Intravascular cutting equipment

Abstract

A device for cutting the wall of a blood vessel (V), for example to score or slice a lesion (L) associated therewith. The device comprises a cutter (10) having a single shaft (12) having a branching portion comprising at least two radially expandable arms. A first expandable arm (16) of the expandable arms comprises at least one blade (20) for slicing or scoring the lesion (L) when expanded. A second expandable arm (18) of the expandable arms may also comprise a blade (20), or may not have a blade. A sheath (S) may also be provided. One or more arms with blades may also comprise a limiter (22) for limiting the cutting depth of the blade (20). An anchor may also be provided to anchor the cutter (10) in the blood vessel (V).

Description

[0001] Join by reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0003] The present disclosure relates to apparatus for providing intravascular treatment, and in particular to devices for cutting a blood vessel wall in a controlled manner, such as for slicing or scoring a lesion associated therewith. Background Art

[0004] Balloon dilatation catheters are used to treat lesions in blood vessels, such as by angioplasty. While used successfully for a variety of applications or locations in the vasculature, certain situations require a different approach given the potential for "elastic recoil," which refers to the inherent resistance of tissue to shape changes and the tendency of tissue to return to its original shape once deformed. In addition, some applications, particularly those "below the knee" (BTK) involving hard calcifications, for which balloon angioplasty alone may be contraindicated. Furthermore, the use of agents to the lesion may be necessary in some cases to enhance treatment, and efficacy may be improved by active cutting prior to application.

[0005] It would therefore be desirable to provide a simple but effective apparatus for cutting a blood vessel wall and in particular slicing and scoring lesions associated therewith. Such a device would be useful in a variety of locations in the vasculature, including locations where particularly hard calcifications may be present and where conditions require a more reliable and effective approach than known proposals. Summary of the invention

[0006] The object of the present invention is to provide a device for intravascular cutting, in particular a cutter for cutting a blood vessel wall (more specifically, a plaque, lesion or other obstruction), which solves and overcomes the above-mentioned limitations and other possible limitations that have not yet been discovered.

[0007] According to one aspect of the present disclosure, a device for slicing or scoring a lesion in a blood vessel includes a sheath and a cutter that extends from the sheath in an expanded position to slice or score the lesion. The cutter includes a single shaft connected to a plurality of expandable arms, the plurality of expandable arms including a first expandable arm having at least one blade for scoring or slicing the lesion when the cutter is in the expanded position.

[0008] In some embodiments, the plurality of expandable arms include at least two expandable arms forming a Y-shape at the distal end of the single shaft. The first expandable arm may include a pair of blades. The second expandable arm may include at least one blade, or may not include a blade. Any expandable arm may include a limiter for limiting the cutting depth of the cutter in the deployed position.

[0009] The plurality of expandable arms includes at least two expandable arms connected to the single shaft at a common bifurcation point.The cutter may include three, four, five or more expandable arms connected to the single shaft.

[0010] An anchor may be provided to anchor the cutter in the blood vessel. In some embodiments, the anchor comprises an expandable element. The expandable element may comprise an expandable balloon or an expandable cage. The anchor may be attached to the cutter or sheath.

[0011] According to another aspect of the present disclosure, a device for slicing or scoring a lesion in a blood vessel is provided. The device includes a cutter, the cutter including a single shaft having a branching portion, the branching portion including at least two expandable arms, the first of the expandable arms including at least one blade for slicing or scoring the lesion when expanded.

[0012] In some embodiments, the device further comprises a sheath for receiving the cutter. The at least two expandable arms may form a Y-shape at the distal end of the single shaft. The first expandable arm comprises a pair of blades and may comprise at least one blade or no blades. The first expandable arm may comprise a limiter for limiting the cutting depth of the cutter.

[0013] The at least two expandable arms may be connected to the single shaft at a common bifurcation point.The cutter may also include three, four, five or more expandable arms.

[0014] An anchor may be provided to anchor the cutter in the vessel. The anchor may include an expandable element. The expandable element may include an expandable balloon or an expandable cage. The anchor may be connected to the cutter or an associated sheath.

[0015] In any embodiments, the cutter may include a shape memory material. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The above and further advantages of the present invention according to the present disclosure may be better understood by referring to the following description in conjunction with the accompanying drawings, in which:

[0017] Figure 1 One embodiment of a cutter according to the present disclosure is shown;

[0018] Figure 1A Shows from Figure 1 A view taken along line 1A-1A;

[0019] Figure 2 is another embodiment of a cutter according to the present disclosure;

[0020] Figure 3 is another embodiment of a cutter according to the present disclosure;

[0021] Figure 4 , Figure 5 , Figure 6 and Figure 7 Various alternative embodiments of cutters according to the present disclosure are shown;

[0022] Figure 8 , Fig. 9 , Fig.10 and Fig.11 Various embodiments of anchors for use in conjunction with any or all of the disclosed cutters are shown;

[0023] Figures 12 to 15 An alternative embodiment is shown.

[0024] The drawings are not necessarily drawn to scale or to proportion. For example, for clarity, the size of some elements may be exaggerated relative to other elements, or several physical components may be included in one functional block or element. In addition, reference numerals may sometimes be repeated in the various drawings to indicate corresponding or similar elements. DETAILED DESCRIPTION

[0025] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts. One of ordinary skill in the art will appreciate that the disclosed invention may be practiced without these specific details. In other cases, well-known methods, processes, components, or structures may not be described in detail to avoid obscuring the disclosed invention.

[0026] Unless otherwise stated, the description provided below and with respect to the drawings applies to all embodiments, and features common to each embodiment are similarly shown and numbered.

[0027] First refer to Figure 1, a cutter 10 according to the present disclosure is shown. The cutter 10 includes an elongated body or shaft 12 having a proximal end 12a and a distal end 12b, which may include an end portion 14 adapted to cut a vessel wall. Although elongated along a longitudinal axis X and in a corresponding longitudinal direction, the shaft 12 is shown in a compact form for ease of illustration and is typically of considerable length (e.g., 50 to 150 centimeters, or other length suitable for allowing the distal end 12b to reach a treatment area of ​​interest in the vascular system while the proximal end 12a remains accessible outside the vascular system).

[0028] Continue to refer Figure 1 as well as Figure 1A , it will be appreciated that the distal end 12b of the single shaft 12 includes at least two radially extendable arms 16, 18 (although only one arm is possible, as described below) emanating from a common bifurcation point B. The arms 16, 18 are shown in a deployed position for cutting and thus provide a Y-shaped configuration for the cutter 10 at the distal end portion 14. However, the arms 16, 18 are generally aligned with the longitudinal axis X in a relaxed or undeployed position in which no radial expansion occurs.

[0029] At least one of the arms, e.g. Figure 1 The first or upper arm 16 in the embodiment includes a distal end or head 16a having a blade 20, which includes a thin cutting edge 20a of various shapes (flat, convex, chiseled, single bevel, double bevel, etc.) to provide precision cutting. Depending on the specific application, the cutting edge 20a may also be serrated (single or double), scalloped, chamfered, wavy or take other shapes or forms, and more than one cutting edge may be provided (e.g., on both the distal and proximal sides of the head 16a or also on its lateral sides).

[0030] In use and for further reference Figure 2 , the cutter 10, while protected by a covering such as a catheter or sheath S during delivery, can be advanced into the blood vessel V to a treatment location, which may include a lesion L that requires scoring or slicing. At this location, the cutter 10 can be advanced from the distal end of the sheath S along the axis X, and the arms 16, 18 are radially expanded from a retracted state (shown in phantom) to an expanded state 16', 18' further away from the axis in a radial direction for providing the slicing or scoring function. The cutter 10 can be moved around within the blood vessel V in order to perform the slicing or scoring function as needed or desired, such as by manual manipulation from a point located outside the body of interest.

[0031] Understandably, Figure 1 The second arm 18 in the embodiment also includes a head 18a having a blade 20 that can be used to score or slice within a blood vessel opposite to the blade 20 associated with the head 16a. Figure 2The second arm 18 in the illustrated embodiment does not include a cutter and can therefore contact another portion of the inner wall of the blood vessel V when expanded to provide a reaction force or counterbalance for achieving a scoring or slicing operation. It will be appreciated that the cutter 10 can also be rotated around the blood vessel V as needed or desired to score or slice other lesions, etc. within the blood vessel, and can be extended or retracted as needed (and it will be appreciated that the cutter will typically be made of a radiopaque material or have radiopaque markings to achieve enhanced positioning under fluoroscopy or other in vivo visualization techniques).

[0032] The radial expansion of the distal portion or tip 14 can be achieved by forming at least the arms 16, 18 from a material that changes shape based on changes in environmental conditions, such as a shape memory material (e.g., Nitinol), which presents a specific configuration based on temperature changes (which can be achieved by supplying fluid via the sheath S or based on body temperature). In particular, superelastic Nitinol can be used, which does not require injection of fluid. It will be appreciated that the degree of expansion can therefore be precisely controlled to ensure that the cutter 10, and in particular the blade 20a, can act to slice or score lesions in a vessel of typical diameter and at the same time will not expand the vessel to avoid elastic retraction. When retraction is required, the cutter 10 can simply be withdrawn into the sheath S and the arms 16, 18 are thus folded. The sheath S can then be withdrawn or repositioned as needed.

[0033] It will be appreciated that the diameter of the blood vessel may vary to some extent. To ensure that the appropriate cutting depth is achieved (particularly without dilating the blood vessel to cause elastic recoil), the cutter 10, and in particular the arm 16 including the blade 20a, may optionally be provided with a limiter 22. Figure 1 and Figure 2 In the example shown, the limiter 22 includes an oversized portion immediately adjacent to the head 16a of the corresponding arm 16 and may be smooth or rounded so as not to provide a cutting function when in contact with material in the blood vessel (e.g., lesions, calcifications, etc.). Depending on the particular application, the position of the limiter 22 may be selected to achieve a desired cutting depth. In addition, the limiter 22 may take other forms, such as Figure 3 The generally spherical bead 24 is shown, and the figure also shows that the second arm 18 includes a blade 20 at its head end.

[0034] Given the above-described branched (forked) arrangement of arms 16, 18 when multiple blades 20 are included, lesions may be sliced ​​or scored on multiple sides of a vessel at once using cutter 10. However, it should be appreciated that additional cutting capabilities may be achieved by providing additional arms emanating from a single shaft 12. Thus, as Figure 4 and Figure 5 As shown, a third arm 26 may be provided to form the three-pronged cutter 10 . Figure 6It is shown that a fourth arm 28 may be provided and Figure 7 It is indicated that a fifth arm 30 may be provided. Of course, any number of arms that space permits may be provided, and as mentioned above, all, some or only one of the arms provided may be suitable for sectioning or scoring a lesion.

[0035] In order to facilitate operation and ensure correct positioning within the blood vessel in a reliable manner, the cutter 10 may include an anchor. Figure 8 As shown, the anchor includes an expandable (expandable) balloon 32 that can be attached to the shaft 12 proximal to the turning point used to form the arms 16, 18 (or more arms, if present). The inflation fluid for the balloon 32 can be provided to the outlet O in the interior compartment of the balloon 32 via the lumen in the shaft 12. The balloon 32 can thus be moved through the sheath S in a collapsed or folded configuration and then expanded within the vessel to provide a positioning function for the associated cutter 10 after expansion. The balloon 32 can be flexible, non-flexible, or semi-flexible.

[0036] like Fig. 9 As shown, the expandable balloon 32 may also be disposed on the sheath S, which may also include an inflation lumen (not shown). Fig.10 and Fig.11 As further shown, instead of an inflatable balloon 32, the anchor may include a self-expanding cage 34. The cage 34 may be disposed within the cutter 10 ( Fig.10 ) or sheath S( Fig.11 )superior.

[0037] Fig.12 , Fig.13 , Fig.14 and Fig.15 An alternative embodiment is shown. Fig.12 In the embodiment of the present invention, the cutter 10 includes only: a single expandable arm 16, which may include a blade and a limiter as described above; and an anchor that can hold the arm in place for scoring or slicing when expanded, such as when an expandable (inflatable) balloon 32 is expanded. Likewise, radial expansion of the arm 16 (note position 16') can be achieved by using a material that changes shape based on changes in environmental conditions, such as a shape memory material (e.g., Nitinol) that assumes a specific configuration based on temperature changes (which can be achieved by supplying fluid through the sheath S or based on body temperature). In particular, superelastic Nitinol can be used, which does not require injection of fluid.

[0038] As described above, the expandable element can be attached to the shaft 12, and the inflation fluid for the balloon 32 can be provided to the outlet O within the interior compartment of the balloon 32 via the lumen in the shaft 12. The balloon 32 can thus be moved through the sheath S in a collapsed or folded configuration and then expanded within the vessel to provide a positioning function for the associated cutter 10 after expansion. Alternatively, as Fig.13 As shown, the balloon 32 may be attached to the catheter or sheath S, and an expandable cage 34 may alternatively be used, such as Fig.14 and Fig.15 shown.

[0039] In summary, a cutter 10 is provided for cutting a vessel wall and in particular for scoring or slicing a lesion in a vessel. A single shaft 12 includes at least two arms 16, 18, at least one of which includes a blade 20 for scoring or slicing a lesion. Both arms 16, 18 may be provided with a blade 20, and a limiter may be provided to limit the depth of cutting achieved and ensure reliable and repeatable results. More than two arms 16, 18 may also be provided, as well as an anchor for helping to center the cutter 10 within the vessel being treated.

[0040] The present disclosure may be considered to relate to the following items:

[0041] 1. A device for slicing or scoring a lesion in a blood vessel, the device comprising:

[0042] sheath; and

[0043] A cutter is configured to extend from the sheath in an extended position for slicing or scoring a lesion, the cutter comprising a single shaft connected to a plurality of expandable arms, the plurality of expandable arms comprising a first expandable arm having at least one blade for scoring or slicing the lesion when the cutter is in the extended position.

[0044] 2. The device according to item 1, wherein the plurality of expandable arms include at least two expandable arms forming a Y shape at the distal end of the single axis.

[0045] 3. An apparatus according to item 1 or 2, wherein the first expandable arm comprises a pair of blades.

[0046] 4. The device according to any one of items 1-3, wherein the second expandable arm includes at least one blade.

[0047] 5. The apparatus of any one of items 1-3, wherein the second expandable arm does not include any blades.

[0048] 6. The apparatus of any one of items 1-5, wherein the first expandable arm comprises a limiter configured to limit a cutting depth of the cutter in the deployed position.

[0049] 7. The apparatus of any one of items 1-6, wherein the plurality of expandable arms comprises at least two expandable arms connected to the single shaft at a common bifurcation point.

[0050] 8. Apparatus according to any of the preceding items, wherein the cutter comprises three expandable arms connected to the single shaft.

[0051] 9. The device according to any of the preceding items, wherein the cutter comprises four expandable arms connected to the single shaft.

[0052] 10. The device according to any of the preceding items, wherein the cutter comprises five expandable arms connected to the single shaft.

[0053] 11. The device according to any one of items 1-10, further comprising an anchor configured to anchor the cutter in a blood vessel.

[0054] 12. The device according to item 11, wherein the anchor comprises an expandable element.

[0055] 13. The device according to item 12, wherein the expandable element comprises an inflatable balloon or an expandable cage.

[0056] 14. Apparatus according to any one of items 11 to 13, wherein the anchor is connected to the cutter.

[0057] 15. The device according to any one of items 11 to 14, wherein the anchor is connected to the sheath.

[0058] 16. A device for slicing or scoring a lesion in a blood vessel, the device comprising:

[0059] A cutter includes a single shaft having a bifurcated portion including at least two expandable arms, a first of which includes at least one blade for slicing or scoring a lesion when expanded.

[0060] 17. The device according to item 16, further comprising a sheath configured to receive the cutter.

[0061] 18. The device according to item 16 or item 17, wherein the at least two expandable arms form a Y shape at the distal end of the single shaft.

[0062] 19. Apparatus according to item 16 or item 17, wherein the first expandable arm comprises a pair of blades.

[0063] 20. The apparatus of any one of items 16-19, wherein the second expandable arm comprises at least one blade.

[0064] 21. The apparatus of any of items 16-19, wherein the second expandable arm does not include any blades.

[0065] 22. The apparatus of any one of items 16-19, wherein the first expandable arm comprises a limiter configured to limit a cutting depth of the cutter.

[0066] 23. The apparatus of any one of items 16-22, wherein at least two expandable arms are connected to the single shaft at a common bifurcation point.

[0067] 24. The apparatus of any of items 16-23, wherein the cutter comprises three expandable arms connected to the single shaft.

[0068] 25. The apparatus of any of items 16-23, wherein the cutter comprises four expandable arms connected to the single shaft.

[0069] 26. The apparatus of any of items 16-23, wherein the cutter comprises five expandable arms connected to the single shaft.

[0070] 27. The device according to any one of items 16-26, further comprising an anchor configured to anchor the cutter in a blood vessel.

[0071] 28. The device according to item 27, wherein the anchor comprises an expandable element.

[0072] 29. The device according to item 28, wherein the expandable element comprises an inflatable balloon or an expandable cage.

[0073] 30. The device according to any one of items 27 to 29, wherein the anchor is connected to the cutter.

[0074] 31. The device according to any one of items 27 to 30, wherein the anchor is connected to the sheath.

[0075] 32. Apparatus according to any of the preceding items, wherein the cutter comprises a shape memory material.

[0076] 33. A device for slicing or scoring a lesion in a blood vessel, the device comprising:

[0077] catheter;

[0078] A cutter is configured to extend from the catheter, the cutter comprising a first expandable arm, the first expandable arm comprising a first blade for slicing or scoring a lesion when expanded.

[0079] An anchor is configured to anchor the cutter in a blood vessel.

[0080] 34. The device according to item 33, wherein the anchor comprises an expandable element.

[0081] 35. The device according to item 33 or 34, wherein the expandable element comprises an inflatable balloon or an expandable cage.

[0082] 36. The apparatus of any of items 33-35, wherein the anchor is connected to the cutter.

[0083] 37. The apparatus of any of items 33-36, wherein the anchor is connected to the catheter.

[0084] 38. The apparatus of any of items 33-37, wherein the cutter comprises a second expandable arm, the second expandable arm comprising a second blade.

[0085] 39. The device according to item 38, wherein the first expandable arm and the second expandable arm form a Y shape at the distal end of a single axis.

[0086] 40. The apparatus of any of items 33-39, wherein the first expandable arm comprises a pair of blades.

[0087] 41. The apparatus of any of items 33-40, wherein the cutter comprises a second expandable arm having at least one blade.

[0088] 42. The apparatus of any of items 33-41, wherein the cutter comprises a second expandable arm that does not include any blade.

[0089] 43. An apparatus according to any of items 33-42, wherein the first expandable arm includes a limiter configured to limit the cutting depth of the cutter.

[0090] 44. The apparatus of any of items 33-43, wherein the cutter comprises a shape memory material.

[0091] 45. The apparatus of any of items 33-44, wherein the catheter comprises a sheath configured to receive the cutter.

[0092] Each of the following terms written in singular grammatical form: "a", "an", and "the", as used herein, means "at least one" or "one or more". The use of the phrase "one or more" herein does not change the intended meaning of "a", "an", or "the". Therefore, unless otherwise expressly defined or described herein, or explicitly stated or otherwise provided herein, the terms "a", "an", and "the" used herein may also refer to and include multiple entities or objects described. For example, the phrases used herein: "a unit", "a device", "a component", "a mechanism", "a part", "an element", and "a step or process" may also refer to and include multiple units, multiple devices, multiple components, multiple mechanisms, multiple parts, multiple elements, and multiple steps or processes, respectively.

[0093] As used herein, each of the following terms: "comprises", "having" and "including" and their linguistic / grammatical variants, derivatives or / and inflections means "including but not limited to", and is deemed to specify stated component(s), feature(s), property(s), parameter(s), integer(s) or step(s), and does not preclude the addition of one or more additional component(s), feature(s), property(s), parameter(s), integer(s) or step(s) or groups thereof. Each of these terms is deemed to have the same meaning as the phrase "consisting essentially of". As used herein, the phrase "consisting of" means "including and limited to". The phrase “consisting essentially of” means that the entity or item (system, system unit, system subunit device, component, subcomponent, mechanism, structure, constituent element or peripheral equipment, accessory or material, method or process, step or process, sub-step or sub-process) that is all or part of an exemplary embodiment of the disclosed invention or / and for implementing an exemplary embodiment of the disclosed invention may include at least one additional feature or characteristic, which is a system unit system subunit device, component, subcomponent, mechanism, structure, component or element or peripheral equipment, accessory or material, step or process, sub-step or sub-process, but each such additional feature or characteristic “does not materially alter the basic novelty and inventive characteristic or special technical characteristic of the claimed item.”

[0094] As used herein, the term "method" refers to steps, processes, ways, means, and / or techniques for completing a given task, including but not limited to those known steps, procedures, ways, means, and / or techniques, or steps, procedures, ways, means, and / or techniques that are readily developed from known steps, procedures, ways, means, and / or techniques by practitioners in the relevant field(s) of the disclosed invention.

[0095] Terms expressing approximation, such as about, substantially, approximately, etc. as used herein refer to ±10% of the stated value.

[0096] It should be fully understood that certain aspects, features, and characteristics of the invention that are illustratively described and presented in the context or format of multiple separate embodiments for clarity may also be illustratively described and presented in the context or format of a single embodiment in any suitable combination or subcombination. Conversely, various aspects, features, and characteristics of the invention that are illustratively described and presented in the context or format of a single embodiment in combination or subcombination may also be illustratively described and presented in the context or format of multiple separate embodiments.

[0097] Although the present invention has been illustratively described and presented by specific exemplary embodiments and examples thereof, it is apparent that many substitutions, modifications and / or variations thereof will be apparent to those skilled in the art. Therefore, it is intended that all such substitutions, modifications and / or variations fall within the spirit of the broad scope of the appended claims and be covered by them.

Claims

1. A device for slicing or scoring a lesion in a blood vessel, the device comprising: jacket; and A cutter, which is used to extend from the sheath in the expanded position for slicing or scoring the lesion, the cutter includes a single shaft connected to a plurality of expandable arms, the plurality of expandable arms extending from the single shaft at a common bifurcation point, the plurality of expandable arms including a first expandable arm having at least one blade and a second expandable arm not including any blade, the at least one blade being used to score or slice the lesion when the cutter is in the expanded position, wherein the second expandable arm contacts the blood vessel when expanded to provide a reaction force or balancing force for the slicing or scoring operation, wherein the at least one blade is exposed to the outside of the device.

2. The device according to claim 1, wherein the plurality of expandable arms include at least two expandable arms forming a Y shape at the distal end of the single shaft.

3. The apparatus of claim 1, wherein the first expandable arm comprises a pair of blades.

4. The apparatus of claim 1, wherein the first expandable arm includes a limiter that limits a cutting depth of the cutter in the deployed position.

5. The apparatus of claim 1, wherein the cutter comprises three expandable arms connected to the single shaft.

6. The apparatus of claim 1 wherein the cutter comprises four expandable arms connected to the single shaft.

7. The apparatus of claim 1 wherein the cutter comprises five expandable arms connected to the single shaft.

8. The device of claim 1, further comprising an anchor for anchoring the cutter in a blood vessel.

9. The device of claim 8, wherein the anchor comprises an expandable element.

10. The device of claim 9, wherein the expandable element comprises an inflatable balloon or an expandable cage.

11. The apparatus of claim 8, wherein the anchor is connected to the cutter.

12. The device of claim 8, wherein the anchor is connected to the sheath.

13. The apparatus of any one of claims 1 to 12, wherein the cutter comprises a shape memory material.

14. A device for slicing or scoring a lesion in a blood vessel, the device comprising: A cutter comprising a single shaft having a branched portion, wherein the branched portion comprises at least two expandable arms extending from the single shaft at a common bifurcation point, wherein a first arm of the at least two expandable arms comprises at least one blade, wherein the at least one blade is used to slice or score the lesion when expanded, wherein the at least one blade is exposed to the exterior of the device, and a second arm of the at least two expandable arms does not comprise any blade, wherein the second arm contacts the blood vessel when expanded to provide a reaction force or a balancing force for the slicing or scoring operation.

15. The device of claim 14, further comprising a sheath for receiving the cutter.

16. The apparatus of claim 14, wherein the at least two expandable arms form a Y-shape at the distal end of the single shaft.

17. The apparatus of claim 14, wherein the first expandable arm comprises a pair of blades.

18. The apparatus of claim 14, wherein the first expandable arm includes a limiter for limiting a cutting depth of the cutter.

19. The apparatus of claim 14, wherein the at least two expandable arms are connected to the single shaft at a common bifurcation point.

20. The apparatus of claim 14, wherein the cutter comprises three expandable arms connected to the single shaft.

21. The apparatus of claim 14, wherein the cutter comprises four expandable arms connected to the single shaft.

22. The apparatus of claim 14, wherein the cutter comprises five expandable arms connected to the single shaft.

23. The device of claim 14, further comprising an anchor for anchoring the cutter in a blood vessel.

24. The device of claim 23, wherein the anchor comprises an expandable element.

25. The device of claim 24, wherein the expandable element comprises an inflatable balloon or an expandable cage.

26. The apparatus of claim 23, wherein the anchor is connected to the cutter.

27. The device of claim 23, wherein the anchor is connected to a sheath.

28. The apparatus of any one of claims 14 to 27, wherein the cutter comprises a shape memory material.

29. An apparatus for slicing or scoring a lesion in a blood vessel, the apparatus comprising: catheter; a cutter extending from the catheter, the cutter comprising a first expandable arm and a second expandable arm, the cutter comprising a single shaft connected to the first expandable arm and the second expandable arm, the first expandable arm and the second expandable arm emanating from the single shaft at a common bifurcation point, the first expandable arm comprising a first blade, the first blade being used to slice or score the lesion when expanded, the second expandable arm not comprising any blade, wherein the second expandable arm contacts the blood vessel when expanded to provide a counter force or counterbalance for the slicing or scoring operation, wherein the first blade is exposed to the exterior of the device; An anchor for anchoring the cutter in the blood vessel.

30. The device of claim 29, wherein the anchor comprises an expandable element.

31. The apparatus of claim 30, wherein the expandable element comprises an inflatable balloon or an expandable cage.

32. The apparatus of claim 29, wherein the anchor is connected to the cutter.

33. The apparatus of claim 29, wherein the anchor is connected to the catheter.

34. The apparatus of claim 29, wherein the cutter comprises a shape memory material.

35. The apparatus of claim 29, wherein the catheter comprises a sheath for receiving the cutter.

36. The apparatus of claim 29, wherein the first expandable arm and the second expandable arm form a Y-shape at the distal end of a single shaft.

37. The apparatus of claim 29, wherein the first expandable arm comprises a pair of blades.

38. The apparatus of claim 29, wherein the first expandable arm includes a limiter for limiting a cutting depth of the cutter.

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