Wedge-shaped cutting instrument for medical balloons

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 invention was filed on September 17, 2015, as U.S. Provisional Application No. 62 / 220,195, and claims the benefit thereof under the provisions of 35 U.S.C. § 119(e), and incorporates by reference all of its content into this application. Any and all applications identified in the application data sheet filed together with this application as claiming foreign or domestic priority are incorporated by reference into this application under 37 C.F.R. § 1.57.

[0002] Embodiments relate to cages for use with medical balloons, such as angioplasty balloons, methods of manufacturing the cages, and methods of treatment with the cages. Embodiments also relate to splines that can be used with various wedge devices and cages. Among these, the wedge cutting device is used to create perforations in intravascular plaque and suppress the generation of injuries that control the propagation of cracks and restrict blood flow.

Background Art

[0003] Atherosclerotic occlusive disease is an initial cause of attacks, leading to heart attacks, limb loss, and death in the United States and the industrial world. Atherosclerotic plaque forms a hard layer along the walls of arteries and contains calcium, cholesterol, hardened thrombus, and cellular debris. As atherosclerosis progresses, the supply of blood flowing through the blood vessels decreases or stops due to occlusion. One of the most widely used methods for treating clinically significant atherosclerotic plaque is balloon angioplasty.

[0004] Balloon angioplasty is a method of dilating blocked or narrowed blood vessels in the body. In this method, a catheter for balloon angioplasty is placed in the artery via percutaneous or remote access through an open end of the artery. The catheter is inserted along the entire length of its guide member. A balloon accompanied by the catheter is positioned at the site of the antheroma plaque that needs treatment. The balloon is generally inflated to the same size as the original diameter of the artery prior to treating the occlusion. [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] When the balloon inflates, the plaque compresses, expands, ruptures, or shatters depending on its composition, location, and the pressure from the balloon. Because the plaque is heterogeneous, it exhibits properties that are soft in some areas and hard in others, resulting in unexpected cleavage surfaces in standard angiography. Balloon angioplasty can cause plaque fragmentation, potentially damaging the artery at the site of vessel formation.

[0006] It is necessary to improve methods for treating occlusion, including balloon angioplasty and other related treatment systems. [Means for solving the problem]

[0007] In embodiments, the cage can be positioned around a medical balloon, such as an angioplasty balloon, to assist in medical procedures. The cage may include at least a first ring and a second ring, as well as a plurality of strip-like bodies. Each strip-like body extends longitudinally between the first and second rings. By bringing the cage closer to the inflated portion while the strip-like bodies are inflating, the first and second rings can be moved closer together. In embodiments, the cage may have spikes on the strip-like bodies, and these spikes It can be used as a wedge-shaped cutting instrument to cut through plaque in blood vessels. In embodiments, a medical balloon catheter is disclosed, and the wedge-shaped cutting instrument and the band can be configured to be attached to the medical balloon catheter or other inflatable member. The balloon catheter may include any number of the following members: Specifically, a striped member having a lumen and defining a longitudinal axis; an inflatable balloon coupled to the striped member distal to the striped member; and multiple bands, each having multiple wedge-shaped cutting instruments spaced apart along the surface of each band, with each band extending longitudinally along the outer surface of the balloon. The wedge-shaped cutting instrument has a band-shaped cut surface in direct proximity to the surface of each band. The cut surface of the wedge-shaped cutting instrument has a length corresponding to the distance between the proximal and distal edges radially outward, and determines the height of each wedge-shaped cutting instrument. The radially outward-facing cut surface has a first width at the proximal edge, a second width smaller than the first width between the proximal and distal edges, and a third width larger than the second width at the distal edge. In embodiments, the second width corresponds to a single point along the length of the radially outward-facing cut surface. The second width corresponds to a center having a central length between the proximal and distal edges. The length of each strip is less than the length of the outer surface of the balloon coaxial with the length direction of each strip. The length of each strip is between about 3% and about 6% of the outer surface of the balloon coaxial with the length direction of each strip. The total length of the radially outward-facing cut surface of each wedge-shaped cutting instrument is less than the total length of the strip-shaped base surface of each wedge-shaped cutting instrument. The radially outward-facing cut surface may have, for example, one or more curved and / or chamfered surfaces. The radially outward-facing cutting surface has a first height at its proximal edge and a second height between its proximal and distal edges. The second height is greater than the first height. In some cases, the maximum height of the radially outward-facing cutting surface can be the midpoint between the first and second boundaryless edges. In some cases, the maximum height of the boundaryless surface can be offset from its proximal and distal edges. In one embodiment, the lateral portion of the wedge-shaped 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 strip may have a fibrous surface. In embodiments, the strip may have a plurality of tabs on its underside opposite the wedge-shaped cutting instrument. A plurality of reliefs may also be arranged on the strip. In some cases, the strip may be a fine strip and have a first end and a second end in the transverse direction. The first and second ends of a plurality of strips may be fixed with adhesive. In embodiments, a hydrophilic smooth layer may be provided on the outer surfaces of the balloon, strip, and wedge-shaped cutting instrument. In embodiments, at least one polymer-retaining layer may be provided on the outer surfaces of the balloon, strip, and wedge-shaped cutting instrument. The balloon may include a cone at its transverse end. The maximum outer diameter of the cone is about 5% larger than the maximum outer diameter of the balloon. In some cases, the cone has rails oriented in the longitudinal direction of the strip.

[0008] The cage can be assembled and / or manufactured by various methods, such as an extrusion process, material removal from a tube, and forming strips by wire splitting.

[0009] The cage can assist in medical procedures in various ways. For example, it can be used to coat the balloon with a drug coating before it is placed. Alternatively, the cage can be inflated to coat the surface of the balloon with the drug coating. In this way, the cage can prevent or suppress the dilution of the drug during transport and can prevent or suppress treatment being administered to unintended areas.

[0010] Furthermore, the cage can prevent or suppress the formation of dog bones by suppressing balloon expansion at its edges compared to its central portion.

[0011] In the embodiment, the balloon catheter includes a striped member, a balloon, and a cage. The striped member may have a striped member that defines the lumen and longitudinal axis. The balloon may be joined to the striped member at its distal edge. A cage can be used to position the balloon. The cage may have a plurality of strips and a plurality of rings. The plurality of rings may be configured to secure the plurality of strips to the balloon catheter. Each strip may have a first ring at its distal edge and a second ring at its proximal edge. At least the intermediate portion of the strip between its distal and proximal edges may be left uncovered by the ring and unconnected to the ring. The balloon and cage may be configured to have an initial state and an inflated state, and the plurality of strips may be configured to move with the balloon as the balloon inflates.

[0012] In the embodiment of the balloon catheter, some of the multiple rings include a heat-shrinkable material. Each band may also have multiple wedge-shaped cutting instruments spaced apart along the band. The multiple rings are fixed to the band at the distal and proximal edges of the balloon. The band may also be fixed at its midpoint and / or ends.

[0013] In embodiments, some of the rings may include partial rings consisting of an upper layer and a lower layer made of a heat-shrinkable material, and the ends of each strip may be sandwiched between the upper and lower layers. In embodiments, hooks may be provided on the strip, and grooves may be provided on the strip, rings, springs, or other features.

[0014] In one embodiment, a cage is constructed by covering a series of strip-shaped bodies with multiple polyurethane coatings. In such an embodiment, the cage includes a complete or partial upper layer made of urethane, polyurethane, or other polymer material, or a multilayer made of these urethanes, etc., and a lower layer made of urethane, polyurethane, or other polymer material. In this case, the multiple strip-shaped bodies are sandwiched between the upper and lower layers. In one embodiment, hooks can be provided on the strip-shaped bodies, and grooves can be provided on the strip-shaped bodies or on rings, springs, or other features.

[0015] The method for modifying a balloon catheter using a cage includes the following steps: arranging multiple strip-like bodies around the inflated balloon of the balloon catheter (the strip-like bodies are arranged at equal intervals around the inflated balloon); applying a ring made of heat-shrinkable material over the entire balloon, covering each end of the multiple strip-like bodies with the ring; and heating the ring to shrink it and fix the multiple strip-like bodies to the balloon (at this time, the portions of the strip-like bodies between the distal and proximal edges remain uncovered by the ring and / or are not joined to the ring).

[0016] In the above method, the strip-shaped bodies may be arranged and extended in the longitudinal direction, and / or the strip-shaped bodies may be arranged in four parallel rows around the balloon. Each row consists of 2 to 6 strip-shaped bodies. The strip-shaped bodies are attached to the balloon permanently or temporarily with an adhesive.

[0017] By applying a ring made of heat-shrinkable material to the balloon, a single ring may cover most of the distal edges of multiple strip-shaped bodies. Alternatively, by applying a ring made of heat-shrinkable material to the balloon, a single ring may cover most of the proximal edges of multiple strip-shaped bodies.

[0018] In embodiments, the cage can be positioned around the angiogenic balloon. The cage may include a first ring, a second ring, and a plurality of strips. Each strip extends longitudinally between the first and second rings. The cage is positioned before inflation. The rings can be positioned beforehand or after inflation, but as the balloon inflates, the first and second rings move closer to each other, and the spacing between the bands widens.

[0019] A method for fabricating a cage for an angiogenesis balloon comprises: extruding a plastic tube into a plurality of splines arranged longitudinally apart along the tube; cutting at least one of the plurality of splines to form a plurality of spikes arranged around the tube; and cutting the tube to form a plurality of longitudinally extending strips (each strip containing at least one spike).

[0020] A method for fabricating a cage for an angiogenesis balloon comprises: forming a wire into multiple longitudinally extending strips; cutting at least two of the strips to form multiple spaced spikes along the strips; and connecting the two strips to the first and second rings such that each strip extends between the first and second rings.

[0021] A method for protecting an angioplasty balloon with a drug coating includes providing an angioplasty balloon coated with a drug, a cage having a first ring, a second ring, and a plurality of bands, the positions before and after inflation being determined, each band extending between the first and second rings, the cage radially covering the angioplasty balloon in the pre-inflation position, so that the surface of the drug-coated angioplasty balloon is not exposed or substantially not exposed, and when moving to the post-inflation position, the first ring and the second ring move closer to each other, the spacing between the bands expands, and the surface of the angioplasty balloon is exposed.

[0022] A method for treating vascular diseases includes applying an angioplasty balloon having a cage with a first ring, a second ring, and a plurality of strips, the strips being selectively drug-coated, arranged to cover the whole, with the positions before and after inflation being determined, and each strip extending between the first ring and the second ring; and inflating the angioplasty balloon at the treatment site. The inflation of the angioplasty balloon brings the first ring and the second ring closer and expands the spacing between the strips. The cage suppresses the inflation of the balloon at its ends compared to its central part to prevent or suppress the occurrence of dogbones.

[0023] In an embodiment, the cage for positioning the angioplasty balloon can include a plurality of rings and a plurality of strips. The plurality of rings can be non-inflatable. 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 strip can have a plurality of protrusions disposed on the surface of the strip. Each ring can be configured to be attached to the ends of the plurality of strips. The plurality of strips 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 shorter than the first length, and the plurality of rings are close to each other such that each strip bends away from each other.

[0024] Hereinafter, these and other features, aspects, and advantages will be described with reference to the drawings, which are for illustrative purposes and do not limit the present invention. Also, in the drawings, like reference numerals indicate corresponding features throughout similar embodiments.

Brief Description of the Drawings

[0025] [Figure 1A] It is a diagram showing a cage disposed on an angioplasty balloon in an inflated position. [Figure 1B]It is a development view when a balloon for angiogenesis is placed in a cage, and it is a view showing the state before inflation. [Figure 2] It is a plan view of a cage having long and short slits. [Figure 3] It is a view showing a balloon for angiogenesis at the treatment site of a blood vessel that has developed a dog bone. [Figure 4A] It is a view during the process of manufacturing a cage by cutting a tube. [Figure 4B] It is a cross-sectional view taken along the B-B line of the view shown in FIG. 4A. [Figure 4C] It is a cross-sectional view shown in FIG. 4B after additional manufacturing processes are performed. [Figure 4D] It is a cross-sectional view of another embodiment having a relatively large lumen. [Figure 4E] It is a view showing in detail a part of another embodiment of the cage. [Figure 5A] It is a view of another embodiment of the cage in the manufacturing process. [Figure 5B] It is a cross-sectional view when the cage shown in FIG. 5A is cut along the B-B line. [Figure 6A] It is a view showing a wire cut to form a strip and a wedge cutting instrument for one embodiment of the cage. [Figure 6B] It is a view showing the cross-section of the cutting wire shown in FIG. 6A. [Figure 7] It is a view showing a plurality of strips coupled by two rings to form a cage. [Figure 8] It is a view showing two rings that fasten the strips to constitute a part of the cage. [Figure 9A] It is a view showing another embodiment of the cage having a conical ring. [Figure 9B] It is a perspective view of a ring having a tapered outer peripheral surface and a screw-shaped feature portion formed on the outer peripheral surface. [Figure 10] It is a view showing the end portion of a strip accommodated and fixed in a multilayer ring forming the end portion of the cage. [Figure 11]This figure shows another embodiment of the end of a strip-shaped body housed and fixed within a multilayer ring forming the end of a cage. [Figure 12] This is a perspective view of the ring. [Figure 13A] This figure shows a band-shaped body with a hook-shaped characteristic portion and a ring. [Figure 13B] This is an end view of a strip-shaped body having a ridge-shaped, hook-like characteristic portion. [Figure 13C] This is a perspective view showing a portion of the cage. [Figure 13D] This figure shows a conical ring at the distal edge that holds multiple band-like structures. [Figure 13E] This figure shows one end of a balloon with a cage arranged around it, illustrating the force acting on the inflated balloon. [Figure 13F] This figure shows one end of a balloon with a cage positioned around it, illustrating the force acting on the balloon in its deflated state. [Figure 14A] This is a side view showing an embodiment of a cage equipped with a strip-shaped body having a hook that can be attached to the inside of a balloon neck. [Figure 14B] Figure 14A is an end view of the cage attached to the balloon shown. [Figure 14C] This is a cross-sectional view of a strip-shaped body having a hook fixed inside a balloon neck. [Figure 14D] This figure shows another embodiment illustrating the end of a strip-shaped body having a multilayer ring that forms the end of a cage. [Figure 14E] This figure shows an example of a band-shaped body held by multiple rings, each having a wedge-shaped cutting instrument protruding from the multiple rings. [Figure 15A] This figure shows a part of an embodiment of an angioplasting balloon, which comprises a band-like structure formed by bonding multiple ring-shaped materials to the surface of the angioplasting balloon in order to form a cage. [Figure 15B] This figure shows an angioplasty balloon comprising a cage having multiple strip-shaped bodies attached to the surface of the angioplasty balloon by multiple rings. [Figure 15C] This figure shows the position of the band-like structures on the surface of the balloon. [Figure 15D] This figure shows another embodiment illustrating the position of the strip-shaped material on the balloon surface. [Figure 15E] This figure shows an example of multiple strip-shaped bodies attached to the surface of a balloon by multiple rings. [Figure 16A] This figure shows an example of a strip-shaped object fixed by a ring. [Figure 16B] This figure shows an example of a strip-shaped object fixed by a ring. [Figure 16C] This figure shows an example of a strip-shaped object fixed by a ring. [Figure 17] This figure shows in detail an embodiment of a cage having a spring. [Figure 18] This figure shows an embodiment of a cage that utilizes a spring, as shown in Figure 17. [Figure 19] This figure shows a part of a cage with springs and spikes. [Figure 20] This is an enlarged view of an embodiment in which a wedge-shaped cutting instrument is provided on a band-shaped body. [Figure 21] This is a perspective view showing various sizes of the wedge-shaped cutting instrument in the embodiment. [Figure 21A] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 21B] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 21C] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 21D] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 21E] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 21F] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 21G] This figure shows an embodiment of a wedge-shaped cutting instrument. [Figure 22A] This diagram shows the geometric configuration of a wedge-shaped incision instrument. [Figure 22B] This diagram shows the geometric configuration of a wedge-shaped incision instrument. [Figure 22C] This diagram shows the geometric configuration of a wedge-shaped incision instrument. [Figure 22D] This diagram shows the geometric configuration of a wedge-shaped incision instrument. [Figure 22E] This diagram shows the geometric configuration of a wedge-shaped incision instrument. [Figure 22F] This diagram shows the geometric configuration of a wedge-shaped incision instrument. [Figure 23A] This diagram shows the asymmetrical geometric configuration of a wedge-shaped incision instrument. [Figure 23B] This diagram shows the asymmetrical geometric configuration of a wedge-shaped incision instrument. [Figure 23C] This diagram shows the asymmetrical geometric configuration of a wedge-shaped incision instrument. [Figure 23D] This diagram shows the asymmetrical geometric configuration of a wedge-shaped incision instrument. [Figure 24] This figure shows how the height of the non-boundary surface 204 changes. [Figure 25A] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25B] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25C] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25D] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25E] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25F] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25G] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25H] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25I] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25J]This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25K] This figure shows an embodiment of a strip-shaped body in which reliefs are formed in various places. [Figure 25L] This figure shows a method for stabilizing a strip-shaped material during the laser cutting manufacturing process. [Figure 25M] This figure shows an embodiment that includes a temporary tab. [Figure 25N] This figure shows an embodiment of the application area for adhesive to bond the lateral ends of a strip-shaped material to the surface of a balloon. [Figure 25O] This figure shows the cone region relative to the balloon. [Figure 25P] This figure shows a conical rail or protrusion. [Figure 26] This figure shows another embodiment of a strip-shaped body having a relief. [Figure 27] This is a cross-sectional view of a wedge-shaped cutting instrument and a balloon with an intervening layer. [Figure 28] This figure shows an embodiment of a pleated balloon having a wedge-shaped cutting instrument between the band-like structure and the pleats. [Modes for carrying out the invention]

[0026] Figures 1A and 1B show embodiments of the cage 10 positioned on the angioplasty balloon 20. Figure 1A shows the inflation position, and Figure 1B shows how the angioplasty balloon inflates within the cage. Here, we first describe the cage 10 in advance of the angioplasty balloon and angioplasty procedure. The cage 10 can be used with medical balloons and other types of balloons used in other procedures.

[0027] The cage 10 has a first ring 12, a second ring 14, and a plurality of strip-like bodies 16. Each strip-like body extends longitudinally between the first ring 12 and the second ring 14. The strip-like bodies and rings can be monolithically formed from a single material. Therefore, the first and second rings can be made from, for example, scraps of cut tubing. The strip-like bodies and rings can be made from separate materials or they can be joined together. The cage shown in Figures 1A and 1B has five strip-like bodies, but it can also have 2 to 10 strip-like bodies.

[0028] Figure 2 is a plan view of a cage made of cut tubes, but the cage can also be constructed from a single flat material. The material can be elastic or semi-elastic and can consist of polymers, copolymers, metals, alloys, or combinations thereof. The strip is typically designed to allow the balloon 20 to be inflated multiple times. Similarly, the strip 16 is configured so that the cage 10 returns to its original position when forces are applied in the longitudinal and axial directions.

[0029] In one embodiment, the cage 10 is assembled, packaged, and sterilized separately from the balloon 20, so that a physician can position the cage 10 around a medical balloon 20, such as an angioplasty balloon, to assist in the procedure. Figure 1B shows the folded balloon 20 before being placed inside the cage 10. The folded balloon 20 can be inserted into the cage 10 without inflating or changing the shape of the cage 10. The cage 10 can completely enclose the balloon 20 before it is placed and inflated. The cage 10 before inflation can be longer than the balloon 20. This allows one or both ends of the cage 10 to move toward each other as the device (e.g., the balloon 20) inflates. The cage 10 is free to move around the entire balloon 20. One or both ends 12,14 of the cage 10 can be fixed to the balloon 20 or to part of another transport device. In one embodiment, the cage 10 is not fixed to any part of the inflated balloon 20. This ensures that the cage 10 does not obstruct the inflation of the balloon 20.

[0030] In this 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 suppress premature contact of the drug with the blood vessels. As can be seen with reference to Figure 1B, the cage 10 is positioned over the entire drug coating on the angioplasty balloon 20 before inflation, preventing premature contact of the drug with the blood vessels. The cage 10 radially covers the balloon 20 so that the surface of the drug-coated balloon 20 has minimal or no contact with the blood vessels. The balloon 20 and cage 10 can be advanced to the treatment site in this embodiment. Although not shown in the figure, this system can be advanced along a guidewire within the vascular structure.

[0031] As shown in Figure 1A, the cage 10 moves to the inflated position. In the inflated position, the first ring 12 and the second ring 14 are close together, and the band expands, exposing the surface of the angiogenic balloon. Dispense. At this position, the drug is positioned so that it comes into contact with the diseased tissue within the blood vessel.

[0032] With currently available systems, it is difficult to predict how much drug will reach the diseased tissue. Numerous factors limit the ability to accurately predict the amount of drug that will reach the diseased tissue. For example, blood flow dilutes the drug on the balloon 20 as it moves towards the treatment site. Also, maneuvering the device within the blood vessel causes the balloon 20 to rub against the lumen wall, thus scraping off some of the drug as it moves towards the treatment site. Therefore, in some cases, the cage 10 provides a physical barrier to protect the drug coating the balloon 20 as it moves towards the treatment site. Thus, as the spacing of the zonal structure increases, the cage 10 is used so that the balloon 20 and the drug coating are exposed to the blood flow within the vessel during the inflation of the balloon 20. In this way, the cage 10 can prevent and reduce drug dilution and treatment of areas of the body that do not require treatment. Alternatively, the amount of drug to be coated on the balloon 20 can be controlled by controlling drug transport.

[0033] In one embodiment, the folded balloon 20 can be positioned throughout the cage 10. As shown in Figure 1A, the cage 10 may have slits between each strip. Alternatively, the slits can be formed to cut between each strip and separate the strips from a single material body. In another embodiment, the slits are equal to the distance between adjacent strips. The distance between strips can be very small, such as that which can be formed by laser cutting, or it can be as large as or greater than the width of the strips. Depending on the size of the slits, the percentage of the surface of the balloon 20 before inflation is 50% or less, and can be 25%, 10%, 5%, 1%, or less.

[0034] As described above, the inflation of the balloon 20 brings the first ring 12 and the second ring 14 closer together, while radially separating the band 16. When the band 16 is inflated, the balloon 20 is exposed to the blood vessels and interacts with them. In the inflated position, the balloon 20 can deliver and administer drugs, stem cells, and other treatments to the blood vessel walls or diseased areas of the blood vessel walls. After the balloon 20 is fully inflated, the percentage of the balloon 20 not covered by the band is 65% to 99%, 75% to 99%, more commonly 80% to 99%, and especially commonly 90% to 99%.

[0035] Drug delivery using cage 10 can be performed before, during, or after angioplasty. At the same time, the cage does not need to cover the entire balloon, nor does it need to control or assist drug delivery.

[0036] In some embodiments, the cage 10 can be used to prevent or suppress dogbone formation of the balloon 20 during angioplasty. Such effects can be used in addition to, or as a substitute for, drug delivery. Figure 3 shows the angioplasty balloon 20 in the treatment area within the blood vessel 2. As shown in the figure, the angioplasty balloon 20 experiences dogbone formation when it inflates. The attached plaque 4 inhibits the inflation of the balloon 20, causing the ends of the balloon 20 to inflate first, rather than concentrating the energy at the center of the balloon 20 where the most inflation energy is needed, due to the plaque 4.

[0037] To prevent dogbone formation, the cage 10, as shown in Figure 1A, can be used to restrict the inflation of the balloon 20, causing the central part of the balloon 20 to inflate first. This is because the cage 10 is furthest from the end of the band that is constrained by the ring. This is due to the fact that the central part has the least resistance. As a result, it is possible to prevent and suppress the dogbone of the balloon 20, regardless of the disease morphology or the morphology of the artery caused by the inflation of the balloon 20.

[0038] A dogbone typically forms when a balloon 20 expands in a blood vessel where plaque is inhibiting expansion, causing both ends of the balloon 20 to expand first (due to a lack of resistance), thus giving the balloon 20 the shape of a dogbone. By enclosing the balloon 20 in a cage 10 and configuring the ring to exhibit different expansion resistances, the ends of the balloon 20 will have the highest resistance, while the center of the balloon 20 will have the lowest resistance. Therefore, the cage 10 controls and limits the expansion of the balloon 20 when the balloon 20 tends to expand in the central part, which corresponds to a typical diseased area.

[0039] The orientation pattern of the strip-shaped body 16 affects expansion and dogbone formation. Returning to Figure 2, the short slits 22 located in the center of the strip-shaped body 16 reduce the stiffness of each strip-shaped body 16. This reduces the resistance to expansion in the central part of the cage 10, thus suppressing the formation of dogbone formation.

[0040] The cage may further have spikes, or wedge-shaped cutting instruments, on the band. These spikes can be used as tools for angiogenesis before a second procedure or during the first procedure. For example, the spikes can assist in cutting and / or perforating plaque before or during an angioplasty. This also assists in drug delivery and / or prevents dogbone formation. The embodiments described herein, like the other benefits and procedures described herein, provide these benefits and can be used in these procedures.

[0041] As described below, spikes can be positioned on the vein in different directions and manner. Any spikes discussed in US8,323,243 by Schneider et al., published April 12, 2012, can be used, and the entire work is incorporated here by reference. Spikes and cages can be used according to the plaque serrated method and other methods described in that document.

[0042] The cage 10 can be manufactured by various methods. For example, methods such as extrusion, pipe cutting, and wire splitting, as detailed below, can be used. Figures 4A to 5B show various embodiments of the cage. Figures 4A and 5A show embodiments of the cage 10 in the manufacturing process. The cage 10 is a tubular body having multiple spaced splines on the pipe. In one embodiment, the pipe is preformed and then machined to obtain the shape shown. The pipe is made of metal or plastic. In another embodiment, the pipe is extruded to obtain the shape shown. For example, a plastic pipe having multiple spaced splines 24 along the length of the pipe can be manufactured by extrusion. Cross-sections of the cage 10 are shown in Figures 4B to 4D and 5A.

[0043] After forming the tube with the splines 24, the material portion of the tube is removed to form a slit and a strip. During part of the removal process, or before the slit formation process, the splines can be formed as spikes or wedge-shaped cutting instruments of different shapes. For example, by machining the splines 24 shown in Figure 4B, a wedge-shaped cutting instrument 26 can be formed as shown in Figures 4C and 4D. In this embodiment, the splines 24 can be manufactured by an additional process, or they can be formed as an initial wedge-shaped cutting instrument as shown without requiring additional machining.

[0044] Figure 4E is a magnified view of a portion of the cage. In this embodiment, the strip-shaped body 16 is It is formed having multiple spikes or wedge-shaped cutting instruments 26. In embodiments, slits can be formed in the tube to form a band-like structure that is close to each other, based on the unfinished cage in Figures 4A and 4B. The wedge-shaped cutting instruments 26 can be formed in a tent-like or axe-head shape with extended tips and base materials. These tips and base materials extend longitudinally along the length of the tube. The wedge-shaped cutting instruments 26 assist in cutting and / or perforating plaque before or during angioplasty. The spacing between the wedge-shaped cutting instruments 26 can be formed by machining or material removal, which can increase the flexibility of the band-like structure. The spacing between the wedge-shaped cutting instruments 26 is twice the length of the wedge-shaped cutting instruments 26, but other spacings can be set. Typical spacings are in the range of 4:1 to 3:1, and more commonly, in the range of 3:1 to 1:1.

[0045] In some embodiments, the splines 24 can be formed from a tube of material. In this case, the cage 10 is an extruded plastic tube having splines for forming wedge-shaped cutting instruments 26, which are cut, polished, electrostatically machined, or molded. The tube can have slits formed along its longitudinal direction. In some cases, the strips 16 are spaced apart, and some or all of the strips 16 have spikes or wedge-shaped cutting instruments 26. As can be seen from the above discussion, in the embodiments shown in Figures 4A to 5B, five slits are formed, forming points on the outer surface.

[0046] In one embodiment, a method for fabricating the cage 10 of an angioplasty balloon 20 includes the step of first extruding a plastic tube having a plurality of spaced-apart splines located along the length of the tube. In another embodiment, the method involves cutting at least one of the plurality of splines to form a plurality of spikes, or wedge-shaped cutting instruments 26, located around the tube. The method further includes cutting the tube to form a plurality of strip-like bodies 16 extending in the length direction. Each strip-like body has at least one spike of the plurality of wedge-shaped cutting instruments 26.

[0047] Figures 6A and 6B show other methods for manufacturing the cage 10. The wire 28 is divided or cut to form three or more strips. These strips can be used as part of the cage 10. In embodiments, the wire 28 is made of an alloy or polymer material. Various different manufacturing methods can be used, including laser cutting and electrostatic discharge machining. The wire 28 can be divided into, for example, four parts. In embodiments, rectangular or other shaped holes 30 can be formed in the wire 28, thereby creating space between the wedge-shaped cutting instruments 26. The four divided parts of the wire 28 form the strips 10 of the cage 10. The cage 10 can be assembled from multiple rings and may contain any number of strips 16. In some cases, the cage 10 can be assembled from 1 to 8 or more strips 16.

[0048] (Systems and methods for joining individual strips) The strips 16 can be fixed in numerous ways to constitute the cage 10. While the strips can be formed from wire, they can also be formed by extrusion, or from flat material bodies or tubes. For example, the embodiments described in relation to Figures 2 and 4A-5B can be modified to provide individual strips, which can then be joined to form the cage.

[0049] In one embodiment, the strip-shaped members can be joined together with two or more rings 12, 14 to form a cage 10. For example, each strip-shaped member constituting the cage 10 is joined to a ring at its end. As shown in Figure 7, each strip-shaped member 16 is fixed at its end with rings 12, 14. When constructing the cage 10, the strip-shaped members 16 can be joined to the rings 12, 14 first before being placed around the balloon, or the cage 10 can be placed around the balloon. The strips can also be assembled around the balloon. For example, the strips can be positioned on the surface of the balloon before joining them to the ring. The cage 10 can be permanently fixed to one or both ends of the balloon 20, or permanently fixed to the balloon catheter. In some embodiments, the rings 12 and 14 can fix the strips to a portion of the balloon or a portion of the balloon catheter. The strip 16 can keep the balloon 20 compressed before it is positioned, and can keep the balloon deflated after it has been inflated.

[0050] Rings 12 and 14 are typically circular bands, but may be of any shape, such as oval, square, elliptical, or rectangular. The rings can generate binding and / or restraining forces. Rings 12 and 14 can be composed of any number of different materials, including one or more metals, polymers, copolymers, elastic materials, thermoplastic elastic materials, adhesives, hydrogels, etc. The rings may be rigid or flexible.

[0051] In some cases, the rings 12 and 14 are made of a heat-shrinkable material or an elastic material that connects, captures, and restrains multiple strips. This prevents and suppresses the movement, displacement, tilting, or twisting of the strip 16 at any point along its length, particularly at the ends of the balloon 20. If the ring is elastic, superelastic, or thermally active, the ring can be positioned around the strip and contracted on the strip to restrain the strip relative to the outer diameter of the balloon 20. Preferably, the ring and strip are positioned around the balloon when the balloon is fully inflated, and heat is applied to the heat-shrinkable ring. In other embodiments, the heat-shrinkable ring is applied when the balloon is deflated.

[0052] As shown in Figures 1A and 1B, the cage is slid by acting on the balloon. However, in other embodiments, the cage can be assembled around the balloon to narrow the cage design. In the modification of balloon 20, inserting the ring onto the balloon catheter from one side of the balloon catheter allows for a smaller inner diameter of the ring compared to when the ring is positioned on the balloon.

[0053] The rings 12 and 14 of the cage 10 can be configured to accommodate the balloon 20 as it transitions from a deflated state to an inflated state. Similar to the cage configuration with the balloon 20 shown in Figure 1B, the strips 16 of the cage 10 are in contact with the balloon 20 when the balloon 20 is deflated. When the balloon 20 inflates, each strip bends into a concave shape (Figure 1A). In this embodiment, the strips 16 are not in contact with the surface of the balloon and are not bonded to it.

[0054] As the balloon 20 begins to deflate, the material properties of the strip 16 cause the balloon 20 to return to its original position. The original position may be completely flat. The strip 16, by returning to its original state, further assists the deflation of the balloon 20. When the strip moves from a concave state to a flat state, the length of the strip changes from the length during inflation ("Le") to the length during deflation ("Ld"). At this time, length Ld is longer than length Le. By straightening the strip 16 axially from length Le to length Ld, the balloon 20 can be extended and the balloon 20 can be deflated more completely.

[0055] The rings 12 and 14 have various shapes and sizes and can secure multiple strip-shaped objects. The following descriptions in relation to the illustrated embodiments are just a few examples.

[0056] Rings 12 and 14 are attached to the band 16 in numerous different ways. For example, the strip-shaped body 16 can be mechanically joined by frictional force, or it can be joined by ultrasonic welding, adhesive, or the like. In Figure 8, the rings 12 and 14 consist of two parts and are joined to the multiple strip-shaped bodies 16 of the cage 10 by rotating the rings in opposite directions (for example, clockwise and counterclockwise). The rings 12 and 14 have holes 32 through which the strip-shaped bodies 16 are inserted and joined to the rings. In particular, the asymmetrical holes 32 can be configured to accommodate strip-shaped bodies having periodically spaced wedge-shaped cutting instruments 26, as shown in Figure 6B.

[0057] As illustrated, the hole 32 may have a narrow section 33 and an expanding section 34. The expanding section 34 may be configured to accommodate the wedge-shaped cutting instrument 26, while the narrow section 33 may be configured to accommodate the width of the strip-shaped body 16 (i.e., the portion between the wedge-shaped cutting instruments 26). The strip-shaped body 16 can be inserted into the hole 32 by fitting the wedge-shaped cutting instrument 26 into the expanding section 34. The strip-shaped body 16 can be fixed in place by rotating the rings 12 and 14 so that the strip-shaped body 16 moves into the narrow section 33. This prevents the wedge-shaped cutting instrument 26 from moving through the narrow section 33, thus fixing the strip-shaped body 16 in place with the rings 12 and 14. As described above, the rings 12 and 14 may be located at one end of the cage 10. Furthermore, as shown in Figure 8, the holes 32 of ring 12 and ring 14 are opposite each other, so the movement of the strip-shaped body 16 is prevented by rotating these two rings in opposite directions.

[0058] The band-shaped body 16 can be fixed by rings 12 and 14 formed in various shapes. For example, Figure 9A shows an embodiment of a cage 10 in which the band-shaped body 16 is fixed at its distal edge by a conical ring 12. Since the end of the cone corresponds to the distal edge of a balloon catheter, a non-traumatic device end can be provided.

[0059] Similarly, Figure 9B shows a ring 12 having a tapered outer diameter with a screw-like characteristic portion on its outer surface. This screw-like characteristic portion may give a negative or positive impression to the outer surface of the end ring.

[0060] The ring 12 shown in Figure 9B can also serve a therapeutic role. The tapered and screw-shaped ring can assist in guiding and inserting the balloon 20 into the narrowed lesion. The coiled outer surface 101 can be configured to provide a gripping or drilling mechanism. This feature allows the operator to guide the balloon into the occluded lesion (whole or partial) by the ring, enabling the balloon 20 to pass through. The screw-shaped feature of the surface 101 can be formed around its outer surface or patterned like a corkscrew. In embodiments, the screw-shaped feature of the outer surface 101 can be macroscopic in size or microscopic in size to provide a surface that is enhanced to allow movement within narrow blood vessels. The feature of the outer surface 101 is inherently mechanical, but can also act as a lubricant. The lubricating function can be further enhanced by hydrophilic or hydrophobic coatings. The surface structure can be modified to allow movement with less energy. In some embodiments, such surface structures can be achieved by adding microscopic scales (such as those found on porcupine quills) or by adding surface roughness (such as that perceived by mosquitoes).

[0061] The ring 12 shown in Figure 9B can be fixed to a strip 16 that is spirally arranged on the surface of the balloon. Compared to the straight strip 16 shown in Figure 9A, the strip 16 joined to the tapered ring 12 can be wrapped around the balloon. At the proximal edge of the balloon, a tapered or non-tapered ring 14 can be used. The shape of the joined strip 16 will have the same pattern as the characteristic portion of the outer surface 101 of the ring 12.

[0062] In Figures 10 and 11, multilayer rings are discussed. Multilayer rings can be used to hold a strip between layers. The ring has at least a base layer 122 and an upper 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 upper layer 121. The upper layer 121 can be made of a compressible material, and the base layer 122 can be made of an incompressible material. The strip 16 is trapped between the base layer 122 and the upper layer 121. The upper layer or the upper layer and base layer can be made of a heat-shrinkable material. In embodiments, the rings 12,14 are formed from a material having a length such that it forms a ring.

[0063] The ring can be formed from a composite layer such that the base layer 122 is less compressible or elastic than the upper layer 121. When energy is applied to the upper layer 121, it shrinks its diameter until it compresses and captures the strip between itself and the base layer. For example, the upper layer 121 can be made of a heat-shrinkable material. In this way, the upper layer 121, the base layer 122, and the strip 16 can form a cage 10 as shown in Figures 10 and 11. In an embodiment, the strip can be joined to a balloon and / or balloon catheter by a ring. The ring, like the upper layer, can be formed from a single layer of heat-shrinkable material located on the strip.

[0064] The strips and rings may include serrations to facilitate joining them together. The strip 16 may include a serration 171 on one of its faces (see Figure 10), or a serration 171 that forms a groove (see Figure 11). In Figure 11, the upper layer 121 is shown as a heat-shrinkable material, but a rigid ring can also be fitted into the serration 171. Such a rigid ring may be part of a single or multi-layered ring, and the base layer 122 may or may not be present.

[0065] Figure 12 shows another embodiment of the rings 12 and 14. Here, the rings 12 and 14 have a plurality of serrated portions, or grooves 17. The grooves 17 have a width such that the strip-shaped body 16 can be accommodated in the width direction at its distal edge. The ends of the strip-shaped body can be joined to the rings 12 and 14 within the grooves 17 by means of adhesive, mechanical bonding, or packaging with heat-shrinkable material around the ring. In this embodiment, the strip-shaped body 16 of Figure 11 is placed inside the rings 12 and 14 of Figure 12, and the serrated portions engage with each other.

[0066] Figures 13A-13C show an example of a strip 16 that includes a fixing portion 181 to improve the retention of the strip 16 on the rings 12 and 14. The fixing portion 181 constitutes a part of the strip 16 having a large surface roughness. The fixing portion 181 is a ridge-shaped, or sawtooth-shaped, element that fits the strip 16 into the ring, i.e., holds the strip on the ring.

[0067] When the rings 12 and 14 are made of polymer material, the fixing portion 181 can be formed in a narrow region at the end of the strip-shaped body 16 (see Figures 13A and 13B), and can also be arranged along the length of the strip-shaped body (when three or more rings are used). As shown in Figure 13A, the fixing portion 181 is pressed into the polymer material at a temperature near or above the glass transition temperature of the polymer material. As a result, the fixing portion 181 can be used to engage, or join, the strip-shaped body 16 with the rings 12 and 14, as shown in Figure 13C.

[0068] In Figure 13A, the rings 12 and 14 are shown incorporating the fixing portion 181 into their bodies. Figure 13A shows a strip-shaped body 16 having a rigid fixing portion 181. Figure 13B shows another embodiment of the fixing portion 181. The fixing portion 181 is formed to be longer than the width of the rings 12 and 14 and is designed to provide tension on the cage 10. It is being done.

[0069] When the rings 12 and 14 are constructed from elastic materials such as rubber or polymers, metal alloys, or spring-like designs, the rings 12 and 14 can be used to supply tension to the cage 10, thereby returning the cage 10 to a relaxed state, i.e., the balloon's deflated state. Furthermore, the portion of the band 16 that does not have the wedge-shaped cutting instrument 26 is made as thin and flexible as possible. This allows the band 16 to be highly flexible at the end of the balloon 20 where the force is most applied.

[0070] Figures 13D to 13F illustrate an example in which the elastic material constituting the ring supplies tension to the cage during balloon inflation and facilitates balloon deflation when the tension is released. In Figure 13D, the cage 10 is positioned close to the balloon 20. The cage 10 consists of multiple strip-shaped bodies 16 fixed to the balloon by rings 12 and 14. The rings 12 and 14 can be formed from an elastic material that allows the wedge-shaped cutting instrument 26 to pull the strip-shaped bodies 16 straight down so that they are perpendicular to the surface of the balloon 20. "A" is a schematic perspective view showing the proximal end of the ring 14. As shown in the figure, the ring 14 is fixed to the external catheter shaft 22 by adhesive 23. An internal guidewire shaft 21 is provided coaxially with respect to 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 connected 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 into the catheter shaft. In an embodiment, the catheter shaft 22 opens directly into the balloon 20 rather than opening within the ring 14 as shown. The ring can be connected to the catheter shaft 22 and / or the balloon 20.

[0071] Figures 13E and 13F show the balloon 20 and cage 10 as the balloon 20 inflates and then deflates. As described above, when the balloon 20 inflates, the elastic material constituting the rings 12 and 14 stretches, causing the cage 10 to expand. In the embodiments shown in Figures 13E and 13F, the rings are made of an elastic polymer material, and the strips 16 can be made of a metal or an inelastic polymer material. As shown in Figure 13E, when the balloon 20 inflates, the strips 16 of the cage 10 begin to move apart. When the balloon 20 inflates, radial and outward forces (as indicated by the arrows) act on the balloon 20, i.e., on the cage 10 due to stretching, to push each strip 16 outward. When the balloon 20 inflates, the rings 12 and 14 are under tension, and the strips 16 stretch as they expand together with the balloon 20, maintaining their alignment.

[0072] The tension facilitates the deflation of the balloon 20. As shown in Figure 13F, as the balloon deflates, the tension acting on the band 16 generates a radial and inward force, causing the band 16 and rings 12 and 14 to return to an unbound state. This force pulls the band 16 flat, providing a narrow profile for retracting the catheter.

[0073] Figures 14A to 14D show embodiments of the strip 16 with various forms of rings. As shown in Figures 14A and 14B, the ring can be formed from the edge on the neck of the balloon 20, and a portion of the catheter can be used to connect the catheter to the balloon 20. The catheter can provide a passage for the gas or liquid expanded within the balloon 20. Additional elements such as overmolding or heat shrinkage can be applied to the connection, as well as adhesives and polymer materials. This prevents pressure from leaking from the balloon 20 along the length of the strip 16 that constitutes the cage 10.

[0074] As shown in Figures 14A to 14D, the hooks 161 at the ends of the strip allow the strip to be easily aligned along the surface of the balloon and oriented in the longitudinal direction of the balloon 20's axis. The hooks 161 can be integrated with each end of the strip 16. The hooks 161 can be formed to cover the periphery of the neck of the balloon 20, extending from the outer diameter portion ("OD") toward the opening and the interior of the neck. The ends of the hooks 161 are located within the inner diameter portion ("ID") of the neck of the balloon 20.

[0075] The strip-shaped body 16 may have hooks 161 at both ends, or it may have a hook at one end. The end can be joined to the balloon catheter in a similar or different manner. For example, heat-shrinkable material may be provided to cover the ends of the strip-shaped body and the balloon. In embodiments, the heat-shrinkable material may be provided to cover the periphery of one end of the strip-shaped body and the balloon, or a rigid ring may be used at the other end of the strip-shaped body and the balloon, which may have a heat-shrinkable layer, as described with respect to Figures 8 to 12.

[0076] The strip may or may not be joined to the balloon at other parts of the balloon. As shown in the figure, the strip 16 may have a hinge or a pre-bent region that matches the shape of the balloon. Therefore, the inflated strip may have a main part having a wedge-shaped cutting instrument 26 parallel to the axis of the balloon. In this case, an inclined portion extends from the main part toward the hook 161. The inclined portion has a predetermined angle when the balloon is inflated, but becomes flat when the balloon is deflated. In the embodiment, the hinge located between the inclined portions will be made of a thinner portion of the material constituting the strip.

[0077] As shown in Figure 14A, the strip can be joined to the balloon by the hook 161 without using a separate ring. The balloon can be attached to a catheter (e.g., an extended tube having one or more lumens) fixed to the hook in place. Although Figure 14A shows one strip for simplicity, two to five or more strips can be used.

[0078] Figure 14C shows details of the hook 161 attached to the balloon 20. As can be seen from the figure, the balloon functions as the base layer 122 of the ring, with the upper layer 121 shown. Adhesive 123 is shown to secure the upper layer 121 to the balloon. In an embodiment, the upper layer 121 can be the tube of a catheter.

[0079] Figure 14D shows a ring consisting of two layers 121 and 122. A two-layer ring can include two layers made of heat-shrinkable material. As described in Figures 10 and 11, the ring shown in Figure 14D is a multilayer ring in which the base layer 122 is less compressible or flexible than the upper layer 121, and when energy is applied to the upper layer, the upper layer is compressed, shrinking its diameter until it traps the strip between the base layer 122 and the upper layer 121, forming a cage 10.

[0080] Figure 14E shows another embodiment of the rings 12,14 that secure the band 16 on the surface of the balloon 20. “A” indicates the portion where the rings 12,14 are secured to the balloon 20 so that the wedge-shaped cutting instrument 26 protrudes from the surface of the rings 12,14. The central portion of the rings 12,14 is cut out to show the lower band 16. The wedge-shaped cutting instrument 26 can be made to protrude from the rings 12,14 in various ways. For example, when the rings 12,14 are secured to the band 16, they can be made to protrude by cutting out the material constituting the rings 12,14. In this case, a hole 27 is formed. The rings 12,14 may have a number of pre-cut holes 27, thereby allowing the wedge-shaped cutting instrument to extend. The rings 12,14 match the inclination of the balloon 20. It can be formed in such a way. For example, by forming a cut 29 in the material that makes up the ring, the ring made of heat-shrinkable material can be made to shrink along the shape of the balloon.

[0081] The rings 12 and 14 can be formed to fit the tapered portion of the balloon 20. For example, the cuts 29 in the ring allow the ring, made of heat-shrinkable material, to shrink along the shape of the balloon.

[0082] As described above, each band 16 can extend between one or more rings, but other rings can be used as needed. For example, especially in the case of long balloons, 3 to 10 or more rings can be used. 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 rings 12, 14, the cage 10 may have a ring 13 or other similar control element, which can maintain the arrangement and orientation of the bands 16 when the balloon 20 inflates toward the arterial wall.

[0083] As shown in Figure 15A, the ring 13 can be part of the overall length of the balloon 20. The design of the ring 13 should be no more than 1.5 times the length of the balloon 20. The ring 13 is 1.0 to 0.5 times the length of the balloon 20. More generally, the length of the ring 13 is 2.5 to 1.5 times the diameter of the balloon 20, and typically 1.5 to 0.5 times. Each ring 12, 13, and 14 can be made of a different material to provide one or more advantages and functions of these rings.

[0084] The ring 13 can be positioned on the outer surface of the balloon body 20. The ring 13 can be designed to hold the body of the strip 16 so as to maintain the position and orientation of the strip 16. As is clear from the figure, the strip 16 does not extend along the shoulder of the balloon. Therefore, the strip can extend parallel to the axis of the balloon. Figure 15A shows only one strip 16 for simplicity, but two to five or more strips can also be used.

[0085] Ring 13 can be positioned over the entire surface of the inflated balloon 20 and may have different properties from rings 12 and 14 positioned at one end of the balloon 20. As shown in Figure 15A, ring 13 positioned over the entire surface of the balloon 20 can be more elastic than rings positioned at the ends of the balloon 20. This allows the ring to accommodate both the inflated and deflated balloon 20. The rings used on the outer diameter of the balloon 20 are positioned at the two ends of each separate strip. The strip 16 may be joined to the rings described above by adhesive, welding, friction, or other methods.

[0086] Rows and / or segments of strips can be arranged around the balloon 20. The rows of strips may or may not extend along the entire length of the balloon 20. The rows of strips may include multiple strips arranged in series, separated by gaps. Arranging strips in series on the balloon can provide greater flexibility and improve transportability through winding anatomy.

[0087] As described above, rings 12, 13, and 14 can be used to hold the strip on the surface of the balloon 20. The rings can be joined to the strip in a number of different ways, as described in this specification. In embodiments, the end of the strip without a wedge-shaped cutting instrument can be joined to the ring, or the end of the strip with a wedge-shaped cutting instrument can be joined to the ring.

[0088] Figure 15B shows another embodiment of a balloon catheter. A balloon 20 is disclosed comprising a cage 10 having strips arranged in four equally spaced rows. Each row has two strips arranged in series. Rings 13 are joined to adjacent strips 16 and span the surface of the balloon 20, properly fixing and oriented the strips 16. Rings 12 and 14 hold down the ends of the strips.

[0089] "A" is a magnified view of the distal edge of the balloon 20 with the cage 10. The hatching in "A" is for visualizing and depicting different parts of the device. As shown in the figure, the end of the balloon 20 has a ring 12 for securing a plurality of strips 16 to the surface of the balloon 20. The balloon 20 is positioned near the catheter 19. The ring 12 can be made of heat-shrinkable material. A wedge-shaped cutting instrument extends through the ring. The arrangement of the strips is further clarified in Figure 15C. Figure 15C shows how a pair of strips 16 are arranged in series, indicating that the strips 16 extend across the entire balloon 20.

[0090] To improve flexibility, the cage 10 may also have rows of more strips 16 than shown in Figures 15B and 15C. Figures 15D to 15E show an example in which five strips are arranged in series on the surface of the balloon 20. As previously mentioned, the strips 16 can be fixed to the surface of the balloon 20 by multiple rings 13. "A" is a notch in the ring 13 to show the gap between two strips arranged in series. As described in relation to Figure 14E, the wedge-shaped cutting instrument can penetrate and protrude through the ring 13 in various ways. For example, the shape of the wedge-shaped cutting instrument can be such that it penetrates the material of the ring 13. Alternatively, the ring 13 can have multiple holes through which the wedge-shaped cutting instrument penetrates.

[0091] In addition to having multiple strip-like bodies arranged in rows, flexibility can be adjusted by adjusting the gaps between the strip-like bodies constituting the rows. Relatively large tolerances are required in the manufacturing process and tool selection to facilitate the setting of linear arrangement (angle misalignment) in the theta direction and space arrangement (gaps) between the strip-like bodies 16. The tolerance for the gap is ±5 mm and the angle misalignment is ±25°. Alternatively, the tolerance for the gap is ±3 mm and the angle misalignment is ±10°. Alternatively, the tolerance for the gap is ±2 mm and the angle misalignment is ±5°. For cage designs with larger curves, the strip-like bodies can be arranged in a linearly continuous periodic arrangement spaced at predetermined intervals. This allows the balloon to control its bendability and provide anatomical space with less stress, enabling effective pushability in the overall system.

[0092] The strip-shaped body 16 shown here has a flat bottom surface. This makes it easier to position the strip-shaped body 16 on the surface of the balloon and maintain the orientation of the wedge-shaped cutting instrument. It also prevents the strip-shaped body 16 from rotating on the surface of the balloon 20.

[0093] Such a band-like and ring-like configuration provides three distinctive effects. First, it ensures the wedge-shaped cutting instrument is perpendicular to the balloon surface. Second, it ensures the band's flatness and inconspicuous height on the balloon, thereby preventing contact with damaged tissue when the wedge-shaped cutting instrument is moved. Third, it assists in balloon deflation or reduces the load on balloon deflation. To achieve these features, the band typically has a flat base and is connected to the balloon at one end by a ring. The band is also folded to limit contact between the wedge-shaped cutting instrument and tissue, and when the ring is formed to cover the wedge-shaped cutting instrument, the instrument penetrates the ring. The majority of wedge-shaped cutting instruments have a height that allows them to penetrate the blood vessel wall. The ring is The design can generate a force that deflates the balloon by pulling the ends of the band or by applying pressure radially, but the ring can be designed to support the band by restricting its movement, promoting the orientation of the wedge-cutting instrument and preventing the band from separating 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-cutting instrument and having a band that is thin enough to be in contact with the balloon, i.e., thin enough to be contained within the folded balloon. Providing space between the wedge-cutting instruments allows the ring to be positioned in that space. The portion of the band without the wedge-cutting instrument is the thinnest. This portion can be enlarged to connect the ring to the band. The band can be most flexible at the ends of the balloon. This is where the greatest force is exerted as the catheter moves. Other benefits and advantages can also be provided.

[0094] Rings 12, 13, and 14 can be joined to the strip in various ways. Figures 16A to 16C show examples of rings 12, 13, and 14 fixed to the strip 16. Figure 16A shows a balloon wrapped in material, with one or more rings fixed to the wrapping material. In Figure 16B, rings 12, 13, and 14 wrap a portion of each strip. This allows the strip to be fixed in the same way as shown in Figure 10. In Figure 10, each ring has an upper layer and a base layer, which wrap a portion of the strip 16. In Figure 16C, rigid rings 12, 13, and 14 are joined to a portion of the balloon. A portion of the strip can also be fixed to the rings.

[0095] Rings 12, 13, and 14 can be constructed in part or in whole from a heat-shrinkable material. The heat-shrinkable material can be formed as an extruded tube that is cross-linked by energy irradiation. This tube is stretched or formed to a desired thickness. The tube can be stretched to have a flexible and microscopically thin wall, a rigid tube with a thick wall, or something in between. The diameter is determined by the cross-linking, and the shrinkage ratio is 2:1 to 10:1. Heat shrinkage typically occurs in the radial direction, but may also occur in the longitudinal direction.

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

[0097] The tubular heat-shrinkable material can be slid along the strip-shaped body 16. The shrinkage ratio of such a tubular material is set to 3:1 or higher (for example, 3.5:1, 4:1, 4.5:1, 5:1, 6:1, etc.). This allows for slow heat shrinkage while preventing deformation of the balloon and other changes in its properties. Such a material has sufficient flexibility to conform to the shape of the balloon within the balloon's diameter range (for example, as is typical for semi-adaptive balloons of about 0.5 mm). The heat-shrinkable material may have an adhesive or other coating to bond the heat-shrinkable material to the balloon. The heat-shrinkable material can be a thin film. Alternatively, instead of a tubular material, the heat-shrinkable material may be in the form of a sheet or a multilayer sheet.

[0098] A method for using a balloon catheter with a cage includes the step of arranging a band around the inflated balloon. The band may have a wedge-shaped cutting instrument. The band is around the balloon The strips can be arranged at equal intervals around the balloon. The strips can initially extend in the longitudinal direction and can be arranged continuously in rows of, for example, 2 to 6 columns. Each column has 2 to 6 strips. The strips can be permanently or temporarily bonded to the balloon with adhesive. The heat-shrinkable material can be arranged as rings around the ends of the strips. Rings made of the heat-shrinkable material can be bonded to or cover the ends of the multi-layered strips arranged around the balloon. Rings made of the heat-shrinkable material can be bonded to or cover the ends of adjacent strips arranged in a continuous row. When heat is applied, the heat-shrinkable material shrinks. The balloon can be shrunk and sterilized as preparation before use.

[0099] Figure 17 shows details of the cage 10. In this embodiment, the band 16 has a section 34 consisting of a spring zone. The spring region of the band provides several benefits. For example, the spring region 34 can increase the flexibility of the cage 10. Increased flexibility of the cage 10 allows it to pass more easily through winding blood vessels. The spring region 34 also functions as a base for a wedge-shaped cutting instrument, allowing the wedge-shaped cutting instrument to remain oriented in the desired direction.

[0100] In embodiments, the spring region 34 can interact with the surface of the balloon 20, which can help position the wedge-shaped cutting instrument 26 so that it protrudes outward. It can also prevent the wedge-shaped cutting instrument from bending or changing position undesirably. In embodiments, the spring region 34 can provide the benefit of assisting in refolding the balloon after inflation. The spring can apply mechanical tension to the balloon 20, compressing it and assisting the ring in compressing the balloon 20 during the compression cycle.

[0101] The spring region 34 has a wavy shape and is coupled to the linear region 36. The wedge-shaped incision instrument can be located in the linear region. In other embodiments, the spring region can also have a sinusoidal shape. As shown in Figure 18, the spring region has a larger amplitude at the proximal edge compared to the distal edge. The period can increase along the spring region toward the linear region at the distal edge, while the amplitude can decrease. In embodiments, one end of the spring region can have a larger amplitude than the other end. In embodiments, the spring region can be symmetrical.

[0102] Figure 18 shows various embodiments of the cage 10 utilizing the spring region 34 and the linear region 36. Any number of different patterns can be used. Figure 19 shows details of the wedge-shaped cutting instrument on the linear region 36.

[0103] In the systems and methods disclosed herein, cages and wedge-shaped cutting instruments can be placed within body cavities, including the lumens of blood vessels such as arteries and veins. Arteries include, for example, coronary arteries, peripheral vessels, carotid arteries, and cerebral arteries. They also include, for example, the ilium, femur, superficial ilium, and other peripheral vascular structures. The system can be used within lumens or transport tubes of the respiratory, digestive, ureteral, reproductive, lymphatic, auditory, visual, and endocrine systems. The devices for forming serrations in one or more systems may take slightly different forms. The system can be used regardless of the location of use, and the system may include a spike (here including a wedge-shaped cutting instrument, spline-like serration elements, and an inflation mechanism), which can be attached to a catheter-like device (like a balloon) to increase or decrease the diameter of the spike's characteristic part.

[0104] Figure 20 is a magnified and detailed view of the wedge-shaped cutting instrument 200 on the band-shaped body 300. The cutting instrument 200 has a band-shaped opposing base surface 202 (referred to here as the interface surface). The base surface 202 of the wedge-shaped cutting instrument 200 can be defined as a base surface that is directly continuous with the surface of the band at the interface between the wedge-shaped cutting instrument and the balloon, where the wedge-shaped cutting instrument 200 protrudes outward. The band can be a spline 300 or other band structure. In the embodiment, the base surface 202 is made of a rigid material that can hold the sharp-angled end and is relatively narrow in width. In embodiments, preferred materials are martensitic stainless steel with a Rockwell C-scale hardness of 52 to 64, but can be manufactured from polymers or copolymers such as 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), or combinations thereof. The polymers or copolymers are not limited to the above materials. The width of the strip can be 0.008 inches or less, 0.010 inches or less, or 0.012 inches or less. In some cases, the width can be between 0.006 and 0.020 inches, or between 0.004 and 0.030 inches. The strip-shaped body 300 is positioned along the length of the balloon, but can also be positioned so as to rise from the longitudinal axis of the balloon at a 90° angle, or even in a spiral pattern at different pitches. In some embodiments, the height of the strip-shaped body 300 can be between 0.004 and 0.010 inches, and even between 0.002 and 0.020 inches.

[0105] In Figure 20, the wedge-shaped incision instrument 200 may have radially outward-facing surfaces 204 (referred to here as non-boundary surfaces). These surfaces may define the upper surface of the wedge-shaped incision instrument 200 from a first end 206 (e.g., proximal edge) to a second end 208 (e.g., distal edge) and be configured to contact body tissue, plaque, or other structural parts. Furthermore, a front surface 210, a rear surface 212, and opposing side surfaces 214, 216 are shown. In embodiments, the side surfaces 214, 216 extend perpendicularly upward along the longitudinal axis of the band, and surface 204 extends between side surfaces 214 and 216 in a manner such as a straight line, a curve, or as otherwise described, at a predetermined angle with respect to the side or side axis. The band, or spline 300, has non-boundary surfaces 302. The non-interface 302, like the side (e.g., 304) and bottom surface 303 of the wedge-shaped cutting instrument 200, can have the same width as the band-shaped opposing surface, i.e., the interface 202.

[0106] Figure 21 is a schematic diagram of an unlimited embodiment of a wedge-shaped cutting instrument. In the embodiment, the length LU of the radially outward-facing surface (e.g., the radially outward-facing surface 204 between the first end 206 and the second end 208) is about 30%, about 20%, or about 10% shorter than the total length LB of the band-shaped opposing surface (the band-shaped opposing surface 202 in Figure 20). In the embodiment, the length LU can be about 50% to about 20% of the length LB, and in some cases, it can be about the same as the length LB. The width WU of the radially outward-facing surface is equal to or less than the width WB of the band-shaped opposing surface. Typically, it can be 10%, 20%, 30%, 40%, 50% or less of the width WB, or between 20% and 50%. In some cases, it can also be increased to 50%, 60%, 70%, 75%, or 80% of the width WB. Therefore, at both ends of surface 202, an angle θ of 90° or less is formed that defines a gradient from the width WB of surface 202 toward the width WU of surface 204. In an embodiment, the width WU of surface 204 can be constant at both ends, or it can be varied along the length LU of surface 204, for example, decreasing from the first side toward a point or portion between the first and second sides, or increasing from a point or portion between the proximal and distal edges toward the distal edge. In an embodiment, the portion located relatively in the center between the proximal and distal edges can have a constant width, and the portion located laterally surrounding the central portion can have a tapered width.

[0107] The width WU of surface 204 is pointed and narrows, but the slope from the width WB of surface 202 to the width WU of surface 204 is inclined at a constant angle θ, as shown in Figure 22A (end face resembling an isosceles triangle) and Figure 22B (isometric view), but may be inclined at double, triple, or more different angles (for example, a first angle of the first part, a second angle of the second part that is smaller or larger than the first angle, and in some cases a third angle of the third part that is smaller or larger than the first angle and smaller or larger than the second angle). Figure 22C is an end view of the wedge-shaped cutting instrument, and Figure 22D is an isometric view of the wedge-shaped cutting instrument. The wedge-shaped cutting instrument has multiple different slopes from the base surface 202 toward surface 204. Here, the angle θ2 between the horizontal plane above and the sloped surface is greater than the angle θ1 between the base plane and the sloped surface intersecting it (in other words, the first slope S1 from the base plane is not steeper than the second slope above it). Figures 22E and 22F are similar to Figures 22C and 22D, except that angle θ2 is smaller than angle θ1 (in other words, the first slope S1 from the base plane is steeper than the second slope above it).

[0108] Furthermore, it is possible to have stepped sections at different heights. In this case, the width narrows with increasing height. When there are multiple stepped sections, the manufacturing method is limited when using the method of sharpening stainless steel reels.

[0109] The height of a radially outward-facing surface (for example, surface 204 in Figure 20) can be the same as the length or width from side 206 to side 208. In an embodiment, the height of surface 204 can be varied from the first end 206 to the second end 208. When surface 204 is varied, it becomes a feature with upright sections, such as a wedge-shaped cutting instrument, spike, or sawtooth. The midpoint of the upright feature along the length of surface 204 between the first end 206 and the second end 208 is the highest point of surface 204, but the highest point may be offset from the midpoint, or there may be multiple highest points. The maximum change in height between the first end 206 and the second end 208 of the surface 204 of the wedge-shaped cutting instrument 200 and the non-boundary surface 302 of the band-shaped body 300 can be less than approximately 80%, less than approximately 70%, less than approximately 60%, less than approximately 50%, less than approximately 40%, less than approximately 30%, less than approximately 20%, and less than approximately 10% of the total height of the wedge-shaped cutting instrument 200.

[0110] In embodiments, the strip-shaped body 300 has a rough or fibrous back surface, which can promote adhesion with the outer surface of the balloon located below. The strip-shaped body can be any desired shape, such as a square, rectangular, or trapezoidal shape, where the width of the bottom surface is approximately or at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the width of the top surface. In embodiments, 1 / 3 to 1 / 2 of the top surface of the strip-shaped body 300 can be covered by the wedge-shaped cutting instrument, and 2 / 3 to 1 / 2 can not be covered by the wedge-shaped cutting instrument.

[0111] In Figure 21, when surface 204 is viewed from above, it can be a straight line extending from one end to the other (for example, the width WU of surface 204 is a point). This is equivalent to a grinding wheel with no clear width, i.e., a “razor-sharp” end face. In embodiments, the view from above may appear as a slightly blurred, non-sharp rectangular surface (for example, 210B or 210C is the top surface, and it cuts away an object on that surface). In this case, the width WU of surface 204 is smaller than the width WB of the opposing surface of the strip, and it directly correlates with the slope from the opposing surface 302 to surface 204. In embodiments, the top surface, i.e., surface 204, can be a straight line, a flat rectangle, a curved surface, or a raised surface (rectangular or quadrilateral in two dimensions). Alternatively, it can be pyramidal, wedge-shaped, trapezoidal, or other polygonal shape.

[0112] In embodiments, for non-sharp surfaces, the width 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. Having a non-sharp surface of the wedge-shaped cutting instrument has the advantage of being able to form, for example, serrations, serrations, or micro-perforations without cutting the entire lumen wall. In embodiments, the surface of the wedge-shaped cutting instrument has a non-sharp width.

[0113] The shape of the wedge-shaped cutting instrument is not limited to those shown in Figures 21A-G, and can take many forms. For example, Figure 21A shows a wedge-shaped cutting instrument erected from a strip-shaped body 300 having a sharp surface 204 extending from end 206 to end 208. Figures 21B and 21C show a wedge-shaped cutting instrument having chamfered portions 780 at both ends of the surface 204, which are inclined toward a sharp midpoint 782, or have ends of length 781. The inclination can be linear or curved, as shown in Figure 21D. As shown in Figure 21B, the wedge-shaped cutting instrument has a portion 780 formed on the side of a surface 204 of minimal / negligible width, which is in the height direction and decreases in width from the first side toward the midpoint 781. This portion 780 then increases in width and decreases in width from the midpoint 781 toward the second side. Figure 21C is similar to the figure shown in Figure 21B, except that the midpoint is a single sharp vertex.

[0114] Figure 21D shows a wedge-shaped cutting instrument having an adducted surface 785 facing radially outward. The height of this surface increases from the end along the first curved surface length, and the width decreases from the first end toward an intermediate region such as the center point 786. Subsequently, along the second curved surface length, the height decreases toward the second end, and the width increases.

[0115] Figures 21E to 21G show examples of wedge-shaped cutting instruments having a non-sharp surface 204 that does not include sharp points or ends (for example, having a width greater than the width of a sharp end). Figure 21E shows a wedge-shaped cutting instrument similar to Figure 21B, except that the surface 204 is completely non-sharp along its length. Figure 21F shows a wedge-shaped cutting instrument similar to Figure 21C, except that the surface 204 is completely non-sharp along its length. Figure 21G shows a wedge-shaped cutting instrument similar to Figure 21D, except that the surface 204 is completely non-sharp along its length.

[0116] A common feature of Figures 21B to 21G is that the width of surface 204 is wider on the sides and narrower or smaller at the midpoint or center. The height of surface 204 is curved or varies from one end to the other, for example, being highest in the center and lowest at the ends when viewed from the side. The narrowest or thinnest part (minimum width) of surface 204 can be located along the longitudinal axis of the strip-like body, or not along the longitudinal axis of the balloon.

[0117] The narrow point or narrow portion does not need to be symmetrical with respect to the midpoint of the plane 204 in the longitudinal direction; it can be asymmetrical with respect to that midpoint.

[0118] Independent of the wedge-shaped cutting instrument, several embodiments are characterized by having a predetermined length and width, a boundary surface 202 having a face 204, an end face or tip, i.e., a strip (e.g., a strip to which a spike is attached, a spline, a balloon, a mold element). The width of the boundary surface 202 can be in the range of 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 any two of these numbers. Wedge-shaped cutting instrument The width of the interface 202 can be fixed, constant, or variable.

[0119] The wedge-shaped incision instrument can be of different sizes and shapes. In one embodiment, the wedge-shaped incision instrument 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 in length at the band portion, or a range of any two of these values, i.e., from 0.01 inches to 0.06 inches, or from 0.01 inches to 0.04 inches. In this embodiment, the wedge-shaped incision instrument can have a height measured from the interface 202 with respect to the band-shaped body of approximately 0.05 inches or less, approximately 0.04 inches or less, approximately 0.03 inches or less, approximately 0.025 inches or less, approximately 0.02 inches or less, approximately 0.015 inches or less, approximately 0.01 inches or less, approximately 0.005 inches or less, or between approximately 0.005 inches and approximately 0.025 inches, between approximately 0.01 inches and approximately 0.025 inches, or between approximately 0.005 inches and approximately 0.015 inches.

[0120] In embodiments, the base surface of the wedge-shaped cutting instrument can be approximately 25 mm or less, approximately 20 mm or less, approximately 15 mm or less, approximately 14 mm or less, approximately 13 mm or less, approximately 12 mm or less, approximately 11 mm or less, approximately 10 mm or less, approximately 9 mm or less, approximately 8 mm or less, approximately 7 mm or less, approximately 6 mm or less, approximately 5 mm or less, approximately 4 mm or less, approximately 3 mm or less, approximately 2 mm or less, approximately 1 mm or less, or any two or more of these values. In embodiments, the base surface of the wedge-shaped cutting instrument can be 2 mm, 2.5 mm, 3 mm, approximately 1 mm to approximately 5 mm, or approximately 1.5 mm to approximately 3.5 mm in length. The wedge-shaped cutting instruments can be arranged separately regularly or irregularly to increase the flexibility of the device. For example, when the wedge-shaped cutting instruments are arranged in the longitudinal direction, the spacing between adjacent wedge-shaped cutting instruments can be 2 to 10 times the base length. In embodiments, a wedge-shaped cutting instrument having a base length of approximately 2.5 mm may have a spacing of 5 mm or 25 mm. In embodiments, the wedge-shaped cutting instrument may initially have a first spacing ratio of approximately 1-4 times the base length, and later a second spacing ratio of approximately 8-10 times the base length. For example, a first group of wedge-shaped cutting instruments with a base length of 2.5 mm may have a spacing of 5 mm, and then a spacing of 20 mm. A second group may have the same size, shape, and spacing as the first group, or it may have different spacing.

[0121] The position of surface 204 relative to the base surface (boundary surface 202) does not necessarily have to be centered or symmetrical. In other words, the midpoint of surface 204 may be offset from the midpoint of the base surface. Figures 23A-B and 24 show another example of a spike where surface 204 is asymmetrical. The asymmetric surface 204 has its center offset across the entire base surface. In this embodiment, only one end of the base surface has a height-inclined end 440, and as shown in Figure 23A, the other end 442 is perpendicular to the base surface 444 at a 90° angle RA. Furthermore, 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. Radially outward-facing surfaces can be limited to areas projecting upward from the base surface. These surfaces may be sharp lines (grinding wheel-like) or, as already mentioned, non-sharp. Figures 23C and 23D show cases where the entire volume or substantially the entire volume of the wedge-shaped cutting instrument is located in the width direction of the band. The proportion of this volume can be approximately 70% or less, approximately 60% or less, approximately 50% or less, approximately 40% or less, and approximately 30% or less of the width or surface area of ​​the band, resulting in the wedge-shaped cutting instrument being positioned either anteriorly or posteriorly to the band.

[0122] Figure 24 shows an embodiment in which the radially outward-facing surface 204 has different heights from the base surface 202 (increasing from the height 24H1 of the first end 206 to the height 24H2 of the second end 208). In this embodiment, the end profile is such that the ends 206 and 2 At point 08, it is rounded with a predetermined radius of curvature. Here, the radius of curvature is large at the end 206 where the height 24H1 is smaller when measured from the base surface 202, and the radius of curvature is small at the end 208 where the height 24H2 is larger when measured from the base surface 202.

[0123] In embodiments where the radially outward-facing surface 204 is located outside the transport device and / or can come into contact with the vascular wall and may rub against and damage the vascular wall as it moves through the artery, the wedge-shaped cutting instrument described herein offers unique advantages that facilitate the transport of the device, including reducing vascular trauma. This can be achieved with a wedge-shaped cutting instrument having a non-sharp surface 204.

[0124] Furthermore, although not theoretically limited, certain shapes can penetrate tissue more effectively. For example, chamfered or rounded radially outward-facing ends can enter blood vessels with less force (requiring less pressure to penetrate tissue). On the other hand, they maintain effective microchannels, weakening the tissue and allowing for vascular expansion with minimal vascular and cellular damage.

[0125] Furthermore, in connection with balloon inflation, there have been previous proposals to form blades, sharp ends, or cut-forming wires on the balloon during angioplasty or other procedures such as cutting or cutting plaque. However, these previous proposals still have problems and disadvantages that are not addressed by the systems and methods disclosed herein. Cutting or cutting plaque or other parts of the lumen wall during angioplasty must be done under high pressure, and such high-pressure work can result in significant damage to the blood vessel. Cutting blades, edges, and cut-forming wires are introduced into the blood vessel wall simultaneously with the inflation of the angioplasty balloon, causing the plaque to expand. During this process, the cutting blades, edges, and cut-forming wires are introduced into the blood vessel wall at an oblique angle to damage and cut the plaque. On the other hand, the wedge-shaped cutting instrument is inflated at low pressure within the plaque to form precise microchannels, serrations, or serrations radially outward, creating precise serrations, cleavage lines, or cleavage surfaces in the plaque on the vessel wall or other areas. The radially outward-facing surface of the wedge-shaped cutting instrument penetrates the plaque or other luminal surfaces in the narrowed area, cutting the plaque or luminal surface.

[0126] The wedge-shaped incision instrument is designed to penetrate (if any, incompletely) a series of serrations into the diseased portion of a blood vessel. The wedge-shaped incision instrument more effectively and gently expands the vascular lumen to form a perforation. The perforation becomes a channel for the drug. The drug can be delivered by using a drug-coated balloon, which is incorporated with or used in conjunction with the disclosed device. In embodiments, the wedge-shaped incision instrument may be detachable from the band and may be coated with or injected with one or more drugs for drug delivery.

[0127] To reduce the rigidity of the spline, i.e., the strip-shaped body, a series of reliefs can be added to the spline, as shown in Figures 25 and 26. The reliefs can be formed in various different ways, such as by removing a portion of the material, and can provide a wedge-shaped cutting instrument with a more flexible strip-shaped body. The reliefs can be formed on the spline on the base surface of the wedge-shaped cutting instrument, i.e., the surface opposite to the surface where the wedge-shaped cutting instrument is directly adjacent, or on both surfaces. Relieves can be formed on the sides of the spline, and openings can also be formed on the base surface of the spline. Thus, any combination of the top surface, bottom surface, sides, and openings of the spline can be added to the spline to constitute a relief.

[0128] In the embodiment, as shown in Figures 25 and 26, the strip-shaped body 300 has a circular, rectangular, straight, triangular, trapezoidal, or a combination thereof shape on its top surface, bottom surface, central part, and non-central part. It has a ribbed, hole-shaped, and slit-shaped relief (see Figures 25 and 26). The strip provides a support base infrastructure, is flexible to precisely orient the wedge-shaped cutting instrument, and follows the movement of the balloon.

[0129] The relief holes shown in Figures 25 and 26 are designed to provide a pathway for a drug, particularly a balloon-based one, through which the drug moves. Furthermore, the strained reliefs formed on the surface improve the mobility of the device within its winding cavities. Figures 25A-C show embodiments of the reliefs 502 on the lower surface 500 of the band-shaped body 300, opposite the interface of the wedge-shaped cutting instrument 200. Figure 25A shows an embodiment in which the reliefs 502 are regularly spaced approximately the length of the interface of the wedge-shaped cutting instrument 200. Figure 25B shows an embodiment in which the reliefs 502 are regularly spaced less than 50% of the length of the interface of the wedge-shaped cutting instrument 200. Figure 25C shows an embodiment in which the reliefs 502 are regularly spaced apart by less than 50% of the length of the interface of the wedge-shaped cutting instruments 200, forming a group on the underside of the wedge-shaped cutting instruments and not present in the space between the wedge-shaped cutting instruments. In other embodiments, the wedge-shaped cutting instruments may be present in a group only on the underside of the space between the wedge-shaped cutting instruments and not on the underside of the wedge-shaped cutting instruments.

[0130] Figures 25D-25E show embodiments in which the relief 502' is present on the upper surface (boundary surface, i.e., upper surface 302) of the band between the wedge-shaped cutting instruments. Figures 25D and 25E show that the relief forms a recess on the upper surface 302 of the band between the wedge-shaped cutting instruments, having a gently curved surface in Figure 25D and a relatively square or rectangular curved surface in Figure 25E. This curved surface may or may not have rounded edges. Figure 25F shows a combination of two different reliefs 502, as seen in the embodiments of Figures 25C and 25D. Other combinations are possible depending on the desired clinical outcome. Figures 25G and 25H show embodiments showing the relief on the front 304 and / or rear surface of the band 300. Figure 25G shows a pyramidal relief 502, while Figure 25H shows an acute-angled relief 502. The relief can be formed axially away from the wedge-shaped cutting instrument, or it can be formed axially together with the wedge-shaped cutting instrument. Figures 25I and 25J show embodiments in which the relief 502 has the form of a vertically oriented through channel (Figure 25I) or a horizontally oriented through channel (Figure 25J). These through channels can be axially away from the wedge-shaped cutting instrument, or they can take other forms. In embodiments, the relief can be inclined with respect to the longitudinal axis of the strip. Figure 25K shows an embodiment in which the relief 502 is formed in the form of a groove on the front and / or rear surface, interface, and / or other locations.

[0131] When removing material from a strip, it is preferable that the strip has tabs along its base surface, i.e., the bonding surface. The tabs can control vibration and displacement of the long strip during material removal. Once material removal is complete, the tabs are removed. In embodiments, the tabs may have insets so as to be fixed to the base surface of the strip. In embodiments, the inset reliefs can function as tabs, which is advantageous, for example, when forming multiple strips from the same sheet as raw material by laser cutting. Supplementary protrusions on or joined to a region adjacent to the raw material being laser-cut can be fitted into the inset reliefs of the strip to maintain the accurate position of the strip during laser cutting. This allows the position of the strip to be maintained during laser cutting, preventing movement or mispositioning of the strip due to laser vibration. Such movement or mispositioning of the strip leads to a decrease in product yield. In embodiments, the reliefs for manufacturing stabilization do not need to be in the form of insets, but may be in the form of protruding outward from the base surface. In the embodiment, these tabs can be removed by laser cutting or other means prior to joining with the outer surface of the balloon, thereby preventing unintended rupture of the balloon. Figures 25L and 25M show a band with a wedge-shaped cutting instrument 200. This figure shows the manufacturing process for 300. The tab 580 can be formed by laser cutting the raw material 581, with one end joined in the vicinity of the raw material 581. The other end is fitted into, for example, a recess relief 502 on the underside of the strip 300. The recess relief 502 can be a pattern of any shape, as described in, for example, Figures 25A-25K. In the embodiment, the recess relief 502 is shown below the wedge-shaped cutting instrument 200. In Figure 25M, if it is not necessary to fix the strip 300 to the raw material 581, the tab 580 is shown cut into segments 588 and 589 in the subsequent manufacturing process. The strip 300 can be separated for attachment to a balloon or other device. The tab can be removed by forming a recess, minimizing the amount of material present below the strip that would interfere when joining the balloon or other inflatable device to the strip.

[0132] In some embodiments, the balloon can be made into a narrow-width pleated shape, which allows the device to be transported through a narrow-diameter introduction sheath. Once the balloon deflates, the balloon's contour when it inflates later will be larger than the original pleated diameter. This newly formed contour may cause the band to scratch the arterial wall or catch on the opening of an auxiliary device such as an introduction sheath. An element with a slope can address these potential problems.

[0133] Figure 25N shows an inclined portion 680 of adhesive or other material disposed at one or both ends 333 of a strip-shaped body 300. The adhesive can be disposed at a lower position on the strip-shaped body (e.g., the underside of the strip-shaped body 300) to connect the strip-shaped body 300 to a balloon. When the inclined portion 680 is made of a material that is relatively more flexible than the strip-shaped body 300 (e.g., adhesive), it can serve as an effective flexible interface between the flexible balloon and the semi-rigid strip-shaped body 300. The inclined portion 680 can be designed to slope gently from the balloon surface to the end of the strip-shaped body. The adhesive inclined portion 680 can hold the strip-shaped body during the procedure and protect it from contact with auxiliary devices.

[0134] In embodiments, a form that can be applied to a balloon is a conical inclined portion. The conical inclined portion can be manufactured by various methods. The conical inclined portion can be applied to relatively large balloons, such as a 6 mm balloon or a 5.5 mm balloon, and can be manufactured for a 5 mm balloon using conventionally known methods. Figure 25O shows an example of a conical inclined portion. The cone 970 has an outer diameter that is at least about 5%, about 10%, about 15%, about 20%, or in the range of about 5 to about 20%, larger than the outer diameter of the balloon 960. The relatively large cone 970 forms a lip 972 between itself and the balloon, which securely fixes the balloon 960. The lip 972 can reduce the proportion of metal strip ends that could damage the balloon when the balloon is deflated and withdrawn from the insertion catheter.

[0135] In the embodiment shown in Figure 25P, a rail 980 is formed along the cone 970. This rail 980 functions as a support structure or rigid structure, assisting in preventing the balloon 960 from rupturing when it is introduced through the introduction catheter. In the embodiment, the rail 980 can be oriented or arranged along the longitudinal axis of the strip, improving the function of pushing the strip towards the center of the balloon when the cone is introduced from the introduction body.

[0136] In an embodiment, the central portion of the balloon described in this specification can be recessed in order to join it with a strip-shaped body. A series of recesses can be formed on the surface of the balloon, and these recesses can be configured to have sufficient width and length to accommodate the strip-shaped body. The depth of the recesses is such that when the balloon is withdrawn, the strip-shaped body is fixed at the opening at the distal edge of the introduction body. To make it eel-deep.

[0137] By forming through-holes or microchannels within or on the spline, a configuration can be made that allows therapeutic agents, such as one or more drugs, nanoparticles, and / or stem cells, to be delivered from the balloon surface to the diseased area on the lumen surface via capillary or diffusion, or to be delivered to the diseased area through the microchannels using the balloon's compressive force. Furthermore, the microchannels, i.e., the modified surface, serve to store the drugs, nanoparticles, stem cells, or other therapeutic agents that are to be placed and protected during transport to the diseased area. In the embodiment, the drug can be any drug. The drugs are those that can be appropriately used in the methods and apparatus of the present invention, depending on the disease to be treated and taking into account their physical properties, and are not particularly limited, but examples include anti-restenotic drugs, proliferation promoters, anti-proliferative agents, anti-inflammatory agents, anti-cancer drugs, mitotic inhibitors, antiplatelet agents, anticoagulants, antifibrin, antithrombin, cell proliferation inhibitors, antibiotics, anti-enzyme agents, antimetabolites, vasogenic agents, cytoprotective agents, angiotensin-converting enzyme (ACE) inhibitors, angiotensin type II receptor antagonists, and / or cardioprotective agents.

[0138] Antiproliferative agents include, but are not limited to, actinomycin, taxol, docetaxel, paclitaxel, sirolimus (rapamycin), biolimus A9 (Biosensor International, Singapore), deforolimus, AP23572 (Ariad Pharmaceuticals), tacrolimus, temsilocimus, pimecrolimus, zotarolimus (ABT-578), and 40-O-(2-hydroxy)ethyl-rapamicin (E Examples include valolimus, 40-O-(3-hydroxypropyl)rapamisin (structural derivative of rapamisin), 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamisin (structural derivative of rapamisin), 40-O-tetrazoyl-rapamisin (structural derivative of rapamisin), 40-O-tetrazoylrapamisin, 40-epi-(N-1-tetrazoyl)-rapamisin, and purphenidone.

[0139] Anti-inflammatory agents can include both steroidal and non-steroidal agents, such as clobetasol, auclofenac, alclometazone dipropionate, algestone acetophenide, α-amylase, amsinafar, amsinafide, amfenac sodium, amiprirose hydrochloride, anakinra, aniolac, anitrazafen, apazone, valsalazid disodium, bendazac, benoxaprofen, benzydamine hydrochloride, bromelain, broperamol, budesonide, and carprofen. Cycloprofen, Syntazone, Criprofen, Clebetasol propionate, Cloverazone butyrate, Clopirac, Cloticazon propionate, Colmetazon acetate, Cortodoxone, Deflazacort, Desonide, Desoxymethasone, Dexamethasone, Dexamethasone dipropionate, Dexamethasone acetate, Dexamethasone phosphate, Momentazone, Cortisone, Cortisone acetate, Hydrocortisone, Prednisone, Prednisone acetate, Betamethasone Betamethasone acetate, diclofenacrine, diclofenac sodium, diflorasone diacetate, diflumidone sodium, diflunisal, difludoprednate, diphthalone, dimethyl sulfoxide, dorosinonide, endrizone, enlimomab, enoricum sodium, epirizole, etodrug, etofenamate, felibinac, phenamol, fenbufen, fenclofenac, fenchlorac, fendozal, fenpiparone, fenthiazac, flazalone, fluazal Cort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, flucortin butyl, fluorometholone acetate, fluquazone, flurbiprofen, flurbiprofen, fluetofen, fluticasone propionate, flaprofen, flobufen, halcinonide, halobetazole propionate, halopredone acetate, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen piconol, ironidap, indomethacin, Indomethacin sodium, indoprofen, indoxol, intrazol, isoflupredone acetate, isoxepak, isoxicam, ketoprofen, lofemisol hydrochloride, romoxicam, loteprednol ethanolate, meclofenamate sodium, meclofenamic acid, mechlorizone dibutyrate, mefanamic acid, mesalamine, mesacrazone, methylprednisolone sulbutanate, moniflemate, nabumetone, naproxen, naproxen sodium, naproxol, mimazon, olsalazine sodium, olgotein, orpanoxin, oxaprozin, oxyfenbutazone, paraniline hydrochloride, pentosan polysulfate sodium, fenbutazone glycerate sodium, pirfenidone, piroxicam, piroxicam cinnamic acid, piroxicam olamine, pirup Examples of drugs that can be used include, but are not limited to, Lofen, Prednazate, Pirferon, Prodric acid, Proquazone, Proxazol, Pyroxazole citrate, Lomexolone, Sarcolex, Sarunasazine, Sanguinalium chloride, Seclazone, Celmethacin, Sudoxicam, Sulindac, Suprofen, Talmethacin, Talniflumate, Tarosalate, Tebuferon, Tenidap, Tenidap sodium, Tenoxicam, Tesicam, Tesimide, Tetridamine, Tiopinac, Thixocortol pivalate, Tolmetin, Tolmetin sodium, Tricolonide, Triflumidate, Didomethacin, Zomepirac sodium, Aspirin (acetylsalicylic acid), Salicylic acid, Adrenocorticosteroids, Glucocorticoids, Tacrolimus, and Pimecrolimus.

[0140] Examples of anti-cancer drugs and mitotic inhibitors include, but are not limited to, paclitaxel, docetaxil, azathioprine, vincristine, vinbalastine, fluorouracil, doxorubicin hydrochloride, and mitomacin.

[0141] Antiplatelet drugs, anticoagulants, antifibrin, and antithrombin include heparin, heparin sodium, low molecular weight heparin, heparinoids, hirudin, argatroban, forskolin, bapiprost, prostalysin, prostalysin dextran, D-phenylalanine-pro-arginine-chloromethyl ketone, dipyradamol, glycoprotein, IIb / IIIa platelet membrane receptor antagonist antibodies, recombinant hirudin, thrombin, ANGIOMAX (registered trademark, bivalirudin manufactured from biogen), nifedipine, and other calcium-based drugs. Examples of such substances include, but are not limited to, mucochannel blockers, fish oil (omega-3 fatty acids), histamine blockers, lovastatin, monoclonal blockers such as platelet-derived growth factor receptors, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotease blockers, triazolopyrimidine, nitric oxide, nitric oxide donors, superoxide dismutase, and 4-amino-2,2,6,6-tetramethylpiperidine-1-oxy (4-amino-TEMPO).

[0142] Examples of 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; cortisin; fibroblast growth factor (FGF) antagonists; fish oil (omega-3 fatty acids); histamine blockers; lovastatin; monochloral blockers, especially platelet-derived growth factor receptor blockers; nitroprusside; phosphodiesterase inhibitors; prostaglandin inhibitors; suramin; serotonin blockers; steroids; thioprotease blockers; triazolopyrimidine; 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 type II receptor antagonists include, but are not limited to, irbesartan and losartan.

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

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

[0147] To place drugs, nanoparticles, stem cells, and other therapeutic agents into specific areas such as relief pores, direct writing processes such as micro-penning (MICROPEN Technology, Inc., Haneoifahrs, New York) are used. Generally, the term "direct writing" refers to a method of operating a stationary pattern-generating device controlled by a computer to apply a fluid material to a given surface in a desired pattern. Micro-penning is a flow-based micro-dispensing technology in which the material to be printed is extruded with high precision through a syringe and pen tip. The pen tip contacts the surface of the material but not the substrate surface, allowing for precise placement of a predetermined amount at a predetermined location.

[0148] Figure 26 shows an embodiment of a striped body 500 with a relief 502 formed on the lower surface of a striped body 300 located opposite the interface of a wedge-shaped incision instrument 200, wherein a relatively large opening 503 is formed between adjacent wedge-shaped incision instruments 200, and the striped body 300 is configured to easily connect with a balloon located below. This is described, for example, in WO2016 / 073490, published on May 12, 2016, and its contents are incorporated herein by reference. The opening 503 can be oval, circular, or other shapes depending on the treatment outcome.

[0149] In embodiments, the longitudinal axes of the strips can be oriented along the balloon and spaced apart from each other. The strips do not completely cover the entire length of the balloon; for example, a balloon with a length of 80 mm may have a strip with a length of 76.6 mm. The length of the strips can be the same as the length of the working balloon, or shorter, so that the balloon can deflate when it reaches the pressure at which it would burst. The length of the strips can be about 15% or less, about 10% or less, about 9% or less, about 8% or less, about 7% or less, about 6% or less, about 5% or less, about 4% or less, about 3% or less, about 2% or less, about 1% or less, or between about 2% and about 8%, between about 3% and about 6%, or between about 4% and about 5% of the total length of the balloon. The length of the balloon does not include the length of the cone.

[0150] In the embodiment, a portion of the strip, for example, the base of the strip, can be roughened (so that its lower surface is in contact with the outer surface of the balloon).

[0151] Spikes (e.g., serrated elements or wedge-shaped cutting instruments) can be fabricated in various shapes using many different methods. One or more additive or subtractive methods can be used in the manufacturing process. Additional methods include, for example, high-energy deposition and laser deposition. Examples of lithography techniques include chemical vapor deposition, self-assembly technology, polymer / metal 3D printing, selective laser sintering, powder printing, and other lithography techniques, although other methods may also be used. Subtractive methods include etching, CNC milling, laser cutting, water jetting, and electrical discharge machining, although other methods may also be used.

[0152] In embodiments, the reels can be manufactured using 300 series or 400 series martensitic stainless steel with a Rockwell C-scale hardness (HRC) of about 52 to about 64, although other materials may also be used. The reels are sharpened at one or both ends. In embodiments, 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. The tolerances for the thickness and width of the reels are about 0.020 inches and about 1 inch or more, respectively. The sharp edges may have a single angle or two or more angles (see, for example, Figures 21 and 22). In embodiments, if the angle of the sharp edge is measured as a gradient from the interface to the height of the non-interface, as shown in Figure 21, the angle may be, for example, 75° or more. On the other hand, if the sharp portion is composed of multiple angles, the angle of its tip can be 75° or less. When the sharp end moves toward the slope side, its angle can be 70° or more, 75° or more, 80° or more, 85° or more, or 90° or more. In addition to the sharp end, in the embodiment, a separate additional end can be formed at the tip of the non-interface of the band, and its height is shorter than that of the sharp end and has a larger angle. The width WU of the non-interface tip can be expressed as the radius of the tip. If the width of the tip is less than 0.01 inches or 0.005 inches, it is a width that can penetrate the diseased part of the blood vessel, and its surface area is minimized, so that contact with the blood vessel is reduced, and the energy required for penetration can be reduced. When the non-interface tip is configured to penetrate a relatively hard surface such as a calcium bed, the position away from the interface is made obtuse or the tip portion at that position is removed to widen the angle of the tip (see WU in Figure 21). This widened tip distributes the load across its entire surface when penetrating hard tissue surfaces, preventing tip deformation. After the reel is sharpened, it is stamped to a predetermined length. In one embodiment, the reel is stamped to a predetermined length after it has hardened.Regardless of stamp forming, the cutting edge portion is passivated and hardened to a hardness of, for example, HRC45. Typically, it is hardened to approximately HRC58 to approximately HRC62. This hardened cutting edge is then used to form spikes, sawtooth, or wedge-shaped cutting instruments using laser cutting, stamp forming, electrical discharge machining, or other metal forming techniques. The sawtooth elements are machined from a reel, hardened, and passivated. If the tip is not sharpened, the tip sharpening process is omitted from the manufacturing process of, for example, a wedge-shaped cutting instrument. Alternatively, a flat surface can be formed by removing a distance of 0.0001 to 0.003 inches, or 0.0001 to 0.0005 inches, from the sharp tip, as shown in Figure 21. The thinnest portion remaining at the sharp tip becomes the non-interface surface of the strip.

[0153] In embodiments, a method for joining strips is disclosed. This method includes processing steps that provide effective retention, vertical orientation, and structural stability of the strips in manufacturing 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 strips are arranged using a strip arrangement mechanism, i.e., a jig, and bonded with medical-grade cyanoacrylate to align them in a predetermined direction. The number of strips can vary, for example, between one and eight, and is typically determined in relation to the number of folds in the balloon, but can also be fewer than the number of folds in the balloon, and the arrangement period of the strips can also be discontinuous. Once the strips are bonded to the surface of the balloon, a single or multilayer topcoat layer, i.e., a retaining layer, is placed on a metal cutting scratching element, i.e., a wedge-shaped cutting instrument, to hold the strips in place. The balloon is protected from wedge-shaped cutting instruments. In embodiments, the coating layer can be applied in a manner similar to coating a strip via a controlled immersion process, thereby forming one or more uniform layers made of urethane or polyurethane. After the retaining layer has hardened, a hydrophilic or other coating can be applied to reduce friction on the balloon and increase its transportability and retrieval. The slip coating on the outer surface reduces the force required when inserting and removing the device, thereby increasing the functionality of the balloon.

[0154] Figure 27 is a cross-sectional view of the strip and wedge-shaped cutting instrument operably bonded to the outer surface of the balloon. A thin polymer layer (e.g., 0.0001 to 0.0009 inches), i.e., less than approximately 0.001 inches thick, so as not to increase the balloon diameter, can be used as a base coat (layer 270A) covering the outside of the balloon. The base coat 270A functions as an interfacial bonding layer for the wedge-shaped cutting instrument to the balloon surface. Layer 270A can be made of the same or similar polymer material as the other layers and bond to the balloon surface chemically, mechanically, or electromagnetically. The base coat layer 270A can be configured to reduce interfacial stress between the outer surface of the balloon and the wedge-shaped cutting instrument. The interface between the two surfaces can sandwich the adhesive layer 270E and the wedge-shaped cutting instrument 200 in a polymer matrix, allowing them to be isolated from the stress on the balloon as it inflates. 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 may include hydrophilic coatings containing silicone and hydrogel polymers such as vinyl polymer molecular chains and non-crosslinked hydrogels. Polyethylene oxide (PEO) is an example of a hydrogel. Neopentyl glycol diacrylate (NPG) is an example of a vinyl polymer. The coating of the above layer can be performed by immersing the balloon in a polymer bath once or multiple times, controlling the insertion and removal time. Alternatively, the coating of the above layer can be formed in angstrom units through single-layer self-assembly using well-known and practical self-assembly methods such as surface ion charging.

[0155] In Figure 27, the bonding layer 270E between the wedge-shaped cutting instrument and the base coat layer is thin (0.0001 to 0.0005 inches), but can also be thicker, up to 0.001 inches. This thickness does not increase the outer diameter of the balloon. The adhesive layer 270E can be composed of cyanoacrylate or other materials. These materials provide a chemical, mechanical, or electromagnetic bond between the base coat layer 270A and the bonding surface of the wedge-shaped cutting instrument. The adhesive layer 270E can be viewed as a functional layer for bonding the wedge-shaped cutting instrument to the balloon, and is the only layer bonding the wedge-shaped cutting instrument 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 low viscosity, allowing for wicking of the adhesive along the interface between the bonding surface of the wedge-shaped cutting instrument and the base coat. Since the adhesive dries instantly, it can be formed as a continuous layer with minimal curing time. Alternatively, a more viscous adhesive can be formed at both ends of the bottom surface of the strip, or periodically between the wedge-shaped cutting instrument and the base layer to have non-adhesive, unbonded portions. More than one adhesive can also be used. For example, a more viscous adhesive can be formed at both ends of the wedge-shaped cutting instrument, and wicking adhesive can be formed on some or all of the unbonded portions. In embodiments, two or more retaining layers (two layers in Figure 27) 270B and 270C can be formed on the base layer 270A, similar to the wedge-shaped cutting instrument. The polymer retaining layer can have a similar size to the base layer, having properties that effectively bond the base layer 270A and the retaining layers 270B and 270C. While the retaining layer can have a similar thickness to the base layer, it is also beneficial for it to be slightly thicker than the base layer. As the base layer and / or retaining layer thicken, the resistance to rupture increases, and the balloon becomes more resistant to wedge-shaped cutting instruments. This can increase resistance to sharp edges of implants remaining in the body or sharp edges of severely calcified diseased areas within blood vessels. In embodiments, a smooth layer 270D is formed on a retaining layer covering the balloon and / or wedge-shaped cutting instrument. Various hydrophilic coatings are available, which can reduce friction and improve the guidance of the balloon in winding, narrow anatomical features. The surface of the balloon can be entirely covered with the hydrophilic coating, or it can be coated after the balloon has deflated and become fold-like. Thus, only the surface exposed during transport will be covered with the hydrophilic coating. Typical hydrophilic coatings are several microns thick and can be as thin as about 10 angstroms.

[0156] In some embodiments, the adhesive may be applied separately to the balloon and the strip before they are joined together. A template may also be used to precisely position the wedge-shaped cutting instrument along the surface of the balloon.

[0157] The retaining layers 270B and 270C may be similar to the base layer in that they have properties that allow the base layer and the retaining layer to bond effectively. The retaining layers may have the same thickness as the base layer, or it may be beneficial to make them slightly thicker, such as having a thickness of approximately 20%, 15%, 10%, or 5% or less than the base layer. Thicker base layers and / or retaining layers increase rupture resistance and increase resistance of the balloon to sharp ends of wedge-shaped cutting instruments or implants remaining in the body, or sharp ends of severely calcified diseased areas within blood vessels. Multiple retaining layers 270B and 270C may be made of the same or different materials.

[0158] Various hydrophilic coatings are available, which can reduce friction and improve the balloon's guidance within winding, narrow, and anatomically distinctive areas. In one embodiment, 270D in Figure 27 is a hydrophilic smooth layer. The balloon surface can be completely covered with the hydrophilic coating, or it can be coated after the balloon has deflated and become foldable. Therefore, only the surface exposed during transport will be covered with the hydrophilic coating. Typical hydrophilic coatings are several microns thick and can be as thin as about 10 angstroms.

[0159] The height of the wedge-shaped incision instrument, the band, and the capsule can be considered a cage used with an inflatable member such as a medical balloon, such as an angioplasty balloon, or a part of a medical balloon, or other inflatable members. In keyhole, i.e., catheter-based surgery, it is preferable that the balloon can be folded down to a portion of its inflated diameter. Therefore, the balloon and cage are folded so that the folded balloon has a contour that allows for effective use. The cage is folded so that the spikes can be oriented so that the balloon does not rupture or damage the inner lining of the lumen during transport, as shown in Figure 28. Figure 28 shows a balloon 1000 having multiple folds 1002, a band 300, and wedge-shaped incision instruments 200 located between the folds. In this case, a single band 300 with multiple wedge-shaped incision instruments 200 is located between two folds 1002. The folds are designed so that the spikes and splines can be effectively oriented. These folds have pleated wedges, which, when closed on the balloon, are designed to form folds on the balloons located between them. Due to the bulk nature of the splines and to minimize the contact area and potential damage to the wedge heads, the pleated wedges have pockets formed along the length of the wedge heads. These pockets position the splines within the pockets, limiting their contact with the pleated wedges. These pockets also serve to facilitate the orientation of the splines and spikes, ensuring that the splines and spikes are properly positioned within the overfolded area. The spikes, such as those used in bellows, are designed to limit contact with the balloon and to be oriented perpendicular to the balloon, thereby limiting the risk of scratching the vascular intima during transport of the device. Such spike orientation is tangential to the balloon surface, as shown in Figure 28.

[0160] Based on the teachings described above, various modifications, alterations, and design changes are certainly possible. Therefore, it should be understood that things beyond those described herein can be done within the scope of the attached claims. Combinations and subcombinations of the features and aspects of the embodiments described above are also included in the present invention. Furthermore, special features, aspects, methods, properties, characteristics, quantities, qualities, elements, etc., related to one embodiment can be used in other embodiments described herein. Therefore, it should be understood that the various features and aspects of the disclosed embodiments can be combined or substituted for each other to form variations of the disclosed invention. Accordingly, the scope of the invention disclosed herein should not be limited by the special embodiments described above. Also, the invention is susceptible to various modifications and selections, the special embodiments of which are shown in the drawings and described in detail. However, it should be understood that the present invention should not be limited to the special forms and methods disclosed, and the present invention includes all modifications, equivalents, and variations of the various embodiments described and the spirit and scope of the attached claims. The methods disclosed herein do not need to be carried out in the order of reference. The methods disclosed herein include actions performed by physicians, but also include actions performed by third parties, either explicitly or implicitly. The scope disclosed herein includes any range, including overlapping ranges, subranges, and combinations thereof. Words such as “up to,” “at least,” “greater than,” “less than,” and “between” include the cited numerical values. The numbers following the words “approximately,” “about,” and “substantially” used herein include the cited numerical values ​​(e.g., approximately 10% = 10%) and represent numerical values ​​close to the numerical value required to perform the desired function and achieve the desired result. For example, “approximately,” “about,” and “substantially” also refer to ranges of 10% or less, 5% or less, 1% or less, 0.1% or less, and 0.01% or less of that numerical value.

Claims

1. A member having a lumen and a fine strip defining a longitudinal axis, A balloon that is connected to the aforementioned thin strip member and has the full length of the balloon during operation, Multiple band-like structures, Equipped with, Each of the plurality of strip-shaped bodies extends longitudinally along the outer surface of the inflatable balloon and has a plurality of wedge-shaped cutting instruments spaced apart along the surface of each strip-shaped body. The surface of each of the aforementioned strip-shaped bodies has a strip-shaped body length extending longitudinally along the respective strip-shaped body and a strip-shaped body width traversing said strip-shaped body length. Each of the plurality of wedge-shaped cutting instruments has a band-shaped base surface that is in direct proximity to the surface of the respective band-shaped body. The aforementioned strip-shaped base surface has a base surface length along the longitudinal direction of the strip-shaped body and a base surface width that crosses the said base surface length. The wedge-shaped cutting instrument has a cutting surface, the cutting surface extending longitudinally between the proximal edge and the distal edge of the cutting surface, The cross-section has a first height at the proximal edge, a second height between the proximal and distal edges, and a third height at the distal edge. A medical balloon catheter characterized in that the second height is greater than the first height, and the third height is lower than the second height.

2. The medical balloon catheter according to claim 1, characterized in that the total volume of the wedge-shaped cutting instrument extends to less than two-thirds of the surface of the band-shaped body.

3. The medical balloon catheter according to claim 1, characterized in that the maximum change in height between the proximal and distal edges of the cut surface of the wedge-shaped cutting instrument and the surface of the band-shaped body between the wedge-shaped cutting instruments is less than 80% of the total height of the wedge-shaped cutting instrument.

4. The medical balloon catheter according to claim 1, characterized in that the length of each of the aforementioned band-shaped bodies is up to 15% shorter than the total length of the balloon during the aforementioned operation.

5. The medical balloon catheter according to claim 1, characterized in that the cut surface is located in the center with respect to the width of the base surface.

6. The medical balloon catheter according to claim 1, characterized in that the midpoint of the cut surface coincides with the midpoint of the strip-shaped base surface.

7. The medical balloon catheter according to claim 1, characterized in that the exposed surface of the inflatable balloon not covered by the plurality of band-shaped bodies is at most 50% in the pre-inflation state.

8. The medical balloon catheter according to claim 1, characterized in that the exposed surface of the inflatable balloon not covered by the plurality of band-shaped bodies is 65% to 99% when the inflatable balloon is fully inflated.

9. The medical balloon catheter according to claim 1, characterized in that the plurality of wedge-shaped cutting instruments are spaced apart at regular intervals.

10. The medical balloon catheter according to claim 1, characterized in that the plurality of wedge-shaped cutting instruments are spaced apart at irregular intervals.

11. The medical balloon catheter according to claim 1, characterized in that the side surface of the wedge-shaped cutting instrument defines an angle of less than 90°.

12. The medical balloon catheter according to claim 1, characterized in that the side surface of the wedge-shaped cutting instrument defines a certain angle of inclination.

13. The wedge-shaped cutting instrument has a length of cut surface extending in the longitudinal direction, and the length of the cut surface is 10% to 50% shorter than the length of the base surface, as described in claim 1 for the medical balloon catheter.

14. The aforementioned wedge-shaped cutting instrument has a cutting surface length extending in the longitudinal direction and a cutting surface width traversing said cutting surface length, The medical balloon catheter according to claim 1, characterized in that the width of the cut surface is 10% to 50% smaller than the width of the base surface.

15. The medical balloon catheter according to claim 1, characterized in that the wedge-shaped cutting instrument has a cutting surface height that extends radially outward.

16. The medical balloon catheter according to claim 1, characterized in that the wedge-shaped cutting instrument has a side surface, and the side surface defines a plurality of different angles.

17. A medical balloon catheter according to claim 1, characterized in that 1 / 3 to 1 / 2 of the surface of the band-shaped body is covered by the plurality of wedge-shaped cutting instruments, and 1 / 2 to 2 / 3 of the surface of the band-shaped body is not covered by the plurality of wedge-shaped cutting instruments.

18. The medical balloon catheter according to claim 1, characterized in that the end of the band-shaped body is not equipped with the wedge-shaped cutting instrument.

19. The medical balloon catheter according to claim 1, characterized in that the space between adjacent wedge-shaped cutting instruments is at least the same length as the base surface length.

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