Cutting blade with shortened tip blade segment

Abstract

A medical device that can be used to rupture or cut an endovascular lesion can include a unitary blade or blade assembly that includes a first end blade segment and a second end blade segment. A length of each of the first and second end blade segments may be defined at least in part by one or more bending points that may be such that the first and second end blade segments can bend at least 30 degrees relative to the longitudinal axis when the integral blade is pressed against a lesion.

Description

Cross Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 468,615, filed May 24, 2023, which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present disclosure relates to angioplasty balloon catheters that include one or more cutting blades mounted on the balloon. More particularly, the present disclosure relates to cutting blades of cutting balloon catheters having shortened tip blade segments. BACKGROUND

[0003] Cardiac and vascular disease is a major problem in the United States and worldwide. Diseases such as atherosclerosis can cause blockages or stenosis in blood vessels. Such blockages can result in oxygen deprivation to the heart, which must be sufficiently oxygenated to maintain its pumping function, with serious consequences, or to other parts of the body, and / or poor blood circulation.

[0004] Occluded, stenotic, or narrowed blood vessels, as well as natural or synthetic arteriovenous dialysis fistulas, can be treated by a recanalization procedure, such as advancing an angioplasty balloon catheter over a guide wire to the occlusion, positioning the balloon on either side of the occlusion. The balloon is then inflated to enlarge the passage at the occlusion.

[0005] One of the major obstacles in treating coronary artery disease and / or treating blocked blood vessels or fistulas is that the passage at the occlusion can re-stenose or re-narrow after an angioplasty or other recanalization procedure. There is evidence that the incidence of restenosis can be reduced by treating the stenosis site with a rupture, cutting, or scoring process during treatment, such as with an angioplasty balloon equipped with a blade member. In addition, treating the stenosis site with a rupture, cutting, or scoring process can also reduce trauma to the treatment site and / or trauma to adjacent healthy tissue. Blade members can also be a beneficial addition to angioplasty when the target occlusion site is hardened or calcified. It is believed that some such hardened lesions can not be dilated by a conventional angioplasty balloon alone. Therefore, angioplasty balloons equipped with blade members have been developed in an attempt to enhance the treatment effect of angioplasty. For example, the blade members can be used to cut, rupture, or score the lesion. While these blade members can include a bend point that allows the blade member to bend, there is a need for a blade member that can bend further so that the tip segment of the blade member can bend a greater angle relative to the end of a calcified portion of the lesion while also being deliverable through a curved portion of the blood vessel. SUMMARY

[0006] The present disclosure relates to various alternative designs, materials, and manufacturing methods for medical device structures and assemblies, and uses thereof. One example is a medical device comprising a catheter shaft having a distal region and an inflatable balloon secured at the distal region. An integral blade member extends longitudinally relative to the inflatable balloon and is an integral blade member secured relative to an outer surface of the inflatable balloon. The integral blade member includes a base extending from a first end to a second end thereof, and a blade portion extending outwardly from the base. The blade portion includes a first terminal blade segment extending from the first end of the integral blade member to a first bend point formed therein, the first terminal blade segment having a first terminal blade segment length, a second terminal blade segment extending from the second end of the integral blade member to a second bend point formed therein, the second terminal blade segment having a second terminal blade segment length, and at least one intermediate blade segment extending between the first and second bend points, each of the at least one intermediate blade segment having an intermediate blade segment length, the intermediate blade segment length being greater than the first and second terminal blade segment lengths.

[0007] Optionally or additionally, the length of the terminal blade segments can be such that when the second bend point is located within two millimeters of an opposite second end of the lesion, the first bend point is located within two millimeters of a first end of the lesion.

[0008] Optionally or additionally, the first bend point can comprise a first gap in the blade portion, and the second bend point can comprise a second gap in the blade portion, wherein the base extends without any gaps.

[0009] Optionally or additionally, the first terminal blade segment length can be equal to the second terminal blade segment length, wherein the base extends without any gaps.

[0010] Optionally or additionally, the first terminal blade segment length can be less than 3 millimeters, and the second terminal blade segment length can be less than 3 millimeters.

[0011] Optionally or additionally, the first terminal blade segment length can be less than 2 millimeters, and the second terminal blade segment length can be less than 2 millimeters.

[0012] Optionally or additionally, the medical device can further include one or more additional monolithic blade members extending longitudinally along an outer surface of the inflatable balloon. Each of the one or more additional monolithic blade members can include a base extending from a first end to a second end thereof, and a blade portion extending outwardly from the base. The blade portion includes a first terminal blade segment extending from the first end of the monolithic blade member to a first bend point formed therein, the first terminal blade segment having a first terminal blade segment length; a second terminal blade segment extending from the second end of the monolithic blade member to a second bend point formed therein, the second terminal blade segment having a second terminal blade segment length; and at least one intermediate blade segment extending between the first bend point and the second bend point, the at least one intermediate blade segment having an intermediate blade segment length that is greater than the first terminal blade segment length and the second terminal blade segment length.

[0013] Another example is a medical device including an inflatable balloon secured to a distal region of a catheter shaft having a longitudinal axis, and a plurality of blade assemblies secured to the inflatable balloon and extending longitudally relative thereto. Each of the plurality of blade assemblies has a longitudinal axis and includes a polymer pad adapted to be secured to the inflatable balloon, and a plurality of blade segments secured within the polymer pad. The plurality of blade segments includes a first terminal blade segment having a length of less than 3 millimeters at a first end of the blade assembly, a second terminal blade segment having a length of less than 3 millimeters at an opposite second end of the blade assembly, and at least one intermediate blade segment disposed between the first terminal blade segment and the second terminal blade segment.

[0014] Optionally or additionally, the polymer pad can include a single polymer pad, each of the plurality of blade segments being axially aligned relative to and secured within the single polymer pad.

[0015] Optionally or additionally, the polymer pad can include a plurality of separate polymer pad segments, each of the plurality of blade segments being secured within an individual one of the plurality of separate polymer pad segments.

[0016] Optionally or additionally, the first terminal blade segment is positioned relative to an adjacent intermediate blade segment such that the first terminal blade segment is capable of bending relative to the longitudinal axis through an angle greater than 30 degrees; the second terminal blade segment is positioned relative to an adjacent intermediate blade segment such that the second terminal blade segment is capable of bending relative to the longitudinal axis through an angle greater than 30 degrees.

[0017] Optionally or additionally, the first terminal blade segment is positioned relative to an adjacent intermediate blade segment such that the first terminal blade segment is capable of bending relative to the longitudinal axis through an angle greater than 45 degrees; the second terminal blade segment is positioned relative to an adjacent intermediate blade segment such that the second terminal blade segment is capable of bending relative to the longitudinal axis through an angle greater than 45 degrees.

[0018] Optionally or additionally, the at least one intermediate blade segment can extend parallel to the longitudinal axis when the first terminal blade segment and the second terminal blade segment are bent at an angle greater than 30 degrees relative to the longitudinal axis.

[0019] Another example is a method of treating an intravascular lesion. The method includes advancing a medical device through a blood vessel to a position proximate to the lesion, the medical device including an inflatable balloon and a monolithic blade including a base extending from a first end to a second end thereof and a blade portion extending outwardly from the base. The blade portion includes a first blade segment extending from the first end of the monolithic blade member to a first bend point formed therein, a second blade segment extending from the second end of the monolithic blade member to a second bend point formed therein, and a third blade segment extending between the first blade segment and the second blade segment. The method includes positioning the medical device such that the first blade segment extends to a distal end of the lesion and the second blade segment extends to a proximal side of the lesion. The inflatable balloon is inflated to urge the monolithic blade toward the lesion, at least one of the first blade segment and the second blade segment being bent at an angle greater than 30 degrees relative to the third blade segment.

[0020] Optionally or additionally, at least one of the first blade segment and the second blade segment can be bent at an angle greater than 45 degrees relative to the third blade segment when the inflatable balloon is inflated.

[0021] Another example is a medical device including a catheter shaft having a distal region and an inflatable balloon secured at the distal region. A monolithic blade member extends longitudinally relative to the inflatable balloon and is secured relative to an outer surface of the inflatable balloon. The monolithic blade member includes a base extending from a first end to a second end thereof and a blade portion extending outwardly from the base. The blade portion includes a first terminal blade segment extending from the first end of the monolithic blade member to a first bend point formed therein, the first terminal blade segment having a first terminal blade segment length, a second terminal blade segment extending from the second end of the monolithic blade member to a second bend point formed therein, the second terminal blade segment having a second terminal blade segment length, and at least one intermediate blade segment between the first bend point and the second bend point, each intermediate blade segment having a length greater than the first terminal blade segment length and the second terminal blade segment length.

[0022] Optionally or additionally, the length of the terminal blade segment can be such that when the second bend point is within two millimeters of an opposite second end of the lesion, the first bend point is within two millimeters of a first end of the lesion.

[0023] Optionally or additionally, the first bend point can include a first gap in the blade portion.

[0024] Optionally or additionally, the second bend point can include a second gap in the blade portion, wherein the base portion extends without any gaps.

[0025] Optionally or additionally, the first end blade segment length can be equal to the second end blade segment length, wherein the base portion extends without any gaps.

[0026] Optionally or additionally, the first end blade segment length can be less than 3 millimeters.

[0027] Optionally or additionally, the first end blade segment length can be less than 2 millimeters.

[0028] Optionally or additionally, the second end blade segment length can be less than 2 millimeters.

[0029] Optionally or additionally, the second end blade segment length can be less than 3 millimeters.

[0030] Optionally or additionally, the medical device can further include one or more additional monolithic blade members extending longitudinally along an outer surface of the inflatable balloon. Each of the one or more additional monolithic blade members can include a base portion extending from a first end to a second end thereof, and a blade portion extending outwardly from the base portion. The blade portion includes a first end blade segment extending from the first end of the monolithic blade member to a first bend point formed therein, the first end blade segment having a first end blade segment length; a second end blade segment extending from the second end of the monolithic blade member to a second bend point formed therein, the second end blade segment having a second end blade segment length; and at least one intermediate blade segment extending between the first bend point and the second bend point, the at least one intermediate blade segment having an intermediate blade segment length that is greater than the first end blade segment length and the second end blade segment length.

[0031] Another example is a medical device including an inflatable balloon secured at a distal region of a catheter shaft having a longitudinal axis. A plurality of monolithic blade members are secured on the inflatable balloon and extend longitudinally relative thereto. Each of the plurality of monolithic blade members includes a base portion extending from a first end to a second end thereof, and a blade portion extending outwardly from the base portion. The blade portion includes a first end blade segment extending from the first end of the monolithic blade member to a first bend point formed therein, the first end blade segment having a length that is less than 3 millimeters; a second end blade segment extending from the second end of the monolithic blade member to a second bend point formed therein, the second end blade segment having a length that is less than 3 millimeters; and at least one intermediate blade segment extending between the first bend point and the second bend point, each of the at least one intermediate blade segment having an intermediate blade segment length that is greater than 3 millimeters.

[0032] Optionally or additionally, the plurality of monolithic blade members can include four blade members, each monolithic blade member arranged about 90 degrees circumferentially from the nearest adjacent monolithic blade member.

[0033] Optionally or additionally, for each of the plurality of monolithic blade members, the first bend point can include a first gap in the blade portion.

[0034] Optionally or additionally, for each of the plurality of monolithic blade members, the second bend point can include a second gap in the blade portion, wherein the base portion extends without any gaps.

[0035] Optionally or additionally, the first bend point can be adapted to enable the first end blade segment to bend more than 30 degrees relative to the longitudinal axis, and the second bend point can be adapted to enable the second end blade segment to bend more than 30 degrees relative to the longitudinal axis.

[0036] Optionally or additionally, the first bend point can be adapted to enable the first end blade segment to bend more than 45 degrees relative to the longitudinal axis.

[0037] Optionally or additionally, the second bend point can be adapted to enable the second end blade segment to bend more than 45 degrees relative to the longitudinal axis.

[0038] Optionally or additionally, when the first end blade segment and the second end blade segment are bent more than 30 degrees relative to the longitudinal axis, the at least one intermediate blade segment can extend parallel to the longitudinal axis.

[0039] Another example is a method of treating an intravascular lesion. The method includes advancing a medical device through a blood vessel to a position proximate to the lesion, the medical device including an inflatable balloon and a monolithic blade including a base portion extending from a first end to a second end thereof and a blade portion extending outwardly from the base portion. The blade portion includes a first blade segment extending from the first end of the monolithic blade member to a first bend point formed therein, a second blade segment extending from the second end of the monolithic blade member to a second bend point formed therein, and a third blade segment extending between the first blade segment and the second blade segment. The method includes positioning the medical device such that the first blade segment extends distal to the lesion and the second blade segment extends proximal to the lesion, and inflating the inflatable balloon to urge the monolithic blade toward the lesion, at least one of the first blade segment and the second blade segment being bent more than 30 degrees relative to the third blade segment.

[0040] Optionally or additionally, when the inflatable balloon is inflated, at least one of the first blade segment and the second blade segment can be bent more than 45 degrees relative to the third blade segment.

[0041] The above summary is intended to assist with an understanding of some innovative features of the present disclosure, and is not meant to be a complete description. The present disclosure can be more completely understood in conjunction with the drawings, detailed description, claims, and abstract. BRIEF DESCRIPTION OF DRAWINGS

[0042] The present disclosure can be more completely understood in conjunction with the following description, and with reference to the drawings, in which:

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

[0044] Figure 2 is a schematic view of a unitary blade member that can be used in Figure 1 an example medical device;

[0045] Figure 3 is a schematic view of a unitary blade member that can be used in Figure 1 an example medical device;

[0046] Figure 4 is a schematic view of a unitary blade member that can be used in Figure 1 an example medical device;

[0047] Figure 5 is a schematic view of a blade assembly that can be used in Figure 1 an example medical device;

[0048] Figure 6 is a schematic view of a blade assembly that can be used in Figure 1 an example medical device;

[0049] Figure 7 is a schematic view of a blade assembly that can be used in Figure 1 an example medical device;

[0050] Figure 8 is a schematic view showing an example medical device of Figure 1 arranged near an intravascular lesion to achieve a 30 degree bend of the distal blade segment;

[0051] Figure 9 is a schematic view showing an example medical device of Figure 1 arranged near an intravascular lesion to achieve a 45 degree bend of the distal blade segment; and

[0052] Figure 10 is a schematic view showing the relationship between blade member length and achievable vessel curvature radius.

[0053] While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular examples described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure. DETAILED DESCRIPTION

[0054] The following description should be read with reference to the drawings, in which like reference numerals refer to like elements throughout the several views. The drawings are not necessarily to scale, with the emphasis instead being placed upon illustrating the principles of the disclosure. Although examples of various components are illustrated, one skilled in the art will recognize that many examples of suitable alternatives can be used.

[0055] All numerical values herein are assumed to be modified by the term "about," unless otherwise explicitly indicated. Numerical ranges are inclusive of the numbers that are endpoints of the range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0056] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise.

[0057] It should be noted that references to "an embodiment," "some embodiments," "other embodiments," etc. mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the purview of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments whether or not explicit

[0058] Figure 1is a partial cross-sectional side view of an example medical device 10. In some cases, the example medical device 10 can be used within a patient’s vasculature to treat a stenosis within the vasculature. In some cases, the medical device 10 can be used to rupture or cut a calcified lesion. As shown, the medical device 10 can define a longitudinal axis “LA”. The medical device 10 includes a catheter shaft 12 having a distal region 14. An inflatable balloon 16 can be secured to the distal region 14 of the catheter shaft 12. One or more monolithic blade members 18 can be mounted on or otherwise secured relative to the inflatable balloon 16. In some cases, the medical device 10 can be advanced through the vasculature to a target region by a guide wire 20. Once positioned at a target location in the vasculature, the inflatable balloon 16 can be inflated to exert a radially outward force on a lesion when the monolithic blade members 18 are in contact with the lesion. As a result, the monolithic blade members 18 can rupture, cut, or score the lesion to help enlarge the lumen proximate the lesion. The target region can be located within any suitable peripheral or cardiac vascular lumen location.

[0059] The number, location, and arrangement of the monolithic blade members 18 about the inflatable balloon 16 can vary. For example, the medical device 10 can include one, two, three, four, five, six, or more monolithic blade members 18 arranged at any location along the inflatable balloon 16 in a regular, irregular, or any other suitable pattern. For example, in some cases, the inflatable balloon 16 can include a plurality of monolithic blade members 18 arranged symmetrically longitudinally along a circumference of the inflatable balloon 16.

[0060] The monolithic blade members 18 can be made of any suitable material, such as a metal, a metal alloy, a polymer, a metal-polymer composite, or the like, or any other suitable material. For example, in some cases, the monolithic blade members 18 can be made of stainless steel, titanium, a nickel-titanium alloy, tantalum, a cobalt-iron-nickel alloy, or other metallic materials. The monolithic blade members 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 configuration.

[0061] The monolithic blade members 18 can be mounted to the inflatable balloon 16 using a variety of techniques. In some cases, each monolithic blade member 18 can include a base having cutouts for flexibility that can be at least partially embedded in a polymer member (not shown) that can itself be secured to an outer surface of the inflatable balloon 16. Additional details regarding how the monolithic blade members 18 are secured to the outer surface of the inflatable balloon 16, including the polymer member described above, are described in U.S. Patent Nos. 9,226,768; 10,046,146; 10,058,349; and 10,729,893, which are incorporated by reference herein in their entireties.

[0062] Inflatable balloon 16 can be made from an angioplasty balloon material, including polymers such as polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene (ETFE), polybutylene terephthalate (PBT), polyurethane, polyvinylchloride (PVC), polyether-ester, polyester, polyamide, elastomeric polyamides, polyether block amide (PEBA), and other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some cases, inflatable balloon 16 can include a single layer of material, while in other cases, inflatable balloon 16 can have a multi-layered construction, including multiple layers of material. For example, in some cases, inflatable balloon 16 can be formed as a co-extruded or tri- extruded structure.

[0063] Inflatable balloon 16 can be configured such that, when deflated, it includes one or more "wings" or winged regions. In some cases, the wings can be configured such that integral blade members 18 can be positioned at the innermost locations of the deflated inflatable balloon 16, with the winged regions of the balloon folds located between adjacent integral blade members 18. Such an arrangement can reduce contact of integral blade members 18 with the blood vessel during delivery of inflatable balloon 16 to the lesion.

[0064] Catheter shaft 12 can be a catheter shaft similar to a typical catheter shaft. For example, catheter shaft 12 can include an outer tubular member 22 and an inner tubular member 24 extending through at least a portion of outer tubular member 22. Outer tubular member 22 and inner tubular member 24 can each be made from a variety of different materials. For example, outer tubular member 22 and inner tubular member 24 can be made from a metal, a metal alloy, a polymer, a metal-polymer composite, or any other suitable material.

[0065] Outer tubular member 22 and inner tubular member 24 can be arranged in any suitable manner. For example, in some embodiments, inner tubular member 24 can be disposed coaxially within outer tubular member 22. According to these embodiments, inner tubular member 24 and outer tubular member 22 can be fixed or unfixed to one another along the general longitudinal axis of catheter shaft 12. Alternatively, inner tubular member 24 can extend along or otherwise be disposed adjacent to the inner wall of outer tubular member 22. In other embodiments, outer tubular member 22 and inner tubular member 24 can be arranged in another desired manner.

[0066] The inner tubular member 24 can include an inner lumen 26. In at least some cases, the inner lumen 26 is a guidewire lumen for receiving a guidewire 20 therethrough. Thus, the medical device 10 can be advanced to a desired location over the guidewire 20. The guidewire lumen 26 can extend substantially along the entire length of the catheter shaft 12, such that the medical device 10 is similar to a traditional "over-the-wire" catheter. Alternatively, as shown, the guidewire lumen 26 can extend only along a portion of the catheter shaft 12, such that the medical device 10 is similar to a "single operator exchange" or "rapid exchange" catheter.

[0067] The catheter shaft 12 can also include an inflation lumen 28, which can be used, for example, to deliver inflation media to and from the inflatable balloon 16 to selectively inflate and / or deflate the inflatable balloon 16. The location and orientation of the inflation lumen 28 can vary depending on the configuration of the outer tubular member 22 and the inner tubular member 24. For example, when the outer tubular member 22 is disposed around the inner tubular member 24, the inflation lumen 28 can be defined within the space between the outer tubular member 22 and the inner tubular member 24. In cases where the outer tubular member 22 is disposed adjacent to the inner tubular member 24, the inflation lumen 28 can be a lumen of the outer tubular member 22.

[0068] The inflatable balloon 16 can be connected to the catheter shaft 12 in a variety of suitable ways. For example, the inflatable balloon 16 can be adhered or heat bonded to the catheter shaft 12. In some embodiments, a proximal waist 30 of the inflatable balloon 16 can be adhered to the catheter shaft 12, e.g., to a distal end of the outer tubular member 22, and a distal waist 32 of the inflatable balloon 16 can be adhered to the catheter shaft 12, e.g., to a distal end of the inner tubular member 24. However, the exact locations of the adhesions can vary.

[0069] Each monolithic blade member 18 can be considered to include a first terminal blade segment 34 at a first end of the monolithic blade member 18 and a second terminal blade segment 36 at an opposite second end of the monolithic blade member 18. As shown, the first terminal blade segment 34 corresponds to the blade segment closest to the proximal end, while the second terminal blade segment 36 corresponds to the blade segment closest to the distal end. In some cases, the first terminal blade segment 34 can correspond to the blade segment closest to the distal end, while the second terminal blade segment 36 can correspond to the blade segment closest to the proximal end. The first terminal blade segment 34 extends from the first end 18a of the monolithic blade member 18 to a first bend point 40 formed in the monolithic blade member 18. The second terminal blade segment 36 extends from the second end 18b of the monolithic blade member 18 to a second bend point 42 formed in the monolithic blade member 18.

[0070] In some cases, the first bending point 40 and the second bending point 42 (whose relative positions can be considered to define the lengths of the first and second distal blade fragments, respectively) are positioned such that when the second bending point 42 is within two millimeters of the second end of the lesion, the first bending point 40 is within two millimeters of the first end of the lesion. In some cases, the length of the first distal blade fragment 34 may be less than three millimeters. In some cases, the length of the first distal blade fragment 34 may be less than two millimeters. In some cases, the length of the second distal blade fragment 36 may be less than three millimeters. In some cases, the length of the second distal blade fragment 36 may be less than two millimeters.

[0071] Each integral blade assembly 18 may include one or more intermediate blade segments 38. As shown, each integral blade assembly 18 includes two intermediate blade segments 38 separated by a third bend point 44. In some cases, each integral blade assembly 18 may include only one intermediate blade segment 38, and therefore does not include the third bend point 44. In some cases, each integral blade assembly 18 may include three or more intermediate blade segments 38, and therefore may include a fourth or even a fifth bend point. It should be understood that the number of intermediate blade segments 38 may depend at least in part on the desired total length of each integral blade assembly 18. In some cases, the inflatable balloon 16 may include two or more integral blade assemblies 18, each having the same total length. In some cases, the inflatable balloon 16 may include two or more integral blade assemblies 18, each having a different total length.

[0072] Figure 2 This is a side view of the integral blade component 18. Figure 2 The integral blade component 18 shown can be considered as... Figure 1 The integral blade member 18 shown is identical. The integral blade member 18 includes a base 46 extending from its first end 46a to its second end 46b. The integral blade member 18 includes a blade portion 48 extending outward from the base 46. The blade portion 48 includes a first end blade segment 34, a second end blade segment 36, and an intermediate blade segment 38, which are separated by a first bending point 40, a second bending point 42, and a third bending point 44, respectively.

[0073] In some cases, as shown, the first bend point 40 and the second bend point 42 can be wider than the third bend point 44 (or any additional intermediate bend points). The first bend point 40 and the second bend point 42 can each be 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% or more wider than the third bend point 44. In some cases, the first bend point 40 and the second bend point 42 being wider can enable the first end blade segment 34 and the second end blade segment 36 to bend a greater angle relative to the adjacent intermediate blade segments 38, respectively, without the first end blade segment 34 and / or the second end blade segment 36 colliding with or otherwise interfering with the adjacent intermediate blade segments 38. In some cases, the first bend point 40 and / or the second bend point 42 can be adapted to allow the first end blade segment 34 and / or the second end blade segment 36 to bend to a position in which they form an angle of up to 90 degrees with the intermediate blade segments 38.

[0074] In some cases, the first bend point 40 can be considered a first gap in the blade portion 48 (e.g., a gap between adjacent portions of the cutting edge of the blade portion 48), the second bend point 42 can be considered a second gap in the blade portion 48 (e.g., a gap between adjacent portions of the cutting edge of the blade portion 48), and the third bend point 44 can be considered a third gap in the blade portion 48 (e.g., a gap between adjacent portions of the cutting edge of the blade portion 48). In some cases, as shown, the gaps extend through the blade portion 48, but not through the base portion 48, meaning that the monolithic blade member 18 is a single, unitary structure formed from a single sheet of material.

[0075] In some cases, the base portion 48 can include thinned regions corresponding to the locations of the bend points 40, 42, and 44. As shown, the base portion 46 includes a first thinned region 50 aligned with the first bend point 40, a second thinned region 52 aligned with the second bend point 42, and a third thinned region 54 aligned with the third bend point 44. It will be appreciated that the thinned regions 50, 52, and 54 cooperate with the gaps corresponding to the bend points 40, 42, and 44 to further increase the flexibility of the monolithic blade member 18. The flexibility of the monolithic blade member 18 helps enable the blade member 18 to be passed through small portions or highly curved portions of the vasculature, as well as to allow the end blade segments 34 and 36 to bend or flex further relative to the intermediate blade segments 38.

[0076] In some cases, the base 48 can include a plurality of T-shaped slots or cutouts 55 that help to further increase the flexibility of the monolithic blade member 18. The T-shaped cutouts 55 also help to anchor the base 48 within a polymer member or pad (not shown) that is itself secured to the inflatable balloon 16 to anchor the monolithic blade member 18 relative to the inflatable balloon 16. In some cases, the material of the polymer member or pad flows into the T-shaped cutouts 55 to further anchor the monolithic blade member 18 relative to the inflatable balloon 16. Further details regarding the T-shaped cutouts 55 and their function are described in previously incorporated by reference U.S. Patent Nos. 9,226,768; 10,046,146; 10,058,349; and 10,729,893. In some cases, there is at least one or more T-shaped cutouts 55 in each blade segment, including the terminal blade segments.

[0077] The monolithic blade member 18 has an overall length “L”. As shown, the overall length L of the monolithic blade member 18 is approximately 10 millimeters. Figure 3 Examples of monolithic blade members having an overall length L of approximately 14 or 15 millimeters are provided, Figure 4 Examples of monolithic blade members having an overall length L of approximately 6 millimeters are provided. It will be appreciated that these examples are merely illustrative, and that the monolithic blade member can have any desired length.

[0078] As can be seen, the base 46 extends beyond the blade portion 48 at a first end 46a and a second end 46b, with the base 46 including a first tail 56 at the first end 46a and a second tail 58 at the second end 46b. In some cases, the additional length provided by the first tail 56 and the second tail 58 can help to secure the base 46 (and in turn the monolithic blade member 18) relative to the inflatable balloon 16. In some cases, the length of the first terminal blade segment 34 can be considered “LI” (including the tail 56). In some cases, the length of the first terminal blade segment 35 can be considered “L2” that does not include the tail 56. Although not labeled, in some cases, the second terminal blade segment 36 can be considered to have similar dimensions.

[0079] In some cases, L1 and L2 may each be equal to or less than 3 mm. In other cases, L1 and L2 may each be equal to or less than 2 mm. In a specific example, when L is 15 mm, L1 may be equal to approximately 2 mm, for example, 2.07 mm, and L2 may be equal to approximately 1.75 mm, for example, 1.74 mm. The length of each intermediate blade segment 38 may be considered as “L3”, which is defined as the distance between the bending points located at both ends of the intermediate blade segment 38, for example, between the first bending point 40 and the third bending point 44, or between the second bending point 42 and the third bending point 44. L3 can be adjusted to provide the desired total length of the integral blade assembly 18. For example, when L is equal to approximately 10 mm, the length L3 of each intermediate blade segment 38 may be equal to approximately 2.75 mm, for example, 2.77 mm.

[0080] Figure 1 and Figure 2 The integral blade component 18 shown is only one example. Figure 3 and Figure 4 Additional details are provided regarding the integral blade component 18. Figure 3 An integral blade component 118 is shown, which can be used as Figure 1 One or more integral blade components 18 are shown. The overall length "L" of the integral blade component 118 is equal to approximately 14 mm. The integral blade component 118 includes a base 146 and a blade portion 148, which is divided into multiple blade segments by a central bend point. In some cases, as shown, the integral blade component 118 includes a first end blade segment 134 and a second end blade segment 136. The length of the first end blade segment 134 can be considered as "L1" (including the first tail 156). The length of the first end blade segment 134 can be considered as "L2" excluding the first tail 156. Although not marked, in some cases, the second end blade segment 136 can be considered to have similar dimensions.

[0081] In some cases, L1 and L2 may each be equal to or less than 3 mm. In other cases, L1 and L2 may each be equal to or less than 2 mm. In a specific example, when L is approximately 14 mm, L1 may be equal to approximately 2.6 mm, for example, 2.60 mm, and L2 may be equal to approximately 2.25 mm, for example, 2.23 mm. The length of each intermediate blade segment 38 can be considered as “L”. 3” L3 is defined as the distance between the bending points located at both ends of the intermediate blade segment 138, such as between the first bending point 140 and the third (and additional) bending point 144. L3 can be adjusted to provide the desired total length of the integral blade component 118. In some cases, for example, L3 can be selected to be equal to L2.

[0082] Figure 4 An integral blade component 218 is shown, which can be used asFigure 1 One or more of the integral blade members 218 shown in FIGS. 1-2. The overall length "L" of the integral blade member 218 is equal to about 6 millimeters. The integral blade member 228 includes a base 246 and a blade portion 248 that is divided into a pair of blade segments by an intermediate bend point 260. In some cases, as shown, the integral blade member 228 includes a first terminal blade segment 234 and a second terminal blade segment 236. The length of the first terminal blade segment 134 can be considered "LI" (including a first tail 256). The length of the first terminal blade segment 234 can be considered "L2" excluding the first tail 256. The length of the second terminal blade segment 236 can be considered "L3" including a second tail 258. The base includes a thinned region 262 corresponding to the bend point 260. In some cases, LI and L3 can each be about 3 millimeters.

[0083] In some cases, blade members such as the blade members 18, 118, and 218 are described as integral, meaning that the blade members 18, 118, and 218 can be formed as a continuous piece of material that extends the entire length of the blade members 18, 118, and 218. In other words, the terminal blade segments and the intermediate blade segments can be formed from a single continuous piece of material. In some cases, some blade assemblies can include a plurality of separate blade segments, with each of the plurality of separate blade segments being axially aligned with one another. Some of the plurality of separate blade segments can be arranged at an acute angle relative to an adjacent blade segment. In some cases, the blade segments can be secured within a polymer pad that is itself adapted to be secured to the outer surface of the inflatable balloon 16. Each blade segment can be secured within its own polymer pad, or at least some of the blade segments can be secured within the same polymer pad. Figures 5 to 7 Examples of exemplary blade assemblies are provided.

[0084] Figure 5 A blade assembly 300 is shown mounted on the inflatable balloon 16. The blade assembly 300 includes a first terminal blade segment 302, a second terminal blade segment 304, and an intermediate blade segment 306. It will be appreciated that the first terminal blade segment 302, the second terminal blade segment 304, and any intermediate blade segments 306 (only one is shown) are formed as independent assemblies that are not directly connected to one another. In some cases, the first terminal blade segment 302, the second terminal blade segment 304, and the intermediate blade segment 306 can be formed as an integral structure, such as the structure shown in FIGS. 1-2, and the individual blade segments can be broken apart or otherwise separated from one another prior to being embedded in a polymer pad for securement to the inflatable balloon 16. Figure 2 Figure 3 Figure 4

[0085] ​​​In some cases, each of the first end blade segment 302 and the second end blade segment 304 can be less than 3 millimeters in length. In some cases, each of the first end blade segment 302 and the second end blade segment 304 can be less than 2 millimeters in length. In some cases, the intermediate blade segment 306 can be greater than 3 millimeters in length, while the first end blade segment 302 and the second end blade segment 304 can be less than 3 millimeters in length.

[0086] In some cases, each of the first end blade segment 302, the second end blade segment 304, and the intermediate blade segment 306 can be secured to a single polymer pad to secure the blade assembly 300 to an inflatable balloon, such as the inflatable balloon 16. In some cases, each of the first end blade segment 302, the second end blade segment 304, and the intermediate blade segment 306 can be secured to its own different polymer pad segment, which are spaced apart from one another.

[0087] The first end blade segment 302 includes a blade portion 308 and a base portion 310. The second end blade segment 304 includes a blade portion 312 and a base portion 314. The intermediate blade segment 306 includes a blade portion 316 and a base portion 318. It should be appreciated that the blade portions 308, 312, and 316 can be adapted to cut or rupture a lesion when the medical device including the blade assembly 300 is advanced through the vasculature to be near a lesion, and the inflatable balloon 16 is inflated to urge the blade assembly 300 radially outward to contact the lesion. The base portions 310, 314, and 318 can each be adapted to embed in a polymer pad for securement to the inflatable balloon 16.

[0088] Figure 6 A blade assembly 320 mounted on the inflatable balloon 16 is shown. The blade assembly 320 includes a first end blade segment 322, a second end blade segment 324, and a plurality of intermediate (two shown) blade segments 326. Although a pair of intermediate blade segments 326 is shown, in some cases, the blade assembly 320 can include only one intermediate blade segment 326. In some cases, the blade assembly 320 can include three, four, or more intermediate blade segments 326 depending on the desired overall length of the blade assembly 320.

[0089] In some cases, the first end blade segment 322, the second end blade segment 324, and the intermediate blade segments 326 can be formed as a unitary structure, for example Figure 2 、 Figure 3 and Figure 4The blade segments can be broken or otherwise separated from one another prior to being embedded in a polymer pad for securement to the inflatable balloon 16. For example, in some cases, the blade segments 322, 324, 326 can be made of stainless steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy, or other metallic material. The blade segments 322, 324, 326 can have a triangular, square, rectangular, circular, or any desired configuration cross-sectional shape. In some cases, the first end blade segment 322, the second end blade segment 324, and the intermediate blade segments 326 can each be equal in length. For example, each of the first end blade segment 322, the second end blade segment 324, and the intermediate blade segments 326 can be less than 3 millimeters in length. As another example, each of the first end blade segment 322, the second end blade segment 324, and the intermediate blade segments 326 can be less than 2 millimeters in length.

[0090] The first end blade segment 322 includes a blade portion 328 and a base portion 330. The second end blade segment 324 includes a blade portion 332 and a base portion 334. Each of the intermediate blade segments 326 includes a blade portion 336 and a base portion 338. The base portion 330 is shown embedded within a polymer pad segment 340, the base portion 334 is shown embedded within a polymer pad segment 342, and each of the base portions 338 is shown embedded within a polymer pad segment 344. In some cases, embedding each of the different blade segments within its own different polymer pad segment can facilitate providing additional flexibility.

[0091] Figure 7 A blade assembly 350 is shown mounted on the inflatable balloon 16. The blade assembly 350 includes the first end blade segment 322, the second end blade segment 324, and a plurality of intermediate (two shown) blade segments 326. Although a pair of intermediate blade segments 326 is shown, in some cases, the blade assembly 350 can include only one intermediate blade segment 326. In some cases, depending on the desired overall length of the blade assembly 350, the blade assembly 350 can include three, four, or more intermediate blade segments 326.

[0092] The first end blade segment 322 includes a blade portion 328 and a base portion 330. The second end blade segment 324 includes a blade portion 332 and a base portion 334. Each of the intermediate blade segments 326 includes a blade portion 336 and a base portion 338. The base portions 330, 334, and 338 are each embedded within a unitary or single polymer pad 352. The polymer pad 352 can be secured to an outer surface of the inflatable balloon 16 to form a medical device.

[0093] Figure 8A medical device 10 is shown deployed within a blood vessel 400 near a lesion 402. In some cases, the size or composition of the lesion 402 can not be uniform. In some cases, the lesion 402 can include a middle portion 402a that is more calcified, and thus less compliant. The lesion 402 can include end portions 402b on either side of the middle portion 402a. The end portions 402b can be less calcified, and thus more compliant. In some cases, when the inflatable balloon 16 is inflated, the middle blade segment 38, driven by the middle portion 408 of the inflatable balloon 16, can exert a greater radial force (as indicated by arrows 408) on the middle portion 402a, while the end blade segments 34 and 36 can exert a greater axial force (as indicated by arrows 412) on the middle portion 402.

[0094] It will be appreciated that the geometry of the lesion 402, and in particular the middle portion 402a, can cause the inflatable balloon 16 to take on a“dog bone” shape when the blade assembly 18 is in contact with the lesion 402, in which the first and second regions 404 and 406 of the inflatable balloon 16 are able to achieve a greater diameter than the middle region of the inflatable balloon 16. This means that the first and second end blade segments 34 and 36 are able to achieve an angle of 30 degrees or greater relative to the middle blade segment 38. In some cases, as shown, the first and second end blade segments 34 and 36 are able to achieve an angle of 45 degrees or greater relative to the middle blade segment 38. These angles can be achieved, for example, by extending the end blade segments 34 and 36 beyond the periphery of the non-compliant or restrictive portion of the lesion 402, such as the middle portion 402a of the lesion 402. Figure 9

[0095] ​The method of treating the lesion 402 can include advancing a medical device, such as the medical device 10, through the blood vessel 400 to a position proximate the lesion 402. In some cases, fluoroscopy and contrast agents can be used to estimate or determine the size of the lesion 402. In some cases, the medical device 10 can be selected such that the monolithic blade 18 (or blade assembly 300, 320, and 350) that forms a part of the medical device 10 is several millimeters longer than the axial length of the non-compliant or restrictive portion (e.g., the middle portion 402a) of the lesion 402. In some cases, the lesion 402 can be longer than the monolithic blade 18 or blade assembly 300, 320, 350. As previously described, the medical device includes the inflatable balloon 16 and the monolithic blade 18. The monolithic blade 18 includes a base 46 and a blade portion 48. The blade portion 48 is divided into a first blade segment, a second blade segment, and a middle third blade segment. The medical device 10 is positioned such that the first blade segment extends beyond the periphery of the restrictive portion 402a of the lesion 402 in a first direction (e.g., beyond the first end extent of the restrictive portion 402a of the lesion 402) and the second blade segment extends beyond the periphery of the restrictive portion 402a of the lesion 402 in a second direction (e.g., beyond the second end extent of the restrictive portion 402a of the lesion 402). The inflatable balloon 16 is inflated to urge the monolithic blade 18 toward the lesion 402. At least one of the first blade segment and the second blade segment is bent at an angle of 30 degrees or more relative to the middle third blade segment. In some cases, at least one of the first blade segment and the second blade segment is bent at an angle of 45 degrees or more relative to the third blade segment when the inflatable balloon 16 is inflated.

[0096] In addition to being able to provide additional disruption force at the periphery of the restrictive portion 402a of the lesion 402, having shorter blade segments in general can improve deliverability of the medical device 10. Figure 10 A curved portion of the blood vessel 400 is schematically illustrated, with a radius of curvature "R" measured to the midpoint of the blood vessel 400. A monolithic blade 440 (corresponding inflatable balloon not shown) including a first blade segment 442 and a second blade segment 444 (separated by a bend point 446) is shown disposed within the curved portion of the blood vessel 400. Each of the first blade segment 442 and the second blade segment 444 has a length "L". It will be appreciated that as the radius of curvature R increases, the length L that the monolithic blade 440 is still allowed to pass through the curved blood vessel will increase. As the radius of curvature R decreases, the length L that the monolithic blade 440 is still allowed to pass through the curved blood vessel will decrease. Of course, the diameter of the blood vessel 400 (represented by diameter "D") will also affect the length of the monolithic blade 440 that a blood vessel with a particular radius of curvature R will allow.

[0097] Having described several exemplary embodiments of the disclosure, those skilled in the art will readily acknowledge that other embodiments and uses of the disclosure are possible within the scope of the appended claims. However, it is noted that the disclosure is not limited to the exemplary embodiments described above. Changes in formulation or form can be made without departing from the scope of the disclosure. The scope of the disclosure is, of course, defined by the language of the claims used in the appended claims section.

Claims

1. A medical device comprising: The duct axis has a distal region; It can be in a balloon, which is fixed to the distal region; as well as An integral blade assembly extending longitudinally relative to the inflatable balloon, the integral blade assembly being fixed relative to the outer surface of the inflatable balloon, the integral blade assembly comprising: The base extends from the first end of the integral blade member to the second end of the integral blade member; A blade portion extending outward from the base, the blade portion comprising: A first end-cutting segment extends from a first end of the integral blade member to a first bend point formed in the integral blade member, the first end-cutting segment having a first end-cutting segment length; A second end-cutting segment extends from the second end of the integral blade member to a second bend point formed in the integral blade member, the second end-cutting segment having a second end-cutting segment length; and At least one intermediate blade segment extends between the first bend point and the second bend point, each of the at least one intermediate blade segment having an intermediate blade segment length greater than the lengths of the first end blade segment and the second end blade segment.

2. The medical device according to claim 1, wherein, The length of the end blade fragment is such that when the second bending point is within two millimeters of the opposite second end of the lesion, the first bending point is within two millimeters of the first end of the lesion.

3. The medical device according to claim 1 or 2, wherein: The first bending point includes the first gap in the blade portion; and The second bending point includes a second gap in the blade portion, wherein the base extends without any gap.

4. The medical device according to any one of the preceding claims, wherein, The length of the first end blade segment is equal to the length of the second end blade segment, wherein the base extends without any gaps.

5. The medical device according to any one of the preceding claims, wherein, The length of the first end blade segment is less than 3 mm, and the length of the second end blade segment is less than 3 mm.

6. The medical device according to any one of the preceding claims, wherein, The length of the first end blade segment is less than 2 mm, and the length of the second end blade segment is less than 2 mm.

7. The medical device according to any one of the preceding claims further comprises one or more additional integral blade members extending longitudinally along the outer surface of the inflatable balloon, each of the one or more additional integral blade members comprising: The base extends from the first end of the integral blade member to the second end of the integral blade member; A blade portion extending outward from the base, the blade portion comprising: A first end-cutting segment extends from a first end of the integral blade member to a first bend point formed in the integral blade member, the first end-cutting segment having a first end-cutting segment length; A second end-cutting segment extends from the second end of the integral blade member to a second bend point formed in the integral blade member, the second end-cutting segment having a second end-cutting segment length; and At least one intermediate blade segment extends between the first bend point and the second bend point, the at least one intermediate blade segment having an intermediate blade segment length greater than the lengths of the first end blade segment and the second end blade segment.

8. A medical device comprising: An inflatable balloon is fixed to the distal region of a catheter shaft with a longitudinal axis; A plurality of blade assemblies, which are fixed to the inflatable balloon and extend longitudinally relative to the inflatable balloon, each of the plurality of blade assemblies having a longitudinal axis and comprising: Polymer pad, adapted to be fixed to the inflatable balloon; and Multiple blade segments are fixed within the polymer pad, the multiple blade segments including: a first end blade segment located at a first end of the blade assembly and having a length of less than 3 mm; a second end blade segment located at a opposite second end of the blade assembly and having a length of less than 3 mm; and at least one intermediate blade segment disposed between the first end blade segment and the second end blade segment.

9. The medical device according to claim 8, wherein, The polymer pad includes a single polymer pad, wherein each of the plurality of blade segments is axially aligned with and fixed within the single polymer pad relative to the single polymer pad.

10. The medical device according to claim 9, wherein, The polymer pad comprises a plurality of individual polymer pad segments, wherein each of the plurality of blade segments is fixed within an individual polymer pad segment of the plurality of individual polymer pad segments.

11. The medical device according to claim 8 or 9, wherein: The first end blade segment is positioned relative to the adjacent intermediate blade segment such that the first end blade segment can bend at an angle greater than 30 degrees relative to the longitudinal axis; and The second end blade segment is positioned relative to the adjacent intermediate blade segment such that the second end blade segment can bend at an angle greater than 30 degrees relative to the longitudinal axis.

12. The medical device according to any one of claims 8-11, wherein: The first end blade segment is positioned relative to the adjacent intermediate blade segment such that the first end blade segment can bend at an angle greater than 45 degrees relative to the longitudinal axis; and The second end blade segment is positioned relative to the adjacent intermediate blade segment such that the second end blade segment can bend at an angle greater than 45 degrees relative to the longitudinal axis.

13. The medical device according to any one of claims 8-12, wherein, When the first end blade segment and the second end blade segment bend at an angle greater than 30 degrees relative to the longitudinal axis, the at least one intermediate blade segment extends parallel to the longitudinal axis.

14. A method for treating intravascular lesions, comprising: The medical device is advanced through the blood vessel to a location near the lesion, the medical device comprising: Inflatable balloon; An integral blade includes a base extending from a first end to a second end of the integral blade member and a blade portion extending outwardly from the base, the blade portion comprising: The first cutting segment extends from the first end of the integral blade member to a first bending point formed in the integral blade member; A second cutting segment extends from the second end of the integral blade member to a second bending point formed in the integral blade member; and The third cut segment extends between the first cut segment and the second cut segment; Position the medical device such that the first blade segment extends distally to the lesion, and the second blade segment extends proximally to the lesion; and The inflatable balloon is inflated to push the monolithic blade toward the lesion, wherein at least one of the first and second blade segments is bent at an angle greater than 30 degrees relative to the third blade segment.

15. The method according to claim 14, wherein, When the inflatable balloon is inflated, at least one of the first and second blade segments bends at an angle greater than 45 degrees relative to the third blade segment.

Images