Vascular treatment device

Abstract

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

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 62 / 717,752, filed on August 10, 2018, which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology relates to treatment devices, systems and methods for treating cardiac disease. In particular, the present technology relates to devices for treating blood vessels and associated systems and methods of use. Background Art

[0004] There are many situations in interventional vascular procedures, where it is necessary to expand a balloon in a blood vessel while maintaining perfusion through the blood vessel. For example, when a balloon-expandable stent is delivered to a coronary artery, it is preferred to maintain blood flow through the artery to avoid ischemic damage to the myocardium perfused by the artery. A device commonly used to maintain blood flow is a perfusion balloon catheter. These catheters typically have a relatively large central guide wire cavity with a hole that passes through the catheter sidewall just proximal to the balloon and enters the cavity. This allows blood to flow through the side hole, flow into the guide wire cavity, and flow out of the distal end of the catheter to maintain perfusion when the balloon is expanded and blocks the blood vessel.

[0005] However, these perfusion balloons are typically used only in smaller vessels, where a relatively small perfusion lumen is sufficient and the catheter can be manufactured with a fixed sized perfusion lumen, such as a lumen with a diameter of less than 2 mm. In larger vessels, such as the aorta, maintaining adequate distal perfusion without a high pressure gradient across the perfusion lumen requires a larger lumen.

[0006] Two common interventional procedures that utilize balloon dilation 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"). Figure 1Delivery of a replacement aortic valve over a conventional balloon catheter is shown. Conventional practice is to inflate the balloon to a large diameter (approximately 20-30 mm) at very high pressure, thereby blocking all flow to the systemic circulation. It also prevents any blood from leaving the left ventricle, which can cause dangerous, rapid dilation of the ventricle. To prevent this dangerous ventricular dilation, a temporary pacing catheter is placed in the heart and the heart is typically paced at a very high rate (~200 beats / minute), which prevents it from filling between heartbeats. Such rapid ventricular pacing can cause myocardial ischemia, malignant arrhythmias, low output, decreased cerebral oxygen saturation, and / or increased procedure time and risk of stroke. To avoid or reduce the likelihood of these dangers, the valvuloplasty or TAVR balloon is typically inflated for less than one minute.

[0007] In a typical balloon catheter, the balloon is formed by a single extrudate, which is expanded into a desired balloon shape and welded or bonded to the shaft of the catheter. The sidewall of the catheter is cut to form an opening to connect the inflation chamber passing through the catheter shaft to the inside of the balloon. In most clinical applications where blood vessels or valves are enlarged, the outer surface of the balloon is circular (that is, with a functional annular cross-sectional shape) to apply a relatively uniform radial force against relative tissue. While maintaining the circular / annular shape and providing a uniform radially outward force, it is difficult to position the perfusion chamber at the outer circumference of the balloon.

[0008] Existing approaches to address the above challenges of creating large perfusion lumens in larger balloon catheters are Flow Valvuloplasty Perfusion Catheter ( Flow Valvuloplasty Perfusion Catheter) (CRBard / Becton Dickenson). The Flow device has several smaller balloons arranged around the periphery of a central lumen and surrounded by a fiber-based shell. When expanded, the balloons keep the central lumen open. However, even when these smaller balloons are inflated to higher pressures, this approach limits the effective pressure that can be applied to the circumference of the balloons. More importantly, the use of multiple balloons employs a large amount of material, which increases the diameter of the device in the non-inflated state and makes delivery of the device through a delivery sheath more difficult. This is especially true in the case of a TAVR balloon with the additional bulk of a prosthetic valve.

[0009]

[0006] Therefore, there remains a need for improved balloons for use in interventional procedures, particularly in the field of interventional cardiology. Summary of the invention

[0010] For example, according to the various aspects described below, including reference Figure 2A-10B , illustrating the subject technology. For convenience, various examples of aspects of the subject technology are described as numbered clauses (1, 2, 3, etc.). These are provided as examples and do not limit the subject technology.

[0011] 1. A device for treating a blood flow channel of a patient, the device comprising:

[0012] an expandable element configured to be positioned within the passageway, the expandable element having a collapsed configuration and an expanded configuration in which the expandable element defines a lumen therethrough; and

[0013] A reinforcement element positioned within the cavity of the expandable element, the reinforcement element having a collapsed structure and an expanded structure, in which the reinforcement element defines a cavity therethrough, wherein the reinforcement element is connected to the expandable element so that expansion of the expandable element causes the reinforcement element to expand radially, thereby creating a perfusion cavity through the device.

[0014] 2. A device for treating heart or cardiovascular disease, the device comprising:

[0015] an expandable element comprising an outer wall and an inner wall that meet at their respective longitudinal ends, wherein the expandable element has a collapsed configuration and an expanded configuration, and wherein the inner wall defines a lumen extending along a longitudinal axis of the expandable element; and

[0016] A reinforcement element is positioned within the cavity, wherein expansion of the expandable element from a collapsed configuration to an expanded configuration causes the reinforcement element to radially expand.

[0017] 3. A device according to claim 1 or claim 2, wherein the device is configured such that expansion of the expandable element when the device is positioned within a channel pushes the reinforcing element toward its expanded structure, thereby allowing blood to flow through the cavity of the reinforcing element and the cavity of the expandable element when the expandable element is in the expanded structure.

[0018] 4. A device according to any of the preceding clauses, wherein the device is configured such that expansion of the expandable element when the device is positioned within a channel pulls the reinforcing element toward its expanded structure, thereby allowing blood to flow through the cavity of the reinforcing element and the cavity of the expandable element when the expandable element is in the expanded structure.

[0019] 5. A device according to any 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.

[0020] 6. The device according to clause 5, wherein the force is a longitudinal tensile force.

[0021] 7. A device according to clause 5, wherein the force is a longitudinal compressive force.

[0022] 8. A device according to any 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.

[0023] 9. The device according to clause 8, wherein the force is a radial expansion force.

[0024] 10. The device of any of the preceding clauses, wherein the reinforcing element is mechanically coupled to the expandable element during delivery of the device through a sheath to a treatment site.

[0025] 11. The device according to any of the preceding clauses, wherein the reinforcing element is always mechanically coupled to the expandable element.

[0026] 12. A device according to any of the preceding clauses, wherein expansion of the expandable element causes the reinforcing element to expand radially to its expanded configuration substantially simultaneously.

[0027] 13. The device according to any of the preceding clauses, wherein the expandable element is an inflatable element configured to expand when an inflation fluid is delivered to an interior region of the inflatable element.

[0028] 14. A device according to any of the preceding clauses, wherein the expandable element extends between a first longitudinal end and a second longitudinal end, and wherein the expandable element comprises a fold at the first longitudinal end and a seam at the second longitudinal end.

[0029] 15. The device according to any of the preceding clauses, wherein the expandable element defines a single continuous inflation cavity.

[0030] 16. The device according to any of the preceding clauses, wherein the expandable element defines a single continuous annular inflation cavity.

[0031] 17. A device according to any of the preceding clauses, wherein the expandable element is a balloon.

[0032] 18. The device according to any of the preceding clauses, wherein the expandable element has a donut-shaped shape in the expanded configuration.

[0033] 19. The device according to any of the preceding clauses, wherein the expandable element has an elongated annular shape in the expanded configuration.

[0034] 20. The device of any of the preceding clauses, wherein the expandable element is configured to be inflated to a pressure of at least about 30 psi to about 105 psi (about 2 to about 7 atmospheres).

[0035] 21. The device of any of the preceding clauses, wherein the expandable element is configured to inflate to an internal pressure sufficient to effectively dilate a stenotic native valve and / or aortic stenosis.

[0036] 22. A device according to any 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.

[0037] 23. A device according to any of the preceding clauses, wherein, when the device is in an expanded state, the diameter of the perfusion lumen is sufficient to minimise any pressure gradient of blood flowing through the perfusion lumen.

[0038] 24. The device according to any of the preceding clauses, wherein the diameter of the perfusion lumen is at least one third of the diameter of the blood flow channel.

[0039] 25. A device according to any of the preceding clauses, wherein expansion of the expandable element creates a perfusion lumen through the expandable element and the reinforcing element, and wherein the perfusion lumen is configured to remain open when the expandable element is in the expanded configuration.

[0040] 26. A device according to any 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.

[0041] 27. The device according to any of the preceding clauses, wherein the reinforcing element is a mesh.

[0042] 28. The device according to any of the preceding clauses, wherein the reinforcing element is a braid.

[0043] 29. The device according to any of the preceding clauses, wherein the reinforcing element is a coil.

[0044] 30. The device according to any of the preceding clauses, wherein the reinforcing element is a laser cut stent.

[0045] 31. The device according to any of the preceding clauses, further comprising a connector having:

[0046] a first portion coupled to the reinforcing element at a first location;

[0047] a second portion coupled to the reinforcing element at a second location; and

[0048] An intermediate portion between the first portion and the second portion, wherein the intermediate portion extends over a radially outer surface of the expandable element.

[0049] 32. The device of clause 31, wherein the intermediate portion of the connector extends generally longitudinally along the radially outer surface of the expandable element.

[0050] 33. The device of clause 31, wherein the connector comprises at least one of a strand, a suture, a wire, a thread, a tether, a fiber, or a filament.

[0051] 34. The device of clause 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.

[0052] 35. The device of clause 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.

[0053] 36. The device according to clause 31, wherein the first position comprises a first eyelet of the reinforcing element and the second position comprises a second eyelet of the reinforcing element.

[0054] 37. The device of clause 36, wherein a longitudinal distance between the first eyelet and the second eyelet decreases in response to expansion of the expandable element.

[0055] 38. The device of clause 36, wherein a longitudinal distance between the first eyelet and the second eyelet increases in response to expansion of the expandable element.

[0056] 39. A device according to any of clauses 36 to 38, wherein the first and second eyelets are arranged substantially circumferentially.

[0057] 40. Apparatus according to any of clauses 36 to 38, wherein the first and second eyelets are circumferentially offset.

[0058] 41. A device according to any of clauses 36 to 40, wherein the first and second eyelets are located at opposite longitudinal ends of the reinforcing element.

[0059] 42. A device according to any of clauses 36 to 40, wherein the first eyelet and the second eyelet are both located between the first and second longitudinal ends of the reinforcing element.

[0060] 43. The device according to any one of clauses 31 to 37 further comprises a plurality of connectors, each connector having a first portion and a second portion connected to the reinforcing element and an intermediate portion between the first portion and the second portion, the intermediate portion extending above the radial outer surface of the expandable element.

[0061] 44. The device of clause 40, wherein the connectors are spaced apart from one another around a radially outer surface of the expandable element.

[0062] 45. A device according to any of the preceding clauses, wherein the reinforcing element extends longitudinally between a first end and a second end and has a first position and a second position, the first position being positioned at a longitudinal position along the reinforcing element between the first end and the second position, wherein the device further comprises a connector extending from the second position through the first position to the first end, then flipping over and extending along the outer surface of the expandable element to the second end of the reinforcing element, then flipping over and extending toward the second end along the reinforcing element through the second position to the first position.

[0063] 46. ​​The device according to any of the preceding clauses, further comprising a travel limiter, the travel limiter being configured to limit the longitudinal extension and / or compression of the reinforcing element in response to expansion of the expandable element.

[0064] 47. The device of clause 46, wherein the travel limiter comprises one or more pairs of opposing eyelets coupled via a flexible connector.

[0065] 48. A device according to clause 47, wherein the longitudinal distance between the opposing eyelets decreases in response to expansion of the expandable element.

[0066] 49. A device according to clause 47 or 48, wherein the connector prevents the apertures from longitudinally overlapping each other or moving past each other.

[0067] 50. The device according to any of the preceding clauses, wherein the reinforcing element comprises a plurality of interconnected struts.

[0068] 51. A device according to any of the preceding clauses, wherein the reinforcing element comprises a first circumferential portion and a second circumferential portion, and wherein (a) the longitudinal length of the first circumferential portion changes when the expandable element expands and contracts, and (b) the longitudinal length of the second circumferential portion remains constant when the expandable element expands and contracts.

[0069] 52. The device according to any of the preceding clauses, wherein the reinforcing element is connected to the expandable element via a flexible connector.

[0070] 53. The device according to any of the preceding clauses, 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.

[0071] 54. A device according to any of the preceding clauses, wherein the end of the reinforcing element is directly attached to the end of the expandable element so that expansion of the expandable element causes lengthening or shortening of the expandable element, thereby causing expansion of the reinforcing element.

[0072] 55. A device according to any of the preceding clauses, wherein the length of the reinforcing element is less than the length of the expandable element.

[0073] 56. A device according to any of the preceding clauses, wherein the length of the reinforcing element is different from the length of the expandable element.

[0074] 57. A device according to any of the preceding clauses, wherein the length of the reinforcing element is greater than the length of the expandable element.

[0075] 58. A device according to any of the preceding clauses, wherein the entire length of the reinforcing element is positioned within the lumen of the expandable element.

[0076] 59. A device according to any of the preceding clauses, wherein a portion of the length of the reinforcing element extends proximally beyond the proximal end of the expandable element, extends distally beyond the distal end of the expandable element, or both.

[0077] 60. The device according to any of the preceding clauses, further comprising a valve coupled to the reinforcement element and / or the expandable element, wherein the valve is configured to control fluid flow through the lumen of the reinforcement element.

[0078] 61. The device according to clause 60, wherein the valve is a one-way valve.

[0079] 62. The device according to clause 60 or 61, wherein the valve is one of an iris valve, a multi-leaf valve, a duckbill valve or a windsock valve.

[0080] 63. The apparatus according to any of the preceding clauses, further comprising an expandable implantable valve device positioned around an outer surface of the expandable element.

[0081] 64. The apparatus of clause 63, wherein the expandable implantable valve device comprises a laser cut stent and a prosthetic heart valve configured for implantation at a native valve annulus.

[0082] 65. A device according to any of the preceding clauses, wherein the channel is a natural valve ring.

[0083] 66. A device according to any of the preceding clauses, wherein the channel is a natural heart valve annulus.

[0084] 67. A device according to any of the preceding clauses, wherein the channel is the aortic valve annulus.

[0085] 68. A device according to any of the preceding clauses, wherein the channel is a blood vessel.

[0086] 69. A system for treating a blood flow path of a patient, the system comprising:

[0087] a processing element, the processing element comprising any of the apparatus described in clauses 1-68; and

[0088] a first elongated member defining a lumen therethrough, the lumen being in fluid communication with an interior region of the expandable element, wherein the first elongated member is configured to deliver a fluid to the interior region of the expandable element to expand the expandable element; and

[0089] A second elongated member, wherein a distal portion of the second elongated member is coupled to the reinforcing element.

[0090] 70. A system according to any of the preceding clauses, wherein the second slender member defines a lumen extending therethrough, and wherein the lumen of the second slender member is configured to slidably receive a guide wire.

[0091] 71. A system according to any of the preceding clauses, wherein only a portion of the reinforcing element is fixed to the second slender member so that the reinforcing element can change length when connected to the second slender member.

[0092] 72. The system of any of the preceding clauses, further comprising a third elongated member configured to receive the first elongated member and the second elongated member therethrough.

[0093] 73. A system according to clause 72, wherein the third slender member terminates distally at a position proximal to the expandable element.

[0094] 74. A system according to any of the preceding clauses, further comprising an atraumatic distal tip at the distal end of the second slender member.

[0095] 75. A method for treating a blood flow channel of a patient using any of the treatment devices, treatment systems or treatment elements of the preceding clauses.

[0096] 76. A method for treating a blood flow path of a patient, the method comprising:

[0097] delivering a treatment element in a collapsed configuration to a treatment site within the blood flow channel, the treatment element comprising an expandable element and a reinforcing element at least partially positioned within a lumen of the expandable element; and

[0098] A perfusion lumen is created by radially expanding the expandable element at the treatment site, wherein the perfusion lumen extends through the treatment element when the expandable element is in an expanded configuration.

[0099] 77. A method according to any of the preceding clauses, wherein radial expansion of the expandable element causes radial expansion of the reinforcing element.

[0100] 78. A method according to any of the preceding clauses, 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.

[0101] 79. A method according to any of the preceding clauses, wherein the reinforcing element has a first position and a second position spaced apart along its longitudinal axis, and wherein radial expansion of the expandable element pulls the first position and the second position in longitudinally opposite directions.

[0102] 80. The method according to any of the preceding clauses, wherein expansion of the expandable element causes the reinforcement element to expand radially, and wherein the perfusion lumen extends through the lumen of the expanded reinforcement element.

[0103] 81. The method of any of the preceding clauses, wherein expanding the expandable element comprises delivering an inflation fluid to an interior region of the expandable element.

[0104] 82. A method according to any of the preceding clauses, wherein the expandable element is a balloon.

[0105] 83. The method of any of the preceding clauses, wherein, when the device is positioned within the blood flow channel, expansion of the expandable element draws the reinforcing element toward its expanded configuration.

[0106] 84. The method of any of the preceding clauses, further comprising applying a radially outward force using the reinforcing element against a radially inner surface of the expandable element.

[0107] 85. A method according to any of the preceding clauses, wherein the processing element is any one of the processing devices and / or processing elements of the preceding clauses. BRIEF DESCRIPTION OF THE DRAWINGS

[0108] Many aspects of the present disclosure may be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present disclosure.

[0109] Figure 1 Depicted is a conventional balloon catheter and replacement valve positioned at the aortic valve during a typical TAVR procedure.

[0110] Figure 2A A side view of a distal portion of a treatment system of the present technology shown in a collapsed state.

[0111] Figure 2B and 2C Front and rear isometric views, respectively, of a distal portion of a treatment system of the present technology shown in an expanded state.

[0112] Figure 2D A cross-sectional side view of a processing system of the present technology in an expanded state.

[0113] Figure 2E The processing system of this technology is along the Figure 2D A sectional end view taken along line 2E-2E in FIG.

[0114] Figure 3Aand 3B Side view and isometric view, respectively, of a mold for forming an expandable element according to the present technology.

[0115] Figure 4A is a side view of a reinforcement element of the present technology in a rolled-up collapsed configuration.

[0116] Figure 4B 1 is a top view of a reinforcement element of the present technology in a lay-flat configuration.

[0117] Figure 5 An isometric view of the processing elements of the present technology.

[0118] Fig. 6A for Figure 4A and 4B An enlarged isolated view of a portion of a reinforcement element when the reinforcement element is in a collapsed state.

[0119] Figure 6B for Fig. 6A The portion of the reinforcing element shown in FIG. Fig. 6A An enlarged separate view of the collapsed state moving to the expanded state.

[0120] Figure 7 1 is a top view of a reinforcement element of the present technology in a lay-flat configuration.

[0121] Fig. 8A A side view of a distal portion of a treatment system of the present technology.

[0122] Figure 8B A rear isometric view of the distal portion of a treatment system of the present technology.

[0123] Fig. 9A A side schematic diagram of a processing system of the present technology shown in an expanded configuration.

[0124] Fig. 9B For along Fig. 9A A cross-sectional end view taken along line 9B-9B.

[0125] Fig. 9C For along Fig. 9A A sectional end view taken along line 9C-9C in FIG.

[0126] Fig. 10A and 10B Different reinforcing elements according to the present technology are shown. DETAILED DESCRIPTION

[0127] Reference below Figure 2A-10BSpecific details of several embodiments of the technology are described. Although many embodiments are described below for devices, systems, and methods for percutaneous replacement of a native aortic valve, other applications and other embodiments in addition to those described herein are also within the scope of the present technology, such as devices, systems, and methods for performing balloon valvuloplasty, for dilating aortic stenosis or other stenoses in the circulatory system, and devices, systems, and methods for percutaneous replacement of a native mitral valve, a native tricuspid valve, and / or a native pulmonary valve. In addition, several other embodiments of the technology may have different structures, components, or procedures than those described herein. Therefore, it will be understood by those of ordinary skill in the art that the technology may have other embodiments with additional elements, or the technology may have other embodiments without the following references. Figure 2A-10B Other embodiments of the features shown and described.

[0128] With respect to the terms "distal" and "proximal" within this specification, unless otherwise indicated, the terms may refer to the relative position of a portion of an interventional device, such as a prosthetic valve device and / or an associated delivery device, relative to an operator and / or a location in the vasculature or heart. For example, in reference to a delivery system including a perfusion device as described herein, "proximal" may refer to a location closer to an operator of the device or a location closer to an incision in the vasculature, and "distal" may refer to a location farther from an operator of the device or away from an incision along the vasculature (e.g., the end of a catheter).

[0129] Figure 2A 1 is a side view of a distal portion of a treatment system 100 of the present technology showing a treatment element 101 in a collapsed state. Figure 2B and 2C 1 and 2 are front isometric and rear isometric views, respectively, of a distal portion of the treatment system 100, wherein the treatment element 101 is in an expanded state. When used herein with reference to the treatment system 100, "expanded configuration" and "collapsed configuration" refer to configurations of the treatment system 100 when the treatment element 101 is expanded or collapsed, respectively. Likewise, the use of "deployed" with respect to the treatment element 101 or the treatment system 100 refers to a configuration in which the treatment element 101 is in a fully or partially expanded configuration.

[0130] The treatment system 100 is configured to position and deploy the treatment element 101 at the treatment site in the patient's blood flow channel to provide a perfusion chamber when the expandable element 104 is deployed during the interventional procedure. When used in this article, "blood flow channel" refers to any anatomical structure through which blood flows regularly. Examples of blood flow channels include natural rings (in the heart or anywhere in the vascular system), ventricles, blood vessels, and other body cavities. The treatment element 101 can be delivered to the treatment site in the blood flow channel by a guide catheter in a collapsed state. When the blood flow channel at or in the heart is treated, the treatment system 100 can be delivered to the heart via a transfemoral, transcaval, transaortic, transvenous, transatrial, axillary / subclavian, or transapical mode relative to the direction of blood flow in an antegrade or retrograde manner, and can include a transseptal intersection from the right atrium to the left atrium.

[0131] The processing system 100 of the present technology can be used in any medical procedure that employs balloon dilation within a blood flow channel, regardless of whether the balloon (or other expandable element) is expanded directly into contact with the surrounding channel tissue or indirectly into contact with another structure (such as a stent, stent graft, or artificial heart valve device) positioned between the balloon and the channel tissue. For example, the processing system 100 disclosed herein provides an enhanced perfusion chamber through the balloon while the balloon expands within the native valve annulus to widen the native valve opening during valvuloplasty or to position an artificial valve during a TAVR procedure. The processing system 100 of the present technology can be used to deliver a repair device or replacement device to any of the four major heart valves (aortic, mitral, tricuspid, and pulmonary artery), as well as to dilate a stenosis or stent in the aorta or any large or other blood vessel, and the like. It can also be used to temporarily seal an aortic rupture, an uncontrolled bleeding site, an aortic dissection, or other areas where it is desired to seal the vessel while maintaining perfusion. In addition, the treatment system 100 of the present technology can be used in transseptal applications and fenestrated aortic applications, where the target vessel or lesion pathway requires navigation through tortuous anatomical structures. In such cases, an external large diameter balloon (such as an expandable element of the present technology) allows fixation adjacent to the target lesion or vessel. In some cases, the treatment system for additional stent or balloon expansion can be delivered through the central lumen of the expandable element of the present technology.

[0132] like Figure 2A-2C In Figure 2D and 2EAs shown in the cross-sectional view of , the treatment system 100 may include a treatment element 101 and one or more elongated members configured to carry or otherwise functionally support the treatment element 101 within a blood flow channel. The treatment element 101 includes an internal reinforcement element 102 (e.g., a stent) and an external expandable element 104 (e.g., a balloon) positioned around the internal reinforcement element 102. As described in more detail below, the internal reinforcement element 102 is coupled to the expandable element 104 so that expansion of the expandable element 104 causes radial expansion of the internal reinforcement element 102, thereby creating a perfusion cavity 108 through the deployed treatment element 101 at the treatment site, which allows blood to flow through the blood flow channel when the expandable element 104 is deployed during an interventional procedure. If the expandable element 104 is to be inflated (or otherwise expanded) without the internal reinforcement element 102 being deployed, the pressure in the expandable element 104 may cause the perfusion cavity 108 to collapse. In this manner, the inner reinforcing element 102 bears against the inner surface of the expandable element 104 to provide a radially outward force to maintain a perfusion lumen through the expandable element 104 as the expandable element 104 expands.

[0133] In some embodiments, the expandable element 104 includes an inflatable element, such as a balloon. The expandable element 104 may include one or more substantially fluid-impermeable materials commonly used for balloons used in interventional procedures, such as polyethylene, polyolefins, polyurethanes, nylons (polyamides), polyethylene terephthalate (PET or polyester), and / or other suitable polymers. In several examples of the technology, the expandable element 104 may include a composite structure formed by one or more polymers and reinforcing fibers (such as Kevlar fibers, carbon fibers, spectra fibers or other high molecular weight polyethylene, or other fibers in any orientation).

[0134] As in Figure 2E As best shown in the cross-sectional view of , the expandable element 104 can include an elongated annular balloon formed by an outer wall 104c and an inner wall 104d, which together surround an inner region 106. The inner region 106 can 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 can be substantially impermeable to the fluid so that when the expandable element 104 is in its collapsed configuration, the delivery of fluid to the inner region 106 forces the outer wall 104c to move radially away from the inner wall 104d, thereby causing the expandable element 104 to expand radially. As it expands radially, it may also lengthen, or it may shorten relative to the elongated member. If the collapsed configuration ( Figure 2A) and its expansion structure ( Figure 2B-2E ) as can be seen by comparison, the expandable element 104 can be slightly longer in its collapsed configuration than in its expanded configuration.

[0135] In some embodiments, such as Figure 2A In the embodiment shown in FIG. 2F, the expandable element 104 may be formed by an inverted tube such that the expandable element 104 includes a first longitudinal end 104a ( Figure 2D ) and at the distal or second longitudinal end 104b ( Figure 2D ) at the crease (and without a seam). In some embodiments, the expandable element 104 includes a proximal end or first longitudinal end 104a ( Figure 2D ) at the crease (and without a seam) and at the distal or second longitudinal end 104b ( Figure 2D ) at a seam. In any case, the fold may include an inverted portion of the tube, and the seam may include a location where two longitudinal ends of the tube meet. Depending on the material used for the expandable element 104 (for example, if polyurethane is used), the seam may be welded, or it may be bonded using a flexible adhesive such as ultraviolet (UV) curable polyurethane methacrylate. An inflation shaft (such as the first slender member 110 described below) can be made of the same or similar material and welded or bonded into the seam. It may be preferable to reduce or otherwise minimize any seams, joints, or welds in the expandable element 104 to reduce the likelihood of a weakened portion of the expandable element 104 having a lower ability to withstand high pressures.

[0136] Figure 3A and 3BAn example mold 300 for forming an expandable element 104 of the present technology is shown. The mold 300 may have a first portion 302, a second portion 304, a third portion 306, and a fourth portion 308 along its length, which produce similar portions of the resulting balloon. Adjacent portions may have a tapered transition portion therebetween. In certain embodiments, the diameter of the second portion 304 may be smaller than the individual diameters of the first, third, and fourth portions 302, 306, 308, and may reflect the inner diameter of the cavity of the expandable element 104. The dotted lines show an example of a tube that has been placed on the mold, blown to fit the mold shape, and then folded over itself so that the resulting structure has a fold 105 at one end and a seam 107 at the other end. A tube (e.g., an elongated member 110) may be inserted into the seam 107 to define an inflation cavity. It will be understood that the expandable element 104 may have other shapes than those shown in the accompanying drawings, and that 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 generally linear portions (as shown in the figures), or all or some portions of the outer wall of the expandable element may have a more rounded profile than depicted in the figures.

[0137] In some embodiments, the expandable element 104 may include a balloon that is everted at both ends so that the two ends overlap along the inner diameter of the balloon. In this configuration, the resulting seam may be disposed at the middle portion of the balloon rather than at the proximal or distal ends. For example, the seam may be disposed along the radially inward surface along the center portion of the balloon. For example, an adhesive may be used to bond the two overlapping ends together. An inflation chamber may be inserted between the two overlapping ends and bonded into the balloon when the ends are bonded together.

[0138] In certain aspects of the present technology, the expandable element 104 can be constructed using two separate layers: (a) a first material or first layer for the inner wall, which can contact the reinforcing element 102 (i.e., facing the lumen 108) and optionally a guide wire shaft (such as the second elongated member 114 described in detail below), and (b) a layer for the outer wall. Fig. 8A and 8B In certain embodiments described herein, the outer wall should be connected to the valve so that there is no leakage path between the expandable element and the valve. The two materials or layers can be bonded at two seams on the distal and proximal sides, with the inflation chamber being welded or bonded to one of the seams.

[0139] In certain embodiments, the expandable element 104 of the present technology may have one or more of the following features: a very low deflated or collapsed profile to minimize the diameter of the device during introduction and removal; a relatively large expanded or dilated profile (e.g., about 20 mm to about 30 mm, for example, to allow for dilation of large valves or vessels such as the aortic valve or the aorta); a large perfusion lumen when inflated or expanded to reduce or minimize any pressure gradients across the expandable element 104 (e.g., when the treatment 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 of the diameter of the blood flow channel); and the ability to withstand high inflation pressures (e.g., at least about 30 psi to about 105 psi (about 2 to about 7 atmospheres)) to effectively dilate a stenotic valve or aortic stenosis.

[0140] The expandable element 104 of the present technology provides multiple advantages over conventional balloon expandable systems. For example, unlike conventional devices, the expandable element 104 is not formed by bonding to the sidewall of a fixed diameter catheter shaft. On the contrary, the expandable element 104 has an elongated annular shape or a torus-like shape, wherein the outer surface has a portion facing the cavity (e.g., radially facing inward) and a portion facing radially outward. Moreover, the elongated annular expandable element 104 of the present technology has a shorter length, and does not require a steep transition angle from a large diameter, because most of the transition is "flipped" by eversion. When navigating in a more curved anatomical structure, the shorter expandable element 104 improves the pushability and manipulability of the treatment system 100.

[0141] Still reference Figure 2A-2E In addition to the treatment element 101, the treatment system 100 may also include one or more slender members. For example, the treatment system 100 may include: a first slender member 110, the first slender member defining a first lumen therethrough (not visible in the accompanying drawings); a second slender member 114, the second slender member defining a second lumen 115 therethrough; the second lumen can be used to deliver a guide wire in front of the rest of the system; and a third slender member 112, the third slender member defining a third lumen 113 therethrough. The first slender member 110 may extend between a proximal end portion (not shown) and a distal end portion that is fluidly coupled to the interior region 106 of the expandable element 104. For example, the distal end portion of the first slender member 110 may be coupled to the interior region 106 of the expandable element 104 via an outer wall 104c and an inner wall 104d ( Figure 2E) is inserted into and / or placed in fluid communication with the interior region 106 of the expandable element 104. The first elongated member 110 can be configured to deliver a fluid (e.g., water, saline, a radiopaque solution, air) to the expandable element 104 to expand the expandable element 104.

[0142] The second elongated member 114 can extend between a proximal end portion (not shown) and a distal end portion located at or near the treatment element 101. The second elongated member 114 can be a generally tubular shaft defining a lumen 115 therethrough. In certain embodiments, the second elongated member 114 is configured to slidably receive a guide wire for atraumatically guiding the catheter to an appropriate position. The second elongated member 114 can extend through the entire length of the perfusion lumen 108 and terminate distally of the distal end of the treatment element 101, the expandable element 104, and / or the reinforcing element 102. In certain embodiments, the second elongated member 114 can terminate at a position that is longitudinally aligned with the distal end of the treatment element 101, the expandable element 104, and / or the reinforcing element 102 or near the distal end of the treatment element, the expandable element, and / or the reinforcing element. In certain embodiments, the second elongated member 114 can have an atraumatic distal tip at its distal end, such as Figures 2A-2D as shown in .

[0143] The second elongated member 114 can be coupled to the reinforcing element 102 so that the reinforcing element 102 is free to contract and expand radially and / or contract and expand longitudinally. For example, the second elongated member 114 can be coupled to the reinforcing element 102 at a single longitudinal position that does not hinder the expansion and contraction of the reinforcing element. In some embodiments, the second elongated member 114 can be coupled to the reinforcing element 102 at multiple longitudinal positions along the reinforcing element 102, each of which does not experience shortening (as described in more detail below).

[0144] The third elongated member 112 may include a generally tubular shaft defining a lumen 113 therethrough. The third elongated member 112 may extend from a proximal portion (not shown) to a distal portion that terminates at a position that is longitudinally aligned with or proximal to the treatment element 101, the expandable element 104, and / or the reinforcing element 102. In some embodiments, the third elongated member 112 terminates at a position that is longitudinally aligned with or distal to the proximal end of the treatment element 101, the expandable element 104, and / or the reinforcing element 102. In some embodiments, the third elongated member 112 extends through the entire length of the treatment element 101, the expandable element 104, and / or the reinforcing element 102.

[0145] The third elongated member 112 may receive one or more elongated members (including tubular shafts) through its lumen 113. For example, Figure 2A-2E As shown in FIG. 1 , the first and second elongated members 110 and 114 extend through the cavity 113 of the third elongated member 112. The third elongated member 112 adds column strength to the processing system 100, thereby improving pushability.

[0146] In some embodiments, the processing system 100 may have Figure 2A-2E More or fewer elongated members or cavities as depicted.

[0147] Figure 4A and Figure 4B Depicted are exemplary reinforcing elements 102 for use with a treatment system 100 of the present technology, wherein the reinforcing elements are each shown in a tubular configuration and laid flat. Figure 4A and 4B As shown, in some embodiments, the reinforcing element 102 can include a mesh (such as a stent) having a generally tubular structure that surrounds a cavity extending between open longitudinal ends. The reinforcing element 102 can have a first end portion 102a, a second end portion 102b, and a length extending along the longitudinal axis L of the reinforcing element 102 therebetween.

[0148] Although the views provided in several of the figures provided herein show an expandable device that is laid flat for ease of explanation and understanding, the device can be formed into a tubular shape. Additionally, when used herein, the term "longitudinal" can refer to a direction along an axis that extends through the lumen of the device when in a tubular configuration, and the term "circumferential" can refer to a direction along an axis that is orthogonal to the longitudinal axis and extends around the circumference of the device when in a tubular configuration.

[0149] According to some embodiments, for example Figure 4A and 4B As shown in , the mesh may include a plurality of struts 210 within a plurality of struts 202a-202d (collectively referred to as "struts 202"), a plurality of first ridges 212 (respectively labeled 212a and 212b) and a plurality of second ridges 214 (respectively labeled 214a, 214b, and 214c) extending generally longitudinally across the struts 202 and between the struts, a plurality of first external eyelets 205, a plurality of second external eyelets 204, a plurality of opposing eyelets 203, and a plurality of joints 230 and 232. The first ridges 212 and the second ridges 214 are collectively referred to herein as "ridges 216". For ease of illustration, in Figure 4B Only selected struts, ridges, eyelets and joints are marked in FIG. In some embodiments, when the reinforcing element 102 is formed into a tubular shape (that is, its processed shape), all struts 202 and ridges 216 can extend along part or all of the circumference of the reinforcing element 102.

[0150] In certain embodiments, for example, Figure 4B , each end of one, some, or all of the struts 210 may be connected to a ridge 216. For example, a first end of all of the struts 210 in all of the strut sections 202 is connected to a first ridge 212 and a second end of all of the struts 210 in all of the strut sections 202 is connected to a second ridge 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 is connected to a first ridge 212 and a second end of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 is connected to a second ridge 214. In some embodiments, a first end and a second end of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 are connected to a first ridge 212. In some embodiments, a first end and a second end of one, some, or all of the struts 210 in one, some, or all of the strut sections 202 are connected to a second ridge 214. The struts 210 may be connected to the first and / or second ridges 212, 214 at a strut-eyelet junction 230 or at a strut junction 232 (only a few are labeled). As depicted, the struts 210 may be arranged in a serpentine pattern, wherein the struts 210 change longitudinal direction after crossing the spine.Some or all of the junctions may be formed at the longitudinal ends of the strut portion 202.

[0151] As previously described, the web of reinforcing element 102 can include first and second ridges 212, 214 extending longitudinally along the web. In some embodiments, all or a portion of one, some, or all of the first ridges 212 can be parallel to all or a portion of one, some, or all of the second ridges 214. In some embodiments, all or a portion of one, some, or all of the first ridges 212 can be parallel to all or a portion of one, some, or all of the other first ridges 212. In some embodiments, all or a portion of one, some, or all of the second ridges 214 can be parallel to all or a portion of one, some, or all of the other second ridges 214. In some embodiments, such as Figure 4B In the embodiment shown in , the first and second ridges 212, 214 alternate around the circumference of the mesh. In some embodiments, at least one first ridge 212 is directly radially adjacent to at least one other first ridge 212, and in some embodiments, at least one second ridge 214 is directly radially adjacent to at least one other second ridge 214.

[0152] like Figure 4B As shown in , the first ridge 212 may extend across less than all of the struts 202, and the second ridge 214 may extend across all of the struts 202. The mesh may include an intermediate region 218 that includes opposing eyelets 203 and a bridging portion 214c of the second ridge 214. The first ridge 212 may not extend into the intermediate region 218 and may therefore form two circumferential portions 212a and 212b spaced apart along the longitudinal axis of the mesh. In certain embodiments, one, some or all of the first ridges 212 may span only two struts 202. Within the intermediate region 218, the periphery of each of the opposing eyelets 203 and the bridging portion 214c of the second ridge 212 may surround a gap 206. The opposing longitudinal ends of the opposing eyelets 203 may be spaced apart a distance d across the gap 206. 1 In some cases, one, some or all of the first ridges 212 extend between the second outer eyelet 204 and an adjacent one of the opposing eyelets 203. The first and second longitudinal ends of one, some or all of the second ridges 214 may terminate at the second outer eyelet 205.

[0153] Figure 5 FIG. 1 is an isolated view of an example of a treatment element 101 shown in an expanded configuration, wherein the treatment element 101 includes Figure 4A and 4B For ease of illustration, the reinforcing element 102 is shown in FIG. Figure 5 The reinforcing element 102 is schematically shown in FIG. Fig. 6Ais an enlarged view of a portion of a reinforcing element 102, which is depicted positioned within the lumen of an expandable element 104 in a collapsed state. Figure 5 and Fig. 6A In some embodiments, the reinforcing element 102 can be coupled to the expandable element 104 via one or more connectors 500. The connectors 500 can include at least one of strands, sutures, threads, lines, tethers, fibers, filaments, or other suitable connecting members. Each connector 500 can have a first portion 500a coupled to the reinforcing element 102 at a first position along the reinforcing element 102, a second portion 500b coupled to the reinforcing element 102 at a second position along the reinforcing element 102, and an intermediate portion 500c extending between the first portion 500a and the second portion 500b. Figure 5 ). In some embodiments, the first position is an eyelet 203a of the opposing eyelet pair, and the second position is the other eyelet 203b of the opposing eyelet pair.

[0154] The intermediate portion 500c of the connector 500 may extend on the radially outer surface of the expandable element 104, such as Figure 5 In some embodiments, all or a portion of the length of the middle portion 500c may extend generally longitudinally along the expandable element 104. Figure 5 As shown in FIG. 1 , in some embodiments, a plurality of connectors 500 can be spaced apart along the radially outer surface of the expandable element 104. In some embodiments, each of such connectors 500 can be individually coupled to the reinforcing element 102 at separate or overlapping locations. For example, each connector 500 can be coupled to a separate eyelet or other structure of the reinforcing element 102, or two or more connectors 500 can be coupled to the same eyelet or other structure of the reinforcing element 102.

[0155] In some embodiments, such as Figures 4A-6B In the embodiment shown in , the first position is positioned at a longitudinal position along the reinforcing element between the first end and the second position, and the connector extends from the second position through the first position to the first end, then flips over and extends along the outer surface of the expandable element to the second end of the reinforcing element, then flips over and extends along the reinforcing element through the second position toward the second end to the first position.

[0156] In use, as the expandable element 104 expands, the outer wall of the expandable element 104 is pushed radially outward, which pushes the intermediate portion 500c of the one or more connectors 500 radially outward or radially away from the reinforcing element 102. As a result, the first portion 500a of the connector 500 pulls the corresponding eyelet ( Figure 6B203a), and the second portion 500b of the connector 500 pulls the corresponding eyelet ( Figure 6B 203b) in the figure, so that the distance d between the relative holes 203a and 203b is 1 During this time, the first ridges 212 are also pulled longitudinally by their corresponding eyelets 203, which applies stress at the joints 230, 232, causing the struts 210 to bend at their joints and angle away from adjacent ridges. As the struts 210 swing outward from the ridges, the struts 210 push radially adjacent ridges away from each other, increasing the distance d between the ridges. 2 (like Figure 6B ) and increasing the diameter of the reinforcing element 102.

[0157] When the connector 500 pulls the opposing eyelets 203 in opposite directions, the circumferential portions 212a, 212b of the first ridge 212 move longitudinally toward each other, thereby shortening the length of the mesh as measured between the second outer eyelets 204. However, the second ridge 214 does not change length. In this way, the reinforcing element 102 has selective shortening along its length.

[0158] Passing the flexible connector through the eyelet causes the eyelet to act as a pulley and thus reduces the force required to achieve expansion. In addition, using the eyelet as a pulley can be beneficial to increase the length of the connector that must be pulled in order to expand the reinforcing element 102, which can be beneficial to provide greater flexibility in the interaction between the expandable element 104 and the reinforcing element 102.

[0159] In some cases, the reinforcing element 102 may include a travel limiting element that prevents the reinforcing element 102 from radially expanding beyond a predetermined diameter and / or extending beyond a predetermined length. For example, the reinforcing element may be designed with a stop or element that interferes once the reinforcing element 102 has been opened to the appropriate diameter. Figures 4A-6B In the example shown in , the connector portions passing through the opposing eyelets limit the radial expansion of the reinforcing element 102. When the opposing eyelets 203 are pulled together and knock over each other, the expansion limit has been reached.

[0160] In certain embodiments, the second outer eyelet 204 can be used as a fairlead to maintain the proper orientation and spacing of the various connectors 500 as they are wrapped around the expandable element 104. For example, a particular connector can be passed through an eyelet at one end of the reinforcing element 102, then through an opposing eyelet further away, then through another opposing eyelet, and then through a second outer eyelet 204 at the opposing end of the reinforcing element 102. Additionally or alternatively, the connector 500 can be passed through two opposing eyelets 203 to form more than one loop, thereby generating additional force when the opposing eyelets 203 are pulled together and allowing the expandable element 104 to more easily expand the reinforcing element 102. Figures 4A-6B The exemplary reinforcing element 102 shown in also provides the benefit of not requiring shortening; as previously described, only selected spines need to be shortened in order to achieve stent expansion. This can facilitate manufacturing and bonding to adjacent catheters and the structure of the expandable element 104.

[0161] The treatment element 101 of the present technology provides multiple advantages over the prior art. For example, since the treatment element 101 and / or the expandable element 104 have a perfusion cavity when expanded, the expandable element 104 can remain expanded at the treatment site for an extended period of time (i.e., one minute or longer). As a result, the treatment element of the present technology provides a more effective expansion of the stenotic natural valve and the artificial stent-valve being transported, thereby reducing the possibility of paravalvular leakage or stent sliding. The extended expansion time also reduces the possibility of incomplete or non-circular stent expansion (which may cause valve leakage and / or increased valve deterioration and early valve failure). In addition, the treatment element of the present technology enables clinicians to expand the valve more slowly or partially expand the valve for a period of time, which improves the final positioning of the artificial valve because it improves the targeting of the position and depth of valve deployment.

[0162] To avoid acute ventricular overdistension and provide meaningful blood flow to the systemic circulation, the perfusion chamber may have a diameter of approximately 0.5 cm. 2 To about 0.8cm 2 The cross-sectional area of ​​the balloon is 1.5 m. In conventional devices, a perfusion lumen of this size presents several challenges. First, it would be impossible for a catheter with such a large fixed lumen to be guided through a percutaneous sheath. Second, such a large perfusion lumen passing through the center of the balloon would also likely collapse under the high pressure of the balloon unless the perfusion lumen was highly reinforced.

[0163] As the expandable element 104 deflates, the reduced fluid pressure within the expandable element 104 will allow the outer wall of the expandable element 104 to decrease, thereby allowing the shoulder of the expandable element 104 to elongate and flatten as the reinforcing element 102 naturally returns to its elongated, low-profile state.

[0164] Figure 7 Another example of a reinforcement element 102 for use with a processing system 100 of the present technology is depicted. Figure 7 The reinforcing element 102 is similar to Figures 4A-6B The reinforcing element 102 is different in that: (a) Figure 7 The reinforcing element 102 does not have a middle region 216 with opposing holes 203, and (b) each of the ridges has a first external hole 204 at one end and a second external hole 205 at the other end. In order to expand the reinforcing element 102, one or more connectors 500 can be passed through or connected to some or all of the first external holes 205 so that the one or more connectors extend from the first external holes 205 at one end of the reinforcing element 102 and extend across the outer wall of the expandable element 104 to the first external holes 205 at the other longitudinal end of the reinforcing element 102. When the expandable element 104 expands, the first external holes are pulled longitudinally, thereby causing radial expansion of the reinforcing element 102. Figures 4A-6B In contrast to the reinforcing element 102, the reinforcing element 102 can change its overall length as it expands. Additionally or alternatively, a compressive longitudinal force can be applied to the second outer eyelet 204 to cause the reinforcing element 102 to expand radially.

[0165] Reinforcement element 102 can be attached to expandable element 104 at the end of reinforcing element 102. For example, reinforcing element 102 can have a finger (not shown) extending from the end of reinforcing element 102, which is folded back against the outside of reinforcing element 102. These fingers can be bonded to the end of expandable element 104, possibly between two tubes forming expandable element. Alternatively, fingers can have eyelets at both ends, and reinforcing connectors can pass back and forth between the eyelets at opposite ends on the outside of expandable element. Therefore, expandable element will be trapped between the support on the inside and the connector on the outside. In order to avoid damaging the vessel wall or heart valve (if it is used to deliver valve), the material of the second layer of expandable element can be placed on these reinforcing connectors, or they can be bonded to the outside of expandable element with adhesive or polymer.

[0166] and Figures 4A-6B The same is true for the reinforcing element 102. Figure 7 The reinforcing element 102 may include a travel limiting element that prevents the reinforcing element 102 from radially expanding beyond a predetermined diameter and / or extending beyond a predetermined length. Figure 7As shown in , the reinforcing element 102 can include a flexible connector (e.g., fiber, suture, etc.) that loops through the first external eyelet 705, thereby coupling the second external eyelet 705 together. In this case, the connector has a length that can be equal to the circumferential length of the desired expanded outer diameter of the reinforcing element 102. When the reinforcing element 102 expands to a preset diameter or length, the connector will prevent additional expansion. Additionally or alternatively, the first external eyelet 205 can be coupled to the first and / or second adjacent eyelets 204, 205 in a manner that limits shortening, thereby limiting the expansion of the outer diameter.

[0167] In certain aspects of the technology, the expandable element 104 can be longer than the reinforcing element 102, and the expansion of the reinforcing element 102 occurs via the elongation of the reinforcing element 102. For example, it can be used in this way Figure 7 The expandable element 104 can be attached to the first external eyelet 205 of the reinforcing element 102. This attachment can be a direct connection by fusing the eyelet or other features to the wall or material (such as a polymer) that constitutes the expandable element 104, or again via a connector 500 that has been passed through the eyelet of the reinforcing element 102 and tied around the expandable element 104 to the eyelet at the other end of the reinforcing element 102.

[0168] Although expansion of the reinforcing element 102 reduces the volume of the expandable element 104 to some extent, many of the embodiments disclosed herein also utilize the expansion force of the expandable element to expand the reinforcing element 102. For example, if the reinforcing element 102 is 30 mm long and has a relaxed diameter of 4 mm, and if the reinforcing element 102 is then expanded to a diameter of 10 mm to create a perfusion cavity, the volume of the reinforcing element 102 will increase by approximately 2.0 cm. 3 If the expandable element 104 surrounding the reinforcing element 102 is initially expanded with an inner diameter of 4 mm and the inner diameter expands to 10 mm, the volume of the expandable element 104 will decrease by the same 2 cc volume. Therefore, in certain embodiments, it may be desirable to have the expandable element 104 elongate as the reinforcing element 102 expands to create a greater volume than it loses through the expansion of the reinforcing element 102, or the pressure of the expandable element 104 may keep the reinforcing element 102 from shrinking. For example, in an example where the expandable element 104 has an outer diameter of 26 mm and an inner diameter of 10 mm, an 8 mm elongation of the expandable element 104 will increase the volume by approximately 3.6 cm. 3Thus, if the reinforcing element 102, expandable element 104, and connector 500 arrangement are designed so that the expandable element 104 stretches 8 mm when the reinforcing element 102 expands, the system should preferably expand the reinforcing element 104 as the expandable element 104 is pressurized.

[0169] In certain aspects of the technology, the perfusion chamber 108 can have a valve, such as a one-way valve, positioned at a location along its length. For example, Fig. 8A and 8B An exemplary treatment system 100 is shown that includes a valve 800. In certain embodiments, positioning the valve 800 at the proximal end of the expandable element 104 may be particularly beneficial, such as Fig. 8A and 8B As shown in Fig. 8A In the example shown in , the portion of the expandable element 104 surrounding the perfusion chamber 108 extends proximally to form a short windsock valve that opens to allow blood to flow from the distal end of the catheter to the proximal end due to blood pressure differences. When the pressure on the proximal side is higher than the pressure on the distal side, the valve flattens against the elongated member 112 and blocks flow. Alternatively, if the expandable element 104 is positioned so that the desired flow direction is from proximal to distal, the valve can be reversed and placed on the distal end of the expandable element 104 so that flow occurs only distally.

[0170] The treatment system 100 may additionally or alternatively include other types of valves, such as iris valves, multi-leaflet valves, duckbill valves, etc. 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 .

[0171] Figures 9A-10B

[0026] Additional embodiments of processing systems 100 in accordance with the present technology are shown. 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 It is a cross-sectional view taken along line 9C-9C. Figures 9A-9C , the treatment system 100 may include an expandable element 904 (e.g., a balloon) carried 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 positioned intravascularly and / or percutaneously at a treatment site at or within a blood flow pathway. The expandable element 904 may have a collapsed configuration (not shown) for delivery to the treatment site and an expanded configuration (e.g., a collapsed configuration) in which the expandable element 904 defines a perfusion lumen 908 therethrough. Fig. 9AAs a result, when the expandable element 904 expands within the blood flow channel, the expandable element 904 allows blood to flow through its lumen 908. The reinforcing element 902 can be disposed within the lumen 908 of the expandable element 904 and is configured to maintain the patency of the lumen 908.

[0172] The carrier shaft 910 can have at least three generally tubular elongated members 912, 914, and 916 extending through at least a portion of its length. For example, the carrier shaft 910 can include: (a) a first elongated member 912 defining a first lumen 913 (e.g., a guidewire lumen) therethrough for atraumatically guiding a catheter to an appropriate location; (b) a second elongated member 914 defining a second lumen 915 (e.g., an inflation lumen) for inflating and deflating the expandable element 904 with saline, contrast media, or other suitable fluids; and (c) a third elongated member 916 defining a third lumen 917 therethrough for delivering an enhancement element 902 (discussed in more detail below) to the lumen 908 of the expandable element 904. In some embodiments, the three lumens 913, 915, 917 can be formed as lumens within a unitary carrier shaft 910, rather than being formed 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.).

[0173] The carrier shaft 910 can extend through the entire length of the perfusion lumen 908 and terminate distally of the distal end of the expandable element 904 and / or the reinforcing element 102. In certain embodiments, the carrier shaft 910 can terminate at a location that is longitudinally aligned with or proximal to the distal ends of the treatment element 101, the expandable element 104, and / or the reinforcing element 102. In other embodiments, the carrier shaft 910 can terminate at a more proximal location, with some or all of the elongated members 912, 914, 916 extending distally beyond the distal end of the carrier shaft 910.

[0174] The first elongated member 912 can extend substantially the entire length of the carrier shaft 910 and is configured to slidably receive a guide wire through the first lumen 913. The second elongated member 914 defining the second lumen 915 can extend between a proximal end portion (not shown) and a distal end portion that is fluidically coupled to an interior region 906 of the expandable element 904. For example, the carrier shaft 910 can have an opening in its sidewall to connect 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 to expand the expandable element 904. In certain embodiments, the second lumen 915 of the second elongated member 914 can be connected to the interior region 906 of the expandable element 904 via a separate tube.

[0175] A third elongated member 916 defining a third lumen 917 may extend between a proximal end portion (not shown) and a distal end portion that terminates adjacent to the proximal end portion of the expandable element 904. In operation, as described in more detail below, a 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. 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 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 elongated pusher element 920. In some embodiments, the pusher element 920 can be an elongated shaft or rod that extends through the cavity 917 and is connected to the proximal end of the reinforcement element 902 at its distal end, so that advancing the pusher element 920 distally causes the reinforcement element 902 to advance distally within the cavity 917.

[0176] In some embodiments, the expandable element 904 can be made of two extruded tubes, such as first and second tubes 904a and 904b, defining an interior region 906. In such embodiments, the first tube 904a can be expanded to form the outer surface of the expandable element 904, and the second tube 904b can be used to form the interior cavity of the expandable element 904. The first and second tubes 904a and 904b can be welded together at their respective proximal and distal ends to form the expandable element 904. The first elongated member 912 can extend between the two expandable elements and extend into the interior region 906. The tubes of the expandable element 904 can 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 of an inverted tube similar to the inverted tube described above with respect to the expandable element 204, wherein the first elongated member 912 extends into the interior region 906 defined by the expandable element.

[0177] The expandable element 904 can be made of one or more materials commonly used for balloons used in interventional procedures, such as polyethylene, polyolefins, polyurethanes, nylon (polyamide), polyethylene terephthalate (PET or polyester), and / or other suitable polymers. The expandable element can also be a composite structure that can include any one or more polymers plus reinforcing fibers, such as Kevlar fibers, carbon fibers, spectral fibers or other high molecular weight polyethylene, or other fibers in any orientation.

[0178] In certain aspects of the described technology, the perfusion chamber 908 can have valves, such as one-way valves, positioned at locations along its length. Fig. 9A As shown in , the treatment system 900 includes a valve 922. In some embodiments, it may be particularly beneficial to position the valve 922 at the proximal end of the expandable element 904. In some embodiments, the portion of the expandable element 904 surrounding the perfusion chamber 908 extends proximally to form a short windsock valve that opens to allow blood to flow from the distal end of the treatment system 900 to the proximal end due to a blood pressure difference. When the pressure on the proximal side is higher than the pressure on the distal side, the valve flattens against the carrier shaft 910 and impedes flow. Alternatively, if the expandable element 904 is placed so that the desired flow direction is from the proximal side to the distal side, the valve 922 can be reversed and placed on the distal end of the expandable element 904 so that the flow is only conducted distally.

[0179] In some embodiments, the reinforcing element 902 can extend through at least a portion of the perfusion lumen 908. For example, Fig. 9AAs shown in FIG. 1 , the reinforcing element 902 may be a wire that is preformed into the shape of a relatively tightly wound coil having approximately the size of the perfusion cavity 908. Advancing the wire through the third lumen 917 of the third elongated member 916 causes the wire to be deployed into the perfusion cavity 908, where it resumes its coiled shape (in Fig. 9A ) and enhances the perfusion lumen 908. The wire can be further advanced distally 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 cross-section of the wire can be circular (e.g., Fig. 10A ), or generally square (e.g. Fig. 10B ), 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 enhance the perfusion lumen 908. The wire may be metallic, polymeric, or any other suitable material. In some embodiments, the wire may be a shape memory material (e.g., Nitinol).

[0180] In certain embodiments, to retrieve the system 900, the reinforcing element 902 (e.g., a coiled wire) can be retracted proximally into the lumen 917 of the third elongated member 916. Once the reinforcing element 902 has been retracted, the expandable element 904 can be deflated (e.g., by applying negative pressure through the second lumen 915 of the second elongated member 914), and the system 900 can be retracted into a catheter or otherwise removed from the treatment site.

[0181] In certain embodiments, the reinforcing element may be a braid, which is preformed to restore a relatively flat, tightly wound tube when it is deployed in the perfusion chamber 908. Such a braided reinforcing element 902 can be attached to the carrier shaft 910 at the distal end and to a pusher element (not shown) at the proximal end portion. When the pusher element is advanced distally relative to the carrier shaft 910, the reinforcing element 902 is shortened and is pushed to present an expanded state. In this expanded state, the braid can provide an increased radial force outward to maintain the patency of the perfusion chamber 908 and / or expand the expandable element 904. This may be advantageous in an embodiment where the reinforcing element 902 is expanded at a time separated from the expansion of the expandable element 904. For example, in the case of using such a structure, a pusher element can be used to expand the reinforcing element before, at the same time, or after the expandable element expansion (e.g., via the expansion carried out by the second chamber 915).

[0182] In those embodiments for valve replacement procedures (such as TAVR), the treatment system 100 can be configured for use with an expandable implantable valve device (not shown). In some embodiments, the valve device can be preloaded around the outer surface of the expandable element 104 so that the valve device and the treatment element 101 are delivered to the natural valve annulus together. When expanded at the treatment site, the treatment element 101 pushes radially outward against the inner surface of the valve device, thereby forcing the valve device to expand radially to be juxtaposed with the annular tissue. In some embodiments, the valve device may have been expanded at the natural valve annulus, and the treatment element 101 can be delivered to the inner region of the valve device and expanded to further expand or fix the valve device at the valve annulus. In some embodiments, the valve device includes only a laser-cut stent, and in some embodiments, the valve device includes a laser-cut stent and an artificial heart valve configured to be implanted at the natural valve annulus.

[0183] in conclusion

[0184] Although many embodiments are described above for systems, devices, and methods for treating cardiac disease, the technology may be applied to other applications and / or other methods, such as pulmonary or brain applications. Moreover, other embodiments besides those described herein are also within the scope of the technology. In addition, several other embodiments of the technology may have different configurations, components, or procedures than those described herein. Therefore, it will be understood by those of ordinary skill in the art that the technology may have other embodiments with additional elements, or the technology may have other embodiments without the above referenced elements. Figure 2A-10B Other embodiments of several of the features shown and described.

[0185] The above detailed description of the embodiments of the technology is not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include plural or singular terms, respectively. Although specific embodiments and examples of the technology are described above for illustrative purposes, various equivalent modifications may be made within the scope of the technology as will be appreciated by those skilled in the relevant art. For example, although the steps are presented in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein may also be combined to provide additional embodiments.

[0186] Moreover, unless the term "or" is explicitly limited to mean only a single item that is mutually exclusive with other items about two or more items in a column, the use of "or" in such a column should be understood to include any single item in column (a), all items in column (b), or any combination of items in column (c). In addition, the term "comprising" is used throughout the text to indicate that at least one or more of the listed features are included, so that any greater number of the same features and / or other features of another type are not excluded. It should also be understood that specific embodiments have been described herein for illustrative purposes, but various modifications may be made without departing from the technology. Further, although the advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also present such advantages, and not all embodiments need to necessarily present such advantages to fall within the scope of the technology. Therefore, the present disclosure and associated technology may cover other embodiments not explicitly shown or described herein.

[0187] In the case of providing a range of values, it should be understood that, unless the context clearly indicates otherwise, it is also specifically disclosed to one-tenth of the unit of the lower limit, to each intermediate value between the upper limit and the lower limit of the range. Each smaller range between any specified value or intermediate value in the specified range and any other specified value or intermediate value in the specified range is included in the present disclosure. The upper and lower limits of these smaller ranges can be included or excluded independently within the scope, and each range that includes any limit, does not include any limit, or includes two limits in the smaller range is also included in the present disclosure, subject to the influence of any explicitly excluded limit in the specified range. In the case where the specified range includes one or two limits, the scope that excludes one or two of those included limits is also included in the present disclosure.

Claims

1. A device for treating a blood flow channel of a patient, the device comprising: an expandable element, wherein the expandable element extends longitudinally between a first longitudinal end of the expandable element and a second longitudinal end of the expandable element, the expandable element being configured to be positioned within the blood flow channel, wherein the expandable element has a collapsed configuration and an expanded configuration in which the expandable element defines a lumen therethrough; a reinforcement element, wherein the reinforcement element extends longitudinally between a first longitudinal end of the reinforcement element and a second longitudinal end of the reinforcement element, wherein the reinforcement element is positioned within the lumen of the expandable element, wherein the reinforcement element has a collapsed configuration and an expanded configuration, wherein in the expanded configuration of the reinforcement element the reinforcement element defines a lumen therethrough; and A connector, the connector having: coupled to a first portion of the reinforcing element at a first location, wherein the first location is positioned within the lumen of the expandable element; coupled to a second portion of the reinforcing element at a second location, wherein the second location is positioned within the lumen of the expandable element; and an intermediate portion between the first portion and the second portion, wherein the intermediate portion extends over a radially outer surface of the expandable element; 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, thereby causing the reinforcing element to expand radially, thereby creating a perfusion lumen through the device.

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

3. The device according to claim 1, characterized in that The force is a longitudinal tensile force.

4. The device according to claim 1, characterized in that The force is a longitudinally compressive force.

5. The device according to claim 1, characterized in that The reinforcing element is mechanically coupled to the expandable element during delivery of the device through the sheath to a treatment site.

6. The device according to claim 1, characterized in that The expandable element is an inflatable element that is configured to expand when an inflation fluid is delivered to an interior region of the inflatable element.

7. The device according to claim 1, characterized in that The expandable element includes a fold at a first longitudinal end of the expandable element and a seam at a second longitudinal end of the expandable element.

8. The device according to claim 1, characterized in that The expandable element defines a single continuous annular inflation cavity.

9. The device according to claim 1, characterized in that The expandable element is a balloon.

10. The device according to claim 1, characterized in that The expandable element has a donut-shaped shape in the expanded configuration.

11. The device according to claim 1, characterized in that The reinforcing element is a laser cut bracket.

12. The device according to claim 1, characterized in that The intermediate portion of the connector extends generally longitudinally along the radially outer surface of the expandable element.

13. The device according to claim 1, characterized in that The connector includes rope strands.

14. The device according to claim 1, characterized in that Expansion of the expandable element causes the connector to pull the first location and the second location toward each other, thereby causing the reinforcing element to expand radially.

15. The device according to claim 1, characterized in that The first location comprises a first eyelet of the reinforcing element and the second location comprises a second eyelet of the reinforcing element.

16. The device according to claim 15, characterized in that A longitudinal distance between the first eyelet and the second eyelet decreases in response to expansion of the expandable element.

17. The device according to claim 15, characterized in that The first eyelet and the second eyelet are generally circumferentially arranged.

18. The device according to claim 1, characterized in that The device comprises a plurality of said connectors.

19. The device according to any one of the preceding claims 1 to 11, characterized in that The first position of the reinforcing element is positioned at a longitudinal position along the reinforcing element between the first longitudinal end of the reinforcing element and the second position of the reinforcing element, wherein the connector extends from the second position of the reinforcing element through the first position of the reinforcing element to the first longitudinal end of the reinforcing element, then flips over and extends along the outer surface of the expandable element to the second longitudinal end of the reinforcing element, then flips over and extends along the reinforcing element through the second position of the reinforcing element toward the second longitudinal end of the reinforcing element to the first position of the reinforcing element.

20. The device of any of the preceding claims 1-11, further comprising a travel limiter configured to limit longitudinal extension and / or compression of the reinforcing element in response to expansion of the expandable element.

21. The device according to claim 20, characterized in that The travel limiter includes one or more pairs of opposing eyelets coupled to each other via flexible connectors.

22. The device of any of the preceding claims 1-11, further comprising a valve coupled to the reinforcing element and / or the expandable element, wherein the valve is configured to control the flow of a fluid through the lumen of the reinforcing element.

23. The device according to claim 1, characterized in that The connector includes a suture.

24. The device according to claim 1, characterized in that The connector includes a wire.

25. The device according to claim 1, characterized in that The connector includes a wire.

26. The device according to claim 1, characterized in that The connector includes a tether.

27. The device according to claim 1, characterized in that The connector includes a fiber.

28. The device according to claim 1, characterized in that The connector includes a filament.

29. A device for treating heart disease or cardiovascular disease, the device comprising: an expandable element, wherein the expandable element extends longitudinally between a first longitudinal end of the expandable element and a second longitudinal end of the expandable element, the expandable element comprising an outer wall and an inner wall, the outer wall and the inner wall converging at their respective longitudinal ends, wherein the expandable element has a collapsed configuration and an expanded configuration, and wherein the inner wall defines a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the cavity, the reinforcing element extending longitudinally between a first longitudinal end of the reinforcing element and a second longitudinal end of the reinforcing element; and A connector, the connector having: coupled to a first portion of the reinforcing element at a first location, wherein the first location is positioned within the lumen of the expandable element; coupled to a second portion of the reinforcing element at a second location, wherein the second location is positioned within the lumen of the expandable element; and an intermediate portion between the first portion and the second portion, wherein the intermediate portion extends over a radially outer surface of the expandable element; The expansion of the expandable element from a collapsed configuration to an expanded configuration applies a longitudinally directed force to the reinforcing element, thereby causing the reinforcing element to expand radially.

30. A system for treating a blood flow path of a patient, the system comprising: A processing element, the processing element comprising: an expandable element extending longitudinally between a first longitudinal end of the expandable element and a second longitudinal end of the expandable element, the expandable element comprising an outer wall and an inner wall that meet at their respective longitudinal ends, wherein the expandable element has a collapsed configuration and an expanded configuration, and wherein the inner wall defines a lumen extending along a longitudinal axis of the expandable element; a reinforcing element positioned within the cavity, the reinforcing element extending longitudinally between a first longitudinal end of the reinforcing element and a second longitudinal end of the reinforcing element; and A connector, the connector having: coupled to a first portion of the reinforcing element at a first location, wherein the first location is positioned within the lumen of the expandable element; coupled to a second portion of the reinforcing element at a second location, wherein the second location is positioned within the lumen of the expandable element; and an intermediate portion between the first portion and the second portion, wherein the intermediate portion extends over a radially outer surface of the expandable element; wherein expansion of the expandable element from a collapsed configuration to an expanded configuration applies a longitudinally directed force to the reinforcing element, thereby causing the reinforcing element to expand radially; a first elongated member defining a lumen therethrough, the lumen of the first elongated member being in fluid communication with an interior region of the expandable element, wherein the first elongated member is configured to deliver a fluid to the interior region of the expandable element to expand the expandable element; and A second elongated member, wherein a distal portion of the second elongated member is coupled to the reinforcing element.

31. The system according to claim 30, characterized in that The second elongated member defines a lumen extending therethrough, and wherein the lumen of the second elongated member is configured to slidably receive a guide wire.

32. A system according to claim 30 or claim 31, characterised in that Only a portion of the reinforcing element is secured to the second elongated member such that the reinforcing element can change length when coupled to the second elongated member.

33. The system of claim 30 or claim 31, further comprising a third elongated member configured to receive the first elongated member and the second elongated member therethrough.

34. The system according to claim 33, characterized in that The third elongated member terminates distally at a location proximal to the expandable element.

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