Abstract: Embodiments of the present disclosure comprise occlusion and drug delivery devices and methods. One aspect of the disclosure comprises a drug delivery device comprising an inner expansion member and an outer drug delivery component. Another aspect of the disclosure comprises bioabsorbable, lumen-occluding implants.

Abstract: A catheter can have a textured outer body surface with protrusions and/or indentations that can reduce friction between the outer body surface and vascular anatomy or an inner lumen of another catheter in contact with the outer body surface. The catheter can include protrusions and/or indentations on an inner lumen surface that can reduce friction between the inner lumen surface and an outer body surface of another catheter within the example catheter. The protrusions can be filled with a lubricant or vasodilating drug, and the protrusions can be configured to break to release the fluid in response to forces on the protrusion during navigation through vascular anatomy and/or an inner lumen of another catheter. The catheter can include a metallic tubular reinforcing layer with openings through which the protrusions and/or indentations extend and/or protrusions and/or indentations shaped into the reinforcing layer.

Abstract: A patient interface device for use in ophthalmic surgery, which includes a rigid body and a suction ring joined to a lower end of the body, where the suction ring includes an annular skirt made of a soft and flexible material and located at a lower end of the suction ring, and where an inner surface, and optionally an outer surface, of the skirt is coated with medication. The medication includes one or more of the following types of medication: anti-inflammatory, antibiotic, numbing, lubricating, and anti-redness. The coating method may include dip coating, sputter deposition, ultrasonic-spraying, and spin-coating. The skirt may be formed by a process that increases its material porosity and/or surface roughness, and may be surface-treated to enhance adhesion and retention of the medication.

Abstract: A drug or agent coated balloon having a length which is adjustable in vivo is described herein. The balloon is configured to be coated or coatable with one or more drugs where the coating may be applied prior to advancement into a patient body or prior to balloon expansion within the patient body. The length of the expandable portion of the balloon is adjustable to approximate a length of the tissue region to be treated. Moreover, the drug-coated balloon may be used alone or it may be utilized to deploy luminal prostheses having one or more linked or otherwise coupled segments.

Abstract: A balloon catheter comprises an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including a generally cylindrical barrel section forming a working surface, and generally conical end sections that do not form a part of the working surface. The balloon further includes at least one radiopaque identifier for indicating the relative position of the working surface, said identifier being provided on at least one of the conical end sections of the balloon so as to define the extent of the working surface. Related aspects are also disclosed.

Abstract: A method of treating an aneurysm, including determining a diameter associated with a vessel having the aneurysm; selecting one of a plurality of braided implants for treating the vessel, wherein each braided implant comprises a porosity substantially consistent over up to a 1 mm diameter range, each braided implant configured to provide consistent porosity over different diameter ranges; and treating the vessel with the one of the plurality of braided implants.

Abstract: A prosthetic valve delivery system may be provided. The prosthetic valve delivery system may include a first catheter and a first steering mechanism configured to bend the first catheter within a first steering plane. The prosthetic valve delivery system may also include a second catheter coaxially arranged within the first catheter and a second steering mechanism configured to bend the second catheter within a second steering plane, different from the first steering plane. Moreover, the prosthetic valve delivery system may include a capsule positioned distal to both the first catheter and the second catheter. The capsule may be configured to retain a prosthetic valve therein during transvascular advancement of the capsule.

Abstract: Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly which can include a first control mechanism, a second control mechanism, and a decoupling mechanism. The delivery systems can also include a delivery catheter extending from the handle assembly. The delivery catheter can include an outer shaft, which can be controlled by the first control mechanism; a prosthesis containing capsule comprising a proximal capsule portion connected to the outer shaft, and a distal capsule portion releasably coupled to the proximal capsule portion. After deploying a valve prosthesis, the capsule can be closed by activating the decoupling mechanism in the handle to rapidly close the distal and proximal capsule portions together. The delivery system can also include a centering element to guide the distal and proximal capsule portions together.

Abstract: A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

Abstract: A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

Abstract: The present invention relates to a method for coating catheter balloons with the pharmacological agent paclitaxel and the biological and biodegradable polymer composition shellac and optionally further components. Moreover the present invention relates to paclitaxel and shellac coated catheter balloons obtained according to the coating methods disclosed herein as well as the use of such coated catheter balloons for the short time release of the pharmaceutically active agent paclitaxel for prophylaxis and treatment of restenosis especially restenosis caused by angioplasty. The coated catheter balloons can be used alone or in combination with a coated or uncoated stent crimped on the catheter balloon before or after the coating with shellac and paclitaxel.

Abstract: An intravascular device can comprise a carrier and an expansion apparatus. The device can be used for intravascular treatment of atherosclerotic plaque. The carrier can be reversibly expandable and collapsible within a vessel and can have ribbon strips extending between opposite ends in a longitudinal direction of the carrier. The ribbon strips can each be formed with a plurality of elongated protrusions thereon. The expansion apparatus can be used to actuate the ribbon strips each with the plurality elongated protrusions to pierce a luminal surface of the plaque with lines or patterns of microperforations which act as serrations for forming cleavage lines or planes in the plaque.

Abstract: A device and method for intravascular treatment of atherosclerotic plaque prior to balloon angioplasty which microperforates the plaque with small sharp spikes acting as serrations for forming cleavage lines or planes in the plaque. The spikes may also be used to transport medication into the plaque. The plaque preparation treatment enables subsequent angioplasty to be performed at low balloon pressures of about 4 atmospheres or less, reduces dissections, and avoids injury to the arterial wall. The subsequent angioplasty may be performed with a drug-eluting balloon (DEB) or drug-coated balloon (DCB). The pre-angioplasty perforation procedure enables more drug to be absorbed during DEB or DCB angioplasty, and makes the need for a stent less likely. Alternatively, any local incidence of plaque dissection after balloon angioplasty may be treated by applying a thin, ring-shaped tack at the dissection site only, rather than applying a stent over the overall plaque site.

Abstract: Loading tools for use with medical devices are disclosed. An example loading tool may be suitable for use with a drug-coated expandable medical device. The loading tool may include a tubular sleeve having a distal end region, a proximal end region, and a lumen extending therethrough. The distal end region may include a reduced distal tip designed to interact with a hemostasis valve having a resilient seal member.

Abstract: A prosthetic heart valve delivery system can include a catheter portion having a sheath that can cover and uncover the prosthetic heart valve mounted on an inner shaft, a handle having a sheath actuator operatively coupled to a proximal portion of the sheath, the inner shaft extending through the handle, and a shaft retractor releasably coupled to a proximal portion of the handle and fixedly coupled to a proximal portion of the inner shaft. A sheath actuator can move the sheath axially relative to the inner shaft when the shaft retractor is coupled to the handle, and a proximal movement of the sheath relative to the inner shaft can cause the sheath to uncover the prosthetic heart valve. The shaft retractor can be operable to retract the inner shaft and the nosecone proximally relative to the sheath when the shaft retractor is released from the handle.

Abstract: The present invention provides insertable medical devices having elastic surfaces associated with bioactive agent-containing microparticulates and a coating material. Upon expansion of the elastic surfaces the microparticulates can be released to a subject.

Abstract: An endovascular delivery system for an endovascular prosthesis includes a radiopaque marker system for accurate delivery of the prosthesis. The radiopaque marker system is disposed within a prosthesis or stent holder within the delivery system. The radiopaque marker system includes a plurality of radiopaque markers that provide different views rotation of the prosthesis or stent holder.

Abstract: A device for ablating target tissue of a patient with an ablative fluid is provided. An elongate shaft includes a proximal portion and a distal portion, and at least one fluid delivery element is attached to the distal portion. The device can be configured to ablate the duodenal mucosa of a patient while avoiding damage to the duodenal adventitial tissue. Systems and methods of treating target tissue are also provided.

Abstract: An implantable medical device deployment system is disclosed that employs both a sheath element and a constraint member to protect implantable medical devices during delivery in a body while providing simple, accurate, and reliable device deployment. The delivery system is configured so that loading and deployment forces are not directly related to device diameter, length, or design, thus allowing a more universal delivery system across various delivered device configurations and product lines. The deployment system can provide numerous benefits, include better protection for drug-coated implantable devices.

Abstract: A system for replacing a heart valve of a patient. The system includes a delivery device and a prosthetic heart valve. The system is configured to be transitionable between a loaded state, a partially deployed state and a deployed state. In the loaded state, the prosthetic heart valve engages a coupling structure and is compressively retained within a primary capsule, which constrains the prosthetic heart valve in a compressed arrangement. In the partially deployed state, the prosthetic heart valve engages the coupling structure and is compressively retained within a secondary capsule, which constrains the prosthetic heart valve to a partially deployed arrangement. The partially deployed arrangement is less compressed than the compressed arrangement and less expanded than a deployed arrangement. In the deployed state, the primary and secondary capsules are retracted from over the prosthetic heart valve, which expands to the deployed arrangement and is released from the coupling structure.

Abstract: An apparatus for performing a medical procedure includes a balloon comprising an inflatable body. A first releasable or frangible connection is provided to maintain the body at a first diameter up to a first inflation pressure, and to release, such as by disconnecting, and thus allow the body to assume a second diameter, such as at a second inflation pressure greater than the first inflation pressure or upon a manual release of the connection by a clinician. Multiple releasable or frangible connections may be provided, including between portions (folds) of the inflatable body of the balloon. This disclosure also pertains to a non-compliant or semi-compliant balloon having a first inflation diameter corresponding to a first range of inflation pressures and a second inflation diameter corresponding to a second inflation pressure greater than the first range of inflation pressures.

Abstract: The present invention is an inflatable balloon which is enclosed by an expandable cover which becomes increasingly porous/permeable during expansion. The balloon is coated or enclosed with a matrix which contains a pharmaceutically active agent. During expansion of the balloon, the pharmaceutically active agent is released or extruded through the expandable cover into a body cavity such as an artery or vein. The present invention also provides for a method of treating a disease or condition by delivering the inflatable balloon to a particular body cavity.

Abstract: An insertion tool for inserting a catheter into a patient's body is disclosed. The insertion tool unifies needle insertion, guidewire advancement, and catheter insertion in a single device. In one embodiment, the insertion tool comprises a housing in which at least a portion of the catheter is initially disposed, a hollow needle distally extending from the housing with at least a portion of the catheter pre-disposed over the needle, and a guidewire pre-disposed within the needle. A guidewire advancement assembly is also included for selectively advancing the guidewire distally past a distal end of the needle in preparation for distal advancement of the catheter. In one embodiment a catheter advancement assembly is also included for selectively advancing the catheter into the patient. Each advancement assembly can include a slide or other actuator that enables a user to selectively advance the desired component. Guidewire and catheter locking systems are also disclosed.

Abstract: Drug delivery systems and methods are disclosed herein. In some embodiments, a drug delivery system can be configured to deliver a drug to a patient in coordination with a physiological parameter of the patient (e.g., the patient's natural cerebrospinal fluid (CSF) pulsation or the patient's heart or respiration rate). In some embodiments, a drug delivery system can be configured to use a combination of infusion and aspiration to control delivery of a drug to a patient. Catheters, controllers, and other components for use in the above systems are also disclosed, as are various methods of using such systems.

Abstract: A balloon coating method for forming a coating layer containing a water-insoluble drug on the outer surface of a balloon of a balloon catheter, wherein the balloon catheter includes an elongate shaft possessing a distal portion at which is provided the balloon which is inflatable. The balloon coating method includes: holding the shaft on a support part capable of rotating about an axis of the balloon; and moving a dispensing tube for supplying a coating liquid containing the drug relative to the balloon in an axial direction of the balloon, while rotating the balloon together with the support part, thereby to coat the outer surface of the balloon with the coating liquid.

Abstract: A medical device may include a catheter, an expandable member, a cover, and an actuator. The catheter may include a longitudinal axis, proximal and distal ends, and a cover lumen extending from the proximal to the distal end. The expandable member may include proximal and distal ends and may be disposed on a distal section of the catheter. The cover may include a first region that may be disposed along the expandable member, and a second region that may extend along a length of the catheter beyond the proximal end of the expandable member towards the proximal end of the catheter. A first end of the cover may invert into the cover lumen. The actuator may be coupled to the first end of the cover and configured to move the first end of the cover towards the proximal end of the catheter along the longitudinal axis of the catheter.

Abstract: Improvements for use with tissue expanders are provided. A first aspect includes a tissue expander device provided with a colorant inside a shell before the shell is inflated with fluid, wherein the colorant mixes with fluid upon injection of fluid into the shell. A second aspect includes a tissue expander device provided with a tread on an exterior surface of the shell. A third aspect includes a system having: a computing device with a visual display screen; a detector connected to the computing device that is configured to detect a port of a tissue expander that is implanted under skin of a patient; and software running on the computing device that receives signals from the detector and causes the visual display screen to show a visual representation of a location of the detected port of the tissue expander.

Abstract: Devices and methods for treating one or more pulmonary diseases while avoiding or minimizing injury to the esophagus and branches of the vagus nerve that run along the outside of the esophagus. The device includes at least one energy delivery element disposed on an elongate member and a means for protecting the esophagus and surrounding tissues, such as esophageal branches of the vagus nerve, during treatment. The energy delivery element is positionable to target at least one nerve in or around the tracheal wall when the elongate member is positioned in the trachea. Energy from the energy delivery element is delivered to the at least one nerve to treat pulmonary symptoms, conditions, and/or diseases, such as asthma, COPD, obstructive lung diseases, or other pulmonary diseases, while the protection means protects the esophagus and surrounding tissues from permanent damage.

Abstract: Devices and methods for securing a cover of a retrieval device while the retrieval device is resheathed to a more proximal position within a delivery sheath are disclosed herein. A retrieval device may include, for example, a securing element configured to grip the cover when the retrieval device is pulled proximally, to thereby secure the cover. A method of positioning the retrieval device may include, for example: (a) advancing the retrieval device distally through a delivery sheath to a partially deployed state while the securing element is in a first state, and (b) retracting the clot retrieval proximally from the partially deployed state while the securing element is in a second state that grips the cover to secure the cover.

Abstract: Briefly, in accordance with one embodiment, a tool for use with an endoscopic procedure comprises a thermoplastic polyurethane expandable vessel.

Abstract: A balloon catheter adapted for use with a guidewire includes an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end. An inflatable balloon is supported along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends. An insert located within the interior compartment of the balloon includes at least a radiopaque portion separate from the shaft. Related methods are also disclosed.

Abstract: Disclosed herein is a balloon coating method for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter, the balloon catheter including the balloon which is inflatable and provided on a distal portion of an elongate shaft. The balloon coating method includes: accommodating the shaft in a groove portion formed in a support base to extend rectilinearly, and closing at least part of the groove portion with a lid portion, thereby to support the shaft such that the shaft can be rotated within the groove portion; and moving a dispensing tube for supplying a coating liquid containing the drug relative to the balloon in an axial direction of the balloon, while rotating the balloon about an axis of the balloon, thereby to coat the outer surface of the balloon with the coating liquid.

Abstract: A catheter system including a delivery sheath and a wire management device. The wire management device is slidably disposed within a lumen of the sheath, and includes a shaft and at least two vane assemblies. The vane assemblies each project from an exterior surface of the shaft and are circumferentially spaced from one another. Further, the vane assemblies are collapsible to a collapsed stated when disposed within the lumen, and are configured to self-expand from the collapsed state toward a normal, expanded state when released from the lumen. The catheter assembly generates a plurality of compartments that are separated from one another by the vane assemblies and along which individual guidewires can be tracked. The compartments maintain the guidewires separate from one to prevent possible twisting. An advancing endograft delivery device tracked over the guidewires collapses the vane assemblies, coalescing the compartments into a single compartment during endograft deployment.

Abstract: A blood clot filter includes a number of locator members and anchor members, each of the members tipped with a retainer encompassed within bio-resorbable cover material. Upon delivery into a blood vessel, the locator and anchor members position the filter near the vessel centerline. After a period of time, the bio-resorbable cover material resorbs, allowing the retainer on the members to penetrate and attach to the vessel wall. A method of implanting the filter includes delivering the filter into a blood vessel and allowing the bio-resorbable cover material to resorb so retainers on the members can engage the vessel walls.

Abstract: Expandable elements having drug-delivery features and associated systems and methods are disclosed herein. In one embodiment, a drug-eluting stent includes a radially expandable cylindrical frame having a plurality of struts. The frame is transformable between a low-profile delivery state and an expanded deployed state. A plurality of drug-delivery features are carried by one of the struts and configured to deliver a drug to a treatment site within the patient or piercing through the tissue wall to break the constricting of the vessel wall inwardly. When the frame is in the expanded state within a body lumen of the patient, the drug-delivery features extend radially outwardly away from the strut and are configured to engage and, in some arrangements, pass through a wall of the body lumen.

Abstract: Expandable elements having drug-delivery features and associated systems and methods are disclosed herein. In one embodiment, a drug-eluting stent includes a radially expandable cylindrical frame having a plurality of struts. The frame is transformable between a low-profile delivery state and an expanded deployed state. A plurality of drug-delivery features are carried by one of the struts and configured to deliver a drug to a treatment site within the patient or piercing through the tissue wall to break the constricting of the vessel wall inwardly. When the frame is in the expanded state within a body lumen of the patient, the drug-delivery features extend radially outwardly away from the strut and are configured to engage and, in some arrangements, pass through a wall of the body lumen.

Abstract: A balloon catheter which can rather smoothly move inside living body organs, and can improve trackability and pushability. The balloon catheter has an inner shaft that includes a guidewire lumen into which a guidewire can be inserted, an outer shaft that forms a fluid lumen for introducing a fluid on an outer periphery of the inner shaft, a membranous material that causes a space portion into which the fluid can flow to communicate with the fluid lumen, and that partitions the space portion on the outer periphery of the distal portion side of the inner shaft, and an inflatable and deflatable balloon in which a lumen into which the fluid can flow is formed on an outer periphery of the membranous material.

Abstract: An apparatus for performing a medical procedure includes a balloon comprising an inflatable body. A first releasable or frangible connection is provided to maintain the body at a first diameter up to a first inflation pressure, and to release, such as by disconnecting, and thus allow the body to assume a second diameter, such as at a second inflation pressure greater than the first inflation pressure or upon a manual release of the connection by a clinician. Multiple releasable or frangible connections may be provided, including between portions (folds) of the inflatable body of the balloon. This disclosure also pertains to a non-compliant or semi-compliant balloon having a first inflation diameter corresponding to a first range of inflation pressures and a second inflation diameter corresponding to a second inflation pressure greater than the first range of inflation pressures.

Abstract: Implantable devices including a biocompatible matrix configured for long term location in adipose tissue and a biologically active agent that can be carried by the matrix and delivered to the adipose tissue following implant therein. The biologically active agent can include a modulator or a precursor thereof that can directly or indirectly modify the gene expression of adipose cells, e.g., adipocytes, and thereby modify the presence or quantity of one or more expression products of the adipose tissue that may act locally on distant from the implant site in an endocrine fashion. Modulators can include small molecules (e.g., resveratrol), polynucleotides (e.g., RNAi), or polypeptides (e.g., antibodies or functional fragments thereof).

Abstract: This disclosure relates to medical devices and related methods. In some embodiments, the methods include applying a material to the balloon and then removing the material from one or more regions of the balloon.

Abstract: A stent with varying porosity is described. The stent can be comprised of multiple stents attached together. A braided stent may have selected regions of increased thickness. The stent may be comprised of wires that are welded together at their ends in order to minimize vessel trauma. The stent may comprise a helically wound radiopaque wire wound through the stent.

Abstract: Various aspects of the present invention provide compositions and implantable devices including a water-insoluble therapeutic agent solubilized in a matrix of a gallate-containing compound. Other aspects provide methods of manufacturing and using such compositions and devices.

Abstract: This present invention concerns a new combination of balloon catheters and formulations containing active substances that adhere to the surface of the balloon membrane. Furthermore the present invention concerns coating processes for the manufacture of these balloon catheters as well as their use in the treatment and prophylaxis of vascular diseases.

Abstract: Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, locating, tracking, monitoring, deflating, and retrieving the same are provided.

Abstract: The present disclosure is directed a method of facilitating treatment via a vascular wall defining a vascular lumen containing an occlusion therein. The method may include providing a first intravascular device having a distal portion and at least one aperture and positioning the distal portion of the first intravascular device in the vascular wall. The method may further include providing a reentry device having a body and a distal tip, the distal tip having a natural state and a compressed state and inserting the distal tip, in the compressed state, in the distal portion of the first intravascular device. The method may further include advancing the distal tip, in the natural state, through the at least one aperture of the first intravascular device.

Abstract: A method for coupling a body conduit to tissue is provided. The method includes engaging an implant about an outer surface of a catheter. The implant receives a bioactive agent having tissue growth properties. The method involves inserting the catheter through the body conduit and into a tissue opening across a resected area, positioning the implant in the resected area, inflating a balloon to anchor the catheter within the tissue opening such that the implant bridges the body conduit and the tissue opening across the resected area, and maintaining the catheter and the implant in vivo to enable the bioactive agent to secure the implant in the resected area to permanently bridge the body conduit and the tissue opening.

Abstract: A method for brachytherapy in a lumpectomy cavity of a breast including, positioning a distal end of a brachytherapy device within the cavity, expanding an expandable surface portion located between proximal and distal ends of the device within the cavity, the source lumen tubes defining a curved configuration within the cavity; and positioning a source of radiation sequentially within one or more source lumens of the source lumen tubes according to a brachytherapy treatment plan. The device includes an inner tube, and a plurality of source lumen tubes located around the inner tube and including distal ends secured together with the inner tube at the distal end disposed within the body cavity, the source lumen tubes comprising proximal portions sufficiently long to extend outside the breast.

Abstract: Present invention relates to a device for controlled release of a bioactive agent. The device comprises a thin film located on the surface of the device, wherein said thin film comprises a bioactive agent-containing layer comprising a polymeric matrix and at least one bioactive agent.

Abstract: An endoluminal device can be configured for precise positioning during deployment within a vessel. The endoluminal device can be a tack, stent, vascular implant or other type of implant. The endoluminal device can have circumferential member with an undulating configuration having multiple inward and outward apexes and struts extending therebetween. Two of the struts can be used to establish a foot for the precise positioning of the device during deployment. A method of placing the endoluminal device can include withdrawing an outer sheath such that a portion of the endoluminal device is expanded prior to the rest of the endoluminal device.

Abstract: The present disclosure is directed to a device. The device may include a distal shaft defining a central lumen and an orienting element comprising at least one inflatable member. Wherein a first portion of the orienting element extending from the shaft in a first direction and a second portion of the orienting element extending from the shaft in a second direction. Further, wherein the second direction is substantially opposite the first direction.