous when the adhesive layer 250 has a short shelf life or is not compatible with the sterilization process.

[0045] According to one embodiment, the adhesive layer 250 may be configured to form a bond with a bodily tissue and avoid forming the bond with other materials, such as a plastic or polymeric material as may be used in forming a catheter, for example. By way of one exemplary implementation, the adhesive layer 250 may be configured to (1) not form a bond materials in contact with the ID 100 during insertion/deployment of the ID 100 and (2) form a bond with the vein wall 17 upon contact (or soon thereafter) of the ID 100 with the vein wall 17 after placement of the ID 100 within the vein 10. In such embodiments, an adhesive of the adhesive layer 250 may include a microbial transglutaminases (mTGs) based, a lysine-based adhesive, or a fibrin-based adhesive which are configured to selectively bind to proteins but do not have any specific affinity to polymer surfaces.

[0046] Exemplary adhesives that may be included, either alone or in combination, in the adhesive layer 250 include: (1) a microbial transglutaminases (mTGs) based adhesive in a liquid, gel, or powder form, with gelatin substrate to improve adhesion and increase dilution resistance as necessary, and which may include any synthetic polymer for use as a thickening agent); (2) cyanoacrylate; (3) lysine-based adhesives such as TissuGlu® which is lysine- urethane-based or BIOGLUE® which is lysine-aldehyde-based; (4) naturally-derived adhesives such as TISSEEL® which is fibrin-based; (5) N-hydroxy-succinimide-(NHS-)activated synthetic polymers such as PROGEL® which is PEG-NHS-based; or (6) photo-activated chemical bonding agents, such as Rose Bengal or IRGACURE® 2959. Any other commercially available tissue adhesives may also be used alone or in combination.

[0047] According to another embodiment, the adhesive layer 250 may be configured to transition from a deactivated state, where the adhesive layer 250 is prevented from forming a bond with at least some materials, to an activated state, where the adhesive layer 250 is configured to form a bond with at least some materials. By way of one example, the ID 100 includes a sacrificial protective layer 260 extending across an outside circumferential surface of the adhesive layer 250, where the presence of the protective layer 260 defines the deactivated state of the adhesive layer 250, and removal or degradation of the protective layer 260 defines the activated state. According to one embodiment, the protective layer 260 may be applied to the adhesive layer 250 during the manufacturing process of the ID 100. Applying the protective layer 260 during the manufacturing process may be advantageous at least because a shelf life of the adhesive layer 250 may be extended by the presence of the protective layer 260. According to another embodiment, the protective layer 260 may be applied to the outside circumferential surface may be applied the adhesive layer 250 by the medical clinician prior to implantation at the same time of applying the adhesive layer 250.

[0048] The protective layer 260 may become removed, degraded, or otherwise rendered inoperable as part of the deployment process. According to one embodiment, the protective layer 260 may include a material that becomes degraded via hydrolysis. For example, the protective layer 260 may include one or more of polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyethylene oxide (PEO), gelatin, pectin, pullulan, or maltodextrin which degrade via surface erosion caused by convection at the surface of the protective layer 260. The protective layer 260 may include also include alginate which degrades via bulk dissolution other than surface erosion. According to another embodiment, the protective layer 260 may include a material that becomes degraded by exposure to cellulase. For example, the protective layer 260 may include one or more of cellulose, methylcellulose, carboxymethylcellulose (CMC), or hydroxypropyl methylcellulose (HPMC).

[0049] According to alternative embodiment, the adhesive layer 250 may include an adhesive that is activated by exposure to light having a specific wavelength, such as a wavelength within the UV spectrum, for example. In such an embodiment, a light source, such as a fiber optic light source, for example, may be advanced along the vein to the ID 100, such that the light source may expose the adhesive layer 250 to the light having the specific wavelength. In some embodiments, the light may be projected radially outward through the stent 210 and/or the sheath 220 to the adhesive layer 250.

[0050] FIGS. 3A-3D illustrate the ID 100 in sequential exemplary steps of a deployment process of the ID 100 within the vein 10, according to some embodiments. FIG.

3 A, according to a first step of the deployment process, shows the vein 10 in the unhealthy expanded state of FIG. IB. An ID assembly 300 is shown disposed within the vein 10 at a location proximal the defective valve 14B. The assembly 300 includes the ID 100, an insertion catheter 310, and a deployment catheter 320, according to some embodiments. The deployment catheter 320 (sometimes referred to as a balloon catheter) includes a balloon 330 at the distal end of the deployment catheter 320. The ID 100 and the deployment catheter 320 are slidably disposed within a lumen of the insertion catheter 310. The ID 100 is transitioned to a collapsed state so that the ID 100 fits within the lumen of the insertion catheter 310 adjacent a distal end 311. In some embodiments, the ID 100 may be constrained in the collapsed state by the insertion catheter 310.

[0051] The deployment catheter 320 is configured to exert a distally oriented force on the ID 100. Accordingly, a distal end 321 of the deployment catheter 320 includes a diameter that is the same or similar to a diameter of the ID 100 in the collapsed state so that the distal end 321 of the deployment catheter 320 can engage a proximal end 301 of the ID 100. The balloon 330 is disposed in a deflated state, and in the deflated state, the balloon 330 is sized to fit within an interior of the ID 100 in the collapsed state. A lumen of the deployment catheter 320 defines fluid communication between the balloon 330 and a fluid delivery device (e.g., a syringe) coupled with the deployment catheter 320 at a proximal end (not shown) of the deployment catheter 320 disposed outside the body of the patient. The ID assembly 300 is inserted within the vein 10 such that the distal end 311 is positioned within the vein 10 at a desired deployment location for the ID 100 with respect to the defective valve 14C.

[0052] FIG. 3B illustrates the ID assembly 300 within the vein 10 according to a second step of the deployment process. In FIG. 3B, the insertion catheter 310 has been proximally displaced with respect to the deployment catheter 310 and the vein 10 in relation to the position illustrated in FIG. 3 A. A such, the deployment catheter 320 has pushed the ID 100 out of the lumen of the insertion catheter 310. Upon exiting the lumen of the insertion catheter 310, the ID 100 expands toward the free state. The balloon 330 remains in the deflated state.

[0053] FIG. 3C illustrates the ID assembly 300 within the vein 10 according to a third step of the deployment process. In FIG. 3C, the balloon 330 has been inflated causing the ID 100 to expand radially toward an expanded state. In the expanded state, the outside circumferential surface of the ID 100 is in contact with (i.e., defines a circumferential contact with) the inside surface 18 of the vein wall 17. As such, the adhesive layer 250 is disposed in contact with the inside surface 18 across the outside circumferential surface of the ID 100. With the adhesive layer 250 in contact with the inside surface 18, the adhesive layer 250 can be activated according to any of the activation methods described above. With the adhesive layer 250 activated, the outside circumferential surface of the ID 100 is bonded to the inside surface 18 of the vein wall 17 such that separation of the inside surface 18 of the vein wall 17 from the outside circumferential surface of the ID 100 ID 100 is prevented. In lieu of or in addition to expanding the ID 100 beyond the free state to cause the outside circumferential surface of the ID 100 to contact the inside surface 18 of the vein wall 17 for bonding as described above in relation to FIG. 3C, a vasoconstrictor may be administered to the patient to cause the expanded portion of the vein 10 contract toward the ID 100 in the free state shown in FIG. 3B.

[0054] FIG. 3D illustrates the ID assembly 300 within the vein 10 according to a fourth step of the deployment process. In FIG. 3D, the balloon 330 has been deflated allowing the ID 100 to contract toward the free state. As the outside circumferential surface of the ID 100 is bonded to the inside surface 18 of the vein wall 17, the vein wall 17 in drawn radially inward as a result of the contraction of the ID 100 toward the free state. As stated, the size (diameter) of the ID 100 can be chosen to correspond to a diameter of the vein 10 in a healthy state. As such, the contraction of the ID 100 toward the free state results in restoring the diameter of the vein 10 to the healthy state, such that the defective valve 14B of FIGS. IB, 3A-3C is transitioned to the restored valve 14C of FIG. 1C, thereby becoming operational.

[0055] After the balloon 330 is deflated, the insertion catheter 310 and the deployment catheter 320 may be extracted from the vein 10. Although not required, the deployment catheter 320 including the balloon 330 may be retracted into the lumen of the insertion catheter 310 prior to extracting the insertion catheter 310 from the vein 10, as illustrated in FIG. 3D.

[0056] Although the deployment process, as shown and described above, places the ID 100 at a proximal side of the defective valve 14B, the deployment process can also be modified to place the ID 100 at a distal side of the valve. For example, the assembly 300 can be inserted into the vein 10 proximal the valve and advanced through the defective valve 14B to the distal side of the defective valve 14B. Alternatively, the assembly 300 can be inserted into the vein 10 at a location distal the valve defective valve 14B and advanced proximally along the vein 10 to the distal side of the defective valve 14B. Furthermore, the deployment process can be performed a second time to place a second ID 100 on the opposite side of the defective valve 14B, thereby more effectively restoring the diameter of the vein 10 to the healthy state, as shown in FIG. 4.

[0057] FIG. 5 illustrates block diagram of a method 500 of treating a defective valve of a vein where the valve is defective due to an expansion of the vein. The method 500, according to some embodiments, may include all or any subset of the following steps, actions, or operations. The method 500 may include contracting the implantable device from the free state to the collapsed state (block 510). Contracting the implantable device includes reducing the diameter of the implantable device from a first diameter of the free state to a second diameter of the collapsed state.

[0058] In some embodiments, the method 500 further includes inserting the implantable device into a lumen of a catheter (block 520) and later removing the implantable device from the lumen of the catheter, where upon the implantable device expands toward the free state (block 550).

[0059] In some embodiments, the method 500 further includes receiving a balloon within an interior of the implantable device (block 530). In some embodiments of the method 500, expanding the implantable device from the collapsed state to the expanded state includes inflating the balloon and contracting the implantable device from the expanded state toward the free state includes deflating the balloon.

[0060] The method 500 may further include placing the implantable device within a bodily conduit with the implantable device in the collapsed state, where the conduit defines a first conduit diameter (block 540). In some embodiments of the method 500, the conduit is a vein, and in some embodiments of the method 500, placing the implantable device within a bodily conduit includes positioning the implantable device adjacent a valve of the vein.

[0061] The method 500 may further include expanding the implantable device from the collapsed state to an expanded state such that an outside circumferential surface of the implantable device is in circumferential contact with an inside surface of the conduit (block 560), where the expanded state of the implantable device defines a third diameter that is greater than the first diameter.

[0062] The method 500 may further include bonding the outside circumferential surface to the inside surface of the conduit via an adhesive layer disposed across the outside circumferential surface (block 570), and the method 500 may further contracting the implantable device from the expanded state toward the free state to define a second conduit diameter that is less than the first conduit diameter (block 580).

[0063] In some embodiments of the method 500, the implantable device includes a sheath that covers the outside circumferential surface of the stent. In some embodiments of the method 500, the adhesive layer is configured to (i) allow the outside circumferential surface to slide with respect to at least a catheter wall and (ii) prevent at least the inside surface from separating away from the outside circumferential surface. In some embodiments of the method 500, bonding the outside circumferential surface to the inside surface includes transitioning an adhesive of the adhesive layer from a deactivated state to an activated state. In some embodiments of the method 500, the adhesive layer includes a protective layer disposed across an outside surface thereof, and transitioning the adhesive from the deactivated state to the activated state includes removing protective layer.

[0064] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and/or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and/or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. An implantable device, comprising: a stent having a hollow cylindrical shape configured for placement with a bodily conduit of a patient, the stent configured to transition between: a free state defining a first diameter, a collapsed state defining a second diameter less than the first diameter, and an expanded state defining a third diameter greater than the first diameter, wherein the stent is biased away from the third diameter toward the first diameter; and an adhesive layer coupled with the stent across an outside circumferential surface thereof, the adhesive layer configured to: allow the outside circumferential surface to slide with respect to at least a catheter wall, and prevent at least an inside surface of the bodily conduit from separating away from the outside circumferential surface.

2. The device according to claim 1, wherein the bodily conduit is a blood vessel.

3. The device according to claim 2, wherein the blood vessel is a vein.

4. The device according to claim 3, wherein the third diameter is sized to define a circumferential contact between the outside circumferential surface and an inside surface of an expanded portion of the vein that includes a valve of the vein, the expanded portion causing the valve to be at least partially inoperable according to a first degree of operability.

5. The device according to claim 4, wherein the first diameter is sized such that when the inside surface is in circumferential contact with the outside circumferential surface, the valve is at least partially operable according to a second degree of operability that is improved over the first degree of operability.

6. The device according to any one of the preceding claims, further comprising a sheath covering the outside circumferential surface of the stent, wherein the adhesive layer is disposed on an outside circumferential surface of the sheath.

7. The device according to claim 6, wherein the sheath includes one or more of a collagen film or a polymeric film.

8. The device according to any one of the preceding claims, wherein the adhesive layer includes an adhesive configured to bind to protein based materials and not bind to polymeric materials.

9. The device according to claim 8, wherein the adhesive includes at least one of a microbial transglutaminases (mTGs), lysine, or fibrin based adhesive.

10. The device according to any one of the preceding claims, wherein the adhesive layer is configured to transition from a deactivated state to an activated state such that: the outside circumferential surface is allowed to slide with respect to the at least a catheter wall in the deactivated state, and the at least an inside surface is prevented from separating away from the outside circumferential surface in the activated state.

11. The device according to claim 10, wherein transitioning from the deactivated state to the activated state includes: removal of a protective layer disposed across an outside surface of the adhesive layer or exposure of the adhesive layer to a specific wavelength of light.

12. The device according to claim 11, wherein the protective layer is configured to degrade due to exposure to cellulase or due to hydrolysis.

13. The device according to claim 12, wherein the protective layer includes one or more of cellulose, methylcellulose, carboxymethyl cellulose (CMC), or hydroxypropyl methylcellulose (HPMC).

14. The device according to claim 12, wherein the protective layer includes one or more of polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyethylene oxide (PEO), gelatin, pectin, pullulan, maltodextrin, cyclodextrin, or alginate.

15. The device according to any one of the preceding claims, wherein a length of the device is less than four times the first diameter.

16. The device according to any one of the preceding claims, wherein a material the stent includes one or more of NITINOL®, stainless steel, cobalt chromium, polylactide, or a metal alloy including at least one of magnesium, iron, or zinc.

17. The device according to any one of the preceding claims, wherein the material of the stent includes a resorbable material.

18. The device according to claim 17, wherein the resorbable material includes polyglycolide, polyhydroxybutyrate (PHB), or a combination thereof.

19. A medical device assembly, comprising: a catheter defining a lumen and a distal end; the implantable device according to any of the preceding claims disposed within the lumen of the catheter adjacent the distal end; and a balloon catheter disposed with the lumen proximal the implantable device, wherein a balloon of the balloon catheter is configured: for placement within an interior of the implantable device when the implantable device is transitioned to the collapsed state, and to expand the implantable device from at least the free state to the expanded state.

20. A method, comprising: contracting an implantable device including a stent from a free state to a collapsed state, the free state defining a first diameter of the device and the collapsed state defining a second diameter less than the first diameter; placing the device within a bodily conduit with the device in the collapsed state, the conduit defining a first conduit diameter; expanding the device from the collapsed state to an expanded state such that an outside circumferential surface of the device is in circumferential contact with an inside surface of the conduit, the expanded state of the device defining a third diameter greater than the first diameter; bonding the outside circumferential surface to the inside surface of the conduit via an adhesive layer disposed across the outside circumferential surface; and contracting the device from the expanded state toward the free state to define a second conduit diameter less than the first conduit diameter.

21. The method according to claim 20, wherein the bodily conduit is a vein.

22. The method according to claim 21, wherein placing the device within the bodily conduit includes positioning the device adjacent a valve of the vein.

23. The method according to any one of claims 20-22, wherein the device includes a sheath covering an outside circumferential surface of the stent.

24. The method according to any one of claims 20-23, further comprising: inserting the device into a lumen of a catheter; and removing the device from the lumen of the catheter.

25. The method according to any one of claims 20-22, wherein the adhesive layer is configured to: allow the outside circumferential surface to slide with respect to at least a catheter wall, and prevent at least the inside surface from separating away from the outside circumferential surface.

26. The method according to any one of claims 20-25, wherein bonding the outside circumferential surface to the inside surface includes transitioning an adhesive of the adhesive layer from a deactivated state to an activated state.

27. The method according to claim 26, wherein: the adhesive layer includes a protective layer disposed across an outside surface thereof, and transitioning the adhesive from the deactivated state to the activated state includes removing the protective layer.

28. The method according to any one of claims 20-27, further comprising receiving a balloon within an interior of the device.

9. The method according to claim 28, wherein: expanding the device from the collapsed state to the expanded state includes inflating the balloon, and contracting the device from the expanded state toward the free state includes deflating the balloon.