Blood vessel nicking device

Abstract

A medical device includes a catheter shaft including a distal region; and an inflatable balloon secured to the distal region of the catheter shaft. The inflatable balloon has an outer surface and defines a centerline when inflated. A blade extends on the outer surface and is secured to the outer surface, the blade having a cutting edge extending from a blade distal end to a blade proximal end, the cutting edge extending to a maximum distance measured at the blade distal end relative to a centerline of the inflatable balloon when the inflatable balloon is inflated, and the cutting edge extending to a maximum distance measured at the blade proximal end relative to the centerline of the inflatable balloon when the inflatable balloon is inflated. And a minimum distance measured at the proximal end of the blade relative to a centerline of an inflatable balloon of the medical device.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 526,766, filed July 14, 2023, which is incorporated herein by reference. Technical Field

[0002] This invention relates to angioplasty balloon catheters comprising one or more cutting blades mounted to a balloon. More particularly, this invention relates to cutting blades in a cutting balloon catheter that taper from distal to proximal. Background Technology

[0003] Heart and vascular disease is a major problem in the United States and globally. Conditions such as atherosclerosis can cause blood vessels to become blocked or narrowed. This blockage can lead to insufficient oxygen supply to the heart, which can have serious consequences because the heart muscle must have enough oxygen to maintain its pumping action; or it can lead to insufficient oxygen supply and / or circulation to other parts of the body.

[0004] Occlusion, stenosis, or narrowing of blood vessels, as well as natural or artificial arteriovenous dialysis fistulas, can be treated with recanalization procedures, such as advancing an angioplasty balloon catheter along a guidewire to the site of occlusion, positioning the balloon across the occlusion. The balloon is then inflated to widen the passage through the occlusion.

[0005] One of the major obstacles to treating coronary artery disease and / or treating blocked vessels or fistulas is that the occluded passageway can restenosis or narrow again after angioplasty or other recanalization procedures. Evidence suggests that, during treatment, for example, using an angioplasty balloon equipped with a blade component to rupture, cut, or score the stenosis can reduce the incidence of restenosis. Additionally, rupturing, cutting, or scoring the stenosis reduces trauma at the treatment site and / or reduces trauma to adjacent healthy tissue. Blade components can also be a beneficial complement to angioplasty when the target occlusion is hardened or calcified. It is believed that the use of a typical angioplasty balloon alone may not be sufficient to dilate some of these hardened lesions. Therefore, angioplasty balloons equipped with blade components have been developed to attempt to enhance angioplasty treatment. Blade components can be adapted to, for example, cut, rupture, or score the lesion. Some lesions are longer than the blade component. There is still a great need for blade components suitable for treating longer lesions while still allowing delivery through the tortuous portions of the vascular system. Summary of the Invention

[0006] This invention relates to several alternative designs, materials, and methods of manufacturing medical device structures and components, and their uses. One example can be found in a medical device. The medical device includes a catheter shaft comprising a distal region; and an inflatable balloon fixed to the distal region of the catheter shaft, the inflatable balloon having an outer surface that defines a centerline upon inflation. A blade extends on and is fixed to the outer surface, the blade having a cutting edge extending from a distal end to a proximal end of the blade, the cutting edge tapering from a maximum distance measured relative to the centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade when the inflatable balloon is inflated.

[0007] Alternatively or additionally, the cutting edge of the blade may include a straight line.

[0008] Alternatively or otherwise, during inflation, the outer surface of the inflatable balloon may be at a constant distance from the centerline of the inflatable balloon.

[0009] Alternatively or additionally, the cutting edge of the blade may taper from the distal end of the blade to the proximal end.

[0010] Alternatively or additionally, the cutting edge of the blade may be defined above the outer surface of the inflatable bladder at a blade height, and the blade height may taper from a maximum blade height at the distal end of the blade to a minimum blade height at the proximal end of the blade.

[0011] Alternatively or additionally, the distance between the outer surface of the inflatable balloon and the centerline of the inflatable balloon may vary during inflation.

[0012] Alternatively or additionally, the distance between the outer surface of the inflatable balloon and the longitudinal axis may be greatest in the distal region of the inflatable balloon and minimum in the proximal region of the inflatable balloon.

[0013] Alternatively or additionally, the cutting edge of the blade may have a constant height relative to the outer surface of the inflatable balloon.

[0014] Alternatively or additionally, the cutting edge of the blade may have a varying height relative to the outer surface of the inflatable bladder.

[0015] Alternatively or additionally, the medical device may also include one or more additional blades, each of which extends on and is attached to an outer surface, each of which has a cutting edge extending from the distal end of the blade to the proximal end of the blade, the cutting edge extending from a maximum distance measured at the distal end of the blade relative to the centerline of the inflatable balloon to a minimum distance measured at the proximal end of the blade relative to the centerline of the inflatable balloon when the inflatable balloon is inflated.

[0016] Another example can be found in a medical device. The medical device includes a catheter shaft comprising a distal region; and an inflatable balloon fixed to the distal region of the catheter shaft. The inflatable balloon includes a midsection of constant diameter corresponding to the location where a polymer pad is fixed to the outer surface of the inflatable balloon; a distal region tapering towards a distal waist; and a proximal region tapering towards a proximal waist. The polymer pad is fixed to the constant-diameter midsection of the inflatable balloon. A blade is fixed within the polymer pad, defining a tapered cutting edge extending from the distal end of the blade to the proximal end of the blade, the tapered cutting edge having a maximum blade height relative to the polymer pad at the distal end of the blade and a minimum blade height relative to the polymer pad at the proximal end of the blade.

[0017] Alternatively or additionally, the middle section with a constant diameter may have a diameter in the range of 1.5 to 2.5 mm when inflated.

[0018] Alternatively or additionally, the minimum blade height may be in the range of 0 to 0.5 mm, and the maximum blade height may be in the range of 1 to 2 mm.

[0019] Another example can be found in a medical device. The medical device includes a catheter shaft that includes a distal region. An inflatable balloon is fixed to the distal region of the catheter shaft and includes a tapered midsection corresponding to a location where a polymer pad is fixed to the outer surface of the inflatable balloon. The tapered midsection tapers from a maximum diameter near the distal region to a minimum diameter near the proximal region. The polymer pad is fixed to the tapered midsection of the inflatable balloon, and a blade is fixed within the polymer pad, the blade defining a cutting edge extending from a distal end to a proximal end of the blade.

[0020] Alternatively or additionally, the cut edge may have a uniform height relative to the polymer pad.

[0021] Another example can be found in a medical device. The medical device includes a catheter shaft including a distal region; and an inflatable balloon fixed to the distal region of the catheter shaft, the inflatable balloon having an outer surface that defines a centerline upon inflation. A blade extends on and is fixed to the outer surface, the blade having a cutting edge extending from a distal end to a proximal end of the blade, the cutting edge tapering from a maximum distance measured relative to the centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade when the inflatable balloon is inflated.

[0022] Alternatively or additionally, the cutting edge of the blade may include a straight line.

[0023] Alternatively or additionally, the minimum distance may be in the range of 1 to 2 millimeters, and the maximum distance may be in the range of 2 to 4 millimeters.

[0024] Alternatively or additionally, the medical device may also include a braid extending through at least a portion of an elongated shaft and / or an inflatable balloon.

[0025] Alternatively or otherwise, during inflation, the outer surface of the inflatable balloon may be at a constant distance from the centerline of the balloon.

[0026] Alternatively or additionally, the cutting edge of the blade may taper from the distal end of the blade to the proximal end.

[0027] Alternatively or additionally, the cutting edge of the blade may be defined above the outer surface of the inflatable bladder at a blade height, and the blade height may taper from a maximum blade height at the distal end of the blade to a minimum blade height at the proximal end of the blade.

[0028] Alternatively or otherwise, the maximum blade height can be in the range of 1 to 2 millimeters.

[0029] Alternatively or additionally, the minimum blade height can be in the range of 0 to 0.5 mm.

[0030] Alternatively or otherwise, the distance between the outer surface of the inflatable balloon and the centerline of the inflatable balloon may be different during inflation.

[0031] Alternatively or additionally, the distance between the outer surface of the inflatable balloon and the longitudinal axis may be greatest in the distal region of the inflatable balloon and minimum in the proximal region of the inflatable balloon.

[0032] Alternatively or additionally, the cutting edge of the blade may have a constant height relative to the outer surface of the inflatable bladder.

[0033] Alternatively or additionally, the cutting edge of the blade may have a different height relative to the outer surface of the inflatable bladder.

[0034] Alternatively or additionally, the medical device may also include one or more additional blades, each of which extends on and is attached to an outer surface, each of which has a cutting edge extending from the distal end of the blade to the proximal end of the blade, wherein when the inflatable balloon is inflated, the cutting edge extends from a maximum distance measured at the distal end of the blade relative to the centerline of the balloon to a minimum distance measured at the proximal end of the blade relative to the centerline of the balloon.

[0035] Another example can be found in a medical device. The medical device includes a catheter shaft comprising a distal region. An inflatable balloon is fixed to the distal region of the catheter shaft and includes a constant-diameter midsection corresponding to the location where a polymer pad is fixed to the outer surface of the inflatable balloon; a distal region tapering towards a distal waist; and a proximal region tapering towards a proximal waist. The polymer pad is fixed to the constant-diameter midsection of the inflatable balloon. A blade is fixed within the polymer pad, defining a tapered cutting edge extending from the distal end of the blade to the proximal end of the blade, the tapered cutting edge having a maximum blade height relative to the polymer pad at the distal end of the blade and a minimum blade height relative to the polymer pad at the proximal end of the blade.

[0036] Alternatively or additionally, the middle section with a constant diameter may have a diameter in the range of 1.5 to 2.5 mm when inflated.

[0037] Alternatively or additionally, the minimum blade height may be in the range of 0 to 0.5 mm, and the maximum blade height may be in the range of 1 to 2 mm.

[0038] Another example can be found in a medical device. The medical device includes a catheter shaft that includes a distal region. An inflatable balloon is fixed to the distal region of the catheter shaft. The inflatable balloon includes a tapered midsection corresponding to a location where a polymer pad is fixed to the outer surface of the inflatable balloon. The tapered midsection tapers from a maximum diameter near the distal region to a minimum diameter near the proximal region. The polymer pad is fixed to the tapered midsection of the inflatable balloon. A blade is fixed within the polymer pad, defining a cutting edge extending from the distal end of the blade to the proximal end of the blade.

[0039] Alternatively or additionally, the cut edge may have a uniform height relative to the polymer pad.

[0040] Alternatively or additionally, the cut edge may have a different height relative to the polymer pad.

[0041] The above description is provided to facilitate understanding of some of the unique innovative features of this invention and is not intended to be an exhaustive description. A full understanding of the invention can be obtained by considering the entire specification, claims, features, and abstract as a whole. Attached Figure Description

[0042] The invention can be more fully understood by considering the following description of various examples in conjunction with the accompanying drawings, wherein:

[0043] Figure 1 This is a schematic partial cross-sectional view of an example medical device;

[0044] Figure 2 This is a schematic diagram of an example medical device;

[0045] Figure 3 This is a schematic diagram of an example medical device;

[0046] Figure 4 This is a schematic diagram of an example medical device;

[0047] Figure 5 This is a schematic diagram of an example medical device;

[0048] Figure 6 This is a schematic diagram of an example medical device;

[0049] Figure 7 This is a schematic diagram of an example medical device;

[0050] Figure 8 This is a schematic diagram of an example medical device;

[0051] Figure 9 This is a schematic diagram of an example medical device;

[0052] Figures 10 to 14 This is a schematic diagram of an example medical device deployed within the vascular system adjacent to the lesion;

[0053] Figure 15 This is a schematic diagram of an example medical device;

[0054] Figure 16 It is along Figure 15 A cross-sectional view taken from line 16-16;

[0055] Figure 17 It is along Figure 15 A cross-sectional view taken from line 17-17;

[0056] Figure 18 This is a schematic diagram of an example medical device;

[0057] Figure 19 It is along Figure 18 A cross-sectional view taken from line 19-19;

[0058] Figure 20 It is along Figure 18 A cross-sectional view taken from line 20-20; and

[0059] Figure 21 It is along Figure 20 The cross-sectional view taken by line 21-21.

[0060] While the invention is adaptable to various modifications and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that it is not intended to limit the invention to the specific examples described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0061] The following description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered in a similar manner. The drawings, which are not necessarily drawn to scale, depict examples that are not intended to limit the scope of the invention. Although examples for various elements are shown, those skilled in the art will recognize that many of the examples provided have suitable alternatives available.

[0062] All numbers are assumed to be modified by the term “about” throughout this document unless the context explicitly indicates otherwise. A description of a range of numbers indicated by an endpoint includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0063] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless otherwise expressly indicated. As used in this specification and the appended claims, the term “or” is generally used in the sense of including “and / or” unless otherwise expressly indicated.

[0064] It should be noted that the embodiments described by references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification may include specific features, structures, or characteristics, but not every embodiment necessarily includes that specific feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in connection with an embodiment, it is contemplated that, whether explicitly described or not, that feature, structure, or characteristic may be applied to other embodiments, unless expressly stated otherwise.

[0065] Figure 1This is a partial cross-sectional view of an example medical device 10. In some cases, the example medical device 10 can be used within a patient's vascular system to treat stenosis within the vascular system. In some cases, the medical device 10 can be used to open or cut calcified lesions. The medical device 10 may define a longitudinal axis "LA," as shown. The medical device 10 includes a catheter shaft 12 having a distal region 14. An inflatable balloon 16 may be secured to the distal region 14 of the catheter shaft 12. One or more blades 18 may be mounted on or otherwise secured relative to the inflatable balloon 16. In some cases, one or more blades 18 may be secured to the inflatable balloon 16 via a polymer pad 19. In some cases, as will be discussed regarding Figures 3 to 7 As described, each of one or more blades 18 may include a base portion at least partially embedded within a polymer pad 19, and a blade portion forming a visible portion of the blade 18. For example, the polymer pad 19 may be adhesively attached to an inflatable balloon 16.

[0066] In some cases, the medical device 10 can be advanced over the guidewire 20 through the vascular system to the target area. Once positioned at the target location in the vascular system, the inflatable balloon 16 can be inflated to apply a radially outward force to the lesion when the blade 18 engages with it. Thus, the blade 18 can dehisce, cut, or score the lesion to enlarge the lumen immediately adjacent to it. The target area can be located in any suitable peripheral or cardiovascular lumen location. In some cases, the medical device 10 can be withdrawn proximally while the inflatable balloon 16 is inflated to dehisce, cut, or score the lesion, particularly when the lesion is longer than the blade 18.

[0067] The number, position, and arrangement of the blades 18 around the inflatable balloon 16 can vary. For example, the medical device 10 may include one, two, three, four, five, six, or more blades 18, arranged regularly, irregularly, or in any other suitable manner at any location along the inflatable balloon 16. For example, in some cases, the inflatable balloon 16 may include a plurality of blades 18 arranged longitudinally symmetrically around the circumference of the inflatable balloon 16.

[0068] The blade 18 can be made of any suitable material, such as metal, metal alloy, polymer, metal-polymer composite, or any other suitable material. For example, in some cases, the blade 18 can be made of stainless steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy, or other metallic materials. The blade 18 can have a triangular cross-sectional shape, a square cross-sectional shape, a rectangular cross-sectional shape, a circular cross-sectional shape, or any other desired shape. In some cases, the blade 18 can be tapered.

[0069] The blades 18 can be attached to the inflatable balloon 16 using various techniques. In some cases, each of the blades 18 may include a base portion that includes cuts to increase flexibility, wherein the base portion may be at least partially embedded in a polymer member (not shown) that itself may be secured to the outer surface of the inflatable balloon 16. Additional details regarding how the blades 18 may be secured to the outer surface of the inflatable balloon 16, including the aforementioned polymer member, are described in, for example, U.S. Patent Nos. 9,226,768, 10,046,146, 10,058,349, and 10,729,893, the entire contents of which are incorporated herein by reference.

[0070] The inflatable balloon 16 may be made of angioplasty balloon materials, including polymers such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), polybutylene terephthalate (PBT), polyurethane, polyvinyl chloride (PVC), polyether esters, polyesters, polyamides, elastomeric polyamides, polyether block amides (PEBA), and other suitable materials or mixtures, compositions, copolymers, polymer / metal composites, etc. In some cases, the inflatable balloon 16 may comprise a single-layer material, while in others, the inflatable balloon 16 may be a multi-layer construction, including multiple layers of material. For example, in some cases, the inflatable balloon 16 may be formed as a co-extrusion or a three-layer extrusion. In some cases, the inflatable balloon 16 may be adapted to be compliant and can inflate at relatively low pressures, such as 2 to 4 atmospheres.

[0071] The inflatable balloon 16 can be configured such that it includes one or more "wings" or wing-shaped regions during scaling. In some cases, the wings can be configured such that the blade members 18 can be positioned at the innermost location of the scaled-up inflatable balloon 16, wherein the folds of the balloon wings are positioned between adjacent blade members 18. This arrangement can reduce the exposure of the blade members 18 to blood vessels during delivery of the inflatable balloon 16 to the lesion.

[0072] The catheter shaft 12 may be a catheter shaft similar to a typical catheter shaft. For example, the catheter shaft 12 may include an outer tubular member 22 and an inner tubular member 24 extending through at least a portion of the outer tubular member 22. The outer tubular member 22 and the inner tubular member 24 may each be made of a variety of different materials. For example, the outer tubular member 22 and the inner tubular member 24 may be made of metal, metal alloy, polymer, metal-polymer composite, or any other suitable material.

[0073] The outer tubular member 22 and the inner tubular member 24 can be arranged in any suitable manner. For example, in some embodiments, the inner tubular member 24 may be coaxially disposed within the outer tubular member 22. According to these embodiments, the inner tubular member 24 and the outer tubular member 22 may be fixed to each other or not fixed to each other along a generally longitudinal axis of the conduit shaft 12. Alternatively, the inner tubular member 24 may be disposed along the inner wall or otherwise adjacent to the inner wall of the outer tubular member 22. In other embodiments, the outer tubular member 22 and the inner tubular member 24 may be arranged in another desired manner.

[0074] The internal tubular member 24 may include a lumen 26. In at least some cases, the lumen 26 is a guidewire lumen for receiving the guidewire 20 passing through it. Thus, the medical device 10 can be advanced along the guidewire 20 to a desired location. The guidewire lumen 26 may extend substantially along the entire length of the catheter shaft 12, making the medical device 10 resemble a conventional "OTW (over-the-wire)" catheter. Alternatively, and as shown, the guidewire lumen 26 may extend only along a portion of the catheter shaft 12, making the medical device 10 resemble a "single-operator-exchange" or "rapid-exchange (Rx)" catheter.

[0075] The catheter shaft 12 may also include an inflatable cavity 28, which can be used, for example, to deliver an inflatable medium to and from the inflatable balloon 16, to selectively inflate and / or deflate the inflatable balloon 16. The location and orientation of the inflatable cavity 28 may vary depending on the morphology of the outer tubular member 22 and the inner tubular member 24. For example, when the outer tubular member 22 surrounds the inner tubular member 24, the inflatable cavity 28 may be defined within the space between the outer tubular member 22 and the inner tubular member 24. When the outer tubular member 22 and the inner tubular member 24 are arranged side by side, the inflatable cavity 28 may be a cavity of the outer tubular member 22.

[0076] The inflatable balloon 16 can be coupled to the catheter shaft 12 in any of a variety of suitable ways. For example, the inflatable balloon 16 can be adhesively or thermally coupled to the catheter shaft 12. In some embodiments, the proximal waist 30 of the inflatable balloon 16 can be coupled to the catheter shaft 12, for example, to the distal end of the outer tubular member 22, and the distal waist 32 of the inflatable balloon 16 can be coupled to the catheter shaft 12, for example, to the distal end of the inner tubular member 24. However, the exact coupling location can vary.

[0077] In some cases, as previously described, the medical device 10 may be adapted to be pulled through the lesion to treat lesions that may be longer than the blade 18. While the blade 18 can theoretically be made of any length, it should be understood that longer blades may be more difficult to deliver, especially through tortuous vascular systems. In some cases, to facilitate easier proximal pulling through the lesion, the blade 18 may be adapted to present a tapered cutting edge to the lesion. In some cases, the tapered blade may be fixed to a balloon of constant diameter, wherein the tapering of the blade provides an overall tapering within the cutting edge exposed to the lesion. In some cases, a blade of constant height may be fixed to a balloon of variable diameter, wherein the variable diameter balloon provides an overall tapering within the cutting edge exposed to the lesion. In some cases, the tapered blade may be fixed to a balloon of variable diameter, such that both the tapered blade and the variable diameter balloon contribute to achieving an overall tapering within the cutting edge exposed to the lesion.

[0078] Figure 2 This is a schematic diagram of an example medical device 34. The example medical device 34 can be considered as an example of medical device 10. Medical device 34 includes an inflatable balloon 16 fixed to a distal region 14 relative to an elongated axis 12. The inflatable balloon 16 can be considered to include a central section 36 of constant diameter, a distal region 38 tapering from the central section 36 to a distal waist 32, and a proximal region 40 tapering from the central section 36 to a proximal waist 30. In some cases, medical device 34 includes one or more tapered blades 18. The tapered blades 18 tapere from a distal end 42 to a proximal end 44 and present a tapered cutting edge 46 extending between the distal end 42 and the proximal end 44. In some cases, the tapered cutting edge 46 adapts medical device 34 to be pulled proximally through the lesion when the inflatable balloon 16 is inflated. The tapered cutting edge 46 can be considered to define a straight line.

[0079] Inflating the inflatable balloon 16 will push the tapered cutting edge 46 to a position capable of cutting or scoring the lesion as the medical device 34 is pulled proximally through the lesion. In some cases, the inflatable balloon 16 may be sized to push the tapered cutting edge 46 to contact the lesion, but its size may not be sufficient to cause the lesion to rupture or otherwise deform. As an example, the inflatable balloon 16 may have a diameter ranging from 1.5 mm to 2.5 mm (within the middle section 36 with a constant diameter), however other sizes are also conceivable.

[0080] The inflatable balloon 16 can be considered to have a centerline CL extending axially through the inflatable balloon 16. In some cases, the centerline CL can be considered to be parallel to... Figure 1The longitudinal axes LA shown are collinear. In some cases, the tapered cutting edge 46 may be measured relative to the distance from the centerline CL. As an example, the tapered cutting edge 46 may taper from a maximum radial distance D1 between the distal end 42 of the tapered blade 18 and the centerline CL to a minimum radial distance D2 between the proximal end 44 of the tapered blade 18 and the centerline CL. In some cases, the maximum distance D1 may be in the range of 2 mm to 4 mm, while the minimum distance D2 may be in the range of 1 mm to 2 mm. In some cases, the tapered blade 18 itself may have a blade height measured relative to the outer surface 50 of the inflatable balloon 16, wherein the maximum blade height is located at the distal end 42 of the tapered blade 18, which is shown as D3. The tapered blade 18 may have a minimum blade height in the range of 0 to 0.5 mm at the proximal end 44 of the tapered blade 18, which is shown as D4.

[0081] In some cases, the conical blade 18 can be directly attached to the outer surface of the inflatable balloon 16. In some cases, such as... Figure 2 As shown, a conical blade 18 can be secured within a polymer pad 48. The conical blade 18 can be shown as including a base portion 52 embedded within the polymer pad 48 and a blade portion 54 extending outwardly from the base portion 52. In some cases, the base portion 52 may be slightly longer than the blade portion 54. In some cases, the blade portion 54 can be considered to define blade heights D3 and D4. In some cases, the base portion 52 may include cuts to increase flexibility, wherein the base portion 52 may be at least partially embedded in the polymer pad 48, which itself may be secured to the outer surface of the inflatable balloon 16. In some cases, the base portion 52 may include a T-shaped slot 56 adapted to provide additional flexibility to the base portion 52 and to facilitate embedding the base portion 52 within the polymer pad 48. Additional details regarding how the blade 18 can be secured to the outer surface of the inflatable balloon 16, including the aforementioned polymer components, are described in, for example, U.S. Patent Nos. 9,226,768, 10,046,146, 10,058,349, and 10,729,893, the entire contents of which are incorporated herein by reference.

[0082] Figure 4 The blade 18 is shown to be secured within a polymer pad 48, with a base portion 52 of the blade 18 embedded within the polymer pad 48, and a blade portion 54 extending outward from the base portion 52. In some cases, as shown, the base portion 52 may extend proximally from the proximal end 44 of the blade 18 a certain distance. In some cases, this extension of the base portion 52 provides a more secure hold of the blade 18 within the polymer pad 48. In some cases, the base portion 52 may include a T-shaped slot 56 adapted to provide additional flexibility to the base portion 52 and to facilitate embedding the base portion 52 within the polymer pad 48. Figure 4 In this design, blade 18 includes a tapered cutting edge 46 that linearly tapers from the distal end 42 of blade 18 to the proximal end 44 of blade 18. In some cases, the tapered cutting edge 46 facilitates the proximal pulling of blade 18 through the lesion when the inflatable balloon 16 is inflated. This can be useful, especially when the lesion is longer than blade 18 or multiple blades 18.

[0083] Figure 5 The blade 18 is shown to be secured within a polymer pad 48, with a base portion 52 of the blade 18 embedded within the polymer pad 48, and a blade portion 54 extending outward from the base portion 52. In some cases, as shown, the base portion 52 may extend proximally from the proximal end 44 of the blade 18 a certain distance. In some cases, this extension of the base portion 52 provides a more secure hold of the blade 18 within the polymer pad 48. In some cases, the base portion 52 may include a T-slot 56 adapted to provide additional flexibility to the base portion 52 and to facilitate embedding the base portion 52 within the polymer pad 48.

[0084] exist Figure 5 In this design, blade 18 includes a first cutting edge portion 58 and a second cutting edge portion 60. As shown, the first cutting edge portion 58 can be considered parallel to or at least substantially parallel to the polymer pad 48, where substantially parallel is defined as a deviation from parallel within 10%. The first cutting edge portion 58 extends between the inflection point 62 and the distal end 42 of blade 18. The second cutting edge portion 60 tapers proximally from the inflection point 62 of blade 18 to the proximal end 44. In some cases, the second cutting edge portion 60 facilitates proximal pulling of blade 18 through the lesion when the inflatable balloon 16 is inflated. This can be useful, especially when the lesion is longer than blade 18 or multiple blades 18.

[0085] Figure 6 The blade 18 is shown to be secured within a polymer pad 48, with a base portion 52 of the blade 18 embedded within the polymer pad 48, and a blade portion 54 extending outward from the base portion 52. In some cases, as shown, the base portion 52 may extend proximally from the proximal end 44 of the blade 18 a certain distance. In some cases, this extension of the base portion 52 provides a more secure hold of the blade 18 within the polymer pad 48. In some cases, the base portion 52 may include a T-slot 56 adapted to provide additional flexibility to the base portion 52 and to facilitate embedding the base portion 52 within the polymer pad 48.

[0086] exist Figure 6In the design, blade 18 includes a first cutting edge portion 64 and a second cutting edge portion 66. As shown, the first cutting edge portion 64 can be considered as tapering distally from the distal end 42 of blade 18 to an inflection point 68, where the inflection point 68 represents the intersection of the first cutting edge portion 64 and the second cutting edge portion 66. The second cutting edge portion 66 can be considered as parallel to or at least substantially parallel to the polymer pad 48, where substantially parallel is defined as a deviation from parallel within 10%. The second cutting edge portion 66 extends from the inflection point 68 of blade 18 to the proximal end 44. In some cases, the first cutting edge portion 64 and the second cutting edge portion 66 facilitate proximal pulling of blade 18 through the lesion when the inflatable balloon 16 is inflated. This can be useful, especially when the lesion is longer than the blade or multiple blades 18.

[0087] Figure 7 The blade 18 is shown to be secured within a polymer pad 48, with a base portion 52 of the blade 18 embedded within the polymer pad 48, and a blade portion 54 extending outward from the base portion 52. In some cases, as shown, the base portion 52 may extend proximally from the proximal end 44 of the blade 18 a certain distance. In some cases, this extension of the base portion 52 provides a more secure hold of the blade 18 within the polymer pad 48. In some cases, the base portion 52 may include a T-slot 56 adapted to provide additional flexibility to the base portion 52 and to facilitate embedding the base portion 52 within the polymer pad 48.

[0088] exist Figure 7 In this design, blade 18 includes a first cutting edge portion 70 and a second cutting edge portion 72. The first cutting edge portion 70 tapers proximally from the distal end 42 of blade 18 to an inflection point 74. The second cutting edge portion 72 tapers proximally from the inflection point 74 of blade 18 at a different angle to the proximal end 44. In some cases, the first cutting edge portion 70 and the second cutting edge portion 72 facilitate proximal pulling of blade 18 through the lesion while the inflatable balloon 16 is inflated. This can be useful, especially when the lesion is longer than blade 18 or multiple blades 18.

[0089] Figure 8 This is a schematic diagram of an example medical device 76. The example medical device 76 can be considered as an example of medical device 10. Medical device 76 includes an inflatable balloon 16a fixed relative to a distal region 14 of an elongated axis 12. The inflatable balloon 16a can be considered to include a mid-section 36a with varying diameter, a distal region 38a tapering from the mid-section 36a to a distal waist 32, and a proximal region 40a tapering from the mid-section 36a to a proximal waist 30.

[0090] The inflatable balloon 16a may be made of angioplasty balloon materials, including polymers such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), polybutylene terephthalate (PBT), polyurethane, polyvinyl chloride (PVC), polyether esters, polyesters, polyamides, elastomeric polyamides, polyether block amides (PEBA), and other suitable materials or mixtures, compositions, copolymers, polymer / metal composites, etc. In some cases, the inflatable balloon 16a may comprise a single-layer material, while in others, the inflatable balloon 16a may be a multi-layer construction, comprising multiple layers of material. For example, in some cases, the inflatable balloon 16a may be formed as a co-extrusion or a tri-extrusion.

[0091] In some cases, the medical device 76 includes one or more blades 18a. The blades 18a have a constant blade height, indicated by D5. The blades 18a extend from a distal end 42 to a proximal end 44a and exhibit a tapered cutting edge 46a extending between the distal end 42a and the proximal end 44a. In some cases, the tapered cutting edge 46a is adapted to pull the medical device 76 proximally through the lesion when the inflatable balloon 16a is inflated. The inflatable balloon 16a may be configured such that it includes one or more "wings" or wing-shaped regions when scaled up. In some cases, the wings may be configured such that the blades 18a can be positioned at the innermost position of the scaled inflatable balloon 16a, wherein folds in the balloon wings are positioned between adjacent blades 18a. This arrangement reduces the exposure of the blades 18a to blood vessels during delivery of the inflatable balloon 16a to the lesion.

[0092] The blade 18a may be made of any suitable material, such as metal, metal alloy, polymer, metal-polymer composite, or any other suitable material. For example, in some cases, the blade 18a may be made of stainless steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy, or other metallic materials. The blade 18a may have a triangular cross-sectional shape, a square cross-sectional shape, a rectangular cross-sectional shape, a circular cross-sectional shape, or any other desired shape.

[0093] The inflatable balloon 16a pushes the tapered cutting edge 46a to a position where the tapered cutting edge 46a can cut or score the lesion when the medical device 76 is pulled proximally through the lesion. In some cases, the inflatable balloon 16a may be sized to push the tapered cutting edge 46a to a position contacting the lesion, but its size itself may not be sufficient to cause the lesion to rupture or otherwise deform. As an example, the inflatable balloon 16a may have a maximum diameter ranging from 1.5 mm to 2.5 mm; however, other sizes are also conceivable. The inflatable balloon 16a can be considered to have a centerline CL extending axially through it. In some cases, the centerline CL may be considered to be aligned with... Figure 1 The longitudinal axes LA shown are collinear. In some cases, the tapered cutting edge 46a can be measured relative to its distance from the centerline CL. As an example, the tapered cutting edge 46a can taper from a maximum radial distance D1 between the distal end 42a of the blade 18 and the centerline CL to a minimum radial distance D2 between the proximal end 44a of the blade 18 and the centerline CL. In some cases, the maximum distance D1 can be in the range of 2 mm to 4 mm, while the minimum distance D2 can be in the range of 1 mm to 2 mm.

[0094] Figure 9 This is a schematic diagram of an example medical device 78. The example medical device 78 can be considered as an example of medical device 10. Medical device 78 includes an inflatable balloon 16b fixed to a distal region 14 relative to an elongated axis 12. The inflatable balloon 16b can be considered to include a mid-section 36b with varying diameter, a distal region 38b tapering from the mid-section 36b to a distal waist 32, and a proximal region 40b tapering from the mid-section 36b to a proximal waist 30.

[0095] The inflatable balloon 16b may be made of angioplasty balloon materials, including polymers such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), polybutylene terephthalate (PBT), polyurethane, polyvinyl chloride (PVC), polyether esters, polyesters, polyamides, elastomeric polyamides, polyether block amides (PEBA), and other suitable materials or mixtures, compositions, copolymers, polymer / metal composites, etc. In some cases, the inflatable balloon 16b may comprise a single-layer material, while in others, the inflatable balloon 16b may be a multi-layer construction, including multiple layers of material. For example, in some cases, the inflatable balloon 16b may be formed as a co-extrusion or a tri-extrusion.

[0096] In some cases, the medical device 78 includes one or more tapered blades 18b. The tapered blades 18b taper from a distal end 42b to a proximal end 44b and exhibit a tapered cutting edge 46b extending between the distal end 42b and the proximal end 44b. It should be understood that in Figure 9 In this configuration, the tapered cutting edge 46b is adapted to pull the medical device 58 proximally through the lesion when the inflatable balloon 16b is inflated. Inflating the inflatable balloon 16b pushes the tapered cutting edge 46b to a position where it can cut or score the lesion while pulling the medical device 78 proximally through it. In some cases, the inflatable balloon 16b may be sized to push the tapered cutting edge 46b to contact the lesion, but its size may not be sufficient to cause the lesion to rupture or otherwise deform. As an example, the inflatable balloon 16b may have a maximum diameter ranging from 1.5 mm to 2.5 mm; however, other sizes are also conceivable.

[0097] The blade 18b can be made of any suitable material, such as metal, metal alloy, polymer, metal-polymer composite, or any other suitable material. For example, in some cases, the blade 18b can be made of stainless steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy, or other metallic materials. The blade 18b can have a triangular cross-sectional shape, a square cross-sectional shape, a rectangular cross-sectional shape, a circular cross-sectional shape, or any other desired shape.

[0098] The inflatable balloon 16b can be considered to have a centerline CL extending axially through it. In some cases, the centerline CL can be considered to be parallel to... Figure 1 The longitudinal axes LA shown are collinear. In some cases, the tapered cutting edge 46b may be measured relative to the distance from the centerline CL. As an example, the tapered cutting edge 46b may taper from a maximum radial distance D1 measured between the distal end 42b of the tapered blade 18b and the centerline CL to a minimum radial distance D2 measured between the proximal end 44b of the tapered blade 18b and the centerline CL. In some cases, the maximum distance D1 may be in the range of 2 mm to 4 mm, while the minimum distance D2 may be in the range of 1 mm to 2 mm. In some cases, the tapered blade 18 itself may have a blade height measured relative to the outer surface 50 of the inflatable balloon 16, wherein the maximum blade height is located at the distal end 42b of the tapered blade 18b, shown as D3. The tapered blade 18b may have a minimum blade height in the range of 0 to 0.5 mm at the proximal end 44b of the tapered blade 18b, shown as D4.

[0099] Figures 10 to 14 A schematic diagram illustrating an example use of the medical device 10 is provided. Although Figures 10 to 14The use of medical device 10 is shown, but it should be understood that medical device 34 (with a balloon 16 of constant diameter and a conical blade 18), medical device 76 (with a conical balloon 16a and a blade 18a of constant height) or medical device 78 (with a conical balloon 16b and a conical blade 18b) can be used in the same manner. Figures 4 to 7 The various blade shapes shown can also be easily used in the same way.

[0100] exist Figure 10 In this process, catheter 84 has been advanced through blood vessel 80 to a position immediately adjacent to lesion 82. For example, lesion 82 may be a calcified lesion. In some cases, lesion 82 may be a fibrous lesion, particularly when lesion 82 is located within the patient's venous system. In some cases, a guidewire, such as guidewire 20 (not in...), may be used. Figure 10 (As shown in the image) Advance catheter 84. In some cases, catheter 84 can be advanced without a guidewire.

[0101] exist Figure 11 As can be seen, the medical device 10 has been advanced through the catheter 84 and begins to extend beyond the distal end 86 of the catheter 84. In some cases, the medical device 10 can be advanced through the catheter 84 without a guidewire. In some cases, the medical device 10 can be advanced on a guidewire, such as guidewire 20 extending through the catheter 84. In some cases, the medical device 10 can be advanced on a guidewire, such as guidewire 20, without using the catheter 84. Figure 11 The location shown. Once the medical device 10 reaches, such as... Figure 11 As shown, with the inflatable balloon 16 positioned distal to the lesion 82, the catheter 84 can be withdrawn (if used).

[0102] exist Figure 12 In the middle, catheter 84 has been withdrawn proximally and no longer extends distally through lesion 82. Inflatable balloon 16 is inflated, which pushes blade 18 in a radially outward direction. Slender shaft 12 can be pulled proximally, thereby pulling inflatable balloon 16 and blade 18 proximally through lesion 82. As inflatable balloon 16 and blade 18 move proximally through lesion 82, blade 18 indents lesion 82. Inflatable balloon 16 and blade 18 will terminate proximally to lesion 82, as... Figure 13 As shown. Subsequently, the inflatable balloon 16 is expandable and contractible, and the medical device 10 can be withdrawn into the catheter 84 by pushing the catheter 84 distally relative to the medical device 10 or by pulling the medical device 10 proximally, so that the medical device 10 returns to the catheter 84, as shown. Figure 14 As shown. The catheter 84 (and medical device 10) is advanced distally again beyond the lesion 82 (as initially in). Figure 10 and Figure 11Before (as shown in the diagram), the rotatable catheter 84 (and medical device 10) can be rotated, and the process can be repeated (as shown in the diagram). Figure 12 and Figure 13 (as shown), to provide additional cuts or notches on lesion 82.

[0103] In some cases, the blade or multiple blades 18 and / or the elongated shaft 12 and / or the inflatable balloon 16 may include an elutable drug coating. In some cases, a drug composition may be injected or otherwise inserted into a lumen extending through the elongated shaft 12 or the catheter 84 to deliver a fluid drug composition in an area immediately adjacent to the lesion 82. In some cases, multiple incisions or fissures are formed within the lesion 82, such as using... Figures 10 to 14 The process shown facilitates increased contact between the drug and the interior of the lesion 82. For example, this can enhance drug efficacy. Various different drugs are conceivable, including those that can help soften or dissolve the lesion 82.

[0104] In some cases, depending on the composition of lesion 82, particularly when lesion 82 is located within the arterial system, the blade or multiple blades 18 may be able to create a fissure within lesion 82. In some cases, depending on the composition of lesion 82, particularly when lesion 82 is located within the venous system, the blade or multiple blades 18 may be able to cut into lesion 82. In some cases, lesions within the venous system may tend to be softer and more fibrous, and therefore will not fissure like those in more calcified lesions within the arterial system. It should be understood that creating fissures or incisions within lesion 82 may allow drugs, such as elutable drugs, to penetrate further into lesion 82.

[0105] In some cases, the catheter shaft 12 and / or the inflatable balloon 16 may include one or more braids that can increase the tensile strength of the catheter shaft 12 and / or the inflatable balloon 16, particularly when the catheter shaft 12 is pulled proximally to pull the blade or multiple blades 18 through the lesion 82. In some cases, the braids may extend at least partially over the blade or multiple blades 18, and in some cases, may help to hold the blade or multiple blades 18 in place relative to the inflatable balloon 16. Figures 15 to 20 Several examples are provided of how one or more braids can be used within the catheter shaft 12 and / or the inflatable balloon 16. Figure 15This is a schematic diagram of an example medical device 90. The example medical device 90 includes an inflatable balloon 16 fixed to an elongated shaft 12. Two visible blades 18 are fixed relative to the inflatable balloon 16. In some cases, only one blade 18 may be fixed relative to the inflatable balloon 16. In some cases, there may be three, four, five, or more blades 18 fixed relative to the inflatable balloon 16. In some cases, if there are two or more blades 18 fixed relative to the inflatable balloon 16, the two or more blades 18 may be circumferentially uniformly spaced around the inflatable balloon 16, or the blades 18 may be circumferentially non-uniformly spaced around the inflatable balloon 16.

[0106] Figure 16 It is along Figure 15 The image shows a cross-sectional view taken by line 16-16, illustrating a cross-section through one wall of the elongated shaft 12. In some cases, the elongated shaft 12 may include an outer polymer layer 100 and an inner polymer layer 102. Each of the outer polymer layer 100 and the inner polymer layer 102 may be formed from any of a variety of different polymers, including those listed below. In some cases, the inner polymer layer 102 may be formed from a lubricating polymer, such as a fluoropolymer. Polytetrafluoroethylene (PTFE) is an example of a fluoropolymer that can be used to form the inner polymer layer 102. In some cases, the inner polymer layer 102 may not be formed from a lubricating polymer but may include a lubricating coating. In some cases, the outer polymer layer 100 may actually comprise two or more different polymer layers. In some cases, the inner polymer layer 102 may actually comprise two or more different polymer layers, wherein the innermost layer is formed from a lubricating polymer and / or includes a lubricating coating.

[0107] A braided fabric 104 is disposed between the outer polymer layer 100 and the inner polymer layer 102. The braided fabric 104 can take any of a variety of forms. For example, the braided fabric 104 can be a knitted or woven fabric. The braided fabric 104 can be formed from any number or pattern of filaments in any desired knitted or woven pattern. For example, the braided fabric 104 can be a 1×1 braid, a 2×2 braid, a 3×3 braid, or a 4×4 braid. The braided fabric 104 can be formed from one or more filaments having a circular cross-sectional profile, as shown. The braided fabric 104 can be formed from one or more filaments having any other cross-sectional profile. For example, the braided fabric 104 can be formed from one or more filaments having a flat or even straight cross-sectional profile. The braided fabric 104 can extend the length of the elongated shaft 12. For example, the braided fabric 104 can extend only a portion of the length of the elongated shaft 12.

[0108] Figure 17 It is along Figure 15The image shows a cross-sectional view taken along line 17-17, illustrating a cross-section through one wall of the inflatable balloon 16. The inflatable balloon 16 includes an outer polymer layer 106 and an inner polymer layer 108. In some cases, the outer polymer layer 106 may be different from the outer polymer layer 100 of the elongated shaft 12. In some cases, the outer polymer layer 106 may be the same polymer as the outer polymer layer 100. The inner polymer layer 108 may be different from the inner polymer layer 102 of the elongated shaft 12. In some cases, the inner polymer layer 108 may be the same polymer as the inner polymer layer 102.

[0109] A braid 104 extends between an outer polymer layer 106 and an inner polymer layer 108. In some cases, the braid 104 may be the same braid extending through the elongated shaft 12. In other cases, the braid 104 may be a separate braid from the braid extending through the elongated shaft 12. The braid 104 may extend at least partially through the elongated shaft 12 and through the inflatable balloon 16 to provide additional tensile strength to the medical device 90. In some cases, the braid 104 may extend all the way through the inflatable balloon 16. In some cases, the braid 104 may extend only partially through the inflatable balloon 16. As an example, the braid 104 may extend from the elongated shaft 12 to the midpoint of the inflatable balloon 16.

[0110] The medical device 90 includes a polymer pad 48 that facilitates securing the blade 18 to an inflatable balloon 16. In some cases, the blade 18 may be partially embedded within the polymer pad 48. As an example, the blade 18 may include a T-shaped slot 56 ( Figure 3 This not only provides additional flexibility but also facilitates embedding the blade 18 within the polymer pad 48. The polymer pad 48 can be formed from any of a variety of different polymers.

[0111] Figure 18 This is a schematic diagram of an example medical device 110. The example medical device 110 includes an inflatable balloon 16 fixed to an elongated shaft 12. Two visible blades 18 are fixed relative to the inflatable balloon 16. In some cases, only one blade 18 may be fixed relative to the inflatable balloon 16. In some cases, there may be three, four, five, or more blades 18 fixed relative to the inflatable balloon 16. In some cases, if there are two or more blades 18 fixed relative to the inflatable balloon 16, the two or more blades 18 may be circumferentially uniformly or non-uniformly spaced around the inflatable balloon 16. Each blade or plurality of blades 18 is fixed to the inflatable balloon 16 via a polymer pad 48.

[0112] In some cases, woven fabric can be used to help secure the blade or multiple blades 18 in place. Figure 19 It is along Figure 18A cross-sectional view taken along lines 19-19. The inflatable balloon 16 includes a polymer layer 112 to which a polymer pad 48 is secured, thereby at least partially anchoring the blade 18 relative to the inflatable balloon 16. An outer layer 114, which may include a braid 116 embedded within the polymer, extends over the polymer layer 112. The outer layer 114 also extends at least partially over the polymer pad 48 and over a portion of the blade 18, thereby further securing the blade 18 relative to the inflatable balloon 16. In some cases, the outer layer 114 may consist only of the braid 116 and may not include the polymer in which the braid 116 is embedded. Thus, the braid 116 may extend radially outward from the base of the blade 18 and / or the polymer pad 48 to further secure the blade 18 to the balloon 16, such that the base of the blade 18 and / or the polymer pad 48 is interposed between the braid 116 and the polymer pad 112 of the balloon 16.

[0113] The woven fabric 116 can take any of a variety of forms. For example, the woven fabric 116 can be a knitted fabric or a woven fabric. The woven fabric 116 can be formed from any number and pattern of filaments, in any desired knitted or woven pattern. For example, the woven fabric 116 can be a 1×1 woven fabric, a 2×2 woven fabric, a 3×3 woven fabric, or a 4×4 woven fabric. The woven fabric 116 can be formed from one or more filaments having a circular cross-sectional profile, as shown. The woven fabric 116 can be formed from one or more filaments having any other cross-sectional profile. For example, the woven fabric 116 can be formed from one or more filaments having a flat or even straight cross-sectional profile. The woven fabric 116 can extend only a portion of the inflatable bladder 16 itself. In some cases, the woven fabric 116 can also extend along at least a portion of the length of the elongated axis 12.

[0114] In some cases, the braid 116 may extend across the length of the inflatable balloon 16. In some cases, the braid 116 may be cut, formed, or otherwise manipulated to cover at least the end and / or base of the blade 18 (e.g., Figure 19 (as shown), while allowing the cutting edge of the blade 18 to extend on the weave 116 in other ways. Figure 20 It is along Figure 19 The image shows a cross-sectional view taken along line 20-20, illustrating how the braid 116 (possibly embedded in the polymer to form the outer layer 114) extends along the length of the blade 18 (and possibly longer) along the inflatable balloon 16. Thus, in some cases, the braid 116 may extend proximally to the proximal end of the blade 18 and / or distally to the distal end of the blade 18. In some cases, the medical device 110 may include another polymer layer 118 covering the braid 116. As an example, the inflatable balloon 16 may be impregnated with a polymer, such as polyurethane, to coat the braid 116, thereby forming the polymer layer 118.

[0115] Figure 21 It is along Figure 20 A cross-sectional view taken along lines 21-21. The blade 18 may be shown as including a base portion 54 embedded within a polymer pad 48 and a blade portion 52 extending outwardly from the base portion 54. As shown, a braided layer 116 extends over at least the base portion 54 of the blade 18 (i.e., radially outward) to further secure the blade 18 in place relative to the inflatable balloon 16. The braided layer 116 may form a layer 114 itself, or may be embedded within the polymer to form a layer 114. In some cases, after the braided layer 116 is placed on the base portion 54 of the blade 18, the assembly (e.g., the balloon 16 and blade 18) may also be impregnated with a polymer, such as polyurethane, to form a polymer layer 118.

[0116] Materials that can be used for the various components and elements of the medical devices disclosed herein may include those commonly associated with medical devices. In some embodiments, the medical device and / or its components may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials.

[0117] Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® available from Bayer or available from Elf). Atochem's CRISTAMID®, elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, MARLEX® low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene ether (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfones, nylon, nylon-12 (such as those available from EMS American) Grilon may use GRILAMID®, perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, polyurethane silicone copolymers (e.g., ElastEon® from Aortech Biomaterials or ChronoSil® from AdvanSource Biomaterials), biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0118] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; mild steels; nickel-titanium alloys such as linearly elastic and / or superelastic nickel-titanium alloys; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.); and nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKE). LVAC®400, NICORROS®400, etc.); nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.); nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY®ALLOYB2®); other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; platinum; palladium; gold; combinations thereof; or any other suitable material.

[0119] In at least some cases, part or all and / or components of the medical device may also be doped with, made of, or otherwise incorporated into a radiopaque material. Radiopaque materials are understood to be capable of producing a relatively bright image on a fluorescent fluoroscopic screen or using another imaging technique during medical procedures. This relatively bright image helps the user of the device determine its location. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into the design of the device to achieve the same result.

[0120] In some cases, a degree of magnetic resonance imaging (MRI) compatibility is endowed to the medical devices and / or other components disclosed herein. For example, the device and / or its components or portions may be made of materials that substantially do not distort images and create a large number of artifacts (e.g., gaps in the image). Certain ferromagnetic materials may be unsuitable, for example, because they may create artifacts in MRI images. The device or its portions may also be made of materials that an MRI machine can image. Some materials exhibiting these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), nickel-titanium, etc.

[0121] In some cases, the medical devices and / or other elements disclosed herein may include suitable therapeutic agents and / or be used for treatment. Some examples of suitable therapeutic agents may include anticoagulants (such as heparin, heparin derivatives, urokinase, and PPack (d-phenylalanine-proline-arginine-chloromethyl ketone); antiproliferative agents (such as enoxaparin, angiopeptidase, monoclonal antibodies that block smooth muscle cell proliferation, hirudin, and acetylsalicylic acid); anti-inflammatory drugs (such as dexamethasone, prednisolone, corticosteroids, budesonide, estrogens, sulfasalazine, and mesalazine); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, vinblastine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors); anesthetics (such as lidocaine, bupivacaine, and ropivacaine); and anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone). Ketones, compounds containing RGD peptides, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides; angiogenesis promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcription activators, and translation promoters); angiogenesis inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcription repressors, translation repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules composed of growth factors and cytotoxins, and bifunctional molecules composed of antibodies and cytotoxins); cholesterol lowering agents; vasodilators; and agents that interfere with endogenous vasoactive mechanisms.

[0122] Several illustrative embodiments of the present invention have been described above, but those skilled in the art will readily understand that other embodiments can be constructed and used within the scope of the appended claims. However, it should be understood that the invention is merely illustrative in many respects. Changes may be made in details, particularly in shape, size, arrangement of parts, and exclusion and order of steps, without departing from the scope of the invention. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

1. A medical device comprising: A catheter axis, the catheter axis including a distal region; An inflatable balloon fixed to the distal region of the catheter axis, the inflatable balloon having an outer surface, the inflatable balloon defining a centerline upon inflation; as well as A blade extending from and fixed to the outer surface, the blade having a cutting edge extending from the distal end of the blade to the proximal end of the blade, wherein, when the inflatable balloon is inflated, the cutting edge tapers from a maximum distance measured at the distal end of the blade relative to the centerline of the balloon to a minimum distance measured at the proximal end of the blade relative to the centerline of the balloon.

2. The medical device of claim 1, wherein the cutting edge of the blade comprises a straight line.

3. The medical device according to any one of claims 1 or 2, wherein, during inflation, the outer surface of the inflatable balloon is at a constant distance from the centerline of the inflatable balloon.

4. The medical device according to any one of claims 1 to 3, wherein the cutting edge of the blade tapers from the distal end of the blade to the proximal end of the blade.

5. The medical device according to any one of claims 1 to 4, wherein the cutting edge of the blade defines a blade height above the outer surface of the inflatable balloon, and the blade height tapers from a maximum blade height at the distal end of the blade to a minimum blade height at the proximal end of the blade.

6. The medical device of claim 1, wherein, during inflation, the outer surface of the inflatable balloon has a varying distance relative to the centerline of the inflatable balloon.

7. The medical device of claim 6, wherein the distance between the outer surface of the inflatable balloon and the longitudinal axis is greatest in the distal region of the inflatable balloon and smallest in the proximal region of the inflatable balloon.

8. The medical device according to any one of claims 6 or 7, wherein the cutting edge of the blade has a constant height relative to the outer surface of the inflatable balloon.

9. The medical device according to any one of claims 6 to 8, wherein the cutting edge of the blade has a varying height relative to the outer surface of the inflatable balloon.

10. The medical device according to any one of claims 1 to 9, further comprising one or more additional blades, each of the one or more additional blades extending from and being attached to the outer surface, each of the one or more additional blades having a cutting edge extending from a distal end of the blade to a proximal end of the blade, extending from a maximum distance measured at the distal end of the blade relative to the centerline of the inflatable balloon to a minimum distance measured at the proximal end of the blade relative to the centerline of the inflatable balloon when the inflatable balloon is inflated.

11. A medical device comprising: A catheter axis, the catheter axis including a distal region; An inflatable balloon fixed to the distal region of the catheter axis, the inflatable balloon comprising: A constant-diameter midsection, the constant-diameter midsection corresponding to the position where the polymer pad is fixed to the outer surface of the inflatable balloon; The distal region that gradually narrows towards the distal waist; and Gradually shrinking to the proximal region near the waist; A polymer pad with a constant diameter at the midsection of the inflatable balloon; and A blade fixed within the polymer pad defines a tapered cutting edge extending from the distal end of the blade to the proximal end of the blade, the tapered cutting edge having a maximum blade height relative to the polymer pad at the distal end of the blade and a minimum blade height relative to the polymer pad at the proximal end of the blade.

12. The medical device of claim 11, wherein the constant-diameter middle section has a diameter in the range of 1.5 to 2.5 mm when inflated.

13. The medical device according to any one of claims 11 or 12, wherein: The minimum blade height is in the range of 0 to 0.5 mm; and The maximum blade height is in the range of 1 to 2 millimeters.

14. A medical device comprising: A catheter axis, the catheter axis including a distal region; An inflatable balloon fixed to the distal region of the catheter axis, the inflatable balloon including a tapered midsection corresponding to the position where the polymer pad is fixed to the outer surface of the inflatable balloon, the tapered midsection tapering from a maximum diameter near the distal region to a minimum diameter near the proximal region; A polymer pad fixed to the conical middle section of the inflatable balloon; as well as A blade fixed within the polymer pad defines a cutting edge extending from the distal end of the blade to the proximal end of the blade.

15. The medical device of claim 14, wherein the cutting edge has a uniform height measured relative to the polymer pad.

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