Vascular treatment devices and related systems and methods of use thereof

Abstract

Disclosed herein are devices, systems, and methods for treating a blood flow passageway. In one example, the treatment device includes an expandable element configured to be positioned within the passageway and a reinforcing element. The expandable element can have an expanded configuration, and in the expanded configuration, the expandable element defines a lumen therethrough. The reinforcing element can be positioned within the lumen of the expandable element. The reinforcing element can be coupled to the expandable element such that expansion of the expandable element causes the reinforcing element to radially expand, thereby creating a perfusion lumen through the device.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of priority to U.S. Provisional Application No. 62 / 717,752, filed Aug. 10, 2018, which is incorporated by reference in its entirety. (Technical field)

[0002] The present technology is directed to therapeutic devices, systems, and methods for treating cardiac disease. In particular, the present technology relates to devices, associated systems, and methods of use for treating blood vessels. [Background technology]

[0003] There are many situations in interventional vascular procedures where there is a need to inflate a balloon within a vessel while maintaining perfusion through that vessel. For example, when delivering a balloon-expandable stent in a coronary artery, it is more preferable to maintain blood flow through the artery and avoid ischemic damage to the myocardium perfused by that artery. One device commonly used to maintain blood flow is a perfusion balloon catheter. These catheters typically have a relatively large central guidewire lumen with a hole into the lumen through the catheter sidewall just proximal to the balloon. This allows blood to flow through the side hole into the guidewire lumen and out the distal end of the catheter to maintain perfusion when the balloon is inflated and occludes the vessel.

[0004] However, these perfusion balloons are typically used only in smaller vessels where a relatively small perfusion lumen is sufficient, and catheters can be made with a fixed size perfusion lumen, e.g., a lumen less than 2 mm in diameter. In larger vessels, such as the aorta, maintaining adequate distal perfusion without high pressure gradients across the perfusion lumen requires a much larger lumen.

[0005] Two common interventional procedures that utilize balloon expansion are (a) balloon valvuloplasty of the aortic valve and (b) catheter-based delivery of a balloon-expandable replacement aortic valve (commonly referred to as "transcatheter aortic valve replacement" or "TAVR"). FIG. 1 shows the delivery of a replacement aortic valve on a conventional balloon catheter. Conventional practice is to inflate the balloon to a large diameter (approximately 20-30 mm) at very high pressure, blocking all flow to the systemic circulation. It also prevents any blood from exiting the left ventricle, which can lead to dangerous acute dilation of the ventricle. To prevent this dangerous dilation of the ventricle, a temporary pacing catheter is placed into the heart, and the heart is typically paced at a very high rate (approximately 200 beats per minute), which prevents it from filling between heartbeats. Such rapid ventricular pacing can cause myocardial ischemia, malignant arrhythmias, low output, desaturation of cerebral oxygen, and / or increased procedure time and risk of stroke. To avoid or reduce the possibility of these risks, valvuloplasty or TAVR balloons are typically inflated for less than one minute.

[0006] In a typical balloon catheter, the balloon is formed from a single extrusion, expanded to a given balloon shape, and welded or bonded to the catheter shaft. The sidewall of the catheter is cut to create an opening to connect the inflation lumen, which extends through the catheter shaft, to the interior of the balloon. In most clinical applications where vessels or valves are being expanded, the outer surface of the balloon is rounded (i.e., has a functionally circular cross-sectional shape) to exert a relatively uniform radial force on the apposing tissue. It is difficult to maintain this rounded / circular shape and position the perfusion lumen at the periphery of the balloon while providing a uniform radial outward force.

[0007] An existing approach to the aforementioned problem of creating a large perfusion lumen within a larger balloon catheter is the TRUE® Flow Valvuloplasty Perfusion Catheter (manufactured by CR Bard / Becton Dickenson). The TRUE® Flow Device has several smaller balloons arranged around the periphery of a central lumen and surrounded by a fiber-based shell. When inflated, the balloons hold the central lumen open. However, this approach limits the effective pressure that can be applied to the circumference of the balloon, even when these smaller balloons are inflated to higher pressures. More importantly, the use of multiple balloons employs a large amount of material, which increases the deflated diameter of the device and makes delivery of the device through the delivery sheath more difficult. This is especially true for TAVR balloons, which have the additional volume of the prosthetic valve.

[0008] Thus, there remains a need for improved balloons for interventional procedures, particularly within the field of interventional cardiology. Summary of the Invention [Means for solving the problem]

[0009] The present technology is illustrated in accordance with various aspects described below, for example with reference to Figures 2A-10B. Various examples of aspects of the technology are described as numbered annotations (1, 2, 3, etc.) for convenience. These are provided as examples and are not intended to be limiting of the technology. 1. A device for treating a blood flow passageway in a patient, the device comprising: an expandable element configured to be positioned within the passageway, the expandable element having a folded configuration, and in the expanded configuration, the expandable element defining a lumen therethrough; a reinforcing element positioned within a lumen of the expandable element, the reinforcing element having a collapsed configuration and an expanded configuration, the reinforcing element defining a lumen therethrough and coupled to the expandable element such that expansion of the expandable element causes the reinforcing element to radially expand, thereby creating a perfusion lumen through the device; A device comprising: 2. A device for treating cardiac or cardiovascular disease, the device comprising: an expandable element comprising an outer wall and an inner wall that meet at their respective longitudinal ends, the expandable element having a collapsed configuration and an expanded configuration, the inner wall defining a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the lumen, wherein expansion of the expandable element from a collapsed configuration to an expanded configuration causes the reinforcing element to expand radially; A device comprising: 3. The device of claim 1 or 2, wherein the device is configured such that expansion of the expandable element while the device is positioned within the passageway urges the reinforcing element toward its expanded configuration, thereby allowing blood flow through the lumen of the reinforcing element and the lumen of the expandable element while the expandable element is in the expanded configuration. 4. The device of any one of the preceding clauses, wherein the device is configured such that while the device is positioned within the passage, expansion of the expandable element pulls the reinforcing element toward its expanded configuration, thereby allowing blood flow through the lumen of the reinforcing element and the lumen of the expandable element while the expandable element is in the expanded configuration. 5. A device described in any one of the preceding clauses, wherein the expandable element causes radial expansion of the reinforcing element by applying a longitudinally directed force to the reinforcing element. 6. The device of claim 5, wherein the force is extensive in the longitudinal direction. 7. The device of claim 5, wherein the force is compressive in the longitudinal direction. 8. A device according to any one of the preceding clauses, wherein the expandable element causes radial expansion of the reinforcing element by applying a radially directed force along the reinforcing element. 9. The device of claim 8, wherein the force is radially extensive. 10. A device described in any one of the preceding clauses, wherein the reinforcing element is mechanically coupled to the expandable element through a sheath to the treatment site during delivery of the device. 11. The device of any one of the preceding clauses, wherein the reinforcing element is mechanically coupled to the expandable element at all times. 12. The device of any one of the preceding clauses, wherein expansion of the expandable element causes substantially simultaneous radial expansion of the reinforcing element to its expanded configuration. 13. The device of any one of the preceding clauses, wherein the expandable element is an expandable element configured to expand when an inflation fluid is delivered to an interior region of the expandable element. 14. The device of any one of the preceding claims, wherein the expandable element extends between first and second longitudinal ends, the expandable element having a fold at the first longitudinal end and a seam at the second longitudinal end. 15. The device of any one of the preceding clauses, wherein the expandable element defines a single continuous inflation cavity. 16. The device of any one of the preceding clauses, wherein the expandable element defines a single, continuous, annular expansion space. 17. The device of any one of the preceding claims, wherein the expandable element is a balloon. 18. The device of any one of the preceding claims, wherein the expandable element has a toroidal shape in the expanded configuration. 19. The device of any one of the preceding clauses, wherein the expandable element has an elongated toroidal shape in the expanded configuration. 20. The device of any one of the preceding claims, wherein the expandable element is configured to be inflated to a pressure of at least about 30 to about 105 psi (about 2 to about 7 atmospheres). 21. The device of any one of the preceding clauses, wherein the expandable element is configured to be inflated to an internal pressure sufficient to effectively dilate a stenosed native valve and / or aortic stenosis. 22. A device according to any one of the preceding clauses, wherein when the device is in an expanded state, the diameter of the perfusion lumen is sufficient to reduce any pressure gradient of blood flowing through the perfusion lumen. 23. A device according to any one of the preceding clauses, wherein when the device is in an expanded state, the diameter of the perfusion lumen is sufficient to minimize any pressure gradient of blood flowing through the perfusion lumen. 24. A device according to any one of the preceding clauses, wherein the diameter of the perfusion lumen is at least one-third the diameter of the blood flow passage. 25. The device of any one of the preceding clauses, wherein expansion of the expandable element creates a perfusion lumen through the expandable element and the reinforcing element, and the perfusion lumen is configured to remain open while the expandable element is in the expanded configuration. 26. The device of any one of the preceding clauses, wherein the device is configured such that shortening of the expandable element causes the reinforcing element to expand radially, thereby increasing the diameter of the lumen of the reinforcing element. 27. The device of any one of the preceding claims, wherein the reinforcing element is a mesh. 28. The device of any one of the preceding claims, wherein the reinforcing element is a braid. 29. The device of any one of the preceding claims, wherein the reinforcing element is a coil. 30. A device according to any one of the preceding clauses, wherein the reinforcing element is a laser cut stent. 31. A first portion coupled to a reinforcing element at a first location; a second portion coupled to the reinforcing element at a second location; an intermediate portion between the first and second portions, the intermediate portion extending over a radially outer surface of the expandable element; 32. The device of any one of the preceding clauses, further comprising a connector having an intermediate portion extending substantially longitudinally along a radially outer surface of the expandable element. 33. The device of claim 31, wherein the connector comprises at least one of a strand, a suture, a wire, a thread, a tether, a fiber, or a filament. 34. The device of claim 31, wherein expansion of the expandable element causes the connector to pull the first and second locations toward each other, thereby causing the reinforcing element to expand radially. 35. The device of claim 31, wherein expansion of the expandable element causes the connector to pull the first and second locations away from each other, thereby causing the reinforcing element to expand radially. 36. The device of claim 31, wherein the first location comprises a first small hole in the reinforcing element and the second location comprises a second small hole in the reinforcing element. 37. The device of claim 36, wherein the longitudinal distance between the first and second ostia decreases in response to expansion of the expandable element. 38. The device of claim 36, wherein the longitudinal distance between the first and second ostia increases in response to expansion of the expandable element. 39. The device of any one of clauses 36-38, wherein the first and second ostia are substantially circumferentially aligned. 40. The device of any one of clauses 36-38, wherein the first and second ostia are circumferentially offset. 41. The device of any one of statements 36-40, wherein the first and second small holes are positioned at opposing longitudinal ends of the reinforcing element. 42. The device of any one of statements 36-40, wherein the first and second small holes are positioned between the first and second longitudinal ends of the reinforcing element. 43. The device of any one of clauses 31-37, further comprising a plurality of connectors having first and second portions each coupled to the reinforcing element and an intermediate portion between the first and second portions, the intermediate portions extending over a radially outer surface of the expandable element. 44. The device of claim 40, wherein the connectors are spaced apart from one another around the radially outer surface of the expandable element. 45. The device of any one of the preceding clauses, wherein the reinforcing element extends longitudinally between a first and second end and has a first location and a second location, the first location being positioned at a longitudinal location along the reinforcing element between the first end and the second location, and the device further comprises a connector, the connector extending from the second location past the first location to the first end, then inverting and extending along the outer surface of the expandable element to the second end of the reinforcing element, then inverting and extending along the reinforcing element toward the second end, past the second location to the first location. 46. ​​The device of any one of the preceding clauses, further comprising a travel limiter configured to limit longitudinal elongation and / or contraction of the stiffening element in response to expansion of the expandable element. 47. The device of claim 46, wherein the travel limiter comprises one or more pairs of opposing eyelets coupled via a flexible connector. 48. The device of claim 47, wherein the longitudinal distance between opposing ostia decreases in response to expansion of the expandable element. 49. The device of claim 47 or 48, wherein the connector prevents the eyelets from longitudinally overlapping or moving past each other. 50. The device of any one of the preceding claims, wherein the reinforcing element comprises a plurality of interconnected struts. 51. A device described in any one of the preceding clauses, wherein the reinforcing element includes a first circumferential portion and a second circumferential portion, and (a) a longitudinal length of the first circumferential portion changes as the expandable element expands and contracts, and (b) a longitudinal length of the second circumferential portion remains constant as the expandable element expands and contracts. 52. A device described in any one of the preceding claims, wherein the reinforcing element is coupled to the expandable element via a flexible connector. 53. The device of any one of the preceding claims, wherein at least a portion of the outer surface of the reinforcing element is adhered to at least a portion of the outer surface of the inner wall of the expandable element. 54. A device described in any one of the preceding paragraphs, wherein the end of the reinforcing element is directly attached to the end of the expandable element such that expansion of the expandable element causes either stretching or contraction of the expandable element, thereby causing expansion of the reinforcing element. 55. The device of any one of the preceding claims, wherein the length of the reinforcing element is less than the length of the expandable element. 56. The device of any one of the preceding claims, wherein the length of the reinforcing element is different from the length of the expandable element. 57. The device of any one of the preceding claims, wherein the length of the reinforcing element is greater than the length of the expandable element. 58. The device of any one of the preceding claims, wherein the entire length of the reinforcing element is positioned within the lumen of the expandable element. 59. A device described in any one of the preceding clauses, wherein a portion of the length of the reinforcing element extends proximally beyond the proximal end of the expandable element, distally beyond the distal end of the expandable element, or both. 60. The device of any one of the preceding claims, further comprising a valve coupled to the reinforcing element and / or the expandable element, the valve configured to control fluid flow through the lumen of the reinforcing element. 61. The device of claim 60, wherein the valve is a one-way valve. 62. The device of claim 60 or 61, wherein the valve is one of an iris valve, a multi-leaflet valve, a duckbill valve, or a windsock valve. 63. The device of any one of the preceding claims, further comprising an expandable embedded valve apparatus positioned about the outer surface of the expandable element. 64. The device of claim 63, wherein the expandable implantable valve apparatus comprises a laser-cut stent and a prosthetic heart valve configured for implantation in the native annulus. 65. The device of any one of the preceding clauses, wherein the passageway is a native valve annulus. 66. The device of any one of the preceding clauses, wherein the passageway is a native heart valve annulus. 67. A device according to any one of the preceding clauses, wherein the passageway is an aortic valve annulus. 68. A device according to any one of the preceding claims, wherein the passageway is a blood vessel. 69. A system for treating a blood flow passageway of a patient, the system comprising: A therapeutic element comprising any of the devices described in appendix 1-68; a first elongate member defining a lumen therethrough, the lumen being in fluid communication with an interior region of the expandable element and configured to deliver fluid to the interior region of the expandable element to expand the expandable element; a second elongated member, a distal portion of the second elongated member being coupled to the reinforcing element; The system comprises: 70. The system of any one of the preceding claims, wherein the second elongate member defines a lumen extending therethrough, the lumen being configured to slidably receive a guidewire. 71. A system described in any one of the preceding claims, wherein only a portion of the reinforcing element is fixed to the second elongated member such that the reinforcing element can change length while coupled to the second elongated member. 72. The system of any one of the preceding clauses, further comprising a third elongated member configured to receive the first elongated member and the second elongated member therethrough. 73. The device of claim 72, wherein the third elongate member terminates distally at a location proximal to the expandable element. 74. The system of any one of the preceding claims, further comprising an atraumatic distal tip at a distal end of the second elongate member. 75. A method of treating a blood flow passageway of a patient using any of the preceding therapeutic devices, systems, or elements. 76. A method of treating a blood flow passageway in a patient, the method comprising: delivering a therapeutic element in a collapsed configuration to a treatment site within a blood flow passage, the therapeutic element comprising an expandable element and a reinforcing element positioned at least partially within a lumen of the expandable element; creating a perfusion lumen by radially expanding the expandable element at the treatment site, the perfusion lumen extending through the treatment element while the expandable element is in an expanded configuration; A method comprising: 77. The method of any one of the preceding claims, wherein radial expansion of the expandable element causes radial expansion of the reinforcing element. 78. The method of any one of the preceding claims, wherein radial expansion of the expandable element exerts a longitudinal compressive force on the reinforcing element, thereby causing the reinforcing element to expand radially within the lumen of the expandable element. 79. The method of any one of the preceding claims, wherein the reinforcing element has first and second locations spaced apart along its longitudinal axis, and radial expansion of the expandable element pulls the first and second locations longitudinally in opposing directions. 80. The method of any one of the preceding claims, wherein expansion of the expandable element radially expands the reinforcing element, and the perfusion lumen extends through the lumen of the expanded reinforcing element. 81. The method of any one of the preceding claims, wherein expanding the expandable element includes delivering an inflation fluid to an interior region of the expandable element. 82. The method of any one of the preceding claims, wherein the expandable element is a balloon. 83. The method of any one of the preceding claims, wherein expansion of the expandable element while the device is positioned within the blood flow passage pulls the reinforcing element toward its expanded configuration. 84. The method of any one of the preceding claims, further comprising exerting a radially outward force on a radially inner surface of the expandable element with the reinforcing element. 85. The method of any one of the preceding claims, wherein the therapeutic element is any of the therapeutic devices and / or therapeutic elements of the preceding claims. The present invention provides, for example, the following: (Item 1) 1. A device for treating a blood flow passageway in a patient, the device comprising: an expandable element configured to be positioned within the passageway, the expandable element having a collapsed configuration and an expanded configuration, wherein in the expanded configuration, the expandable element defines a lumen therethrough; a reinforcing element positioned within the lumen of the expandable element; Equipped with A device, wherein the reinforcing element has a collapsed configuration and an expanded configuration, in which the reinforcing element defines a lumen therethrough, and the reinforcing element is coupled to the expandable element such that expansion of the expandable element causes the reinforcing element to expand radially, thereby creating a perfusion lumen through the device. (Item 2) Item 1, the device being configured such that while the device is positioned within the passageway, expansion of the expandable element pulls the reinforcing element toward its expanded configuration, thereby allowing blood flow through the lumen of the reinforcing element and the lumen of the expandable element while the expandable element is in the expanded configuration. (Item 3) 3. The device of any one of claims 1-2, wherein the expandable element causes radial expansion of the stiffening element by applying a longitudinally directed force to the stiffening element. (Item 4) 4. The device of claim 3, wherein the force is extensive in a longitudinal direction. (Item 5) 4. The device of claim 3, wherein the force is compressive in the longitudinal direction. (Item 6) 6. The device of any one of items 1-5, wherein the reinforcing element is mechanically coupled to the expandable element during delivery of the device through a sheath to a treatment site. (Item 7) 7. The device of any one of claims 1-6, wherein the expandable element is an expandable element configured to expand when an inflation fluid is delivered to an interior region of the expandable element. (Item 8) 8. The device of any one of claims 1-7, wherein the expandable element extends between first and second longitudinal ends, the expandable element comprising a fold at the first longitudinal end and a seam at the second longitudinal end. (Item 9) 9. The device of any one of claims 1-8, wherein the expandable element defines a single continuous annular expansion space. (Item 10) 10. The device of any one of claims 1-9, wherein the expandable element is a balloon. (Item 11) 11. The device of any one of claims 1-10, wherein the expandable element has a toroidal shape in the expanded configuration. (Item 12) 12. The device of any one of claims 1-11, wherein the reinforcing element is a laser cut stent. (Item 13) The connector further comprises: a first portion coupled to the reinforcing element at a first location; a second portion coupled to the reinforcing element at a second location; an intermediate portion between the first and second portions; and having 13. The device of any one of items 1-12, wherein the intermediate portion extends over a radially outer surface of the expandable element. (Item 14) Item 14. The device of item 13, wherein the intermediate portion of the connector extends substantially longitudinally along the radially outer surface of the expandable element. (Item 15) Item 14. The device of item 13, wherein the connector comprises at least one of a strand, a suture, a wire, a thread, a tether, a fiber, or a filament. (Item 16) Item 14. The device of item 13, wherein expansion of the expandable element causes the connector to pull the first and second locations toward one another, thereby causing the stiffening element to expand radially. (Item 17) Item 14. The device of item 13, wherein the first location comprises a first pore of the stiffening element and the second location comprises a second pore of the stiffening element. (Item 18) Item 18. The device of item 17, wherein the longitudinal distance between the first and second ostia decreases in response to expansion of the expandable element. (Item 19) Item 19. The device of item 17 or item 18, wherein the first and second ostia are substantially circumferentially aligned. (Item 20) 20. The device of any one of items 13-19, further comprising a plurality of connectors, each of the plurality of connectors having first and second portions coupled to the reinforcing element and an intermediate portion between the first and second portions, the intermediate portion extending over the radially outer surface of the expandable element. (Item 21) 21. The device of any one of items 1-20, wherein the reinforcing element extends longitudinally between first and second ends and has a first location and a second location, the first location being positioned at a longitudinal location along the reinforcing element between the first end and the second location, the device further comprising a connector, the connector extending from the second location past the first location to the first end, then inverting and extending along an outer surface of the expandable element to the second end of the reinforcing element, then inverting and extending along the reinforcing element toward the second end, past the second location to the first location. (Item 22) 22. The device of any one of claims 1-21, further comprising a travel limiter, the travel limiter configured to limit longitudinal elongation and / or contraction of the stiffening element in response to expansion of the expandable element. (Item 23) Item 23. The device of item 22, wherein the travel limiter comprises one or more pairs of opposing eyelets coupled together via a flexible connector. (Item 24) 24. The device of any one of claims 1-23, further comprising a valve coupled to the reinforcing element and / or the expandable element, the valve configured to control fluid flow through the lumen of the reinforcing element. (Item 25) 1. A device for treating cardiac or cardiovascular disease, the device comprising: an expandable element comprising an outer wall and an inner wall, the outer wall and the inner wall meeting at their respective longitudinal ends, the expandable element having a collapsed configuration and an expanded configuration, the inner wall defining a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the lumen; Equipped with A device, wherein expansion of the expandable element from a collapsed configuration to an expanded configuration causes the stiffening element to radially expand. (Item 26) 1. A system for treating a blood flow passageway of a patient, the system comprising: A therapeutic element, the therapeutic element comprising: an expandable element comprising an outer wall and an inner wall, the outer wall and the inner wall meeting at their respective longitudinal ends, the expandable element having a collapsed configuration and an expanded configuration, the inner wall defining a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the lumen, wherein expansion of the expandable element from a collapsed configuration to an expanded configuration causes the reinforcing element to radially expand; and A therapeutic element comprising: a first elongate member defining a lumen therethrough, the lumen being in fluid communication with an interior region of the expandable element and configured to deliver fluid to the interior region of the expandable element to expand the expandable element; a second elongated member, a distal portion of the second elongated member being coupled to the stiffening element; The system comprises: (Item 27) Item 27. The system of item 26, wherein the second elongate member defines a lumen extending therethrough, the lumen configured to slidably receive a guidewire. (Item 28) Item 28. The system of item 26 or 27, wherein only a portion of the reinforcing element is fixed to the second elongate member, whereby the reinforcing element is coupled to the second elongate member but is variable in length. (Item 29) 29. The system of any one of claims 26-28, further comprising a third elongate member, the third elongate member configured to receive the first elongate member and the second elongate member therethrough. (Item 30) 30. The device of claim 29, wherein the third elongate member terminates distally at a location proximal to the expandable element. [Brief description of the drawings]

[0010] Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure.

[0011] [Figure 1] FIG. 1 depicts a conventional balloon catheter and replacement valve positioned at the aortic valve during a typical TAVR procedure.

[0012] [Figure 2A] FIG. 2A is a side view of a distal portion of the treatment system of the present technology shown in a folded state.

[0013] [Figure 2B] 2B and 2C are front and back isometric views, respectively, of a distal portion of the treatment system of the present technology shown in an expanded state. [Figure 2C] 2B and 2C are front and back isometric views, respectively, of a distal portion of the treatment system of the present technology shown in an expanded state.

[0014] [Figure 2D] FIG. 2D is a cross-sectional side view of the treatment system of the present technology in an expanded state.

[0015] [Figure 2E] FIG. 2E is a cross-sectional end view of the treatment system of the present technology taken along line 2E-2E of FIG. 2D.

[0016] [Diagram 3] 3A and 3B are side and isometric views, respectively, of a mold for forming an expandable element in accordance with the present technology.

[0017] [Figure 4A] FIG. 4A is a side view of a reinforcing element of the present technology in a rolled up, folded state.

[0018] [Figure 4B] FIG. 4B is a top view of the stiffening element of the technology in a laid-flat configuration.

[0019] [Diagram 5] FIG. 5 is an isometric view of the treatment element of the present technology.

[0020] [Figure 6A] FIG. 6A is an enlarged, isolated view of a portion of the reinforcing element of FIGS. 4A and 4B while the reinforcing element is in a folded state.

[0021] [Figure 6B] 6B is an enlarged, isolated view of a portion of the reinforcing element shown in FIG. 6A as the reinforcing element moves from the collapsed state of FIG. 6A to an expanded state.

[0022] [Figure 7] FIG. 7 is a top view of a stiffening element of the present technology in a laid flat configuration.

[0023] [Figure 8A] FIG. 8A is a side view of a distal portion of the treatment system of the present technology.

[0024] [Figure 8B] FIG. 8B is a rear isometric view of the distal portion of the treatment system of the present technology.

[0025] [Figure 9A] FIG. 9A is a schematic side view of the treatment system of the present technology shown in an expanded configuration.

[0026] [Figure 9B]FIG. 9B is a cross-sectional end view taken along line 9B-9B of FIG. 9A.

[0027] [Figure 9C] FIG. 9C is a cross-sectional end view taken along line 9C-9C of FIG. 9A.

[0028] [Figure 10] 10A and 10B illustrate different reinforcing elements according to the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Specific details of some embodiments of the present technology are described below with reference to Figures 2A-10B. Although many of the embodiments are described below with respect to devices, systems, and methods for percutaneous replacement of a native aortic valve, in addition to those described herein, other applications and other embodiments are also within the scope of the present technology, such as devices, systems, and methods for performing balloon valvuloplasty to dilate aortic stenosis or other stenosis in the circulatory system, and devices, systems, and methods for percutaneous replacement of a native mitral valve, native tricuspid valve, and / or native pulmonary valve. In addition, some other embodiments of the present technology can have different configurations, components, or procedures than those described herein. Those skilled in the art will therefore understand that the present technology can have other embodiments with additional elements, or that the present technology can have other embodiments without some of the features shown and described below with reference to Figures 2A-10B.

[0030] With respect to the terms "distal" and "proximal" within this description, unless otherwise specified, the terms can refer to the relative location of a portion of an interventional device, such as a prosthetic valve device and / or associated delivery device, relative to an operator and / or a location in the vasculature or heart. For example, in referring to a delivery system including a perfusion device described herein, "proximal" can refer to a location closer to the operator of the device or an incision into the vasculature, and "distal" can refer to a location further from the operator of the device, or further from an incision along the vasculature (e.g., the end of a catheter).

[0031] FIG 2A is a side view of a distal portion of the treatment system 100 of the present technology, shown with the treatment element 101 in a folded state. FIGs 2B and 2C are front and back isometric views, respectively, of the distal portion of the treatment system 100, with the treatment element 101 in an expanded state. As used herein, with reference to the treatment system 100, "expanded configuration" and "folded configuration" refer to configurations of the treatment system 100 when the treatment element 101 is expanded or folded, respectively. Similarly, the use of "deployed" with respect to the treatment element 101 or treatment system 100 refers to a configuration in which the treatment element 101 is fully or partially in an expanded configuration.

[0032] The treatment system 100 is configured to position and deploy the treatment element 101 at a treatment site within a patient's blood flow passageway and provide a perfusion lumen while the expandable element 104 is deployed during an interventional procedure. As used herein, a "blood flow passageway" refers to any anatomical structure through which blood flows in an orderly manner. Examples of blood flow passageways include natural valve annuli (anywhere within the heart or vasculature), heart chambers, blood vessels, and other body lumens. The treatment element 101 may be delivered in a collapsed state through a guide catheter to a treatment site within the blood flow passageway. When treating the heart or a blood flow passageway therein, the treatment system 100 may deliver the treatment element 100 to the heart via a transfemoral, transcaval, transaortic, transvenous, transatrial, transaxillary / subclavian, or transapical approach in an antegrade or retrograde direction relative to the direction of blood flow, including a transseptal crossing from the right atrium to the left atrium.

[0033] The treatment system 100 of the present technology may be used in any medical procedure employing balloon expansion within a blood flow passageway, whether the balloon (or other expandable element) is expanded to directly contact the surrounding passageway tissue or indirectly (with another structure (such as a stent, stent graft, or artificial heart valve device) positioned between the balloon and the passageway tissue). The treatment system 100 disclosed herein provides a reinforced perfusion lumen through the balloon, for example, while the balloon is expanded within the native valve annulus to widen the native valve opening during valvuloplasty or while positioning a prosthetic valve during a TAVR procedure. The treatment system 100 of the present technology may be used for delivery of repair or replacement devices to any of the four major heart valves (aortic, mitral, tricuspid, and pulmonary), and for expansion of stenoses or stents, or otherwise, in the aorta or any of the great vessels or other blood vessels. It may also be used to temporarily seal aortic ruptures, sites of uncontrolled bleeding, aortic dissections, or other areas where sealing of the vessel is desired while maintaining perfusion. In addition, the treatment system 100 of the present technology may also be utilized in transseptal and fenestrated aortic applications where access to the target vessel or lesion requires navigation through a tortuous anatomy. In such scenarios, an outer large diameter balloon (such as the expandable element of the present technology) allows fixation adjacent to the target lesion or vessel. In some cases, an additional stent or treatment system for balloon expansion may be delivered through the central lumen of the expandable element of the present technology.

[0034] As shown in Figures 2A-2C and the cross-sectional views of Figures 2D and 2E, treatment system 100 may include a therapeutic element 101 and one or more elongate members configured to carry or otherwise operatively support therapeutic element 101 within a blood flow passageway. The therapeutic element 101 includes an inner reinforcing element 102 (e.g., a stent) and an outer expandable element 104 (e.g., a balloon) positioned about reinforcing element 102. As described in more detail below, reinforcing element 102 is coupled to expandable element 104 such that expansion of expandable element 104 causes radial expansion of reinforcing element 102, thereby creating a perfusion lumen 108 through deployed therapeutic element 101 at the treatment site that allows blood to flow through the passageway while expandable element 104 is deployed during an interventional procedure. If the expandable element 104 is inflated (or otherwise expanded) without deploying the internal reinforcing element 102, the pressure within the expandable element 104 may collapse the perfusion lumen 108. Thus, the reinforcing element 102 provides a radially outward force against the inner surface of the expandable element 104 while the expandable element 104 is expanded, maintaining a perfusion lumen through the expandable element 104.

[0035] In some embodiments, the expandable element 104 comprises an inflatable element, such as a balloon. The expandable element 104 may include one or more substantially fluid impermeable materials used for balloons typically used in interventional procedures, such as polyethylene, polyolefin, polyurethane, nylon (polyamide), polyethylene terephthalate (PET or polyester), and / or other suitable polymers. In some examples of the present technology, the expandable element 104 may comprise a composite structure formed from one or more polymers and reinforcing fibers, such as Kevlar, carbon fiber, Spectra, or other high molecular weight polyethylene, or other fibers in any orientation.

[0036] As shown in most detail in the cross-sectional view of FIG. 2E, the expandable element 104 may comprise an elongated annular balloon formed of an outer wall 104c and an inner wall 104d that together enclose an interior region 106. The interior region 106 may be configured to receive a fluid to inflate or otherwise expand the expandable element 104. The outer wall 104c and the inner wall 104d of the expandable element 104 may be substantially impermeable to fluid, such that when the expandable element 104 is in its folded configuration, delivery of fluid to the interior region 106 urges the outer wall 104c radially away from the inner wall 104d, thereby radially expanding the expandable element 104. It may become longer or may shorten relative to the elongated member when radially expanding. As can be seen by comparing the collapsed configuration of the expandable element 104 (FIG. 2A) to its expanded configuration (FIGS. 2B-2E), the expandable element 104 may be slightly longer in its collapsed configuration than in its expanded configuration.

[0037] In some embodiments, such as those shown in FIGS. 2A-2F, the expandable element 104 may be formed from an everted tube, with the expandable element 104 having a seam at the proximal or first longitudinal end 104a (FIG. 2D) and a turn (no seam) at the distal or second longitudinal end 104b (FIG. 2D). In some embodiments, the expandable element 104 has a turn (no seam) at the proximal or first longitudinal end 104a (FIG. 2D) and a seam at the distal or second longitudinal end 104b (FIG. 2D). In either case, the turn may include an everted portion of the tube, and the seam may include where two longitudinal ends of the tube meet. Depending on the material used for the expandable element 104 (e.g., when using polyurethane), the seam may be welded or it may be bonded using a flexible bonding agent such as a UV-curable urethane methacrylate. The expansion shaft (such as the first elongate member 110 described below) can be made from the same or similar materials and welded or bonded into a seam. It may be more preferable to reduce or otherwise minimize any seams, joints, or welds in the expandable element 104 to reduce the chance of having weak sections of the expandable element 104 that are less able to withstand high pressures.

[0038] 3A and 3B show an exemplary mold 300 for forming the expandable element 104 of the present technology. The mold 300 can have a first portion 302, a second portion 304, a third portion 306, and a fourth portion 308 along its length, which result in similar sections of the resulting balloon. Adjacent portions can have tapered transitions between them. In some embodiments, the diameter of the second portion 304 can be less than the individual diameters of the first, third, and fourth portions 302, 306, 308 and can reflect the inner diameter of the lumen of the expandable element 104. The dashed lines show an example of a tube that is placed on the mold, insufflated to fit the mold shape, and then folded back on itself, with the resulting structure having a fold 105 at one end and a seam 107 at the other end. A tube (e.g., elongated member 110) can be inserted into the seam 107 to define an inflation lumen. It should be understood that the expandable element 104 may have other shapes than those shown in the drawings, and the mold 300 may have other shapes. When in its expanded configuration, the outer wall of the expandable element 104 may have a profile consisting of approximately linear segments (as shown in the figures), or all or a portion of the outer wall of the expandable element may have a more rounded profile than that depicted in the drawings.

[0039] In some embodiments, the expandable element 104 may comprise a balloon that is folded over at both ends, with the two ends overlapping along the inner diameter of the balloon. In this configuration, the resulting seam may be located at the middle portion of the balloon, rather than at the proximal or distal ends. For example, the seam may be located along the central portion of the balloon along the radially inward surface. The two overlapping ends may be bonded together, for example, using an adhesive. An inflation lumen may be inserted between these two overlapping ends and bonded into the balloon when the ends are bonded together.

[0040] In some aspects of the present technology, the expandable element 104 may be constructed using two separate layers: (a) a first material or layer for the inner wall, which may contact the reinforcing element 102 (i.e., facing the lumen 108) and may optionally contact the guidewire shaft (such as the second elongate member 114, described in more detail below), and (b) one for the outer wall. In some embodiments where the therapeutic element 101 includes a valve (such as those described with respect to Figures 8A and 8B), the outer wall should be connected to the valve such that there is no path for leakage between the expandable element and the valve. The two materials or layers may be joined at two seams, distal and proximal, and the inflation lumen is welded or bonded into one of the seams.

[0041] In some embodiments, the expandable element 104 of the present technology may have one or more of the following characteristics: a very thin contracted or folded profile to minimize the diameter of the device upon introduction and removal; a relatively large inflated or expanded profile (e.g., about 20 mm to about 30 mm to allow for expansion of large valves or vessels such as the aortic valve or aorta); a large perfusion conduit that, when inflated or expanded, reduces or minimizes any pressure gradients across the expandable element 104 (e.g., when the therapeutic element 101 is in the expanded state, the diameter of the perfusion lumen 108 is sufficient to minimize any pressure gradients of blood flowing through the perfusion lumen and / or the diameter of the perfusion lumen is at least one-third the diameter of the blood flow passage); and the ability to withstand high inflation pressures (e.g., at least 30 to about 105 psi (about 2 to about 7 atmospheres)) to effectively dilate a stenosed valve or aortic stenosis.

[0042] The expandable element 104 of the present technology offers several advantages over conventional balloon-expandable systems. For example, unlike conventional devices, the expandable element 104 is not formed from a sidewall that is joined to a fixed diameter catheter shaft. Rather, the expandable element 104 has an elongated annular or toroidal shape with an exterior surface that has both a lumen-facing (e.g., radially inwardly facing) portion and a radially outwardly facing portion. Additionally, the elongated annular expandable element 104 of the present technology has a shorter length without requiring a steeper transition angle from a larger diameter because many of the transitions are "inverted" by turning back. The shorter expandable element 104 improves the pushability and maneuverability of the treatment system 100 when navigating more tortuous anatomy.

[0043] 2A-2E, in addition to the treatment element 101, the treatment system 100 may also include one or more elongate members. For example, the treatment system 100 may include a first elongate member 110 defining a first lumen (not visible in the drawings), a second elongate member 114 defining a second lumen 115 that may be used to deliver a guidewire prior to the remainder of the system, and a third elongate member 112 defining a third lumen 113. The first elongate member 110 may extend between a proximal end portion (not shown) fluidly coupled to the interior region 106 of the expandable element 104 and a distal end portion. For example, a distal end portion of the first elongate member 110 may be inserted into and / or placed in fluid communication with the interior region 106 of the expandable element 104 via a joint between the outer and inner walls 104c, 104d (FIG. 2E) at the proximal end portion of the therapeutic element 101. The first elongate member 110 may be configured to deliver a fluid (e.g., water, saline, radiopaque solution, air) to the expandable element 104 causing it to expand.

[0044] The second elongated member 114 may extend between a proximal end portion (not shown) located at or near the therapeutic element 101 and a distal end portion. The second elongated member 114 may be a generally tubular shaft defining a lumen 115. In some embodiments, the second elongated member 114 is configured to slidably receive a guidewire for atraumatic guidance of the catheter to the appropriate location. The second elongated member 114 may extend through the entire length of the perfusion lumen 108 and terminate distal to the distal ends of the therapeutic element 101, the expandable element 104, and / or the reinforcing element 102. In some embodiments, the second elongated member 114 may terminate at a location longitudinally aligned with or proximal to the distal ends of the therapeutic element 101, the expandable element 104, and / or the reinforcing element 102. In some embodiments, the second elongate member 114 can have an atraumatic distal tip at its distal end, as shown in Figures 2A-2D.

[0045] The second elongate member 114 may be coupled to the reinforcing element 102 such that the reinforcing element 102 is free to contract and expand radially and / or longitudinally. For example, the second elongate member 114 may be coupled to the reinforcing element 102 at a single longitudinal location that does not impede the expansion and contraction of the reinforcing element. In some embodiments, the second elongate member 114 may be coupled to the reinforcing element 102 at multiple longitudinal locations along the reinforcing element 102, each of which does not undergo foreshortening (as described in more detail below).

[0046] The third elongate member 112 may comprise a generally tubular shaft defining a lumen 113 therethrough. The third elongate member 112 may extend from a proximal portion (not shown) to a distal portion that terminates at a location longitudinally aligned with or proximal to the therapeutic element 101, the expandable element 104, and / or the reinforcing element 102. In some embodiments, the third elongate member 112 terminates at a location longitudinally aligned with or distal or proximal to the therapeutic element 101, the expandable element 104, and / or the reinforcing element 102. In some embodiments, the third elongate member 112 extends throughout the entire length of the therapeutic element 101, the expandable element 104, and / or the reinforcing element 102.

[0047] The third elongate member 112 may receive one or more elongate members (including tubular shafts) through its lumen 113. For example, as shown in Figures 2A-2E, the first and second elongate members 110 and 114 extend through the lumen 113 of the third elongate member 112. The third elongate member 112 adds column strength to the treatment system 100, thereby improving pushability.

[0048] In some embodiments, the treatment system 100 may have more or fewer elongate members or lumens than those depicted in Figures 2A-2E.

[0049] 4A and 4B depict exemplary reinforcing elements 102 for use with the treatment system 100 of the present technology shown in tubular or flat-laid configurations, respectively. As demonstrated by FIGURES 4A and 4B, in some embodiments, the reinforcing element 102 may comprise a mesh (such as a stent) having a generally tubular structure enclosing a lumen extending between open longitudinal ends. The reinforcing element 102 may have a first end 102a, a second end 102b, and a length extending therebetween along the longitudinal axis L of the reinforcing element 102.

[0050] Although the illustrations provided in some of the figures provided herein show the expandable device lying flat for ease of illustration and understanding, the device can also be formed in a tubular shape. As also used herein, the term "longitudinal" can refer to a direction along an axis extending through the lumen of the device while in the tubular configuration, and the term "circumferential" can refer to a direction along an axis that is perpendicular to the longitudinal axis and extends around the circumference of the device when in the tubular configuration.

[0051] 4A and 4B, the mesh can comprise a plurality of struts 210 in a plurality of strut sections 202a-202d (collectively referred to as "strut sections 202"), a plurality of first spines 212 (individually labeled as 212a and 212b) and a plurality of second spines 214 (individually labeled as 214a, 214b, and 214c) extending substantially longitudinally across and between the strut sections 202, a plurality of first outer eyelets 205, a plurality of second outer eyelets 204, a plurality of opposing eyelets 203, and a plurality of junctions 230 and 232. The first and second spines 212 and 214 are collectively referred to herein as "spines 216." Only selected ones of the struts, spines, eyelets, and joints are labeled in Figure 4B for ease of illustration. In some embodiments, all of the strut sections 202 and spines 216 can extend along some or all of the circumference of the reinforcing element 102 when it forms a tubular shape (i.e., its healing shape).

[0052] 4B, for example, a first end of all of the struts 210 in all of the strut sections 202 connects to the first spine 212 and a second end of all of the struts 210 in all of the strut sections 202 connects to the second spine 214. In some embodiments, a first end of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 connects to the first spine 212 and a second end of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 connects to the second spine 214. In some embodiments, the first and second ends of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 connect to the first spine 212. In some embodiments, the first and second ends of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 connect to the second spine 214. The struts 210 may connect to the first and / or second spines 212, 214 at strut-to-ostium junctions 230 or strut junctions 232 (only some are labeled). As depicted, the struts 210 can be arranged in a serpentine pattern where the struts 210 change longitudinal direction after crossing the spines. Some or all of the junctions can be formed at the longitudinal ends of the strut sections 202.

[0053] As previously mentioned, the mesh of the reinforcing element 102 may include first and second spines 212, 214 extending longitudinally along the mesh. In some embodiments, all or a portion of one, some, or all of the first spines 212 may be parallel to all or a portion of one, some, or all of the second spines 214. In some embodiments, all or a portion of one, some, or all of the first spines 212 may be parallel to all or a portion of one, some, or all of the other first spines 212. In some embodiments, all or a portion of one, some, or all of the second spines 214 may be parallel to all or a portion of one, some, or all of the other second spines 214. In some embodiments, such as that shown in FIG. 4B, the first and second spines 212, 214 alternate around the circumference of the mesh. In some embodiments, at least one first spine 212 is directly radially adjacent to at least one other first spine 212, and in some embodiments, at least one second spine 214 is directly radially adjacent to at least one other second spine 214.

[0054] As shown in FIG. 4B, the first spine 212 may extend across less than all of the strut segments 202, and the second spine 214 may extend across all of the strut segments 202. The mesh may include an intermediate region 218 that includes opposing ostia 203 and a bridging portion 214c of the second spine 214. The first spine 212 may not extend into the intermediate region 218, thus forming two circumferential sections 212a and 212b spaced apart along the longitudinal axis of the mesh. In some embodiments, one, some, or all of the first spines 212 may span only two strut segments 202. Within the intermediate region 218, the periphery of each of the opposing ostia 203 and the bridging portion 214c of the second spine 212 may enclose the gap 206. Opposing longitudinal ends of opposing ostia 203 may be separated by a distance d1 across gap 206. In some cases, one, some, or all of the first spines 212 extend between the second outer ostium 204 and an adjacent one of the opposing ostia 203. One, some, or all of the first and second longitudinal ends of the second spines 214 may terminate at the second outer ostium 205.

[0055] FIG. 5 is an isolated view of one example of a therapeutic element 101 shown in an expanded configuration, including the reinforcing element 102 shown in FIGS. 4A and 4B. The reinforcing element 102 is shown diagrammatically in FIG. 5 for ease of illustration. FIG. 6A is an enlarged view of a portion of the reinforcing element 102 depicted as positioned in a folded state within the lumen of the expandable element 104. With reference to FIGS. 5 and 6A, in some embodiments, the reinforcing element 102 may be coupled to the expandable element 104 via one or more connectors 500. The connectors 500 may comprise at least one of a strand, a suture, a wire, a thread, a tether, a fiber, a filament, or other suitable connecting member. Each connector 500 may have a first portion 500a coupled to the reinforcing element 102 at a first location along the reinforcing element 102, a second portion 500b coupled to the reinforcing element 102 at a second location along the reinforcing element 102, and an intermediate portion 500c (FIG. 5) extending between the first and second portions 500a and 500b. In some embodiments, the first location is the eyelet 203a of the opposing eyelet pair and the second location is the other eyelet 203b of the opposing eyelet pair.

[0056] An intermediate portion 500c of the connector 500 may extend over the radially outer surface of the expandable element 104, as shown in FIG. 5. In some embodiments, all or a portion of the length of the intermediate portion 500c may extend substantially longitudinally along the expandable element 104. As shown in FIG. 5, in some embodiments, multiple connectors 500 may be spaced along the radially outer surface of the expandable element 104. In some embodiments, each such connector 500 may be separately coupled to the reinforcing element 102 at separate or overlapping locations. For example, each connector 500 may be coupled to a separate eyelet or other structure of the reinforcing element 102, or two or more connectors 500 may be coupled to the same eyelet or other structure of the reinforcing element 102.

[0057] In some embodiments, such as those shown in FIGS. 4A-6B, the first location is positioned at a longitudinal location along the stiffening element between the first end and the second location, and the connector extends from the second location past the first location to the first end, then inverts and extends along the outer surface of the expandable element to the second end of the stiffening element, then inverts and extends along the stiffening element toward the second end, past the second location, back to the first location.

[0058] In use, as the expandable element 104 is expanded, the outer wall of the expandable element 104 is forced radially outward, which pushes the intermediate portion 500c of the connector 500 radially outward, or radially away from the stiffening element 102. As a result, the first portion 500a of the connector 500 pulls the corresponding ostium (203a in FIG. 6B) in a first longitudinal direction, The second portion 500b of the connector 500 pulls the corresponding eyelets (203b in FIG. 6B) in a second longitudinal direction opposite the first longitudinal direction, thereby decreasing the distance d1 between the opposing eyelets 203a and 203b. During this time, the first spines 212 are also pulled longitudinally by their corresponding eyelets 203, which stresses the joints 230, 232, thereby causing the struts 210 to flex at their joints and bend away from the adjacent spines. As the struts 210 swing away from the spines, they push the adjacent spines radially away from each other, thereby increasing the distance d2 between the spines (as shown in FIG. 6B) and increasing the diameter of the reinforcing element 102.

[0059] As the connector 500 pulls the opposing ostia 203 in opposite directions, the circumferential sections 212a, 212b of the first spine 212 move longitudinally toward one another, thereby shortening the length of the mesh as measured between the second outer ostia 204. The second spine 214, however, does not change in length. Thus, the reinforcing element 102 has selective shortening along its length.

[0060] Threading a flexible connector through the eyelet allows the eyelet to act as a pulley, thereby reducing the force required to effect expansion. Additionally, using the eyelet as a pulley can be advantageous to increase the length of the connector that must be pulled to expand the stiffening element 102, which can be advantageous to provide more flexibility in the interaction between the expandable element 104 and the stiffening element 102.

[0061] In some cases, the reinforcing element 102 may include a movement limiting element that prevents the reinforcing element 102 from expanding radially beyond a predetermined diameter and / or from lengthening beyond a predetermined length. For example, the reinforcing element may be designed with a stop or element that interferes with the reinforcing element 102 opening to an appropriate diameter. In the example shown in Figures 4A-6B, connector portions threaded through opposing eyelets limit the radial expansion of the reinforcing element 102. The expansion limit has been reached when the opposing eyelets 203 are drawn together and impinge on each other.

[0062] In some embodiments, the second outer eyelet 204 can be used as a guide to keep the individual connectors 500 properly oriented and spaced as they wrap around the expandable element 104. For example, a particular connector may pass through an eyelet at one end of the reinforcing element 102, then through a more distant opposing eyelet, then through another opposing eyelet, then through the second outer eyelet 204 at the opposite end of the reinforcing element 102. Additionally or alternatively, the connector 500 can make two or more loops through two opposing eyelets 203, creating additional force when the opposing eyelets 203 are pulled together, making it easier for the expandable element 104 to expand the reinforcing element 102. The exemplary reinforcing element 102 shown in FIGS. 4A-6B also offers the advantage of not having to foreshorten; only selecting the spines that need to foreshorten to effect expansion of the stent, as discussed above. This can aid in the manufacture and joining of adjacent catheter and expandable element 104 structures.

[0063] The therapeutic element 101 of the present technology offers several advantages over the prior art. For example, because the therapeutic element 101 and / or expandable element 104 have a perfusion lumen when expanded, the expandable element 104 can remain expanded at the treatment site for extended periods of time (i.e., times of 1 minute or more). As a result, the therapeutic element of the present technology provides more effective expansion of the stenotic native valve and the prosthetic stent valve being delivered, thereby reducing the likelihood of perivalvular leakage or stent slippage. The extended expansion time also reduces the likelihood of incomplete or non-circular stent expansion, which can lead to increased valve leakage and / or valve deterioration and premature valve failure. In addition, the therapeutic element of the present technology allows the clinician to expand the valve more slowly or leave the valve in a partially expanded state for a period of time, which improves the targeting of the location and depth of valve deployment, thus improving the final positioning of the prosthetic valve.

[0064] To avoid acute ventricular hyperdistension and provide meaningful blood flow to the systemic circulation, the perfusion lumen should be approximately 0.5 cm 2 ~about 0.8cm 2 A perfusion lumen of this size in a conventional device would face several challenges. First, for a catheter with such a large fixed lumen, it would not be possible to introduce it through a percutaneous sheath. Second, such a large perfusion lumen extending through the center of the balloon would also likely collapse under the high pressure of the balloon unless the perfusion lumen was highly reinforced.

[0065] When the expandable element 104 is contracted, the reduced fluid pressure within the expandable element 104 will allow the outer wall of the expandable element 104 to decrease, thereby allowing the shoulders of the expandable element 104 to elongate and flatten such that the stiffening element 102 naturally resumes its elongated and low-profile state.

[0066] FIG. 7 depicts another example of a reinforcing element 102 for use with the treatment system 100 of the present technology. The reinforcing element 102 of FIG. 7 is similar to the reinforcing element 102 of FIGS. 4A-6B, except that: (a) the reinforcing element 102 of FIG. 7 does not have a middle region 216 with opposing eyelets 203, and (b) each of the spines has a first outer eyelet 204 at one end and a second outer eyelet 205 at the other end. To expand the reinforcing element 102, one or more connectors 500 may be threaded or coupled to some or all of the first outer eyelets 205, the connectors extending from the first outer eyelet 205 at one end of the reinforcing element 102, across the outer wall of the expandable element 104, to the first outer eyelet 205 at the other longitudinal end of the reinforcing element 102. As the expandable element 104 expands, the first outer pore is pulled longitudinally, thereby causing radial expansion of the reinforcing element 102. In contrast to the reinforcing element 102 of Figures 4A-6B, the reinforcing element 102 may change its overall length as it expands. Additionally or alternatively, a compressive longitudinal force may be applied to the second outer pore 204, causing the reinforcing element 102 to radially expand.

[0067] The reinforcing element 102 may be attached to the expandable element 104 at both ends of the reinforcing element 102. For example, the reinforcing element 102 may have fingers (not shown) extending from both ends of the reinforcing element 102, which are folded back against the outside of the reinforcing element 102. These fingers may be bonded to both ends of the expandable element 104, perhaps between the two tubes that form the expandable element. Alternatively, the fingers may have eyelets on both ends, and the reinforcing connectors may be threaded back and forth between the eyelets at the opposing ends, on the outside of the expandable element. Thus, the expandable element would be captured between the inner stent and the outer connector. To avoid damaging the vessel walls or heart valves (if being used for valve delivery), a second layer of expandable element material may be placed over these reinforcing connectors, or they may be bonded to the outside of the expandable element with an adhesive or polymer.

[0068] As is true for the reinforcing element 102 of FIGS. 4A-6B, the reinforcing element 102 of FIG. 7 may include a movement limiting element that prevents the reinforcing element 102 from radially expanding beyond a predetermined diameter and / or extending beyond a predetermined length. For example, as depicted in FIG. 7, the reinforcing element 102 may include a flexible connector (e.g., fiber, suture, etc.) that loops through the first outer eyelet 705, thereby coupling the second outer eyelet 705 together. The connector in this case may have a length that is comparable to the circumferential length of the desired expanded outer diameter of the reinforcing element 102. Once the reinforcing element 102 has expanded to a preset diameter or length, the connector will prevent further expansion. Additionally or alternatively, the first outer eyelet 205 may be coupled to the first and / or second adjacent eyelets 204, 205 in a manner that limits foreshortening, thereby limiting the expansion of the outer diameter.

[0069] In some aspects of the present technology, the expandable element 104 may be longer than the reinforcing element 102, with expansion of the reinforcing element 102 occurring via stretching of the reinforcing element 102. For example, the reinforcing element 102 of FIG. 7 may be used in such a manner. The expandable element 104 may be attached to a first exterior eyelet 205 of the reinforcing element 102. This attachment may be by fusing the eyelet or other feature with the wall or material comprising the expandable element 104 (such as a polymer), or again, may be a direct connection via a connector 500 that is threaded through the eyelet of the reinforcing element 102 and around the expandable element 104, through an eyelet at the other end of the reinforcing element 102.

[0070] Many of the embodiments disclosed herein utilize the force of expansion of the expandable element to expand the reinforcing element 102, even though the expansion of the reinforcing element 102 reduces to some extent the volume of the expandable element 104. For example, if the reinforcing element 102 is 30 mm long and has a loose diameter of 4 mm, and the reinforcing element 102 is then expanded to a diameter of 10 mm to create a perfusion lumen, the volume of the reinforcing element 102 will be approximately 2.0 cm 3If the expandable element 104 surrounding the reinforcing element 102 is initially inflated with an inner diameter of 4 mm and the inner diameter expands to 10 mm, the volume of the expandable element 104 will be reduced by that same 2 cc of volume. Thus, in some embodiments, it may be advantageous for the expandable element 104 to stretch so that the reinforcing element 102 expands and creates more volume than it loses through the expansion of the reinforcing element 102, or so that the pressure of the expandable element 104 may keep the reinforcing element 102 in a contracted state. For example, in an example in which the expandable element 104 has an outer diameter of 26 mm and an inner diameter of 10 mm, an 8 mm stretch of the expandable element 104 will result in an additional approximately 3.6 cm 3 Thus, if the arrangement of the stiffening element 102, the expandable element 104, and the connector 500 is designed such that as the stiffening element 102 expands, the expandable element 104 stretches 8 mm, the system should preferentially expand the stiffening element 104 as the expandable element 104 is pressurized.

[0071] In some aspects of the present technology, the perfusion lumen 108 may have a valve, such as a one-way valve, positioned at a location along its length. Figures 8A and 8B, for example, show an exemplary treatment system 100 including a valve 800. In some embodiments, it may be beneficial to position the valve 800 at the proximal end of the expandable element 104, particularly as shown in Figures 8A and 8B. In the example shown in Figure 8A, a portion of the expandable element 104 surrounding the perfusion lumen 108 is extended proximally to form a short windsock valve that opens to allow blood to flow from the distal end to the proximal end of the catheter due to pressure differences. When the proximal pressure is higher than the distal pressure, the valve flattens against the elongate member 112, preventing flow. Alternatively, if the expandable element 104 is installed in such a way that the desired direction of flow is from proximal to distal, the valve may be reversed and placed on the distal end of the expandable element 104 such that flow proceeds only in the distal direction.

[0072] The treatment system 100 may additionally or alternatively include other types of valves, such as iris valves, multi-leaflet valves, duckbill valves, and others. Furthermore, the valve 800 may be positioned at the distal end of the expandable element 104, or anywhere along the length of the expandable element 104.

[0073] 9A-10B illustrate additional embodiments of a treatment system 100 in accordance with the present technology. FIG. 9A is a cross-sectional side view of a distal portion of the treatment system 100, FIG. 9B is a cross-sectional view taken along line 9B-9B, and FIG. 9C is a cross-sectional view taken along line 9C-9C. Referring together to FIGS. 9A-9C, the treatment system 100 may include an expandable element 904 (e.g., a balloon) supported by a distal portion of an elongated carrier shaft 910. The expandable element 904 and the distal portion of the carrier shaft 910 may be configured to be transvascularly and / or percutaneously positioned at a blood flow passage or treatment site therein. The expandable element 904 may have a collapsed configuration (not shown) for delivery to the treatment site and an expanded configuration (as shown in FIG. 9A) in which the expandable element 904 defines a perfusion lumen 908 therethrough. As a result, when the expandable element 904 is expanded within the blood flow passageway, the expandable element 904 allows blood flow through its lumen 908. The reinforcing element 902 can be disposed within the lumen 908 of the expandable element 904 and configured to maintain patency of the lumen 908.

[0074] The carrier shaft 910 may have at least three generally tubular elongated members 912, 914, and 916 extending at least a portion of its length therethrough. For example, the carrier shaft 910 may include: (a) a first elongated member 912 defining a first lumen 913 (such as a guidewire lumen) therethrough for atraumatic guidance of the catheter to an appropriate location, (b) a second elongated member 914 defining a second lumen 915 (such as an inflation lumen) for inflation and deflation of the expandable element 904 with saline, contrast, or other suitable fluid, and (c) a third elongated member 916 defining a third lumen 917 therethrough for delivery of the reinforcing element 902 to the lumen 908 of the expandable element 904 (discussed in more detail below). In some embodiments, the three lumens 913, 915, 917 can be formed as lumens within the unitary carrier shaft 910, rather than as lumens defined by separate tubular members disposed within a common lumen of the carrier shaft 910. In some embodiments, the carrier shaft 910 can have more or fewer shafts or lumens (e.g., one shaft, two shafts, four shafts, five shafts, etc. and / or one lumen, two lumens, four lumens, five lumens, etc.).

[0075] The carrier shaft 910 may extend through the entire length of the perfusion lumen 908 and terminate distal to the distal ends of the expandable element 904 and / or the reinforcing element 102. In some embodiments, the carrier shaft 910 may terminate at a location that is longitudinally aligned with or proximal to the distal ends of the therapeutic element 101, the expandable element 104, and / or the reinforcing element 102. In other embodiments, the carrier shaft 910 may terminate at a more proximal location, with some or all of the elongate members 912, 914, 916 extending distally beyond the distal end of the carrier shaft 910.

[0076] The first elongated member 912 can extend substantially the entire length of the carrier shaft 910 and be configured to slidably receive a guidewire through the first lumen 913. The second elongated member 914, defining a second lumen 915, can extend between a proximal end portion (not shown) and a distal end portion that is fluidly coupled to the interior region 906 of the expandable element 904. For example, the carrier shaft 910 can have an opening in its sidewall that connects the second lumen 915 of the second elongated member 914 to the interior region 906 of the expandable element 904 (between the first and second tubes 904a, 904b). The second lumen 915 defined by the second elongated member 914 can be configured to deliver a fluid (e.g., saline, contrast solution) to the expandable element 904, causing the expandable element 904 to expand. In some embodiments, the second lumen 915 of the second elongate member 914 may be connected to the interior region 906 of the expandable element 904 via a separate tube.

[0077] A third elongate member 916 defining a third lumen 917 may extend between a proximal end portion (not shown) and a distal end portion terminating adjacent the proximal end portion of the expandable element 904. In operation, the reinforcing element 902 (e.g., a wire) may be advanced through the third lumen 917, out of an opening 918 in the carrier shaft 910, and into the lumen 908 of the expandable element 904, as described in more detail below. For example, the third lumen 917 may terminate at an opening 918 formed in a sidewall of the carrier shaft 910. The opening 918 may face toward the perfusion lumen 908 of the expandable element 904 at or near the proximal end portion of the expandable element 904. To facilitate advancement through the lumen 917, the reinforcing element 918 may be coupled to an elongate pusher element 920. In some embodiments, the pusher element 920 can be an elongate shaft or rod that extends through the lumen 917 and is coupled at its distal end to the proximal end of the reinforcing element 902 such that advancing the pusher element 920 distally advances the reinforcing element 902 distally within the lumen 917.

[0078] In some embodiments, the expandable element 904 may be made from two extruded tubes, such as first and second tubes 904a and 904b, thereby defining the interior region 906. In such embodiments, the first tube 904a may be expanded to form the outer surface of the expandable element 904, and the second tube 904b may be used to form the inner lumen of the expandable element 904. The first and second tubes 904a and 904b may be welded together at their respective proximal and distal ends to form the expandable element 904. A first elongated member 912 may extend between these two expandable elements and into the interior region 906. The tubes of the expandable element 904 may be welded around the carrier shaft 910 at the proximal and distal ends of the expandable element 904. In some embodiments, the expandable element can be formed from an inverted tube similar to that described above with respect to the expandable element 204, with the first elongate member 912 extending into the interior region 906 defined by the expandable element.

[0079] The expandable element 904 may be made from one or more materials used for balloons typically used in interventional procedures, such as polyethylene, polyolefin, polyurethane, nylon (polyamide), polyethylene terephthalate (PET or polyester), and / or other suitable polymers. The expandable element may also be a composite structure that may include any polymer or multiple polymers and reinforcing fibers, such as Kevlar, carbon fiber, Spectra, or other high molecular weight polyethylene, or other fibers in any orientation.

[0080] In some aspects of the present technology, the perfusion lumen 908 may have valves, such as one-way valves, positioned at locations along its length. As shown in FIG. 9A, for example, the treatment system 900 includes a valve 922. In some embodiments, it may be beneficial to position the valve 922 at the proximal end of the expandable element 904, among other things. In some embodiments, a portion of the expandable element 904 surrounding the perfusion lumen 908 extends proximally to form a short windsock valve that opens to allow blood to flow from the distal end to the proximal end of the treatment system 900 due to blood pressure differentials. When the proximal pressure is higher than the distal pressure, the valve flattens against the carrier shaft 910, preventing flow. Alternatively, if the expandable element 904 is installed in such a way that the desired direction of flow is from proximal to distal, the valve 922 may be reversed and positioned on the distal end of the expandable element 904 such that flow proceeds only in the distal direction.

[0081] In some embodiments, the reinforcing element 902 may extend through at least a portion of the perfusion lumen 908. As shown in FIG. 9A, for example, the reinforcing element 902 can be a pre-formed wire such that the reinforcing element 902 assumes the shape of a relatively tightly wound coil and approximately the size of the perfusion lumen 908. Advancing the wire through the third lumen 917 of the third elongate member 916 causes the wire to deploy into the perfusion lumen 908, regaining its coiled shape (shown in FIG. 9A), reinforcing the lumen 908. The wire can be advanced distally further into the perfusion lumen 908 until the distal end of the wire is at or near the distal portion of the expandable element 904. The wire can be rounded (e.g., FIG. 10A) or generally square (e.g., FIG. 10B) in cross-section, or relatively ribbon-shaped, depending on the size and shape of the third lumen 917 and the number of coils desired to be deployed to reinforce the perfusion lumen 908. The wire can be a metal, a polymer, or any other suitable material, hi some embodiments, the wire can be a shape memory material (e.g., Nitinol).

[0082] In some embodiments, to retrieve the system 900, the reinforcing element 902 (e.g., a coiled wire) may be retracted proximally into the lumen 917 of the third elongate member 916. Once the reinforcing element 902 is retracted, the expandable element 904 may be contracted (e.g., by applying negative pressure via the second lumen 915 of the second elongate member 914) and the system 900 may be retracted into a catheter or otherwise removed from the treatment site.

[0083] In some embodiments, the reinforcing element may be a pre-formed braid such that when deployed into the perfusion lumen 908, it is caused to recover into a relatively flat, tightly wound tube. Such a braided reinforcing element 902 may be attached to a carrier shaft 910 at a distal end and to a pusher element (not shown) at a proximal end portion. When the pusher element is advanced distally relative to the carrier shaft 910, the reinforcing element 902 is forced to shorten and assume an expanded state. In this expanded state, the braid may provide an increased outward radial force to maintain patency of the perfusion lumen 908 and / or expand the expandable element 904. This may be advantageous in embodiments where it is preferred to expand the reinforcing element 902 at a separate time from the expansion of the expandable element 904. For example, using such a configuration, the pusher element may be used to expand the reinforcing element before, simultaneously with, or after the expansion of the expandable element (e.g., via inflation through the second lumen 915).

[0084] In those embodiments for use in valve replacement procedures (such as TAVR), the treatment system 100 may be configured for use with an expandable implantable valve device (not shown). In some embodiments, the valve device may be preloaded around the outer surface of the expandable element 104 such that the valve device and therapeutic element 101 are delivered together to the native annulus. When expanded at the treatment site, the therapeutic element 101 presses radially outward against the inner surface of the valve device, thereby urging the valve device to radially expand into apposition with the annular tissue. In some embodiments, the valve device is already expanded at the native annulus and the therapeutic element 101 may be delivered to an interior region of the valve device and expanded to further expand or secure the valve device at the annulus. In some embodiments, the valve device comprises only a laser-cut stent, and in some embodiments, the valve device comprises a laser-cut stent and a prosthetic heart valve configured for implantation at the native annulus. (Conclusion)

[0085] Although many of the embodiments are described above with respect to systems, devices, and methods for treating heart disease, the technology is also applicable to other applications and / or other approaches, such as lung or brain applications. Furthermore, other embodiments in addition to those described herein are also within the scope of the technology. In addition, some other embodiments of the technology may have different configurations, components, or procedures than those described herein. Those skilled in the art will therefore understand that the technology may have other embodiments with additional elements, or may have other embodiments without some of the features shown and described above with reference to Figures 2A-10B.

[0086] The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular terms, respectively. Specific embodiments of the present technology, and examples thereof, are described above for illustrative purposes, but various equivalent modifications are possible within the scope of the present technology, as those skilled in the art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0087] Further, unless the word "or" is expressly limited with reference to a list of two or more items to mean only a single item exclusively from the other items, the use of "or" in such a list shall be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. In addition, the term "comprising" is used throughout to mean including at least the recited features, so that any greater number of the same features and / or other features of additional types are not excluded. Although specific embodiments are described herein for purposes of illustration, it should also be understood that various modifications can be made without departing from the technology. Furthermore, while advantages associated with certain embodiments of the technology are described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and associated technology may encompass other embodiments not expressly shown and described herein.

[0088] Where a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of that range, to one-tenth of the unit of the lower limit, is also specifically disclosed, unless the context clearly dictates otherwise. Each smaller range between any stated or intervening value in a stated range and any other stated or intervening value in that stated range is also encompassed within the disclosure. The upper and lower limits of these smaller ranges may be independently included or excluded within the range, and each range in which either or both of the limits are included in the smaller range, or not included at all, is also encompassed within the disclosure, subject to any specifically excluded limits in the stated range. If a stated range includes one or both of its limits, then ranges excluding either or both of those included limits are also included in the disclosure.

Claims

1. 1. A device for treating a blood flow passageway in a patient, the device comprising: an expandable element configured to be positioned within the passageway, the expandable element having a collapsed configuration and an expanded configuration, wherein in the expanded configuration, the expandable element defines a lumen therethrough; a reinforcing element positioned within the lumen of the expandable element, the reinforcing element having a collapsed configuration and an expanded configuration, the reinforcing element defining a lumen therethrough; and A connector, the connector comprising: a first portion coupled to the stiffening element at a first location located within the lumen of the expandable element; a second portion coupled to the stiffening element at a second location located within the lumen of the expandable element; an intermediate portion between the first portion and the second portion, the intermediate portion extending over a radially outer surface of the expandable element; A connector having Equipped with A device wherein the reinforcing element is coupled to the expandable element via the connector such that expansion of the expandable element applies a longitudinally directed force to the reinforcing element that causes the reinforcing element to radially expand, thereby creating a perfusion lumen through the device.

2. 2. The device of claim 1, wherein the device is configured such that while the device is positioned within the passageway, expansion of the expandable element pulls the reinforcing element toward its expanded configuration, thereby allowing blood flow through the lumen of the reinforcing element and the lumen of the expandable element while the expandable element is in the expanded configuration.

3. 3. The device of claim 1 or claim 2, wherein the force is extensive in the longitudinal direction.

4. The device of claim 1 or claim 2, wherein the force is compressive in the longitudinal direction.

5. The device of any one of claims 1 to 4, wherein the stiffening element is mechanically coupled to the expandable element during delivery of the device through a sheath to a treatment site.

6. The device of any one of claims 1 to 5, wherein the expandable element is an inflatable element configured to expand when an inflation fluid is delivered to an interior region of the expandable element.

7. 7. The device of claim 1, wherein the expandable element extends between a first longitudinal end and a second longitudinal end, the expandable element comprising a fold at the first longitudinal end and a seam at the second longitudinal end.

8. The device of any one of claims 1 to 7, wherein the expandable element defines a single continuous annular expansion space.

9. The device of any one of claims 1 to 8, wherein the expandable element is a balloon.

10. The device of any one of claims 1 to 9, wherein the expandable element has a toroidal shape in the expanded configuration.

11. The device of any one of claims 1 to 10, wherein the reinforcing element is a laser cut stent.

12. The device of claim 1 , wherein the intermediate portion of the connector extends substantially longitudinally along the radially outer surface of the expandable element.

13. The device of claim 1 , wherein the connector comprises at least one of a strand, a suture, a wire, a thread, a tether, a fiber, or a filament.

14. The device of claim 1 , wherein expansion of the expandable element causes the connector to pull the first location and the second location toward one another, thereby causing the stiffening element to radially expand.

15. The device of claim 1 , wherein the first location comprises a first pore of the stiffening element and the second location comprises a second pore of the stiffening element.

16. The device of claim 15 , wherein the longitudinal distance between the first ostium and the second ostium decreases in response to expansion of the expandable element.

17. 17. The device of claim 15 or claim 16, wherein the first ostium and the second ostium are substantially circumferentially aligned.

18. A device described in any one of claims 1 to 17, wherein the connector comprises a plurality of connectors.

19. 19. The device of any one of claims 1 to 18, wherein the reinforcing element extends longitudinally between a first end and a second end, the first location being positioned at a longitudinal location along the reinforcing element between the first end and the second location, and the connector extends from the second location past the first location to the first end, then inverts and extends along the radially outer surface of the expandable element to the second end of the reinforcing element, then inverts and extends along the reinforcing element toward the first end, past the second location to the first location.

20. A device as described in any one of claims 1 to 19, further comprising a movement limiter configured to limit longitudinal extension and / or contraction of the reinforcing element in response to expansion of the expandable element.

21. 21. The device of claim 20, wherein the travel limiter comprises one or more pairs of opposing eyelets coupled to one another via a flexible connector.

22. A device as described in any one of claims 1 to 21, further comprising a valve coupled to the reinforcing element and / or the expandable element, the valve configured to control fluid flow through the lumen of the reinforcing element.

23. 1. A device for treating cardiac or cardiovascular disease, the device comprising: an expandable element comprising an outer wall and an inner wall, the outer wall and the inner wall meeting at their respective longitudinal ends, the expandable element having a collapsed configuration and an expanded configuration, the inner wall defining a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the lumen; and A connector, the connector comprising: a first portion coupled to the stiffening element at a first location located within the lumen of the expandable element; a second portion coupled to the stiffening element at a second location located within the lumen of the expandable element; an intermediate portion between the first portion and the second portion, the intermediate portion extending over a radially outer surface of the expandable element; A connector having Equipped with The reinforcing element is coupled to the expandable element via the connector such that expansion of the expandable element from a collapsed configuration to an expanded configuration applies a longitudinally directed force to the reinforcing element causing the reinforcing element to radially expand.

24. 1. A system for treating a blood flow passageway of a patient, the system comprising: A therapeutic element, the therapeutic element comprising: an expandable element comprising an outer wall and an inner wall, the outer wall and the inner wall meeting at their respective longitudinal ends, the expandable element having a collapsed configuration and an expanded configuration, the inner wall defining a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the lumen; and A connector, the connector comprising: a first portion coupled to the stiffening element at a first location located within the lumen of the expandable element; a second portion coupled to the stiffening element at a second location located within the lumen of the expandable element; an intermediate portion between the first portion and the second portion, the intermediate portion extending over a radially outer surface of the expandable element; A connector having Equipped with a treatment element, the reinforcing element being coupled to the expandable element via the connector such that expansion of the expandable element from a collapsed configuration to an expanded configuration exerts a longitudinally directed force on the reinforcing element, thereby causing the reinforcing element to expand radially; and a first elongated member defining a lumen therethrough, the lumen being in fluid communication with an interior region of the expandable element, the first elongated member being configured to deliver a fluid to the interior region of the expandable element to expand the expandable element; a second elongated member, a distal portion of the second elongated member being coupled to the stiffening element; The system comprises:

25. 25. The system of claim 24, wherein the second elongate member defines a lumen extending therethrough, the lumen configured to slidably receive a guidewire.

26. 26. The system of claim 24 or claim 25, wherein only a portion of the reinforcing element is fixed to the second elongate member, such that the reinforcing element is coupled to the second elongate member but is variable in length.

27. ​​A system as described in any one of claims 24 to 26, further comprising a third elongated member, the third elongated member configured to receive the first elongated member and the second elongated member through the third elongated member.

28. The system of claim 27 , wherein the third elongate member terminates distally at a location proximal to the expandable element.

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