Medical balloon catheter with enhanced pushability

Abstract

Systems and methods may involve a wedge-shaped dissector attached to a strip that is in turn attached to a medical balloon for forming teeth in vessel wall tissue for angioplasty and drug delivery.

Description

[0001] [Cross-reference to related applications]

[0002] This application claims the benefit of U.S. Patent Application No. 62 / 703,419 filed on July 25, 2018 and U.S. Patent Application No. 62 / 827,124 filed on March 31, 2019 as a non-provisional application, both of which are incorporated herein by reference in their entirety. This application also incorporates U.S. Patent Application No. 2018 / 0200491 to Giasolli et al., which claims the benefit of U.S. Patent Application No. 62 / 423,117 filed on November 16, 2016 and U.S. Patent Application No. 62 / 522,482 filed on June 20, 2017 as a non-provisional application under 35 U.S.C. §119(e), each of which is incorporated herein by reference in its entirety. This application also relates to U.S. Patent Application No. 15 / 268,407 filed on September 16, 2016, the contents of which are incorporated herein by reference in their entirety under 37 CFR 1.57. [Background technology] [Technical field]

[0003] Certain embodiments disclosed herein generally relate to cages for medical balloons (e.g., angioplasty balloons) and methods of depositing drugs into tissue via serrations. Methods of making the cages and processing methods involving the cages are also disclosed, as well as features of various wedge dissectors and splines that can be used with the cages. Among other things, the wedge dissectors can be used to create perforations in plaques in blood vessels for controlling crack propagation and reducing cuts that restrict blood flow. Background Art

[0005] Atherosclerotic occlusive disease is the leading cause of stroke, heart attack, limb loss and death in the United States and the industrialized world. Atherosclerotic plaques form hard layers along the arterial walls and are composed of calcium, cholesterol, compacted thrombi and cellular debris. As atherosclerotic disease progresses, blood supply through a particular blood vessel is reduced or even prevented by the occlusive process. One of the most widely used methods for treating clinically significant atherosclerotic plaques is balloon angioplasty.

[0006] Balloon angioplasty is a method of opening blocked or narrowed blood vessels in vivo. A balloon angioplasty catheter is placed into the artery from a remote access site created percutaneously or by open exposure of the artery. The catheter is passed along the inside of the blood vessel by a wire that guides the path of the catheter. The portion of the catheter to which the balloon is attached is placed at the location of the atherosclerotic plaque that requires treatment. The balloon is usually inflated to a size that corresponds to the original diameter of the artery before occlusive disease developed.

[0007] When the balloon is inflated, the plaque is stretched, compressed, fractured, or ruptured, depending on its composition, location, and the amount of pressure applied by the balloon. Plaques are heterogeneous and can be soft in some areas or hard in other areas, resulting in unpredictable cleavage planes under standard balloon angioplasty. Balloon angioplasty can cause plaque rupture and sometimes even lead to arterial damage at the site of angioplasty. [Summary of the invention]

[0008] There is a continuing need for improvements in methods for treating occlusive diseases including balloon angioplasty and other related treatment systems. In some embodiments, a method for pretreating a site in a blood vessel by inflating a pretreatment balloon at the treatment site in the blood vessel to create a plurality of microcracks in the media layer of the blood vessel wall can improve drug uptake from a drug eluting balloon at a treatment site in the blood vessel. The pretreatment balloon has a plurality of strips, each strip containing a plurality of wedge-shaped dissectors spaced apart along the surface of each strip. The strips extend longitudinally along the outer surface of the pretreatment balloon. The pretreatment balloon is then removed and a drug eluting balloon is placed at the site. The drug eluting balloon will inflate to contact the blood vessel wall and allow the drug to elute from the surface of the drug eluting balloon into the microcracks, through the intima and into the media. In some embodiments, the plurality of wedge-shaped dissectors are equally spaced apart, or the plurality of strips of the wedge-shaped dissectors are all of the same length.

[0009] In some embodiments, a method of pretreating a site in a blood vessel by expanding a pretreatment balloon at a site in the blood vessel to create a plurality of microcracks in the media layer of the blood vessel wall can improve the enhancement of drug uptake from a drug eluting balloon at a treatment site in the blood vessel. The pretreatment balloon has a plurality of strips, each strip containing a plurality of wedge-shaped dissectors spaced along the surface of each strip. The strips extend longitudinally along the outer surface of the pretreatment balloon. The pretreatment balloon will then be deflated and rotated a small angle, which in some cases is different from the spacing of each strip along the circumference of the balloon. As a non-limiting example, if there are 4 wedge-shaped dissectors spaced 90 degrees along the circumference of the balloon, the balloon can be rotated, for example 45 degrees, and then re-inflated to create new dentations along the blood vessel wall that previously had no dentations. The pretreatment balloon will then be re-inflated so that the strips on the pretreatment balloon are in a different position than the original inflation, and the wedge-shaped dissectors are in a position to create dentations in the area of ​​the blood vessel wall that previously had no dentations. The pretreatment balloon is then removed and a drug eluting balloon is placed at the site. The drug eluting balloon will expand to contact the vessel wall and allow the drug to elute from the surface of the drug eluting balloon into the microcracks, through the intima and into the media. A plurality of wedge-shaped dissectors may be equally spaced, or a plurality of strips of the wedge-shaped dissectors may all have the same length. In some cases, the small angle may be about 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90 degrees or greater or less, or a range including any two of the above values. In some embodiments, the balloon may be rotated between about 1 degree and about 30 degrees, or the fraction of the angle may be between about 5 degrees and about 20 degrees. In some embodiments, the balloon may be rotated once in a first direction, and then repeated 1, 2, 3, 4, 5 or more times in the same or opposite direction to increase the number of teeth in the vessel wall.

[0010] In some embodiments, the method of pre-treating the site is accomplished with a wedge-shaped dissector having a radially outwardly facing surface that is rectangular in shape.

[0011] In some embodiments, a method of depositing a drug through a tissue dent uses a pretreatment balloon having an elongated member having an inner lumen defining a longitudinal axis, an inflatable balloon connected to the elongated member at a distal end of the elongated member, a plurality of strips, wherein each of the plurality of strips has a plurality of wedge-shaped dissectors spaced along a surface of each strip, and each strip extends longitudinally along an outer surface of the balloon. In this example, the wedge-shaped dissector has a base surface facing the strip directly adjacent to the surface of each strip, an unhoned radially outwardly facing surface having a length between a proximal edge of the radially outwardly facing surface and a distal edge of the radially outwardly facing surface and defining a height of each wedge-shaped dissector, and a side surface between the base surface facing the strip and the radially outwardly facing surface. The radially outwardly facing surface has a first width at the proximal edge, a second width less than the first width between the proximal edge and the distal edge, and a third width greater than the second width at the distal edge. The second width may correspond to a single point along the length of the radially outward surface, or the second width may correspond to a central segment having a central length between the proximal edge and the distal edge. The length of each strip may be less than the length of the outer surface of the airbag coaxial with the length of each strip, or the length of each strip may be between about 3% and about 6% less than the length of the outer surface of the airbag coaxial with the length of each strip. The total length of the radially outward facing surface of each wedge-shaped dissector may be less than the total length of the base surface facing the strip of each wedge-shaped dissector. In another embodiment, the radially outward surface has a curved surface or has at least one chamfered surface or a first height at the proximal edge and a second height between the proximal edge and the distal edge, wherein the second height is greater than the first height. In some embodiments, the maximum height of the radially outward facing surface is at the midpoint between the first unbounded edge and the second unbounded edge. The maximum height of the unbounded surface may be offset from the midpoint between the proximal edge and the distal edge. The side surface section of the wedge-shaped dissector from the base surface facing the strip to the proximal edge can have a first section with a first slope and a second section with a second slope different from the first slope. The strip can have a textured surface. The strip can also have multiple release elements. The method can also have a pre-treatment balloon, which has a plurality of strips having an elongated length, having first and second side edges, wherein the first and second side edges of the plurality of strips are defined by an adhesive. The method can also use a hydrophilic slip layer around the outer surface of the balloon, the strips, and the wedge-shaped dissector. In another embodiment, the method uses at least one polymer retaining layer around the outer surface of the balloon, the strips, and the wedge-shaped dissector. The balloon of the method can have a taper around the lateral end of the balloon, wherein the taper has a maximum outer diameter greater than about 5% of the maximum outer diameter of the balloon.The taper may include a track oriented with the longitudinal axis of the strip.

[0012] In some embodiments, the method of attaching a wedge-shaped dissector to a medical air bag can be achieved by providing a strip, the strip comprising a plurality of wedge-shaped dissectors spaced longitudinally along the surface of the strip. Each wedge-shaped dissector has a base surface facing the strip directly adjacent to the first surface of the strip, an unpolished radially outwardly facing surface, the unpolished radially outwardly facing surface having a length between the proximal edge of the radially outwardly facing surface and the distal edge of the radially outwardly facing surface and defining the height of each wedge-shaped dissector, and a side surface between the base surface facing the strip and the radially outwardly facing surface. Each unpolished radially outwardly facing surface of each wedge-shaped dissector is attached to the linear free edge of the strip carrier at the attachment area, wherein there is a gap in the attachment area, and the strip has a second surface relative to the first surface of the strip. Then, the second surface of the strip is attached to the surface of the medical air bag and is detached from the strip from the strip carrier after the second surface of the strip is attached to the medical air bag. The second surface of the strip can be bonded to the surface of the medical air bag with an adhesive. Mechanical force may be used to achieve separation of the tape carrier from the tape. The tape carrier may also be formed integrally with the tape. In some cases, chemical etching is used to create the tape carrier and the tape.

[0013] In some embodiments, the carrier system for attaching a wedge-shaped dissector to a medical airbag has a strip, which includes a plurality of wedge-shaped dissectors spaced longitudinally along the surface of the strip. Each wedge-shaped dissector has a base surface facing the strip directly adjacent to the first surface of the strip, an unpolished radially outward-facing surface, the unpolished radially outward-facing surface has a length between the proximal edge of the radially outward-facing surface and the distal edge of the radially outward-facing surface and defines the height of each wedge-shaped dissector, and a side surface between the base surface facing the strip and the radially outward-facing surface. The strip has a second surface relative to the first surface of the strip, and the strip carrier has a free edge. The unpolished radially outward-facing surface of each wedge-shaped dissector is attached to the free edge of the strip carrier at the attachment area. There is a gap in the attachment area, and these attachment areas are configured to separate when a mechanical force is applied. In some cases, the carrier system strip is made of metal. The strip can be made of stainless steel, or the carrier system can be the same material as the strip.

[0014] In some embodiments, a method for producing a serration at a treatment site in a blood vessel has a serration balloon with a plurality of strips. Each of the plurality of strips includes a plurality of wedge-shaped dissectors spaced apart along the surface of each strip, and each strip extends longitudinally along the outer surface of the serration-shaped balloon. Each wedge-shaped dissector has a radially outward surface and a side surface. The serration balloon is expanded at the site so that the radially outward surfaces of the plurality of wedge-shaped dissectors directly contact the tissue of the intimal layer of the vessel wall, forming a cleavage surface into the media layer of the vessel wall. Continued expansion of the serration balloon is then performed so that the radially outward surfaces of the plurality of wedge-shaped dissectors no longer contact the tissue of the media layer of the vessel wall, and the side surfaces of the wedge-shaped dissectors contact the tissue of the media layer of the vessel wall to expand the cleavage surface. The cleavage surface may have a depth of about 0.3 mm to about 1.5 mm, or the cleavage surface may have a depth of about 0.5 mm to about 1.2 mm.

[0015] In some embodiments, a medical balloon catheter with enhanced pushability is disclosed herein. The catheter may include any number of the following: an outer shaft, the outer shaft including an elongated member, the elongated member including an inner diameter and an outer diameter; an inner member; and an elongated coil positioned between the outer shaft and the inner member, the coil extending substantially the entire length of the outer shaft. In some embodiments, the elongated coil includes one or more tapered portions that taper from a first larger diameter to a second smaller diameter. In some embodiments, the outer shaft includes one or more tapered portions that taper from a first larger diameter to a second smaller diameter. In some embodiments, the one or more tapered portions of the elongated coil are substantially associated with the one or more tapered portions of the outer shaft.

[0016] In some configurations, the coil includes at least two tapered portions.

[0017] In some configurations, one or more tapered portions of the coil include a pitch between about 0 degrees and about 15 degrees.

[0018] In some configurations, the one or more tapered portions of the coil are present entirely only between about 5 cm and about 50 cm from the distal tip of the catheter.

[0019] In some configurations, the coil is fused to the outer shaft at least at the proximal end of the catheter and / or the distal end of the catheter.

[0020] In some configurations, the inner member includes a guide wire.

[0021] In some configurations, the catheter further includes an expandable member associated with the catheter, wherein the elongated coil extends through the expandable member.

[0022] In some configurations, the expandable member includes a balloon.

[0023] In some configurations, the expandable balloon includes a plurality of strips, each strip including a plurality of wedge-shaped dissectors thereon.

[0024] In some configurations, the wedge-shaped dissector is configured to create teeth in a blood vessel without cutting the vessel.

[0025] In some configurations, the wedge-shaped dissector is configured to cut through a portion of a blood vessel.

[0026] Also disclosed herein is a method for creating dentations in a treatment site in a blood vessel, comprising providing a balloon catheter comprising a balloon, the balloon comprising a plurality of strips, each strip comprising a plurality of wedge-shaped dissectors, the balloon catheter further comprising an inner member, an outer sheath, and an elongated tapered coil between a matching tapered outer sheath and a non-tapered inner member, the elongated coil extending substantially the entire length of the balloon catheter and through the balloon; inflating the balloon at the site to create a plurality of microcracks in the media layer of the blood vessel wall without cutting the blood vessel wall; and removing the balloon from the site.

[0027] In some configurations, the method further includes performing an index procedure at the site.

[0028] In some configurations, the index procedure is selected from the group consisting of: endovascular aortic repair (EVAR), fenestrated endovascular aortic repair (FEVAR), transcatheter aortic valve replacement (TAVR), transcatheter mitral valve repair or replacement, and thoracic endovascular aortic repair (TEVAR).

Brief Description of the Drawings

[0029] These and other features, aspects and advantages are described below with reference to the accompanying drawings, which are intended to illustrate rather than limit the present invention. In the accompanying drawings, the same reference numerals always indicate corresponding features throughout similar embodiments.

[0030] Figure 1A The cage is shown in an expanded position placed on an angioplasty balloon.

[0031] Figure 1B An exploded view of an angioplasty balloon that may be placed within a cage is shown, both of which are shown in a pre-expanded position.

[0032] Figure 2 Shown is a schematic diagram of a cage plate showing both long and short cuts.

[0033] Figure 3 An angioplasty balloon is shown within a blood vessel at a treatment site experiencing dog-boning.

[0034] Figure 4A An unfinished cage is shown cut from a tube during the manufacturing process.

[0035] Figure 4B yes Figure 4A Cross section of the unfinished cage taken along line BB.

[0036] Figure 4C shows the Figure 4B cross section.

[0037] Figure 4D A cross section of another embodiment having a larger lumen is shown.

[0038] Figure 4E A detailed view of a portion of another embodiment of a cage is shown.

[0039] Figure 5A Another embodiment of a cage is shown unfinished during the manufacturing process.

[0040] Figure 5B Shown is a view taken along line BB Figure 5A Cross section of an unfinished cage.

[0041] Fig. 6A Wire cuts of the strips and wedge dissector used to form an embodiment of a cage are shown.

[0042] Figure 6B Shows Fig. 6A The cross section of the cutting line.

[0043] Figure 7 Schematic diagram showing multiple strips connected by two rings to form a cage.

[0044] Figure 8 A two part ring is shown which may be used to capture the straps to form part of a cage.

[0045] Fig. 9A is another embodiment of a cage having a tapered ring.

[0046] Fig. 9B is a perspective view of a ring having a tapered outer diameter, wherein the ring includes a helical feature on its outer surface.

[0047] Fig.10 Shown are strap ends configured to receive and be secured by multiple layers of rings to form cage ends.

[0048] Fig.11 Another embodiment of a strap end configured to receive and be secured by multiple layers of rings to form a cage end is shown.

[0049] Fig.12 is a perspective view of the ring.

[0050] Fig.13A A strap with hook features and loops is shown.

[0051] Fig. 13B is an end view of a strip with ridged hook features.

[0052] Fig. 13C A perspective view of a portion of a cage is shown.

[0053] Fig.13D Shown is a view of a tapered distal ring holding multiple strips.

[0054] Figure 13E-13F Shown is a view of one end of an airbag with a cage disposed around the airbag and the forces applied to the airbag during inflation and deflation.

[0055] Fig.14A Shown is a side view of an embodiment of a cage having a strap with hooks that can be attached to the inside of the neck of an air bag.

[0056] Fig. 14B Shown is attached to Fig.14A End view of the cage on the airbag shown in .

[0057] Fig. 14C is a schematic cross-sectional view of a strap with hooks that lock into the neck of an air bag.

[0058] Fig.14D is an alternative embodiment of the ends of the strip having multiple layers of loops to form the ends of the cage.

[0059] Fig.14E An embodiment of a strap held by a plurality of loops with wedge-shaped dissectors protruding from the plurality of loops is shown.

[0060] Fig.15A A partial view of one embodiment of an angioplasty balloon having a strap embodiment is shown with a plurality of rings of material bonded to the angioplasty balloon to form a cage.

[0061] Fig. 15B The invention is an angioplasty balloon having a cage with a plurality of segmented strips bonded to the surface of the balloon by a plurality of rings.

[0062] Fig. 15C An example of placing a segmented strip on the surface of an airbag is shown.

[0063] Fig.15D Another example is placing multiple segmented strips onto the surface of an angioplasty balloon.

[0064] Fig.15E An example of multiple segmented strips bonded to the balloon surface by multiple loops is shown.

[0065] Figure 16A-16C Several embodiments of straps secured by loops are shown.

[0066] Fig.17 A schematic diagram showing details of an embodiment of a cage with springs is shown.

[0067] Fig.18 Shows the use of Fig.18 Various embodiments of the cage in terms of the spring component.

[0068] Fig.19 A portion of a cage including a spring strap and a spike configuration is shown.

[0069] Fig. 20 is a close up detail view of an embodiment of a wedge shaped dissector on its associated strip.

[0070] Fig.21 Schematic perspective views showing different sizes and nomenclature of a wedge-shaped dissector according to some embodiments.

[0071] Figure 21A-21G Various embodiments of wedge-shaped dissector geometries are shown.

[0072] Figure 22A-22F Corresponding end and isometric views of different wedge-shaped dissector geometries are shown in accordance with some embodiments.

[0073] Figure 23A-23D Corresponding end and isometric views of various asymmetric wedge dissector geometries are shown in accordance with some embodiments.

[0074] Not limited by theory, Fig.23E , Fig.23F and Figure 23F.1 A potential mechanism of action of the tooth device is shown.

[0075] Fig.24 An embodiment is shown showing how the non-bonding surface 204 may have varying heights according to some embodiments.

[0076] Figure 25A-25K Different embodiments of straps with relief elements in various positions are shown.

[0077] Figure 25L and Figure 25M Embodiments of methods of stabilizing a strip during a laser cutting manufacturing process and involving temporary tabs are shown in accordance with some embodiments.

[0078] Fig.25N An embodiment of an adhesive ramp for bonding the lateral ends of the strip to the surface of the airbag is shown in accordance with some embodiments. Figure 25N.1 Another image of the bevel feature shown in a side view is shown to illustrate the distance the bevel extends from the edge of the strip.

[0079] Fig.25O A conical ramp for an airbag is shown in accordance with some embodiments.

[0080] Figure 25P A series of tapered rails or struts are shown in accordance with some embodiments.

[0081] Fig.26 Another embodiment of a strap having a release element in accordance with some embodiments is shown.

[0082] Fig. 27 A schematic cross-section of an air balloon with a wedge-shaped dissector and an intermediate layer is shown.

[0083] Fig.28 An embodiment of a pleated balloon with straps and wedge-shaped dissectors between the pleats is shown. Fig.28A and Fig.28B Drug retention data in tissue for a dentine system followed by DCB versus POBA followed by DCB is shown.

[0084] Fig.29 is a graphic representation of the simplified equations for the tangential stress in a cylinder with known wall thickness and the tangential tension in a cylinder assuming no wall thickness.

[0085] Fig.30 Balloon pressure versus diameter increase is shown.

[0086] Fig.31A It is shown that the tip does not contact the entire surface of the crack created by the tip. Fig.31B These teeth were shown to be able to penetrate into the mid-layer tissue in each patient examined with OCT imaging. Fig.31C The waist is shown when the air bag is inflated to 4 ATM in the left middle image. Fig.31D Shown is the OCT image on the left, illustrating the intimal anatomy.

[0087] Fig.32 An embodiment of an improved cutting balloon for producing teeth is shown.

[0088] Fig.33 A diagram of a modified cutting balloon is shown, where flexibility is further enhanced and cutting is completely or partially replaced with a tooth-like blade pattern.

[0089] Figure 34-34M An embodiment of a catheter is shown that may include a coil located in the space between an outer catheter shaft and an inner member (guidewire shaft), and a tortuous anatomy that may be navigated by the catheter.

[0090] Fig.34N Shown is a simplified view of an artery in the tibia, which is often occluded for a long length. Occlusions greater than 200 mm are not uncommon in the posterior and anterior tibial arteries.

[0091] Fig.34O An embodiment of a method for producing an airbag-in-airbag design is schematically shown.

[0092] Figure 35A-Figure 35B An embodiment of a strip having a wedge-shaped dissector with a sloped, non-linear edge is shown.

[0093] Fig.36 It is shown that the tip of the wedge-shaped dissector can have various unique features on the end that contacts the tissue (eg, the radially outward facing surface).

[0094] Fig.37 is another design showing an alternative variation of the tooth-like edge of the wedge-shaped dissector, wherein the center section may include a small depression as shown.

[0095] Fig.38 A wedge-shaped dissector is shown with a rounded, dual-ridged contact surface at the tip that can provide effective tissue penetration.

[0096] Fig.39 A variation on the design is shown that provides a relatively sharp, pointed dual contact surface at the end of each wedge-shaped dissector, thereby providing effective tissue penetration.

[0097] Fig.40 A similar design is shown providing relatively sharp, pointed dual contact surfaces at the end of each wedge-shaped dissector that provide effective tissue penetration, the dual contact surfaces abutting central deeper and shallower valleys / depressions, respectively.

[0098] Fig.41A It is shown that a strip can be manufactured that includes multiple strips (eg, two identical strips) that are contacted end-to-end in a wedge-shaped dissector frame.

[0099] Fig.41B and Fig.41C It is shown that in some embodiments, multiple strips can be bent or folded into a curved form.

[0100] Fig.41D and Fig.41EAn alternative embodiment is shown having a tooth-like tip comprising a plurality of pointed surfaces with a central concave portion located therebetween.

[0101] Fig.42 A series of figures are shown showing the ability to take a stack of straps connected to a blank that can be discarded at any point in the strap attachment process. The radially distal ends abut against a continuous edge for easy disconnection.

[0102] Fig.43 An embodiment showing a close-up view of attaching the ends of the strips to the blank.

[0103] Fig.44A and Fig.44B Isotropic etching is shown, where etching occurs in more than one direction (both vertically and horizontally under the mask).

[0104] Fig.45A It is shown that the strip can be placed over a through hole embedded in the airbag. Fig.45B It is shown that the strip can be placed over a through hole embedded in the bladder wall.

[0105] Fig.46 In some embodiments shown a series of 4 A-frame strips may be placed over multiple through holes embedded in the bladder wall.

[0106] Fig.47 An embodiment of what an array of stripes would appear on a mask set prior to chemical etching is shown (including a close-up inset).

[0107] Figure 48a shows an array of strips. Figure 48b shows a detailed close-up image of adjacent wedge-shaped dissectors with detachable areas. Figure 48c shows a toothed strip connected to a strip carrier for alignment, control, placement, and ease of manufacturing. Figure 48d shows an embodiment of a strip carrier reversibly attached to a strip.

[0108] Figure 49-49J Different views of one embodiment of an overall system for producing a dentoplasty are shown showing a series of dent-like or scored wedge-shaped dissectors on the outer diameter of the catheter attached to a catheter having a guidewire hub and a balloon-expandable hub. [Specific embodiment]

[0109] Figure 1A and Figure 1B An embodiment of the cage 10 is shown positioned on an angioplasty balloon 20. Figure 1A The expanded position is shown. Figure 1BIt is shown how an angioplasty balloon may be advanced into the cage. The cage 10 is described herein primarily with respect to angioplasty balloon 20 and angioplasty. It should be understood that the cage 10 may be used with other types of medical balloons and in other procedures.

[0110] The cage 10 may include a first ring 12 and a second ring 14, and a plurality of straps 16. Each strap may extend longitudinally between the first ring 12 and the second ring 14. The straps and rings may be made of an integral component formed from a single piece of material. Thus, for example, the first and second rings may be the ends of a cut tube. The straps and rings may also be made of separate materials and connected together. As shown, Figure 1A and Figure 1B The cage is shown having five straps 16, but other numbers of straps may be used, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, etc.

[0111] Figure 2 A plan view of a cut tube embodiment of the cage is shown, but some embodiments of the cage may alternatively be made from a single flat piece of material. The material may be elastic or semi-elastic and made from a polymer, copolymer, metal, alloy, or a combination of these. The straps are typically designed to enable the airbag 20 to be inflated multiple times. Likewise, the straps 16 may be configured so that the cage 10 can exert force longitudinally and axially or in a direction that enables the straps 16 to return to an initial position.

[0112] In some embodiments, the cage 10 is prefabricated, packaged, and sterilized separately from the balloon 20, thereby allowing a physician to position the cage 10 around a medical balloon 20 (eg, an angioplasty balloon) to assist in a medical procedure during surgery. Figure 1B The airbag 20 is shown in a folded state before deployment and before placement within the cage 10. The folded airbag 20 can be pushed into the cage 10 without expanding or changing the shape of the cage 10. The cage 10 can completely surround and enclose the airbag 20 before the airbag is deployed or inflated. The cage 10 in the pre-expanded state can be longer than the airbag 20. This can allow one or both ends of the cage 10 to move toward each other while the device (e.g., the airbag 20) is inflated. The cage 10 can float freely on the airbag 20. One or both ends 12, 14 of the cage 10 can be fixed to the airbag 20 or another part of the delivery device. In some embodiments, the cage 10 is not attached to any part of the inflated airbag 20. This can prevent the cage 10 from interfering with the airbag 20 when the airbag 20 is inflated.

[0113] In some examples, the cage 10 can be used with an angioplasty balloon 20 having a drug coating so that the drug coating can be protected. The cage 10 can prevent or reduce premature exposure of the drug to the blood vessel. Figure 1BAs will be appreciated, the cage 10 can be positioned over the drug coated angioplasty balloon 20 in a pre-expanded state to prevent premature exposure of the drug to the vessel. The cage 10 can radially cover the balloon 20 so that a minimal amount of the surface of the angioplasty balloon 20 having the drug coating is exposed or substantially not exposed. In this configuration, the balloon 20 and cage 10 can be advanced to the treatment site. Although not shown, the system can be advanced within the vasculature over a guide wire.

[0114] like Figure 1A As shown, the cage 10 can be moved to an expanded position. In the expanded position, the first ring 12 and the second ring 14 are closer together, and the strip is expanded, thereby exposing the angioplasty balloon surface. In this position, the drug can be placed in contact with the diseased tissue in the blood vessel.

[0115] In currently available systems, it is often difficult to predict how much drug will reach the diseased tissue. There are many factors that limit the ability to accurately predict how much drug will be transferred to the diseased tissue. For example, blood flow can dilute the drug on the balloon 20 when the drug is advanced to the treatment site. In addition, navigating the device through the blood vessel can cause the balloon 20 to rub against the inner surface of the lumen, thereby removing some of the drug when the balloon 20 is advanced to the treatment position. Therefore, in some instances, the cage 10 can provide a physical barrier to protect the drug covering of the balloon 20 during advancement to the treatment position. In this way, the cage 10 can be used so that the balloon 20 and the drug covering are only exposed to the blood flow in the blood vessel as the space between the strips increases during the expansion of the balloon 20. In this way, the cage 10 can prevent or reduce the chance that the drug will be diluted or the drug will treat an area of ​​the body that is not intended to be treated. In some variations, this can allow for more controlled delivery of the drug while reducing the amount of drug that needs to be coated on the balloon 20.

[0116] In some embodiments, the folded airbag 20 can be positioned completely within the cage 10. Figure 1A As shown, the cage 10 may have slits between each of the straps 16. In some variations, the slits may be formed by cutting between each of the straps 16 to separate them from a single sheet of material. In other embodiments, the slits are actually just spaces between adjacent straps. The spaces between the straps may be a minute amount (such as would be formed by laser cutting) or much larger (such as equal to or larger than the width of the straps themselves). Depending on the size of the slits, the exposed surface of the balloon 20 in the pre-expanded position is no more than 50% and may be as low as 25%, 10%, 5%, 1% or less.

[0117] As previously described, the expansion of the balloon 20 moves the first ring 12 and the second ring 14 closer together while moving the strips 16 further radially apart. With the strips 16 in the expanded position, the balloon 20 is more exposed to and can interact with the vessel wall. In the expanded position, the balloon 20 can deliver drugs, stem cells, or other treatments to the vessel wall or to a diseased area of ​​the vessel wall. When the balloon 20 is fully expanded, the exposed surface of the balloon 20 not covered by the strips 16 can be between 65% and 99%, 75% and 99%, more commonly 80% and 99%, or most commonly 90% and 99%, among other ranges.

[0118] Drug delivery using cage 10 can be used before, during or after angioplasty. Also, there is no requirement that the cage cover the entire balloon or be used to control or assist drug delivery.

[0119] In some embodiments, the cage 10 can be used to prevent or reduce the dog bone effect of the balloon 20 during an angioplasty procedure. This can be in addition to or instead of assisting with drug delivery. Figure 3 An angioplasty balloon 20 is shown within a blood vessel 2 at a treatment site. As shown, the angioplasty balloon 20 is experiencing a dog bone effect when inflated. The plaque buildup 4 resists the inflation of the balloon 20, forcing the ends of the balloon 20 to inflate first, rather than concentrating the inflation energy in the center of the balloon 20 at the plaque 4 where it is needed most.

[0120] To prevent the dog bone effect, such as Figure 1A The cage 10 shown in FIG. 1 can constrain the balloon 20 when expanded to cause the middle portion of the balloon 20 to expand first. This is because the middle region of the cage 10 can be designed to have the least resistance to expansion, being farthest from the ends of the bands closed by the loops. This can prevent or reduce the dog bone effect of the balloon 20, independent of the disease morphology or arterial morphology in which the balloon 20 is expanded.

[0121] The dog bone effect typically occurs when a balloon 20 is inflated in a blood vessel with plaque, where the plaque resists expansion, forcing the ends of the balloon 20 to inflate first (due to lack of resistance), causing the balloon 20 to assume the shape of a dog bone. By encapsulating the balloon 20 with the cage 10 and configuring the rings to exhibit different resistances to expansion, the ends of the balloon 20 can have the highest resistance and the center of the balloon 20 can have the lowest resistance. Thus, the cage 10 can help control and limit the expansion of the balloon 20, as the balloon 20 will tend to inflate more easily in the center (which is typically the diseased area).

[0122] The pattern and orientation of the strips 16 can affect the expansion and dog bone effect. Figure 2, the short slits 22 positioned in the center of the straps 16 can reduce the stiffness of the center of each strap 16. This can help reduce the possibility of a dog bone effect by further reducing the resistance to expansion in the center of the cage 10.

[0123] The cage may further include spikes or wedge-shaped dissectors on the strips. The spikes may be used as vessel preparation tools prior to secondary treatment or during primary treatment. For example, these spikes may assist in cutting and / or perforating plaque prior to or during an angioplasty procedure. This may assist or replace drug delivery and / or prevent the dog bone effect. It will be appreciated that any of the embodiments described herein may provide any of these benefits and / or be used in any of these procedures, as well as other benefits and procedures described herein.

[0124] As will be further described below, the spikes can be positioned on the strip in any number of different orientations and configurations. The spikes can be any of the spikes discussed in U.S. Pat. No. 8,323,243, issued Dec. 4, 2012 to Schneider et al., which is incorporated herein by reference in its entirety. The spikes and cages can also be used in accordance with the plaque cutting tooth method and other methods described therein.

[0125] The cage 10 can be made in many ways. For example, an extrusion process can be used, a tube can be cut, and / or wire segmented as will be described in more detail below. Figure 4A-Figure 5B Initially, various embodiments of the cage will be described. Figure 4A and Figure 5A An embodiment of a cage 10 is shown during a manufacturing process. Each cage 10 is in the form of a tube having a plurality of splines 24 spaced apart on the tube. In some embodiments, the tube may be prefabricated and then machined into the illustrated shape. The tube may be made of metal or plastic, among other materials. In other embodiments, the tube is extruded to form the illustrated shape. For example, a method of manufacturing the tube may include extruding a plastic tube having a plurality of spaced apart splines 24 positioned longitudinally along the tube. Figure 4B-4D and Figure 5A A cross section of the cage is shown in FIG.

[0126] After forming the tube with the pegs 24, material of the tube may be removed to form the slits and strips 16. As part of the removal process, or before forming the slits, the pegs may be shaped to form different shaped spikes or wedge-shaped dissectors 26. For example, Figure 4B The square bolt 24 shown can be processed to form Figure 4C and Figure 4DSharp wedge-shaped dissector 26 is shown. In some embodiments, square peg 24 can be manufactured using an additive process and initially formed into wedge-shaped dissector 26 as shown, without requiring additional machining or other work.

[0127] See now Figure 4E , shows an enlarged detail view of a portion of the cage. In this embodiment, the strip 16 has been formed with a plurality of spikes or wedge-shaped dissectors 26. In some embodiments, from Figure 4A and Figure 4B At the base of the unfinished cage, slits may be cut in the tubing to form adjacent strips. The wedge-shaped dissector 26 may be made as a tent or mandrel having an elongated tip and a base, both of which extend longitudinally along the longitudinal axis of the tube. The wedge-shaped dissector 26 may assist in cutting and / or perforating plaque prior to or during angioplasty. The spaces between the wedge-shaped dissectors 26 may be machined or otherwise formed to remove material and increase the flexibility of the strips. The spacing between the wedge-shaped dissectors 26 is shown as twice the length of the wedge-shaped dissector 26, but other spacings may also be used. Typically, the spacing length may be a spacing to length of 4:1 to 3:1, and more commonly a spacing to length of 3:1 to 1:1.

[0128] With regard to the manufacture of the pegs, in some embodiments, the pegs 26 are made from a tube of material where the cage 10 is a plastic extruded tube with the pegs cut, ground, EDMed, or molded to form the wedge-shaped dissectors 26. The tube may be manufactured with slits along its length. In some instances, the ends of the tube remain intact to form a loop. In some variations, the strips 16 are spaced apart with some or all of the strips 16 having spikes or wedge-shaped dissectors 26. As will be appreciated from the above discussion, in Figure 4A-Figure 5B In the embodiment shown in , five slits are made to form the outward points.

[0129] In some embodiments, a method of manufacturing a cage 10 for an angioplasty balloon 20 may include first extruding a plastic tube having a plurality of spaced-apart pegs longitudinally positioned along the tube. In some instances, the method may then include cutting at least one of the plurality of pegs to form a plurality of spikes or wedge-shaped dissectors 26 positioned circumferentially around the tube. In some variations, the method may also include cutting the tube to form a plurality of longitudinally extending strips 16, each strip including at least one spike of a plurality of wedge-shaped dissectors 26.

[0130] See now Figure 6A-6B, another method of manufacturing the cage 10 will be described. The wire 28 can be split or cut to form three or more strips 16, which can be used to form a portion of the cage 10. In some examples, the wire 28 is composed of an alloy or polymer material. Any number of different manufacturing methods can be used, including laser cutting and electrical discharge machining. In some variations, the wire 28 can be divided into multiple parts, such as four quarters. In some embodiments, square or other shaped holes 30 can be cut into the wire 28 to form spaces between the wedge-shaped dissectors 26. Each portion of the wire can then be separated to form the strips 16 of the cage 10. The cage 10 can be assembled with multiple rings and include any number of strips 16. In some examples, the cage 10 can be assembled from 1, 2, 3, 4, 5, 6, 7, 8 or more strips 16.

[0131] The strips 16 may be attached in many ways to form the cage 10. In addition, to forming the strips from wire, they may also be extruded and / or formed from flat sheets of material and / or tubing. For example, it will be appreciated that referring to Figure 2 , Figure 4A-Figure 5B The described embodiments may be modified to provide individual strips which may then be connected to form a cage.

[0132] In some embodiments, a strap may be connected to two or more rings 12, 14 to form a cage 10. For example, each strap of the cage 10 may be joined to a ring at either end. Figure 7 As shown, each individual strap 16 is secured at either end by a loop 12, 14. When constructing the cage 10, the straps 16 may be first attached to the loops 12, 14 before being positioned around the airbag, or the cage may be assembled around the airbag. For example, one or more straps may be placed on the surface of the airbag 20 before being attached to the loops. The cage 10 may be permanently secured to one or both ends of the airbag 20 or to a balloon catheter. In some embodiments, the loops 12, 14 may hold the straps against a portion of the airbag or balloon catheter. The straps 16 may also help keep the airbag 20 in a compressed state prior to deployment, and may help deflate the airbag after expansion.

[0133] The rings 12, 14 are typically circular bands, but they can be bands of any number of shapes, including oval, square, elliptical, rectangular, etc. The rings can also create a restraining and / or restraining force. The rings 12, 14 can be any number of different materials, including one or more of metals, polymers, copolymers, elastomers, thermoplastic elastomers, glues, or hydrogels. The rings can be rigid or flexible.

[0134] In some examples, the rings 12, 14 may be composed of a heat shrink material or a material with elastic properties that binds, captures or constrains the plurality of straps 16 and prevents or limits the straps 16 from moving, sliding, tilting or twisting at any point along the length of the straps, but particularly at either end of the airbag 20. When the rings are elastic, superelastic or thermoactive, the rings may be placed around the straps and allowed to shrink onto the straps so that the straps 16 are held against the outer diameter of the airbag 20. Preferably, the rings and straps are positioned around the airbag in a fully inflated state, and heat is then applied to the heat shrink rings. In other embodiments, the heat shrink rings are applied when the airbag is in a deflated state.

[0135] As about Figure 1A and Figure 1B As discussed, a cage can be formed and slid onto the balloon. However, in some embodiments, assembling the cage around the balloon can allow for a smaller cage design. When retrofitting the balloon 20, the ring can be advanced onto the balloon catheter from either side, which can allow for a smaller ring interior dimension than having a cage with the ring advanced over the balloon.

[0136] The rings 12, 14 of the cage 10 may be configured to accommodate the air bag 20 as the air bag 20 transitions from a deflated shape to an inflated shape. Figure 1B The configuration of the cage with the airbag shown in FIG. 1 is not different, and the straps 16 of the cage 10 can contact the airbag 20 when the airbag 20 is in the collapsed configuration. When the airbag 20 is inflated, each strap 16 bends with the airbag 20 in a concave orientation ( Figure 1A ). In some examples, the strips 16 are free floating and not bonded to the balloon surface.

[0137] As the air bag 20 begins to deflate, the material properties of the straps 16 may allow them to begin to return to their original position. This may be a completely flat position. As the straps 16 return to their original position, this may provide additional force to assist in the deflation of the air bag 20. As the straps 16 move from the concave position to the flat linear position, the straps 16 move from the extended length (“L e ”) to the deflated length (“L d ”), where L d L e The strip 16 is axially extending from L e To L d The straightening of the airbag 20 stretches the airbag 20 and facilitates a more complete deflation of the airbag 20.

[0138] The loops 12, 14 may have a variety of shapes and sizes that may secure the plurality of straps 16. The following discussion of certain illustrated embodiments are but a few such examples.

[0139] The loops 12, 14 may be connected to the strap 16 in a number of different ways. The loops may be mechanically attached to the strap 16, such as by a friction fit, or may be connected using ultrasonic welding, adhesives, etc. Figure 8 , each ring 12, 14 may be a two-part ring that can be connected to one or more straps 16 of the cage 10 by rotating in opposite directions (e.g., clockwise and counterclockwise). The rings 12, 14 may include holes 32 through which the straps 16 may be advanced to connect to the rings. In particular, the asymmetric shape of the holes 32 may be configured to accommodate a strap 16 having periodically spaced wedge-shaped dissectors 26, such as Figure 6B shown.

[0140] As shown, the hole 32 may have a narrower portion 33 and a wider portion 34. The wider portion 34 may be configured to accommodate the wedge-shaped dissector 26, while the narrower portion 33 may be configured to accommodate the width of the strap 16 (i.e., the space between the wedge-shaped dissectors). By fitting the wedge-shaped dissector 26 through the wider portion 34, the strap 16 may be advanced through the hole 32. In some instances, the strap 16 may then be secured by rotating the rings 12, 14 so that the strap 16 is moved into the narrower portion 33. This may secure the strap 16 to the rings 12, 14 when the wedge-shaped dissector 26 cannot move past the narrower portion 33. As described above, two rings 12, 14 may be present at either end of the cage 10. Additionally, as shown in FIG. Figure 8 As shown, because the holes 32 of the ring 12 and the holes 32 of the ring 14 are opposed, this further prevents movement of the strap 16 by rotating the two parts of the ring in opposite directions.

[0141] The strap 16 may be secured by loops 12, 14 formed of a variety of shapes. For example, Fig. 9A An embodiment of the cage 10 is shown in which the straps 16 are secured at the distal end with a tapered ring 12. The tapered end may be the distal end of a balloon catheter and may provide an atraumatic end of the device.

[0142] Similarly, Fig. 9B A ring 12 having a tapered outer diameter is shown with a helical feature 101 on its outer surface. The helical feature 101 may provide a concave or convex footprint around the outer surface of the distal ring.

[0143] Fig. 9BThe ring 12 shown in can also be used for therapeutic purposes. In some instances, the conical and spiral features on the ring can help the balloon 20 navigate and enter the narrow lesion area. The coiled outer surface 101 can be configured to provide a clamping or tunneling mechanism. This feature can allow the ring to help the operator navigate through the occluded lesion area (completely or partially) and enable the balloon 20 to pass therein. The concave or convex impression 101 can be circumferential or patterned like a cork screw. In some embodiments, the concave or convex impression 101 can be a large notch or have microscopic features that provide an enhanced surface to enable passage through the narrowed area in the blood vessel. In some instances, the function of the outer surface 101 of the ring can be described as acting like a lubricant, although the feature is mechanical in nature. This function can be further enhanced with a hydrophilic, hydrophobic coating. The surface texture can also be changed to help pass through with less energy. In some embodiments, this can be achieved by adding tiny scales (as seen in porcupine quills) or enhanced surface roughness (as used by mosquitoes in nature).

[0144] Fig. 9B The ring 12 shown in FIG. 1 can be fastened to a strip 16 which is arranged circumferentially around the surface of the airbag in a spiral manner. Fig. 9A Compared to the linear strip 16 shown in FIG. 1 , the strip 16 attached to the tapered ring 12 can be wrapped around the balloon. A tapered or untapered ring 14 can be used at the proximal end of the balloon. In some examples, the configuration of the attached strip 16 can follow the same pattern as the concave or convex traces 101 on the ring 12.

[0145] Now go to Figure 10-11 , a multi-layer ring will be discussed. A ring having multiple layers can be used to hold the strip between layers. The ring can have at least one bottom layer 122 and one top layer 121. Figure 10-11 As seen in FIG. 1 , the loops 12, 14 may have an incompressible bottom layer 122 and a compressible, heat-compressible, or electrostatically compressible layer 121. The top layer 121 may be made of a compressible material, while the bottom layer 122 may be made of an incompressible material, and the strip 16 may be captured between them. In some examples, the top layer or the top and bottom layers may be made of a heat-shrinkable material. In some embodiments, the loops 12, 14 may be formed from a segment of material that is wrapped around itself to form a layer of loop.

[0146] The ring can be made of composite material layers, where the bottom layer 122 is less compressible or elastic than the top layer 121. Energy can be added to the top layer 121 to reduce the diameter of the top layer until the top layer compresses and captures the strips between the bottom layers 122. For example, the top layer 121 can be a heat shrink material. In this way, the top layer 121, the bottom layer 122 and the strips 16 can form the cage 10, such as Fig.10 and Fig.11In some embodiments, the strap may be attached to a balloon and / or balloon catheter, and the ring is made of a single layer of heat shrink material similar to a top layer located above the strap.

[0147] The strap or loop may include notches to facilitate attachment to one another. The strap 16 may include notches 171 (eg, Fig.10 As shown) or a notch 171 on one surface of the strip 16, the notch may form a groove (as shown Fig.11 Although Fig.11 In the embodiment, the top layer 121 is shown as a heat shrink material, but it will be understood that in other embodiments, a rigid ring can be press-fit into the notch 171. Such a rigid ring can be part of a single or multi-layer ring, so a corresponding bottom layer 122 may or may not be present.

[0148] Fig.12 Another embodiment of the rings 12, 14 is shown. Here, the rings 12, 14 may include a plurality of notches or grooves 17. The grooves 17 may have a width that may accommodate the width of the distal end of the strip 16. One end of the strip may be attached to the rings 12, 14 in the grooves 17 by using an adhesive, a mechanical connection, wrapping a heat shrink material around the ring, etc. In some embodiments, Fig.11 The strip 16 can be placed Fig.12 The rings 12, 14 are provided so that the notches engage with each other.

[0149] Figure 13A-13C An example of a strap 16 is shown that includes a securing feature 181 that improves retention of the strap 16 to the rings 12, 14. In some variations, the securing feature 181 forms a portion of the strap 16 with a higher surface roughness. This may be in the form of ridges or other toothed elements as shown that help embed the strap 16 into the ring or retain the strap on the ring.

[0150] When the loops 12, 14 are a polymer material, the securing feature 181 may be formed as a narrowed portion of the strap 16 at the end (eg, Figure 13A-13B ), or strategically placed along the length of the strip (such as in the case where three or more loops are used). The securing features 181 can be aligned with the loops 12, 14. During manufacturing, the securing features 181 can be pressed into the polymer material at high temperature, such as Fig.13A As shown, where the polymer material is close to or greater than the glass transition temperature of the material. In doing so, the fixing feature 181 can be used to join or connect the strip 16 to the rings 12, 14, such as Fig. 13C shown.

[0151] exist Fig.13A , the rings 12, 14 are shown as incorporating securing features 181 into the body of the ring material. Fig.13A The strip 16 is shown with the ridged hook features 181 prior to being pressed into the loop material. Fig. 13B A perspective view of another embodiment of a securing feature 181 is shown. In some examples, the securing feature 181 can be significantly longer than the loops 12, 14, and wider and designed to provide tension on the cage 10.

[0152] When the rings 12, 14 are made of an elastic material (such as rubber or a polymer, or a metal alloy or a design with spring-like elastic properties), the rings 12, 14 can be used to provide tension on the cage 10 to enable the cage 10 to return to the relaxed, deflated balloon 20 position. In addition, the portion of the strap 16 without the wedge dissector is the thinnest and most flexible. This can allow the strap 16 to be most flexible at the edge of the balloon 20 where the force is greatest.

[0153] Figure 13D-13F An example is shown where the elastic material of the ring can provide tension on the cage during inflation and then help deflate the balloon when the tension is released. Fig.13D , cage 10 is arranged around balloon 20. Cage 10 can be composed of multiple strips 16, which are fixed to balloon by rings 12, 14. In some instances, rings 12, 14 can be made of long elastic material, which can help pull strips 16 down to a linear position so that the wedge-shaped dissector is perpendicular to the surface of balloon 20. Marking "A" provides a schematic perspective view of the proximal end of ring 14. As shown, ring 14 is fixed around outer catheter shaft 22 by adhesive 23. Similarly, inner guide wire shaft 21 can extend concentrically with balloon 20. Guide wire shaft 21 can be fixed relative to catheter shaft 22. For example, guide wire shaft 21 and catheter shaft 22 can be connected to different ports on the joint, such as the bifurcated Luer (luer) joint shown at the proximal end of balloon catheter. The balloon can be inflated by injecting fluid into the catheter shaft. It should be understood that in some embodiments, catheter shaft 22 is directly opened inside balloon 20, rather than opening at ring 14 as shown. The ring may be attached to the catheter shaft 22 and / or the balloon 20 .

[0154] Figure 13E-13F The balloon 20 and cage 10 are shown as the balloon 20 is inflated and then deflated. As described above, in some examples, the elastic material of the rings 12, 14 can stretch to allow the cage 10 to expand as the balloon 20 is inflated. Figure 13E-13F In some of the embodiments shown, the rings may be made of an elastic polymer and the straps may be made of metal or a non-elastic polymer. Fig.13EAs shown, when the balloon 20 is inflated, the straps 16 of the cage 10 begin to move apart. To push each strap 16 outward, as the balloon 20 is inflated, a force is applied radially outward (as shown by the arrows) on the balloon 20, and by extension the cage 10. As the balloon 20 is inflated, the rings 12, 14 are under tension and are able to stretch sufficiently to allow the straps 16 to remain aligned while the balloon 20 is inflated.

[0155] This tension can also help the airbag 20 to deflate. During the airbag deflation period, Fig.13F As shown, when the straps 16 and rings 12, 14 tend to want to return to a relaxed state, the tension on the straps 16 applies a force radially inward. This force pulls the straps 16 and allows them to flatten, thereby providing a narrowed profile for catheter retrieval.

[0156] See now Figures 14A-14D , shows another embodiment of the strip 16 with various types of loops. Figure 14A-14B As shown, in some examples, the ring can be made from a lip on the neck of the balloon 20 and a portion of the catheter body that is used to bond the catheter to the balloon 20. The catheter can provide a passage for gas or liquid inflation of the balloon 20. Additional components such as an overmold or heat shrink can be added to the bonded joint, such as glue or polymer materials can be added. In some examples, this can be used to prevent pressure from leaking out of the balloon 20 along the length of the strip 16 that forms the cage 10.

[0157] like Figures 14A-14D As shown in FIG. 1 , the hooks 161 at the ends of the straps can enable the straps to be easily aligned along the surface of the airbag and can help orient the straps in a longitudinal orientation relative to the axis of the airbag 20. The hooks 161 can be integrally formed in each end of the straps 16. The hooks 161 can wrap around the lip of the neck of the airbag 20 from the outer diameter ("OD") of the neck of the airbag 20 around the opening and enter the neck where the ends of the hooks 161 rest within the inner diameter ("ID") of the neck of the airbag 20.

[0158] Both ends of the strap 16 may have hooks 161, or only one end may have a hook. In addition, the ends may be attached to the balloon catheter in the same or different ways. For example, a heat shrink material may be wrapped around the ends of the strap and balloon. In some embodiments, the heat shrink material is wrapped around one end, and a rigid ring (such as about Figure 8-Figure 12 A rigid ring (such as those discussed) may be used at the other end, which rigid ring may also include a heat shrink layer.

[0159] The strap may or may not be connected to the airbag at other locations. As shown, the strap 16 may also have a hinge or pre-bent area corresponding to the shape of the airbag. Therefore, the strap in the expanded state may have a main portion with a wedge-shaped dissector 26 parallel to the axis of the airbag. The angled portion may extend from the main portion to the hook 161. When the airbag is expanded as shown, the angled portion may form an angle, but when the airbag is deflated, the angled portion may be flat. In some embodiments, the hinge between the portions may be formed by thinner material portions.

[0160] like Fig.14A By using hook 161, the strap can be attached to the balloon without a separate ring. The balloon can be glued to a catheter (e.g., an elongated tube with one or more lumens), which can also hold the hook in place. For simplicity, Fig.14A One strip is shown, but it will be appreciated that 2, 3, 4 ( Fig. 14B ), 5 or more strips.

[0161] Fig. 14C A detailed view of hook 161 attached to balloon 20 is shown. As can be seen, the balloon can be used as the bottom layer 122 of the ring and the top layer 122 is also shown. Adhesive 123 is also shown securing the top layer 121 to the balloon. In some embodiments, the top layer 121 can be a tube of a catheter.

[0162] Fig.14D A double layer 121, 122 ring is shown. The double layer ring may include two layers of heat shrink material. Figure 10-11 As discussed, Fig.14D The ring shown in can be a multi-layer ring, wherein the bottom layer 122 is less compressible or elastic than the top layer 121, and wherein energy is added to the top layer, thereby producing a reduction in the diameter of the top layer until the top layer compresses and captures the strip between the bottom layer 122 and the top layer 121 to produce the cage 10.

[0163] Fig.14E Another embodiment of a ring 12, 14 is shown that secures a strap 16 to the surface of a balloon 20. As shown in callout "A", the ring 12, 14 can be secured to the balloon 20 such that a wedge-shaped dissector protrudes through the surface of the ring 12, 14. Callout "A" includes a cutout of the ring 12, 14 at the center to show the strap 16 underneath. The wedge-shaped dissector can protrude through the ring 12, 14 in a variety of ways. For example, the shape of the wedge-shaped dissector can cut through the material of the ring 12, 14 when the ring 12, 14 is secured to the strap 16. This can form a hole 27. The ring 12, 14 can also have a plurality of holes 27 pre-cut into the ring 12, 14 to allow the wedge-shaped dissector to extend through.

[0164] It can also be seen that the rings 12, 14 can be shaped to correspond to the tapered portion of the bladder 20. For example, material cutouts 29 in the rings can help the rings, which are made of heat shrink material, to shrink into the shape of the bladder.

[0165] As described above, each of the strips 16 may extend between one or two rings, but additional rings may be used as desired. For example, three, four, five, six, seven, eight, nine, or ten, or more rings may be used, particularly for longer balloons. As an example, an angioplasty balloon 20 having a length of 300 mm may be fitted with a cage 10 having two rings 12 and 14 at either end. In addition to the rings 12, 14, the cage 10 may include a ring 13 or other similar control element that may help the strips 16 maintain alignment and orientation as the balloon 20 is inflated toward the arterial wall.

[0166] like Fig.15A As shown, the ring 13 can be a portion of the total length of the balloon 20. Some ring 13 designs are less than 1.5 times the length of the balloon 20. In other examples, the ring is between 1.0-0.5 times the length of the balloon 20. More commonly, the length of the ring 13 is between 2.5 and 1.5 times the diameter of the balloon 20 and typically between 1.5 and 0.5 times the diameter of the balloon 20. Each ring 12, 13, 14 can be made of different materials in order to provide more than one advantage and function of the rings 12, 13, 14.

[0167] The ring 13 may be placed on the outer surface of the body of the airbag 20. In some examples, the ring 13 may be designed to hold the body of the strap 16 so that the position and orientation of the strap 16 can be maintained. It can also be seen that the strap 16 does not extend along the shoulder of the airbag. Therefore, the strap can be elongated and can extend parallel to the axis of the airbag. For simplicity, Fig.15A One strip 16 is shown, but it will be appreciated that 2, 3, 4, 5 or more strips may be used.

[0168] The ring 13 may be positioned over the area of ​​the inflated balloon 20 and may have different properties than the rings 12, 14 on either end of the balloon 20. Fig.15A As shown, in some embodiments, the rings 13 positioned on the surface of the balloon 20 may be more elastic in nature than the rings positioned on the ends of the balloon 20. This may allow the rings to accommodate the expansion and refolding of the balloon 20. In some examples, the rings used on the outer diameter of the balloon 20 are placed on both ends of each separate strip. The strips 16 may also be bonded, welded, restrained by friction fit, or otherwise attached to any of the above rings.

[0169] In some embodiments, multiple rows of strips and / or strip portions may be placed around the balloon 20. Some rows may extend the entire length of the balloon 20 and other rows may not extend. In some examples, a row may include multiple strips in series separated by gaps. Placing the strips in series on the balloon may provide greater flexibility, which may improve deliverability through tortuous anatomical structures.

[0170] As previously described, the loops 12, 14, 13 can be used to hold the straps on the surface of the balloon 20. The loops can be connected to the straps in any number of different ways, as described in various embodiments herein. In some embodiments, the ends of the straps 16 without the wedge-shaped dissector can be used to attach to the loops. In other embodiments, the ends with the wedge-shaped dissector can be attached to the loops.

[0171] Fig. 15B Another embodiment of a balloon catheter is shown. A balloon 20 is shown having a cage 10 with four rows of equally spaced strips 16. Each row has two strips 16 placed in series. Rings 13 attach adjacent strips 16 to properly secure and orient the strips 16 across the surface of the balloon 20. Rings 12, 14 hold the other ends of the strips.

[0172] Label "A" provides an enlarged view of the distal end of the balloon 20 with the cage 10. The hatching shown in label "A" is used to help visualize and depict the different parts of the device. As shown, the end of the balloon 20 includes a ring 12 that secures a plurality of straps 16 to the surface of the balloon 20. The balloon 20 is arranged around the catheter 19. The ring 12 can be a heat shrink material. A wedge-shaped dissector is also shown extending through the ring. Fig. 15C The placement of the straps is further illustrated in FIG. 2 , which shows how a pair of straps 16 are arranged in series so that the straps 16 span the length of the air bag 20 .

[0173] To improve flexibility, the cage 10 may have Fig. 15B and Fig. 15C A greater number of strips 16 than shown in FIG. Figure 15D-15E An example is shown in which five strips 16 are placed in series on the surface of the airbag 20. As previously described, each of these strips 16 can be fixed to the surface of the airbag 20 by a plurality of loops 13. The notation "A" provides a cutout of the loop 13 to show the gap between two strips 16 in series. As described above, Fig.14E As described, the wedge-shaped dissector can be extended through the ring 13 in a variety of ways. For example, the shape of the wedge-shaped dissector can allow the wedge-shaped dissector to pierce the material of the ring 13. Likewise, the ring 13 can have a plurality of holes cut into the ring 13 to allow the wedge-shaped dissector to pierce through.

[0174] In addition to having multiple strips in a row, the gaps between the strips in the row can also be adjusted to increase flexibility. For ease of manufacturing, the linear alignment (angular drift) and spacing alignment (gap) between the strips 16 in the theta direction around the radius can have relatively wide tolerances, allowing more options in developing manufacturing processes and selecting tools. In some cases, the gap tolerance can be ±5mm and angular drift ±25 degrees; ±3mm and angular offset ±10 degrees; and ±2mm and angular offset ±5 degrees. Cage designs that require greater bending can utilize periodic strip arrangements in a linear sequence with spaced-apart strips. This can enable the balloon to manage bending and rotation in anatomical space with less stress on the strips and more efficient pushability of the entire system.

[0175] As shown here, many of the strips 16 have a flat bottom. This can help the strips 16 to lie on the surface of the balloon and maintain the orientation of the wedge-shaped dissector. This can prevent rotational movement of the strips 16 on the surface of the balloon 20.

[0176] Three unique features that can be achieved by all strap and ring configurations are 1) perpendicularity of the wedge dissector to the balloon surface, 2) maintaining a flat and low profile of the strap on the balloon, helping to limit damage to tissue by the wedge dissector as it travels, and 3) aiding in the deflation of the balloon or creating a minimal burden on typical balloon deflation characteristics. To achieve these features, the straps typically have a flat base, are attached to the balloon by loops on either end of the strap, are folded to limit the interaction of the wedge dissector with tissue during its travel, and when the loops are placed on the wedge dissector, the wedge dissector pierces the loops and most of the height of the wedge dissector remains available for penetrating the vessel. While some designs utilize loops to generate forces on the balloon, either by pulling on the strap end-to-end or by applying radial compression to achieve more efficient balloon deflation, in most designs the loops support the strap by limiting strap movement, helping to orient the wedge dissector and prevent the strap from separating from the balloon. Design features that contribute to these functional properties include: a strap with a flat bottom that enables a wedge dissector to be stably oriented, but thin enough to be placed tangentially to the balloon or contained in the fold of the balloon during folding, the spaces between the wedge dissectors have no cutting edges that enable the loop to be placed in the space and supported by the strap, and the ends of the strap can be thinnest without a wedge dissector, thereby allowing a greater surface area for the loop to bind to the strap and allowing the strap to be most flexible at the edge of the balloon where forces are greatest during movement of the catheter into and out of the deployment site. It will be appreciated that other benefits and advantages may also be provided.

[0177] The loops 12, 13, 14 may be attached to the strap 16 in various ways. Figure 16A-16CAn example of loops 12 , 13 , 14 fixed to a strap 16 is shown. Fig.16A The material is shown wrapped around the airbag to form loops 12, 13, 14, so that the material of the loops can be secured to more than one strap. Fig. 16B As shown, loops 12, 13, 14 may be wrapped around a portion of each strip. This may be done in the same manner as Fig.10 This can be accomplished in the same manner as shown, where each loop can have a top layer and a bottom layer surrounding a portion of the strip 16 . Fig. 16C Solid rings 12, 13, 14 are shown which may be attached to a portion of the air bag. A portion of a strap may be secured to the rings.

[0178] As discussed herein, many embodiments may use heat shrink materials for portions of or all of the rings 12, 13, 14. Heat shrink materials typically start with extruded tubing that is cross-linked using a radiation form. The tubing can be stretched or otherwise formed to the desired thickness. For example, it can be stretched into a flexible micro-thin walled tubing, it can be made rigid from thick walled tubing, or it can be made moderately flexible. Cross-linking can produce diameter memory and can be designed to have shrink ratios from 2:1 to 10:1. Heat shrinks typically shrink only in the radial direction, but can also shrink in length.

[0179] The heat shrink material can be made of thermoplastic materials such as polyolefins, fluoropolymers (including fluorinated ethylene-propylene (FEP)), polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF) (e.g., KYNAR), polyvinyl chloride (PVC), neoprene, silicone, elastomers or synthetic rubbers, and fluoropolymer elastomers (e.g., VITON). When a flexible material is required, such as a material that is inflated with an air bag, the heat shrink material can include one or more of polyolefins, silicones, elastomers, or VITON (synthetic rubber and fluoropolymer elastomers).

[0180] Heat shrink material in the form of a tube can be used to slide onto or over the strip 16. The tube can have a shrink ratio of 3:1 or higher (e.g., 3.5:1, 4:1, 4.5:1, 5:1, 6:1) and allow for gentle heat shrinking to prevent any balloon deformation or other changes in balloon properties. The material can be flexible enough to conform to the balloon over a range of balloon diameters (e.g., typical semi-compliant balloon technology with a range of ~0.5 mm diameters), and can have an adhesive or other coating to support bonding of the heat shrink material to the balloon. The heat shrink material can be a film. The heat shrink material can also be in the form of a sheet or multi-layer sheet rather than a tube.

[0181] A method of retrofitting a balloon catheter with a cage may include any of the following steps. Strips are placed around an inflated balloon. The strips may include wedge-shaped dissectors. The strips may be positioned equidistantly spaced around the inflated balloon. The strips may extend primarily longitudinally. The strips may be arranged in series in rows, such as 2-6 rows, each row having 2-6 strips. The strips may be permanently or temporarily secured to the balloon with an adhesive. Heat shrink material may be positioned as loops around the ends of the strips. Individual loops of heat shrink material may connect or cover the ends of multiple strips positioned around the balloon. Individual loops of heat shrink material may also connect or cover the ends of adjacent strips arranged in series in rows. Heat may then be applied to shrink the heat shrink material. The balloon may be deflated and then sterilized for use.

[0182] Now go to Fig.17 , a schematic diagram showing details of the cage 10 is shown. In some embodiments, the strip 16 is shown having a portion 34 comprised of a spring region. The spring portion of the strip 16 can provide a number of benefits. For example, the spring member 34 can increase the flexibility of the cage 10. Increasing the flexibility of the cage 10 can allow the cage 10 to more easily navigate the tortuous geometry of a blood vessel. The spring member 34 can also provide a wider base for the wedge dissector 26 to help the wedge dissector 26 remain in a desired orientation.

[0183] In some embodiments, the spring member 34 can engage with the surface of the balloon 20. The spring portion can help the strap 16 remain in the correct position when the wedge-shaped dissector 26 is in the outwardly extended orientation. In some instances, the spring member can counteract the lateral bending moment on the spikes so that the wedge-shaped dissector 26 does not bend, flex, or change position in an undesirable amount. In some embodiments, the spring member 34 can also provide the benefit of assisting the balloon 20 in expanding after refolding. The spring can add mechanical tension on the balloon 20 to return it to a compressed state and further help the rings compress the balloon 20 during the deflation cycle.

[0184] The spring portion 34 may have a wavy configuration and be connected to the straight portion 36. In some examples, the wedge-shaped dissector 26 may be located on the straight portion. In other embodiments, the spring member may be a sinusoidal curve. Fig.18 As shown, the spring member is shown to have a larger amplitude at the proximal end than at the distal end. In the spring portion along the straight portion in the distal direction, the amplitude can decrease and the period increases. In some embodiments, one side of the spring member can have a larger amplitude than the opposite side. In some embodiments, the spring member can be symmetrical.

[0185] Fig.18 Various embodiments of cage 10 are shown that utilize spring members 34 and linear members 36. Any number of different patterns may be used. Fig.19Details of the wedge-shaped dissector 26 on the straight portion 36 are shown.

[0186] Systems and methods as disclosed herein can deploy cages and wedge-shaped dissectors in any body lumen (including vascular lumens, such as arteries and veins). The artery can be a coronary artery, a peripheral artery, or a carotid artery or other cerebral artery, for example, or an iliac artery, a femoral artery, a superficial femoral artery, an iliac artery, or other peripheral vascular system. The device can also be used in any lumen or transport conduit in the respiratory system, the digestive system, the urinary system, the reproductive system, the lymphatic system, the auditory system, the visual system, or the endocrine system. It should be understood that the device for generating teeth in any one, two or more of these systems can take slightly different forms. Independent of the position where the device may be used, some embodiments of the device include spikes (also referred to herein as wedge-shaped dissectors, or teeth elements on square bolts) and an expandable mechanism to increase and reduce the diameter of the spike features (such as balloons), both of which are attached to the base catheter-like device.

[0187] In some embodiments, for example, Fig. 20 As shown, Fig. 20300, which may also be referred to herein as a bonding surface. The strip-facing base surface 202 of the wedge-shaped dissector 200 may be defined by the outwardly protruding base of the wedge 200 and may be directly continuous with the surface of the strip at the interface between the wedge-shaped dissector and the air bag. The strip may be a square peg 300 or other ribbon-like structure. In some embodiments, the strip-facing base surface 202 has a relatively narrow width made of a hard material capable of retaining a sharp edge. In some embodiments, the preferred material is martensitic stainless steel having a hardness of 52 to 64 on the Rockwell C scale (HRC), although other materials including polymers or copolymers may be used, including but not limited to polyolefins, fluoropolymers (including fluorinated ethylene-propylene (FEP), polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF) (e.g., KYNAR), polyvinyl chloride (PVC), neoprene, silicone, elastomers or synthetic rubbers, and fluoropolymer elastomers (e.g., VITON), or combinations thereof. In some embodiments, the strip width (circumferential direction) is about or no more than about 0.008 inches, 0.010 inches, or about 0.010 inches. In some cases, the width may be between about 0.006 inches and about 0.020 inches or between about 0.004 inches and about 0.030 inches. In some embodiments, the strip 300 generally extends longitudinally over the length of the edge of the working airbag, but may also be oriented at an angle up to and including 90 degrees to the longitudinal axis of the airbag (or other expandable structure), or oriented in a spiral manner with a varying pitch. In some embodiments, the height of the base strip 300 may be between 0.004 inches and about 0.010 inches, or in some embodiments, between about 0.002 inches and about 0.020 inches.

[0188] Still reference Fig. 20, the wedge-shaped dissector 200 may also include a radially outwardly facing surface 204 (which may be referred to herein as a non-binding surface) that may define the top surface of the wedge-shaped dissector 200 from a first (e.g., proximal) edge 206 to a second (e.g., distal) edge 208 and is configured to contact tissue, plaque, or other structure within the body. Also shown are a front surface 210, a rear surface 212, and opposing side surfaces 214 and 216. In some embodiments, the side surfaces 214, 216 extend upwardly generally perpendicular to the longitudinal axis of the strip, and the radially outwardly facing surface extends at an angle to the side surface / side surface axis between the linear, curved, or other geometrically shaped side surfaces as described elsewhere herein. Also shown is a strip or peg 300 having a non-binding (e.g., upwardly facing) surface 302 that may be coextensive with the strip-facing surface or border 202 of the wedge-shaped dissector 200 and the side surfaces (e.g., 304) and downwardly facing surface 303.

[0189] Fig.21 is a schematic diagram showing several possible non-limiting embodiments of a wedge-shaped dissector. In some embodiments, the length L of the radially outwardly facing surface U (For example, Fig. 20 The radially outwardly facing surface 204 between the first edge 206 and the second edge 208 is greater than the total length L of the surface facing the strip. B ( Fig. 20 In some embodiments, the radially outwardly facing surface length L is about 30%, 20%, or 10% less than the surface 202 facing the strip. U can be larger than the surface length L facing the strip B Smaller by about 50% to about 20%, and sometimes with the length L of the surface facing the strip B In some cases, the radially outward surface width W U Equal to or less than the surface width W facing the strip B , and typically on the surface facing the stripe with a width W B 10%, 20%, 30%, 40% or 50% or less than about 10%, 20%, 30%, 40% or 50% of the surface width W facing the stripe. B About 20% to about 50% smaller, and sometimes about or up to the width W of the surface facing the strip B Thus, in some embodiments, the width W of the surface facing the stripe is about 50%, 60%, 70%, 75% or 80%. B At least one of the edges of the strip has an angle θ of about 90 degrees or less, which defines a width W from the surface facing the strip. B to the width W on the surface facing the strip BThe width W of the radially outwardly facing surface on at least one of the edges U Although in some embodiments, the radially outwardly facing surface width W U The width W of the radially outwardly facing surface is constant from edge to edge, and in some embodiments, U Length L of the surface facing radially outward U The width of the radially outwardly facing surface portion may vary, as described elsewhere herein, such as decreasing from a first lateral edge to a point or portion between the first lateral edge and the second lateral edge of the radially outwardly facing surface portion, and then increasing from a point or portion between the proximal edge and the distal edge to the distal edge. In some embodiments, a relatively central portion between the proximal edge and the distal edge has a constant width, while a lateral portion surrounding the relatively central portion has a variable width, such as a tapered width.

[0190] Although the radially outward width W U It can be evolved to a point, from the base width W facing the stripe to the base surface 202 facing the stripe B The radially outwardly facing width W of the radially outwardly facing surface 204 is inclined at a single constant inclination angle θ or bevel angle U ,like Fig.22A (similar to an end view of an isosceles triangle) and Fig. 22B (isometric view), it may also include multiple different angles in some embodiments, such as more than a single oblique angle, such as double, triple, or more oblique angles (e.g., a first angle at a first segment of its height, a second angle less than or greater than the first angle at a second segment of its height, and in some cases, a third angle less than or greater than the first angle and less than or greater than the second angle at a third segment of its height). Fig. 22C An end view of a wedge-shaped dissector is shown, and Fig.22D An isometric view of a wedge-shaped dissector is shown having a plurality of different slopes and associated angles from the base surface facing the strap to the surface facing radially outward, wherein the angle θ2 between the horizontal plane and the upward slope after the transition point is greater than the angle θ1 between the horizontal base edge facing the strap and the intersecting upward slope (in other words, the first slope S1 from the bottom edge of the base edge facing the strap is less steep than the second slope S2 rising upward after the transition point). Fig.22E and Fig.22F Shows something like Fig. 22C and Fig.22D An embodiment of the invention, except that the angle θ2 is less than the angle θ1 (in other words, the first slope S1 from the bottom edge of the base edge facing the strip is steeper than the second slope S2 after the transition point).

[0191] Alternatively, some embodiments may also include a series of steps at different heights where the width transitions to a narrower width and then continues to climb in height. When a series of steps is used instead of a bevel, sometimes it may be necessary to grind an edge using methods other than a stainless steel scroll due to manufacturing limitations.

[0192] In some embodiments, the radially outwardly facing edge or surface (e.g., Fig. 20 In some embodiments, the shape of the radially outwardly facing surface 204) may have the same height from one edge 206 to the other edge 208 of the radially outwardly facing length or width. In some embodiments, the height along the radially outwardly facing surface 204 may vary from one edge 206 to the other edge 208. When the radially outwardly facing edge or surface 204 varies, the radially outwardly facing edge generally has a series of raised features referred to herein as wedge-shaped dissectors, spikes, or teeth elements 200. In some embodiments, the midpoint of these raised features along the radially outwardly facing length 204 between the edges 206, 208 is the highest point of the radially outwardly facing surface. However, in some embodiments, the highest point deviates from the midpoint, and there may be multiple highest points scattered relative to the lower points of the combined / bottom surface 202. In some embodiments, the maximum change in height between the edges 206, 208 of the radially outward surface 204 of the wedge-shaped dissector 200 and the radially outward surface 302 of the base strip 300 between the wedge-shaped dissector 200 can be less than approximately 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, or less than the total height of the wedge-shaped dissector 200.

[0193] In some embodiments, the base strip 300 has a roughened or otherwise textured lower surface to aid in adhesion to the outer surface of the underlying airbag. The base strip may have any desired geometry, such as a square, rectangular, or in some embodiments, a trapezoid, wherein the bottom surface has a greater width, such as approximately or at least approximately 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more of the top surface. In some embodiments, between about 1 / 3 and 1 / 2 of the top surface of the strip 300 is covered by the wedge-shaped dissector 200, while between about 1 / 2 and 2 / 3 of the top surface is free of the wedge-shaped dissector 200.

[0194] Reference Fig.21 In some embodiments, the radially outward-facing surface, viewed from the top, can be viewed as a line extending from one edge of the radially outward-facing length to another edge of the radially outward-facing length (e.g., where W Uis a point, assuming 210A is the radially outward facing surface of the device). This would resemble a polished or "razor sharp" edge with no apparent width. In other embodiments, the top view would appear as a slightly less sharp, unpolished surface that resembles a rectangle (e.g., if 210B or 210C were the top of the device, and assuming everything above those lines was cut away), where the radially outward facing surface W U The width of the top or radially outward facing surface is less than the base surface WB facing the stripe, but the slope or slopes between the width edge and the height from the base surface facing the stripe to the radially outward facing surface are directly related. In some embodiments, the top or radially outward facing surface can be a line, a flat rectangle, a rounded or mountain-shaped surface (which may appear rectangular or square in a two-dimensional perspective), or take the shape of a pyramid, wedge, trapezoid, or other polygonal shape.

[0195] In some embodiments, the unpolished width can be a width of, for example, about or greater than about 1 nm, 5 nm, 10 nm, 50 nm, 100 nm, 500 nm, 1 μm, 2 μm, 5 μm, or 10 μm measured at a radially outwardly facing edge or surface. In some embodiments, the unpolished radially outwardly facing surface of the wedge-shaped dissector can be advantageous because, for example, in the case of creating teeth, depressions, and / or microperforations in the wedge-shaped dissector target, a slightly less sharp / relatively less pointed edge than a polished edge is desirable, rather than cutting through the entire lumen wall. In some embodiments, the entire radially outwardly facing wedge-shaped dissector surface has an unpolished width.

[0196] The shape of the wedge dissector can take many forms, including Figure 21A-21G Additional non-limiting embodiments are shown. For example, Fig.21A The wedge-shaped dissector 200 is shown ascending from a base strip 300 having a ground / sharp radially outwardly facing surface 204 from edge 206 to edge 208 . Figure 21B-Figure 21C The wedge-shaped dissector shown has chamfered portions 780 of the radially outwardly facing surfaces on both lateral edges that slope or otherwise rise upward to a polished central single point 782 or edge having a length 781. The bevel may be a straight bevel, or follow a bevel as follows: Fig.21D The curve shown in Fig. 21B As shown, the wedge-shaped dissector includes lateral portions 780 having radially outward facing surfaces that increase in height but decrease in width from a first edge to a central mid-portion 781 of length having minimal / negligible width, then increases in width and decreases in width from the midpoint to a second edge. Fig. 21C Shows something like Fig. 21B The wedge-shaped dissector of FIG. 782 differs in that the middle portion is a single polished apex.

[0197] Fig.21D A wedge-shaped dissector is shown having a radially outwardly facing surface 785, the height of which increases from an edge along a first curved length, but the width decreases from the first edge to a central region such as midpoint 786, and then along a second curved length to the other edge, the height decreases and the width increases.

[0198] Figure 21E-21G An embodiment of a wedge-shaped dissector is shown having an unground radially outwardly facing surface that does not include a sharp ground point or edge (eg, having a width greater than the width of a ground edge). Fig.21E shows a slight resemblance to Fig. 21B An embodiment of a wedge-shaped dissector is completely unground except for the radially outwardly facing surface along its length. Fig.21F shows a slight resemblance to Fig. 21C An embodiment of a wedge-shaped dissector is completely unground except for the radially outwardly facing surface along its length. Figure 21G shows a slight resemblance to Fig.21D An embodiment of a wedge-shaped dissector is completely unground except for the radially outwardly facing surface along its length.

[0199] Figure 21B-Figure 21G A commonality of the embodiments is that the width of the radially outward facing surface is greater (wider) at the lateral edges and narrower / smaller at more central locations at a center point or longer center portion. The height of the radially outward facing surface from one edge to another can be curved or otherwise variable, for example, with the highest point more centrally located and having the shortest height at one or more edges when viewed from the side. In these embodiments, the orientation of the narrowest or thinnest (smallest width) cross-section of the radially outward facing surface can be along the longitudinal axis of the strip, which can be aligned or not aligned with the longitudinal axis of the airbag.

[0200] In other embodiments, the narrower point or portion need not be symmetrical about the midpoint of the length of the radially outward facing surface, but in some cases may be asymmetrical / offset from the midpoint of the length.

[0201] Regardless of the geometry of the wedge-shaped dissector, some embodiments are characterized by including an end 202 or base (e.g., the spike has a base that "attaches" to the balloon or some molded element, whether it is a peg (or strap) and a radially outward facing surface 204 at the end or tip having a length and width. In some embodiments, the width of the radially outward facing end is about or about 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20% or less less than the width of the base end facing the strap, or a range including any two of the above values. The width of the base end of the wedge-shaped dissector facing the strap (and the peg / strap) can be fixed / constant, or in some embodiments, variable.

[0202] The wedge-shaped dissector can have a variety of different sizes and shapes. In some embodiments, the length of the wedge-shaped dissector at the base end facing the strip is about or less than, for example, about 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, or 0.01 inches, or a range comprising any two of the above values, or the length is between about 0.01 inches and about 0.06 inches, or between about 0.01 inches and about 0.04 inches. In some embodiments, the height of the wedge-shaped dissector measured from the non-bonded edge of the base strip can be about or less than about 0.05 inches, 0.04 inches, 0.03 inches, 0.025 inches, 0.02 inches, 0.015 inches, 0.01 inches, or 0.005 inches, or in some embodiments, between about 0.005 inches and about 0.025 inches, or between about 0.01 inches and about 0.025 inches, or between about 0.005 inches and about 0.015 inches.

[0203] In some embodiments, the length of the base of the wedge-shaped dissector facing the strip can be about or less than about 25mm, 20mm, 15mm, 14mm, 13mm, 12mm, 11mm, 10mm, 9mm, 8mm, 7mm, 6mm, 5mm, 4mm, 3mm, 2mm or 1mm, or a range comprising any two or more of the aforementioned values. In some embodiments, the length of the base of the wedge-shaped dissector facing the strip can be 2mm, 2.5mm or 3mm, or between about 1mm to about 5mm, or between about 1.5mm to about 3.5mm. The wedge-shaped dissector can be spaced apart in a regular or irregular manner to increase the flexibility of the device. For example, the spacing between adjacent wedge-shaped dissectors can be, for example, about 2 times to about 10 times the length of the base of the wedge-shaped strip facing the wedge-shaped dissector, wherein the wedge-shaped dissector is longitudinally positioned. For example, in some embodiments, wedge-shaped dissectors having a base length of the wedge facing the strip of about 2.5 mm in length may have a spacing of about 5 mm between them, or a spacing of about 25 mm between them. In some embodiments, a group of wedge-shaped dissectors may be spaced apart at a first smaller ratio, such as about 1-4 times the base length of the wedge-shaped dissector facing the strip, and then a group may be spaced apart at a second larger ratio, such as about 8-10 times the base length of the wedge-shaped dissector facing the strip. For example, a first group of wedge-shaped dissectors having a base length facing the strip of 2.5 mm may have a spacing of 5 mm between them, and then a second group of wedge-shaped dissectors may be spaced apart from the first group by 20 mm. The second group may have the same or different size, shape, and / or spacing as the first group.

[0204] In some embodiments, the position of the radially outwardly facing surface relative to the base surface facing the strip is not always centered or symmetrical. In other words, the midpoint of the radially outwardly facing surface may be offset from the midpoint of the base surface facing the strip. Figure 23A-23B and Fig.24 An asymmetric radially outward facing surface is shown as an alternative embodiment of the spike. The asymmetric radially outward facing surface can be off-center relative to the radially outward facing width edge aligned directly above the base width edge facing the strip. In this configuration, only one base width edge facing the strip has an inclined edge 440 that rises in height away from the radially outward facing surface, while the other height edge 442 is perpendicular to the bottom surface 444 facing the strip at a 90 degree angle RA (right angle), as best shown by Fig.23AIn addition, the radially outwardly facing surface may be chamfered or beveled or have a radius at one or both of the width ends and / or at one or both of the length ends. In some variations, the radially outwardly facing surface location is limited to an area protruding upward on the base surface facing the strip. The radially outwardly facing surface may be, for example, a sharp line (e.g., a polished edge) or any of the described surfaces or any of the described unpolished edge variations. Figure 23C-Figure 23D An embodiment is shown in which the total volume or substantially the entire volume of the wedge cutter rises / appears over less than the entire width (or surface area) of the base of the strip, for example equal to or less than approximately 70%, 60%, 50%, 40% or 30% of the width or surface area of ​​the strip, and the wedge cutter is therefore offset asymmetrically forward or rearward from the longitudinal axis of the strip.

[0205] Fig.24 One embodiment is shown showing how the radially outward facing surface 204 can have a varying height from the base strip-facing surface 202 (increasing from a first height 24H1 at a first edge 206 to a second height 24H2 at a second edge 208) and can include an edge profile that is rounded with a radius of curvature of the radially outward facing length edges 206, 208. Here, we see a wider radius of curvature at one edge 206, which has a short height 24H1 measured from the base strip-facing surface 202, while the opposite edge 208 has a narrower radius of curvature and has a longer height 24H2 measured from the base strip-facing surface 202.

[0206] In some embodiments, the various wedge-shaped dissector features described herein may provide unique advantages to aid in the delivery of the device, including, but not limited to, reduced vessel trauma if the radially outwardly facing surface is positioned on the exterior of the delivery device and / or may contact the lumen wall and potentially scrape the vessel wall during movement through the artery. For example, this may be the case in embodiments having a wedge-shaped dissector that has an unpolished radially outwardly facing surface.

[0207] Additionally, without being limited by theory, certain shapes may provide more efficient penetration of tissue. For example, a wedge-shaped dissector including chamfered or rounded radially outwardly facing edges may potentially enter a vessel wall with less force (requiring less pressure to penetrate tissue) while still maintaining effective microchannels 5100 to weaken tissue and enable tissue expansion with minimal vessel trauma and cellular damage.

[0208] In addition, although there are existing solutions for providing blades or sharp edges or scoring lines on balloons during angioplasty or other procedures associated with balloon dilation for cutting or scoring plaques, these existing methods are believed to have problems or disadvantages that are eliminated or avoided by the systems and methods disclosed herein. Cutting or scoring the lumen wall (such as plaques, for example) during angioplasty can be performed at high pressures, which can result in a high degree of damage to the blood vessel. While the angioplasty balloon is dilated to dilate the plaque, the cutting blade, edge or scoring line can be forced into the wall of the blood vessel. In this process, the cutting blade, edge or scoring line can be forced into the blood vessel wall at an oblique angle and can dig out the plaque, potentially increasing the tendency of dissection. In contrast, in some embodiments, the application of a wedge-shaped dissector can be expanded into the plaque at low pressures to form precise microperforations, teeth and / or indentations in a radially outward direction, which form precise notches, cutting lines or planes in other locations or other targets in the plaque or lumen wall. The radially outward facing surface of the wedge-shaped dissector can be pushed into small surface area plaque or other luminal surfaces and is less likely to dig out the plaque or luminal surface.

[0209] In some embodiments, the wedge-shaped dissector can be designed to provide a series of directed punctures or teeth that enter the diseased vessel wall (but in some cases do not completely penetrate the diseased vessel wall), which in some cases can produce predictable and controlled expansion of the lumen along the teeth-like lines with minimal trauma and without cutting with a blade with a ground / sharp edge. The perforations can be used as Fig.23E , such as microchannels, for passage of drugs or other agents as shown in the drawings. Drugs or other agents can be delivered using a drug coated balloon in combination with the devices disclosed herein or on a separate device used after use of the disclosed devices. In some embodiments, the wedge-shaped dissector can be detachable from the base strip and / or coated or otherwise impregnated with one or more agents for drug delivery. The wedge-shaped dissector can create a linear line of weakness or perforation without cutting a continuous axial portion of the vessel wall, which can achieve more effective and gentle vessel lumen expansion 5110, such as Fig.23F and 23F.1As shown. Examples of the stages of progressive expansion and dentations can be seen in 5110, 5130, 5140, 5150. The balloon can be inflated, and as the pressure in the balloon increases, the following series of events can occur: the balloon deploys in the artery and the strips are exposed from their resting position within the folds; the ends (e.g., radially outward surfaces) of the wedge-shaped dissectors on the strips contact the vessel wall; the relatively narrow profile of the ends penetrates the wall, thereby creating a nucleation site for the cracking event; the cracks rapidly generate cracks along the luminal surface, and due to the proximity and alignment of the cracks, the cracks coalesce to become long cracks along the luminal surface, which can extend along the entire length of the strip, less than the length of the strip, or greater than the length of the strip; it has been found that the depth of crack penetration is generally similar to the depth of the media layer tissue.

[0210] In order to reduce the potential rigidity of the square bolt or base strip, it is envisioned that in some embodiments, a series of release elements on the square bolt can be added, as shown in Figures 25 and Fig.26 As shown. These release elements can be produced in many different ways, the purpose of which is to remove material and provide a more flexible square bolt for the wedge to be facing the base of the strip. The release element can be formed at the base of the square bolt opposite the base surface of the wedge cutter facing the strip, at the top of the square bolt directly adjacent to the base surface of the wedge cutter facing the strip, or at both locations, namely the top and bottom. The release element can also be formed on the side of the square bolt, or openings can be added to the square bolt in the base facing the strip through other areas of the square bolt. Any combination of top, bottom, sides or openings can be added to the square bolt to provide a release element.

[0211] In some embodiments, as shown in FIG. 25 and Fig.26 As shown, the strip 300 can have release holes or slits located at the top, bottom, center, or off-center, and these release holes or slits are circular, rectangular, linear, triangular, or elliptical, or a combination thereof (see FIGS. 25 and Fig.26 ). The strips provide a support base infrastructure that is intended to be flexible and follow the movement of the airbag so that the wedges are properly oriented.

[0212] Figure 25 and Fig.26 The release apertures illustrated in the drawings can be specifically designed to provide pathways through which balloon-based pharmacological agents can be delivered; in addition, they provide strain relief in the surface to enhance the deliverability of the device in tortuous anatomies. Figures 25A-25C An embodiment of a wedge-shaped dissector having a release element 502 on a lower surface 500 of the strap 300 that is opposite the engagement surface of the wedge-shaped dissector 200 is shown. Fig.25AOne embodiment is shown in which the release elements 502 are regularly spaced about the length of the engagement surface of each wedge-shaped dissector 200 . Fig.25B An embodiment is shown in which the release elements 502 are regularly spaced 50% or less of the length of the engagement surface of each wedge-shaped dissector 200 . Fig.25C One embodiment is shown in which each release element 502 is spaced 50% or less of the length of the engagement surface of each wedge dissector 200, but the release elements 502 are grouped only under the wedge dissectors and are not present under the strap portions between the wedge dissectors. In other embodiments, the release elements 502 are grouped only under the strap portions between the wedge dissectors and not under the strap portions directly under the wedge dissectors.

[0213] Figure 25D-Figure 25E An embodiment is shown in which the release element 502 is present on the top (joined or upward facing surface 302) of the strip between the wedge-shaped dissectors. Fig.25D and Fig.25E In the embodiment, the release element forms a depression in the upwardly facing surface 302 of the strip between the wedge-shaped dissectors, with a Fig.25D The generally curved base shown, and Fig.25E A relatively more square or rectangular base is shown, with or without rounded edges. Fig.25F It is combined in Fig.25C and 25D 00147] This is an example of an embodiment of two different kinds of release elements 502 found in the embodiments of FIG. Other arrangements of combinations are possible, depending on the desired clinical outcome. Figure 25G and Fig.25H Other embodiments are shown in which the release element 502 is located on the front side surface 304 and / or the back side surface of the strap 300 . Figure 25G A pyramid-shaped release element 502 is generally shown, and Fig.25H Generally shown is an arcuate release element 502. The release element can be axially spaced from the wedge-shaped dissector as shown, and / or spaced in axial alignment with the wedge-shaped dissector in other embodiments. Fig.25I and Fig.25J The release element 502 is shown in a vertical position ( Fig.25I ) or horizontal ( Fig.25J ) oriented through-channel, which can be axially spaced from the wedge-shaped dissector as shown, or in another configuration. In some embodiments, the release element can be oriented at an oblique angle to the longitudinal axis of the strip. Figure 25K One embodiment is shown in which the release element 502 takes the form of a groove located on the front surface and / or the rear surface, in conjunction with the base surface, and / or other locations.

[0214] To assist in the removal of material from the initial blade, in some embodiments, the strips may include tabs along the base or bonding surface. These tabs can help control the long strips from vibration or movement during the material removal process. Once the manufacturing is completed, the tabs are removed. In some embodiments, the tabs have inserts, which are located at the base of the strips. In some embodiments, when multiple strips are laser cut, for example, from the same source material sheet, the inserted release element can be used as the tab, and this is advantageous during the manufacturing process. In some embodiments, a complementary protrusion (e.g., a tab or related structure) on or connected to an adjacent area of ​​the source material to be laser cut can be loaded into the inserted release element of the strip adjacent to the source material to maintain proper alignment of the strip during the laser cutting / manufacturing process. This can keep the strip in place during laser cutting and prevent the strip from undesirable migration and misalignment relative to the adjacent material area due to, for example, laser vibration, which may reduce product yield. In some embodiments, the release element for manufacturing stability purposes does not require an insert and can take the form of a tab protruding outward from the base of the tab. In some embodiments, these tabs are later removed by laser cutting or other methods prior to bonding or other attachment to the outer surface of the airbag in order to prevent inadvertent punctures of the airbag. Figure 25L and Figure 25M Some embodiments are shown in FIG. 5 , which schematically shows a strip 300 with a wedge-shaped dissector 200 during the strip and manufacturing process. Also shown is a tab 580 that can be laser cut from a source material and connected at one end to an adjacent area of ​​the source material 581 and at the other end inserted into an insertion release element 502, for example, in the lower surface of the strip. The insertion release element 502 can be previously, for example, Figure 25A-25K or any pattern described in other figures, and in some embodiments is shown below the wedge-shaped dissector 200. Figure 25M A tab 580 is shown which may be cut into sections 588, 589 after the manufacturing process, when no longer needed to hold the strap 300 in place relative to the adjacent source material 581, and the strap 300 may then be separated for attachment to an air bag or other device. The insert may allow the tab to be removed while minimizing the amount of material that may hang below the bottom of the strap, which may interfere with the strap's engagement with the air bag or other inflation device.

[0215] In some embodiments, the balloon can be pleated and curled down to a very narrow profile, thereby allowing the device to be delivered through an introducer sheath with a narrow diameter. Once the balloon is deployed and deflated, the balloon profile after expansion can be larger than its original folds and curling diameter. The new profile can have a strip located at the protrusion of the balloon profile, which may scrape the arterial wall or hook on the opening of an accessory device (such as an introducer sheath). According to some embodiments, the following elements, which are generally described as ramps, can solve this potential problem.

[0216] Fig.25N Schematically illustrated is an embodiment of a ramp 680 of adhesive or other material placed at (e.g., above) one (as shown) or both side ends 333 of some or all of the strips 300. This can be used in some cases to attach the strips 300 to the balloon, in addition to placing adhesive at other locations, such as below the strips (e.g., on the lower surface of the strips 300). The ramp 680 can provide an effective flexible interface between the edge of the flexible balloon (not shown) and the semi-rigid strip 300 because the ramp 680 can be made of a relatively more flexible material (e.g., adhesive) than the material of the strips 300. In some embodiments, the ramp 680 can be designed to slope gently from the balloon surface (not shown) to the edge of the strip. In some embodiments, the adhesive ramp 680 can advantageously retain the strips and provide protection from undesirable interactions of the strips 300 with auxiliary devices during surgery.

[0217] In some embodiments, the lateral edges of these strips may include glue bevels 680 to hold the strips 300 and provide protection from interaction with auxiliary devices during surgery. The bevels may be produced using UV glue, using repeated deposition and curing steps in a series of lay-up and build-up layers until the bevels are produced, such as Figure 25N.1 Alternatively, the bevel can be preformed into the desired shape and then bonded to the surface using cyanoacrylate, UV glue, or other materials or methods, thereby providing a chemical, mechanical, or electromagnetic bond between the preformed bevel and the balloon surface to bond the preformed bevel to the balloon surface. Note that in this embodiment, the top of the adhesive layer is close to the top of the tape protrusion (wedge-shaped dissector end) 681. In some embodiments, depending on the desired results, the bevel can extend laterally beyond the rear edge of the strip by a distance between about 0.008 inches to about 0.040, between about 0.08 inches to about 0.012 inches, between about 0.010 inches to about 0.040 inches, between about 0.020 inches to about 0.030 inches, or other dimensions.

[0218] In some embodiments, a feature that can be incorporated into the balloon element is a tapered ramp. The tapered ramp feature can be implemented in several ways. In one embodiment, the tapered ramp is made by taking a tapered configuration for a larger balloon (e.g., taking a tapered shape for a 6 mm balloon or a 5.5 mm balloon) and combining it using known methods to attach to a 5 mm balloon. Fig.25O 960 . In some cases, the outer diameter of the tapered member 970 is larger than the outer diameter of the balloon 960, for example, about or at least about 5%, 10%, 15%, 20% or more, or in some embodiments, about 5% to about 20% larger than the outer diameter of the balloon 960. The relatively large tapered member 970 will be positioned protruding from the balloon 960, thereby creating a lip 972 at the intersection of the balloon body. The lip 972 can be helpful in reducing the possibility of the edge of the metal band being blocked or lifted when the balloon is deflated and retracted through the introducer catheter.

[0219] In some embodiments, Figure 25P As shown, a series of tracks 980 are included along the tapered member 970 to serve as a support or reinforcement structure and to help deflate the balloon 960 as it enters the introducer catheter (not shown). In some embodiments, the tracks 980 are oriented / aligned with the longitudinal axis of the strap, further enhancing the function of pushing the strap toward the middle of the balloon as the tapered member is pulled through the introducer.

[0220] In some embodiments, airbags are also disclosed herein that can have depressions in the outer surface of the airbag for strap attachment. A series of depressions can be created on the surface of the airbag. In some embodiments, the depressions can be configured to be wide enough and long enough to allow the strap to be placed within the depressions, such as completely placed within the depressions. The depth of the depressions can be sized to limit the possibility that the straps may get stuck on the distal opening of the introducer during retraction of the airbag.

[0221] The use of through holes or microchannels 5100 in or on the sides of the pegs can provide a mechanism for providing therapeutic agents, such as Fig.23EAs shown, for example, one or more drugs, nanoparticles and / or stem cells are transported from the balloon surface to the surface of the diseased site by capillary action or diffusion, and / or the balloon pressure is used to force the drug, nanoparticle and / or stem cell to pass through the microchannel 5100 to reach the surface or enter the diseased site. Alternatively, the microchannel 5100 or the modified surface can provide a storage space for drugs, nanoparticles or stem cells or other therapeutic agents to place and protect them during delivery to the diseased site. In some embodiments, the drug can be any drug known in the art. In some embodiments, depending on the specific disease being treated and taking into account the physical properties of the drug, examples of drugs that can be applied to the methods and devices of the present invention include, but are not limited to: anti-restenosis drugs, pro- or anti-proliferative drugs, anti-angiogenic drugs, anti-mitotic drugs, antiplatelet drugs, anticoagulant drugs, antifibrin drugs, antithrombin drugs, anti-cell growth inhibitors, antibiotic drugs, anti-enzyme drugs, anti-metabolites, angiogenic drugs, cytoprotective drugs, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and / or cardioprotective drugs.

[0222] Examples of antiproliferative drugs include, but are not limited to, actinomycin, taxol, docetaxel, paclitaxel, sirolimus (rapamycin), biolimus (sirolimus) A9 (Biosensors International, Singapore), deforolimus, AP23572 (Ariad Pharmaceuticals), tacrolimus, temsirolimus, pimecrolimus, zotarolimus ABT-578), 40-O-(2-hydroxy)ethyl rapamycin (everolimus), 40-O-(3-hydroxypropyl)rapamycin (a structural derivative of rapamycin), 40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin (a structural derivative of rapamycin), 40-O-tetrazolyl rapamycin (a structural derivative of rapamycin), 40-epi-(N-1-tetrazolyl)-rapamycin, and pirfenidone.

[0223] Examples of anti-inflammatory drugs include both steroidal and nonsteroidal (NSAID) anti-inflammatory agents, such as, but not limited to, clobetasol, alclofenac, benclomethasone dipropionate, progesterone acetate, alpha amylase, ancifar, ancifit, amfenac sodium, amipridaxer hydrochloride, anakinra, aniroic acid, anizafen, azapropazone, balsalazide disodium, benzydamide, benprofen, benzydamine hydrochloride, bromelain, bropimol, budesonide, carprofen, ciprofen, cinpentazone, criprofen, clobetasol propionate, clobetasone butyrate, clopirac, clothiocarb propionate, cortisone acetate, cortodoxone, deflazacort, desonide, dexamethasone, dexamethasone dipropionate salt, dexamethasone acetate, dexamethasone phosphate, limusone, cortisone, cortisone acetate, hydrocortisone, prednisone, prednisone acetate, betamethasone, betamethasone acetate, diclofenac potassium, diclofenac sodium, diflorasone difluoroacetate, diflunisal sodium, difluprednate, difluphenazine, dimethyl sulfoxide, hydroxycinonide, medizone, enmotumomab, fenamic acid sodium, etodolac, etofenac, felbinac, fenamox, fenbufen, fencloac, fencloac (diaphragm), fendosal, fenpyroximate, diflufenamic acid, flurazepam, flurazepam, flufenamic acid, flunitrin acetate, flunixin, flunixin meglumine, fluocortol butylate, fluorometholone acetate, flurbiprofen, fluralprofen, fluticasone propionate, furaprofen, furobufen, halcinonide, halobetasol propionate, halopednisone acetate, ibuprofen aluminum, ibuprofen aluminum, ibuprofen insulin, ilonidapol, indomethacin, indomethacin sodium, indoprofen, inoxicam, ketoprofen, lomexazole hydrochloride, lornoxicam, loteprednol etabonate, meclofenamic acid sodium, meclofenamic acid, meclofenamic acid dibutyrate, mefenamic acid, mesalamine, mesilazine, methylprednisolone sulfoheptate, morphine, nabumetone, naproxen, naproxen sodium, naproxen, nemazo, olsalazine sodium, ocuproin, oxaprozin, hydroxy Cibylbutazone, paraniline hydrochloride, piroxicam cinnamate, piroxicam ethanolamine, piroprofen, prenazad, prifetone, produracil, proquinezone, proxazole, proxazole citrate, rimexolone, clomazalide, salsaquine, salacridine, salsalate, hemocyanin chloride, dexamethasone, tamostat, tamostat, tenifite, todap sodium, tenoxicam, tacoracetam, benzylisoquinolone, tetrahydroindole, tiopine, tiocortisone pivalate, tolmetin sodium, triclosan, triflubamate, azidoindolic acid, aspirin (acetylsalicylic acid), salicylic acid, corticosteroids, glucocorticoids, tacrolimus and pimecrolimus.

[0224] Examples of anti-tumor agents and anti-mitotic agents include, but are not limited to, paclitaxel, docetaxel, methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride, and mitomycin.

[0225] Examples of antiplatelet drugs, anticoagulant drugs, antifibrin drugs, and antithrombin drugs include, but are not limited to, heparin, heparin sodium, low molecular weight heparin, heparinoids, hirudin, argatroban, forskolin, prostacyclin, prostacyclin, prostacyclin dextran, proline-arginine-chloromethyl, dipyridamole, glycoprotein IIb / IIIa platelet membrane receptor antagonist antibodies, recombinant hirudin, and thrombin, e.g. Thrombin inhibitors (bivastatin from Biogen), calcium channel blockers such as nifedipine, colchicine, fish oil (omega 3-fatty acids), histamine antagonists, lovastatin, monoclonal antibodies such as for platelet-derived growth factor (PDGF) receptors, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioproteinase inhibitors, triazolopyrimidines, nitric oxide or nitric oxide donors, superoxide dismutase, superoxide dismutase mimetics, and 4-amino-2,2,6,6-tetramethylpiperidin-1-oxyl (4-amino-TEMPO).

[0226] Examples of cytostatic or antiproliferative drugs include, but are not limited to, angiopeptides, angiotensin converting enzyme inhibitors such as captopril, cilazapril or lisinopril, calcium channel blockers such as nifedipine; colchicine, fibroblast growth factor (FGF) antagonists; fish oil (ω-3-fatty acids); histamine antagonists; lovastatin, monoclonal antibodies such as, but not limited to, those specific for platelet-derived growth factor (PDGF) receptors; sodium nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioproteinase inhibitors, triazolopyrimidines (PDGF antagonists) and nitric oxide.

[0227] Examples of ACE inhibitors include, but are not limited to, quinapril, perindopril, ramipril, captopril, benazepril, trandolapril, fosinopril, lisinopril, moexipril, and enalapril.

[0228] Examples of angiotensin II receptor antagonists include, but are not limited to, irbesartan and losartan.

[0229] Other therapeutic agents that may find beneficial use in the present invention include, but are not limited to, interferon-alpha, genetically engineered endothelial cells, dexamethasone, antisense molecules that bind to complementary DNA to inhibit transcription, and ribozymes, antibodies, receptor ligands such as the nuclear receptor ligands estradiol and retinoids, thiazolidinediones (glitazones), enzymes, adhesion peptides, coagulation factors, inhibitors or clot-lytic drugs such as streptokinase and tissue plasminogen activator, antigens for immunization, hormones and growth factors, oligonucleotides such as antisense oligonucleotides and ribozymes and retroviral vectors for gene therapy, antiviral drugs and diuretics.

[0230] In other embodiments, combinations of any two, three, or other numbers of the foregoing drugs or other therapeutic agents may be utilized, depending on the desired clinical outcome.

[0231] One method for placing drugs, nanoparticles, stem cells or other therapeutic agents in specific areas, such as release holes, is to use a direct write process, such as MICRO-PENNING technology (MICROPEN Technologies, Honeoye Falls, NY), to deposit materials onto a surface. In general, the term "direct write" describes a printing or patterning method that uses a computerized motion control console and a stationary pattern generation device to dispense a flowable material in a designed pattern onto a surface. MICRO-PENNING is a flow-based microdispensing technology in which the printed material is extruded and controlled to a high degree by a syringe and a precision pen tip. The pen tip "rides" on the surface of the material, does not contact the substrate surface, and is able to place a precise amount of material in a precise location.

[0232] Fig.26 An embodiment of a strap 500 is shown with a release element 502 on the lower surface of the strap 300 opposite the engagement surface of the wedge-shaped dissector 200, with additional relatively large holes 503 between the wedge-shaped dissectors 200, which holes can be configured to facilitate bonding of the strap 300 to the underlying air bag, as disclosed, for example, in PCT publication WO 2016 / 073490 published on May 12, 2016, which is incorporated by reference in its entirety. The holes 503 can be relatively oval, circular, or any other shape, depending on the desired clinical outcome.

[0233] In some embodiments, the longitudinal axes of the strips are oriented longitudinally along the airbag and are spaced apart from each other. In some embodiments, the strips do not completely cover the length of the airbag. For example, in one embodiment, an 80 mm long airbag may have a strip measuring 76.6 mm. Although the length of the strips may be the same as the defined working airbag length, in some embodiments, the length of the strips is shorter than the defined working airbag length to allow the airbag to shrink, which is typically observed when the airbag reaches the rated burst pressure. In some cases, the length of each strip may be no shorter than the entire working airbag length by no more than about 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2% or 1%, or between about 1% and about 7%, between about 1% and about 5%, or between about 1% and about 4%. In some embodiments, the working airbag length does not include the length of the cone.

[0234] In some embodiments, a portion of the strap, for example, the base of the strap (eg, the lowermost surface configured to attach to the outer surface of the airbag) may be roughened to aid adhesion.

[0235] The spikes (e.g., tooth elements or wedge-shaped dissectors) can be manufactured in many different manufacturing methods and in a wide range of shapes. With respect to manufacturing processes, one or more additive or subtractive processes can be used to manufacture the device. Additive processes such as high energy vapor deposition (e.g., laser chemical vapor deposition), self-assembly techniques, polymer / metal 3D printing, selective laser sintering, powder printers or other stereolithography are a few such options, but other additive processes can be used. Alternatively, subtractive processes such as etching, CNC milling, laser cutting, water jetting or electrical discharge machining are just some examples, but other subtractive processes can also be used.

[0236] In some embodiments, the manufacturing method includes using a martensitic stainless steel spool, such as 300 or 400 series stainless steel having a hardness of about 52 to about 64 on the Rockwell C scale (HRC), but other materials may also be used. The spool is ground or precisely unground on one or both sides of one edge of the steel. In some embodiments, the steel is in the form of a thin coil, between about 0.005 inches and about 0.020 inches thick or between about 0.007 inches and about 0.015 inches thick, and / or between about 0.25 inches and about 0.75 inches wide, but the width can range from 0.005 inches to about 0.005 inches and 0.020 inches and between 0.15 inches and 1 inch. In some embodiments, the tolerances for the thickness and width of the spool are greater on the higher ends and can have a thickness greater than about 0.005 inches and a width greater than about 0.5 inches. The edges that are ground or unground can be a single grind or two or more grind angles (e.g., such as Fig.21 22). In some embodiments, when the angle of the polished edge is measured from Fig.21 When the slope of the height of the bonding end to the non-bonding end shown in , the angle of the grinded edge can be, for example, greater than about 75 degrees. However, when more than one grinding angle is used, the angle of the end can be less than, for example, about 75 degrees. In some embodiments, as the grinded edge moves toward the grinding edge in a series of bevels, it has an angle of about or at least about 70, 75, 80, 85, 90 degrees or more. In addition to the grinded edge, independent of the number of grinded angles, in some embodiments, a separate and additional edge is created at the very end of the non-bonded edge of these strips. When added, the additional end edge height from the grinded edge to the non-bonded edge is usually very short and typically has a much larger angle than the entire grinded edge. Regardless of the number of grinded angles used, the width W of the non-bonded end is ucan be described as the radius of the tip. The width W of the non-binding tip u When the width is less than about 0.015 inches or 0.006 inches in some cases, the surface area is minimized to have a less significant contact surface with the blood vessel, thereby reducing the energy requirements for penetration. When the tip is configured for penetration into a harder surface (such as a calcium bed), in some cases, a more obtuse angle or removal of the unbound tip at a greater distance from the unbound surface can produce a wider tip edge (see Fig.21 , W u ). Without being limited by theory, when the end is pressed into a rigid tissue surface, this wider edge distributes the load over a larger surface area, thereby creating a more effective resistance to deformation of the end. Once the spool is sharpened, it is punched into the desired blade length. In some embodiments, the spool is hardened and then punched into the desired length. Regardless of the time when the punching occurs, in some cases, the blade can be dulled and hardened above, for example, about HRC45. But more typically in the range of about HRC58 to about HRC62. The hardened blade can then be laser cut, stamped, EDM or another precise metal forming technology utilizing spikes, tooth elements or wedge-shaped dissectors. In some cases, the tooth-shaped elements are processed on the spool and then hardened and dulled. In some embodiments of the strips where the ends are not sharpened grinding edges, the ends of the blades produced during the spool sharpening step are removed during the wedge-shaped dissector and strip manufacturing steps. In some cases, material removal is designed to start a distance, such as from about 0.0001 inches to about 0.003 inches below the ground edge, or from about 0.0001 inches to about 0.0005 inches from the ground edge, to produce a Fig.21 The thinnest edge remaining on the previously sanded edge side (now the flat top in some cases) is what will become the non-bonding surface of the strip.

[0237] To aid in the removal of material from the initial blade configuration, such as Figure 25L and Figure 25M As shown, the straps are typically designed with tabs along the base or bonding surface. The tabs help control the long straps from vibrating or moving during material removal. Once fabrication is complete, the tabs are removed. In a preferred embodiment, the tabs have inserts that are located at the base of the strap. The inserts allow the tabs to be removed while minimizing the amount of material that could potentially hang below the base of the strap, which could interfere with the strap being bonded to an air bag or other inflatable device.

[0238] In certain embodiments, a method for attaching a strip is disclosed. The method may include any number of processing steps, which provide effective strip retention, vertical orientation and structural stability during manufacture and use. In one embodiment, the bonding surface is usually coated with a base coating of a suitable material (such as a polymer of polyurethane) by a controlled dipping process to produce a uniform polyurethane layer. The coating is dried and usually 3 or 4 strips are aligned with a strip alignment mechanism or a fixture, and medical grade cyanoacrylate is bonded in place in a predetermined direction. The number and period of the strips can be variable, from, for example, 1 to 8, and are usually related to the same number of airbag wrinkles, but can be less than the number of wrinkles, and the periodicity can be non-sequential. Once the strip is bonded to the airbag surface, a single or a series of multiple top coatings or retaining layers are placed above the metal interrupted scoring element or wedge cutter to keep the above-mentioned strips and protect the airbag from the thin end damage of the scoring element. In certain embodiments, these layers use a process similar to the base or pre-coating, using a controlled dipping process to produce one or more uniform urethane or polyurethane layers. In some embodiments, there is no base coating and only one top coating. The number of base coatings and top coatings can vary between 0-4 for either base coating or top coating. Once the one or more retention layers are cured, a hydrophilic layer or other coating can be applied to reduce airbag friction and increase the transportability and retractability of the airbag. When loaded, an external slip coating can increase the functionality of the airbag by reducing the force of inserting and retracting the device.

[0239] Fig. 27The schematic cross-sectional view of the strip and wedge cutter operably attached to the outer surface of the airbag according to some embodiments of the present invention is shown.In some embodiments, a typically thin (e.g., 0.0001 inch to 0.0009 inch) or approximately or less than approximately 0.001 inch polymer layer (e.g., for limiting the increase of the airbag diameter profile) can be used as a base coating (layer 270A) covering the outer airbag surface. The base coating 270A provides an interfacial bonding layer to the airbag surface for the interrupted scoring element. The layer 270A can be made of polymer chemicals identical or similar to other layers, while providing chemical, mechanical or electromagnetic bonding to the airbag surface. The base coating 270A can be configured to and may be able to reduce the interfacial strain between the bonding surface of the airbag outer surface and the metal scoring element. The strain between the above two surfaces is reduced by allowing adhesive layer 270E and scoring element 200 to be sandwiched in a polymer matrix that is independent of the airbag strain and a little isolated during airbag expansion and pressure. Although typical base coating 270A is a polymer, such as urethane or polyurethane, the layer can be various other materials. In some embodiments, the above-mentioned coating can include, for example, silicone resins and hydrophilic coatings containing hydrogel polymers, such as polymer networks of vinyl polymers and uncrosslinked hydrogels. Polyethylene oxide (PEO) is an example of a hydrogel. An example of a vinyl polymer is neopentyl glycol diacrylate (PG). The deposition of this layer can be completed by immersing the airbag or airbag matrix in a polymer bath once or multiple times in two directions or one direction at a controlled rate under controlled insertion and extraction conditions. Alternatively, by using known and practical self-assembly techniques, surface ion charge techniques are usually adopted, and the layer can be deposited on the Angstrom layer by the self-assembly of a monolayer.

[0240] Still see Fig. 27, the bonding layer 270E between the metal scratch element and the base coating can be typically thin (0.0001 inches to 0.0005 inches), but in some embodiments can be as thick as 0.001 inches and thin enough to limit the increase in the diameter profile of the airbag. The adhesive layer 270E can be a cyanoacrylate, but can be made of other bonding materials (such as UV curing glue) that provide chemical, mechanical or electromagnetic bonding between the base coating 270A and the bonding surface of the metal scratch element. This layer 270E can be regarded as a functional layer that connects the bonding surface of the metal scratch element to the airbag and is sometimes the only layer between the bonding surface of the metal scratch element and the outer airbag surface. The layer 270E can be one or more adhesive products. In a preferred embodiment, the adhesive layer 270E is a single adhesive with low viscosity, thereby allowing the adhesive to wick along the interface of the bonding surface of the metal scratch element and the base coating. In some embodiments, the adhesive dries quickly, allowing a continuous layer to be applied on top of the adhesive layer with minimal curing delay. In other manufacturing methods, a more viscous adhesive layer can be placed at both ends of the bottom of these strips or periodically between the bonding surface of the metal scratch element and the base layer, allowing the unbonded portion to be free or unbonded. In another method, more than one adhesive can be used. For example, a higher viscosity adhesive can be used at either end of the bonding surface of the metal interrupt scratch element, and then the adhesive can be wicked on some or all of the unbonded portions. In some embodiments, one (e.g., a single layer) two or more retaining layers ( Fig. 27In certain embodiments, the polymer retaining layer 270B, 270C can be present on the base layer 270A and the scratch element. In certain embodiments, the polymer retaining layer can be similar to the base layer, and has the size with enough characteristics as described above for the base layer, so that the base layer 270A and retaining layers 270B, 270C produce effective combination between layers. In some cases, (one or more) retaining layers can be designed to provide a thickness similar to the base layer, and it may be useful to make the retaining layer thicker than the base layer at other times. Thicker base and / or retaining layer can provide larger puncture resistance and increased air bag resistance from metal interruption scratch element, from any sharp edge of the implant staying in the body or from the durability of the potential puncture of the sharp edge found in the disease blood vessel of for example severe calcification. In certain embodiments, the outer sliding layer 270D can also be present on this or these retaining layers above the air bag and / or the scratch element. There are multiple hydrophilic coatings on the market to reduce friction, and provide the navigation of the increased air bag by tortuous and narrow anatomical structure. In some embodiments, the balloon surface can be completely encapsulated in the hydrophilic coating, while in other embodiments, the balloon can be coated after pleating or after pleating and curling, and thus only the surface that would normally be exposed during delivery is coated with the hydrophilic coating. Typical hydrophilic coatings are several microns thick and can be as thin as about 10 angstroms in some embodiments.

[0241] In some embodiments, the adhesive may be applied separately to the bladder and the strap, and the two components then bonded together.A template may be used to ensure proper positioning of the scoring elements along the surface of the bladder.

[0242] The polymer retention layer 270B, 270C may generally be similar to the base layer with sufficient properties so that the base layer and the retention layer create an effective bond between the layers. Sometimes, the retention layer may be designed to provide a thickness similar to the base layer, while other times it may be useful to make the retention layer slightly thicker than the base layer, for example, about or no more than about 20%, 15%, 10% or 5% thicker in some cases. The thicker base and / or retention layer provides greater puncture resistance and increased durability for the balloon, preventing potential punctures from scratching elements from metal interruptions, from any sharp edges of the implant left in the body, or from sharp edges found in severely calcified diseased blood vessels. In some embodiments with multiple retention layers 270B, 270C, these layers may be made of the same or different materials.

[0243] There are a variety of hydrophilic coatings on the market that can reduce friction and provide navigation of the enlarged balloon through tortuous and narrow anatomical structures. In some embodiments, Fig. 27Layer 270D may be a hydrophilic slip layer. In a preferred embodiment, the balloon surface may be completely embedded in the hydrophilic coating, while in other embodiments, the balloon may be coated after pleating or after pleating and curling, and thus only the surface that is typically exposed during delivery is coated with the hydrophilic coating. Typical hydrophilic coatings are several microns thick and may be as thin as, for example, 10 angstroms.

[0244] The height of the wedge-shaped dissectors, strips, and layers of the outer balloon encapsulation process can be viewed as a cage for use with an expandable member (e.g., a medical balloon, such as an angioplasty balloon) or as part of a medical procedure involving a medical balloon or other expandable member. In order to effectively perform an open-hole or catheter-based procedure, the ability to fold the balloon to a diameter that is a fraction of the intended inflated diameter can be valuable. Therefore, the balloon, and in some cases the cage, is often folded, wherein the contours of the folded balloon can be effectively used. In one such embodiment, the cage is folded in a manner that provides for the orientation of the spikes, thereby avoiding puncturing the balloon or scraping the inner membrane of the lumen during delivery and removal, such as Fig.28 shown. Fig.28 An air bag 1000 is shown having a plurality of pleats 1002 and strips 300 and associated wedge-shaped dissectors 200 between the pleats, thereby allowing a single strip 300 with its plurality of wedge-shaped cutters 200 to be located between two pleats 1002. The pleating tool is designed to provide effective orientation of spikes and pegs. The pleating tool may have a series of pleated wedges, each of which provides the ability to curl the air bag between the wedges when the wedge-shaped element is closed down onto the air bag. Due to the volume of the peg element and the desire to minimize contact and potential damage to the wedge head, the wedge is designed to have a series of recesses extending over the length of the wedge head. The recesses in the wedge head provide the ability for the peg feature to rest within the recesses and limit the peg contact with the wedge. The recesses may also provide the ability to assist in the orientation of the peg features and spike features so that the orientation of the features limits contact with the balloon, such as over-folding, and limits orientation, such as perpendicular to the balloon, which may result in scraping of the endothelium during transport of the device on the balloon. Fig.28 As shown, one such orientation of the spikes may be at a tangential orientation (significantly downward) relative to the balloon surface.

[0245] In some embodiments, disclosed herein are systems and methods for producing linear incisions by preparing serrations in tissue. It is well understood in the field of cardiovascular disease that the application of interventional methods to increase the lumen size in occluded lesions helps blood flow and increases the likelihood that the vessel will remain open longer than when the minimum lumen gain is achieved after surgery. There are multiple options for increasing lumen diameter. Basically, plain old balloon angioplasty (POBA) is usually used or percutaneous transluminal angioplasty (PTA) or similar methods are used to open the diseased lesion tissue. In addition, more professional equipment, such as cutting balloons, AngioSculpt balloon catheters (Spectranetics, Spectranetics), Chocolate stents (Cordis, Cordis), etc., provide mechanisms to assist or control balloon energy. Products in this general category generally provide an external structure on the surface of the balloon (attached or unattached), which is designed to first contact the vessel wall and press into the vessel wall surface with balloon pressure. The theory is that the structures on the outer surface create a localized increase in the force on the lumen, which in turn helps to allow for incision into the surface and dilation of the artery as the balloon expands. While these designs offer some advantages over POBAs or balloons alone, they are limited in their effectiveness and ability to promote lumen dilation, particularly in the complexity of the diseases for which they may be used.

[0246] An alternative to creating an external structure with a line of compression along the intimal layer is to create a line of serrations along the lumen. The effectiveness of serrations in aiding the separation of materials (e.g., paper, stamps, cardboard, granite, marble, etc.) is well understood, and because the morphology of diseased tissue often involves both soft and hard materials, the advantage of the serration technique is that it can effectively aid in the dilation of the vessel. There are several ways to create teeth, including those described in the following patent documents: US9,480,826 issued on November 1, 2016, PCT publication WO 2015 / 187872 published on December 10, 2015, PCT publication WO 2016 / 073511 published on May 12, 2016, PCT publication WO 2016 / 073490 published on May 12, 2016, and U.S. Patent Application No. 15 / 268,407 filed on September 16, 2016, each of which is incorporated herein by reference in its entirety. For example, a series of tooth elements can provide features that are configured to create teeth or linear toothed scratches at a deployment site.

[0247] In some embodiments, the inclusion of serration technology is advantageous for balloons, not only for use in preparing tissue prior to or concurrently with the use of a drug coated balloon, but also as a separate step in a drug delivery mechanism. Inclusion of a drug coating on, around, and / or within a reservoir or region adjacent to the serration features on the balloon can facilitate the serrations of the serration-shaped balloon to deliver the desired drug or other therapeutic agent(s) deeper into the desired target location, such as at the intimal, medial, or adventitial surface of a vascular lumen wall.

[0248] Typically, drug-coated balloons are coated on their surface. When a non-toothed drug-coated balloon is inflated, it contacts the inner membrane and begins to elute the drug present on its surface, which inhibits the ability of the balloon's surface to provide drug delivery into deep tissue spaces. In some embodiments, the following disclosure includes a variety of assemblies and methods of using these assemblies that can effectively deliver drugs to tissues by using teeth independent of design elements, including but not limited to any number of the following:

[0249] 1) Surfaces capable of radial expansion (e.g., compliant or semi-compliant balloons);

[0250] 2) a series of drug-coated strips comprising a plurality of wedge-shaped dissectors spaced apart along the surface of each strip (in some embodiments, the space between each wedge-shaped dissector is not as long as the length of the wedge-shaped dissector itself, and / or the height of the wedge-shaped dissector is a fraction of the balloon diameter);

[0251] 3) In some cases, the protrusion can be an A-frame structure that is angled from its base to its tip, and wherein the long well or space within the A-frame structure becomes a drug storage area;

[0252] 4) The sidewalls of the wedge-shaped dissector on the A-frame may include a series of holes and / or microchannels to allow drug migration to the discontinuous surface directly beneath the teeth;

[0253] 5) Single or series of wells where drugs, stem cells or other therapeutic agents can be placed within each A-frame structure of the strip;

[0254] 6a) These wells may include depressions into the balloon surface, or separate conduit-like channels along the balloon body that may include finely defined holes (made by laser drilling or other precision methods) into which larger volumes of therapeutic agents are placed;

[0255] 6a.1) In some cases, the catheter channel fits into the inner diameter of the catheter shaft and may run through the entire length of the catheter shaft to the hub to allow drug to be delivered from a port on the hub through the channel to the balloon surface;

[0256] 6b) During balloon inflation, the outward balloon pressure can: a) exert a force on the recessed well, thereby displacing the space where the therapeutic agent resides, or b) expand the finely defined pores and allow the drug to pass through the pores; this in turn moves the therapeutic agent outward and promotes release of the therapeutic agent into the damaged tissue;

[0257] 6c) typically capturing the holes, straps, lifting elements and A-frames within the folded portion of the balloon upon balloon delivery, thereby minimizing systemic penetration of the therapeutic agent into the tissue;

[0258] 7) When the balloon is expanded, the toothed A-frame separates the intimal tissue layer, exposes the media layer, and in some cases opens the media layer and adventitia layer to allow the therapeutic agent placed in the folded portion of the balloon to be primarily expelled deep into the vessel wall and / or exposed;

[0259] 8) Allowing therapeutic agents and drugs to elute from the surface of the serrated drug eluting balloon into the incisions and microcracks created by the serrated A-frame, through the intima and into the media or adventitia.

[0260] In some embodiments, the present invention relates to the use of tooth technology in conjunction with endovascular surgery, wherein the design of the tooth technology includes a novel drug delivery design in combination with: a drug contained near or below the tooth element; or a channel through which the drug can travel from a more proximal portion of the delivery system to the balloon surface and be released into the tissue through the pathway created by the tooth element.

[0261] In some embodiments, the tooth element can be combined with a multilayer (e.g., double or triple) polymer, such as a polymer previously disclosed in U.S. Patent Application No. 15 / 268,407, wherein the space between the base polymer and one or more top layers can be used as a drug storage space. In some embodiments, the bottom polymer is removed, and the space between the airbag surface and the one or more top layers can be used as a drug storage space. For example, by spraying, dipping or utilizing nanotechnology self-assembly technology, wherein the drug is encapsulated between the base and top layers of the polymer, it is possible to facilitate deposition of the drug in the space. In some embodiments, the drug storage layer is not exposed to the environment due to the encapsulation of its top layer, thereby limiting its exposure to the body or the unperforated inner membrane layer. The inclusion of a drug coating on, around and / or in the encapsulation layer is conducive to the teeth of the toothed airbag delivering the drug primarily to the sub-intima.

[0262] Also disclosed is a method for producing linear dentations. In some embodiments, this can be achieved by including a series of elevated elements on a wedge-shaped dissector, which typically have a radially outward surface, the surface having a narrow portion oriented circumferentially and a longer portion oriented longitudinally (but may also be spirally or otherwise oriented). Such elevated elements can be designed so that when a deflated, pleated and curled balloon containing the elevated elements inside it expands at the repair site, the elevated elements unfold. The elevated elements contact the vessel wall, in some cases perpendicular, parallel or oblique to the longitudinal axis of the vessel sidewall, and destroy the diseased vascular intima. Each row of wedge-shaped dissectors micropunctures the tissue, wherein the destroyed intima is spaced apart by a complete intima, which can be, in effect, a line of dentations in the tissue. This process may be referred to herein as dentation plasty.

[0263] In some embodiments, about or at least about one, two, three, four or more serration lines along the tissue surface can effectively produce linear serrations with minimal tissue damage. These serration lines collectively produce a series of weakened lines in the serration-like surface. When serration technology is used for existing balloon angioplasty, this may be referred to as serration angioplasty in this article. The orientation of the serration lines can be aligned with a layer in the cell matrix layer or consistent with other biological purposes. For example, in the leg artery, the orientation of the inner layer of tissue is longitudinally oriented along the axis of the artery, so in some embodiments, this serration angioplasty design may have rows of longitudinally oriented raised elements for producing serration angioplasty, but in some cases, the design may be such that it is vertically aligned with the longitudinal axis of the artery or deviates at a certain acute angle.

[0264] The penetration depth of the raised element is a configurable factor in the design of the tooth forming device. First, the ability to penetrate the surface of the target tissue or wall can be directly located at the height of each tooth element (or wedge-shaped dissector) protruding from the carrier. Secondly, the depth can be limited to the expandable diameter of the carrier (typically an air bag). Once the tooth feature penetrates the surface, the penetration depth can extend beyond the height of the wedge-shaped dissector because the crack depth can be affected by the strain force generated by the air bag. When the air bag expands, it opens the teeth and can affect the crack expansion into deeper tissue than the original wedge-shaped dissector contacted. Therefore, the end of the wedge-shaped dissector only produces initial microperforations, after which the end does not contact the tissue it penetrates. Once the end has penetrated the inner membrane, the side wall of the wedge-shaped dissector produces a cutting stress that applies a prying force on the side wall of the penetrated tissue. The cutting stress increases the strain exerted on the wall by the inflated balloon, and the stress is amplified, enabling tooth angioplasty to open vessels with hardened and softened calcified plaque at less pressure than when the balloon alone or a balloon with linear projections is used to score the intima.

[0265] In some embodiments, the dentation device can be used with surface expansion and slit assistance to use a DEB (drug eluting balloon). Without being limited by theory, the dentation plasty design can produce two effects, one mechanical and one biological. The dentation plasty can produce mechanical assistance to arterial expansion along the entire surface of the plaque through the slender microperforation line to assist surface expansion through slit mechanics. In addition, the dentation plasty can produce microwells or perforations that pass through the inner membrane and enter the middle membrane together with the microchannel 5100 to help drug collection and retention when the agent is introduced in combination with the dentation device. The method for producing the dentation plasty can include inflating a balloon, the balloon comprising a series of strips, the strips comprising a plurality of wedge-shaped dissectors spaced equidistantly along the surface of each strip. Alternatively, the spacing of the wedge-shaped dissectors can be variable, with periodic larger spacings between shorter spacings. In addition, some methods utilize multiple strips, wherein the spacing or length of the wedge-shaped dissectors is variable. In some embodiments, during the initial penetration of the strip, the tooth pattern can be a "dash" of 300 to 100 microns and a "dot" of 200 to 50 microns cut along the dash-dotted line, or a combination of "dots" and "dashes" in some embodiments. The length of the "dash"-like features can vary, but are typically between 100 and 600 microns long, and these features represent spaces of the inner membrane that are initially unaffected by the strip. The length of the "dot"-like features can vary, but are typically between 10 and 500 microns long, and these features represent areas of the inner membrane that are initially penetrated by the strip.

[0266] In some embodiments, dentation plasty can advantageously reduce the rate of dissection. In some embodiments, a pre-dentation plasty increase in surface area can be provided to the DEB, thereby reducing the pressure required to dilate atherosclerotic plaques, especially when the plaques contain a large amount of calcium.

[0267] In understanding the value provided by microperforations, it is necessary to examine the mechanical properties of unprepared plaque rupture relative to prepared ones. The basic steps in material fracture include void formation, void coalescence (also known as crack formation), crack propagation, and eventual failure. This phenomenon can be further studied mathematically using the method of rupture mechanics. Assuming that the surface is isotropic and the surface crack in the arterial lumen is semi-elliptical in shape, the maximum crack opening displacement COD max yes:

[0268]

[0269] Where σ = applied strain, d = crack depth, and E = elastic modulus.

[0270] Assuming that the area is a perfect triangle with crack opening displacement variation, the total surface area Ac of the crack is A c =1 / 2db∑COD / (b+1)

[0271] Where b is the crack length and ∑COD is the sum of the crack opening displacements. To simplify the equation, we assume that ∑COD / (b+1) is equal to 1 / 2COD max .

[0272] Therefore, the A related to the material c become

[0273]

[0274] This equation shows that the total surface area of ​​the crack is A c , t will increase with the applied strain σ and exponentially with increasing depth d. The strain energy release rate (or energy release rate) is the energy dissipated during the rupture process per unit of newly created rupture surface area. And d is directly related to the ability to effectively penetrate tissue. The ability of a single elevated element or wedge-shaped dissector to penetrate deeper is greatly enhanced by microperforations or teeth.

[0275] In the case of conventional balloon angioplasty, the energy required to cause crack formation (starting with void formation), then produce crack expansion, and ultimately failure can be very high. Inducing void formation without the introduction of nucleation sites (d in the above formula) requires a higher initial strain (σ in the above formula), and once the crack starts, the energy is quickly dissipated over the newly formed crack surface area, resulting in unpredictability of plaque tearing or dissection during angioplasty. Individual raised elements or wedge-shaped dissectors on the outside of the balloon can penetrate first (form a void) and provide preparation for the pressure of the tooth balloon, more effectively opening the artery with less pressure. By using the plaque preparation devices and techniques disclosed herein (including but not limited to the tooth balloon product line), the stress concentration and corresponding strain release are assisted by a series of voids that are designed to provide more uniform release across the entire surface of the plaque. In some cases, the target can penetrate deep into the tissue bed. The total surface area A of the crack is determined by the total surface area of ​​the crack. c The derived equation provides insight into certain advantages that the dentation technology may have over existing technologies in certain situations. By creating microperforations in the plaque surface, the device can relax plaque and dilate at low angioplasty pressures. In clinical trials, pressures as low as 3 ATM were effective in opening diseased arteries using the dentation angioplasty technology. Low-pressure angioplasty minimizes acute injury and enables a smoother post-angioplasty surface in some situations.

[0276] Table 1: Angioplasty with dentate preparation versus conventional and DEB angioplasty: comparison

[0277]

[0278] In some embodiments, the systems and methods can be used as devices to assist in atherectomy. In order to provide effective plaque removal or remove other diseased outcroppings found in blood vessels throughout the body, it is sometimes recommended to pre-treat the blood vessels to facilitate effective overflow of diseased tissue. Alternatively, it is sometimes recommended to perform atherectomy after angioplasty. When angioplasty is used before and / or after atherectomy, it can be expected that by forming a tooth pattern on the surface to achieve effective pre-treatment or intraluminal enhancement after resection, the toothed plasty device can provide a method of weakening cellular or molecular bonds, which provides more or less more effective atherectomy.

[0279] In some embodiments, the atherectomy enhancement tool may include one or more of the following features, not necessarily in the order presented:

[0280] The dentation plasty device expands, allowing the dentation element to penetrate the vessel wall;

[0281] The tooth elements pierce the intimal layer of the wall and disrupt the tissue, producing tooth-like markings;

[0282] Device expansion continues and induces stress on the vessel wall;

[0283] Stress builds up, seeking areas of weakness to relieve strain;

[0284] Linear cuts are then produced;

[0285] Linear tooth-like markings create areas of supply change release (weak lines);

[0286] The strain is dispersed rapidly along said line;

[0287] The sub intimal layers of the blood vessels are able to continue to expand without tearing all the tissue layers;

[0288] Although the tooth elements protrude from the expansion device, the ability of the tooth elements to continue to penetrate the vessel to the depth of penetration is limited by a number of factors;

[0289] If the vessel is healthy, the tissue expands and thins around the area of ​​the expansion event, and the absolute penetration depth is controlled by the limit of the expansion device diameter, which is pre-measured to not exceed the relative vessel diameter;

[0290] If the vessel is diseased, penetration depth may be limited not only by the balloon diameter, but also by the dilated artery (lesion tension), the thickness of the diseased portion (sclerotic vessel), and / or the energy used to dilate the balloon;

[0291] Arteries (blood vessels) are pre-treated for atherectomy;

[0292] The atherectomy tool enables more efficient navigation and collection of diseased tissue due to the concentrically oriented plaque fragmentation into manageable segments that require less rotational energy to be removed from the cellular matrix and more easily pass through the atherectomy tool into the collection cup;

[0293] Non-concentric (eccentric) plaques may not rupture directly because the nature of the balloon energy is dispersed more effectively into the portion of the artery with a higher elastic module. The tissue may therefore expand more on the healthy vessel wall side and less on the diseased vessel wall side. In this case, the effect may be that the healthy vessel expands or moves away from the rotor of the atherectomy. The rotor can more easily find and cut off the diseased tissue, thereby limiting or reducing the interaction of the rotor head with healthy tissue.

[0294] Concentric or eccentric continuous lesions present additional challenges to atherectomy tools, and such lesion morphology can create very high strains in the vessel wall in front of the rotor head (due to the pushing of the vessel) and in the area just passed where the rotor head of tissue in the area is very close to where the rotor head just passed (due to traction or pulling and torque). In order to minimize the pushing and pulling experienced by the artery, it is recommended to effectively pre-treat the vessel. A very effective pre-treat that can be done in some embodiments is to release the lesion binding energy created by the morphology of the lesion portion prior to atherectomy. Teeth and linear slits can be very effective tools in this regard.

[0295] Non-contiguous lesions behave similarly to continuous lesions, but with the added challenge of healthy arteries being interwoven throughout the diseased region. Due to this unique challenge, it is best to disrupt the diseased portion as described previously in the non-concentric and concentric plaque modifications, but also push the healthy tissue out of the same plane as the diseased portion. By pushing the diseased tissue out of the way, the atherectomy rotor head is able to resect the diseased tissue and reduces the tendency of the rotor head to tear and cut less healthy intima or healthy media tissue.

[0296] Drug-coated or drug-eluting balloons (DCBs or DEBs) are designed to treat atherosclerotic occlusive disease. Preliminary results of clinical trials appear to show that DCBs provide new progress in endovascular therapy. The design of existing drug-eluting or drug-coated balloons can produce long-term arterial patency based on the local delivery of therapeutic agents that restrict cell growth. Most DCBs available today use paclitaxel or another agent in combination with different carriers and excipients to provide balloon adhesion and drug delivery. When DEB angioplasty is performed, the drug is transferred to the vessel wall and transported to the cell matrix by diffusion and convection transfer, and if the drug is crystalline, the drug can stay in the tissue for many days. The drugs and coating methods used can be designed to achieve a variety of effects. Regardless of the coating used, the mechanism used for delivery, the angioplasty balloon has not changed significantly compared to the original balloon angioplasty. The balloon angioplasty method that makes these devices work is a blunt, strain-loaded, unpredictable tissue injury event that often produces a ruptured, irregular vascular surface. The blunt, high-pressure nature of the balloon angioplasty mechanism can cause trauma to arterial tissue. Pressurization and expansion of the angioplasty balloon within a sclerotic, calcified atherosclerotic lesion often results in plaque tearing or rupture, which often requires restoration of the arterial lumen, which is usually achieved through tissue compression with subsequent therapy with an implantable stent. Once pressure in the tissue exceeds the strain limit of the diseased morphology, plaque rupture quickly follows, followed by crack propagation. Dissection secondary to cracking is a form of balloon angioplasty-induced arterial trauma in which sections of tissue are no longer bonded and freely fluctuate in arterial blood flow. The extent of dissection can serve as an important predictor of clinical outcome. Because dissection creates an irregular and potentially unstable luminal flow surface, stents are often placed to create a smooth surface and stabilize the plaque and treat angioplasty-induced dissection. The need for stent placement accompanies acute postangioplasty dissection, which occurs in 25% to 50% of cases after standard balloon angioplasty. . Since the purpose of DEB angioplasty is to minimize the need for stenting, the dissection defeats the purpose of drug coatings or drug eluting balloons, as a stent will be needed. Using coatings on these balloons may not add anything to provide control over these dissections, and thus may not reduce the need for stents.

[0297] If standard DEB angioplasty is used without a plaque pretreatment step, the amount of initial surface contact is defined by the morphology of the lumen. Better efficacy of drug delivery has been observed in porcine studies using dentine angioplasty compared to POBA prior to DEB. Fig.28A and Fig.28B shown.

[0298] Fig.28Ais a graph showing the amount of paclitaxel (PTX) drug retained in the tissue wall after 7 days in an experiment with a dentate balloon followed by DCB (263.5 μg / mg) compared to an experiment with POBA followed by DCB (181.8 μg / mg) where the expansion was 1.2 times the vessel reference diameter. As shown, the dentate balloon device surprisingly and advantageously enables more than 1.5 times the amount of drug to be retained in the tissue wall compared to POBA.

[0299] Fig.28B 7 days after the tooth balloon device was surprisingly and advantageously able to retain more than 2.7 times the amount of drug in the tissue wall compared to POBA.

[0300] The method for achieving the enhanced drug uptake shown in the above figure (data collected at 7 days post-treatment) comparing pre-treatment of porcine blood vessels with a dentate balloon device or POBA followed by a drug eluting balloon may include any number of the following steps:

[0301] pretreating the site in the blood vessel by expanding a pretreatment balloon at the site to create a plurality of microcracks in the wall of the blood vessel, the pretreatment balloon comprising a plurality of strips, each of the plurality of strips comprising a plurality of wedge-shaped dissectors spaced along a surface of each strip, each strip extending longitudinally along an outer surface of the pretreatment balloon;

[0302] removing the pretreatment balloon from the site;

[0303] positioning a drug eluting balloon at the site; and

[0304] The drug eluting balloon is inflated to bring the balloon into contact with the vessel wall and allow the drug to elute from the surface of the drug eluting balloon into the microcracks, through the intima and into the media. In some embodiments, the amount of drug or other therapeutic agent eluted is sufficient to prevent or reduce restenosis.

[0305] In some embodiments, the pretreatment balloon can be the same balloon as the drug eluting balloon (e.g., can be a drug coated or drug eluting pretreatment balloon), so that no pretreatment balloon removal step is required. However, in some embodiments, the drug eluting balloon is separate from the pretreatment balloon.

[0306] In addition to showing a 1.5 to 2.7-fold increase in drug uptake after 7 days via dentine balloon pretreatment with POBA, it was observed that the drug distribution uniformity in the tissues of the proximal, middle, and distal segments was more uniform in the dentine balloon group compared to the POBA group in the study.

[0307] The method for producing microcrack planes may include rotation and re-inflation of a toothed angiography balloon. At each continuous inflation, a new set of microcrack planes is produced. As the crack area increases, the number and depth of nucleation sites increase, which in turn provides more mechanical effects to reduce the need to establish a large amount of strain during the increase in atmospheric pressure in the balloon. In addition, the increased crack planes provide increased micropores for capturing, collecting and evenly distributing pharmacokinetics throughout the tissue when used in conjunction with DEB. In one such method, the toothed device can be inflated to produce microcrack planes, and then the balloon is deflated to rotate it between a small angle (e.g., up to about half of the angle between adjacent spike-shaped strips), and to re-inflate it. By increasing the number of microcracks, some embodiments of the method can further significantly increase drug uptake, such as at least about 1.5 times, 2 times, 2.5 times, 3 times or even more.

[0308] In some embodiments, a pre-treatment balloon (such as a dentitionplasty balloon) can increase the effectiveness of a drug eluting balloon (e.g., the pre-treatment balloon can increase the surface area and enable deeper tissue access in the tissue wall) because the pre-treatment balloon can reduce the volume of drug required for the drug eluting balloon.

[0309] In some cases, DEB can contact new surface area for drug delivery. In certain embodiments, another advantage of dentation angioplasty is the mechanical effect that allows tissue relaxation. DEB angioplasty pretreatment before dentation angioplasty of calcified or thrombotic tissue can reduce the rigidity of tissue surface and the limited or combined behavior. The ability to keep the atherosclerotic surface in a more open structure and to contact it when the DEB surface expands can be achieved by pre-perforating using dentation angioplasty. The result is plaque relaxation, opening many microcrack planes, allowing the plaque surface to produce a more uniform intraluminal surface roughness, while minimizing the typical tearing associated with angioplasty (which produces unpredictable intraluminal surface roughness).

[0310] In some embodiments, a method of generating a serration line through a series of events is disclosed. A method can generate a serration line within a blood vessel, comprising treating a site of a blood vessel by inflating a treatment balloon at the site to generate a plurality of microcracks in the wall of the blood vessel, the treatment balloon comprising a plurality of strips, each of the plurality of strips comprising a plurality of wedge-shaped dissectors spaced along a surface of each strip, each strip extending longitudinally along an outer surface of the pre-treatment balloon. Additionally, in some embodiments, the method for dentation plasty may include one or more of the following features:

[0311] 1. The device can be expanded to allow multiple strips including multiple wedge-shaped dissectors or elevated elements to penetrate the vessel wall.

[0312] 2. Multiple wedge-shaped dissectors can pierce the intimal layer of the wall and disrupt the tissue, creating tooth-like markings.

[0313] 3. Expansion of the device can generally be continuous by increasing the balloon carrier pressure and inducing strain on the vessel wall.

[0314] 4. When stress builds, tissues seek out weak areas to relieve strain:

[0315] a. Linear cuts are produced by releasing strain energy propagating along the tooth-like line.

[0316] b. The strain is dispersed rapidly along the tooth-like lines.

[0317] c. Linear tooth-like markings create areas for strain relief (lines of weakness).

[0318] 5. The subintimal layer of the blood vessel can achieve continuous and effective expansion

[0319] 6. When the wedge-shaped dissector or tooth-like element is protruded from the expansion device, the ability of the tooth-like element to continue to penetrate to a depth is limited by a number of factors.

[0320] a. If the vessel is healthy, the tissue expands and thins around the area of ​​the expansion event, with the absolute penetration depth being controlled by the operator by limiting the expansion device diameter.

[0321] b. If the vessel is diseased, the penetration depth may be limited not only by the balloon diameter, but also by the limitations of the dilated artery (lesion tension), the thickness of the disease (sclerotic vessels), and the limitations of the energy that the dilation device can accommodate (i.e., the limitations of the pressure that the balloon can maintain).

[0322] Fracture is the propagation of a crack through a material. In some cases, there are three fracture mechanics modes, including an opening mode produced by tensile stresses perpendicular to the crack plane, a sliding mode in which shear stresses act parallel to the crack plane and perpendicular to the crack front, and a tearing mode in which shear stresses act parallel to the crack plane and parallel to the crack front. Fracture mechanics was developed by British aeronautical engineer AAGriffith during World War I to explain the failure of brittle materials. Griffith's work was inspired by two contradictory facts: (1) the stress required to break bulk glass was measured to be about 100 MPa (15,000 psi), while (2) the theoretical stress required to break atomic bonds was about 10,000 MPa (1,500,000 psi). A theory was needed to reconcile these conflicting observations. Through a series of experiments on glass fibers, Griffith's observations showed that the low fracture strength observed experimentally and the size dependence of the strength were due to the presence of microscopic cracks in the bulk material.

[0323] To test the crack hypothesis, Griffith introduced artificial cracks into his experimental glass samples. The artificial cracks were in the form of surface cracks that were much larger than other cracks in the sample. The experiments showed that the square root of the crack depth (a) was proportional to the fracture stress (σ f )) is almost constant, C F (crack constant) is expressed by the following formula:

[0324]

[0325] From this understanding, it follows that introducing artificial fractures in the form of microperforations or dents into diseased vessels will reduce the energy required to dilate the lumen of the diseased vessel. Thus, Griffith's formula can be rewritten as:

[0326]

[0327] It can be understood that the square root of the sum of the defect depth (a) from 0 to n and the rupture stress (σ f ) is almost constant C S (constant with teeth)

[0328] According to these two equations, we can assume that increasing the number of artificial cracks, C S Will itself produce a constant C with cracks F The lower constant observed. Mathematical expression:

[0329] C S <C F

[0330] Therefore, if C S Less than C F , then the fracture stress (σf ) must also be smaller. When predicting small crack propagation, it has been noted experimentally that the creation of linear teeth provides a line of weakness in the lumen surface, allowing cracks to propagate along the line of weakness at lower balloon inflation pressures. This phenomenon is well understood in mechanical engineering, and the scientific knowledge is often used to limit and prevent crack formation and propagation. In some applications, teeth are used to help facilitate separation of materials along predictable lines, such as FedEx packages, postage stamps, or perforated paper, etc.

[0331] Discussed here is the correlation between the pressure in a cylindrical balloon and the effect of pressure exerted on the arterial wall with a certain depth of teeth under certain conditions.

[0332] The hoop stress produced by the internal pressure of a thin-walled cylinder (or tooth-like balloon in some cases) is estimated by examining Laplace's equation:

[0333]

[0334] where α is the hoop stress, t is the thickness of the balloon, P is the pressure, and R is the radius of the balloon. This principle of fluid dynamics also governs how pressure is distributed along the balloon as parts of the balloon expand into a spherical shape while other parts remain cylindrical. Pascal's law states that surface tension is reduced to half in the inflated spherical region, while in the cylindrical region the tension remains the same multiple of pressure times radius.

[0335] Applying new variables based on the dynamics of the diseased vessel, we assign t to the thickness of the diseased area, α to the strain σ applied in our previous equation, while R and P remain unchanged.

[0336] From the equation we defined earlier, COD max , we can solve for the applied strain σ, and substituting this strain for the hoop stress from Laplace's equation, we arrive at a new formula for the pressure:

[0337]

[0338] This equation shows that the crack opening displacement (COD) is directly related to the pressure (P), the depth of the crack (d), the radius of the air pocket (R), and is inversely proportional to the thickness of the lesion (t).

[0339] According to Laplace's law, for a balloon with twice the radius, the sidewall tension will be twice as great. If a certain amount of pressure needs to be applied to overcome the elasticity of the larger balloon and cause it to expand further, then twice the pressure is required to begin to expand the smaller balloon. According to the equation above, the tooth device can change this dynamic and provide a mechanism to reduce the pressure required to begin expanding the balloon by the product of pressure, crack depth, and balloon radius.

[0340] The tension in the walls of arteries and veins in the human body is a classic example of Laplace's law. This geometric law applied to pipes or tubes states that for a given internal fluid pressure, the wall tension will be proportional to the radius of the vessel. The implication of this law for large arteries with comparable blood pressures is that larger arteries should have stronger walls, because an artery with twice the radius should be able to withstand twice the wall tension. Arteries are reinforced with fibrous bands to strengthen them against the risk of aneurysms. Tiny capillaries, on the other hand, rely on their small size. The walls of the capillaries in the human circulatory system are so thin that they appear transparent under a microscope, but they withstand pressures up to about half the full blood pressure. Laplace's law provides insight into how they withstand such pressures: their small size means that the wall tension for a given internal pressure is much less than that of larger arteries. Assuming that the peak blood pressure in the left ventricle is about 120 mmHg, the pressure at the beginning of the capillary system can be 50 mmHg. The large radius of the large arteries means that for pressures in this range, they should have strong walls to withstand the resulting large wall tensions. According to Poiseuille's law, larger arteries offer less resistance to flow than smaller vessels, so the pressure drop between them is only half the total drop. Capillaries offer a lot of resistance to blood flow, but don't require much strength in their walls. The body's larger arteries are subject to higher wall tension than smaller arteries and capillaries. This wall tension follows the dictates of Laplace's law, a geometric relationship that states that wall tension is proportional to radius for a given blood pressure. If an artery wall develops a weak spot and thus expands, it would seem that the expansion would provide some relief, but in fact the opposite is true. In a classic "vicious cycle," the expansion puts even more tension on the weakened vessel wall. The weakened vessel can continue to expand in what is called an aneurysm. If left unchecked, this condition can lead to a ruptured vessel, so an aneurysm requires immediate medical attention. Since a spherical membrane has half the wall tension for a given radius, a localized weak spot in an artery can get some temporary tension relief by expanding toward the sphere. By introducing a serrated area of ​​weakness in the artery by passing a wedge-shaped dissector into the diseased vessel segment, the serration technique helps the vessel dilate at lower pressures and breaks the "vicious cycle" by reducing wall thickness at several locations and producing a regional increase in vessel wall tension as the arterial diameter expands.

[0341] The tension in the wall can be directly proportional to the pressure in the balloon. The wall stress can be indirectly proportional to the wall thickness, as in Fig.29 Schematically shown in FIG. Fig.29 is a graphic representation of the simplified equations for the tangential stress in a cylinder with known wall thickness and the tangential tension in a cylinder assuming no wall thickness.

[0342] In some cases, the pressure in the balloon may be indirectly proportional to the balloon radius.

[0343] In some cases, balloon dilation can result in uncontrolled dissection. The radial force of the angioplasty balloon induces plaque rupture at the area of ​​fixed stenosis. There is often evidence of dissection on complete images taken immediately after angioplasty, where contrast fills the flap in the plaque. Predicting the location of microfracture nucleation and the behavior of the ruptured body within the balloon angioplasty area can be difficult and may be easily interpreted as uncontrolled.

[0344] Excessive tension on the balloon surface can create microcracks, which can then create dissections or tears along the artery. Control of the energy delivered from the balloon to the diseased site or to the elevation element can be simulated, and the design of the wedge element can be optimized for disease morphology, lumen size and shape, or a variety of other factors. Fig.30 The model shown in shows four distinct regions that may represent balloon angioplasty. Region 1 occurs as the balloon is inflated but before the balloon contacts the surface, and region 2 is the settling region when the balloon (and any external features on the balloon) aligns with the surface topography and achieves a "close" relationship and the balloon pressure begins to increase rapidly. Region 3 is the working phase of balloon expansion as the balloon increases outward pressure against the lesion topography. Region 4 is the post-yield phase, which begins at an inflection point where a yield event may occur due to a dissection event in the endothelium or expansion of the adventitia layer.

[0345] Region 1 is the initial inflation zone where the prevailing pressure drives the balloon expansion. In this region, the friction between the anatomical features and the balloon catheter will appear, and any torque in the catheter and friction from balloon deployment and any catheter defects such as kinks or glue anomalies will also be shown in this region.

[0346] Region 2 is the balloon alignment or conformation region where the balloon matches the endothelium and any mechanical features on the outside of the balloon contact and align themselves to the vessel wall. This region is non-linear as it is a complex function of the complex geometry of the lesion site and the pairing of the deployed balloon and any surface modification features. This region contains the initiation effects shown as macro effects related to the alignment of the modification features and micro effects including stress-induced deformation of the mechanically modified surface, local surface roughness, and the direction of entry of the mechanical element.

[0347] Region 3 is the semi-elastic expansion region where the slope of the force-diameter characteristic curve is constant. The semi-elastic expansion region force-diameter slope is an important characteristic of every balloon. The steeper sloped curves collectively produce higher strains and tensions on healthy and diseased tissues. This applied tensile stress can produce undesirable and uncontrolled tearing or sectioning planes.

[0348] Region 4 is the post-yield period, which begins at the inflection point where a yield event may occur due to anatomical events in the endothelium or expansion of the adventitia. Fig.30 The relationship between balloon pressure and diameter expansion is shown. Fig.30 Four regions are shown as the vessel diameter increases for the POBA balloon and the dentate balloon.

[0349] The equations above and elsewhere disclosed herein provide non-limiting possible models for the mechanisms of action of the organization of certain systems and methods disclosed herein, and the present invention is not intended to be limited by any particular theory.

[0350] In some embodiments, the tooth balloon system includes one or more of: a wire external to the balloon; a blade; and a tooth strip. Fig.31A Schematic illustration of the strains generated by balloon inflation and tooth element penetration into the tissue bed:

[0351] Fig.31A It is shown that once the tip 3110 initially penetrates into the tissue 3140, the cutting stress overcomes the need for tip penetration. Further expansion of the tissue advances deeper into the tissue 3140 through the crack 3120, which provides a weakness of the tissue for the tooth element 3150. As the tooth element 3150 penetrates the tissue, the tip 3110 does not contact the tissue 3140 and the crack generation 3120 is assisted by the sidewalls 3130 of the tooth element 3150 and the strain 3100 generated by the balloon expansion. Due to the design and nature of the strain 3100 caused by the balloon expansion, the tip 3110 and the advancing crack 3120 plane quickly migrate into the space beyond the tip surface so that the tip (e.g., in some cases, the radially outward surface of the wedge-shaped dissector) is no longer in direct contact with the leading edge 3120 of the crack / cleavage plane.

[0352] Fig.31B is a chart showing that the teeth were able to successfully penetrate into the inner tissue layer of the blood vessel wall in each patient examined with OCT imaging. In some embodiments, a method of creating teeth at a treatment site in a blood vessel may include providing a tooth-shaped balloon including a plurality of strips. Each of the plurality of strips may include a plurality of wedge-shaped dissectors spaced apart along the surface of each strip. Each strip may extend longitudinally along the outer surface of the tooth-shaped balloon. Each wedge-shaped dissector may include a radially outward surface and a side surface. The tooth-shaped balloon may then be expanded at the site so that the radially outward surfaces of the plurality of wedge-shaped dissectors directly contact the tissue of the intimal layer of the blood vessel wall, forming a cleavage surface into the media layer of the blood vessel wall. The tooth-shaped balloon may continue to expand so that the radially outward surfaces of the plurality of wedge-shaped dissectors no longer contact the tissue of the media layer of the blood vessel wall, and the side surfaces of the wedge-shaped dissectors contact the tissue of the media layer of the blood vessel wall to expand the cleavage surface. In some embodiments, the cleavage plane produced may have a total depth or depth within the middle film layer between about 0.2 mm and about 2.0 mm, such as between about 0.3 mm and about 1.5 mm, or between about 0.5 mm and about 1.2 mm. In some embodiments, the total depth or depth of the cleavage plane within the middle film layer may be about 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 1.6 mm, 1.7 mm, 1.8 mm, 1.9 mm, 2.0 mm, or a range including any two of the above values. In some embodiments, the cleavage plane does not intersect with other cleavage planes.

[0353] The use of single or multiple (double or triple) coatings on top of these strips and / or airbags has been described in previous applications. In some cases, it is contemplated that it would be advantageous to have the ends of the strips without a top coating. Removal of the top coating can be achieved by a variety of processes, including but not limited to a laser ablation step that selectively removes the top coating to selectively completely or almost completely remove the top coating (leaving a very thin film), wherein the remaining thickness is about or less than about 20 μm, 10 μm, 5 μm, 3 μm, 1 μm or less in some cases. Alternatively, in some embodiments, the coating can be sprayed on the entire surface of the airbag surface, but the ends of these strips are carefully avoided.

[0354] The various designs of these strips can in some cases not only provide features that may be beneficial to drug delivery, but can also help more effective tissue penetration in a variety of cells and diseased morphologies. For example, a terminal design with more than one contact surface can be beneficial to provide effective penetration into thick calcified or fibrotic tissues. In addition, a terminal design with a steeper angle (e.g., less than 15 degrees in some cases) can be beneficial to penetrate deeper into diseased vessels, thereby providing better nucleation sites for crack propagation. As described above, the penetration depth can help reduce the pressure required to initiate cracks and allow for increased crack opening displacement. In some cases, wider angles (such as those greater than 20 degrees) can effectively lyse hard, calcium-rich, diseased blood vessels.

[0355] The design of the odontoplasty balloon can vary based on the type of disease being treated. In some cases, the design of the strips and elevated elements (e.g., wedge-shaped dissectors) can be effective on a wide range of heterogeneous plaque morphologies, including circumferential and non-circumferential plaques. For example, in some cases, the use of a round elevated element with a narrow tip can effectively penetrate both hard and soft tissues and limit damage to the underlying cellular matrix by minimizing the necessary pressure required to initiate nucleation sites to form cracks and ultimately lumen expansion 5100.

[0356] The design of some embodiments of the serration-shaped balloon may provide the unique advantage of being able to achieve low-pressure dilation in a variety of disease forms (e.g., in some cases, about or less than about 9, 8, 7, 6, 5, 4, 3.5, 3, 2.5, 2 ATM, or less ATM). We observed low-pressure (3 ATM) angioplasty during the PRELUDE study. During the PRELUDE trial, physicians routinely inflated the serration-shaped balloon device up to about 3 or about 4 ATM and held pressure for 30 seconds. It was observed that when the balloon was inflated, it would often do so at the waist, with the middle of the balloon inflating less than the ends of the balloon (commonly referred to as a dog-bone shape). Without increasing the pressure, the physician would hold pressure at 3 or 4 ATM for 30 seconds. After 30 seconds, the physician would take an angiographic image and the waist would typically disappear, the balloon would be fully inflated and apposed, and the artery would appear to have dilated ( Figure 3 A) This phenomenon is considered unique and is not usually seen with low-pressure angioplasty.

[0357] Fig.31CFluoroscopic images of the serrated balloon inflation procedure are shown. The leftmost image shows the arterial stenosis seen in the absence of contrast along the length of the vessel. As shown, the waist can be seen when the balloon is inflated to 4ATM in the left middle image. In the right middle image, using the same 4ATM, only 30 seconds after the first use, the fully inflated balloon can be seen. The rightmost image shows a successful revascularization following the procedure.

[0358] Fig.31D An OCT image is shown on the left, illustrating the intimal anatomy. The IVUS image on the right shows calcification disruption and disruption into the media exposed layer to allow for advantageous drug delivery in some cases.

[0359] Fig.32 An embodiment of a modified cutting balloon for producing teeth is shown. In some embodiments, teeth or tooth-like beneficial effects can be achieved by modifying a cutting balloon catheter, for example, in U.S. Patent Application No. 2006 / 0184191 to O'Brien, the entire contents of which are incorporated herein by reference. The balloon catheter may include a catheter shaft having a balloon coupled thereto. One or more cutting members or blades may be coupled to the balloon. The balloon may include one or more discrete flexible points or regions 3200 to enhance the flexibility of the cutting balloon catheter. The interruptions in one or more cutting members may be aligned with one or more discrete flexible points in the balloon. In some embodiments, the flexible points may be arranged every 5 mm on 10 mm and 15 mm lengths (6 mm length = 0, 10 mm length = 1, 15 mm length = 2). Atherotomes (a microsurgical blade) with flexible points can help track lesions that may not have been accessible before in some cases.

[0360] Fig.33 An illustration of an improved cutting balloon is shown in which flexibility is further enhanced and the cutting is completely or partially replaced by a pattern of toothed blades 3350. Fig.32As shown, the number, position and arrangement of cutting members 3320 around balloon 3316 can be varied. For example, catheter 3310 can include one, two, three, four, five, six or more cutting members 3320, which are arranged at any position along balloon 3316 and in a regular, irregular or any other suitable pattern. The pattern may include a generally spiral orientation of cutting members 3320. Catheter 3310 may include a plurality of cutting members 3320, which are equidistantly placed around balloon 3316 and extend generally longitudinally. Generally, cutting members 3320 can be configured to provide variable flexibility or otherwise change the flexibility of catheter 3310. For example, increasing the flexibility of cutting members 3320, balloon 3316 and / or catheter 3310 may be desirable because it can improve the tracking ability and general delivery ability of catheter 3310 through generally curved anatomical structures. In addition, increasing flexibility can allow catheter 3310 to be navigated to a greater number of intravascular locations, including some locations that may not be easily reached by other less flexible cutting balloon catheters. In general, the enhanced flexibility can be the result of a structural feature of the cutting member 3320, a structural modification of the cutting member 3320, and / or a structural feature of the cutting balloon 3316. For example, the cutting member 3320 can include a first portion 3344a, a second portion 3344b, and a gap or interruption 3346 disposed between the first portion 3344a and the second portion 3344b. The interruption 3346 can be configured to provide a flexible area, such as a space between the first portion 3344a and the second portion 3344b. In some embodiments, the interruption 3346 can be defined by a downward deflection or slot formed in the cutting surface of the cutting member 3320. Alternatively, the interruption 3346 can be a region of the cutting member 3320 having a reduced wall thickness, or can include a material having increased flexibility relative to the material of the first and second portions 3344a, 3344b. The interruption 3346 can also include an external connector connected to the first portion 3344a and the second portion 3344b to bridge the portions 3344a, 3344b. Separating the portions 3344a, 3344b can increase the flexibility of the cutting member 3320 and / or the overall flexibility of the catheter 3310.

[0361] In some embodiments, a series of cutting elements (or micro-atherosclerosis cutters) as described above can be placed linearly along the surface of the balloon, and these cutting elements are spaced apart by the gap in the upper surface of the blade. In the above schematic illustration, the gap length is approximately one-tenth of the length of the length of the individual blade. In some embodiments, the gap length and the length ratio of the blade can be, for example, between about 1 / 15 and about 1 / 1, between about 1 / 10 and about 1 / 1, between about 1 / 5 and about 1 / 1, between about 1 / 5 and about 1 / 2, or about 1 / 15, 1 / 14, 1 / 13, 1 / 12, 1 / 11, 1 / 10, 1 / 9, 1 / 8, 1 / 7, 1 / 6, 1 / 5, 1 / 4, 1 / 3, 1 / 2, 1 / 1, 1 / 1.5, 2 / 1 or the range of any two of the above values.

[0362] A kind of improved cutting member is described here, its size provides more flexible, more stable design, and can form tooth or be similar to tooth in tissue.The improved cutting member embodiment can provide for example about or greater than about 8,9,10,11,12,13,14,15,20 degree or greater lateral bending, with or without wherein cutting surface is less or without the part of tooth.Some embodiments can comprise a series of cutting members, between cutting members or on the end of cutting members, cutting members are series connection or have the cycle of tooth feature (for example, raising element) as described in other various places of this paper.Cutting member (X) can have for example in the range of 0.01 inch to about 0.10 inch when being divided into a plurality of discontinuous parts, and they are separated by the interval (Y) of for example about 0.01 inch to about 0.08 inch.The whole cutting blade can have discontinuous part at any one or any number of positions along described blade. Once pressure is applied to the tissue by the balloon, the resulting tissue rupture may appear as a series of dots and dashes or any combination of dots and dashes produced by the combined improved cutting members, thereby piercing the tissue only in the narrow area where the discontinuous cutting member (X) is located. The effect of this discontinuous local penetration is that the balloon with the improved cutting blade produces a new angioplasty effect, called toothing plasty. For example, one such toothing plasty design may be a small raised feature that can produce a dot-like effect (or toothing feature) on the end of the cutting blade in the tissue, followed by a longer raised feature that can produce a dash in the center portion of the blade. Other toothing plasty designs may mix small and longer raised features in an alternating pattern, or a series of dots separated by one or more dashed lines in a repeating or non-repeating pattern. This embodiment may have 1, 3, 4, 5, 6 or 8 members, such as blades (or a combination of these numbers of members, such as blades), on the outside of the balloon, wherein the blades are typically smaller than the balloon body length. Such a device configured for dentation angioplasty can be used as a stand-alone angioplasty balloon or as a pre-treatment device prior to subsequent treatment. Subsequent treatment would include, but is not limited to: stenting, placement of a drug eluting stent, performing atherectomy, high pressure balloon-like or drug coated balloon treatment. Regardless of whether the device is used as a pre-treatment device for subsequent therapy or stand-alone therapy, by using the improved atherectomy as disclosed herein, the device effectively manages plaque or calcium by weakening binding, inducing cell or structural dissociation, and minimizing cell or structural compression typically produced by angioplasty alone. The dentation angioplasty allows the lumen of the lesion to be safely expanded using low pressure and accurately expanded and stretched to the desired diameter without the creation of numerous and extensive dissections and raised flaps. The dentations can enable the plaque to expand more evenly and smoothly and avoid the formation of random cracks that may lead to dissection and residual stenosis.In some cases, the plaque can also be expanded with a lower pressure than that used in standard balloon angioplasty after pretreatment with teeth. The lower intra-balloon pressure (e.g., less than or equal to 4, 3.5, 3, 2.5, 2 atm or less) applied by the balloon combined with the improved cutting member causes less destruction of the plaque, less dissection, and less damage to the arterial wall. This "low pressure" or "minimum damage" tooth angioplasty is less likely to cause the biological response of new intimal hyperplasia or smooth muscle cell replication that usually accompanies balloon angioplasty. In addition, during balloon angioplasty, the teeth can allow the plaque to expand with less rupture or destruction of the plaque. By pretreating the plaque with a balloon with teeth, the number and severity of dissections can be reduced. This reduces the need for stent placement to treat dissections or residual stenosis after balloon angioplasty with teeth. In some cases, due to the pretreatment of the plaque with perforations, the subsequent balloon angioplasty can be performed at a low balloon pressure of about 4 atmospheres or less to avoid damaging the arterial wall or its intimal tissue. By performing plaque pretreatment and then performing low-pressure angioplasty, there is a lower likelihood that a deep dissection will occur that produces deep tissue tearing and still potentially exposes the media layer of the artery. In some cases, exposure from deep tissue within the arterial wall can stimulate thrombosis through collagen exposure and also stimulate smooth muscle cell growth, which can then cause neointimal hyperplastic occlusion of the artery. Compared with conventional cutting or scoring devices, this reduction in the number of dissections and the reduction in severity can be a favorable differentiating factor in some cases.

[0363] Entrapment Coil Design

[0364] The bonding material is conducive to increasing the pushability of the device. When the physician encounters a lesion such as a chronic total occlusion (CTO), the ability to pass through the lesion may be challenging for a conventional catheter. In order to increase pushability, the catheter may include fibers, high-density polymers and / or metal parts. These materials can be bonded to a main shaft, an internal member or a polymer matrix as a separate component. When used as a separate component, the increased components are typically placed between the outer sheaths in the internal member. In one embodiment, a coil is designed, such as a metal coil, which can be inserted between the internal member and the outer sheath. The coil pitch can be, for example, an angle between tightly wound to 35 degrees, and the coil pitch may or may not change along the entire length of the catheter. The coil generally includes a section that is gradually reduced from a first diameter to a second diameter that is less than the first diameter. The catheter shaft is generally designed to have a tapered section, which is designed to follow the coil tapered section to keep the coil tightly trapped between the internal member and the outer sheath of the catheter. In some embodiments, the reduction of the outer diameter can occur or begin at the proximal side of the balloon. For example, in some embodiments, the tapered section or sections may be completely proximal to the proximal end of the balloon, or the distal end of the balloon. In some embodiments, the tapered section or sections may be within the insertable working length of the catheter (e.g., positionable in a body cavity). In some embodiments, the starting point (e.g., proximal end) of the tapered section may be at the distal end of the strain relief element, such as within a range of about 10, 9, 8, 7, 6, 5, 4, 3, 2, 1 centimeters or less, or two values ​​including the foregoing values.

[0365] Fig.343400. In the embodiment of the catheter 3310, the catheter 3310 may include a coil 3400 in the space between the outer catheter shaft 3410 and the inner member (guide wire shaft) 3420. Typically, the coil may be made of a metal or alloy, such as stainless steel, but may also be a polymer material. The coil 3400 may be designed to have one or more tapered portions from a larger diameter 3430 to a smaller diameter 3440. The tapered portion of the coil may be wound between, for example, a 0 degree pitch and a 15 degree pitch. A lower pitch may provide greater pushability, while a higher pitch may provide greater flexibility. In some embodiments, the pitch angle may be approximately 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35 degrees or greater, or a range including any two of the above values. In some embodiments with multiple tapers (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10 or more tapers, or a range including any two of the foregoing values), each taper or one or more of the tapers may have the same or different pitches therefrom. The coil may typically be located in a space between the inner diameter of the outer shaft of the catheter and the outer diameter of the inner member, through which the guide wire passes. In some embodiments, the outer diameter of the coil matches or substantially matches the inner diameter of the outer shaft through at least a portion of the axial length of the coil and the outer shaft, so that the outer diameter of the coil is no greater than about 15%, 10%, 5%, 4%, 3%, 2%, 1% or more or less of the outer shaft. Embodiments in which the surface (e.g., the outer diameter surface of the coil and the inner diameter surface of the outer shaft) contacts or almost contacts the device may provide greater stability and greater effective pushability in tortuous anatomical structures. In some embodiments, the taper of the coil matches a similar taper of the outer shaft, so that when the coil tapers from one outer diameter to another smaller outer diameter, the outer shaft can follow the matching or substantially matching taper. In addition to the coil following the tapered portion of the outer shaft, the coil can be further reduced in size and follow the outer diameter of the inner member or a typical radiopaque marker that is integral with the inner member. In some cases, the support of the inner member on the smaller coil diameter and the support of the outer shaft on the tapered portion and on the larger coil diameter jointly increase the stability of the coil. In embodiments where the coil is supported along its entire length, the coil is less likely to become unfolded or unwound. The combination of one or more coils and adjacent shafts can advantageously increase the robustness of the device and its ability to transfer energy to the catheter tip, particularly when the catheter body is bent through tortuous anatomical structures.

[0366] In some embodiments, the tapered portion of the coil matches a similar tapered portion of the outer shaft, so when the coil tapers from one outer diameter to another, the outer shaft can hit the matching tapered portion. The outer dimension of the largest area of ​​the coil may be between about 0.030 inches and about 0.150 inches in some cases, such as between about 0.070 inches and about 0.050 inches. The outer diameter of the smallest diameter portion of the coil may be, for example, between about 0.025 inches and about 0.045 inches, or between about 0.030 inches and about 0.040 inches. There may be a single transient taper from a larger diameter to a smaller diameter, but in some embodiments there may be up to 2, 3, 4, 5 or more tapered portions of diameter with varying angles. The outer shaft may be similar in design, with 1 to 5 or more tapered sections, for example bumping down from one diameter to another diameter. In some embodiments, the outer dimension of the largest area of ​​the outer shaft is between about 0.030 inches and about 0.150 inches, or between about 0.050 inches and about 0.075 inches. In some embodiments, the outer diameter of the smallest diameter portion of the outer shaft can be, for example, between about 0.020 inches and about 0.080 inches, or between about 0.0030 inches and about 0.065 inches. In some embodiments, the coil thickness can range from about 0.0001 inches to about 0.0010 inches thick, or between about 0.0002 inches and about 0.0005 inches thick. The width of the coil can range, for example, from about 0.006 inches to about 0.040 inches thick, about 0.040 inches to about 0.008 inches thick, or about 0.020 inches to about 0.010 inches thick. In some cases, the coil may extend the entire length of the catheter from the connector to the end, or substantially the entire length, or at least about 50%, 60%, 70%, 80%, 90%, 95% or more, or the entire axial length of the catheter, or a range comprising any two of the above values. The length of the system (and / or coil) can be, for example, in the range of about 20 cm to about 250 cm, such as about 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250 cm or more, or a range comprising any two of the above values. In some cases, the length of the taper from the larger diameter coil to the smaller diameter may occur over a narrow length of the entire coil, such as about or less than about 50%, 40%, 30%, 25%, 20%, 15%, 10%, 5%, or less of the entire axial length of the coil, such as between about 10% and about 40%, or about 15% to about 30% of the entire axial length of the coil.The axial length of the tapered section of the shaft from the larger diameter shaft to the smaller diameter shaft is configured to match or substantially match the tapered section of the coil, which can occur over the entire narrow length of the shaft in some cases, such as about or less than about 50%, 40%, 30%, 25%, 20%, 15%, 10%, 5%, or less of the entire axial length of the shaft, such as between about 10% and about 40%, or between about 15% and about 30% of the entire axial length of the shaft. The tapered section length can be, for example, between about 0.01 cm and about 10 cm, between about 0.03 cm and about 10 cm, between about 0.05 cm and about 10 cm, between about 0.3 cm and about 5 cm, between about 0.5 cm and about 5 cm, and other ranges combining any two of the above values. In some cases, the location where the tapered length ends and the smaller diameter coil begins can be, for example, at or near the distal end of the catheter, and typically between about 5 cm and about 50 cm measured from the end of the catheter, or can be measured from the proximal leg of the balloon. In some embodiments, the coil can be fused or otherwise connected to the outer sheath at the proximal end, typically with a UV adhesive, before being bonded to the joint, but other commonly used bonding methods can be used. In other embodiments, the coil is directly bonded to the joint at the same time as the outer sheath and / or inner member, or is bonded to the joint separately from the outer sheath and / or inner member. The coil can be fused to the end, balloon, balloon assembly, and / or inner member at the distal end, thereby jointly creating a joint created using thermal energy, for example to allow all or some of the polymer layers to reflow and solidify into a single fused joint, but other commonly used bonding methods can also be used.

[0367] Fig.34A An embodiment of a catheter comprising a shaft is shown, comprising an insertable axial length 34L and a coil extending axially along substantially the entire length of the shaft. The catheter may include a strain relief element 3470 having a distal end 3472 spaced apart from a tapered section 3471, which in turn may be spaced apart from a proximal end 3475 of a balloon 3477 in some embodiments.

[0368] Fig.34B Shown by Fig.34A A cross section of the axis of line AA (the coil is removed for clarity). Fig.34C Shown by Fig.34A Cross section of the axis of line BB (the coil is removed for clarity). Fig.34D shows a schematic cross-sectional view of the tapered portion of the coil A within the tapered portion of the main shaft B, Fig.34E The tapered region is also schematically shown. Fig.34FA schematic diagram of a balloon catheter is shown, which includes a coil 3488 extending within the inner surface of a balloon 3490, with a wedge-shaped dissector 3492 on the outer surface of the balloon. As shown, the coil 3488 generally extends proximally (not shown) through the shaft 3486, and in some designs, if the shaft is also distal to the balloon, the coil extends distally. In some embodiments, the coil extends from the joint to the tip in the interstitial space between the main shaft of the catheter and the inner member. Figure 34G An embodiment of a coil 3488 extending through a balloon as previously described is shown, with one or more gaps or coil separation portions 3489 within the balloon configured to aid in seeing the radiopaque markers typically embedded or locked into the inner member, which extend along the entire length of the catheter from the interface to the end. In some embodiments, alternatively or additionally, the coil separation portion 3489 may be outside the balloon, such as at the distal end or within the catheter shaft. In other embodiments, the coil may remain continuous and a radiopaque coating may be applied to a portion of the coil. In other embodiments, the coil itself may be made of more than one material, with a portion of the coil being more radiopaque than other portions of the coil. In designs using more than one material, the more radiopaque area may be used to define the working area of ​​the device. The working area will be interpreted by the physician as the area in which the device is aligned with the desired treatment area. Fig.34H One embodiment of a coil 3488 is schematically shown extending through the length of the catheter between the outer sheath 3498 and the inner member 3497 . Fig.34I The coil 3488 is schematically shown extending the entire length of the balloon 3490 and extending proximally and distally. Figure 34J-Figure 34K A view of the distal end 3481 of the coil 3488 is shown fused or otherwise bonded to the distal tip portion 3471 of the catheter as previously described. Figure 34L An embodiment of a proximal bonding area of ​​a balloon is schematically illustrated, showing the coil 3488, outer sheath 3498, and inner member 3497. Figure 34M A schematic cross-sectional view through the proximal joint of the catheter system is shown, showing the coil 3488, outer sheath 3498 and inner member 3497, which may be joined or otherwise attached together as described above.

[0369] Some non-limiting features of the coils are also described. (1) Tolerance stack-the coil thickness can preferably be adapted to the contour needs of the system. Thus, for example, the 5F system can be less than about 0.08, 0.075, 0.07, 0.066, 0.063, 0.060 or less inches (or a range including any two of the above values) for the outer diameter of the catheter shaft. The catheter shaft tolerance can be matched to the coil tolerance, which can be matched to the radiopaque marker (if required in the system), which can be matched to the tolerance stack of the internal components. This stack may require precision manufacturing; in some embodiments, catheter designs with coils may choose to combine more than one material together. (2) Addressing tortuosity-as physicians address complex disease in the most distal areas of the body, the need for more efficient designs becomes more relevant. Currently, few devices are able to track disease areas below the popliteal and especially below the ankle joint over a guidewire. The main difficulty in tracking these most distal vessels is caused by the complexity of the disease and the anatomical tortuosity of the vessels in these arterial pathways. The anterior tibia, for example, typically has two 90-degree bends in a short 5 cm length. The ability of extruded polymer materials alone (i.e., without coils) to effectively address these bends and still achieve effective pushability has been shown to be poor. The design with coils provides the system with increased column strength without reducing the effective ability to address curved anatomical structures. (3) System-controlled effect conversion - In some catheter-based devices, the physician will preferably be able to control the orientation of the entire system by changing the orientation of an interface or handle that remains outside the patient. If these devices are laid freely on a table without constraints and the physician rotates the handle, the entire device typically rotates. However, when the device is introduced into the patient's body, it usually has to travel through a series of bends and can be twisted when it is pushed onto the site where the device will be used. Once in the position, the physician's ability to rotate the device is very limited, largely due to the friction of all the bends and the device's inability to effectively transfer the rotational energy at the handle to the distal end of the catheter. The use of the snare coil technology provides the ability of the coil to more effectively convert the rotational energy down the device. (4) Use of periodic adhesive bonds - In some embodiments, the use of periodic adhesive bonds can be used to assist in the transition of system control. These embodiments include a single or a group of areas where the coil and outer sheath are "bonded" together. The use of bonded areas of the catheter can be used to assist in the transition of energy along the catheter body. While tapering the coil and outer shaft and using different pitches in the coil design can be effective in providing enhanced system control, some embodiments include one, two or more adhesive bonds to further enhance the control of the system for the physician. (5) Materials and processes for manufacturing the coil - In tests conducted to date, a range of stainless steel materials with varying thicknesses, widths, tapers, and lengths have been shown to be effective.Other materials with similar geometries may also be effective. Plastic materials such as polymers or copolymers may be extruded and then cut to form a coil, or may start as a flat strip and be heated and wound around a mandrel to form a coil shape and then cooled to maintain its shape. For metals, such as stainless steel, the material may start as a tubing and then be cut to form a coil, or may start in a flat strip and be heated if necessary and wound around a mandrel to form a coil shape, and then cooled to maintain its shape if necessary. Other manufacturing methods generally known in the industry may also be used to form the coil. (6) Pushability of the distal tapered region - Having an effective tapered portion can provide enhanced pushability in the distal portion, where the device has minimal linear conversion of energy. Similarly, in cases such as lower extremity tibial disease, the distal portion of the device can successfully track two right-angle bends separated by only about 5 centimeters, for example. Fig.34N The tibial artery branch segment schematically shown in FIG. In contrast, the linear pushability of conventional systems may be affected at each additional turn. The reduction in diameter can advantageously and effectively tighten the column strength and enable a greater degree of momentum transfer through the bend and to the end of the system.

[0370] Airbag-in-airbag design

[0371] In some embodiments, it may be preferred to use a single preformed cover or top bladder in place of a top coating (as described herein, U.S. Patent Application No. 2017 / 0333686 to Schneider et al. and U.S. Patent Application No. 2017 / 0080192 to Giasolli et al., both of which are incorporated herein by reference in their entirety). The use of a preformed cover can provide a range of added value, such as ease of manufacturing, precise control of thickness, increased retention of the strips, uniformity of the outer layer, and / or the ability to use a wider range of materials on the outermost surface. The range of materials can include almost any material that can be extruded and blown into an airbag mold. In some embodiments, these preformed coatings can be made of more than a single material or more than a single layer, but are typically made of a material that is more stretchable or flexible than the base airbag. Because the functional properties of the preformed cover or outer airbag are different from those of the inner airbag, the materials used to construct it are typically different. For the outer balloon, the main requirement of the balloon may be to allow the elevated elements (e.g., wedge-shaped dissectors / teeth) to effectively penetrate under high loads but not tear along the spaces between the elevated elements during high-pressure expansion of the base balloon. The size of the balloon may be the same or different from the size of the base balloon, without being limited by the material used to construct the outer balloon. In some embodiments, the length and diameter of the outer balloon are both greater than the length and diameter of the base balloon. Due to the above-mentioned Laplace formula, we note that the tangential stress on the balloon surface is proportional to the radius of the balloon and the pressure inside the balloon. Therefore, the selected materials and the sizes of the inner and outer balloons may need to change at different diameters of the balloon. Therefore, a 2.5 mm diameter balloon may require more stretchable materials than a 5.0 mm diameter balloon because the tension on the balloon surface is 1 / 2 at the same pressure. In addition to the different lengths and diameters between the two balloons, the angles and lengths of the cones on the ends of the two balloons may be different. The balloon can be designed to stretch or conform to the pressure being delivered. When this occurs, the balloon typically increases in both diameter and length, and the preformed covering or outer balloon is designed to accommodate this expansion. In some embodiments, the preformed coating has a length that is less than the base balloon, such as about, at least about, or no more than about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20% or more less than the length of the base balloon, or a range including any two of the foregoing values. In some embodiments, the preformed covering or outer balloon has a length that is less than the length of the base balloon by about 5 mm, 4 mm, 3 mm, 2.5 mm, 2 mm, 1.5 mm, or 1 mm, or a range including any two of the foregoing values.In some embodiments, the preformed coating has a diameter greater than the base balloon, such as about, at least about, or no more than about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, or more than the length of the base balloon, or a range including any two of the foregoing values. In some embodiments, the diameter of the preformed covering or outer balloon is about 0.05 mm, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.1 mm, 1.2 mm, 1.3 mm, 1.4 mm, 1.5 mm, 2 mm or more, or a range including any two of the foregoing values, greater than the diameter of the base balloon.

[0372] In some cases, the outer balloon (or preformed cover) can be larger in size than the inner balloon to aid in manufacturing. In some embodiments, the outer balloon can have a length, diameter, and / or thickness that is more or less than about, at least about, or no more than about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50% or a range comprising any two of the foregoing values ​​relative to the base (inner) balloon. In some embodiments, a balloon having teeth bonded to a surface is expanded inside a preformed cover. Fig.34OSchematically illustrates an embodiment of a method for producing a balloon-in-balloon design. As shown in the inset ①, a balloon angioplasty (POBA) base balloon 5100 that typically provides the desired support on a short catheter can be used alone or only with a single base coating (or multiple base coatings in other cases). As shown in the inset ②, a strip with a wedge-shaped dissector 5102 can be attached to the base balloon 5100, for example, the outer surface of the balloon, as described elsewhere herein, to produce a tooth-shaped balloon. As shown in the inset ③, the balloon 5100 with the attached wedge-shaped dissector and strip can then be pleated. As shown in the inset ④, the balloon 5100 with the pleats of the attached wedge-shaped dissector and strip can then be inserted into the second balloon 5104 or in other outer wall structures or coverings that do not include any teeth / wedge-shaped dissectors on the outer surface. As shown in the inset ⑤, the inner tooth balloon 5100 can then be expanded. In some embodiments, the entire airbag and the strip are bonded to the outer prefabricated cover. The final airbag inner airbag construct 5199 is shown in the inset ⑥. The bonding of these two layers is typically accomplished with, for example, UV-curable glue or other adhesives, which are evenly coated on the surface of the inner airbag before sliding the outer prefabricated cover to cover the inner airbag. The inner airbag is then inflated, for example to high pressure (e.g., greater than about 5, 6, 7, 8 or more ATM), then exposed to UV light and allowed to be cured. The contact of the two surfaces under pressure load evenly disperses the glue, allowing a uniform coating thickness on the airbag body and airbag cone surface before the curing cycle. Alternatively, in some embodiments, it can be designed that the strip will be bonded to the airbag mold during the airbag blow molding process. When the strip is bonded to the manufacture of the airbag, it is designed that the inner and outer airbags can be laminated or thermally bonded with the strips bonded to the laminate layer. When incorporating the strap into the manufacture of the airbag pair, it is contemplated that the strap may first be pressed into the outer airbag, such as from the ID (inside diameter) of the airbag, and then the inner airbag will expand and fuse into the outer airbag, thereby creating a fused bond of the airbags in which the base of the strap is placed. As is typical in other manufacturing techniques, the raised element is raised above the outer surface of the outer airbag.

[0373] Interface bonding between prefabricated cover and base airbag.

[0374] The spacing between the top surfaces of the raised elements or base strips can be considered as a stretchable membrane that holds the strips and stabilizes the raised elements to the airbag surface. In some embodiments, the space between the raised elements can be bonded to the base airbag and the strips. In other embodiments, the space may not be bonded to the base airbag, allowing the prefabricated airbag to float freely in the strip portion while the two airbags are selectively bonded elsewhere. In embodiments where the strip area is not selectively bonded, the inner airbag can effectively fall off during deflation. When the system is deflated, the outer airbag deflates at a slightly different rate than the inner airbag because the airbag system is not fully bonded into a single unit. Due to the change in the deflation rate, local gaps are generated between the airbags. The space created by the local gaps enables the toothed strips to retract into the space. In this way, the recessed height or profile of the raised elements of the strip body or the raised elements above the outer airbag is minimized, and in some cases, all the raised elements are completely recessed into the space between the airbags. Such embodiments may be advantageous, for example, in reducing the risk of the teeth snagging on undesirable portions of the anatomy, such as vessels or bifurcations other than the target treatment location, during insertion or removal of the device. However, in some embodiments, a preformed covering or outer balloon is joined to the base balloon as a single unit.

[0375] TAVR Indications

[0376] In some embodiments, the serration device can be used to prepare for a large-bore sheath (e.g., greater than 12 Fr) to enter a vessel, such as required for, for example, endovascular aneurysm repair (EVAR), fenestrated endovascular aortic repair (FEVAR), transcatheter aortic valve replacement (TAVR), transcatheter mitral valve repair or replacement, or thoracic endovascular aortic repair (TEVAR). Placing a large-bore sheath in a severely diseased and / or calcified iliac artery or infrarenal aorta for access can cause dissection or trauma to the artery. If the lumen of the access artery is not sufficient to accommodate the sheath, the advancement of the large-bore sheath for device delivery can cause damage to a small or calcified or severely diseased iliac artery. Similarly, the expansion of the dilation sheath for device delivery can cause damage when it expands to accommodate a large diameter indexing surgical catheter. The serration balloon will be used to create a serration effect in the access artery (iliac or infrarenal aorta or common carotid artery or subclavian artery, which can be used to enter a large-bore sheath), enabling more control during the use of a large-bore delivery sheath. This technique will allow for dilation of the access artery, create an adequate lumen for placement of the sheath, and reduce the likelihood of dissection or trauma to the access artery that may occur during dilation of the dilation sheath.

[0377] The use of odontoplasty to access various procedures is another area of ​​use, for example, 8-12 mm diameter vessels or balloons. For TEVAR and EVAR, a potential problem is access through the femoral or iliac arteries. Prior to placement of the sheath, an odontoplasty procedure utilizing a catheter with a wedge-shaped dissector as disclosed herein may be performed. This can advantageously help dilate (pre-dilate) the healthy or diseased tissue prior to performing the index procedure.

[0378] FIG. 35a above shows an embodiment of a strip 3500 with a wedge-shaped dissector having an inclined nonlinear edge 3510. The wedge-shaped dissector may include a radially outwardly facing peak 3570. The strip 3500 has a top surface 3550 and a side surface 3560. The inclined nonlinear edge 3520 may have an upper concave or convex feature 3530 that is different from the bottom concave or convex feature 3540 along one or both inclined sides. Another view can be seen in the end view illustration of FIG. 35b.

[0379] In the side view shown in Figure 35b, the bottom portion 3540 is a biconcave portion of the strip 3500 that has a greater thickness than the upper biconcave portion 3530. The upper biconcave portion 3530 shows the thinner biconcave portion of the strip 3500 as it narrows toward the end 3580, which in some cases may be radially outwardly facing. Other design and manufacturing techniques may create a series of recesses on the side of the strip.

[0380] like Fig.36 As shown in the top of the wedge-shaped dissector 3570, various unique features 3600 can be present on the end (e.g., radially outwardly facing surface) 3580 that contacts the tissue. As shown, the wedge-shaped dissector 3570 has the appearance of a toothed end with micro-dimples, valleys, or features 3600 near the apex of the radially outer surface of the wedge-shaped dissector 3580, which have a small (e.g., less than about 10%, 8%, 6%, 4%, 2%, or less) height increase or decrease relative to the overall height of the wedge-shaped dissector, which is laterally bordered by a center portion 3610 that can be flat-topped as shown.

[0381] Fig.37 Another design shows an alternative variation of the tooth-like edge of the wedge-shaped dissector 3510, wherein the center portion may include a small depression 3700 as shown, the depth of which may have a height increase or decrease of, for example, less than about 10%, 8%, 6%, 4%, 2% or less relative to the overall height of the wedge-shaped dissector.

[0382] In another embodiment, Fig.38As shown, the wedge-shaped dissector 3510 may include a rounded, double-peaked contact surface 3800 at the tip 3580 that may provide effective tissue penetration. In some cases, the effect of multiple contact points on the surface of the wedge-shaped dissector 3510 may provide better penetration (point sources) for various disease morphologies including calcifications while still being able to achieve a serration effect across the lesion, thereby facilitating arterial lumen augmentation with minimal balloon pressure.

[0383] Fig.39 A variation on the design is shown that provides a relatively sharp, pointed dual contact surface at the end 3900 of each wedge-shaped dissector 3510 that can provide effective tissue penetration. Fig.40 Also shown is a similar design that provides relatively sharp, pointed dual contact surfaces at the end of each wedge-shaped dissector that can provide effective tissue penetration, which abut central wider and shallower valleys / depressions 4000, respectively.

[0384]

[00136] Disclosed below are, in some embodiments, a series of frameworks that follow to demonstrate designs for providing one, two, or more therapeutic agents into a region creating an anatomical plane.

[0385] like Fig.41A As shown, the strip 3500 can be manufactured to include multiple strips (e.g., two identical strips) that only touch end to end 4100 in a wedge-shaped dissector frame or carrier 4110. This wedge-shaped dissector frame 4110 can potentially be produced via a mechanical removal process (such as chemical etching). In some embodiments, the strip 3500 can be easily and cleanly separated from the frame 4110 and the mirror image strip by mechanical force or other means without changing the wedge-shaped dissector geometry of the strip 3500. In some embodiments, the frame or carrier 4110 can remain attached to the strip 3500 until the surface of the strip opposite the base of the wedge-shaped dissector is bonded or otherwise attached to the surface of the airbag, as described elsewhere herein.

[0386] Fig.41B and Fig.41C It is shown that in some embodiments, multiple strips 4100 can be bent or folded into a curved form 4120, leaving the end 4100 intact and creating an A-frame 4130 with an open gap or well in the outward facing surface of the combined A-frame wedge dissector 3510 assembly.

[0387] Fig.41D and Fig.41E An alternative embodiment is shown having a toothed tip 4160 comprising a plurality of pointed surfaces with a central concave portion 4150 (with a central concave portion 4150) therebetween. Fig.41B and Fig.41CThe strip 3500 with the toothed ends 4160 may be bent, thereby leaving the toothed ends 4160 intact and creating an A-frame with the toothed ends 4160 having an open gap or well.

[0388] In some embodiments, the distance between adjacent base strips at the base is between about 30 μm and about 260 μm, between about 60 μm and about 190 μm, or between about 90 μm and about 130 μm. In some embodiments, the size (e.g., width) of the gap at the vertex of the "A" of the A-frame can be, for example, between about 10 μm and about 150 μm, between about 25 μm and about 100 μm, or between about 50 μm and about 75 μm. In some embodiments, the angle of the vertex of the "A" of the A-frame defined by the intersection of the distal portions of the two wedge-shaped dissectors can be, for example, between about 5 degrees and about 45 degrees, such as between about 10 degrees and about 30 degrees, or between about 15 degrees and about 22 degrees.

[0389] Fig.42 A demonstration series is shown that illustrates the ability to take a stack of strips 4200 connected to a blank or carrier 4300 that can be discarded at any point in the strip attachment process (before placement on the balloon, during balloon placement, or after the strips are glued to the balloon). This process provides automation, assistance in picking and placing the strips, and helps to accurately align the strips and balloon. The radial distal end 4210 can abut against a continuous free edge 4220 or other continuous or discontinuous surface to allow simple separation of the strips. In some embodiments, a carrier system for attaching a wedge-shaped dissector to a medical balloon may include a strip that includes a plurality of wedge-shaped dissectors spaced longitudinally along the surface of the strip. Each wedge-shaped dissector may include a base surface facing the strip directly adjacent to the first surface of the strip, an unpolished radially outward surface, and a side surface between the base surface facing the strip and the radially outward surface, the radially outward surface having a length between the proximal edge of the radially outward surface and the distal edge of the radially outward surface, and defining the height of each wedge-shaped dissector. The strip may also include a second surface opposite to the first surface of the strip and a strip carrier including a free edge. The unpolished radially outward surface of each wedge-shaped dissector may be reversibly connected to the free edge of the strip carrier in the connection region. The region between the connection regions may define a gap and be configured to separate when a mechanical force is applied. In some embodiments, the second surface of the strip may be attached to the surface of the medical airbag, and after the second surface of the strip is attached to the medical airbag, the strip carrier is separated from the strip. In some embodiments, the strip carrier may be integrally formed with the strip and produced using a process such as chemical etching. The strip carrier may be made of the same or different material as the strip.

[0390] Fig.43 An embodiment of a close-up view of the radially outward surface 4325 of the wedge-shaped dissector 4100 attached to the free edge 4220 of the blank or carrier 4300 is shown. Also shown are gaps 4280 between the attachment areas 4328 where the base surface of the strip does not contact the corresponding free edge 4420 of the blank or carrier. In some embodiments, the surface area of ​​each or all of the gaps 4280 is about, at least about, or about or greater than about 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 250%, 300% or more relative to the surface area of ​​the wedge-shaped dissector of each strip or each wedge-shaped dissector. In some embodiments, the most proximal free edge 4420 of the blank or carrier 4300 is in contact with the most distal edge or surface of the wedge-shaped dissector 4325 (e.g., is the only contacting edge) such that the intersection or contact point between the strip / wedge-shaped dissector 4100 and the blank 4300 extends only along a straight line and has no or substantially no overlap in dimension, e.g. Fig.43 In some embodiments, the strips and the associated wedge-shaped dissectors may be overlapped in one or more dimensions, such as by grooves or trenches in the free edge of the blank. In other embodiments, the connecting region need not be along a continuous free edge of the blank or carrier, but rather a separate interval between a projection of the blank or carrier and the wedge-shaped dissector. The projection may be a mirror image or other pattern of the wedge-shaped dissector.

[0391] Fig.44A and Fig.44B A description of an embodiment of a manufacturing process for manufacturing a dentition plasty strip, cutting member, or wedge dissector 3510 is shown, which utilizes a reel of a suitable material (such as a metal, such as a stainless steel material blank 4410). The blank 4410 can be formed or ground to have or not have a grinding edge. The grinding edge 4430 can be manufactured with a single or multiple facets on its edge and can be ground to a fine end (e.g., polished) or ground to a narrow but flat side (e.g., unpolished). In some embodiments, a cross-sectional view of the ground grinding blank 4430 can be a triangular-like shape, potentially having multiple bevels on the ascending side of the equilateral triangle bevel.

[0392] In addition to the above-mentioned material grinding manufacturing technology, the manufacture of stainless steel tooth blades can be achieved using other batch processing technologies.

[0393] Since such grinding, punching, and etching are mass-processing techniques, a technique for realizing low-cost manufacturing of tooth tips is envisioned.

[0394] In some embodiments, the description of fabrication steps to be included in chemical etching may include some or all of the following steps.

[0395] The mask or mask set 4400 includes information and design details for making a series of toothed blades, cutting members, or wedge-shaped dissectors that can be placed on top of the photoresist layer 4420. Each mask 4400 is a series of openings for allowing light to shine through the mask 4400. The mask sets 4400 can be identical or can be slightly different from each other to allow partial etching through a single side of the stainless steel material 4410.

[0396] Chemical etching of the stainless steel tape or sheet 4410 using a mask, photoresist, and etching material may be advantageously applied to allow large quantities of material to be etched at low cost.

[0397] Batch chemical etching can allow for high volume manufacturing of extremely repeatable and low-cost components. Traditionally, chemical etching produces rounded edges with gently sloped sidewalls that pass through the material at angles approaching 90 degrees. To achieve a more gentle slope angle, grayscale masking was considered, but with poor results. Instead of the grayscale masking technique, new masking techniques utilize relatively narrow apertures and narrow slit-like patterns to successfully control the etch rate. By controlling the flow of the etched material through the resist layer, angles for blade-like structures have been achieved.

[0398] Double sided mask exposure can enable etching through the material from both sides. In the case of double sided exposure, the edge profile produces a larger controlled mirror image profile on either side of the stainless steel material.

[0399] Fig.45B It is shown that the strip 3500 can be placed over a through hole 4500 embedded in the balloon wall 4510. The through hole can be a hole extruded before manufacturing the balloon, thereby providing a conduit through which a certain volume of one or more therapeutic agents can pass and be delivered to the tooth tissue. Fig.45A In some embodiments, the strip 3500 can be placed over a series of through holes 4520 formed by laser cutting or other methods of piercing the balloon wall 4510, down to a separate conduit created during the extrusion process, thereby providing a conduit through which a certain volume of one or more therapeutic agents can pass and be delivered to the tooth tissue.

[0400] Fig.46In some embodiments shown, a series of multiple, for example, 4, A-frame strips 3500 (or non-A-frame strips with wedge-shaped dissectors as disclosed herein) may be placed over through holes 4600 embedded in the balloon wall 4610. The A-frame strips 3500 may be regularly spaced as described above, or irregularly spaced in other embodiments.

[0401] In other words, in some embodiments, the design of the "A frame" strip 3500 includes a first strip 3510 and a second strip 3520 spaced apart at their respective bases, each strip including a wedge-shaped dissector 3510 having a peripheral radially outward surface, the wedge-shaped dissectors 3510 of the first strip 3510 and the second strip 3520 contacting each other at a portion of the periphery of each radially outward surface, wherein there is a vertex gap where the wedge-shaped dissectors 3510 of the first strip 3510 and the wedge-shaped dissectors 3510 of the second strip 3520 do not contact each other, wherein the gap is configured to accommodate a drug reservoir hole 4500 therethrough.

[0402] Fig.47 An embodiment of an array of strips 3500 is shown on a set of masks 4700 prior to chemical etching (with a close-up insert). Each array of strips 3500 may include a removable region 4710 between adjacent wedge-shaped dissectors 3510.

[0403] FIG. 48a shows a strip array 3500. FIG. 48b shows a detailed close-up image of adjacent wedge-shaped dissectors 3510 with removable areas 4710. FIG. 48c shows a tooth strip 3500 reversibly connected to a strip carrier 4810 for alignment, control, placement, and ease of manufacturing. Three chemical etching variations of the connection of the strip carrier 4810 to the strip 3500 with different geometries are shown in Etch 1 4820, Etch 2 4830, and Etch 3 4840. A close-up shows how the wedge-shaped dissectors 3510 on the side are connected to the strip carrier 4810. FIG. 48d shows another embodiment of a strip carrier 4480 of a wedge-shaped dissector reversibly attached to a strip 4890. The strip carrier 4880 can have any suitable geometry and in some cases has rounded or other tabs 4882, holes 4884, lateral tabs 4886, or other features for alignment, control, placement, and ease of manufacturing. In some embodiments, the strip carrier includes protrusions that may be a mirror image of the wedge-shaped dissector of the strip to allow for easy removal, such as after the strip has been bonded or otherwise secured to a balloon (not shown).

[0404] above Fig.49is an illustration of one embodiment of an overall system for producing a dentoplasty showing a series of dent-like or scored wedge-shaped dissectors 3510 on the outer diameter of a balloon 3316 attached to a catheter 3310 having a guidewire hub 4900 and a balloon expansion hub 4910. Figure 49A-49J Additional views of one embodiment of a odontoplasty system are shown.

[0405] According to the above teachings, different other modifications, adaptations, and alternative designs are certainly possible. Therefore, it should be understood here that within the scope of the appended claims, the present invention can be implemented in a manner different from that specifically described herein. It is conceivable that various combinations or sub-combinations can be made to the specific features and aspects of the embodiments disclosed above, and these combinations or sub-combinations still fall within one or more inventions. Further, the disclosure of any specific features, aspects, methods, properties, characteristics, qualities, attributes, elements, etc. of the embodiments herein can be used for all other embodiments set forth herein. Therefore, it should be understood that the different features and aspects of the disclosed embodiments can be combined or replaced with each other to form different modes of the disclosed invention. Therefore, the scope of the present invention disclosed herein is intended not to be limited by the specific disclosed embodiments described above. In addition, although the present invention is susceptible to different modifications and alternative forms, its specific examples have been shown in the drawings and described in detail herein. However, it should be understood that the present invention is not limited to the specific forms or methods disclosed, but on the contrary, the present invention will cover all modifications, equivalents and substitutions that fall within the spirit and scope of the various embodiments described and the appended claims. Any method disclosed herein does not need to be performed in the order listed. The methods disclosed herein include certain actions taken by the practitioner; however, the methods may also include any third-party instructions for these actions, either explicitly or implicitly. For example, an action such as "generating microperforations in an arterial plaque" includes "instructing the generation of microperforations in an arterial plaque." The ranges disclosed herein also include any and all overlaps, sub-ranges, and combinations thereof. Language such as "up to," "at least," "greater than," "less than," "between," and the like include the listed numbers. Numbers followed by terms such as "approximately," "about," and "substantially" used herein include the listed numbers (e.g., about 10% = 10%), and also represent an amount close to the amount that still performs the desired function or achieves the desired result. For example, the terms "approximately," "about," and "substantially" may refer to an amount within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount.

Claims

1. A medical balloon catheter, comprising: an elongated member including a lumen, the elongated member defining a longitudinal axis; a first inflatable balloon connected to the elongated member near a distal end of the elongated member; a plurality of straps, each strap of the plurality of straps comprising a plurality of wedge-shaped dissectors spaced along a surface of each strap, and each strap extending longitudinally along an outer surface of the first inflatable balloon; wherein each wedge-shaped dissector forms a radially outwardly facing surface; A second inflatable balloon covers at least a portion of an outer surface of the first inflatable balloon, wherein a tip of the wedge-shaped dissector is elevated above the outer surface of the second inflatable balloon.

2. The medical balloon catheter according to claim 1, wherein: The second inflatable balloon covers the plurality of wedge-shaped dissectors.

3. The medical balloon catheter according to claim 1, wherein: The second inflatable airbag has a length shorter than the first inflatable airbag.

4. The medical balloon catheter according to claim 1, wherein: The diameter of the second inflatable airbag is greater than the diameter of the first inflatable airbag.

5. The medical balloon catheter according to claim 1, wherein: The second inflatable airbag has a thickness greater than a thickness of the first inflatable airbag.

6. The medical balloon catheter according to claim 1, wherein: The second inflatable bladder comprises a different material than the first inflatable bladder.

7. The medical balloon catheter according to claim 1, wherein: The angle of the taper at the end of the second inflatable airbag is different from the angle of the taper at the end of the first inflatable airbag.

8. The medical balloon catheter according to claim 1, wherein: The length of the taper at the end of the second inflatable airbag is different from the length of the taper at the end of the first inflatable airbag.

9. The medical balloon catheter according to claim 1, wherein: The first inflatable bladder is configured to inflate inside the second inflatable bladder.

10. The medical balloon catheter according to claim 1, wherein: The first inflatable bladder is configured to be pleated prior to being inserted into the interior of the second inflatable bladder.

11. The medical balloon catheter according to claim 1, wherein: The second inflatable bladder provides a uniform outer layer over the plurality of strips.

12. A medical balloon catheter, comprising: an elongated member including a lumen, the elongated member defining a longitudinal axis; a first inflatable balloon connected to the elongated member near a distal end of the elongated member; a plurality of straps, each strap of the plurality of straps comprising a plurality of wedge-shaped dissectors spaced along a surface of the strap, and each strap extending longitudinally along an outer surface of the first inflatable balloon; wherein each wedge-shaped dissector forms a radially outwardly facing surface; a preformed covering overlying the plurality of strips including the plurality of wedge-shaped dissectors, wherein the preformed covering is configured to allow the plurality of wedge-shaped dissectors to effectively penetrate plaque without tearing along spaces between the wedge-shaped dissectors during inflation of the first inflatable balloon, wherein the ends of the wedge-shaped dissectors are elevated above an outer surface of the preformed covering.

13. The medical balloon catheter according to claim 12, wherein: The prefabricated covering comprises a single material.

14. The medical balloon catheter according to claim 12, wherein: The prefabricated covering comprises a plurality of materials.

15. The medical balloon catheter according to claim 12, wherein: The prefabricated covering comprises a single layer.

16. The medical balloon catheter according to claim 12, wherein: The prefabricated covering comprises a plurality of layers.

17. The medical balloon catheter according to claim 12, wherein: The prefabricated cover comprises a different material than the first inflatable bladder.

18. The medical balloon catheter according to claim 12, wherein: The prefabricated cover is bonded to the first inflatable bladder.

19. The medical balloon catheter according to claim 12, wherein: The preformed covering is more stretchable or more flexible than the first inflatable bladder.

20. The medical balloon catheter according to claim 12, wherein: The prefabricated covering has a diameter greater than a diameter of the first inflatable bladder.

21. The medical balloon catheter according to claim 12, wherein: The length of the prefabricated cover is less than the diameter of the first inflatable bladder.

22. A medical balloon catheter, comprising: an elongated member including a lumen, the elongated member defining a longitudinal axis; a first inflatable balloon connected to the elongated member near a distal end of the elongated member; a plurality of straps, each strap of the plurality of straps comprising a plurality of wedge-shaped dissectors spaced along a surface of the strap, and each strap extending longitudinally along an outer surface of the first inflatable balloon; wherein each wedge-shaped dissector forms a radially outwardly facing surface; and a second inflatable bladder covering at least a portion of an outer surface of the first inflatable bladder, wherein the second inflatable bladder forms a stretchable membrane between the plurality of wedge-shaped dissectors, the stretchable membrane retaining the plurality of straps and stabilizing the plurality of wedge-shaped dissectors, wherein the ends of the wedge-shaped dissectors are elevated above the outer surface of the second inflatable bladder.

23. The medical balloon catheter according to claim 22, wherein: At least one dimension of the second inflatable bladder is larger than the first inflatable bladder.

24. The medical balloon catheter according to claim 22, wherein: At least a portion of the first inflatable bladder is coupled to the second inflatable bladder.

25. The medical balloon catheter according to claim 22, wherein: The radially outwardly facing surface is unground.

26. A method for producing an airbag-in-airbag design, the method comprising: providing a base balloon that typically provides the desired support over a short catheter; attaching a strip having a wedge-shaped dissector to the base bladder on an outer surface of the base bladder; pleating said base bladder with said wedge-shaped dissector and said straps attached; inserting the pleated base balloon with the wedge-shaped dissector and the straps attached into a second balloon or other outer wall structure or covering that does not include any teeth / wedge-shaped dissectors on the outer surface; and The base balloon is inflated wherein the tip of the wedge-shaped dissector is elevated above the outer surface of the second balloon or other outer wall structure or covering.

27. The method according to claim 26, wherein: The entire base bladder and the strips are bonded to the second bladder or the other outer wall structure or covering.

28. The method according to claim 27, wherein: The two layers are bonded together by UV-curable glue or other adhesive, wherein the UV-curable glue or other adhesive is evenly applied to the surface of the base airbag before the second airbag or the other outer wall structure or covering is slid onto the base airbag.

29. The method according to claim 28, wherein: The base bladder is inflated, then exposed to UV light and allowed to cure.

30. The method of claim 26, wherein: The base balloon is inflated at 5 atm or more.

31. The method of claim 28, wherein: The contact of the two surfaces under pressure load causes the glue to be evenly dispersed, allowing a uniform coating thickness to be formed on the body of the base bladder and on the cone surface of the base bladder before a curing cycle.

32. The method of claim 26, wherein: During the air bag blow molding process, the strips are incorporated into the air bag mold.

33. The method of claim 32, wherein: The base bladder and the second bladder or the other outer wall structure or covering are laminated or heat bonded with the strips incorporated in a laminate layer.

34. The method of claim 32, wherein: When the strip is incorporated into the manufacture of an airbag pair, the strip is first pressed from the inner diameter of the airbag into the second airbag or the other outer wall structure or covering, and then the base airbag is expanded and fused into the second airbag or the other outer wall structure or covering, thereby creating a fused bond of the airbag with the base of the strip placed therein.

35. A pretreatment balloon configured to expand at a site to create a plurality of microcracks in the media layer of a blood vessel wall, the pretreatment balloon comprising: an elongated member having an internal lumen, the elongated member defining a longitudinal axis; an inflatable base bladder connected to the elongated member at a distal end of the elongated member; a plurality of straps, each strap of the plurality of straps having a plurality of wedge-shaped dissectors spaced along a surface of the strap, and each strap extending longitudinally along an outer surface of the balloon; At least one retaining layer surrounds the outer surface of the balloon, the straps, and the wedge-shaped dissector, wherein a tip of the wedge-shaped dissector is elevated above the outer surface of the at least one retaining layer.

36. The pretreatment balloon of claim 35, wherein: The at least one retaining layer comprises a single preformed cover or top bladder.

37. The pretreatment balloon of claim 35, wherein: The at least one retention layer comprises a material that is more stretchable or more flexible than the inflatable base bladder.

38. The pretreatment balloon of claim 37, wherein: The at least one retention layer is configured to allow the plurality of wedge-shaped dissectors to effectively penetrate under high loads but not tear the at least one retention layer along spaces between the plurality of wedge-shaped dissectors during high pressure inflation of the inflatable base bladder.

39. The pretreatment balloon of claim 37, wherein: The at least one retention layer has a length that is less than a length of the inflatable base bladder.

Images