INTRAVASCULAR CATHETER HAVING AN EXPANDABLE INCISING PORTION AND EMBOLIC PROTECTION DEVICE

An intravascular catheter device and methods for using the same are provided. An expandable portion is provided at a distal end of a flexible catheter tube and includes struts operable between a first position and a second position where the struts are moved outward from the first position. An incising member is provided at, and extends along a lengthwise dimension of, and outward from, at least one of the struts. An embolic protection device is provided which is configured for movement between a first position and a second position where the embolic protection device is enlarged relative to said first position.

BACKGROUND OF THE INVENTION

This invention relates in general to intravascular catheters, such as can be used during minimally invasive surgical procedures. In particular, this invention relates to an intravascular catheter having an expandable incising portion.

Atherosclerosis is a chronic condition in which atheromatous plaque accumulates on the inner walls of a blood vessel. As a result, the blood vessel walls can become inflamed and, over time, may harden to form atherosclerotic lesions that cause a narrowing of the vessel lumen. In severe cases, the atherosclerotic lesions can rupture and induce the formation of thrombus (i.e., blood clots), which can prevent blood flow through the narrowed vessel lumen.

There are known procedures and devices for treating or otherwise reducing the risks associated with atherosclerosis. For example, an angioplasty is a procedure in which a balloon catheter is inserted into a narrowed region of the vessel lumen via a delivery catheter. The balloon catheter includes a flexible tube having an inflatable balloon at an end thereof. Once positioned in the narrowed region, the balloon is inflated in order to dilate the narrowed vessel lumen. The pressure in the balloon is generally sufficient to compress the accumulated plaque. However, in some cases it would be desirable to fragment the atherosclerotic lesions. Thus, it would be desirable to provide an intravascular catheter having an expandable portion that can be selectively controlled by a user and adapted to create incisions in atherosclerotic material to facilitate fragmentation of the material during an angioplasty procedure.

Embolism is a risk sometimes associated with many surgical procedures, such as angioplasty and the treatment of other peripheral artery diseases. A blood clot, air bubble, plaque fragment, or other embolism may be formed or be dislodged and travel through the patient's vascular system and cause damage. Embolic protection devices are sometimes placed in the patient's vascular system during surgical procedures in order to catch and remove emboli that may form or be dislodged. Use of such devices generally requires selection of the proper device, insertion and positioning of the device, performing the treatment, and removing said device. Proper design, inventory, and selection of embolic protection devices can be difficult as different treatment sites, procedures, and varying patient anatomy may require a healthcare provider to keep an inventory of many different devices to provide proper protection in the various conditions that may be encountered. Further, placement of these devices can be time consuming and expensive. Further still, the placed devices may be cumbersome and difficult to work around.

SUMMARY OF THE INVENTION

This invention relates to an intravascular catheter device for use during a surgical procedure. The catheter device includes a catheter tube having an expandable portion with a plurality of struts each defining an outer surface. The expandable portion is operable between a closed position, wherein the expandable portion has a first diameter, and an opened position, wherein the expandable portion has a second diameter that is larger than the first diameter. An incising element is provided on the outer surface of at least one of the struts. The incising element has a sharpened edge that extends outwardly in a radial direction from the outer surface of the strut for creating an incision in atherosclerotic material located within a blood vessel when the expandable portion is in the opened position.

An embolic protection device may be integrated with the expandable portion. In exemplary embodiments, the embolic protection device is a mesh or film having a series of apertures located thereon. The embolic protection device may be positioned on the distal end of the expandable portion such that the embolic protection device forms a catch net when the expandable portion is placed in the opened position. The intravascular catheter device, and thus the net, may be positioned downstream of the treatment area with the net in the opened position such that the blood flow runs through the net once the intravascular device is positioned. The intravascular device may be retracted against the blood flow during treatment, thereby capturing any emboli that may be formed or dislodged as the intravascular device negotiates the treatment area. Once reaching the end of the treatment site, the surgeon may close the net, thereby trapping any captured emboli. The intravascular device, and thus the trapped emboli, may then be removed from the patient.

In exemplary embodiments, without limitation, the embolic protection device may be provided distal to the expandable portion. The embolic protection device in such embodiments may be configured for movement between the opened and closed positions, such as with movement of the expandable portion, though such is not required.

In exemplary embodiments, without limitation, multiple expandable portions may be provided. The multiple expandable portions may be the same or different from one another. The multiple expandable portions may be offset from one another, such as along an inner sleeve and/or angularly. In this fashion, additional incisions may be made in a single pass, for example.

Various aspects of this invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiments, when read in light of the accompanying drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, there is illustrated inFIG.1a catheter device, indicated generally at10, in accordance with this invention. The illustrated catheter device10is configured to treat or reduce the risks associated with atherosclerosis. In general, the catheter device10includes an expandable incising portion that can be inserted into a blood vessel and expanded to create incisions in atherosclerotic material that has accumulated on inner walls of the blood vessel. The incisions facilitate the fragmentation of the atherosclerotic material during a subsequent angioplasty or atherectomy procedure. Although the catheter device10will be described and illustrated in the context of treating atherosclerosis, it should be appreciated that the catheter device10can be used in any desired environment and for any desired purpose.

Referring now toFIGS.1and2, the illustrated catheter device10includes a handle assembly, indicated generally at20. The illustrated handle assembly20includes an elongated, cylindrical handle body21. The handle body21may alternatively have any other shape that is suitable for easy handling by a surgeon. Further, the handle body21can be made from any suitably rigid material including, but not limited to, stainless steel or polymers.

As shown inFIG.2, the illustrated handle body21defines an internal chamber22. A passage23extends into an end portion of the handle body21for communication with the internal chamber22. The handle body21further includes a slot24that extends through a side wall thereof for communication with the internal chamber22. The illustrated slot24may have any length or width as desired. As shown inFIG.1, an indicator24A may be provided on the handle body21adjacent to the slot24. For example, the indicator24A can be a visual scale or any other indicating means, the purpose of which will be explained below.

The illustrated handle assembly20also includes a control member25that is supported on the handle body21for sliding movement within the slot24. For example, the control member25is movable between a forward position (shown inFIG.2), a rearward position (shown inFIG.5), or any position therebetween, which will be further explained below. As shown inFIG.2, the illustrated control member25includes a base portion26that is disposed within the internal chamber22of the handle body21. The base portion26may define an outer cross-sectional shape that generally corresponds with a cross-sectional shape of the internal chamber22, although such is not required. Alternatively, (or in addition), the control member25may be movably supported on the handle body21by a bearing, a bushing, a guide rail, or any other structural means. In other embodiments, the control member25may be supported for rotational movement, pivotal movement, or any other type of movement relative to the handle body21, the purpose of which will become apparent below. The visual indicator24A, described above, is configured to identify the relative position of the control member25with respect to the handle body21.

The illustrated handle assembly20also includes a locking mechanism27that is configured to temporarily secure the control member25in a desired position, although such is not required. As shown inFIG.2, the illustrated locking mechanism27includes a plurality of protrusions that are spaced apart from one another along an inner surface of the slot24. The control member25frictionally engages the protrusions to hold the control member25in the desired position. Alternatively, the locking mechanism27may be a threaded fastener, a pivotal latch, a push-button release, or any other mechanism that is configured to secure the control member25in a desired position.

Referring now toFIGS.1through3, the illustrated catheter device10also includes a catheter tube30that extends from the handle assembly20. The catheter tube30is an elongated, flexible member having a proximal end that is secured to the handle assembly20and a distal end that extends therefrom. The catheter tube30can be made from any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, or stainless steel. Further, the catheter tube30can have any outer diameter, length, or wall thickness.

As shown inFIG.2, the proximal end of the catheter tube30is secured to the handle body21and communicates with the internal cavity22through the passage23. The catheter tube30may be secured to the handle body21using a flanged connection, a fused connection, an adhesive, a press-fit connection, a threaded connection, or any other securing means. Alternatively, the catheter tube30may be secured to the handle body21using a connector or any other type of attachment device.

As shown inFIGS.1and3, an expandable portion32is provided on the distal end of the catheter tube30. The illustrated expandable portion32is a cylindrical member having a longitudinal axis. The expandable portion32can be made from a generally resilient material that is able to flex between various positions, such as polyvinyl, polyethylene, nitinol, or stainless steel. The expandable portion32can be secured to the catheter tube30in any manner including, but not limited to, a fused connection, an adhesive, a press-fit connection, a threaded connection, or any other securing means. Alternatively, the expandable portion32can be integrally formed from the catheter tube30. Further, the expandable portion32can have any outer diameter, length, or wall thickness.

The illustrated expandable portion32has a pair of struts34A and34B. The illustrated struts34A and34B are separated by a pair of longitudinally extending slits35A and35B that extend through side walls of the expandable portion32. As shown inFIG.4, the slits35A and35B are equally spaced apart from one another around the circumference of the expandable portion32such that the struts34A and34B have the same circumferential widths, although such is not required. The struts34A and34B may have any length, circumferential width, or cross-sectional shape as desired.

As shown inFIGS.3and4, the illustrated expandable portion32also includes a pair of incising elements36that are respectively provided along outer surfaces of the struts34A and34B. The incising elements36can be atherotomes or other incising members having arcuate shaped sharpened edges, for example, that are configured to create incisions in atherosclerotic material as will be explained below. The illustrated incising elements36extend parallel with the longitudinal axis of the expandable portion32and outwardly in a radial direction therefrom. The incising elements36are equally spaced apart from one another around the circumference of the expandable portion32. The expandable portion32may, however, have any number or configuration of incising elements36provided around the circumference thereof. Further, the incising elements36can have any cross-sectional shape, longitudinal length, or height and can be made from any suitable material including, but not limited to, tempered steel, stainless steel, high carbon steel, or ceramics. The incising elements36can be molded with the struts34A and34B or may otherwise be secured thereto in any manner such as, for example, using a welded or soldered connection, an adhesive, or any other fastening means.

The distal end of the expandable portion32may optionally include a tip member38. The illustrated tip member38has a generally conical shape that facilitates insertion of the catheter tube30within a blood vessel50(seeFIGS.3and4) and subsequent travel therethrough. The tip member38may, however, have any desired shape. An aperture may axially extend through the tip member38, the purpose of which will be explained below. The tip member38can be integrally formed with the expandable portion32or may be secured thereto, such as with an adhesive or the like. Further, the tip member38can be made from any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, stainless steel, or polyether block amide.

As shown inFIGS.2through4, the illustrated catheter device10also includes an inner sleeve40, although such is not required. The inner sleeve40is a flexible, tubular member that is supported for sliding movement within the catheter tube30, the purpose of which will be explained below. The inner sleeve40can be made from any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, stainless steel, or a woven material. Further, the inner sleeve40can have any outer diameter, length, or wall thickness. The inner sleeve40need not be a tubular member but may alternatively be a solid wire, a braided wire, or the like.

As shown inFIG.2, a proximal end of the inner sleeve40extends from the catheter tube30and into the internal chamber22of the handle body21. The proximal end of the inner sleeve40is secured to the base portion26of the control member25for sliding movement therewith, the purpose of which will be explained below. The inner sleeve40can be secured to the base portion26by a flanged connection, a fused connection, an adhesive, a threaded connection, or any other securing means.

As shown inFIG.3, the inner sleeve40extends through an entire length of the catheter tube30. A distal end of the inner sleeve40that is opposite the handle assembly20is secured to the tip member38, which is in turn secured to the expandable portion32. The inner sleeve40may be secured to the tip member38in any manner including, but not limited to, a fused connection, an adhesive, a fastener, or the like.

Referring back toFIGS.1and2, the illustrated catheter device10also includes a protective sheath42that is supported for sliding movement along an outer surface of the catheter tube30, although such is not required. The protective sheath42can be made from any biocompatible material including, but not limited to, polyvinyl, polyethylene, nitinol, or stainless steel. Further, the protective sheath42can have any outer diameter, length, or wall thickness. The purpose of the protective sheath42will be explained below.

The illustrated protective sheath42includes a flange44that facilitates sliding movement of the protective sheath42relative to the catheter tube30. The illustrated flange44is an annular member that is located at an end of the protective sheath42nearest the handle assembly20. The flange44can be integrally formed with the protective sheath42or may otherwise be secured thereto in any manner, such as with an adhesive or the like. It should be appreciated that the flange44can have any shape or may alternatively be configured in any manner to accomplish the functions described herein and below.

The operation of the catheter device10will now be described with reference toFIGS.1through7. Referring initially toFIGS.1through4, the catheter device10is illustrated in a first operating mode. In the first operating mode, the control member25on the handle assembly20is located in the forward position relative to the handle body21. The inner sleeve40fully extends into the catheter tube30such that the expandable portion32is in a closed position, as shown inFIGS.3and4. In the closed position, the struts34A and34B are generally parallel with one another and with the inner sleeve40. The slits35A and35B (illustrated by the dashed lines inFIG.3) remain in a generally closed configuration. As such, the expandable portion32defines an initial diameter D1, which is generally the same diameter as the remaining length of the catheter tube30. The initial diameter D1of the expandable portion32may, however, be any desired dimension.

When the catheter device10is in the first operating mode, the distal end of the catheter tube30can be percutaneously inserted into a blood vessel50, as shown inFIGS.3and4. The illustrated catheter tube30is then advanced through the blood vessel50along a guide wire52, which extends through the catheter device10. For example, the guide wire52may fully extend through the inner sleeve40, into the internal chamber22of the handle body21, and exit a rear end of the handle assembly20(seeFIG.2). The catheter tube30is advanced along the guide wire52until the expandable portion32is positioned in a narrowed region of the blood vessel50caused by atherosclerotic material54. Alternatively, the catheter tube30can be inserted into the blood vessel50and guided therethrough by a delivery catheter (not shown) or any other suitable procedure. During insertion and advancement of the catheter tube30through the blood vessel50, the optional protective sheath42is preferably positioned over the expandable portion32, thereby preventing the incising elements36from coming into contact with inner walls of the blood vessel50.

Once the expandable portion32is positioned in the narrowed region of the blood vessel50, the incising elements36can be exposed by sliding the protective sheath42back from the distal end of the catheter tube30, as indicated by the direction arrows inFIG.3. The illustrated protective sheath42can be moved in this manner by pulling the flange44towards the handle assembly20, which is indicated by the direction arrows inFIG.2.

Referring now toFIGS.5through7, the catheter device10is illustrated in a second operating mode. To achieve the second operating mode, the control member25is moved from the forward position to the rearward position, as indicated by the direction arrow inFIG.5. As the control member25is moved to the rearward position, the inner sleeve40is drawn within the catheter tube30thereby reducing the relative length of the inner sleeve40with respect to the catheter tube30. The distal end of the inner sleeve40is attached to the tip member38, as described above, causing the expandable portion32to become axially compressed between the tip member38and the distal end of the catheter tube30. As a result, the struts34A and34B bow or expand outwardly in a generally arcuate fashion thereby defining an opened position. In the opened position, the expandable portion32defines a second diameter D2that is larger than the initial diameter D1when the expandable portion32is in the closed position. As shown inFIG.6, the incising elements36are respectively positioned along the radially outer most surfaces of the struts34A and34B. Further, the outer most surfaces of the struts34A and34B may define a generally flat portion along a length thereof in the opened position, the purpose of which will be explained below, although such is not required. It should be appreciated that the struts34A and34B can have any lengths such that the expandable portion32can achieve a desired overall second diameter D2in the opened position.

During operation of the catheter device10, the second diameter D2can be increased or decreased by selective movement of the control member25between the forward and rearward positions. For example, a larger second diameter D2can be achieved by moving the control member25further towards the rearward position. Conversely, a smaller second diameter D2can be achieved by moving the control member25further towards the forward position. The visual indicator24A can be used to identify the instantaneous second diameter D2of the expandable portion32. Alternatively (or in addition), the struts34A and34B may be biased in the opened position so as to automatically expand outwardly to the second diameter D2when the protective sheath42is slid back from the expandable portion32. As such, sliding movement of the protective sheath42relative to the struts34A and34B can be used to selectively control the second diameter D2. In this configuration, the inner sleeve40and the movable components of the handle assembly20may not be necessary.

When the catheter device10is in the second operating mode, the expandable portion32can be pulled along the guide wire52through the narrowed region of the blood vessel50. This can be accomplished by pulling on the handle assembly20. In doing so, the incising elements36engage the atherosclerotic material54and create longitudinal incisions56therein. As shown inFIGS.6and7, the outer surface area of the arcuate shaped struts34A and34B, which is adjacent to the incising element36, is configured to ride along a surface of the atherosclerotic material54, thereby limiting the depth of the incisions56and preventing the incising members36from cutting the walls of the blood vessel50. The expandable portion32can be moved any distance along the guide wire52to create incisions56having any desired length. After the incisions56are made in the atherosclerotic material54, the catheter device10can be returned to the first operating mode (shown inFIGS.1through4) by moving the control member25to the forward position. In doing so, the expandable portion32returns to the closed position. The protective sheath42can be slid over the expandable portion32and the catheter tube30may be removed from the blood vessel50.

Alternatively, the catheter device10can be used to create additional incisions56in the atherosclerotic material54. For example, after the catheter device10has been returned to the first operating mode, the expandable portion32can be relocated within the narrowed region of the blood vessel50. The catheter tube30can then be rotated within the blood vessel50by rotating the handle assembly20so as to align the incising elements36with other portions of the atherosclerotic material54. The previous steps can then be repeated any number of times to make multiple passes through the narrowed region of the blood vessel50and create additional incisions in the atherosclerotic material54.

Thus, it should be appreciated that the illustrated catheter device10is advantageous in many respects. In one example, the second diameter D2of the expandable portion32can be selectively controlled by operation of the handle assembly20or by sliding movement of the protective sheath42. This enables the catheter device10to be adapted for use in blood vessels50of different sizes or varying diameters. In another example, the illustrated catheter device10can apply varying magnitudes of radial forces to the atherosclerotic material54by controlling the amount of force being applied to the control member25on the handle assembly20. This enables the catheter device10to generate sufficient radial force to create incisions56in atherosclerotic material54while reducing the potential for tearing the walls of the blood vessel50. In yet another example, the catheter device10can be used to make any number of passes during a single procedure to make multiple incisions56in atherosclerotic material54of varying lengths and shapes.

Referring now toFIGS.8through10, there is illustrated a catheter tube130having an expandable portion132, in accordance with a second embodiment of this invention. The catheter tube130and the expandable portion132may include any structural features as described and illustrated above in the previous embodiment, although such is not required. Similar features have been numbered with common reference numerals but have been increased by 100 (i.e., 110, 120, 130, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

For example, the catheter tube130may extend from a handle assembly (not shown) as described above in the first embodiment. The expandable portion132is provided on a distal end of the catheter tube130and may include a tip member138. The catheter tube130may also include an inner sleeve140and a protective sheath (not shown), which is also described above in the first embodiment.

In the illustrated embodiment, however, the expandable portion132includes four struts134A,1348,134C, and134D that are respectively separated by four longitudinally extending slits135A,135B,135C, and135D. The illustrated struts134A,134B,134C, and134D each include an incising element136, although such is not required. It should be appreciated that the expandable portion132may have any number or configuration of struts and incising elements as desired.

As shown inFIG.8, the illustrated expandable portion132further includes recessed portions160that respectively extend into the outer surfaces of the struts134A,134B,134C, and134D. For example, the struts134A,134B,134C, and134D can be slightly bowed inwardly toward the inner sleeve140when in the closed position or, alternatively, may have a reduced thickness along a central portion thereof to create the recessed portions160. The illustrated incising elements136are respectively disposed within the recessed portions160. Thus, when the catheter tube130is inserted into a blood vessel, as described above, the recessed portions160help to prevent the incising elements136from coming into contact with inner walls of the blood vessel. On the other hand, when the expandable portion132is expanded to an opened position, as explained below, the incising elements136become exposed from the recessed portions160. It should be appreciated that the recessed portions160can eliminate or reduce the need for the protective sheath (not shown). The guide wire152may extend through the entire device.

The expandable portion132can be operated between a closed position (shown inFIG.8) and an opened position (shown inFIGS.9and10) by selective movement of the inner sleeve140relative to the catheter tube130, as described above in the first embodiment. Alternatively (or in addition), the struts134A,1348,134C, and134D can be biased in the opened position. In such an embodiment, the protective sheath (not shown) can be used to effect movement of the expandable portion132between the closed position and the opened position.

Referring now toFIGS.11through13, there is illustrated a catheter tube230having an expandable portion232, in accordance with a third embodiment of this invention. The catheter tube230and the expandable portion232may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased by 200 (i.e., 210, 220, 230, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

For example, the catheter tube230may extend from a handle assembly (not shown) as described above in the first embodiment. The expandable portion232is provided on a distal end of the catheter tube230and includes a pair of struts234A and234B that are separated by a pair of longitudinally extending slits235A and235B. The catheter tube230may also include a tip member238, an inner sleeve240, and a protective sheath (not shown), which is described above in the first embodiment. The guide wire252may extend through the entire device.

In the illustrated embodiment, however, the expandable portion232includes a first pair of weakened regions237A,237B and a second pair of weakened regions239A,239B that are respectively located at opposite ends of the struts234A and234B. The illustrated weakened regions237A,237B and239A,239B are formed by enlarged apertures that extend through side walls of the expandable portion232that function as hinges. The weakened regions237A,237B and239A,239B may help reduce the amount of bending stress in the side walls of the expandable portion232when the struts234A and234B are moved to an opened position. The struts234A and234B may include any number or configuration of weakened regions. Further, it should be appreciated that any of the other embodiments in this disclosure may also include weakened regions237A,237B and239A,239B.

The illustrated struts234A and234B remain generally flat along respective lengths thereof in both a closed position (shown inFIG.11) and an opened position (shown inFIGS.12and13) so as to form an apex, although such a configuration is not required. The incising elements236are provided along the generally flat portion of the respective struts234A and234B. As such, the incising elements236may also function as stiffening members for increasing the strength of the struts234A and234B. Further, this configuration can reduce the amount of stress in the connection between the incising elements236and the struts234A and234B, which may otherwise be caused by bowing of the struts234A and234B.

As shown inFIG.12, end portions of the incising elements236may extend beyond the apex that is formed by each of the respective struts234A and234B. This configuration can increase the effective height of the incising elements236when the expandable portion232is in the opened position. As such, the incising elements236may have a reduced height when the expandable portion232is in the closed position, which may eliminate the need for the protective sheath (not shown).

The expandable portion232can be operated between the closed position and the opened position by selective movement of the inner sleeve240relative to the catheter tube230, as described above in the first embodiment. Alternatively (or in addition), the struts234A and234B can be biased in the opened position. In such an embodiment, the protective sheath (not shown) can be used to effect movement of the expandable portion232between the closed position and the opened position.

Referring now toFIGS.14through16, there is illustrated a catheter tube330having an expandable portion332, in accordance with a fourth embodiment of this invention. The catheter tube330and the expandable portion332may include any structural features as described and illustrated above in the previous embodiments, although such is not required. Similar features have been numbered with common reference numerals but have been increased by 300 (i.e., 310, 320, 330, etc.). It should be appreciated that similar features are structured similarly, operate similarly, and/or have the same function unless otherwise indicated by the drawings or this specification.

For example, the catheter tube330may extend from a handle assembly (not shown) as described above in the first embodiment. The expandable portion332is provided on a distal end of the catheter tube330and may include a tip member338. The catheter tube330may also include an inner sleeve340that is attached to the tip member338and a protective sheath (not shown), which is also described above in the first embodiment. The guide wire352may extend through the entire device.

In the illustrated embodiment, however, the expandable portion332includes a pair of struts334A and334B that are supported thereon in a cantilevered manner (i.e., not attached to one another or to the tip member338at their distal ends), the purpose of which will be explained below. The struts334A and334B are separated by a pair of longitudinally extending slits335A and335B that extend from the end of the expandable portion332. A pair of incising elements336is respectively provided along outer surfaces of the struts334A and334B. It should be appreciated, however, that the expandable portion332may have any number or configuration of struts and incising elements as desired.

As shown inFIGS.15and16, the illustrated struts334A and334B are supported on the expandable portion332so that they can be splayed open in a Y-shaped configuration. For example, the struts334A and334B can be splayed open by drawing the inner sleeve340within the catheter tube330, as described above in the first embodiment. In doing so, the tip member338slides along the inner surfaces of the struts334A and334B and pivots them outwardly. Alternatively (or in addition), the struts334A and334B can be biased in the splayed open position. In such an embodiment, the protective sheath (not shown) can be used to effect movement of the expandable portion332between a closed position and the splayed open position.

The struts334A and334B remain generally flat along their respective lengths in both a closed position (shown inFIG.14) and the splayed open position, although such is not required. As such, the incising elements336may also function as stiffening members for increasing the strength of the struts334A and334B. Further, this configuration can reduce the amount of stress in the connection between the incising elements336and the struts334A and334B, which may otherwise be caused by bowing of the struts334A and334B.

As shown inFIG.15, end portions of the incising elements336may extend beyond the distal ends of the respective struts334A and334B. This configuration can increase the effective height of the incising elements336when the expandable portion332is in the splayed open position. As such, the incising elements336may have a reduced height when the expandable portion332is in the closed position, which may eliminate the need for the protective sheath (not shown).

FIGS.17and18illustrate another exemplary embodiment of the present invention. Specifically,FIG.17illustrates the device ofFIG.8with an exemplary embolic protection device90installed thereon, whileFIG.18illustrates the device ofFIG.17with the expandable portion132in the opened position. The embolic protection device90may comprise a basket configured to trap emboli for subsequent removal from the treatment site.

The basket may surround the outer surface of the struts134A,1348, and134C as well as cover the gaps between said struts134A,134B, and134C when the expandable portion132is in both the closed and the opened positions. To accomplish this, the basket may be configured to stretch and deform or may comprise excess and/or overlapping material when the expandable portion132is in the closed position that unfurls when the expandable portion132is in the opened position.

The basket may also cover the front and/or rear of the expandable portion132. However, in exemplary embodiments of the present invention, the basket may be open on the proximal end and attached, sealed, bonded, or otherwise adhered to the tip member138on the distal end. In this way, the basket creates an opening on the proximal end, and is substantially or partially sealed on the distal end by the combination of the basket, guide wire152, inner sleeve140, and struts134A,134B, and134C. As will be explained in greater detail herein, the basket may be comprised of a woven material or otherwise comprise a plurality of apertures along the side walls thereof. In exemplary embodiments of the present invention, these apertures may be configured to permit blood to flow therethrough while preventing emboli and other particulate over a specified size from traveling therebeyond. In this way, the blood flow, and any emboli or other particulate contained therein, are forced to enter the basket's opening on the proximal end and leave only if the matter fits through the apertures provided in the sidewalls of the basket.

In exemplary embodiments of the present invention, the basket is comprised of a mesh. The mesh may be of any size, shape, or configuration. The mesh may be comprised of nitinol, polytetrafluoroethylene (PTFE), a metallic, a polymer, or the like and may extend over any section or the entirety of the expandable portion132. The mesh may be woven such that the apertures are sized to permit blood (including, for example without limitation, healthy cells, plasma, and platelets) flow therethrough, while trapping emboli and other particulate larger than the apertures provided in the mesh.

The embolic protection device90may extend over some or all of the expandable portion132. In exemplary embodiments of the present invention, the embolic protection device90extends over substantially the distal half of the expandable portion132while the incising elements136may extend over substantially the proximal half of the expandable portion132. Regardless, an expandable hoop91may be located on the outer surface of the expandable portion132and may assist in securing and preserving the shape of the basket. The expandable hoop91may be located at substantially the midline of the expandable portion132, though any location is contemplated. The expandable hoop91may be comprised of nitinol, PTFE, a metallic, a polymer, or the like and may be configured to expand and collapse when the expandable portion is moved between the opened and the closed positions.

The expandable hoop91may be configured to match the outer diameter of the expandable portion132when the expandable portion132is in both the opened and the closed positions and may be configured to fit inside the sheath42if one is being used. In exemplary embodiments of the present invention, the expandable hoop91may operate by a telescoping mechanism such that portions of the expandable hoop91slide atop one another. In other exemplary embodiments, the expandable hoop91may be configured to deform by elongating and reorienting at an increased lateral angle such that the expandable hoop91may be placed substantially flush with the outer surface of the expandable portion132, when the expandable portion132is in the collapsed position and/or is forced inside the sheath42.

The expandable hoop91may provide an attachment point for the basket. For example, but not to serve as a limitation, in embodiments where the basket is the mesh or other woven material, the mesh may be woven around the expandable hoop91. In other exemplary embodiments, the basket may be welded, soldered, adhered, or otherwise bonded to the expandable hoop91and/or directly to the struts134A,134B, and134C or other parts of the intravascular catheter device10.

In exemplary methods utilizing the present invention, the expandable portion132may be placed in the closed position and positioned downstream from the treatment area. The expandable portion132may be placed in the opened position. The embolic protection device90may be automatically deployed when the expandable portion132is placed in the opened position as the basket, and the optional expandable hoop91if utilized, may expand when the struts134A,1348, and134C are placed in the opened position and collapse when the struts134A,134B, and134C are placed in the closed position. However, in exemplary embodiments of the present invention, the expandable hoop91may be moved between the closed and the opened positions independently of the expandable portion132. For example, but without limitation, the expandable hoop91may be configured to automatically expand when removed from the sheath42. Regardless, the expandable portion132may next be retracted along some or all of the treatment area to facilitate fragmentation of the atherosclerotic plaque. The expandable portion132and the embolic protection device90may then be placed in the closed position, thereby trapping any emboli caught in the basket during the procedure. This process may be repeated multiple times over the same treatment area or over multiple treatment areas.

Similarly,FIG.19illustrates the device ofFIG.11with another exemplary embolic protection device90installed thereon, whileFIG.20illustrates the device ofFIG.19with the expandable portion232in the opened position. The embolic protection device90may be similar to the one shown and described with respect toFIGS.17and18, and may be similarly operated.

FIGS.21and22illustrate another exemplary embodiment of the embolic protection device90. The basket of the embolic protection device90may be a film or covering having a number of apertures92located therein. Any size, shape, number, and configuration of the apertures92are contemplated. In exemplary embodiments of the present invention, the film or covering is comprised of PTFE, though any material is contemplated. Similarly, the film or covering may be attached to the expandable hoop91, though such is not required. The embolic protection device90may otherwise be similar to the one shown and described with respect toFIGS.17-20, and may be similarly operated.

FIGS.23and24illustrate another exemplary embodiment of the catheter device410. Similar features may be numbered with common reference numerals but increased by a multiple of 100 (i.e., 10 to 410, 36 to 436, etc.) and/or with a prime mark added (i.e., 32 to 432 or 432′). The device410may comprise an inner sleeve440. The inner sleeve440may be configured for sliding movement within a catheter tube430. The catheter tube430is not illustrated inFIG.23, but is illustrated inFIG.24, such that the inner sleeve440and catheter tube430may be better illustrated. The catheter tube430may extend from a handle assembly. The inner sleeve440may pass into the handle assembly where it is selectively controlled by mechanism(s), such as but not limited to clamps, to selectively arrest or permit movement of the inner sleeve440, such as by manual extension or retraction.

The device410may comprise one or more expandable portions432,432′. A single one of the expandable portions432may be provided. In other exemplary embodiments, without limitation, multiple ones of the expandable portions432,432′ may be provided. For example, without limitation, a first and second expandable portion432,432′ may be provided. The multiple ones of the expandable portions432,432′ may be offset from one another. The offset may be axially along a longitudinal axis of the inner sleeve440and/or catheter tube430and/or radially about the same. For example, without limitation, first and second expandable portion432,432′ may be provided in front of, and behind, one another. The first and second expandable portion432,432′ may immediately abut one another or may be spaced apart. Alternatively, or additionally, first and second expandable portion432,432′ may be offset in a radial fashion, such that the second one of the expandable portions432′ is rotated relative to the first one of the expandable portions432. For example, without limitation, first and second expandable portion432,432′ may be offset radially approximately 30 degrees (e.g., between 25 and 35 degrees, as a non-limiting example). In this fashion, struts434,434′ and associated incising elements436,436′ may be offset radially so as to provide additional points of incision in a single pass of the device410. Any number of expandable portions432,432′ may be provided with any type of kind of radial, axial, and/or other type of kind of offset.

The one or more of the expandable portions432,432′ may be provided along the inner sleeve440and/or catheter tube430. In exemplary embodiments, without limitation, a proximal end of a first one of the one or more expandable portions432,432′ may be attached to a distal end of the catheter tube430. The inner sleeve440may extend within the first one of the one or more expandable portions432,432′. A distal end of at least the last one of the multiple expandable portions432,432′ may be attached to the inner sleeve440. However, distal ends of some or all of each other one of the multiple expandable portions432,432′ may alternatively or additionally be also attached to the inner sleeve440. For example, without limitation, a first end of the struts434,434′, such as the proximal end, for each respective one of the expandable portion(s)432,432′ may be connected to the inner sleeve440. Such connection may be direct and/or by way of the first common portion(s)431,431′. Regardless, retraction of the inner sleeve440may be configured to cause each of the one or more expandable portions432,432′ to move into an opened or expanded position.

Where multiple ones of the expandable portions432,432′ are utilized, a section of catheter tube430, a limiter, or other component may extend between each of the multiple expandable portions432,432′. A distal end of each subsequent one of the multiple expandable portions432,432′ may be connected to the section of catheter tube430, a limiter, or other component as provided and/or to the inner sleeve440. Alternatively, or additionally, the multiple expandable portions432,432′ may be directly connected to one another or permitted to slidably abut one another. Regardless, retraction of the inner sleeve440may be configured to cause each of the multiple expandable portions432,432′ to move into an opened or expanded position upon movement of the inner sleeve440.

The struts434,434′ may alternatively or additionally be biased in the opened position. For example, without limitation, the struts434,434′ may be configured to automatically bow outward once the sheath is adequately retracted. A second end of the struts434,434′, such as the distal end and/or the second common portion(s)433,433′, may be configured for free sliding movement along the inner sleeve440in exemplary embodiments, though such is not required. In this manner, when exposed, the struts434,434′ may be permitted to retract axially along the inner sleeve440to permit movement into the second, expanded position. The expandable portions432,432′ may be spaced apart, such as along the inner sleeve440, to permit movement of the second end of the struts434,434′ between the first, collapsed position and the second, expanded position.

Each of the one or more expandable portions432,432′ may comprise a plurality of struts434. In exemplary embodiments, without limitation, each of the one or more expandable portions432,432′ comprises three struts434A,4346,434C,434A′,4346′,434C′, though any number of struts434may be utilized. Each of the expandable portions432,432′ may comprise a same or different number of struts434. The struts434, in exemplary embodiments without limitation, may comprise flattened outer surfaces, which may be utilized to ride along plaque or other material within a human vascular system, such as to limit a depth of penetration of incising elements436,436′ into the same. The inner surfaces of the struts434may likewise by flattened.

The struts434may comprise one or more memory materials, such as nitinol. In this fashion, the struts434may be biased into the opened or expanded position. Control of such movement of the struts434, in exemplary embodiments without limitation, may be provided by movement of a sheath to cover or uncover the struts434, thus allowing them to expand or forcing them into a compressed or closed position. Such movement control may be in addition to, or alternative to, use of the inner sleeve440.

Some or all of the struts434of some or all of the one or more expandable portions432,432′ may comprise incising elements436. In exemplary embodiments, each of the struts434A,4346,434C,434A′,4346′,434C′ may comprise a respective one of the incising elements436A,4366,436C,436A′,4366′,436C′. The incising elements436may be provided at a proximal portion, such as a proximal half, of the struts434, though any location may be utilized. The incising elements436may extend lengthwise along the struts434, such as but not limited to, linearly and/or along a midline thereof, though such is not required. The incising elements436may comprise cuboid members which may comprise a sharpened edge along an upper surface thereof, though any size and/or shape may be utilized. The incising elements436may be configured to create axially extending slits in plaque or other material when the device410is placed within a vascular system and retreated axially, such as while in the opened or expanded position.

In exemplary embodiments, without limitation, at least a portion of the incising elements436may be elevated when the expandable portion(s)434,434′ are placed in the expanded position.

The struts434may be connected at a first common portion431at a first end thereof and a second common portion433at a second end thereof. The common portions431,433may serve to connect the expandable portions432,432′ to the inner sleeve440, the catheter tube430, and/or other component(s). Weakened or hinging portions may be provided between the struts434and the common portions431,433to facilitate movement of the struts434, each of which may comprise two sections which move relative to one another and the common portions431,433in a hinged manner, though such is not required.

Some or all components of the device410, including but not limited to some or all components of the expandable portions432,432′, may be provided and/or made as shown and/or described in US Pub. No. 2021/0220008 filed Jul. 22, 2021, the disclosures of which are hereby incorporated by reference as if fully restated herein.

The embolic protection device490may be integrated with one or more of the one or more expandable portions432,432′, such as surrounding outer surfaces of the struts434,434′, or may be separate therefrom. For example, without limitation, the embolic protection device490may be provided distal to each of the one or more expandable portions432,432′. The embolic protection device490may be attached to the inner sleeve440and/or the catheter tube430. The embolic protection device490may be configured to move between a collapsed position and an expanded position with the expandable portions432,432′, though such is not required.

The embolic protection device490may comprise an expandable hoop491and/or filtering portion493. The filtering portion493may comprise a mesh and/or a material comprising one or more apertures. The filtering portion493may be configured to capture particulate above a predetermined size. The filtering portion493may extend form the expandable hoop491to a distal end of the inner sleeve440in exemplary embodiments, without limitation.

The expandable hoop491may comprise one or more memory materials, such as nitinol, and may be biased in an opened position. In this fashion, when a sheath uncovers the embolic protection device490it may be automatically moved into an opened or expanded position.

Alternatively, or additionally, the embolic protection device490may be configured for such movement upon axial movement of the inner sleeve440. For example, without limitation, as internal structure of the embolic protection device490may be connected to the inner sleeve440. As another example, without limitation, such as illustrated inFIG.25, a compartment495may be provided configured to force compaction of the embolic protection device490upon axial forward movement of the inner sleeve440distally and permit expansion of the embolic protection device490upon axial retraction of the inner sleeve440proximally.

The embolic protection device490may be configured to form a substantially conical shape when expanded, however any shape may be utilized. The compartment495may likewise be conical in shape, however any shape may be utilized.

The device410may be configured to cause opening of the embolic protection device490with the one or more expandable portions432,432′, such as by way of the inner sleeve440. However, in other exemplary embodiments, the embolic protection device490and/or some or all of the one or more expandable portions432,432′ may be independently operable, such as by way of separate inner sleeves440nested inside one another. The device410may be configured to accommodate a guide wire, such as passing through the inner sleeve440. The device410may be used substantially as shown and/or described herein.

It is notable that while the embolic protection device90,490is illustrated with respect to the devices ofFIGS.8-9,11-12, and23-24it is contemplated that the embolic device90,490may be utilized with any of the embodiments of the present invention as shown and/or described herein.

While some reference is made herein to use with plaque, the devices and/or methods show and/or described herein may be used in any application. Such applications may include, for example without limitation, the human vascular system and related diseases or disorders, such as but not limited to peripheral artery disease, arterial-vascular fistula treatment, combinations thereof, or the like.

The principle and mode of operation of this invention have been explained and illustrated in its preferred embodiments. However, it must be understood that this invention may be practiced otherwise than as specifically explained and illustrated without departing from its spirit or scope.