Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: A balloon catheter 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 connected to the distal end of the shaft, the balloon including a working surface. A radiopaque identifier is provided for identifying the working surface. A receiver adjacent the proximal end of the shaft is adapted for allowing the shaft to move relative to the receiver in at least the longitudinal direction.

Abstract: A system for treatment of an aneurysm includes an intrasaccular device that can be delivered using a catheter. The device can include at least one expandable structure adapted to transition from a compressed configuration to an expanded configuration when released into the aneurysm. The expandable structure can have a specific shape or porosity. Multiple expandable structures can also be used, in which case each of the expandable structures can have a unique shape or porosity profile. The morphology of the aneurysm and orientation of any connecting arteries can determine the type, size, shape, number, and porosity profile of the expandable structure used in treating the aneurysm.

Abstract: This patent document discloses perfusion catheters and related methods for treating complications related to CTO interventions or dilating a vessel occlusion while maintaining a passage through the treated vessel segment. A perfusion catheter can include an inflatable balloon coiled in a helical manner around a central axis into a series of windings. An inner surface of the series of windings, when inflated, can define a passage through the inflatable balloon. A catheter can also include an elongate shaft extending from a proximal portion to a distal portion, having an inner surface that defines a lumen for providing inflation fluid to, or withdrawing inflation fluid from, a distal end of the inflatable balloon. A catheter can further include a guidewire support tube including a lumen, separate from the lumen from the elongate shaft and the passage through the inflatable balloon, for receiving a guidewire.

Abstract: The present teachings provide systems, devices, and methods for reshaping the heart and reducing valve regurgitation. A device can be positioned proximate the heart and have a delivery profile and an inflated profile. The device can have a primary cavity and a secondary cavity, and an adhesive inside the secondary cavity. An injectable medium can be injected to the primary cavity of the device. As the primary cavity is filled, the adhesive is forced out of the secondary cavity to adhere the device. The inflated device can exert pressure on the heart, change the shape of a valve annulus, and allow a better coaptation of the valve leaflets.

Abstract: The invention relates to a balloon catheter, in particular for the widening of stents in fenestrations and for T-branch protheses, being provided with a balloon (4), a supply line in the catheter (2) leading to the balloon (4), which allows the balloon (4) to be pressurized, and a central lumen (3) for a guidewire, with the balloon (4) in the expanded state having at least two areas (P, D, M) of different diameter, with these areas merging into one another by forming a step.

Abstract: An apparatus for performing a medical procedure and, in particular, an aortic valvuloplasty, in a vessel for transmitting a flow of fluid. The apparatus comprises a shaft, an inflatable perfusion balloon supported by the shaft and including an internal passage for permitting the fluid flow in the vessel while the perfusion balloon is in an inflated condition, and a valve for controlling the fluid flow within the passage. The valve may be connected to the shaft, or may comprise an elongated tube partially connected to the balloon. The balloon may comprise a plurality of cells in a single cross-section, each cell including a neck, and the valve may be positioned in a space between the shaft and the necks for controlling the fluid flow within the passage. A connector may also be provided to control the position of the valve.

Abstract: An inflatable structure for use in biological lumens and methods of making and using the same are disclosed. The structure can have an inflatable balloon encircled by a shell. The shell can have proximal and distal tapered necks, longitudinally-oriented flutes, and apertures at the proximal and distal ends of the shell. The apertures can be recessed in the flutes in the necks. The shell can also have fiber reinforced walls.

Abstract: A method of inflating a catheter balloon may include providing a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: Devices for preventing and/or otherwise inhibiting biofilm formation include a lumen and/or a cavity coupled with a wall configured for holding oils, which leach through the wall of the devices to a surface, the oils at the surface creating a smooth surface coating.

Abstract: Described is an inflatable implant suitable for placement in the human body and left there for an indeterminate and potentially lengthy period of time. The implant includes at least one bladder wall. The bladder wall will define at least one fillable volume and may form more than one independent fillable volumes. The wall and filler material may be selected to deliver treatment materials to the locale of the implant site or to remove amounts of harmful materials from such a region. The implant may, with an appropriate filler material or bladder wall material, be used in cooperation with an appropriate radio frequency (RF) source to cause the increase of a localized internal temperature and a resulting tissue change such as coagulation, ablation, or the like. Methods of using the implant are also described.

Abstract: The invention relates to a balloon catheter, in particular for the widening of stents in fenestrations, being provided with a first inner balloon (4), a second outer balloon (5), with said second balloon (5) completely enclosing the first balloon (4), separate supply lines in the catheter (2) leading to the first (4) and second balloon (5), which allow the balloons (4, 5) to be pressurized independently of one another, a central lumen (3) for a guidewire, wherein in the expanded state, both balloons (4, 5) in the proximal region (P) have a diameter which is enlarged in relation to that of the distal region (D).

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until implantable device is deployed a an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: The invention comprises an indwelling medical device which is capable of delivering a therapeutic agent evenly along the length of the indwelling portion, including the outer wall, of the device.

Abstract: A plurality of structural layers having different properties are nested together to form the medical balloon. Certain embodiments include at least one layer comprising a fiber-reinforced polymer. The layers of the balloons can slide relative to one another in use. A structural layer may comprise metal reinforcing fibers suspended in a polymer matrix.

Abstract: A system for implanting an implantable medical device (IMD) within a patient may include an IMD including an attachment member, and a delivery catheter including at least one tethering device having at least a portion positioned within a restrainer. The tethering device(s) is configured to removably tether to the attachment member of the IMD. The restrainer is configured to maintain the tethering device(s) in alignment along a delivery path of the delivery catheter.

Abstract: Implantable devices such as stents, coils, implantable contraceptives, vascular plugs, vena cava filters, left atrial appendage (LAA) closure devices employing an adhesive component to assist in securing or holding the implant in place within a lumen of a patient's body.

Abstract: A method for infusing a liquid into a patient's vasculature in accordance with an infusion protocol is disclosed. For this method, an infusion catheter having a multi-lumen infusion unit that is mounted adjacent the catheter's distal end is positioned in an artery within a predetermined distance from an intended target tissue surface. An inflation balloon is then deployed to at least partially occlude the artery and a force is exerted on the liquid to establish a flow rate for the liquid in the catheter. Specifically, the force is exerted to infuse the liquid from the catheter through the infusion unit and into the vasculature with a homogeneous distribution of the liquid to cover the intended surface of the target tissue. The flow rate can be established in accordance with an infusion protocol that is characterized by time and liquid volume parameters based on viscosity and pressure values in the liquid.

Abstract: Provided is a coated implantable medical device, comprising: a substrate; and a coating disposed on the substrate, wherein the coating comprises at least one polymer and at least one pharmaceutical agent in a therapeutically desirable morphology and/or at least one active biological agent and optionally, one or more pharmaceutical carrying agents; wherein substantially all of pharmaceutical agent and/or active biological agent remains within the coating and on the substrate until the implantable device is deployed at an intervention site inside the body of a subject and wherein upon deployment of the medical device in the body of the subject a portion of the pharmaceutical agent and/or active biological agent is delivered at the intervention site along with at least a portion of the polymer and/or a at least a portion of the pharmaceutical carrying agents.

Abstract: A multi-lumen catheter, for insertion into and draining a body cavity, that mitigates the risk of obstruction of the drainage ports and drainage lumen of the catheter, reduces the detrimental effects caused by the suction forces of the drainage ports on the body cavity being drained, and reduces the risk of infection of the body cavity being drained by decreasing the residual volume of fluid retained in the body cavity being drained. These advantages are achieved by the novel approach of disposing a perforated filter membrane over a segmented retention element and also over the drainage ports of the drainage lumen of the catheter thereby creating internal interstitial drainage channels and internal interstitial drainage cavities.

Abstract: Embodiments are presented of a balloon assembly operable to provide a balloon diameter vs. balloon pressure profile generally depicting a balloon inflation sequence providing at least one intermediate inflated diameter and a final inflated diameter of a balloon such that the balloon attains the at least one intermediate diameter at a predetermined pressure, and attains the final diameter at a final predetermined pressure that is lower than a predetermined pressure of a last intermediate pressure.

Abstract: An aortic occluder catheter with expandable balloons for increasing cerebral blood blow has one or more balloons on a catheter shaft. To assist the balloon in bearing up against arterial blood flow while positioned retrograde in the aorta, the balloon is bonded to the catheter shaft in tension.

Abstract: Cell attachment coatings for articles such as implantable medical devices and cell culture vessels are disclosed. The coatings include an intermediate coater layer which includes a phosphorous-containing component that is bonded in the coating by reacted photoreactive functional groups. The coating also include a second coated layer including an immobilized ECM protein or peptide that includes an active portion of an ECM protein that is able to serve as an outer layer to contact cells during use. The coatings promoted enhanced cell binding and growth.

Abstract: A stylet-guided balloon vertebroplasty system, as well as methods for bone augmentation using same are provided. In certain embodiments, a pre-curved stylet with an overlying delivery tube may be used to target an approximately centered target site within a bone structure, facilitating direction thereto of an expandable member useful for creating a cavity that may receive curable material to restore bone height and/or to reinforce the bone structure.

Abstract: A system for treating a bifurcation includes first and second delivery catheters. The first catheter has a first shaft, a first expandable member adjacent the distal end of the first shaft, an auxiliary expandable member disposed under the first expandable member, and a first radially expandable stent disposed over both the first expandable member and the auxiliary expandable member. The second delivery catheter has a second shaft, and a second expandable member adjacent the distal end of the second shaft. A portion of the second catheter is disposed under a portion of the first stent, and a portion of the second delivery catheter passes through a side hole in the first stent. The first stent is crimped over the first and second catheters such that the first stent remains attached to the first and the second catheters during advancement of the catheters through a blood vessel.

Abstract: An angioplasty balloon (40) is provided with a plurality of scoring elements (44) extending along the balloon (40). Within the scoring element (44) there are provided channels or lumens (36) extending therethrough. The channels or lumens (36) provide for Rayleigh scattering of ultrasonic waves directed to the balloon (40), thereby being visible by imaging devices. The channels or lumens (36) provide visibility of the balloon (40) during medical procedures, both when the balloon (40) is in a deflated, wrapped, condition and also when the balloon (40) is inflated. It is not necessary to use contrast media to fill the balloon (40).

Abstract: Embodiments of the present invention include methods of treating, preventing, and/or ameliorating a vascular disease and/or disorder in a diabetic or pre-diabetic patient. The methods include implanting a stent in a vascular region in a diabetic or pre-diabetic patient, and prior to and/or during the implantation procedure, delivering a lubricant formulation to the vascular region. The stent may be a bare metal stent, or a drug eluting stent, such as a metal stent with a coating including a drug, such as everolimus or sirolimus.

Abstract: The present disclosure generally provides a multiple balloon assembly used as part of the distal region of a medical device that is capable of delivering a therapeutic agent into a body vessel having bodily fluid. The multiple balloon assembly comprises an inner balloon and an outer balloon. The outer balloon further comprises a proximal taper region, a middle region, and a distal taper region. The inflation of the inner balloon causes the middle region of the outer balloon to contact the inner wall of the body vessel, thereby, occluding the flow of fluid through the body vessel. The proximal taper region and the distal taper region are configured such that they do not touch the inner wall of the body vessel. One of the distal taper and proximal taper regions has a plurality of apertures configured to allow for the therapeutic agent to be delivered into the body vessel at a predetermined rate.

Abstract: Improved systems, devices, and methods for delivering cryogenic cooling fluid to cryosurgical probes such as cryosurgical endovascular balloon catheters take advantage of the transients during the initiation and termination of cryogenic fluid flow to moderate the treatment temperatures of tissues engaged by the probe. A flow limiting element along a cryogenic fluid path intermittently interrupts the flow of cooling fluid, often cycling both the fluid flow and treatment temperature. This can maintain the tissue treatment temperature within a predetermined range which is above the treatment temperature provided by a steady flow of cryogenic fluid. In another aspect, room temperature single-use cooling fluid cartridges are filled with a sufficient quantity of cryosurgical fluid to effect a desired endovascular cryosurgical treatment.

Abstract: A weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.

Abstract: A fistula catheter that can prevent separating from the fistula by an inner balloon even if an outer balloon collapses by configuring an internal fixed part with an inner side balloon and an outer side balloon is disclosed. The fistula catheter A has an external fixed part, a supply tube with a primary cavity and a secondary cavity, and an internal fixed part on the tip end side outer periphery of the supply tube, expandable by a compound liquid that includes barium sulfate and distilled water supplied though the secondary cavity. The internal fixed part can be an inner balloon and an outer balloon that communicate with the secondary cavity through filler ports on the peripheral surface of the supply tube. A filter on the filler port can enable distilled water in the compound liquid to be filled into the outer balloon from the secondary cavity through the filter, and the compound liquid can be filled into the inner balloon.

Abstract: A weeping balloon catheter includes a catheter having an elongate tubular body defining an inflation lumen and a combination lumen that terminates at an open distal end of the elongate tubular body. A dilation balloon is disposed at a distal end of the elongate tubular body and is in fluid communication with the inflation lumen. A drug delivery balloon is disposed at least partially over the dilation balloon and includes at least one drug release opening through an outer wall of the drug delivery balloon. The drug delivery balloon is in fluid communication with the combination lumen through a sidewall opening of the elongate tubular body.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.

Abstract: A device (1) comprises a sheath (9) for protecting a balloon catheter (2) from contamination with bodily fluids and other matter during the carrying out of a procedure or investigation at a remote site in a human or animal body. The sheath (9) defines a catheter accommodating portion (14) and a balloon accommodating portion (15) for accommodating a catheter (4) and a balloon (8) of the balloon catheter (2) therein. The sheath (9) is of a flexible material having a closed distal end (11) and a proximal opening (13) at a proximal end (10) thereof to a hollow interior region (12) within which the balloon catheter (2) is accommodated. A guide wire engaging distal portion (19) engages and locates a guide wire (7) within the sheath (9). The balloon accommodating portion (15) permits inflating of the balloon (8) to a predefined volume.

Abstract: An interspinous process spacer diagnostic parallel balloon catheter and method. The balloon catheter has a plurality of main expandable members disposed one inside another, a distal expandable member and a proximal expandable member that all can be expanded from a collapsed configuration to an expanded configuration and then collapsed again to a collapsed configuration. The device can be used to determine whether a particular patient is a candidate for implantation of an interspinous process spacer to treat the symptoms of lumbar spinal stenosis and the size of such a spacer if indicated.

Abstract: A medical device including an outer balloon, an inner balloon, and at least one delivery unit is disclosed. The outer balloon defines a first internal cavity that remains in fluid communication with a first inflation lumen. The inner balloon is disposed within the first internal cavity, and defines a second internal cavity that is in fluid communication with a second inflation lumen. Each delivery unit includes at least one needle configured to pierce a tissue and at least one reservoir containing a material. Further, inflation of the outer balloon or the inner balloon is structured and arranged to deliver the material into the tissue through the needle lumen.

Abstract: A nasally inserted airway opening device with inflatable cuff is provided to treat obstructive sleep apnea. The airway opening device includes a hollow flexible tube extending between a proximal end and a distal end, and an inflatable cuff attached to the tube at or near the distal end. The inflatable cuff may be inflated and deflated via the tube. The inflatable cuff defines an interior through hole extending along the length thereof. When deflated, the inflatable cuff may be packed closely to the tube and may be inserted or removed through a nostril of a user. When inserted through the user's nostril and positioned in the user's oropharynx or naso-oropharynx and inflated, the inflatable cuff prevents soft tissue in the user's naso-oropharynx from collapsing toward the posterior pharyngeal wall while simultaneously allowing airflow through the through hole. A method for utilizing the airway opening device to prevent/treat sleep apnea is also provided.

Abstract: A catheter and methods for luminal therapy are provided wherein a catheter has an outer balloon with a multiplicity of apertures for infusing one or more therapeutic agents into a vessel wall, an intermediate balloon having a multiplicity of apertures offset from the apertures of outer balloon to serve as a baffle that reduces jetting and promotes uniform distribution of therapeutic agent exiting through the outer balloon, and an impermeable inner balloon disposed within the intermediate balloon that enables the intermediate and outer balloons to be forced into engagement with the vessel wall to dilate the vessel and disrupt plaque lining the vessel wall and to also facilitate the uniform delivery of the therapeutic agent.

Abstract: A fistula catheter that can prevent separating from the fistula by an inner balloon even if an outer balloon collapses by configuring an internal fixed part with an inner side balloon and an outer side balloon is disclosed. The fistula catheter A has an external fixed part, a supply tube with a primary cavity and a secondary cavity, and an internal fixed part on the tip end side outer periphery of the supply tube, expandable by a compound liquid that includes barium sulfate and distilled water supplied though the secondary cavity. The internal fixed part can be an inner balloon and an outer balloon that communicate with the secondary cavity through filler ports on the peripheral surface of the supply tube. A filter on the filler port can enable distilled water in the compound liquid to be filled into the outer balloon from the secondary cavity through the filter, and the compound liquid can be filled into the inner balloon.

Abstract: A balloon catheter for dilation of stenotic tissue within a tubular member of the body such as a blood vessel provides fluid flow such as blood flow through the balloon while it is being inflated and after it has been inflated. For valvuloplasty applications or for predilitation prior to a TAVI procedure the balloon is placed across the stenotic aortic valve leaflets and inflated to push the leaflets aside to create a greater blood flow area or allow improved subsequent passage of the large TAVI catheter across the stenotic aortic valve leaflets. As the balloon is inflated in diameter, it is required to reduce in length; this length reduction causes a braided inner tubing to also reduce in length. The braided inner tube is thereby required it to increase in diameter during the balloon inflation and create a suitably large blood flow path through the inner tubing.

Abstract: Methods and devices for bonding a balloon assembly, such as a balloon assembly including an inner balloon and an outer balloon, to a catheter shaft are disclosed. In some cases, a proximal waist of the inner balloon may be bonded to an interior surface of an outer tubular member of the catheter shaft and a proximal waist of the outer balloon may be bonded to an exterior surface of the outer tubular member. In other cases, the proximal waist of the inner balloon may be bonded to a reduced diameter portion of the outer tubular member of the catheter shaft and the proximal waist of the outer balloon may be bonded to the outer tubular member, such as a non-reduced outer diameter portion of the outer tubular member.

Abstract: Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel.

Abstract: A catheter device for irradiating tissue surrounding a body site within a body of a patient, includes an elongated shaft which has a distal portion configured to be deployed within the body site. A treatment location at the distal portion has one or more radiation guides configured to receive a radiation source to irradiate tissue at least in part surrounding the body site. An inflatable multilayered balloon is located to surround the treatment location with a wall thereof having at least two layers including a first layer separate from, inside, and in contact with a second layer around an entire periphery of the first layer, and each of the first layer and the second layer being secured to the distal portion of the elongated shaft.

Abstract: Catheter balloons (10) for delivering a bioactive (260) to a body vessel in a greater amount and/or more quickly are provided, as well as related methods of treatment. The catheter balloon may include a dual balloon assembly at the distal portion (300) of the catheter having an inner balloon (44), an outer balloon (42) with apertures (43) concentrically arrayed around the inner balloon, and a catheter shaft (30) adapted to deliver a carrier (270) through the apertures of the outer balloon. The bioactive is disposed on a portion of at least one of the inner and outer balloon surfaces. Radial outward expansion of the inner balloon urges the outer balloon into contact with the wall of the body vessel. The carrier is introducible within the catheter shaft to pass through the annular lumen (242) between the balloons and through the apertures of the outer balloon. The carrier interacts with the bioactive in order to release a therapeutically effective amount of drug to the wall of the body vessel.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: Methods and systems for delivering toxin and toxin fragments to a patient's nasal cavity provide for both release of the toxin and delivery of energy which selectively porates target cells to enhance uptake of the toxin. The use of energy-mediated delivery is particularly advantageous with light chain fragment toxins which lack cell binding capacity.

Abstract: Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Abstract: Photodynamic bone stabilization and drug delivery systems are disclosed herein. In an embodiment, a photodynamic bone stabilization and drug delivery system of the present disclosure includes an insertion catheter having an inner void for passing at least one light-sensitive liquid, and an inner lumen; an expandable portion releasably engaging a distal end of the insertion catheter, wherein the expandable portion comprises an inner expandable portion in communication with the inner lumen of the insertion catheter and sufficiently designed to maintain a light-sensitive liquid therein; and an outer expandable portion, surrounding the inner expandable portion, sufficiently designed to house and release at least one additive from the outer expandable portion in an outward direction from the inner expandable portion; and a light-conducting fiber sized to pass through the inner lumen of the insertion catheter and into the inner expandable portion for delivering light energy to the light-sensitive liquid.

Abstract: The present invention relates to a catheter assembly that can deliver a therapeutic composition. The catheter assembly can include an outer balloon with openings for releasing the therapeutic composition. When the catheter assembly is in its contracted state, the openings are closed, and the assembly retains the therapeutic composition. When the catheter assembly is in its dilated state, the openings are open, and the therapeutic composition is released. The present invention also includes methods of making and using such a catheter assembly.

Abstract: Balloon catheters, and methods of treatment therewith, are provided including an inflatable first balloon at least partially enclosed by an expandable second balloon that has holes. The annular space between the first balloon and the second balloon is configured to promote delivery of the fluid evenly through holes in the second balloon to avoid problems of underloading and/or overloading. Preferably, the annular space is in communication with the holes, and the annular space is configured to receive and then to release and distribute the fluid via the holes in a substantially uniform manner such that even amounts of fluid are released in the distal and proximal holes. The first balloon may have various configurations including being tapered relative to the second balloon. The second balloon may also be tapered accordingly. The device may also include raised portions disposed in the annular space and configured to define channels having various configurations.