Multi-inflation intravascular medical device

Abstract

A medical device (10) includes a catheter (15), an expandable member (20), a covering (27), a covering lumen (32), and an actuator. The catheter includes a longitudinal axis (17), a proximal end (18), and a distal end (19); the covering lumen extends from the proximal end to the distal end. The expandable member includes a proximal end (24) and a distal end (25) and is disposed on a distal section (16) of the catheter. The covering includes a first region (50) disposable along the expandable member and a second region (52) disposable along a length of the catheter extending beyond the proximal end of the expandable member toward the proximal end of the catheter. A first end of the covering is turned in to the covering lumen. The actuator is coupled to the first end of the covering and is configured to move the first end of the covering along the longitudinal axis of the catheter toward the proximal end of the catheter.

Description

[0001] This application is a divisional application of application number 201880061215.0, filed March 20, 2020, entitled “Multiple Inflation Endovascular Medical Device,” which claims priority to U.S. Application No. 15 / 711,265, filed September 21, 2017, the entire disclosure of which is incorporated herein by reference.

[0002] CLAIM OF PRIORITY

[0003] This patent application claims priority to U.S. Application No. 15 / 711,265, filed September 21, 2017, the entire disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0004] The present disclosure relates generally to occlusion and therapeutic agent delivery devices, systems, and methods, and in particular to occlusion and therapeutic agent delivery devices, systems, and methods configured for repeated inflation of a single expandable member having a longitudinally movable covering to provide multiple therapeutic or functional surfaces. BACKGROUND

[0005] Vascular diseases such as arteriosclerosis, arterial occlusion, vascular prophylactic interventions, phlebitis, intimal hyperplasia, plaques, vascular dissections, peripheral arterial disease, aneurysmal disease, stenosis, and restenosis are major causes of death and morbidity in humans. Vascular diseases are caused by a variety of reasons and in some cases require surgical or endovascular intervention. Trauma to the vascular system can also require surgical intervention to treat the traumatized anatomy. A common method of treatment for vascular disease is short or long term contact of tissue with an endovascular medical device such as a balloon or stent coated with a therapeutic agent that stops or mitigates the vascular disease at the site of contact. When the endovascular medical device is in contact with the diseased vascular tissue, the therapeutic agent elutes from the endovascular medical device into the surrounding tissue at the site of contact, thereby treating the vascular disease on a local level. Long term contact, e.g., implantation, of endovascular medical devices including vascular grafts, stent grafts, and stents, and short term contact of vascular medical devices including catheter-based balloons are often performed to treat vascular disease and vascular trauma.

[0006] It is generally preferred to treat vascular disease on a local, rather than a systemic, level. Systemic administration of therapeutic agents (e.g., drugs and dense materials) can produce undesirable side effects compared to local administration of therapeutic agents to treat vascular disease. Conventionally, drug-coated endovascular medical devices have become a standard technique for locally administering drugs to target tissue. For example, drug-coated balloons (DCBs) have been used to locally administer drugs to target tissue to treat vascular disease, including coronary artery disease and peripheral artery disease (see, e.g., U.S. Patent No. 5,102,402 to Dror et al. (hereinafter “Dror”). Dror discloses placing a DCB in a vessel lumen to treat a vessel wall, inflating the DCB, and contacting an outer surface of the DCB with the vessel wall of the lumen to deliver a drug into the vessel wall.

[0007] As described by Dror, however, many drug-coated endovascular medical devices are configured for a single treatment or therapy via a single inflation of an expandable member having a single, uniform functional surface. Conventional devices require invasive surgery to pass the drug-coated endovascular medical device to the treatment site and are suitable for only a single treatment at that site. After the single treatment, the expandable member is typically deflated and the drug-coated endovascular medical device is withdrawn from the body. In certain situations, however, multiple treatments or multiple treatment surfaces can be needed at the treatment site. Accordingly, there is a need for occlusions and therapeutic agent delivery devices, systems, and methods that are capable of providing repeated treatments at a treatment site. SUMMARY

[0008] Various embodiments are directed to a medical device comprising (i) a catheter comprising a longitudinal axis, a proximal end, a distal end, and a cover lumen extending from the proximal end of the catheter to the distal end of the catheter; and (ii) an expandable member comprising a proximal end and a distal end. The expandable member is disposed on a distal section of the catheter. The medical device further comprises (iii) a cover comprising a first region and a second region. The first region is disposed along the expandable member, e.g., overlapping or covering the expandable member, and the second region extends along a length of the catheter beyond the proximal end of the expandable member toward the proximal end of the catheter. A first end of the cover is turned inward into the cover lumen and adjacent the distal end of the catheter. The medical device further comprises (iv) an actuator coupled to the first end of the cover and configured to retract the first end of the cover along the longitudinal axis of the catheter through the cover lumen toward the proximal end of the catheter.

[0009] In some embodiments, a medical device includes a catheter having a longitudinal axis, a proximal end, a distal end, and a covering lumen extending from the proximal end of the catheter to the distal end of the catheter. The medical device also includes an expandable member having a proximal end and a distal end. The expandable member can be disposed on the catheter. The medical device can also include a covering including a first region, a second region, and a third region. A first end of the covering can be invaginated into the covering lumen. An actuator can be coupled to the first end of the covering and can be configured to move the first end of the covering along the longitudinal axis of the catheter toward the proximal end of the catheter. The first region can include a therapeutic agent disposed on a surface of the first region of the covering. The second region can include at least one aperture through which the expandable member can expand. The third region can include an endoprosthesis.

[0010] In certain embodiments, the covering includes polytetrafluoroethylene, expanded polytetrafluoroethylene, or an expanded copolymer of polytetrafluoroethylene.

[0011] In various embodiments, a length of the covering can be at least twice a working length of the expandable member. In some embodiments, a sheath is disposed along at least a portion of the second region of the covering. In some embodiments, the second region of the covering is less inflatable than the expandable member. In certain embodiments, the therapeutic agent includes paclitaxel, docetaxel, prospaxel, arsenic trioxide, thalidomide, atorvastatin, cerivastatin sodium, fluvastatin, betamethasone dipropionate, dexamethasone 21-palmitate, sirolimus, everolimus, zotarolimus, biolimus, or temsirolimus.

[0012] In various embodiments, a medical device includes a catheter, an expandable member, a covering, and an actuator. The catheter can include a proximal end, a distal end, a covering lumen extending from the distal end of the catheter to the proximal end. The expandable member can be disposed on the catheter and have a working length. The covering can include a plurality of regions, and a first end of the covering can be invaginated into the covering lumen of the catheter. A length of the covering can be at least twice the working length of the expandable member. The actuator can be coupled to the first end of the covering and configured to move the first end of the covering along a longitudinal axis of the catheter toward the proximal end of the catheter.

[0013] In some embodiments, a therapeutic agent is disposed on a first region of the plurality of regions of the covering or on a second region of the plurality of regions of the covering.

[0014] In some embodiments, the second therapeutic agent can be disposed on a surface of the other of the first region and the second region of the covering. In other embodiments, the first endoprosthesis can be disposed on a surface of the other of the first region and the second region of the covering, and the second endoprosthesis can be disposed on a surface of a third region of the plurality of regions. In some embodiments, the first endoprosthesis can have a first length, and the second endoprosthesis has a second length that can be different than the first length.

[0015] In certain embodiments, the first therapeutic agent can be different than the second therapeutic agent. In some embodiments, at least one of the first therapeutic agent and the second therapeutic agent includes a densified material configured to increase a coefficient of friction on a surface of the region on which the densified material is disposed. In certain embodiments, the other of the first therapeutic agent and the second therapeutic agent that does not include a densified material can include at least one of paclitaxel, docetaxel, prospaxel, arsenic trioxide, thalidomide, atorvastatin, cerivastatin sodium, fluvastatin, betamethasone dipropionate, dexamethasone 21-palmitate, sirolimus, everolimus, zotarolimus, biolimus, or temsirolimus.

[0016] In some embodiments, the first therapeutic agent and the second therapeutic agent are the same therapeutic agent. In certain embodiments, the first therapeutic agent can be at a first dosage density, and the second therapeutic agent can be at a second dosage density that is different than the first dosage density.

[0017] In various embodiments, a third therapeutic agent is disposed on a surface of a third region of the plurality of regions of the covering, the third therapeutic agent can be different than at least one of the first therapeutic agent and the second therapeutic agent. In some embodiments, a length of the first region of the plurality of regions is greater than a working length of the expandable member, and a length of the second region of the plurality of regions can also be greater than the working length of the expandable member.

[0018] In some embodiments, the third region of the plurality of regions can include an endoprosthesis.

[0019] In various embodiments, a medical device includes a catheter, an expandable member, a covering, and an actuator. The catheter can include a longitudinal axis, a proximal end, a distal end, and a covering lumen extending from the proximal end of the catheter to the distal end of the catheter. The expandable member can include a proximal end and a distal end and can be disposed on the catheter. The covering can include a plurality of regions, and a first region of the plurality of regions can have at least one aperture. A first end of the covering can be inverted into the covering lumen. The actuator can be coupled to the first end of the covering and configured to move the first end of the covering along the longitudinal axis of the catheter toward the proximal end of the catheter.

[0020] In some embodiments, the second region of the plurality of regions includes a therapeutic agent disposed on a surface of the second region.

[0021] In some embodiments, the first region of the plurality of regions is less expandable than the expandable member.

[0022] In some embodiments, at least two regions of the plurality of regions are each at least as long as a working length of the expandable member.

[0023] In some embodiments, the at least one aperture includes a portion of the first region that is weaker than a remainder of the first region of the plurality of regions.

[0024] In some embodiments, the second region of the plurality of regions further includes an endoprosthesis.

[0025] In various embodiments, a medical device includes a catheter, an expandable member, a covering, and an actuator. The catheter can include a longitudinal axis, a proximal end, a distal end, and a covering lumen extending from the proximal end of the catheter to the distal end of the catheter. The expandable member can include a proximal end and a distal end, and a working length. The expandable member can be disposed on the catheter. The covering can include a plurality of regions. The actuator can be coupled to a first end of the covering and configured to move the first end of the covering along the longitudinal axis of the catheter toward the proximal end of the catheter.

[0026] In some embodiments, the first region of the plurality of regions and the second region of the plurality of regions each have a length at least equal to a working length of the expandable member.

[0027] In some embodiments, a sheath can be disposed along at least a portion of the first region of the covering, wherein the first region of the covering extends between the proximal end of the expandable member and the proximal end of the catheter. Optionally, the covering can include at least one wire coupled to the actuator. Optionally, the at least one wire can be integral with the covering.

[0028] In some embodiments, a third region of the plurality of regions has a length at least equal to a working length of the expandable member.

[0029] In some embodiments, a first region of the plurality of regions has a first nominal diameter, and a second region of the plurality of regions has a second nominal diameter different from the first nominal diameter. A third region of the plurality of regions can have a third nominal diameter that can be different from the first nominal diameter and the second nominal diameter.

[0030] In some embodiments, a first region of the plurality of regions is positioned around the expandable member, and a second region of the plurality of regions is positioned around the catheter.

[0031] In various embodiments, a method of treatment includes providing a medical device having an expandable member and a covering. The covering can include a first region and a second region. The method can include inserting the medical device into a peripheral blood vessel and expanding the expandable member when the first region of the covering is positioned over the expandable member such that the first region of the covering provides a first treatment to a vessel wall. An actuator can be activated to draw the first region into a lumen of the medical device and position the second region of the covering over the expandable member. The expandable member can be expanded with the second region of the covering over the expandable member such that the second region of the covering provides a second treatment to the vessel wall. The first treatment can be different than the second treatment, and each of the first and second treatments can be provided to the vessel wall prior to removal of the medical device assembly from the body lumen.

[0032] In some embodiments, at least one of the first and second treatments can include delivering a therapeutic agent to the vessel wall.

[0033] In some embodiments, the second region of the covering includes a plurality of pores through which the expandable member expands. Providing the second treatment can include contacting the vessel wall (surface) and abrading deposits from the vessel wall surface. Optionally, the method can further include expanding the expandable member with a third region of the covering over the expandable member such that the third region of the covering provides a third treatment to the vessel wall. Each of the first, second, and third treatments can be provided to the vessel wall prior to removal of the medical device assembly from the blood vessel.

[0034] In some embodiments, the third treatment can include positioning an endoprosthesis positioned around the third region of the covering into contact with at least a portion of the vessel wall.

[0035] In some embodiments, the first treatment can include delivering a first therapeutic agent to the vessel wall, and the second treatment can include delivering a second therapeutic agent to the vessel wall, the first therapeutic agent being different than the second therapeutic agent.

[0036] In some embodiments, the method of treatment can include expanding the expandable member with a third region of the covering over the expandable member such that the third region of the covering provides a third treatment to the vessel wall. The third region of the covering can include an endoprosthesis, and the third treatment can include deploying the endoprosthesis in the vessel wall. Further, each of the first, second, and third treatments can be provided to the vessel wall prior to removal of the medical device assembly from the body lumen.

[0037] In some embodiments, the first treatment can be performed prior to the third treatment, and the first treatment can include contacting the vessel wall (surface) and abrading deposits from the vessel wall surface.

[0038] In some embodiments, the first treatment can include delivering a first therapeutic agent to the vessel wall.

[0039] In some embodiments, the first treatment is performed prior to the third treatment, and the second treatment can be performed after the third treatment. Optionally, the second region can include an endoprosthesis, and the second treatment can include deploying a second endoprosthesis in the vessel wall. Further, optionally, the first diameter of the endoprosthesis of the third region is different than the second diameter of the second endoprosthesis of the second region. Also optionally, the first length of the endoprosthesis of the third region can be different than the second length of the second endoprosthesis of the second region.

[0040] In some embodiments, the second treatment can include delivering a therapeutic agent to the vessel wall.

[0041] In some embodiments, the method includes expanding the expandable member with the fourth region of the covering over the expandable member such that the fourth region of the covering provides a fourth treatment to the vessel wall. The first, second, third, and fourth treatments to the vessel wall can be provided prior to removing the medical device assembly from the body lumen.

[0042] According to some aspects, the covering is at least partially formed of an expanded fluoropolymer. Optionally, the expanded fluoropolymer includes expanded polytetrafluoroethylene, expanded polytetrafluoroethylene, or an expanded copolymer of polytetrafluoroethylene. BRIEF DESCRIPTION OF DRAWINGS

[0043] The accompanying drawings are included to provide a further understanding of the embodiments described herein and are incorporated in and constitute a part of this specification, illustrate examples of the present disclosure, and together with the description serve to explain the principles of the embodiments of the present disclosure.

[0044] Figure 1 is a perspective view of a medical device including an expandable member assembly and a catheter according to embodiments of the present disclosure;

[0045] Figure 2 is a side cross-sectional view of a distal region of an expandable member assembly according to embodiments of the present disclosure;

[0046] Figure 3 is a front cross-sectional view of a catheter including a covering lumen according to embodiments of the present disclosure;

[0047] Figure 4 is a side cross-sectional view of a proximal region of an expandable member assembly according to embodiments of the present disclosure;

[0048] Figure 5A is a side view of an expandable member assembly including a first region of a covering having a first coating or treatment surface disposed along an expandable member in an inflated state according to embodiments of the present disclosure;

[0049] Figure 5B is a side view of an expandable member assembly including a second region of a covering having a second coating or therapeutic surface disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0050] Figure 5C is a side view of an expandable member assembly including a third region of a covering having a third coating or therapeutic surface disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0051] Figure 6A is a side view of an expandable member assembly including a first region of a covering having a first nominal diameter disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0052] Figure 6B is a side view of an expandable member assembly including a second region of a covering having a second nominal diameter disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0053] Figure 6C is a side view of an expandable member assembly including a third region of a covering having a third nominal diameter disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0054] Figure 7A is a side view of an expandable member assembly including a first region of a covering having a hole disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0055] Figure 7B is a side view of an expandable member assembly including a second region of a covering having a score disposed along an expandable member in an inflated state, according to embodiments of the present disclosure;

[0056] Figure 7C is a side view of an expandable member assembly including a third region of a covering disposed along an expandable member in a first inflated state, according to embodiments of the present disclosure;

[0057] Figure 7D is a side view of an expandable member assembly including a third region of a covering disposed along an expandable member in a second inflated state, according to embodiments of the present disclosure;

[0058] Figure 8Ais a side view of an expandable member assembly including a first region of the expandable member having a coating according to embodiments of the present disclosure, the first region disposed along the expandable member in a second inflated state;

[0059] Figure 8B is a side view of an expandable member assembly including a first region of the expandable member having a coating according to embodiments of the present disclosure, the first region disposed along the expandable member in a second inflated state;

[0060] Figure 9 is a front view of a catheter according to embodiments of the present disclosure;

[0061] Figure 10A is a cross-sectional front view of a medical device including an expandable member in a first inflated position according to embodiments of the present disclosure;

[0062] Figure 10B is a cross-sectional front view of a medical device having an expandable member in a second inflated position according to embodiments of the present disclosure; and

[0063] Figure 11 is a side view of an expandable member assembly including a first region of the expandable member having a coating according to embodiments of the present disclosure, the first region disposed along the expandable member in a second inflated state.

[0064] Figure 12 is a side view of an expandable member assembly including a first region of the expandable member having a coating according to embodiments of the present disclosure, the first region disposed along the expandable member in a second inflated state.

[0065] Figure 13 is a side view of an expandable member assembly including a first region of the expandable member having a coating according to embodiments of the present disclosure, the first region disposed along the expandable member in a second inflated state. DETAILED DESCRIPTION

[0066] I. INTRODUCTION

[0067] Various embodiments described herein relate to occlusion and therapeutic agent delivery devices, systems, and methods capable of deploying an expandable member within a lumen of a tubular structure (e.g., a blood vessel or a catheter) to treat a site on the tubular structure and inflating the expandable member to a nominal diameter such that a surface of the expandable member (or a covering on the expandable member) contacts a wall of the tubular structure to deliver a treatment or therapy to the site on the tubular structure. A problem associated with many conventional occlusion and therapeutic agent delivery devices, systems, and methods is that the expandable member (or a covering on the expandable member) is only configured with a single treatment surface or therapy. After the single treatment surface or therapy is administered, the expandable member is typically deflated and the device is withdrawn from the body.

[0068] Various embodiments described herein relate to occlusion and therapeutic agent delivery devices, systems, and methods capable of repeatedly inflating a single expandable member having a longitudinally movable covering to provide multiple treatments or multiple functional surfaces. For example, various embodiments of the present disclosure relate to medical devices comprising (i) a catheter comprising a longitudinal axis, a proximal end, a distal end, and a covering lumen extending from the proximal end of the catheter to the distal end of the catheter; and (ii) an expandable member comprising a proximal end and a distal end. The expandable member is disposed on a distal section of the catheter. The medical device further comprises (iii) a covering comprising a first region and a second region. The first region is disposed along the expandable member, e.g., overlapping or covering the expandable member, the second region extends along the length of the catheter beyond the proximal end of the expandable member toward the proximal end of the catheter, and a first end of the covering is inverted into the covering lumen. The medical device further comprises (iv) an actuator coupled to the first end of the covering and configured to retract the first end of the covering along the longitudinal axis of the catheter through the covering lumen toward the proximal end of the catheter. As a portion of the covering is retracted into the covering lumen, an unretracted outer portion of the covering is pulled in a distal direction toward the distal end of the catheter such that a previously un-deployed region of the covering is positioned over the expandable member for subsequent treatment or therapy at a treatment site.

[0069] Advantageously, this approach provides occlusion and therapeutic agent delivery devices, systems, and methods capable of repeatedly inflating a single expandable member having a longitudinally movable covering to provide multiple treatments or multiple functional surfaces. For example, the movable covering can be segmented into multiple regions, each region having a specific therapeutic agent coating (e.g., same or different drugs and / or dosage of drugs), inflation profile (e.g., same or different nominal diameter), functional surface (e.g., same or different surface texture and / or surface features), and / or endoprosthesis device (e.g., expandable stent, self-expanding stent, one or more stents having same or different diameters and / or lengths). Further, the therapeutic agent delivery devices, systems, and methods can optionally include a cylindrical (cannular) sheath disposed along at least a portion of the movable covering that covers and protects one or more regions of the movable covering during deployment to a treatment site. The sheath can also protect one or more regions of the movable covering when the expandable member is expanded and radially presses the exposed regions of the expandable member against a treatment site.

[0070] II. DEFINITIONS

[0071] As used herein, the terms “a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise.

[0072] The preposition "between" when used to define a range of values (e.g., between x and y) means that the range includes the endpoints of the given range (e.g., x and y) and the values between the endpoints.

[0073] As used herein, the term "coating" refers to one or more materials disposed on a surface of a substrate. In the present disclosure, the substrate can comprise a structural layer or a structural substrate or an expandable member or a cover. The coating can be located entirely on the surface or can be wholly or partially incorporated into openings or holes present in the substrate. The latter coating configuration is commonly referred to in the art as "absorbed" or "filled" material.

[0074] As used herein, the term "comprise" (and any form of comprise, such as "comprises" and "comprising," "have" (and any form of have, such as "has" and "having") "include" (and any form of include, such as "includes" and "including") and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, any apparatus, system, and method that "comprises," "has," "includes" or "contains" one or more elements possesses those one or more elements, but is not limited to possessing only those one or more elements. Likewise, an element of an apparatus, system, and method that "comprises," "has," "includes" or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features.

[0075] Any of the apparatuses, systems, and methods herein can be comprised of or consist essentially of the described any elements and / or features and / or steps (rather than comprising / comprising / include / including). Accordingly, in any claim that follows any of the appended claims, the term "comprising," as used in the claims, should not be interpreted as being open-ended, unless the phrase "comprising at least one of" is used. Accordingly, the term "comprising" as used in the claims does not, without more constraints, foreclose additional claim elements an apparatus, system, and / or method that "comprises" at least one of a given list of elements can potentially be read to include each member of the given list of elements, but not including any member of the given list of elements not expressly recited. Additionally, the term "comprising" as used in the claims does not, without more constraints, foreclose additional claim elements an apparatus, system, and / or method that "comprises" at least one of a given list of elements can potentially be read to include each member of the given list of elements, but not including any member of the given list of elements not expressly recited. Additionally, the term "comprising" as used in the claims does not, without more constraints, foreclose additional claim elements an apparatus, system, and / or method that "comprises" at least one of a given list of elements can potentially be read to include each member of the given list of elements, but not including any member of the given list of elements not expressly recited. Additionally, the term "comprising" as used in the claims does not, without more constraints, foreclose additional claim elements an apparatus, system, and / or method that "comprises" at least one of a given list of elements can potentially be read to include each member of the given list of elements, but not including any member of the given list of elements not expressly recited.

[0076] As used herein, "delivery diameter" refers to the diameter or cross-sectional width of a tubular form that is substantially equal to or slightly greater than the diameter or cross-sectional width of the tubular form during passage through the vasculature, prior to inflation.

[0077] As used herein, "deploy" refers to the actuation or placement of a device at a treatment or therapeutic site. The deployment process can be performed in stages.

[0078] As used herein, the terms "first," "second," "third,"... "sixth," and the like identify and distinguish particular regions or components of the occlusive and therapeutic agent delivery devices, and are not used herein to indicate a particular deployment order unless otherwise stated.

[0079] As used herein, the term "inverted" refers to a material doubling on itself, either internally or externally.

[0080] As used herein, the terms "micropores" and "microporous" refer to openings in a material, such as the areas between nodes and fibers of expanded polytetrafluoroethylene (ePTFE). Typically, as is the case with ePTFE, these micropores contain air when the material is not "wetted."

[0081] As used herein, a "non-compliant" balloon is a balloon that has less than about 10% increase in diameter when inflated from a nominal inflation pressure to a rated burst pressure.

[0082] As used herein, "nominal diameter" refers to the approximate diameter of a balloon at a nominal inflation pressure. Beyond this state, an increase in pressure (e.g., to a rated burst pressure) results in less than 20% increase in diameter, less than 15% increase in diameter, or less than 10% increase in diameter. Typically, the nominal diameter is the marked diameter as indicated on the instructions for an end user, such as a clinician.

[0083] As used herein, the terms "proximal" and "distal" are similarly used for the purpose of identifying and distinguishing particular regions or components of the occlusive and therapeutic agent delivery devices. "Proximal" is used to identify a location or portion of an assembly that is closer to a physician or clinician and / or closer to an entry site through which the assembly is passed when inserted. Distal is used to identify a location or portion of an assembly that is further from a physician or clinician and / or further from an entry site through which the assembly is passed when inserted. The term "longitudinal" refers to a direction relative to the length of the device, and the term "lateral" refers to a direction perpendicular to the longitudinal direction, such as the width of the device.

[0084] As used herein, a "semi-compliant" balloon is a balloon that has less than about 20% increase in diameter when inflated from a nominal inflation pressure to a rated burst pressure (e.g., less than 20% increase in diameter of the balloon relative to the nominal diameter).

[0085] As used herein, the terms "substantially," "approximately," and "about" are defined (limited) as understood by one of ordinary skill in the art: to a great extent, but not necessarily wholly, as the terms are understood by a person of ordinary skill in the art. In any disclosed embodiment, the term "substantially," "approximately," or "about" can be replaced with a specific "within a percentage," where the percentage includes 0.1%, 1%, 5%, and 10%. The term "majority" means at least half.

[0086] As used herein, the term "microstructure of variable permeability" refers to a structure or material that has a resistance to fluid transfer in a first state that is greater than the resistance of the same structure or material in a second state, and the resistance changes between the two states. Those skilled in the art will appreciate various methods of characterizing the change in permeability in the first state versus the second state. These methods include, but are not limited to, characterization of air or liquid flux through the microstructure at a given pressure differential, characterization of the pressure differential of different fluid strikes through the microstructure such as the break-in water pressure or the bubble point, characterization of the porosity, and visual characterization such as the spacing between nodes or fibrils as measured from an image (e.g., from a scanning electron microscope or optical microscope). One non-limiting embodiment of a variable permeability material includes a material that has a substantially closed microstructure when the material is not under strain, and a more open microstructure when the material is under strain.

[0087] As used herein, the terms "wet," "wetting," and "wetted" refer to the displacement of air in a microporous material by a fluid. Wetting of the material reduces the resistance to subsequent fluid transfer and aids in the flow of fluid through the microporous material. Furthermore, these microporous materials are intended to be open cell structures, meaning that the micropores are interconnected, rather than closed cell structures. This allows for fluid flow through the material. Capillary effects can also play an important role in the fluid flow through the material when wetting occurs, particularly for highly porous materials with small interconnected pores. Wetting can be accomplished with the aid of one or more surfactants added to the fluid. Surfactants can adsorb onto the fluid-vapor interface, the solid-fluid interface, and the solid-vapor interface, which in turn alters the wetting properties of the hydrophobic material. Wetting will also depend on the viscosity of the fluid.

[0088] As used herein, the term "working length" is the length of the substantially straight body portion of an expandable member (e.g., a balloon) that corresponds to the approximate length of the expandable member between the opposing shoulder / tapered portions as indicated by "W" in Figure 1 As used herein, the term "working length" is the length of the substantially straight body portion of an expandable member (e.g., a balloon) that corresponds to the approximate length of the expandable member between the opposing shoulder / tapered portions as indicated by "W" in

[0089] III. Obstruction and therapeutic agent delivery devices and systems

[0090] Figure 1 A medical device 5 is shown that includes an expandable member assembly 10 and a catheter 15. In various embodiments, the catheter 15 has a cylindrical form and includes a longitudinal axis 17, a proximal end 18, a distal end 19, and an optional cover lumen 32 extending from the proximal end 18 to the distal end 19. The expandable member assembly 10 includes an inflatable or expandable member 20 positioned on a distal section 16 of the catheter 15. As shown, the expandable member 20 includes a body section 21 that can be substantially cylindrical along a working length (W), two opposing leg portions 22, and a shoulder / tapered portion 23 that can be integrally connected to the body section 21 and the two opposing leg portions 22. The body section 21, the leg portions 22, and the shoulder / tapered portion 23 define a total length of the expandable member 20 from a proximal end 24 to a distal end 25. In some embodiments, the expandable member 20 includes a thermoplastic polymer material including polyurethane, PET, PEBAX, polytetrafluoroethylene (PTFE), polyamides such as Nylon 12, Nylon 11, Nylon 9, Nylon 6 / 9, Nylon 6 / 6, and combinations thereof.

[0091] The medical device 5 has a first section SI extending from the distal end 19 of the catheter 15 to the proximal end 24 of the expandable member 20. The medical device 5 also has a second section S2 extending from the proximal end 24 of the expandable member 20 to the proximal end 18 of the catheter 15. The medical device 5 also has a third section S3 corresponding to the length of the catheter 15 extending within the cover lumen 32 of the catheter 15 from the distal end 19 of the catheter 15 to the proximal end 18 of the catheter 15.

[0092] The working length (W) of the expandable member 20 can be from about 10 mm to about 400 mm, from about 10 mm to about 250 mm, or from about 10 mm to 150 mm. Similarly, the nominal diameter of the expandable member 20 can be from about 2 mm to about 100 mm, from about 2 mm to about 60 mm, or from about 2 mm to 30 mm. For example, the expandable member 20 can have a nominal diameter of about 4 mm to about 10 mm and a working length (W) of about 25 mm to about 50 mm, or a nominal diameter of about 6 mm to about 25 mm and a working length (W) of about 15 mm to about 75 mm. It should be appreciated that the expandable member 20 can have any appropriate size and dimensions for clinical applications.

[0093] In various embodiments, the expandable member 20 is attached or mounted to the catheter 15 at the leg portions 22 such that the catheter 15 is in fluid communication with the expandable member 20. For example, the catheter 15 can include one or more lumens, one of which can be in fluid communication with the chamber of the expandable member 20 through a hole in the catheter for supplying inflation fluid to inflate the expandable member 20 balloon in a tubular structure such as a vessel of a patient. The catheter 15 can be coupled to any suitable inflation-deflation device, such as a syringe, an indeflator, a pump, or any other device for directing inflation fluid through the catheter 15 and into the expandable member 20, for example, via the port 26. According to some embodiments, the inflation-deflation device can push fluid into and withdraw fluid from the chamber of the expandable member 20 via the catheter 15 to inflate and deflate (collapse) the expandable member 20. To aid in controlling the diameter of the balloon, the catheter 15 and expandable member 20 can be aspirated (air removed and replaced with fluid) prior to inflating the expandable member 20 with inflation fluid. The inflation fluid used to aspirate the catheter 15 and expandable member 20 and / or to inflate the expandable member 20 can include a contrast agent (e.g., an imaging agent that allows the expandable member 20 to be imaged by an imaging modality), or a mixture of contrast agent and saline.

[0094] The expandable member assembly 10 further includes a covering 27. The covering 27 includes a plurality of regions that can be disposed over the first section SI, the second section S2, and the third section S3 of the medical device 5. In various embodiments, the covering 27 has a first region distributed along the first section SI of the medical device 5. In other embodiments, the covering 27 has a first region distributed along the first section SI of the medical device and a second region distributed along the second section S2 of the medical device 5. In certain embodiments, the covering 27 has a first region distributed along the first section SI of the medical device 5, a second region distributed along a portion of the second section S2 of the medical device 5, and another region distributed along another portion of the second section S2 of the medical device. The covering 27 also has a region that is turned into the covering lumen 32 and is distributed along the third section S3 of the medical device 5 within the covering lumen 32 of the catheter 15. In various embodiments, the total length of the regions of the covering 27 distributed along the first section SI and the second section S2 of the medical device 5 is longer than the total length of the expandable member 20 by a multiple (e.g., 1, 2, 3, 4, or 2 to 8, or 2 to 4). In some embodiments, the total length of the regions of the covering 27 distributed along the first section SI and the second section S2 of the medical device 5 is longer than the working length (W) of the expandable member 20 by a multiple (e.g., 1, 2, 3, 4, or 2 to 8, or 2 to 4). The total length of the regions of the covering 27 distributed along the first section SI and the second section S2 of the medical device 5 can be from about 50 mm to about 2000 mm, from about 50 mm to about 1250 mm, or from about 50 mm to 750 mm.

[0095] In some embodiments, during manufacture or assembly, the covering of the covering 27 is initially positioned within the covering lumen and then turned or folded over onto the expandable member. In some embodiments, during manufacture or assembly, the covering of the covering 27 is initially positioned on the expandable member and then turned or folded into the covering lumen.

[0096] In some embodiments, the covering 27 includes a porous layer, such as, but not limited to, a porous fluoropolymer layer. According to certain embodiments, the porous fluoropolymer layer can include, but is not limited to, a perfluoroelastomer or the like, a polytetrafluoroethylene (PTFE) or the like, and an expanded fluoropolymer or the like. Non-limiting examples of expanded fluoropolymers include ePTFE, expanded modified polytetrafluoroethylene, and copolymers of expanded polytetrafluoroethylene. For example, an extruded ePTFE tube, a helically wound ePTFE tube, or a cigarette wound ePTFE tube.

[0097] Various expanded PTFE mixtures, expanded modified PTFE, and expanded PTFE copolymers have been disclosed in the art, such as U.S. Patent No. 5,708,044 to Branca; U.S. Patent No. 6,541,589 to Baillie; U.S. Patent No. 7,531,611 to Sabol et al.; U.S. Patent Application No. 8,637,144 to Ford; and U.S. Patent Application No. 8,937,105 to Xu et al. U.S. Publication No. US20160143579 discloses additional embodiments and methods of making suitable for embodiments herein.

[0098] According to various embodiments, the plurality of regions (e.g., first, second, and third regions) of the covering 27 distributed along the first and second sections S1, S2 of the medical device 5 are configured to move longitudinally on the expandable member 20 in a distal direction during the entire deployment of the expandable member assembly 10 within the patient’s tubular structure, such that repeated inflation of the expandable member 20 can cause different regions of the covering 27 to apply multiple treatments or functional surfaces to the tubular structure without the need to remove the assembly 10 from the body lumen in which it resides. In some embodiments, the covering 27 is wrapped around the entire circumference of the expandable member 20 and covers the entire length of the expandable member 20 from the proximal end 24 to the distal end 25. In other embodiments, the covering 27 is wrapped around a portion of the circumference of the expandable member 20 and / or covers a portion of the length of the expandable member 20 from the proximal end 24 to the distal end 25.

[0099] According to various embodiments, the medical device 5 can also include an actuator 35 coupled to the first end of the covering 27 that has been inverted into the covering lumen 32 (one of the one or more lumens in the catheter 15) of the catheter 15. The actuator 35 is configured to move portions of the covering 27 throughout deployment (unfolding) of the expandable member assembly 10 via a mechanical system (e.g., a traditional unfolding knob or a handle with mechanical advantage by use of a knob or slider) such that repeated inflation of the expandable member 20 causes different portions of the covering 27 to exert multiple therapeutic or functional surfaces. For example, a length of the covering 27 can be inverted into the covering lumen 32 at the distal end 19 of the catheter 15 and can be disposed along at least a portion of the third section S3 of the medical device 5. The covering 27 positioned within the third section S3 can be moved (e.g., pulled) via the actuator 35 through the covering lumen 32 toward the proximal end 18 of the catheter 15. Alternatively, in some embodiments, a length of the covering 27 can be inverted into the covering lumen 32 at the proximal end 18 of the catheter 15 and moved (e.g., pulled) via the actuator 35 through the covering lumen 32 toward the distal end 19 of the catheter 15. Thus, as the covering 27 is pulled through the covering lumen 32, an initially proximally disposed region of the covering 27 along the catheter 15 is moved along the length of the catheter 15 toward the distal end 19 of the catheter 15 such that the region of the covering 27 becomes disposed along the expandable member 20.

[0100] In some embodiments, the covering 27 includes a porous layer to which one or more coatings can be applied. The one or more coatings can include therapeutic agents that can be applied to a region of the covering 27 such that the therapeutic agent coating substantially covers the working length (W) of the expandable member 20. Alternatively, one or more therapeutic agent coatings can be applied to a portion of the covering 27 such that the therapeutic agent coating substantially covers the working length (W) of the expandable member 20 and is disposed on at least one of the opposing leg regions 22 and / or shoulder / taper regions 23. The same therapeutic agent coating can be disposed on one or more regions of the covering 27, one or more different therapeutic agent coatings can be disposed on one or more regions of the covering 27, no coating can be disposed on one or more regions of the covering 27, and / or the therapeutic agent coating can include one or more radiopaque elements, as described in further detail herein.

[0101] In some embodiments, the outer surface of the covering 27 and / or expandable member 20 can have a surface texture and / or surface feature. The surface texture and / or surface feature can be a portion of a region of the covering 27 and / or expandable member 20 such that the surface texture and / or surface feature extends along the working length (W) of the expandable member 20. Alternatively, the surface texture and / or surface feature can be a portion of a region of the covering 27 and / or expandable member 20 such that the surface texture and / or surface feature extends along the working length (W) of the expandable member 20 and is disposed on at least a portion of the opposing leg portions 22 and / or shoulder / tapered portions 23. The same surface texture and / or surface feature can be disposed on one or more regions of the covering 27, one or more surface textures and / or surface features can be disposed on one or more regions of the covering 27, no surface texture and / or surface feature can be disposed on one or more regions of the covering 27, and / or the surface texture and / or surface feature can include one or more radiopaque elements, as described in further detail herein.

[0102] In some embodiments, one or more endoprostheses can be disposed on one or more regions of the covering 27. The endoprostheses can be positioned on a region that includes an additional surface feature and / or therapeutic agent coating. In other embodiments, the endoprostheses can be positioned on a region of the covering 27 without any additional surface feature or therapeutic agent coating.

[0103] The expandable member assembly 10 can also include a cylindrical sheath 37 disposed about a portion of the cover 27 along at least a portion of the second section S2 of the medical device 5. In some embodiments, the sheath 37 is wrapped around the entire circumference of the cover 27 and covers the entire length of the cover 27 disposed along the second section S2 of the medical device 5. In other embodiments, the sheath 37 is wrapped around a portion of the circumference of the cover 27 and / or covers a portion of the length of the cover 27 disposed along the second section S2 of the medical device 5. The sheath 37 can protect a therapeutic agent coating (e.g., a drug coating or a densification coating) on the outer surface of the cover 27 positioned beneath the sheath 37 during placement of the expandable member assembly 10 in a tubular structure of a patient. The sheath 37 can also maintain a portion of the cover 27 beneath the sheath 37 at a delivery diameter during use of the expandable member assembly 10. In some embodiments, the sheath 37 is bonded to a region of the catheter 15 by an adhesive. For example, the sheath 37 can be bonded (glued) to a handle or hub at the proximal end 18 of the catheter 15. In other embodiments, the sheath 37 is not bonded (glued) to the catheter 15.In various embodiments, the sheath 37 can comprise a polymeric tube or a tube comprising other suitable materials including, but not limited to, thermoplastics such as, but not limited to, polymethyl methacrylate (PMMA or acrylic), polystyrene (PS), acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC), modified polyethylene terephthalate (PETG), cellulose acetate-butyrate (CAB); semi-crystalline commodity plastics including polyethylene (PE), high-density polyethylene (HDPE), low-density polyethylene (LDPE or LLDPE), polypropylene (PP), polymethylpentene (PMP); polycarbonate (PC), polyphenylene oxide (PPO), modified polyphenylene oxide (modified PPO), polyphenelyne ether (PPE), modified polyphenelyne ether (modified PPE), thermoplastic polyurethane (TPU); polyamides such as nylon 11 and nylon 12, polyoxymethylene (POM or acetal), polyethylene terephthalate (PET, thermoplastic polyester), polybutylene terephthalate (PBT, thermoplastic polyester), polyimide (PI, imidized plastic), polyamide-imide (PAI, imidized plastic), polybenzimidazole (PBI, imidized plastic); polysulfone (PSU), polyetherimide (PEI), polyethersulfone (PES), polyarylsulfone (PAS); polyphenylene sulfide (PPS), polyether ether ketone (PEEK); fluoropolymers including fluorinated ethylene propylene (FEP), ethylene-chlorotrifluoroethylene (ECTFE), ethylene, ethylene-tetrafluoroethylene copolymer (ETFE), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy (PFA), or combinations, copolymers, or derivatives thereof. Other generally known medical grade materials include elastomeric silicone polymers, polyether block amides (e.g. Specifically, the polyamides can include nylon 12, nylon 11, nylon 9, nylon 6 / 9, and nylon 6 / 6. In certain embodiments, PET, nylon, and PE can be selected for medical balloons used in coronary angioplasty or other high pressure applications. The specific selection of materials depends on the desired characteristics / anticipated applications of the balloon.

[0104] Figure 2 A cross-sectional view depicting a region of a medical device including a portion of the expandable member assembly 10 at the distal end 19 of the catheter 15. Although Figure 2A covering 27 is depicted positioned on the outer surface of the expandable member 20, but in some embodiments, additional elements can be positioned between the outer surface of the expandable member 20 and the covering 27, such as an endoprosthesis (e.g., a stent). In some embodiments, one or more endoprostheses can be positioned on the outer surface of the covering 27. The covering 27 can be inverted into the distal end 19 of the catheter 15 and into the covering lumen 32 of the catheter 15. In Figure 2 The covering lumen 32 that receives the covering 27 includes two openings in the illustrated embodiment. The covering 27 is divided into two sections, each of which enters a respective opening that together define the covering lumen 32. The covering 27 can be further divided into two sections when the covering 27 is pulled through the covering lumen 32. The catheter 15 also includes a guidewire lumen 38 and an inflation lumen 40 (which is not visibly distinguished from the guidewire lumen 38 in the cross-sectional view of Figure 2 In some embodiments, optional tips can be affixed to the distal end 19 of the catheter 15 at the distal end of the catheter 15 by adhesive or another suitable bonding means.

[0105] Figure 3 A front cross-sectional view of the catheter 15 is depicted. The catheter 15 has openings that together define a covering lumen 32 that receives a covering 27. The catheter 15 also includes a guidewire lumen 38 that can receive a guidewire. The catheter 15 also includes an inflation lumen 39 that can be in fluid communication with the expandable member 20. As Figure 2 shown, a portion of the covering 27 is inverted into the covering lumen 32 and extends through the covering lumen 32 along the length of the catheter 15. The portion of the covering 27 that is inverted into the covering lumen 32 is coupled to an actuator at one end (not shown).

[0106] In some embodiments, the covering lumen 32 includes more or fewer openings that receive the covering 27. For example, as Figure 9 shown, in some embodiments, a catheter 30 for a medical device of the present disclosure can include a covering lumen 31 that includes a single opening. The catheter 30 can also include an inflation lumen 33. In some embodiments, the catheter 30 can also include an additional lumen for a guidewire.

[0107] Figure 4 A cross-sectional view of another portion of the medical device at the proximal end 24 of the expandable member 20 is depicted. As Figure 4 shown, a sheath 37 surrounds a portion of the covering 27 that extends along the length of the catheter 15. As Figure 2The covering 27 is also shown surrounding the expandable member 20. The length of the covering 27 that is inverted into the covering lumen 32 of the catheter 15 is also shown extending within the covering lumen 32 along the length of the third section S3 of the medical device along the length of the catheter 15. In Figure 4 In a cross-sectional view, the inflation lumen 40 (shown in Figure 3 is not visibly distinguished from the guidewire lumen 38.

[0108] Embodiments including one or more coatings

[0109] Figure 5A An expandable member assembly 40 of a medical device 41 according to embodiments of the present disclosure is depicted. The expandable member assembly 40 is positioned on a catheter 42 of the medical device 41. The expandable member assembly 40 includes an expandable member 44 positioned on a distal section 45 of the catheter 42. The expandable member assembly 40 also includes a covering 48 positioned around the expandable member 44 and extending along the length of the catheter 42 toward a proximal end 43 of the catheter 42. The covering 48 includes a first region 50, a second region 52, and a third region 54. In some embodiments, as shown, the lengths of the first region 50, the second region 52, and the third region 54 can each be approximately equal to the overall length of the expandable member 44. Figure 5A In some embodiments, as shown, the lengths of the first region 50, the second region 52, and the third region 54 can each be approximately equal to the working length (W) of the expandable member 44 at a nominal diameter, for example within 10% or 20% deviation of the working length. In some embodiments, the length of one or more of the first region, the second region, and the third region 50, 52, 54 can be greater than or less than the overall length of the expandable member 44. Figure 5A In some embodiments, as shown, the lengths of the first region 50, the second region 52, and the third region 54 can each be approximately equal to the working length (W) of the expandable member 44 at a nominal diameter, for example within 10% or 20% deviation of the working length. In some embodiments, the length of one or more of the first region, the second region, and the third region 50, 52, 54 can be greater than or less than the overall length of the expandable member 44.

[0110] One end of the covering 48 can be inverted into the covering lumen at the distal end 46 of the catheter 42. The covering 48 can be coupled to an actuator (not shown) of the medical device 41. The actuator can pull the end of the covering 48 positioned within the covering lumen from the distal end 46 of the catheter 42 to the proximal end 43 of the catheter 42 in various increments. In some embodiments, the covering 48 can be inverted into the proximal end 43 of the catheter 42 and pulled by the actuator to the distal end 43 of the catheter 42.

[0111] In some embodiments, one or more coatings can be positioned on the outer surface of the covering 48. The coatings can include one or more radiopaque elements and / or one or more therapeutic agents, such as a therapeutic drug agent. In some embodiments, the coatings can include a dense material positioned on the outer surface of the covering 48 that can increase the coefficient of friction of the surface of the covering 48. In some embodiments, one or more endoprostheses can be positioned on the outer surface of the covering 48. In some embodiments, the endoprostheses can be positioned between a region of the covering 48 that includes a pre-medication (e.g., a therapeutic agent coating or surface feature for removing plaque or other deposits from the walls of the lumen) and a region of the covering 48 that includes a post-medication (e.g., a therapeutic agent coating). In other embodiments, one or more endoprostheses can be positioned on the outer surface of the covering 48 along any length of the covering 48.

[0112] Therapeutic agent

[0113] The therapeutic agent can include, but is not limited to, abciximab, acemetacin, acetylvismione B, aclarubicin, adenosylmethionine, adriamycin, aescin, afromoson, akagerine, aldesleukin, amidarone, aminoglutethimide, aminoglutethemide, amsacrine, anakinra, anastrozole, anemonin, anol, antifungal agents, antithrombotic agents, thrombolytic agents such as tissue plasminogen activator (tPA), apocymarin, argatroban, aristolactam-All, aristolochic acid, arsenic and arsenic-containing oxides, salts, chelates, and organic compounds, ascomycin, asparaginase, aspirin, atorvastatin, auranofin, azathioprine, azithromycin, baccatine, bactiricin, basiliximab, bendamustine, benzocaine, berberine, betulinol, betulinic acid, bilobaphenol, biolimus, bisparthenolidine, bleomycin, bombrestatin, boswellic acid and derivatives thereof, bruceanoles A, B, C, cycloathyiadin A, busulfan, antithrombin, bivalirudin, cadherin, camptothecin, capecitabine, o-carbamoylphenoxyacetic acid, carboplatin, carmustine, celecoxib, cepharanthine, cerivastatin sodium, CETP inhibitors, chlorambucil, chloroquine phosphate, cictoxin, ciprofloxacin, cisplatin, cladribine, clarithromycin, colchicine, concanamycin, coumarin, C-type natriuretic peptide (CNP), cudxaisoflavone A, curcumin, cyclophosphamide, cyclosporin A, cytarabine, dacarbazine, dalizumab, dactinomycin, dapsone, daunorubicin, diclofenac, 1,11-dimethoxycanthin-6-one, docetaxel, doxorubicin, duocarmycin, epothilone A and B, erythromycin, estramustine, etoposide, everolimus, filgrastim, fluridil, fluvastatin, fludarabine, fludarabin-5’-dihydrogenphosphate, fluorouracil, fumidil, hexestrol diphosphate, gemcitabine, ghalakinoside, ginkgol, ginkolic acid, glycoside 1a,4-hydroxyoxycyclophosphamide, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, maytansinol, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mytomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, bismuth and bismuth compounds or chelates, irinotecan, topotecan, hydroxyurea, miltefosine, pentostatine, pegaspargase, exemestane, letrozole, formestane, smooth muscle cell (SMC) proliferation inhibitor-2 co, mitoxantrone, mycophenolate, c-myc antisense, b-myc antisense, [3-1 apachone, podophyllotoxin, podophyllic acid-2-ethylhydrazide, sargramostim (rhuGM-CSF), pegylated interferon ct-2b, lanograstim (r-HuG-CSF), polyethylene glycol, selectin (cytokine antagonist), cytokine inhibitors, COX-2 inhibitors, NFkB, amprenavir, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1-hydloxyl l-methoxycanthin-6-one, scopoletin, nitric oxide donors (NO donors), pentaerythritol pentaerythiltol tetranitrate, synxloimines, S-nitrosodeilvatives, tamoxifen, staurosporine, [3-estradiol, ct-estradiol, estradiol, estrone, ethinyl estradiol, medroxyprogesterone, estradiol cypionate, estradiol benzoate, tranilast, gossypol and other terpenoids for the treatment of cancer, verapamil, tyrosine kinase inhibitors (tyrosine phosphates), paclitaxel, paclitaxel derivatives, 6-hydroxy paclitaxel, 2'-succinyl paclitaxel, 2'-succinyl paclitaxel tilethanolamine, 2'-glutaryl paclitaxel, 2'-glutaryl paclitaxel tilethanolamine, T-O-ester of paclitaxel with N-(dimethylaminoethyl)glutamide,T-O-ester of paclitaxel with N-(dimethylaminoethyl) glutamid hydrochloride, taxotere carbon monoxide (MCS), carbon monoxide macrocyclic oligomers, moφhinobutazone, clonazepate, lidocaine, ketoprofen, mefenamic acid, piroxicam, penicillamine, hydroxychloroquine, sodium aurothiomalate, acetyldigoxin, [3-sitosterol sitosteiln, myrtecaine, polyethylene glycol monododecyl ether, vanillyl nonamide, levomenthol, ellipticine, D-24851 (antibody (Calbiochem)), colchicine, cytochalasins A-E, indanocine, nocadazole, S 100 protein, bacitracin, vitronectin receptor antagonists, nitrogen, Statin, guanidyl cyclase stimulator tissue inhibitor of metal proteinase and 2, free nucleic acids, nucleic acids incorporated into virus transmitters, DNA and RNA fragments, plasminogen activator inhibitor-1, plasminogen activator inhibitor-2, antisense oligonucleotides, vascular endothelial growth factor (VEGF) inhibitors, insulin-like growth factor (IGF)-1, active substances in the antibiotic group such as cefadroxil, cefazolin, cefalexin, cefotixin, tobramycin, gentamicin, penicillins such as dicloxacillin, oxacillin, sulfonamides, metronidazole, enoxaparin, desulphated and N-reacetylated hepailn, tissue plasminogen activator, GpIIb / IIIa platelet cell membrane receptor, factor Xa inhibitor antibodies, hepailn, hirudin, r-hirudin, PPACK, protamine, pro-urokinase, streptokinase, warfarin, urokinase, vasodilators such as dipyramidol, zolimidine, nitroprusside, PDGF antagonists such as triazolopyilmidine and serotonin (5-hydroxytryptamine), and the like.Seramine), angiotensin-converting enzyme (ACE) inhibitors such as captopril, cilazapill, lisinopill, enalapril, losartan, thioprotease inhibitors, cyclic prostaglandins, vapaporprost, interferon α, [3 and γ], histamine antagonists, serotonin receptor blockers, apoptosis inhibitors, apoptosis regulators, such as p65, NF-κB or Bcl-xL antisense oligonucleotides, flubutanol, nifedipine, tocopherol tranilast, moxifloxacin, tea polyphenols, epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, etoposide, dicloxacillin, tetracycline, triamcinolone, styromycin, procainimide, retinoic acid, quinidine, diisopropyridine, flecainide, propafenone, sotoprolol, natural and synthetic. Steroids such as inotodiol, maquiroside A, ghalakinoside, mansonine, strebloside, hydrocortisone, betamethasone, dexamethasone; nonsteroidal anti-inflammatory drugs (NSAIDs) such as fenoporfen, ibuprofen, indomethacin, naproxen, phenobarbital; and other antiviral drugs such as acyclovir, ganciclovir, zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine; antiprozoal drugs such as chloroquine, mefloquine, quinine; and natural terpenoids such as eurythrin and barringtogenol C21-angelic acid ester. C21-angelate), 14-dehydloagrostistachin, agroskeiln, agrostistachin, 17-hydroxyagrostistachin, lecithin, 4,7-oxocyclic anisic acid, bacitracin B1, B2, B3 and B7, baicalin, anti-dysentery crotonin C, yadanzioside N and P, isodeoxygentisin, gentisin lactone A and B, coronailn A, B, C and D, ursolic acid, hypodipic acid Aacid A), iso-illodogermanal, cantenfoliol, effusantin A, limocitrin A and B, longikauiln B, sculponeatin C, kamebaunin, leukamenin A and B, 13,18-dehydro-6-alpha-senecioyloxychapariln, taxol A and B, regenilol, triptolide, gelsemin, hydroxyanopterin, protoanemonin, cheliburin chloride, sinomontanine A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxypregnadien-3,20-dion, sychnolide, indicine, indicine-N-oxide, peganine, incensole, podophyllotoxin, rosmaridiphenol A and B, larreatin, malloterin, ergosterol, isobutyryl ergosterol, quercitrin A, marchantia A, cantansin, lycoricidine, margetine, pancratistatin, liilodenine, bisparthenolidine, oxosparteine, perforatin A, ursolic acid, deoxypsorospermin, psycorubin, irilmaun A, sanguinailne, manu wheat acid, 3-hydroxy-4-methoxybenzoic acid, 3-hydroxy-4-methoxybenzaldehyde, 3-hydroxy-4-methoxybenzyl alcohol, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzyl salicylate, 3-hydroxy-4-methoxybenzyl acetate, 3-hydroxy-4-methoxybenzyl formate, 3-hydroxy-4-methoxybenzylacid), methylsorbifolin, sphatheliachromen, arbutin, glycine, stripe glycoside, dihydrousambaraensine, hydroxyusambailne, strychnopentamine, strychnophylline, strychbalinine, strychbalinine, goose down extract, oxycorticinine, daphnein, larchinol, methoxylicillinol iresinol), hardener, eugenol, sirolimus (rapamycin), rapamycin with arsenic or arsenic compounds or arsenic-containing compounds, somatostatin, tacrolimus, roxithromycin, triacetylpyridinium, simvastatin, rosuvastatin, vinblastine, vincilstine, vindesin, thalidomide, teniposide, vinorelbine, chlorocyclophosphamide, sosoxan, temozolomide, thlotepa, retinoic acid, spiramycin, umbelliferone, desacetylvismione A, propargyl ketone A and B, zeoiln, fasudil.

[0114] The outer surface of one or more regions 50, 52, 54 of the covering 48 may have a coating. In some embodiments, such as Figure 5A As shown, a first region 50 of the cover 48 may be uncoated, a second region 52 of the cover 48 may have a coating 64, and a third region 54 of the cover 48 may have a coating 66. In some embodiments, coating 64 may include a first therapeutic agent, while coating 66 may include a second therapeutic agent different from the first therapeutic agent. In use, the first region 50 of the cover 48 may be uncoated and may be positioned around the expandable member 44 to perform typical angioplasty or other treatments prior to intracavitary administration of a therapeutic agent. In such embodiments, coating 64 on the second region 52 of the expandable member 44 may include paclitaxel, while coating 66 on the third region 54 may include heparin. In some embodiments, the outer surface of one or more regions 50, 52, 54 of the cover 48 may have a coating, and one or more regions 50, 52, 54 of the cover 48 may have an embedded prosthesis. The coating on one or more regions 50, 52, 54 of the cover 48 may be used as a pre-treatment (to be applied before positioning the embedded prosthesis) or a post-treatment (to be applied after positioning the embedded prosthesis).

[0115] In some embodiments, one or more regions 50, 52, 54 of the covering 48 can have the same coating. In some embodiments, one or more regions 50, 52, 54 of the covering 48 can have no coating. In embodiments where one or more regions have the same coating, the coating dosage can vary between the regions. For example, the coating 64 can include a first dosage of a therapeutic agent, and the coating 66 of the third region 54 of the covering 48 can include a second dosage of the same therapeutic agent that is different than the first dosage. In some embodiments, the second dosage can be at least about 50% greater than the first dosage. In some embodiments, the second dosage can be about 90% of the first dosage. In such embodiments, where the second region 52 having the first dosage of the therapeutic agent is disposed about the expandable member 44, the expandable member 44 can be inflated at the first location. The expandable member 44 can be deflated, and the covering 48 can be pulled through the covering lumen to position the third region 54 of the covering 48 having the second dosage of the therapeutic agent about the expandable member 44. The expandable member 44 can be re-inflated at the same location to apply the second dosage. In some embodiments, where the third region 54 of the covering 48 is disposed about the expandable member, the expandable member assembly 40 can be repositioned at a different treatment site in the body prior to inflating the expandable member 44 to provide a therapeutic treatment at the different treatment site.

[0116] The sheath 70 can be positioned to extend proximally along a length of the catheter 42, from the proximal end 71 of the expandable member 44, about a portion of the covering 48. The sheath 70 can protect the coatings 64, 66 positioned on the outer surface of the covering 48 during placement of the expandable member assembly 40 within the body lumen. The sheath 70 can include a polymeric material or any other suitable material. The sheath 70 can be directly coupled to the catheter 42, for example, via an adhesive. In some embodiments, the sheath 70 can be coupled to the hub of the medical device 41, or can otherwise be secured in place.

[0117] One or more coatings on the outer surface of the covering 48 can be applied to the body lumen in a particular order. For example, with reference to FIG. 1, the coating 64 can be applied to the second region 52 of the covering 48 prior to the coating 66 being applied to the third region 54 of the covering 48. In some embodiments, the coating 66 can be applied to the third region 54 of the covering 48 prior to the coating 64 being applied to the second region 52 of the covering 48. Figure 5AThe medical device 41 can be positioned within a body cavity, and with the first region 50 of the cover 48 surrounding the expandable member 44, the expandable member 44 can be inflated at the treatment site. The uncoated outer surface of the first region 50 of the cover 48 can be used to perform typical angioplasty or other medical treatments within the body cavity. The expandable member 44 can then be deflated, and the first region 50 of the cover 48 can be inverted into the cover lumen of the catheter 42 and pulled through the cover lumen, such that the second region 52 of the cover 48 moves toward the distal end 46 of the catheter 42 and is positioned around the expandable member 44. Before each respective region unfolds, a sheath 70 protects the coatings 64, 66 on the second region 52 and the third region 54 of the cover 48.

[0118] like Figure 5B As shown, with the second region 52 of the cover 48 positioned around the expandable member 44, the expandable member 44 can be re-inflated. During re-inflation of the expandable member 44, a coating 64 on the outer surface of the second region 52 of the expandable member 44 can be applied to the body cavity at the treatment site. In some embodiments, the coating 64 on the second region 52 of the expandable member 44 may include paclitaxel. In some embodiments, the coating 64 may include a dense material. The dense material of the coating 64 can increase the coefficient of friction of the surface on which the coating 64 is positioned. The increased friction between the coating 64 and the vessel wall can scrape away plaque or other deposits from the vessel wall. The expandable member 44 can then deflate again, and the second region 52 of the cover 48 can be pulled through the cover lumen of the catheter 42 such that a third region 54 of the cover 48, including the coating 64, moves toward the distal end 46 of the catheter 42 and is positioned around the expandable member 44.

[0119] like Figure 5C As shown, when the second region 52 of the cover 48 is pulled through the cover lumen of the catheter 42, the third region 54 of the cover 48 moves toward the distal end 46 of the catheter 42 and is positioned around the expandable member 44. When the third region 54 of the cover 48 moves to the position surrounding the expandable member 44, a portion of the catheter 42 may be exposed at the proximal end 71 of the expandable member 44. Upon re-inflation of the expandable member 44, a coating 66 on the outer surface of the second region 60 of the expandable member 44 may be applied to the body cavity at the treatment site. In some embodiments, the coating 66 on the third region 54 may comprise heparin.

[0120] In some embodiments of the present disclosure, the covering 48 can include more or fewer regions. Further, the coatings 64, 66 on the surface of the covering 48 can be the same or different. Each of the coatings 64, 66 can be positioned on the outer surface 60 of the covering 48 without contacting each other. In some embodiments, a coating can be located on the surface of the first region 50 of the covering 48. In some embodiments, the bushing 70 can not be included. In some embodiments, the length of one or more of the first, second, third regions 50, 52, 54 of the covering 48 can be equal to or greater than the working length of the expandable member 44 when the expandable member 44 is inflated to the nominal diameter.

[0121] Embodiments having varying inflation profiles

[0122] Figures 6A to 6C A medical device 81 is depicted that includes an expandable member assembly 80 and a catheter 88 according to embodiments of the present disclosure. The expandable member assembly 80 can include a covering 82 positioned around an expandable member 84 at a distal section 85 of the catheter 88. The covering 82 can also extend along the length of the catheter 88 beyond the proximal end 87 of the expandable member 84. In some embodiments of the present disclosure, the covering can not completely surround the expandable member 84 and / or the catheter 88. In some embodiments, the covering can include or can be coupled to a string or strip of material at one end of the covering. The string or strip of material can be attached to an actuator (not shown) that can pull the covering into and through the covering lumen. In some embodiments, as shown, the covering 82 is turned inside out into the covering lumen at the distal end 86 of the catheter 88, although in some embodiments, the covering 82 can be turned inside out into the covering lumen at the proximal end 89 of the catheter 88. The end of the covering 82 that is turned inside out into the covering lumen at the distal end 86 of the catheter 88 can be coupled to an actuator (not shown) and can be moved through the covering lumen along the length of the catheter 88 toward the proximal end 89 of the catheter 88. Figures 6A to 6C

[0123] As Figure 6A ​As shown, the length of the covering 82 can be greater than the working length (W) of the expandable member 84 by a factor of two or more. The covering 82 can comprise ePTFE; for example, the covering can comprise an extruded ePTFE tube, a helically wound ePTFE tube, or a cigarette wound ePTFE tube. The covering 82 can comprise a first region 90, a second region 92, and a third region 94. In some embodiments, each of the first, second, and third regions 90, 92, 94 of the covering 82 can be substantially equal to the working length (W) of the expandable member 84. In some embodiments, the length of one or more of the first, second, and third regions 90, 92, 94 of the covering 82 can be approximately equal to the total length of the expandable member 84. In some embodiments, the length of one or more of the first, second, and third regions 90, 92, 94 of the covering 82 can be greater than or less than the total length of the expandable member 84 or the working length of the expandable member 84. In some embodiments, the length of one or more of the first, second, and third regions 90, 92, 94 of the covering 82 can be greater than the total length of the expandable member 84 or the working length of the expandable member 84. In some embodiments, the length of one or more of the first, second, and third regions 90, 92, 94 of the covering 82 can be less than the total length of the expandable member 84 or the working length of the expandable member 84. Figures 6A to 6C In the illustrated embodiment, the length of each of the first, second, and third regions 90, 92, 94 is approximately equal to the total length of the expandable member 84, for example, within 10% or 20% of the total length.

[0124] One or more of the first, second, and third regions 90, 92, 94 of the covering 82 can have a varying nominal diameter. In some embodiments, the radial strength of the first, second, and third regions 90, 92, 94 of the covering 82 can dictate the nominal diameter of each region of the covering 82. The covering 82 can comprise a single continuous material. In some embodiments, the covering 82 comprises a polymer having a node and fibril microstructure. See, e.g., U.S. Patent No. 3,962,153. A tube of such material can be placed over a mandrel, compressed longitudinally, and heat treated to maintain the compressed state (see, e.g., U.S. Patent No. 5,308,664). The amount of longitudinal compression dictates the radial strength. More longitudinal compression results in higher radial strength (i.e., higher compression ratio). The first, second, and third regions 90, 92, 94 of the covering can thus have discrete regions with varying amounts of longitudinal compression (compression ratio) and result in discrete regions of radial strength along the length of the covering. The varying radial strength will then dictate the inflation profile (e.g., nominal diameter) of the expandable member on which the covering 82 is positioned.

[0125] In another embodiment, radial expansion can be dictated by helically winding a film and then longitudinally compressing or necking the film to a reduced diameter. When the film is placed around a balloon and then expanded, the film will limit the radial expansion. In some embodiments, the diameter of the film at the inflation profile (i.e., at the nominal diameter) can be determined by the necking of the film.

[0126] In some embodiments, one or more of the first, second, and third regions 90, 92, 94 of the cover 82 can comprise a material that is resistant to expansion. In such embodiments, one or more of the first, second, and third regions 90, 92, 94 can have the same radial strength, and can have a varying nominal diameter defined by the diameter of the region. One or more of the first, second, and third regions 90, 92, 94 can comprise one or more pleats or folds when in a delivery configuration. The pleats or folds can unfurl when the respective region expands to the nominal diameter.

[0127] According to the present disclosure, embodiments of covers comprising discrete regions of radial strength can incorporate varying wall thicknesses and cross-sectional profiles. For example, a cover can have a circular, oval, triangular, square, rectangular, or polygonal cross-sectional shape along the length of the individual cover in different regions. A cover can also incorporate wall sections of varying thickness. Various cross-sectional profiles and various wall thicknesses can be combined along the length of an individual cover. Covers having discrete regions of radial strength according to certain aspects can also incorporate a lubricious coating, a drug eluting coating, an antimicrobial coating, a visualization aid, or other additives that enhance the functionality of the device at various regions along the length of the cover.

[0128] In some embodiments, the radial strength of the cover 82 can vary between the first, second, and third regions 90, 92, 94 of the cover 82. The cover 82 is positioned about the expandable member 84, and can limit the radial expansion of the expandable member 84 upon inflation to determine the nominal diameter of the expandable member 84. The varying radial strength of the first, second, and third regions 90, 92, 94 can determine the nominal diameter of the expandable member 84 when each of the first, second, and third regions 90, 92, 94 is positioned over the expandable member 84.

[0129] In some aspects, the nominal diameter of the individual regions (e.g., regions 90, 92, 94) of a cover (e.g., cover 82) can be selected to deliver a particular endoprosthesis. In such embodiments, one or more endoprostheses can be positioned along the individual regions of the cover for deployment in a lumen of the body. The one or more endoprostheses can have the same or varying lengths. In some embodiments, the one or more endoprostheses can have the same or varying diameters that can correspond to the nominal diameter of the region of the cover over which the respective endoprosthesis is disposed.

[0130] Figure 6AA first region 90 of a cover 82 positioned around an expandable member 84 is shown. The expandable member 84 and the cover 82 are inflated to a nominal diameter D1, which can be determined by the radial strength of the first region 90 of the cover 82 covering the expandable member 84. The nominal diameter D1 can be, for example, between approximately 2 mm and approximately 4 mm, between approximately 2 mm and approximately 5 mm, or between approximately 2 mm and approximately 6 mm. In some aspects, the nominal diameter D1 can be approximately 4 mm. The expandable member 84 can collapse, and the end of the cover 82 turned inward into the cover lumen of the conduit 88 can move through the cover lumen toward the proximal end 89 of the conduit 88. As the first region 90 of the cover 82 turns inward into the cover lumen and moves toward the proximal end 89 of the conduit 88, a second region 92 of the cover 82 can move along the conduit 88 toward the distal end 86, and the second region 92 can be positioned around the expandable member 84.

[0131] like Figure 6B As shown, with the second region 92 of the cover 82 surrounding the expandable member 84, the expandable member 84 can be re-inflated. The radial strength of the second region 92 can be less than the radial strength of the first region 90 of the cover 82. The lower radial strength of the second region 92 can constrain the expandable member 84 to a nominal diameter D2 greater than the nominal diameter D1, optionally by 1% to 30%, for example, by 1% to 10%. For example, the expandable member 84 can be constrained to a nominal diameter between approximately 3 mm and approximately 4 mm, between approximately 3 mm and approximately 5 mm, or between approximately 3 mm and approximately 6 mm. In some aspects, the nominal diameter D2 can be approximately 5 mm. The expandable member 84 can collapse, and the cover 82 can be further pulled through the cover lumen of the conduit 88 toward the proximal end 89 of the conduit 88. The cover 82 can be pulled through the cover lumen of the conduit 88 until the third region 94 of the cover 82 is positioned around the expandable member 84. The radial strength of the third region 94 of the cover 82 may be lower than that of the second region 92 of the cover 82.

[0132] like Figure 6C As shown, with the third region 94 of the cover 82 surrounding the expandable member 84, the expandable member 84 can be re-inflated. The radial strength of the third region 94 can be less than the radial strength of the second region 92 of the cover 82. The lower radial strength of the third region 94 can constrain the expandable member 84 to a nominal diameter D3 greater than the nominal diameter D2, optionally by 1% to 30%, for example, by 1% to 10%. For example, the expandable member 84 can be constrained to a nominal diameter between approximately 4 mm and approximately 5 mm, between approximately 4 mm and approximately 6 mm, or between approximately 4 mm and approximately 7 mm. In some aspects, the nominal diameter D3 can be approximately 6 mm. Although inFigures 6A to 6C Three regions of the cover 82 are shown, but the cover 82 can include more or fewer regions. In some embodiments, multiple regions of the cover 82 can have different inflation profiles, such as but not limited to different nominal diameters, different working lengths, and / or different inflated shapes. In other embodiments, multiple regions of the cover 82 can have different inflation sequences along different portions of each of the regions 90, 92, 94 of the cover 82.

[0133] Various expandable member profiles can be obtained by using a cover having discrete regions with varying radial strength or varying nominal diameter along a portion of the cover over the expandable member. In some embodiments of the present disclosure, the discrete regions of radial strength along a portion of the cover can dictate the expansion profile or expansion sequence of an underlying expandable member. In some embodiments, the cover can be configured to have a weaker (or easier to expand) region and at least one stronger (or more difficult to expand) region along a portion of the cover over the expandable member.

[0134] In some embodiments, an expandable member positioned under a region of the cover can first be inflated at one end (at a first pressure) and then gradually inflated along the length of the expandable member at a higher pressure. The cover or regions of the cover can have 2, 3, 4, 5, 6, 7, 8, 9, 10, or more discrete regions of varying radial strength. The individual discrete regions of radial strength can be arranged in any desired sequence along a single region or multiple regions of the cover. The radial strength of the discrete regions can also be individually adjusted to expand at any desired pressure. The discrete regions of radial strength can be combined with non-expandable regions or regions of very low radial strength. The controlled expansion profile or expansion sequence can be used to achieve or improve various medical and industrial applications. In some embodiments, the inflation profile and / or inflation sequence of the regions of the cover 82 can be used to deliver a particular endoprosthesis. In some embodiments, multiple endoprostheses can be delivered using a single assembly having a cover including multiple regions. In some embodiments, multiple endoprostheses can be expanded via the same or different expansion profiles, with each expansion profile dictated by the portion of the cover over which the endoprosthesis is disposed. Each endoprosthesis can be positioned over a region of the cover having a desired expansion profile for the particular endoprosthesis disposed thereon.

[0135] Embodiments having varying surface topography

[0136] In some embodiments, the expandable member assembly of a medical device can have a variable topography. The topography of the expandable member assembly can affect the physical interaction between the expandable member assembly and the body or devices inside the body. The ability to control the topography, or three-dimensional surface features, of the expandable member assembly allows the expandable member assembly to interact with the body in new or improved patterns. An expandable member assembly used inside the body can generally interact with the body by contact with the outer surface of the expandable member of the expandable member assembly, or in some embodiments, the outer surface of the covering of the expandable member assembly.

[0137] In some embodiments, the expandable member assembly can have a varying topography and preconfigured surface texture defined by the region of the covering positioned around the expandable member. In some embodiments, the texture of the covering can vary along the length of the covering. For example, the textured network can include beads, filaments, fibers, loops, weaves, knits, and / or braids, which can be wrapped or otherwise disposed on or within the covering. The textured network creates a raised surface pattern that can provide a therapeutic effect. In some embodiments, the therapeutic effect can be provided to the lumen wall prior to deployment of the endoprosthesis. In some embodiments, the therapeutic effect can be provided to the lumen wall after deployment of the endoprosthesis. In some embodiments, the therapeutic effect can be provided both before and after deployment of the endoprosthesis. The endoprosthesis can be deployed with the same assembly that provides the therapeutic effect, without the need to remove the assembly from the lumen.

[0138] In some embodiments, the region of the covering includes at least one aperture and a portion that is more resistant to deformation in the radial direction than the expandable member, either because the covering includes a less compliant material or has a lower upper limit of expansion than the expandable member. In this way, the expandable member is configured to expand around the aperture beyond the covering at a given volume / pressure. In some embodiments, the covering can have a varying topography surface at various points along the length of the covering. In some embodiments, a therapeutic agent can be located within the aperture, preferably in solid or viscous form. When inflated, the underlying expandable member will protrude through the aperture of the covering and deliver the therapeutic agent outside of the covering. In this way, the therapeutic agent can be delivered to the surrounding tissue, such as the intima of a blood vessel.

[0139] Figures 7A to 7D A side view of a medical device 100 including an expandable member assembly 101 positioned on a catheter 106 is depicted in accordance with embodiments of the present disclosure. Figures 7A to 7DAn expandable member assembly 101 having varying topography in various inflated states is shown. The expandable member assembly 101 includes an expandable member 102 and a cover 104. The expandable member 102 and the cover 104 can be attached to a catheter 106. The catheter 106 is in fluid communication with the expandable member 102 such that fluid can be introduced into the expandable member 102 through the catheter 106. The catheter 106 can be coupled to any suitable medical device, such as a syringe, an indeflator, a pump, or any other device for directing fluid through the catheter 106 and into the expandable member 102.

[0140] The cover 104 is disposed on an outer surface of the expandable member 102 and extends proximally from a proximal end 110 of the expandable member 102 along a length of the catheter 106 toward a proximal end 112 of the catheter 106. The length of the cover 104 can be two, three, four, or more times greater than (two, three, four, or more times the length of) the total length of the expandable member 102. In some embodiments, the length of the cover 104 can be two, three, four, or more times greater than (two, three, four, or more times the length of) the working length of the expandable member 102 at a nominal diameter. The cover 104 can include a first region 114, a second region 116, and a third region 118, and terminate at a proximal end 109. Each of the first region 114, the second region 116, and the third region 118 of the cover 104 can extend along the expandable member 102 and along the length of the catheter 106 beyond the proximal end 110 of the expandable member 102.

[0141] The first region, the second region, and the third region 114, 116, 118 of the cover 104 can have different characteristics as shown Figures 7A to 7D The sheath 119 can surround at least a portion of the first region, the second region, and the third region 114, 116, 118 of the cover 104. In some embodiments, the sheath 119 can protect a coating on a surface of the cover 104. In some embodiments, the sheath 119 can hold a portion of the cover 104 at a desired diameter, for example, the sheath 119 can hold the second region and the third region 116, 118 of the cover 104 at a desired diameter that is less than a delivery diameter of the second region and the third region 116, 118 of the cover 104.

[0142] As Figure 7AAs shown, a first region 114 of the cover 104 may include at least one hole 120. The first region 114 of the cover 104 may constrain a region of the expandable member 102 during inflation. The constraining effect of the first region 114 of the cover 104 causes the expandable member 102 to expand at the hole 120 in the first region 114 of the cover 104. Figure 7A As shown, the diameter of the portion of the expandable member 102 that expands through the hole 120 in the first region 114 of the cover 104 is shown as "D1". Figure 7A As shown, a first region 114 of the cover 104 positioned over the expandable member 102 has a diameter of “D2”. The hole 120 may include an opening or a weakened portion in the first region 114 of the cover 104. In this respect, an opening may be a hole, a cut, or any other discontinuity in the material of the first region 114 of the cover 104. For example, a hole may be formed by piercing the first region 114 of the cover 104. Alternatively, the hole 120 may include a segment of the first region 114 in which a region of material has been removed or otherwise weakened, such that the weakened region deforms or detaches at least partially in response to the inflation of the expandable member 102, and allows inflation beyond a first inflation state. The hole 120 may be formed by any suitable means, including cutting, punching, laser cutting, piercing, and / or punching / piercing, etc. In various embodiments, the first region 114 of the cover 104 may include a mesh structure.

[0143] In some embodiments, the therapeutic agent may be disposed on the inner or outer surface of the expandable member 102, on a portion of the cover 104, or disposed within the expandable member 102. For example, a coating comprising the therapeutic agent may be applied to the outer surface 108 of the expandable member 102. When the expandable member 102 protrudes through the orifice 120, the therapeutic agent may be released in a localized portion of the body cavity. The therapeutic agent may comprise a liquid or solid form. The liquid form may have a desired viscosity suitable for the desired treatment. In some embodiments, the expandable member assembly 101 may also have a coating comprising the therapeutic agent disposed on, disposed within, configured to temporarily fill, or otherwise integrated with one or more of the first, second, and third regions 114, 116, 118 of the cover 104.

[0144] The expandable member 102 can include any suitable compliant expandable member. As noted above, the compliant expandable member can include a polymeric material. Example materials for compliant (compliant) expandable members include elastomers, such as polyurethane and silicone, natural rubber or latex products, synthetic rubbers, such as nitrile, or other synthetic or naturally occurring polymeric materials. In various embodiments, the expandable member 102 can not be fully compliant (not fully compliant), but more compliant (more compliant) than the first region 114 of the cover 104 and sufficiently flexible to inflate to a diameter greater than the diameter of the first region 114 constraining the expandable member 102 under a given pressure and thereby create the protrusion 122 of the expandable member 102. Thus, semi-compliant or non-compliant (semi-compliant or non-compliant) expandable members can be used. Optionally, the first region 114 of the cover 104 can include varying sized apertures. Increasing the size of the apertures can allow for wider (or "fatter") protrusions. By combining varying sized apertures with a tapered cover profile, the "scraping" effect of the assembly can be enhanced from proximal to distal, or vice versa, due to the varying protrusion height of the expandable member 102.

[0145] In some embodiments of the present disclosure, the first region 114 of the cover 104 can include a wall having a region with a reduced or lesser compliance than other, more distensible regions of the wall. The other regions are substantially primarily "apertures" that allow the underlying expandable member 102 to expand outwardly relative to the reduced or lesser compliance region of the first region 114 of the cover 104. The more distensible regions can include an upper limit of distension. The reduced compliance region can be formed by laser densification or by absorption of a polymer that reduces compliance in the absorption region. In one embodiment, the reduced compliance region has substantially the same thickness as the more distensible regions. Similarly, other embodiments described herein, the first region 114 of the cover 104 can be formed via tape wrapping or extrusion and can include ePTFE or any other material whose compliance can be varied at discrete locations.

[0146] In various embodiments of the present disclosure, the first region 114 of the cover 104 can include any form of dimensional restriction that acts to constrain the expandable member 102 along the contact points. Alternatively, the first region 114 of the cover 104 can include a form that is more non-compliant (more non-compliant) than the expandable member 102 such that the expandable member 102 is constrained along the contact points. As such, the first region 114 of the cover 104 can be comprised of any material that does not significantly deform beyond the first inflated state during inflation of the expandable member 102.

[0147] With the described components, the compliance of at least a portion of the cover can be adapted and / or the pattern of the apertures along at least a portion of the cover can be adapted to control the topography of the expandable member assembly. For example, the pattern of apertures can include many small apertures to achieve a "fine texture" pattern, or can include fewer larger openings to achieve a more "coarse texture" pattern. It will be appreciated that any possible pattern of apertures or combination of patterns of apertures are contemplated herein. For example, a first region of the cover can include a checkerboard pattern of apertures, and a second region of the cover can include a diamond pattern.

[0148] In other embodiments of the present disclosure, the expandable member extending through the cover can define ridges and troughs, for example, extending parallel to the longitudinal axis of the expandable member. In one embodiment, these provide blood perfusion between the expandable member and the vessel wall when the expandable member is expanded during treatment. In some embodiments, the first region 114 of the cover 104 can not include apertures 120. In some embodiments, the first region 114 of the cover 104 can include only a therapeutic agent coating, for example, but not limited to, a drug coating.

[0149] Figure 7A A first region 114 of the cover 104 is depicted around the expandable member 102 in an inflated profile. As shown in Figure 7B The expandable member 102 can be deflated and the first region 114 of the cover 104 can be everted into the cover lumen of the catheter 106 and can be pulled toward the proximal end 112 of the catheter 106 by an actuator (not shown). As the first region 114 of the cover 104 is pulled through the cover lumen of the catheter 106, the second region 116 of the cover 104 moves from its position around the catheter 106 and becomes positioned around the expandable member 102. The surface topography of the second region 116 of the cover 104 can be different from the first region 114 of the cover 104.

[0150] In some embodiments, as shown in Figure 7B The second region 116 of the cover 104 can include a plurality of scored sections 124. Upon inflation, as shown in Figure 7B The scored sections 124 will partially separate from the surface 126 of the cover 104 and will form outwardly extending protrusions. The broken sections of the cover 104 resulting from the breaking of the scores 124 form apertures 128 in which the expandable member 102 can be at least partially exposed. In various embodiments, one or more of the scores 124 can be formed as a through cut in the material of the second region 116 of the cover that does not necessarily break in order to achieve the desired effect.

[0151] The scoring and subsequent breaking of the score can enable the sharp object to be inserted into the body in a substantially unsharpened state and then provide for deployment (expansion) of the sharp object at a particular time. In addition, the scoring and subsequent breaking can facilitate delivery of a therapeutic agent. For example, a therapeutic agent can be disposed between the expandable member 102 and the second region 116 of the covering 104. The covering 104 can seal the therapeutic agent above the expandable member 102 such that, when placed into the body, the therapeutic agent is substantially maintained in the space between the expandable member 102 and the covering 104. When the scored portion 124 of the covering 104 breaks, the therapeutic agent can be released into a local portion of the body. In some embodiments, the second region 116 of the covering can remove plaque and / or other deposits from the lumen wall. In some embodiments, a therapeutic coating can be applied to the lumen wall through the first region 114 without removing the medical device 100 from the lumen, prior to removing plaque and / or other deposits from the wall with the scored portion 124 of the second region 116 of the covering 104.

[0152] The expandable member 102 can be deflated and the second region 116 of the covering 104 can be pulled through the covering lumen of the catheter 106. As the second region 116 is inverted into the catheter 106 and moved toward the proximal end 112 of the catheter, the third region 118 of the covering 104 can be moved from under the sheath 119 to surround the expandable member 102 (as shown in Figure 7C Figure 7A As shown in Figure 7C When the covering 104 is moved, the proximal end 109 of the covering 104 is now positioned closer to the expandable member 102. In some embodiments, as shown in Figure 7C The third region 118 of the covering 104 can include varying radial strength along the length of the third region 118 of the covering 104 to define an order of inflation of the third region 118 when positioned over the expandable member 102, as shown in

[0153] When the underlying expandable member 102 is inflated, the middle portion 134 of the third region 118 having the lower radial strength can expand and thus allow the expandable member 102 to expand while the first and second ends 130, 132 of the third region 118 are constrained at the smaller diameter and thereby constrain the expandable member 102 at the smaller diameter. When the expandable member 102 is inflated to a greater pressure, the first and second ends 130, 132 of the third region 118 of the covering 104 can expand, allowing the expandable member 102 to also expand, to a larger diameter, as shown in​Figure 7D The swelling is shown in the figure.

[0154] like Figures 7C to 7D As shown, the expandable member 102 placed under the third region 118 of the cover 104 can first expand to the nominal diameter at the middle portion 134 of the third region 118, and as the pressure increases, the expandable member 102 can expand to the nominal diameter at the first end and the second end 130, 132 of the third region 118. Figure 7C and 7D The expansion sequence shown can be used to realize or improve various medical and industrial applications. For example, a stent that is prone to longitudinal compression during expansion can be expanded by an expandable member and cover as described in embodiments of this disclosure. The stent can expand outward from the center, thus maintaining longitudinal tension of the stent during expansion. An example of such a stent is described in U.S. Patent Application Publication No. 2009 / 0182413. Longitudinal tension prevents the stent from being longitudinally compressed. The cover may be configured to control the expansion sequence of the underlying expandable member to inflate in such a sequence according to the type of stent, the size of the stent, or other stent features that may define a desired inflation sequence for the stent to be delivered. In some embodiments, multiple regions of the cover may be configured to deliver a particular stent. In some embodiments, the cover may be configured to deliver multiple stents of the same stent type via varying regions of the cover. In some embodiments, various regions of the cover may be configured to deliver multiple different stents.

[0155] In other embodiments, the radial strength of each portion of the third region 118 may differ from that of the others. Figure 7C and 7D The embodiments shown are used to determine different expansion profiles or sequences for a lower (or upper) expandable element. For example, in some embodiments, the opposite (opposite) configuration of the third region 118 of the cover 104 can cause the expandable member 102 to expand from the ends 130, 132 toward the middle portion 134, thereby compressing the covered device. Heart valve stents may require stents that expand in a specific “hourglass” shape, where the hourglass shape develops in a specific sequence. In other applications, expansion may begin at one end of the expandable member 102 and develop to the opposite end, thereby producing a “push” or peristaltic movement. In some embodiments, a coating may be positioned on one or more of the first region 114, the second region 116, and the third region 118. The coating may include a therapeutic agent, as described above in the title " Therapeutic agent Examples of this treatment are provided below.

[0156] In some embodiments of the present disclosure, one or more regions of the covering can also affect the general profile of the expandable member over which the covering is positioned. For example, in the first inflated state, a first region of the covering positioned around the expandable member assembly can have a diameter that is larger or smaller than the diameter at different locations along the expandable member, for example, to form a tapered shape. Thus, although the expandable member can be inflated in a cylindrical shape, one of the regions of the covering can have a non-cylindrical shape, and that non-cylindrical shape can be the general profile of the expandable member assembly when the expandable member is inflated and the region of the covering has the non-cylindrical shape. For example, such a generally tapered profile can be used to better conform to, for example, a cardiovascular vessel diameter that varies with length. Additionally, due to the change in profile size, injury or thrombus "scraping" effects of the expandable member assembly can be enhanced from proximal to distal, or vice versa from distal to proximal.

[0157] Figures 8A to 8B A medical device 200 including an expandable member assembly 201 according to embodiments of the present disclosure is depicted. The expandable member assembly 201 includes a covering 204 covering an expandable member 202. The medical device 200 can include a catheter 206 to which the expandable member 202 and the covering 204 are attached. The catheter 206 can be in fluid communication with the expandable member 202 such that fluid can be introduced into the expandable member 202 through the catheter 206. The covering 204 is disposed on an outer surface of the expandable member 202 and extends beyond a proximal end 208 of the expandable member 202 along a length of the catheter 206 toward a proximal end 210 of the catheter 206. The length of the covering 204 can be two, three, four, or more times greater than (two, three, four, or more times the working length of the expandable member at a nominal diameter). A sheath 212 can be disposed around at least a portion of the covering 204 extending along the catheter 206.

[0158] The covering 204 can include a first region 214 and a second region 216. In some embodiments, the covering 204 can include more or fewer regions. The first region 214 and the second region 216 can have different characteristics, including varying nominal diameters, varying surface topographies, and / or varying coatings. In some embodiments, the first region 214 and the second region 216 can have the same characteristics. Figures 8A to 8B In the illustrated embodiment of the present disclosure, the first region 214 of the covering 204 can include apertures 218. The first region 214 of the covering 204 can constrain a region of the expandable member 202 during inflation. The constraining effect of the first region 214 of the covering 204 causes the expandable member 202 to expand through the apertures 218 in the first region 214 of the covering 204.

[0159] During treatment of the lesion, the expandable member assembly 201 can be inflated at the treatment site. The expandable member assembly 201 can be inflated while a first region 214 of the cover 204 is positioned around the expandable member 202. After treatment of the treatment site using the textured surface of the expandable member assembly 201, the expandable member 202, defined by the first region 214 and the expandable member 202, can be deflated. The cover 204 can be pulled through a cover lumen in the catheter 206 and moved through the cover lumen towards the proximal end 210 of the catheter 206. As the first region 214 of the cover 204 is pulled out from the expandable member 202 and through the cover lumen, a second region 216 of the cover 204 is pulled out from under the sheath 212 and moved into place around the expandable member 204. The second region 216 of the cover 204 may include a coating 220. The coating 220 may include a therapeutic agent. During the initial placement of the expandable component assembly 201 at the treatment site and during the unfolding of the expandable component assembly 201 and the positioning of the first region 214 around the expandable component 202, the coating 220 can be protected by the sheath 212.

[0160] like Figure 8B As shown, with the second region 216 of the cover 204 positioned around the expandable member 202, the expandable member 202 can be re-inflated. Figure 8B In the inflated state shown, when the expandable member 202 expands with the second region 216 of the cover 204 positioned around the expandable member 202, the coating 220 on the second region 216 of the cover 204 can contact and be delivered to the treatment site.

[0161] In some embodiments of this disclosure, the features of the first region 214 and the second region 216 may be related to... Figure 8A , 8B The features shown may differ. For example, one or both of the first region 214 and the second region 216 may provide a different surface topography, a specific inflation sequence (e.g., inflation from the middle region of the expandable member outwards to the ends), a specific inflation shape (e.g., a consistent diameter along the working length of the expandable member), or other features associated with the inflation profile of the expandable member assembly. In some embodiments, one or both of the first region 214 and the second region 216 of the cover 104 may also include a coating, which includes a therapeutic agent, a hydrophilic coating, a hydrophobic coating, or other suitable coating for the expandable member assembly. Various combinations of therapeutic agents, textures, inflation profiles, and prostheses may be used on regions 214, 216 of the cover 104.

[0162] Figure 10A and 10BA cross-sectional elevation view of a portion of an expandable member assembly 300 of a medical device according to embodiments of the present disclosure is shown. The expandable member assembly 300 includes an expandable member 302 and a covering 304. Figure 10A The expandable member 302 is shown in an un-inflated state, and Figure 10B The expandable member 302 is shown in a partially inflated state. The covering 304 can include two or more regions. Each of the two or more regions of the covering 304 can have different characteristics. For example, in Figure 10A and 10B A first region 305 of the covering 304 covering the expandable member 302 can include a radial strength or other characteristic configured to control the diameter of the covering 304, and thereby control the diameter of the underlying expandable member 302 when the expandable member 302 is inflated. As shown in Figure 10A The expandable member 302 in a deflated or partially deflated configuration can include a pleat or wing 306. Although two wings 306 are shown in Figure 10A In some embodiments, more or fewer wings can be used, such as but not limited to 5 or 6. In some embodiments, the pleats or wings 306 can be oriented along a longitudinal axis of the expandable member 302, in other embodiments, the pleats or wings 306 can be oriented along an axis perpendicular to the longitudinal axis described above. As the expandable member 302 inflates, the wings 306 can deploy. The torsional stress of the deployed wings 306 can exert a force or stress on the walls of the blood vessel in which the wings 306 are deployed. The first region 305 of the covering 304 covering the expandable member 302 can control the expansion of the expandable member 302, and can prevent the wings 306 from exerting potentially damaging stresses on the walls of the blood vessel as the wings 306 deploy. In some embodiments, another region (not shown) of the covering 304 can include different characteristics, such as but not limited to a coating, a different radial strength, or a different surface topography. The other region (not shown) of the covering 304 can be positioned around the expandable member 302 before or after the first region 205, and can include different characteristics than the first region 205. For example, the other region of the covering 304 can include a coating, a surface topography, a varying radial strength along the length of the other region, a different coefficient of friction on the surface of the other region, or other characteristics. The covering 304 can be inverted into the covering lumen 308 of the catheter 310 and moved along the longitudinal axis of the catheter 310 to position the other region of the covering 304 over the expandable member 302. In some embodiments, the covering 304 can include additional regions having the same or different characteristics as the other region of the covering 304.

[0163] Figure 11A side view of a medical device including an expandable member assembly 350 and a catheter 353 according to embodiments of the present disclosure is depicted. The expandable member assembly 350 includes a covering 352 positioned about at least a portion of an expandable member 354. The covering 352 also extends beyond a proximal end 355 of the expandable member 344 along a length of the catheter 353 toward the proximal end 355 of the catheter 353. The covering 352 can include a first region 357, as shown, that surrounds the expandable member 354. The covering 352 also includes a second region 358 that extends along the length of the catheter 353. The length of each of the first region 357 and the second region 358 can be approximately equal to the total length of the expandable member 354, in some embodiments one or more of the first region 357 and the second region 356 can have a different length. A sheath 360 is positioned about at least a portion of the second region 358 of the covering 352. The sheath 360 can include a polymeric material or any other suitable material. In some embodiments, the first region 357 and the second region 358 of the covering 352 can have different characteristics such as, but not limited to, different radial strength, different surface texture, different surface topography, and / or different coatings. Figure 11

[0164] ​In embodiments of the present disclosure, the first region 357 of the covering 352 can include a microstructure of variable permeability. At least one hydrophilic coating containing at least one therapeutic agent can be disposed on the expandable member 354. During use, with the first region 357 positioned about the expandable member 354, the underlying hydrophilic coating becomes hydrated or partially hydrated and facilitates the transfer of fluid across the first region 357 of the covering 352. However, the closed microstructure of the first region 357 in the unexpanded state prevents unwanted premature release of the therapeutic agent when in the unexpanded state. Upon expansion, the orientation or configuration of the microstructure of the material comprising the first region 357 shifts from a substantially closed microstructure to a substantially open microstructure, allowing the hydrated or partially hydrated coating to transfer outward, the first region 357 being disposed over the expandable member. This feature of the microstructure of the material is one embodiment of a microstructure of variable permeability. Once the hydrated or partially hydrated hydrophilic coating passes through the first region 357 of the covering 352, the therapeutic agent is delivered to the treatment site. In one embodiment, the hydrated or partially hydrated coating includes the therapeutic agent, and upon expansion of the first region 357, the therapeutic agent is transferred through the first region 357 of the covering 352. In another embodiment, the first region 357 of the covering 352 has a relatively closed microstructure when there is no strain on the outer sheath. In another embodiment, the first region 357 has a more open microstructure when the first region 357 is under strain (i.e., under strain diametrically). The strain on the first region 357 can be imparted by the underlying expandable member during expansion.

[0165] Materials that can exhibit microstructures that exhibit variable permeability are known in the art. These include, but are not limited to, fibrillated structures such as expanded fluoropolymers (e.g., ePTFE) or expanded polyethylene (as described in U.S. Patent 6,743,388); fibrous structures (such as woven or braided fabrics; nonwoven mats of fibers, microfibers, or nanofibers; materials made from processes such as electrospinning or rapid spinning; polymeric materials composed of melt or solution processable materials such as fluoropolymers, polyamides, polyurethanes, polyolefins, polyesters, polyglycolic acid (PGA), polylactic acid (PLA), and trisalkyl carbonate (TMC), etc.; thin films with openings created during processing (e.g., laser or mechanical drilling); open cell foams; microporous membranes made from materials such as fluoropolymers, polyamides, polyurethanes, polyolefins, polyesters, PGA, PLA, TMC, etc.; porous polyglycolide-trimethylene carbonate copolymer (PGA:TMC) materials (as described in U.S. Patent 8,048,503); or combinations of the above. Processes of the above materials can be used to modulate, enhance, or control the permeability between the first closed state and the second expanded state. Such processes can assist in closing the microstructure in the first state (thus presenting a lower magnetic permeability), can assist in opening the microstructure in the second state, or a combination of both. Such processes that can assist in closing the microstructure can include, but are not limited to: calendering, coating (discontinuous or continuous), compaction, densification, coalescing, thermal cycling, or retraction, and the like. Such processes that can assist in opening the microstructure can include, but are not limited to: expansion, perforation, slitting (cutting out slots), patterned densification and / or coating, and the like. In another embodiment, the material includes micropores between nodes interconnected by fibrils, such as in ePTFE. In another embodiment, the material includes micropores in substantially nodeless ePTFE, as described in U.S. Patent 5,476,589.

[0166] Once the therapeutic agent has been eluted through the first region 357 by expansion of the first region 357 of the covering 352, the expandable member can be deflated and the covering 352 can be pulled through the covering lumen of the catheter 353 to move the second region 358 into position around the expandable member 354. The permeable microstructure of the second region 358 can be different than the first region 357. In some embodiments, the second region 356 can have a different nominal diameter, a different surface topography, a different inflation profile, a different inflation sequence, and / or an additional coating on the surface of the second region 356 than the first region 357.

[0167] Figure 12A medical device 400 is depicted including an expandable member assembly 402 and a catheter 404 according to embodiments of the present disclosure. The expandable member assembly 402 may include a cover 406 positioned around the expandable member 408 at a distal segment 410 of the catheter 404. The cover 406 may extend along the length of the catheter 404 beyond the proximal end 412 of the expandable member 408. In some embodiments, the cover 406 may not completely surround the expandable member 408, as shown at the distal end 414. The cover 406 may not completely surround the catheter 404. Figure 12 In the illustrated embodiment, the expandable component assembly 402 may include one or more wires 416. These wires 416 may be inverted within the lumen of the conduit 404 and may be attached to an actuator (not shown) that may pull the cover 406 into and through the cover lumen of the conduit 404. In some embodiments, one or more wires 416 are integral with the cover 406. In some embodiments, one or more wires 416 are coupled to the cover 406.

[0168] Figure 13 A medical device 500 is depicted including an expandable member assembly 501 according to embodiments of the present disclosure. The expandable member assembly 501 includes a cover 502 covering an expandable member 504. The medical device 200 may include a catheter 506, to which the expandable member 504 and the cover 502 are attached. The catheter 506 may be in fluid communication with the expandable member 504, allowing fluid to be introduced into the expandable member 504 through the catheter 506. The cover 502 is disposed on the outer surface of the expandable member 504 and extends along the length of the catheter 506 toward the proximal end 510 of the catheter 506 beyond the proximal end 508 of the expandable member 504. The length of the cover 502 may be two, three, four, or more times greater than the working length of the expandable member 502 at its nominal diameter. Although not explicitly stated... Figure 13 As shown in the figure, but in some embodiments, a sheath may be provided around at least a portion of the cover 502 extending along the conduit 506.

[0169] The covering 502 may include multiple regions, such as, but not limited to, a first region 512, a second region 514, a third region 516, and a fourth region 518. In some embodiments, the covering 502 may include more or fewer regions. The various regions 512, 514, 516, and 518 may have the same or different characteristics, including nominal diameter, surface morphology, embedded prosthesis, and / or therapeutic coating. Figure 13In embodiments of the present disclosure shown in FIG. 5, the first region 512 of the covering 502 can include features that serve as a pre-treatment to the vessel wall prior to delivery of an endoluminal prosthesis (e.g., a stent) via a different region of the covering 502. In some embodiments, the features that serve as a pre-treatment can include a therapeutic coating (e.g., paclitaxel), a surface topography (e.g., a surface topography for removing plaque and / or other deposits from the vessel wall), or other suitable pre-treatment features. In certain embodiments, the pre-treatment can impart a vibration to the expandable member 504, and in such embodiments, the first region 512 can be a strip or a line of the covering 502 and can not surround the entire expandable member 504. In some embodiments, the surface topography of the first region 512 can include holes through which the expandable member 504 can expand and contact the vessel wall.

[0170] After the expandable member 504 is expanded to provide the pre-treatment of the first region 512 of the covering 502 with the first region 512 positioned about the expandable member 504, the expandable member 504 can be deflated and the covering 502 can be pulled through the covering lumen in the catheter 506 and moved through the covering lumen toward the proximal end 510 of the catheter 506. As the first region 514 of the covering 502 is pulled out of the expandable member 504 and through the covering lumen, the second region 514 of the covering 502 moves into position about the expandable member 504.

[0171] With the second region 514 positioned around the expandable member 504, the expandable member 504 can be re-inflated. The second region 514 of the cover 502 can include an endoprosthesis, such as but not limited to a stent 520. The stent 520 can be positioned around the second region 514 of the cover 502 and can be positioned around the expandable member 504 when the second region 514 is positioned around the expandable member 504. The stent 520 can be a self-expanding stent (a type of expandable stent that expands by expansion of the expandable member) or any other suitable stent type, although other types of endoprostheses can be used in some embodiments. With the second region 514 of the cover 502 positioned around the expandable member 504, the stent 520 can be deployed within the vessel wall. In some embodiments, the second region 514 of the cover 502 can also have a specific inflation order (e.g., inflate from the middle region out to the ends of the expandable member), a specific inflation shape (e.g., a uniform diameter along the working length of the expandable member), or other characteristics associated with the inflation profile of the expandable member assembly, which can correspond to the type of endoprosthesis being deployed (e.g., inflate from the center out, or from the ends in). With the stent 520 deployed, the expandable member 504 can be deflated and the second region 514 can be pulled through the cover lumen of the catheter 506 to position a third region 516 of the cover 502 around the expandable member 504.

[0172] With the third region 516 positioned around the expandable member 504, the expandable member 504 can be re-inflated. The third region 516 of the cover 502 can include features that serve as a post-treatment to the vessel wall after delivery of an endoprosthesis, such as the stent 520. The features that serve as a post-treatment can include a therapeutic coating, such as but not limited to a therapeutic coating that minimizes stent restenosis, a therapeutic coating that provides an anti-inflammatory effect, a statin, an atherosclerosis reversal, or other suitable post-treatment features. With the expandable member 504 re-inflated with the third region 516 positioned around the expandable member 504, the third region 516 can contact the vessel wall and provide a post-treatment to the vessel wall. In some embodiments, the cover 502 can not include a region for providing a post-treatment. In other embodiments, the cover 502 can include multiple regions for providing one or more post-treatments after delivery of an endoprosthesis. After the expandable member 504 is inflated and expanded for providing a post-treatment with the third region 516 positioned around the expandable member 504, the expandable member 504 can be deflated and the cover 502 can be pulled through the cover lumen of the catheter 506 to position a third region 516 of the cover 502 around the expandable member 504.

[0173] With the fourth region 518 positioned around the expandable member 504, the expandable member 504 can be re-inflated. The fourth region 518 of the cover 502 can include another endoprosthesis, such as but not limited to an additional stent 522. The additional stent 522 can be the same type of stent as the stent 520, or can be a different type than the stent 520. In some embodiments, the stent 522 can be the same type of stent as the stent 520, but can have a different diameter and / or a different length. With the fourth region 518 of the cover 502 (including the additional stent 522) positioned around the expandable member 504, the expandable member 504 can be inflated and the stent 522 can be deployed within the vessel wall. In some embodiments, the fourth region 518 of the cover 502 can also have a particular inflation order (e.g., inflate from the middle region outward to the ends of the expandable member), a particular inflation shape (e.g., a uniform diameter along the working length of the expandable member), or other characteristics associated with the inflation profile of the expandable member assembly, which can correspond to the type of endoprosthesis being deployed (e.g., inflate from the center outward, or from the ends inward). With the additional stent 522 deployed, the expandable member 504 can be deflated and the medical device 500 can be removed from the patient's vessel. As described above with reference to Figure 13 , the medical device 500 including the cover 504 can allow for multiple treatments (a plurality of treatments) of the vessel wall without removing the medical device 500, such as but not limited to providing a pre-treatment, deployment of a stent, a post-treatment, and deployment of an additional stent. In some embodiments, the cover 504 can include more or fewer regions, and each of the characteristics of the regions of the cover 504 can be changed, removed, or otherwise altered. In some embodiments, additional endoprostheses can be deployed, different pre-treatments and / or post-treatments can be applied, additional or fewer pre-treatments or post-treatments can be applied, and / or other changes to the characteristics of the regions of the cover 504 can be made.

[0174] The cover of the expandable member assembly can include multiple regions with the same or different features as described herein. The following chart provides examples of various combinations of the features described above with respect to one or more embodiments of the disclosure. The following chart is not an exhaustive list of potential combinations as additional combinations of features are contemplated by the disclosure. Further, "Region 1," "Region 2," "Region 3," and "Region 4" as described below do not refer to any order of placement of the regions along the length of the catheter. For example, Region 3 can be positioned adjacent to Region 1 and Region 4. "Region 1," "Region 2," "Region 3," and "Region 4" also do not indicate a deployment order during use. Additionally, when used in the same instance, "Drug 1," "Drug 2," "Drug 3," "Drug 4" are used to identify different drugs. Thus, each of Drug 1, Drug 2, Drug 3, and Drug 4 in a single embodiment is optionally selected from the non-exclusive list of drugs provided above under the heading "Non-Exclusive Drug List" as long as each of Drug 1, Drug 2, Drug 3, and Drug 4 is different in each example in which it appears. Thus, "Drug 1" or similar notation (e.g., "Shape 1," "Texture 1," "Endoprosthesis 1") repeated in a single embodiment refers to the same drug (or other feature) within a single embodiment, but each such term does not refer to the same drug (shape or texture) between embodiments. For example, "Drug 1" in Example No. 1 can be different than "Drug 1" in Example No. 2, similarly, "Shape 1" in Example No. 2 can be different than "Shape 1" in Example No. 3. Further, the list is not exhaustive and any of the listed characteristics can be replaced with another, different characteristic. Therapeutic agent

[0175] As used hereinafter, texture refers to surface topography, such as but not limited to the surface topographies specifically disclosed herein (e.g., surface topography defined by pores, scored portions, beads, filaments, fibers, loops, knits, weaves, braid, and / or densification materials that alter the coefficient of friction of the surface of the cover). As used hereinafter, shape refers to an inflation profile (e.g., a particular nominal diameter, working length, or other inflation shape) or a series of inflations along a region of the cover. As used hereinafter, endoprosthesis refers to the inclusion of an endoprosthesis on a region of the cover (e.g., a stent). In some examples below, "x" is used to indicate that the cover does not include that region. Additionally, each of the examples below can be modified by removing a region, adding a region, or changing a characteristic or feature of a region.

[0176]

[0177]

[0178] ​The foregoing description of certain embodiments of the application, including exemplary embodiments, is presented for the purpose of illustration and description and is not intended to be exhaustive or to limit the disclosure to the precise form disclosed. Numerous modifications, adaptations, and uses of the disclosure will be apparent to those skilled in the art.

[0179] A medical device is presented, the medical device comprising: a catheter comprising a longitudinal axis, a proximal end, a distal end, and a covering lumen extending from the proximal end of the catheter to the distal end of the catheter; an expandable member comprising a proximal end and a distal end, wherein the expandable member is disposed on the catheter; a covering comprising a plurality of regions, wherein a first region of the plurality of regions has at least one aperture, and a first end of the covering is invaginated into the covering lumen; and an actuator coupled to the first end of the covering, the actuator configured to move the first end of the covering along the longitudinal axis of the catheter toward the proximal end of the catheter.

[0180] In some embodiments, a second region of the plurality of regions comprises a therapeutic agent disposed on a surface of the second region.

[0181] In some embodiments, the first region of the plurality of regions is less expandable than the expandable member.

[0182] In some embodiments, at least two regions of the plurality of regions each have a length at least as long as a working length of the expandable member.

[0183] In some embodiments, the at least one aperture comprises a portion of the first region of the plurality of regions that is weaker than a remainder of the first region.

[0184] In some embodiments, a second region of the plurality of regions further comprises an endoprosthesis.

[0185] A medical device is presented, the medical device comprising: a catheter comprising a longitudinal axis, a proximal end, a distal end, and a covering lumen extending from the proximal end of the catheter to the distal end of the catheter; an expandable member comprising a proximal end and a distal end, the expandable member having a working length, wherein the expandable member is disposed on the catheter; a covering comprising at least one region; and an actuator coupled to a first end of the covering, the actuator configured to move the first end of the covering along the longitudinal axis of the catheter toward the proximal end of the catheter.

[0186] In some embodiments, a first region and a second region of the covering each have a length at least equal to the working length of the expandable member.

[0187] In some embodiments, the medical device further comprises a sheath disposed along at least a portion of a first region of the covering, wherein the first region of the covering extends between the proximal end of the expandable member and the proximal end of the catheter.

[0188] In some embodiments, the covering comprises at least one wire coupled to the actuator.

[0189] In some embodiments, the at least one wire is integral with the covering.

[0190] In some embodiments, the covering comprises a third region having a length at least equal to a working length of the expandable member.

[0191] In some embodiments, the first region of the covering has a first nominal diameter, the second region of the covering has a second nominal diameter different from the first nominal diameter, and the third region of the covering has a third nominal diameter different from the first and second nominal diameters.

[0192] In some embodiments, the first region of the covering is positioned around the expandable member and the second region of the covering is positioned around the catheter.

Claims

1. A medical device, comprising: a catheter having a proximal end, a distal end, a covering lumen extending from the distal end of the catheter to the proximal end; an expandable member disposed on the catheter, the expandable member having a working length; a covering positioned over the expandable member and comprising a plurality of regions and having a length that is at least twice the working length of the expandable member, a first end of the covering turned in to the covering lumen of the catheter; and an actuator coupled to the first end of the covering and configured to move the first end of the covering along a longitudinal axis of the catheter toward the proximal end of the catheter, and wherein the covering covers at least a portion of a circumference of the expandable member and the covering covers a portion of a length of the expandable member from the proximal end to the distal end.

2. The medical device of claim 1, wherein further comprising a first therapeutic agent disposed on a surface of one of a first region of the plurality of regions or a second region of the plurality of regions.

3. The medical device of claim 2, wherein further comprising a second therapeutic agent disposed on a surface of the other of the first region and the second region of the covering.

4. The medical device of claim 3, wherein, the first therapeutic agent is different than the second therapeutic agent.

5. The medical device of claim 3, wherein, at least one of the first therapeutic agent and the second therapeutic agent comprises a densified material configured to increase a coefficient of friction of a surface of a region in which the densified material is disposed.

6. The medical device of claim 3, wherein, the first therapeutic agent and the second therapeutic agent are the same therapeutic agent.

7. The medical device of claim 6, wherein, the first therapeutic agent is at a first dosage density and the second therapeutic agent is at a second dosage density different than the first dosage density.

8. The medical device of claim 2, wherein further comprising a first endoprosthesis disposed on a surface of the other of the first region and the second region of the covering.

9. The medical device of claim 8, wherein further comprising a second endoprosthesis disposed on a surface of a third region of the plurality of regions of the covering.

10. The medical device of claim 9, wherein, the first endoprosthesis has a first length and the second endoprosthesis has a second length different than the first length.

11. The medical device of claim 3, wherein, a third therapeutic agent is disposed on a surface of the third region of the plurality of regions of the covering, the third therapeutic agent being different than at least one of the first therapeutic agent and the second therapeutic agent.

12. The medical device of claim 2, wherein, the first region of the plurality of regions has a length greater than the working length of the expandable member, and wherein the second region of the plurality of regions has a length greater than the working length of the expandable member.

13. The medical device of claim 5, wherein further comprising a third region of the plurality of regions, wherein the third region further comprises an endoprosthesis.

14. The medical device of claim 5, wherein, the other of the first therapeutic agent and the second therapeutic agent that does not comprise a densified material comprises at least one of paclitaxel, docetaxel, prospaxel, arsenic trioxide, thalidomide, atorvastatin, cerivastatin, fluvastatin, betamethasone dipropionate, dexamethasone 21-palmitate, sirolimus, everolimus, zotarolimus, biolimus, or temsirolimus.

15. A medical device, comprising: A catheter comprising: a proximal end, a distal end, a covering lumen extending from the distal end of the catheter to the proximal end; an expandable member disposed on the catheter and having a working length; a covering positioned over the expandable member and comprising a plurality of zones and having a length that is at least twice the working length of the expandable member, a first end of the covering configured to be inverted into the covering lumen of the catheter at the distal end of the catheter by translating the covering into the covering lumen and through the covering lumen at the first end; and, an actuator coupled to the first end of the covering and configured to move the first end of the covering toward the proximal end of the catheter along a longitudinal axis of the catheter; a first therapeutic agent disposed on a surface of one of a first zone of the plurality of zones or a second zone of the plurality of zones; and a second therapeutic agent disposed on a surface of the other of the first zone and the second zone of the covering, at least one of the first therapeutic agent and the second therapeutic agent comprising a densified material configured to increase a coefficient of friction of a surface of a zone in which the densified material is disposed, the first therapeutic agent and the second therapeutic agent being the same therapeutic agent, and the first therapeutic agent being at a first dosage density and the second therapeutic agent being at a second dosage density different from the first dosage density, and wherein the covering covers at least a portion of a circumference of the expandable member, and the covering covers a portion of a length of the expandable member from the proximal end to the distal end.

16. The medical device of claim 15, wherein a first endoprosthesis disposed on a surface of the other of the first zone and the second zone of the covering is further included.

17. The medical device of claim 15, wherein, a third therapeutic agent disposed on a surface of a third zone of the plurality of zones of the covering, the third therapeutic agent being different from at least one of the first therapeutic agent and the second therapeutic agent.

18. The medical device of claim 15, wherein, the first zone of the plurality of zones has a length that is greater than the working length of the expandable member, and wherein the second zone of the plurality of zones has a length that is greater than the working length of the expandable member.

19. The medical device of claim 15, wherein a third zone of the plurality of zones is further included, wherein the third zone further comprises an endoprosthesis.

20. The medical device of claim 15, wherein, the other of the first therapeutic agent and the second therapeutic agent that does not comprise a densified material comprises at least one of paclitaxel, docetaxel, prospaxel, arsenic trioxide, thalidomide, atorvastatin, cerivastatin, fluvastatin, betamethasone dipropionate, dexamethasone 21-palmitate, temsirolimus, everolimus, zotarolimus, biolimus, or ranolimus.

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