Wedge incision tool for medical baloon

Abstract

To provide a wedge incision tool for a medical balloon.SOLUTION: A cage is positioned around a medical balloon such as an angioplasty balloon, and assists a medical treatment. The cage includes multiple belt-like bodies, and each belt-like body is extended between a pair of rings including a first ring and a second ring. When the balloon is expanded, the first ring and the second ring are brought close mutually, and the belt-like bodies become expandable outward. The cage may have a wedge incision tool on the belt-like body.SELECTED DRAWING: Figure 21D

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Application No. 62 / 220,195, filed on September 17, 2015, under 35 U.S.C. §119(e), the entire contents of which are incorporated herein by reference. Any and all applications for which a claim of foreign or domestic priority is identified in an Application Data Sheet filed with this application are hereby incorporated by reference under 35 U.S.C. §1.57.

[0002] The embodiments relate to cages for use with medical balloons, such as angioplasty balloons, methods for making and treating with the cages, as well as various wedge-shaped instruments and splines that can be used with the cages. Among these, wedge-shaped cutting instruments are used to perforate plaque in blood vessels to control the propagation of fissures and reduce the creation of lesions that restrict blood flow. [Background technology]

[0003] Atherosclerotic occlusive disease is the primary cause of stroke, heart attacks, limb loss, and death in the United States and in industry. Atherosclerotic plaque forms a hard layer along the walls of arteries and contains calcium, cholesterol, hardened blood clots, and cellular debris. As atheroma progresses, the supply of blood flowing through the blood vessels is reduced or stopped by blockage. Balloon angioplasty is one of the most widely used procedures for treating clinically significant atherosclerotic plaque.

[0004] Balloon angioplasty is a method for expanding blocked or narrowed blood vessels in the body. In this procedure, a balloon angioplasty catheter is placed into the artery, either percutaneously or by remote access through the open end of the artery. The catheter is inserted along the blood vessel over the catheter's guide member. The balloon associated with the catheter is placed at the site of the atheromatous plaque that requires treatment. The balloon is typically inflated to the same size as the artery's original diameter prior to treatment of the blockage. Summary of the Invention [Problem to be solved by the invention]

[0005] When the balloon is inflated, the plaque compresses or stretches, cracking or shattering depending on its composition, location, and the pressure from the balloon. Because plaque is heterogeneous, it exhibits properties such as being soft in some places and hard in others, resulting in unexpected cleavage surfaces during standard angioplasty. Balloon angioplasty can cause plaque fragmentation and damage the artery at the site of the angioplasty.

[0006] There is a need for improved methods of treating occlusions, including balloon angioplasty and other related treatment systems. [Means for solving the problem]

[0007] In embodiments, the cage can be disposed around a medical balloon, such as an angioplasty balloon, to assist in a medical procedure. The cage can include at least a first ring and a second ring, and a plurality of bands. Each band extends longitudinally between the first and second rings. While the bands are inflated, the cage can be moved toward the inflated portion to move the first and second rings closer together. In embodiments, the cage can include spikes on the bands, the spikes can be moved toward the first and second rings closer together. can be used as a wedge dissector to dissect plaque in a blood vessel. In an embodiment, a medical balloon catheter is disclosed, and the wedge dissector and the band can be configured to be attached to the medical balloon catheter or other inflatable member. The balloon catheter can include any number of members, such as a strip having an internal lumen and defining a longitudinal axis, an inflatable balloon coupled to the strip distally of the strip, and a plurality of bands, each band having a plurality of wedge dissectors spaced apart along a surface of each strip, each band extending longitudinally along an outer surface of the balloon. The wedge dissector has a cutting surface of the strip directly adjacent a surface of each strip, and the cutting surface of the wedge dissector has a length corresponding to a length between radially outward proximal and distal edges, and determines a height of each wedge dissector. The radially outwardly facing face has a first width at the proximal edge, a second width between the proximal and distal edges that is less than the first width, and a third width at the distal edge that is greater than the second width. In an embodiment, the second width corresponds to a single point along the length of the radially outwardly facing face. The second width corresponds to a center portion having a center length between the proximal and distal edges. The length of each band is less than the length of the balloon's outer surface that is coaxial with the length of each band. The length of each band is between about 3% and about 6% of the balloon's outer surface that is coaxial with the length of each band. The total length of the radially outwardly facing face of each wedge-shaped dissector is less than the total length of the base surface of each wedge-shaped dissector band. The radially outwardly facing face can have, for example, one or more curved and / or chamfered surfaces. The radially outward cutting surface has a first height at the proximal edge and a second height between the proximal and distal edges. The second height is greater than the first height. In some cases, the maximum height of the radially outward cutting surface can be a midpoint between the first unbounded end and the second unbounded end. In some cases, the maximum height of the unbounded surface can be offset from its proximal and distal edges. In embodiments, a side portion of the wedge cutting instrument from the base surface to the proximal edge has a first portion having a first slope and a second portion having a second slope different from the first slope.The band may have a fibrous surface. In embodiments, the band may have a plurality of tabs on an underside opposite the wedge cutting device. The band may also have a plurality of reliefs disposed thereon. In some cases, the band may be a strip having a first and second lateral end. The first and second ends of the plurality of bands may be secured with an adhesive. In some embodiments, the balloon, band, and wedge cutting device may have a hydrophilic lubricating layer disposed on the outer surface. In some embodiments, the balloon, band, and wedge cutting device may have at least one polymeric retaining layer disposed on the outer surface. The balloon may include a cone at its lateral end. The maximum outer diameter of the cone is about 5% greater than the maximum outer diameter of the balloon. In some cases, the cone has tracks oriented along the length of the band.

[0008] The cage may be constructed and / or manufactured in a variety of ways, such as, for example, an extrusion process, removing material from a tube, or splitting wire to form bands.

[0009] The cage can assist in a medical procedure in a variety of ways. For example, it can apply a drug coating prior to deployment of the balloon, or it can inflate the cage to cover the drug coating on the balloon. In this way, the cage can prevent or limit dilution of the drug during delivery and prevent or limit the administration of treatment to unintended sites.

[0010] The cage may also restrict balloon expansion at its ends relative to its center, preventing or reducing dog-boning.

[0011] In an embodiment, the balloon catheter comprises a strip member, a balloon and a cage. The strip member can have a lumen, a strip member defining a longitudinal axis. The balloon can be joined to the strip member at a distal edge of the strip member. A cage can be used to position the balloon. The cage can have a plurality of bands and a plurality of rings. The plurality of rings can be configured to secure the plurality of bands to the balloon catheter. Each band can have a first ring at a distal edge and a second ring at a proximal edge. At least an intermediate portion between the distal and proximal edges of the band can be left uncovered by the ring and can be left unconnected to the ring. The balloon and cage can be configured to have an initial state and an inflated state, and the plurality of bands can be configured to move with the balloon when the balloon is inflated.

[0012] According to an embodiment of the balloon catheter, some of the rings include heat shrink material, and each cuff can have a number of wedge-shaped dissectors spaced along the cuff. The rings are secured to the cuffs at distal and proximal edges of the balloon. The cuffs may be secured at midpoints and / or ends.

[0013] In embodiments, some of the rings may include partial rings with upper and lower layers of heat shrink material, and an end of each strip may be sandwiched between the upper and lower layers. In embodiments, hooks may be disposed on the strips, and grooves may be provided on the strips or on the rings, springs, or other features.

[0014] In embodiments, a series of polyurethane coatings are applied to create a cage. Such embodiments include a complete or partial top layer of urethane, polyurethane, or other polymeric material, or multiple layers of urethane, etc., and a bottom layer of urethane, polyurethane, or other polymeric material, such that the cage is sandwiched between the top and bottom layers. In embodiments, hooks can be disposed on the strips, and grooves can be provided on the strips or on rings, springs, or other features.

[0015] A method of modifying a balloon catheter with a cage includes disposing a plurality of bands around an inflated balloon of a balloon catheter, with the bands being evenly spaced around the inflated balloon, applying a ring of heat shrink material around the balloon to cover each end of the bands with the ring, and heating the ring to shrink the ring and secure the bands to the balloon, with the portions of the bands between the distal and proximal edges remaining uncovered and / or not bonded to the ring.

[0016] The method may include arranging the bands to extend longitudinally and / or arranging the bands in four parallel rows around the balloon, each row consisting of 2-6 bands, and the bands being permanently or temporarily attached to the balloon by an adhesive.

[0017] A ring of heat shrink material may be applied to the balloon such that a single ring covers most of the distal edges of the bands, and a ring of heat shrink material may be applied to the balloon such that a single ring covers most of the proximal edges of the bands.

[0018] In embodiments, a cage may be disposed about the angioplasty balloon. The cage may include a first ring, a second ring, and a plurality of bands. Each band extends longitudinally between the first and second rings. The cage may be in a pre-inflation position. The balloon may be disposed in a pre-inflated position or in a post-inflated position, but as the balloon expands, the first and second rings move closer together and the bands become more spaced apart.

[0019] A method of making a cage for an angioplasty balloon comprises extruding a plastic tube with a plurality of splines spaced longitudinally along the tube, cutting at least one of the splines to form a plurality of spikes disposed circumferentially around the tube, and cutting the tube to form a plurality of longitudinally extending bands, each band including at least one spike.

[0020] A method of making a cage for an angioplasty balloon includes forming a wire into a plurality of longitudinally extending bands, cutting at least two of the bands to form a plurality of spaced spikes along the bands, and connecting the two bands to first and second rings such that each band extends between the first and second rings.

[0021] A method of protecting an angioplasty balloon with a drug coating includes providing a drug-coated angioplasty balloon; providing a cage having defined pre-inflation and post-inflation positions, the cage having a first ring, a second ring and a plurality of bands, each band extending between the first and second rings, radially covering the angioplasty balloon in the pre-inflation position such that the drug-coated surface of the angioplasty balloon is not or substantially not exposed; and when transitioning to the post-inflation position, the first and second rings approach each other, the spacing between the bands increases, and the surface of the angioplasty balloon is exposed.

[0022] A method of treating a vascular disease includes applying an angioplasty balloon having a cage having a first ring, a second ring and a plurality of bands, the first ring having a selectively drug coated, fully covering arrangement, and having defined pre- and post-inflation positions, each band extending between the first and second rings, and inflating the angioplasty balloon at a treatment site, the inflation of the angioplasty balloon bringing the first and second rings closer together and expanding the spacing of the bands, the cage restricting balloon expansion at the ends relative to the center to prevent or inhibit the occurrence of dog-bones.

[0023] In an embodiment, a cage for positioning an angioplasty balloon can include a plurality of rings and a plurality of bands. The plurality of rings can be non-distensible. At least one of the plurality of rings can be configured to be disposed around a first end of the angioplasty balloon and can be configured to be disposed around a second end of the angioplasty balloon. Each band can have a plurality of protrusions disposed on a surface of the band. Each ring can be configured to attach to an end of the plurality of bands. The plurality of bands can be coupled to the plurality of rings. In an embodiment, the cage can have a first length and a second length. The second length is less than the first length, and the plurality of rings are adjacent to one another such that each band is bent apart.

[0024] These and other features, aspects and advantages are described hereinafter with reference to the drawings, which are intended for illustrative purposes and not for limiting purposes, and in which like reference characters indicate corresponding features throughout like embodiments. [Brief description of the drawings]

[0025] [Figure 1A] FIG. 13 shows a cage disposed on an angioplasty balloon in an inflated position. [Figure 1B]FIG. 2 is a development view of an angioplasty balloon placed within a cage, showing the state prior to inflation. [Diagram 2] FIG. 1 is a plan view of a cage having long and short slits. [Diagram 3] FIG. 13 shows an angioplasty balloon at the treatment site of a blood vessel that has developed a dogbone. [Figure 4A] This is a diagram showing the process of cutting the tube to manufacture the cage. [Figure 4B] 4B is a cross-sectional view taken along line BB in the diagram shown in FIG. 4A. [Figure 4C] FIG. 4C is a cross-sectional view of the device shown in FIG. 4B after additional manufacturing steps have been performed. [Figure 4D] FIG. 13 is a cross-sectional view of another embodiment having a relatively large lumen. [Figure 4E] FIG. 13 shows a detailed view of a portion of another embodiment of the cage. [Figure 5A] 13A-13C are views of another embodiment of a cage in process. [Figure 5B] FIG. 5B is a cross-sectional view of the cage shown in FIG. 5A taken along line BB. [Figure 6A] FIG. 13 shows the wires cut to form bands and wedge cutting instruments for one embodiment of the cage. [Figure 6B] FIG. 6B is a cross-sectional view of the cutting wire shown in FIG. 6A. [Figure 7] FIG. 1 shows multiple strips joined by two rings to form a cage. [Figure 8] FIG. 1 shows two rings that fasten the straps together to form part of the cage. [Figure 9A] FIG. 13 shows another embodiment of a cage having conical rings. [Figure 9B] FIG. 1 is a perspective view of a ring having a tapered outer periphery with screw-like features formed thereon. [Figure 10] FIG. 13 shows the ends of the straps received and fixed in the multi-layer rings forming the ends of the cage. [Figure 11]13 shows another embodiment of the ends of the straps housed and fixed in the multi-layer rings forming the ends of the cage. FIG. [Figure 12] FIG. [Figure 13A] FIG. 1 shows a band having hook features and rings. [Figure 13B] FIG. 13 is an end view of a strip having ridge-shaped hook features. [Figure 13C] FIG. 2 is a perspective view showing a portion of the cage. [Figure 13D] FIG. 13 shows a conical ring at the distal edge that holds multiple bands. [Figure 13E] FIG. 13 shows one end of a balloon with a cage disposed around the balloon and illustrating the forces acting on the balloon in an inflated state. [Figure 13F] FIG. 13 shows one end of a balloon with a cage disposed around the balloon and illustrating the forces acting on the balloon in an uninflated state. [Figure 14A] FIG. 13 is a side view of an embodiment of a cage with straps having hooks that can be attached to the inside of a balloon neck. [Figure 14B] FIG. 14B is an end view of the cage attached to the balloon shown in FIG. 14A. [Figure 14C] FIG. 13 is a cross-sectional view of a band having hooks secured to the interior of a balloon neck. [Figure 14D] FIG. 13 shows another embodiment showing the ends of a band with multiple rings forming the ends of a cage. [Figure 14E] FIG. 13 shows an example of a band held by multiple rings with a wedge-shaped cutting device protruding from the rings. [Figure 15A] FIG. 1 illustrates a portion of an embodiment of an angioplasty balloon comprising bands of material bonded to the surface of the angioplasty balloon with multiple rings of material to form a cage. [Figure 15B] FIG. 2 shows an angioplasty balloon with a cage having multiple bands attached to its surface by multiple rings. [Figure 15C] FIG. 13 shows the location of bands on the balloon surface. [Figure 15D] FIG. 13 is a diagram of another embodiment showing the location of bands on the balloon surface. [Figure 15E] FIG. 13 shows an example of multiple bands attached to the surface of a balloon by multiple rings. [Figure 16A] FIG. 1 shows an example of a strip secured by a ring. [Figure 16B] FIG. 1 shows an example of a strip secured by a ring. [Figure 16C] FIG. 1 shows an example of a strip secured by a ring. [Figure 17] FIG. 13 shows a detailed view of an embodiment of a cage with a spring. [Figure 18] FIG. 18 shows an embodiment of the cage utilizing the spring shown in FIG. 17. [Figure 19] FIG. 1 shows a portion of a cage with springs and spikes. [Figure 20] FIG. 13 is a close-up view of an embodiment with a wedge cutting device on the fascia. [Figure 21] 1A-1C are perspective views of various sizes of wedge cutting instruments according to embodiments. [Figure 21A] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 21B] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 21C] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 21D] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 21E] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 21F] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 21G] 1 illustrates an embodiment of a wedge cutting instrument. [Figure 22A] FIG. 1 illustrates the geometry of a wedge cutting instrument. [Figure 22B] FIG. 1 illustrates the geometry of a wedge cutting instrument. [Figure 22C] FIG. 1 illustrates the geometry of a wedge cutting instrument. [Figure 22D] FIG. 1 illustrates the geometry of a wedge cutting instrument. [Figure 22E] FIG. 1 illustrates the geometry of a wedge cutting instrument. [Figure 22F] FIG. 1 illustrates the geometry of a wedge cutting instrument. [Figure 23A] FIG. 1 illustrates an asymmetrical geometric configuration of a wedge cutting instrument. [Figure 23B] FIG. 1 illustrates an asymmetrical geometric configuration of a wedge cutting instrument. [Figure 23C] FIG. 1 illustrates an asymmetrical geometric configuration of a wedge cutting instrument. [Figure 23D] FIG. 1 illustrates an asymmetrical geometric configuration of a wedge cutting instrument. [Figure 24] FIG. 2 is a diagram showing how the height of the non-boundary surface 204 changes. [Figure 25A] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25B] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25C] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25D] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25E] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25F] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25G] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Fig. 25H] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25I] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25J]FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25K] FIG. 1 shows an embodiment of a band with relief formed at various locations. [Figure 25L] 13A-13C illustrate a method of stabilizing the ribbon during the laser cutting manufacturing process. [Figure 25M] FIG. 13 illustrates an embodiment including a temporary tab. [Figure 25N] 13A-13C show embodiments of adhesive application areas for bonding the lateral ends of the bands to the surface of the balloon. [Figure 25O] FIG. 13 illustrates a cone region relative to a balloon. [Figure 25P] FIG. 13 shows a cone-shaped track or protrusion. [Figure 26] FIG. 13 shows another embodiment of a strip with relief. [Figure 27] FIG. 13 is a cross-sectional view of a balloon having a wedge-shaped dissector and an intervening layer. [Figure 28] 13A-13C show an embodiment of a pleated balloon having a wedge dissector between the band and the pleat. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] 1A and 1B show an embodiment of a cage 10 positioned over an angioplasty balloon 20. FIG. 1A shows the inflated position, and FIG. 1B shows how the angioplasty balloon is inflated in the cage. The cage 10 will be described first in conjunction with the angioplasty balloon and angioplasty procedure. The cage 10 can be used with other types of balloons used in medical and other procedures.

[0027] The cage 10 includes a first ring 12, a second ring 14, and a number of bands 16. Each band extends longitudinally between the first ring 12 and the second ring 14. The bands and rings may be monolithically formed from a single body of material. Thus, the first and second rings may be comprised of, for example, cut tubing remnants. The bands and rings may be comprised of separate materials or may be bonded together. The cage shown in Figures 1A and 1B includes five bands, but may include between two and ten bands.

[0028] 2 is a plan view of the cage made of cut tubes, the cage may also be constructed from a single flat piece of material. The material may be elastic or semi-elastic and may be made from polymers, copolymers, metals, alloys, and combinations thereof. The bands are typically designed to allow multiple inflations of the balloon 20. Similarly, the bands 16 are designed to allow the cage 10 to return to its original position under longitudinal and axial forces.

[0029] In an embodiment, the cage 10 is assembled, packaged, and sterilized separately from the balloon 20, so that a physician can place the cage 10 around a medical balloon 20, such as an angioplasty balloon, to assist in the procedure. FIG. 1B shows the balloon 20 in a folded state prior to placement within the cage 10. The folded balloon 20 can be inserted into the cage 10 without inflating the cage 10 or changing its shape. The cage 10 can completely surround the balloon 20 prior to placement and inflation of the balloon 20. The cage 10 prior to inflation can be longer than the balloon 20, such that one or both ends of the cage 10 move towards each other as the device (e.g., the balloon 20) inflates. The cage 10 is free throughout the balloon 20. One or both ends 12, 14 of the cage 10 can be fixed to the balloon 20 or to a portion of another delivery device. In an embodiment, the cage 10 is not fixed to any part of the inflated balloon 20. This ensures that the cage 10 does not interfere with the inflation of the balloon 20.

[0030] In an embodiment, the cage 10 can be used with a drug-coated angioplasty balloon 20 to protect the drug coating. The cage 10 can prevent and inhibit premature contact of the drug with the blood vessel. As can be seen with reference to FIG. 1B, the cage 10 is positioned over the entire drug coated on the angioplasty balloon 20 prior to inflation of the angioplasty balloon 20 to prevent premature contact of the drug with the blood vessel. The cage 10 radially covers the balloon 20 such that the drug-coated surface of the balloon 20 has minimal or no contact with the blood vessel. The balloon 20 and cage 10 can be advanced in this manner to the treatment site. Although not shown, the system can be advanced over a guidewire within the vasculature.

[0031] As shown in Figure 1A, the cage 10 transitions to an expanded position in which the first ring 12 and the second ring 14 are brought into close proximity and the bands expand to expose the surface of the angioplasty balloon. In this position, the drug is placed into the blood vessel and into contact with the diseased tissue.

[0032] With currently available systems, it is difficult to predict how much of the drug will reach the diseased tissue. There are many factors that limit accurate prediction of how much of the drug will reach the diseased tissue. For example, blood flow dilutes the drug on the balloon 20 as it advances toward the treatment site. Also, maneuvering the device within the blood vessel causes the balloon 20 to rub against the intraluminal wall, shedding some of the drug as it advances toward the treatment site. Thus, in some cases, the cage 10 provides a physical barrier to protect the drug coating the balloon 20 while it advances toward the treatment site. In this way, the cage 10 is used such that the balloon 20 and drug coating are exposed to the blood flowing through the blood vessel during inflation of the balloon 20 as the band spacing increases. In this way, the cage 10 can prevent and reduce drug dilution and treatment of body parts that do not require treatment. In other words, the amount of drug to be coated on the balloon 20 can be reduced by controlling the delivery of the drug.

[0033] In an embodiment, the folded balloon 20 can be located throughout the entire cage 10. As shown in FIG. 1A, the cage 10 can have slits between each band. In other words, the slits can be formed to cut between each of the bands and separate them from a single body of material. In another embodiment, the slits are equal to the spacing between adjacent bands. The spacing between bands can be very small, such as can be formed by laser cutting, or can be as large as the width of the band or larger. Depending on the size of the slits, the percentage of the surface of the balloon 20 exposed prior to inflation can be 50% or less, 25%, 10%, 5%, 1% or less.

[0034] As previously described, expansion of the balloon 20 brings the first ring 12 and the second ring 14 closer together while radially separating the bands 16. With the bands 16 in the expanded position, the balloon 20 is exposed to and interacts with the blood vessel. In the expanded position, the balloon 20 is capable of delivering and administering drugs, stem cells, and other therapeutics to the vessel wall or diseased areas of the vessel wall. After the balloon 20 is fully expanded, the percentage of the balloon 20 that is not covered by the bands is between 65% and 99%, between 75% and 99%, more typically between 80% and 99%, and most typically between 90% and 99%.

[0035] Drug delivery using the cage 10 can be performed before, during, or after the angioplasty procedure, and the cage does not need to completely cover the balloon or control or assist drug delivery.

[0036] In embodiments, the cage 10 can be used to prevent or inhibit dog-boning of the balloon 20 during angioplasty procedures. Such an effect can be used in addition to or instead of drug delivery. FIG. 3 illustrates an angioplasty balloon 20 at a treatment site within a blood vessel 2. As shown, the angioplasty balloon 20 experiences dog-boning when inflated. The attached plaque 4 inhibits the expansion of the balloon 20, causing both ends of the balloon 20 to inflate first, rather than concentrating energy at the center of the balloon 20 where the most expansion energy is needed, at the plaque 4.

[0037] To prevent dogbones, the cage 10 as shown in FIG. 1A can be forced to restrict the inflation of the balloon 20 to inflate the center of the balloon 20 first. This is because the cage 10 is the part of the balloon 20 furthest from the ends where the bands are restrained by the rings. This is because the center portion has the least resistance, and this makes it possible to prevent and suppress dog-boning of the balloon 20 regardless of the shape of the disease or the shape of the artery caused by the expansion of the balloon 20.

[0038] Dog-boning typically occurs when the balloon 20 is expanded in a vessel where plaque inhibits expansion, causing both ends of the balloon 20 to expand first (due to lack of resistance) and give the balloon 20 a dog-bone shape. By encasing the balloon 20 in the cage 10 and configuring the rings to have different resistance to expansion, both ends of the balloon 20 have the most resistance and the center of the balloon 20 has the least resistance. Thus, the cage 10 controls and limits the expansion of the balloon 20 when it would tend to expand in the center, which corresponds to the typical diseased area.

[0039] The orientation pattern of the strips 16 affects expansion and dog-boning. Returning to Figure 2, the short slits 22 located in the center of the strips 16 reduce the stiffness of each strip 16. This reduces the resistance to expansion in the center of the cage 10, thereby reducing the occurrence of dog-boning.

[0040] The cage can further include spikes or wedge dissection tools on the bands. The spikes can be used as an angioplasty tool prior to the second procedure or during the first procedure. For example, the spikes can assist in cutting and / or perforating the plaque prior to or during the angioplasty procedure. This can also assist with drug delivery and / or prevent dog bones. The embodiments described herein provide these benefits and can be used in these procedures, as well as other benefits and procedures described herein.

[0041] The spikes can be positioned on the band in different orientations and configurations, as described below. The spikes can be any of those discussed in US 8,323,243 by Schneider et al., issued April 12, 2012, which is incorporated herein by reference in its entirety. Spikes and cages can be used according to the plaque serration method and other methods described therein.

[0042] The cage 10 can be made in a variety of ways, including extrusion, cutting a tube, or wire severing as described in more detail below. Various cage embodiments are shown in Figures 4A-5B. Figures 4A and 5A show an embodiment of the cage 10 in process. The cage 10 is a tubular body with a number of splines spaced apart on the tube. In an embodiment, the tube is preformed and then machined to the shape shown. The tube may be made of metal or plastic. In another embodiment, the tube is extruded to the shape shown. For example, a plastic tube may be extruded with a number of splines 24 spaced apart along the length of the tube. A cross section of the cage 10 is shown in Figures 4B-4D and 5A.

[0043] After forming the tube with splines 24, portions of the tube material are removed to form the slits and bands. The splines can be formed into different spike or wedge cutters as part of the removal process or prior to the slit formation process. For example, the splines 24 shown in FIG. 4B can be machined into the wedge cutter 26 shown in FIGS. 4C and 4D. In embodiments, the splines 24 can be manufactured with additional processes or can be the initial wedge cutter as shown without additional machining or the like.

[0044] FIG. 4E shows a close-up of a portion of the cage. In this embodiment, the straps 16 are The cage is formed with a plurality of spikes or wedge cutters 26. In embodiments, the cage blank of FIGS. 4A and 4B can be slit into the tube to form adjacent bands. The wedge cutters 26 can be tent-shaped or axe-shaped with extended tips and bases. The tips and bases extend longitudinally along the length of the tube. The wedge cutters 26 assist in cutting and / or perforating the plaque prior to or during the angioplasty procedure. The spacing between the wedge cutters 26 can be formed by machining or material removal to increase the flexibility of the bands. The spacing between the wedge cutters 26 is twice the length of the wedge cutters 26, although other spacings can be used. Exemplary spacings are in the range of 4:1 to 3:1, more commonly 3:1 to 1:1.

[0045] In an embodiment, the splines 24 may be formed from a tube of material. In this case, the cage 10 is an extruded tube of plastic with splines that are cut, ground, EDMed, or stamped to form the wedge cutting devices 26. The tube may be slit along its length. In some cases, the bands 16 are spaced apart and some or all of the bands 16 have spikes or wedge cutting devices 26. As can be seen from the above discussion, in the embodiment shown in Figures 4A-5B, five slits are formed to form points on the periphery.

[0046] In an embodiment, a method of making the cage 10 of the angioplasty balloon 20 includes first extruding a plastic tube having a plurality of spaced apart splines located along the length of the tube. In an embodiment, the method includes cutting at least one of the splines to form a plurality of spikes or wedge cutting devices 26 located around the circumference of the tube. The method further includes cutting the tube to form a plurality of longitudinally extending bands 16, each band having at least one spike of the plurality of wedge cutting devices 26.

[0047] 6A and 6B illustrate another method of manufacturing the cage 10. The wire 28 is segmented or cut to form three or more bands. These bands can be used to construct the cage 10. In an embodiment, the wire 28 is made of an alloy or polymeric material. A variety of different manufacturing methods can be used, including laser cutting and electrical discharge machining. The wire 28 can be segmented, for example, into four portions. In an embodiment, rectangular or other shaped holes 30 can be formed in the wire 28 to provide spaces between the wedge-shaped cutting instruments 26. The four segments of the wire 28 form the bands 10 of the cage 10. The cage 10 can be assembled with multiple rings and can include any number of bands 16. In some cases, the cage 10 can be assembled from one to eight or more bands 16.

[0048] Systems and Methods for Joining Individual Straps The straps 16 can be secured together to form the cage 10 in a number of ways. As opposed to forming the straps from wire, the straps can be formed by extrusion or from a flat piece of material or a tube. For example, the embodiment described in connection with Figures 2 and 4A-5B can be modified to provide individual straps that are joined together to form the cage.

[0049] In embodiments, the straps may be joined together with two or more rings 12, 14 to form the cage 10. For example, the individual straps that make up the cage 10 may be joined at their ends with rings. As shown in FIG. 7, the individual straps 16 are secured at their ends with rings 12, 14. In constructing the cage 10, the straps 16 may be first joined to the rings 12, 14 before being placed around the balloon, or the cage 10 may be secured to the balloon prior to placement. Alternatively, the bands may be assembled around the ring. For example, one or more bands may be disposed on the surface of the balloon prior to bonding with the ring. The cage 10 may be permanently secured to one or both ends of the balloon 20, or may be permanently secured to the balloon catheter. In embodiments, the rings 12, 14 may secure the bands to a portion of the balloon or to a portion of the balloon catheter. The bands 16 may hold the balloon in a compressed state prior to deployment of the balloon 20, and may hold the balloon in a deflated state after inflation.

[0050] The rings 12, 14 are typically circular bands, but may be any shape, such as oval, square, elliptical, rectangular, etc. The rings may create a binding and / or restraining force. The rings 12, 14 may be constructed from any number of different materials, including one or more metals, polymers, copolymers, elastomers, thermoplastic elastomers, adhesives, hydrogels, etc. The rings may be rigid or flexible.

[0051] In some cases, the rings 12, 14 are made of a heat shrink material or other elastic material that bonds, captures, and constrains the bands 16 to prevent or inhibit the bands 16 from moving, shifting, tilting, or twisting anywhere along their length, particularly at the ends of the balloon 20. If the rings are elastic, superelastic, or thermally active, the rings can be placed around the bands and contracted onto the bands to constrain the bands against the outer diameter of the balloon 20. Preferably, the rings and bands are placed around the balloon when the balloon is fully inflated and heat is applied to the heat shrink ring. In other embodiments, the heat shrink ring is applied when the balloon is in a deflated state.

[0052] 1A and 1B, the cage is actuated and slid onto the balloon. However, in other embodiments, the cage can be assembled around the balloon to narrow the cage design. In modifying the balloon 20, the ring can be inserted onto the balloon catheter from one side of the balloon catheter, allowing for a smaller inner diameter of the ring compared to placing the ring on the balloon.

[0053] The rings 12, 14 of the cage 10 can be configured to contain the balloon 20 as it transitions from a deflated state to an inflated state. Similar to the cage configuration with balloon 20 shown in FIG. 1B, the bands 16 of the cage 10 are in contact with the balloon 20 when the balloon 20 is in a deflated state. When the balloon 20 is inflated, each band bends concavely (FIG. 1A). In an embodiment, the bands 16 are non-contacting and not bonded to the surface of the balloon.

[0054] As the balloon 20 begins to deflate, the material properties of the bands 16 cause the balloon 20 to return to its original position, which may be a completely flat state. The bands 16 return to their original state to further assist in the deflation of the balloon 20. As the bands move from a concave state to a flat state, the length of the bands transitions from an inflated length ("Le") to a deflated length ("Ld"), where Ld is greater than Le. Straightening the bands 16 axially from length Le to length Ld can be used to elongate the balloon 20 and more fully deflate the balloon 20.

[0055] The rings 12, 14 can have a variety of shapes and sizes and can secure multiple straps, and what is described below with respect to the illustrated embodiments are just a few examples.

[0056] The rings 12, 14 may be attached to the strip 16 in a number of different ways. For example, the rings 12, 14 may be mechanically joined to the bands 16 by friction, ultrasonic welding, adhesives, etc. In Fig. 8, the rings 12, 14 are two-part and are coupled to the bands 16 of the cage 10 by rotating the rings in opposite directions (e.g., clockwise and counterclockwise). The rings 12, 14 have holes 32 through which the bands 16 are inserted and coupled to the rings. In particular, the asymmetric holes 32 may be configured to accommodate bands having periodically spaced wedge-shaped cutting tools 26 as shown in Fig. 6B.

[0057] As shown, the aperture 32 can have a narrow portion 33 and an enlarged portion 34. The enlarged portion 34 can be configured to accommodate the wedge cutting device 26, while the narrow portion 33 can be configured to accommodate the width of the band 16 (i.e., the portion between the wedge cutting devices 26). The band 16 can be inserted into the aperture 32 by fitting the wedge cutting device 26 into the enlarged portion 34. The band 16 can be secured by rotating the rings 12, 14 such that the band 16 moves into the narrow portion 33. This prevents the wedge cutting device 26 from moving past the narrow portion 33, and the rings 12, 14 secure the band 16. As mentioned above, the rings 12, 14 can be at one end of the cage 10. Also, as shown in FIG. 8, the holes 32 of the ring 12 and the holes 32 of the ring 14 face each other, so that the movement of the strip 16 is prevented by rotating these two rings in opposite directions.

[0058] The cuffs 16 can be secured by rings 12, 14 formed in a variety of shapes. For example, Figure 9A shows an embodiment of a cage 10 in which the cuffs 16 are secured at their distal edges by conical rings 12. The end of the cone corresponds to the distal edge of a balloon catheter, providing an atraumatic end of the device.

[0059] Similarly, Figure 9B shows a ring 12 having a tapered outer diameter with a screw-like feature on its outer surface that may or may not impact the outer surface of the end ring.

[0060] The ring 12 shown in FIG. 9B can also serve a therapeutic role. The tapered and screw-like ring can help guide and insert the balloon 20 into a narrow lesion. The coiled outer surface 101 can be configured to provide a gripping or burrowing feature. This feature can help the operator guide the balloon into a occluded lesion (whole or part) and allow passage of the balloon 20. The screw features of the surface 101 can be formed around its circumference or can be patterned like a corkscrew. In embodiments, the screw features of the outer surface 101 can be macroscopic or microscopic to provide an enhanced surface for navigation through narrow vessels. The features of the outer surface 101 are mechanical in nature, but can also act as lubricants. The lubricant function can be further enhanced by the application of hydrophilic and hydrophobic coatings. The surface structure can be modified to require less energy to navigate. In embodiments, such surface structure can be achieved by adding microscopic scales (such as those found on porcupine quills) or surface roughness (as perceived by mosquitoes).

[0061] The ring 12 shown in Figure 9B can be secured to a band 16 arranged in a helical fashion on the balloon surface. In comparison to the straight band 16 shown in Figure 9A, the tapered ring 12 and bonded band 16 can be wrapped around the balloon. At the proximal edge of the balloon, a tapered or non-tapered ring 14 can be used. The configuration of the bonded band 16 follows the same pattern as the features of the outer surface 101 of the ring 12.

[0062] In Figures 10 and 11, multi-layer rings are discussed. Multi-layer rings can be used to hold strips between layers. The rings have at least a base layer 122 and a top layer 121. As seen in Figures 10 and 11, the rings 12, 14 have an incompressible base layer 122 and a thermally or electrostatically compressible top layer 121. The top layer 121 can be made of a compressible material and the base layer 122 can be made of a non-compressible material. The strips 16 are captured between the base layer 122 and the top layer 121. The top layer or the top layer and the base layer can be made of a heat shrink material. In an embodiment, the rings 12, 14 are made of a material having a length such that they form a ring.

[0063] The ring may be formed from layers of a composite material, where the base layer 122 is less compressible or elastic than the top layer 121. When energy is applied to the top layer 121, it contracts in diameter until it compresses and traps the bands between it and the base layer. For example, the top layer 121 may be a heat shrink material. In this manner, the top layer 121, the base layer 122 and the bands 16 may form a cage 10 as seen in Figures 10 and 11. In an embodiment, the bands may be joined to the balloon and / or balloon catheter by a ring. The ring may be formed from a single layer of heat shrink material over the bands, as well as the top layer.

[0064] The strips and rings may include serrations to facilitate bonding together. Strips 16 may include serrations 171 on one side thereof (see FIG. 10) or may include serrations 171 forming grooves (see FIG. 11). In FIG. 11, top layer 121 is shown as a heat shrink material, but a rigid ring may also fit over serrations 171. Such a rigid ring may be part of a single or multi-layer ring, and base layer 122 may or may not be present.

[0065] FIG. 12 illustrates another embodiment of rings 12, 14. Here, rings 12, 14 have a plurality of serrations or grooves 17. Groove 17 is sized to accommodate band 16 widthwise at its distal edge. The ends of the band can be joined to rings 12, 14 within groove 17 by adhesive, mechanical bonding, wrapping heat shrink material around the ring, or the like. In an embodiment, band 16 of FIG. 11 is disposed within ring 12, 14 of FIG. 12 such that the serrations engage each other.

[0066] 13A-13C show an example of a strip 16 including fasteners 181 that improve the retention of the strip 16 on the rings 12, 14. The fasteners 181 form a portion of the strip 16 that has a high surface roughness. The fasteners 181 are ridge-shaped or sawtooth-like elements that fit the strip 16 within or retain it on the rings.

[0067] If the rings 12, 14 are made of a polymeric material, the fasteners 181 can be formed in a narrowed area at the end of the strip 16 (see Figures 13A and 13B) or can be disposed along the length of the strip (if more than two rings are used). The fasteners 181 are pressed into the polymeric material at or near the glass transition temperature of the polymeric material, as shown in Figure 13A. The fasteners 181 can then be used to engage or bond the strip 16 to the rings 12, 14, as shown in Figure 13C.

[0068] In Fig. 13A, the rings 12, 14 are shown incorporating a fastener 181 within their body. Fig. 13A shows a band 16 having a rigid fastener 181. Fig. 13B shows another embodiment of the fastener 181. The fastener 181 is longer than the width of the rings 12, 14 and is designed to provide tension on the cage 10. It is being installed.

[0069] When the rings 12, 14 are constructed from an elastic material such as rubber or a polymer, a metal alloy, or a spring-like elastic design, the rings 12, 14 can be used to provide tension to the cage 10, thereby returning it to its relaxed, or balloon-deflated, state. Additionally, the portions of the bands 16 that do not have the wedge dissector 26 are the thinnest and most flexible, allowing the bands 16 to be flexible at the ends of the balloon 20 where the forces are greatest.

[0070] 13D-13F show an example in which the elastic material of the rings provides tension to the cage during balloon inflation and facilitates balloon deflation when the tension is released. In FIG. 13D, the cage 10 is disposed adjacent to the balloon 20. The cage 10 is comprised of a number of bands 16 secured to the balloon by rings 12, 14. The rings 12, 14 may be made of an elastic material that allows a wedge-shaped dissector 26 to pull the bands 16 straight down so that they are perpendicular to the surface of the balloon 20. "A" is a schematic perspective view of the proximal end of the ring 14. As shown, the ring 14 is secured to an outer catheter shaft 22 by adhesive 23. An inner guidewire shaft 21 is coaxial with the balloon 20. The guidewire shaft 21 is fixed to the catheter shaft 22. For example, both the guidewire shaft 21 and the catheter shaft 22 can be attached to different ports on the hub, such as the two-pronged luer shown at the proximal end of the balloon catheter. The balloon can be inflated by injecting fluid inside the catheter shaft. In an embodiment, the catheter shaft 22 opens directly into the interior of the balloon 20, rather than opening into the ring 14 as shown. The ring can be attached to the catheter shaft 22 and / or the balloon 20.

[0071] 13E and 13F show the balloon 20 and the cage 10 as the balloon 20 expands and then contracts. As described above, when the balloon 20 expands, the elastic material comprising the rings 12, 14 stretches, causing the cage 10 to expand. In the embodiment shown in FIG. 13E and 13F, the rings are constructed from an elastic polymeric material, and the bands 16 can be constructed from a metal or non-elastic polymeric material. As the balloon 20 expands, as shown in FIG. 13E, the bands 16 of the cage 10 begin to move apart. As the balloon 20 expands, a radial, outwardly directed (as indicated by the arrows) force is exerted on the balloon 20, and thus on the cage 10 due to the stretching, to push each band 16 outward. As the balloon 20 expands, the rings 12, 14 are under tension, and the bands 16 stretch to remain aligned as they expand with the balloon 20.

[0072] The tension helps to deflate the balloon 20. As shown in Figure 13F, during balloon deflation, the tension on the cuff 16 creates a radially inward force that causes the cuff 16 and rings 12, 14 to return to an unconstrained state. This force pulls the cuff 16 flattened, providing a narrow profile for retracting the catheter.

[0073] 14A-14D show embodiments of bands 16 with various ring configurations. As shown in FIGS. 14A and 14B, the rings can be formed from the edges on the neck of the balloon 20, and a portion of the catheter can be used to bond the catheter to the balloon 20. The catheter can provide a passageway for gas or liquid expanded within the balloon 20. Additional elements such as overmolding or heat shrink can be applied to the bond, as well as adhesives or polymeric materials. This can prevent pressure leakage from the balloon 20 along the length of the bands 16 that make up the cage 10.

[0074] As shown in Figures 14A-14D, hooks 161 at the ends of the bands allow the bands to be easily aligned along the surface of the balloon and to orient the bands along the axial length of the balloon 20. The hooks 161 can be integral to each end of the bands 16. The hooks 161 can be formed around the edge of the neck of the balloon 20 from the outer diameter ("OD") to the opening and into the neck. The ends of the hooks 161 are located within the inner diameter ("ID") of the neck of the balloon 20.

[0075] The band 16 can have hooks 161 on both ends or can have a hook on one end. The ends can be attached to the balloon catheter in a similar or different manner. For example, heat shrink material can be placed over the ends of the band and balloon. In embodiments, heat shrink material can be placed around one end of the band and balloon or a rigid ring can be used around the other end of the band and balloon which may have a heat shrink layer as described with respect to Figures 8-12.

[0076] The bands may or may not be attached to the balloon at other portions of the balloon. As shown, the bands 16 may have hinges or pre-bent regions that conform to the shape of the balloon. Thus, the inflated bands may have a main section with a wedge-shaped dissector 26 parallel to the axis of the balloon. In this case, a ramp extends from the main section to the hook 161. The ramp has an angle when the balloon is inflated, but becomes flat when the balloon is deflated. In an embodiment, the hinges between the ramps will be formed by the reduced thickness of the material that makes up the bands.

[0077] As shown in Figure 14A, the bands can be joined to the balloon without a separate ring by hooks 161. The balloon can be attached to a catheter (e.g., an elongated tube with one or more lumens) that is secured in place to the hooks. Although one band is shown in Figure 14A for simplicity, 2-5 or more bands can be used.

[0078] 14C shows a detail of the hook 161 joining to the balloon 20. As can be seen, the balloon serves as the base layer 122 of the ring, and the top layer 121 is shown. Adhesive 123 is shown securing the top layer 121 to the balloon. In an embodiment, the top layer 121 can be the tube of a catheter.

[0079] Figure 14D shows a ring made of two layers 121, 122. A two layer ring can include two layers of heat shrink material. As discussed in Figures 10 and 11, the ring shown in Figure 14D is a multi-layer ring, where the base layer 122 is less compressible or flexible than the top layer 121, and when energy is applied to the top layer, the top layer compresses and shrinks in diameter until it traps the band between the base layer 122 and the top layer 121, creating the cage 10.

[0080] FIG. 14E shows another embodiment of the rings 12,14 securing the band 16 on the surface of the balloon 20. "A" shows the rings 12,14 secured to the balloon 20 such that the wedge dissector 26 protrudes from the surface of the rings 12,14. The center of the rings 12,14 has been cut away to show the lower band 16. The wedge dissector 26 can protrude from the rings 12,14 in a variety of ways. For example, by cutting out the material that the rings 12,14 are made of when secured to the band 16. In this case, holes 27 are formed. The rings 12,14 can have multiple holes 27 cut in them to allow the wedge dissector to extend. The rings 12,14 are aligned with the slope of the balloon 20. For example, cuts 29 can be made in the material that makes up the ring, allowing the ring of heat shrink material to shrink to the shape of the balloon.

[0081] The rings 12, 14 can be shaped to match the tapered portion of the balloon 20. For example, notches 29 in the rings allow the rings of heat shrink material to shrink to the shape of the balloon.

[0082] As discussed above, each band 16 can extend between one or more rings, although other rings can be used if desired. For example, three to ten or more rings can be used, particularly for longer balloons. As an example, an angioplasty balloon 20 having a length of 300 mm can be fitted into a cage 10 having two rings 12, 14 at each end. In addition to the rings 12, 14, the cage 10 can include rings 13 or other similar control elements to maintain alignment and orientation of the bands 16 as the balloon 20 is inflated against the arterial wall.

[0083] As shown in FIG. 15A, ring 13 can be a portion of the overall length of balloon 20. Ring 13 is designed to be no more than 1.5 times the length of balloon 20. Ring 13 is 1.0 to 0.5 times the length of balloon 20. More typically, the length of ring 13 is 2.5 to 1.5 times the diameter of balloon 20, typically 1.5 to 0.5 times. Each ring 12, 13, 14 can be constructed of different materials to provide one or more of the benefits and functions of these rings.

[0084] The ring 13 may be disposed on the outer surface of the balloon 20 body. The ring 13 may be designed to hold the body of the band 16 so that the band 16 can be maintained in position and orientation. As can be seen, the band 16 does not extend along the shoulder of the balloon. Thus, the band can extend parallel to the axis of the balloon. FIG. 15A shows only one band 16 for simplicity, but two to five or more bands may be used.

[0085] The rings 13 may be located all over the inflated balloon 20 and may have different properties than the rings 12, 14 located at one end of the balloon 20. As shown in FIG. 15A, the rings 13 located all over the surface of the balloon 20 may be more elastic than the rings located at the end of the balloon 20. This allows the rings to accommodate the inflated and deflated balloon 20. The rings used on the outer diameter of the balloon 20 are located at the two ends of each separate strap. The straps 16 may be joined to the rings by adhesive, welding, friction, or other methods.

[0086] An array of bands and / or band segments may be disposed about the periphery of the balloon 20. The array of bands may or may not extend the entire length of the balloon 20. The array of bands may include multiple bands arranged in series separated by gaps. Having series bands on the balloon may provide more flexibility and improve transport through tortuous anatomy.

[0087] As previously mentioned, rings 12, 13, and 14 can be used to hold the band on the surface of balloon 20. The rings can be attached to the band in a number of different ways, as described herein. In embodiments, the end of the band that does not have a wedge dissector can be attached to the ring, or the end of the band that has a wedge dissector can be attached to the ring.

[0088] FIG. 15B shows another embodiment of a balloon catheter. A balloon 20 is shown with a cage 10 having four equally spaced rows of bands. Each row has two serially arranged bands. Rings 13 join adjacent bands 16 to properly secure and orient the bands 16 across the surface of the balloon 20. Rings 12 and 14 hold down the ends of the bands.

[0089] "A" shows a close-up of the distal edge of the balloon 20 with the cage 10. The hatching in "A" is to visualize and depict different parts of the device. As shown, the end of the balloon 20 has a ring 12 for fixing a number of bands 16 to the surface of the balloon 20. The balloon 20 is disposed adjacent to the catheter 19. The ring 12 can be made of a heat shrink material. A wedge dissector extends through the ring. The arrangement of the bands is further clarified in FIG. 15C, which shows how a pair of bands 16 are arranged in series, showing that the bands 16 span the entire balloon 20.

[0090] To improve flexibility, the cage 10 may have more rows of bands 16 than those shown in Figs. 15B and 15C. Figs. 15D-15E show an example in which five bands are arranged in series on the surface of the balloon 20. As previously described, the bands 16 may be secured to the surface of the balloon 20 by multiple rings 13. "A" shows a cut-out of the ring 13 to show the gap between two bands arranged in series. As described in relation to Fig. 14E, the wedge dissector may protrude through the ring 13 in a variety of ways. For example, the shape of the wedge dissector may be such that it penetrates the material of the ring 13. Alternatively, the ring 13 may have multiple holes through which the wedge dissector may penetrate.

[0091] In addition to having multiple bands arranged in rows, the gap between the bands in the rows can be adjusted to adjust flexibility. To facilitate the linear alignment (angular offset) and spacing (gap) between bands 16, a relatively large tolerance is required in the manufacturing process and tooling. The gap tolerance is ±5mm and the angular offset is ±25°. Alternatively, the gap tolerance is ±3mm and the angular offset is ±10°. Alternatively, the gap tolerance is ±2mm and the angular offset is ±5°. For cage designs with larger bends, the bands can be spaced apart in a linear sequence at a predetermined interval. This allows the balloon to control bending and provide anatomical space with less stress, allowing for effective pushability of the entire system.

[0092] The straps 16 shown here have a flat bottom surface, which makes it easier to place the straps 16 on the surface of the balloon and maintain the orientation of the wedge cutting tool, and also prevents rotational movement of the straps 16 on the surface of the balloon 20.

[0093] Such band and ring configurations provide three distinctive functions and effects: first, perpendicularity of the wedge dissector relative to the balloon surface; second, flatness and low profile of the band on the balloon, which prevents the wedge dissector from contacting damaged tissue when moved; and third, assisting or reducing the load on the balloon deflation. To achieve these features, the band typically has a flat bottom and is connected to the balloon at one end by a ring. The band also folds to limit the wedge dissector's contact with tissue, and when the ring is formed over the wedge dissector, the wedge dissector breaks through the ring. The majority of wedge dissectors have a height that allows them to penetrate the vessel wall. The ring is The bands can be designed to generate a force to deflate the balloon by pulling the bands end to end or by applying radial pressure, while the rings can be designed to support the bands by restricting their movement, facilitating the orientation of the wedge dissector and preventing the bands from moving away from the balloon. Design features that contribute to these functional properties include having a flat bottom surface that can stabilize the orientation of the wedge dissector and having a band that is thin enough to be in contact with the balloon, i.e., to be included in the folded balloon. Providing a space between the wedge dissectors allows the rings to be placed in the space. The portion of the band that does not have the wedge dissector is the thinnest. This portion can be made larger to allow the ring to bond to the band. The bands can be most flexible at the ends of the balloon, where the force is greatest as the catheter moves. Other benefits and advantages can also be provided.

[0094] The rings 12, 13, 14 can be attached to the bands in a variety of ways. Figures 16A-16C show examples of rings 12, 13, 14 secured to bands 16. In Figure 16A, a material is wrapped around the balloon and one or more rings are secured to the wrapping material. In Figure 16B, the rings 12, 13, 14 encase a portion of each band, thereby securing the bands in the same manner as shown in Figure 10, where each ring has a top layer and a base layer that encases a portion of band 16. In Figure 16C, the rigid rings 12, 13, 14 are attached to a portion of the balloon. A portion of the band can also be secured to the rings.

[0095] The rings 12, 13, 14 may be constructed in part or entirely from a heat shrink material. The heat shrink material may be formed as an extruded tube that is cross-linked by energy irradiation. The tube is stretched or formed to the desired thickness. The tube may be stretched to be flexible and microscopically thin-walled, or stiff with a thick wall, or anything in between. The cross-linking determines the diameter, and the shrink ratio may be between 2:1 and 10:1. The heat shrinkage is typically radial, but may also be longitudinal.

[0096] The heat shrink material can be made from polyolefins, fluoropolymers (including fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF) (e.g., KYNAR), polyvinyl chloride (PVC), neoprene, silicone, elastomers, synthetic rubber, fluoropolymer elastomers (e.g., VITON). If a flexible material is desired that expands with the balloon, the heat shrink material can include one or more of the following: polyolefin, silicone, elastomer, VITON (synthetic rubber and fluoropolymer elastomer).

[0097] The tubular heat shrink material can be slid over the ribbon 16. The shrink ratio of such a tube is set to 3:1 or more (e.g., 3.5:1, 4:1, 4.5:1, 5:1, 6:1, etc.). This allows for slow heat shrinking while preventing deformation or other changes in the balloon's properties. Such a material is flexible enough to conform to the shape of the balloon within the diameter range (e.g., a semi-compliant balloon of about 0.5 mm). The heat shrink material may have an adhesive or other coating that bonds the heat shrink material to the balloon. The heat shrink material can be a thin film. Instead of a tube, the heat shrink material can be in the form of a sheet or multi-layered sheets.

[0098] A method of using a balloon catheter having a cage includes disposing a cuff around an inflated balloon. The cuff may include a wedge-shaped dissector. The cuff may extend around the balloon. The bands may be arranged at equal intervals around the balloon. The bands may initially extend lengthwise and may be arranged in successive rows, for example, 2-6 rows. Each row may have 2-6 bands. The bands may be permanently or temporarily bonded to the balloon with an adhesive. The heat shrink material may be arranged as a ring around the ends of the bands. The ring of heat shrink material may be bonded to or cover the ends of multiple bands arranged around the balloon. The ring of heat shrink material may be bonded to or cover the ends of adjacent bands arranged in a successive row. When heat is applied, the heat shrink material shrinks. The balloon may be deflated and sterilized in preparation for use.

[0099] 17 shows a detailed view of the cage 10. In an embodiment, the fascia 16 has a section 34 that is a spring zone. The spring region of the fascia provides several benefits. For example, the spring region 34 can increase the flexibility of the cage 10. The increased flexibility of the cage 10 allows the cage 10 to pass through tortuous vessels more easily. The spring region 34 acts as a base for a wedge cutting instrument, allowing the wedge cutting instrument to remain oriented in a desired direction.

[0100] In embodiments, the spring region 34 can interact with the surface of the balloon 20 and can help position the bands so that the wedge dissector 26 protrudes outward. It can also prevent the wedge dissector from undesirably bending or changing position. In embodiments, the spring region 34 can provide the benefit of assisting in refolding the balloon after inflation. The spring can provide mechanical tension to the balloon 20, keeping the balloon 20 in a compressed state and assisting the ring in compressing the balloon 20 during the compression cycle.

[0101] The spring region 34 has a wave-like configuration and is joined to a straight region 36. A wedge-shaped cutting tool can be located in the straight region. In other embodiments, the spring region can be in the form of a sine wave. As shown in FIG. 18, the spring region has a greater amplitude at the proximal edge compared to the distal edge. The period can decrease in amplitude while increasing along the spring region toward the straight region at the distal edge. In embodiments, one end of the spring region can have a greater amplitude than the other end of the spring region. In embodiments, the spring region can be symmetrical.

[0102] Figure 18 shows various embodiments of the cage 10 utilizing spring regions 34 and straight regions 36. Any number of different patterns may be used. Figure 19 shows a detail of a wedge cutting tool on the straight region 36.

[0103] In the disclosed systems and methods, the cage or wedge cutting device can be placed within a body cavity, including the lumen of a blood vessel, such as an artery or vein. Arteries include, for example, coronary, peripheral, carotid, and cerebral arteries, as well as iliac, femoral, superficial iliac, and other peripheral vasculature. The system can be used within cavities or ducts, such as the respiratory, digestive, urinary, reproductive, lymphatic, auditory, visual, and endocrine systems. The device for forming the sawtooth in one or more of the systems can take slightly different forms. Regardless of the location of use, the system can be used and can include a spike (here including a wedge cutting device, a sawtooth element on a spline, and an inflation mechanism) that can be attached to a catheter-like device (such as a balloon) to increase or decrease the diameter of the spike feature.

[0104] FIG. 20 shows an enlarged detailed view of the wedge cutting device 200 on the band 300. The cutting tool 200 has opposing base surfaces 202 (referred to herein as interfaces) in the form of a band. The base surface 202 of the wedge cutting tool 200 can be defined as the base surface from which the wedge cutting tool 200 projects and which is directly continuous with the surface of the band at the interface between the wedge cutting tool and the balloon. The band can be a spline 300 or other band structure. In an embodiment, the base surface 202 is made of a stiff material capable of retaining sharp edges and is relatively narrow in width. In an embodiment, the preferred material is martensitic stainless steel having a hardness of 52 to 64 on the Rockwell C scale, but the material may be made from a polymer or copolymer, such as polyolefin, fluoropolymer (including fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF) (e.g., KYNAR), polyvinyl chloride (PVC), neoprene, silicone, elastomer, synthetic rubber, fluoropolymer elastomer (e.g., VITON), or combinations thereof. However, the polymer or copolymer is not limited to the above materials. The width of the strip may be 0.008 inches or less, 0.010 inches or less, or 0.012 inches or less. In some cases, the width may be between 0.006 and 0.020 inches, or between 0.004 and 0.030 inches. The bands 300 run along the length of the balloon, but can also be positioned at 90° angles from the longitudinal axis of the balloon, or even helically with different pitches. In embodiments, the height of the bands 300 can be between 0.004 and 0.010 inches, or even between 0.004 and 0.010 inches, or even between 0.002 and 0.020 inches.

[0105] 20, the wedge cutting tool 200 can have a radially outwardly facing surface 204 (referred to herein as a non-boundary surface). This surface defines the upper surface of the wedge cutting tool 200 from a first end 206 (e.g., a proximal edge) to a second end 208 (e.g., a distal edge) and can be configured to contact tissue, plaque, or other structures of the body. Additionally, a front surface 210, a rear surface 212, and opposing side surfaces 214, 216 are shown. In an embodiment, the side surfaces 214, 216 extend perpendicularly upwardly to the longitudinal axis of the fascia, and the surface 204 extends between the side surfaces 214 and 216 in a linear, curved, or otherwise angled configuration relative to the side or side axis. The fascia or spline 300 has a non-boundary surface 302. The non-boundary surfaces 302 , as well as the sides (eg, 304 ) and bottom surface 303 of the wedge-shaped cutting device 200 , can have the same width as the band-like opposing surfaces or bounding surfaces 202 .

[0106] FIG. 21 is a schematic diagram of a non-limiting embodiment of a wedge-shaped cutting instrument. In an embodiment, the length LU of the radially outwardly facing surface (e.g., the radially outwardly facing surface 204 between the first end 206 and the second end 208) is about 30%, about 20%, or about 10% less than the overall length LB of the band-like opposing surface (the band-like opposing surface 202 in FIG. 20). In an embodiment, the length LU can be about 50% to about 20% of the length LB, and in some cases can be about the same as the length LB. The width WU of the radially outwardly facing surface is equal to or less than the width WB of the band-like opposing surface. Typically, the width WU can be 10%, 20%, 30%, 40%, 50% or less of the width WB, or between 20% and 50%. In some cases, the width WU can be increased to 50%, 60%, 70%, 75%, or 80% of the width WB. Thus, at both ends of surface 202, an angle θ of 90° or less is formed that defines a gradient from width WB of surface 202 to width WU of surface 204. In embodiments, width WU of surface 204 may be constant at both ends or may vary along length LU of surface 204, such as decreasing from a first side to a point or portion between the first and second sides, or increasing from a point or portion between the proximal and distal edges to the distal edge. In embodiments, a relatively centrally located portion between the proximal and distal edges may have a constant width, and laterally located portions surrounding the central portion may have tapered widths.

[0107] The width WU of face 204 narrows to a point, but the slope from width WB of face 202 to width WU of face 204 may be sloped at a constant angle θ as shown in FIG. 22A (end view resembling an isosceles triangle) and FIG. 22B (isometric view), but may be sloped at multiple different angles, such as double, triple, or more (e.g., a first angle on a first portion, a second angle smaller or larger than the first angle on a second portion, and in some cases a third angle smaller or larger than the first angle and smaller or larger than the second angle on a third portion). FIG. 22C is an end view of a wedge dissector, and FIG. 22D is an isometric view of a wedge dissector. The wedge dissector has multiple different slopes from base 202 to face 204. Here, the angle θ2 between the horizontal plane above the base surface and the inclined surface is larger than the angle θ1 between the base surface and the inclined surface that intersects with the base surface (in other words, the first gradient S1 from the base surface is not steeper than the second gradient above it). Figures 22E and 22F are similar to Figures 22C and 22D, except that the angle θ2 is smaller than the angle θ1 (in other words, the first gradient S1 from the base surface is steeper than the second gradient above it).

[0108] It is also possible to have steps at different heights. In this case, the width narrows with the height. When multiple steps are included, the method of sharpening a stainless steel reel is limited.

[0109] The height of a radially outwardly facing surface (e.g., surface 204 in FIG. 20) may be the same as the length or width from side 206 to side 208. In embodiments, the height of surface 204 may vary from first end 206 to second end 208. As surface 204 varies, the surface may have an elevated feature such as a wedge dissector, spike, or sawtooth. The midpoint of the elevated feature along the length of surface 204 between first end 206 and second end 208 is the highest point of surface 204, although the highest point may be offset from the midpoint and there may be multiple elevated points. The maximum change in height between the first end 206 and second end 208 of the face 204 of the wedge-shaped cutting device 200 and the non-boundary surface 302 of the band 300 can be less than about 80%, less than about 70%, less than about 60%, less than about 50%, less than about 40%, less than about 30%, less than about 20%, or less than about 10% of the overall height of the wedge-shaped cutting device 200.

[0110] In embodiments, the bands 300 may have a rough or fibrous underside to promote adhesion to the outer surface of the underlying balloon. The bands may be of any desired shape, such as square, rectangular, or trapezoidal, with a bottom width that is approximately or at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the top width. In embodiments, 1 / 3 to 1 / 2 of the top surface of the bands 300 may be covered by the wedge dissector and 2 / 3 to 1 / 2 may be uncovered by the wedge dissector.

[0111] In FIG. 21, when viewed from above, surface 204 may be a straight line extending from one end of surface 204 to the other (e.g., width WU of surface 204 is a point). This is equivalent to a grindstone or "razor sharpened" edge without a distinct width. In some embodiments, the top view may appear as a slightly blurred, unsharp rectangular surface (e.g., 210B or 210C may be a top surface that cuts away an object that is on that surface). In this case, width WU of surface 204 is smaller than width WB of the opposing surface of the strip, and directly correlates to the slope from opposing surface 302 to surface 204. In some embodiments, top surface or surface 204 may be a straight line, a flat rectangular surface, or a curved or raised surface (e.g., rectangular or square in two dimensions). Alternatively, it may be a pyramid, wedge, trapezoid, or other polygonal shape.

[0112] In an embodiment, the non-sharp surface can be, for example, about 1 nm or more, about 5 nm or more, about 10 nm or more, about 50 nm or more, about 100 nm or more, about 500 nm or more, about 1 μm or more, about 2 μm or more, about 5 μm or more, or about 10 μm or more. If the surface of the wedge-shaped incision instrument is non-sharp, it has the advantage that, for example, sawtooth, serrated portion, and micro-perforation can be formed, and the entire lumen wall is not cut. In an embodiment, the surface of the wedge-shaped incision instrument has a non-sharp width.

[0113] The shape of the wedge dissector is not limited to that shown in Figures 21A-G and can take many forms. For example, Figure 21A shows a wedge dissector erected from a band 300 with a sharp surface 204 from end 206 to end 208. Figures 21B and 21C show a wedge dissector with chamfered portions 780 at both ends of the surface 204 and sloping to a sharp midpoint 782 or end of length 781. The slope can be a linear slope or a curved slope as shown in Figure 21D. As shown in Figure 21B, the wedge dissector has a portion 780 formed on the side portion of the surface 204 of minimal / negligible width that decreases in width from the height and the first side to the midpoint 781. This portion 780 then increases in width and decreases in width from the midpoint 781 to the second side. FIG. 21C is similar to the view shown in FIG. 21B, except that the midpoint is a single sharp apex.

[0114] 21D shows a wedge-shaped cutting instrument having a radially outwardly facing axial surface 785 that increases in height from the end along a first curved length and decreases in width from the first end to an intermediate region, such as a center point 786. It then decreases in height and increases in width along a second curved length toward the second end.

[0115] Figures 21E-G show examples of wedge dissectors that do not include a sharp point or end, but have a blunt surface 204 (e.g., a width greater than the width of the sharp end). Figure 21E shows a wedge dissector similar to Figure 21B, except that surface 204 is completely blunt along its length. Figure 21F shows a wedge dissector similar to Figure 21C, except that surface 204 is completely blunt along its length. Figure 21G shows a wedge dissector similar to Figure 21D, except that surface 204 is completely blunt along its length.

[0116] 21B-21G have in common that the width of surface 204 is wider at the sides and narrower or smaller at the midpoint or center. The height of surface 204 may be arcuate or vary from one end to the other, e.g., highest at the center and lowest at the ends when viewed from the side. The narrowest or thinnest portion (smallest width) of surface 204 may be along the longitudinal axis of the band, which may or may not be along the longitudinal axis of the balloon.

[0117] The narrowing point or portion need not be symmetrical about the midpoint of the length of face 204, but may be asymmetrical about that midpoint.

[0118] Independent of the wedge dissection device, some embodiments are characterized by having an interface 202 or band (e.g., a band with spikes attached, a spline, a balloon, a mold element) having a predetermined length and width, a face 204, an end face or tip. The width of the interface 202 can be about 90% or less, about 85% or less, about 80% or less, about 75% or less, about 70% or less, about 65% or less, about 60% or less, about 55% or less, about 50% or less, about 45% or less, about 40% or less, about 35% or less, about 30% or less, about 25% or less, about 20% or less, or a range between any two of these numbers, of the width of the band 300. Wedge Dissection Device The width of the interface 202 may be fixed or constant, or variable.

[0119] The wedge dissector can be of different sizes and shapes, in embodiments, the wedge dissector can be 0.10 inches, 0.09 inches, 0.08 inches, 0.07 inches, 0.06 inches, 0.05 inches, 0.04 inches, 0.03 inches, 0.02 inches, 0.01 inches long at the band, or a range between any two of these values, i.e., 0.01 inches to 0.06 inches, or 0.01 inches to 0.04 inches long. In embodiments, the wedge cutting device can have a height, measured from the interface 202 to the band, of about 0.05 inches or less, about 0.04 inches or less, about 0.03 inches or less, about 0.025 inches or less, about 0.02 inches or less, about 0.015 inches or less, about 0.01 inches or less, about 0.005 inches or less, or between about 0.005 inches and about 0.025 inches, between about 0.01 inches and about 0.025 inches, or between about 0.005 inches and about 0.015 inches.

[0120] In embodiments, the base surface of the wedge dissector can be about 25 mm or less, about 20 mm or less, about 15 mm or less, about 14 mm or less, about 13 mm or less, about 12 mm or less, about 11 mm or less, about 10 mm or less, about 9 mm or less, about 8 mm or less, about 7 mm or less, about 6 mm or less, about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm or less, about 1 mm or less, or a range of any two or more of these values. In embodiments, the base surface of the wedge dissector can be 2 mm, 2.5 mm, 3 mm, about 1 mm to about 5 mm, about 1.5 mm to about 3.5 mm in length. The wedge dissectors can be spaced apart in a regular or irregular manner to increase the flexibility of the device. For example, when the wedge dissectors are arranged longitudinally, the spacing between adjacent wedge dissectors can be 2 to 10 times the base length. In embodiments, wedge dissectors having a base length of about 2.5 mm may have 5 mm separation spacing or 25 mm separation spacing. In embodiments, the wedge dissectors may initially have a first spacing ratio of about 1-4 times the base length and then a second spacing ratio of about 8-10 times the base length. For example, a first group of wedge dissectors with a base length of 2.5 mm may have 5 mm separation spacing and then 20 mm separation spacing. The second group may be the same size, shape and separation spacing as the first group or may be different.

[0121] The position of the surface 204 relative to the base surface (boundary surface 202) does not have to be always centered or symmetrical. In other words, the midpoint of the surface 204 may be offset from the midpoint of the base surface. Figures 23A-B and 24 show another example of a spike in which the surface 204 is asymmetric. The asymmetric surface 204 is offset from its center over the entire base surface. In this form, only one end of the base surface has an end 440 that is inclined in the height direction, and the other end 442 is perpendicular to the base surface 444 at an angle RA of 90°, as shown in Figure 23A. In addition, the radially outward facing surfaces at one or both ends in the width direction and / or one or both ends in the length direction may be chamfered, inclined, or have a radius of curvature. The radially outward facing surfaces may be limited to only the area that protrudes upward from the base surface. The surfaces may be sharp line-shaped (grindstone-shaped) or, as already mentioned, non-sharp. 23C and 23D show the entire or substantially entire volume of the wedge cutting device lies across the width of the band, which may be about 70% or less, about 60% or less, about 50% or less, about 40% or less, or about 30% or less of the width or surface area of ​​the band, resulting in the wedge cutting device being displaced in front of or behind the band.

[0122] 24 illustrates an embodiment where the radially outwardly facing surface 204 has different heights from the base surface 202, increasing from a height 24H1 at the first end 206 to a height 24H2 at the second end 208. In this embodiment, the end profile is 08, the end 206 has a smaller height 24H1 as measured from the base surface 202, and the end 208 has a larger height 24H2 as measured from the base surface 202, and the end 208 has a smaller radius of curvature.

[0123] In embodiments where the radially outwardly facing surface 204 is located on the exterior of the delivery device and / or may contact the lumen wall and potentially scrape and traumatize the vessel wall as it travels through the artery, the wedge cutting instruments described herein provide unique advantages that facilitate delivery of the device, including reducing trauma to the vessel. This can be achieved with a wedge cutting instrument having a blunt surface 204.

[0124] Also, without being limited by theory, certain shapes may penetrate tissue more effectively: for example, beveled or rounded radially outward ends may enter blood vessels with less force (not as much pressure is required to penetrate tissue) while retaining effective microchannels and fragile tissue, allowing blood vessel expansion with minimal blood vessel trauma and cell damage.

[0125] Additionally, while there have been prior proposals to form blades, sharp edges, cut wires, etc., on the balloon to cut or score plaque during angioplasty or other procedures in conjunction with balloon inflation, such prior proposals suffer from problems and disadvantages that are eliminated by the systems and methods disclosed herein. Cutting or scoring plaque or other lumen walls during angioplasty must be performed under high pressure, which can result in significant trauma to the vessel. The cutting blades, edges, or cut wires penetrate the vessel wall and expand the plaque simultaneously with inflation of the angioplasty balloon. During this process, the cutting blades, edges, or cut wires penetrate the vessel wall at an oblique angle to score and cut the plaque. Meanwhile, the wedge cutting instrument is inflated at low pressure within the plaque to create precise microchannels, sawtooth, or serrations radially outward to create precise serrations, cleavage lines, or cleavage surfaces in the plaque or other portion of the vessel wall, with the radially outward facing surface of the wedge cutting instrument penetrating the plaque or other luminal surface of the narrowed region to cut the plaque or luminal surface.

[0126] The wedge cutter is designed with a series of serrations that penetrate (in some cases incompletely) into the diseased portion of the vessel. The wedge cutter more effectively and gently dilates the vessel lumen to create a perforation. The perforation provides a passageway for the drug. Drugs can be delivered by using a drug-coated balloon incorporated with the devices disclosed herein or on a device used subsequently to the devices disclosed herein. In embodiments, the wedge cutter can be detachable from the band and can be coated with or injected with one or more drugs for drug delivery.

[0127] To reduce the stiffness of the spline or fascia, a series of reliefs can be added on the spline as shown in Figures 25 and 26. The reliefs can be formed in a variety of different ways, such as by removing a portion of material, to provide a wedge cutting tool with a more flexible fascia. The reliefs can be formed on the spline's base surface, i.e., the surface opposite the surface to which the wedge cutting tool is placed directly adjacent, or on both surfaces. The reliefs can be formed on the sides of the spline, or openings can be formed in the base surface of the spline. Thus, any combination of the top, bottom, sides, and openings of the spline can be added to the spline to form the reliefs.

[0128] In an embodiment, as shown in FIG. 25 and FIG. 26, the strip 300 may be circular, rectangular, linear, triangular, trapezoidal, or a combination thereof on its top surface, bottom surface, central portion, and non-central portion. (See Figures 25 and 26.) The band provides a supportive base infrastructure and is flexible to precisely orient the wedge cutting instrument and follows the movement of the balloon.

[0129] The relief holes shown in Figures 25 and 26 are specifically designed to provide a balloon-based drug passageway through which the drug travels. The relief with surface distortion also improves the device's mobility in tortuous cavities. Figures 25A-C show an embodiment of reliefs 502 on the underside 500 of the band 300 opposite the boundary surface of the wedge dissector 200. Figure 25A shows an embodiment in which the reliefs 502 are regularly spaced approximately the length of the boundary surface of the wedge dissector 200. Figure 25B shows an embodiment in which the reliefs 502 are regularly spaced less than 50% of the length of the boundary surface of the wedge dissector 200. 25C illustrates an embodiment in which the reliefs 502 are regularly spaced apart by 50% or less of the length of the interface of the wedge dissectors 200 and are grouped under the wedge dissectors and absent from the spaces between the wedge dissectors. In other embodiments, the wedge dissectors may be grouped only under the spaces between the wedge dissectors and absent from the wedge dissectors.

[0130] 25D-25E are embodiments in which a relief 502' is present on the upper surface (interface or upper surface 302) of the fascia between the wedge-shaped incisors. In Figs. 25D and 25E, the relief forms a recess in the upper surface 302 of the fascia between the wedge-shaped incisors, in Fig. 25D it has a gentle curve, and in Fig. 25E it has a relatively square or rectangular curve. This curve may or may not have rounded edges. Fig. 25F is a combination of two different reliefs 502, as seen in the embodiment of Figs. 25C and 25D. Other combinations are possible depending on the desired clinical result. Figs. 25G and 25H are embodiments showing a relief on the anterior surface 304 and / or posterior surface of the fascia 300. Fig. 25G has a pyramidal relief 502, while Fig. 25H has a sharp relief 502. The relief can be formed axially away from the wedge cutting device or axially along with the wedge cutting device. Figures 25I and 25J show an embodiment in which the relief 502 is in the form of vertically oriented through channels (Figure 25I) or horizontally oriented through channels (Figure 25J). The through channels can be axially away from the wedge cutting device or can have other forms. In an embodiment, the relief can be inclined with respect to the longitudinal axis of the band. Figure 25K shows an embodiment in which the relief 502 is formed in the form of a groove on the front and / or back surface, on the boundary surface, and / or at other locations.

[0131] During material removal from the strip, the strip preferably has a tab along its base or bonding surface. The tab can control vibration or shifting of the long strip during material removal. Once material removal is complete, the tab is removed. In embodiments, the tab can have an inset so that it is secured to the base surface of the strip. In embodiments, an inset relief can function as a tab, which is advantageous, for example, when multiple strips are laser cut from the same sheet of feedstock. Complementary protrusions on or attached to adjacent areas of the feedstock to be laser cut can be fitted into the inset relief of the strip to maintain accurate positioning of the strip during laser cutting. This can help maintain the position of the strip during laser cutting and prevent movement or misplacement of the strip due to laser vibration. Such movement or misplacement of the strip can result in reduced product yield. In embodiments, the relief for production stabilization does not have to be inset, but can be in the form of a protruding outwardly extending portion from the base surface. In embodiments, these tabs may be laser cut or otherwise removed prior to bonding to the outer surface of the balloon to prevent unintentional rupture of the balloon. 25A-25K. In one embodiment, the inset relief 502 is shown below the wedge cutting tool 200. In FIG. 25M, the tab 580 is shown cut into segments 588 and 589 in a subsequent manufacturing step when the band 300 does not need to be secured to the feedstock 581. The band 300 can be separated for attachment to a balloon or other device. By forming the inset, the tab can be eliminated and the amount of material underneath the band that gets in the way of joining the band to a balloon or other inflation device can be minimized.

[0132] In embodiments, the balloon can be pleated to a narrow width, allowing for transport of the device through a narrow diameter introducer sheath. Once the balloon is deflated, the balloon's profile upon subsequent expansion is larger than the original pleated diameter. This newly formed profile can cause the bands to scratch the arterial wall or get caught in the opening of an auxiliary device such as an introducer sheath. The tapered element can address this potential problem.

[0133] FIG. 25N illustrates a tapered section 680 of adhesive or other material disposed at one or both ends 333 of the band 300. The adhesive can be disposed at a lower location of the band (e.g., at the underside of the band 300) to connect the band 300 to the balloon. When constructed of a relatively more flexible material (e.g., adhesive) than the band 300, the tapered section 680 can be effectively a flexible interface between the flexible balloon and the semi-rigid band 300. The tapered section 680 can be designed to slope gently from the balloon surface to the end of the band. The adhesive tapered section 680 can hold the band in place and protect it from contact with ancillary devices during the procedure.

[0134] In the embodiment, the form that can be applied to the balloon is a conical inclined portion. The conical inclined portion can be made by various methods. The conical inclined portion can be made by a conventionally known method for a 5 mm balloon, for example, by applying it to a relatively large balloon such as a 6 mm balloon or a 5.5 mm balloon. FIG. 25O is a diagram showing an example of a conical inclined portion. The cone 970 has an outer diameter at least about 5%, about 10%, about 15%, about 20% larger than the outer diameter of the balloon 960, or an outer diameter in the range of about 5 to about 20% larger. The relatively large cone 970 forms a lip 972 between the balloon and the cone 970 to sufficiently fix the balloon 960. The lip 972 can reduce the proportion of the ends of the metal band that would damage the balloon when the balloon is deflated and pulled out of the introduction catheter.

[0135] In the embodiment shown in Figure 25P, a track 980 is formed along the cone 970. The track 980 acts as a support or rigidity structure to assist in preventing the balloon 960 from collapsing as it is introduced through the introducer catheter. In an embodiment, the track 980 may be oriented or aligned along the longitudinal axis of the band to enhance the ability of the band to be pushed into the center of the balloon as the cone is introduced through the introducer.

[0136] In embodiments, the balloon described herein can be recessed in the center for attachment of the band. A series of recesses can be formed on the balloon surface and configured to be wide and long enough to accommodate the band. The depth of the recesses is determined so that the band is secured to the opening at the distal edge of the introducer upon withdrawal of the balloon. The depth shall be as follows.

[0137] By forming through-holes or microchannels in or on the splines, therapeutic agents such as one or more drugs, nanoparticles, and / or stem cells can be delivered to the diseased area of ​​the lumen surface from the balloon surface via capillary or diffusion, or through the microchannels using the pressure of the balloon. The microchannels or modified surface can also serve as a reservoir for drugs, nanoparticles, stem cells, or other therapeutic agents to be delivered and protected during delivery to the diseased area. In embodiments, the drug can be any drug. The drug may be appropriately used in the method and device of the present invention depending on the disease to be treated and taking into account its physical properties, and may include, but is not limited to, anti-restenosis drugs, proliferation promoters, anti-proliferative drugs, anti-inflammatory drugs, antineoplastic drugs, mitotic inhibitors, antiplatelet drugs, anticoagulants, antifibrin drugs, antithrombin drugs, cell proliferation inhibitors, antibiotics, antienzymes, metabolic antagonists, angiogenic drugs, cytoprotective drugs, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, and / or cardioprotective drugs.

[0138] Antiproliferative agents include, but are not limited to, actinomycin, taxol, docetaxel, paclitaxel, sirolimus (rapamycin), Biolimus A9 (Biosensor International, Singapore), deforolimus, AP23572 (Aryad Pharmaceuticals), tacrolimus, temsirolimus, pimecrolimus, zotarolimus (ABT-578), 40-O-(2-hydroxy)ethyl-rapamycin (Ethyl rapamycin), valorimus), 40-O-(3-hydroxypropyl)rapamycin (structural derivative of rapamycin), 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin (structural derivative of rapamycin), 40-O-tetrazoyl-rapamycin (structural derivative of rapamycin), 40-O-tetrazoylrapamycin, 40-epi-(N-1-tetrazoyl)-rapamycin, and pruphenidone.

[0139] Anti-inflammatory agents may include both steroidal and non-steroidal agents, such as clobetasol, auclofenac, alclometazon dipropionate, algestone acetophenide, alpha-amylase, amcinafal, amcinafide, amfenac sodium, amiprirose hydrochloride, anakinra, aniolac, anitrazafen, apazone, balsalazide disodium, bendazac, benoxaprofen, benzydamine hydrochloride, bromelain, broperamol, budesonide, carprofen, cycloprofen, synthazone, cliprofen, clebetasol propionate, cloverazon butyrate, clopirac, cloticazon propionate, cormetazon acetate, cortodoxone, deflazacort, desonide, desoximetasone, dexamethasone, dexamethasone dipropionate, dexamethasone acetate, dexamethasone phosphate, momentasone, cortisone, cortisone acetate, hydrocortisone, prednisone, prednisone acetate, betamethasone betamethasone acetate, diclofenaclin, diclofenac sodium, diflorasone diacetate, diflumidone sodium, diflunisal, difludoprednate, diphthalone, dimethylsulfoxide, drocinonide, endorizon, enrimomab, enolicam sodium, epirizole, etodolac, etofenamate, felibinac, fenamol, fenbufen, fenclofenac, fenclorac, fendosal, fenpiparone, fentiazac, furazarone, fluazane Cort, flufenamic acid, flumisole, flunisolide acetate, flunixin, flunixin meglumine, flucortin butyl, fluorometholone acetate, fluquazone, flurbiprofen, flurbiprofen, fluetofen, fluticasone propionate, furaprofen, flobufen, halcinonide, halobetasol propionate, halopredone acetate, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, ironidap, indomethacin, Indomethacin sodium, indoprofen, indoxol, intrasol, isoflupredone acetate, isoxepac, isoxicam, ketoprofen, lofemizole hydrochloride, romoxicam, loteprednol etabonate, meclofenamate sodium, meclofenamic acid, meclorizone dibutyrate, mefanamic acid, mesalamine, mesaclazone, methylprednisolone sulptanate, moniflumate, nabumetone, naproxen, naproxen sodium, naproxol, mimazone, olsalazine sodium, orgotein, orpanoxin, oxaprozin, oxyphenbutazone, paraniline hydrochloride, pentosan polysulfate sodium, phenbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamate, piroxicam olamine, pirp Examples of the anti-inflammatory drugs include, but are not limited to, rophene, prednazate, pirferon, prodric acid, proquazone, proxazol, piroxazole citrate, lomexolone, sarcorex, salnasadine, sanguinarium chloride, seclazone, selmetacin, sudoxicam, sulindac, suprofen, talmetacin, talniflumate, talosalate, tebuferone, tenidap, tenidap sodium, tenoxicam, tesicam, tesimide, tetridamine, thiopinac, tixocortol pivalate, tolmetin, tolmetin sodium, tricoronide, triflumidate, zidometacin, zomepirac sodium, aspirin (acetylsalicylic acid), salicylic acid, adrenocorticosteroids, glucocorticoids, tacrolimus, and pimecrolimus.

[0140] Antineoplastic and mitotic inhibitors include, but are not limited to, paclitaxel, docetaxel, azathioprine, vincristine, vinballastine, fluorouracil, doxorubicin hydrochloride, and mitomacin.

[0141] Antiplatelet drugs, anticoagulants, antifibrins, and antithrombins include heparin, heparin sodium, low molecular weight heparin, heparinoids, hirudin, argatroban, forskolin, bapiprost, prostalisin, prostalisin dextran, D-phenylalanine-pro-arginine-chloromethylketone, dipyradamole, glycoproteins, IIb / IIIa platelet membrane receptor antagonist antibodies, recombinant hirudin, thrombin, ANGIOMAX (registered trademark, bivalirudin manufactured by Biogen), calcium ions such as nifedipine, etc. These include, but are not limited to, mu channel blockers, fish oil (omega-3 fatty acids), histamine blockers, lovastatin, monoclonal blockers, especially platelet derived growth factor receptors, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprosthesis blockers, triazolopyrimidines, nitric oxide, nitric oxide donors, superoxide dismutase, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxy (4-amino-TEMPO), and the like.

[0142] Cell proliferation inhibitors include, but are not limited to, angiopeptin converting enzyme inhibitors such as angiopeptin, captopril, cilazapril, and lisinopril, calcium channel blockers such as nifedipine, colchicine, fibroblast growth factor (FGF) antagonists, fish oil (omega-3 fatty acids), histamine blockers, monoclonal blockers such as lovastatin, especially platelet derived growth factor receptors, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprosthesis blockers, triazolopyrimidines, and nitric oxide.

[0143] Angiotensin-converting enzyme (ACE) inhibitors include, but are not limited to, quinapril, perindopril, ramipril, captopril, benazepril, trandolapril, fosinopril, moexipril, and enalapril.

[0144] Examples of angiotensin II type receptor antagonists include, but are not limited to, irbesartan and losartan.

[0145] Other therapeutic agents include α-interferon that acts on endothelial cells, dexamethasone, antisense molecules that bind to DNA and prevent its rewriting, ribozymes, antibodies, nuclear receptor ligands such as estradiol and retinoids, thiazolidinediones (glitazones), enzymes, adhesion peptides, blood coagulation factor blockers, blood dissolving agents such as streptokinase and tissue plasminogen activator, immune antigens, hormones and growth factors, antisense oligonucleotides used in gene therapy, oligonucleotides such as ribozymes and retroviral vectors, antiviral drugs, and diuretics.

[0146] In embodiments, any two or more of the above-mentioned drugs and therapeutic agents may be used in combination, depending on the desired therapeutic outcome.

[0147] Drugs, nanoparticles, stem cells, and other therapeutic agents can be deposited in specific areas, such as relief holes, using direct-write processes such as MICRO-PENNING (MICROPEN Technologies, Inc., Hanneoi-Falls, NY). In general, the term "direct-write" refers to a computer-controlled method of motion of a stationary pattern generator that deposits a flowable material onto a surface in a desired pattern. MICRO-PENNING is a flow-based, micro-deposition technology in which the material to be printed is extruded with high precision through a syringe and a pen tip. The pen tip contacts the surface of the material but not the substrate surface, allowing precise deposition of a given amount at a given location.

[0148] 26 shows an embodiment of a strip 500 with a relief 502 formed on the underside of the band 300 opposite the boundary surface of the wedge cutting device 200, with relatively large openings 503 formed between adjacent wedge cutting devices 200 to facilitate bonding of the band 300 to an underlying balloon, as described, for example, in WO2016 / 073490 published May 12, 2016, the contents of which are incorporated herein by reference. The openings 503 can be oval, circular, or other shapes depending on the treatment outcome.

[0149] In embodiments, the longitudinal axes of the bands can be oriented along the balloon and spaced apart from each other. The bands do not completely cover the entire length of the balloon, for example, an 80 mm long balloon can have bands that are 76.6 mm long. The length of the bands can be the same as the working balloon length, but shorter than the working balloon length to allow the balloon to contract when the balloon reaches burst pressure. The length of the bands can be less than about 15%, less than about 10%, less than about 9%, less than about 8%, less than about 7%, less than about 6%, less than about 5%, less than about 4%, less than about 3%, less than about 2%, less than about 1%, or between about 2% and about 8%, between about 3% and about 6%, or between about 4% and about 5% of the entire balloon length. The length of the balloon does not include the length of the cone.

[0150] In embodiments, a portion of the band, for example the base of the band, can be roughened (such that its undersurface interfaces with the outer surface of the balloon).

[0151] The spikes (e.g., serrated elements or wedge-shaped cutting tools) can be made in a variety of shapes in many different ways. The manufacturing process can use one or more additive or subtractive methods. Additive methods include, for example, high energy deposition, laser, or laser beam deposition. These include chemical vapor deposition, self-assembly techniques, polymer / metal 3D printing, selective laser sintering, powder printing, and other lithographic techniques, but others may be used, and subtractive methods include etching, CNC milling, laser cutting, waterjetting, and electrical discharge machining, but others may be used.

[0152] In an embodiment, the reel can be made of 300 or 400 series martensitic stainless steel having a Rockwell C hardness (HRC) of about 52 to about 64, although other materials can be used. The reel is sharpened at one or both ends. In an embodiment, the stainless steel can be about 0.007 inches to about 0.015 inches thick and about 0.25 inches to about 0.75 inches wide, but can also be about 0.005 inches to about 0.020 inches thick and about 0.15 inches to about 1 inch wide. Acceptable ranges for the thickness and width of the reel are about 0.020 inches or more and about 1 inch or more, respectively. The sharp portion can have a single angle or two or more angles (see, e.g., Figures 21 and 22). In an embodiment, the angle of the sharp portion can be, for example, 75 degrees or more, when measured as the slope from the boundary surface to the height of the non-boundary surface, as shown in Figure 21. On the other hand, if the sharp portion is composed of multiple angles, the angle of the tip can be 75° or less. If the sharp end is moved to the bevel side, the angle can be 70° or more, 75° or more, 80° or more, 85° or more, 90° or more. In addition to the sharp end, in embodiments, a separate additional end can be formed at the non-boundary end of the band, which has a shorter height and a larger angle than the sharp end. The width WU of the non-boundary end can be expressed as the radius of the end. If the width of the end is less than 0.01 inches or 0.005 inches, it can penetrate the diseased part of the blood vessel, and the surface area is minimized and the contact with the blood vessel is smaller, so that the energy required for penetration can be reduced. If the non-boundary end is configured to penetrate a relatively hard surface such as a calcium bed, the end can be made wider by making the angle obtuse or removing the tip part away from the boundary surface (see WU in FIG. 21). The widened tip spreads the load over its entire surface area when penetrating a hard tissue surface and prevents deformation of the tip. After the reel is sharpened, it is stamped to a predetermined length. In an embodiment, the reel is hardened and then stamped to a predetermined length.Regardless of the stamp forming, the tip blade is passivated and hardened to a hardness of, for example, HRC 45. Typically, it is hardened to about HRC 58 to about HRC 62. The hardened blade is laser cut, stamped, EDMed, or other metal forming techniques into a spike, saw, or wedge cutting tool. The saw element is machined from a reel and hardened and passivated. If the tip is not sharpened, the step of sharpening the tip is omitted from the manufacturing process for, for example, a wedge cutting tool. Alternatively, a distance of 0.0001 inch to 0.003 inch, or 0.0001 inch to 0.0005 inch, may be removed from the sharp tip to form a flat surface as shown in FIG. 21. The thinnest remaining portion of the sharp tip becomes the non-interface of the strip.

[0153] In an embodiment, a method for bonding the bands is disclosed. The method includes processing steps that provide effective band retention, vertical orientation, and structural stability during manufacture and use. The interface is coated with a polymer such as polyurethane through a controlled dipping process that forms a uniform polyurethane layer. After the coating dries, three or four bands are aligned using a band alignment mechanism or tool and glued with a medical grade cyanoacrylate to align them in a predetermined direction. The number of bands can vary, for example, from one to eight, and is typically determined in relation to the number of folds in the balloon, but can be less than the number of folds in the balloon, and the bands can be periodically arranged with a discontinuous period. Once the bands are bonded to the balloon surface, a single or multiple top coat layer or retention layer is disposed on a metal splitting and scratching element or wedge cutting tool to hold the bands in place. , protecting the balloon from wedge dissection tools. In embodiments, the coating layer can be applied in a manner similar to that used to coat the ribbons using a controlled dipping process to form one or more uniform layers of urethane or polyurethane. After the retention layer has cured, a hydrophilic or other coating can be applied to reduce friction on the balloon and increase transportability and retrievability of the balloon. A slip coating on the outer periphery can increase the functionality of the balloon by reducing the forces required for insertion and removal of the device.

[0154] FIG. 27 is a cross-sectional view of the band and wedge dissector operatively bonded to the outer surface of the balloon. A thin (e.g., 0.0001 inch to 0.0009 inch) polymer layer, i.e., about 0.001 inch or less thick so that the diameter of the balloon does not increase, can be used as a base coat (layer 270A) that covers the outside of the balloon. The base coat 270A serves as an interface bonding layer for the wedge dissector to the balloon surface. Layer 270A can be made of the same or similar polymeric material as the other layers and chemically, mechanically, or electromagnetically bonded to the balloon surface. The base coat layer 270A can be configured to reduce the interface stress between the outer balloon surface and the wedge dissector. The interface between the two surfaces can sandwich the adhesive layer 270E and the wedge dissector 200 in a polymer matrix, isolating them from the stresses of the balloon as it expands. The base coat layer 270A can be made of, for example, urethane or polyurethane, but can also be made of other materials. In embodiments, the coating can include silicone and hydrophilic coatings including hydrogel polymers, such as vinyl polymer chains and non-crosslinked hydrogels. Polyethylene oxide (PEO) is an example of a hydrogel. An example of a vinyl polymer is neopentyl glycol diacrylate (NPG). The layers can be coated by immersing the balloon in a polymer bath one or more times with controlled insertion and removal times. The layers can also be coated through self-assembly of a single layer using well-known practical self-assembly techniques, such as surface ionic charging, to form angstrom-level layers.

[0155] In FIG. 27, the bonding layer 270E between the wedge cutter and the basecoat layer is thin (0.0001 to 0.0005 inches) but can be as thick as 0.001 inches. This thickness does not increase the outer diameter of the balloon. The adhesive layer 270E can be made of cyanoacrylate or other materials. These materials provide a chemical, mechanical, or electromagnetic bond between the basecoat layer 270A and the interface of the wedge cutter. The adhesive layer 270E can be viewed as a functional layer for bonding the wedge cutter to the balloon and is the only layer bonding the wedge cutter to the outer surface of the balloon. This adhesive layer 270E can be one or more adhesive products. The adhesive layer 270E is a single adhesive with a low viscosity that allows for wicking of the adhesive along the interface of the interface of the wedge cutter and the basecoat. The adhesive dries instantly and can be applied as a continuous layer with minimal curing time. A more viscous adhesive can be applied to both ends of the bottom surface of the strip, or can be applied periodically between the wedge cutter and the base layer to provide non-adhesive, non-bonded portions. More than one adhesive can also be used. For example, a more viscous adhesive can be applied to both ends of the wedge cutter and a wicking adhesive can be applied to some or all of the non-bonded portions. In an embodiment, two or more retention layers (two layers in FIG. 27) 270B and 270C can be applied on the base layer 270A, as can the wedge cutter. The polymer retention layer can have dimensions similar to the base layer with properties that allow for effective bonding between the base layer 270A and the retention layers 270B and 270C. The retention layer can have a thickness similar to the base layer, while it may be beneficial to have a layer that is slightly thicker than the base layer. A thicker base layer and / or retention layer may increase the burst resistance of the balloon and improve its resistance to wedge dissectors. The balloon may be provided with a hydrophilic coating to reduce friction and improve guidance of the balloon through narrow and tortuous anatomical features. The hydrophilic coating may be applied to the entire surface of the balloon, or may be applied after the balloon is deflated and crimped. Thus, only the surface exposed during shipping is covered with the hydrophilic coating. A typical hydrophilic coating is a few microns thick and may be as thin as about 10 Angstroms.

[0156] In embodiments, the adhesive may be applied separately to the balloon and the band and then bonded together. A template may be used to accurately position the wedge dissector along the surface of the balloon.

[0157] The retention layers 270B and 270C can be similar to the base layer with properties that allow for effective bonding between the base layer and the retention layer. The retention layer can be of similar thickness to the base layer, or may be beneficially slightly thicker than the base layer, such as having a thickness of about 20% or less, about 15% or less, about 10% or less, or about 5% or less. Thicker base and / or retention layers can provide increased burst resistance and resistance to sharp edges of the balloon, wedge dissection instruments, or implants remaining in the body or sharp edges of heavily calcified lesions in blood vessels. The retention layers 270B and 270C can be constructed of the same or different materials.

[0158] A variety of hydrophilic coatings are available that can reduce friction and improve guidance of the balloon through tortuous and narrow anatomical features. In an embodiment, 270D in FIG. 27 is a hydrophilic slipping layer. The surface of the balloon can be entirely covered with the hydrophilic coating, or it can be coated after the balloon is deflated and crimped. Thus, only the surfaces exposed during shipping are covered with the hydrophilic coating. A typical hydrophilic coat is a few microns thick and can be as thin as about 10 Angstroms.

[0159] The height of the wedge dissector, bands, and capsule can be considered as a cage for use with an inflatable member, such as a medical balloon, such as an angioplasty balloon, or a portion of a medical balloon, or other inflatable member. In keyhole, i.e., catheter-based procedures, it is preferable to be able to collapse the balloon to a portion of its inflated diameter. Thus, the balloon and cage are folded to provide a profile for the collapsed balloon to be effectively used. The cage is folded to provide a profile for the spikes to be oriented so as not to burst the balloon or to not damage the lining of the lumen during shipping, as shown in FIG. 28. FIG. 28 illustrates a balloon 1000 with multiple pleats 1002, bands 300, and wedge dissector 200 located between the pleats. In this case, a single band 300 with multiple wedge dissectors 200 is located between two pleats 1002. The pleats are designed to provide an effective orientation of the spikes and splines. These pleats have pleat wedges that, when closed on the balloon, can form pleats in the balloon located between them. Due to the bulk of the splines and to minimize the contact area and potential damage of the wedge head, the pleat wedges have pockets formed along the length of the wedge head that restrict the splines from being disposed within the pocket and contacting the pleat wedges. The pockets function to aid in the orientation of the splines and spikes and prevent the splines and spikes from overfolding. The orientation of such spikes is tangential to the balloon surface, as shown in FIG. 28.

[0160] Based on the teachings above, various changes, modifications, and alterations are possible. It is therefore to be understood that within the scope of the appended claims, other things can be done than as described herein. Combinations and subcombinations of the features and aspects of the above-described embodiments are also included in the present invention. Also, specific features, aspects, methods, properties, characteristics, quantities, attributes, elements, etc., associated with one embodiment can be used in other embodiments described herein. It is therefore to be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another to form modified modes of the disclosed invention. Therefore, the scope of the invention disclosed herein should not be limited to the specific embodiments described above. Also, while the invention is susceptible to various modifications and alternatives, specific examples thereof have been shown in the drawings and have been described in detail. However, it is to be understood that the invention should not be limited to the specific forms and methods disclosed, and the invention includes all modifications, equivalents, and variations within the spirit and scope of the various embodiments described and the appended claims. The methods disclosed herein need not be performed in the order of recitation. The methods disclosed herein include actions performed by a physician, but also explicitly or implicitly include actions performed by a third party. The ranges disclosed herein include any ranges, including all overlapping ranges, subranges, and combinations thereof. Words such as "up to," "at least," "more than," "less than," "between," and the like, are inclusive of the recited numerical value. As used herein, the words "approximately," "about," and "substantially" are inclusive of the recited numerical value (e.g., about 10%=10%) and represent a numerical value that is close to the recited numerical value to perform the desired function or achieve the desired result. For example, "approximately," "about," and "substantially" refer to a range of 10% or less, a range of 5% or less, a range of 1% or less, a range of 0.1% or less, and a range of 0.01% or less of the numerical value.

Claims

1. a strip member having an internal lumen and defining a longitudinal axis; an inflatable balloon connected to the strip member distal to the strip member; A plurality of strips; Equipped with each of the plurality of bands having a plurality of wedge-shaped cutting devices spaced along a surface of the respective band, each of the bands extending longitudinally along an outer surface of the balloon; the wedge cutting device having a band-like base surface immediately adjacent a surface of each of the bands, a radially outward cutting surface having a length corresponding to a length between a radially outward proximal edge and a radially outward distal edge and defining a height of the wedge cutting device, and a side surface located between the base surface and the cutting surface; 1. A medical balloon catheter, comprising: a cutting surface having a first width at the proximal edge; a second width between the proximal edge and the distal edge that is smaller than the first width; and a third width at the distal edge that is larger than the second width.

2. 2. The medical balloon catheter of claim 1, wherein the second width corresponds to a single point along the length of the radially outward cutting surface.

3. 2. The medical balloon catheter of claim 1, wherein the second width corresponds to a center portion having a center length between the proximal edge and the distal edge.

4. 2. The medical balloon catheter of claim 1, wherein the length of each band is less than the length of an outer surface of the balloon that is coaxial with the length of each band.

5. 2. The medical balloon catheter of claim 1, wherein the length of each band is between about 3% and about 6% of the outer surface of the balloon coaxial with the length of each band.

6. 2. The medical balloon catheter of claim 1, wherein the overall length of the radially outward cutting surface of each wedge-shaped cutting device is less than the overall length of the band-like base surface of the wedge-shaped cutting device.

7. 2. The medical balloon catheter according to claim 1, wherein the radially outward cutting surface has a curved surface.

8. 2. The medical balloon catheter of claim 1, wherein the radially outwardly facing cutting surface has at least one chamfer.

9. 2. The medical balloon catheter of claim 1, wherein the radially outward cutting surface has a first height at the proximal edge and a second height between the proximal edge and the distal edge, the second height being greater than the first height.

10. 2. The medical balloon catheter according to claim 1, wherein the maximum height of the radially outward cut surface is a midpoint between the first unbounded end and the second unbounded end.

11. 2. The medical balloon catheter of claim 1, wherein a maximum height of the unbounded surface is offset from the proximal and distal edges.

12. 2. The medical balloon catheter of claim 1, wherein a side portion of the wedge-shaped cutting device from the base surface to the proximal edge has a first portion having a first slope and a second portion having a second slope different from the first slope.

13. 2. The medical balloon catheter of claim 1, wherein the band has a fibrous surface.

14. 2. The medical balloon catheter of claim 1, further comprising a plurality of tabs on an underside of said cuff opposite said wedge cutting device.

15. 2. The medical balloon catheter of claim 1, comprising a plurality of reliefs on said band.

16. 14. The medical balloon catheter of claim 13, wherein the plurality of bands are strips having first and second transverse ends, the first and second ends being secured together by an adhesive.

17. 2. The medical balloon catheter according to claim 1, further comprising a hydrophilic lubricating layer on the outer surfaces of said balloon, said band and said wedge-shaped cutting device.

18. 2. The medical balloon catheter of claim 1, further comprising at least one polymeric retaining layer on the outer surfaces of said balloon, said cuff and said wedge cutting device.

19. 2. The medical balloon catheter of claim 1, wherein the balloon includes a cone at a lateral end, the cone having a maximum outer diameter greater than about 5% of the maximum outer diameter of the balloon.

20. 2. The medical balloon catheter of claim 1, wherein the cone has tracks oriented along the longitudinal axis of the band.

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