Cutting edge with shortened end cutting edge section

Abstract

A medical device useful for cracking or cutting lesions within blood vessels may comprise an integrated blade or blade assembly including a first end-edge section and a second end-edge section. The lengths of the first end-edge section and the second end-edge section may be at least partially defined by one or more bending points, allowing the integrated blade to flex at least 30 degrees with respect to its longitudinal axis when pressed against a lesion.

Description

Technical Field

[0001] The present disclosure is directed to an angioplasty balloon catheter, which comprises one or more cutting blades attached to the balloon. More specifically, the present disclosure is directed to the cutting blades of a cutting balloon catheter having a plurality of shortened end blade segments.

Background Art

[0002] Diseases of the heart and blood vessels are a major problem in the United States and around the world. Conditions such as atherosclerosis lead to the blood vessels becoming blocked or narrowed. This blockage can lead to a lack of oxygen supply to the heart, and since the myocardium must be adequately oxygenated to maintain the pumping action of the blood by the myocardium, this can have serious consequences, namely a lack of oxygen supply and / or circulation to other areas of the body.

[0003] Occluded, stenosed, or narrowed blood vessels can be treated by a recanalization procedure, such as by advancing an angioplasty balloon catheter on a guide wire so that the balloon is positioned across the occlusion, for example. Then the balloon is inflated to expand the path through the occlusion.

[0004] One of the major obstacles when treating coronary artery disease and / or occluded vessels or fistulas is restenosis or restenosis of the pathway through the occlusion following angioplasty or other recanalization procedures. For example, it has been shown that cracking, cutting, or scraping the stenosis during treatment using an angioplasty balloon equipped with a blade can reduce the incidence of restenosis. Furthermore, cracking, cutting, or incising the stenosis can reduce trauma at the treatment site and / or to adjacent healthy tissue. Blades can also be a beneficial addition to angioplasty when the target occlusion is hardened or calcified. Typical angioplasty balloons alone are thought to be unable to dilate parts of such hardened lesions. Therefore, angioplasty balloons equipped with blades have been developed to enhance angioplasty. Blades can be applied, for example, to cut, crack, or incise the lesion. Such blade members may include a bending point that allows the blade member to bend, but there is a continuing need for blade members that allow for further flexing, so that the distal portion of the blade member bends to a larger angle relative to the end of the calcified portion of the lesion, and similarly to allow delivery through the tortuous portions of the vascular structure. [Overview of the Initiative]

[0005] This disclosure covers several alternative designs, alternative materials and methods, and their use relating to the manufacture of medical device structures and assemblies. An example can be found in a medical device comprising a catheter shaft having a distal region and an inflatable balloon fixed to the distal region. An integral blade member extends longitudinally with respect to the inflatable balloon and is fixed to the outer surface of the inflatable balloon. The integral blade member includes a base extending from a first end of the integral blade member to a second end of the integral blade member and a blade portion extending outward from the base. The blade portion comprises a first end blade section extending from the first end of the integral blade member to a first bending point formed in the integral blade member and having a first end blade section length, a second end blade section extending from the second end of the integral blade member to a second bending point formed in the integral blade member and having a second end blade section length, and at least one intermediate blade member extending between the first bending point and the second bending point, each of which intermediate blade members comprises an intermediate blade section length greater than the length of the first end blade section and the length of the second end blade section.

[0006] Alternatively, or in addition, the terminal cutting edge length may allow the first bending point to be located within 2 mm of the first end of the lesion when the second bending point is located within 2 mm of the opposing second end of the lesion.

[0007] Alternatively or in addition, the first bending point may have a first gap in the blade portion, the second bending point may have a second gap in the blade portion, and the base portion may extend without gaps. Alternatively, or in addition, the length of the first end cutting edge section may be equal to the length of the second cutting edge section, and the base may extend without gap.

[0008] Alternatively, or in addition, the first end blade section may have a length of less than 3 mm, and the second end blade member may have a length of less than 3 mm. Alternatively, or in addition, the first end blade section may have a length of less than 2 mm, and the second end blade member may have a length of less than 2 mm.

[0009] Alternatively or in addition, the medical device may further comprise 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 may comprise a base extending from a first end of the integral blade member to a second end of the integral blade member and a blade portion extending outward from the base. The blade portion may comprise a first end blade portion extending from the first end of the blade member of the single material to a first bending point formed in the integral blade member and having a first end blade portion length, a second end blade portion extending from the second end of the integral blade to a second bending point formed in the integral blade member and having a second end blade portion length, and at least one intermediate blade portion extending between the first bending point and the second bending point, wherein the at least one intermediate blade portion has an intermediate blade portion length greater than the length of the first end blade portion and the length of the second end blade portion.

[0010] Another example can be found in a medical device comprising an inflatable balloon fixed to the distal region of a catheter shaft having a longitudinal axis, and a plurality of blade assemblies fixed to the inflatable balloon and extending longitudinally with respect to the inflatable balloon. Each of the plurality of blade assemblies has a longitudinal axis and comprises a polymer pad applied to be fixed to the inflatable balloon and a plurality of segments fixed within the polymer pad. The plurality of blade segments comprises a first end blade segment having a length of less than 3 mm at a first end of the blade assembly, a second end blade segment having a length of less than 3 mm at an opposing second end of the blade assembly, and at least one intermediate blade segment positioned between the first end blade segment and the second end blade segment.

[0011] Alternatively, or in addition, the polymer pad may comprise a single polymer pad, each of the plurality of blade sections being axially arranged with respect to the single polymer pad and fixed within the single polymer pad.

[0012] Alternatively or in addition, the polymer pad may comprise a plurality of individual polymer pad sections, and each blade section of the plurality of blade sections is fixed within an individual polymer pad section among the plurality of individual pad sections.

[0013] Alternatively or in addition, the first end cutting section may be positioned relative to an adjacent intermediate cutting section such that it can bend at an angle greater than 30 degrees from the longitudinal axis, and the second end cutting section may be positioned relative to an adjacent intermediate cutting section such that it can bend at an angle greater than 30 degrees from the longitudinal axis.

[0014] Alternatively or in addition, the first end cutting section may be positioned relative to an adjacent intermediate cutting section such that it can bend at an angle greater than 45 degrees from the longitudinal axis, and the second end cutting section may be positioned relative to an adjacent intermediate cutting section such that it can bend at an angle greater than 45 degrees from the longitudinal axis.

[0015] Alternatively, or in addition, the at least one intermediate cutting edge section may extend parallel to the longitudinal axis, while the first and second end cutting edge sections are deflected at an angle greater than 30 degrees from the longitudinal axis.

[0016] Another example can be found in a method for treating intravascular lesions. This method involves advancing a medical device through the blood vessel to a location proximal to the lesion, the medical device comprising an inflatable balloon and an integral blade including a base and a blade, the base extending from a first end of the integral blade member to a second end of the integral blade member, and the blade extending outward from the base. The blade comprises a first blade segment extending from the first end of the integral blade member to a first bending point formed in the integral blade member, a second blade segment extending from the second end of the integral blade member to a second bending point formed in the integral blade member, 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. The inflatable balloon is inflated to apply force to the integrated blade toward the lesion, causing the first and second blade sections to bend to an angle greater than 30 degrees relative to the third blade section.

[0017] Alternatively, or in addition, at least one of the first blade section and the second blade section may bend to an angle greater than 45 degrees with respect to the third blade section when the inflatable balloon is inflated.

[0018] Another example can be found in a medical device comprising a catheter shaft having a distal region and an inflatable balloon fixed to the distal region. An integral blade member extends longitudinally with respect to the inflatable balloon and is fixed to the outer surface of the inflatable balloon. The integral blade member comprises a base extending from a first end to a second end and a blade extending outward from the base. The blade portion comprises a first end blade section extending from the first end of the integral blade member to a first bending point formed in the integral blade member and having a first end blade section length, a second end blade section extending from the second end of the integral blade member to a second bending point formed in the integral blade member and having a second end blade section length, and at least one intermediate blade section extending between the first bending point and the second bending point, each of which at least one intermediate blade section comprises at least one intermediate blade section having an intermediate blade section length greater than the length of the first end blade member section and the length of the second end blade member section.

[0019] Alternatively, or in addition, when the second bending point is located within 2 mm of the opposing second end of the lesion, the terminal cutting edge length allows the first bending point to be located within 2 mm of the first end of the lesion.

[0020] Alternatively, or in addition, the first bending point may have a first gap in the blade portion. Alternatively, or in addition, the second bending point may have a second gap in the blade portion, while the base portion extends without a gap.

[0021] Alternatively, or in addition, the length of the first end cutting edge section is equal to the length of the second cutting edge section, and the base extends without gap. Alternatively, or in addition, the first end cutting edge section may have a length of less than 3 mm.

[0022] Alternatively, or in addition, the first end cutting edge section may have a length of less than 2 mm. Alternatively, or in addition, the second end cutting edge section may have a length of less than 2 mm. Alternatively, or in addition, the second end cutting edge section may have a length of less than 3 mm.

[0023] Alternatively or in addition, the medical device may further comprise 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 includes a base extending from a first end of the integral blade member to a second end of the integral blade member and a blade portion extending outward from the base. The blade portion comprises a first end blade portion extending from the first end of the integral blade member to a first bending point formed in the integral blade member and having a first end blade portion length; a second end blade portion extending from the second end of the integral blade to a second bending point formed in the integral blade member and having a second end blade portion length; and at least one intermediate blade portion extending between the first bending point and the second bending point, having an intermediate blade portion length greater than the first end blade portion length and the second end blade portion length.

[0024] Another example can be found in a medical device comprising an inflatable balloon fixed to the distal region of a catheter shaft having a longitudinal axis. A plurality of integral blade members are fixed to the inflatable balloon and extend longitudinally with respect to the inflatable balloon. Each of the plurality of integral blade members comprises a base portion extending from a first end of the integral blade member to a second end of the integral blade member, and a blade portion extending outward from the base portion. The blade portion comprises a first end blade section extending from the first end of the integral blade member to a first bending point formed in the integral blade member and having a length of less than 3 mm, a second end blade section extending from the second end of the integral blade member to a second bending point formed in the integral blade member and having a length of less than 3 mm, and at least one intermediate blade section extending between the first bending point and the second bending point, each of which has a length greater than 3 mm.

[0025] Alternatively or additionally, the plurality of integral blade members may comprise four blade members, each being circumferentially spaced from the nearest adjacent integral blade member by approximately 90 degrees. Alternatively or additionally, for each of the plurality of integral blade members, the first pivot point may comprise a first gap in the blade portion.

[0026] Alternatively or additionally, for each of the plurality of integral blade members, the second pivot point may comprise a second gap in the blade portion, the base portion extending without a gap. Alternatively or additionally, the first bend point may be applied to allow the first distal blade segment to bend at an angle greater than 30 degrees from the longitudinal axis, and the second bend point may be applied to allow the second distal blade segment to bend at an angle greater than 30 degrees from the longitudinal axis.

[0027] Alternatively or additionally, the first bend may be applied to allow the first distal blade segment to bend at an angle greater than 45 degrees from the longitudinal axis. Alternatively or additionally, the second bend point may be applied to allow the second distal blade segment to bend at an angle greater than 45 degrees from the longitudinal axis.

[0028] Alternatively or additionally, while the at least one intermediate blade segment may extend parallel to the longitudinal axis, the first distal blade segment and the second distal blade segment bend at an angle greater than 30 degrees from the longitudinal axis.

[0029] Another example of a method for treating intravascular lesions can be found. The method involves advancing a medical device through the blood vessel to a location proximal to the lesion, the medical device comprising an inflatable balloon and an integral blade including a base and a blade, the base extending from a first end of the integral blade member to a second end of the integral blade member, and the blade extending outward from the base. The blade comprises a first blade section extending from the first end of the integral blade member to a first bending point formed in the integral blade member, a second blade section extending from the second end of the integral blade member to a second bending point formed in the integral blade member, and a third blade section extending between the first blade section and the second blade section. The method includes positioning the medical device such that the first blade section extends distal to the lesion and the second blade section extends proximal to the lesion, and inflating the inflatable balloon to apply force to the integral blade toward the lesion, such that at least one of the first blade section and the second blade section bends to an angle greater than 30 degrees relative to the third blade section.

[0030] Alternatively, or in addition, at least one of the first blade section and the second blade section may bend to an angle greater than 45 degrees with respect to the third blade section when the inflatable balloon is inflated.

[0031] The prior art summary is provided to facilitate understanding of some of the inventive features specific to this disclosure and is not intended to be a complete description. A complete understanding of this disclosure is obtained by taking a comprehensive look at the entire specification, claims, drawings, and abstract. [Brief explanation of the drawing]

[0032] This disclosure can be better understood by considering the following descriptions of various examples in combination with the accompanying drawings. [Figure 1] Figure 1 is a schematic partial cross-sectional view of an exemplary medical device. [Figure 2]Figure 2 is a schematic diagram of an integrated blade member that can be used in the exemplary medical device shown in Figure 1. [Figure 3] Figure 3 is a schematic diagram of an integrated blade member that can be used in the exemplary medical device shown in Figure 1. [Figure 4] Figure 4 is a schematic diagram of an integrated blade member that can be used in the exemplary medical device shown in Figure 1. [Figure 5] Figure 5 is a schematic diagram of a blade assembly that can be used in the exemplary medical device shown in Figure 1. [Figure 6] Figure 6 is a schematic diagram of a blade assembly that can be used in the exemplary medical device shown in Figure 1. [Figure 7] Figure 7 is a schematic diagram of a blade assembly that can be used in the exemplary medical device shown in Figure 1. [Figure 8] Figure 8 is a schematic diagram showing an exemplary medical device from Figure 1 positioned proximal to a lesion within a blood vessel, with the terminal blade section achieving a 30-degree bend. [Figure 9] Figure 9 is a schematic diagram showing an exemplary medical device from Figure 1 positioned proximal to a lesion within a blood vessel, with the distal blade section achieving a 45-degree bend. [Figure 10] Figure 10 is a schematic diagram showing the relationship between the blade length and the achievable radius of curvature of the blood vessel.

[0033] While this disclosure can be modified into various forms and alternatives, their specific features are illustrated and described in detail in the drawings. However, it should be understood that the intention is not to limit this disclosure to the specific examples described. Rather, the intention is to encompass all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. [Modes for carrying out the invention]

[0034] The following description should be read with reference to the drawings, where similar elements found in other drawings are numbered in a similar manner. The drawings are not necessarily to scale and are not intended to illustrate examples that limit the scope of this disclosure. While examples are illustrated for various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that can be used.

[0035] Unless the content explicitly specifies otherwise, all numbers in this specification shall be considered to be modified by the term “about.” Numerical ranges with multiple endpoints include all digits contained within that range (for example, 1–5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0036] As used in this specification and the attached claims, the singular forms “a,” “an,” and “the” include multiple subjects unless the content explicitly specifies otherwise. As used in this specification and the attached claims, the term “or” is generally used to mean including “and / or” unless the content explicitly specifies otherwise.

[0037] References in this specification such as “one embodiment,” “several embodiments,” and “other embodiments” indicate that the described embodiments may possess certain features, structures, or characteristics, but it should be noted that not all embodiments necessarily possess those specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiments. Moreover, when certain features, structures, or characteristics are described in conjunction with a particular embodiment, it should be considered that those features, structures, or characteristics may be applicable to other embodiments, whether explicitly described or not, unless explicitly stated otherwise.

[0038] Figure 1 is a partial side cross-sectional view of an exemplary medical device 10. In some examples, the exemplary medical device 10 may be used within a patient's vascular structure to treat stenosis within that vascular structure. In some examples, the medical device 10 may be used to crack or cut a calcium lesion. The medical device 10 may define a longitudinal axis "LA" as shown in the figure. The medical device 10 comprises a catheter shaft 12 having a distal region 14. An inflatable balloon 16 may be fixed to the distal region 14 of the catheter shaft 12. One or more integral blade members 18 may be attached to the inflatable balloon 16, or otherwise fixed to the inflatable balloon 16. In some examples, the medical device 10 may be advanced through the vascular structure to a target region on a guidewire 20. Once positioned at the target location in the vascular structure, the inflatable balloon 16 may be inflated to apply a radially outward force to the lesion so that the plurality of integral blade members 18 engage with the lesion. Therefore, the multiple integrated blade members 18 can create cracks, cuts, or incisions in the lesion, making it easier to enlarge the lumen proximal to the lesion. The target area is located inside any suitable peripheral or cardiovascular lumen.

[0039] The number, position, and arrangement of the multiple integrated blade members 18 around the inflatable balloon 16 can be changed. For example, the medical device 10 may have one, two, three, four, five, six, or more integrated blade members 18 arranged regularly, irregularly, or in any other suitable pattern at any position along the inflatable balloon 16. For example, in some examples, the inflatable balloon 16 may have multiple integrated blade members 18 arranged symmetrically around the inflatable balloon 16 along its longitudinal direction.

[0040] Multiple integrated blade members 18 can be formed from any suitable material (e.g., metal, alloy, polymer, metal-polymer composite, etc., or any other suitable material). For example, multiple integrated blade members 18 can be formed from steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy, or, in some cases, other metallic materials. Multiple integrated 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 shape.

[0041] Multiple integrated blade members 18 can be attached to an inflatable balloon 16 using various techniques. In some cases, each of the multiple integrated blade members 18 has a base with multiple notches for flexibility, the base being at least partially embedded in a polymer member (not shown), the polymer member itself being fixed to the outer surface of the inflatable balloon 16. Additional details on how the integrated blade members 18 can be fixed to the outer surface of the inflatable balloon 16 (including the aforementioned polymer member) are described, for example, in U.S. Patent Nos. 9,226,768, 10,046,146, 10,058,349 and 10,729,893, which are incorporated in whole by reference.

[0042] The inflatable balloon 16 may be formed from angioplasty balloon material, which includes polymers (e.g., polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), polybutylene terephthalate (PBT), polyurethane, polyvinyl chloride (PVC), polyether esters, polyesters, polyamides, elastic polyamides, polyether block amides (PEBA), and similarly other suitable materials or mixtures, combinations thereof, copolymers, polymer / metal composites, etc.). In some examples, the inflatable balloon 16 may consist of a single layer of material, while in other examples, the inflatable balloon 16 may be formed from a multilayer structure consisting of multiple material layers. For example, in some examples, the inflatable balloon 16 may be formed as a co-extruded or three-layer extruded product.

[0043] The inflatable balloon 16 may be configured to have one or more "wings" or wing-shaped regions when deflated. In some examples, the wings may be configured such that a plurality of integral blade members 18 are positioned at the innermost position in the deflated inflatable balloon 16, and the wings in the folded portion of the balloon are positioned between adjacent integral blade members 18. This arrangement can prevent the plurality of integral blade members 18 from being exposed to blood vessels during delivery of the inflatable balloon 16 to a lesion.

[0044] The catheter shaft 12 may be a catheter shaft similar to a typical catheter shaft. For example, the catheter shaft 12 may comprise an outer tubular member 22 and an inner tubular member 24 that penetrates at least a portion of the outer tubular member 22. The outer tubular member 22 and the inner tubular member 24 can each be manufactured from a number of different materials. For example, the outer tubular member 22 and the inner tubular member 24 may be formed from metal, alloy, polymer, metal-polymer composite or any other suitable material.

[0045] 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 can be arranged coaxially within the outer tubular member 22. According to such embodiments, the inner tubular member 24 and the outer tubular member 22 can be fixed to or not fixed to each other along the approximate longitudinal axis of the catheter shaft 12. Alternatively, the inner tubular member 24 can be arranged following the inner wall of the outer tubular member 22 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 can be arranged in another desired manner.

[0046] The inner tubular member 24 may be provided with an inner lumen 26. In at least some examples, the inner lumen 26 is a guidewire lumen for receiving the guidewire 20 through the guidewire lumen. Thus, the medical device 10 can advance along the guidewire 20 to a desired position. The guidewire lumen 26 may extend substantially along the entire length of the catheter shaft 12, and the medical device 10 is similar to a conventional "over-the-wire" catheter. Alternatively, as shown in the figure, the guidewire lumen 26 may extend along only a portion of the catheter shaft 12, and the medical device 10 is similar to a "single-operator-exchange" catheter or a "rapid-exchange" catheter.

[0047] The catheter shaft 12 may also be provided with an expansion lumen 28, which can be used, for example, to transport an expansion medium to or from the inflatable balloon 16 to selectively inflate and / or deflate the inflatable balloon 16. The position or arrangement of the expansion lumen 28 can be changed depending on the configuration 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 expansion lumen 28 may be defined within the space between the outer tubular member 22 and the inner tubular member 24. In an example where the outer tubular member 22 is positioned alongside the inner tubular member 24, the expansion lumen 28 may be the lumen of the outer tubular member 22.

[0048] The inflatable balloon 16 can be attached to the catheter shaft 12 by any of a number of suitable methods. For example, the inflatable balloon 16 can be attached to the catheter shaft 12 with adhesive or thermally. In some embodiments, the proximal waist 30 of the inflatable balloon 16 is attached to the distal end of the catheter shaft 12, for example, the outer tubular member 22, and the distal waist 32 of the inflatable balloon 16 is attached to the distal end of the catheter shaft 12, for example, the inner tubular member 24. However, the exact attachment position can be changed.

[0049] Each of the multiple integral blade members 18 may be considered to have a first end blade section 34 at the first end of the integral blade member 18 and a second end blade section 36 at the opposing second end of the integral blade member 18. As shown in the figures, the first end blade section 34 corresponds to the most proximal blade portion, and the second end blade section 36 corresponds to the most distal blade portion. In some examples, the first end blade section 34 may correspond to the most distal blade portion, and the second end blade section 36 may correspond to the most proximal blade portion. The first end blade section 34 extends from the first end 18a of the integral blade member 18 to a first bending point 40 formed in the integral blade member 18. The second end blade section 36 extends from the second end 18b of the integral blade member 18 to a second bending point 42 formed in the integral blade member 18.

[0050] In some examples, the first inflection point 40 and the second inflection point 42 may be considered to define the lengths of the first and second end cutting sections, respectively, when the first inflection point 40 is within 2 mm of the first end of the lesion, the second inflection point 42 is within 2 mm of the second end of the lesion. In some examples, the first end cutting section 34 may have a length of less than 3 mm. In some examples, the first end cutting section 34 may have a length of less than 2 mm. In some examples, the second end cutting section 36 may have a length of less than 3 mm. In some examples, the second end cutting section 36 may have a length of less than 2 mm.

[0051] Each of the multiple integrated blade members 18 may have one or more intermediate blade members 38. As shown in the figure, each integrated blade member 18 has two intermediate blade sections 38, which are separated by a third bending point 44. In some examples, each integrated blade member 18 has only one intermediate blade section 38 and does not have a third bending point 44. In some examples, each integrated blade member 18 may have three or more intermediate blade sections 38 and may have a fourth bending point or even a fifth bending point. It should be understood that the number of intermediate blade sections 38 can be determined based at least in part on the desired overall length for each integrated blade member 18. In some examples, the inflatable balloon 16 has two or more integrated blade members 18, each having the same overall length. In some examples, the inflatable balloon 16 has two or more integrated blade members 18, each having a different overall length.

[0052] Figure 2 is a side view of one of several integrated blade members 18. The integrated blade member 18 shown in Figure 2 can be considered to be the same as the integrated blade member 18 shown in Figure 1. The integrated blade member 18 includes a base portion 46 extending from a first end 46a to a second end 46b. The integrated blade member 18 includes a blade portion 48 extending outward from the base portion 46. The blade portion 48 includes a first end blade section 34, a second end blade section 36, and an intermediate blade section 38, separated by a first bending point 40, a second bending point 42, and a third bending point 44, respectively.

[0053] In some examples, as shown in the figure, the first inflection point 40 and the second inflection point 42 may be wider than the third inflection point 44 (or any additional intervening inflection point). The first inflection point 40 and the second inflection point 42 may each be 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% or more wider than the third inflection point 44. In some examples, making the first inflection point 40 and the second inflection point 42 wider allows the first end cutting edge section 34 and / or the second end cutting edge section 36 to flex to a relatively large angle relative to the adjacent intermediate cutting edge section 38 without being collided with or obstructed by the adjacent intermediate cutting edge section 38. In some examples, the first bending point 40 and / or the second bending point 42 may be applied such that the first end cutting section 34 and / or the second end cutting section 36 bend to a position where the first end cutting section 34 and / or the second end cutting section 36 form an angle of up to 90 degrees with respect to the intermediate cutting section 38.

[0054] In some cases, the first bending point 40 may be considered as a first gap in the blade portion 48 (for example, the gap between adjacent portions of the cutting edge of the blade portion 48), the second bending point 42 may be considered as a second gap in the blade portion 48 (for example, the gap between adjacent portions of the cutting edge of the blade portion 48), and the third bending point 44 may be considered as a third gap in the blade portion 48 (for example, the gap between adjacent portions of the cutting edge of the blade portion 48). In some cases, as shown in the figure, the gap penetrates the blade portion 48 but not the base portion 48, which means that the integrated blade member 18 is a single unit structure and is formed from a single material.

[0055] In some examples, the base 48 may have thin-walled regions corresponding to the arrangement of the inflection points 40, 42, and 44. As shown in the figure, the base 46 has a first thin-walled region 50 aligned with the first inflection point 40, a second thin-walled region 52 aligned with the second inflection point 42, and a third thin-walled region 54 aligned with the third inflection point 44. It should be understood that the thin-walled regions 50, 52, and 54 work in cooperation with the gaps corresponding to the inflection points 40, 42, and 44 to further improve the flexibility of the integrated blade member 18. The flexibility of the integrated blade member 18 allows it to guide small or greatly curved portions of the vascular structure, and similarly helps the terminal blade sections 34 and 36 to bend or flex further with respect to the intermediate blade section 38.

[0056] In some examples, the base 48 may have numerous T-shaped slots or notches 55 that help to further improve the flexibility of the integrated blade member 18. The T-shaped notches 55 also help to anchor the base 48 into a polymer member or polymer pad (not shown), which is itself fixed to an inflatable balloon 16 to anchor the integrated blade member 18 to the balloon 16. In some examples, the material of the polymer member or polymer pad flows into the T-shaped notches 55, further anchoring the integrated blade member 18 to the inflatable balloon 16. Further details regarding the T-shaped notches 55 and their function 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. In some cases, at least one or more T-shaped notches 55 are present in each of the blade sections (including the end blades).

[0057] The integrated blade member 18 has an overall length "L". As shown in the figures, the integrated blade member 18 has an overall length L equal to approximately 10 mm. Figure 3 provides an example of an integrated blade member having an overall length L of approximately 14 mm or 15 mm, and Figure 4 provides an example of an integrated blade member having an overall length L of approximately 6 mm. Please understand that these examples are merely illustrative, as the integrated blade member can have any desired length.

[0058] It can be understood that the base 46 extends beyond the blade portion 48 at the first end 46a and the second end 46b, and that the base 46 has a first tail portion 56 at the first end 46a and a second tail portion 58 at the second end 46b. In some examples, the additional length provided by the first tail portion 56 and the second tail portion 58 may be useful when securing the base 46 (i.e., the integrated blade member 18) to the inflatable balloon 16. In some examples, the first end blade portion 34 may be considered to have a length "L1" (including the tail portion 56). In some examples, the first end blade portion 35 may be considered to have a length "L2" excluding the tail portion 56. Although not marked, in some examples, the second end blade portion 36 may be considered to have similar dimensions.

[0059] In some examples, L1 and L2 may each be 3 mm or less. In some examples, L1 and L2 may each be 2 mm or less. In a particular example, when L is 15 mm, L1 may be approximately equal to 2 mm, for example 2.07 mm, and L2 may be approximately equal to 1.75 mm, for example 1.74 mm. Each of the intermediate blade sections 38 may be considered to have a length "L3", the length "L3" being defined as the distance between a plurality of bending points located at both ends of the intermediate blade section 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 may be adjusted to provide the desired overall length of the integrated blade member 18. As an example, when L is approximately equal to 10 mm, each of the intermediate blade sections 38 may have a length L3 that is approximately equal to 2.75 mm, for example 2.77 mm.

[0060] The multiple integrated blade members 18 shown in Figures 1 and 2 are merely examples. Figures 3 and 4 provide additional details regarding the integrated blade members 18. Figure 3 shows an integrated blade member 118 that can be used as one or more integrated blade members 18 shown in Figure 1. The integrated blade member 118 has an overall length "L" equal to approximately 14 mm. The integrated blade member 118 comprises a base 146 and a blade portion 148 that is divided into numerous blade sections via intervening bending points. In some examples, as shown in the figures, the integrated blade member 118 comprises a first end blade section 134 and a second end blade section 136. The first end blade section 134 may be conceivable having a length "L1" including a first tail 156. The first end blade section 134 may be conceivable having a length "L2" without including the first tail 156. Although not labeled, in some examples the second end blade section 136 may be conceivable having similar dimensions.

[0061] In some examples, L1 and L2 may each be 3 mm or less. In some examples, L1 and L2 may each be 2 mm or less. In a particular example, when L is approximately 14 mm, L1 may be approximately equal to 2.6 mm, for example 2.60 mm, and L2 may be approximately equal to 2.25 mm, for example 2.23 mm. Each of the intermediate blade members 38 may be conceivable having a length "L3" defined as the distance between a plurality of bending points located at both ends of the intermediate blade member 138, for example between the first bending point 140 and the third (and additional) bending point 144. L3 may be adjusted to provide a desired overall length for the integrated blade member 118. In some examples, L3 may be selected to be equal to, for example, L2.

[0062] Figure 4 shows an integral blade member 218 that can be used as one or more integral blade members 18 shown in Figure 1. The integral blade member 218 has an overall length "L" equal to approximately 6 mm. The integral blade member 228 comprises a base 246 and a blade portion 248 that is divided into a pair of blade sections via an intervening bending point 260. In some examples, as shown in the figure, the integral blade member 228 comprises a first end blade section 234 and a second end blade section 236. The first end blade section 134 may be conceived to have a length "L1" including a first tail 256. The first end blade section 234 may be conceived to have a length "L2" excluding the first tail 256. The second end blade section 236 may be conceived to have a length "L3" including a second tail 258. The base includes a thin-walled region 262 corresponding to the bending point 260. In some cases, L2 and L3 can each be approximately 3 mm.

[0063] In some examples, multiple blade members, such as 18, 118, and 218, are described as a single unit, meaning that the multiple blade members 18, 118, and 218 may be formed from a single continuous material extending over the entire length of the multiple blade members 18, 118, and 218. In other words, multiple end blade sections and (one or more) intermediate blade sections may be formed from a single continuous material. In some examples, several blade assemblies may comprise multiple spaced blade sections, each of which is axially aligned with the others. Some of these spaced blade sections may be positioned at an acute angle to adjacent blade sections. In some examples, blade sections may be fixed within a polymer pad, which is applied to be fixed to the outer surface of an inflatable balloon 16. Each blade section may be fixed within its own polymer pad, or at least some blade sections may be fixed within the same polymer pad. Figures 5 to 7 provide examples of exemplary blade assemblies.

[0064] Figure 5 shows a blade assembly 300 attached to an inflatable balloon 16. The blade assembly 300 comprises a first end blade section 302, a second end blade section 304, and an intervening blade section 306. It should be understood that the first end blade section 302, the second end blade section 304, and several intervening blade sections 306 (only one is shown) are formed as separate elements that do not directly contact each other. In some examples, the first end blade section 302, the second end blade section 304, and the intervening blade section 306 are formed as a unit structure (as shown, for example, with respect to Figures 2, 3, and 4), and the individual blade sections may be ruptured or separated from each other before being embedded in a polymer pad for fixation to the inflatable balloon 16.

[0065] In some examples, the first end cutting section 302 and the second end cutting section 304 may each have a length of less than 3 mm. In some examples, the first end cutting section 302 and the second end cutting section 304 may each have a length of less than 2 mm. In some examples, the intervening cutting section 306 may have a length greater than 3 mm, while the first end cutting section 302 and the second end cutting section 304 may have a length of less than 3 mm.

[0066] In some examples, each of the first end blade section 302, the second end blade section 304, and the intervening blade section 306 may be fixed to a single polymer pad for securing the blade assembly 300 to an inflatable balloon such as the inflatable balloon 16. In some examples, each of the first end blade section 302, the second end blade section 304, and the intervening blade section 306 may be fixed individually to their own unique polymer pads that are spaced apart from each other.

[0067] The first terminal blade section 302 comprises a blade portion 308 and a base portion 310. The second terminal blade section 304 comprises a blade portion 312 and a base portion 314. The intervening blade section 306 comprises a blade portion 316 and a base portion 318. It should be understood that the blade portions 308, 312, and 316 may be applied to cut or crack a lesion when the medical device comprising the blade assembly 300 is advanced through a vascular structure and positioned proximal to the lesion, and the inflatable balloon 16 is inflated to drive the blade assembly 300 in a radially outward direction to engage with the lesion. The base portions 310, 314, and 318 may each be applied to be embedded in a polymer pad for fixation to the inflatable balloon 16.

[0068] Figure 6 shows a blade assembly 320 attached to an inflatable balloon 16. The blade assembly 320 comprises a first end blade section 322, a second end blade section 324, and several (two are shown) intervening blade sections 326. Although a pair of intervening blade sections 326 are shown, in some examples the blade assembly 320 may comprise only one intervening blade assembly 326. In some examples, depending on the desired overall length of the blade assembly 320, the blade assembly 320 may comprise three, four, or more intervening blade sections 326.

[0069] In some examples, the first end blade section 322, the second end blade section 324, and the intervening blade section 326 may be formed as a unit structure, as shown, for example, with respect to Figures 2, 3, and 4, and the individual blade sections may be ruptured or separated from each other before being embedded in a polymer pad for fixation to the inflatable balloon 16. For example, the blade sections 322, 324, and 326 may be formed from stainless steel, titanium, nickel-titanium alloy, tantalum, iron-cobalt-nickel alloy, or, in some examples, other metallic materials. The blade sections 322, 324, and 326 may have a cross-sectional shape of triangular, square, rectangular, circular, or any desired shape. In some examples, the first end blade section 322, the second end blade section 324, and the intervening blade section 326 may each be of equal length. For example, each of the first end blade section 322, the second end blade section 324, and the intervening blade section 326 may have a length of less than 3 mm. As an alternative example, the first end blade section 322, the second end blade section 324, and the intervening blade section 326 may have a length of less than 2 mm.

[0070] The first end blade section 322 comprises a blade portion 328 and a base portion 330. The second end blade section 324 comprises a blade portion 332 and a base portion 334. Each intervening blade section 326 comprises a blade portion 336 and a base portion 338. The base portion 330 is shown embedded within a polymer pad section 340, the base portion 334 is shown embedded within a polymer pad section 342, and each base portion 338 is shown embedded within a polymer pad section 344. In some examples, embedding each specific blade portion within its own specific polymer pad section may be beneficial in providing further flexibility.

[0071] Figure 7 shows a blade assembly 350 attached to an inflatable balloon 16. The blade assembly 350 comprises a first end blade section 322, a second end blade section 324, and several (two are shown) intervening blade sections 326. While a pair of intervening blade sections 326 are shown, in some examples the blade assembly 350 may comprise only one intervening blade section 326. In some examples, the blade assembly may comprise three, four, or more intervening blade sections 326, depending on the desired overall length of the blade assembly 350.

[0072] The first end blade section 322 comprises a blade portion 328 and a base portion 330. The second end blade section 324 comprises a blade portion 332 and a base portion 334. Each intervening blade section 326 comprises a blade portion 336 and a base portion 338. The base portions 330, 334, and 338 can each be embedded in a unit polymer pad or a single polymer pad 352. The polymer pad 352 can be fixed to the outer surface of an inflatable balloon 16 to form a medical device.

[0073] Figure 8 shows a medical device 10 positioned proximal to a lesion 402 within a blood vessel 400. In some cases, the lesion 402 may be non-uniform in size or composition. In some cases, the lesion 402 may include a less flexible central portion 402a due to being very calcified. The lesion 402 may have end portions 402b on either side of the central portion 402a. The end portions 402b may be less flexible because they are less calcified. In some cases, when the inflatable balloon 16 is inflated, the intermediate blade section 38 may be driven by the intermediate portion 408 of the inflatable balloon 16 and apply further radial force to the central portion 402a as indicated by arrow 408, and the terminal blade sections 34 and 36 may apply further axial force to the central portion 402 as indicated by arrow 412.

[0074] When the blade assembly 18 engages with the lesion 402 and the first region 404 and the second region 406 of the inflatable balloon 16 achieve a larger diameter than the intermediate region of the inflatable balloon 16, the inflatable balloon 16 can achieve a "dogbone" shape depending on the geometry of the lesion 402, particularly the central portion 402a. This means that the first and second terminal blade sections 34 and 36 may achieve angles of 30 degrees or more with respect to the intermediate blade section 38. In some cases, as shown in Figure 9, the first and second terminal blade sections 34 and 36 may achieve angles of 45 degrees or more with respect to the intermediate blade section 38. These angles can be achieved, for example, by having terminal blade sections 34 and 36 that extend beyond the outer edge of the non-deformable or restrictive portion of the lesion 402 (e.g., the central portion 402a of the lesion 402).

[0075] A method for treating the lesion 402 may include advancing a medical device, such as a medical device 10, through a blood vessel 400 to a position proximal to the lesion 402. In some examples, the diameter of the lesion 402 may be estimated or determined using a fluorescence spectrometer and a contrast agent. In some examples, the medical device 10 may be selected such that an integral blade 18 (or blade assemblies 300, 320, and 350) forming part of the medical device 10 is several millimeters longer than the axial length of the non-deformable or restricting portion of the lesion 402 (e.g., the central portion 402a). In some examples, the lesion 402 may be longer than the integral blade 18 or blade assemblies 300, 320, and 350. As previously stated, the medical device may comprise an inflatable balloon 16 and an integral blade 18. The integral blade 18 may comprise a base 46 and a blade portion 48. The blade portion 48 may be divided into a first blade section, a second blade section and an intervening third blade section. The medical device 10 is positioned such that the first blade segment extends in a first direction beyond the outer edge of the resistant portion 402a of the lesion 402 (e.g., beyond the first terminal range of the resistant portion 402a of the lesion 402), and the second blade segment extends in a second direction beyond the outer edge of the restricting portion 402a of the lesion 402 (e.g., beyond the second terminal range of the restricting portion 402a of the lesion 402). The inflatable balloon 16 is inflated to apply force to the integrated blade 18 toward the lesion 402. At least one of the first and second blade segments is deflected to an angle of 30 degrees or more with respect to the intervening third blade segment. In some examples, when the inflatable balloon 16 is inflated, at least one of the first and second blade segments is deflected to an angle of 45 degrees or more with respect to the third blade segment.

[0076] In addition to providing further breaking force to the outer edge of the resistant portion 402a of the lesion 402, the deliverability of the medical device 10 can usually be improved by making the blade sections shorter. Figure 10 schematically shows a curved portion of a blood vessel 400, where the radius of curvature "R" is measured at the center of the blood vessel 400. A single blade 440 (corresponding inflatable balloon not shown) comprising a first blade section 342 and a second blade section 444 separated by a bending point 446 is shown to be positioned within the curved portion of the blood vessel 400. Each of the first blade section 442 and the second blade section 444 has a length "L". As understood, as the radius of curvature R increases, the length L that allows the single blade 440 to pass further through the curved blood vessel increases. As the radius of curvature R decreases, the length L that allows the single blade 440 to pass further through the curved blood vessel decreases. Of course, the diameter of the vessel 400 (indicated by diameter "D") also affects which length of blade can pass through a vessel with a particular radius of curvature R.

[0077] Therefore, having described several exemplary embodiments of this disclosure, those skilled in the art will immediately understand that other embodiments may be formed and used within the scope of the claims attached herein. However, it should be understood that this disclosure is in many respects merely illustrative. Modifications may be made to the details, particularly the shape, size, arrangement and omission and order of steps, without exceeding the scope of this disclosure. The scope of this disclosure is, of course, defined by the language in which the attached claims are expressed.

Claims

1. It is a medical device, A catheter shaft having a distal region, An inflatable balloon fixed to the distal region, The inflatable balloon is provided with an integral blade member that extends longitudinally and is fixed to the outer surface of the inflatable balloon. The integrated blade member is A base portion extending from the first end of the integrated blade member to the second end of the integrated blade member, It comprises a blade portion extending outward from the base portion, The blade portion is, A first end blade section extends from the first end of the integrated blade member to a first bending point formed in the integrated blade member and has a first end blade section length, A second end blade section extends from the second end of the integral blade member to a second bending point formed in the integral blade member, and has a second end blade section length, A medical device comprising at least one intermediate blade section extending between the first bending point and the second bending point, wherein each of the at least one intermediate blade section includes at least one intermediate blade section having an intermediate blade section length greater than the length of the first end blade member section and the length of the second end blade member section.

2. The medical device according to claim 1, wherein the length of the terminal blade section allows the first bending point to be located within 2 mm from the first end of the lesion when the second bending point is located within 2 mm from the opposing second end of the lesion.

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

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

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

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

7. A medical device according to any one of the preceding claims, further comprising one or more additional integral blade members extending longitudinally along the outer surface of the inflatable balloon, wherein each of the one or more additional integral blade members is A base portion extending from the first end of the integrated blade member to the second end of the integrated blade member, It comprises a blade portion extending outward from the base portion, This blade part is The first end blade section extends from the first end of the integrated blade member to a first bending point formed in the integrated blade member and has a first end blade section length, The second end blade section extends from the second end of the integral blade to a second bending point formed in the integral blade member and has a second end blade section length, A medical device comprising at least one intermediate blade section extending between the first bending point and the second bending point, wherein the at least one intermediate blade section has an intermediate blade section length greater than the length of the first end blade section and the length of the second end blade section.

8. It is a medical device, An inflatable balloon fixed to the distal region of a catheter shaft having a longitudinal axis, Fixed to the inflatable balloon and extending longitudinally with respect to the inflatable balloon It comprises multiple blade assemblies, Each of the multiple blade assemblies has a longitudinal axis, A polymer pad applied to be fixed to the inflatable balloon, A medical device comprising a plurality of blade sections fixed within the polymer pad, each blade section including a first end blade section having a length of less than 3 mm at a first end of the blade assembly, a second end blade section having a length of less than 3 mm at an opposing second end of the blade assembly, and at least one intermediate blade section disposed between the first end blade section and the second end blade section.

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

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

11. The first end cutting edge section is positioned relative to adjacent intermediate cutting edge sections so that it can be deflected from the longitudinal axis at an angle greater than 30 degrees. The medical device according to claim 8 or 9, wherein the second end blade section is positioned relative to an adjacent intermediate blade section so that the second end blade section can be deflected from the longitudinal axis at an angle greater than 30 degrees.

12. The first end cutting edge section is positioned relative to adjacent intermediate cutting edge sections so that it can be deflected from the longitudinal axis at an angle greater than 45 degrees. The medical device according to any one of claims 8 to 11, wherein the second end blade section is positioned relative to an adjacent intermediate blade section so that the second end blade section can be deflected from the longitudinal axis at an angle greater than 45 degrees.

13. The medical device according to any one of claims 8 to 12, wherein the at least one intermediate blade section extends parallel to the longitudinal axis, while the first and second end blade sections are deflected at an angle greater than 30 degrees from the longitudinal axis.

14. A method for treating intravascular lesions, this method is The medical device is advanced through the blood vessel to a location proximal to the lesion, The medical device is An inflatable balloon, A single blade member comprises a base portion extending from a first end of the single blade member to a second end of the single blade member, and a blade portion extending outward from the base portion. The blade portion is, A first blade section extending from the first end of the integrated blade member to a first bending point formed in the integrated blade member, A second blade section extending from the second end of the integrated blade member to a second bending point formed in the integrated blade member, Including a third blade section extending between the first blade section and the second blade section, To advance the medical device, The medical device is positioned such that the first blade section extends distal to the lesion and the second blade section extends proximal to the lesion. A method for treating an intravascular lesion, comprising inflating the inflatable balloon to apply force to the integral blade toward the lesion, such that at least one of the first blade section and the second blade section bends to an angle greater than 30 degrees relative to the third blade section.

15. The method according to claim 14, wherein when the inflatable balloon is inflated, at least one of the first blade section and the second blade section bends to an angle greater than 45 degrees with respect to the third blade section.

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