Balloon catheter with reduced residual stenosis and method of use

Abstract

Systems and methods may include wedge dissectors attached to strips, which in turn are attached to medical balloons, for forming teeth within vascular wall tissue for angioplasty and reducing vascular retraction, reducing residual stenosis, and increasing volumetric blood flow after angioplasty. Designs, methods of use, anticipated outcomes, and processes for constructing airbags of this type are described herein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. US63 / 355324, filed on June 24, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Certain embodiments disclosed herein generally relate to a series of serrations integrated with medical balloons (e.g., angioplasty balloons), and methods of depositing drugs into tissues through serrations. Methods of making the series of serrations and treatment methods involving the series of serrations are also disclosed, as well as various wedge-shaped dissectors and square plug features collectively referred to as serrations. Among other things, the wedge-shaped dissectors can be particularly useful for creating perforations in diseased treatment areas to control crack propagation, reduce flow-restricting dissections, reduce the need for implants such as stents, reduce recoil, increase lumen gain, and increase flow in diseased treatment areas. Background Art

[0004] Atherosclerotic occlusive disease is a leading cause of stroke, heart attack, limb loss, and death in the United States and the industrialized world. Atherosclerotic plaques form a hard layer along the arterial wall and include calcium, cholesterol, compressed thrombi, and cellular debris. As atherosclerotic disease progresses, the blood supply intended to pass through a particular blood vessel is diminished or even blocked by the occlusive process. One of the most widely used methods for treating significant atherosclerotic plaques clinically is balloon angioplasty.

[0005] Balloon angioplasty is a method of opening blocked or narrowed blood vessels in the body. A balloon angioplasty catheter is placed into a diseased vessel (such as an artery) from a remote access site created percutaneously or via exposed arteries. The catheter is passed along the inside of the diseased vessel via 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 disease (e.g., atherosclerotic plaque) that needs to be treated. The balloon is typically inflated to a size that corresponds to a reference diameter of the vessel before occlusive disease develops.

[0006] When the balloon is inflated, the plaque is stretched, compressed, fractured or destroyed, depending on the balloon's composition, location and the amount of pressure applied by the balloon. Plaques are heterogeneous and may be soft in some areas or hard in other areas, resulting in unpredictable cleavage surfaces with standard balloon angioplasty. Balloon angioplasty can cause plaque rupture and sometimes even damage the artery at the site of the angioplasty.

[0007] Stenotic lesions in peripheral arteries reduce blood flow to the feet, which can limit the patient's mobility, produce pain, inhibit wound healing, and in the most severe cases lead to tissue loss, infection, and amputation. A well-recognized goal of performing balloon angioplasty in peripheral arteries is to open stenotic lesions and restore blood flow to the feet. Blood flow is related to the cross-sectional area within the artery, and therefore it is critical to restore tight stenotic lesions to their adjacent vessel reference diameters with minimal vascular damage. The basic mechanism of action of balloon angioplasty is to increase the radial dilation force applied to the stenosis, ultimately causing the lesion to yield. Summary of the invention

[0008] Meeting the need to increase arterial diameter while minimizing vascular injury requires an innovative approach to exploit the mechanism of action of angioplasty. An innovative serration balloon catheter recognizes this goal and gathers evidence to increase lumen gain, reduce vessel recoil, and increase volume flow while minimizing the extent of dissection (a form of vascular injury) and the need for stents. In addition to increasing blood flow, the serration design included in this and related patents is a serration angioplasty balloon that combines angioplasty with longitudinally oriented serrations through the intima of the artery, thereby modifying the mechanism of action of angioplasty alone.

[0009] The combined features of angioplasty and dentations can produce the following advantages: minimal atmospheric pressure is required to achieve improved blood flow. A set of stainless steel strips are integrated into the angioplasty balloon, which create a series of dents along the intima when the balloon is inflated and typically penetrate the media (e.g. Figure 1 ). The serrations facilitate the direction of angioplasty energy along these weakened lines along the axis of the artery. As the lumen expands, the intimal and medial tissues separate more gently and predictably, allowing for more efficient blood flow through the repaired thick stenotic lesion tissue. Figure 1 Shown are scanning electron micrographs showing the effect of teeth in porcine tissue after 7 days of healing.

[0010] Dentation angioplasty improves arterial volume flow rate (evidence calculated using Besseille's law)

[0011] The mathematical method of evaluating the improvement in arterial flow allows the comparison of data between conventional angioplasty and dentate angioplasty. With this algorithm, data from various studies can be evaluated independently of the reference diameter of the arterial vessels of each study, thus enabling the comparison of flow improvement between studies.

[0012] To assess the volumetric improvement in blood flow, the derived equation utilized an established fluid dynamics equation (Besseuille's law) which states that flow is directly related to the fourth power of the radius of the conduit. Additional variables including pressure, length, and viscosity coefficient (see Equation 1) were included in the Berseuille's law. Due to the nature of the disease morphology and the inaccessibility of tissues in vivo, a simplified fluid dynamics model (Equation 2) was considered valid for comparison purposes.

[0013]

[0014] Formula 1: Besseille's law

[0015] Where R is the radius of the artery, n is the viscosity coefficient of the blood, L is the length of the vessel (or diseased portion), and P1-P2 is the pressure difference.

[0016] First, a set of assumptions is reflected that are applied to Berseille's law to provide an equation that can provide insights into various cardiovascular studies by evaluating the improvements in arterial flow in various studies.

[0017] In the traditional equation, Besseüller's law requires laminar flow (e.g., flow cannot be turbulent) and that the liquid is an incompressible fluid. Although it can be assumed that blood is incompressible and generally flows in laminar behavior in the body, turbulent flow has been shown to exist in the arterial system and has been shown to increase over diseased lesions. Regardless of this assumption, the use of Besseüller's law is derived by the second order integral of the circumference of the conduit. Therefore, as the radius R of the artery increases, the flow rate increases exponentially. In a diseased vessel where a stenotic lesion reduces the radius of the vessel segment by half, the resistance within this stenotic segment increases by a factor of 16, assuming perfusion alone. Note that in Figure 2 (shown as flat horizontal and vertical lines), how low the % of maximum distal flow is when the peripheral artery is at 50% of its maximum radius.

[0018] Therefore, the volume flow rate may be highly dependent on the cross-section of the artery. For peripheral arteries, this simple analogy suggests that restoring the lumen diameter to its unconstrained diameter will increase the flow rate to more distal tissues (i.e., the crura). The ability of dentate angioplasty to consistently produce a larger lumen has been observed ( Fig.76 , 78A and 78B), resulting in higher volume flow rates than conventional balloon angioplasty ( Fig.75). The ability of dentation angioplasty to achieve higher volumetric flow rates can be described as or associated with an optimized result (such as "vascular remodeling"). Vascular remodeling is based on the assumption that the inner diameter (D) and wall thickness (w) of each segment in the network undergo continuous structural adaptation in response to the stimulus experienced by the segment. Therefore, as observed by the dentation angioplasty embodiments, when diseased vessels are effectively treated so that the vessel performance (compliance, flow dynamics, and inner diameter) is improved, it is appropriate to associate these results with active vascular remodeling. From the lumen outward, the layers of the lumen include the intima, the internal elastic sheet, the middle membrane, the external elastic sheet, and the outer membrane. As described herein, the dentation angioplasty creates a series of discontinuous gaps in the vessel wall, generally penetrating the intima, the internal elastic sheet and entering the middle membrane. In some methods, only the intima is penetrated. In some methods, only the intima and the internal elastic sheet are penetrated. In some methods, only the intima, the internal elastic sheet, and the middle membrane are penetrated. In some methods, the middle membrane is penetrated to a certain depth within the middle membrane. In some methods, the tunica media is penetrated to the outer elastic sheet. In some methods, the outer elastic sheet is not penetrated. In some methods, the tunica media is completely penetrated. In some methods, the tunica media is partially penetrated. In some methods, only the tunica intima, the inner elastic sheet, the tunica media and the outer elastic sheet are penetrated. In some methods, the outer membrane is not penetrated. In some methods, the outer membrane is partially penetrated. In some methods, the inner elastic sheet is penetrated, but the outer elastic sheet is not penetrated. In some methods, at least the inner elastic sheet is penetrated. In the case where the inner elastic sheet is serrated and allowed to relax under balloon pressure, the treated diseased area becomes less turbulent, less violent, with fewer interruptions or disturbances in the flow stream, thereby reducing wall friction or flow resistance. It is observed in the vast majority of clinical cases where serrated angioplasty is used as a stand-alone or combined treatment that the final result shows arterial contours and flow dynamics with little or no vascular or disease discontinuity or flow interruption. This phenomenon is described herein as stage 1 active vascular remodeling.

[0019] The method used to evaluate flow improvement for any intervention is to first calculate the initial arterial flow (F i ), which is calculated by taking the fourth power of half the product of the mean initial RVD and (1-% stenosis). The final arterial flow (F f ), the final arterial flow is calculated by taking half the product of the mean final RVD and (1-% residual stenosis) raised to the fourth power. Taking these two values, the flow change F can be calculated f -F i Therefore, the % flow improvement of the intervention is simply (F f -F i ) / F i Finally, when the dataset(1) With the dataset (2) When comparing data sets (1) Relative to the dataset (2) The % flow improvement can be achieved by adding the % improvement (研究1) Minus % Improvement (研究2) Divide by % improvement (研究2) to calculate.

[0020] F≈r 4

[0021] Equation 2: Simplified version of Besseille's law, where F is the flow in the artery and r is the radius.

[0022] F i =((RVD / 2)X(1-% stenosis)) 4

[0023] Among them, F i It is the initial flow rate on the stenotic lesion tissue.

[0024] F f =((RVD / 2)X(1-% residual stenosis)) 4

[0025] Therefore, % flow improvement in artery = (F f -F i ) / F i .

[0026] Among them, F i is the initial arterial flow, F f is the final arterial flow.

[0027] Finally, a comparative analysis can be performed between multiple studies with different pre-treatment vessel radii by comparing the % flow improvement between studies. A limitation of this technique is that the largest influencing variable is the degree of initial stenosis. As the initial % stenosis increases, the flow radius decreases, and for every small increase in initial stenosis, the flow radius shrinks rapidly to the fourth power.

[0028] To reduce the possibility of miscalculation in highly occluded vessels, (r 后 / r 前 ) 4 Calculate the volume flow rate ratio, where r 后 is the vessel radius after treatment, and r 前 is the vessel radius before treatment. The vessel radius (r) was calculated as follows: r = RVD x (1-% stenosis) / 2.

[0029] Assumptions used to derive the simplified equation, flow rate = r 4 :

[0030] Flow limitation or reduction associated with turbulence is not considered. Information to assess the potential for turbulence (ie, stenosis characteristics, precise three-dimensional arterial architecture, etc.) is lacking in the literature.

[0031] Interventional data such as balloon size setting and balloon pressure, while providing insights into compliance relative to vessel size setting, do not provide insights into final flow volume.

[0032] The cross section is assumed to be circular (like a pipe), but biological growth is rarely truly circular.

[0033] Two comparative models were identified to evaluate acute improvements in peripheral arterial function following treatment. Fig.75 ) evaluates the change in volume flow rate, and the second model ( Fig.76 ) evaluated the improvement in residual stenosis relative to pre-treatment RVD (before treatment). Using either approach, the reviewed data showed that serrated balloon angioplasty was consistently superior to conventional balloon angioplasty. For stenotic lesions ranging from 62% to 93%, serrated balloon angioplasty achieved a mean flow rate ratio that was 2.4 times that of conventional balloon angioplasty, and for stenotic lesions ranging from 99% to 100%, 62% less residual stenosis was achieved. In order to simplify the method used to calculate the effect of residual stenosis, a simple derivation of Berseuge's law is considered. To illustrate the method, the method is used to calculate the effect on the volume of flow when a 5% increase in vessel radius is achieved.

[0034] As blood flows along a blood vessel, the flow rate F (the volume of blood flowing through a given point per unit time) is proportional to the fourth power of the vessel radius r:

[0035] F = kr 4

[0036] Equation 3: Simplified version of Besseille's law, where F is the flow in the artery, and r is the radius, and k is a constant.

[0037] Partially blocked arteries can be dilated by a procedure called angioplasty, in which a catheter with a balloon on the end is inflated inside the artery to widen it, with the goal of restoring normal blood flow. It turns out that the relative change in flow is highly dependent on radius, since flow is proportional to the fourth power of the radius, r. Therefore, a relative change in r can significantly increase flow. The question is how would a 5% increase in radius affect the flow of blood? Apply the differential equation to solve, where flow is equal to the constant k times r 4 The differential equation is shown below.

[0038] F=k(1.00r) 4

[0039]

[0040] Therefore, a 5% increase in radius can be expressed as a multiple of 1.05.

[0041] F=k(1.05r) 4

[0042]

[0043] Comparing the differential equations, a relative change in radius of .05 (5%) results in a relative increase in blood flow of about .20 (20%). Since the change in radius is directly proportional to the change in diameter, the effect of the increase in blood flow remains constant. Even a small increase in diameter can have a huge effect on flow.

[0044] During angioplasty, a balloon is used to stretch and open the artery. However, after the balloon is removed, stenosis or narrowing of the vessel wall often occurs. Stenosis can be the cause of significant loss of luminal gain.

[0045] However, the serration technology described herein has several advantages over traditional angioplasty. The serration technology can significantly control stenosis by achieving a more permanent lumen gain after the balloon is removed. The serration technology can significantly control stenosis by dilating the balloon in a different manner than angioplasty. While angioplasty relies on high pressure to stretch the artery open, the serration technology provides nucleation sites for one or more permanent cleavage lines. The serration technology can significantly control residual stenosis by changing the surface of the plaque while allowing the plaque to adhere to the vessel wall. Due to the permanent changes, the vessel cannot quickly return to its pre-enlargement diameter. The cleavage lines are created through a low-pressure crack propagation process. Reshaping the vessel through the serration technology,

[0046] As shown in the above equation, any increase in radius can have a significant effect on flow. Increasing the radius by only 5% can increase flow by 20%. In other words, any permanent change in radius can increase flow by a factor of four. Any permanent change in diameter can have a proportional effect on flow. In other words, a 5% reduction in residual stenosis can increase blood flow by 20%. Controlling the inherent narrowing ability of a vessel can produce a significant gain in luminal flow.

[0047] A simple equation for estimating the final post-treatment flow rate can be viewed as:

[0048] F=k[(1+L)r] 4

[0049]

[0050] Equation 4: Simplified version where F is the flow in the artery, and r is the radius, and k is a constant, and L is the percentage of residual stenosis reduction.

[0051] In many cases, a significant increase in volume flow is required to protect tissues, save limbs and organs, which can be a matter of life or death. The volume flow of a vessel is directly related to the vessel diameter. Vascular stenosis refers to the narrowing of a vessel, such as the accumulation of plaque on the vessel wall. The calculations in this article indicate that designs that can reduce the radius of the vessel or the interference of obstacles to the normalized or healthy radius are needed. Active vascular remodeling is needed to restore the vessel diameter and thus reduce stenosis. Toothed angioplasty has shown effective clinical performance to increase the vessel diameter while reducing the dissection that causes blood flow interruption and pressure drop at the lesion. Toothed angioplasty can create punctures along the internal elastic lamina, which allows the internal elastic lamina to relax under balloon pressure or tear along the toothed weakened lines to restore the normalized or healthy vessel radius. Because toothed angioplasty does not disturb the vast majority of the plaque surface, the plaque remains largely attached to the enlarged vessel wall. The teeth form cleavage planes that separate the plaque only along longitudinal lines. Toothed angioplasty can reduce turbulence or roughness in the treated area and reduce interruption or disturbance of the flow stream. Stenosis angioplasty can make the treated area more uniform in arterial diameter across the entire treatment area. Uniformity of vessel diameter or low percentage variation in vessel diameter across the treatment area aids volume flow by limiting regional disruption to the flow path. Stenosis angioplasty can reduce wall friction or flow resistance. Stenosis angioplasty can increase local vessel size by relaxing the internal elastic lamella along the cleavage planes. Active remodeling increases vessel size to increase blood flow. Active remodeling is an outward compensatory remodeling of the diameter of the vessel. Stenosis angioplasty has clinically demonstrated the ability to both increase lumen gain and reduce recoil with low residual stenosis. In the second stage of active remodeling, lumen recovery can be viewed as a relaxation event within the cellular network of the vessel wall, including remodeling of the internal elastic lamella after serration and dilation at low pressure. The final stage of active remodeling, lumen enlargement can restore the diseased vessel diameter to a pre-disease state. Lumen enlargement can restore the diseased vessel diameter to the adjacent non-diseased diameter. Lumen enlargement can restore the vessel diameter to a normalized vessel diameter. Lumen enlargement can restore the vessel diameter to the average diameter of healthy patients.

[0052] Designs that can adjust arterial diameter to nominal values ​​without causing vascular damage or vascular reactivity are of great clinical value and are contemplated herein. Stenosis angioplasty can produce progressive luminal gain. Stenosis angioplasty can dilate a vessel without damaging underlying tissue or structures. In some methods, the outer elastic sheet is not penetrated and remains intact. In some methods, the outer elastic sheet is not penetrated and remains intact. Stenosis angioplasty forms longitudinal cleavage planes under low pressure, resulting in significantly reduced elevation of the plaque surface and separation of the plaque from the vessel wall.

[0053] The technologies available on the market have not lived up to expectations, with most leaving a residual stenosis of 30% or greater. These technologies are unable to restore the normalized or healthy radius of the vessel. Instead, at least 30% of the ideal diameter of the resulting vessel remains blocked. Residual stenosis is either a result of the inefficiency of the technology in restoring the vessel to its nominal diameter or a decrease in diameter following treatment, commonly referred to as recoil. Retraction may be caused by the inherent properties of the diseased vessel, which can be stretched by the angioplasty balloon but will return to the pre-treatment diameter once the pressure from the balloon is removed. Notably, recoil can occur even if calcium deposits are disrupted during angioplasty. The blood vessel itself may include an annular elastic layer that forms the boundary between the layers of the vessel. The blood vessel itself may have elastin fibers. Elastic structures in the blood vessel are important for rheological function by regulating the inner diameter of the vessel. However, these same elastic structures may contribute to recoil following angioplasty. The blood vessel tends to return to its original diameter. Therefore, angioplasty procedures that stretch the vessel wall attempt to counteract the natural tendency of the vessel. Residual stenosis may be caused by the non-permanent nature of the applied pressure, which may only temporarily reshape the vessel. Retraction is primarily driven by elastin in the unruptured arteries. This elastin tends to return to its original state. Therefore, stretching a vessel during angioplasty is similar to stretching a rubber band. After the pressure is removed, the vessel retracts toward its original diameter. To a lesser extent, retraction can also be driven by unaltered plaque, which can also retract to its original diameter. When balloon pressure is removed, the vessel's elastin can recover alone, or in combination with any remaining plaque, significantly reducing any luminal gain. It is common for the vessel to retract after angioplasty when balloon pressure is removed, resulting in a decrease in the vessel's diameter. The extent of retraction is related to many variables, including lesion location and size, as well as patient-specific factors and the treatment device. Elastic retraction of the vessel resulting in residual stenosis is a significant limitation of current technology.

[0054] To enable greater vessel growth, angioplasty with a tooth design feature offers several unique advantages, including low-pressure angiography. This enables inspection of the vessel through a radiopaque substance. Toothed angioplasty advantageously allows calcium fragmentation, also described as lithotripsy. This allows for subsequent or simultaneous treatment of the plaque surface. In some methods, additional energy is applied to the plaque, such as ultrasound, electrical or hydraulic shock waves. The value of lithotripsy using teeth (whether using ultrasound or shock waves, or not) is the ability to break up the plaque into smaller particles, allowing for more effective vascular dilation and enabling therapeutic agents to pass through the diseased area and into deeper tissue. Toothed angioplasty advantageously allows linear destructive intimal separation. The serrations are oriented longitudinally within the vessel. The intima is the inner layer adjacent to the lumen of the vessel. In some methods, the plaque remains buried beneath the intima or adhered to the intima. The teeth can extend through the intima and / or the internal elastic lamella to initiate nucleation of the cleavage plane. The cleavage plane can extend through at least some layers of the intima, internal elastic sheet, and / or media. Toothed angioplasty advantageously allows for vessel lumen gain without vessel rupture. The cleavage plane does not extend completely through the layers of the vessel. The cleavage plane does not extend through the adventitia layer. The cleavage plane does not extend through connective tissue. The cleavage plane does not rupture the vessel wall. Toothed angioplasty can have these advantages and more, while using familiar angioplasty techniques. Here, designs and methods are explored that are intended to limit residual stenosis and increase volume flow through the vessel after treatment.

[0055] In vessels with poor or no blood flow for extended periods of time, it has been noted that myogenic mechanisms may occur. Myogenic mechanisms are contractions initiated by the muscle fibers rather than external stimuli. Contraction can significantly reduce blood flow. If the pressure within the vessel increases suddenly, such as after angioplasty, the vessel will respond with contraction. It is worth noting that the myogenic mechanism may be what has been described in the literature as retraction or more commonly vasospasm. This is part of the autoregulatory mechanism of the vessel, which maintains a constant blood flow at varying pressures. The response is initiated by the vessel itself. Reducing the pressure within the vessel causes relaxation and vasodilation. When the angioplasty balloon is removed, the autoregulatory mechanism contracts to reduce luminal gain.

[0056] The ability of dentate angioplasty to penetrate the internal elastic lamella of a blood vessel can limit the ability of the blood vessel to undergo myogenic mechanisms and subsequent vasospasm. The dentate angioplasty can limit the contraction of myocytes by penetrating the internal elastic lamella. The circumference of the blood vessel can be interrupted along the cleavage line, thereby limiting the contraction ability of the muscle fibers. The dentate angioplasty can change the autoregulatory mechanism of contracted blood vessels to maintain a constant and thus reduced blood flow. In addition, the application of dentate angioplasty under low pressure allows the penetration of the internal elastic lamella and encourages its separation along the penetrated dentate line. The wedge-shaped dissector described herein can form a depression in the plaque surface under low pressure. The wedge-shaped dissector can start crack propagation through the plaque and vascular layers. Crack propagation can be considered as two processes, namely the penetrating behavior at the wedge-shaped dissector and the shear stress effect at the plane oriented to the load direction. The wedge-shaped dissector can initiate cracks. However, the blunt edge of the wedge-shaped dissector will not cut or scratch the plaque and the underlying tissue. On the contrary, the low pressure of the balloon helps the shearing of the plane, thereby controlling and slowing the crack propagation through the tissue layer. The tension applied by the balloon to the lumen and plaque surface can promote stable cleavage growth. The low pressure applied by the balloon can prevent unstable growth or fracture. The depth of the cleavage can be controlled in part by the initial penetration depth of the wedge dissector and the low-pressure balloon angioplasty. Crack growth is controlled to extend through a specific layer while leaving other layers of the vessel wall intact.

[0057] The tooth technology is the only known method that can accurately control the start and end of the cleavage plane. The cleavage plane can extend through at least some layers of the inner membrane, the inner elastic sheet and / or the middle membrane. In some methods, the crack growth can stop before reaching the outer elastic sheet. In some methods, the crack growth can stop before reaching the outer membrane. In some methods, the crack growth can stop before extending through the outer membrane. Crack propagation can be stopped due to limited driving force from the low-pressure airbag. Crack propagation can be stopped due to a small penetration depth of the starting crack. Crack propagation can be stopped due to changes in the composition of the layer. Crack propagation can be stopped due to an increase in resistance from the layer. Crack propagation can be slow and steady. Crack propagation can occur over a long period of time. Crack propagation can occur in 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 35 seconds, 40 seconds, 45 seconds, 50 seconds, 55 seconds, 60 seconds, 70 seconds, 80 seconds, 90 seconds, 100 seconds, 120 seconds, 180 seconds, more than 30 seconds, more than 45 seconds, more than 60 seconds or any range of two values ​​in the above value. In some cases, the outer elastic sheet can also be penetrated and encouraged to separate, while minimizing cell trauma and the histological reaction to the cell separation event. Crack can extend through the outer elastic sheet. Crack can extend through the adventitia. The adventitia is the outermost layer of blood vessel, which contains tissue, nerves and vasa vasorum. Low-pressure crack propagation can extend through the vascular layer at a controlled, slow and stable speed. Crack propagation forms an interruption on the circumference of blood vessel, thereby longitudinally segmenting blood vessels in the treatment site. Controlled low-pressure crack propagation can minimize the trauma to single cells and tissues. In some cases, the outer elastic sheet is not penetrated.

[0058] It is conceivable that designs that are intended to change tissues in a more natural and less damaging way are valuable for tissue healing. Although not bound by theory, controlled slow, low-pressure expansion and crack propagation are more like a steady pull on the tissue, resulting in separation at the cellular level. This is in contrast to the cutting action, where the cutting blade relies on high pressure at the edge to push the material away. The cutting edge will crush the wider cell band below the edge. Instead of relying on the cutting edge, the teeth can rely on crack propagation, which can extend through a single row of cells. The crack can separate adjacent cells, causing much less cell trauma. Crack propagation can also occur at a lower pressure than the pressure required for cutting. Low pressure only needs to continue slow crack propagation, without requiring higher forces to cut or score tissue. The separation force can be imparted by the tension on the surface of the luminal wall, stretching the tissue to further cracks, rather than high forces concentrated at the tip of the blade. Therefore, the tooth technology can separate cells better than the sharpest knife. The crack extends between individual cells, smaller than the thinnest blade edge. The wedge dissector itself does not extend between individual cells, but rather the crack initiated by the wedge dissector extends between individual cells. The crack propagates at lower pressures. The tooth technique can create a longitudinal cleavage plane in a more natural manner by separating tissue at the cellular level. This separation causes less trauma by affecting a smaller surface area. This separation causes less trauma by affecting a small number of cells. This separation causes less trauma by gently pushing cells along the crack in a slow and controlled manner. In some cases, gentle tearing allows tissue to repair more easily. During tissue repair, cells migrate to the crack site and eventually form new granulation tissue that matures into scar tissue. In some cases, scar tissue can restore tissue structure and function over time. The crack can form a thin, narrow line between cells, which is easier to repair than a thick cut or slice, thereby reducing healing time. The crack can form with a limited penetration depth, which may also be easier to repair than a deeper cut. The crack can form along a vessel with a limited length, limited by the length of the lesion, which may also be easier to repair than a longer length cut. In addition, reducing trauma to cells can promote healing. These contemplated designs (including teeth, where tissue is minimally torn at the gross anatomical level and separation is encouraged at the cellular level) provide advantages including reduced healing time and increased cell repair. It is contemplated that in some of these designs, the tear region is shallow in depth and short in length, limiting cell trauma and encouraging cell repair.

[0059] In angioplasty, in some methods, a balloon with an inflated diameter greater than the expected diameter of the vessel is utilized. This can be communicated by a ratio between the expected vessel diameter and the balloon diameter. For example, a ratio of 1:1 is equal to the expected vessel diameter and the balloon diameter. In this example, an expected vessel diameter of 5 mm would utilize a 5 mm balloon. As discussed herein, the autoregulatory mechanisms of the vessel can cause retraction, causing the vessel to shrink after the balloon is removed. In some methods, the ratio is different from 1:1, such as 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, or 1:2. For example, a ratio of 1:1.1 would utilize a larger balloon (equal to the vessel diameter times 1.1) compared to the expected diameter of the vessel. In this example, an expected vessel diameter of 5 mm would utilize a 5.5 mm balloon. For example, a ratio of 1:2 would utilize a larger balloon (equal to the vessel diameter times 2) compared to the expected diameter of the vessel. In this example, an expected vessel diameter of 5 mm would utilize a 10 mm balloon.

[0060] The dentation angioplasty procedure can utilize a balloon having an inflated diameter that is larger than the expected diameter of the vessel. In some embodiments, designs using dentation features with a balloon to reference vessel size ratio of 1:1.1 have been shown to facilitate acute radial dilation of the vessel with minimal vascular response or vasospasm. To further increase the diameter of the vessel, it is contemplated to use a balloon size with a ratio greater than 1:1.1 to the vessel reference diameter. It is contemplated to use a dentation angioplasty balloon to reference artery ratio of 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9 or 1:2 or fractions between these ratios. The dentation balloon design enables larger artery growth, thereby allowing for better residual blood flow and low residual stenosis. This includes designs that can be used with balloon to artery ratios greater than 1:1.1.

[0061] Using Equation 2: Based on the simplified version of Besseure's law above, it can be calculated that the percentage of the total possible flow volume that a vessel can produce is directly related to the residual stenosis that impedes flow and thus limits the total flow volume. When the vessel opens toward the pre-diseased diameter or the native vessel reference diameter, the volume flow rate approaches 100% ( Figure 2). A 1:1 ratio would be adequate if there were no other forces acting (such as cellular or systemic mechanisms that could encourage contraction upon removal of the outward balloon force). The balloon structure and its outward force on the diseased vessel limits the ability of the vessel to contract during balloon inflation. However, when the balloon is removed, muscle fibers as well as other cellular structures (including but not limited to elastin rings such as the internal elastic lamella) will inherently contract on their own after the balloon is removed. Several mechanisms can cause vessel contraction after balloon deflation. The blood vessels, interstitial tissue, and muscle tissue itself can counteract the angioplasty by recoil.

[0062] Retraction of the vessel after angioplasty is thought to be caused by a combination of factors, including the elastic or inelastic properties of the arterial wall rather than the mechanical forces applied during the procedure.

[0063] During angioplasty, when a balloon is inflated within a narrowed or blocked segment of a diseased artery, outward pressure is applied to the arterial wall. The pressure from the inflated balloon stretches the vessel wall, causing it to expand and widen the blocked segment. The diameter of the vessel is temporarily enlarged. However, once the balloon is deflated and removed, the vessel wall contracts inward, reducing the original gain achieved during angioplasty, which is understood as recoil.

[0064] The degree of recoil may vary depending on the patient's specific anatomy, disease state, and location of the vessel blockage. If the vessel wall is particularly rigid or fibrotic, it may be more susceptible to recoil after the balloon is removed. Additionally, if the balloon is not inflated to the appropriate pressure or is undersized relative to the vessel, the balloon may not fully stretch the arterial wall, resulting in incomplete dilation and an increased risk of recoil.

[0065] In some cases, the use of stents can help prevent recoil by providing a scaffold to keep the vessel wall open after angioplasty. However, not every patient or every blockage requires or desires a stent. In contrast, the tooth technology described herein addresses the recoil problem caused by vascular remodeling through a more permanent change in the radius of the vessel. Vascular remodeling can last longer. Vascular remodeling can be non-acute. While other angioplasty techniques may temporarily change the diameter of the vessel, the tooth technology can cause lasting changes, including minutes, hours, days and months after the procedure. The tooth technology greatly improves the recoil, resulting in a more permanent change in the diameter of the vessel. The tooth technology has the ability to dilate the vessel to limit recoil, enabling the maximum lumen, and therefore the maximum volume flow through the vessel is expected. As described herein, a slight increase in radius can increase the flow fourfold. Similarly, a slight reduction in residual stenosis can increase the flow fourfold. Therefore, if the radius or stenosis is permanently changed, clinically significant results may occur. This article describes the use of tooth angioplasty that can perform minimal vascular trauma with maximum volume blood flow. The embodiments herein are non-limiting. The present disclosure contemplates other embodiments that enable minimal vascular trauma with maximum volumetric blood flow. The present disclosure contemplates other embodiments of vascular remodeling. The present disclosure contemplates other embodiments of permanent gain in radius and reduction in stenosis.

[0066] As described herein, the serration angioplasty technique induces a series of weakened lines oriented longitudinally toward the vessel axis and, with the help of balloon pressure, effects arterial dilation. Dilation occurs with less pressure required. The low pressure of the balloon gradually dilates the artery and gradually expands the cracks. This low-pressure dilation is slow and controlled. The series of serrations limits the typical arterial vasoconstriction physiology when angioplasty is performed alone. The serration technique has less retraction due to the way tissue and plaque are separated. The serration angioplasty technique provides the greatest opportunity for the vessel to reach the vessel reference diameter. The serration angioplasty technique produces predictable, reproducible lumen gain. The serration angioplasty technique allows controlled depth crack propagation, resulting in a well-defined circumferential segment along the vessel wall. Contractile forces are inherently limited by the cleavage planes, which limits the ability of the muscle fibers to contract. In a study of the serration angioplasty technique, physicians were encouraged to increase the balloon diameter by 0.5 mm when the residual stenosis did not meet the study endpoint of 30%. For example, if the residual stenosis is greater than 30%, the physician may increase the ratio from 1:1 to 1:1.1 to achieve an expected diameter of 5 mm using a 5.5 mm balloon. The increase in balloon diameter allows for acute radial dilation of the vessel with minimal vasoconstriction. The increase in balloon diameter may also improve blood flow dynamics by reducing residual stenosis. Methods are contemplated for selecting a balloon diameter that is larger than a reference diameter of the vessel to improve vascular hemodynamics and improve vascular tone at the systemic and cellular levels. Such methods include expanding the size of the dentate balloon technique such that the technique aims to produce a size that is 1.1 times the interpreted size of the vessel. These methods may utilize techniques with ratios of 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, or 1:2 to utilize a balloon that is larger than the expected diameter of the vessel.

[0067] It is known and reported that vessel measurements from angiography show vessel dimensions that are smaller than those obtained from intravascular ultrasound or optical coherence tomography. Angiographic imaging is the examination of blood vessels by x-ray techniques using radiopaque materials. Angiographic imaging provides a perspective view of the flow path but does not provide any perspective image reference for the thickness of the media or adventitia layers. Diseased states of the vessels can produce vessel layers that vary widely in thickness, limiting valid interpretation of the native or healthy diameter of the vessel. Thus, measurements from commonly used angiography techniques may produce imaging that is susceptible to misinterpretation of the true native vessel diameter. This misinterpretation of the imaging may guide the physician to select a treatment modality that is undersized for the true native vessel diameter and thereby limit the full potential of the luminal volume capacity of the transport vessel. Dentation angioplasty may be designed to provide effective vascular treatment with the goal of more fully dilating the vessel and reducing vessel retraction using a treatment size setting that is greater than a 1:1.1 ratio to vessel size. It is contemplated that increasing the size setting of the treatment selection to a ratio of 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9 or 1:2 to the vessel size or above 1:1, above 1:1.1, above 1:1.2, above 1:1.3, above 1:1.3, above 1:1.4, above 1:1.5, above 1:1.6, above 1:1.7, above 1:1.8, above 1:1.9, above 1:2 or any of the above ranges may provide greater advantages and increase volumetric flow rate. In some embodiments, increasing the size setting of the balloon may prevent incomplete expansion. In some embodiments, increasing the size setting of the balloon may reduce the risk of retraction. In some embodiments, increasing the size setting of the balloon may increase the radius of the vessel such that the percentage of flow relative to the increase in radius increases fourfold. In some embodiments, increasing the size setting of the balloon may reduce stenosis of the vessel such that the percentage of flow relative to the reduction in stenosis increases fourfold. The dentate angioplasty procedure can be designed to provide effective vascular treatment with the goal of more fully dilating the vessel to less than 30% stenosis.

[0068] There is a continuing need for improvements in methods for treating occlusive disease, including balloon angioplasty, and other related treatment systems. In some embodiments, the ability to inexpensively attach a focal intimal rupture device is desired. The design of such a balloon requires an innovative manufacturing method so that features above the balloon surface can be effectively placed with minimal addition to the cost of the balloon. Embodiments that enable features to be fused or integrated within the balloon blowing cycle or in tandem with the balloon blowing provide significant cost savings and enable more efficient balloon designs. It is contemplated that desirable balloon features such as pushability, traversability, contour, firmness, flexibility, and the ability to deliver drugs can be incorporated into balloon designs including diameter, length, and conical shape, regardless of features protruding above the balloon surface. All embodiments incorporate features and processes that contribute independently or collectively to strategic cost reduction of catheter-based balloon designs.

[0069] Airbag Features

[0070] Pushability, traversability and flexibility are all desirable features of intravascular technology. Many contemplated designs incorporate longitudinally oriented structures that are incorporated between polymer layers. In some embodiments, the main shaft includes a longitudinally oriented structure. In some embodiments, the internal member includes a longitudinally oriented structure. In some embodiments, the airbag includes a longitudinally oriented structure. The longitudinally oriented structure can be in the form of a strip. The longitudinally oriented structure can be in the form of a ridge. The longitudinally oriented structure can include the same material as the main shaft, internal member or airbag to which the longitudinally oriented structure is attached. The longitudinally oriented structure can include a different material from the main shaft, internal member or airbag to which the longitudinally oriented structure is attached. The longitudinally oriented structure can include the same density as the main shaft, internal member or airbag to which the longitudinally oriented structure is attached. The longitudinally oriented structure can include a different density from the main shaft, internal member or airbag to which the longitudinally oriented structure is attached. The longitudinally oriented structure can provide structural stability. The longitudinally oriented structure can allow energy to be transmitted across the airbag body. The longitudinally oriented structure can include one or more structures. The longitudinally oriented structure can be circumferentially arranged around the main shaft, internal member or airbag to which the longitudinally oriented structure is attached. The longitudinally oriented structures can be equally spaced. The longitudinally oriented structures may be spaced unequally apart.The main shaft, inner member or bladder may include a single longitudinally oriented structure or one or more longitudinally oriented structures.

[0071] The longitudinally oriented structure can help transfer energy from the user to improve the pushability of the device. The longitudinally oriented structure can help transfer energy from the user to improve the crossability of the device. The longitudinally oriented structure can help transfer energy from the user to improve the traceability of the device. The longitudinally oriented structure can keep the device flexible to navigate the vascular system. Therefore, it is necessary to improve pushability and crossability while maintaining flexibility and traceability. Including a longitudinally oriented structure in each area of ​​the main shaft, internal member or balloon, where the ridge of denser material can help energy transfer to help improve pushability while minimizing the reduction of traceability. Two common design criteria for balloon catheters are pushability and navigation ability or traceability. The catheter must be pushed from the proximal end to allow the catheter to pass through the blood vessel. The catheter must be able to navigate nonlinear, tortuous blood vessels. Therefore, these two features are opposite, because increasing pushability usually reduces navigation or traceability. The toothed balloon balances these criteria in part due to the longitudinally oriented structure. The longitudinally oriented structure can be made of metal, polymer or other rigid or semi-rigid material. The longitudinally oriented structure provides structural stability for the transmission of energy across the balloon body. The longitudinally oriented structure provides structural stability while maintaining flexibility when navigating through twisted anatomical features. When metal is used, the material flexibility of the longitudinally oriented structure can be improved by 1, 2, 3, 4 or more tempering steps. Tempering can be carried out at a much lower temperature than the annealing process, for example, below 300C, or more commonly between 300C and 400C, or at a higher temperature, such as between 400C and 500C. The longitudinally oriented structure can be a strip with a wedge-shaped dissector. The longitudinally oriented structure can deflect along the length, thereby increasing navigation capabilities. Two or more longitudinally oriented structures can bend independently of each other. The longitudinally oriented structure can resist compression. The longitudinally oriented structure can allow bending in one direction, but resist bending in another direction. In some embodiments, the longitudinally oriented structures can be decoupled from each other. The longitudinally oriented structures can be spaced apart from each other. The longitudinally oriented structures can be bent along the blood vessel. The longitudinally oriented structure can transmit thrust. The longitudinally oriented structure can transmit force without longitudinal bending. The longitudinally oriented structure can transmit force without longitudinal kinking. Due in part to the incorporation of these features and the fact that they are longitudinally oriented, the balloon is easier to push and is able to traverse highly rigid and diseased lesions. The ability to traverse complete or highly stenotic occlusions is due in part to the enhanced rigidity provided to the balloon body by these longitudinally oriented beam-like structures of the strips. The longitudinal beam elements of the strips are symmetrically oriented around the surface of the balloon body, which enhances the column strength. It is the enhanced column strength provided by the beam array of the strips that improves pushability and traversability.The beam design of the strip with its flat bottom and periodic raised wedge-shaped dissectors provides a pliable and flexible beam that provides increased flexibility and torque capability while minimizing brittleness and maintaining designed column strength. The beam can be more stable when the beam of the strip is captured or retained within the balloon layer stack. After pleating the strip under the folded portion of the balloon wings and curling the balloon wings on top of the strip, the stack of material layers that make up the balloon layer, in addition to the strip, improves stability and enhances the ability of the tooth balloon to transfer forces from the delivery catheter to the distal end of the balloon and the catheter tip (. Fig.79 ). Longitudinally oriented structures such as beams embedded and folded within the balloon enhance the column strength of the balloon, enabling better energy transfer from the catheter body across the balloon body to the tip of the catheter. Longitudinally oriented structures significantly improve pushability without adversely affecting the ability to navigate to the lesion. The strips can be designed to avoid bending and kinking along the column while flexing and deflecting as they traverse along the vasculature.

[0072] 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. This pretreatment balloon embodiment has a plurality of strips, wherein each strip contains 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. This pretreatment balloon embodiment can 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 apart 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 is then 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. It should be understood that in a clinical setting, the effect of rotating a specified or intended degree may be complex due to the tortuosity and degree of disease in an individual's blood vessels. It is expected that the need to predict the rotation angle is less important, and the doctor inflates the balloon, deflates, pulls back at least 1 cm, then rotates the proximal hub, and then reinserts the balloon, which typically will allow the balloon to rotate and be oriented at an angle different from the initial inflation. The pre-treatment 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 microcracks, through the intima, and in some cases through the internal elastic sheet, and in some cases into the media or other subintimal tissue beds. In some embodiments, in some cases, the design of the pre-treatment balloon can be rotated between about 1 degree and about 180 degrees or the small angle separates the wedge-shaped dissector. Typically, the wedge-shaped dissector is placed at circumferential intervals of a division of 360 degrees. Thus, if there are three wedge-shaped dissectors, the circumferential spacing is equal to 360 divided by 3, or 120 degrees. In some embodiments, the balloon can 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.

[0073] As a non-limiting example, the balloon can be rotated and then re-inflated to form new teeth along the vessel wall where there were no teeth before. The balloon can be rotated 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130 degrees, 135 degrees, 140 degrees, 145 degrees, 150 degrees, 155 degrees, 160 degrees, 165 degrees, 170 degrees, 175 degrees, 180 degrees, or any range of two of the above values. As a non-limiting example, the balloon can be inflated to create a first set of teeth. The balloon can be deflated, rotated, and then re-inflated to create new teeth. The balloon can be rotated into position to create a second set of teeth along the same section of the blood vessel. The balloon can be rotated to create teeth where there were no teeth before. As a non-limiting example, if there are four strip wedge dissectors spaced 90 degrees apart, the balloon can be rotated 45 degrees to space the teeth equally along the circumference of the blood vessel. As a non-limiting example, if there are four strip wedge dissectors spaced 90 degrees apart, the balloon can be rotated less than 45 degrees to space the teeth unequally along the circumference of the blood vessel. As a non-limiting example, if there are three strip wedge dissectors spaced 120 degrees apart, the balloon can be rotated 60 degrees to space the teeth equally along the circumference of the blood vessel. As a non-limiting example, if there are three strip wedge dissectors spaced 120 degrees apart, the balloon can be rotated less than 60 degrees to space the teeth unequally along the circumference of the blood vessel.

[0074] In some embodiments, the pretreatment method of the site is achieved by using wedge-shaped dissectors with radially outward surfaces that are approximately rectangular, elliptical, or oval. In some embodiments, the shape is generally more elliptical, but the arc from the minor axis to the vertex of the major axis does not follow basic ellipse mathematics. Under these conditions, the final shape is more like a pointed oval.

[0075] In some embodiments, a method of depositing a drug through a tooth in a tissue uses a pretreatment balloon having an elongated member, an expandable balloon connected to the elongated member at a distal end of the elongated member, and a plurality of strips, the elongated member having an inner cavity defining a longitudinal axis, each of the plurality of strips having a plurality of wedge-shaped dissectors spaced along the surface of each strip, and each strip extending longitudinally along the outer surface of the balloon. The wedge-shaped dissectors in this example have a bottom surface facing the strip, an unhoned radially outward surface, and a side surface between the bottom surface facing the strip and the radially outward surface, the bottom surface being directly adjacent to the surface of each strip, the radially outward surface having a length between a proximal edge of the radially outward surface and a distal edge of the radially outward surface and defining the height of each wedge-shaped dissector. The radially outward surface has a first width at the proximal edge, a second width between the proximal edge and the distal edge, and a third width at the distal edge, the second width being less than the first width, and the third width being greater than the second width. 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 section 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 about 1% to about 50% 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 surface of each wedge-shaped dissector may be less than the total length of the bottom surface facing the strip of each wedge-shaped dissector. In another example, the radially outward surface has a curved surface or a chamfered surface, or has 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 surface is located at the midpoint between the first non-bonding edge and the second non-bonding edge. The maximum height of the non-bonding 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 bottom surface facing the strip to the proximal edge may have one or more parabolic slopes, which will be produced by chemical etching. The strip tip is typically connected to the carrier tip. The shape of the carrier tip typically has similar features to the strip in slope and size.

[0076] In some embodiments, a method of attaching a wedge-shaped dissector to a medical balloon with or without teeth may be achieved by providing a strip comprising a plurality of wedge-shaped dissectors spaced longitudinally along the surface of the strip. Each wedge-shaped dissector has a carrier tip face facing the strip tip directly opposite the strip, and due to the fact that the carrier and the strip tip are etched from the same material and remain attached, when the carrier tip face facing the strip tip is separated, an unpolished radially outward surface is produced when the carrier is separated from the strip tip. Once separated, the now free radially outward surface has a length between the proximal edge of the radially outward surface and the distal edge of the radially outward surface and defines the height of each wedge-shaped dissector, and the side surface is located between the bottom surface facing the strip and the radially outward surface.

[0077] In certain embodiments, each unpolished radially outward surface of each wedge-shaped dissector is attached to an unpolished radially outward carrier at an attachment zone, wherein a gap is defined in the region between the attachment zones, and the strip has a second surface relative to the first surface of the strip. Then, the second surface of the strip is placed in an airbag blowing chuck and aligned with the expected final placement of the second surface in a medical airbag, integral with the medical airbag or adjacent to the medical airbag on the surface. After the second surface of the strip is attached to the medical airbag, the strip carrier is removed from the strip. The second surface of the strip can be bonded to the surface of the medical airbag with an adhesive and / or by other processes such as fusion and / or lamination. Mechanical force, laser cutting or other means can be used to complete the removal of the strip carrier from the strip. The strip carrier can also be formed integrally with the strip. In some cases, chemical etching is used to produce the strip carrier and the strip.

[0078] 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 bottom surface facing the strip, an unpolished radially outward surface, and a side surface between the bottom surface facing the strip and the radially outward surface, the bottom surface is directly adjacent to the first surface of the strip, the radially outward surface has a length between the proximal edge of the radially outward surface and the distal edge of the radially outward surface and defines the height of each wedge-shaped dissector. 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 surface of each wedge-shaped dissector is attached to the free edge of the strip carrier at an attachment area that typically reflects the shape and period of the wedge-shaped dissector. There is a gap between the attachment areas, and the attachment areas are configured to be separated when mechanical force or repeated bidirectional torsion is applied. In some cases, the carrier system is made of metals such as stainless steel together with the strip. Other suitable materials include polymers, copolymers, and novel materials with composite components.

[0079] In some methods, the attachment of the strip to the airbag is completed during the airbag blowing cycle or in a second or third or any number of steps after the airbag is blown. In these methods, the carrier is designed to be integrated with the airbag blowing mold. One blowing method uses strips that have a compatible material, such as a polymer or copolymer layer, on the outer surface of the strip. The coating volume is typically designed to encapsulate the base of the strip and in some cases create an area adjacent to the base of the strip on the airbag surface that can be used as a protective bed for the strip to lie flat on. The coating of the strip can be accomplished in many different ways, including but not limited to dipping, spraying, lamination, or preformed attachment methods.

[0080] A variety of methods can be utilized to laminate materials together. In some embodiments, the use of lamination is disclosed for the purpose of illustrating the bonding of metal strips to the outer surface of an air bag.

[0081] When a laminated stack is used, the component strips are typically integrated with long metal sheets or rolls of metal, with thousands to millions of strips per roll. The metal rolls may typically be chemically etched to produce the desired design of the carrier and strips with the desired wedge-shaped anatomical pattern. The etched rolls are then laminated with polymers, copolymers, or fiber-reinforced polymers, typically forming a sandwich-like construction with both sides laminated, etc.

[0082] In some embodiments, one or more polymer layers may include a fiber reinforced polymer applied in a laminated structure and include reinforcing fibers embedded in the polymer. The polymer also serves as a bonding means between the layers. Reinforcing fibers suitable for use in fiber reinforced polymers include, for example, glass fibers, carbon fibers, and metal fibers, and may also include stretched thermoplastic polymer fibers, such as aramid fibers, PBO fibers (Zylon TM )、M5 TM Fiber and ultra-high molecular weight polyethylene or polypropylene fiber, and / or the combination of the above-mentioned fibers. Mixed and / or interwoven fiber bundles, such as yarn bundles, can also be used. Such yarn bundles include thermoplastic polymers in the form of reinforcing fibers and fibers. The example of a suitable matrix material for reinforcing fibers is a thermoplastic polymer, such as polyamide, polyimide, polyether sulfone, polyether ether ketone, polyurethane, polyethylene, polypropylene, polyphenylene sulfide (PPS), polyamide-imide, acrylonitrile butadiene styrene (ABS), styrene / maleic anhydride (SMA), polycarbonate, polyphenylene oxide blend (PPO), thermoplastic polyesters, such as polyethylene terephthalate, polybutylene terephthalate, and mixtures and copolymers of one or more of the above-mentioned polymers.

[0083] In embodiments for attaching the strap to the airbag, it is contemplated that the polymer may be included directly on the base and / or sides of the strap. In one method of manufacturing the strap, it is contemplated that chemical etching may be used, while other methods such as electrochemical machining or other low cost high throughput, top-down (material removal) or bottom-up (material deposition) processes are contemplated. The strap may be constructed by removing material to create a wedge-shaped dissector. The strap may be constructed by adding material to create a wedge-shaped dissector.

[0084] like Figure 2 Schematically shown, when the strip is made from and into a reel of material, it is conceivable to provide a polymer layer on both sides (top and bottom) of the base of the strip using a secondary process like lamination.

[0085] The lamination process lays flat a sandwich of materials that captures the stainless steel strip reel and creates a fused surface of material that is able to flex with the flexible bladder and effectively adhere to the inflexible material strip, e.g. Figure 3 An embodiment of the invention is schematically shown in FIG.

[0086] In some configurations, the catheter further includes an expandable member associated with the catheter.

[0087] In some configurations, the expandable member comprises a balloon.

[0088] In some configurations, the expandable balloon includes a plurality of strips, each strip including a plurality of wedge-shaped dissectors thereon.

[0089] In some configurations, it is contemplated that the use of an additional energy source in conjunction with the teeth on the outer surface of the balloon can add additional benefits. In some embodiments, the additional energy source can be separated from the catheter by the balloon and the wedge-shaped dissector. In some embodiments, the additional energy source can be integrated with the catheter by the balloon and the wedge-shaped dissector. The energy source can provide energy in conjunction with the teeth on the outer surface of the balloon. The energy source can provide various functions, such as compressing plaques, expanding cracks, rupturing media plaques, rupturing intimal plaques, lesion preparation and / or destroying plaques. One such energy source is ultrasonic vibration, ultrasound or spark-derived energy that can be emitted from a transducer in the balloon body. In some embodiments, in the case of vibration energy, energy can be transmitted through the guide wire of the catheter. In some embodiments, in the case of vibration energy, energy can be transmitted through other separate and independent elements (such as metal elements). Vibration energy can be transmitted using longitudinal, radial or torsional oriented vibrations or any combination thereof. In some embodiments, in addition to the multiple strips, acoustic energy or other energy can be transmitted through the medium (usually liquid, but sometimes gas) used to fill the balloon and through the balloon wall. In this design, the wedge-shaped dissector can have the same or slightly different shapes so that acoustic or sound wave energy can be effectively conducted into the tissue. Therefore, the design of the wedge-shaped dissector can achieve a more effective form of transmission of acoustic energy or other energy into the diseased tissue. In some embodiments, it is envisioned that pneumatic and / or hydraulic energy delivery is used. It can be envisioned that by using additional energy sources such as ultrasound, pneumatic and / or hydraulic, spark or other energy sources, less toothed strips may be required to produce effective results. In addition, with fewer wedges and longer gaps, the periodicity of the wedge-shaped dissector can be made longer while producing effective results. The shape of the wedge can be made shallower or shorter while producing effective results. Another benefit of combining multiple forms of energy (i.e., ultrasound and pressure) with teeth is that the complexity of ultrasound or other energy emission sources can be reduced. Therefore, in some cases, it may be preferred to use a series of 3, 2 or 1 transducers, arc generators or pneumatic and / or hydraulic pumps to produce effective lumen gain or break the disease state of some patients. Energy delivery and teeth may have a synergistic effect. Energy delivery may be more effective in combination with nucleation points provided by a wedge dissector. A wedge dissector may increase energy conduction through tissue. A wedge dissector may focus energy delivery. A wedge dissector combined with energy delivery may more easily penetrate plaque. With both modalities, cracks may propagate more easily or more quickly. With both modalities, cracks may propagate in a more controlled manner. This combination of modalities may provide advantages by reducing the complexity of an integrated system with a balloon and a wedge dissector while minimizing the disadvantages of poor tissue conduction of energy through a diseased tissue state and into tissue by utilizing a wedge dissector to more efficiently deliver energy through the diseased tissue state.

[0090] Also disclosed herein is a method for creating serrations in a treatment site in a blood vessel: providing a balloon catheter comprising a balloon incorporating a plurality of strips, each strip comprising a plurality of wedge-shaped dissectors, the balloon catheter further comprising an inner member, a tapered outer sheath, and an elongated tapered coil between the matching tapered outer sheath and the non-tapered inner member, the elongated coil extending substantially the entire length of the balloon catheter and through the balloon; expanding the balloon at the site to create a plurality of microcracks in the media layer of the vessel wall without cutting the vessel wall; and removing the balloon from the site.

[0091] Also disclosed herein is a method for producing a dentation in a treatment site in a blood vessel: providing a balloon catheter comprising a balloon incorporating a plurality of strips, each strip comprising a plurality of wedge-shaped dissectors attached during the balloon blowing process or at any point during manufacturing, the balloon catheter further comprising an inner member, an outer sheath, a hub, and a tip; expanding the balloon at the site to produce a plurality of microcracks in the intimal layer of the vessel wall without cutting the vessel wall; and removing the balloon from the site. In some embodiments, the selected balloon is larger than the expected diameter of the vessel. This can be conveyed by a ratio between the expected vessel diameter and the balloon diameter. In some methods, the ratio is 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, 1:2, or any range thereof. The blood vessel can be dilated for a variety of clinical purposes. In some embodiments, the use of dentation angioplasty can minimize the risk of scar tissue formation, thereby reducing the likelihood of restenosis over time. Therefore, the functional use of a larger balloon diameter (which results in a larger vessel size) can maximize volumetric blood flow. In addition, there is a clinical need for delivering larger sized devices through blood vessels. By using larger balloons, these larger sized devices can be delivered. The clinical need for delivering larger sized devices through enlarged blood vessels is well known and can be complex to achieve without negative clinical outcomes. Typically, when a vessel is enlarged beyond its natural diameter, the vessel may be dissected, perforated, embolized, or restenoticed. The vessel can be dilated to deliver a larger sized primary or secondary therapy. In some treatment options or methods, dilating the balloon to a larger diameter may produce positive vascular remodeling, where over time the vessel diameter returns to a non-diseased or healthy diameter. In some treatment options or methods, the result is the highest possible volumetric flow through the vessel. The highest possible volume flow rate can be achieved with an enlarged balloon, such as a ratio of 1:1.1, 1:1.2, 1:1.3, 1:1.4, 1:1.5, 1:1.6, 1:1.7, 1:1.8, 1:1.9, 1:2, or any range thereof. The highest possible volume flow rate can be used in an effort to heal a wound. The highest possible volume flow rate can be used to maintain tissue longevity. The highest possible volume flow rate can be used for healing of downstream tissue. There may be additional clinical reasons to provide the highest possible volume flow rate.

[0092] In some configurations, the method further includes performing an index, starting, or initial procedure at the site.

[0093] In some configurations, the primary surgery 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).

[0094] In some embodiments, an intravascular device is provided. The intravascular device may include an airbag. The intravascular device may include a plurality of strips. In some embodiments, each of the plurality of strips includes a plurality of wedge-shaped dissectors spaced apart along the surface of each strip. In some embodiments, each strip extends along the outer surface of the airbag. In some embodiments, the wedge-shaped dissector includes a bottom surface, an unpolished radially outward surface, and an inclined sidewall extending from the bottom surface to the unpolished radially outward surface. In some embodiments, the airbag is configured to expand and create a leaflet between the plurality of strips. In some embodiments, the leaflet applies a force to the inclined sidewall of the wedge-shaped dissector to rotate the wedge-shaped dissector from a generally tangential orientation to a generally vertical orientation.

[0095] In some embodiments, the leaflets apply a force to the inclined sidewalls of the wedge-shaped dissector to rotate the wedge-shaped dissector from a generally vertical orientation to a generally tangential orientation. In some embodiments, the intravascular device is bidirectional to allow the plurality of strips to rotate clockwise or counterclockwise. In some embodiments, before inflation, the plurality of strips point counterclockwise in a generally tangential orientation. In some embodiments, after inflation, the plurality of strips point counterclockwise in a generally tangential orientation. In some embodiments, the plurality of strips are at least partially covered by the folds of the balloon in a generally tangential orientation. In some embodiments, each strip is at least partially covered by the folds of the balloon when the balloon is deflated. In some embodiments, the covered strips are located near the bottom of the pleated wings of the balloon. In some embodiments, the covered strips are oriented so that the unpolished radially outward surface is tangential to the circumference of the inner member, thereby limiting the unpolished radially outward surface from contacting the pleated wings of the balloon. In some embodiments, the inclined sidewalls combined with the expansion of the leaflets are configured to allow more effective control of the generally vertical orientation of the wedge-shaped dissector. In some embodiments, the unpolished radially outward surface is configured to contact the vessel wall while producing little separation of plaque from the vessel wall. In some embodiments, the leaflets are configured to exert tension on the vessel wall near the area where the wedge-shaped dissector contacts the vessel wall. In some embodiments, the leaflets are configured to exert a force on the vessel wall, thereby pulling the vessel wall away from the wedge-shaped dissector. In some embodiments, the leaflets are configured to exert a force on the vessel wall that allows the unpolished radially outward surface to produce teeth in the vessel wall. In some embodiments, the leaflets are configured to exert a force on the vessel wall that allows the unpolished radially outward surface to produce a linear dissection line. In some embodiments, the inclined sidewalls are combined with the expansion of the leaflets to produce multiple longitudinally oriented lines into or through one or more layers of tissue. The unpolished radially outward surface of each wedge-shaped dissector can be configured to penetrate the layers of the vascular anatomical structure. In some embodiments, the inclined sidewalls are combined with the expansion of the leaflets to produce multiple longitudinally oriented lines through the intimal layer. In some embodiments, the inclined sidewalls are combined with the expansion of the leaflets to produce multiple longitudinally oriented lines through the internal elastic sheet layer. In some embodiments, the sloping sidewalls in combination with the expansion of the leaflets are configured to produce multiple longitudinally oriented lines into the media layer. In some embodiments, the sloping sidewalls in combination with the expansion of the leaflets are configured to produce a luminal gain that is independent of the size of the artery. In some embodiments, the sloping sidewalls in combination with the expansion of the leaflets are configured to produce multiple longitudinally oriented lines to the media layer, enabling greater arterial dilation that increases volumetric blood flow. In some embodiments, the sloping sidewalls in combination with the expansion of the leaflets are configured to produce multiple longitudinally oriented lines to the media layer that improve stenosis. In some embodiments, the sloping sidewalls in combination with the expansion of the leaflets are configured to cause positive vascular remodeling.In some embodiments, the inclined sidewalls in combination with the expansion of the leaflets are configured to maintain a generally vertical orientation of the wedge-shaped dissector as the wedge-shaped dissector induces a dissection node in the intima. In some embodiments, the inclined sidewalls in combination with the expansion of the leaflets are configured to change the pressure distribution at the vessel wall, thereby allowing the wedge-shaped dissector to further penetrate the vessel wall. In some embodiments, the balloon is configured to deliver energy. In some embodiments, the strips improve trackability and pushability by transmitting force longitudinally along the balloon.

[0096] In some embodiments, an intravascular device is provided. The intravascular device may include an airbag. The intravascular device may include a plurality of strips. In some embodiments, each of the plurality of strips includes a plurality of wedge-shaped dissectors spaced along the surface of each strip. In some embodiments, each strip extends along the outer surface of the airbag. The intravascular device may include a prefabricated covering. In some embodiments, the combination of the prefabricated covering and the airbag having the plurality of strips is formed by inflating the airbag having the plurality of strips within the prefabricated covering and applying heat to the plurality of strips, so that the prefabricated covering softens and the plurality of wedge-shaped dissectors extend through the prefabricated covering.

[0097] In some embodiments, the preformed cover hardens around the plurality of wedge-shaped dissectors. In some embodiments, each strip is bonded to the outer surface of the airbag or the base coating of the airbag with an adhesive. In some embodiments, the airbag having the plurality of strips is configured to be pleated before being inserted into the preformed cover. In some embodiments, the adhesive is configured to be applied to the airbag having the plurality of strips and then the airbag is inserted into the preformed cover. In some embodiments, the plurality of wedge-shaped dissectors are configured to rotate from a generally tangential orientation to a generally vertical orientation when the airbag having the plurality of strips is inflated within the preformed cover. In some embodiments, the plurality of wedge-shaped dissectors include an unpolished radially outward surface that does not pierce the preformed cover during inflation of the airbag. In some embodiments, the expansion of the airbag evenly distributes the adhesive between the airbag and the preformed cover. In some embodiments, the preformed cover provides a thicker layer around the wedge-shaped dissectors. In some embodiments, the preformed cover near the wedge-shaped dissectors limits the ability of the preformed cover to tear in the space between adjacent wedge-shaped dissectors. In some embodiments, only a single wedge-shaped dissector extends through the preformed covering. In some embodiments, the preformed covering remains intact along the longitudinal space between adjacent wedge-shaped dissectors. In some embodiments, the preformed covering includes re-hardened material that extends longitudinally along the inclined sidewalls of the wedge-shaped dissector. In some embodiments, the preformed covering includes re-hardened material that extends laterally along the proximal and / or distal edges of the wedge-shaped dissector. In some embodiments, the preformed covering, the airbag, and the multiple strips are combined together. In some embodiments, the preformed covering, the airbag, and the multiple strips are pleated. In some embodiments, the preformed covering helps to retain the multiple strips relative to the airbag. In some embodiments, the wedge-shaped dissector is configured to rotate from a generally tangential orientation to a generally vertical orientation within the blood vessel. In some embodiments, the preformed covering and the airbag are configured to act integrally to apply tension on the vessel wall to produce a linear dissection line.

[0098] In some embodiments, an intravascular device is provided. The intravascular device may include an airbag. The intravascular device may include a plurality of strips. In some embodiments, each of the plurality of strips includes a plurality of dissectors spaced apart along the surface of each strip. In some embodiments, each strip extends along the outer surface of the airbag. In some embodiments, the dissector includes a bottom surface, an outward surface, and an inclined sidewall extending from the bottom surface to a radially outward surface. In some embodiments, the airbag is configured to expand and create a leaflet between the plurality of strips. In some embodiments, the leaflet applies a force to the inclined sidewall of the dissector to rotate the dissector from a generally tangential orientation to a generally vertical orientation.

[0099] In some embodiments, the intravascular device is bidirectional to allow the plurality of strips to rotate clockwise or counterclockwise. In some embodiments, the plurality of strips point counterclockwise in a generally tangential orientation before and after inflation. In some embodiments, the plurality of strips are at least partially covered by the folds of the balloon in a generally tangential orientation. In some embodiments, the intravascular device allows for more effective control of the generally vertical orientation of the wedge-shaped dissector. In some embodiments, the intravascular device is configured to contact the vessel wall while producing little separation of plaque from the vessel wall. In some embodiments, the leaflets are configured to apply tension to the vessel wall. In some embodiments, the leaflets are configured to apply force to the vessel wall to pull the tissue away from the dissector. In some embodiments, the intravascular device is configured to produce teeth in the vessel wall. In some embodiments, the intravascular device is configured to produce a linear dissection line.

[0100] In some embodiments, a method is provided. The method may include providing an intravascular device for angioplasty treatment, the intravascular device including a balloon and a strip including a plurality of microperforators. The method may include expanding the balloon to rotate the microperforators from a first position to a second, more vertical position, wherein the strip is disposed between the lobes of the balloon. The method may include expanding the balloon to create serrations, indentations, and / or microperforations in the vessel wall by moving the strip radially outward and applying a force to the vessel wall. The method may include expanding the balloon to a higher pressure to cause crack propagation along the serrations, indentations, and / or microperforations in the vessel wall to the media layer.

[0101] In some embodiments, the method may include pleating the balloon. In some embodiments, the method may include placing a strip within the folded portion of the balloon. In some embodiments, the intravascular device is provided with a tangentially oriented strip. In some embodiments, the intravascular device is provided with a strip at least partially covered with a balloon material. In some embodiments, the balloon is expanded at a pressure below 4 atmospheres to rotate the microperforator. In some embodiments, expanding the balloon to rotate the microperforator further includes exposing the strip by pulling back the balloon material. In some embodiments, expanding the balloon to rotate the microperforator further includes expanding the vessel wall. In some embodiments, expanding the balloon to produce dentations, indentations, and / or microperforations further includes maintaining the balloon at a pressure between 2 atmospheres and 4 atmospheres for 60 seconds. In some embodiments, expanding the balloon to a higher pressure further includes maintaining the balloon at a pressure between 4 atmospheres and 6 atmospheres for a short period of time of 60 seconds or less. In some embodiments, expanding the balloon to a higher pressure produces a stable and more repeatable lumen gain, regardless of artery size. In some embodiments, expanding the balloon to a higher pressure produces improved lumen gain and blood flow. In some embodiments, dilating the balloon to a higher pressure improves final stenosis by about 50% relative to POBA alone. In some embodiments, dilating the balloon to a higher pressure produces a stable and more reproducible lumen gain independent of calcification. In some embodiments, dilating the balloon to a higher pressure may produce positive vascular remodeling, wherein the vessel diameter returns to a non-diseased diameter over time. In some embodiments, the method may include positioning the balloon near the treatment site, wherein during positioning, the strip transmits a force along the axis of the balloon. In some embodiments, the method may include plasma functionalization of the strip. In some embodiments, the method may include applying ultrasound to the vessel wall. In some embodiments, the method may include performing a subsequent angioplasty with a drug-coated balloon.

[0102] In some embodiments, an intravascular device is provided. The intravascular device may include a balloon configured to reversibly expand and contract within a blood vessel. The intravascular device may include a strip that includes a plurality of microperforators. In some embodiments, each microperforator includes an unpolished tip and the strip includes spaces between adjacent microperforators. In some embodiments, the balloon is configured to expand by moving the strip radially outward and applying force to the vessel wall to create teeth, indentations, and / or microperforations in the vessel wall.

[0103] In some embodiments, the intravascular device is configured to produce predictable and repeatable crack propagation along teeth, indentations and / or microperforations. In some embodiments, the intravascular device is configured to increase arterial diameter while minimizing vascular damage. In some embodiments, the intravascular device is configured to increase volume flow. In some embodiments, the intravascular device is configured to require minimal atmospheric pressure to achieve improvements in blood flow. In some embodiments, the intravascular device is configured to promote angioplasty energy along teeth, indentations and / or microperforations to separate intima and media tissues. In some embodiments, the intravascular device is configured to improve one or more of the compliance, flow dynamics and inner diameter of the blood vessel. In some embodiments, the intravascular device is configured to serrate the internal elastic sheet. In some embodiments, the intravascular device is configured to allow the treated diseased area to become less disordered by generating fewer interruptions or disturbances in the flow stream. In some embodiments, relative to a single POBA, the intravascular device is configured to improve residual stenosis by about 50%. In some embodiments, the intravascular device is configured to improve traceability, pushability and the transmission of force across a balloon with a strip. In some embodiments, the strips increase column strength when the strips are oriented transversely. In some embodiments, the method may include a plasma functionalized layer on the strips. In some embodiments, the balloon is configured to produce consistent lumen gain. In some embodiments, the method may include an energy source configured to disrupt calcium deposits. In some embodiments, the balloon is configured to produce dents, indentations, and / or microperforations at pressures below 4 atmospheres.

[0104] In some embodiments, a medical catheter having a toothed metal embedded therein is provided. The catheter may include an outer shaft including an elongated member having an inner diameter and an outer diameter. The catheter may include an inner member. The catheter may include a balloon that is blown with metal embedded in the balloon material so that a portion of the metal protrudes above the surface of the balloon diameter:

[0105] In some embodiments, the metal protruding above the balloon diameter has a protruding portion and an unprotruding portion. In some embodiments, the internal member includes a guidewire lumen. In some embodiments, the metal includes a plurality of strips, each of which includes a plurality of wedge-shaped dissectors. In some embodiments, the wedge-shaped dissector is configured to produce a tooth in the blood vessel without cutting the blood vessel. In some embodiments, the height or amount of the metal of the wedge-shaped dissector protruding above the balloon surface to form a plurality of strips is less than the thickness of the healthy tissue wall, thereby limiting or preventing piercing the entire blood vessel wall. The height of the wedge-shaped dissector can limit the penetration of tissue layers. The height of the wedge-shaped dissector can be higher than the threshold for starting crack expansion. The height of the wedge-shaped dissector can form a tiny thorn with limited penetration depth. The height of the wedge-shaped dissector can be selected to promote slow, stable crack expansion through tissue. In some embodiments, the wedge-shaped dissector is configured to cut a portion of the blood vessel through crack expansion. In some embodiments, the catheter can include spaced ridges on the outer surface of the balloon, which are configured to prevent metal from damaging the balloon.

[0106] In some embodiments, a method of blowing a metal-embedded airbag is provided. The method may include positioning an airbag extrusion relative to an airbag mold, the airbag mold including a plurality of separation sections and open spaces between the plurality of separation sections. The method may include positioning a metal element in the separation section of the mold. The method may include positioning a retaining material on the metal element. The method may include heating the airbag. The method may include expanding the airbag. In some embodiments, the metal element includes a strip and a micro-wedge.

[0107] In some embodiments, an intravascular device is provided. The intravascular device may include a base balloon. The intravascular device may include a plurality of strips, each of the plurality of strips including a plurality of wedge-shaped dissectors spaced along a surface of each strip. The intravascular device may include a preformed covering. In some embodiments, the base balloon includes a lower compliance and the preformed covering includes a higher compliance.

[0108] In some embodiments, the base balloon comprises a non-compliant balloon. In some embodiments, the base balloon comprises a semi-compliant balloon. In some embodiments, the base balloon is configured to expand to a specific diameter. In some embodiments, the base balloon is configured to apply a specific pressure on the vessel wall without additional radial expansion. In some embodiments, the preformed covering is configured to minimize surface tearing along a portion of one of the plurality of strips. In some embodiments, the preformed covering is configured to minimize surface tearing between adjacent wedge-shaped dissectors. In some embodiments, the preformed covering is configured to minimize surface tearing caused by a wedge-shaped dissector. In some embodiments, the preformed covering is configured to minimize surface tearing caused by calcified atherosclerosis. In some embodiments, the preformed covering is configured to hold a plurality of strips between the base balloon and the preformed covering.

[0109] In some embodiments, a method of manufacturing an intravascular device is provided. The method may include selecting a first extruded tube and blow molding a base balloon. The method may include selecting a plurality of strips, each of the plurality of strips including a plurality of wedge-shaped dissectors spaced along a surface of each strip. The method may include selecting a second extruded tube and blow molding a preformed covering. The method may include altering the compliance of the base balloon, the preformed covering, or both the base balloon and the preformed covering during the manufacturing process.

[0110] In some embodiments, changing the compliance comprises changing the molecular orientation of the polymer chains. In some embodiments, changing the compliance comprises changing the process of producing the first extruded tube or the second extruded tube. In some embodiments, changing the compliance comprises a change in the forming process. In some embodiments, changing the compliance comprises a change in the balloon modeling process. In some embodiments, changing the compliance comprises orienting the polymer chains biaxially. In some embodiments, changing the compliance comprises increasing the tear resistance of the preformed covering. In some embodiments, the base balloon comprises a lower compliance and the preformed covering comprises a higher compliance. In some embodiments, changing the compliance comprises changing the temperature of the heated jaws. In some embodiments, changing the compliance comprises changing the pre-pressing and / or pre-heating time. In some embodiments, changing the compliance comprises changing the forming pressure and / or forming time. In some embodiments, changing the compliance comprises changing the distal tensile load and / or the proximal tensile load. In some embodiments, changing the compliance comprises changing the distance between the extrusion tool and the cooling bath. In some embodiments, changing the compliance comprises changing the speed of the gear pump during the extrusion process. In some embodiments, changing the compliance comprises changing the inner diameter and / or outer diameter of the first extruded tube or the second extruded tube. In some embodiments, modifying the compliance comprises modifying the drawdown and die head of the first extrusion tube or the second extrusion tube. In some embodiments, modifying the compliance comprises modifying the final molecular orientation of the polymer chains.

[0111] In some embodiments, a method is provided. The method may include providing an intravascular device. In some embodiments, the intravascular device may include a base balloon. In some embodiments, the intravascular device may include a plurality of strips, each of the plurality of strips including a plurality of wedge-shaped dissectors spaced along a surface of each strip. In some embodiments, the intravascular device may include a preformed covering. The method may include expanding the intravascular device within a blood vessel, wherein a ratio between a reference blood vessel diameter and a diameter of the expanded intravascular device is greater than 1:1.

[0112] In some embodiments, the ratio between the reference vessel diameter and the diameter of the expanded intravascular device is greater than 1:1.1. In some embodiments, the ratio between the reference vessel diameter and the diameter of the expanded intravascular device is greater than 1:1.2. In some embodiments, the ratio between the reference vessel diameter and the diameter of the expanded intravascular device is greater than 1:1.3. In some embodiments, the intravascular device expansion enables greater arterial growth. In some embodiments, the intravascular device expansion enables better residual blood flow. In some embodiments, the intravascular device expansion provides low residual stenosis.

[0113] In some embodiments, systems and methods may include any number of the features of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0114] 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.

[0115] Figure 1 An example of a tooth under an electron microscope is shown.

[0116] Figure 2 Shown is the maximum distal flow in a peripheral artery as a percentage of vessel reduction assuming that the pressure within the vessel remains constant.

[0117] Figure 3 An example of an unrolling scroll is shown.

[0118] Figure 4 An example of a multi-layer strip is illustrated.

[0119] Figure 5 An angioplasty balloon is shown within a blood vessel at a treatment site experiencing dog-boning.

[0120] Figure 6 A detailed view of a portion of another embodiment of a cage is shown.

[0121] Figure 7 is another embodiment of a cage having a conical ring.

[0122] Figure 8 Illustrated is a view of a conical distal ring holding multiple strips.

[0123] FIG. 9A to FIG. 9B Shown is a view of one end of an airbag with a cage disposed about the airbag and the forces applied to the airbag during inflation and deflation.

[0124] Fig.10 An embodiment of a strap held by a plurality of loops from which wedge-shaped dissectors protrude is shown.

[0125] Figures 11 to 13 Several embodiments of straps secured by loops are shown.

[0126] Fig.14 is a close-up detail view of an embodiment of a wedge-shaped dissector on its associated strips.

[0127] Fig.15 Schematic perspective views illustrating various sizes and terms for a wedge-shaped dissector according to some embodiments are illustrated.

[0128] Figures 16 to 22 Various embodiments of wedge-shaped dissector geometries are illustrated.

[0129] FIG. 22A to FIG. 22F Respective end and isometric views of various wedge-shaped dissector geometries are illustrated in accordance with some embodiments.

[0130] FIG. 23A to FIG. 23D Respective end and isometric views of various asymmetric wedge dissector geometries are illustrated in accordance with some embodiments.

[0131] Not limited by theory, Fig.23E , Fig.23F and Figure 23F.1 A potential mechanism of action of the tooth device is shown.

[0132] Fig.24 An embodiment illustrating how the non-bonding surface 204 may have varying heights is illustrated in accordance with some embodiments.

[0133] FIG. 25A to FIG. 25K Various embodiments of straps with releases in various positions are illustrated.

[0134] Figure 25L-25Q An embodiment of a method for stabilizing a strap during a laser cutting manufacturing process and involving temporary tabs is illustrated in accordance with some embodiments.

[0135] Fig.26 An embodiment of an adhesive ramp for bonding the lateral ends of the strip to the airbag surface is illustrated in accordance with some embodiments. Fig.26A Another image of the ramp feature is shown in a side view to illustrate the distance the ramp extends from the edge of the strip.

[0136] Fig. 27 A conical ramp for an air bag is illustrated in accordance with some embodiments.

[0137] Fig.28 A series of conical rails or struts are illustrated in accordance with some embodiments.

[0138] Fig.29 Another embodiment of a strap with a release is illustrated in accordance with some embodiments.

[0139] FIG. 30A to FIG. 30B A schematic cross-section of a balloon with a wedge-shaped dissector and an intermediate layer is illustrated.

[0140] Fig.31 An embodiment of a pleated balloon having straps and wedge-shaped dissectors between the pleats is illustrated.

[0141] Fig.32 An embodiment of an improved cutting balloon for producing teeth is illustrated.

[0142] Fig.33 An illustration of a modified cutting balloon is shown, where flexibility is further enhanced and the cutting is completely or partially replaced by a toothed blade pattern.

[0143] Fig.34 An embodiment of a method for producing an airbag design in an airbag is schematically illustrated.

[0144] FIG. 35A to FIG. 35B An embodiment of a strip having a wedge-shaped dissector with a sloped, non-linear edge is illustrated.

[0145] Fig.36 The top of the wedge-shaped dissector illustrated may have various unique features on the tip (eg, radially outward surface) that contacts tissue.

[0146] Fig.37 is another design illustrating an alternative variation of the toothed edge of a wedge-shaped dissector, wherein the center section may include a small depression as shown.

[0147] Fig.38 Wedge-shaped dissectors having a rounded, double-humped contact surface at the tip are illustrated, which may provide effective tissue penetration.

[0148] Fig.39 A variation on the design is illustrated that provides relatively sharp pointed dual contact surfaces at the tip of each wedge-shaped dissector, thereby providing effective tissue penetration.

[0149] Fig.40 A similar design is illustrated that provides relatively sharp pointed dual contact surfaces at the tip of each wedge-shaped dissector to provide effective tissue penetration, which abut central deeper and shallower grooves / depressions, respectively.

[0150] Fig.41A It is illustrated that the strip can be manufactured to include multiple strips (eg, two identical strips) that are in tip-to-tip contact in a wedge-shaped dissector frame.

[0151] Fig.41B and Fig.41C It is illustrated that in some embodiments the plurality of strips may be bent or folded into a curved form.

[0152] Fig.41D and Fig.41E An alternative embodiment is illustrated having toothed tips comprising a plurality of pointed surfaces with a central concave section therebetween.

[0153] Fig.42A series of diagrams are illustrated showing the ability to employ a stack of straps connected to a blank that can be discarded at any point in the strap attachment process. The radially distal tip abuts against a continuous edge to facilitate breaking.

[0154] Fig.43 An embodiment of a close-up view of the attachment of the strip tip to the blank is illustrated.

[0155] Fig.44A and Fig.44B Isotropic etching is illustrated, where etching occurs in more than one direction (vertically and horizontally under the mask).

[0156] Fig.45A It is shown that the strips can be placed over through holes embedded in the airbag. Fig.45B It is shown that the strips can be placed over through holes embedded in the balloon wall.

[0157] Fig.46 It is illustrated that in some embodiments, a series of 4A frame strips may be placed over through holes embedded in the bladder wall.

[0158] Fig.47 An embodiment of what an array of stripes may appear on a mask set prior to chemical etching is illustrated (including a close-up inset).

[0159] Figure 48a shows an array of strips. Figure 48b shows a detailed close-up image of adjacent wedge-shaped dissectors with removable areas. Figure 48c shows a strip of teeth connected to a strip carrier for alignment, control, placement, and ease of manufacturing. Figure 48d illustrates an embodiment of a strip carrier reversibly attached to a strip.

[0160] Figures 49 to 49J Various views of one embodiment of an overall system for producing a dentitionplasty are illustrated showing a series of serrated or scored wedge-shaped dissectors on the outer diameter of a catheter to which it is attached via a guidewire hub and a balloon inflation hub.

[0161] Fig.50 An extrusion-blown airbag having a set of longitudinally oriented ridges of material is schematically illustrated in accordance with some embodiments.

[0162] Fig.51 Schematically illustrated are groups of strips placed in an air bag blowing mold prior to an air bag blowing process according to some embodiments.

[0163] Fig.52 An extrusion is schematically illustrated that includes optical markings to aid in the orientation of the extrusion during the balloon blowing process, according to some embodiments.

[0164] Fig.53An embodiment is shown in which the extrusion for the blown airbag has a second retaining layer having a glass transition temperature slightly lower than the glass transition temperature of the airbag itself.

[0165] Fig.54 Schematically illustrated is a perspective view of a mold (shown only partially and transparently) according to some embodiments, wherein a series of strips are shown clamped into a modified air bag blowing machine.

[0166] Fig.55 A strip and bonding material surrounding the base of the strip are schematically illustrated according to some embodiments.

[0167] Fig.56 A cross-sectional view schematically illustrates placement of straps and strap retention material onto one side of a single air bag blow mold in accordance with some embodiments.

[0168] Fig.57 Schematically illustrated are 3 strips captured within a set of three molds at 120 degree angles to each other, according to some embodiments.

[0169] Fig.58 Schematically illustrates an enlarged view of a strip and retention material captured between two sides of an air bag mold, according to some embodiments.

[0170] Fig.59 A cross-section of an air bag is schematically illustrated, according to some embodiments, with a strip and retention material bonded together and removed from an air bag blowing machine.

[0171] Fig.60 Schematically illustrates three strips bonded to a balloon surface with a retaining layer according to some embodiments.

[0172] Fig.61 An enlarged view of this strip after the retention layer has been bonded to the airbag surface is schematically illustrated in accordance with some embodiments.

[0173] Fig.62 A perspective view of three strips incorporating a retention layer is schematically illustrated, according to some embodiments, showing the minimum surface area covered by the retention layer on the outer surface of the airbag relative to the entire airbag surface.

[0174] Fig.63 A top view is schematically illustrated, with the retention layer shown covering the top of the strap between the wedge-shaped dissectors and outwardly covering some small portion of the balloon surface so that the feet rest on the balloon to aid in strap retention.

[0175] Fig.64 The retention layer is schematically illustrated, being minimized with no footprint on either side of the strip along the bladder surface.

[0176] Fig.65 The pillows of the retaining members adjacent to the strip are schematically illustrated, with the spacing of the pillows similar to the tips of the strip shown in a dotted pattern.

[0177] Fig.66 Schematically illustrated is a cross-sectional view of a retained strap with a retention layer thereon, with minimal retention material and an accompanying pair of airbag protection pillows on either side as protection zones to minimize strap puncture of the airbag.

[0178] Fig.67 An embodiment is schematically illustrated where only a single pillow is located in the region of the lay-flat strip, without an opposing pillow, as shown.

[0179] Fig.68 A variation of the same concept of a minimum retention area of ​​a strip is schematically illustrated, but with the pillow area on one side of the strip containing less material than the pillow area on the opposite side of the strip.

[0180] Fig.69 A variation of the same concept of a minimum retention area of ​​a strip is schematically illustrated, but with additional material shown on the proximal edge of the strip.

[0181] Fig.70 Schematically illustrates how protection zones (raised pillow-shaped areas) integrated into the airbag provide a variation of airbag protection during folding and rolling of the airbag.

[0182] Fig.71 An embodiment of an array of smaller strip portions is schematically illustrated, where four wedge-shaped dissectors are connected by a base, followed by a gap and another array of four wedge-shaped dissectors.

[0183] Fig.72 An embodiment in which the individual wedge dissectors are not connected is schematically illustrated.

[0184] Fig.73 A side view of a strip integrated onto the surface of an airbag is schematically illustrated.

[0185] FIG. 74A to FIG. 74E is a series of diagrams showing the mechanism by which the toothed strip elements are rotated from a tangential orientation to emerge and be oriented vertically.

[0186] Fig.75 It is a data curve graph of the flow rate ratio after treatment / before treatment and the radius before treatment.

[0187] Fig.76 is a graph comparing the percentage of stenosis after treatment with a plain balloon and a dentate balloon.

[0188] FIG. 77A to FIG. 77B A set of images taken from within the artery before and after treatment with the toothed balloon technique.

[0189] FIG. 78A to FIG. 78B is a graph showing a comparison of lumen gain between the effects of a normal balloon and a dentate balloon.

[0190] Fig.79 is a graph comparing the transfer of force from the hub of the catheter and the tip of the catheter.

[0191] Fig.80 The incidence of dissection of dentate balloon catheters at different clinical sites is shown.

[0192] Fig.81 Illustrated is a schematic diagram of a manufacturing process for producing a wedge-shaped dissector having an unground edge from a razor blade, according to some embodiments. DETAILED DESCRIPTION

[0193] The spikes may be positioned on the strip in any number of different orientations and configurations as further described below. The spikes may 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 may also be used in accordance with the patch sawtooth method and other methods described therein.

[0194] Reference now Figure 6 , showing 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 the base of the unfinished cage, slits may be cut into the tube to form adjacent strips. The wedge-shaped dissectors 26 may be made into a tent or axe shape having an elongated tip and base, both extending longitudinally along the longitudinal axis of the tube. The wedge-shaped dissectors 26 may help cut and / or perforate plaque before or during an angioplasty procedure. The spaces between the wedge-shaped dissectors 26 may be machined or otherwise formed to remove material and increase the flexibility of the strip. The spaces between the wedge-shaped dissectors 26 are shown as being twice the length of the wedge-shaped dissectors 26, but other spacings may also be used. Typically, the spacing length may be a space to length ratio of 4:1 to 3:1, with a more common space to length ratio of 2:1 to 1:1.

[0195] In some embodiments, rows of strips and / or strip segments may be placed around the balloon 20. Some rows may extend the entire length of the balloon 20, but others may not. In some examples, a row may include multiple strips connected in series, separated by gaps. Placing the strips in series on the balloon may provide greater flexibility, which may improve its ability to be delivered through tortuous anatomical structures.

[0196] As shown herein, many of the strips 16 have a flat bottom. This can help the strips 16 to be placed 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.

[0197] Unique functional features that some embodiments of the embedded strap configuration are intended to achieve include any number of the following features: 1) perpendicularity of the wedge dissector relative to the balloon surface, 2) maintaining a flat and low profile of the strap on the balloon in the deflated state, and 3) helping to limit the wedge dissector from damaging the balloon or tissue during delivery or retraction. Design features that help achieve these functional features include: the strap has a flat bottom that achieves a stable orientation of the wedge dissector, but is thin enough to lie flat tangentially to the balloon or be contained in the folded portion of the balloon during folding, an area on the balloon surface having a slightly increased thickness to limit puncture, and spacing between wedge dissectors without raised areas or cutting edges. It should be understood that other benefits and advantages may also be provided.

[0198] The method of blowing a balloon catheter with metal (including toothed strips) on the outside can include any of the following: laminating a strip reel with a material layer stack, which is positioned to allow polymer deposition to the base of the strip. The laminated strip is positioned in a series of molds designed to accommodate the strip. The strip typically includes a wedge-shaped dissector as described above. The strip can be positioned equidistantly around the center point where the balloon will be blown. The strip is typically oriented to extend mainly in the longitudinal direction. Especially in longer balloons, the strip can be positioned in rows in series, such as 1 to 8 rows, with 1 to 25 strips or more in each row. In some embodiments, the base area of ​​the strip is pre-impregnated, laminated or coated with a material having a glass transition temperature similar to or lower than the glass transition temperature of the balloon material. In some embodiments, the coating is a series of one or more materials. In the case of more than a single material, the collected material pile can be designed to provide adhesion between the elastic balloon surface and the non-elastic strip surface. All strips are placed between the balloon blowing molds in such a way that the coating below the base can be positioned within the diameter of the balloon blowing mold. The design of the mold and the strip being attached. The intravascular device may include a prefabricated covering as described herein. The prefabricated covering may be formed by a second balloon blowing process. In some embodiments, the combination of the prefabricated covering and the balloon with the multiple strips is formed by inflating the balloon with the multiple strips in the prefabricated covering and applying heat to the multiple strips so that the prefabricated covering softens and the multiple wedge-shaped dissectors extend through the prefabricated covering. Alternatively, a second balloon blowing sample process is envisioned to provide a unique mechanism for fusing the strips to the balloon. In this alternative process, there may be polymers, extrudates, laminates or other fused materials on the strips. The strips with the fused material are strategically placed in the second balloon blowing sample machine to allow the strips to be accurately positioned to the balloon. In the second machine, the base balloon is inflated and energy, such as heat or ultraviolet light, is applied. Energy can be applied to the entire area or to specific areas where the strips are placed in the machine. The energy can allow the fused material to move toward the elastic phase of the material and enable a fusion event to occur between the base airbag and the base material. The fused material is designed to flow through the interface of the airbag and the area between the strips. In some embodiments, the fused material flows along some portions of the outer surface of the airbag, providing a more durable attachment area and a buffer zone to protect the base airbag from being damaged by the teeth when it is caught in the wings of the airbag when pleated and folded.

[0199] The method of remodeling the balloon catheter with a series of metal strips may include any of the following steps. The strips are positioned around the inflated balloon or during the balloon blowing cycle. The strips may include wedge-shaped dissectors. These strips may be positioned equidistantly around the inflated balloon. The strips may extend primarily longitudinally. These strips may be positioned individually, or in series in rows, such as 2, 3, 4, 5, 6 or 7 rows, each row having a single strip to any position between 2, 3, 4, 5, 6, 7, 8, 9 or more segmented strips, with any number of wedge-shaped dissector arrays, or even up to one hundred or more separate wedge-shaped dissectors separated from each other. In some embodiments, it is conceivable that a separate wedge-shaped dissector is placed on the balloon surface without combining with adjacent wedge-shaped dissectors. When more than one wedge-shaped dissector is connected, they may form a wedge-shaped dissector strip. In some embodiments, the strip and the wedge-shaped dissector comprise the same material. In some embodiments, the strip and the wedge-shaped dissector are formed integrally. In some embodiments, the strip and the wedge-shaped dissector comprise different materials. In some embodiments, the strips and wedge-shaped dissectors are formed separately. In some embodiments, the space between the wedge-shaped dissectors is non-metallic. A single wedge-shaped dissector or strips can be permanently or temporarily attached to the balloon with an adhesive. The intravascular device may include a prefabricated covering as described herein. The prefabricated covering can be formed by a second balloon blowing process. In some embodiments, the combination of the prefabricated covering and the balloon having the multiple strips is formed by inflating the balloon having the multiple strips within the prefabricated covering and applying heat to the multiple strips so that the prefabricated covering softens and the multiple wedge-shaped dissectors extend through the prefabricated covering.

[0200] The loops 12, 13, 14 may be attached to the strap 16 in various ways. Figures 11 to 13 An example of the fixing of the loops 12 , 13 , 14 to the strap 16 is shown. Fig.11 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.12 As shown, loops 12, 13, 14 may be wrapped around a portion of each strip. Fig.10 , where each loop may have an upper layer and a bottom layer around which a portion of the strip 16 is wrapped. Fig.13 Solid rings 12, 13, 14 are shown which may be attached to a portion of the airbag. A portion of the strap may be fixed to the rings.

[0201] The heat shrink material may be positioned as a ring around the ends of the strips. A single ring of heat shrink material may connect or cover the ends of multiple strips positioned circumferentially around the airbag. A single ring of heat shrink material may also connect or cover the ends of adjacent strips positioned in series in a row. Heat may then be applied to shrink the heat shrink material. The airbag may be deflated and then sterilized for use.

[0202] The system and method disclosed herein can be deployed in any body cavity including a vascular lumen by cage and wedge-shaped dissector, such as an artery and a vein. The artery can be a coronary artery, a peripheral artery, or a carotid artery or other cerebral artery, such as an iliac artery, a femoral artery, a superficial femoral artery, a popliteal artery, anterior tibial artery and posterior tibial artery, a peroneal artery or other peripheral vascular systems. The device can also be used for any lumen or delivery conduit found in any of the vascular, respiratory, digestive, urinary, reproductive, lymphatic, auditory, visual or endocrine systems. It should be understood that the device for producing teeth in any one, two or more of these anatomical regions can have slightly different catheter bodies and features. In some systems, the design can include features found in similar monorail designs, while other systems can provide rapid exchange of similar design features. Other design features can also be included, and each can take slightly different forms. Regardless of where the device may be used, some embodiments of the device include spikes (also referred to herein as wedge-shaped dissectors, or serrated elements) that can be connected together on a supporting square bolt and an expandable mechanism to increase and decrease the diameter of the spike feature (such as a balloon). The teeth portion and the balloon together create a toothed balloon element. The toothed balloon element is then attached to the base catheter-like device.

[0203] In some embodiments, such as for example Fig.14As shown in FIG. 1 , which is a close-up detail view of an embodiment of a wedge-shaped dissector 200 on an associated strip 300, the wedge-shaped dissector 200 may include a strip-facing bottom surface 202 (which may also be referred to herein as a bonding surface). The strip-facing bottom surface 202 of the wedge-shaped dissector 200 may be defined by the outwardly protruding base of the wedge 200 and is 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 strip-like structure. In some embodiments, this strip-facing bottom surface 202 has a relatively narrow width made of a hard material capable of holding a sharp edge. In some embodiments, the preferred material is martensitic stainless steel, having a hardness as low as 48 and as high as 70, but more typically 52 to 64, on the Rockwell C scale (HRC), although other materials including polymers or copolymers may also be used, including but not limited to polyolefins, fluoropolymers including fluorinated ethylene (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. The strips and wedge dissectors may have a hardness of 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, or any range of the above values ​​on the Rockwell C scale (HRC). In some embodiments, the width of the strip (circumferential direction) is about or no more than about .004 inches, .005 inches, or .006 inches. In some cases, the width can be between about .006 inches and about .020 inches or between about .004 inches and about .030 inches. In some embodiments, the strip 300 typically extends longitudinally the length of the edge of the working airbag, but can 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 can be between about .004 inches and about .010 inches, or in some embodiments, between about .002 inches and about .020 inches.

[0204] Still reference Fig.14, the wedge-shaped dissector 200 may also include a radially outward surface 204 (which may be referred to herein as a non-binding surface) that defines a top surface of the wedge-shaped dissector 200 extending from a first (e.g., proximal) edge 206 to a second (e.g., distal) edge 208 and 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 outward surface extends at an angle to the side surface / side surface axis between the side surfaces that are straight, curved, or other geometric shapes 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 surface facing the strip or the border 202 of the wedge-shaped dissector 200, as well as the side surfaces (e.g., 304) and the lower surface 303.

[0205] Fig.15 is a schematic diagram illustrating several possible non-limiting embodiments of a wedge-shaped dissector. In some embodiments, the radially outward surface L U (For example, in Fig.14 The length of the radially outward surface 204 between the first edge 206 and the second edge 208 is greater than the length of the surface L facing the strip. B ( Fig.14 The total length of the strip-facing surface 202 in the radial direction is less than about 30%, 20%, or 10%. In some embodiments, the length L of the radially outward surface U can be greater than the length L of the surface facing the strip B Smaller by about 50% to about 20% and sometimes with respect to the length L of the surface facing the strip B The width W of the radially outward surface U In some cases equal to or less than the width W of the surface facing the stripe B, , typically at the width W of the surface facing the strip B The width W of the surface facing the stripe is between about 10%, 20%, 30%, 40% or 50% or less than the width W of the surface facing the stripe. B 10%, 20%, 30%, 40% or 50% of the width W of the surface facing the stripe B Between about 20% and about 50%, sometimes the width W of the surface facing the strip B The radially outward surface width W is about or up to about 50%, 60%, 70%, 75% or 80%. U In some cases, it is equal to or less than 0.01 inches. The radially outward surface width W UIn some cases, the radially outward surface width W is equal to or between 0.005 inches and 0.002 inches, or 0.002 inches and 0.001 inches, or 0.0012 inches and 0.0002 inches. U In some cases, the radially outward surface area (L U ×W U ) can be compared to the surface area facing the strip (L B ×W B ) is about 30% to about 10% smaller. Thus, in some embodiments, there is an angle θ equal to or less than about 90 degrees, which defines the width W from the surface facing the strip. B to the width W on the surface facing the strip B The width W of the radially outward surface of at least one of the edges U Although in some embodiments, the width W of the radially outward surface U is constant from edge to edge, but in some embodiments the width W of the radially outward surface U The length L of the radially outward surface U The width of the radially outward surface segment varies, as described elsewhere herein, such as decreasing from a first lateral edge to a point or segment between the first and second lateral edges of the radially outward surface segment, and then increasing from a point or segment between the proximal and distal edges to the distal edge. In some embodiments, a relatively central segment between the proximal and distal edges has a constant width, while lateral segments surrounding the relatively central segment have a variable, such as a tapered, width.

[0206] Although the radially outward width W U It can be changed to a point from the base width W facing the stripe to the bottom surface 202 facing the stripe. B The radially outward width W of the radially outward 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 one inclined angle, such as two, three or more oblique angles (for example, a first angle is at a first segment of its height, a second angle is less than or greater than the first angle is at a second segment of its height, and in some cases, a third angle is less than or greater than the first angle and less than or greater than the second angle is at a third segment of its height). Fig. 22C An end view of a wedge-shaped dissector is shown, and Fig.22D Illustrated in its isometric view, the wedge-shaped dissector has multiple different slopes and associated angles from the bottom surface facing the strap to the radially outward surface, 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 not as steep as the second slope S2 rising upward after the transition point). Fig.22E and Fig.22F The diagram is similar to 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).

[0207] 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 to an edge using methods other than a stainless steel scroll due to manufacturing limitations. For example, when chemical etching is used to form a width W from the surface facing the strip, the width W B Width W to radial outward U In the case of a step, the shape of the sidewall may not have a single slope. The sidewall may tend to be concave, with one or more series of concave etched regions extending from the surface facing the stripe by a width W. B Transition to radially outward width W U .

[0208] In some embodiments, the radially outward edge or surface (eg Fig.14The shape of the radially outward surface 204) can be the same as the height from one edge 206 to the other edge 208 of the radially outward length or width. In some embodiments, the height along the radially outward surface 204 can vary from one edge 206 to the other edge 208. When the radially outward edge or surface 204 varies, typically, the radially outward edge has a series of raised features, referred to herein as wedge-shaped dissectors, spikes, or serrated elements 200. In some embodiments, the midpoint of these raised features along the radially outward length 204 between the edges 206, 208 is the highest point of the radially outward surface. However, in some embodiments, the highest point is offset from the midpoint, and there may be multiple highest points scattered through lower points relative to the bonding / bottom surface 202. In some embodiments, the maximum height change between the edges 206, 208 of the radially outward surface 204 of the wedge dissector 200 and the radially outward surface 302 of the base strip 300 between the wedge dissector 200 can be less than about 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10% or less than the total height of the wedge dissector 200.

[0209] In some embodiments, the base strip 300 has a rough or textured lower surface to aid in adhesion to the outer surface of the underlying airbag. The base strip can have any desired geometric shape, such as a square, rectangular, or in some embodiments, a trapezoidal shape, with a bottom surface having a greater width, such as about or at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more of the top surface. In some embodiments, about 1 / 3 of the top surface of the strip 300 and about 1 / 3 of the top surface of the strip 300 are substantially parallel to the bottom surface of the strip 300. 1 / 2 is covered by a wedge-shaped dissector (also called a micro-wedge) 200, while about 1 There is no wedge-shaped dissector 200 on the top surface between 1 / 2 and 2 / 3.

[0210] refer to Fig.21 In some embodiments, the radially outward surface can be viewed from the top as a line extending from one edge of the radially outward length to another edge of the radially outward length (e.g., assuming that 210A is the radially outward surface of the device, W U is a point). This would resemble a polished or "razor sharpened" edge with no apparent width. In other embodiments, the top view would appear as a slightly dull, unpolished surface that resembles a rectangle (e.g., if 210B or 210C were the top of the device, and it was assumed that everything above those lines was cut away), where the width W of the radially outward surface is U Smaller than the width W of the bottom surface facing the strip B, but is directly related to one or more slopes between the width edge and the height from the bottom surface facing the strip to the radially outward surface. In some embodiments, the top or radially outward surface can be a line, a flat rectangle, a circle, or a shaped surface (which may appear rectangular or square in a 2-dimensional perspective), or take the shape of a pyramid, wedge, trapezoid, or other polygon.

[0211] In some embodiments, the unpolished width can be about, for example, about 1 nm, 5 nm, 10 nm, 50 nm, 100 nm, 500 nm, 1 μm, 2 μm, 5 μm, 7 μm, 10 μm, 15 μm, 20 μm, 25 μm, and 30 μm, or a combination thereof, measured from a radially outward edge or surface. In some embodiments, an unpolished radially outward surface of a wedge-shaped dissector can be advantageous because, for example, in situations where teeth, indentations, and / or microperforations are created in the wedge-shaped dissector target, a slightly blunt / relatively less sharp edge is desirable, rather than cutting through the entire lumen wall. In some embodiments, the entire radially outward wedge-shaped dissector surface has an unpolished width.

[0212] The shape of the wedge dissector can take many forms, including Figures 16 to 22 Other non-limiting embodiments shown. For example, Fig.16 The wedge-shaped dissector 200 is illustrated protruding from a base strip 300 having a ground / sharp radially outward surface 204 from edge 206 to edge 208 . Figure 17 to Figure 18 The illustrated wedge-shaped dissector has chamfered sections 780 of 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 slope, or along a straight line as shown below. Fig.19 The curve shown in Fig.17 As shown, the wedge-shaped dissector includes lateral segments 780 of a radially outward surface that increase in height but decrease in width from a first edge to a central mid-portion 781 of length having minimal / negligible width, which then increases in width and decreases in width from the midpoint to a second edge. Fig.18 The diagram is similar to Fig.17 The wedge-shaped dissector of FIG. 782 differs in that the middle portion is a single polished apex.

[0213] Fig.19 A wedge-shaped dissector is illustrated having a radially outward surface 785 that increases in height from an edge along a first curved length, but decreases in width from the first edge to a center region (e.g., midpoint 786), and then decreases in height and increases in width along a second curved length to another edge.

[0214] Figure 20 to Figure 22 An embodiment of a wedge-shaped dissector is illustrated having an unground, radially outward surface, but does not include a sharp ground point or edge (eg, having a width greater than the width of the ground edge). Fig. 20 An embodiment of a wedge-shaped dissector is shown, which is somewhat similar to Fig.17 A wedge-shaped dissector, except that the radially outward surface is completely unground along its length. Fig.21 An embodiment of a wedge-shaped dissector is shown, which is somewhat similar to Fig.18 A wedge-shaped dissector, except that the radially outward surface is completely unground along its length. Fig. 22 An embodiment of a wedge-shaped dissector is shown, which is somewhat similar to Fig.19 A wedge-shaped dissector, except that the radially outward surface is completely unground along its length.

[0215] Figures 17 to 22 A commonality of the embodiments of the present invention is that the width of the radially outward surfaces is greater (wider) at the lateral edges and narrower / smaller at a more central location at a center point or longer central portion. The height of the radially outward surface from one edge to the other can be arcuate or variable, such as having 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) portion of the radially outward surface can be along the longitudinal axis of the strip, which can be aligned or not aligned with the longitudinal axis of the airbag.

[0216] In other embodiments, the narrower point or section need not be symmetrical about the midpoint of the length of the radially outward surface, but in some cases may be asymmetrical / offset from the midpoint of that length.

[0217] Regardless of the geometry of the wedge-shaped dissector, some embodiments are characterized by including an end 202 or base (e.g., the spikes have a base that "attaches" to the balloon or some shaped element, whether it is a peg (or strap)) having a combined length and width and a radially outward surface 204 at the end or tip having a length and width. In some embodiments, the width of the radially outward end is about or less than about 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20% or less of the width of the bottom end facing the strap, or a range comprising any two of the foregoing values. The width of the wedge-shaped dissector (and peg / strap) facing the bottom end of the strap can be fixed / constant, or alternatively variable in some embodiments.

[0218] 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 bottom 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 approximately or less than approximately 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 approximately 0.005 inches and approximately 0.025 inches, or between approximately 0.01 inches and approximately 0.025 inches, or between approximately 0.005 inches and approximately 0.015 inches.

[0219] In certain embodiments, the length of the base of the wedge-shaped dissector (or miniature wedge) 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 above values. In certain 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 and about 5mm, or between about 1.5mm and 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, a wedge-shaped dissector having a base length of the wedge facing the strip of about 2.5 mm long may have a space of about 5 mm between them, or a space of about 25 mm. In some embodiments, a group of wedge-shaped dissectors may be spaced apart at a first smaller ratio, such as about 1 to 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 to 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 space 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 be the same or different in size, shape, and / or spacing from the first group.

[0220] In some embodiments, the position of the radially outward surface relative to the bottom surface facing the stripe is not always centered or symmetrical. In other words, the midpoint of the radially outward surface can be offset from the midpoint of the bottom surface facing the stripe. FIG. 23A to FIG. 23B and Fig.24 An asymmetric radially outward surface is illustrated as an alternative embodiment of the spike. The asymmetric radially outward surface can be off-center relative to the radially outward 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 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 shown. Fig.23A In addition, the edges of the radially outward surfaces at one or both width ends and / or at one or both length ends may be chamfered or beveled or have a radius. In some variations, the radially outward surface location is limited to an area protruding upward on the bottom surface facing the strip. The radially outward 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. FIG. 23C to FIG. 23D An embodiment is illustrated in which the total or substantially all volume of the wedge-shaped dissector projects / appears over less than the entire width (or surface area) of the base of the strip, e.g., equal to or less than about 70%, 60%, 50%, 40% or 30% of the width or surface area of ​​the strip, and the wedge-shaped dissector is thus offset asymmetrically forwardly or rearwardly from the longitudinal axis of the strip.

[0221] Fig.24 The illustrated embodiment illustrates how the radially outward surface 204 may have a varying height (increasing from a first height 24H1 at a first edge 206 to a second height 24H2 at a second edge 208) from the strip-facing bottom surface 202, and may include an edge profile that is rounded with a radius of curvature of the radially outward length edges 206, 208. Here, a wider radius of curvature is shown at one edge 206, which has a short height 24H1 measured from the strip-facing bottom surface 202, while the opposite edge 208 has a narrower radius of curvature and has a longer height 24H2 measured from the strip-facing bottom surface 202.

[0222] 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 outward 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 where the wedge-shaped dissector has an unpolished, radially outward surface.

[0223] Additionally, without being limited by theory, certain shapes may provide more effective penetration of tissue. For example, a wedge-shaped dissector including chamfered or rounded radially outward edges may potentially enter a vessel wall with less force (requiring less pressure to penetrate the tissue) while still maintaining effective microchannels 5100 to weaken and dilate the tissue with minimal vessel damage and cell injury.

[0224] In addition, although there are existing solutions for providing blades or sharp edges or scoring wires on balloons during angioplasty or other surgeries associated with balloon dilation for cutting or scoring plaques, these existing methods are considered to have problems or disadvantages, which can be eliminated or avoided by the systems and methods disclosed herein. Cutting or scoring the cavity wall (e.g., plaque) during angioplasty can be performed under high pressure, which can cause great damage to the blood vessel. While the angioplasty balloon is dilated to expand the plaque, the cutting blade, edge, or scoring wire can be forced into the wall of the blood vessel. In this process, the cutting blade, edge, or scoring wire can be forced into the vessel wall at an oblique angle and can dig out the plaque, which potentially increases the tendency to dissect and the potential need for implants such as stents. In contrast, in some embodiments, the use of a wedge-shaped dissector can be expanded into the plaque at low pressure to form precise microperforations, teeth, and / or indentations in a radially outward direction, thereby forming precise indentations, cleavage lines, or cleavage planes in the plaque or in other locations of the cavity wall or other targets. The radially outward surface of the wedge-shaped dissector can be pushed into plaque or other luminal surfaces in a small surface area, making it less likely to dig out the plaque or luminal surface.

[0225] In some embodiments, the wedge-shaped dissector can be designed to provide a series of directed punctures or teeth in the diseased vessel wall (but in some cases not completely through), which in some cases can produce predictable and controlled luminal dilation along the tooth line with minimal damage and without being cut by a blade with a ground / sharp edge. These perforations can be used as passages, such as microchannels for drugs or other agents, such as Fig.23E As shown. Drugs or other agents can be delivered by using a drug-coated balloon that is incorporated into the device disclosed herein or on a separate device that is used after use of the device disclosed herein. In some embodiments, the wedge-shaped dissector can be detached 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 segment of the vessel wall, which can achieve more effective and gentler dilation of the vessel lumen 5110, as shown. Fig.23F and Figure 23F.1As shown. Examples of gradual expansion and sawtooth stages can be seen at 5110, 5130, 5140, 5150. The balloon can be inflated, and as the air pressure in the balloon increases, the following series of events may occur: the balloon deploys in the artery and the strip emerges from its resting place within the folded portion; the tip of the wedge-shaped dissector on the strip (e.g., the radially outward surface) contacts the vessel wall; the relatively narrow profile of the tip penetrates the vessel wall, creating a nucleation point for cracking events; these cracks rapidly generate cracks along the inner surface of the lumen; due to the proximity and alignment of the cracks, the cracks connect to form long cracks along the inner surface of the lumen, 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 penetration depth of the crack is typically similar to the depth of the media tissue.

[0226] In order to reduce the potential rigidity of the square bolt or base strip, it is contemplated in some embodiments to add a series of releases to the square bolt, as shown in Figures 25 and (to) Fig.29 As shown. The release piece can be created in many different ways, the intention being to remove some material and provide a more flexible square bolt for the wedge where the base facing the strap is located. The release piece can be formed at the base of the square bolt opposite the bottom surface of the wedge dissector facing the strap, at the top of the square bolt directly adjacent to the bottom surface of the wedge dissector facing the strap, or at both locations, i.e., the top and bottom. The release piece can also be formed on the side of the square bolt, or an aperture can be added to the square bolt in the base facing the strap through other areas of the square bolt. Any combination of the top, bottom, sides, or apertures can be added to the square bolt to provide a release piece.

[0227] In some embodiments, as shown in FIG. 25 to Fig. 20 As shown, the strip 300 may have a release hole or slit located at the top, bottom, center, or off-center, which may be circular, rectangular, linear, triangular, or oval, or a combination of the above (see FIGS. 25 to 33 ). Fig.29 ). These strips provide the basic structure of the support base and are intended to be flexible and follow the movement of the airbag, thus allowing the wedge-shaped elements to be properly oriented.

[0228] As shown in Figure 25 to Fig.29 The release hole schematic shown can be specifically designed to provide migration pathways for balloon-based pharmacological agents; in addition, the release holes provide strain relief on the surface to enhance the delivery capabilities of the device in tortuous anatomical structures. FIG. 25A to FIG. 25C An embodiment of a wedge-shaped dissector is illustrated having a release 502 on a lower surface 500 of the strap 300 opposite the engagement surface of the wedge-shaped dissector 200 . Fig.25A One embodiment is illustrated in which the release members 502 are regularly spaced about the length of the engagement surface of each wedge-shaped dissector 200 . Fig.25BOne embodiment is illustrated in which the release members 502 are regularly spaced apart 50% or less of the length of the engagement surface of each wedge-shaped dissector 200 . Fig.25C One embodiment is illustrated in which each release 502 is spaced 50% or less of the length of the engagement surface of each wedge-shaped dissector 200, but the releases 502 are grouped only under the wedge-shaped dissectors and not under the strap portions between the wedge-shaped dissectors. In other embodiments, the releases 502 are grouped only under the strap portions between the wedge-shaped dissectors and not under the strap portions directly below the wedge-shaped dissectors.

[0229] FIG. 25D to FIG. 25E An embodiment is illustrated in which the release 502 is present on the top (engaging or upward facing surface 302) of the strip between the wedge-shaped dissectors. Fig.25D and Fig.25E In the embodiment, the release member forms a depression in the upwardly facing surface 302 of the strip between the wedge-shaped dissectors, having a Fig.25D The generally curved base shown, and Fig.25E Relatively square or rectangular bases are shown, with or without rounded edges. Fig.25F It is combined in Fig.25C and Fig.25D 502. Other combinations and arrangements are possible, depending on the desired clinical results. Figure 25G and Fig.25H In other illustrated embodiments, the release member 502 is located on the front surface 304 and / or the rear surface of the strap 300 . Figure 25G A generally pyramid-shaped release member 502 is shown, and Fig.25H A generally arcuate release 502 is illustrated. These releases can be axially spaced from the wedge-shaped dissector as shown, and / or axially aligned with the wedge-shaped dissector in other embodiments. Fig.25I and Fig.25J In the illustrated embodiment, the release member 502 is vertical ( Fig.25I ) or horizontal ( Fig.25J ) oriented through-channel, which may be axially spaced apart from the wedge-shaped dissector as shown, or in other configurations. In some embodiments, the release member may be oriented at an oblique angle relative to the longitudinal axis of the strip. Figure 25K One embodiment is illustrated in which the release 502 takes the form of a slot on the front and / or rear surfaces, on a combined bottom surface, and / or at other locations. Figure 25LBridges or tabs are illustrated under the functional part or wedge dissector 200. These bridges or tabs connect the functional part 200 to the bulk material. In the case where the functional part is removed from the bulk material using a technique in which the radially outward surface 204 of the wedge dissector 200 is not bonded, the functional part typically requires a series of bridges leading to the bulk material. The bridge features can be made using a variety of manufacturing processes. In some processes, the bridges are made by removing the base material with a laser or other energy point line that precisely removes the predetermined material, leaving the bridges on the remaining working part. In other processes, the bridges can be made using other forms of material removal, including chemical etching. Alternative bridges made using chemical etching are shown in FIG. Figures 25N to 25Q Medium picture. Figures 25N to 25Q The bridges shown may include a partial etching through the base material, as indicated by the shaded area at the base of the strip (e.g., the lowermost surface configured to attach to the outer surface of the airbag). Regardless of the bridge design, all bridge designs are snap-break, where the break of the bridge is always above the base of the strip (e.g., the lowermost surface configured to attach to the outer surface of the airbag).

[0230] In some embodiments, the balloon can be pleated and curled into a very narrow profile, allowing the device to be delivered through a narrow diameter introducer sheath. Once the balloon has been deployed and deflated, the balloon profile after inflation may be larger than its original pleated and curled diameter. This new profile may have bands outside the balloon profile, thus potentially scratching the arterial wall or snagging on the opening of an accessory device (e.g., an introducer sheath). According to some embodiments, the following elements, generally described as ramps, can address this potential problem.

[0231] Fig.26 Schematically illustrates an embodiment of a ramp 680 of adhesive or other material placed at (e.g., above) one (as shown) or both lateral ends 333 of some or all of the strips 300. When the strips are embedded in the airbag, in some cases, the ramp can be an additional material in the airbag mold, or a separate adhesive, a bonded additional material, or a material from a laminated structure placed at other locations (e.g., the distal and proximal ends of the strips). The ramp 680 can provide an effective flexible interface between the edge of the flexible airbag (not shown) and the semi-rigid strip 300 because the ramp 680 can be made of a relatively softer material (e.g., adhesive, a stack of material layers) than the strips 300. In some embodiments, the ramp 680 can be designed to slope gently from the airbag surface (not shown) to the strip edge. In some embodiments, the adhesive ramp 680 can advantageously both retain the strip and provide protection to prevent the strip 300 from undesirable interaction with auxiliary devices during surgery.

[0232] In some embodiments, the lateral edges of the strips may include glued ramps 680 to hold the strips 300 and provide protection during surgery to prevent the strips from interacting with auxiliary devices. The ramps may be created using UV glue, using repeated deposition and curing steps in a series of flat and stacked layers until the ramps are created, such as Fig.26A As shown. Alternatively, the ramp can be preformed into the desired shape and then bonded to the balloon surface using cyanoacrylate, UV glue, or other materials or methods to provide a chemical, mechanical, or electromagnetic bond between the preformed ramp and the balloon surface. It should be noted that in this embodiment, the top of the adhesive layer is close to the top of the strip protrusion (wedge-shaped dissector tip) 681. In some embodiments, the ramp can extend laterally beyond the rear edge of the strip by a distance between about 0.008 inches and about 0.040, between about 0.008 inches and about 0.012 inches, between about 0.010 inches and about 0.040 inches, between about 0.020 inches and about 0.030 inches, or other dimensions, depending on the desired results.

[0233] In some embodiments, a feature that can be incorporated into the balloon element is a conical ramp. The conical ramp feature can be achieved in a variety of ways. In one embodiment, the conical ramp is made by taking the conical configuration used for a larger balloon, for example taking the cone used for a 6 mm balloon or a 5.5 mm balloon and incorporating it using known methods to attach to a 5 mm balloon. One such embodiment is Fig. 27 970. The outer diameter of the cone 970 can be larger than the outer diameter of the balloon 960 in some cases, such as 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 cone 970 will be located outside the balloon 960, thereby creating a lip 972 where the balloon body intersects. The lip 972 can help reduce the possibility of the edge of the metal strap being caught or lifted when the balloon is deflated and retracted through the introducer catheter.

[0234] In some embodiments, Fig.28 As shown, a series of rails 980 are included along the cone 970 to serve as a support or reinforcement structure and to help collapse the balloon 960 as the balloon enters the introducer catheter (not shown). In some embodiments, the rails 980 are aligned / aligned with the longitudinal axis of the strap, further enhancing the function of pushing the strap toward the middle of the balloon as the cone is pulled through the introducer.

[0235] In some embodiments, the present invention also discloses an airbag that can have depressions in the outer surface of the airbag for attaching a strap. 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 in the depressions, such as completely in the depressions. The depth of the depressions can be sized to limit the possibility that the strap may get stuck on the distal opening of the introducer during retraction of the airbag.

[0236] 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.23E As shown, for example, one or more drugs, nanoparticles and / or stem cells are transported from the balloon surface to the surface of the diseased lumen 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 part. 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 part. 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-inflammatory drugs, anti-tumor drugs, anti-mitotic drugs, anti-platelet drugs, anticoagulants, anti-fibrin drugs, antithrombin, anti-cell growth inhibitors, antibiotic drugs, anti-enzymes, anti-metabolites, angiogenic drugs, cytoprotective drugs, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists and / or cardioprotective drugs.

[0237] 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-tetrazolylrapamycin (a structural derivative of rapamycin), 40-O-tetrazolylrapamycin, 40-epi-(N-1-tetrazolyl)-rapamycin, and pirfenidone.

[0238] Examples of anti-inflammatory drugs include both steroidal and nonsteroidal (NSAID) anti-inflammatory agents, such as, but not limited to, clobetasol, alclofenac, beloclimethasone 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, cliprofen, clobetasol propionate, clobetasone butyrate, clopirac, clothiocarb propionate, cortisone acetate, cortodoxone, deflazacort, desonide, dexamethasone, dexamethasone di propionate, dexamethasone acetate, dexamethasone phosphate, limusone, cortisone, cortisone acetate, hydrocortisone, prednisone, prednisone acetate, betamethasone, betamethasone acetate, diclofenac potassium, diclofenac sodium, diflorasone difluoroacetate, diflunisal, difluprednate, difluphenazine, dimethyl sulfoxide, hydroxycinonide, medizone, enmotumomab, phenammonium sodium, etodolac, etofenac, felbinac, fenamox, fenbufen, fenclorac, fenclorac, fendosal, phenoxadione, diflubenzyl, flurazepam, flurazepam, flufenamic acid, flurazepam, flunitrin acetate, flunixin, flunixin meglumine, flucortin Ester, 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 methyl, mefenamic acid, mesalazine, mesilazine, methylprednisolone sulfoheptate, morphine, nabumetone, naproxen, naproxen sodium, naproxen, nimazo, olsalazine sodium, ocuproin, opanosin, oxaprozin, hydroxybutyrate Pyrrofen, paraniline hydrochloride, piroxicam cinnamate, piroxicam ethanolamine, piroprofen, prenazad, prifedipine, produracil, proquinezone, proxazole, proxazole citrate, rimexolone, clomazalide, salsaquine, salacil, sanacidin, salsalate, hemocyanin chloride, dexamethasone, tamostat, tamostat, tenifite, todap sodium, tenoxicam, tacoracetam, benzylisoquinone, tetrahydroindole, tiopine, tiocortisone pivalate, tolmetin sodium, triclosan, trifluanidate, azidoindolic acid, aspirin (acetylsalicylic acid), salicylic acid, corticosteroids, glucocorticoids, tacrolimus and pimecrolimus.

[0239] Examples of antineoplastic and antimitotic drugs include, but are not limited to, paclitaxel, docetaxel, methotrexate, azathioprine, vincristine, vinblastine, fluorouracil, doxorubicin hydrochloride, and mitomycin.

[0240] Examples of antiplatelet drugs, anticoagulants, 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).

[0241] 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.

[0242] Examples of ACE inhibitors include, but are not limited to, quinapril, perindopril, ramipril, captopril, benazepril, trandolapril, fosinopril, lisinopril, moexipril, and enalapril.

[0243] Examples of angiotensin II receptor antagonists include, but are not limited to, irbesartan and losartan.

[0244] 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.

[0245] In other embodiments, combinations of any two, three, or other numbers of the foregoing drugs or other therapeutic agents may be used, depending on the desired clinical outcome.

[0246] 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 with a syringe and a precision pen tip with a high degree of control. 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.

[0247] Fig.29 An embodiment of a strap 500 is shown with a release 502 on the lower surface of the strap 300 opposite the engagement surface of the wedge-shaped dissector 200, and additional relatively large apertures 503 between the wedge-shaped dissectors 200, which can be configured to facilitate engagement of the strap 300 to the underlying balloon, as disclosed, for example, in PCT Publication No. WO 2016 / 073490, published on May 12, 2016, which is incorporated herein by reference in its entirety. The apertures 503 can be relatively oval, circular, or any other shape, depending on the desired clinical outcome.

[0248] 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 length of the defined working airbag, in some embodiments, the length of the strips is shorter than the length of the defined working airbag to allow the airbag to shrink, which is typically observed when the airbag reaches the rated burst pressure. The length of each strip may be no shorter than the total working airbag length by no more than about 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2% or 1%, between about 1% and about 7%, or between about 1% and about 5%, or between about 1% and about 4% in some cases. In some embodiments, the working airbag length does not include the length of the cone.

[0249] In some embodiments, a portion of the strap, such as 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.

[0250] Spikes (e.g., serrated elements or wedge-shaped dissectors) can be made using many different manufacturing methods and have a wide range of shapes. With respect to manufacturing processes, these devices can be made using one or more additive or subtractive processes. Additive processes such as high energy vapor deposition, such as laser chemical vapor deposition, self-assembly techniques, polymer / metal 3D printing, selective laser sintering, powder printers or other stereolithography are some such options, but other additive processes may also 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 may also be used.

[0251] In some embodiments, a manufacturing method includes using a martensitic stainless steel spool, such as a 300 or 400 series stainless steel having a hardness as low as 48 and as high as 70 on the Rockwell C scale (HRC), but more typically about 52 to about 64, or a wider Mohs hardness range between 4 and 7, although other materials may 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 spool strip having a thickness between about 0.004 inches and about 0.020 inches or a thickness between about 0.005 inches and about 0.010 inches, and can be as wide as the processing system can handle. Sometimes the width is greater than or equal to 36 inches. The ground or unground edge can be a single ground angle or have two or more ground angles (e.g. Figures 15 to 22 In some embodiments, when the angle of the polished edge is measured from Fig.15 When the slope of the bonding end to the non-bonding end height shown in , the angle of the grinding edge can be, for example, greater than about 75 degrees. However, when more than one grinding angle is used, then the tip angle can be less than, for example, about 75 degrees. In some embodiments, when the grinding edge is measured as the width W of the surface facing the strip, B The radial width W U When the unground edge moves toward the ground edge in a series of bevel angles, the unground edge has an angle of about 70 degrees, at least about 75 degrees, 80 degrees, 85 degrees, or more. In addition to the ground edge, regardless of the number of ground angles, in some embodiments, a separate additional edge is created at the tip of the non-bonding edge of the strips. When added, the height of the additional tip edge from the ground edge to the non-bonding edge is generally very short and typically has an angle much greater than the angle of the entire ground edge. Regardless of the number of ground angles used, the width W of the non-bonding tip is generally about 100 degrees, ... ucan be described as the radius of the tip. The width Wu of the non-binding tip is the penetration edge into the diseased tissue, and 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 required for penetration. When the tip is configured to penetrate a harder surface (such as a calcium bed), in some cases, using a more obtuse angle or removing the non-binding tip at a greater distance from the non-binding surface can produce a wider tip edge (see Fig.15 , Wu). Without being limited by theory, such a wider edge distributes the load over a larger surface area, creating a more effective resistance to tip deformation when the tip is pressed into a rigid tissue surface. Once the spool is sharpened, it is punched into a blade of the desired 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 blunted and hardened to, for example, above about HRC 45, but more typically in the range of about HRC 58 to about HRC 62. The hardened blade can then be laser cut, stamped, EDM (electric discharge machining) or other precision metal forming techniques to have spikes, serrated elements or wedge dissectors. In some cases, the toothed elements can be machined into the spool and then hardened and blunted. In some embodiments of the strip where the tip is not a sharpened ground edge, the tip of the blade created during the spool sharpening step is removed during the wedge dissector and strip manufacturing steps. In some cases, Fig.81 The material removal (711) shown is designed to start from, for example, about 0.0001 inches to about 0.003 inches below the ground edge, or to remove about .0001 inches to about .0005 inches from the ground edge (710) to produce a material removal of, for example, about 0.0001 inches to about 0.003 inches below the ground edge. Fig.15 Flat top (Wu) shown. The thinnest edge remaining on the previously sanded edge side (now flat top in some cases) is the non-bonding surface that will become the strip.

[0252] In some 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 typically coated with a primer 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 typically 3 or 4 strips are aligned with a strip alignment mechanism or a fixture, and are glued in place with a predetermined orientation with medical grade cyanoacrylate. The number and periodicity of the strips can be variable, such as 1 to 8, and are typically associated with the same number of balloon folds, but can be less than the number of folds, and the periodicity can be non-sequential. Once the strip is bonded to the balloon surface, a single or a series of multiple top coatings or retention layers are placed above the metal interrupted scoring element or wedge-shaped dissector to keep the strip and protect the balloon from the thin tip damage of the scoring element. In some 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 primer and only 1 top coat. The number of primers and top coats can vary between 0 and 4 for either primer or top coat. 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 delivery and retraction capabilities of the airbag. When incorporated, an external slip coating can increase the functionality of the airbag by reducing the force of inserting and retracting the device.

[0253] Fig. 30AThe schematic cross-sectional view of the strip and wedge-shaped dissector that are operably attached to the outer surface of the airbag according to some embodiments of the present invention is illustrated. In certain embodiments, a typically thin (e.g., 0.0001 inch to 0.0009 inch) or polymer layer (e.g., for limiting the increase of the airbag diameter profile) of about or less than about 0.001 inch can be used as a primer (layer 270A) covering the outer surface of the airbag. This primer 270A provides an interfacial bonding layer with the airbag surface for the interrupted scoring element. This 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. This primer 270A can be configured to and potentially can reduce the interfacial strain between the outer surface of the airbag and the bonding surface of the metal scoring element. The strain between the 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 undercoat layer 270A is a polymer, such as urethane or polyurethane, this layer can be various other materials. In some embodiments, the coating can include silicone 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 (NPG). The deposition of this layer can be completed by immersing the airbag or airbag matrix in a polymer bath in two directions or one direction at a controlled rate under controlled insertion and extraction conditions. Alternatively, various known processes can be used to spray or deposit each layer, including using known and practiced self-assembly techniques, typically using surface ion charging, and coating a monolayer by self-assembly.

[0254] Still refer to Fig. 30A, the bonding layer 270E between the metal scoring element 200 and the primer 270A can typically be as thin as 0.0002 inches to 0.001 inches, but more typically between 0.0006 inches and 0.001 inches, and in some embodiments can be as thick as 0.002 inches. In some embodiments, the bonding layer is designed to be thin enough to limit the increase in the diameter profile of the airbag. The adhesive layer 270E can be cyanoacrylate, or it can be made of other bonding materials, such as UV curing glue, which provide chemical, mechanical or electromagnetic bonding between the primer 270A and the bonding surface of the metal scoring element. This layer 270E can be regarded as a functional layer connecting the bonding surface of the metal scoring element to the airbag, and sometimes it is the only layer between the bonding surface of the metal scoring element and the outer surface of the airbag. This 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 scoring element and the primer. In some embodiments, the adhesive material dries quickly, allowing successive layers to be applied on top of the adhesive layer with minimal curing delay. In other manufacturing methods, a higher viscosity adhesive layer can be placed at both ends of the bottom of the strip or periodically located between the bonding surface of the metal scoring element and the bottom 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 interrupted scoring element, and then a wicking adhesive can be used on some or all of the unbonded portions. In some embodiments, there can be one (e.g., a single layer), two or more (e.g., a single layer) on the bottom layer 270A and the scoring element. Fig. 27In some embodiments, the polymer retaining layer can be similar to the above-mentioned bottom layer with sufficient characteristics and have the same size, so that the bottom layer 270A and retaining layers 270B and 270C can produce effective combination between these layers. In some cases, the retaining layer can be designed to provide a thickness similar to the bottom layer, and other times the retaining layer may be useful than the slightly thick bottom layer. In some cases, thicker bottom layer and / or retaining layer can provide the larger puncture resistance and durability of improvement of the air bag, prevent from the scoring element of metal interruption, from any sharp edge of the implant staying in the body or for example from the potential puncture of the sharp edge in the diseased blood vessel of severe calcification. In some embodiments, there can also be an external sliding layer 270D above the retaining layer on the air bag and / or the scoring element. There are multiple hydrophilic coatings on the market that can reduce friction, and provide the navigation of the enlarged air bag through tortuous and narrow anatomical structures. In some embodiments, the balloon surface can be completely wrapped in a 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 typically be exposed during delivery is coated with the hydrophilic coating. In some embodiments, the hydrophilic coating is typically a few microns thick and can be as thin as about 10 angstroms.

[0255] In some embodiments, the adhesive may be applied separately to the balloon and the strip, and the two components then bonded together.A template may be used to ensure proper positioning of the scoring element along the balloon surface.

[0256] The polymer retention layer 270B, 270C can typically be similar to the bottom layer with sufficient properties so that the bottom layer and the retention layer produce an effective bond between these layers. Sometimes the retention layer can be designed to provide a thickness similar to the bottom layer, while at other times it may be useful for the retention layer to be slightly thicker than the bottom layer, for example, in some cases the thickness increase is about or does not exceed about 20%, 15%, 10% or 5%. The thicker bottom layer and / or retention layer provides greater puncture resistance and improved durability of the balloon, preventing potential puncture from scoring elements of metal interruptions, from any sharp edges of implants left in the body, or from sharp edges in severely calcified diseased blood vessels. In some embodiments with multiple retention layers 270B, 270C, these layers can be made of the same or different materials.

[0257] exist Fig. 30B In the embodiment of the present invention, the addition of surface functionalization is applied to the strips 200. Functionalization can be done in a large plasma chamber under vacuum conditions, where hundreds of strips 200 are placed in the plasma field. The deposited functionalization layer is typically very thin, on the order of hundreds of angstroms. Using surface enhancement or functionalization can produce an effective bonding surface.

[0258] The airbag can have Fig. 30A any characteristics. Fig. 30B A schematic cross-sectional view of a strip and a wedge-shaped dissector operably attached to the outer surface of an airbag according to some embodiments is illustrated. A polymer layer can be used as a primer (layer 270A) covering the outer surface of the airbag. A bonding layer 270E (e.g., glue) can be located between the strip 200 and the primer 270A. In certain embodiments, one (e.g., a single layer), two, three or more retaining layers 270B, 270C can be present on the bottom layer 270A and the strip 200. Retaining layer 270B can be a prefabricated coating bonding layer. Retaining layer 270C can be a prefabricated coating. In certain embodiments, an external sliding layer 270D can also be present above the retaining layer on the airbag and / or the strip 200. Fig. 30B The airbag in may include a plasma layer 280 .

[0259] Plasma cleaning can be beneficial to the bonding coefficient between the two surfaces. Although plasma cleaning is very effective for improving adhesion under certain conditions, in some embodiments, cleaning the surface is not enough. Using surface functionalization by coupling amino groups to the surface can provide additional benefits. In order to achieve effective functionalized surfaces for polymer adhesion to the metal strip surface 200, plasma technology can be used to apply pre-selected amino groups. The plasma process has three active plasma steps, that is, steps for intentional physical or chemical changes to the strip surface. The three active plasma steps are 1) cleaning, 2) activation and 3) functionalization. The plasma process is designed to clean the substrate of the strip 200 (step 1) and fill the stainless steel substrate of the strip 200 with side vinyl (steps 2 and 3), which will easily react with the UV cyanoacrylate adhesive used to bond the stainless steel strip to the bonding layer 270E, the pre-coating bonding layer 270B, the pre-coating 270C and / or the external sliding layer 270D. Functionalization adopts the coupling of acrylic functional organosilane. Functionalization, known as silanization, employs two steps, hydroxylation (step 2), which fills the base of the strip 200 with atomically thin (less than 50 angstroms) hydroxyl groups, followed by silanization (step 3), with a thickness ranging from 100 to 500 angstroms, in which the organosilane couples to the pendant hydroxyl groups via a condensation reaction. Low-power plasma initiates the reaction under conditions much milder than those achieved thermally or by catalysis. Although other techniques are known to be capable of depositing angstrom-thin layers, the use of plasma techniques has shown effective and repeatable results for the functionalization of stainless steel strips 200.

[0260] The strip 200 may include a surface treatment applied to the surface of the strip. The surface treatment may include a plasma treatment. The process may be completed in a chamber. The one or more strips 200 may be placed in a chamber under vacuum. The chamber may be placed in a plasma field. Plasma may be deposited on the entire surface of the strip 200. Plasma may be deposited on one or more surfaces of the strip 200. Plasma may be deposited as a functionalized layer. The outer surface of the strip 200 may include a thin plasma layer. The layer may be 100 angstroms, 200 angstroms, 300 angstroms, 400 angstroms, 500 angstroms, 600 angstroms, 700 angstroms, 800 angstroms, 900 angstroms, or any range of two or more of the above values. The plasma layer 280 may help with bonding to other layers. The plasma layer 280 may help with bonding between the strip 200 and the primer 270A. The plasma layer 280 may help with bonding between the strip 200 and the adhesive 270E. The plasma layer 280 may help with bonding between the strip 200 and the PFC bonding layer 270B. The plasma layer 280 may facilitate bonding between the strip 200 and the PFC 270C. The plasma layer 280 may be an enhanced bonding surface.

[0261] Plasma layer 280 can improve the bonding coefficient between two surfaces, such as the bonding coefficient between the surface of strip 200 and another layer. In some embodiments, strip 200 undergoes plasma cleaning. Plasma cleaning can improve the surface of strip 200 to improve bonding. In some embodiments, plasma cleaning is used in combination with surface functionalization. Surface functionalization can include coupling amino groups to the surface. Plasma layer 280 can include one or more amino groups. Amino groups can help adhesion between the metal surface of strip 200 and the additional polymer / adhesive layer. Amino groups can act as a bridge to improve adhesion between these different materials. Amino groups can act as a bridge between a metal layer and a non-metallic layer. The plasma process can apply amino groups. Amino groups can be pre-selected based on the layers to be bonded. Plasma layer 280 can include amino groups to help adhesion between layers.

[0262] The process may include one or more steps. These steps may be considered active plasma steps. The process may include physical changes to the surface of the strip 200. The process may include chemical changes to the surface of the strip 200. The process may include cleaning. The plasma process may be designed to clean the surface of the strip 200. The process may clean the entire outer surface of the strip 200. Cleaning may be a prerequisite for subsequent coating of the surface of the strip 200. Cleaning may be a surface treatment. Cleaning may remove impurities and / or contaminants from the surface of the strip 200.

[0263] The process may include activation. Plasma activation may improve the surface adhesion properties of the strip 200. The process may fill the surface of the strip 200 with amino acids. In some embodiments, the strip 200 is filled with side vinyls. The amino acids (e.g., side vinyls) are configured to react with adhesives. The amino acids (e.g., side vinyls) are configured to react with UV cyanoacrylate adhesives. The UV cyanoacrylate adhesive is applied to one or more layers to bond the strip 200 to these layers. The UV cyanoacrylate adhesive may be used to bond the strip 200 to the base coating 270A. The adhesive 270E may be a UV cyanoacrylate adhesive. The UV cyanoacrylate adhesive may be used to bond the strip 200 to the PFC 270C. The PFC bonding layer 270B may be a UV cyanoacrylate adhesive.

[0264] The process may include functionalization. Plasma functionalization may improve the surface adhesion properties of the strip 200. The process may couple an acrylic functional organosilane. This may be a coupling agent for a photocurable composite material. The process may include hydroxylation. Hydroxylation may fill the surface of the strip 200 with hydroxyl groups. The hydroxyl groups may be less than 50 angstroms, for example, the layer may be 5 angstroms, 10 angstroms, 15 angstroms, 20 angstroms, 25 angstroms, 30 angstroms, 35 angstroms, 40 angstroms, 45 angstroms, 50 angstroms, or any range of two or more of the above values. The process may include silanization. Silanization may include a layer having a thickness in the range of 100 to 500 angstroms, for example, 100 angstroms, 200 angstroms, 300 angstroms, 400 angstroms, 500 angstroms, or any range of two or more of the above values. The organosilane couples to the pendant hydroxyl groups through a condensation reaction. The process may cause a thin layer of material to be deposited on the surface of the strip 200. The process may produce uniform cleaning. The process may produce uniform distribution. The method may produce uniform surface functionalization. This process can produce a surface of the strip 200 suitable for bonding to other layers. This process can produce more effective adhesion between layers. This process can produce effective and repeatable bonding between layers.

[0265] Fig. 30B A modified layer stack with strip retention is shown. Fig. 30A Many layers as described in . Fig. 30B The pre-coat layer 270C, PFC bonding layer 270B, strip 200, adhesive layer 270E and primer layer 270A are shown. This figure also shows a plasma layer 280 covering the entire strip 200. The deposition of functional siloxane is coupled to the base of the strip 200 by condensation with hydroxyl groups, which depends mainly on the nickel, titanium and chromium content of the stainless steel of the strip 200. An example of a chemical equation for this process (depending on the type of glue used) is:

[0266] Stainless steel

[0267] There are a variety of hydrophilic coatings on the market that can reduce friction and provide navigation of enlarged balloons through tortuous and narrow anatomical structures. In addition, there are a variety of commercially available methods for coating balloons, including dipping, spraying, and other forms of deposition. In some embodiments, Fig. 30A Layer 270D may be a hydrophilic sliding layer. In a preferred embodiment, the balloon surface may be completely wrapped in a hydrophilic coating. In other embodiments, the balloon may be coated after pleating or after pleating and curling, and only in these embodiments, the surface that would typically be exposed during transport is coated by one of the above-described deposition methods. The surface may be only partially coated with a hydrophilic coating, covering only the surface exposed after the balloon is pleated and folded. In some embodiments, the thickness of a typical hydrophilic coating is less than a few hundred microns, and may be as thin as, for example, 100 angstroms, and more than one coating may be incorporated.

[0268] The height of the wedge-shaped dissectors, strips, and layers of the external 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 surgical procedure involving a medical balloon or other expandable member. In order to effectively perform critical opening or catheter-based procedures, the ability to fold the balloon to a diameter that is a fraction of the intended inflation diameter can be valuable. Therefore, the balloon, and in some cases the cage, is typically 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 an orientation of the spikes so as to avoid puncturing the balloon or scratching the lining of the lumen during delivery and removal, such as Fig.28 As shown in the picture. Fig.28 An air bag 1000 having a plurality of pleats 1002 and a strip 300 located between the pleats and an associated wedge-shaped dissector 200 between the pleats is illustrated, allowing a single strip 300 with its multiple wedge-shaped dissectors 200 to be located between two pleats 1002. The pleating tool is designed to provide effective orientation of the spikes and the pegs. The pleating tool can have a series of pleated wedges, each of which provides the ability to curl the air bag between the wedges when the wedge elements are closed onto the air bag. Due to the volume of the peg elements and the desire to minimize contact and potential damage to the wedge heads, these wedges are designed to have a series of pockets extending along the length of the wedge heads. The pockets in the wedge heads provide the ability to place the peg features in the pockets and limit contact of the pegs with the wedges. These bags may also provide the ability to assist in the orientation of the peg and spike features so that the features are oriented to limit contact with the balloon, such as when folded, and to limit orientation, such as perpendicular to the balloon, which may result in scraping of the vascular endothelium during delivery of the device over the balloon. Fig.31As shown, one such orientation of the spikes might be in a tangential orientation to the balloon surface, an apparent flat orientation.

[0269] In some embodiments, disclosed herein are systems and methods for producing a straight incision by preparing teeth 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 lesion tissue helps blood flow and increases the possibility of the blood vessel remaining open for a longer time compared to the minimum lumen gain achieved after surgery. There are multiple options for increasing the lumen diameter. Basically, plain old balloon angioplasty (POBA) or percutaneous transluminal angioplasty (PTA) or similar methods are usually used to open the diseased lesion tissue. In addition, more professional devices, 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 usually provide external structures on the surface of the balloon (attached or unattached), which are 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 cause a local increase in the forces on the lumen, which in turn helps allow penetration of the surface and dilation of the artery as the balloon expands. Although these designs offer some advantages over POBAs or ordinary balloons alone, their effectiveness and ability to promote lumen dilation are limited, particularly in the complexity of the diseases for which they may be used.

[0270] An alternative to the external structure of the compression line produced along the inner membrane is to produce a serrated line longitudinally along the lumen. The effectiveness of teeth in helping materials to separate (e.g., paper, stamps, cardboard, granite, marble, etc.) is well understood, and because the morphology of diseased tissue generally involves soft and hard materials, the advantage of teeth technology is that it can effectively help blood vessels to dilate. There are several methods for producing teeth, including those described in the following documents: U.S. Patent No. 9480,826 issued on November 1, 2016, PCT Publication No. WO 2015 / 187872 published on December 10, 2015, PCT Publication No. WO 2016 / 073511 published on May 12, 2016, PCT Publication No. 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 may provide features configured to create teeth or linear toothed scoring at the deployment site.

[0271] In some embodiments, the lumen gain of the dentate angioplasty is superior to that of a balloon alone. Improvements in lumen gain have been documented (Figure 78), with a 49% improvement in final stenosis with the dentate balloon compared to a conventional balloon alone. The increased lumen diameter improves flow ( Fig.75 and Fig.76 ). Applying Besseille's law to vascular blood flow allows the calculation of volumetric flow rate. Improvements in the mean flow rate ratio, defined as: (post-intervention radius / pre-intervention radius) to the fourth power, can be compared. Fig.75 A data set comparing normal balloons to denticle balloons is shown along with a set of power fit curves. Fig.75 It is shown that dentation balloon angioplasty can achieve more than a doubling of the mean flow rate ratio.

[0272] In some embodiments, the inclusion of serration technology is advantageous for balloons not only for preparing tissue prior to or concurrently with the use of a drug-coated balloon, but also as a single-step 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 aid the serrations of the serrated balloon in delivering the desired drug or other therapeutic agent deeper into the desired target location, such as the intimal, medial, or adventitia surface of the lumen wall.

[0273] Typically, drug-coated balloons are coated on their surface. When a non-toothed drug-coated balloon is expanded, the balloon contacts the lining and begins to push out the drug residing on its surface, which inhibits the ability of the balloon surface to deliver the drug to deep tissue spaces. In some embodiments, the following disclosure includes components and methods of using components that can effectively deliver drugs to tissues using teeth independent of design elements, including but not limited to any number of the following:

[0274] 1) A surface capable of radial expansion (e.g., a compliant or semi-compliant balloon);

[0275] 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 the wedge-shaped dissectors is not as long as the length of the wedge-shaped dissectors themselves, and / or the height of the wedge-shaped dissectors is a fraction of the balloon diameter);

[0276] 3) The protrusion may in some cases be an A-frame structure that is angled from its base to its tip, and the long well or space within the A-frame structure becomes the drug storage area;

[0277] 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 interrupted surface just below the teeth;

[0278] 5) Individual or series of wells where drugs, stem cells or other therapeutic agents can be placed within each A-frame structure of the strip;

[0279] 6a) These wells may include depressions in the balloon surface, or separate conduit-like channels along the balloon body, which may include finely defined holes (made by laser drilling or other fine methods) to allow for the placement of larger volumes of therapeutic agents;

[0280] 6a.1) In some cases, the catheter channel is incorporated 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 delivery from a port on the hub through the channel to the balloon surface;

[0281] 6b) During balloon inflation, the outward balloon pressure can: a) exert a force on the recessed wells, thereby displacing the volume where the therapeutic agent resides, or b) dilate the finely defined pores and allow the drug to pass through these pores; this in turn moves the therapeutic agent outward and promotes release of the therapeutic agent into the damaged tissue;

[0282] 6c) typically capturing the apertures, straps, lifting elements and A-frame within a folded portion of the balloon during balloon delivery, thereby minimizing systemic penetration of the therapeutic agent into the tissue;

[0283] 7) upon balloon expansion, the toothed A-shaped frame separates the intimal tissue layers, exposes the media, and in some cases opens the media layer and adventitia layer to allow the therapeutic agent captured in the folded portion of the balloon to be primarily expelled deep into the vessel wall and / or exposed;

[0284] 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.

[0285] In some embodiments, the present invention involves the use of tooth technology in combination with endovascular surgery, wherein the design of the tooth technology includes a novel drug delivery design in combination with: drugs selectively placed on the balloon; drug wells contained near or below the tooth element; or pathways 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 an inlet created by the tooth element.

[0286] In certain embodiments, tooth element can be combined with multilayer (for example double or triple) polymer, for example, the polymer previously disclosed in U.S. Patent Application No. 15 / 268,407, wherein the space between base polymer and one or more top layers can be used as drug storage space. In certain embodiments, bottom polymer is removed, and the space between airbag surface and the one or more top layers can be used as drug storage space. For example, by spraying, dipping or utilizing nanotechnology self-assembly technology, wherein drug is encapsulated between the bottom layer and the top layer of polymer, can contribute to depositing drug in this space. In certain embodiments, drug storage layer is not exposed to environment due to the encapsulation of its top layer, thereby limiting its exposure to health or unperforated inner membrane layer. The tooth that comprises drug coating on, around and / or in the encapsulation layer is conducive to the tooth of toothed airbag and drug is mainly transported to sub-intima.

[0287] Fig.32 An embodiment of a modified cutting balloon for producing serrations is illustrated. In some embodiments, the beneficial effects of serrations or serrations can be achieved by modifying a cutting balloon catheter, for example, as described in U.S. Publication No. 2006 / 0184191 to O'Brien, which is incorporated herein by reference in its entirety. The balloon catheter can include a catheter shaft having a balloon coupled thereto. One or more cutting members or blades can be connected to the balloon. The balloon can include one or more discrete flexible points or flexible regions 3200 to enhance the flexibility of the cutting balloon catheter. Interruptions in one or more cutting members can be aligned with one or more discrete flexible points in the balloon. In some embodiments, the flexible points can be positioned every 5 mm on 10 mm and 15 mm lengths (6 mm length = 0, 10 mm length = 1, 15 mm length = 2). An atherotome blade with flexible points can help track diseased tissue that may have been previously inaccessible in some cases.

[0288] Fig.33 An illustration of a modified 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, location and arrangement of cutting members 3320 around balloon 3316 can be different. 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 can include a generally spiral orientation of cutting members 3320. Catheter 3310 can include multiple 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 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 this 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 larger 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 groove 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 so as 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.

[0289] In certain embodiments, a series of cutting elements (or micro-atherotome blades) as described above can be placed linearly along the surface of the air bag, spaced apart by the gap in the upper surface of the blade. In the schematic diagram above, the gap length is about one-tenth of the length of the single-degree blade. In certain embodiments, the ratio of the gap length to the blade length 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 for 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 scope of two values ​​including any of the above values.

[0290] A kind of improved cutting member is described herein, and its size provides more flexible, more stable design, and can be sawtoothed or approximate to tooth in tissue.The embodiment of improved cutting member can provide lateral flexion of about or greater than about 8,9,10,11,12,13,14,15,20 or more degrees, with or without the part of wherein cutting surface less or without tooth.Some embodiments can include a series of cutting members, and these cutting members have the cycle of tooth feature (e.g., element of lifting) as described elsewhere herein in series or between the end of cutting member or on the end.Cutting member (X) can have the length in the range of, for example, 0.01 inch to about 0.10 inch when being divided into a plurality of discrete parts, and these parts are separated by the space (Y) of, for example, about 0.01 inch to about 0.08 inch.In some designs, the length of cutting member (X) is divided into a plurality of discrete parts, and these discrete parts are separated by the space (Y) of 1:2,1:2.5,1:3,1:3.5 or 1:4, and the space between wherein cutting member is greater than the length of cutting member. The entire cutting blade may have discrete portions at any one or any number of locations along the 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 member, thereby piercing the tissue only in the narrow area where the discrete cutting member (X) is located. The effect of this discrete local penetration is that the balloon with the improved cutting blade produces a new angioplasty effect known as serration angioplasty. For example, one such serration angioplasty design may be small raised features that can produce a dot-like effect (or tooth-like feature) in the tissue at the end of the cutting blade, followed by longer raised features that can produce dashes in the center portion of the blade. Other serration angioplasty designs may mix small raised features and longer raised features in an alternating pattern, or mix a series of dots separated by one or more dashes in a repeating or non-repeating pattern. This embodiment can 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 length of the balloon body. Such a device configured for dentation plasty or dentation angioplasty can be used as a stand-alone angioplasty balloon or a preparation device before subsequent treatment. Subsequent treatment includes, but is not limited to: stent implantation, placement of drug eluting stents, performing atherectomy, high pressure balloon dilation or drug coated balloon treatment or other endovascular procedures requiring effective lumen preparation.Whether the device is used as a preparatory device for subsequent treatment or as a stand-alone treatment, the device effectively controls plaque or calcium by weakening the binding moiety, initiating cell or structure separation, and minimizing cell or structure compression (typically produced by angioplasty alone) by using the modified atherotome blade (toothed features) as disclosed herein. The toothed atherotome allows the diseased lumen to be safely dilated at low pressure and precisely enlarged and stretched to the desired diameter without the creation of extensive parenchymal dissection and raised flaps (. Fig.80 ). The teeth can make the plaque expand more evenly and smoothly, avoiding the formation of random cracks that may lead to dissection and residual stenosis. After treatment or pretreatment with teeth, the plaque can also be expanded with a pressure lower than that used in standard balloon angioplasty. The lower intra-balloon pressure (e.g., less than, equal to 4 atmospheres, 3.5 atmospheres, 3 atmospheres, 2.5 atmospheres, 2 atmospheres, 1 atmosphere, 0.5 atmosphere or a combination thereof) applied by the balloon combined with the improved cutting member causes less rupture of the plaque, less dissection, and less damage to the arterial wall. This "low pressure" or "mini-injury" tooth angioplasty is less likely to cause the biological response of neointimal 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 breakage or rupture of the plaque. By preparing the plaque with a balloon having teeth (which can serrate the interior of the blood vessel), the number and severity of dissections can be reduced. This reduces the need for stent placement after balloon angioplasty with denticles to treat dissected or residual stenosis.

[0291] As described herein, dentate vessels open at lower pressures and are able to maintain effective lumen gain over time. Observations were made 15 minutes or more after the dentate angioplasty, where the appearance of lumen gain was maintained. The concept of vessel retraction or a decrease in the lumen of the vessel after being stretched open may occur, and a design that can overcome the tendency of vessel retraction is required. For dentate angioplasty, it has been observed clinically that almost no retraction is recorded. To evaluate retraction events, doctors collected angiographic images after and 15 minutes after the dentate angioplasty. The images were evaluated for changes in vessel diameter or retraction, and the result was that almost no retraction was detected. These observations were unexpected and encouraged further experimental designs to study dentate angioplasty embodiments designed to reduce retraction. This reduction in retraction can be seen in both the arterial system and the venous system, especially in diseases found in anastomoses or near arteriovenous anastomoses. The dentate balloon described herein has shown effective results in reducing and in some cases eliminating retraction in the arterial system. It was also observed that dentation angioplasty with a balloon smaller than the vessel reference diameter could be used to pre-treat the diseased area.

[0292] This pretreatment can provide an equally effective dentate angioplasty treatment, while in some cases including a subsequent balloon angioplasty that will be performed at a low balloon pressure of about 4 atmospheres or less, so as to avoid damaging the arterial wall or its subintimal tissue. By performing plaque preparation followed by low-pressure angioplasty, there is less likelihood of a dissection that produces deep tissue tears, while still potentially exposing the media layer of the artery. In some cases, exposing the deep artery from within the arterial wall can stimulate thrombosis through collagen exposure, and also stimulate smooth muscle cell growth, which can subsequently cause neointimal hyperplastic occlusion of the artery. This reduction in the number of dissections and the reduction in severity can be a favorable differentiating factor in some cases compared to conventional cutting or scoring devices and other forms of plaque rupture (including but not limited to angioplasty that delivers ultrasonic energy).

[0293] Strips blown into airbag design

[0294] In some embodiments, the use of a strip embedded in the airbag in place of a top coating (as described herein and, for example, in U.S. Publication No. 2017 / 0333686 to Schneider et al. and U.S. Publication No. 2017 / 0080192 to Giasolli et al., both of which are incorporated herein by reference in their entirety) or in place of a preformed cover or top airbag coating (as described herein and, for example, in U.S. Publication No. 2020 / 0155815A1 to Giasolli et al., which is incorporated herein by reference in its entirety) may be preferred. The use of an embedded strip may provide a range of added value, such as ease of manufacturing, precise control of thickness, increased retention of the strip, uniformity of the outer layer, the ability to curl the airbag into a smaller profile, and / or the ability to use a wider range of materials for use as the airbag and for protecting the features of the airbag. The range of materials in which the strip may be embedded may include almost any material that can be both extruded and blown in an airbag mold. In some embodiments, the embedded airbag may be made of more than one material or more than one layer. When more than one layer is used, the top layer is typically made of a material that is more stretchable or more flexible than the base balloon. Because the functional characteristics of the embedded balloon are different from the balloon in the balloon design, the materials and processes used to construct the embedded balloon are typically different. In the case of the outer surface of the embedded balloon, the main requirement is to maintain the lifting elements (such as wedge-shaped dissectors / teeth) while allowing the tip to protrude above the base balloon. Regardless of the materials and processes used to construct the embedded balloon, the size of the balloon can be the same or different than the size of a conventional base balloon. Due to the above-mentioned Laplace formula, the tangential stress on the surface of the balloon is proportional to the radius of the balloon and the pressure inside the balloon. Therefore, the selected materials and dimensions of the embedded balloon may need to vary depending on the different diameters of the balloon. Therefore, a balloon with a diameter of 2.5 mm may require a more stretchable material than a balloon with a diameter of 5.0 mm because the tension on the surface of the balloon is at the same pressure. 1 / 2 high.

[0295] Interface bonding between prefabricated cover and base airbag.

[0296] The spacing between the top surfaces of the elements or base strips of the lifting can be considered as a stretchable membrane, which holds the strips and stabilizes the elements of the lifting to the airbag surface. In some embodiments, this space between the elements of the lifting can be combined with the base airbag and the strips. In other embodiments, the space may not be combined with the base airbag, thereby allowing the prefabricated airbag to float freely in the strip portion, while the two airbags are selectively combined to other places. In the embodiment where the strip area is not selectively combined, during the deflation event, the internal airbag may actually fall off. When the system is deflated, the deflation rate of the external airbag is slightly different from the deflation rate of the internal airbag, because the airbag system is not fully combined into a single unit. Due to the change in the deflation rate, a regional gap is generated between the airbags. The space generated by the regional gap enables the toothed strip to retract into the space. In this way, the height or profile of the depression of the lifting element or the lifting element of the strip body located above the external airbag is minimized, and in some cases, all the lifting elements are completely recessed into the space between the airbags. Such embodiments may be advantageous, for example, in reducing the risk of the teeth becoming lodged in 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.

[0297] like Fig.34 As shown, in some embodiments, a balloon having teeth bonded to a surface is inflated within a preformed covering. Fig.34 An embodiment of a method for producing an airbag design in an airbag is schematically illustrated. Figure 1As shown, a basic balloon 5100 is provided. In some embodiments, the basic balloon 5100 can be a plain old balloon angioplasty (POBA) balloon. The basic balloon 5100 provides the desired support for the blood vessel. The basic balloon 5100 provides the desired support for the tooth. The basic balloon 5100 can have any features for implementing the method described herein. The basic balloon 5100 can adapt to the pressure described herein. The basic balloon 5100 can be expanded to the diameter described herein. The basic balloon 5100 can typically be set on a short catheter. The basic balloon 5100 can be located at the distal end of the catheter. The basic balloon 5100 can be located at any point along the length of the catheter. The basic balloon 5100 can be used alone. The basic balloon 5100 can be used with only a single primer. In other cases, the basic balloon 5100 can be used with multiple primers. The basic balloon 5100 can include any material described herein. The basic balloon 5100 can be compliant. The base balloon 5100 can be non-compliant. The base balloon 5100 can be made of polyester or nylon. The base balloon can be designed to expand to a specific diameter. The base balloon can be designed to handle over-inflation diameter without radial expansion. The base balloon 5100 can be semi-compliant. The base balloon 5100 can be made of Pebax or higher hardness polyurethane. The base balloon 5100 can be inflated to various diameters based on pressure. The base balloon 5100 can conform to the lumen size. The base balloon 5100 can be elastomeric. The base balloon 5100 can be made of polyurethane, nylon, polyethylene, polyolefin copolymers, polyethylene terephthalate, or silicon, or any combination of materials. The base balloon 5100 can be inflated by filling a certain volume of inflation medium.

[0298] If small Figure 2As shown, a strip with a wedge-shaped dissector 5102 can be attached to a base airbag 5100. A strip with a wedge-shaped dissector 5102 can be attached to the base airbag 5100, and can be attached with an adhesive along the base of the strip 5102. The strip with a wedge-shaped dissector 5102 can be applied longitudinally to the base airbag 5100. The strip with a wedge-shaped dissector 5102 can be applied to the outer surface of the base airbag 5100. The strip with a wedge-shaped dissector 5102 can be applied as described elsewhere herein, for example, to create a toothed airbag. In the embodiment shown, four strips with a wedge-shaped dissector 5102 are applied to the base airbag 5100. The toothed airbag can include any number of strips with a wedge-shaped dissector 5102, including one, two, three, four, five, six, seven, eight, or any range of two or more of the above values. The strips with wedge-shaped dissectors 5102 may be equally spaced around the circumference of the base balloon 5100. The strips with wedge-shaped dissectors 5102 may be unequally spaced around the circumference of the base balloon 5100. Adjacent strips may be separated by 30 degrees, 45 degrees, 60 degrees, 75 degrees, 90 degrees, 105 degrees, 120 degrees, 135 degrees, 150 degrees, 165 degrees, 180 degrees, or any range of two or more of the foregoing values.

[0299] If small Figure 3 As shown in , the basic airbag 5100 with the strips having the wedge-shaped dissector 5102 attached thereto can then be pleated. A single strip having the wedge-shaped dissector 5102 can be located between the surface of the basic airbag 5100 and the pleats. The strips having the wedge-shaped dissector 5102 can be in a tangential orientation as described herein. The tangential orientation allows the strips 5102 to rest on the surface of the basic airbag 5100. The tangential orientation allows the strips 5102 to have a low-profile assembly configuration. The wedge-shaped dissector 5102 can be completely covered by the pleats. The wedge-shaped dissector 5102 can be at least partially covered by the pleats. The airbag 5100 can include one or more pleats, such as one pleat, two pleats, three pleats, four pleats, five pleats, six pleats, or any range of two values ​​in the above values. The number of pleats can correspond to the number of strips having the wedge-shaped dissector 5102.

[0300] Once pleated, adhesive is applied to the outer surface of the pleated base airbag 5100. The adhesive is a series of glue lines that can be applied to the pleated areas on the airbag surface. For an airbag with three pleats, three glue lines can be applied. For an airbag with four pleats, four glue lines can be applied. The same method of applying glue to all pleats will apply to any number of pleats. In some methods, glue lines are applied to all pleats. In alternative methods, the adhesive can be sprayed or applied by other means. The volume of glue is typically related to the amount of surface area of ​​the inflated airbag. For airbags of larger diameter or longer lengths, a larger amount of glue is used. As described herein, the final volume of glue is applied, which provides an effective combination of the internal base airbag with the external prefabricated covering. In some methods, the adhesive is only applied to the outer surface of the pleated base airbag 5100, and the adhesive is not applied to the strip with the wedge-shaped dissector 5102. When the adhesive is applied, the strip with the wedge-shaped dissector 5102 can be covered by the pleats, or at least partially covered by the pleats. For example, if the strip with the wedge-shaped dissector 5102 is completely covered by the pleats, the adhesive can be applied circumferentially. If the strip with the wedge-shaped dissector 5102 is only partially covered by the pleats, the adhesive can be applied longitudinally.

[0301] If small Figure 4 As shown, the folded balloon 5100 with adhesive applied and a strip with a wedge-shaped dissector 5102 attached can then be inserted into the preformed covering 5104. The adhesive can act as a lubricant to facilitate sliding. The base balloon 5100 can be centered within the preformed covering 5104. The preformed covering 5104 can be a second balloon. The preformed covering 5104 can be any outer wall structure. The preformed covering 5104 can be any covering. The preformed covering 5104 can not include any teeth / wedge-shaped dissectors on its outer surface. The preformed covering 5104 can include any material described herein. The preformed covering 5104 can be a plain old balloon angioplasty (POBA) balloon. The preformed covering 5104 and the base balloon 5100 can include the same material. The preformed covering 5104 and the base balloon 5100 can include different materials. The preformed cover 5104 and the base bladder 5100 may comprise the same or similar dimensions. The preformed cover 5104 and the base bladder 5100 may comprise different dimensions. The preformed cover 5104 may be slightly larger in diameter and / or length than the base bladder 5100. The pleated bladder 5100 may have a low profile assembly configuration for insertion into the preformed cover 5104.

[0302] If small Figure 5As shown, the internal toothed base balloon 5100 can then be inflated. The strip with the wedge-shaped dissector 5102 can be rotated from a tangential orientation under the folds of the base balloon 5100 to be exposed by the base balloon 5100 and oriented vertically within the preformed cover 5104. The expansion of the base balloon 5100 can cause the strip with the wedge-shaped dissector 5102 to rotate from a generally tangential orientation to a generally vertical orientation. During the expansion of the base balloon 5100, the strip with the wedge-shaped dissector 5102 begins to rotate within the preformed cover 5104. The base balloon 5100 can form a leaflet. The leaflets of the base balloon 5100 can expose the strip with the wedge-shaped dissector 5102 when the leaflets expand. The leaflets of the base balloon 5100 can expand to contact the preformed cover 5104. The base balloon 5100 can be inflated until the leaflets rest against the preformed cover 5104. The direction in which the strap with the wedge-shaped dissector 5102 rotates when inflated can be defined by the orientation of how the base bladder 5100 is pleated. The lobes of the base bladder 5100 can assist in the rotation of the strap with the wedge-shaped dissector 5102. The lobes of the base bladder 5100 can apply torque to the inclined surface of the wedge-shaped dissector 5102. The controlled expansion of the lobes of the base bladder 5100 can cause the strap 5102 to reliably rotate to a more vertical orientation relative to the shaped sidewalls and rigidity of the strap 5102. The base bladder 5100 can be inflated to a high pressure within the preformed cover 5104. The base airbag 5100 can be inflated to 4 atmospheres, at least 4 atmospheres, 4.5 atmospheres, at most 4.5 atmospheres, at least 4.5 atmospheres, no more than 4.5 atmospheres, 5 atmospheres, at most 5 atmospheres, at least 5 atmospheres, no more than 5 atmospheres, 5.5 atmospheres, at most 5.5 atmospheres, at least 5.5 atmospheres, no more than 5.5 atmospheres, 6 atmospheres, at most 6 atmospheres, at least 6 atmospheres, no more than 6 atmospheres, 7 atmospheres, at most 7 atmospheres, at least 7 atmospheres, no more than 7 atmospheres Pressure, 8 atmospheres, up to 8 atmospheres, at least 8 atmospheres, no more than 8 atmospheres, 9 atmospheres, up to 9 atmospheres, at least 9 atmospheres, no more than 9 atmospheres, 10 atmospheres, up to 10 atmospheres, at least 10 atmospheres, no more than 10 atmospheres, 11 atmospheres, up to 11 atmospheres, at least 11 atmospheres, no more than 11 atmospheres, 12 atmospheres, up to 12 atmospheres, at least 12 atmospheres, no more than 12 atmospheres, between 4 atmospheres and 6 atmospheres, or any range of two of the above values.

[0303] When the inner base balloon 5100 with the strips 5102 is inflated, the tip of the wedge-shaped dissector can be retracted into the inner diameter of the preformed covering 5104. In many cases, the tip of the wedge-shaped dissector will not pierce the preformed covering 5104. As described herein, the tip of the wedge-shaped dissector can be unpolished. The design of the unpolished edge of the tip of the wedge-shaped dissector produces a blunt force or abutment force on the preformed covering 5104. In contrast, when the base balloon 5100 expands and contacts the preformed covering 5104, the polished or sharp edge will pierce the preformed covering 5104. Without the polished or sharp edge, the preformed covering stretches under the outward force applied by the inflated base balloon 5100 with the strips 5102. The unpolished surface of the wedge-shaped dissector causes the preformed covering 5104 to stretch. In some methods, the unpolished surface of the wedge-shaped dissector does not pierce the preformed covering 5104.

[0304] In some methods, the preformed covering 5104 may change near the wedge-shaped dissector of the strip 5102. The preformed covering 5104 may change when the base bladder 5100 is inflated. The preformed covering 5104 may change when the strip 5102 contacts the preformed covering 5104. The method may include using an opposing mechanical force to weaken the preformed covering 5104. The method may include using one or more heating sources to weaken the preformed covering 5104. The heat source may be a heated soldering iron. The method may include using an electrical discharge to weaken the preformed covering 5104. The method may include using any other delivery system to weaken the preformed covering 5104. The method may include weakening the preformed covering 5104 at the area where the tip of the strip 5102 pushes outward on the preformed covering 5104. In some methods, a heated soldering iron or other heat source is used. In some methods, heat above the transition temperature of the preformed covering 5104 is applied to the tip of the strip 5102. Heat can be applied to the preformed covering 5104 near the strip 5102. Heat can be along the length of the strip 5102. Heat can be applied near the strip. Heat can weaken the preformed covering 5104 near the strip 5102.

[0305] When the base bladder 5100 expands and contacts the inner surface of the preformed cover 5104, the adhesive applied in the pleats is evenly distributed. The adhesive can be applied to the outer surface of the pleats of the base bladder 5100. The pleats can expand under pressure to form lobes. The lobes can press against the inner surface of the preformed cover 5104. The expansion of the base bladder 5100 can evenly distribute the adhesive between the base bladder 5100 and the preformed cover 5104. In some embodiments, the adhesive is evenly distributed along the entire inner surface of the preformed cover 5104. In some embodiments, the adhesive extends between the tip and the preformed cover 5104.

[0306] The basic airbag 5100 may include one or more primer layers. The primer layer may be any material described herein, including polyurethane. The adhesive may be deployed in the interior space between the basic airbag 5100 and the prefabricated cover 5104. The adhesive may be deployed in the interior space between the polyurethane primer layer covering the basic airbag 5100 and the prefabricated cover 5104. The adhesive may provide a uniform thin layer of adhesive material between these layers. The adhesive may provide a uniform thin layer of adhesive material between the basic airbag 5100 and the prefabricated cover 5104. The adhesive may provide a uniform thin layer of adhesive material between one or more primer layers (if provided on the basic airbag 5100) and the prefabricated cover 5104.

[0307] In some embodiments, the pairing of the base balloon 5100 and the preformed cover 5104 has one or more functions. The first function is that the pairing is designed to maintain balloon pressure during the expected use. The base balloon 5100 and the preformed cover 5104 can maintain the expanded diameter within a smaller tolerance. The base balloon 5100 and the preformed cover 5104 can maintain a more consistent balloon pressure.

[0308] The second function is that the pairing is designed to limit tearing of the preformed covering 5104, thereby allowing the preformed covering 5104 to hold the metal strip while allowing the lifting elements or teeth to penetrate the preformed covering 5104 layer. The preformed covering 5104 can be designed to prevent longitudinal tearing. The preformed covering 5104 can be designed to prevent tearing between adjacent wedge-shaped dissectors. The preformed covering 5104 can be designed to prevent tearing along the strip. The preformed covering 5104 can be designed to prevent tearing to expose the strip. The preformed covering 5104 can be designed to hold the strip. The preformed covering 5104 can extend above the surface of the strip between adjacent wedge-shaped dissectors. The preformed covering 5104 can extend circumferentially. The preformed covering 5104 can extend around the circumference of the base bladder 5100.

[0309] The third function of the pairing is designed to minimize penetration of the base balloon 5100 by the raised elements on the strips during pleating and curling of the pairing into a tight fit diameter. The preformed cover 5104 can protect the base balloon 5100 from penetration. The strips lie flat tangentially relative to the base balloon and the preformed cover 5104. The wedge-shaped dissector rests on the outer surface of the preformed cover 5104. The preformed cover 5104 can include a material designed to prevent penetration by the wedge-shaped dissector. The preformed cover 5104 can include a material designed to prevent tearing along the line of the wedge-shaped dissector that passes through the preformed cover. The preformed cover 5104 can protect the base balloon 5100 during pleating. The preformed cover 5104 can protect the base balloon 5100 during curling. The preformed cover 5104 can protect the base balloon 5100 when the balloon is in a low-profile insertion configuration.

[0310] The fourth function is to minimize puncture of the base balloon 5100 by natural disease (e.g., calcified atherosclerosis) or other external penetration sources. The preformed covering 5104 can protect the base balloon 5100 from puncture. The preformed covering 5104 can interact with the lumen of the blood vessel. The preformed covering 5104 can include a material designed to prevent puncture by the rough surface of the plaque. The preformed covering 5104 can protect the base balloon 5100 from the plaque during insertion. The preformed covering 5104 can protect the base balloon 5100 from the plaque during inflation.

[0311] In some embodiments, the diameter of the base bladder 5100 is designed to apply uniform pressure to the inner diameter of the prefabricated cover 5104 during the explicit manufacturing process. The bladder 5100 expanded under pressure is used to discharge the uncured liquid adhesive between the base bladder 5100 and the prefabricated cover 5104 through the holes in the prefabricated cover 5104, and these holes are located at the location where the lifted element penetrates the prefabricated cover 5104. The bladder 5100 expanded under pressure can distribute the adhesive in a thin layer to cover at least a portion of the lifted element. The bladder 5100 expanded under pressure can distribute the adhesive in a thin layer to cover at least a portion of the strip. The bladder 5100 expanded under pressure can distribute the adhesive in a thin layer between the base bladder 5100 and the prefabricated cover 5104. The adhesive can be cured to form an integral structure between the base bladder 5100 and the prefabricated cover 5104.

[0312] In some embodiments, the design of the base balloon 5100 has a high expansion ratio, which reduces the compliance of the balloon within the nominal pressure range expected during surgery. The base balloon 5100 can be non-compliant. The base balloon 5100 can be semi-compliant. The base balloon 5100 can help control the maximum expansion diameter of the balloon. The base balloon 5100 can be expanded to a specific diameter or a specific diameter within a certain tolerance. The base balloon 5100 can apply a specific pressure on the vessel wall without additional radial expansion. In some embodiments, the preformed cover 5104 is designed to have a high compliance or low expansion ratio, with the aim of minimizing surface tearing caused by penetration of tooth-like elements, natural diseases (e.g., calcified atherosclerosis) or other external penetration sources. The preformed cover 5104 can be compliant. As described herein, the combination of a low-compliance base balloon 5100 and a high-compliance preformed cover 5104 has several advantages. The design features effectively hold the strip as a system. The design features serve to minimize the ability of the preformed covering to tear along a portion of the strip, such as between the wedge-shaped dissectors. The design features serve to minimize the ability of the strip or plaque to pierce the preformed coating and underlying balloon. The design features serve to allow for good pressure maintenance throughout the procedure.

[0313] One method of reducing the compliance of the base balloon 5100 or increasing the compliance of the preformed cover 5104 is to change the manufacturing process at the balloon tube extrusion process and / or the balloon molding process. The base balloon 5100 can be formed by an extruded tube blown during the balloon molding process. The preformed cover 5104 can be formed by an extruded tube blown during the balloon molding process. During the process of manufacturing the base balloon 5100 and / or the preformed cover 5104, the compliance can be changed. In some embodiments, the manufacturing method is applied to change the molecular orientation of the polymer chain. The molecular orientation of the polymer chain of the base balloon 5100 can be changed. The molecular orientation of the polymer chain of the preformed cover 5104 can be changed. The molecular biaxial orientation of the molecules can be encouraged by changing the production process of the extrudate or raw material used to manufacture the base balloon 5100 or to manufacture the preformed cover 5104, changing the forming process, or changing the balloon modeling process. The molecular orientation of the polymer chain of the base balloon 5100 can be biaxially oriented. The molecular orientation of the polymer chains of the preformed cover 5104 can be biaxially oriented. In some methods, biaxial orientation produces a material that provides unique properties, including tear resistance or limiting or increasing material compliance. Biaxial orientation of the base bladder 5100 can promote reduced compliance in the base bladder 5100. Biaxial orientation of the base bladder 5100 can promote increased compliance of the preformed cover 5104. Biaxial orientation of the base bladder 5100 can promote tear resistance.

[0314] In order to affect the characteristics of the basic airbag 5100 and / or the prefabricated cover 5104, changes in blow molding parameters and / or extrusion parameters are envisioned, but are not limited to these two manufacturing process areas or the parameters listed in this article. Changes in the airbag molding method that can be used to affect the behavior of the basic airbag 5100 or the prefabricated cover 5104 include a set of four blow molding parameters to affect the desired characteristics, including: changing the temperature of the heated jaws, changing the pre-pressing / preheating time, changing the forming pressure / forming time and / or changing the distal tensile load / proximal tensile load. These blow molding parameters can promote the desired molecular orientation. Changing any of these parameters will make the performance characteristics of the basic airbag 5100 or the prefabricated cover 5104 slightly different. In addition, changes in the extrusion parameters that can be used to affect the behavior of the basic airbag 5100 or the prefabricated cover 5104 include: changes in the distance between the extrusion tool and the cooling bath, and changes in the speed of the gear pump during the extrusion process, both of which can affect the performance characteristics of the basic airbag 5100 or the prefabricated cover 5104.

[0315] Other characteristics that are believed to produce the desired properties of the base balloon 5100 or preformed cover 5104 include the inner and outer diameters of the extrudate, the stretching of the extrudate and the die head, and / or the final molecular orientation of the polymer chains. Such changes to the balloon in balloon design can provide many advantages. The base balloon 5100 can be designed to have low compliance so that the base balloon does not expand radially with increasing pressure. The preformed cover 5104 can be designed to have high compliance so that the preformed cover 5104 avoids tearing.

[0316] In some methods, the application of heat and / or force can facilitate the change of the preformed covering 5102. In some methods, heat and / or force can be applied to the strip 5102 while it is in contact with the preformed covering 5104. A heat source, such as a heated soldering iron, can be rolled over the tips of the strip 5102. In methods where heat is applied to the tips of the strip, the heat from the heat source, such as a heated soldering iron, can melt or liquefy the preformed covering 5104. The heat source can be used to melt the material around each tip of the strip 5102. When the material of the preformed covering 5104 melts in the area of ​​the tips of the strip 5102, the tips of the strip 5102 can protrude through the melt-out holes in the preformed covering 5104. The tips of the strip 5102 can rise above the outer surface of the preformed covering 5104. When the heat is removed, the melted material of the preformed covering 5104 quickly re-hardens in the area around the tips of the strips 5102. The re-hardened material provides a thicker, more durable and tougher layer of the preformed covering 5104. The melted and re-hardened material of the preformed covering 5104 surrounds the tips of the strips 5102. The additional material around each tip of the strips 5102 increases the tear resistance of the preformed covering 5104. The additional material around each tip of the strips 5102 limits the ability of the preformed covering 5104 to tear in the spaces between the strips.

[0317] In some embodiments, the preformed covering 5104 is melted along the unpolished surface of the wedge-shaped dissector. The strip 5102 can have a longitudinal space between adjacent wedge-shaped dissectors along a single strip. The preformed covering 5104 can be melted only along the unpolished surface so that only a single wedge-shaped dissector extends through the hole in the preformed covering 5104. The preformed covering 5104 can remain intact along the longitudinal space between adjacent wedge-shaped dissectors. The preformed covering 5104 can remain intact along the circumferential space between adjacent wedge-shaped dissectors. The re-hardened material can surround the wedge-shaped dissector extending through the preformed covering 5104. The re-hardened material can extend longitudinally along the inclined surface of the wedge-shaped dissector. The re-hardened material can extend laterally along the proximal edge and / or distal edge of the wedge-shaped dissector. The re-hardened material can strengthen the preformed covering 5104 near the wedge-shaped dissector. In some methods, the wedge-shaped dissector can only extend through the preformed covering 5104 when force and / or heat are applied to create an opening in the preformed covering 5104. The unpolished surface cannot pierce the preformed covering 5104 until heat or force is applied and the preformed covering 5104 stretches under pressure from the base airbag 5104. The application of force and / or heat weakens the preformed covering 5104 near the wedge-shaped dissector. The preformed covering 5104 melts around the wedge-shaped dissector, forming a thickened material around the wedge-shaped dissector. The force and / or heat allows the wedge-shaped dissector to extend through the preformed covering 5104. The force and / or heat strengthens the preformed covering 5104 near the wedge-shaped dissector to prevent or reduce tearing of the preformed covering 5104. The re-hardened material is more difficult to tear between the wedge-shaped dissectors. The re-hardened material is more difficult to tear in the area near the wedge-shaped dissector. The re-hardened material is more difficult to tear in the area that is most prone to tearing. The method of melting the material of the preformed cover 5104 around the extruded tip of the strip 5102 increases tear resistance in the area most susceptible to tearing, thereby increasing the robustness and durability of the system.

[0318] The preformed covering 5104 can assist in the retention of the strip 5102 relative to the base balloon 5100. The preformed covering 5104 can enhance the attachment of the strip 5102. An important feature of the preformed covering 5104 is to prevent the strip 5102 from falling off the balloon during endovascular procedures. During expansion and interaction with plaque, the strip 5102 can be subjected to significant forces within the vascular system. The preformed covering 5104 provides a retaining layer between the strip 5102 and the base balloon 5100. Methods of assisting the protrusion of the tip (e.g., by applying force and / or heat to weaken the preformed covering 5104) can have the added benefit of localized material thickening near the wedge-shaped dissector. The material thickening of the preformed covering 5104 can be designed to increase the functional effect of the preformed covering 5104 as a strip retention feature.

[0319] If small Figure 5 As shown, the internal toothed base airbag 5100 is inflated. The wedge-shaped dissector extends through the opening in the preformed covering 5104. The opening in the preformed covering 5104 surrounds each wedge-shaped dissector. The preformed covering 5104 is continuous between each wedge-shaped dissector. The opening in the preformed covering 5104 can have a thickened wall around the wedge-shaped dissector. In some methods, an adhesive can be distributed into the opening of the preformed covering 5104. The adhesive can form a thin layer between the hardened, thickened material of the preformed covering 5104 and the wedge-shaped dissector.

[0320] In some embodiments, the entire space between the base bladder 5100, the strip with the wedge-shaped dissector 5102, and the outer prefabricated cover 5104 is bonded together. The adhesive may form a thin layer between the base bladder 5100, the strip with the wedge-shaped dissector 5102, and the outer prefabricated cover 5104. The base bladder 5100, the strip with the wedge-shaped dissector 5102, and the outer prefabricated cover 5104 may be exposed to UV light to cure the adhesive. Figure 6 The final airbag-in-airbag structure 5199 is seen in FIG. The bonding of the two layers is typically accomplished using, for example, a UV curable glue or other adhesive that is evenly applied to the surface of the inner base airbag 5100 before sliding the outer prefabricated cover 5104 onto the inner base airbag 5100, such as a small Figure 3 and small Figure 4 The inner base airbag is then inflated to a high pressure (e.g., greater than about 5 atmospheres, 6 atmospheres, 7 atmospheres, 8 atmospheres or more), such as a small Figure 5 As shown, then exposed to UV light and allowed to cure. Under pressure load, the contact of the two surfaces of the basic airbag 5100 and the prefabricated covering 5104 evenly disperses the adhesive. The contact and pressure between the basic airbag 5100 and the prefabricated covering 5104 achieve a uniform coating thickness on the airbag body and the airbag cone surface before the curing cycle. The final airbag-in-airbag structure 5199 can be pleated. The final airbag-in-airbag structure 5199 can be used in any method described herein. The final airbag-in-airbag structure 5199 is a toothed airbag. The wedge-shaped dissector of the strip 5102 can be rotated from a tangential orientation to a vertical orientation within a blood vessel. The prefabricated covering 5104 and the basic airbag 5100 can act as a whole to form a leaflet to contact the blood vessel wall. The prefabricated covering 5104 and the basic airbag 5100 can act as a whole to rotate the strip to a vertical orientation. The preformed covering 5104 and the base balloon 5100 can function as a whole to exert tension on the vessel wall to create a straight dissection line.

[0321] The final balloon-in-balloon structure 5199 can have several advantages. The strips 5102 can be attached to the base balloon 5100. The preformed cover 5104 can functionally reinforce this attachment of the strips. Adhesive can be applied to the folds of the base balloon 5100. The adhesive can be used as a lubricant to slide the base balloon 5100 into the preformed cover 5104. When the base balloon 5100 is inflated, the strips 5102 can self-position within the preformed cover 5104. The strips 5102 can rotate to a vertical orientation within the preformed cover 5104. Under the pressure applied by the base balloon 5100, the wedge-shaped dissector will not pierce the preformed cover 5104. The preformed cover 5104 can be a durable, flexible material. The preformed cover 5104 can be penetrated by the wedge-shaped dissector by applying heat. Heat interacts with the preformed cover 5104 to melt the preformed cover 5104 near the wedge dissector. The wedge dissector pierces the preformed cover 5104 under the application of heat, and ridges are formed by the softened material of the preformed cover 5104 around the wedge dissector. The preformed cover 5104 surrounds each individual wedge dissector. The unpolished surface extends from the preformed cover 5104. Most of the height of the wedge dissector is exposed. The preformed cover 5104 can be a thin layer so that most of the height of the wedge dissector extends from the preformed cover 5104. When the heat is withdrawn, the preformed cover 5104 forms a hardened ridge around the wedge dissector. The adhesive previously applied to the folds of the base balloon 5100 can be distributed in the space between the wedge dissector and the hardened ridge of the preformed cover 5104. The balloon structure 5199 in the balloon can be exposed to light to cure the adhesive. The final balloon-in-balloon structure 5199 can be a new toothed balloon. The final balloon-in-balloon structure 5199 advantageously includes a preformed covering 5104 that forms a thin layer on the base balloon 5100 and the longitudinal space between the wedge-shaped dissectors of the strips 5102. The preformed covering 5104 can be a thin durable layer. In some embodiments, the preformed covering 5104 can better support the strips 5102 attached to the base balloon 5100 than only an adhesive layer between the base balloon 5100 and the strips 5102. In some embodiments, the preformed covering 5104 can strengthen the connection between the strips 5102 and the balloon 5100 to keep the strips 5102 in place. In some methods, the dynamics of the artery geometry can be used to separate the strips 5102 from the base balloon 5100. Such dynamics can be overcome by a preformed covering 5104 that strengthens the connection between the strap 5102 and the base bladder 5100. The preformed covering 5104 can extend uniformly over the base bladder 5100 and between the wedge-shaped dissectors, exposing the wedge-shaped dissectors only from the openings in the preformed covering 5104. The preformed covering 5104 can provide a consistent retention force for the strap 5102.

[0322] like Fig.41A As shown, the strip 3500 can be manufactured to include multiple strips (e.g., two identical strips) that make only tip-to-tip contact 4100 in a wedge-shaped dissector frame or carrier 4110. This wedge-shaped dissector frame 4110 can potentially be produced by a mechanical removal process (e.g., 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, as described elsewhere herein, 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.

[0323] Fig.41B and Fig.41C It is illustrated that in some embodiments, the plurality of strips 4100 can be bent or folded into a curved form 4120, leaving the tip 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.

[0324] Fig.41D and Fig.41E An alternative embodiment is shown having toothed tips 4160 that include a plurality of pointed surfaces with a central concave section 4150 (with Fig.41B and Fig.41C 4140 in the center flat section 4140). The strip 3500 with the serrated tips 4160 can be bent, leaving the serrated tips 4160 intact and creating an A-shaped frame with the serrated tips 4160 having gaps or wells.

[0325] 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, for example, the width of the gap at the vertex of the "A" of the A-shaped 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-shaped 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, for example, between about 10 degrees and about 30 degrees, or between about 15 degrees and about 22 degrees.

[0326] Fig.42A series of figures are illustrated showing the ability to employ 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 gluing the strips to the balloon). This process facilitates automation, pick and place of the strips, and facilitates precise alignment of the strips and balloon. The radially distal tip 4210 can abut against a continuous free edge 4220 or other continuous or discontinuous surface to allow for easy separation of the strips. In some embodiments, a carrier system for attaching a wedge-shaped dissector to a medical balloon can 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 bottom surface facing the strip, an unpolished radially outward surface, and a side surface between the bottom surface facing the strip and the radially outward surface, the bottom surface being directly adjacent to the first surface of the strip, 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 attached to the free edge of the strip carrier at the attachment zone. The region between the attachment zones 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 formed integrally with the strip and produced using processes such as chemical etching. The strip carrier may be made of the same or different material as the strip.

[0327] Fig.43 An embodiment of a close-up view of the attachment process of the radially outward surface 4325 of the wedge-shaped dissector 4100 to the free edge 4220 of the blank or carrier 4300 is illustrated. Also shown are gaps 4280 between the attachment areas 4328 where the bottom surface of the strip is not in contact with the corresponding free edge 4420 of the blank or carrier. In some embodiments, the surface area of ​​each gap or all 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 of 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 edge in contact), 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.43The height dimension between any portion of the strip or the wedge-shaped dissector of the strip and the blank or carrier shown. In some embodiments, this can advantageously allow the strip and the associated wedge-shaped dissector to be simply separated from the carrier. In other embodiments, there can be overlap in one or more dimensions between the attachment area of ​​the carrier and the strip and the associated wedge-shaped dissector, such as by a groove or trench in the free edge of the blank. In other embodiments, the attachment area does not need to be along a continuous free edge of the blank or carrier, but rather a separate interval between the projections of the blank or carrier and the wedge-shaped dissector. These projections can be mirror images or other patterns of the wedge-shaped dissector.

[0328] Fig.44A and Fig.44B Illustrated is a description of an embodiment of a manufacturing process for manufacturing a dentoplasty strip, cutting member, or wedge dissector 3510 utilizing a spool of a suitable material, such as a metal, such as a stainless steel material reservoir 4410. The reservoir 4410 may be shaped or ground, with or without a ground edge. The ground edge 4430 may be manufactured with a single or multiple facets on its edge, and may be ground to a fine point (e.g., ground) or have narrow but flat sides (e.g., unground). In some embodiments, a cross-sectional view of the ground grinding reservoir 4430 may be a triangular-like shape, with potential multiple slopes on the ascending side of an equilateral triangle slope.

[0329] In addition to the above-mentioned material grinding manufacturing technology, the manufacture of stainless steel toothed blades can be achieved through other batch processing technologies.

[0330] Therefore, grinding, stamping, etching, electrochemical machining and electrical discharge machining or a combination of these processes are batch processing techniques that can be used alone or in combination to achieve low-cost manufacturing of the toothed tips.

[0331] In some embodiments, a description of fabrication steps involved in chemical etching may include some or all of the following.

[0332] The mask or mask set 4400 includes information and design details for producing 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 for partial etching through of a single side of the stainless steel material 4410.

[0333] Chemical etching of the stainless steel roll 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.

[0334] Batch chemical etching can allow for high volume manufacturing of extremely repeatable and low-cost parts. 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 grayscale masking, 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.

[0335] Double sided mask exposure can enable etching through the material from both sides. By double sided exposure, the edge profile produces a large controlled mirror image profile on either side of the stainless steel material.

[0336] 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 the balloon is manufactured, thereby providing a conduit through which a volume of therapeutic agent can pass and be delivered to the tooth tissue. Fig.45A Similarly, 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 volume of therapeutic agent can be passed and delivered to the tooth tissue.

[0337] Fig.46 It is illustrated that in some embodiments, a series of multiple (e.g., 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 above A-frame strips 3500 may be regularly spaced as shown above, or irregularly spaced in other embodiments.

[0338] 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 radially outward surface with a perimeter, the wedge-shaped dissectors 3510 of the first strip 3510 and the second strip 3520 contacting each other at a portion of the perimeter of each radially outward surface, wherein there is an apex gap at a location 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 storage hole 4500 therethrough.

[0339] Fig.47An embodiment of an array of stripes 3500 disposed on a mask 4700 prior to chemical etching is illustrated (with an inset close-up view). Each array of stripes 3500 may include a separable region 4710 between adjacent wedge-shaped dissectors 3510.

[0340] FIG48a shows a strip array 3500. FIG48b shows a detailed close-up image of adjacent wedge dissectors 3510 with detachable regions 4710. FIG48c 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 strips 3500 with different geometries are shown in Etch 1 4820, Etch 2 4830, and Etch 3 4840. A close-up view illustrates how the wedge dissectors 3510 on the side are connected to the strip carrier 4810. FIG48d illustrates another embodiment of a strip carrier 4480 of a wedge dissector reversibly attached to a strip 4890. The strap carrier 4880 can have any suitable geometry, and in some cases has rounded or other tabs 4882, apertures 4884, lateral tabs 4886, or other features for alignment, control, placement, and ease of manufacturing. In some embodiments, the strap carrier includes protrusions that can be a mirror image of the wedge-shaped dissector of the strap to allow for easy removal, such as after the strap has been bonded or otherwise secured to a balloon (not shown).

[0341] above Fig.49 is an illustration of one embodiment of an overall system for producing a dentoplasty showing a series of serrated or scored wedge-shaped dissectors 3510 on the outer diameter of a balloon 3316 attached to a catheter 3310 via a guidewire hub 4900 and a balloon inflation hub 4910. FIG. 49A to FIG. 49J Additional views of one embodiment of a odontoplasty system are illustrated.

[0342] Fig.50 An airbag blown from an extrusion having a set of longitudinally oriented ridges of material is schematically illustrated in accordance with some embodiments. The ridges of material may be the same as the airbag or may be different. The number and location of the ridges typically corresponds to the location of the strip tips when laid flat in a pleated and curled position. The ridges provide areas of the blown airbag that are thicker than the ridgeless areas. The thicker areas act as buffers or pillows to limit and prevent accidental bursting of the airbag due to the strips being held on the airbag surface.

[0343] Fig.51Schematically illustrates multiple sets of strips placed in an airbag blowing mold prior to the airbag blowing process according to some embodiments. In this design, the strips provide the ability to be precisely placed within the mold set by integrating alignment elements into the carrier piece of the strips. The mold (e.g., multiple, such as 3 separate sections as shown) allows for proper positioning of the strips to allow the base of the strips to have sufficient height consistent with the intended location, thereby allowing the strips to be embedded into the airbag matrix during heating and airbag blowing.

[0344] Fig.52 Schematically illustrates an extrusion according to some embodiments that includes optical markings to aid in the orientation of the extrusion during the balloon blowing process. In some embodiments as shown, there are three zones (highlighted) that serve as optical reference planes to orient the extrusion during the balloon blowing process, allowing the strips to be properly positioned to align with the ridges, which are precisely positioned as pillow zones (e.g., protection zones) to protect the balloon during the pleating and folding process.

[0345] Fig.53 An embodiment is illustrated in which the extrusion used to blow the airbag has a second retention layer that has a slightly lower glass transition temperature than the glass transition temperature of the airbag itself. The second layer provides a slightly more forgiving effective material area to allow the strip to be embedded therein. During heating of the extrusion and blowing in the airbag mold, the top retention layer flows more easily into the cavity designed in the mold of the airbag mold, providing space to encapsulate the strip, as shown. Also, in this design, control of the strip depth is achieved through the design of the mold and the strip carrier, allowing for more efficient positioning of the strip with a high level of tolerance and minimal control effort.

[0346] Fig.54 A perspective view of a mold according to some embodiments (shown only partially and transparently) is schematically illustrated, wherein a series of strips are shown clamped into a modified airbag blowing machine. The partial and transparent mold is shown in three sections, each covering about 120 degrees of the airbag surface. A series of features on the strip carrier can be seen, including a hole and a cutout in the center of the carrier. These features are designed to align and help the strips to be precisely positioned to a narrow range of positions aligned with a zone of the airbag surface during the blowing cycle.

[0347] Fig.55 The strip and the binding material around the base of the strip according to some embodiments are schematically illustrated. In this cross-sectional view, the binding material is a single material, but can be more than one material layer, such as 2 layers, 3 layers or more layers. The binding material is designed to provide effective strip retention to the balloon. Therefore, the material is designed to provide flexibility and durability of strip retention under various force load conditions of the system during delivery, inflation, rupture of diseased tissue and retraction.

[0348] Fig.56 Schematically illustrates a cross-sectional view of a strip and strip retaining material being placed onto one side of a single air bag blowing mold in accordance with some embodiments. It should be noted that the shape of the mold for the air bag blowing system can be aligned with the tapered shape of the strip. When the mold is designed in this manner, the alignment enables control of the position of the strip on the air bag and reduces the likelihood of retaining material flowing over the tip of the strip.

[0349] Fig.57 Schematically illustrated are 3 strips captured within a set of three molds at 120 degree angles to each other according to some embodiments. The strips are placed in the dye cavity prior to the balloon blowing process, allowing the retention material to protrude into the balloon blowing cavity, while control of the depth of penetration into the cavity is achieved through the mold design. Other embodiments may include 2 strips spaced 180 degrees apart, 4 strips spaced 90 degrees apart, or irregularly spaced strips in other embodiments.

[0350] Fig.58 Schematically illustrates an enlarged view of a strip and retention material captured between two sides of a balloon mold according to some embodiments. The balloon mold shows a contoured shape to allow the retention material to flow in. As the mold is heated to form the balloon, the retention material is also heated. The heating can be high enough, near or above the glass transition temperature of the balloon material and the retention material, so that the materials can effectively flow together and become a single composite material.

[0351] Fig.59 A cross section of an airbag according to some embodiments is schematically illustrated, wherein the strip and retention material are combined and removed from an airbag blowing machine. Here, the strip is effectively bonded to the airbag surface, wherein the retention material is bonded or fused to the outer surface of the airbag. It should be noted that the airbag and retention material can be made of multiple layers. In some cases, the outermost layer of retention material and the outermost layer of the airbag are the same material or are made of a material designed to effectively fuse at airbag blowing temperatures. The design of the retention layer can include multiple layers so that some layers have higher levels of elasticity while other layers are less elastic. By combining elastic layers and inelastic layers, the retention layer can provide greater retention for highly elastic airbags and highly inelastic strips.

[0352] Fig.60 Schematically illustrates three strips bonded to the balloon surface with a retaining layer according to some embodiments. In this step, the carrier is removed and the balloon is fully inflated to show the orientation of the strips during deployment.

[0353] Fig.61Schematically illustrates an enlarged view of this strap after a retention layer has been bonded to the airbag surface according to some embodiments. The retention layer is shown wrapped around the strap under the strap and spread out far enough on both sides of the strap to allow the strap to lie flat on the retention layer when folded.

[0354] Fig.62 A perspective view of three strips incorporating a retention layer is schematically illustrated, according to some embodiments, showing the minimum surface area covered by the retention layer on the outer surface of the airbag relative to the entire airbag surface.

[0355] Fig.63 A top view is schematically illustrated, with the retention layer shown covering the top of the straps between the wedge-shaped dissectors and outwardly covering some small portion of the balloon surface so that the feet rest on the balloon to aid in strap retention. According to some embodiments, the height of the retention layer above the straps is typically minimal.

[0356] Fig.64 A retention layer is schematically illustrated which is minimized without a footprint on either side of the strip along the airbag surface. In this embodiment, it is conceivable that two or more further rows of material, identical or different to the retention layer, extend horizontally to the strip at a distance that allows the formation of a protection zone (pillow zone) in the region where the strip tip lies flat on the airbag during pleating and folding.

[0357] Fig.65 The pillows of the retaining members adjacent to the straps are schematically illustrated, with spacing of the pillows similar to the tips of the straps shown in a dotted pattern. These individual pillows provide a very small surface area retention zone to protect the airbag while minimizing the additional volume of the airbag.

[0358] Fig.66 Schematically illustrated is a cross-sectional view of a retained strap with a retention layer thereon, with minimal retention material and an accompanying pair of airbag protection pillows on either side as protection zones to minimize strap puncture of the airbag.

[0359] Fig.67 An embodiment is schematically illustrated where only a single pillow is located in the region of the lay-flat strip, without an opposing pillow, as shown.

[0360] Fig.68 A variation of the same concept of a minimum retention area of ​​a strip is schematically illustrated, but with the pillow area on one side of the strip containing less material than the pillow area on the opposite side of the strip.

[0361] Fig.69A variation of the same concept of a minimum retention area of ​​a strip is schematically illustrated, but with additional material shown on the proximal edge of the strip. The additional material area provides a more structured retention area typically found at the end of a strip.

[0362] Fig.70 Schematic illustrations of how protected areas (raised pillow-shaped areas) integrated into an airbag during folding and curling of the airbag provide variations in airbag protection. In some embodiments, these design variations can provide the ability to more tightly fold and curl a series of micro-wedges into an airbag while minimizing the possibility of holes being formed in the airbag by the sharp edges of individual micro-wedges. Three non-limiting variations of the pillow-shaped areas are illustrated as A, B, and C. In each illustration, the strip can be located within the folded portion of the airbag. In variation A, one short pillow-shaped piece is placed on the folded material of the airbag, while two short pillow-shaped pieces are placed on the inner circumference of the folded portion of the airbag to protect the airbag from being punctured. In variation B, one long pillow-shaped piece is placed on the folded material of the airbag, while one long pillow-shaped piece is placed on the inner circumference of the folded portion of the airbag to protect the airbag from being punctured. In variant C, a long pillow is placed on the folded material of the airbag and a short pillow is placed on the inner circumference of the folded portion of the airbag to protect the airbag from being punctured. Any variation in the length and number of pillows can be envisioned on the folded material of the airbag or on the inner circumference of the folded portion of the airbag to protect the airbag from being punctured.

[0363] Fig.71 An embodiment of an array of smaller strip portions is schematically illustrated, wherein four wedge-shaped dissectors are connected by a base, followed by a gap and another array of four wedge-shaped dissectors. This design variation can allow wedge-shaped dissectors of any length to be combined and separated from adjacent arrays. For example, arrays of five, six, or more are contemplated, as well as arrays of two or three. The retaining and pillow designs can follow any of the design patterns described above.

[0364] Fig.72 Schematically illustrates an embodiment where individual wedge dissectors are not connected. In some embodiments, some areas of the balloon may have wedge dissectors that are not connected, while other areas of the balloon may be connected as shown on the right side of the illustration. The retention and pillow design may follow any of the design patterns described previously.

[0365] Fig.73A side view of a strip integrated onto the balloon surface is schematically illustrated. An additional holding area is shown at the last wedge dissector closest to the cone body of the balloon. The cone of the balloon can have large stresses thereon during delivery and retrieval; furthermore, it is well known in the balloon blowing art that the cone of the balloon can have a gentle slope in the area near the edge of the cone. For this reason and others not listed here, regardless of whether the strips are bonded together, it may be advantageous to place additional material at the distal end of the wedge dissector.

[0366] FIG. 74A to FIG. 74E 1 is a series of illustrations showing the mechanism by which the toothed strip element 200 is rotated from the tangential orientation under the wing of the balloon material to be exposed and oriented vertically in a very tight stenotic lesion. This series of illustrations shows the delivery configuration and subsequent expansion of the balloon. In general, the strip 200 rotates during the expansion of the balloon 100. The strip 200 is delivered in a tangential orientation. During delivery, the strip 200 can be at least partially or completely covered by the balloon 100. The strip 200 is laid flat during delivery. The expansion of the balloon can cause the strip 200 to rotate from a tangential orientation to a vertical orientation. In addition, the deflation of the balloon can cause the strip 200 to rotate from a vertical orientation to a tangential orientation. The strip 200 can rotate in a blood vessel with a very small diameter. The strip 200 can rotate in a small diameter stenotic lesion. The mechanism of the expansion of the balloon 100 contributes to the serration and subsequent crack propagation. These figures illustrate how balloon expansion occurs.

[0367] Fig.74A The folded and wrapped airbag 100 is illustrated. The airbag can be folded into a small profile. The airbag 100 can include one or more pleats, such as one pleat, two pleats, three pleats, four pleats, five pleats, six pleats, or any range of two values ​​in the above values. The number of pleats can correspond to the number of strips 200. In the illustrated embodiment, the airbag 100 includes three strips 200, and the airbag 100 includes three pleats. The pleats can be designed to at least partially cover the strips 200. The pleats can cover the height of the strips 200. The pleats can cover the tip of the strips 200. The pleats can be suspended above the strips 200. The strips 200 can be disposed between the pleats and the surface of the airbag. The strips 200 can be disposed in a bag. The strips 200 can be contained in the folded portion of the airbag 100. The pleats can form wings 110. The wings 110 can be a portion of the airbag 100 that overlies a portion of the strips 200. Wing 110 may be a flap of material of airbag 100. Wing 110 may be configured to be inflated as described herein.

[0368] During insertion, the strip 200 may be at least partially covered by the balloon 100. The balloon 100, and in particular the wings 110, may act as a buffer between the vessel lumen and the strip 200 during delivery or retrieval. The balloon 100 may cover the tip of the strip 200. The tip of the strip 200 may be covered to protect the unpolished tip of the strip 200. The tip of the strip 200 may be covered to protect the vessel wall during insertion and retrieval.

[0369] The strip 200 is delivered in a tangential orientation. The tangential orientation allows the strip 200 to rest on the surface of the balloon. The tangential orientation allows the strip 200 to have a low profile delivery configuration. The tangential orientation allows the unpolished tip to be covered by the wings 110. The tangential orientation reduces the diameter of the catheter used for delivery and retrieval. The tangential orientation allows the strip 200 to be contained within the folded portion or fold of the balloon 200. The tangential orientation allows the strip 200 to lie flat. The strip 200 can be close to or against the internal components of the balloon catheter 150. The small profile diameter of the catheter includes the thickness of the strip 200. The small profile diameter of the catheter does not include the height of the strip 200. Due to the tangential orientation of the strip 200 for delivery, the small profile diameter of the catheter can be smaller. If the strip 200 is oriented vertically, the delivery diameter will be larger. The delivery diameter can be smaller than the diameter of the blood vessel.

[0370] The location of the strap 200 within the folded portion of the airbag 100 provides advantages during the inflation cycle as described above. The location of the strap 200 within the folded portion of the airbag 100 enables the strap 200 to be moved from Fig.74A The strip 200 is rotated in their tangential orientation as shown. Once the balloon is located within the treatment site, the strip 200 is rotated. Once the balloon 100 is inflated, the strip 200 is rotated. The strip 200 has a tangential orientation for delivery. The tangential orientation for delivery allows the strip 200 to be gathered into the folds of the balloon 100.

[0371] As described above, the wings 110 of the airbag 100 provide advantages during the inflation cycle. The airbag material 100 can be overlaid on the strips 200. The airbag material can overhang the tip of each strip 200. The airbag material is shown forming pleats or wings 110. In some embodiments, the wings 110 can extend beyond the strip tips 200. In some embodiments, the wings 110 do not extend beyond the adjacent strips 200. The wings 110 only cover a portion of one strip 200. The wings 110 do not completely cover another strip.

[0372] Fig.74BThe illustration shows an initial expansion event where fluid enters the balloon 100 and expands the balloon structure. At this stage of expansion, the strips 200 begin to rotate to a vertical orientation. An occluded circle 300 is shown with an inner diameter of 2 mm, representing a surface that may limit the expansion and rotation of the strip element 200. When the balloon 100 is filled with contrast agent, the pressure within the balloon 100 is negligible, but sufficient to begin to unfold. As the balloon 100 unfolds, the wings 110 of the balloon 100 that buried the strips 200 peel away. At the same time, the areas between the strips 200 where there is minimal filling resistance begin to fill and begin to apply slight pressure to the inner wall of the strips 200 facing the inner member of the balloon catheter 150.

[0373] This figure illustrates the initial expansion of the balloon 100. The balloon 100 is positioned within the blood vessel 300. The blood vessel wall 300 is illustrated as a circle, but the blood vessel wall can have any cross-sectional shape. Fluid can begin to enter the balloon 100. The fluid can expand the balloon 100. The balloon 100 can form leaflets 120. The leaflets 120 can be located between the strips 200. The balloon can have any number of leaflets, such as one leaflet, two leaflets, three leaflets, four leaflets, five leaflets, six leaflets, or any range of two of the above values. The leaflets 120 can expand. The leaflets 120 can expand from a position that does not contact the blood vessel wall 300 to a position that contacts the blood vessel wall 300. The balloon 100 can be inflated until the leaflets 120 rest against the blood vessel wall 300. Continued filling of the balloon 100 can cause a larger surface area of ​​the leaflets 120 to contact the blood vessel wall 300. The fluid enters the balloon 100 and expands the leaflets 120. The leaflets 120 may expand uniformly. The leaflets 120 may expand simultaneously. The leaflets 120 may expand non-uniformly. The leaflets 120 may expand sequentially. The leaflets 120 may expand passively based on the geometry of the vessel wall 300. The leaflets 120 may expand based on the area of ​​the balloon 100 that has low resistance.

[0374] The strap 200 can rotate. The strap 200 can rotate as the airbag 100 expands. As the airbag deflates, the strap can rotate, as described herein. The direction in which the strap 200 rotates can be defined by the orientation of the airbag 100 and how the strap 200 is pleated. The direction in which the strap 200 rotates can be determined by whether the airbag 100 is expanding or contracting. For the following description, the strap 200 is not necessarily the same as the airbag 100. FIG. 74A to FIG. 74E , the strip 200 is oriented tangentially and counterclockwise. FIG. 74A to FIG. 74EIn the series, the airbag is being inflated and the strap 200 is rotated from a transverse orientation to a vertical orientation by rotating clockwise during inflation. During deflation, the strap 200 is rotated from a vertical orientation to a transverse orientation by rotating counterclockwise. In other embodiments, the strap 200 is oriented to point tangentially clockwise. In this embodiment, the strap 200 is rotated from a transverse orientation to a vertical orientation by rotating counterclockwise during inflation. During deflation, the strap 200 is rotated from a vertical orientation to a transverse orientation by rotating clockwise. Due to the orientation of the pleats placed during the manufacturing process, the strap 200 is able to rotate in either direction. The pleats can help define the direction in which the strap points clockwise or counterclockwise. The pleats can help reliably unfold and rotate the strap during inflation. The pleats can help reliably refold and rotate the strap during deflation. The strap 200 can rotate clockwise or counterclockwise. During the inflation and deflation cycles, the strap 200 rotates outward and backward. During inflation, the strap 200 rotates in a first direction. During deflation, the strap 200 rotates in an opposite second direction. The strap 200 reliably and repeatedly rotates from a lateral orientation to a vertical orientation and vice versa. During a procedure, inflation and deflation cycles may occur more than once. Repositioning of the strap 200 under the pleats or balloon wings 110 may occur multiple times during a single procedure.

[0375] The strip 200 may be rotated from a tangential orientation to a less tangential orientation. The strip 200 may be rotated from a tangential orientation to a more perpendicular orientation. The strip 200 may be rotated relative to the inner member of the balloon catheter 150. The strip 200 may be rotated under the influence of the expansion of the balloon 100. The strip 200 may begin to rotate to a perpendicular orientation. The strip 200 may be rotated to the vessel wall 300. The tip of the strip 200 may be unground. The tip of the strip 200 may be rotated until the tip contacts the vessel wall 300. The vessel wall 300 may have any diameter. The leaflets 120 may rest against the vessel wall 300. The unground tip may rest against the vessel wall 300. The vessel wall 300 may limit the expansion of the leaflets 120. The vessel wall 300 may limit the rotation of the strip 200.

[0376] The balloon 100 continues to fill with fluid. The fluid can be any fluid, such as a liquid or a gas. The fluid can be a contrast agent. The pressure in the balloon 100 can be low, such as negligible, less than 0.5 atmospheres, less than 1 atmosphere, less than 2 atmospheres. The low pressure can allow the balloon 100 to expand. As the balloon fills, the balloon 100 forms larger leaflets 120. As the balloon fills, the wings 110 of the balloon 100 begin to pull back. The wings 110 of the balloon 100 fill with fluid. The wings 110 of the balloon 100 begin to merge with the leaflets 120. The wings 110 of the balloon 100 expose the unpolished tips of the straps 200. The wings 110 of the balloon 100 expose the sides or height of the straps 200. The wings 110 of the balloon 100 expose the straps 200.

[0377] The leaflets 120 continue to expand. The leaflets 120 are the areas of the balloon 100 between adjacent strips 200. The leaflets 120 are subject to minimal resistance to filling. The filling of the leaflets 120 is not constrained by the strips 200. The leaflets 120 have a smaller resistance to filling than the wings 110. As the wings 110 merge with the leaflets 120, the wings 110 fill and become the leaflets 120. The wings 110 move to the areas between adjacent strips 200. The wings 100 move to expose the strips 100. The fluid fills these areas with minimal resistance to filling. The leaflets 120 apply pressure to the inner wall of the blood vessel 300. The leaflets 120 apply pressure to the strips 200. The leaflets 120 apply pressure to the inner wall of the strips 200. The leaflets 120 apply pressure to the inner wall of the strips that face the inner member or lumen of the balloon catheter 150. The leaflets 120 apply pressure to rotate the strips 200. The leaflets 120 apply pressure to orient the strip 200 perpendicular to the inner member or lumen of the balloon catheter 150 .

[0378] Although not limited by theory, there may be a portion of the leaflets 130 that causes the rotation. The portion 130 may be located between the surface of the strap 200 and the inner member of the balloon catheter 150. As the portion 130 of the leaflets 120 expands, the portion 130 may exert a force or torque on the strap 200. The expansion pressure of the leaflets 120 may overcome the rigidity and resistance to twisting of the strap 200, thereby rotating the strap 200. The rigidity of the strap keeps the strap 200 in a transverse orientation during delivery. The pressure of the leaflets 120 must overcome this rigidity to rotate the strap 200. The expansion of the leaflets 120 may cause the rotation to occur. The direction of rotation of the strap 200 may be affected by the pleating. The pleats may guide the expansion of the leaflets 120. With respect to the shaped sidewalls and the rigidity of the strap 200, the controlled expansion of the leaflets 120 may cause a reliable and predictable rotation. The rotation is bidirectional. The strap 200 may rotate in one direction when inflated and in another direction when deflated. The strap 200 may be reversibly changeable between configurations. The shape of the lobe 120 may be load centered. The lobe 120 may allow the strap 200 to rotate to a vertical orientation. The lobe 120 may allow the strap 200 to repeatedly return to a vertical orientation. The lobe 120 may allow the strap 200 to repeatedly return to a lateral orientation.

[0379] Fig.74CA continued expansion event is shown, wherein the fluid fills a majority of the balloon 100 and expands the balloon structure 100 to contact nearly all of the diseased vessel 300. At this stage of expansion, the pressure is still low (less than 2 atmospheres), but sufficient to force the strips 200 into a vertical orientation. Note that a circle...

Claims

1. An intravascular device, comprising: Basic airbag; a plurality of strips, each strip of the plurality of strips comprising a plurality of wedge-shaped dissectors spaced along a surface of each strip; as well as Prefabricated coverings, Wherein, the base airbag comprises a lower compliance and the prefabricated cover comprises a higher compliance.

2. The intravascular device of claim 1, wherein: The base balloon includes a non-compliant balloon.

3. The intravascular device of claim 1, wherein: The base balloon includes a semi-compliant balloon.

4. The intravascular device of claim 1, wherein: The base balloon is configured to expand to a specific diameter.

5. The intravascular device of claim 1, wherein: The base balloon is configured to exert a specific pressure on the vessel wall without additional radial expansion.

6. The intravascular device of claim 1, wherein: The preformed covering is configured to minimize surface tearing along a portion of a strip of the plurality of strips.

7. The intravascular device of claim 1, wherein: The preformed covering is configured to minimize surface tearing between adjacent wedge-shaped dissectors.

8. The intravascular device of claim 1, wherein: The preformed covering is configured to minimize surface tearing caused by the wedge-shaped dissector.

9. The intravascular device of claim 1, wherein: The preformed covering is configured to minimize surface tearing caused by calcified atherosclerosis.

10. The intravascular device of claim 1, wherein: The prefabricated cover is configured to retain the plurality of straps between the base bladder and the prefabricated cover.

11. A method of manufacturing an intravascular device, comprising: Selecting a first extruded tube and blowing a base bladder; selecting a plurality of strips, each strip of the plurality of strips comprising a plurality of wedge-shaped dissectors spaced along a surface of each strip; Selecting a second extruded tube and blow molding the preformed cover; as well as The compliance of the base bladder, the prefabricated cover, or both the base bladder and the prefabricated cover is altered during the manufacturing process.

12. The method of claim 11, wherein: Modifying the compliance includes modifying the molecular orientation of the polymer chains.

13. The method of claim 11, wherein: Modifying the compliance includes changing a process for producing the first extruded tube or the second extruded tube.

14. The method of claim 11, wherein: Modifying the compliance includes changes in the forming process.

15. The method of claim 11, wherein: Changing the compliance includes changes in the balloon modeling process.

16. The method of claim 11, wherein: Modifying the compliance includes biaxially orienting the polymer chains.

17. The method of claim 11, wherein: Modifying the compliance includes increasing the tear resistance of the preformed covering.

18. The method of claim 11, wherein: The base bladder includes a lower compliance and the preformed cover includes a higher compliance.

19. The method of claim 11, wherein: Modifying the compliance includes changing the temperature of the heated jaws.

20. The method of claim 11, wherein: Modifying the compliance includes changing the pre-compression and / or pre-heating time.

21. The method of claim 11, wherein: Modifying the compliance includes changing the forming pressure and / or the forming time.

22. The method of claim 11, wherein: Modifying the compliance includes changing the distal tensile load and / or the proximal tensile load.

23. The method of claim 11, wherein: Modifying the compliance includes changing the distance between the extrusion tool and the cooling bath.

24. The method of claim 11, wherein: Modifying the compliance includes changing the speed of the gear pump during the extrusion process.

25. The method of claim 11, wherein: Modifying the compliance includes changing an inner diameter and / or an outer diameter of the first extruded tube or the second extruded tube.

26. The method of claim 11, wherein: Modifying the compliance includes changing the stretching and die head of the first extruded tube or the second extruded tube.

27. The method of claim 11, wherein: Modifying the compliance involves changing the final molecular orientation of the polymer chains.

28. A method comprising: An intravascular device is provided, wherein the intravascular device comprises: Basic airbag; a plurality of strips, each strip of the plurality of strips comprising a plurality of wedge-shaped dissectors spaced along a surface of each strip; and Prefabricated coverings, The intravascular device is expanded within the blood vessel, wherein a ratio between a reference blood vessel diameter and a diameter of the expanded intravascular device is greater than 1:

1.

29. The method of claim 28, wherein: The ratio is greater than 1:1.

1.

30. The method of claim 28, wherein: The ratio is greater than 1:1.

2.

31. The method of claim 28, wherein: The ratio is greater than 1:1.

3.

32. The method of claim 28, wherein: Expanding the intravascular device enables greater arterial growth.

33. The method of claim 28, wherein: Expanding the intravascular device enables better residual blood flow.

34. The method of claim 28, wherein: Expanding the intravascular device provides low residual stenosis.

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