Method and system for reducing limb ischemia
The device with radially expandable features addresses limb ischemia by creating channels within the blood vessel to enhance blood flow, effectively reducing occlusion-related ischemia and improving patient outcomes.
Patent Information
- Application Number
- JP2024566340
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-05-10
- Filing Date
- 2023-05-10
- Publication Date
- 2025-06-03
AI Technical Summary
Limb ischemia, a sudden decrease in limb perfusion, often occurs due to blood occlusion by indwelling sheaths and/or catheters, local occlusions, or persistent occlusions, posing a significant threat to limb viability and patient safety.
A device comprising a tubular member with radially expandable features, such as balloons or a hydraulic skeleton, that can selectively expand to create channels within the blood vessel, allowing blood to flow around or through the device and reducing occlusion-related ischemia.
The device effectively reduces and prevents limb ischemia by promoting blood flow through the creation of channels within the blood vessel, thereby improving patient outcomes and reducing complications associated with occluded arteries.
Smart Images
Figure 2025517162000001_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications
[0001] This application claims the priority of U.S. Patent Application No. 63 / 340,358, filed on May 10, 2022, the entire disclosure of which is incorporated herein by reference.
[0002] Technical Field
[0002] The present disclosure relates to methods, devices, and systems for use in preventing limb ischemia such as that resulting from the use of mechanical circulatory assist devices.
Background Art
[0003] Background
[0003] Limb ischemia is a rapid and sudden decrease in limb perfusion and often threatens the viability of the limbs. This can occur as a result of blood occlusion by indwelling sheaths and / or catheters, local occlusion (e.g., atherosclerotic stenosis), and / or persistent occlusion due to small vessels and / or large sheaths. It can also occur as a result of closure problems.
[0004]
[0004] Limb ischemia is associated with mortality, and some literature has shown that the incidence of limb ischemia can be high. Thus, limb ischemia can have an adverse effect on patients in addition to having an adverse effect on ongoing clinical trials.
Summary of the Invention
Means for Solving the Problems
[0005] Summary
[0005] In various aspects, a device may be provided. The device may include a tubular member. The device may include one or more radially expandable features disposed on an outer surface of the tubular member. The one or more radially expandable features may be configured to selectively expand from a collapsed configuration to an expanded configuration such that blood within a patient's blood vessel flows from a location upstream of the one or more radially expandable features, around and / or through the one or more radially expandable features, and to a location downstream of the one or more radially expandable features.
[0006]
[0006] The one or more radially expandable features may include one or more balloons. The one or more radially expandable features may extend along a portion of the length of the tubular member. Each radially expandable feature may have the same axial length. In some embodiments, at least one of the one or more radially expandable features may have an axial length different from another of the one or more radially expandable features.
[0007]
[0007] The one or more radially expandable features may include a plurality of radially expandable features. Each radially expandable feature may be circumferentially spaced from an adjacent radially expandable feature by the same distance. In some embodiments, each of the plurality of radially expandable features may be circumferentially spaced from an adjacent radially expandable feature. The circumferential spacing distance of a first adjacent pair of adjacent radially expandable features may be different from the circumferential spacing distance of a second adjacent pair of adjacent radially expandable features.
[0008]
[0008] The central axis of each radially expandable feature may be parallel to the central axis of the tubular member. At least one radially expandable feature may be disposed on the outer surface of the tubular member in a helical pattern. At least one radially expandable feature may have an elliptical or circular cross-sectional shape. At least one radially expandable feature may have a polygonal cross-sectional shape.
[0009]
[0009] Each of the radially expandable features may be fluidly connected to a fluid source. Each of the radially expandable features may be operably connected to a connector. The radially expandable feature may include a hydraulic skeleton.
[0010]
[0010] In various aspects, a device may be provided. The device may include a tubular member and may include a hydraulic skeleton coupled to the tubular member. The hydraulic skeleton may be configured to selectively expand (“expand”) or contract (“compress”). The hydraulic skeleton may be configured to expand from a folded configuration to an expanded configuration and create at least a first channel to allow blood to flow from a point upstream of the hydraulic skeleton through the first channel to a point downstream of the hydraulic skeleton.
[0011]
[0011] The hydraulic skeleton may be configured to selectively expand or contract to create at least a first channel and a second channel. The cross-sectional area of the first channel and the cross-sectional area of the second channel may be the same. The cross-sectional area of the first channel and the cross-sectional area of the second channel may be different. The cross-sectional area of the first channel may be controlled separately from the cross-sectional area of the second channel. The tubular member may be configured to slidably receive a second tubular member. The device may include a valve at the proximal end of the tubular member, and the valve may be operably coupled to the second channel.
[0012]
[0012] The hydraulic skeleton may extend entirely around the perimeter of the tubular member. The hydraulic skeleton may extend only a portion around the perimeter of the tubular member. The hydraulic skeleton may be coupled to the distal end of the tubular member. At least a portion of the hydraulic skeleton may extend along the axial length of the tubular member. When the hydraulic skeleton expands, the diameter of the first channel may increase. The hydraulic skeleton may include a plurality of annular rings.
[0013]
[0013] In various aspects, a method can be provided. The method can include disposing a tubular member within a blood vessel, the tubular member having an outer surface and at least one radially expandable member coupled to the outer surface. The method can include enabling blood to flow from a location upstream of at least one radially expandable feature, around and / or through at least one radially expandable feature (e.g., through an opening or channel created by the feature), to a location downstream of at least one radially expandable feature by expanding at least one radially expandable feature from a collapsed configuration to an expanded configuration.
[0014]
[0014] The step of expanding at least one radially expandable feature can include expanding a portion of the blood vessel around at least one radially expandable feature.
[0015]
[0015] The step of expanding from a collapsed configuration to an expanded configuration can include expanding all of a plurality of radially expandable features simultaneously. The step of expanding from a collapsed configuration to an expanded configuration can include selectively expanding fewer than all of a plurality of radially expandable features.
[0016]
[0016] The step of expanding from a collapsed configuration to an expanded configuration can be performed automatically based on received information. The received information can be a determination that an ischemic event is occurring or likely to occur. The received information can be a value from a sensor.
[0017]
[0017] The method can include measuring pressures within the blood vessel, such as upstream and / or downstream of the radially expandable feature. At least one radially expandable feature can include a balloon. At least one radially expandable feature can include a hydrostatic skeleton.
[0018] Brief Description of the Drawings
[0018] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention above and the detailed description of the embodiments below, serve to explain the principles of the invention.
Brief Description of the Drawings
[0019]
Figure 1A
[0019] It is a diagram of a device disposed within a blood vessel.
Figure 1B
[0020] It shows a cross-section of the device of FIG. 1.
Figure 1C
[0021] It shows a cross-section of another embodiment of the device according to the present disclosure.
Figure 2A
[0022] It is a diagram of a device disposed within a blood vessel.
Figure 2B
[0023] It is a diagram of an embodiment of a cross-section of the device of FIG. 2A.
Figure 2C
[0023] It is a diagram of an embodiment of a cross-section of the device of FIG. 2A.
Figure 2D
[0024] It is a diagram of another embodiment of the position of the device within the blood vessel.
Figure 2E
[0025] It is a diagram of an embodiment of a cross-section of the device of FIG. 2D.
Figure 2F
[0025] It is a diagram of an embodiment of a cross-section of the device of FIG. 2D.
Figure 2G
[0026] It is a diagram of another embodiment of the position of the device within the blood vessel.
Figure 3
[0027] It is a flowchart of a method.
Modes for Carrying Out the Invention
[0020] Detailed Description
[0028] The following description and drawings merely illustrate the principles of the present invention. Accordingly, it will be appreciated that those skilled in the art can devise various configurations that embody the principles of the present invention and fall within its scope even if not explicitly described or illustrated herein. Further, all examples described herein are expressly intended solely for illustrative purposes to assist the reader in understanding the principles of the present invention and the concepts contributed by the inventors to the art, and are to be construed as not being limited to such specifically described examples and conditions. Additionally, the term "or" as used herein refers to non-exclusive "or" unless otherwise indicated (e.g., "or otherwise" or "or alternatively"). Also, the various embodiments described herein are not necessarily mutually exclusive, and some embodiments can be combined with one or more other embodiments to form new embodiments.
[0021]
[0029] Numerous innovative teachings of this application will be described with particular reference to presently preferred exemplary embodiments. However, it should be understood that such embodiments merely provide some examples of many advantageous uses of the innovative teachings herein. Generally, the descriptions made in the specification of this application do not necessarily limit any of the various claimed inventions. Further, some descriptions may apply to some features of some inventions but not to others. Those skilled in the art based on the teachings herein will understand that the present invention is applicable to various other technical fields or embodiments.
[0022]
[0030] As is well known, limb ischemia is a rapid and sudden decrease in perfusion of a patient's limbs, which can occur due to interruption of blood flow by an indwelling sheath and / or catheter, local occlusion (e.g., atherosclerotic stenosis), and / or persistent occlusion resulting from small blood vessels and / or large sheaths. Limb ischemia can also result from the use of closure devices.
[0023]
[0031] In some cases, to address limb ischemia, a small-diameter catheter may be inserted distally to provide antegrade blood flow to the ischemic limb. For example, the catheter may be inserted into either the dorsalis pedis artery or the posterior tibial artery. As will be appreciated, antegrade blood flow may be introduced at any suitable time (e.g., at the time of initial ECMO cannula insertion, or implantation of a mechanical circulatory support device, or later, such as after ischemia is detected). In some cases, conventional solutions may not be available to all patients. For example, some patients may not have a dorsalis pedis artery or a posterior tibial artery large enough to introduce a catheter.
[0024]
[0032] The inventors recognize that rapid identification and treatment of ischemic events can lead to improved patient outcomes. The inventors also recognize the advantage of promoting and providing perfusion to the distal extremities by dilating the vasculature around at least a portion of a fully inserted cannula (e.g., an introducer sheath) in patients with occluded arteries. For example, as described herein, by dilating the vasculature around at least a portion of the cannula, blood flow (e.g., retrograde blood flow) may be able to progress and pass around the cannula. In this regard, the devices and methods of the present disclosure can address unmet needs of currently existing distal limb perfusion techniques. The devices and methods of the present disclosure may also potentially reduce the number of insertion sites in a patient, thereby potentially reducing the risks of infection, sepsis, bleeding, hematoma, ischemia, and pseudoaneurysm.
[0025]
[0033] In various aspects, devices and methods can be provided for promoting and providing perfusion of the distal extremities and reducing limb ischemia. Referring to FIG. 1A, device 100 can include a tubular member 110 that can be inserted into a patient's vasculature. For example, the tubular member can be designed to pass through the skin 22 and be inserted into the blood vessel 10 at the access point 20, as shown in FIG. 1A. In some embodiments, the tubular member can be a sheath, cannula, and / or catheter, although other suitable tubular members may be used. The tubular member can be constructed from any suitable material such as nitinol, a medical grade polymer (such as polyurethane), and / or combinations thereof. In other embodiments, the tubular member may be formed from other suitable materials.
[0026]
[0034] As described herein, the tubular member can be configured to selectively expand at least a portion of the patient's vasculature surrounding the tubular member. In this regard, as shown in FIGS. 1A - 1C, the tubular member includes one or more features 120 configured to expand radially to move at least a portion 12 of the blood vessel 10 away from the tubular member in order to allow blood to flow 140 from a point 141 upstream of the feature to a point 142 downstream of the feature between the tubular member and the blood vessel. For example, in some embodiments, the feature can have a folded configuration, such as when the tubular member is inserted into the patient, and an expanded configuration, as shown in FIG. 1A, in which one or more features are expanded to move a portion 12 of the blood vessel away from the sheath. As will be appreciated, the diameter of the tubular member (e.g., the distance from the center of the tubular member to the outermost extent of the expandable feature) is greater when the feature is in the expanded configuration than when the feature is in the folded configuration.
[0027]
[0035] The feature portion can be composed of any suitable material such as Nitinol, medical grade polymers (such as polyurethane), or other suitable materials. As will be understood, the feature portion can be formed of an expandable material. In some embodiments, the feature portion can each include a balloon that can be inflated, for example, by the controlled addition of fluid from fluid source 132. In some embodiments, the device can include a controller 130 that selectively expands and / or contracts the feature portion by adding and / or removing fluid from the feature portion. In some embodiments, the fluid can be saline, although other suitable fluids, such as gas, may be used. In some embodiments, the fluid can pass through one or more lumens (not shown) within the tubular member. In this regard, the fluid source can be fluidly coupled to the feature portion via one or more of the more lumens within the tubular member skeleton
[0028]
[0036] As shown in FIGS. 1A - 1C, the tubular member can include a plurality of feature portions 120 that extend around the perimeter of the tubular member. Referring to FIG. 1B, the feature portions can be configured such that each feature portion 120 can be disposed on the outer surface 112 of the tubular member 110. The inner surface 114 of the tubular member can define a lumen 116 that extends therethrough.
[0029]
[0037] The number of feature portions can vary. As seen in FIG. 1B, the device can have three feature portions. In FIG. 1C, the device is shown as having five feature portions. However, any number of feature portions can be present. For example, in some embodiments, the tubular member can have one or more expandable feature portions.
[0030]
[0038] In various embodiments, the arrangement of the radially expandable features may vary. In some embodiments, one or more radially expandable features may extend along a portion of the axial length 122 of the tubular member. In some embodiments, each radially expandable feature may have the same axial length. In some embodiments, the radially expandable features may not be the same. For example, at least one radially expandable feature may have an axial length different from that of another. In another example, at least one radially expandable feature may have a diameter different from the diameter of another radially expandable feature. In some embodiments, the central axis of each radially expandable feature may be parallel to the central axis of the tubular member. In some embodiments, the radially expandable features may be arranged in a helical pattern (or a partial helical pattern) on the outer surface of the tubular member.
[0031]
[0039] As will be appreciated, in some embodiments, the features that expand radially are not only circumferentially spaced from each other, but may also be spaced along the axial length of the tubular member.
[0032]
[0040] The device may include a plurality of radially expandable features. The features may be arranged in various ways relative to each other. For example, each radially expandable feature may be circumferentially spaced from an adjacent radially expandable feature by the same distance. In some embodiments, the circumferential spacing distance of adjacent pairs of a plurality of adjacent radially expandable features is different from the circumferential spacing distance of different adjacent pairs of the plurality of adjacent radially expandable features.
[0033]
[0041] The shape of the radially expandable features can vary. The radially expandable features may have an elliptical or circular cross-sectional shape, a polygonal cross-sectional shape, or a combination thereof. Each feature may have the same cross-sectional shape. In some embodiments, at least one feature has a cross-sectional shape different from that of another feature.
[0034]
[0042] As will be appreciated, the feature portion may be attached to the tubular member by any suitable method. For example, the feature portion can be attached to the tubular member by adhesion, bonding, or other methods. In such embodiments, the feature portion may not be removable from the tubular member. As will be appreciated, in some embodiments, the feature portion may also be integrally formed with the tubular member. In still other embodiments, the feature portion may be configured to be attachable (e.g., by a clinician) to the tubular member before inserting the tubular member into the patient's vasculature.
[0035]
[0043] In some embodiments, the radially expanding feature portion can be configured as a hydraulic skeleton, as shown in FIGS. 2A - 2C. Referring to FIG. 2A, in some embodiments, the device 200 can include a tubular member 110 having a hydraulic skeleton 220 coupled to the tubular member. As will be appreciated, the hydraulic skeleton can be attached by a method similar to the methods of the feature portions described herein. The hydraulic skeleton may include any suitable flexible material such as polyurethane or Teflon that can be expanded to a specific pressure corresponding to a specific outer diameter. As understood from the above perspective, the hydraulic skeleton can be connected to a fluid source and a controller that can selectively add and / or remove fluid from the skeleton to selectively expand the hydraulic skeleton to allow blood flow around the tubular member. Similar to the above example, the hydraulic skeleton can have a folded configuration and an expanded configuration.
[0036]
[0044] In some embodiments, the hydraulic skeleton can be configured to be selectively expanded or contracted, creating at least a first channel 222 (see FIGS. 2B and 2E) to allow blood to flow from a point 141 upstream of the hydraulic skeleton, through the first channel, to a point 142 downstream of the hydraulic skeleton. As will be appreciated, similar to the above example, the expansion of the hydraulic skeleton can also increase the diameter of the patient's vasculature around the expanded skeleton.
[0037]
[0045] In some embodiments, the maximum diameter (such as the maximum effective diameter) of the first channel can be 1Fr, 3Fr, 5Fr, 7Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 15Fr, 17Fr, 20Fr, or 23Fr. In some embodiments, the hydraulic skeleton can be configured to selectively expand or contract to create at least a first channel 222 and optionally a second channel 223 (see FIGS. 2C and 2F). In some embodiments, the maximum diameter (such as the maximum effective diameter) of the second channel can be 1Fr, 3Fr, 5Fr, 7Fr, 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 15Fr, 17Fr, 20Fr, or 23Fr. As will be understood, the first channel and / or the second channel can have any suitable diameter. Further understood, the hydraulic skeleton can be formed having any other suitable number of channels. In embodiments having more than one channel, the effective diameter of the first channel and the effective diameter of the second channel may be the same, but the diameters may also be different. Further understood, the first channel and / or the second channel can have any suitable shape.
[0038]
[0046] When first deployed and in a folded configuration, the hydraulic skeleton has a minimum cross-section. When expanded and in an expanded configuration, the hydraulic skeleton can have a cross-sectional area that is less than or equal to the cross-sectional area of the tubular member. In some embodiments, the hydraulic skeleton can have a cross-sectional area that is relatively smaller than the cross-sectional area of the tubular member. Referring to FIG. 2B, a relatively small hydraulic skeleton having a single channel (e.g., only the first channel 222) is shown. In other embodiments, the hydraulic skeleton can have the same diameter as the tubular member. In yet other embodiments, as shown in FIGS. 2D-2F, the hydraulic skeleton can have a cross-sectional area that is greater than the cross-sectional area of the tubular member. FIGS. 2D and 2E show a hydraulic skeleton having a relatively large cross-sectional area relative to the tubular member.
[0039]
[0047] Referring to FIG. 2C, the outer surface 112 of the tubular member 110 may form a portion of the first channel 222. Also, as shown, in some embodiments, the backbone may include a plurality of channels, such as for example a first channel 222 and a second channel 223. In some embodiments, the backbone may include a separator 225 such that at least two channels are separately controllable. As will be appreciated, in some embodiments, the separator may include a membrane that separates the first channel from the second channel. In other embodiments, the separator may be a portion of the backbone and may itself be expandable. In some embodiments, the cross-sectional area of the first channel may be the same as the cross-sectional area of the second channel. In some embodiments, the cross-sectional area of the first channel may be different from the cross-sectional area of the second channel.
[0040]
[0048] In some embodiments, the diameter of the first channel may increase as the hydraulic backbone expands.
[0041]
[0049] In some embodiments, the cross-sectional area of the first channel may be controlled separately from the cross-sectional area of the second channel. For example, as seen in FIG. 2C, a membrane or partition 225 can fluidly separate the portion of the backbone around the first channel 222 from the portion around the second channel 223, thus allowing each section to be controlled separately. In some embodiments, the device simply has two separate hydraulic backbones, each having a single channel.
[0042]
[0050] In some embodiments, the tubular member 200 may be configured to slidably receive an additional tubular member 230 (such as a catheter). This may be received, for example, through a channel or lumen 202 (see, e.g., FIG. 2A). In some embodiments, the maximum diameter (such as the maximum effective diameter) of the channel or lumen 202 may be 9Fr, 10Fr, 11Fr, 12Fr, 13Fr, 15Fr, 17Fr, 20Fr, or 23Fr.
[0043]
[0051] In some embodiments, the device may include a valve 212 at the proximal end 118 of the tubular member 110. The valve may be operably coupled to the channel or lumen 202. The valve may be configured to receive an additional tubular member 230. In some embodiments, the tubular member 110 and the additional tubular member 230 may be integrally formed.
[0044]
[0052] The hydraulic skeleton may be coupled at or near the distal end of the tubular member. In some embodiments, the hydraulic skeleton may extend entirely around the tubular member. In some embodiments, the hydraulic skeleton may extend only partially around the tubular member.
[0045]
[0053] In some embodiments, only a single hydraulic skeleton may be present. In some embodiments, multiple hydraulic skeletons may be present.
[0046]
[0054] Referring to FIG. 2D, it can be seen that at least a portion of the hydraulic skeleton 220 may extend along the axial length 122 of the tubular member.
[0047]
[0055] In some embodiments, the hydraulic skeleton 220 may include a plurality of axially spaced rings 240, each ring being able to contact the tubular member 110. In some embodiments, each ring may be individually controlled (e.g., selectively expanded by fluid). In some embodiments, the entire skeleton is controlled as an aggregate unit. In some embodiments, two or more rings may be separated by a connector 241 that allows fluid to pass from one ring to an interconnected ring. In some embodiments, the connector may also maintain a predetermined distance between adjacent rings.
[0048]
[0056] In some embodiments, the rings may form a single channel extending through the hydraulic skeleton (e.g., see FIG. 2E). In some embodiments, as seen in FIG. 2F, one or more rings may define two channels.
[0049]
[0057] Although illustrated and described as enabling blood flow through the channels of the hydraulic skeleton, it will be understood that the channels may be configured for the passage of other devices. For example, referring to FIG. 2G, the hydraulic skeleton may be configured to allow an additional tubular member 250 to extend at least partially through the hydraulic skeleton. In some embodiments, the tubular member 250 may extend through the entire hydraulic skeleton. The additional tubular member may extend through one or more rings 240 of the hydraulic skeleton. In some embodiments, the tubular member 250 may extend through only one of the channels of the hydraulic skeleton.
[0050]
[0058] In various aspects, as described in the methods provided herein, the devices used herein can be used to reduce and / or prevent limb ischemia. Referring to FIG. 3, method 300 may include 310 disposing a tubular member within a blood vessel. In some embodiments, the tubular member may enable the passage of one or more medical devices, such as a mechanical circulatory assist device used to treat a patient. As will be understood, in some cases, the tubular member may reduce and / or prevent blood flow through the blood vessel at at least one portion of the blood vessel that may cause ischemia.
[0051]
[0059] Accordingly, the method may also include expanding a portion of the blood vessel to enable blood to flow from a point upstream of at least one radially expandable feature to around at least one radially expandable feature or through at least one radially expandable feature and to a point downstream of at least one radially expandable feature, by expanding at least one radially expandable feature from a collapsed configuration to an expanded configuration 320. In some embodiments, the expandable feature may include a hydraulic skeleton, and the method may include enabling blood to flow through one or more channels of the expanded hydraulic skeleton.
[0052]
[0060] In some embodiments, expanding from a folded configuration to an expanded configuration can include expanding all of a plurality of radially expandable features simultaneously. Expanding from an inflated folded configuration to an expanded configuration can also include selectively expanding fewer than all of the plurality of radially expandable features.
[0053]
[0061] In some embodiments, expanding at least one radially expandable feature can include inflating at least one expandable feature by supplying fluid from a fluid source to the expandable feature.
[0054]
[0062] In some embodiments, expanding from a folded configuration to an expanded configuration can include receiving information and then automatically expanding from the folded configuration to the expanded configuration based on the received information. For example, referring to FIG. 1A, the disclosed device can include one or more sensors 102 (such as one or more pressure sensors disposed along an intravascular device). In some embodiments, based on information received from the sensors, the method can include automatically expanding a feature from a folded configuration to an expanded configuration. In some embodiments, one or more processors can determine, based on values from one or more sensors (or from another device such as a monitoring patch or a mechanical circulatory support device), that an ischemic event is occurring or likely to occur, and based on that determination, automatically expand one or more features from a folded configuration to an expanded configuration. As will be appreciated, the method can include collecting data necessary to enable such automatic correction, such as measuring intravascular pressures upstream and / or downstream of the radially expandable feature.
[0055]
[0063] When a medical treatment or assistance (e.g., via a device inserted into a patient's vasculature through a tubular member) is completed, the method may include removing the tubular member from the patient. In this regard, the method may then include contracting at least one expandable feature such that at least one feature returns to a folded state. This step may also include ensuring that all of the radially expandable features are in a folded configuration. The method may finally include removing the tubular member from the blood vessel and closing the administration site.
[0056]
[0064] With reference to the figures that identify like or identical elements with like reference numerals, embodiments of the present disclosure will be described in detail. It should be understood that the disclosed embodiments are merely examples of the present disclosure, which may be embodied in various forms. To avoid obscuring the present disclosure with unnecessary detail, well-known functions or structures will not be described in detail. Accordingly, the specific structural and functional details disclosed herein should not be construed as limiting, but only as a representative basis for the claims and for teaching one of ordinary skill in the art how to make and use the present disclosure in substantially any appropriately detailed structure.
[0057]
[0065] Although various embodiments incorporating the teachings of the present invention are shown and described in detail herein, one of ordinary skill in the art can readily devise many other various embodiments that still incorporate these teachings. Accordingly, while the foregoing relates to various embodiments of the present invention, other and further embodiments of the present invention may be devised without departing from its basic scope.
Claims
**Claim 1** A tubular member, One or more radially expandable features disposed on an outer surface of the tubular member, the one or more radially expandable features being configured to selectively expand from a folded configuration to an expanded configuration, such that blood within a patient's blood vessel flows from a point upstream of the one or more radially expandable features, around and / or through the one or more radially expandable features, to a point downstream of the one or more radially expandable features. One or more radially expandable features, A device comprising. **Claim 2** The device of claim 1, wherein the one or more radially expandable features include one or more balloons. **Claim 3** The device of claim 1, wherein the one or more radially expandable features extend along a portion of the length of the tubular member. **Claim 4** The device of claim 1, wherein each radially expandable feature has the same axial length. **Claim 5** The device of claim 1, wherein at least one of the one or more radially expandable features has an axial length different from that of another of the one or more radially expandable features. **Claim 6** The device of claim 1, wherein the one or more radially expandable features include a plurality of radially expandable features. **Claim 7** The device of claim 6, wherein each of the plurality of radially expandable features is circumferentially spaced from an adjacent radially expandable feature by the same distance. **Claim 8** The device of claim 6, wherein each of the plurality of radially expandable features is circumferentially spaced from an adjacent radially expandable feature, and a circumferential spacing distance of a first adjacent pair of the plurality of adjacent radially expandable features is different from a circumferential spacing distance of a second adjacent pair of the plurality of adjacent radially expandable features. **Claim 9** The device of claim 1, wherein a central axis of each radially expandable feature is parallel to a central axis of the tubular member. **Claim 10** The device of claim 1, wherein at least one radially expandable feature is disposed on the outer surface of the tubular member in a helical pattern. **Claim 11** The device according to claim 1, wherein at least one radially expandable feature has an elliptical or circular cross-sectional shape.
12. The device according to claim 1, wherein at least one radially expandable feature has a polygonal cross-sectional shape.
13. The device according to claim 1, wherein each of the at least one radially expandable feature is fluidly connected to a fluid source.
14. The device according to claim 1, wherein each of the at least one radially expandable feature is operably connected to a connector.
15. The device according to claim 1, wherein the at least one radially expandable feature includes a hydraulic skeleton.
16. A tubular member, A hydraulic skeleton coupled to the tubular member, the hydraulic skeleton being configured to selectively expand from a folded configuration to an expanded configuration, and the first channel being created to allow blood to flow from a point upstream of the hydraulic skeleton through the first channel to a point downstream of the hydraulic skeleton. A hydraulic skeleton that creates at least the first channel, A device comprising.
17. The device according to claim 16, wherein the hydraulic skeleton is configured to selectively expand or contract so as to create at least the first channel and the second channel.
18. The device according to claim 17, wherein the cross-sectional area of the first channel is the same as the cross-sectional area of the second channel.
19. The device according to claim 17, wherein the cross-sectional area of the first channel is different from the cross-sectional area of the second channel.
20. The device according to claim 17, wherein the cross-sectional area of the first channel is controlled separately from the cross-sectional area of the second channel.
21. The device according to claim 17, wherein the tubular member is configured to slidably receive a second tubular member.
22. The device according to claim 17, further comprising a valve at a proximal end of the tubular member, the valve being operably coupled to the second channel.
23. The device according to claim 17, wherein the hydraulic skeleton extends entirely around the tubular member.
24. The device according to claim 17, wherein the hydraulic skeleton extends only partially around the tubular member.
25. The device according to claim 17, wherein the hydraulic skeleton is coupled to the distal end of the tubular member.
26. The device according to claim 17, wherein at least a portion of the hydraulic skeleton extends along the axial length of the tubular member.
27. The device according to claim 17, wherein when the hydraulic skeleton expands, the diameter of the first channel increases.
28. The device according to claim 17, wherein the hydraulic skeleton includes a plurality of annular rings.
29. Placing a tubular member within a blood vessel, the tubular member having an outer surface and at least one radially expandable member coupled to the outer surface; Expanding the at least one radially expandable feature from a collapsed configuration to an expanded configuration to enable blood to flow from a point upstream of the at least one radially expandable feature, around and / or through the at least one radially expandable feature, to a point downstream of the at least one radially expandable feature; A method comprising the steps of:
30. The method according to claim 29, wherein the step of expanding the at least one radially expandable feature includes expanding a portion of the blood vessel around the at least one radially expandable feature.
31. The method according to claim 29, wherein expanding the at least one radially expandable feature from the collapsed configuration to the expanded configuration includes expanding all of a plurality of radially expandable features simultaneously.
32. The method according to claim 29, wherein expanding the at least one radially expandable feature from the collapsed configuration to the expanded configuration includes selectively expanding fewer than all of a plurality of radially expandable features.
33. The method according to claim 29, wherein expanding the at least one radially expandable feature from the collapsed configuration to the expanded configuration is performed automatically based on received information.
34. The method according to claim 33, wherein the received information is a determination that an ischemic event is occurring or likely to occur.
35. The method according to claim 33, wherein the received information is a value from a sensor.
36. The method according to claim 29, further comprising measuring the pressure within the blood vessel. **Claim 37** The method according to claim 29, wherein the position is upstream of the one or more radially expandable features. **Claim 38** The method according to claim 29, wherein the position is downstream of the one or more radially expandable features. **Claim 39** The method according to claim 29, wherein the at least one radially expandable feature comprises a balloon. **Claim 40** The method according to claim 29, wherein the at least one radially expandable feature comprises a hydraulic skeleton.