Balloon catheter system for delivery of therapeutic agent

Abstract

A delivery system (200) for administering a therapeutic agent to a target location within a vasculature includes a first catheter (210) with an expandable cage (240) at its distal end and a first occluding balloon (220). A second catheter (212) with a second balloon (230) occludes a second end of the target location. A therapeutic agent can be infused into the target location between the first balloon and the second balloon by either an infusion aperture or a weeping section (222) of the first balloon or second balloon. The system allows for precise delivery of the therapeutic agent to the target location by occluding both ends of the target area and dilating the target location with the expandable cage. The therapeutic agent is administered while the target location is in the dilated position mitigating recurrence of symptoms of occluded vessels and promoting absorption.

Description

BALLOON CATHETER SYSTEM FOR DELIVERY OF THERAPEUTIC AGENTBACKGROUND

[0001] Restoring patency to blood vessels can be achieved through various vascular stenosis treatments such as, for example, Percutaneous Transluminal Angioplasty (PTA). However, subsequent to these treatments, there is sometimes a restenosis caused by several factors including elastic recoil and neointimal hyperplasia (NIH).

[0002] Elastic recoil refers to recurrent luminal narrowing typically occurring within the short-term time window of between a few minutes to 24 hours after the PTA procedure. Typically, a buildup of deposits within the vessel lumen has reduced patency. Mechanically stretching the vessel wall to restore patency distends the normal outer shape of the vessel. When the mechanical force that dilates the vessel, e.g., balloon or stent, is removed the elasticity of the vessel wall may cause elastic recoil and a return of the symptoms relating to reduced patency. Neointimal hyperplasia (NIH) refers to the proliferation and migration of vascular smooth muscle cells, primarily in the tunica intima. As a result, the vessel wall thickens, causing reduced patency and restenosis. While PTA is effective in resolving vascular stenosis, the short-term and long-term effects of elastic recoil and NIH can limit the overall efficacy of the procedure.

[0003] Stents were developed to improve the short-term and long-term efficacy of PTA treatments, however, the presence of the stent structure created additional problems. The presence of a foreign body within the vessel wall caused the buildup of additional deposits, causing thrombosis, causing thickening of tissues, and the reoccurrence of symptoms. Further, mechanical failure of the stent results in the collapse of the stent, or parts of the stent breaking loose and entering the circulation system.

[0004] What is needed, therefore, is a system and method to treat vascular stenosis and address the foregoing problems. Embodiments described herein are directed to dilating a target area and treating the vessel wall with a therapeutic agent in the dilated position to maintain patency and mitigate restenosis.SUMMARY

[0005] Embodiments disclosed herein are directed to systems and methods for delivering therapeutic agents to a target location within a vasculature. Embodiments maintainexpansion of the vessel while delivering biological or chemical therapeutic agents. The therapeutic agents are directed to treat the vessel wall to mitigate the return of symptoms of reduced vessel patency. For example, during the re-modeling of the vessel wall collagen matrix, maintaining wall expansion during the delivery of the therapeutic agent is necessary to stabilize the vessel wall dimensions in the expanded state and prevent recoil. Moreover, holding the vessel in an expanded state potentially allows increased drug absorption or absorption speed by altered permeability. Exemplary target vessels can include arteries, veins, arteriovenous (“AV”) fistulas and other bodily conduits.

[0006] In some aspects, the techniques described herein relate to a delivery system for providing a therapeutic agent to a target location within a vasculature, the delivery system including, a first catheter defining a first lumen in communication with a first aperture at a distal end thereof, the first catheter including a cage coupled to the distal end of the first catheter and transitionable between a collapsed configuration and an expanded configuration, and a first balloon disposed annularly about an outer surface of the first catheter, the first balloon configured to transition to an expanded configuration to occlude a first end of the target location, and a second catheter defining a second lumen in communication with a second aperture at a distal end thereof, the second catheter including a second balloon disposed annularly about an outer surface and configured to transition to an expanded configuration to occlude a second end of the target location.

[0007] In some aspects, the techniques described herein relate to a delivery system, wherein the first aperture is configured to infuse the therapeutic agent to the target location and the second aperture is configured to drain a fluid from the target location.

[0008] In some aspects, the techniques described herein relate to a delivery system, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive (e.g. BioGlue®, or the like), a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

[0009] In some aspects, the techniques described herein relate to a delivery system, wherein one or both of the first balloon and the second balloon each include a weeping section disposed over a portion thereof and configured to be porous for infusing the therapeutic agent into the target location.

[0010] In some aspects, the techniques described herein relate to a delivery system, wherein the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

[0011] In some aspects, the techniques described herein relate to a delivery system, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

[0012] In some aspects, the techniques described herein relate to a delivery system, wherein the cage is biased towards the collapsed configuration and is transitioned to the expanded configuration by withdrawing a wire proximally through the first catheter.

[0013] In some aspects, the techniques described herein relate to a delivery system, wherein the cage is biased towards the expanded configuration and is transitioned to the collapsed configuration by urging a wire distally relative to the first catheter.

[0014] In some aspects, the techniques described herein relate to a delivery system, wherein the cage is biased towards the expanded configuration and is urged towards the expanded configuration by withdrawing a rod proximally relative to the first catheter.

[0015] In some aspects, the techniques described herein relate to a delivery system, further including a hypotube slidably engaged within the second lumen, a distal end of the hypotube extending through the second aperture into the target location, the hypotube defining a hypotube lumen communicating with a hypotube lumen aperture at the distal end of the hypotube.

[0016] In some aspects, the techniques described herein relate to a delivery system, wherein the hypotube lumen aperture is configured to infuse the therapeutic agent to the target location and the second aperture is configured to drain a fluid from the target location.

[0017] In some aspects, the techniques described herein relate to a method of delivering a therapeutic agent to a target location within a vasculature, the method including, advancing a first catheter in a first direction through the vasculature to the target location, the first catheter includes a first balloon disposed annularly about an outer surface thereof and is aligned with a first end of the target location, transitioning a cage, which is coupled to a distal end of the first catheter, to an expanded configuration, inflating the first balloon to occlude the first end of thetarget location, advancing a second catheter in a second direction through the vasculature to the target location, inflating a second balloon disposed annularly about the second catheter to occlude a second end of the target location, infusing the therapeutic agent into the target location, and draining a fluid from the target location.

[0018] In some aspects, the techniques described herein relate to a method, further including infusing the therapeutic agent through a first aperture at a distal end of the first catheter into the target location and draining the fluid from the target location through a second aperture at a distal end of the second catheter.

[0019] In some aspects, the techniques described herein relate to a method, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive (e.g. BioGlue®, or the like), a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

[0020] In some aspects, the techniques described herein relate to a method, further including infusing the therapeutic agent into the target location through a weeping section disposed over a portion of one or both of the first balloon and the second balloon.

[0021] In some aspects, the techniques described herein relate to a method, wherein the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

[0022] In some aspects, the techniques described herein relate to a method, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

[0023] In some aspects, the techniques described herein relate to a method, wherein the cage is biased towards a collapsed configuration and is transitioned to the expanded configuration by withdrawing a wire proximally through the first catheter.

[0024] In some aspects, the techniques described herein relate to a method, wherein the cage is biased towards the expanded configuration and is transitioned to a collapsed configuration by urging a wire distally relative to the first catheter.

[0025] In some aspects, the techniques described herein relate to a method, further including a hypotube slidably engaged within the second catheter, a distal end of the hypotube extending from the second catheter into the target location, the hypotube defining a hypotube lumen communicating with a hypotube lumen aperture at the distal end of the hypotube.

[0026] In some aspects, the techniques described herein relate to a method, further including infusing the therapeutic agent into the target location through the hypotube lumen aperture.

[0027] In some aspects, the techniques described herein relate to a delivery system for providing a therapeutic agent to a target location within a vasculature, the delivery system including, a catheter, a cage slidably engaged with an outer surface of the catheter and transitionable between a collapsed configuration and an expanded configuration, a first balloon disposed annularly about the outer surface of the catheter at a first longitudinal location and configured to transition to an expanded configuration to occlude a first end of the target location, a second balloon disposed annularly about the outer surface of the catheter at a second longitudinal location and configured to transition to an expanded configuration to occlude a second end of the target location, one or both of the first balloon and the second balloon including a weeping section to infuse the therapeutic agent to the target location, and a drainage aperture disposed on the catheter between the first balloon and the second balloon to drain a fluid from the target location.

[0028] In some aspects, the techniques described herein relate to a delivery system, wherein the drainage aperture is disposed adjacent one of the first balloon or the second balloon, or disposed adjacent a mid-point between the first balloon and the second balloon.

[0029] In some aspects, the techniques described herein relate to a delivery system, further including an infusion aperture disposed on the catheter between the first balloon and the second balloon and configured to infuse the therapeutic agent into the target location.

[0030] In some aspects, the techniques described herein relate to a delivery system, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive (e.g. BioGlue®, or the like), a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

[0031] In some aspects, the techniques described herein relate to a delivery system, wherein the weeping section extends over a portion of one or both of the first balloon and the second balloon, the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

[0032] In some aspects, the techniques described herein relate to a delivery system, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

[0033] In some aspects, the techniques described herein relate to a delivery system, wherein the cage is biased towards the collapsed configuration and is transitioned to the expanded configuration by in one or both of the first balloon and the second balloon transitioning to the expanded configuration.

[0034] In some aspects, the techniques described herein relate to a method of delivering a therapeutic agent to a target location within a vasculature, the method including, advancing a catheter to the target location, inflating a first balloon disposed annularly about an outer surface of the catheter at a first longitudinal location on the catheter to occlude a first end of the target location, inflating a second balloon disposed annularly about the outer surface of the catheter at a second longitudinal location on the catheter to occlude a second end of the target location, transitioning a cage that is slidably engaged with the outer surface of the catheter to an expanded configuration, infusing the therapeutic agent into the target location, and draining a fluid from the target location by a drainage aperture disposed on the catheter between the first balloon and the second balloon.

[0035] In some aspects, the techniques described herein relate to a method, wherein the drainage aperture is disposed adjacent one of the first balloon or the second balloon, or disposed adjacent a mid-point between the first balloon and the second balloon.

[0036] In some aspects, the techniques described herein relate to a method, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive (e.g. BioGlue®, or the like), a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

[0037] In some aspects, the techniques described herein relate to a method, wherein infusing the therapeutic agent into the target location includes infusing the therapeutic agent through one or both of an infusion aperture disposed on the catheter between the first balloon and the second balloon, and a weeping section disposed on one or both of the first balloon and the second balloon.

[0038] In some aspects, the techniques described herein relate to a method, wherein the weeping section extends over a portion of one or both of the first balloon and the second balloon, the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

[0039] In some aspects, the techniques described herein relate to a method, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

[0040] In some aspects, the techniques described herein relate to a method, wherein the cage is biased towards a collapsed configuration and is transitioned to the expanded configuration by inflating one or both of the first balloon and the second balloon.BRIEF DESCRIPTION OF DRAWINGS

[0041] A more particular description of the present disclosure will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. Example embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0042] FIG. 1 shows a side view of an embodiment of a therapeutic agent delivery system in an expanded configuration and including a catheter, a first balloon, a second balloon, and a cage, in accordance with embodiments disclosed herein.

[0043] FIG. 2 shows a side view of an embodiment of a therapeutic agent delivery system in an expanded configuration, in accordance with embodiments disclosed herein.

[0044] FIG. 3A shows a perspective view of a cage of the system of FIG. 1 in a collapsed configuration, in accordance with embodiments disclosed herein.

[0045] FIG. 3B shows a perspective view of a cage of the system of FIG. 1 in an expanded configuration, in accordance with embodiments disclosed herein.

[0046] FIG. 4 shows a side view of a double catheter therapeutic agent deliver system in an expanded configuration and including a first catheter having a first balloon and a cage, and a second catheter having a second balloon, in accordance with embodiments disclosed herein.

[0047] FIG. 5 shows a perspective view of a cage of the system of FIG. 4, in accordance with embodiments disclosed herein.

[0048] FIG. 6 shows an embodiment of a double catheter therapeutic agent deliver system in an expanded configuration including a first catheter having a first balloon and a cage, and a second catheter having a second balloon and a hypotube, in accordance with embodiments disclosed herein.DESCRIPTION

[0049] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein. It is understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0050] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “right,” “left,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction.Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Also, the words “including,” “has,” and “having,” as used herein, including the claims, shall have the same meaning as the word “comprising.”

[0051] In the following description, the terms “or” and “and / or” as used herein are to be interpreted as inclusive or meaning any one or any combination. As an example, “A, B or C” or “A, B and / or C” mean “any of the following, A, B, C, A and B, A and C, B and C, A, B and C.” An exception to this definition will occur only when a combination of elements, components, functions, steps or acts are in some way inherently mutually exclusive.

[0052] With respect to “proximal,” a “proximal portion” or a “proximal end portion” of, for example, a catheter or system disclosed herein includes a portion of the catheter or system intended to be near or relatively nearer to a clinician when the catheter or system is used on a patient. Likewise, a “proximal length” of, for example, the catheter or system includes a length of the catheter or system intended to be near or relatively nearer to the clinician when the catheter or system is used on the patient. A “proximal end” of, for example, the catheter or system includes an end of the catheter or system intended to be near or relatively nearer to the clinician when the catheter or system is used on the patient. The proximal portion, the proximal end portion, or the proximal length of the catheter or system can include the proximal end of the catheter or system; however, the proximal portion, the proximal end portion, or the proximal length of the catheter or system need not include the proximal end of the catheter or system. That is, unless context suggests otherwise, the proximal portion, the proximal end portion, or the proximal length of the catheter or system is not necessarily a terminal portion or terminal length of the catheter or system.

[0053] With respect to “distal,” a “distal portion” or a “distal end portion” of, for example, a catheter or system disclosed herein includes a portion of the catheter or system intended to be near or relatively nearer to a patient when the catheter or system is used on a patient. Likewise, a “distal length” of, for example, the catheter or system includes a length of the catheter or system intended to be near or relatively nearer to the patient when the catheter or system is used on the patient. A “distal end” of, for example, the catheter or system includes an end of the catheter or system intended to be near or relatively nearer to the patient when the catheter or system is used on the patient. The distal portion, the distal end portion, or the distal length of the catheter or system can include the distal end of the catheter or system; however,the distal portion, the distal end portion, or the distal length of the catheter or system need not include the distal end of the catheter or system. That is, unless context suggests otherwise, the distal portion, the distal end portion, or the distal length of the catheter or system is not necessarily a terminal portion or terminal length of the catheter or system.

[0054] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art.

[0055] FIG. 1 shows an embodiment of a therapeutic agent 70 delivery system (“system”) 100 generally including a catheter 110, a first balloon 120 and a second balloon 130. In an embodiment, the system 100 further includes a cage 140. The first balloon 120, second balloon 130, and cage 140 are each configured to transition between a collapsed configuration and an expanded configuration. In an embodiment, the system 100 in the collapsed configuration is advanced to a target location 90 within a vessel 80. The system 100 can be transitioned to an expanded configuration to dilate the target location 90 and treat the target location 90 with a therapeutic agent 70 while maintaining the target location 90 in the dilated state. Once the treatment is complete the system 100 can be transitioned to the collapsed configuration and withdrawn from the target location 90.

[0056] Exemplary therapeutic agents 70 can include biological agents, chemical agents, chemical fixation agents, glutaraldehyde, theaflavin, surgical adhesive (e.g. BioGlue®, Gluetiss®, or the like), cross-linking drugs, antiproliferative drugs, thrombolytic drugs, cancer treatment drugs, paclitaxel, sirolimus, cross-linkers, cross-link breakers, denaturants, combinations thereof, or the like. Exemplary target locations can include intravascular locations within arteries or veins, AV fistulas, or the like, and can be for the treatment of elastic recoil and / or neointimal hyperplasia (NUT) that can occur subsequent to vascular stenosis or Percutaneous Transluminal Angioplasty (PTA) treatments.

[0057] With continued reference to FIG. 1, in an embodiment, the system 100 is advanced to a target location 90 in a collapsed configuration. Optionally the system 100 in the collapsed configuration can be disposed within a delivery catheter 102 and advanced to the target location 90 therein. The delivery catheter 102 can maintain the system 100 in the collapsed configuration and provide a smooth outer profile to prevent the system 100 from catching on vessel walls during advancement to the target location 90. Once the system 100 is aligned with the target location 90 the delivery catheter 102 can be withdrawn proximallyrelative to the system 100. Alternatively, the system 100 can be advanced distally relative to the delivery catheter 102 to align the system 100 with the target location 90.

[0058] The first balloon 120 is disposed annularly about an outer surface of the catheter 110 at a first longitudinal position and can be aligned with a first end of the target location 90. The second balloon 130 is disposed annularly about an outer surface of the catheter 110 at a second longitudinal position and can be aligned with a second end of the target location 90. The first balloon 120 is in fluid communication with a lumen of the catheter 110 and can be inflated to an expanded configuration to occlude the first end of the target location 90. The second balloon 130 ins in fluid communication with a lumen of the catheter 110 and can be inflated to an expanded configuration to occlude the second end of the target location 90. In the expanded configuration, one or both of the first balloon 120 and the second balloon 130 can form a fluid tight seal between the vessel wall and the respective first balloon 120 and second balloon 130 to mitigate or prevent any fluid from flowing to / from the target location 90. As shown, the first balloon 120 and the second balloon 130 include a spherical shape, however, it will be appreciated that other three-dimensional shapes including oblong, toroidal, cylindrical, or the like, are also contemplated.

[0059] In an embodiment, the first balloon 120 can be in fluid communication with a first lumen of the catheter 110 and the second balloon 130 can be in fluid communication with a second lumen of the catheter 110. Advantageously, each of the first balloon 120 and the second balloon 130 can be inflated and deflated independently of each other. In an embodiment, the first balloon 120 and the second balloon 130 are in fluid communication with a first lumen of the catheter. Advantageously, each of the first balloon 120 and the second balloon 130 can be inflated and deflated simultaneously. Further the catheter 110 requires fewer numbers of lumen and provides a smaller cross-sectional profile when in the collapsed configuration.

[0060] As shown in FIG. 1, one or both of the first balloon 120 and the second balloon 130 are disposed within a cage 140. The cage 140 is slidably engaged with an outer surface of the catheter 110. As one or both of the first balloon 120 and the second balloon 130 are inflated the balloons 120, 130, can transition the cage 140 from a collapsed configuration to an expanded configuration. In the expanded configuration, the cage 140 provides structural support to the vessel walls and dilates the vessel walls to restore patency to the target location 90. FIGS. 3A-3B show further details of the cage 140, as described herein.

[0061] With continued reference to FIG. 1, with the first balloon 120, second balloon 130, and cage 140 in the expanded configuration, a therapeutic agent 70 can be introduced to the target location 90 that is disposed between the first balloon 120 and the second balloon 130. In an embodiment, one or both of the first balloon 120 and the second balloon 130 occludes the vessel to prevent the therapeutic agent 70 from flowing beyond either of the first balloon 120 or the second balloon 130, keeping the therapeutic agent 70 concentrated at the target location 90 and improving the efficacy of the treatment.

[0062] In an embodiment, the first balloon 120 includes a weeping section 122 disposed over a portion of the surface of the first balloon 120. The weeping section 122 includes a plurality of apertures, perforations, laser cut holes, laser cut lines, one or more porous materials (e.g., expanded polytetrafluoroethylene (“ePTFE”)), combinations thereof, or the like, configured to allow a portion of the balloon to be porous. The first balloon 120 can be inflated by the therapeutic agent 70 introduced into the first balloon 120 by way of a lumen of the catheter 110. In the collapsed configuration, the plurality of apertures of the weeping section 122 can remain closed preventing the therapeutic agent 70 from exiting from the first balloon 120. As the first balloon 120 fills with the therapeutic agent 70 and expands, the expanding surface of the first balloon 120 can cause the plurality of apertures of the weeping section 122 to expand and open allowing the weeping section 122 to become porous and allowing the therapeutic agent 70 to exude from the first balloon 120.

[0063] In an embodiment, the rate of fluid flow across the weeping section 122 can be modified by the number, size, or configuration of the plurality of apertures, and / or by the viscosity, surface tension, or pressure of fluid within the balloon 120. In an embodiment, the weeping section 122 can be formed from a woven material and the rate of permeability across the weeping section 122 can be modified by the thickness of the woven material, the pattern of weave for the woven material, or combinations thereof. In an embodiment, the entire balloon 120 is formed of a woven material that further includes a non-porous coating, an impermeable layer, or laminate, or combinations thereof disposed over a portion of the balloon to form a non-porous section. As such, the portion of the balloon 120 not covered by the coating or laminate layers defines the weeping section 122.

[0064] In an embodiment, one or both of the first balloon 120 and the second balloon 130 include a dual balloon construction. For example, the first balloon 120 includes an interior balloon and an exterior balloon. The interior balloon can be inflated to transition the balloonfrom the collapsed configuration to the expanded configuration. The therapeutic agent 70 can then be introduced to the exterior balloon, i.e., between the outer surface of the interior balloon and the inner surface of the exterior balloon. The exterior balloon can include the weeping section 122, as described herein and can allow the therapeutic agent 70 to exude from the exterior balloon. Advantageously, the rate of fluid flow across the weeping section 122 can be controlled by modifying the inflation pressure of the inner balloon.

[0065] In an embodiment, the weeping section 122 can be made selectively permeable by incorporating a dissolvable coating into the wall of the balloon, and / or temporarily plugging the plurality of apertures with the dissolvable coating. Once the dissolvable coating comes in contact with a specific fluid, for example, blood, plasma, flushing solution, and / or therapeutic agent 70, the dissolvable coating dissolves allowing fluid to pass through the weeping section 122. In an embodiment, the weeping section 122 can be made selectively permeable in response to the surface tension of the fluid in contact with the weeping section 122. For example, in response to a change in surface tension between the blood, plasma, flushing solution, or therapeutic agent 70 on the inside or the outside of the balloon 120, the porosity of the weeping section 122 can change to either increase or decrease fluid flow across the weeping section 122. By way of an example, the porosity of the weeping section 122 can be reduced when in contact with blood on the outside of the balloon 120. However, once the target location 90 is purged with flushing solution, the porosity of the weeping section 122 can be increased in the presence of the flushing solution with a different surface tension. These, and other combinations or configurations of modifying the porosity of the weeping section 122 are also contemplated.

[0066] In an embodiment, the permeability of the weeping section 122 can be modified by iontophoresis, where an electrical current is applied to the weeping section 122 to change the plurality of apertures of the balloon 120. Advantageously, the electrified surface of the balloon 120 can also stimulate the vessel wall at the target location 90 to further improve the permeability of the vascular tissue to the therapeutic agent 70 and / or increase uptake of the therapeutic agent into the tissues.

[0067] As shown in FIG. 1, the weeping section 122 is disposed over a portion of the outer surface of the first balloon 120 that is disposed adjacent the second balloon 130, i.e., disposed towards the target location 90. In an embodiment, the weeping section 122 extends over a surface of the first balloon 120 that is equal to, or less than, half of the surface area ofthe first balloon 120. In an embodiment, the weeping section 122 extends over a portion of the first balloon 120 that is less than half of the surface area of the first balloon 120, such that the outer diameter of the first balloon 120 that contacts a vessel wall does not include a weeping section. As such the therapeutic agent 70 does not leak in between the first balloon 120 and the vessel wall, or leak outside of the target location 90. This can be important to increase the efficacy of the therapeutic agent 70 and / or to prevent exposing areas outside of the target location 90 to the therapeutic agent 70, which may have detrimental effects.

[0068] As the therapeutic agent 70 is introduced into the target location 90, the therapeutic agent 70 displaces any fluid that is retained between the first balloon 120 and the second balloon 130. The displaced fluids, e.g., blood, plasma, flushing fluids, saline fluids, combinations thereof, or the like, can be drained from the target location 90 through a drainage aperture 150 that is in fluid communication with a lumen of the catheter 110. The drainage aperture 150 is disposed on a portion of the catheter 110 disposed between the first balloon 120 and the second balloon 130. In an embodiment, the drainage aperture 150 is disposed adjacent the second balloon 130.

[0069] In an embodiment, the second balloon 130 can include a second weeping section 132, as described herein. The second weeping section 132 can be instead of, or in addition to, the first weeping section 122. In an embodiment, the drainage aperture 150 can be disposed on the catheter 110 adjacent the first balloon 120, or disposed on the catheter 110 adjacent a mid-point between the first balloon 120 and the second balloon 130. As such, the therapeutic agent 70 can be exuded from the first weeping section 122 of the first balloon 120 towards a drainage aperture 150 disposed adjacent the second balloon 130, from the second weeping section 132 of the second balloon 130 towards a drainage aperture 150 disposed adjacent the first balloon 120, from both the first weeping section 122 and the second weeping section 132 towards a drainage aperture 150 disposed adjacent a mid-point, or combinations thereof.

[0070] In an embodiment, fluids are passively drained from the target location by way of the aperture 150 that is in communication with a lumen of the catheter 110. As the fluids are urged into the target location, e.g., from the weeping section 122, fluids within the target location 90 are passively displaced through the drainage aperture 150. Alternatively, or in addition to passive drainage of fluids, fluids can also be aspirated from the target location 90 by way of the drainage aperture 150. In an embodiment, a vacuum pump or similar device canbe in fluid communication with the drainage aperture 150 to actively aspirate fluids from the target location 90 by way of the drainage aperture 150.

[0071] In an embodiment, as shown in FIG. 2, the therapeutic agent 70 can be introduced to the target location 90 by way of an infusion aperture 152 that is in fluid communication with an infusion lumen of the catheter 110. Further, fluids can be drained from the target location 90 by way of the drainage aperture 150, as described herein. As shown, the infusion aperture 152 can be disposed on the catheter 110 and adjacent the first balloon 120, and the drainage aperture 150 can be disposed on the catheter 110 adjacent the second balloon 130. It will be appreciated, however, that the opposite configuration, i.e., the infusion aperture 152 is disposed adjacent the second balloon 130 and the drainage aperture 150 is disposed adjacent the first balloon 120, or other configurations of infusion aperture 152, drainage aperture 150, first balloon 120, and second balloon 130, are also contemplated.

[0072] In an embodiment, the system 100 includes one or both of a first weeping section 122 and a second weeping section 132 on the first balloon 120 and second balloon 130, respectively, in addition to the infusion aperture 152 and the drainage aperture 150. In an embodiment, as shown in FIG. 2, the system 100 including the infusion aperture 152 can be formed without one or both of the first weeping section 122 and the second weeping section 132. As such, the therapeutic agent 70 can purge any fluids from the target location to ensure exposure of the therapeutic agent 70 to the vessel walls of the target location 90. Moreover, the vessel walls are exposed to the therapeutic agent 70 in the expanded position, held there by the first balloon 120, second balloon 130, and / or the cage 140 in the expanded configuration.

[0073] In an embodiment, prior to the treatment agent being introduced to the target location 90, the target location 90 can be flushed, for example, with a saline solution, Ringer’s solution, water, or the like. In an embodiment, once the treatment is complete, the target location 90 can be flushed with a saline solution, or the like, by the same fluid pathway that the therapeutic agent 70 was administered to the target location 90. In an embodiment, one or more of the catheter 110, first balloon 120, second balloon 130, and cage 140 can include one or more sensors, for example, pressure sensors, flow sensors, temperature sensors, pH sensors, electro-physiological sensors, combinations thereof, or the like. The sensors can be configured to detect one or more stages of the treatment process by the system 100 and provide an indication to the user. For example, the sensors can detect when the first balloon 120 and the second balloon 130 are inflated, the cage 140 is expanded, when the treatment fluid 70 isflowing to the site, when the target site 90 is purged of blood, fluid, or treatment fluid 70, combinations thereof, or the like.

[0074] Once the treatment and / or flushing is complete, the first balloon 120 and the second balloon 130 can be deflated, allowing the cage 140 to transition to the collapsed configuration, the cage 140 being biased to the collapsed configuration. The system 100 can optionally be withdrawn into the delivery catheter 102 and withdrawn from the target location 90.

[0075] FIGS. 3A-3B show further details of the cage 140. As will be appreciated, the cage 140 as shown is exemplary and other configurations or designs of expandable cage or stent are contemplated to fall within the scope of the present invention. In an embodiment, the cage 140 can include a plurality of struts 146 forming an interlocking, or mesh, structure. The struts 146 are configured to pivot relative to each other at a plurality of joints 148 disposed in between the struts 146, allowing the cage 140 to transition between a collapsed configuration (FIG. 3A) and an expanded configuration (FIG. 3B). As shown in FIG. 3 A, in the collapsed configuration, the cage 140 defines a substantially uniform outer diameter between a first end 142 and a second end 144. As such, the cage 140 defines a reduced outer profile to facilitate advancing through tortuous vascular pathways to the target location. As shown in FIG. 3B, in the expanded configuration, a mid-section of the cage 140 defines a larger outer diameter than the diameter of one or both of the first end 142 and the second end 144. As such, the midsection of the cage 140 can dilate the target location 90 of the vessel 80. Further, the expanded mesh structure allows exposure of the therapeutic agent 70 to the vessel walls of the target location 90.

[0076] One or both of the first end 142 and the second end 144 of the cage 140 define a lumen extending longitudinally and having an inner diameter equal to, or less than, the outer diameter of the catheter 110. As such, the catheter 110 can slidably engage the first end 142 and the second end 144 to align the cage 140 with the catheter 110, as described herein. In an embodiment, the cage 140 can be formed of a plastic, polymer, metal, stainless steel, alloy, composite, shape memory material, super-elastic material, an alloy including one or more of Cobalt, Chromium, Nickel and / or Titanium, Nitinol, or the like.

[0077] FIGS. 4-6 show an embodiment of a double catheter therapeutic agent 70 deliver system (“double catheter system”) 200. The double catheter system 200 generally includes afirst catheter 210 including a first lumen that is in fluid communication with an aperture 252 at a distal end 214 of the first catheter 210. The first catheter 210 further includes a cage 240 coupled to the distal end 214, and a first balloon 220 disposed annularly about a distal portion of the first catheter 210. The first balloon 220 is in fluid communication with a second lumen of the first catheter 210. The system 200 further includes a second catheter 212 including a first lumen that is in fluid communication with an aperture 250 at a distal end 216 of the second catheter 212. The second catheter 212 including a second balloon 230 disposed annually about a distal portion thereof and is in fluid communication with a second lumen of the second catheter 212.

[0078] The first catheter 210 can be advanced through the vasculature in a first direction such that the cage 240 is aligned with a target location 90 and the first balloon 220 is aligned with a first end of the target location 90. The second catheter 212 can be advanced to the target location through the vasculature in a second direction, opposite to the first direction, such that the second balloon 230 is aligned with a second end of the target location 90 and the end 216 of the second catheter 212 is disposed within the target location 90, i.e. between the first balloon 220 and the second balloon 230. Optionally, the first catheter 210, first balloon 220, and cage 240 assembly, in the collapsed configuration, can be disposed within a delivery catheter 202 and advanced through the vasculature to the target location 90, as described herein. Similarly, the second catheter 212 and second balloon 230 assembly in the collapsed configuration can also be disposed within a second delivery catheter (not shown) and advanced to the target location 90, as described herein.

[0079] Once the first balloon 220 is aligned with a first end of the target location 90 and the second balloon 230 is aligned with a second end of the target location 90, each of the first balloon 220 and the second balloon 230 can be inflated to occlude the first end and the second end of the target location 90 respectively, as described herein. Further, the cage 240 can be transitioned from a collapsed configuration to an expanded configuration, as described in more detail herein. In the expanded configuration, the cage 240 can dilate the target location 90.

[0080] In an embodiment, the first catheter 210 includes an infusion aperture 252 disposed at the distal end 214 thereof and in fluid communication with a lumen of the catheter 210. In an embodiment, one or both of the first balloon 220 and the second balloon each include a weeping section, as described herein. For example, as shown, the first balloon 220 includesa first weeping section 222 disposed over a surface of the first balloon 220, adjacent the cage 240. As such, a therapeutic agent 70 can be introduced into the target location 90 by way of one or both of the infusion aperture 252 and the first weeping section 222. In an embodiment, the second catheter 212 includes a drainage aperture 250 disposed at a distal end 216 thereof and configured to drain or aspirate fluids from the target location 90, as described herein.

[0081] FIG. 5 shows further details of the cage 240 of the double catheter system 200. The cage 240 includes a first end 242 and a second end 244 disposed at an opposite end of the cage 240 from the first end 242. The cage 240 includes a plurality of struts 246 and joints 248 configured to allow the cage to transition between a collapsed configuration and an expanded configuration, as described herein. In an embodiment, the cage 240 further includes a wire 238 fixedly coupled to the first end 242 and slidably engaged with the second end 244. In an embodiment, the cage 240 is biased towards the collapsed configuration and can be transitioned from a collapsed configuration to an expanded configuration by withdrawing the wire 238 proximally, relative to the first catheter 210. The second end 244 abuts against the distal end 214 of the first catheter 210 compressing the cage 240 therebetween and transitioning the cage 240 to the expanded configuration.

[0082] In an embodiment, the cage 240 can be biased towards the expanded configuration and can be transitioned to the collapsed configuration by urging the wire 238 distally relative to the catheter 210. The second end 244 of the cage 240 can be fixedly attached to the end 214 of the first catheter 210. Urging the wire 238 distally relative to the catheter 210 can urge the first end 242 of the cage 240 away from the second end 244 causing the cage 240 to transition to the collapsed configuration.

[0083] The wire 238 can be formed of a single wire, or a plurality of wires woven or twisted together. The wire 238 can be formed of the same material as the cage 240 or from a different material. The wire 238 can be formed of a plastic, polymer, metal, stainless steel, alloy, composite, shape memory material, super-elastic material, an alloy including one or more of Cobalt, Chromium, Nickel and / or Titanium, Nitinol, or the like.

[0084] In an embodiment, as shown in FIG. 6, the double catheter system 200 can further include a hypotube 260 disposed within a lumen of the second catheter 212. The distal end 264 of the hypotube 260 includes an infusion aperture 262 in fluid communication with a hypotube lumen. Once the second balloon 230 is positioned and inflated, the distal end 264 ofthe hypotube 260 can be advanced through the target location 90 to a point that is adjacent the first balloon 220. The therapeutic agent 70 can be infused into the target location 90 by way of the hypotube infusion aperture 262 and can be drained or aspirated from the target location 90 by way of the second catheter drainage aperture 250.

[0085] Advantageously, the double catheter system 200 allows the relative positions of the first balloon 220 and the second balloon 230 to be adjusted to suit different sized target locations without having to provide different sized systems, increasing versatility and reducing inventory costs and logistics. Further the double catheter system 200 provides a smaller cross- sectional profile when in the collapsed configuration due to a reduced number of lumens within a single catheter, allowing the system 200 to negotiate smaller blood vessels. Advantageously, the hypotube 260 is slidably engaged with the second catheter 212. As such, the position of the distal end 264 of the hypotube 260 can be adjusted to suit different sized target locations 90.

[0086] Advantageously, embodiments described herein can deliver a therapeutic agent 70 while the vessel is in a dilated state. In the dilated state, the vessel wall is allowed to remodel cross-linking vessel tissues (e.g., collagen) in the expanded configuration, termed “locking” the wall proteins in the new expanded configuration, mitigating elastic recoil. Further, embodiments maintain the vessel wall in an expanded state that allows for increased drug absorption or increased absorption speed due to the increased surface area of the vessel wall.

[0087] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A delivery system for providing a therapeutic agent to a target location within a vasculature, the delivery system comprising: a first catheter defining a first lumen in communication with a first aperture at a distal end thereof, the first catheter including a cage coupled to the distal end of the first catheter and transitionable between a collapsed configuration and an expanded configuration, and a first balloon disposed annularly about an outer surface of the first catheter, the first balloon configured to transition to an expanded configuration to occlude a first end of the target location; and a second catheter defining a second lumen in communication with a second aperture at a distal end thereof, the second catheter including a second balloon disposed annularly about an outer surface and configured to transition to an expanded configuration to occlude a second end of the target location.

2. The delivery system according to claim 1, wherein the first aperture is configured to infuse the therapeutic agent to the target location and the second aperture is configured to drain a fluid from the target location.

3. The delivery system according to any of the preceding claims, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive, a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

4. The delivery system according to any of the preceding claims, wherein one or both of the first balloon and the second balloon each include a weeping section disposed over a portion thereof and configured to be porous for infusing the therapeutic agent into the target location.

5. The delivery system according to claim 4, wherein the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

6. The delivery system according to either claim 4 or claim 5, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

7. The delivery system according to any of the preceding claims, wherein the cage is biased towards the collapsed configuration and is transitioned to the expanded configuration by withdrawing a wire proximally through the first catheter.

8. The delivery system according to any of claims 1-6, wherein the cage is biased towards the expanded configuration and is transitioned to the collapsed configuration by urging a wire distally relative to the first catheter.

9. The delivery system according to any of claims 1-6, wherein the cage is biased towards the expanded configuration and is urged towards the expanded configuration by withdrawing a rod proximally relative to the first catheter.

10. The delivery system according to any of the preceding claims, further including a hypotube slidably engaged within the second lumen, a distal end of the hypotube extending through the second aperture into the target location, the hypotube defining a hypotube lumen communicating with a hypotube lumen aperture at the distal end of the hypotube.

11. The delivery system according to claim 10, wherein the hypotube lumen aperture is configured to infuse the therapeutic agent to the target location and the second aperture is configured to drain a fluid from the target location.

12. A method of delivering a therapeutic agent to a target location within a vasculature, the method comprising: advancing a first catheter in a first direction through the vasculature to the target location, the first catheter includes a first balloon disposed annularly about an outer surface thereof and is aligned with a first end of the target location; transitioning a cage, which is coupled to a distal end of the first catheter, to an expanded configuration; inflating the first balloon to occlude the first end of the target location; advancing a second catheter in a second direction through the vasculature to the target location;inflating a second balloon disposed annularly about the second catheter to occlude a second end of the target location; infusing the therapeutic agent into the target location; and draining a fluid from the target location.

13. The method according to claim 12, further including infusing the therapeutic agent through a first aperture at a distal end of the first catheter into the target location and draining the fluid from the target location through a second aperture at a distal end of the second catheter.

14. The method according to either claim 12 or claim 13, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive, a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

15. The method according to any of claims 12-14, further including infusing the therapeutic agent into the target location through a weeping section disposed over a portion of one or both of the first balloon and the second balloon.

16. The method according to claim 15, wherein the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

17. The method according to either claim 15 or claim 16, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

18. The method according to any of claims 12-17, wherein the cage is biased towards a collapsed configuration and is transitioned to the expanded configuration by withdrawing a wire proximally through the first catheter.

19. The method according to any of claims 12-17, wherein the cage is biased towards the expanded configuration and is transitioned to a collapsed configuration by urging a wire distally relative to the first catheter.

20. The method according to any of claims 12-19, further including a hypotube slidably engaged within the second catheter, a distal end of the hypotube extending from thesecond catheter into the target location, the hypotube defining a hypotube lumen communicating with a hypotube lumen aperture at the distal end of the hypotube.

21. The method according to claim 20, further including infusing the therapeutic agent into the target location through the hypotube lumen aperture.

22. A delivery system for providing a therapeutic agent to a target location within a vasculature, the delivery system comprising: a catheter; a cage slidably engaged with an outer surface of the catheter and transitionable between a collapsed configuration and an expanded configuration; a first balloon disposed annularly about the outer surface of the catheter at a first longitudinal location and configured to transition to an expanded configuration to occlude a first end of the target location; a second balloon disposed annularly about the outer surface of the catheter at a second longitudinal location and configured to transition to an expanded configuration to occlude a second end of the target location; one or both of the first balloon and the second balloon including a weeping section to infuse the therapeutic agent to the target location; and a drainage aperture disposed on the catheter between the first balloon and the second balloon to drain a fluid from the target location.

23. The delivery system according to claim 22, wherein the drainage aperture is disposed adjacent one of the first balloon or the second balloon, or disposed adjacent a midpoint between the first balloon and the second balloon.

24. The delivery system according to either claim 22 or claim 23, further including an infusion aperture disposed on the catheter between the first balloon and the second balloon and configured to infuse the therapeutic agent into the target location.

25. The delivery system according to any of claims 22-24, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive, a cross-linking drug, an antiproliferative drug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

26. The delivery system according to any of claims 22-25, wherein the weeping section extends over a portion of one or both of the first balloon and the second balloon, the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

27. The delivery system according to claim 26, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

28. The delivery system according to any of claims 22-27, wherein the cage is biased towards the collapsed configuration and is transitioned to the expanded configuration by in one or both of the first balloon and the second balloon transitioning to the expanded configuration.

29. A method of delivering a therapeutic agent to a target location within a vasculature, the method comprising: advancing a catheter to the target location, inflating a first balloon disposed annularly about an outer surface of the catheter at a first longitudinal location on the catheter to occlude a first end of the target location; inflating a second balloon disposed annularly about the outer surface of the catheter at a second longitudinal location on the catheter to occlude a second end of the target location; transitioning a cage that is slidably engaged with the outer surface of the catheter to an expanded configuration; infusing the therapeutic agent into the target location; and draining a fluid from the target location by a drainage aperture disposed on the catheter between the first balloon and the second balloon.

30. The method according to claim 29, wherein the drainage aperture is disposed adjacent one of the first balloon or the second balloon, or disposed adjacent a mid-point between the first balloon and the second balloon.

31. The method according to either claim 29 or claim 30, wherein the therapeutic agent includes one or more of a biological agent, a chemical agent, a chemical fixation agent, a glutaraldehyde, a theaflavin, a surgical adhesive, a cross-linking drug, an antiproliferativedrug, a thrombolytic drug, a cancer treatment drug, a paclitaxel, a sirolimus, a cross-linker, a cross-link breaker, and a denaturant.

32. The method according to any of claims 29-31, wherein infusing the therapeutic agent into the target location includes infusing the therapeutic agent through one or both of an infusion aperture disposed on the catheter between the first balloon and the second balloon, and a weeping section disposed on one or both of the first balloon and the second balloon.

33. The method according to claim 32, wherein the weeping section extends over a portion of one or both of the first balloon and the second balloon, the portion is equal to, or less than, half of the outer surface of the first balloon or the second balloon.

34. The method according to claim 33, wherein the portion is disposed on a surface of either of the first balloon or the second balloon and facing towards the target location.

35. The method according to any of claims 29-34, wherein the cage is biased towards a collapsed configuration and is transitioned to the expanded configuration by inflating one or both of the first balloon and the second balloon.

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