JP7189863B2 - A perfusion balloon having a selectively actuatable valve - Google Patents

Description

[0001] All publications and patent applications mentioned herein are incorporated by reference to the same extent as if each publication or patent application were specifically and individually indicated to be incorporated by reference. incorporated herein.

[0002] Expandable devices such as balloons are widely used in medical procedures. In the case of a balloon, it is inserted, typically at the end of the catheter, until the balloon reaches the area of interest. The balloon is inflated by applying pressure to it. In one variation of use, the balloon creates a space within the body when inflated.

[0003] Balloons can be used in valves associated with the heart, including aortic valve balloon angioplasty (BAV) (Hara et al., Percutaneous Balloon Aortic Valvuloplasty Review: Regeneration Time?, 2007). ;115:e334-8) and during transcatheter aortic valve implantation (TAVI). In such procedures, the inflated balloon is designed to allow continuous blood flow or perfusion. However, when the balloon is inflated, the heart valve is necessarily temporarily disabled. This can lead to obstruction of blood flow, including by creating undesirable reflux.

[0004] Thus, during a procedure, particularly when used in connection with a procedure involving valves that are disabled as a result of the procedure or otherwise, valves used to modulate fluid flow in a selective manner. It would be desirable to provide a viable perfusion balloon.

[0005] In general, perfusion balloons with selectively actuatable valves are proposed. More specifically, an inflatable perfusion balloon includes a passageway for permitting fluid flow when the balloon is inflated; an inflatable valve that can be used to selectively occlude the passageway; It has

[0006] According to more specific aspects of the present disclosure, an apparatus is provided for performing a medical procedure on a tube for transporting a fluid stream. The device includes an inflatable perfusion balloon for permitting fluid flow within the vessel in an inflated state. An inflatable valve is provided to control fluid flow within the vessel (eg, by regulating fluid flow through the perfusion balloon when inflated).

[0007] In one possible embodiment, the inflatable valve comprises a balloon associated with an internal passageway of the perfusion balloon. The balloon may comprise a substantially spherical balloon. A catheter shaft may be provided to support the perfusion balloon. The catheter shaft includes at least one lumen for receiving a support (eg, a guidewire tube having an inflation) for supporting an inflatable valve. In one particular embodiment, the inflatable valve is movable relative to the support between a first position that substantially blocks fluid flow and a second position that permits fluid flow. is.

[0008] Another aspect of the present disclosure relates to an apparatus for use in performing a medical procedure on a tube for transporting fluid flow. This device is equipped with a perfusion balloon. The perfusion balloon has a passageway associated with the opening for receiving fluid flow within the vessel and a selectively positionable valve within the vessel to control the fluid flow.

[0009] In one embodiment, the valve comprises an inflatable balloon positioned within the internal passageway of the perfusion balloon. The balloon may comprise a substantially spherical balloon. A catheter shaft for supporting the perfusion balloon has at least one lumen for receiving a support for supporting the inflatable valve. The valve may be movable between a first position substantially blocking fluid flow through the passageway and a second position permitting fluid flow through the passageway.

[00010] In any embodiment, the perfusion balloon may comprise multiple cells in a single cross-section of the perfusion balloon. Each cell has a neck that extends to the catheter shaft that supports the perfusion balloon. The multiple necks together form a retainer for the inflatable valve. The retainer may be located at the proximal end of the perfusion balloon.

[00011] A further aspect of the present disclosure relates to an apparatus for use in performing a medical procedure on a tube for transporting a flow of fluid. The device includes a first inflatable balloon having a passageway for permitting fluid flow within the vessel in an inflated state, and a second inflatable balloon for controlling fluid flow to the passageway. I have.

[00012] In one embodiment, a catheter shaft is provided to support the first inflatable balloon. The catheter shaft includes a first tube having a first lumen in fluid communication with the first inflatable balloon and a second tube having a second lumen in fluid communication with the second inflatable balloon. a tube (eg, a portion of a guidewire tube). The inflatable balloon is positioned between a first position substantially occluding fluid flow through the passageway and a second position permitting fluid flow through the passageway (e.g., in an associated guidewire tube). along).

[00013] Another aspect of the present disclosure relates to an apparatus for use in performing a medical procedure on a tube for transporting a flow of fluid. The device comprises a support. The support includes an inflatable balloon configured for sliding movement from a first proximal position to a second distal position. The support may comprise a tube having an inflation lumen for supplying fluid to the balloon. The balloon may be generally spherical and has a proximal neck and a distal neck.

[00014] A further aspect of the invention relates to an apparatus for use in performing a medical procedure on a tube for transporting a fluid stream. The device includes a balloon having a generally spherical inflatable body, a proximal neck and a distal neck. The proximal and distal necks have generally circular cross-sections. A support may also be provided to support the balloon. The support has an inflation lumen in fluid communication with the inflatable body. A perfusion balloon configured to receive the balloon may also be provided.

[00015] A further aspect of the present disclosure relates to an apparatus for use in performing a medical procedure on a tube for transporting fluid flow. The device includes a first inflatable balloon and a catheter shaft supporting the first inflatable balloon. The catheter shaft has a first lumen and a guidewire tube positioned within the first lumen. The guidewire tube has an inflation lumen for supplying inflation fluid to the inflatable balloon and a guidewire lumen for receiving the guidewire.

[00016] In one embodiment, the catheter tube includes a second lumen for supplying inflation fluid to the first inflatable balloon. The device may further comprise a second inflatable balloon in fluid communication with the inflation lumen of the guidewire tube. The first inflatable balloon may comprise an irrigation balloon and the second inflatable balloon is positioned within the irrigation balloon. A perfusion balloon may comprise multiple inflatable cells in a single cross-section of the balloon. Each cell has a proximal neck in fluid communication with the first lumen. The first inflatable balloon may comprise a substantially spherical balloon.

[00017] The present disclosure also relates to methods of performing valvuloplasty using any of the disclosed devices. The method includes providing a perfusion balloon adjacent to the valve. The perfusion balloon includes a passageway for transporting fluid flow. The method further comprises providing a balloon and regulating fluid flow through the perfusion balloon. The method may further comprise inflating the balloon.

[00018] Fig. 4 is a schematic side view of the inflatable device in an expanded state; [00019] FIG. 2 is a side cross-sectional view of the device of FIG. 1 along line 2-2, with the inflatable valve in a first position for obstructing flow through the central passageway of the device; [00020] Fig. 2A is a cross-sectional view taken along line 2A-2A of Fig. 2; [00021] FIG. 2 is a side cross-sectional view of the device of FIG. 1 with the inflatable valve in a second position to allow flow through the central passageway of the device; [00022] Fig. 3A is a cross-sectional view along line 3A-3A of Fig. 2; [00023] Fig. 7 is an enlarged partial cutaway view of the inflatable valve in a second position; [00024] Fig. 4A is a partial cross-sectional view taken along line 4A-4A of Fig. 4; [00025] Fig. 5 is an enlarged partial cutaway view of the inflatable valve in a first position; [00026] Fig. 5A is a partial cross-sectional view taken along line 5A-5A of Fig. 5;

[00027] The disclosed invention relates to an inflatable device that essentially falls within the perfusion balloon category. The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention may be realized by reference to the following detailed description, which sets forth illustrative embodiments in which the principles of the invention are employed, and the accompanying drawings.

[00028] FIG. 1 illustrates an inflatable device 10. As shown in FIG. Device 10 includes a perfusion balloon 12 in an inflated state ready for treatment (although the balloon is typically transported through the vasculature to a selected treatment area (e.g., the aortic valve)). folded on purpose). Looking at the inflated state, the balloon 12 of device 10 has a plurality of inflatable cells 12a (eight are shown, but any number) in at least a single cross-section of the balloon (see, e.g., FIGS. 2A and 3A). may be provided). A retainer (eg, a tubular flexible sheath or covering) (not shown) is provided over a central portion of the cells 12a to retain the cells 12a in a generally annular configuration in the illustrated embodiment. may also function to protect the cell when in contact with a constriction valve or the like.

[00029] The cells 12a may be individual or discrete individually inflatable balloons. Each cell 12a has a separate inflation lumen via neck 12b as described above and via neck 12c at the distal end, which is sealed at the distal end. or be part of a single balloon. The latter can be achieved by a segmented elongated structure folded in a manner that causes the cells 12a to form passages P extending along the central axis X. FIG. Fluid (e.g., blood) can continue to flow along the central axis X even when the balloon 12 is fully inflated (this may be done by a single inflation lumen, or , each balloon may have its own inflation lumen). A complete description of this type of balloon can be found in International Patent Application Publication No. WO2012099979. However, other forms of perfusion balloons may also be used (e.g., tubular balloons, those with perimeter (e.g., helical) channels for the purpose of allowing fluid flow to occur during inflation, or technology, etc.).

[00030] In any case, the device 10 may comprise an inner shaft or tube 14 having an inflation lumen L extending along the central axis X. As shown in FIG. Inner tube 14 may form part of a catheter tube or shaft 16, which includes lumen N in which inner tube 14 is positioned. The perfusion balloon 12 may then be attached to the catheter shaft 16, eg, at the proximal neck 12b forming the entrance to the passageway P. As shown in FIG. Passageway P may receive inflation fluid through lumen N.

[00031] According to one aspect of the present disclosure, a valve is provided to selectively regulate the flow of fluid through passage P. In one embodiment, the valve comprises a selectively inflatable device such as balloon 18 . Balloon 18 may be positioned within passageway P, eg, at its proximal open end, to provide a one-way valve function during the procedure.

[00032] The balloon 18 may be generally spherical in shape, but may take other forms as well. Balloon 18 may be supported by a support (eg, guidewire tube 14) to extend through passageway P without obstructing passageway P. This support may be fixed or movable relative to the perfusion balloon 12 . Guidewire tube 14 may include an inflation lumen L (see FIG. 2) for transferring fluid to selectively inflate balloon 18, as described in more detail below. The balloon 18 may also move relative to the underlying support (tube 14).

[00033] Returning to Figures 2 and 2A, it can be seen that the balloon 18 when inflated and advanced in a distal direction D (opposite to the proximal direction) is configured to regulate fluid flow. I understand. Specifically, the balloon 18 may substantially or completely occlude the passageway P, thereby restricting fluid flow (at this distal position, which therefore corresponds to the closed position of the valve so formed). is substantially or completely occluded. Movement of balloon 18 to this position may be accomplished by moving an associated support (e.g., guidewire tube 14) or, in particular, within a vessel (e.g., as a result of the pumping action of blood moving the heart). as) and automatically as a result of changing the fluid pressure created by the flow in passage P.

[00034] As can be seen from Figures 3 and 3A, the inflated balloon 18'
Fluid F may flow through the space between the proximal necks 12b associated with the individual cells 12a when withdrawn from the cell in the opposite (proximal) direction. Since this proximal position corresponds to the open state of the valve so formed, fluid F then enters passageway P and eventually perfuses through balloon 12 and distal neck 12c. It can exit in the space(s) between them and continue through the vessel (away from the heart in the case of the aortic valve). In this condition, it can be seen that neck 12b collectively forms a retainer or cage for engaging balloon 18 to prevent further proximal movement. Selective actuation of balloon 18 as it is inflated by the rhythm of flow produced by the heartbeat can be used to mimic the natural flow produced by associated valves that are rendered inoperable as a result of the procedure. A valve is obtained.

[00035] FIG. 4 illustrates one method of selectively delivering inflation fluid to balloon 18. In FIG. As noted above, a guidewire tube 14 may be provided within the inflation lumen L for providing fluid communication to the interior of the balloon 18 via one or more openings O, for example. The proximal and distal tubular extensions or necks 18a, 18b of balloon 18a are connected to corresponding proximal and distal ends of an inflatable spherical body. These necks 18a, 18b are positioned over the tube 14 to contain the inflation fluid within the internal inflation compartment of the balloon 18 and at the same time occlude the passageway P to achieve selective regulation of flow. Form a seal to allow sliding movement. As can be appreciated, the necks 18 a , 18 b may be generally circular in cross-section and may have an inner diameter that slightly exceeds the outer diameter of the tube 14 . A fluid-tight seal can thereby be formed in this manner. Necks 18a, 18b may be elongated in the direction of axis A and may enter shaft 16 and passageway P at the proximal and distal ends, respectively, as a result of controlled sliding movement (Fig. 2). and compare FIG. 3).

[00036] As can be seen by comparing Figures 4, 4A with Figures 5, 5A, the opening O communicates with the interior of the balloon 18 at one location (proximal) and then the balloon opens to the other. It may be configured to remain occluded by an extension (in this case, proximal extension 18a) when moved to a (distal) position. Tube 14 may be coaxial and may include a guidewire lumen G defined by inner tube 14a. Guidewire lumen G may extend the entire length of tube 14 (while inflation lumen L may terminate at or near opening O).

[00037] Various materials may be used to form the desired structure. These include those outlined in International Patent Application Publication No. WO2012099979. Balloon 18 may be formed from a polyurethane material. Inflation of balloon 18 may be accomplished using a device separate from that used to inflate perfusion balloon 12 . This allows a method of selective control of valves so formed.

[00038] The foregoing description is intended to provide an illustration of the concepts of the invention and is not intended to limit the invention to any particular aspect or form. Any element described herein in the singular may be in the plural (i.e., anything described as "one" may be greater than one), and a plurality of elements may be May be used individually. Disclosed features of single variations of elements, devices, methods, or combinations thereof may be used or applied to other variations, such as dimensions, burst pressures, shapes, materials, or combinations thereof. Any species element of a family element may have the characteristics or elements of any other species element of that family. The terms "substantially" or "substantially" mean that the value can vary depending on the circumstances (eg, up to 10% of the given conditions). The above-described structures, elements or complete assemblies and methods of carrying out the invention and the elements thereof, and variations of aspects of the invention, may be combined and modified with each other in any combination and with any obvious modifications. You can The following are various aspects of the present invention as originally filed.
(Mode 1) A device for performing a medical procedure in a tube for transporting a fluid stream, comprising:
an inflatable perfusion balloon for allowing flow of said fluid within said tube when in an inflated state;
an inflatable valve for controlling the flow of said fluid;
A device comprising
(Mode 2) The device according to Mode 1,
The apparatus, wherein the inflatable valve comprises a balloon associated with an internal passageway of the perfusion balloon.
(Mode 3) The device according to mode 2,
The apparatus, wherein the balloon comprises a generally spherical balloon.
(Mode 4) The device according to Mode 1,
further comprising a catheter shaft for supporting the perfusion balloon;
The apparatus, wherein the catheter shaft comprises at least one lumen for receiving a support for supporting the inflatable valve.
(Mode 5) The device according to Mode 4,
The apparatus of claim 1, wherein the inflatable valve is movable relative to the support between a first position substantially occluding fluid flow and a second position permitting fluid flow.
(Mode 6) The device according to mode 4,
The apparatus, wherein the support comprises an inflation lumen for the inflatable valve.
(Mode 7) A device for use in performing a medical procedure in a tube for transporting a fluid stream, comprising:
a perfusion balloon having a passageway associated with an opening for receiving flow of said fluid within said tube;
a valve selectively positionable within said passageway for controlling the flow of said fluid;
A device comprising
(Mode 8) The device according to mode 7, comprising:
The apparatus, wherein the valve comprises an inflatable balloon positioned within the internal passageway of the perfusion balloon.
(Mode 9) The device according to mode 8, comprising:
The apparatus, wherein the inflatable balloon comprises a substantially spherical balloon.
(Mode 10) The device according to mode 7, comprising:
further comprising a catheter shaft for supporting the perfusion balloon;
The apparatus, wherein the catheter shaft comprises at least one lumen for receiving a support for supporting the inflatable valve.
(Mode 11) The device according to mode 7, comprising:
The apparatus of claim 1, wherein the valve is movable between a first position substantially blocking fluid flow to the passageway and a second position permitting fluid flow to the passageway.
(Mode 12) The device according to mode 11, comprising:
The apparatus of claim 1, wherein said perfusion balloon comprises a retainer at its proximal end for retaining said valve in said second position.
(Mode 13) The device according to any one of Modes 1 to 12,
The apparatus of claim 1, wherein the perfusion balloon comprises multiple cells in a single cross-section of the perfusion balloon.
(Mode 14) The apparatus according to mode 13, comprising:
each cell comprising a neck extending to a catheter shaft supporting the perfusion balloon;
The device, wherein the neck portion together forms a retainer for the inflatable valve.
(Mode 15) The apparatus according to mode 14, comprising:
The apparatus of claim 1, wherein the retainer is located at a proximal end of the perfusion balloon.
Embodiment 16. An apparatus for use in performing a medical procedure in a tube for transporting fluid flow, comprising:
a first inflatable balloon having a passageway for transporting fluid in an inflated state;
a second inflatable balloon for controlling flow of said fluid through said passageway;
A device comprising
(Mode 17) The device according to mode 16, comprising:
further comprising a catheter shaft for supporting said first inflatable balloon;
The apparatus of claim 1, wherein the catheter shaft comprises a first lumen in fluid communication with the first inflatable balloon and a second lumen in fluid communication with the second inflatable balloon.
(Mode 18) The device according to mode 16, comprising:
The apparatus of claim 1, wherein the second inflatable balloon is movable from a first position substantially occluding fluid flow through the passageway to a second position permitting fluid flow through the passageway.
(Mode 19) The device according to mode 16, comprising:
The second inflatable balloon moves from a first position substantially occluding fluid flow through the passageway to a second position permitting fluid flow through the passageway. a balloon moveable along a guidewire tube.
(Mode 20) The device according to mode 16, comprising:
wherein the first balloon comprises a plurality of cells in a single cross-section of the balloon;
The apparatus, wherein the second balloon comprises a generally spherical balloon.
(Mode 21) A device for use in performing a medical procedure in a tube for transporting fluid flow, comprising:
An apparatus comprising a support having an inflatable balloon configured for sliding movement from a first proximal position to a second distal position.
(Mode 22) The device according to mode 21, comprising:
The apparatus, wherein the support comprises a tube having an inflation lumen for supplying fluid to the balloon.
(Mode 23) A device according to Mode 21 or Mode 22, wherein
The apparatus of claim 1, wherein the balloon is generally spherical and comprises a proximal neck and a distal neck.
Mode 24. A device for use in performing a medical procedure in a tube for transporting a fluid stream, comprising:
A balloon having a generally spherical inflatable body, a proximal neck, and a distal neck
Device
(Mode 25) The device according to mode 24, comprising:
The proximal neck and the distal neck have generally circular cross-sections
Device
(Mode 26) The device of Mode 24 or Mode 25, wherein
further comprising a support for supporting the balloon;
The apparatus, wherein the support comprises an inflation lumen in fluid communication with the inflatable body.
(Mode 27) The device according to any one of Modes 21 to 25,
The apparatus further comprising a perfusion balloon configured to receive said balloon.
Embodiment 28. A device for use in performing a medical procedure in a tube for transporting a fluid stream, comprising:
a first inflatable balloon;
a catheter shaft supporting the first inflatable balloon and having a first lumen;
A guidewire tube positioned within the first lumen having an inflation lumen for supplying inflation fluid to the inflatable balloon and a guidewire lumen for receiving a guidewire. guide wire tube and
A device comprising
(Mode 29) The device according to mode 28, comprising:
The apparatus, wherein the catheter tube comprises a second lumen for supplying inflation fluid to the first inflatable balloon.
(Mode 30) A device according to Mode 28 or Mode 29, wherein
The apparatus further comprising a second inflatable balloon in fluid communication with the inflation lumen of the guidewire tube.
(Mode 31) The device according to mode 30, comprising:
said first inflatable balloon comprises a perfusion balloon;
The apparatus, wherein the second inflatable balloon is positioned within the perfusion balloon.
(Mode 32) The device according to mode 31, comprising:
said perfusion balloon comprising a plurality of inflatable cells in a single cross-section of said balloon;
The apparatus, wherein each cell comprises a proximal neck in fluid communication with said first lumen.
(Mode 33) The device according to any one of Modes 28 to 32,
The apparatus, wherein the first inflatable balloon comprises a substantially spherical balloon.
Aspect 34. A method of performing valvuloplasty using the apparatus of any one of Aspects 1-27.
(Mode 35) A method of performing a procedure on a valve associated with a tube for transporting a flow of fluid, comprising:
providing a first balloon adjacent to the valve having a passageway for transporting the fluid flow;
providing a second balloon to regulate the flow of said fluid through said first balloon;
How to prepare.
(Mode 36) The method according to Mode 35, comprising:
The method further comprising inflating the first balloon and the second balloon simultaneously.

Claims (4)

1. A device for use in performing a medical procedure on a tube for transporting a fluid stream comprising:
an inflatable perfusion balloon (12) configured to form a passageway (P) to allow fluid flow ;
a catheter shaft (16) supporting the perfusion balloon (12) and having a first lumen (N);
an inflatable balloon (18) disposed within the perfusion balloon (12);
A guidewire tube (14) positioned within said first lumen (N) and having an opening (O) for conducting inflation fluid through said opening (O) to said inflatable balloon (18). said guidewire tube (14) having an inflation lumen (L) for feeding and a guidewire lumen (G) for receiving a guidewire ;
The inflatable balloon (18) is supported by the guidewire tube (14) and is in a first position substantially occluding fluid flow through the passageway (P) and the passageway (P). A device axially moveable between a second position that permits fluid flow therethrough . 2. The device of claim 1, wherein
The apparatus, wherein said catheter shaft (16) is capable of supplying inflation fluid from said first lumen (N) to said perfusion balloon (12). 3. A device according to claim 1 or 2,
The perfusion balloon (12) is an outer inflation balloon (12) extending from the catheter shaft (16) and the inflatable balloon (18) is a spherical inflation balloon fitted over the guidewire tube (14). (18) , the device. 4. A device according to claim 3 , wherein
The perfusion balloon (12) comprises a plurality of inflatable cells (12a) in a single cross section of the balloon, each cell having a proximal neck (12b) in fluid communication with the first lumen. Prepare, equipment.

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