JP2020058846A - Perfusion balloon with selectively actuatable valve - Google Patents

Abstract

To provide an apparatus for performing a medical procedure, particularly an aortic valvuloplasty, in a vessel for transmitting a flow of fluid.SOLUTION: A device 10 includes a first inflatable balloon, such as a perfusion balloon 12, with a plurality of cells 12a in a single cross-section of the balloon for permitting the fluid flow in the vessel. An inflatable valve capable of taking the form of a second inflatable balloon 18 may be provided for controlling the fluid flow through the first balloon when inflated. Selective movement of the first balloon when inflated via the flow rhythms created by the beating heart provides a one-way valve that can be used to mimic the natural flow created by the valve under treatment.SELECTED DRAWING: Figure 1

Description

  [0001] All publications and patent applications mentioned herein are referenced to the same extent as if each publication or patent application was 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 typically inserted at the end of the catheter until the balloon reaches the area of interest. By applying pressure to the balloon, the balloon is inflated. 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?" Issue 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 always temporarily disabled. This can lead to obstruction of blood flow, including by creating unwanted reflux.

  [0004] Accordingly, used to regulate fluid flow in a selective manner during a procedure, particularly when used in conjunction with a procedure that includes a valve that is disabled as a result of the procedure or otherwise. It is desirable to provide a possible perfusion balloon.

  [0005] Generally, a perfusion balloon with a selectively actuatable valve is proposed. More specifically, an inflatable perfusion balloon includes a passageway for allowing fluid flow in the inflated condition of the balloon, and an inflatable valve that can be used to selectively occlude the passageway. Is equipped with.

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

  [0007] In one possible embodiment, the inflatable valve comprises a balloon associated with an internal passage of the perfusion balloon. The balloon may include a substantially spherical balloon. A catheter shaft may be provided to support the perfusion balloon. The catheter shaft comprises at least one lumen for receiving a support for supporting an inflatable valve (eg, a guidewire tube with inflation). 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 allows fluid flow. Is.

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

  [0009] In one embodiment, the valve comprises an inflatable balloon positioned within an internal passage of the perfusion balloon. The balloon may include a substantially spherical balloon. A catheter shaft for supporting a perfusion balloon comprises at least one lumen for receiving a support for supporting an inflatable valve. The valve may be moveable between a first position that substantially blocks fluid flow through the passage and a second position that allows fluid flow through the passage.

[00010] In any embodiment, the perfusion balloon may comprise multiple cells in a single cross section of the perfusion balloon. Each cell includes a neck extending to the catheter shaft that supports the perfusion balloon. The plurality of 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 in a tube for transferring a flow of fluid. The device includes a first inflatable balloon having a passageway for allowing fluid flow in the tube in an inflated state and a second inflatable balloon for controlling fluid flow to the passageway. I have it.

[00012] In one embodiment, a catheter shaft is provided to support the first inflatable balloon. The catheter shaft has a first tube having a first lumen in fluid communication with a first inflatable balloon and a second tube having a second lumen in fluid communication with a second inflatable balloon. A tube (eg, a portion of a guide wire tube). The inflatable balloon is disposed between a first position that substantially occludes fluid flow through the passageway and a second position that allows fluid flow through the passageway (e.g., in an associated guidewire tube). It may be movable (along).

[00013] Another aspect of the disclosure relates to an apparatus for use in performing a medical procedure in a tube for transporting a flow of fluid. The device comprises a support. The support comprises an inflatable balloon configured to slidably move 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 comprises 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 in a tube for transferring a flow of fluid. The device comprises a balloon having a generally spherical inflatable body, a proximal neck and a distal neck. The proximal and distal necks have a generally circular cross section. A support may also be provided to support the balloon. The support includes 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 a device for use in performing a medical procedure in a tube for transferring a fluid stream. The device includes a first inflatable balloon and a catheter shaft that supports the first inflatable balloon. The catheter shaft comprises a first lumen and a guidewire tube positioned within the first lumen. The guidewire tube includes 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 comprises a second lumen for supplying inflation fluid to the first inflatable balloon. The device may further include a second inflatable balloon in fluid communication with the inflation lumen of the guidewire tube. The first inflatable balloon may comprise a perfusion balloon and the second inflatable balloon is positioned within the perfusion balloon. The perfusion balloon may comprise multiple inflatable cells in a single cross section of the balloon. Each cell comprises a proximal neck in fluid communication with the first lumen. The first inflatable balloon may comprise a generally spherical balloon.

[00017] The present disclosure also relates to methods of performing valvuloplasty using any of the disclosed devices. The method comprises providing a perfusion balloon adjacent the valve. The irrigation balloon comprises a passageway for transferring a fluid flow. The method further comprises providing a balloon to regulate fluid flow through the perfusion balloon. The method may further include inflating the balloon.

[00018] FIG. 18 is a schematic side view of an inflatable device in an expanded state. [00019] FIG. 2B is a side cross-sectional view of the device of FIG. 1 taken along line 2-2 with the inflatable valve in a first position for blocking flow through the central passageway of the device. [00020] FIG. 3B is a cross-sectional view taken along line 2A-2A of FIG. [00021] FIG. 2 is a side cross-sectional view of the device of FIG. 1 with an inflatable valve in a second position to allow flow through the central passageway of the device. [00022] FIG. 3A is a cross-sectional view taken along the line 3A-3A of FIG. [00023] FIG. 3D is an enlarged partial cutaway view of the inflatable valve in the second position. [00024] FIG. 4A is a partial cross-sectional view taken along line 4A-4A of FIG. [00025] FIG. 3D is an enlarged partial cutaway view of the inflatable valve in the first position. [00026] FIG. 5A is a partial cross-sectional view taken along line 5A-5A of FIG.

[00027] The disclosed invention relates to an inflatable device that essentially falls within the category of a perfusion balloon. The novel features of the invention are set forth in the claims which follow. A better understanding of the features and advantages of the present invention may be obtained by reference to the following detailed description and exemplary drawings that illustrate exemplary embodiments in which the principles of the invention are used.

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

[00029] The cells 12a may be individual, ie, discrete, individually inflatable balloons. Each cell 12a has an inflation lumen separated via a neck 12b as described above and via a neck 12c at the distal end, which seals at the distal end. It may be part of a single balloon. The latter may be achieved by a segmented elongate structure folded in a manner that causes the cells 12a to form passageways P extending along the central axis X. Fluid (eg, blood) may continue to flow along central axis X even when balloon 12 is fully inflated (this may be done by a single inflation lumen, or , Each balloon may have its own inflation lumen). A full description of this type of balloon can be found in International Patent Application Publication WO201299979. However, other forms of perfusion balloons may also be used (eg, tubular balloons, those with peripheral (eg, spiral) channels for the purpose of allowing fluid flow to occur during inflation, or these Any combination of technologies).

[00030] In any case, the device 10 may include an inner shaft or tube 14 having an inflation lumen L extending along a central axis X. Inner tube 14 may form a portion of a catheter tube or shaft 16, which comprises a lumen N in which inner tube 14 is positioned. The perfusion balloon 12 may then be attached to the catheter shaft 16, for example at the proximal neck 12b forming the entrance to the passage P. Passage 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 passageway P. In one embodiment, the valve comprises a selectively inflatable device, such as balloon 18. Balloon 18 may be positioned within passageway P, for example at its proximal open end, to provide a one-way valve function during a procedure.

[00032] The balloon 18 may have a generally spherical shape, although other configurations are possible as well. Balloon 18 may be supported by a support (eg, guidewire tube 14) for extending through passage P without obstructing passage P. The support may be fixed or moveable with respect to the perfusion balloon 12. As described in more detail below, the guidewire tube 14 may include an inflation lumen L (see FIG. 2) for transporting fluid to selectively inflate the balloon 18. The balloon 18 may also move relative to the underlying support (tube 14).

[00033] Returning to Figures 2 and 2A, the balloon 18 when inflated and advanced in the distal direction D (opposite the proximal direction) may be configured to regulate fluid flow. I understand. Specifically, balloon 18 may substantially or completely occlude passageway P, thereby allowing fluid flow (at this distal position, which corresponds to the closed position of the valve so formed). Are blocked substantially or completely. Movement of balloon 18 to this position may be accomplished by moving an associated support (eg, guidewire tube 14) or, in particular, as a result of blood pumping movements within the vessel (eg, moving the heart). And as a result of varying the fluid pressure created by the flow in passage P.

[00034] As can be seen from FIGS. 3 and 3A, the inflated balloon 18 'has a passage P
When withdrawn in the opposite (proximal) direction from, the fluid F may flow through the space between the proximal necks 12b associated with individual cells 12a. This proximal position corresponds to the open state of the valve so formed so that the fluid F then enters the passage P and eventually perfuses through the balloon 12 and the distal neck 12c. It can exit in the space (s) between them and continue through the duct (in the case of the aortic valve, away from the heart). It can be seen that in this condition the neck 12b collectively forms a retainer or cage to engage the balloon 18 and prevent further movement in the proximal direction. A one-way that can be used to simulate the natural flow created by the associated valve that is deprived as a result of the procedure by the selective actuation of balloon 18 when inflated by the flow rhythm created by the beating heart. The valve is obtained.

[00035] FIG. 4 illustrates one method of selectively delivering inflation fluid to the balloon 18. As mentioned above, the guidewire tube 14 may be provided within the inflation lumen L for communicating fluid into the interior of the balloon 18, for example via one or more openings O. Tubular extensions, or necks 18a, 18b, located proximal and distal to the balloon 18a are connected to corresponding proximal and distal ends of the inflatable spherical body. These necks 18a, 18b are located above the tube 14 to contain inflation fluid within the internal inflation compartment of the balloon 18 while at the same time achieving a selective regulation of flow by occluding the passage P. Form a seal to allow sliding movement. As can be appreciated, the necks 18a, 18b may be substantially circular in cross section and may have an inner diameter that is slightly above the outer diameter of the tube 14. Thereby, a fluid tight seal can be formed in this way. Neck portions 18a, 18b may be elongated in the direction of axis A and may enter shaft 16 and passageway P at their 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 FIGS. 4, 4A and 5, 5A, the opening O communicates with the interior of the balloon 18 at one location (proximal), which then causes the balloon to It may be configured to remain blocked by the extension (in this case, the proximal extension 18a) when moved to the position (distal). The tube 14 may be coaxial and may include a guidewire lumen G formed by the 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. It includes such as outlined in International Patent Application Publication WO201299979. Balloon 18 may be formed from a polyurethane material. Inflation of balloon 18 may be accomplished using a device other than that used to inflate perfusion balloon 12. Thereby, a method of selective control of the valve thus formed is possible.

[00038] The descriptions above are intended to provide examples of the concepts of the present invention, and are not intended to limit the present invention to the particular embodiments or forms. Any element described herein as a singular may be in the plural (ie, anything described as "one" may be more than one) and more than one element may be It may be used individually. The disclosed features of a single variation of an element, device, method or combination thereof may be used or applied to other variations, for example size, burst pressure, shape, material, or combinations thereof. Any seed element of a family element may have the features or elements of any other species element of that family. The term "substantially" or "substantially" means that the value may change depending on the circumstances (for example, up to 10% of a given condition). The above-described configurations, elements or complete assemblies and methods for practicing the invention and those elements, as well as variations of aspects of the invention, may be combined or modified with each other in any combination, with any obvious modification. You can

[00038] The descriptions above are intended to provide examples of the concepts of the present invention, and are not intended to limit the present invention to the particular embodiments or forms. Any element described herein as a singular may be in the plural (ie, anything described as "one" may be more than one) and more than one element may be It may be used individually. The disclosed features of a single variation of an element, device, method or combination thereof may be used or applied to other variations, for example size, burst pressure, shape, material, or combinations thereof. Any seed element of a family element may have the features or elements of any other species element of that family. The term "substantially" or "substantially" means that the value may change depending on the circumstances (for example, up to 10% of a given condition). The above-described configurations, elements or complete assemblies and methods for practicing the invention and those elements, as well as variations of aspects of the invention, may be combined or modified with each other in any combination, with any obvious modification. You can The following are various forms of the present invention as originally filed with the present application.
(Mode 1) A device for performing a medical procedure in a tube for transferring a fluid flow,
An inflatable perfusion balloon to allow the flow of the fluid within the vessel when in the inflated state;
An inflatable valve for controlling the flow of the fluid,
A device comprising.
(Mode 2) The device according to mode 1,
The device wherein the inflatable valve comprises a balloon associated with an internal passage of the perfusion balloon.
(Mode 3) The device according to mode 2,
The device, wherein the balloon comprises a substantially spherical balloon.
(Mode 4) The apparatus according to mode 1,
Furthermore, a catheter shaft for supporting the perfusion balloon is provided,
The device 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 wherein the inflatable valve is movable with respect to the support between a first position that substantially blocks fluid flow and a second position that allows fluid flow.
(Mode 6) The apparatus according to mode 4,
The device, 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 transferring a fluid flow, comprising:
An irrigation balloon having a passageway associated with an opening for receiving the flow of fluid in the vessel;
A selectively positionable valve within the passageway for controlling the fluid flow;
A device comprising.
(Mode 8) The apparatus according to mode 7,
The device, wherein the valve comprises an inflatable balloon positioned within an internal passage of the perfusion balloon.
(Mode 9) The device according to mode 8,
The device, wherein the inflatable balloon comprises a substantially spherical balloon.
(Mode 10) The apparatus according to mode 7,
Furthermore, a catheter shaft for supporting the perfusion balloon is provided,
The device 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,
The valve is movable between a first position that substantially blocks fluid flow to the passage and a second position that allows fluid flow to the passage.
(Mode 12) The apparatus according to mode 11,
The device, wherein the perfusion balloon comprises a retainer at a proximal end to retain the valve in the second position.
(Mode 13) The apparatus according to any one of modes 1 to 12,
The apparatus wherein the perfusion balloon comprises a plurality of cells in a single cross section of the perfusion balloon.
(Mode 14) The apparatus according to mode 13,
Each cell comprises 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,
The device, wherein the retainer is located at a proximal end of the perfusion balloon.
(Mode 16) A device for use in performing a medical procedure in a tube for transferring a fluid stream,
A first inflatable balloon having a passage for transferring fluid in an inflated state;
A second inflatable balloon for controlling the flow of the fluid through the passage;
A device comprising.
(Mode 17) The apparatus according to mode 16,
Further comprising a catheter shaft for supporting the first inflatable balloon,
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 apparatus according to mode 16,
The device, wherein the second inflatable balloon is moveable from a first position that substantially blocks fluid flow through the passageway to a second position that allows fluid flow through the passageway.
(Mode 19) The apparatus according to mode 16,
The second inflatable balloon is the first inflatable from a first position that substantially blocks fluid flow through the passageway to a second position that allows fluid flow through the passageway. A device that can be moved along a guide wire tube in a flexible balloon.
(Mode 20) The apparatus according to mode 16,
The first balloon comprises a plurality of cells in a single cross section of the balloon,
The apparatus wherein the second balloon comprises a substantially spherical balloon.
Embodiment 21: A device for use in performing a medical procedure in a conduit for transferring a fluid stream,
An apparatus comprising a support having an inflatable balloon configured to slidably move from a first proximal position to a second distal position.
(Mode 22) The apparatus according to mode 21,
The device, wherein the support comprises a tube having an inflation lumen for supplying fluid to the balloon.
(Mode 23) The apparatus according to Mode 21 or Mode 22,
The device, 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 transferring a fluid stream,
A balloon having a generally spherical inflatable body, a proximal neck portion, and a distal neck portion
apparatus
(Mode 25) The apparatus according to mode 24,
The proximal neck and the distal neck have a generally circular cross section
apparatus
(Mode 26) The apparatus according to Mode 24 or Mode 25,
Furthermore, a support for supporting the balloon is provided,
The device, wherein the support comprises an inflation lumen in fluid communication with the inflatable body.
(Mode 27) The apparatus according to any one of modes 21 to 25,
The apparatus further comprising a perfusion balloon configured to receive the balloon.
(Mode 28) A device for use in performing a medical procedure in a tube for transferring a fluid stream, the apparatus 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, the guidewire tube having an inflation lumen for supplying inflation fluid to the inflatable balloon and a guidewire lumen for receiving the guidewire. With guidewire tube
A device comprising.
(Mode 29) The apparatus according to mode 28,
The device, wherein the catheter tube comprises a second lumen for supplying inflation fluid to the first inflatable balloon.
(Mode 30) The device according to mode 28 or mode 29,
The apparatus further comprising a second inflatable balloon in fluid communication with the inflation lumen of the guidewire tube.
(Mode 31) The apparatus according to mode 30,
The first inflatable balloon comprises a perfusion balloon,
The device wherein the second inflatable balloon is positioned within the perfusion balloon.
(Mode 32) The apparatus according to mode 31,
The perfusion balloon comprises a plurality of inflatable cells in a single cross section of the balloon,
The device, wherein each cell comprises a proximal neck in fluid communication with the first lumen.
(Mode 33) The apparatus according to any one of modes 28 to 32,
The device, wherein the first inflatable balloon comprises a generally spherical balloon.
(Mode 34) A method for performing valvuloplasty using the apparatus according to any one of modes 1 to 27.
(Mode 35) A method of performing a procedure on a valve associated with a tube for transferring a fluid stream, the method comprising:
Providing a first balloon having a passageway for transferring the fluid flow adjacent the valve;
Providing a second balloon to regulate the flow of the fluid through the first balloon;
A method comprising.
(Mode 36) The method according to mode 35,
The method further comprising the step of simultaneously inflating the first balloon and the second balloon.

Claims (36)

A device for performing a medical procedure in a tube for transferring a fluid stream, comprising:
An inflatable perfusion balloon to allow the flow of the fluid within the vessel when in the inflated state;
An inflatable valve for controlling the flow of the fluid. The device according to claim 1, wherein
The inflatable valve comprises a balloon associated with an internal passage of the perfusion balloon. The device according to claim 2, wherein
The balloon comprises a substantially spherical balloon. The device according to claim 1, wherein
Furthermore, a catheter shaft for supporting the perfusion balloon is provided,
The catheter shaft comprises at least one lumen for receiving a support for supporting the inflatable valve. The device of claim 4, wherein
The inflatable valve is movable with respect to the support between a first position that substantially blocks fluid flow and a second position that allows fluid flow. The device of claim 4, wherein
The support comprises an inflation lumen for the inflatable valve. A device for use in performing a medical procedure in a tube for transferring a fluid stream, comprising:
An irrigation balloon having a passageway associated with an opening for receiving the flow of fluid in the vessel;
A selectively positionable valve in the passage for controlling the flow of the fluid. The device of claim 7, wherein
The valve comprises an inflatable balloon positioned within an internal passage of the perfusion balloon. The device according to claim 8, wherein
The inflatable balloon comprises a substantially spherical balloon. The device of claim 7, wherein
Furthermore, a catheter shaft for supporting the perfusion balloon is provided,
The catheter shaft comprises at least one lumen for receiving a support for supporting the inflatable valve. The device of claim 7, wherein
The valve is moveable between a first position that substantially blocks fluid flow to the passage and a second position that allows fluid flow to the passage. The device of claim 11, wherein
The perfusion balloon comprises a retainer at a proximal end to retain the valve in the second position. A device according to any one of claims 1 to 12, wherein
The perfusion balloon comprises a plurality of cells in a single cross section of the perfusion balloon. The device of claim 13, wherein
Each cell comprises a neck extending to a catheter shaft supporting the perfusion balloon,
The neck portion together forms a retainer for the inflatable valve. The device according to claim 14, wherein
The device wherein the retainer is located at the proximal end of the perfusion balloon. A device for use in performing a medical procedure in a tube for transferring a fluid stream, comprising:
A first inflatable balloon having a passage for transferring fluid in an inflated state;
A second inflatable balloon for controlling the flow of the fluid through the passage. The device of claim 16, wherein
Further comprising a catheter shaft for supporting the first inflatable balloon,
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. The device of claim 16, wherein
The second inflatable balloon is moveable from a first position that substantially blocks fluid flow through the passageway to a second position that allows fluid flow through the passageway. The device of claim 16, wherein
The second inflatable balloon is the first inflatable from a first position that substantially blocks fluid flow through the passageway to a second position that allows fluid flow through the passageway. A device that can be moved along a guide wire tube in a flexible balloon. The device of claim 16, wherein
The first balloon comprises a plurality of cells in a single cross section of the balloon,
The second balloon comprises a substantially spherical balloon. A device for use in performing a medical procedure in a tube for transferring a fluid stream, comprising:
An apparatus comprising a support having an inflatable balloon configured to slidably move from a first proximal position to a second distal position. 22. The device of claim 21, wherein
The support comprises a tube having an inflation lumen for supplying fluid to the balloon. A device according to claim 21 or claim 22,
The balloon is generally spherical and comprises a proximal neck and a distal neck. A device for use in performing a medical procedure in a tube for transferring a fluid stream, comprising:
A device comprising a balloon having a generally spherical inflatable body, a proximal neck and a distal neck The device of claim 24, wherein
The proximal neck and the distal neck have a substantially circular cross section 26. The device according to claim 24 or claim 25,
Furthermore, a support for supporting the balloon is provided,
The support comprises an inflation lumen in fluid communication with the inflatable body. 26. The device according to any one of claims 21 to 25,
The apparatus further comprising a perfusion balloon configured to receive the balloon. A device for use in performing a medical procedure in a tube for transferring 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 the guidewire. A device with a guide wire tube. The device of claim 28, wherein
The catheter tube comprises a second lumen for supplying inflation fluid to the first inflatable balloon. A device according to claim 28 or claim 29, wherein
The apparatus further comprising a second inflatable balloon in fluid communication with the inflation lumen of the guidewire tube. 31. The device of claim 30, wherein
The first inflatable balloon comprises a perfusion balloon,
The second inflatable balloon is positioned within the perfusion balloon. The device of claim 31, wherein
The perfusion balloon comprises a plurality of inflatable cells in a single cross section of the balloon,
Each cell comprises a proximal neck in fluid communication with the first lumen. 33. A device according to any one of claims 28 to 32,
The first inflatable balloon comprises a substantially spherical balloon.   28. A method of performing valvuloplasty using the device of any one of claims 1-27. A method of performing a procedure on a valve associated with a tube for transferring a fluid stream, the method comprising:
Providing a first balloon having a passageway for transferring the fluid flow adjacent the valve;
Providing a second balloon to regulate the flow of the fluid through the first balloon;
A method comprising. The method of claim 35, wherein
The method further comprising the step of simultaneously inflating the first balloon and the second balloon.

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