Patent Application
20230041152
The present technology is directed 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.
There are many situations in interventional vascular procedures where there is a need to inflate a balloon in a vessel while maintaining perfusion through that vessel. For example, when delivering a balloon-expandable stent in a coronary artery, it is preferable to maintain blood flow through the artery to avoid ischemic damage to the myocardium perfused by that artery. One device commonly used to maintain blood flow is a perfusion balloon catheter. These catheters typically have a relatively large central guidewire lumen with holes through the catheter sidewall into the lumen just proximal to the balloon. This allows blood to flow through the side holes, into the guidewire lumen, and out the distal end of the catheter to maintain perfusion when the balloon is inflated and occluding the vessel.
However, these perfusion balloons are typically only used in smaller vessels where a relatively small perfusion lumen is sufficient, and the catheter can be made with a perfusion lumen of a fixed size, for example a lumen of less than 2 mm in diameter. In larger vessels such as the aorta, maintaining adequate distal perfusion without a high pressure gradient through the perfusion lumen requires a much larger lumen.
Two common interventional procedures that utilize balloon expansion are (a) balloon valvuloplasty of the aortic valve, and (b) catheter-based delivery of balloon-expandable replacement aortic valves (commonly referred to as “transcatheter aortic valve replacement” or “TAVR”).
In a typical balloon catheter, the balloon is formed from a single extrusion which is expanded into the desired balloon shape and welded or bonded to the shaft of a catheter. The sidewall of the catheter is cut to create an opening to connect an inflation lumen running through the catheter shaft to the interior of the balloon. In most clinical applications in which a vessel or valve is being dilated, the outer surface of the balloon is rounded (i.e., has a functionally circular cross-sectional shape) so as to apply a relatively even radial force against the apposing tissue. It is difficult to locate a perfusion lumen at the outer circumference of the balloon while maintaining this rounded/circular shape and providing even radially outward force.
An existing approach to the foregoing challenge of creating a large perfusion lumen in larger balloon catheters is the TRUE® Flow Valvuloplasty Perfusion Catheter (C.R. Bard/Becton Dickenson). The TRUE® Flow device has several smaller balloons arranged around the periphery of a central lumen and surrounded by a fiber-based shell. When inflated, the balloons hold the central lumen open. However, this approach limits the effective pressure which can be applied to the circumference of the balloon, even when these smaller balloons are inflated to a higher pressure. More importantly, the use of multiple balloons employs a large amount of material which increases a deflated diameter of the device and makes delivery of the device through a delivery sheath more difficult. This is especially true in the case of a TAVR balloon that has the additional bulk of the prosthetic valve.
Therefore, there remains a need for improved balloons for interventional procedures, especially within the field of interventional cardiology.
The subject technology is illustrated, for example, according to various aspects described below, including with reference to
1. A device for treating a blood flow passage of a patient, the device comprising:
2. A device for treating cardiac or cardiovascular disease, the device comprising:
3. The device of Clause 1 or Clause 2, wherein the device is configured such that expansion of the expandable element while the device is positioned within the passage urges the reinforcing element towards its expanded configuration, thereby allowing blood flow through the lumen of the reinforcing element and the lumen of the expandable element while the expandable element is in the expanded configuration.
4. The device of any one of the preceding Clauses, wherein the device is configured such that expansion of the expandable element while the device is positioned within the passage pulls the reinforcing element towards its expanded configuration, thereby allowing blood flow through the lumen of the reinforcing element and the lumen of the expandable element while the expandable element is in the expanded configuration.
5. The device of any one of the preceding Clauses, wherein the expandable element causes radial expansion of the reinforcing element by applying a longitudinally oriented force to the reinforcing element.
6. The device of Clause 5, wherein the force is longitudinally extensive.
7. The device of Clause 5, wherein the force is longitudinally compressive.
8. The device of any one of the preceding Clauses, wherein the expandable element causes radial expansion of the reinforcing element by applying a radially oriented force along the reinforcing element.
9. The device of Clause 8, wherein the force is radially extensive.
10. The device of any one 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.
11. The device of any one of the preceding Clauses, wherein the reinforcing element is mechanically coupled to the expandable element at all times.
12. The device of any one of the preceding Clauses, wherein expansion of the expandable element causes substantially simultaneous radial expansion of the reinforcing element to its expanded configuration.
13. The device of any one of the preceding Clauses, wherein the expandable element is an inflatable element configured to expand when an inflation fluid is delivered to an interior region of the inflatable element.
14. The device of any one of the preceding Clauses, wherein the expandable element extends between first and second longitudinal ends, and wherein the expandable element comprises a fold at the first longitudinal end and a seam at the second longitudinal end.
15. The device of any one of the preceding Clauses, wherein the expandable element defines a single, continuous inflation cavity.
16. The device of any one of the preceding Clauses, wherein the expandable element defines a single, continuous, annular inflation cavity.
17. The device of any one of the preceding Clauses, wherein the expandable element is a balloon.
18. The device of any one of the preceding Clauses, wherein the expandable element has a toroidal shape in the expanded configuration.
19. The device of any one of the preceding Clauses, wherein the expandable element has an elongated toroidal shape in the expanded configuration.
20. The device of any one of the preceding Clauses, wherein the expandable element is configured to be inflated to a pressure of at least about 30 to about 105 psi (about 2 to about 7 atmospheres).
21. The device of any one of the preceding Clauses, wherein the expandable element is configured to be inflated to an internal pressure sufficient to effectively dilate stenosed native valves and/or aortic strictures.
22. The device of any one of the preceding Clauses, wherein a diameter of the perfusion lumen when the device is in an expanded state is sufficient to reduce any pressure gradient of blood flowing through the perfusion lumen.
23. The device of any one of the preceding Clauses, wherein a diameter of the perfusion lumen when the device is in an expanded state is sufficient to minimize any pressure gradient of blood flowing through the perfusion lumen.
24. The device of any one of the preceding Clauses, wherein a diameter of the perfusion lumen is at least one-third of a diameter of the blood flow passage.
25. The device of any one of the preceding Clauses, wherein expansion of the expandable element creates a perfusion lumen through the expandable element and the reinforcing element, and wherein the perfusion lumen is configured to remain open while the expandable element is in the expanded configuration.
26. The device of any one of the preceding Clauses, wherein the device is configured such that foreshortening of the expandable element urges the reinforcing element to radially expand, thereby increasing a diameter of the lumen of the reinforcing element.
27. The device of any one of the preceding Clauses, wherein the reinforcing element is a mesh.
28. The device of any one of the preceding Clauses, wherein the reinforcing element is a braid.
29. The device of any one of the preceding Clauses, wherein the reinforcing element is a coil.
30. The device of any one of the preceding Clauses, wherein the reinforcing element is a laser-cut stent.
31. The device of any one of the preceding Clauses, further comprising a connector having:
32. The device of Clause 31, wherein the intermediate portion of the connector extends substantially longitudinally along the radially outer surface of the expandable element.
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.
34. The device of Clause 31, wherein expansion of the expandable element causes the connector to pull the first and second locations toward one another, thereby causing the reinforcing element to radially expand.
35. The device of Clause 31, wherein expansion of the expandable element causes the connector to pull the first and second locations away from one another, thereby causing the reinforcing element to radially expand.
36. The device of Clause 31, wherein the first location comprises a first eyelet of the reinforcing element and the second location comprises a second eyelet of the reinforcing element.
37. The device of Clause 36, wherein a longitudinal distance between the first and second eyelets decreases in response to expansion of the expandable element.
38. The device of Clause 36, wherein a longitudinal distance between the first and second eyelets increases in response to expansion of the expandable element.
39. The device of any one of Clauses 36 to 38, wherein the first and second eyelets are substantially circumferentially aligned.
40. The device of any one of Clauses 36 to 38, wherein the first and second eyelets are circumferentially offset.
41. The device of any one of Clauses 36 to 40, wherein the first and second eyelets are positioned at opposing longitudinal ends of the reinforcing element.
42. The device of any one of Clauses 36 to 40, wherein both of the first and second eyelets are positioned between the first and second longitudinal ends of the reinforcing element.
43. The device of any one of Clauses 31 to 37, further comprising a plurality of connectors, each having first and second portions coupled to the reinforcing element and an intermediate portion between the first and second portions, the intermediate portion extending over the radially outer surface of the expandable element.
44. The device of Clause 40, wherein the connectors are spaced apart from one another around the radially outer surface of the expandable element.
45. The device of any one of the preceding Clauses, the reinforcing element extending longitudinally between first and second ends and having a first location and a second location, the first location positioned at a longitudinal location along the reinforcing element between the first end and the second location, wherein the device further comprises a connector that extends from the second location past the first location to the first end, then inverts and extends along an outer surface of the expandable element to the second end of the reinforcing element, then inverts and extends along the reinforcing element towards the second end past the second location to the first location.
46. The device of any one of the preceding Clauses, further comprising a travel limiter configured to limit longitudinal elongation and/or compression of the reinforcing element in response to expansion of the expandable element.
47. The device of Clause 46, wherein the travel limiter comprises one or more pairs of opposing eyelets coupled via a flexible connector.
48. The device of Clause 47, wherein a longitudinal distance between opposing eyelets decreases in response to expansion of the expandable element.
49. The device of Clause 47 or 48, wherein the connector prevents the eyelets from longitudinally overlapping or moving past one another.
50. The device of any one of the preceding Clauses, wherein the reinforcing element comprises a plurality of interconnected struts.
51. The device of any one of the preceding Clauses, wherein the reinforcing element includes a first circumferential portion and a second circumferential portion, and wherein (a) a longitudinal length of the first circumferential portion changes as the expandable element expands and contracts, and (b) a longitudinal length of the second circumferential portion remain constant as the expandable element expands and contracts.
52. The device of any one of the preceding Clauses, wherein the reinforcing element is coupled to the expandable element via a flexible connector.
53. The device of any one of the preceding Clauses, wherein at least a portion of an outer surface of the reinforcing element is adhered to at least a portion of the outer surface of the inner wall of the expandable element.
54. The device of any one of the preceding Clauses, wherein the ends of the reinforcing element are directly attached to the ends of the expandable element such that expansion of the expandable element causes either lengthening or foreshortening of the expandable element, thereby causing expansion of the reinforcing element.
55. The device of any one of the preceding Clauses, wherein a length of the reinforcing element is less than a length of the expandable element.
56. The device of any one of the preceding Clauses, wherein a length of the reinforcing element is different than a length of the expandable element.
57. The device of any one of the preceding Clauses, wherein a length of the reinforcing element is greater than a length of the expandable element.
58. The device of any one of the preceding Clauses, wherein an entire length of the reinforcing element is positioned within the lumen of the expandable element.
59. The device of any one of the preceding Clauses, wherein a portion of the length of the reinforcing element extends proximally beyond a proximal end of the expandable element, distally beyond a distal end of the expandable element, or both.
60. The device of any one of the preceding Clauses, further comprising a valve coupled to the reinforcing element and/or the expandable element, wherein the valve is configured to control fluid flow through the lumen of the reinforcing element.
61. The device of Clause 60, wherein the valve is a one-way valve.
62. The device of Clause 60 or 61, wherein the valve is one of an iris valve, a multi-leaflet valve, a duckbill valve, or a windsock valve.
63. The device of any one of the preceding Clauses, further comprising an expandable implantable valve apparatus positioned around an outer surface of the expandable element.
64. The device of Clause 63, wherein the expandable implantable valve apparatus comprises a laser-cut stent and a prosthetic heart valve configured for implantation at a native valve annulus.
65. The device of any one of the preceding Clauses, wherein the passage is a native valve annulus.
66. The device of any one of the preceding Clauses, wherein the passage is a native heart valve annulus.
67. The device of any one of the preceding Clauses, wherein the passage is an aortic valve annulus.
68. The device of any one of the preceding Clauses, wherein the passage is a blood vessel.
69. A system for treating a blood flow passage of a patient, the system comprising:
70. The system of any one of the preceding Clauses, wherein the second elongated member defines a lumen extending therethrough, and wherein the lumen is configured to slidably receive a guidewire.
71. The system of any one of the preceding Clauses, wherein only a portion of the reinforcing element is fixed to the second elongated member such that the reinforcing element can change in length while coupled to the second elongated member.
72. The system of any one of the preceding Clauses, further comprising a third elongated member configured to receive the first elongated member and the second elongated member therethrough.
73. The system of Clause 72, wherein the third elongated member terminates distally at a location proximal of the expandable element.
74. The system of any one of the preceding Clauses, further comprising an atraumatic distal tip at a distal end of the second elongated member.
75. A method for treating a blood flow passage of a patient with any of the treatment devices, treatment systems, or treatment elements of the preceding Clauses.
76. A method for treating a blood flow passage of a patient, the method comprising:
77. The method of any one of the preceding Clauses, wherein radial expansion of the expandable element causes radial expansion of the reinforcing element.
78. The method of any one of the preceding Clauses, wherein radial expansion of the expandable element exerts a longitudinally compressive force on the reinforcing element, thereby causing the reinforcing element to radially expand within the lumen of the expandable element.
79. The method of any one of the preceding Clauses, wherein the reinforcing element has first and second locations spaced apart along its longitudinal axis, and wherein radial expansion of the expandable element pulls the first and second locations in longitudinally opposing directions.
80. The method of any one of the preceding Clauses, wherein expansion of the expandable element radially expands the reinforcing element, and wherein the perfusion lumen extends through a lumen of the expanded reinforcing element.
81. The method of any one of the preceding Clauses, wherein expanding the expandable element comprises delivering an inflation fluid to an interior region of the expandable element.
82. The method of any one of the preceding Clauses, wherein the expandable element is a balloon.
83. The method of any one of the preceding Clauses, wherein expansion of the expandable element while the device is positioned within the blood flow passage pulls the reinforcing element towards its expanded configuration.
84. The method of any one of the preceding Clauses, further comprising exerting a radially outward force against a radially inner surface of the expandable element with the reinforcing element.
85. The method of any one of the preceding Clauses, wherein the treatment element is any of the treatment devices and/or treatment elements of the preceding Clauses.
86. A device for treating a blood flow passage of a patient, the device comprising:
87. A device for treating cardiac or cardiovascular disease, the device comprising:
88. The device of Clause 86 or Clause 87, wherein the reinforcing element is braided or woven.
89. The device of any one of Clauses 86 to 88, wherein the reinforcing element is generally tubular.
90. The device of any one of Clauses 86 to 89, wherein expansion of the expandable element causes the reinforcing element to radially expand.
91. The device of any one of Clauses 86 to 90, wherein expansion of the reinforcing element causes the expandable element to radially expand.
92. The device of any one of Clauses 86 to 91, wherein the reinforcing element is coupled to the expandable element.
93. The device of any one of Clauses 86 to 91, wherein the reinforcing element and the expandable element are configured to radially expand independently of each other.
94. The device of any one of Clauses 86 to 93, further comprising an expandable implantable valve apparatus positioned around an outer surface of the expandable element.
95. A system for treating a blood flow passage of a patient, the system comprising:
96. The system of Clause 95, wherein distal movement of the pushing element causes distal movement of the proximal end portion of the reinforcing element.
97. The system of Clause 95 or Clause 96, wherein the distal end portion of the pushing element is configured to substantially abut the proximal end portion of the reinforcing element.
98. The system of any one of Clauses 95 to 97, wherein, distal movement of the proximal end portion of the reinforcement element causes the reinforcing element to axially compress and radially expand.
99. The system of any one of Clauses 95 to 98, wherein the pushing element is configured to apply a distally directed force to the proximal end portion of the reinforcing element.
100. The system of any one of Clauses 95 to 99, wherein the distal end portion of the pushing element has a tubular shape.
101. The system of any one of Clauses 95 to 100 wherein the pushing element exits the third lumen through an opening in a sidewall of the third elongated member.
102. The system of any one of Clauses 95 to 101, wherein the reinforcing element is configured to contact an inner wall of the expandable element.
103. The system of any one of Clauses 95 to 102, wherein the distal portion of the second elongated member is coupled to the distal portion of the reinforcing element via a coupler.
104. The system of any one of Clauses 95 to 103, further comprising a stopper configured to limit axial translation of the pushing element and/or axial compression of the reinforcing element.
105. The system of Clause 104, wherein the stopper is positioned proximal of the coupler.
106. The system of Clause 105, wherein a distal end portion of the stopper is secured to the coupler.
107. The system of any one of Clauses 104 to 106, wherein a proximal end portion of the stopper is secured to the pushing element.
108. The system of any one of Clauses 104 to 107, wherein the stopper is secured to the second elongated member.
109. The system of any one of Clauses 103 to 108, wherein the coupler has a generally tubular shape.
110. The system of any one of Clauses 103 to 109, wherein the distal portion of the reinforcing element is positioned between the coupler and the second elongated member.
111. The system of any one of Clauses 103 to 110, wherein the expandable element is secured to the coupler by a tether.
112. The system of any one of Clauses 95 to 111, wherein the expandable element is secured to the second elongated member and/or the third elongated member by a tether.
113. A system for treating a blood flow passage of a patient, the system comprising:
114. The system of Clause 113, wherein, when the reinforcing element is in the expanded configuration, the lumen of the proximal shoulder and/or the lumen of the distal shoulder at least partially align with the lumen defined by the reinforcing element.
115. The system of Clause 113 or Clause 114, wherein, when the reinforcing element is in the expanded configuration, the lumens of the proximal and distal shoulders and the lumen of the reinforcing element are fluidically coupled.
116. The system of any one of Clauses 113 to 115, wherein the distal and proximal shoulders have an average radial dimension that is greater than a radial dimension of the intermediate portion.
117. The system of any one of Clauses 113 to 116, wherein the distal and proximal shoulders have a largest radial dimension that is greater than a radial dimension of the intermediate portion.
118. The system of any one of Clauses 113 to 117, further comprising a one-way valve positioned proximal of the treatment element.
119. A device for treating a blood flow passage of a patient, the device comprising:
120. The device of Clause 119, wherein the opening extends through the inner and outer surfaces.
121. The device of Clause 119 or Clause 120, wherein the first expandable element comprises a balloon.
122. The device of any one of Clauses 119 to 121, wherein the second expandable element comprises at least one of a braid, a weave, a stent, or a coil.
123. A system for treating a blood flow passage of a patient, the system comprising:
124. The system of Clause 123, wherein the second portion is proximal of the first portion.
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
Specific details of several embodiments of the technology are described below with reference to
With regard to the terms “distal” and “proximal” within this description, unless otherwise specified, the terms can reference a relative position of the portions of an interventional device such as a prosthetic valve device and/or an associated delivery device with reference to an operator and/or a location in the vasculature or heart. For example, in referring to a delivery system including the perfusion devices described herein, “proximal” can refer to a position closer to the operator of the device or an incision into the vasculature, and “distal” can refer to a position that is more distant from the operator of the device or further from the incision along the vasculature (e.g., the end of the catheter).
The treatment system 100 is configured to position and deploy the treatment element 101 at a treatment site within a blood flow passage of a patient to provide a perfusion lumen while the expandable element 104 is deployed during an interventional procedure. As used herein, “blood flow passage” refers to any anatomical structure through which blood regularly flows. Examples of blood flow passages include a native annulus (in the heart or anywhere in the vasculature), a heart chamber, a blood vessel, and other body lumens. The treatment element 101 may be delivered in the collapsed state through a guide catheter to the treatment site within the blood flow passage. When treating a blood flow passage at or within the heart, the treatment system 100 may deliver the treatment element 100 to the heart via transfemoral, transcaval, trans-aortic, trans-venous, trans-atrial, transaxilliary/subclavian, or trans-apical approaches, antegrade or retrograde to the direction of blood flow, and may include trans-septal crossing from the right atrium to the left atrium.
The treatment systems 100 of the present technology may be used in any medical procedure that employs balloon expansion within a blood flow passage, regardless of whether the balloon (or other expandable element) is expanded directly into contact with the surrounding passage tissue or indirectly with another structure positioned between the balloon and the passage tissue (such as a stent, stent-graft, or prosthetic heart valve apparatus). The treatment systems 100 disclosed herein, for example, provide a reinforced perfusion lumen through a balloon while the balloon is expanded within a native valve annulus to widen the native valve opening during a valvuloplasty or to position a prosthetic valve during a TAVR procedure. The treatment systems 100 of the present technology may be used for delivery of repair or replacement devices to any of the four major cardiac valves (aortic, mitral, tricuspid, and pulmonic), as well as dilation of strictures or stents in the aorta or any of the great vessels or other blood vessels, and others. It might also be used for temporary sealing of aortic ruptures, uncontrolled bleeding sites, aortic dissections, or other areas where sealing of the vessel while sustaining perfusion is desired. Additionally, the treatment systems 100 of the present technology may be utilized in trans-septal as well as fenestrated aortic applications, where target vessel or lesion access requires navigation through tortuous anatomy. In such scenarios, an outer, large diameter balloon (such as the expandable element of the present technology) allows for fixation adjacent to the target lesion or vessel. In some cases, treatment systems for additional stent or balloon dilation could be delivered through the central lumen of the expandable element of the present technology.
As shown in
In some embodiments, the expandable element 104 comprises an inflatable element, such as a balloon. The expandable element 104 can comprise one or more substantially fluid-impermeable materials commonly used for balloons used in interventional procedures, such as polyethylene, polyolefin, polyurethane, nylon (polyamide), polyethylene terephthalate (PET or polyester), and/or other suitable polymers. In several examples of the technology, the expandable element 104 may comprise a composite structure formed of one or more polymer(s) and reinforcing fibers, such as Kevlar, carbon-fiber, spectra or other high molecular weight polyethylenes, or other fibers in any orientation.
As best shown in the cross-sectional view of
In some embodiments, such as that shown in
In some embodiments, the expandable element 104 may comprise a balloon that is everted at both ends so that the two ends overlap along the interior diameter of the balloon. In this configuration, the resulting seam may be disposed at an intermediate portion of the balloon rather than at a proximal or distal end. For example, the seam may be disposed along a central portion of the balloon along the radially inward surface. The two overlapping ends may be bonded together using adhesive, for example. The inflation lumen may be inserted between these two overlapping ends and bonded into the balloon when the ends are bonded together.
In some aspects of the present technology, the expandable element 104 may be constructed using two discrete layers: (a) a first material or layer for the inner wall that may contact the reinforcing element 102 (i.e., facing the lumen 108) and optionally a guidewire shaft (such as the second elongated member 114, detailed below), and (b) one for the outer wall. In some embodiments where the treatment element 101 includes a valve (such as that described with respect to
In some 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 device diameter on introduction and removal; a relatively large inflated or expanded profile (e.g., about 20 mm to about 30 mm, for example to allow 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 gradient across the expandable element 104 (for example, a diameter of the perfusion lumen 108 when the treatment element 101 is in an expanded state is sufficient to minimize any pressure gradient of blood flowing through the perfusion lumen and/or a diameter of the perfusion lumen is at least one-third of a diameter of the blood flow passage); and capability of withstanding high inflation pressures (e.g., at least about 30 to about 105 psi (about 2 to about 7 atmospheres)) to effectively dilate stenosed valves or aortic strictures.
The expandable element 104 of the present technology provides several advantages over conventional balloon-expandable systems. For example, unlike conventional devices, the expandable element 104 is not formed of a sidewall bonded to a fixed-diameter catheter shaft. Rather, the expandable element 104 has an elongated, annular or toroidal shape with an exterior surface that has both a luminal-facing (e.g., radially inward-facing) portion and a radially outward-facing portion. Moreover, the elongated, annular expandable element 104 of the present technology has a shorter length without necessitating a steeper transition angle from the large diameter since much of the transition is “reversed” by the eversion. The shorter expandable element 104 improves pushability and maneuverability of the treatment system 100 when navigating the more tortuous anatomy.
Referring still to
The second elongated member 114 may 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 some embodiments, the second elongated member 114 is configured to slidably receive a guidewire for atraumatic guidance of the catheter to the appropriate location. The second elongated member 114 may extend through the entire length of the perfusion lumen 108 and terminate distal to a distal end of the treatment element 101, the expandable element 104, and/or the reinforcing element 102. In some embodiments, the second elongated member 114 may terminate at a location that is longitudinally aligned with or proximal of a distal end of the treatment element 101, the expandable element 104, and/or the reinforcing element 102. In some embodiments, the second elongated member 114 may have an atraumatic distal tip at its distal end, as shown in
The second elongated member 114 may be coupled to the reinforcing element 102 such that the reinforcing element 102 is free to radially contract and expand and/or longitudinally contract and expand. For example, the second elongated member 114 may be coupled to the reinforcing element 102 at a single longitudinal location that does not hinder expansion and contraction of the reinforcing element. In some embodiments, the second elongated member 114 may be coupled to the reinforcing element 102 at multiple longitudinal locations along the reinforcing element 102, each of which is not subject to foreshortening (as described in greater detail below).
The third elongated member 112 may comprise 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 location longitudinal aligned with or proximal of 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 location longitudinally aligned with or distal to a 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.
The third elongated member 112 may receive one or more elongated members (including tubular shafts) through its lumen 113. For example, as shown in
In some embodiments, the treatment system 100 may have more or fewer elongated members or lumens than that depicted in
While the views provided in several of the figures provided herein show expandable devices laid flat for ease of explanation and understanding, the devices can be formed into a tubular shape. Also, as used herein, the term “longitudinal” can refer to a direction along an axis that extends through the lumen of the device while 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.
According to some embodiments, for example as shown in
In some embodiments, for example as shown in
As previously mentioned, the mesh of the reinforcing element 102 may include first and second spines 212, 214 that extend longitudinally along the mesh. In some embodiments, all or a portion of one, some, or all of the first spines 212 can be parallel to all or a portion of one, some, or all of the second spines 214. In some embodiments, all or some of one, some, or all of the first spines 212 can be parallel to all or a portion of one, some, or all of the other first spines 212. In some embodiments, all or some of one, some, or all of the second spines 214 can be parallel to all or a portion of one, some, or all of the other second spines 214. In some embodiments, such as that shown in
As shown in
The intermediate portion 500c of the connector 500 may extend over a radially outer surface of the expandable element 104, as shown in
In some embodiments, such as that shown in
In use, as the expandable element 104 is inflated, the outer wall of the expandable element 104 is pushed radially outwardly which pushes the intermediate portion 500c of the connector(s) 500 radially outwardly or radially away from the reinforcing element 102. As a result, the first portion 500a of the connector 500 pulls the corresponding eyelet (203a in
As the connectors 500 pull the opposing eyelets 203 in opposite directions, the circumferential sections 212a, 212b of the first spines 212 move longitudinally towards one another, thereby shortening a length of the mesh as measured between the second outer eyelets 204. The second spines 214, however, do not change in length. As such, the reinforcing element 102 has selective foreshortening along its length.
Passing a flexible connector through the eyelets makes the eyelets act as pulleys and thereby reduces the force required to effect expansion. Using the eyelets as pulleys additionally can be advantageous for increasing the length of connector that must be pulled in order to expand the reinforcing element 102, which can be advantageous to provide more flexibility in the interaction between the expandable element 104 and the reinforcing element 102.
In some instances, 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 from lengthening beyond a predetermined length. For example, the reinforcing element could be designed with stops or elements which interfere once the reinforcing element 102 has opened to an appropriate diameter. In the examples shown in
In some embodiments, the second outer eyelets 204 can be used as fairleads to keep the individual connectors 500 oriented and spaced appropriately as they wrap around the expandable element 104. For example, a particular connector could pass through an eyelet at one end of the reinforcing element 102, then through the more distant opposing eyelet, then through the other opposing eyelet, and then through the second outer eyelet 204 at the opposite end of the reinforcing element 102. Additionally or alternatively, the connector 500 can make more than one loop through the two opposing eyelets 203, creating additional force when pulling the opposing eyelets 203 together and making it easier for the expandable element 104 to expand the reinforcing element 102. The example reinforcing element 102 shown in
The treatment element 101 of the present technology provides several advantages over the prior art. For example, because the treatment element 101 and/or expandable element 104 has a perfusion lumen when expanded, the expandable element 104 can remain expanded at the treatment site for an extended period of time (i.e., a minute or more). As a result, the treatment elements of the present technology provide more effective dilation of the stenosed native valve and of the prosthetic stent-valve being delivered, thereby reducing the likelihood of perivalvular leakage or stent slippage. The extended expansion time also reduces the possibility of incomplete or non-circular stent expansion, which can lead to valve leakage and/or increased valve deterioration and early valve failure. Additionally, the treatment elements of the present technology enable the clinician to dilate the valve more slowly or leave the valve partially dilated for a period of time, which improves the final positioning of the prosthetic valve as it improves targeting of position and depth of the valve deployment.
To avoid acute ventricular overexpansion and provide meaningful blood flow to the systemic circulation, the perfusion lumen may have a cross-sectional area of about 0.5 cm2 to about 0.8 cm2. A perfusion lumen of this size in the convention devices faces several challenges. First, for a catheter having such a large fixed lumen, it would not be possible to introduce it through a percutaneous sheath. Secondly, such a large perfusion lumen running through the center of the balloon would also be likely to collapse under the high pressure of the balloon unless the perfusion lumen is highly reinforced.
When the expandable element 104 is deflated, the decreasing fluid pressure within the expandable element 104 will allow the outer wall of the expandable element 104 to decrease, thereby allowing the shoulders of the expandable element 104 to elongate and flatten as the reinforcing element 102 naturally resumes its elongated, low-profile state.
The reinforcing element 102 may be attached to the expandable element 104 at the ends of the reinforcing element 102. For example, the reinforcing element 102 may have fingers (not shown) extending from the ends of the reinforcing element 102 which are folded back against the outside of the reinforcing element 102. These fingers may be bonded to the ends of the expandable element 104, perhaps between the two tubes which form the expandable element. Alternatively, the fingers might have eyelets on both ends, and reinforcing connectors might be threaded back and forth between the eyelets at opposite ends over the outside of the expandable element. Therefore, the expandable element would be trapped between the stent on the inside, and the connectors on the outside. To avoid damaging the vessel wall or the heart valve (if it is being used for delivery of a valve), a second layer of expandable element material might be placed over these reinforcing connectors, or they might be bonded to the outside of the expandable element with adhesive or polymer.
As was the case with the reinforcing element 102 of
In some aspects of the technology, the expandable element 104 may be longer than the reinforcing element 102 and expansion of the reinforcing element 102 occurs via elongation of the reinforcing element 102. The reinforcing element 102 of
Many of the embodiments disclosed herein utilize the force of the expandable element's expansion to expand the reinforcing element 102, even though expansion of the reinforcing element 102 reduces a volume of the expandable element 104 to some degree. For example, if the reinforcing element 102 were 30 mm long and had a relaxed diameter of 4 mm, and the reinforcing element 102 was then expanded to a diameter of 10 mm to create a perfusion lumen, then a volume of the reinforcing element 102 would increase by approximately 2.0 cm3. If the expandable element 104 surrounding the reinforcing element 102 is initially inflated with an interior diameter of 4 mm and the interior diameter expands to 10 mm, then a volume of the expandable element 104 would be reduced by that same 2 cc of volume. Therefore, in some embodiments it may be advantageous for the expandable element 104 to elongate as the reinforcing element 102 expands to create more volume than it is losing via the expansion of the reinforcing element 102, or the pressure of the expandable element 104 may keep the reinforcing element 102 deflated. For example, in an example where the expandable element 104 has an outer diameter of 26 mm and an interior diameter of 10 mm, elongation of the expandable element 104 by 8 mm would add approximately an additional 3.6 cm3 of volume. Therefore, if the reinforcing element 102, the expandable element 104, and the connector 500 arrangement is designed so that the expandable element 104 elongates by 8 mm as the reinforcing element 104 expands, then the system should preferentially cause the reinforcing element 104 to expand as the expandable element 104 is pressurized.
In some aspects of the technology, the perfusion lumen 108 may have a valve, such as a one-way valve, positioned at a location along its length.
The treatment system 100 may additionally or alternatively include other types of valves, such as an iris valve, a multi-leaflet valve, a duckbill valve, and others. Moreover, the valve 800 may be positioned at the distal end of the expandable element 104 or at any location along the length of the expandable element 104.
The carrier shaft 910 may have at least three generally tubular elongated members 912, 914 and 916 extending at least a portion of its length therethrough. For example, the carrier shaft 910 may include: (a) a first elongated member 912 defining a first lumen 913 therethrough (such as a guidewire lumen) for atraumatic guidance of the catheter to the appropriate location; (b) a second elongated member 914 having defining a second lumen 915 (such as an inflation lumen) for inflation and deflation of the expandable element 904 with saline, contrast medium, or other appropriate fluid; and (c) a third elongated member 916 defining a third lumen 917 therethrough for delivery of a reinforcing element 902 (discussed in greater 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 as lumens defined by separate tubular members disposed within a common lumen of the carrier shaft 910. In some embodiments, the carrier shaft 910 may 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.).
The carrier shaft 910 may extend through the entire length of the perfusion lumen 908 and terminate distal to a distal end of the expandable element 904, and/or the reinforcing element 102. In some embodiments, the carrier shaft 910 may terminate at a location that is longitudinally aligned with or proximal of a distal end of the treatment element 101, the expandable element 104, and/or the reinforcing element 102. In other embodiments, the carrier shaft 910 may terminate at a more proximal location, with some or all of the elongated members 912, 914916 extending distally beyond a distal end of the carrier shaft 910.
The first elongated member 912 can extend substantially the entire length of the carrier shaft 910 and be configured to slidably receive a guidewire through the first lumen 913. The second elongated member 914 defining the second lumen 915 may extend between a proximal end portion (not shown) and a distal end portion that is fluidically coupled to the interior region 906 of the expandable element 904. For example, the carrier shaft 910 may 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 may be configured to deliver a fluid (e.g., saline, contrast solution) to the expandable element 904 to expand the expandable element 904. In some embodiments, second lumen 915 of the second elongated member 914 may be connected to the interior region 906 of the expandable element 904 via a separate tube.
The 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 a proximal end portion of the expandable element 904. In operation, 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, as described in more detail below. For example, third lumen 917 may terminate at the opening 918 formed in a sidewall of the carrier shaft 910. The opening 918 may face towards the perfusion lumen 908 of the expandable element 904, at or near a 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 extending through the lumen 917 and coupled at its distal end to a proximal end of the reinforcing element 902, such that distally advancing the pusher element 920 causes the reinforcing element 902 to be distally advanced within the lumen 917.
In some embodiments, the expandable element 904 may be made from two extruded tubes, such as first and second tubes 904a and 904b, thereby defining an interior region 906. In such embodiments, the first tube 904a may be expanded to form the outer surface of the expandable element 904, and the second tube 904b may be used to form the inner lumen of the expandable element 904. The first and second tubes 904a and 904b may be welded together at their respective proximal and distal ends to form the expandable element 904. The first elongated member 912 may extend between these two expandable elements and into the interior region 906. The tubes of the expandable element 904 may be welded around the carrier shaft 910 at the proximal and distal ends of the expandable element 904. In some embodiments, the expandable element may be formed of an inverted tube similar to that described above with respect to expandable element 204, with the first elongated member 912 extending into the interior region 906 defined by the expandable element.
The expandable element 904 may be made from one or more materials commonly used for balloons used in interventional procedures, such as polyethylene, polyolefin, polyurethane, nylon (polyamide), polyethylene terephthalate (PET or polyester), and/or other suitable polymers. The expandable element may also be a composite structure which may contain any polymer or polymers plus reinforcing fibers such as Kevlar, carbon-fiber, spectra or other high molecular weight polyethylenes, or other fibers in any orientation.
In some aspects of the technology, the perfusion lumen 908 may have a valve, such as a one-way valve, positioned at a location along its length. As shown in
In some embodiments, the reinforcing element 902 may extend through at least a portion of the perfusion lumen 908. As shown in
In some embodiments, to retrieve the system 900, the reinforcing element 902 (e.g., a coiled wire) may be proximally retracted into the lumen 917 of the third elongated member 916. Once the reinforcing element 902 has been retracted, the expandable element 904 may be deflated (e.g., by applying negative pressure via the second lumen 915 of the second elongated member 914), and the system 900 may be retracted into a catheter or otherwise removed from the treatment site.
In some embodiments, the reinforcing element could be a braid which is pre-formed to resume a relatively flat, close-wound tube when it is deployed into the perfusion lumen 908. Such a braided reinforcing element 902 can be attached at a distal end to the carrier shaft 910 and at a proximal end portion to a pusher element (not shown). When the pusher element is distally advanced relative to the carrier shaft 910, the reinforcing element 902 is foreshortened and urged to assume an expanded state. In this expanded state, the braid may provide an increased outward radial force to maintain patency of the perfusion lumen 908 and/or expand the expandable element 904. This may be advantageous in embodiments where it is preferred to expand the reinforcing element 902 at a separate time from expansion of the expandable element 904. For example, using such a configuration, the pusher element could be used to expand the reinforcing element before, concurrently with, or after expansion of the expandable element (e.g., via inflation through the second lumen 915).
The treatment system 1100 may further comprise one or more elongated members. For example, the treatment system 1100 may comprise a first elongated member 1110 defining a first lumen therethrough (not visible in the drawings), a second elongated member 1114 defining a second lumen 1115 therethrough, which might be used to deliver a guidewire GW in advance of the rest of the system, and a third elongated member 1112 defining a third lumen 1113 therethrough. The first elongated member 1110 may extend between a proximal end portion (not shown) and a distal end portion that is fluidically coupled to the interior region 1106 of the expandable element 1104. For example, a distal end portion of the first elongated member 1110 may be inserted into and/or placed into fluid communication with the interior region 1106 of the expandable element 1104 via a seam between the outer and inner walls at a proximal end portion of the treatment element 1101. The first elongated member 1110 may be configured to deliver a fluid (e.g., water, saline, a radiopaque solution, air) to the expandable element 1104 to expand the expandable element 1104.
The second elongated member 1114 may extend between a proximal end portion (not shown) and a distal end portion located at or near the treatment element 1101. The second elongated member 1114 can be a generally tubular shaft defining a lumen 1115 therethrough. In some embodiments, the second elongated member 1114 is configured to slidably receive a guidewire GW for atraumatic guidance of the catheter to the appropriate location. The second elongated member 1114 may extend through the entire length of the perfusion lumen 1108 and terminate distal to a distal end of the treatment element 1101, the expandable element 1104, and/or the reinforcing element 1102. In some embodiments, the second elongated member 1114 may terminate at a location that is longitudinally aligned with or proximal of a distal end of the treatment element 1101, the expandable element 1104, and/or the reinforcing element 1102. In some embodiments, the second elongated member 1114 may have an atraumatic distal tip at its distal end (such as that shown in
A distal portion of the reinforcing element 1102 may be fixed to the second elongated member 1114 while a proximal portion of the reinforcing element 1102 may be configured to move axially relative to the second elongated member 1114. This way, movement of the proximal portion of the reinforcing element 1102 distally and proximally causes the reinforcing element to expand and contract, respectively.
The third elongated member 1112 may comprise a generally tubular shaft defining a lumen 1113 therethrough. The third elongated member 1112 may extend from a proximal portion (not shown) to a distal portion that terminates at a location longitudinally aligned with or proximal of the treatment element 1101, the expandable element 1104, and/or the reinforcing element 1102. In some embodiments, the third elongated member 1112 terminates at a location longitudinally aligned with or distal to a proximal end of the treatment element 1101, the expandable element 1104, and/or the reinforcing element 1102. In some embodiments, the third elongated member 1112 extends through the entire length of the treatment element 1101, the expandable element 1104, and/or the reinforcing element 1102.
The third elongated member 1112 may receive one or more elongated members (including tubular shafts) through its lumen 1113. For example, as shown in
In some embodiments, the third elongated member 1112 may have an opening 1131 (e.g., a side port) through its sidewall, and the treatment system 1100 may include a pusher 1130 extending from the proximal portion of the treatment system 1100 to the distal portion, through the opening 1131, and terminating at or proximate the proximal end of the reinforcing element 1102. In some embodiments, at least a portion of the length of the pusher 1130 may have a hollow, hemispherical shape surrounding an elongated opening 1132 so that a distal portion of the pusher 1130 can slide over the second elongated member 1114. A distal terminus of the pusher 1130 may have a complete tubular shape (as shown in
A distal end of the pusher 1130 may abut a proximal end of the reinforcing element 1102, either directly or indirectly via a coupler (not shown). In any case, distal movement of the pusher 1130 pushes the proximal end of the reinforcing element 1102 distally, thereby causing more of the length of the reinforcing element 1102 to exit the lumen 1113 of the third elongated member 1112 into the lumen 1108 of the expandable element 1104. As the proximal portion of the reinforcing element 1102 is pushed distally (while the distal portion is held stationary), the portion of the reinforcing element 1102 released into the lumen 1108 radially expands into apposition with an inner surface of the expandable element 1104. The reinforcing element 1102 may be expanded within the lumen 1108 of the expandable element 1104 while the expandable element 1104 is deflated, partially inflated, or fully inflated.
A distal end portion of the treatment element 1101 may include a coupler 1116 that surrounds a distal end portion of the reinforcing element 1102. For example, the coupler 1116 may be positioned around the reinforcing element 1102 to secure the distal end portion of the reinforcing element 1102 to the second elongated member 1114.
In some embodiments, the expandable element 1104 may be coupled at its proximal end portion to a distal portion of the third elongated member 1112, and may be coupled at its distal end portion to the coupler 1116 and/or the second elongated member 1114. As shown in
According to some embodiments, the treatment element 1101 includes a stopper 1134 positioned within the lumen of the reinforcing element 1102 between the coupler 1116 and the pusher 1130 such that the stopper 1134 may limit the amount of axial compression exerted on the reinforcing element 1102. In some embodiments, a distal end of the stopper 1134 may be fixed to the coupler 1116 or the proximal end of the stopper 1134 may be fixed to the pusher 1130.
As shown in
The treatment system 1300 may include a catheter 1340 having one or more lumens. The treatment element 1301 can be carried by a distal portion of the catheter 1340. The catheter 1340 may include a guidewire lumen 1342 that is configured to slidably receive a guidewire GW. The guidewire lumen 1342 can be integral with a body of the catheter 1340 or can be defined by a separate shaft extending through a lumen of the catheter 1340 or axially along an outer surface of the catheter 1340.
The expandable element 1304 can be coupled to the distal portion of the catheter 1340. For example, a first, radially-inner portion of the expandable element 1304 can be coupled to the catheter 1340 (for example, along one or both of the annular shoulders 1350a, 1350b described herein). In some embodiments the catheter 1340 includes an inflation lumen 1310 fluidically coupled to an interior region 1306 of the expandable element 1304. The inflation lumen 1310 can be integral with a body of the catheter 1340 or can be defined by a separate shaft extending through a lumen of the catheter 1340 or axially along an outer surface of the catheter 1340.
In some embodiments, for example as shown in
As shown in
For example, the distal annular shoulder 1350b may have one or more distal lumens 1352b, and the proximal annular shoulder 1350a may have one or more proximal lumens 1352a. A diameter of the catheter 1340 along the narrowed region 1344 may be less than the average diameter of the catheter 1340 along each of the shoulder regions 1350a, 1350b. When the expandable element 1304 is in an expanded state (as shown in
The treatment element 1501 may have a collapsed state (not shown) and an expanded state (
In those embodiments for use in a valve replacement procedure (such as TAVR), any of the treatment systems disclosed herein may be configured for use with an expandable implantable valve apparatus (not shown). In some embodiments, the valve apparatus may be pre-loaded around an outer surface of the expandable element such that the valve apparatus and the treatment element are delivered to the native valve annulus together. When expanded at the treatment site, the treatment element pushes radially outwardly against an inner surface of the valve apparatus, thereby forcing the valve apparatus to radially expand into apposition with the annular tissue. In some embodiments, the valve apparatus may already be expanded at the native valve annulus and the treatment element may be delivered to an interior region of the valve apparatus and expanded to further expand or secure the valve apparatus at the annulus. In some embodiments the valve apparatus comprises only a laser-cut stent, and in some embodiments the valve apparatus comprises a laser-cut stent and a prosthetic heart valve configured for implantation at a native valve annulus.
Although many of the embodiments are described above with respect to systems, devices, and methods for treating cardiac disease, the technology is applicable to other applications and/or other approaches, such as pulmonary or cerebral applications. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above with reference to
The above detailed descriptions of embodiments of the technology are 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 the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, to between the upper and lower limits of that range is also specifically disclosed. Each smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in that stated range is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included or excluded in the range, and each range where either, neither or both limits are included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
The present application claims the benefit of priority to U.S. Pat. No. 62/976,342, filed Feb. 13, 2020, which is incorporated by reference herein in its entirety. The present application incorporates by reference each of the following in their entireties: PCT Application No. PCT/US19/46070, filed Aug. 9, 2019, and U.S. Provisional Application No. 62/717,752, filed Aug. 10, 2018.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2021/018047 | 2/12/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62976342 | Feb 2020 | US |
