Balloon catheter for reducing residual stenosis and method of using the same

Abstract

The system and method include attaching a wedge dissector attached to a strip to a medical balloon for forming a fenestration in the vessel wall tissue for angioplasty and drug delivery. The systems and methods described herein can include a wedge dissector connected to a strip attached to a medical balloon, thereby forming a fenestration in the vessel wall tissue, performing angioplasty, and promoting reduction of vascular recoil, reduction of residual stenosis, and increase of blood flow after angioplasty. The design, method of use, intended results, and manufacturing process of this type of balloon are described herein.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 355,324, filed on June 24, 2022, the entire content of which is incorporated herein by reference.

Background Art

[0002] Certain embodiments disclosed herein generally relate to a method of depositing a drug into tissue via a series of serrated structures and serrations integrated with a medical balloon, such as an angioplasty balloon. Methods of manufacturing a series of serrated structures and treatment methods including a series of serrated structures are also disclosed, along with the features of various wedge dissectors (wedge dissectors) and splines that are collectively serrated structures. The wedge dissector is used to form perforations in the disease treatment area in order to control the propagation of cracks, reduce dissociation that restricts flow, reduce the need for implants such as stents, reduce recoil, increase lumen dilation, and increase flow in the disease treatment area.

[0003] Atherosclerotic occlusive disease is a major cause of stroke, heart attack, limb loss, and death in the United States and developed industrial countries. Atherosclerotic plaque forms a hard layer along the walls of arteries and is composed of calcium, cholesterol, compressed thrombus, and cell debris. As atherosclerotic disease progresses, the blood supply attempting to pass through certain blood vessels decreases or may even be blocked by the occlusion process. One of the most widely used methods for treating clinically significant atherosclerotic plaque is balloon angioplasty.

[0004] Balloon angioplasty is a method of opening blocked or narrowed blood vessels in the body. A catheter for balloon angioplasty is inserted into a symptomatic blood vessel (such as an artery) from a remote access site created by percutaneous or open exposure of the artery. The catheter moves along the inside of the symptomatic blood vessel over a wire that guides the catheter. The portion of the catheter with the balloon attached is placed at the location of the disease (such as atherosclerotic plaque) that requires treatment. The balloon is generally inflated to a size that matches the reference vessel diameter of the artery before the onset of the occlusive disease.

Summary of the Invention

Problems to be Solved by the Invention

[0005] When the balloon expands, the plaque is stretched, compressed, crushed or destroyed depending on its composition, location and the magnitude of the pressure exerted by the balloon. Since the plaque is non-uniform, soft in some parts and hard in others, unpredictable cleavage planes are formed in standard balloon angioplasty. Balloon angioplasty can disrupt the plaque and sometimes cause arterial injury at the angioplasty site.

[0006] Peripheral arterial stenosis lesions reduce blood flow to the feet, limit the patient's mobility, cause pain, inhibit healing, and in the most severe cases, can result in tissue loss, infection and the need for amputation. One of the aims of balloon angioplasty in peripheral arteries is to open the stenotic lesion and restore blood flow to the feet. Since blood flow is related to the cross-sectional area within the artery, it is important to return a narrow stenotic lesion to the adjacent reference vessel diameter with minimal vascular damage. The basic mechanism of balloon angioplasty is to increase the radial expansion force applied to the stenosis and ultimately heal the lesion.

Means for Solving the Problems

[0007] To address the desire to increase the diameter of an artery while minimizing vascular injury, an innovative approach that utilizes the mechanism of action of angioplasty is needed. The innovative serration balloon catheter recognized the above objective and collected evidence regarding increased lumen dilation, reduced vascular recoil, and increased volumetric blood flow while minimizing the degree of dissociation (a form of vascular injury) and the need for stents. The serration design included in this patent and related patents is a serration angioplasty balloon that combines angioplasty and longitudinal serrations through the vascular intima, thereby changing the mechanism of action of angioplasty alone.

[0008] By combining angioplasty and serration technology, the pressure required to improve blood flow can be minimized. A set of stainless-steel strips are incorporated into the angioplasty balloon, and when the balloon expands, a series of serrated lines are created along the intima, typically penetrating the media (shown in Figure 1). The serrated lines cause the energy of the angioplasty to follow these vulnerable lines along the arterial axis. As the lumen expands, the intimal and medial tissues separate more gently and predictably, and blood flow can pass well through the repaired stenotic site. Figure 1 is a scanning electron micrograph showing the effect of serration in porcine tissue 7 days after healing.

[0009] Improvement of arterial volumetric flow by serration angioplasty (evidence by calculations applying Poiseuille's law) A mathematical approach for evaluating the improvement of arterial flow allows for the comparison of data from conventional angioplasty and serration angioplasty. This type of algorithm enables the evaluation of data from various studies regardless of the reference vessel diameter of the arteries in each study, allowing for the comparison of flow improvements between studies.

[0010] To evaluate the improvement in blood flow, the derived equation utilizes the established hydrodynamic equation (Poiseuille's law) that flow is directly correlated with the fourth power of the radius of the pipe. Poiseuille's law includes additional variables such as pressure, length, and viscosity coefficient (see Equation 1). Due to the nature of the disease form and the impossibility of accessing (approaching) the in-vivo tissue, a simplified hydrodynamic model (Equation 2) is claimed to be effective for comparison.

[0011]

Equation

[0012] Here, R is the radius of the artery, n is the viscosity coefficient of the blood, L is the length of the blood vessel (or lesion), and P1 - P2 is the pressure difference.

[0013] First, by reflecting a series of assumptions applied to Poiseuille's law and evaluating the improvement in arterial flow between studies, an equation is provided that may give insights between cardiovascular studies.

[0014] In the conventional equation, Poiseuille's law requires laminar flow (e.g., the flow must not be turbulent) and that the liquid is an incompressible fluid. Blood is incompressible and is usually considered to flow like laminar flow in the body, but it has been shown that there is turbulent flow in the arterial system and it has been confirmed that the turbulent flow increases when passing through a lesion. Regardless of such assumptions that conflict with the use of Poiseuille's law, this law is derived by the second integral of the circumference of the pipe. Therefore, when the radius R of the artery increases, the flow rate increases exponentially. In a diseased blood vessel where the radius of the blood vessel is reduced by half due to a stenotic lesion, assuming perfusion alone, the resistance within the narrowed segment increases 16-fold. Figure 2 (indicated by the red horizontal and vertical lines) shows how low the % maximum distal flow becomes when the peripheral artery reaches 50% of its maximum radius.

[0015] Therefore, the volumetric flow rate depends greatly on the cross-sectional area of the artery. In the case of peripheral arteries, this simple analogy shows the value of restoring the lumen diameter to its original, unconstrained diameter, which means an increase in blood flow to more distal tissues (i.e., the foot). For rotational angioplasty, the ability to consistently form larger lumens, resulting in higher volumetric flow rates than conventional balloon angioplasty (Figure 75), has been observed (Figures 76, 78A, 78B). The ability of rotational angioplasty to achieve higher volumetric flow rates can be explained as or associated with "vascular remodeling". Vascular remodeling is based on the hypothesis that the inner diameter (D) and wall thickness (w) of each segment in the vascular network undergo continuous structural adaptation in response to the stimuli experienced by that segment. Therefore, when diseased blood vessels are effectively treated such that the behavior of the blood vessels (conformability, hydrodynamics, and inner diameter) is improved, as observed in examples of rotational angioplasty, it is appropriate to associate these results with positive remodeling of the blood vessels. Moving from the inside out, the layers of the blood vessel wall include the intima, internal elastic lamina, media, external elastic lamina, and adventitia. As described herein, rotational angioplasty creates a series of discontinuous voids in the blood vessel wall, typically penetrating the intima, internal elastic lamina, and reaching the media. In some methods, only the intima is penetrated. In some methods, only the intima and internal elastic lamina are penetrated. In some methods, only the intima, internal elastic lamina, and media are penetrated. In some methods, it penetrates to a certain depth within the media. In some methods, it penetrates to the external elastic lamina. In some methods, it does not penetrate the external elastic lamina. In some methods, it completely penetrates the media. In some methods, it partially penetrates the media. In some methods, it penetrates only the intima, internal elastic lamina, media, and external elastic lamina. In some methods, it does not penetrate the adventitia. In some methods, it partially penetrates the adventitia. In some methods, it penetrates the internal elastic lamina but not the external elastic lamina. In some methods, it penetrates at least the internal elastic lamina. The internal elastic membrane has serrations and relaxes under the pressure of the balloon, so that the treated lesion has reduced turbulence, reduced roughness, fewer interruptions and disturbances in the flow, and reduced wall friction and flow resistance.According to observations seen in most clinical cases where balloon angioplasty is used either alone or in combination therapy, the final result shows arterial contours and flow dynamics with little or no discontinuity of blood vessels or lesions and no flow disturbances. This phenomenon is referred to in this specification as stage 1 positive vascular remodeling.

[0016] The method for evaluating the improvement in flow rate for any intervention begins by first calculating the initial arterial flow rate (F i ). The initial arterial flow rate (F i ) is obtained by taking the fourth power of the product of half of the average initial RVD and (1 - % stenosis). Next, the final arterial flow rate (F f ) is determined. The final arterial flow rate (F f ) is obtained by taking the fourth power of the product of half of the average final RVD and (1 - % residual stenosis). Taking these two values, the change in flow rate can be calculated as F f - F i . Therefore, the improvement rate (%) of flow rate due to the intervention can simply be (F f - F i ) / F i . Finally, when comparing dataset (1) with dataset (2), the improvement rate (%) of the flow rate of dataset (1) relative to dataset (2) can be calculated by dividing the value obtained by subtracting the improvement rate (%) (test 2) from the improvement rate (%) (test 1) by the improvement rate (%) (test 2).

[0017]

Number

[0018]

Number

[0019]

Number

[0020] Here, F i is the initial arterial flow, and F f is the final arterial flow.

[0021] Finally, a comparative analysis can be performed by comparing the improvement rates of the flow rate among multiple studies with different vascular radii before treatment. The limitation of this method is that the largest contributing variable is the degree of initial stenosis. As the initial stenosis rate (%) increases, the radius of the flow decreases. This radius, when calculated to the fourth power, decreases very rapidly with a slight increase in the initial stenosis.

[0022] To reduce the possibility of computational misunderstandings in highly occluded blood vessels, the volume flow ratio is calculated as (r post / r pre ). 4 Here, r post is the vascular radius after treatment, and r pre is the vascular radius before treatment. The vascular radius (r) should be r = RVD × (1 - % stenosis) / 2.

[0023] Assumptions used to derive the simplified equation, flow = r 4 :

[0024] Flow limitations and decreases related to turbulent flow are not considered. Information for evaluating the possibility of turbulent flow is lacking in the literature (i.e., stenosis characteristics, accurate three-dimensional arterial structure, etc.).

[0025] Interventional data such as balloon size and balloon pressure provide insights into the followability with respect to vessel size but do not provide insights into the final flow rate.

[0026] There is an assumption that the cross-section is round (like a pipe), but biological growth is rarely exactly round.

[0027] Two comparative models were identified to evaluate the acute improvement after treatment in peripheral arteries. One model (Figure 75) evaluated the change in volume flow rate, and the other model (Figure 76) evaluated the improvement of residual stenosis relative to pre-treatment RVD (before treatment). According to the data examined, serrated balloon angioplasty consistently outperformed conventional balloon angioplasty in both ways. Serrated balloon angioplasty achieved an average flow velocity ratio 2.4 times that of conventional balloon angioplasty for 62% - 93% of stenotic lesions and reduced the residual stenosis by 62% for 99 - 100% of stenotic lesions.

[0028] To simplify the method of calculating the impact of residual stenosis, consider a simple derivation of Poiseuille's law. To show this method, this method is used to calculate the impact on flow rate when the blood vessel radius increases by 5%.

[0029]

Number

[0030] An operation called angioplasty can be used to expand a partially blocked artery. In this operation, a catheter with a balloon tip structure is inflated inside the artery to widen the artery and restore normal blood flow. Since blood flow is proportional to the fourth power of the radius r, it has been shown that the relative change in blood flow strongly depends on the radius. Therefore, the relative change in radius r dramatically increases blood flow. Here, the question is what effect it has on blood flow when the radius increases by 5%. To solve this problem, a differential equation is applied to the equation stating that blood flow is equal to a constant k multiplied by the fourth power of the radius r. The equation and the differential equation are shown below.

Number

[0031] Therefore, a 5% increase in radius can be expressed as 1.05 times.

Number

[0032] Comparing the differential equations, it can be seen that when the radius changes relatively by 0.05 (5%), the blood flow increases relatively by about 0.20 (20%). Since the change in radius is directly proportional to the change in diameter, the effect on the increase in blood flow is similarly maintained. Even a slight increase in diameter has a significant impact on blood flow.

[0033] In the field of angioplasty, a balloon is used to expand an artery. However, after the balloon is removed, stenosis of the blood vessel wall may occur again. This stenosis can cause a significant loss of the lumen expansion effect (lumen gain).

[0034] The scoring technique described herein has several advantages over conventional angioplasty. The scoring technique can significantly control stenosis by achieving a more permanent lumen expansion after balloon removal. Furthermore, the scoring technique can significantly control stenosis by expanding the balloon in a manner different from angioplasty. While angioplasty expands the artery with high pressure, the scoring technique provides a crack generation site for one or more fracture lines. The scoring technique can significantly control residual stenosis by modifying the surface while keeping the plaque attached to the blood vessel wall. This permanent structural change makes it impossible for the blood vessel to return to its pre-expansion diameter. This fracture line is formed through a crack propagation process under low pressure. By remodeling the blood vessel with the scoring technique, the following features can be obtained.

[0035] As shown by the above equation, even a slight increase in radius has a significant impact on blood flow. Just increasing the radius by only 5% causes the blood flow to increase by 20%. In other words, a permanent change in radius has the potential to increase the blood flow fourfold. Also, a permanent change in diameter has a proportional impact on blood flow. In other words, reducing the residual stenosis by 5% increases the blood flow by 20%. By controlling the inherent property of the blood vessel to narrow, a dramatic increase in the lumen blood flow can be achieved.

[0036] A simple equation for evaluating the blood flow after the final treatment is as follows.

Number

[0037] Equation 4: A simplified version, where F is the blood flow in the artery, r is the radius, k is a constant, and L represents the reduction rate of the residual stenosis.

[0038] In many cases, to maintain tissue and save limbs and organs, a significant increase in volumetric flow (blood flow) is a life-or-death factor. The volumetric flow of blood vessels is directly correlated with the vessel diameter. Vascular stenosis refers to a condition in which the blood vessels become narrower due to the accumulation of plaques on the vessel walls, etc. The calculations described herein indicate the need for a design that can reduce interference with the vascular radius or occlusion to a normal or healthy radius. It is necessary to reduce stenosis by restoring the diameter of the blood vessels through positive remodeling (reconstruction) of the blood vessels. Serration angioplasty has shown clinical effectiveness in expanding the blood vessel diameter, reducing dissection that blocks blood flow and causes a pressure drop across the lesion, and reducing dissociation (dissection). Serration angioplasty creates punctate cracks (prick points) along the internal elastic lamina. As a result, the internal elastic lamina can be relaxed under balloon pressure or torn along the serrated vulnerable line, allowing the blood vessel to be restored to a normal or healthy radius. Also, serration angioplasty does not disrupt most of the plaque surface, and the plaque remains mainly attached to the expanded blood vessel wall. By serration, a fracture surface is formed, and the plaque separates only along the longitudinal line. Furthermore, serration angioplasty reduces turbulence or flow disruption of the blood flow in the treatment area, forming a smoother blood vessel inner surface. Serration angioplasty can enhance the uniformity of the artery diameter throughout the treatment area. The uniformity of the blood vessel diameter or the low variability of the blood vessel diameter throughout the treatment area effectively improves the volumetric flow by suppressing local turbulence in the blood flow path. Also, serration angioplasty can reduce the friction or fluid resistance of the blood vessel wall. Furthermore, serration angioplasty can expand the local blood vessel size by relaxing the internal elastic lamina along the fracture surface. Positive remodeling increases blood flow by expanding the blood vessel size. Positive remodeling is an outward compensatory remodeling (remodeling) of the blood vessel diameter. Clinically, serration angioplasty has been shown to promote lumen expansion and reduce vascular recoil (elastic rebound) under a low residual stenosis rate.In the second stage of positive remodeling, after selection and dilation under low pressure, restoration of the lumen, including remodeling of the internal elastic lamina, is confirmed as a relaxation phenomenon within the cellular network of the vessel wall. In the final stage of positive remodeling, due to lumen dilation, the diameter of the blood vessel at the diseased site returns to the pre-disease state. Lumen dilation can restore the diameter of the blood vessel at the diseased site to the diameter of the blood vessel at the adjacent non-diseased site. Lumen dilation can restore the diameter of the blood vessel to the diameter of a normalized blood vessel. Lumen dilation can restore the diameter of the blood vessel to the average diameter of a healthy person's blood vessel.

[0039] A design that can displace the diameter of an artery to its nominal value without causing vascular injury or vascular reaction has great clinical value and is contemplated herein. Serial angioplasty enables progressive lumen dilation. Serial angioplasty can dilate a blood vessel without damaging the underlying tissue or structure. In one method, the external elastic lamina is not penetrated and remains intact. In one method, the adventitia is not penetrated and remains intact. Serial angioplasty forms a longitudinal cleavage plane under low pressure and significantly suppresses plaque surface detachment and separation of the plaque from the vessel wall.

[0040] Most of the technologies on the market leave a residual stenosis of more than 30% and do not achieve the goal. These technologies cannot restore the blood vessel to a normalized radius or a healthy radius. Yes. As a result, the blood vessel remains with at least 30% of the ideal diameter blocked. The residual stenosis is due to the inefficiency of the technique to restore the blood vessel to its nominal diameter or the post-treatment decrease in diameter (often called recoil). Recoil can be caused by the inherent properties of the diseased blood vessel. This blood vessel is temporarily expanded by an angioplasty balloon, but when the pressure of the balloon is removed, it tries to return to its pre-treatment diameter. Recoil can occur even if calcium deposits are disrupted during angioplasty. There may be ring-shaped elastic layers in the blood vessel itself that form the boundaries between the vessel layers. Also, the blood vessel itself may contain elastin fibers. The elastic structure within the blood vessel plays an important role in the rheology function (flow characteristics function) by regulating the inner diameter of the blood vessel. However, these same elastic structures can contribute to recoil after angioplasty. The blood vessel has a tendency to return to its original diameter. Therefore, angioplasty, which expands the wall of the blood vessel, opposes the natural tendency of the blood vessel to return. Residual stenosis can be caused by the application of pressure not being permanent and remaining only a temporary vascular remodeling. Recoil is mainly caused by the elastin in the artery that was not destroyed. Elastin has the property of trying to return to its original state. Therefore, expanding the blood vessel during angioplasty is similar to the act of stretching a rubber band. When the pressure of the balloon is removed, the blood vessel tries to return to its original diameter. Also, to a lesser extent, recoil can be caused by non-modified plaques. Plaques also try to return to their original diameter. When the pressure of the balloon is removed, the elastin of the blood vessel can recover alone or in combination with residual plaques, significantly reducing the lumen enlargement effect. After angioplasty, when the balloon pressure is removed, the blood vessel generally returns and the diameter decreases. The degree of recoil correlates with many variables such as the location and size of the lesion, patient-specific factors, and the treatment device used. The elastic recoil of the blood vessel causes residual stenosis and is a significant limitation in current technology.

[0041] To promote blood vessel growth, angioplasty with a serration design offers multiple unique advantages, including low-pressure angiography. This low-pressure angiography enables the examination of blood vessels using a contrast agent. Serrated angioplasty has the advantage of enabling calcium fragmentation (lithotripsy; also called pulverization). This allows for subsequent or simultaneous treatment of the plaque surface. In one method, additional energy such as ultrasonic, electrical, or hydraulic shock waves is applied to the plaque. The pulverization using serrations is valuable in that it can break the plaque into smaller particles whether ultrasonic or shock waves are used or not. This enables more effective vasodilation and facilitates the delivery of therapeutic agents to deep tissues through the diseased area. Serrated angioplasty has the advantage of enabling intimal dissection with linear disruption. The serration lines are arranged longitudinally within the blood vessel. The intima is the inner layer located near the lumen of the blood vessel. In one method, the plaque is buried beneath the intima or adheres to the intima. Serrations can penetrate the intima and / or the internal elastic lamina and initiate the generation of a dissection plane. The dissection plane can progress through at least one of the intima, the internal elastic lamina, and / or the media. Serrated angioplasty has the advantage of enabling the expansion of the blood vessel lumen without accompanying blood vessel rupture. The dissection plane does not progress through the entire layer of the blood vessel. The dissection plane does not pass through the adventitial layer. The dissection plane does not pass through the connective tissue. The dissection plane does not rupture the blood vessel wall. Serrated angioplasty has these advantages and at the same time can utilize conventional angioplasty techniques. Examine the design and methods aimed at suppressing residual stenosis after treatment and increasing the volumetric flow rate through the blood vessel.

[0042] In blood vessels with poor or completely blocked blood flow over a long period, a myogenic mechanism has been confirmed to occur. The myogenic mechanism is a mechanism in which the muscle fibers themselves cause contraction, rather than an external stimulus. This contraction significantly reduces blood flow. For example, when the pressure inside the blood vessel suddenly rises, such as after angioplasty, the blood vessel responds by contracting. The myogenic mechanism is described in the literature as "recoil" or more generally "vasospasm". This is a phenomenon. It is part of the autoregulatory mechanism that maintains a constant blood flow even under different pressures in blood vessels. This response is caused by the blood vessels themselves. When the pressure inside the blood vessels decreases, the blood vessels relax and vasodilation occurs. When the balloon in angioplasty is removed, the autoregulatory mechanism causes contraction and suppresses the enlargement of the blood vessel lumen.

[0043] Serration angioplasty can suppress the blood vessels from undergoing myogenic mechanisms and subsequent vasospasm by penetrating the internal elastic lamina of the blood vessels. Also, serration angioplasty can suppress the contraction of muscle cells by penetrating the internal elastic lamina. The periphery of the blood vessel is blocked along the dissection plane, thereby suppressing the contraction ability of muscle fibers. Furthermore, serration angioplasty can change the autoregulatory mechanism that contracts the blood vessels to maintain a constant (i.e., reduced) blood flow. Also, by performing serration angioplasty at a low pressure, it can penetrate the internal elastic lamina and promote separation along the serrated line at the penetration site. The wedge incision instrument described in this specification can form a depression on the plaque surface under low pressure. The wedge incision instrument can initiate crack propagation in the plaque and the layers of the blood vessel. Crack propagation can be understood as two processes, namely, the penetration action by the wedge incision instrument and the shear stress effect in a plane oriented in the loading direction. The wedge incision instrument initiates cracks. However, when the end of the wedge incision instrument is not sharp, it does not cut or score the plaque and its underlying tissue. Rather, a low-pressure balloon causes shear in the plane, leading the tissue layer to a controlled and gentle crack propagation. The tension applied by the balloon to the blood vessel lumen surface and the plaque promotes the stable growth of the crack plane (dissection plane). Performing the balloon procedure at a low pressure prevents unstable crack propagation and rupture. The depth of the dissection plane can be mainly controlled by the initial penetration depth of the wedge incision instrument and low-pressure balloon angioplasty. The growth of the crack is controlled to pass through specific layers of the blood vessel wall, and other layers are kept intact.

[0044] The serration technique is the only known method that can precisely control the starting and ending points of the dissection plane. The dissection plane can pass through at least a part of the intima, internal elastic lamina, and / or media. In one method, the crack propagation can stop before reaching the external elastic lamina. In one method, the crack propagation can stop before reaching the adventitia. In one method, the crack propagation can stop before passing through the adventitia. The crack propagation can stop due to the limitation of the driving force from the low-pressure balloon. The crack propagation can stop due to the shallow initial penetration depth that initiates the crack. The crack propagation can stop due to the change in the layer composition. The crack propagation can stop due to the increase in the resistance by the layers. The crack propagation can occur gently and stably. The crack propagation can occur over a long period of time. The 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 in the range of any two of these values. In some cases, the external elastic lamina is also penetrated, and separation can be promoted while minimizing extracellular trauma and histological reactions during cell separation. The crack can pass through the external elastic lamina. The crack can pass through the adventitia. The adventitia is the outermost layer of the blood vessel and contains tissues, nerves, and nutrient blood vessels. The crack propagation under low pressure can pass through the layers of the blood vessel at a gentle and stable rate. The crack propagation can block around the blood vessel and longitudinally divide the blood vessel at the treatment site. The crack propagation under controlled low pressure minimizes trauma to individual cells and tissues. In some cases, it does not penetrate the external elastic lamina.

[0045] Designs that modify tissue in a more natural and less damaging way are thought to be useful for tissue healing. Without being bound by theory, controlled, gentle, and low-pressure expansion and crack propagation are similar to a gentle pulling action that separates tissue at the cellular level. This is in contrast to the cutting action where the blade tip uses high pressure to push aside the material. The cutting blade crushes a wide range of cells under its tip. Instead of relying on a cutting blade, serration relies on crack propagation that can progress through a single row of cells. The crack separates adjacent cells and can significantly reduce damage to the cells. Crack propagation can occur at a lower pressure than the pressure required for cutting. The low pressure is not for cutting or scoring the tissue but for continuing gentle crack propagation It is only necessary for the scalpel. The separating force does not depend on a strong force concentrated at the cutting edge, but is imparted by stretching the tissue by the tension on the surface of the blood vessel wall and further advancing the crack. For this reason, the serration technique can achieve cell separation superior to the sharpest scalpel. The crack can progress between cells thinner than the thinnest cutting edge. The wedge dissector itself does not pass between cells, but the crack initiated by the wedge dissector progresses between cells. The crack can progress under low pressure. The serration technique can form a longitudinal dissection plane in a more natural form by separating the tissue at the cell level. This separation can reduce trauma by affecting a smaller surface area. This separation can reduce trauma by having less impact on cells. This separation can reduce trauma by gently and controllably spreading the cells along the crack. In some cases, this gentle tearing can make the tissue easier to repair. During the tissue repair process, cells move to the crack site and eventually form granulation tissue, which matures into scar tissue. In some cases, the scar tissue can restore the tissue structure and function over time. The crack can form a thin and narrow line between cells. This is easier to repair than a thick cut surface or laceration and can shorten the healing time. The crack may be formed with a shallow penetration depth and may be easier to repair than a deep laceration. The crack is formed along the blood vessel within a range limited to the length of the lesion and may be easier to repair than a long cut. Furthermore, the reduction of trauma to cells can promote healing. The assumed designs including these serrations can provide advantages such as shortening the healing time and improving cell repair by minimally tearing the tissue at the macroscopic anatomical level and promoting separation at the cell level. Also, in some cases, in these designs, the formation of the tear site at a shallow depth and short length can suppress trauma to cells and promote cell repair.

[0046] In angioplasty, in one method, a balloon having a diameter at expansion that is larger than the predicted diameter of the blood vessel can be used. This can be expressed as a ratio of the predicted diameter of the blood vessel to the diameter of the balloon. For example, a ratio of 1:1 indicates that the predicted diameter of the blood vessel and the diameter of the balloon are equal. In this example, if the predicted diameter of the blood vessel is 5 mm (full-width), a 5 mm (full-width) balloon can be used. As described herein, due to the autoregulation mechanism of the blood vessel, the blood vessel can contract and recoil can occur after balloon removal. In one method, the ratio is different from 1:1 and can be, for example, 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 indicates using a balloon that is larger than the predicted diameter of the blood vessel (equal to 1.1 times the diameter of the blood vessel). In this example, if the predicted diameter of the blood vessel is 5 mm, a 5.5 mm balloon can be used. Further, a ratio of 1:2 indicates using a balloon that is larger than the predicted diameter of the blood vessel (equal to 2 times the diameter of the blood vessel). In this example, if the predicted diameter of the blood vessel is 5 mm (full-width), a 10 mm balloon can be used.

[0047] Celiation angioplasty can use a balloon having a diameter at expansion that is larger than the predicted diameter of the blood vessel. In one embodiment, the use of a celiation structure design having a balloon ratio of 1:1.1 with respect to the diameter of the reference blood vessel can promote acute-phase blood vessel radius expansion and minimize blood vessel reaction or vasospasm. Further, to expand the diameter of the blood vessel further, it is envisioned to use a balloon size with a ratio greater than 1:1.1 with respect to the reference blood vessel diameter. The ratio of the celiation angioplasty balloon to the reference blood vessel diameter is envisioned to be 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, and values between these ratios. The celiation balloon design can allow for further growth of the blood vessel and achieve better residual blood flow and low residual stenosis. This includes designs where the balloon ratio to the blood vessel exceeds 1::1.1.

[0048] Equation 2: Using Poiseuille's law, the percentage of the total flow that the blood vessel can produce is , directly correlated to the residual stenosis that impedes blood flow and as a result can be calculated to limit the total flow. When the blood vessel is dilated to its pre-disease diameter or its original reference vessel diameter, the volumetric flow approaches 100 percent (Figure 2). A 1:1 ratio is sufficient when no other factors such as cells or systemic mechanisms that promote vasoconstriction of the blood vessel when the outward force of the balloon is removed are acting. The balloon structure and the outward force on the diseased blood vessel suppress vasoconstriction during balloon dilation. However, when the balloon is removed, other cellular structures such as elastin rings including but not limited to muscle fibers and the internal elastic lamina may contract autonomously due to their inherent properties. There are several mechanisms that can cause the blood vessel to contract after balloon deflation. The blood vessel, interstitial tissue, and muscle tissue itself can oppose angioplasty via recoil.

[0049] Vascular recoil after angioplasty is understood to be caused by a combination of multiple factors including the elastic or inelastic properties of the arterial wall, as opposed to the mechanical forces applied during the procedure.

[0050] During angioplasty, when the balloon is inflated within the stenotic or occluded portion of the diseased artery, an outward pressure is applied to the arterial wall. The pressure from the inflated balloon stretches the blood vessel wall, causing the blood vessel wall to expand and the occluded portion to widen. As a result, the diameter of the blood vessel is temporarily increased. However, immediately when the balloon is deflated and removed, the blood vessel wall contracts inward, and it is known that the increase in diameter obtained during angioplasty decreases, which is understood as recoil.

[0051] The degree of recoil varies depending on the patient's specific anatomical structure, disease state, and the location of the vascular occlusion site. When the blood vessel wall is particularly hardened or fibrotic, the blood vessel wall may be more prone to recoil after balloon removal. Additionally, if the balloon is not inflated to an appropriate pressure or if the size of the balloon is too small for the blood vessel, the balloon may not stretch the arterial wall sufficiently, resulting in incomplete dilation and an increased risk of recoil.

[0052] In some cases, the use of a stent can provide a support structure that holds the vessel wall open after angioplasty and can prevent recoil. However, stents are not necessarily required or desirable for all patients or all occluded sites. Instead, the scoring techniques described herein address recoil through vascular remodeling (remodeling) through more permanent changes to the radius of the blood vessel. Vascular remodeling can be more long-term. Also, this vascular remodeling can be non-acute. While other angioplasty techniques can temporarily change the vessel diameter, the scoring technique provides a sustained change over a period of minutes, hours, days, months, etc. after the procedure. The scoring technique significantly suppresses recoil and achieves a more permanent change in the vessel diameter. Also, the scoring technique has the ability to dilate the blood vessel to suppress recoil, and it is desirable to secure the largest lumen and as a result enable the largest volume of blood flow. As described herein, a slight increase in radius can quadruple blood flow. Similarly, a slight reduction in residual stenosis can also quadruple blood flow. Thus, a permanent change in radius or stenosis can result in clinically significant outcomes. Further, this specification describes a scoring angioplasty that can achieve the largest volume of blood flow with minimal vascular damage. This example is not limiting. The disclosure includes other examples that can achieve the largest volume of blood flow with minimal vascular damage. Also, the disclosure includes other examples of vascular remodeling. Further, the disclosure includes other examples related to a permanent increase in radius and a reduction in stenosis.

[0053] The scoring angioplasty technique described herein creates a series of weak lines longitudinally oriented along the axis of the blood vessel and promotes dilation of the artery by balloon pressure. This dilation is achieved at a lower pressure than conventionally. By the low-pressure dilation of the balloon, the artery is gradually dilated and the cracks gradually progress. This low-pressure dilation is slow and controlled. The scoring A series of serrated cracks caused by Yon suppress the typical vasoconstriction physiology that occurs with conventional angioplasty alone. The serration technique reduces recoil by the way in which tissue and plaque are separated. Serrated angioplasty provides the greatest chance for the blood vessel to reach the reference vessel diameter. Also, serrated angioplasty achieves a predictable and reproducible lumen increase. Furthermore, serrated angioplasty enables control of the depth of crack progression and forms distinct circumferential segments in the vessel wall. The contractile force is essentially limited by the dissection plane, and the contractile ability of muscle fibers is suppressed. In the study of serrated angioplasty technology, when the evaluation goal of the test of 30 percent residual stenosis was not met, physicians were recommended to expand the balloon diameter by 0.5 mm. For example, when the target diameter was 5 mm and the residual stenosis exceeded 30 percent, physicians increased the ratio from 1:1 to 1:1.1 and used a 5.5 mm balloon. This expansion of the balloon diameter resulted in acute-phase blood vessel radius expansion with minimal vasoconstriction. Also, this expansion of the balloon diameter improved hemodynamics by reducing residual stenosis. A technique of selecting a balloon diameter exceeding the reference vessel diameter has been conceived to improve hemodynamics and vascular regulatory functions at the cellular and systemic levels. Such a technique includes expanding the serrated angioplasty balloon and aiming for a balloon diameter more than 1.1 times the blood vessel size. This technique can 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 for using a large-diameter balloon exceeding the target diameter of the blood vessel.

[0054] As known findings regarding blood vessel measurement, it has been reported that blood vessel dimensions by angiography (angiogram) are shown to be smaller than the measurement results by intravascular ultrasound or optical coherence tomography. An angiography image is a blood vessel examination by X-ray technology using a radiopaque substance. An angiography image provides visual information on the blood flow path but does not provide visual reference information on the layer thickness of the tunica media and adventitia. The diseased state of blood vessels causes diversity in the thickness of blood vessel layers, which may make it difficult to accurately understand the original or normal diameter of blood vessels. As a result, generally used angiography measurements may generate images that are likely to misidentify the true normal blood vessel diameter. This misidentification of the image may cause a doctor to select an undersized treatment size for the true normal blood vessel diameter, and there is a possibility that the lumen volume capacity of the transport blood vessel cannot be maximally exerted. Cellation angioplasty is designed to more completely expand blood vessels and reduce blood vessel recoil, and can provide treatment using a treatment size of 1:1.1 or more with respect to the blood vessel size. As treatment options, for the blood vessel size, balloon sizes in the range 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., or 1:2, and further 1:1 or more, 1:1.1 or more, 1:1.2 or more, 1:1.3 or more, 1:1.4 or more, 1:1.5 or more, 1:1.6 or more, 1:1.7 or more, 1:1.8 or more, 1:1.9 or more, 1:2 or more are selected, and it is envisioned to provide a great advantage of increasing the blood volume rate. In one embodiment, the expansion of the balloon size can prevent incomplete expansion. In one embodiment, the expansion of the balloon size can reduce the risk of recoil. In one embodiment, the expansion of the balloon size can increase the blood vessel radius and result in a four-fold increase in blood flow with respect to the percentage increase in the radius. In one embodiment, the expansion of the balloon size can reduce blood vessel stenosis and result in a four-fold increase in blood flow with respect to the percentage decrease in the stenosis rate. Cellation angioplasty can be designed to more completely expand blood vessels and achieve a stenosis rate of less than 30 percent.

[0055] There is a continuing need to improve methods of treating occlusive diseases, including balloon angioplasty and other related treatment systems. In some embodiments, there is a need for the ability to inexpensively attach a local intimal disruption device. Such balloon designs require innovative approaches to manufacturing, such as effectively providing features on the balloon surface with a minimal additional cost relative to the cost of the balloon. Embodiments that can fuse or integrate features within or directly into the balloon blow molding cycle enable significant cost savings and more effective balloon designs. Embodiments with desirable balloon features, such as pushability, crossing ability, profile, robustness, flexibility, drug delivery capabilities, etc., are envisioned and can be incorporated into balloon designs, including diameter, length, and conical shape, such that all can be incorporated regardless of features protruding above the balloon surface. In all embodiments, features and processes are incorporated that singly or collectively facilitate strategic cost reduction of catheter-based balloon designs.

[0056] (Features of the balloon) Pushability, crossing ability, and flexibility are all functions desired in endovascular treatment techniques. Many of the envisioned designs incorporate longitudinally oriented structures that are incorporated between polymer layers. In one embodiment, the main shaft includes a longitudinally oriented structure. In one embodiment, the inner member includes a longitudinally oriented structure. In one embodiment, the balloon includes a longitudinally oriented structure. The longitudinally oriented structure may be in the form of a strip. The longitudinally oriented structure may be in the form of a ridge. The longitudinally oriented structure may include the same material as the main shaft, inner member, or balloon to which the longitudinally oriented structure is attached. The longitudinally oriented structure may include a different material from the main shaft, inner member, or balloon to which the longitudinally oriented structure is attached. The longitudinally oriented structure may include the same density as the main shaft, inner member, or balloon to which the longitudinally oriented structure is attached. The longitudinally oriented structure may include a different density from the main shaft, inner member, or balloon to which the longitudinally oriented structure is attached. The longitudinally oriented structure may provide structural stability. The longitudinally oriented structure may allow for energy transfer across the balloon body. The longitudinally oriented structure may include one or more structures. The longitudinally oriented structure may be circumferentially disposed around the main shaft, inner member, or balloon to which the longitudinally oriented structure is attached. The longitudinally oriented structures may be equally spaced. The longitudinally oriented structures may be unequally spaced. The main shaft, inner member, or balloon may include a single longitudinally oriented structure or one or more longitudinally oriented structures.

[0057] In one embodiment, the longitudinally oriented structure can assist in energy transfer from the user and improve the pushability of the device. The longitudinally oriented structure can assist in energy transfer from the user and improve the crossability of the device. The longitudinally oriented structure can assist in energy transfer from the user and improve the trackability of the device. The longitudinally oriented structure can enable the device to maintain flexibility as it progresses within a blood vessel. Therefore, it is required to improve pushability and crossability while maintaining flexibility and trackability. By including a longitudinally oriented structure in the main shaft, inner member, or balloon, raised portions made of a denser material can assist in energy transfer, improve pushability, and minimize a decrease in trackability. Two typical design criteria in the design of a balloon catheter are pushability and trackability, i.e., navigation ability. The catheter needs to be advanced from the proximal end and pass through the blood vessel. Also, the catheter must progress through a highly curved and flexible blood vessel. However, increasing pushability usually decreases navigation, i.e., trackability, so these two characteristics are contradictory. The serrated balloon partially reconciles this contradictory requirement with a longitudinally oriented structure. The longitudinally oriented structure can be composed of metal, polymer, or other rigid or semi-rigid materials. The longitudinally oriented structure can provide structural stability in energy transfer across the balloon body. Further, the longitudinally oriented structure can provide structural stability while maintaining flexibility when passing through anatomically complex curves. When metal is used, the material flexibility of the longitudinally oriented structure can be improved by one, two, three, four or more annealing processes. Annealing can be performed at a lower temperature than annealing, for example, less than 300 °C, or generally in the range of 300 °C to 400 °C, or even in the range of 400 °C to 500 °C. The longitudinally oriented structure is a wedge It may be a strip with a shape cutting device. The structure oriented in the longitudinal direction deflects along its length, thereby improving the navigation ability. Two or more structures oriented in the longitudinal direction can bend independently of each other. The structure oriented in the longitudinal direction has resistance to compression. Further, it can allow bending in a specific direction while suppressing bending in other directions. In one embodiment, the structures oriented in the longitudinal direction are not coupled to each other. Also, the structures oriented in the longitudinal direction can be arranged at intervals from each other. The structure oriented in the longitudinal direction curves along the blood vessel. The structure oriented in the longitudinal direction transmits the pushing force of the user. The structure oriented in the longitudinal direction can transmit force without bending in the longitudinal direction. The structure oriented in the longitudinal direction can transmit force without bending in the longitudinal direction. With these features and the arrangement of the structure oriented in the longitudinal direction, the balloon has high push-through ability and the ability to pass through very hardened lesion sites. The ability to pass through this total occlusion or highly stenotic occlusion site is due in part to the improved rigidity provided by the beam-like structure oriented in the longitudinal direction of the strip (strip) to the balloon body. The beam-like elements in the longitudinal direction of the strip are oriented symmetrically about the surface of the balloon body, improving the column strength. By improving the column strength due to the beam-like structure of the strip, the push-through ability and the passing ability are improved. The beam design of the strip having a flat bottom and periodically raised wedge-shaped cutting devices provides a flexible and flexible beam, minimizing brittleness and maintaining column strength while improving flexibility and torque ability. When the beam of the strip is captured or held in a laminate (stack) of balloon layers, the beam becomes more stable. After pleating the strip under the folded portion of the balloon wing and compressing (crimping) the balloon wing onto the strip, in addition to the strip, the layer of material forming the balloon layer improves stability and the ability of the balloon to transmit force from the delivery catheter to the balloon distal end and catheter tip (see FIG. 79). The longitudinally oriented structure, such as a beam, embedded and folded in the balloon strengthens the column strength of the balloon and improves the energy transmission from the delivery catheter to the balloon body to the catheter tip.A longitudinally oriented structure significantly improves pushability while not adversely affecting the navigation ability to the lesion site. Further, the strip can be designed to avoid buckling and bending along the column while exhibiting bending and flexure when passing through the blood vessel.

[0058] In some embodiments, drug uptake from a drug-eluting balloon at a treatment site within a blood vessel is improved by a method of pretreating the site within the blood vessel by expanding a pretreatment balloon at the site to form a plurality of microcracks in the media layer of the blood vessel wall. Examples of pretreatment balloons have a plurality of strips. Each strip includes a plurality of wedge dissectors spaced along the surface of each strip. These strips extend longitudinally along the outer surface of the pretreatment balloon. The pretreatment balloon according to this embodiment is then deflated and optionally rotated by an angle different from the spacing between the strips along the circumference of the balloon. As a non-limiting example, if there are four wedge dissectors at 90-degree intervals along the circumference of the balloon, the balloon can be rotated, for example, 45 degrees and then reinflated to form new serrations, i.e., sawtooth marks, along the blood vessel wall where there was previously none. Then, the pretreatment balloon is reinflated so that the strips of the pretreatment balloon are positioned at a different position than at the original inflation, and the wedge dissectors are positioned at positions to form serrations in areas of the blood vessel wall that were previously without serrations (also referred to as sawteeth, sawtooth marks). In a clinical setting, due to the degree of vascular tortuosity and disease of an individual, it is understood that the effects of a specific or intentional rotation become complex. The need to predict the rotation angle is not so important, and by having the physician inflate, deflate, pull the balloon back at least 1 cm, rotate the proximal hub, and then reinsert the balloon, it is generally expected that the balloon will rotate and be at a different angle than at the first inflation. Then, the pretreatment balloon is removed and the drug-eluting balloon is placed at the site. The drug-eluting balloon expands to contact the blood vessel wall, and the drug passes from the surface of the drug-eluting balloon through the microcracks, through the intima, and optionally through the internal elastic lamina. It is also possible to penetrate into the tunica media or other subintimal tissue layers. In some embodiments, the pretreatment balloon can optionally be rotated between about 1° and about 180°, or aiming at the angle for separating the angiotome. Usually, the angiotomes are circumferentially spaced apart by dividing 360°. Thus, when there are three angiotomes, the circumferential spacing is the value obtained by dividing 360° by 3, that is, 120°. In some embodiments, after rotating the balloon one turn in the first direction, it can be repeatedly rotated one, two, three, four, five or more times in the same direction or the opposite direction to increase the number of serrations (sawtooth marks) on the blood vessel wall.

[0059] In a non-limiting example, after being rotated, the balloon can be expanded again to create new dissections at sites on the vessel wall where no dissections have been formed so far. The balloon can be rotated through 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 over a range including two of these values. In a non-limiting example, the balloon is expanded to create an initial group of dissections. Next, the balloon is contracted, rotated, and then expanded again to create a new group of dissections. The balloon can be rotated in place to form a second group of dissections on the same vessel segment. Also, the balloon can be rotated to create new dissections at sites where no dissections have been formed so far. In a non-limiting example, when four strip-shaped wedge dissection devices are arranged at 90-degree intervals, by rotating the balloon 45 degrees, dissections can be provided at equal intervals around the vessel. In a non-limiting example, when four strip-shaped wedge dissection devices are arranged at 90-degree intervals, by rotating the balloon less than 45 degrees, dissections can be provided at unequal intervals around the vessel. In a non-limiting example, when three strip-shaped wedge dissection devices are arranged at 120-degree intervals, by rotating the balloon 60 degrees, dissections can be provided at equal intervals around the vessel. In a non-limiting example, when three strip-shaped wedge dissection devices are arranged at 120-degree intervals, by rotating the balloon less than 60 degrees, dissections can be provided at unequal intervals around the vessel.

[0060] In some embodiments, the pre-treatment method of the site is achieved using a wedge dissection device having a radially outer-facing surface having a shape approximating a rectangle, an ellipse or an ellipse. In some embodiments, the shape is generally more elliptical, but the arc from the minor axis to the apex of the major axis does not follow basic ellipse mathematics. Under such conditions, the final shape is closer to a sharper ellipse.

[0061] In some embodiments, the method of depositing a drug through serrations (saw marks) in tissue uses a pre-treatment balloon. The pre-treatment balloon has an elongated member having an inner passage defining a longitudinal axis, an inflatable balloon connected to the elongated member at the distal end of the elongated member, and a plurality of strips. Each strip has a plurality of wedge dissection devices spaced along the surface of the strip. Each strip extends longitudinally along the outer surface of the balloon. The wedge dissection device of this example has a strip-facing base surface that is directly adjacent to the surface of each strip, a radially outer-facing surface that is not honed (hereinafter also referred to as the radially outer surface), and a side surface between the strip-facing base surface and the radially outer surface. The radially outer surface has a length between the proximal edge and the distal edge of the surface and defines the height of each wedge dissection device. The radially outer surface has a first width at the proximal edge, a second width smaller than the first width between the proximal edge and the distal edge, and a third width larger than the second width at the distal edge. The second width corresponds to a single point along the length of the radially outer surface, or the second width corresponds to a central segment having a central length between the proximal edge and the distal edge. Each The length of the strip may be less than the length of the outer surface of the balloon coaxial with the length of the strip, or alternatively, the length of each strip may be about 1% to about 50% less than the length of the outer surface of the balloon coaxial with the length of the strip. The total length of the radially outer surface of each wedge cutting device may be less than the total length of the base surface facing the strip of each wedge cutting device. In another example, the radially outer surface has a curved surface, or has a chamfered surface, or has a first height at the proximal edge and a second height between the proximal edge and the distal edge, and the second height is greater than the first height. In some embodiments, the maximum height of the radially outer surface is at the midpoint between a first edge without a boundary and a second edge without a boundary. The maximum height of the surface without a boundary may be offset from the midpoint between the proximal edge and the distal edge. The side segment of the wedge cutting device from the base surface facing the strip to the proximal edge may have one or more parabolic inclined surfaces such as those generated by chemical etching. The tip of the strip is usually connected to the tip of the carrier. The shape of the tip of the carrier usually has features with similar inclination and dimensions as the strip.

[0062] In some embodiments, the method of attaching the wedge cutting device can be achieved by providing a strip including a plurality of wedge cutting devices spaced longitudinally along the surface of the strip, whether or not the medical balloon has serrations. Each of the wedge cutting devices has a strip tip-facing carrier tip surface facing the tip of the strip. Due to the fact that the carrier and the strip tip are etched from the same material and remain attached, when the carrier is separated from the strip tip, a non-polished (honed) radially outer surface is formed. When separated, the freed radially outer surface has a length between the proximal edge of the radially outer surface and the distal edge of the radially outer surface, defines the height of each wedge cutting device, and has a side surface between the base surface facing the strip and the radially outer surface.

[0063] In some embodiments, the unhoned radially outer surface of each wedge dissection device is attached to a carrier of the unhoned radially outer surface in the attachment region. The region between the attachment regions defines a void, and the strip has a second surface opposite the first surface of the strip. Next, the second surface of the strip is placed into a collet for blow molding the balloon and is positioned at the final placement location of the second surface within or integrally with the medical balloon or adjacent to the surface of the balloon. After the second surface of the strip is attached to the medical balloon, the carrier of the strip is separated from the strip. The second surface of the strip is adhered to the surface of the medical balloon by an adhesive and / or attached to the surface of the medical balloon by other processes such as fusion and / or lamination. The separation of the strip carrier from the strip can be achieved using mechanical force, laser cutting, or other means. The strip carrier may be integrally formed with the strip. Optionally, the strip carrier and the strip are created using chemical etching.

[0064] In some embodiments, a carrier system for attaching a wedge cutting device to a medical balloon has a strip having a plurality of wedge cutting devices spaced longitudinally along a surface of the strip. Each of the wedge cutting devices has a base surface facing the strip directly adjacent to a first surface of the strip, a radially outer surface that is not honed, and a side surface between the base surface facing the strip and the radially outer surface. The radially outer surface has a length between a proximal edge and a distal edge of the radially outer surface and defines the height of each wedge cutting device. The strip has a second surface opposite the first surface of the strip, and the strip carrier has a free end. The non-honed radially outer surface of each wedge cutting device is generally an attachment area that reflects the shape and periodicity of the wedge cutting device and is attached to the free end of the strip carrier. There are gaps between the attachment areas, and the attachment areas are configured to be separated when a mechanical force or a repeated bidirectional torsional force is applied. In one example, the carrier system together with the strip is formed from a metal such as stainless steel. Other suitable materials include polymers, copolymers, novel materials of composite compositions, etc. Composite compositions and the like.

[0065] In one method, attachment of the strip to the balloon is completed during balloon blow molding or in a second, third, or any number of steps after balloon blow molding. In this method, the carrier is designed to be integrated with the balloon blow molding mold. In one blow molding method, a strip having a conforming material such as a polymer or copolymer layer on its outer surface is used. The coating amount is typically set to wrap around the base portion of the strip, and in one example, is set to form an area near the base portion of the strip on the balloon surface that functions as a protective floor for the strip to lie on. Coating of the strip can be performed in various ways such as dipping, painting, lamination, preform adhesion, etc., but is not limited thereto.

[0066] A number of approaches can be utilized to laminate materials. In some examples, it is disclosed to use lamination for the purpose of explaining the joining of a metallic strip to the outer surface of a balloon.

[0067] When using a stack of laminate layers (laminate), the components of the strip are typically integrally formed with a long metallic sheet or roll having thousands to millions of strips per roll. The metallic roll is usually chemically etched to form the intended design of a carrier and a strip having a desired wedge cross-sectional shape. The etched roll is then laminated with a polymer, copolymer or fiber-reinforced polymer, typically resulting in a sandwich-like structure laminated on both sides.

[0068] In some of the examples, one or more polymer layers can include a fiber-reinforced polymer applied to the laminate, including reinforcing fibers embedded in the polymer. The polymer also acts as various interlayer bonding means. Examples of reinforcing fibers suitable for use in fiber-reinforced polymers include, for example, glass fibers, carbon fibers, metal fibers, and, if necessary, aramid fibers, PBO fibers (Zylon), M5 fibers, ultra-high molecular weight polyethylene or polypropylene fibers and other drawn thermoplastic polymer fibers, and / or combinations of the above fibers can also be mentioned. Also, entanglements of fibers such as rovings and / or entangled bundles may be used. Such rovings include reinforcing fibers and thermoplastic polymers in fiber form. Examples of matrix materials suitable for reinforcing fibers include polyamides, polyimides, polyethersulfones, polyetheretherketones, polyurethanes, polyethylenes, polypropylenes, polyphenylene sulfides (PPS), polyamideimides, acrylonitrile butadiene styrenes (ABS), styrene / maleic anhydride (SMA), polycarbonates, polyphenylene oxide blends (PPO), polyethylene terephthalates, thermoplastic polyesters such as polybutylene terephthalate, and mixtures or copolymers of one or more of the above polymers.

[0069] In an example of attaching the strip to the balloon, it is envisioned that the polymer is directly contained in the base portion and / or the side surface of the strip. In one method of manufacturing the strip, the use of chemical etching is envisioned, but other methods using electrochemical machining or other low-cost, mass-producible top-down (material removal) processes or bottom-up (material deposition) processes are also envisioned. The strip can be formed by removing material so as to form a fenestration device. The strip can be formed by adding material so as to form a fenestration device.

[0070] As schematically shown in FIG. 2, when the strip is manufactured from a reel of material, the use of a secondary process such as lamination is envisioned to provide polymer layers on both sides (upper and lower) on the base of the strip.

[0071] The lamination process can capture a reel-shaped strip of stainless steel and lay down a sandwich of materials, generating a fused surface of material that can effectively adhere to a flexible balloon and flex with the non-flexible strip material, as schematically shown in one example of FIG. 3.

[0072] In some configurations, the catheter further comprises an expandable member associated with the catheter.

[0073] In some configurations, the expandable member includes a balloon.

[0074] In some configurations, the expandable balloon includes a plurality of strips, each strip including a plurality of wedge-shaped fenestration devices thereon.

[0075] In one configuration, it is envisioned that additional benefits can be added by using an additional energy source in combination with the serrations on the outer surface of the balloon. In one embodiment, the additional energy source may be spaced apart from the catheter with the balloon and the angioplasty device. In one embodiment, the additional energy source may be integrated with the catheter with the balloon and the angioplasty device. The energy source can supply energy in combination with the serrations on the outer surface of the balloon. The energy source can provide various functions such as plaque compression, crack progression, medial plaque disruption, intimal plaque disruption, lesion pretreatment, and / or plaque disruption. One such energy source is energy from ultrasonic vibrations, ultrasound, or sparks that may be emitted from a transducer within the balloon body. In one embodiment, in the case of vibrational energy, the energy can be transmitted through the guide wire of the catheter. In one embodiment, in the case of vibrational energy, the energy can be transmitted through other separate and independent elements such as metal elements. The vibrational energy can be transmitted using longitudinal, radial, or torsional vibrations or any combination thereof. In one embodiment, acoustic energy or other energy can be transmitted through the medium (often a liquid, optionally a gas) filling the balloon, through the balloon wall and the plurality of bands. In such a design, the angioplasty device may have the same or slightly different shapes so as to effectively convert acoustic waves or sonic energy into tissue. Thereby, the design of the angioplasty device enables more effective transmission of acoustic energy or other energy to diseased tissue. In some embodiments, supply by pneumatic energy or hydraulic energy is envisioned. It is envisioned that the use of additional energy sources such as ultrasound, pneumatic and / or hydraulic, sparks, or other energy sources may require fewer serrated bands to achieve effective results. Furthermore, with fewer wedges and wider gaps, the period of the angioplasty device can be made longer to obtain effective results. Effective results can also be obtained by making the shape of the wedge shallower or shorter.Another advantage of combining multiple energy modalities (e.g., ultrasound and pressure) with a serrated structure (serration) is that it can simplify the structure of the ultrasound or other energy emitting source. Thus, in some cases, the use of 3, 2, or 1 transducer, arc generator, or pneumatic and / or hydraulic pump may be preferred for effective lumen dilation or fragmentation of diseased states. The energy supply and serration have a synergistic effect. The energy supply may be more effective when combined with the site where the crack generated by the angioplasty instrument occurs. The angioplasty instrument can improve the energy transfer to the tissue. The angioplasty instrument can concentrate the energy supply. The angioplasty instrument can more easily penetrate the plaque when combined with the energy supply. The crack can progress more easily or rapidly by both methods. The crack can progress in a more controlled form by both methods. The combination of these multiple methods has balloons and angioplasty instruments while minimizing the drawback of poor energy transfer through the diseased tissue state. Advantages can be provided by reducing the complexity of the integrated system and by more effectively transmitting energy through diseased tissue using an angioplasty instrument.

[0076] Also described herein is a method of forming serrations or saw marks at a treatment site within a blood vessel, comprising providing a balloon catheter including a balloon having a plurality of bands. Each band includes a plurality of angioplasty instruments. The balloon catheter further includes an inner member, a tapered outer sheath, and an elongated tapered coil between the tapered outer sheath and the non-tapered inner member. The elongated coil penetrates the balloon substantially along the entire length of the balloon catheter. The balloon is expanded at a predetermined site to form a plurality of microcracks in the tunica media layer of the blood vessel wall without cutting the blood vessel wall, and the balloon is removed from the site.

[0077] Also, in this specification, a method of forming serrations in a treatment site within a blood vessel includes providing a balloon catheter including a plurality of ribbons incorporated therein. Each ribbon includes a plurality of angiotome devices attached during balloon blow molding or at any point during normal operation. The balloon catheter further includes an inner member, an outer sheath, a hub, and a tip. Further, the method includes expanding the balloon at a predetermined site to form a plurality of microcracks in the intimal layer of the blood vessel wall without cutting the blood vessel wall, and removing the balloon from the site. In one embodiment, a balloon larger than the diameter of the blood vessel assumed is selected. This selection is indicated by the ratio of the diameter of the assumed blood vessel to the diameter of the balloon. In one embodiment, the ratio can be 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 within these ranges. The blood vessel can be expanded for various clinical purposes. In one embodiment, the use of serration angioplasty can reduce the risk of scar tissue formation and suppress the possibility of long-term restenosis. Therefore, expanding the blood vessel size with a larger balloon diameter maximizes blood flow. There are also clinical needs to deliver larger devices through the blood vessel. By using a larger balloon, these larger devices can be delivered. The clinical need to deliver larger devices through the expanded blood vessel is widely known and can be difficult to achieve without causing negative clinical outcomes. Often, when expanding the blood vessel to a size beyond its original diameter, dissociation, perforation, embolism, or restenosis can occur in the blood vessel. The blood vessel can be expanded for the delivery of a larger primary or secondary therapy. In some treatment options or methods, expanding the balloon to a larger diameter causes positive remodeling, and over time, the blood vessel diameter can return to a non-diseased or healthy diameter. In some treatment options or methods, the goal is to generate the maximum possible volume of blood flow through the blood vessel. The maximum volume of blood flow can be achieved with an expanded balloon.Such balloons have 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 within these ranges. The maximum volumetric blood flow can be used for wound healing. The maximum volumetric blood flow can be used to maintain tissue viability. The maximum volumetric blood flow can be used for the healing of downstream tissue. Additionally, there may be other clinical reasons for providing the maximum volumetric blood flow.

[0078] In some configurations, the method further includes performing an index procedure at a predetermined site.

[0079] In some configurations, the index procedure is selected from the group consisting of endovascular aortic repair (EVAR), fenestrated endovascular aortic repair (FEVAR), transcatheter aortic valve replacement (TAVR), transcatheter mitral valve repair or replacement, and thoracic endovascular aortic repair (TEVAR).

[0080] In some embodiments, an intravascular device is provided. The intravascular device includes a balloon. The intravascular device includes a plurality of strips. In some embodiments, each of the plurality of strips includes a plurality of angiotome devices spaced along the surface of each strip. In some embodiments, each strip extends along the outer surface of the balloon. In some embodiments, the angiotome device includes a base surface, a surface facing radially outward that is not honed, and an inclined sidewall extending from the base surface to the surface facing radially outward. In some embodiments, the balloon is configured to expand to form a lobe between the plurality of strips. In some embodiments, the lobe applies a force to the inclined sidewall of the angiotome device to rotate the angiotome device generally from a tangential direction to a generally perpendicular direction.

[0081] In some embodiments, the lobe applies a force to the inclined sidewall of the angiotome to rotate the angiotome from a generally perpendicular direction to a generally tangential direction. In some embodiments, the intravascular device is bidirectional such that the plurality of bands are rotatable in a clockwise or counterclockwise direction. In some embodiments, the plurality of bands face counterclockwise in a generally tangential direction prior to inflation. In some embodiments, the plurality of bands point counterclockwise in a generally tangential direction after inflation. In some embodiments, the plurality of bands are generally at least partially covered by the balloon pleats in a tangential direction. In some embodiments, each band is at least partially covered by the balloon pleats when the balloon is deflated. In some embodiments, the covered band is disposed near the base of the balloon pleated wing. In some embodiments, the covered band is oriented such that the non-polished (un-honed) radially outward facing surface is tangentially positioned along the circumference of the inner member and is arranged such that the non-polished (un-honed) radially outward facing surface does not contact the balloon pleated wing. In some embodiments, the combination of the inclined sidewall and the inflation of the lobe is configured to more effectively enable control of the generally perpendicular direction of the angiotome. In some embodiments, the non-polished radially outward facing surface is configured to contact the vessel wall such that little plaque separation from the vessel wall occurs. In some embodiments, the lobe is configured to exert a tensile force on the vessel wall near the region where the angiotome contacts the vessel wall. In some embodiments, the lobe is configured to exert a force on the vessel wall to pull the vessel wall away from the angiotome. In some embodiments, the lobe is configured to exert a force on the vessel wall such that the non-polished radially outward facing surface forms serrations (saw marks) on the vessel wall. In some embodiments, the lobe is configured to exert a force on the vessel wall such that the non-polished radially outward facing surface forms a linear cut line.In some embodiments, the angled sidewall is configured to generate a plurality of longitudinally oriented lines within and / or through one or more layers of tissue in combination with the inflation of the lobe. The non-honed radially outward facing surface of each angled incision device may be configured to penetrate a layer of the vascular structure. In some embodiments, the angled wall may be configured to generate a plurality of longitudinally oriented lines through the intimal layer in combination with the expansion of the lobe. In some embodiments, the angled sidewall may be configured to generate a plurality of longitudinally oriented lines through the internal elastic lamina layer in combination with the expansion of the lobe. In some embodiments, the angled sidewall may be configured to generate a plurality of longitudinally oriented lines within the media layer in combination with the expansion of the lobe. In some embodiments, the angled sidewall may be configured to provide lumen enlargement independent of the dimensions of the artery in combination with the expansion of the lobe. In some embodiments, the angled sidewall in combination with the expansion of the lobe is configured to form a plurality of longitudinally oriented lines to an inner layer that allows for greater arterial dilation to increase volumetric blood flow. In some embodiments, the angled sidewall in combination with the expansion of the lobe is configured to form a plurality of longitudinally oriented lines to an inner layer that improves stenosis. In some embodiments, the angled sidewall in combination with the expansion of the lobe causes positive vascular remodeling. configured. In some embodiments, the angled sidewall in combination with the expansion of the lobe is configured to maintain the substantially vertical orientation of the angled incision device when the angled incision device induces nodes of separation in the intima. In some embodiments, the combination of the angled sidewall and the expansion of the lobe is configured to change the pressure distribution in the vascular wall that allows the angled incision device to further penetrate the vascular wall. In some embodiments, the balloon is configured to supply energy. In some embodiments, the band is configured to improve trackability and pushability by translating a force longitudinally along the balloon.

[0082] In some embodiments, an intravascular device is provided. The intravascular device includes a balloon. The intravascular device includes a plurality of strips. In some embodiments, each strip of the plurality of strips includes a plurality of angiotome devices spaced along the surface of each strip. In some embodiments, each strip extends along the outer surface of the balloon. The intravascular device includes a prefabricated cover (hereinafter also referred to as a prehub cover). In some embodiments, the combination of the prehub cover and the balloon having a plurality of strips is formed by inflating the balloon having a plurality of strips within the prehub cover and applying heat to the plurality of strips such that the prehub cover softens and the plurality of angiotome devices extend through the prehub cover.

[0083] In some embodiments, the prehub cover cures around a plurality of angioplasty devices. In some embodiments, each strip is adhered to the outer surface of the balloon or the base coat of the balloon with an adhesive. In some embodiments, a balloon having a plurality of strips is configured to be pleated prior to insertion into the prehub cover. In some embodiments, the adhesive is applied to the balloon having a plurality of strips prior to insertion into the prehub cover. In some embodiments, the plurality of angioplasty devices are configured to rotate from a substantially tangential direction to a substantially perpendicular direction when the balloon having the plurality of strips expands within the prehub cover. In some embodiments, the plurality of angioplasty devices have a non-polished radially outward facing surface that does not puncture the prehub cover during balloon inflation. In some embodiments, balloon inflation evenly distributes the adhesive between the balloon and the prehub cover. In some embodiments, the prehub cover provides a relatively thick layer surrounding the angioplasty device. In some embodiments, the prehub cover near the angioplasty device limits the ability of the prehub cover to tear at the space between adjacent angioplasty devices. In some embodiments, only the individual angioplasty devices extend through the prehub cover. In some embodiments, the prehub cover remains intact along the longitudinal space between adjacent angioplasty devices. In some embodiments, the prehub cover consists of a recured material that extends longitudinally along the angled sidewalls of the angioplasty device. In some embodiments, the prehub cover consists of a recured material that extends laterally along the proximal edge and / or distal edge of the angioplasty device. In some embodiments, the prehub cover, the balloon, and the plurality of strips are adhered to each other. In some embodiments, the prehub cover, the balloon, and the plurality of strips are pleated. In some embodiments, the prehub cover facilitates retention of the plurality of strips to the balloon. In some embodiments, the angioplasty device is configured to rotate from a substantially tangential direction to a substantially perpendicular direction within a blood vessel. In some embodiments, the prehub cover and the balloon are configured to function integrally to apply a tensile force to the blood vessel wall to form a linear cut line.

[0084] In some embodiments, an intravascular device is provided. The intravascular device includes a balloon. The intravascular device includes a plurality of strips. In some embodiments, each strip of the plurality of strips includes a plurality of incision instruments spaced along the surface of each strip. In some embodiments, each strip extends along the outer surface of the balloon. In some embodiments, the incision instrument comprises a base surface, an outward-facing surface, and a side wall extending from the base surface to a radially outward-facing surface. In some embodiments, the balloon is configured to expand and form lobes between the plurality of strips. In some embodiments, the lobes apply a force to the inclined side wall of the incision instrument to rotate the incision instrument from a substantially tangential direction to a substantially perpendicular direction.

[0085] In some embodiments, the intravascular device is bidirectional such that the plurality of strips are rotatable in a clockwise or counterclockwise direction. In some embodiments, the plurality of strips face in a counterclockwise direction in a substantially tangential direction before and after inflation. In some embodiments, the plurality of strips are at least partially covered by the pleats of the balloon in a substantially tangential direction. In some embodiments, the intravascular device enables more effective control of the substantially tangential direction of the wedge incision instrument. In some embodiments, the intravascular device is configured to contact the vessel wall while causing little separation of plaque from the vessel wall. In some embodiments, the lobes are configured to exert a tensile force on the vessel wall. In some embodiments, the lobes are configured to exert a force on the vessel wall and pull tissue away from the incision instrument. In some embodiments, the intravascular device is configured to form serrations in the vessel wall. In some embodiments, the intravascular device is configured to form a straight cut line.

[0086] In some embodiments, a method is provided. The method includes providing an intravascular device for angioplasty treatment that includes a balloon and a strip including a plurality of microperforators. The method includes expanding the balloon to rotate the microperforators from a first position to a more perpendicular second position. The strip is disposed between the lobes of the balloon. The method includes expanding the balloon to form serrations, depressions, and / or microperforations in the vessel wall by moving the strip radially outward and applying a force to the vessel wall. The method includes expanding the balloon at a higher pressure to propagate cracks along the serrations, depressions, and / or microperforations in the vessel wall to an inner layer.

[0087] In some embodiments, the method includes pleating the balloon. In some embodiments, the method includes placing a strip within the folds of the balloon. In some embodiments, the intravascular device comprises a strip disposed tangentially. In some embodiments, the intravascular device comprises a strip at least partially covered with balloon material. In some embodiments, the balloon is inflated at a pressure of 4 atmospheres or less to rotate the microperforation device. In some embodiments, inflating the balloon to rotate the microperforation device further includes covering the strip by pulling back the balloon material. In some embodiments, inflating the balloon to rotate the microperforation device further includes expanding the vessel wall. In some embodiments, inflating the balloon to form serrations, depressions and / or microperforations further includes holding the balloon at a pressure between 2 and 4 atmospheres for 60 seconds. In some embodiments, inflating the balloon at a higher pressure further includes holding the balloon for a short time of 60 seconds or less at a pressure between 4 and 6 atmospheres. In some embodiments, inflating the balloon at a higher pressure results in a stable, more reproducible lumen increase that is independent of arterial dimensions. In some embodiments, inflating the balloon at a higher pressure improves lumen dilation and blood flow. In some embodiments, inflating the balloon at a higher pressure improves the final stenosis by about 50% compared to the case of POBA alone. In some embodiments, inflating the balloon at a higher pressure provides a stable, more reproducible lumen dilation that is independent of calcification. In some embodiments, inflating the balloon at a higher pressure results in positive remodeling of the blood vessel and the diameter of the blood vessel returns to the non-diseased diameter over time. In some embodiments, the method includes positioning the balloon near the treatment site. Here, the strip is during positioning Translate the force along the axis of the balloon. In some embodiments, the method can include plasma functionalization of the strip. In some embodiments, the method includes applying ultrasound towards the vessel wall. In some embodiments, the method includes angioplasty with a balloon coated with a drug.

[0088] In some embodiments, an intravascular device is provided. The intravascular device includes a balloon configured to expand and contract reversibly within a blood vessel. The intravascular device can include a strip including a plurality of microperforation devices. In some embodiments, each microperforation device includes an unpolished tip, and the strip includes a space between adjacent microperforation devices. In some embodiments, the balloon is configured to expand to form serrations, depressions, and / or microperforations in the vessel wall by moving the strip radially outward to apply a force to the vessel wall.

[0089] In some embodiments, the intravascular device is configured to cause predictable and repeatable crack propagation along serrations, depressions, and / or microperforations. In some embodiments, the intravascular device is configured to increase the diameter of an artery while minimizing damage to the blood vessel. In some embodiments, the intravascular device is configured to increase volumetric flow rate. In some embodiments, the intravascular device is configured to require a minimal atmospheric pressure to improve blood flow. In some embodiments, the intravascular device is configured to follow angioplasty energy along serrations, depressions, and / or microperforations to facilitate separation of the intima from the inner tissue. In some embodiments, the intravascular device is configured to improve one or more of the inner diameter, compliance, and flow dynamics of a blood vessel. In some embodiments, the intravascular device is configured to serrate the internal elastic lamina. In some embodiments, the intravascular device is configured to reduce the likelihood of turbulent flow in the treated diseased area by reducing flow interruption or disturbance. In some embodiments, the intravascular device is configured to improve residual stenosis by approximately 50% compared to the case of POBA alone. In some embodiments, the intravascular device is configured to improve the tracking, pushability, and translatability of the force across the balloon using a strip. In some embodiments, the strip improves column strength when the strip is oriented laterally. In some embodiments, the method may include a plasma-functionalized layer on the strip. In some embodiments, the balloon is configured to provide a consistent lumen expansion. In some embodiments, the method may include an energy source configured to disrupt calcium deposition. In some embodiments, the balloon is configured to form serrations, depressions, and / or microperforations at a pressure of less than 4 atmospheres.

[0090] In some embodiments, a medical catheter with serrated metal embedded therein is provided. The catheter includes an outer shaft consisting of an elongated member having an inner diameter and an outer diameter. The catheter includes an inner member. The catheter includes a balloon that has metal embedded in the balloon material and expands such that a portion of the metal protrudes beyond the surface of the balloon diameter.

[0091] In some embodiments, the metal that protrudes higher than the balloon diameter has raised and non-raised portions. In some embodiments, the inner member includes a guidewire lumen. In some embodiments, the metal includes a plurality of strips, and each strip includes a plurality of angioplasty devices thereon. In some embodiments, the angioplasty devices are configured to form serrations (saw marks) in a blood vessel without cutting the blood vessel. In some embodiments, the height or amount of the metal protruding on the balloon surface to form the plurality of strips of angioplasty devices is set to be less than the thickness of the healthy tissue wall, thereby restricting or preventing penetration through the entire blood vessel wall. The height of the angioplasty device can limit penetration into the tissue layer. The height of the angioplasty device can exceed the threshold for initiating crack propagation. The height of the angioplasty device can form a minute puncture wound with a limited depth of penetration. The height of the angioplasty device can be selected to promote slow and stable crack propagation through the tissue. In some embodiments, the angioplasty device is configured to cut a portion of the blood vessel through crack propagation. In some embodiments, the catheter includes raised portions spaced apart on the outer surface of the balloon and configured to inhibit the metal from damaging the balloon.

[0092] In some embodiments, a method of blow molding a balloon embedded with metal is provided. The method includes positioning an extruded balloon body relative to a balloon mold. The mold includes a plurality of separated segments and a space between the plurality of separated segments. The method includes positioning a metal element on the separated segments of the mold. The method includes positioning a retaining member over the metal element. The method includes heating the balloon. The method includes inflating the balloon. In some embodiments, the metal element includes a strip and a micro-wedge.

[0093] In one embodiment, an intravascular device is provided. The intravascular device can include a base balloon. The intravascular device includes a plurality of strips, and a plurality of wedge cutting devices can be spaced apart on the surface of each strip. The intravascular device can include a prehub cover (premanufactured cover). In one embodiment, the base balloon has lower compliance and the prehub cover has higher compliance.

[0094] In one embodiment, the base balloon includes a non-compliant balloon. In one embodiment, the base balloon includes a semi-compliant balloon. In one embodiment, the base balloon is configured to expand to a specific diameter. In one embodiment, the base balloon is configured to apply a specific pressure to the blood vessel wall without additional radial expansion. In one embodiment, the prehub cover is configured to minimize damage along a portion of one of the plurality of strips. In one embodiment, the prehub cover is configured to minimize surface damage between adjacent wedge cutting devices. In one embodiment, the prehub cover is configured to minimize surface damage by the wedge cutting devices. In one embodiment, the prehub cover is configured to minimize surface damage due to calcified arteriosclerosis. In one embodiment, the prehub cover is configured to hold the plurality of strips between the base balloon and the prehub cover.

[0095] In one embodiment, a method for manufacturing an intravascular device is provided. The method includes selecting a first extruded tube and blow molding a base balloon. The method includes selecting a plurality of strips. Each strip of the plurality of strips has a plurality of wedge cutting instruments spaced along the surface of each strip. The method includes selecting a second extruded tube and blow molding a prehub cover (pre-manufactured cover). The method includes changing the compliance of the base balloon or the prehub cover, or both the base balloon and the prehub cover.

[0096] In one embodiment, the step of changing the compliance includes changing the molecular orientation of the polymer chains. In one embodiment, the step of changing the compliance includes changing the manufacturing process of the first extruded tube or the second extruded tube. In one embodiment, the step of changing the compliance includes changing the molding process. In one embodiment, the step of changing the compliance includes changing the balloon molding process. In one embodiment, the step of changing the compliance includes biaxially orienting the polymer chains. In one embodiment, the step of changing the compliance includes improving the tear resistance of the prehub cover. In one embodiment, the base balloon has a lower compliance and the prehub cover has a higher compliance. In one embodiment, the step of changing the compliance includes that of the heating jo including changing the temperature. In one embodiment, the step of changing the followability includes changing the preliminary pressure and / or the preheating time. In one embodiment, the step of changing the followability includes changing the molding pressure and / or the molding time. In one embodiment, the step of changing the followability includes changing the tensile load (tensile load) on the distal side and / or the proximal side. In one embodiment, the step of changing the followability includes changing the distance between the extrusion tool and the cooling tank. In one embodiment, the step of changing the followability includes changing the speed of the gear pump during the extrusion process. In one embodiment, the step of changing the followability includes changing the inner diameter and / or the outer diameter of the first extruded tube or the second extruded tube. In one embodiment, the step of changing the followability includes changing the stretching and the die head of the first extruded tube or the second extruded tube. In one embodiment, the step of changing the followability includes changing the final molecular orientation of the polymer chains.

[0097] In one embodiment, a method is provided. The method includes the step of providing an intravascular device. In one embodiment, the intravascular device includes a base balloon. In one embodiment, the intravascular device includes a plurality of belts. Each of the plurality of belts has a plurality of wedge cutting instruments spaced along the surface of the belt. In one embodiment, the intravascular device includes a prehub cover (pre-manufactured cover). The method includes the step of expanding the intravascular device within the blood vessel. The ratio of the reference blood vessel diameter to the diameter of the expanded intravascular device exceeds 1:1.

[0098] In one embodiment, the ratio of the reference blood vessel diameter to the diameter of the expanded intravascular device exceeds 1:1.1. In one embodiment, the ratio of the reference blood vessel diameter to the diameter of the expanded intravascular device exceeds 1:1.2. In one embodiment, the ratio of the reference blood vessel diameter to the diameter of the expanded intravascular device exceeds 1::1.3. In one embodiment, the expansion of the intravascular device enables greater arterial growth. In one embodiment, the expansion of the intravascular device improves the residual blood flow. In one embodiment, the expansion of the intravascular device reduces the residual stenosis.

[0099] In some embodiments, the system and method can include any number of features of the present disclosure.

Brief Description of the Drawings

[0100] The above and other features, aspects and advantages will be described below with reference to the drawings, which are intended to illustrate the invention but not to limit the invention. In the drawings, like reference characters consistently denote corresponding features throughout the like embodiments.

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DETAILED DESCRIPTION OF THE INVENTION

[0101] The spikes can be arranged on the belt in any number of different directions and configurations, as will be further described below. The spikes can be any of the spikes described in U.S. Patent No. 8,323,243 to Schneider et al. (issued December 4, 2012, which is hereby incorporated by reference in its entirety). The spikes and the cage can also be used according to the plaque serration method and other methods described in the above specification.

[0102] Next, referring to FIG. 6, an enlarged detailed view of a portion of the cage is shown. In this embodiment, the strip 16 is formed with a plurality of spikes or wedge dissectors 26. In some embodiments, slits can be made in the tube to form adjacent strips from the base portion of the incomplete cage. The wedge dissector 26 can be shaped like a tent or an ax head having an elongated tip and a base portion, and both wedge dissectors extend longitudinally along the longitudinal axis of the tube. The wedge dissector 26 aids in cutting and / or perforating the plaque before or during the angioplasty procedure. The space between the wedge dissectors 26 can be formed by machining or other methods to remove material and increase the flexibility of the strip. The space between the wedge dissectors 26 is shown to be approximately twice the length of the wedge dissector 26, but other spacings may be used. Typically, the length of the spacing can be between 4:1 and 3:1 with respect to the length, and more generally, between 2:1 and 1:1 with respect to the length.

[0103] In some embodiments, a row of strips and / or strip segments can be disposed around the balloon 20. Some rows may extend over the entire length of the balloon 20, while other rows may not extend over the entire length. In some examples, the row includes a plurality of strips in series separated by gaps. Disposing the strips in series on the balloon can provide higher flexibility, thereby improving the deliverability through tortuous anatomical structures.

[0104] As shown herein, many of the strips 16 have a flat bottom. This aids in disposing the strip 16 on the surface of the balloon and maintaining the orientation of the wedge dissector. Thereby, rotation of the strip 16 on the surface of the balloon 20 can be prevented.

[0105] The unique functional characteristics aimed at achieving the configuration of the embedded strip according to some embodiments include 1) The perpendicularity of the wedge cutting instrument to the balloon surface, 2) maintaining a flat and low profile of the strip on the balloon in the contracted state, and 3) assistance for limiting damage to the balloon or tissue by the wedge cutting instrument during delivery or contraction are included. Design features contributing to these functional characteristics include strips, regions, and intervals. The strip has a flat bottom enabling a stable orientation of the wedge cutting instrument, but is a strip laid tangentially to the balloon or having a thickness sufficient to be accommodated in the fold of the balloon during folding. The region is a region on the balloon surface with a slightly increased thickness to limit puncturing, and the interval is the interval between wedge cutting instruments having no raised region or cutting edge. It will be understood that other advantages and benefits can also be provided.

[0106] The process of forming a balloon catheter having a metal (including a serrated strip) on the outside can include any of the following: stacking a reel of the strip with a laminate (stack) of layers of material arranged to allow deposition of the polymer onto the base portion of the strip; positioning the stacked strip in a series of molds designed to accommodate the strip, the strip including a wedge cutting device as described above; the strip being equally spaced around the center point into which the balloon is inflated; typically, the strip being arranged to extend mainly in the longitudinal direction; in the case of a particularly long balloon, the strip may be continuously arranged in a plurality of rows such as 1 to 8 rows, with 1 to 25 or more strips being arranged; in some embodiments, the base region of the strip is pre-dipped, laminated or coated with a material having a glass transition temperature equal to or lower than that of the balloon material; in some embodiments, the coating is one or more series of materials; in the case of a single or more materials, the collected stack of materials can be designed to provide adhesion between the elastic balloon surface and the inelastic strip surface; when all the strips are placed in the balloon blow molding mold, the coating under the base will be positioned within the diameter of the blow molding mold; the mold is designed and the strip is attached; the intravascular device can include the prehub cover (pre-manufactured cover) described herein; the prehub cover can be formed by a second balloon blow molding process; in one embodiment, the combination of the prehub cover and the balloon with a plurality of strips involves inflating the balloon with a plurality of strips within the prehub cover, applying heat to the plurality of strips to soften the pre-manufactured cover, and protruding a plurality of wedge cutting devices through the pre-manufactured cover; also, as another method, a method of fusing the strip to the balloon by a process similar to the second balloon blow molding can be considered; in this process, the strip is provided with a polymer, extrudate, laminate or other fusing material; the strip with the fusing material is strategically placed within the second balloon blow device and the strip can be accurately positioned onto the base balloon; the base balloon is inflated within the second device and energy such as heat or ultraviolet light is applied.Energy is applied to the entire device or a specific area of the device where the strip is disposed. By the energy, the fusion material transitions to an elastic phase, enabling fusion between the base balloon and the substrate. The fusion material is designed to flow in an area including the interface between the balloon and the strip. In one embodiment, the fusion material flows along a portion of the outer surface of the balloon, forming a more durable joint area and providing a buffer layer that protects the base balloon from serrated protrusions trapped within the wings of the balloon in the pleating and folding process.

[0107] A method of retrofitting a series of metallic strips to a balloon catheter can include any of the following steps. Disposing the strip around the balloon after inflation or during balloon blowmolding. The strip includes a wedge cutting device. The strips are spaced equidistantly around the inflated balloon. The strips mainly extend longitudinally. The strips may be disposed individually, or may be disposed continuously in rows such as 2 rows, 3 rows, 4 rows, 5 rows, 6 rows, or 7 rows, or may be disposed from a single strip to a row of 2, 3, 4, 5, 6, 7, 8, 9, or more divided strips. Further, an array of any number of wedge cutting devices or up to 100 or more individual wedge cutting devices can be spaced apart from each other. In some embodiments, the individual wedge cutting devices are not coupled to adjacent wedge cutting devices and the b It is contemplated to be disposed on the surface of the ring. By connecting a plurality of wedge cutting devices, a strip of the wedge cutting devices can be formed. In some embodiments, the strip and the wedge cutting devices comprise the same material. In some embodiments, the strip and the wedge cutting devices are integrally formed. In some embodiments, the strip and the wedge cutting devices comprise different materials. In some embodiments, the strip and the wedge cutting devices are separately formed. In some embodiments, the gap between the wedge cutting devices is non-metallic. The individual wedge cutting devices or the strip are permanently or temporarily attached to the balloon using an adhesive. The intravascular device includes a prehub cover (pre-manufactured cover). The prehub cover is formed by a second balloon blowing process. In some embodiments, the combination of the balloon with a plurality of strips and the prehub cover is formed by inflating the balloon with a plurality of strips within the prehub cover and applying heat to the plurality of strips such that the prehub cover softens and the plurality of wedge cutting devices penetrate the prehub cover.

[0108] Rings 12, 13, 14 are attached to the strip 16 in various ways. FIGS. 11-13 show examples of rings 12, 13, 14 fixed to the strip 16. FIG. 11 shows the material wrapped around the balloon to form rings 12, 13, 14, with the material of the rings fixed to the plurality of strips. In some embodiments, as shown in FIG. 12, rings 12, 13, 14 are wrapped around a portion of each strip. This can be achieved in the same manner as illustrated in FIG. 10. Each of the rings can have an upper layer and a lower layer that wrap around a portion of the strip 16. FIG. 13 illustrates solid rings 12, 13, 14 attached to a portion of the balloon. A portion of the strip is fixed to the rings.

[0109] The heat shrinkable material may be arranged as a ring around the end of the strip. Each individual ring of the heat shrinkable material may be connected to the ends of a plurality of strips arranged circumferentially around the balloon, or may cover the ends. Also, each individual ring of the heat shrinkable material may be connected to the ends of adjacent strips arranged continuously, or may cover the ends. Thereafter, heat is applied to shrink the heat shrinkable material. After the balloon is shrunk, it can be sterilized in preparation for use.

[0110] The systems and methods disclosed herein can deploy a cage and a fenestration device in any body lumen including vascular lumens such as arteries and veins. Arteries can be, for example, coronary arteries, peripheral arteries, or carotid or other cerebral arteries such as iliac arteries, femoral arteries, superficial femoral arteries, popliteal arteries, anterior and posterior tibial arteries, peroneal arteries, or other peripheral blood vessels. The device can also be used in any lumen or transport vessel found in any of the vascular, respiratory, digestive, urinary, genital, lymphatic, auditory, optical, or endocrine systems. It will be appreciated that devices for creating serrations (sawtooth marks) in any one, two, or more of these anatomical regions may have slightly different catheter bodies and features. In one system, features such as those found in a monorail design are included in the design, and in other systems, design features such as rapid exchange are provided. Other design features may also be included and may take subtly different forms. Regardless of where the device may be used, some embodiments of the device include spikes (also referred to herein as fenestration devices or serration (sawtooth) elements) that may be coupled together on a support spline and an expandable mechanism (such as a balloon) for increasing or decreasing the diameter of the spike features. By combining the serrated portion and the balloon, a serrated balloon element is formed. The serrated balloon element is then attached to a base catheter-like device.

[0111] In some embodiments, for example, as shown in FIG. 14, which is a detailed enlarged view of an embodiment of the sphincterotomy instrument 200 on the strip 300, the sphincterotomy instrument 200 includes a base surface 202 (also referred to herein as the boundary surface) facing the strip. The base surface 202 of the sphincterotomy instrument 200 facing the strip may be defined by a base portion where the wedge 200 protrudes outward and is directly continuous with the surface of the strip at the interface between the sphincterotomy instrument and the balloon. The strip is, It can be a spline 300 or other strip-like structure. In some embodiments, the base surface 202 facing this strip has a relatively narrow width formed of a hard material capable of holding a sharp edge. In some embodiments, the preferred material is martensitic stainless steel, the hardness of which ranges from 48 to 70, more generally in the range of 52 to 64 on the Rockwell C scale (HRC), but polyolefin, fluoropolymer (including fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF) (e.g., KYNAR)), polyvinyl chloride (PVC), neoprene, silicone, elastomer or synthetic rubber and fluoropolymer elastomer (e.g., VITON) may be included, and materials including polymers or copolymers not limited to these or combinations thereof may also be used. The hardness of the strip and the wedge cutting instrument can be any 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 value within the range of these values on the Rockwell C scale (HRC). In some embodiments, the strip has a width (oriented circumferentially) of about 0.004 inches, 0.005 inches or less than 0.006 inches. In some cases, the width is from about 0.006 inches to about 0.020 inches or from about 0.004 inches to about 0.030 inches. In some embodiments, the strip 300 typically extends longitudinally along the edge of the working balloon, but at an angle from 0 to 90 degrees and including 90 degrees from the longitudinal axis of the balloon (or other inflatable structure), or is helically oriented at various pitches. In some embodiments, the height of the base strip 300 is from about 0.004 inches to about 0.010 inches or from about 0.002 inches to about 0.020 inches.

[0112] Referring to FIG. 14, the wedge dissection instrument 200 includes a radially outer-facing surface 204 (also referred to herein as a non-boundary surface). The radially outer-facing surface 204 defines the upper surface of the wedge dissection instrument 200 extending from a first (e.g., proximal) edge 206 to a second (e.g., distal) edge 208 and is configured to contact tissue, plaque, or other structures within the body. Also illustrated are a front surface 210, a rear surface 212, and opposing side surfaces 214, 216. In some embodiments, the surfaces 214, 216 extend upwardly substantially perpendicular to the longitudinal axis of the strip, and the radially outer-facing surface extends between the side surfaces at a predetermined angle with respect to the side surface / side axis and has a linear, curved, or other shape as described elsewhere herein. Also illustrated is a strip or spline 300 having a non-boundary surface (e.g., an upward-facing surface) 302, side surfaces (e.g., 304), and a downward-facing surface 303 that are coaxial with the strip-facing surface or boundary surface 202 of the wedge dissection instrument 200.

[0113] FIG. 15 is a schematic view showing some non-limiting embodiments of the wedge dissection instrument. In some embodiments, the length L of the radially outer-facing surface U (e.g., the radially outer-facing surface 204 between the first edge 206 and the second edge 208 shown in FIG. 14) is about 30%, 20%, or 10% less than the total length L of the strip-facing surface (of the strip-facing surface 202 in FIG. 14). B In some embodiments, the length L of the radially outer-facing surface U is about 50% to about 20% less than the length L of the strip-facing surface, and optionally, is of the same order of length as the strip-facing surface length L B . The width W of the radially outer-facing surface B is optionally equal to or less than the width W of the strip-facing surface, typically about 10%, 20%, 30%, 40%, or 50% or less of the width W of the strip-facing surface, or about 20% to about 50% of the width W of the strip-facing surface, and optionally, the width W of the strip-facing surface U is the same as or less than the width W of the strip-facing surface B , typically about 10%, 20%, 30%, 40%, or 50% or less of the width W of the strip-facing surface, or about 20% to about 50% of the width W of the strip-facing surface, and optionally, the width W of the strip-facing surface B is about 10%, 20%, 30%, 40%, or 50% or less of the width W of the strip-facing surface, or about 20% to about 50% of the width W of the strip-facing surface, and optionally, the width W of the strip-facing surface B is about 20% to about 50% of the width W of the strip-facing surface, and optionally, the width W of the strip-facing surface BThe width W of the radially outwardly facing surface is about 50%, 60%, 70%, 75% or 80% of the U may be 0.01 inches or less in some cases. The width W of the radially outwardly facing surface U The width W of the radially outwardly facing surface may range from 0.005 inches to 0.002 inches, from 0.002 inches to 0.001 inches, or from 0.0012 inches to 0.0002 inches, as the case may be. U is sometimes 0.0011 inch, 0.0009 inch, 0.0008 inch, 0.0007 inch, 0.0006 inch, 0.000 5 inches, 0.0004 inches, or 0.0003 inches. In some embodiments, the surface area of ​​the radially outwardly facing surface (L U ×W U ) is the surface area facing the strip (L B ×W B ) is about 30% to about 10% smaller than the width W B Width W of the surface facing radially outward from U The angle θ defining the inclination to the width W of the surface facing the strip B At least one of the ends of the groove has an angle of about 90° or less than about 90°. U is constant from edge to edge, but in one embodiment, the width W U is the length L of the radially outwardly facing surface, as described elsewhere herein. U , e.g., decreasing from a first lateral edge to a point or segment between the first and second lateral edges of the radially outwardly facing surface segment, and then increasing from the 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, e.g., tapered, width.

[0114] Width W of the surface facing radially outward Uis the width W of the base facing the strip of the base surface 202 facing the strip B to the width W of the surface 204 facing radially outward from that base U up to, having a constant single inclination angle θ or bevel as shown in FIGS. 22A (end view similar to an isosceles triangle) and 22B (isometric view), sloping to reach said point, although in some embodiments it can include a plurality of different angles exceeding a single inclination angle, such as two, three or more bevels (e.g., a first angle for a first segment of said height, a second angle less than or greater than the first angle for a second portion of said height, and, optionally, a third angle for a third portion of said height, less than or greater than the first angle and less than or greater than the second angle). FIG. 22C shows an end view. FIG. 22D shows an isometric view of a wedge cutting device having a plurality of different slopes and corresponding angles from the base surface facing the strip to the surface facing radially outward. The angle θ2 between the horizontal above the transition point and the upward slope is greater than the angle θ1 between the base edge facing the horizontally oriented strip and the upward slope intersecting it (in other words, the first slope S1 from the base edge of the base surface facing the strip is gentler than the second slope S2 at a higher position after the transition point). FIGS. 22E and 22F show embodiments similar to FIGS. 22C and 22D except where the angle θ2 is less than the angle θ1 (in other words, the first slope S1 from the base edge of the base surface facing the strip is steeper than the second slope S2 above the transition point).

[0115] Alternatively, some embodiments include a different series of steps at different heights, transitioning to a narrower width and then continuing to increase in height. When using a series of steps instead of a bevel, there may be processing limitations when polishing or honing the edge by methods other than a stainless steel reel. When using chemical etching to form steps from the width W of the surface facing the strip B to the width W of the surface facing radially outward U the shape of the sidewall may not have a single inclination. The sidewall is the width W of the surface facing the strip BThe width W of the surface facing radially outward therefrom U tends to be concave, having one or a series of concave etching regions that transition to

[0116] In some embodiments, the shape of the surface or edge facing radially outward (e.g., the surface 204 facing radially outward shown in FIG. 14) can be the same height from one edge 206 to the other edge 208 of the length or width facing radially outward. In some embodiments, the height along the surface 204 facing radially outward varies from one edge 206 to the other edge 208. When the edge or surface 204 facing radially outward changes, typically, the edge facing radially outward has a series of raised features referred to herein as a wedge cutting device, spike, or serrated element 200. In some embodiments, the midpoint of these raised features along the surface 204 facing radially outward between the edges 206, 208 is the highest point of the surface facing radially outward. However, in some embodiments, the highest point may be offset from the midpoint and may have multiple highest points sandwiched between low points relative to the boundary / base surface 202. The maximum change in height between the edges 206, 208 of the surface 204 facing radially outward of the wedge cutting device 200 and the surface 302 facing radially outward of the base strip 300 between the wedge cutting devices 200 is, in some embodiments, about 80%, 70%, 60%, 50%, 40%, 30%, 20%, 10% or less of the total height of the wedge cutting device 200. In some embodiments, the base strip 300 has a roughened lower surface or a lower surface textured in other ways to assist in adhering to the outer surface of the balloon. The base strip can have any desired shape, such as square, rectangular, or in some embodiments trapezoidal, and the lower surface can have a width that is, for example, about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% or more of the upper surface. In some embodiments, about 1 / 3 to 1 / 2 of the upper surface of the strip 300 is covered by a wedge cutting device (also referred to as a micro-wedge) 200, and about 1 / 2 to 2 / 3 of the upper surface is without the wedge cutting device 200.

[0117] In some embodiments, the base strip 300 has a roughened lower surface or a lower surface textured in other ways to assist in adhering to the outer surface of the balloon. The base strip can have any desired shape, such as square, rectangular, or in some embodiments trapezoidal, and the lower surface can have a width that is, for example, about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100% or more of the upper surface. In some embodiments, about 1 / 3 to 1 / 2 of the upper surface of the strip 300 is covered by a wedge cutting device (also referred to as a micro-wedge) 200, and about 1 / 2 to 2 / 3 of the upper surface is without the wedge cutting device 200.

[0118] Referring to FIG. 21, in some embodiments, the radially outward-facing surface as viewed from above can be seen as a line extending from one edge of the radially outward-facing length to the other edge of the radially outward-facing length (e.g., assuming 210A is the radially outward-facing surface of the device, W U is a point). This appears to be deceptively narrow, honed (polished) or similar to a sharp edge like a razor. In other embodiments, the top view can be seen as a slightly dull, unpolished surface similar to a rectangle (e.g., assuming 210B or 210C is the top surface of the device and all above these lines are cut off), and the width W U of the radially outward-facing surface is smaller than the width W B of the base surface facing the strip and is directly related to the width and height of the slope from the base surface facing the strip to the radially outward-facing surface. In some embodiments, the top or radially outward-facing surface can be linear, flat rectangular, rounded or raised (appearing rectangular or square in two dimensions), pyramidal, wedge-shaped, trapezoidal, or other polygonal shapes.

[0119] In some embodiments, the unpolished width can be, for example, measured at the radially outward-facing surface or edge and be a width or combination of widths of 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. In some embodiments, the unpolished radially outward-facing surface of the wedge dissection device is slightly duller / relatively less sharp than the polished (honed) edge, and thus is advantageous, for example, in cases where it is desirable to form serrations, depressions, and / or microperforations rather than forming a cut that penetrates the entire lumen wall in the intended portion of the wedge dissection device. In some embodiments, the entire radially outward-facing surface of the wedge dissection device has an unpolished width.

[0120] The shape of the wedge cutting instrument can take many forms, as shown in further non-limiting embodiments such as those shown in FIGS. 16-22. For example, the wedge cutting instrument 200 rising from the base strip 300 shown in FIG. 16 has a radially outward facing surface 204 that is polished (honed) / sharp from edge 206 to edge 208. The wedge cutting instruments shown in FIGS. 17 and 18 have chamfer segments 780 of a radially outward facing surface on both side edges that slope to an edge having a polished (honed) central point 782 or length 781 or are otherwise sloped upward. The slope may be a linear slope or, as shown in FIG. 19, a curved slope. As shown in FIG. 17, the wedge cutting instrument includes a lateral segment 780 of the radially outward facing surface. The central intermediate portion 781 has a minimum / slight width, and the lateral segment 780 decreases in width as the height increases to the intermediate portion 781 at the first edge and then increases in width as the height decreases from the intermediate portion at the second edge. FIG. 18 shows a wedge cutting instrument similar to FIG. 17 except that the intermediate portion is a single polished (honed) point 782.

[0121] FIG. 19 shows a wedge cutting instrument having a radially outward facing surface 785. This cutting instrument decreases in width from the first edge to a central region such as the intermediate point 786 as the height increases along a first curved length and then increases in width as the height decreases to the other edge along a second curved length.

[0122] Figures 20 - 22 show embodiments of a wedge dissection instrument having a non - honed radially - outwardly facing surface that does not include sharp honed points or edges (e.g., having a width greater than the width of the honed edge). Figure 20 shows an embodiment of a wedge dissection instrument that is somewhat similar to that of Figure 17, except that the radially - outwardly facing surface is not completely honed along its length. Figure 21 is a view showing an embodiment of a wedge dissection instrument that is somewhat similar to that of Figure 18, except that the radially - outwardly facing surface is not completely honed along its length direction. Figure 22 shows an embodiment of a wedge dissection instrument that is somewhat similar to that of Figure 19, except that the radially - outwardly facing surface is not completely honed along its length direction.

[0123] One common feature of the embodiments of Figures 17 - 22 is that the width of the radially - outwardly facing surface is greater (wider) at the side edges and narrower (smaller) at the central point or longer central segment. The height of the radially - outwardly facing surface from one edge to the other can be variable, for example, arch - shaped or otherwise, being highest at the center and shortest at one or more edges when viewed from the side. In these embodiments, the orientation of the narrowest or thinnest (narrowest in width) portion of the radially - outwardly facing surface may be along the longitudinal axis of the strip, and this longitudinal axis may or may not be aligned with the longitudinal axis of the balloon.

[0124] In other embodiments, the narrower point or segment need not be symmetric about the mid - point of the length of the radially - outwardly facing surface and may, in some cases, be asymmetric / offset from the mid - point of the length.

[0125] Regardless of the geometric shape of the wedge cutting device, in some embodiments, it features a boundary end 202 or base portion having a length and a width (e.g., a spike has a base portion to which it is "attached" whether it is a spline (or strip), a balloon, or some kind of shaped element), a radially outward-facing surface 204 having a length and a width, an end, or a tip. In some embodiments, the width of the radially outward-facing surface or end is about 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20% or less of the width of the base portion facing the strip, or is in a range including any two of the aforementioned values. The width of the base end of the wedge cutting device (as well as the spline / strip) facing the strip may be fixed / constant or alternatively variable.

[0126] The wedge cutting device may have a number of different sizes and shapes. In some embodiments, the length of the wedge cutting device in the base portion facing the strip is, for example, about 0.10 inches, about 0.09 inches, about 0.08 inches, about 0.07 inches, about 0.06 inches, about 0.05 inches, about 0.04 inches, about 0.03 inches, about 0.02 inches, or about 0.01 inches or less, or a length in a range including any two of the aforementioned values, about 0.01 inches to about 0.06 inches, or about 0.01 inches to about 0.04 inches. In some embodiments, the height of the wedge cutting device measured from the unconnected end of the base strip is about 0.05 inches, about 0.04 inches, about 0.03 inches, about 0.025 inches, about 0.025 inches, about 0.01 inches, or about 0.005 inches or less, or about 0.005 inches to about 0.025 inches, about 0.01 inches to about 0.025 inches inches, or about 0.005 inches to about 0.015 inches.

[0127] In some embodiments, the angiotome (or micro-wedge) has a base length facing a wedge-shaped strip having a length of about 25 mm, about 20 mm, about 15 mm, about 14 mm, about 13 mm, about 12 mm, about 11 mm, about 10 mm, about 9 mm, about 8 mm, about 7 mm, about 6 mm, about 5 mm, about 4 mm, about 3 mm, about 2 mm, or about 1 mm or less, or a range incorporating any two or more of the foregoing values. In some embodiments, the angiotome has a base length facing a wedge-shaped strip having a length of 2 mm, 2.5 mm, or 3 mm, or a length of about 1 mm to about 5 mm, or a length of about 1.5 mm to about 3.5 mm. The angiotomes can be spaced regularly or irregularly to increase the flexibility of the device. For example, the spacing between adjacent angiotomes can be, for example, about 2 to about 10 times the length of the base facing the wedge-shaped strip of the angiotome when the angiotomes are arranged in the longitudinal direction. For example, in some embodiments, an angiotome having a base length facing a wedge-shaped strip of about 2.5 mm has a spacing of about 5 mm between the incisors, or a spacing of about 25 mm between them. In some embodiments, a group of angiotomes may be spaced at a small first ratio, for example, about 1 to 4 times the length of the base facing the strip of the angiotome, and then at a large second ratio, for example, about 8 to 10 times the length of the base facing the strip of the angiotome. For example, a first group of angiotomes having a base length facing a 2.5 mm strip has a spacing of 5 mm between the incisors, and then a second group of angiotomes has a spacing of 20 mm from the first group. The second group may have the same size, shape, and spacing as the first group, or different sizes, shapes, and spacings.

[0128] In some embodiments, the position of the surface facing radially outward with respect to the base surface facing the strip is not necessarily centered or symmetric. In other words, the midpoint of the surface facing radially outward can be offset from the midpoint of the base surface facing the strip. FIGS. 23A - B and 24 show an alternative embodiment of the spike with an asymmetric surface facing radially outward. The asymmetric surface facing radially outward is offset from the center with respect to the alignment of the radially outward facing edge directly above the base portion facing the strip. In this configuration, as can be seen from FIG. 23A, only one edge of the base portion facing the strip has an edge 440 inclined in the height direction from the surface facing radially outward, and the other edge 442 stands perpendicular at 90° (right angle) RA with respect to the base surface 444 facing the strip. Additionally, the edges of the surface facing radially outward can be chamfered or have a bevel or radius at one or both of the widthwise ends and / or one or both of the lengthwise ends. In some variations, the position of the surface facing radially outward is limited to the region projected upward onto the base surface facing the strip. The surface facing radially outward can be, for example, either a sharp line (e.g., a honed edge) or a variation of the non - honed edges described herein. In the embodiments shown in FIGS. 23C, 23D, the total volume or substantial total volume of the wedge - cutting instrument rises / lies below the full width (or surface area) of the base portion of the strip, such that, for example, it is about 70%, 60%, 50%, 40%, or 30% or less of the width or surface area of the strip, and thus the wedge - cutting instrument is asymmetrically offset forward or backward from the longitudinal axis of the strip.

[0129] FIG. 24 shows an embodiment in which the radially outer-facing surface 204 has a varying height (increasing from the first height 24H1 at the first edge 206 to the second height 24H2 at the second edge 208) from the base surface 202 facing the strip, and includes an edge profile with rounded radii of curvature at the edges 206, 208. One edge 206 has a large radius of curvature and a low height 24H1 measured from the base surface 202 facing the strip, while the opposite edge 208 has a small radius of curvature and a high height 24H2 measured from the base surface 202 facing the strip.

[0130] In some embodiments, the various features of the wedge dilation devices described herein provide a unique advantage of assisting in the delivery of a device that includes reducing vascular trauma when the radially outer-facing surface is disposed outside the delivery device and / or contacts the lumen wall and may rub against the vessel wall during movement within the artery. The above features are not limited to this. This is the case, for example, for embodiments having a wedge dilation device with a radially outer-facing surface that is not polished (honed).

[0131] In addition, without being limited to theory, certain shapes result in a more effective penetration into tissue. For example, a wedge dilation device including a chamfered or rounded radially outer-facing edge enters the vessel wall with less force (requiring less pressure to penetrate the tissue) while maintaining an effective microchannel 5100 that weakens the tissue, minimizes vascular trauma and cell damage, and allows for tissue dilation.

[0132] Furthermore, there has been a proposal to provide a blade or sharp edge or scoring wire on the balloon during angioplasty or other procedures to cut or remove plaque in conjunction with balloon expansion. However, the method according to this proposal has problems or drawbacks, which are eliminated or avoided by the systems and methods disclosed herein. Cutting or removing the lumen wall, such as plaque, during angioplasty is performed at high pressure and thus may cause high damage to the blood vessel. While expanding the angioplasty balloon to expand the plaque, a cutting blade, edge or scoring wire is pushed into the wall of the blood vessel. During this process, the cutting blade, edge or scoring wire is pushed into the blood vessel wall at an inclined angle, which may plow the plaque and increase the tendency for dissociation and the potential need for an implant such as a stent. In contrast, in some embodiments, the wedge dilatation device can be expanded against the plaque at low pressure to form precise depressions, cleavage lines or planes, precise micro-perforations, serrations and / or depressions directed radially outward to form precise depressions, cleavage lines or planes at other locations or other target sites of the plaque or lumen wall. The radially outward facing surface of the wedge dilatation device is pushed into the plaque or other lumen surface with a small surface area, thereby much reducing the possibility of plowing the plaque or lumen surface.

[0133] In some embodiments, the wedge dissector is designed to form a series of directed punctures or serrations in the diseased vessel wall (but not necessarily completely penetrate in some cases). As shown in FIG. 23E, the perforations can function as passageways such as microchannels for pharmaceutical or other agents. The pharmaceutical or other agent can be delivered using a drug-coated balloon incorporated either with the devices disclosed herein or in a separate device used after use of the disclosed devices. In some embodiments, the wedge dissection device is removable from the base strip and / or is coated or impregnated with one or more agents for delivery of the agent. As shown in FIGS. 23F and 23F.1, the wedge dissection device forms a linear line of weaknesses or perforations that allow for a more effective and gentle lumen dilation 5110 of the vessel without cutting a continuous axial segment of the vessel wall. Examples of the stepwise dilation and serration formation of 5110, 5130, 5140, 5150 are shown. When the balloon is inflated and the pressure within the balloon is increased, the following series of events occur. The balloon is deployed within the artery and the strip is exposed from its folded rest position. The tip of the wedge dissection device on the strip (e.g., the radially outward facing surface) contacts the wall. The relatively narrow outer shape of the tip penetrates the wall to form sites that serve as nuclei for multiple fissures, and multiple fissures rapidly crack along the luminal surface. Due to the proximity and alignment of the cracks, the cracks become long cracks along the luminal surface. The long crack extends the entire length of the strip or extends less than or more than the length of the strip.

[0134] To reduce the potential stiffness of the spline or base strip, FIGS. 25 and 29 (or As shown in FIGS. 25-29, in some embodiments, a series of reliefs can be added to the spline. The reliefs are manufactured in many different ways, with the intention that material is removed to provide a more flexible spline for the wedge against the base facing the strip. The reliefs can be formed in the base portion of the spline facing the base surface facing the strip of the wedge cutting instrument, the upper portion of the spline directly adjacent to the base surface facing the strip of the wedge cutting instrument, or both positions, such as a combination of upper and lower. The reliefs can be formed on the side of the spline, or alternatively, an opening facing the base portion can be added to the spline by other regions of the spline. Any combination of upper, lower, side, or through openings can be added to the spline to provide the reliefs.

[0135] In some embodiments, as shown in FIGS. 25-29, the strip 300 can have relief holes or slits in the upper, bottom, central, or off-center positions (see FIGS. 25-29). The strip can have any shape of circular, rectangular, linear, triangular, elliptical, or combinations thereof. The strip provides a support base intended to be flexible and follow the movement of the balloon so that the wedge is correctly oriented.

[0136] The escape holes, as shown in FIGS. 25-29, are specifically designed to provide a path for the movement of balloon-based pharmacological agents. Further, the escape holes provide a relief on the surface to enhance the deliverability of the device in tortuous anatomical structures. FIGS. 25A-25C show an embodiment of a wedge cutting device having a relief 502 on the lower surface 500 of the strip 300 opposite the interface surface of the wedge cutting device 200. FIG. 25A shows an embodiment where the reliefs 502 are spaced substantially regularly with respect to the length of the interface surface of each wedge cutting device 200. FIG. 25B shows an embodiment where the reliefs 502 are regularly arranged at intervals of 50% or less of the length of the interface surface of each wedge cutting device 200. FIG. 25C shows an embodiment where each relief 502 is arranged at an interval of 50% or less of the length of the interface surface of each wedge cutting device 200, and the reliefs 502 are disposed only below the wedge cutting device and do not exist below the strip between the wedge cutting devices. In other embodiments, the reliefs 502 are disposed only below the strip section between the wedge cutting devices and do not exist below the strip section directly below the wedge cutting device.

[0137] Figures 25D - 25E show an embodiment in which the relief portion 502 is formed on the upper surface (interface surface or upward-facing surface 302) of the strip between the wedge dissection instruments. In FIGS. 25D and 25E, the relief portion forms a depression with or without a rounded edge on the surface 302 facing the upper surface of the strip between the wedge dissection instruments having a curved base as shown in FIG. 25D and a relatively square or rectangular base as shown in FIG. 25E. FIG. 25F is an embodiment combining two different types of relief portions 502 found in the embodiments of FIGS. 25C and 25D. Other combinations are possible depending on the desired clinical outcome. FIGS. 25G and 25H show other embodiments in which the relief portion 502 is provided on the front surface 304 and / or the rear surface of the strip 300. FIG. 25G illustrates a generally pyramidal relief portion 502, and FIG. 25H illustrates a generally arcuate relief portion 502. The relief portion (relief) is axially spaced from the wedge dissection instrument as shown, and / or in other embodiments is axially spaced and aligned with the wedge dissection instrument. FIGS. 25I and 25J show embodiments in which the relief portion 502 takes the form of a through-channel oriented in the vertical direction (FIG. 25I) or the horizontal direction (FIG. 25J), which are axially spaced from the wedge dissection instrument as shown or arranged in another configuration. In some embodiments, the relief portion may be oriented obliquely with respect to the longitudinal axis of the strip. FIG. 25K shows an embodiment in which the relief portion 502 takes the form of a slot provided on the front surface and / or the rear surface, the boundary base surface and / or other positions. FIG. 25L shows a bridge or tab disposed under the functional portion or the wedge dissection instrument 200. These bridges or tabs connect the functional portion 200 to the bulk material. Using a technique in which the radially outer-facing surface 204 of the wedge dissection instrument 200 is in an unconstrained state, the function When a functional part is removed from a bulk material, the functional part typically requires a series of bridges to the bulk material. The bridges can be fabricated by various manufacturing processes. In some processes, the bridges are formed by removing the base material using a laser or other energy beam to precisely remove a predetermined material and leave the bridges on the functional part. In other processes, bridges can be formed using other material removal methods including chemical etching. Examples of alternative bridges formed using chemical etching are shown in FIGS. 25N - 25Q. The bridges shown in FIGS. 25N - 25Q can include partially etching the substrate, as indicated by the hatched regions shown on the base of the strip (e.g., the lowermost surface attached to the outer surface of the balloon). Regardless of the bridge design, all bridges are designed to be snap - broken, and the break position of the bridge is always set to be above the base of the strip (e.g., the lowermost surface attached to the outer surface of the balloon).

[0138] In some embodiments, the balloon is pleated and compressed (crimped) such that its outer shape becomes very thin and the device can be delivered through a thin - diameter introducer sheath. When the balloon is expanded and contracted, the profile of the balloon after inflation is larger than the original diameter with pleats and folds formed. This new balloon shape has a strip located on the outer side of the balloon shape that may rub against the arterial wall or catch on the openings of ancillary devices such as the introducer sheath. According to some embodiments, the following elements, generally described as ramps, address this potential problem.

[0139] FIG. 26 schematically shows an embodiment in which a lamp 680 of an adhesive or other material is disposed on one or both (e.g., thereon) of the lateral ends 333 of a part or all of the strip 300. When the strip is embedded in a balloon, the lamp can, in some cases, be an additional material within the balloon mold, or the adhesive alone, an adhesively bonded additional material, or material from a laminate disposed at other locations such as the distal and proximal ends of the strip. The lamp 680 is formed from a material that is relatively more flexible than the material of the strip 300 (e.g., an adhesive, a layer laminate of materials), thereby providing an effective and flexible interface between the end of a flexible balloon (not shown) and the semi-rigid strip 300. The lamp 680 is designed in some embodiments to slope gently from the balloon surface (not shown) to the end of the strip. In some embodiments, the adhesive lamp 680 advantageously holds the strip while providing protection from an undesirable interaction between the strip 300 and an auxiliary device during treatment.

[0140] In some embodiments, the side edges of the strip include an adhesive lamp 680 for holding the strip 300 and protecting it from interacting with an auxiliary device during treatment. The lamp can be manufactured using a UV adhesive that repeats a series of deposition and curing steps to stack and build up layers until the lamp is formed, as seen in FIG. 26A. Alternatively, the tape can be preformed into the desired shape and adhered to the surface using a cyanoacrylate, a UV adhesive, or other material or method that provides a chemical, mechanical, or electromagnetic bond between the preformed tape and the balloon surface. Note that in this embodiment, the top of the adhesive layer is near the top of the strip projection (wedge dissector tip) 681. In some embodiments, the lamp extends laterally beyond the edge of the strip by a length of about 0.008 inches to about 0.040 inches, about 0.008 inches to about 0.012 inches, about 0.010 inches to about 0.040 inches, about 0.020 inches to about 0.030 inches, or other dimensions depending on the desired result.

[0141] In some embodiments, a feature that can be incorporated into the balloon element is a conical lamp. The features of the conical lamp can be implemented in several ways. In one embodiment, the conical lamp includes a conical structure for a larger balloon, such as a cone for a 6 mm balloon or a cone for a 5.5 mm balloon, and is formed by incorporating it using known methods so as to be attached to a 5 mm balloon. Such an embodiment is schematically shown in FIG. 27. The cone 970 can have an outer diameter that is, in some cases, larger than the outer diameter of the balloon 960, such as about 5%, 10%, 15%, 20% or more of the outer diameter of the balloon 960, or in some embodiments, about 5% to about 20% larger than the outer diameter of the balloon 960. The relatively large cone 970 is disposed at the position of the balloon 960 that forms a lip portion 972 at the intersection with the balloon body. The lip 972 is beneficial for reducing the catching or lifting of the ends of the metal strip when the balloon contracts and is pulled through the introducer catheter.

[0142] In some embodiments shown in FIG. 28, a series of rails 980 are included along the cone 970, which function as a support structure or a reinforcing structure and assist in preventing the balloon 960 from collapsing when the balloon 960 enters an introducer catheter (not shown). In some embodiments, the rails 980 are oriented / aligned with respect to the longitudinal axis of the strip, further enhancing the function of pushing the strip towards the center of the balloon when the cone is pulled through the introducer catheter.

[0143] In some embodiments, balloons are also disclosed herein that can have depressions disposed on the outer surface of the balloon for attaching the strip. A series of depressions can be formed on the surface of the balloon. The depressions are configured in some embodiments to have a sufficient width and length such that the strip can be disposed within the depression, for example, throughout the depression. The depth of the depression can be sized to limit the possibility of the strip catching on the distal opening of the introducer during balloon contraction.

[0144] As shown in FIG. 23E, by using through-holes or microchannels 5100 either within the spline or on the spline side surface, a mechanism can be provided where therapeutic agents such as, for example, one or more drugs, nanoparticles, and / or stem cells are sent from the balloon surface to the diseased lumen surface by capillary action or diffusion, and / or the use of balloon pressure to forcibly deliver drugs, nanoparticles, and / or stem cells to the surface or diseased site through the microchannels 5100. Alternatively, the microchannels 5100 or the modified surface can provide a reservoir for placing and protecting drugs, nanoparticles, stem cells, or other therapeutic agents while transporting them to the affected area. In some embodiments, the drug can be any drug known in the art. In some embodiments, examples of drugs suitable for use in the methods and devices of the present invention, depending on the specific disease being treated and considering the physical properties of the drug, include, but are not limited to, anti-restenosis, growth-promoting or anti-proliferative, anti-inflammatory drugs, anti-neoplastic drugs, anti-mitotic drugs, antiplatelet drugs, anticoagulant drugs, antifibrin drugs, antithrombin drugs, cell-activating drugs, antibiotics, anti-enzyme drugs, anti-metabolic drugs, angiogenesis drugs, cytoprotective drugs, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, and / or cardioprotective drugs.

[0145] Examples of anti-proliferative drugs include actinomycin, taxol, docetaxel, paclitaxel, sirolimus (rapamycin), biolimus 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-tetrazole-rapamycin (a structural derivative of rapamycin), 40-O-tetrazolyl-rapamycin, 40-epi-(N-1-tetrazole)-rapamycin, and pirfenidone, but are not limited thereto None.

[0146] Examples of anti-inflammatory drugs include steroid and non-steroid (NSAID) anti-inflammatory drugs, for example, but not limited to, clobetasol, alclofenac, alclometasone dipropionate, algestone acetonide, α-amylase, amcinafal, amcinafide, amphfenac sodium, amyloproxen hydrochloride, anakinra, anilerac, anitrazafen, apazone, balsalazide disodium, bendazac, benoxaprofen, benzidamine hydrochloride, bromelain, broperamol, budesonide, carprofen, cicloprofen, cintazone, cliprofen, clobetasol propionate, clobetasone butyrate, clopirac, clocortolone propionate, clobetasone butyrate ester, clopirac, clocortolone propionate ester, cormetasone acetate, cortodoxone, deflazacort, desonide, desoxymethasone, dexamethasone, dexamethasone dipropionate acetate dexamethasone, dexamethasone phosphate, mometasone, cortisone, cortisone acetate, hydrocortisone, prednin, prednin acetate, betamethasone, betamethasone acetate, diclofenac potassium, diclofenac sodium, diflazone diacetate, diflumidone sodium, diflunisal, difluprednate, diftalone, dimethyl sulfoxide, drosninide, endrysone, enlimomab, enolicam sodium, epirizole, etodolac, etofenamate, felbinac, fenamol, fenbufen, fenclofenac, fenclorac, fendosal, fenpipolone, fentiazac, flazarone, fluazacort, flufenamic acid, flumizole, flunisolide acetate, flunixin, flunixin meglumine, fluocortin butyl, fluorometholone acetate, flucazone, flurbiprofen, fluretofen, fluticasone propionate, flaprofen, flobufen, halcinonide, halobetasol propionate, halopredone acetate, ibufenac, ibuprofen, ibuprofen aluminum, ibuprofen picolol iron dip, indomethacin, indomethacin sodium, indoprofen, indoxole, intrazole, isoflupredone acetate, isoxepac, isoxicam, ketoprofen,Rofemizole Hydrochloride, Lornoxicam Roteprednol Etabonate, Sodium Meclofenamate, Meclofenamic Acid, Meclorizone Dibutyrate, Mefenamic Acid, Mesalamine, Mesecrazone, Methylprednisolone Streptate, Momiflumate, Nabumetone, Naproxen, Sodium Naproxen, Naproxol, Nimazone, Sodium Orsalazine, Orgotein, Orpanoxin, Oxaprozin, Oxyphenbutazone, Para - niline Hydrochloride, Sodium Pentosan Polysulfate, Sodium Glycerate Fenbutazone, Pirfenidone, Piroxicam, Cinnamate Piroxicam, Olamine Piroxicam, Pilprofen, Prednazate, Prefenolone, Prodolic Acid, Procazone, Proxazole, Proxazole Citrate, Remexolone, Romazarit, Sarcorex, SarnaSedine, Salsalate, Sodium SanguiNarilate, Secrazone, Celmetacin, Sudoxicam, Sulindac, Suprofen, Talmetacin, Talniflumate, Talosalate, Tebufenolone, Tenidap, Sodium Tenidap, Tenoxicam, Tecicam, Tecimid, Tetridamine, Thiopyrac, Tixocortol Pivalate, Tolmetin, Sodium Tolmetin Triflumidate, Zidometacin, Sodium Zomepirac, Aspirin (acetylsalicylic acid), Salicylic Acid, Corticosteroid, Glucocorticoid, Tacrolimus, Pimecrolimus, and the like, but not limited thereto.

[0147] Examples of anti - malignant tumor agents and anti - irritant agents include, but are not limited to, Paclitaxel, Docetaxel, Methotrexate, Azathioprine, Vincristine, Vinblastine, Fluorouracil, Doxorubicin Hydrochloride, and Mitomycin.

[0148] Examples of anti - platelet drugs, anticoagulants, anti - fibrin drugs, and anti - thrombin drugs include, but are not limited to, Heparin, Sodium Heparin, Low - molecular - weight Heparin, Heparinoid, Hirudin, Argatroban, F Examples include, but are not limited to, orcothiolin, beraprost, prostacyclin, prostacyclin dextran D-phe-pro-arg-chloromethyl ketone, dipyridamole, glycoprotein IIb / IIIa platelet membrane receptor antagonist antibody, recombinant hirudin, and thrombin inhibitors such as ANGIOMAX (registered trademark: bivalirudin, Biogen), calcium antagonists such as nifedipine, colchicine, fish oil (omega-3 fatty acids), histamine antagonists, lovastatin, monoclonal antibodies specific for platelet-derived growth factor (PDGF) receptors, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine, nitric oxide or nitric oxide donors, superoxide dismutase, superoxide dismutase mimics, 4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO).

[0149] Examples of cell activators or anti-proliferative agents include, but are not limited to, angiotensin-converting enzyme inhibitors such as angiotensin, captopril, cilazapril or lisinopril, calcium antagonists such as nifedipine; colchicine, fibroblast growth factor (FGF) antagonists; fish oil (ω-3-fatty acids); histamine antagonists; lovastatin, monoclonal antibodies specific for platelet-derived growth factor (PDGF) receptors, nitroprusside, phosphodiesterase inhibitors, prostaglandin inhibitors, suramin, serotonin blockers, steroids, thioprotease inhibitors, triazolopyrimidine (PDGF antagonist) and nitric oxide.

[0150] Examples of ACE inhibitors include, but are not limited to, quinapril, perindopril, ramipril, captopril, benazepril,trandolapril, fosinopril, lisinopril, moexipril and enalapril.

[0151] Examples of angiotensin II receptor antagonists include, but are not limited to, irbesartan and losartan.

[0152] Other therapeutic agents for which beneficial use may be found in this specification include α-interferon, genetically engineered endothelial cells, dexamethasone, antisense molecules that bind to complementary DNA and inhibit transcription, and ribozymes, antibodies, receptor ligands such as estradiol and retinoids which are nuclear receptor ligands, thiazolidinedione (glitazone), enzymes, adhesion peptides, blood coagulation factors, inhibitors or thrombolytic agents such as streptokinase and tissue plasminogen, thiazolidine (glitazone), enzymes, adhesion peptides, blood coagulation factors, inhibitors or thrombolytic agents such as streptokinase and tissue plasminogen activator, antigens for immunization, hormones and growth factors, oligonucleotides such as antisense oligonucleotides and ribozymes, retroviral vectors for gene therapy, antiviral agents, diuretics, etc., but are not limited thereto.

[0153] In other embodiments, any two, three or other number of combinations of the aforementioned agents or other therapeutic agents may be utilized depending on the desired clinical outcome.

[0154] One method for depositing a drug, nanoparticle, stem cell, or other therapeutic agent in a specific region such as a relief hole is to use a direct writing process, for example, MICRO-PENNING (MICROPEN Technologies, located in Honeyoye Falls, New York), to deposit the material on the surface. Generally, the term "direct writing" refers to a printing or patterning method that uses a computerized motion control stage equipped with a stationary pattern generation device to eject a flowable material of a designed pattern onto the surface. Micro-penning is a flow-based microdispensing technology, and the printed material is extruded through a syringe and a precision pen tip with high degree of control. The pen tip "rides" on the surface of the material, does not touch the substrate surface, and can place an accurate amount of material in an accurate position.

[0155] FIG. 29 shows an embodiment of a strip 500 having a relief portion 502 on the lower surface of the strip 300 facing the interface of the wedge cutting instrument 200 and having an additional relatively large opening 503 configured to facilitate attachment of the strip 300 to the lower balloon between the wedge cutting instruments 200. This is disclosed, for example, in WO2016 / 073490, published on May 12, 2016, which is hereby incorporated by reference in its entirety. The opening 503 can be elliptical, circular, or any other shape depending on the desired clinical result.

[0156] In some embodiments, the longitudinal axis of the strip is longitudinally oriented along the balloon and spaced apart from each other. In some embodiments, the strip does not completely cover the length of the balloon. For example, in one embodiment, a balloon having a length of 80 mm has a strip with a length of 76.6 mm. The length of the strip can be the same as the length of the defined working balloon, but in some embodiments, the length of the strip is shorter than the length of the defined working balloon to allow for the shrinkage of the balloon typically observed when the balloon reaches its rated burst pressure. The length of each strip can, in some cases, be about 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, or 1% or less than the length of the overall working balloon, or about 1% to about 7%, about 1% to about 5%, or about 1% to about 4% shorter. In some embodiments, the length of the working balloon does not include the length of the cone.

[0157] In some embodiments, a portion of the strip, such as the base portion of the strip (e.g., the lowermost surface configured to be attached to the outer surface of the balloon), is roughened to assist in adhesion.

[0158] Spikes (e.g., serrated elements or wedge dissection instruments) are formed with many different manufacturing methods and a wide range of shapes. With respect to the manufacturing process, the device is formed using one or more additive or subtractive processes. Additive processes such as high energy vapor phase growth, e.g., laser chemical vapor deposition, self-assembly techniques, polymer / metal 3D printing, selective laser sintering, powder printers, or other stereolithography are some options, but other additive processes may be used. Alternatively, subtractive processes such as etching, CNC milling, laser cutting, water jet, electrical discharge machining are an example, but other subtractive processes may be used.

[0159] In some embodiments, the manufacturing method includes using a reel of martensitic stainless steel such as 300 or 400 series stainless steel having a hardness of about 48 to about 70 on the Rockwell C scale (HRC), more typically about 52 to about 64, or a wider Mohs range of 4 to 7, although other materials may be used. The reel may or may not be honed at the edges on one or both sides of the steel. In some embodiments, the steel stock is in the form of a thin reel strip having a thickness of about 0.004 inches to about 0.020 inches, or a thickness of about 0.005 inches to about 0.010 inches, and can be of a width within the range that can be handled by the processing system. The width can be made as large as the processing system can handle. The edges that are or are not honed can have a single hone or two or more hone angles (e.g., as illustrated in FIGS. 15 - 22). In some embodiments, when the angle of the honed edge is measured as the slope from the bounded end to the unbounded end height shown in FIG. 15, the angle of the honed edge can be greater than, for example, about 75 degrees. However, when multiple hone angles are used, the tip angle can be less than, for example, about 75 degrees. In some embodiments, the honed edge has a width W facing the surface of the strip B and a width W facing radially outward UWhen measured as the angle between, the unhoned edge, as it approaches the honed edge in a series of cutting edges, has an angle in the amount of about, at least about, or between 70 degrees, 75 degrees, 80 degrees, 85 degrees or more. In addition to the honed edge, in some embodiments, regardless of the number of honed angles, a separate additional edge is created at the very tip of the unjoined edge of the strip. When added, the height of the additional tip edge from the honed edge to the unjoined edge is often very short and typically has an angle much larger than the entire honed edge. Regardless of the number of honing angles used, the width Wu of the non-bound tip can be described as the radius of the tip. The width Wu of the non-bound tip is the penetration edge into the lesion and, in some cases, when the width is less than about 0.015 inches or less than 0.006 inches, the surface area is minimized and the contact surface with the blood vessel becomes less prominent, allowing a reduction in the amount of energy required for penetration. If the tip is configured to penetrate a hard surface such as a calcium bed, in some cases, a wider tip edge can be formed by making it more obtuse or removing the unjoined tip at a greater distance from the unjoined surface (see Figure 15, Wu). Without being bound by theory, this wider edge disperses the load over a larger surface area and creates a more effective resistance to tip deformation when the tip is pressed into the hard tissue surface. Once the reel is sharpened, it is embossed to the desired blade length. In some embodiments, the reel is hardened and then embossed to the desired length. Regardless of when stamping occurs, the blade can be passivated in some cases and hardened, for example, to above about HRC45, but more typically in the range of about HRC58 to about HRC62. The hardened blade can utilize spike, serrated elements, or wedge dissection instruments by laser cutting, stamping, EDM machining, or other precision metal forming techniques. In some cases, the serrated elements are machined on the reel, then hardened and passivated.In some embodiments of the strip that is not a honed edge with a sharp tip, the tip of the blade generated in the sharpening step of the reel is removed in the manufacturing step of the wedge dissection instrument and the strip. Optionally, the material removal (711) shown in FIG. 81 is designed to start at a distance such as from about 0.0001 inches to about 0.003 inches below the honed edge (710), or about 0.0001 inches to about 0.0005 inches is removed from the honed edge (710) to produce a flat top (Wu) as shown in FIG. 15. The thinnest edge remaining on the side of the previously honed edge (optionally a flat top) becomes the non-boundary surface of the strip.

[0160] In some embodiments, methods of attaching the strip are disclosed. The method can include any number of processing steps that provide effective retention, vertical orientation, and structural stability of the strip during manufacture and use. In one embodiment, the interface is typically coated with a base coat of a suitable material, such as a polymer, e.g., polyurethane, through a controlled dipping process that produces a uniform layer of polyurethane. The coating is dried, and typically three to four strips are aligned with a strip alignment mechanism or jig and adhered in a predetermined direction with a medical cyanoacrylate. The number and periodicity of the strips can vary, e.g., from 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 - continuous. When the strip is adhered to the balloon surface, a single or a series of top coats or retention layers are placed over a metallic interrupted scoring element or a wedge - cutting device to hold the strip and protect the balloon from the thin tip of the scoring element. In some embodiments, these layers follow a process similar to the base coat or pre - coat using a controlled dipping process that produces one or more uniform layers of urethane or polyurethane. In some embodiments, there is no base coat and there is only one top coat. The number of base coats and top coats can be varied between 0 and 4 for either the base coat or the top coat. Once the retention layer has cured, in order to reduce the friction of the balloon and enhance balloon delivery and retrievability, a hydrophilic coating or other coating can be applied. Applying an outer slip coating reduces the forces when inserting and housing the balloon, thus improving the functionality of the balloon.

[0161] Figure 30A shows a schematic cross-sectional view of a belt and a wedge cutting device operably attached to the outer surface of a balloon, according to some embodiments of the present invention. A polymer layer, typically thin (e.g., 0.0001 inches to 0.0009 inches), and in some embodiments about 0.001 inches or less, such as to limit the increase in the balloon diameter profile, can be used as a base coat (layer 270A) covering the outer balloon surface. This base coat 270A provides an interfacial bonding layer for the interrupted scoring elements to the balloon surface. This layer 270A can be formed from the same or similar polymers as the other layers while providing chemical, mechanical, or electromagnetic bonding to the balloon surface. This base coat layer 270A can be configured to reduce, and potentially reduce, the interfacial strain between the outer balloon surface and the bonding surface of the metallic scoring elements. The strain between the two surfaces is reduced by sandwiching the adhesive layer 270E and the scoring element 200 within a polymer matrix that is independent of, and to some extent isolated from, the strain of the balloon during balloon inflation and pressurization. A typical base coat 270A is a polymer, such as urethane or polyurethane, although this layer can be made of various other materials. In some embodiments, the coating can include silicone and hydrophilic coatings, including hydrogel polymers such as, for example, a polymer network of a vinyl polymer and a non-crosslinked hydrogel. Polyethylene oxide (PEO) is an example of a hydrogel. An example of a vinyl polymer is neopentyl glycol diacrylate (NPG). Film formation of the layer can be performed by immersing the balloon or the matrix of the balloon, singly or continuously, into a polymer bath at a controlled rate in both directions or one direction under controlled insertion and extraction conditions. As another method, the layer can also be spray-coated or deposited using various known processes. Such processes include self-assembly techniques that are known and in practical use, typically coating of a monolayer by self-assembly using surface ion charging.

[0162] Referring to FIG. 30A, the bonding layer 270E between the metallic scoring element 200 and the base coat 270A can typically be made as thin as from 0.0002 inches to 0.001 inches, more typically from 0.0006 inches to 0.001 inches, and in some embodiments can be as thick as 0.002 inches. In some embodiments, the adhesive layer is designed to be thin enough to limit the increase in the balloon's diameter profile. The adhesive layer 270E can be a cyanoacrylate, but can also be made from other adhesive materials such as a UV curable adhesive that provides a chemical, mechanical, or electromagnetic bond between the base coat 270A and the bonding surface of the metallic scoring element. This layer 270E can be regarded as a functional layer when bonding the bonding surface of the metallic scoring element to the balloon, and may be the only layer between the bonding surface of the metallic scoring element and the outer balloon surface. This layer 270E can be one or more adhesive products. In a preferred embodiment, the adhesive layer 270E is a low viscosity single adhesive that allows wicking of the adhesive along the interface between the bonding surface of the metallic scoring element and the base coat. In some embodiments, the adhesive material dries quickly and a continuous layer can be applied over the adhesive layer with minimal cure delay. In other manufacturing methods, a more viscous adhesive layer can be placed at both ends of the bottom of the strip, or periodically between the bonding surface of the metallic scoring element and the base layer to leave unbonded portions free or non-adhesive. Yet another method can use multiple adhesives. For example, a more viscous adhesive can be used at both ends of the interrupted bonding surface of the metallic scoring element, and then a wicking adhesive can be used on some or all of the unbonded portions. In some embodiments, one layer (e.g., a single layer), two layers, or more retention layers (two layers shown in FIG. 27) 270B, 270C are It can be made to exist on the base layer 270A in the same manner as the scoring element. The polymer retention layer, in some embodiments, is similar to that described above for a base layer having sufficient properties such that effective bonding occurs between the base layer 270A and the retention layers 270B, 270C at the layer interface, and can have such dimensions. In some cases, the retention layer can be designed to provide a thickness similar to that of the base layer, although it may also be useful to make the retention layer slightly thicker than the base layer. A thicker base layer and / or retention layer can, depending on the situation, provide greater puncture resistance and improved balloon durability against potential punctures from interrupted metallic scoring elements, any sharp edges from implants left in the body, or sharp edges found, for example, in severely calcified diseased blood vessels. In some embodiments, the outer slip layer 270D can also be present over the retention layer(s) on the balloon and / or the scoring element. Various hydrophilic coatings are commercially available and reduce friction and improve balloon navigation through tortuous and narrow anatomical features. In some embodiments, the surface of the balloon can be completely coated with a hydrophilic coating, while in other embodiments, only the surfaces that are normally exposed during delivery can be coated with a hydrophilic coating since the balloon can be coated after pleating or after pleating and compression (crimping). The thickness of a typical hydrophilic coating is on the order of a few microns and can be made as thin as about 10 angstroms in some embodiments.

[0163] In some embodiments, an adhesive can be applied separately to the balloon and the strip and then the two components can be adhered together. A template can be used to ensure proper positioning of the scoring element along the surface of the balloon.

[0164] The holding polymer layers 270B, 270C can typically be of the same kind as the base layer having sufficient properties such that an effective bond occurs between the base layer and the holding layer at the layer interface. The holding layer may be designed to have the same thickness as the base layer, but it may also be useful to make the holding layer slightly thicker than the base layer, and it may be 20%, 15%, 10%, or 5% or less thicker. A thicker base layer and / or holding layer provides greater puncture resistance and improved balloon durability against potential punctures from interrupted scoring elements made of metal, any sharp edges from implants left in the body, or sharp edges found in severely calcified diseased blood vessels. In some embodiments having multiple holding layers 270B, 270C, the layers can be made of the same material or different materials.

[0165] In FIG. 30B, the addition of surface functionalization is applied to the strip 200. This functionalization can be performed using hundreds of strips 200 placed in a plasma field within a large plasma chamber under vacuum conditions. The deposited functionalized layer is typically very thin on the order of hundreds of angstroms. By using surface strengthening or functional group attachment, an effective bonding surface is obtained.

[0166] The balloon can have any of the features of FIG. 30A. FIG. 30B shows a schematic cross-sectional view of a strip and a wedge cutting device operably attached to the outer surface of a balloon according to some embodiments. A polymer layer can be used as a base coat (layer 270A) covering the outer surface of the balloon. A bonding layer 270E, such as an adhesive, may be present between the strip 200 and the base coat 270A. In some embodiments, one (e.g., a single layer), two, three, or more holding layers 270B, 270C may be present on the base layer 270A and the strip 200. The holding layer 270B can be a pre-formed coating adhesive layer. The holding layer 270C can be a pre-formed coating. In some embodiments, an outer slip layer 270D may also be present on the holding layer(s) on the balloon and / or the strip 200. The balloon of FIG. 30B can include a plasma layer 280.

[0167] Plasma cleaning can provide advantages to the adhesion coefficient between two surfaces. Plasma cleaning is very effective in improving adhesion under certain conditions, but in some embodiments, simply cleaning the surface is not sufficient. The use of surface functionalization by bonding amino groups to the surface can provide additional advantages. Plasma technology can be used to apply a preselected amino group in order to achieve a surface that is effectively functionalized for polymer adhesion to the surface of a metal strip 200. The plasma process has three active plasma steps, i.e., steps where intentional physical or chemical changes occur 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 impart pendant vinyl groups to the stainless steel substrate of the strip 200 that readily react with a UV cyanoacrylate adhesive used to bond the stainless steel strip to a bonding layer 270E, a pre-formed coating bonding layer 270B, a pre-formed coating 270C, and / or an outer slip layer 270D (steps 2 and 3). Functionalization uses the coupling of acrylic-functional organosilanes. The functionalization designated as silanization employs two steps, i.e., hydroxylation (step 2) to introduce hydroxyl groups of atomic-level thinness (less than 50 angstroms) to the substrate of the strip 200, followed by silanization (step 3) with a thickness in the range of 100 - 500 angstroms where the organic silane binds to the pendant hydroxyl groups via a condensation reaction. The use of low-power plasma initiates the reaction under conditions much milder than heat or catalytic reactions. Although there are other known techniques for depositing thin layers of angstroms, the use of plasma technology has shown effective and reproducible results for the purpose of functionalizing the stainless steel strip 200.

[0168] The strip 200 can include a surface treatment applied to the surface of the strip. The surface treatment can include a plasma treatment. The treatment can be completed within a chamber. One or more strips 200 can be placed within the chamber under vacuum. The chamber can be placed within a plasma field. The plasma can be deposited over the entire surface of the strip 200. The plasma can be deposited on one or more surfaces of the strip 200. The plasma can be deposited as a functionalized layer. The outer surface of the strip 200 can include a thin plasma layer. This layer can 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 aforementioned values. The plasma layer 280 can facilitate bonding to other layers. The plasma layer 280 can facilitate bonding between the strip 200 and the base coat 270A. The plasma layer 280 can facilitate bonding between the strip 200 and the adhesive 270E. The plasma layer 280 can facilitate bonding between the strip 200 and the PFC bonding layer 270B. The plasma layer 280 can facilitate bonding between the strip 200 and the PFC 270C. The plasma layer 280 can result in a strengthened bonding surface.

[0169] The plasma layer 280 can improve the bonding coefficient between the surface of the strip 200 and two surfaces such as another layer. In some embodiments, the strip 200 is subjected to plasma cleaning. Plasma cleaning can improve the surface of the strip 200 and enhance the bondability. In some embodiments, plasma cleaning is used in combination with surface functionalization. Surface functionalization can include bonding amino groups to the surface. The plasma layer 280 can contain one or more amino groups. The amino groups can promote the adhesion between the metal surface of the strip 200 and an additional polymer / adhesive layer. The amino groups can function as a bridge to improve the adhesion between these different materials. The amino groups can function as a bridge between the metal layer and the non-metal layer. Amino groups can be applied by a plasma process. The amino groups can be pre-selected based on the layers to be joined. Pr The plasma layer 280 can contain amino groups to promote adhesion between layers.

[0170] The process can include one or more steps. These steps can be considered active plasma steps. The process can include physical changes to the surface of the strip 200. The process can include chemical changes to the surface of the strip 200. The process can include cleaning. The plasma process can be designed to clean the surface of the strip 200. The process can clean the entire outer surface of the strip 200. Cleaning can be a prerequisite for subsequent coating of the surface of the strip 200. Cleaning can be a surface treatment. Cleaning can remove impurities and / or contaminants from the surface of the strip 200.

[0171] The process can include activation. Plasma activation can improve the surface adhesion properties of the strip 200. This process can add amino acids to the surface of the strip 200. In some embodiments, pendent vinyl groups are disposed on the strip 200. Amino acids such as pendent vinyl groups are configured to react with an adhesive. Amino acids such as pendent vinyl groups are configured to react with a UV cyanoacrylate adhesive. The UV cyanoacrylate adhesive is applied to one or more layers to adhere the strip 200 to the layer. The UV cyanoacrylate adhesive can be used to adhere the strip 200 to the base coat 270A. The adhesive 270E can be a UV cyanoacrylate adhesive. The UV cyanoacrylate adhesive can be used to adhere the strip 200 to the PFC 270C. The PFC adhesive layer 270B can be a UV cyanoacrylate adhesive.

[0172] The process can include functionalization. Plasma functionalization can improve the surface adhesion properties of the strip 200. This process can couple an acrylic-functional organosilane. This can be a coupling agent for a photocurable composition. The process can include hydroxylation. Hydroxylation can impart hydroxyl groups to the surface of the strip 200. The hydroxyl groups can be less than 50 angstroms, for example, the layer can 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 foregoing values. The process can include silanization. Silanization can 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 foregoing values. The organosilane binds to the pendant hydroxyl groups via a condensation reaction. This process can deposit a thin layer of material on the surface of the strip 200. This process can result in uniform cleaning. The process can result in a uniform distribution. The process can result in uniform surface functionalization. The process can result in a surface of the strip 200 suitable for adhering to other layers. The process can result in more effective adhesion between layers. The process can result in effective and repeatable adhesion between layers.

[0173] Figure 30B shows a modified layer stack for retaining the strip. Many of the layers described in Figure 30A can be included. Figure 30B illustrates a pre-formed coating 270C, a PFC bonding layer 270B, a strip 200, an adhesive layer 270E, and a base coat 270A. This figure also shows a plasma layer 280 that covers the entire strip 200. The deposition of the functional siloxane is bonded to the substrate of the strip 200 mainly through condensation with hydroxyl groups that depend on the nickel, titanium, and chromium content of the stainless steel of the strip 200. An example of the chemical formula of this process (depending on the type of adhesive used) is as follows.

[0174] [Chemical Formula]

[0175] To reduce friction and improve the navigation of the balloon through tortuous and narrow anatomical shapes, various hydrophilic coatings are commercially available. Furthermore, as methods for coating the balloon, various methods such as dipping, spraying, and other vapor depositions are commercially available. In some embodiments, layer 270D of Figure 30A can be a hydrophilic slip layer. In a preferred embodiment, the balloon surface can be completely wrapped with a hydrophilic coating. In other embodiments, the balloon can be coated after pleating, or after pleating and compression (crimping), and in only these embodiments, the surfaces that are typically exposed during delivery are coated via any of the above deposition methods. The surface may only be partially coated with a hydrophilic coating that covers only the surfaces that are 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 can be as thin as, for example, 100 angstroms and can incorporate more than a single coating.

[0176] The height of the wedge dissection instrument, the strip, and the layer in the outer balloon encapsulation process can be regarded as a cage for use with an inflatable member such as a medical balloon for angioplasty or as part of a medical procedure that includes an inflatable member such as a medical balloon. To effectively perform keyhole or catheter-based surgery, it is valuable for the balloon to be foldable to a diameter that is a fraction of the intended inflated diameter. Thus, the balloon and optionally the cage are generally folded such that the outer shape of the folded balloon can be effectively used. In one such embodiment, the cage is folded by a method that provides an orientation of spikes that avoids puncturing the balloon or scraping the lumen endothelium during delivery and removal, as illustrated in FIG. 28. FIG. 28 illustrates a balloon 1000 having a plurality of pleats 1002, a strip 300 between the pleats, and corresponding wedge dissection instruments 200, such that a single strip 300 having a plurality of wedge dissection instruments 200 is located between two pleats 1002. A pleating tool was designed that provides an effective orientation of the spikes and splines. The pleating tool has a series of pleating wedges, each wedge providing the ability to compress (crimp) the balloon between the wedges when the wedge elements are closed on the balloon. Because the spline elements are bulky and to minimize contact and potential damage to the wedge head, the wedges are designed with a series of pockets extending along the length of the wedge head. The pockets in the wedge head provide the ability for the spline features to be located within the pockets and limit contact between the spline and the wedge. The pockets can also provide the ability to assist in the orientation of the spline and spike features, and the orientation of the features limits contact with the balloon such as overfolding and limits orientations such as a perpendicular orientation to the balloon that can cause abrasion of the vessel endothelium during delivery of the device on the balloon. Such spike orientations can include a tangential direction to the balloon surface, an apparent lateral orientation, as shown in FIG. 31.

[0177] In some embodiments, a system and method are disclosed herein for creating a linear incision by forming serrations in tissue. It is well known in cardiovascular disease that applying an interventional method to increase the lumen size of an occlusive lesion can improve blood flow and increase the likelihood that the blood vessel will remain open longer than when minimal lumen dilation is achieved after treatment. There are various options for methods of expanding the lumen diameter. As a basic method, percutaneous balloon angioplasty (POBA), percutaneous transluminal angioplasty (PTA), or similar methods are often used to open the lesion. Additionally, there are more specialized instruments with mechanisms for assisting or controlling balloon energy, such as cutting balloons, AngioSculpt; (manufactured by Spectranetics), Chocolate; (manufactured by Cordis), etc. Products belonging to such general categories often have an external structure (whether attached or not) on the surface of the balloon, designed to first contact the wall and be pushed into the surface of the wall by the pressure of the balloon. Theoretically, the structure on the outer surface locally increases the force applied to the lumen, resulting in the lumen surface being incised and allowing the artery to expand with the expansion of the balloon. Although these balloon designs have some advantages compared to POBA or a plain balloon alone, they all have limitations in terms of their effectiveness and their ability to promote lumen expansion, especially in potentially complex diseases. AngioSculpt; manufactured by Spectranetics

[0178] As an alternative to an external structure that forms a compression line along the inner membrane, there is a method of forming a longitudinally serrated line along the lumen. The effectiveness of serrations (sawteeth) in assisting the separation of materials (such as paper, stamps, cardboard, granite, marble, etc.) is well understood, and since disease morphologies often include both soft and hard materials, serration technology is advantageous for effectively assisting in the dilation of blood vessels. There are several methods of forming serrations, which are disclosed in U.S. Patent No. 9,480,826 issued on November 1, 2016, WO2015 / 187872 published on December 10, 2015, WO2016 / 073511 published on May 12, 2016, WO2016 / 073490 published on May 12, 2016, and U.S. Patent Application No. 15 / 268,407 filed on September 16, 2016. The above-mentioned documents are hereby incorporated by reference in their entirety into this specification. For example, a series of serration elements can provide features configured to generate serrations or linear sawtooth marks at the deployment site.

[0179] In some embodiments, the dilation of the lumen by serration angioplasty is superior to balloon alone. An improvement in the dilation of the lumen has been recorded (Figure 78), and the final stenosis was improved by 49% with the serration balloon compared to the normal balloon alone. The increase in the lumen diameter improves blood flow (Figures 75 and 76). Applying Poiseuille's law to the blood flow in the blood vessel, the volumetric flow rate can be calculated. The improvement in the average flow ratio can be compared, which can be defined as the fourth power of (radius after intervention / radius before intervention). A dataset and a power fitting curve comparing a normal balloon and a serration balloon are shown in Figure 75. Figure 75 shows that serration balloon angioplasty can achieve more than twice the average flow ratio.

[0180] In some embodiments, including serration techniques provides advantages to the balloon not only for preparing tissue before or simultaneously with the use of a balloon coated with a drug, but also as a single-step drug delivery mechanism. By applying a drug coating on, around, and / or within a reservoir or region adjacent to the serration of the balloon, the serration of the serration balloon can facilitate the delivery of a desired drug or other therapeutic agent to a desired depth at a desired target location, such as the intimal, medial, or adventitial surface of the lumen wall.

[0181] Typically, a balloon coated with a drug is made with a drug coating on its surface. However, when a balloon without serrations (sawteeth) expands, it contacts the intima and begins to elute the drug present on its surface, thus inhibiting the ability of the balloon's surface to deliver the drug to the deep tissue space. The following disclosure includes, but is not limited to, components and methods of using components that can effectively deliver drugs into tissue using serrations (sawteeth) that are independent of design elements in some embodiments.

[0182] 1) A radially expandable surface (e.g., a compliant balloon or a semi-compliant balloon). balloon).

[0183] 2) A series of drug-coated strips including a plurality of wedge incising devices spaced along the surface of each strip (in some embodiments, the space between each wedge incising device is not as long as the length of the wedge incising device itself and / or the height of the wedge incising device is only a small part of the balloon diameter).

[0184] 3) The protrusion can optionally have an angled A-frame structure from the base to the tip, and the long well or space within the A-frame structure becomes a drug reservoir region.

[0185] 4) The side wall of the wedge cutting device on the A-frame can include a series of openings and / or microchannels to enable the transfer of the agent to the interrupted surface directly below the serration.

[0186] 5) A single or series of wells within each A-frame structure of the strip where a drug, stem cell, or other therapeutic agent can be placed.

[0187] 6a) The well can include either a depression in the balloon surface or a separate catheter-like channel along the balloon body, which can include fine pores (created by laser drilling or other precision methods) to allow for the presence of a greater amount of therapeutic agent.

[0188] 6a.1) Optionally, the catheter channel can be incorporated into the inner diameter of the catheter shaft and can return to the hub over the entire length of the shaft, allowing for the delivery of the agent from the port of the hub through the channel to the balloon surface.

[0189] 6b) During balloon inflation, the outward balloon pressure can a) apply force to the recessed well, displacing the volume in which the therapeutic agent is present, or b) expand the fine pores to allow the agent to pass through the pores.

[0190] 6c) Typically, upon delivery of the balloon, the well, strip, raised element, and A-frame are captured within the folds of the balloon, minimizing systemic leaching of the therapeutic agent.

[0191] 7) As the balloon expands, the serrated A-frame separates the intimal tissue layer to expose the media, and in some cases the media layer and adventitial layer open, and the therapeutic agent captured within the folds of the balloon is mainly discharged deep into the vascular wall and / or exposed.

[0192] 8) The therapeutic agent and drug elute from the surface of the serrated drug-eluting balloon into the incisions and microcracks formed by the serrated A-frame and elute through the intima into the media or adventitia.

[0193] In some embodiments, the present invention relates to the use of serration technology in combination with intravascular procedures, and the design of the serration technology includes a novel drug delivery design combined with a drug selectively disposed on the balloon, a well of the drug contained near or below the serration element, or a path through which the drug moves from a more proximal portion of the delivery system to the balloon surface and into the tissue through an access formed by the serration element.

[0194] In some embodiments, the serration element can be combined with a multilayer, such as a two - or three - layer polymer disclosed in U.S. Patent Application No. 15 / 268,407, and the space between the base polymer and one or more top layers can be used as a drug reservoir space. In some embodiments, the bottom polymer is removed, and the space between the balloon's surface and one or more top layers can be used as a drug reservoir space. The deposition of the drug into this space can be facilitated, for example, by spray coating, dipping, or the use of nanotechnology self - assembly techniques where the drug is encapsulated between the base and top layers of the polymer. In some embodiments, the drug reservoir layer is not exposed to the environment due to the encapsulation of one or more top layers, thus limiting exposure to the body or an intact intimal layer. The inclusion of a drug coating on, around, and / or within the encapsulated layer facilitates drug delivery mainly subintimally by the serration of the serrated balloon.

[0195] FIG. 32 shows an example of a cutting balloon that has been improved to form serrations. In some examples, the beneficial effects of serrations can be achieved by improving the cutting balloon catheter, as disclosed, for example, in U.S. Patent Application Publication No. 2006 / 0184191 by O'Brien (incorporated herein by reference). The balloon catheter can include a catheter shaft having a balloon attached thereto. One or more cutting members or blades are attached to the balloon. The balloon can include one or more discrete points or regions 3200 of flexibility to increase the flexibility of the cutting balloon catheter. The cuts of the one or more cutting members may be aligned with one or more discrete flexible points of the balloon. In some examples, the flexible points can be arranged every 5 mm at lengths of 10 mm and 15 mm (length of 6 mm = 0, length of 10 mm = 1, length of 15 mm = 2). An atherotome including flexible points may, in some cases, assist in tracking lesions that were previously inaccessible.

[0196] FIG. 33 is an explanatory view of an improved cutting balloon, in which the balloon has even greater flexibility and the cutting is replaced entirely or in part by the pattern of serrated blades 3350. As shown in FIG. 32, the cutting members 3320 may differ in number, position, and arrangement with respect to balloon 3316. For example, catheter 3310 can include one, two, three, four, five, six, or more cutting members 3320 arranged at any position along balloon 3316 in a regular, irregular, or any other suitable pattern. The pattern can include a generally helical orientation of the cutting members 3320. Catheter 3310 can include a plurality of cutting members 3320 arranged equidistantly with respect to balloon 3316 that extends generally longitudinally. Generally, the cutting members 3320 can be configured to provide variable flexibility or otherwise change the flexibility of catheter 3310. Increasing the flexibility of cutting members 3320, balloon 3316, and / or catheter 3310 is desirable because, for example, it can improve the tracking ability and general deliverability of catheter 3310 through tortuous anatomical structures. Further, increasing flexibility allows catheter 3310 to be moved to more intravascular positions, including positions that may not be easily reachable with other less flexible cutting balloon catheters. Generally, the increased flexibility is the result of the structural characteristics of the cutting members 3320, the structural modification of the cutting members 3320, and / or the structural characteristics of the cutting balloon 3316. For example, the cutting member 3320 can include a first section 3344a, a second section 3344b, and a gap or notch 3346 disposed between the first section 3344a and the second section 3344b. The notch 3346 may be configured to provide a flexible region such as the space between the first section 3344a and the second section 3344b. In some embodiments, the notch 3346 may be defined by a downward bend or slot formed in the cutting surface of the cutting member 3320.Alternatively, the cut 3346 need not be a physical gap between the first section 3344a and the second section 3344b, but the cut 3346 may be a region of the cutting member 3320 having a reduced wall thickness, or may be composed of a material having increased flexibility with respect to the materials of the first and second sections 3344a, 3344b. The cut 3346 may also be composed of an external connector that is connected to both the first section 3344a and the second section 3344b to bridge the sections 3344a, 3344b. By separating the sections 3344a, 3344b, the flexibility of the cutting member 3320 and / or the overall flexibility of the catheter 3310 can be increased. In some embodiments, a series of cutting elements (or microtomes) as described above can be arranged linearly along the surface of the balloon with a gap between them on the upper surface of the blade. In the schematic diagram above, the length of the gap is about one tenth of the length of an individual blade. In some embodiments, the ratio of the gap length to the blade length can be, for example, about 1 / 15 to about 1 / 1, about 1 / 10 to about 1 / 1, about 1 / 5 to about 1 / 1, about 1 / 5 to about 1 / 2, or about 1 / 15, about 1 / 14, about 1 / 13, about 1 / 12, about 1 / 11, about 1 / 10, about 1 / 9, about 1 / 8, about 1 / 7, about 1 / 6, about 1 / 5, about 1 / 4, about 1 / 3, about 1 / 2, about 1 / 1, about 1 / 1.5, about 2 / 1, or a range including any two of the foregoing values.

[0197]

[0198] ​This specification describes an improved cutting member that provides a more flexible and stable design and has dimensions that can form serrations or sawtooth marks in tissue. Examples of the improved cutting member can provide a lateral bend of about 8 degrees, 9 degrees, 10 degrees, 11 degrees, 12 degrees, 13 degrees, 14 degrees, 15 degrees, 20 degrees, or more, regardless of whether the cutting surface is not serrated or has a low degree of serration. Some embodiments can include a series of cutting members having serrated features (e.g., raised elements) as described elsewhere in this specification, in series or between or at the ends of the cutting members. When the cutting member (X) is divided into a plurality of discrete sections, it can have a length in the range of, for example, about 0.01 inches to about 0.10 inches and can be separated by a space (Y) in the range of, for example, about 0.01 inches to about 0.08 inches. In some designs, the length of the cutting member (X) is divided into a plurality of discrete sections separated by a ratio of 1:2, 1:2.5, 1:3, 1:3.5, or 1:4, and the space (Y) between the cutting members is set to be larger than the length of the cutting member. The entire cutting blade may have discrete sections at any one or any number of positions along the blade. When pressure is applied to the tissue by the balloon, the resulting tissue disruption may appear as a series of dots and dashes, or any combination of dots and dashes, caused by the joined improved cutting members, and penetrate the tissue only in the narrow region where the discrete cutting members (X) are located. The effect of this discrete local penetration is that a balloon with an improved cutting edge produces a new angioplasty effect called serratoplasty. For example, one such serratoplasty design has small raised features at both ends of the cutting blade that can produce a dot-like effect (or serrated-like features) in the tissue, and then long raised features in the central portion of the blade that can produce a dash. In the serratoplasty design, a pattern of alternating small and long raises, or a non-repeating pattern, may mix a series of dots separated by one or more dashes.One embodiment may have 1, 3, 4, 5, 6, or 8 members, such as blades (or combinations of these numbers of members, such as blades), on the outside of the balloon, and the blades are typically shorter than the length of the balloon body. The device configured for seratoplasty or serration angioplasty can be used as a single angioplasty balloon or as a preparatory device prior to subsequent treatment. Subsequent treatments include, but are not limited to, stent placement, drug-eluting stent placement, atherectomy, high-pressure balloon placement, drug-coated balloon treatment, or other endovascular treatments that require effective lumen formation. Whether the device is used as a preparatory device for subsequent treatment or as a single treatment, through the use of a modified athereotome (serrated feature) as disclosed herein, the device effectively manages plaque or calcium by weakening the bond, initiating cell or structural dissociation, and minimizing cell or structural compression that generally occurs by angioplasty alone. Seratoplasty results in numerous substantial dissections and raised flaps. Without forming, it is possible to safely and accurately expand and stretch a diseased lumen to a desired diameter using low pressure (Figure 80). The serration can expand the plaque more evenly and smoothly, avoiding the formation of random cracks that lead to dissection and residual stenosis. After treating or pretreating the plaque with serration, in some cases, it is also possible to expand at a pressure lower than the pressure used in standard balloon angioplasty. The low balloon internal pressure (e.g., 4, 3.5, 3, 2.5, 2, 1, 0.5 atm or less, or a combination thereof) applied by the balloon adhered with the improved cutting member reduces plaque disruption, reduces dissection, and reduces arterial wall damage. This "low pressure" or "minimally invasive" seratoplasty is less likely to cause biological reactions involving neointimal hyperplasia and smooth muscle cell replication that often occur after balloon angioplasty. In addition, serration allows plaque expansion by reducing plaque fragmentation and disruption during balloon angioplasty. By preparing the plaque using a balloon with serrations (forming serration marks in the blood vessel), the number and severity of dissections can be reduced. This reduces the need for stent placement to treat dissections and residual stenosis after balloon angioplasty with serration.

[0199] As described herein, serrated blood vessels open at lower pressures and are able to maintain effective lumen dilation over time. After serration angioplasty, it has been observed that the dilation of the blood vessel lumen is maintained even after more than 15 minutes. After the blood vessel is stretched, the concept that the blood vessel recoils or the blood vessel lumen decreases by reaction is possible, and a design that can overcome the tendency of the blood vessel to contract is required. Clinically, it has been observed that little atrophy occurs in serration angioplasty. To evaluate the phenomenon of atrophy, physicians collected angiographic images after serration angioplasty and 15 minutes after serration angioplasty. As a result of evaluating the change in blood vessel diameter and the atrophy of the blood vessel in this image, little atrophy was detected. These observations are unexpected and encourage further experimental designs to investigate examples of serration angioplasty designed to reduce atrophy. The phenomenon of reduced atrophy is seen in both the arterial and venous systems, particularly in diseases found near anastomoses or arteriovenous anastomoses. The serrated balloon described herein has shown effective results in reducing and in some cases eliminating atrophy in the arterial system. Also, it has been confirmed that serration angioplasty with a balloon smaller than the reference blood vessel diameter can be used for pretreatment of the diseased site.

[0200] This pretreatment can provide an equally effective rotational angioplasty treatment at a low balloon pressure of about 4 atmospheres or less for the preparation of plaques with perforations, including, if appropriate, subsequent balloon angioplasty, so as to avoid damage to the arterial wall or its subintimal tissue. By performing plaque preparation and then low-pressure angioplasty, while there is a possibility of exposing the media layer of the artery, the likelihood of dissection occurring that results in deep tissue tearing is reduced. Exposure of deep tissue from within the arterial wall can, in some cases, stimulate thrombosis due to exposure of collagen and also stimulate the proliferation of smooth muscle cells, which later causes neointimal hyperplastic occlusion of the artery. This reduction in the number and severity of such dissections can, in some cases, be an advantageous differentiating factor compared to other forms of plaque disruption techniques, including but not limited to conventional cutting or scoring devices and angioplasty that supplies ultrasonic energy.

[0201] Strip incorporated into the balloon design In some embodiments, instead of a top coat, (as disclosed in this specification and, for example, U.S. Patent Application Publication No. 2017 / 0333686 to Schneider et al. and U.S. Patent Application Publication No. 2017 / 0080192 to Giasolli et al., the entire disclosures of which are incorporated herein by reference), or instead of a prehub cover (premanufactured cover) or a top balloon coat (not only described herein but also, for example, and U.S. Patent Application Publication No. 2020 / 0155815 to Giasolli et al., the entire disclosure of which is incorporated herein by reference), a strip is embedded in the balloon Use is preferred. The use of an embedded strip can provide a series of added values, such as ease of manufacture, accurate control of thickness, increased retention of the strip, uniformity of the outer layer, the ability to compress (crimp) the balloon to a lower profile, and / or the ability to use a wider range of materials for use as a balloon and for features to protect the balloon. The range of materials into which the strip can be embedded can include almost all materials that can be extruded and blown into a balloon shape. In some embodiments, the embedded balloon may be formed of a single material or more than one layer of material. When using more than one layer, the top layer is usually formed of a material that is more stretchable or flexible than the base balloon. Since the functional characteristics of the embedded balloon are different from those of the balloon in the balloon design, the materials and processes used to construct it are usually different. In the case of the outer surface of the embedded balloon, the main requirement is to hold the raised element (e.g., wedge cutting device / serration) while being able to raise the tip higher than the base balloon. Regardless of the materials and processes used in the manufacture of the embedded balloon, the dimensions of the balloon may be the same as or different from those of a normal base balloon. According to the aforementioned Laplace's formula, the tangential stress on the balloon surface is directly proportional to the radius of the balloon and the pressure inside the balloon. Therefore, if the diameter of the balloon is different, it is necessary to change the material selected and the dimensions of the embedded balloon. Thus, for a balloon with a diameter of 2.5 mm, even at the same pressure, the tension on the balloon surface is 1 / 2 that of a balloon with a diameter of 5.0 mm, so a material with higher stretchability than a balloon with a diameter of 5.0 mm may be required.

[0202] Interface adhesion between the prehub cover and the base balloon The spacing between the raised elements or the upper surface of the base strip can be considered as an expandable and contractible membrane that holds the strip and stabilizes the raised elements on the balloon surface. In some embodiments, the space between these raised elements may be adhered to the base balloon and the strip. In other embodiments, this space is not adhered to the base balloon, allowing the prehub balloon to float freely in the strip region, while both balloons may be selectively adhered elsewhere. In embodiments where the strip region is not selectively adhered, the inner balloon may potentially drop substantially during contraction. When the balloon system contracts, the outer balloon contracts at a slightly different rate than the inner balloon. The variation in contraction rate creates local voids between the balloons. This space allows the serrated strip to retract into the space. As a result, the raised elements of the strip body have the height or profile of the raised elements located on the outer balloon minimized, and in some cases, all of the raised elements are completely retracted into the space between the balloons. Such embodiments can be advantageous, for example, in reducing the risk that the serrations catch on unwanted portions of anatomical structures such as blood vessels or branches outside the target treatment location during insertion or removal of the device. However, in some embodiments, the prehub cover balloon or the outer balloon is adhered to the base balloon and integrated.

[0203] As shown in FIG. 34, in some embodiments, a balloon having serrations adhered to its surface expands within a prefabricated cover (prehub cover). FIG. 34 schematically shows an example of a method for manufacturing a balloon-in-balloon design. As shown in panel 1, a base balloon 5100 is provided. In some embodiments, the base balloon 5100 can be a Plain Old Balloon Angioplasty (POBA) balloon. The base balloon 5100 provides the desired support to the blood vessel. The base balloon 5100 provides the desired support to the serrations. The base balloon 5100 can have any characteristics for achieving the methods described herein. The base balloon 5100 can correspond to the pressures described herein. The base balloon 5100 can expand to the diameters described herein. The base balloon 5100 can typically be disposed on a short catheter. The base balloon 5100 can be disposed at the distal end of the catheter. The base balloon 5100 can be disposed at any position along the length of the catheter. The base ball The balloon 5100 can also be used alone. The base balloon 5100 can be used with only a single base coat. The base balloon 5100 can, in other cases, be used with multiple base coats. The base balloon 5100 can be composed of any of the materials described herein. The base balloon 5100 can be compliant. The base balloon 5100 can be non-compliant. The base balloon 5100 can be formed from polyester or nylon. The base balloon can be designed to expand to a specific diameter. The base balloon is designed to accommodate an overinflated diameter without radial expansion. The base balloon 5100 can be semi-compliant. The base balloon 5100 can be composed of Pebax or high durometer polyurethane. The base balloon 5100 can expand to various diameters in response to pressure. The base balloon 5100 can conform to the size of the lumen. The base balloon 5100 can be elastomeric. The base balloon 5100 can be made of polyurethane, nylon, polyethylene, polyolefin copolymer, polyethylene terephthalate or silicone, or any combination of materials. The base balloon 5100 can be inflated by an inflation medium that fills the volume.

[0204] As shown in Panel 2, the strip with the angiotome 5102 can be attached to the base balloon 5100. The strip with the angiotome 5102 can be attached to the base balloon 5100 with an adhesive along the base portion of the strip 5102. The strip with the angiotome 5102 can be applied longitudinally to the base balloon 5100. The strip including the angiotome 5102 is attached to the outer surface of the base balloon 5100. The strip including the angiotome 5102 can be applied, for example, as described elsewhere in this specification, to form a serrated balloon. In the illustrated embodiment, a strip including four angiotomes 5102 is applied to the base balloon 5100. The serrated balloon can include any number of strips including the angiotome 5102, including 1, 2, 3, 4, 5, 6, 7, 8, or any range including any two or more of the foregoing values. The strips including the angiotome 5102 are arranged equidistantly on the circumference of the base balloon 5100. The strips including the angiotome 5102 are arranged equidistantly on the circumference of the base balloon 5100. Adjacent strips can 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 including any two or more of the foregoing values.

[0205] As shown in panel 3, the base balloon 5100 with the strip having the wedge cutting device 5102 is then pleated. A single strip having the wedge cutting device 5102 can be positioned between the surface of the base balloon 5100 and the pleats. The strip having the wedge cutting device 5102 can be in a tangential direction, as described herein. The tangential direction allows the strip 5102 to lie across the surface of the base balloon 5100. Due to the tangential direction, the strip 5102 can have a thin assembly configuration. The wedge cutting device 5102 is completely covered by the pleats. The wedge cutting device 5102 is at least partially covered by the pleats. The balloon 5100 can include one or more pleats, for example, one pleat, two pleats, three pleats, four pleats, five pleats, six pleats, or any range of any two of the foregoing values. The number of pleats can correspond to the number of strips having the wedge cutting device 5102.

[0206] Once the pleats are formed, an adhesive is applied to the outer surface of the pleated base balloon 5100. The adhesive is a plurality of adhesive lines that can be applied to the pleated area of the balloon surface. In the case of a balloon with three pleats, three adhesive lines can be applied. For a balloon with four pleats, four adhesives can be applied. The method of applying the adhesive to all the pleats is the same regardless of the number of pleats. Some In the method, an adhesive is applied to all the pleats. In another method, the adhesive can also be sprayed or applied by other means. The amount of the adhesive is usually associated with the surface area of the inflated balloon. For balloons with a large diameter or a long length, the amount of the adhesive is increased. The final amount of the adhesive is applied to effectively adhere the inner base balloon to the outer prehub cover as described herein. In some methods, the adhesive is applied only to the outer surface of the pleated base balloon 5100 and not to the strip 5102 with the wedge cutting device. The strip with the wedge cutting device 5102 can be covered or at least partially covered by the pleats while the adhesive is being applied. The adhesive can be applied circumferentially, for example, when the strip with the wedge cutting device 5102 is completely covered by the pleats. The adhesive can be applied longitudinally when the strip with the wedge cutting device 5102 is only partially covered by the pleats.

[0207] As shown in panel 4, the pleated balloon 5100 with the adhesive applied and the strip with the wedge dissection device 5102 attached is then inserted into the prehub cover 5104. The adhesive functions as a lubricant and promotes slippage. The base balloon 5100 is disposed centrally within the prehub cover 5104. The prehub cover 5104 can be a second balloon. The prehub cover 5104 can have any outer wall structure. The prehub cover 5104 can have any coating. The prehub cover 5104 may not include any serrations / wedge dissection devices on its outer surface. The prehub cover 5104 is made of any material described herein. The prehub cover 5104 can be a percutaneous transluminal balloon angioplasty (POBA) balloon. The prehub cover 5104 and the base balloon 5100 may be formed from the same material. The prehub cover 5104 and the base balloon 5100 may be formed of different materials. The prehub cover 5104 and the base balloon 5100 have the same or similar dimensions. The prehub cover 5104 and the base balloon 5100 have different dimensions. The prehub cover 5104 can be slightly larger in diameter and / or length than the base balloon 5100. The pleated balloon 5100 can have a thin assembly configuration for insertion into the prehub cover 5104.

[0208] As shown in panel 5, the inner serrated base balloon 5100 can then be inflated. The strip having the wedge cutting instrument 5102 rotates from the tangential direction under the pleats of the base balloon 5100 to a state not covered by the base balloon 5100 and is oriented vertically within the prehub cover 5104. Due to the inflation of the base balloon 5100, the strip having the wedge cutting instrument 5102 can change its orientation from a substantially tangential direction to a substantially vertical direction. During the inflation of the base balloon 5100, the strip having the wedge cutting instrument 5102 begins to rotate within the prehub cover 5104. The base balloon 5100 can form lobes. The lobes of the base balloon 5100 can cover the strip having the wedge cutting instrument 5102 when the lobes are inflated. The lobes of the base balloon 5100 can expand in contact with the prehub cover 5104. The base balloon 5100 can expand until the lobes are stationary relative to the prehub cover 5104. The direction in which the strip having the wedge cutting instrument 5102 rotates during inflation can be defined by the direction in which the base balloon 5100 is pleated. The lobes of the base balloon 5100 can facilitate the rotation of the strip provided with the wedge cutting instrument 5102. The lobes of the base balloon 5100 can apply torque to the inclined surface of the wedge cutting instrument 5102. In relation to the shape of the sidewalls and the rigidity of the strip 5102, the controlled inflation of the lobes of the base balloon 5100 reliably rotates the strip 5102 in a more vertical direction. The base balloon 5100 expands to a high pressure within the prehub cover 5104. The base balloon 5100 is 4 atmospheres, at least 4 atmospheres, 4.5 atmospheres, at least 4.5 atmospheres or less, 5 atmospheres, at least 5 atmospheres or less, 5.5 atmospheres, at least 5.5 atmospheres or less, 5.5 atmospheres, 6 atmospheres, up to 6 atmospheres, at least 6 atmospheres, not exceeding 6 atmospheres, 7 atmospheres, up to 7 atmospheres, at least It can be inflated to at least 7 atmospheres, not exceeding 7 atmospheres, 8 atmospheres, up to 8 atmospheres, at least 8 atmospheres, not exceeding 8 atmospheres, 9 atmospheres, up to 9 atmospheres, at least 9 atmospheres, not exceeding 9 atmospheres, 10 atmospheres, up to 10 atmospheres, at least 10 atmospheres, 10 atmospheres or less, 11 atmospheres, up to 11 atmospheres, at least 11 atmospheres, 11 atmospheres or less, 12 atmospheres, up to 12 atmospheres, at least 12 atmospheres, 12 atmospheres or less, 4 atmospheres or more and 6 atmospheres or less, or expandable up to two ranges of the aforementioned values.

[0209] When the inner base balloon 5100 including the strip 5102 expands, the tip of the wedge dissection instrument can depress the inner diameter of the prehub cover 5104. In many cases, the tip of the wedge dissection instrument does not penetrate the prehub cover 5104. The tip of the wedge dissection instrument may not be polished (honed) as described herein. The design of the unpolished (unhoned) edge of the tip of the wedge dissection instrument creates a blunt or abutting force against the prehub cover 5104. In contrast, a honed or sharp edge penetrates the prehub cover 5104 upon expansion of the base balloon 5100 and contact with the prehub cover 5104. In the absence of a sharp or sharp edge, the prehub cover extends under the outward force exerted by the inflated base balloon 5100 together with the strip 5102. The unpolished (unhoned) surface of the wedge dissection instrument causes the prehub cover 5104 to extend. The unpolished (unhoned) surface of the dissector of the wedge dissection instrument may not penetrate the prehub cover 5104 depending on the method.

[0210] In some methods, the prehub cover 5104 can be varied near the wedge cutting instrument of the strip 5102. The prehub cover 5104 can be varied while the base balloon 5100 is inflated. The prehub cover 5104 can be varied when the strip 5102 is in contact with the prehub cover 5104. This method can include the use of opposing mechanical forces to weaken the prehub cover 5104. This method can include the use of one or more heat sources to weaken the prehub cover 5104. The heat source is a heating iron. This method can include the use of electrical discharge to weaken the prehub cover 5104. This method can include the use of any other delivery system to weaken the prehub cover 5104. This method can include weakening the prehub cover 5104 in the area where the tip of the strip 5102 is pushing the prehub cover 5104 outward. In some methods, a heating iron or other heat source is used. In some methods, heat higher than the transition temperature of the prehub cover 5104 is applied to the tip of the strip 5102. The heat can be applied to the prehub cover 5104 near the strip 5102. The heat can be applied along the length of the strip 5102. The heat can be applied in the vicinity of the strip. The heat can weaken the prehub cover 5104 in the vicinity of the strip 5102.

[0211] When the base balloon 5100 expands and contacts the inner surface of the prehub cover 5104, the adhesive applied to the pleats is uniformly dispersed. The adhesive can be applied to the outer surface of the pleats of the base balloon 5100. The pleats can be pressured to expand and can form lobes. The lobes can be pressed against the inner surface of the prehub cover 5104. The expansion of the base balloon 5100 can evenly distribute the adhesive between the base balloon 5100 and the prehub cover 5104. In some embodiments, the adhesive is uniformly distributed along the entire inner surface of the prehub cover 5104. In some embodiments, the adhesive extends between the tip and the prehub cover 5104.

[0212] The base balloon 5100 can include one or more base coats. The base coat can be any material described herein that includes polyurethane. The adhesive can extend within the internal space between the base balloon 5100 and the prefabricated cover 5104. The adhesive can extend within the internal space between the polyurethane base coat covering the base balloon 5100 and the prefabricated cover 5104. The adhesive can provide a uniform thin layer of adhesive material between layers. The adhesive can provide a uniform thin layer of adhesive material between the base balloon 5100 and the prefabricated cover 5104. When provided on the base balloon 5100, the adhesive can provide a uniform thin layer of adhesive material between one or more base coats and the prefabricated cover 5104.

[0213] In some embodiments, the combination of the base balloon 5100 and the prefabricated cover (premanufactured cover) 5104 has one or more features. The first feature is that this combination is designed to maintain the pressure of the balloon during a given use. The base balloon 5100 and the prefabricated cover 5104 can maintain the inflated diameter within a smaller allowable range. The base balloon 5100 and the prefabricated cover 5104 can maintain a more constant balloon pressure.

[0214] The second feature is that this combination is designed to suppress tearing of the prehub cover 5104, thereby enabling the prehub cover 5104 to hold a metal strip while allowing the raised elements or teeth to penetrate the layer of the prehub cover 5104. The prehub cover 5104 can be designed to prevent longitudinal tearing. The prehub cover 5104 can be designed to prevent tearing between adjacent wedge cutting instruments. The prehub cover 5104 can be designed to prevent tearing along the strip. The prehub cover 5104 can be designed to prevent tearing that exposes the strip. The prehub cover 5104 can be designed to hold the strip. The prehub cover 5104 can extend to cover the surface of the strip between adjacent wedge cutting instruments. The prehub cover 5104 can extend circumferentially. The prehub cover 5104 can extend to surround the base balloon 5100.

[0215] The third feature is that the combination is designed such that when it is tightly bundled and folded (pleated) into a diameter for compression (crimping), the base balloon 5100 is minimized from perforation by the raised elements on the strip. The prehub cover 5104 can prevent the base balloon 5100 from being perforated. The strip is arranged tangentially with respect to the base balloon and the prehub cover 5104. The wedge cutting instruments are arranged to contact the outer surface of the prehub cover 5104. The prehub cover 5104 can include a material designed to prevent perforation by the wedge cutting instruments. The prehub cover 5104 can include a material designed to prevent tearing along the row of wedge cutting instruments penetrating the prehub cover 5104. The prehub cover 5104 can protect the base balloon 5100 when folding (forming pleats). The prehub cover 5104 can protect the base balloon 5100 when compressing (crimping). The prehub cover 5104 can protect the base balloon 5100 when the balloon is in a low-profile insertion configuration.

[0216] The fourth function is to minimize the perforation of the base balloon 5100 due to existing diseases (e.g., calcified arteriosclerosis) or other external perforating factors. The prehub cover 5104 can prevent the base balloon 5100 from being perforated. The prehub cover 5104 can interact with the lumen of the blood vessel. The prehub cover 5104 can include a material designed to prevent perforation by the rough surface of the plaque. The prehub cover 5104 can protect the base balloon 5100 from the plaque during insertion. The prehub cover 5104 can protect the base balloon 5100 from the plaque during expansion.

[0217] In some embodiments, the diameter of the base balloon 5100 is designed to apply a uniform pressure to the inner diameter of the prehub cover 5104 during the manufacturing process. The base balloon 5100 that expands under pressure is uncured through the opening of the prehub cover 5104 at the location where the raised element penetrates between the base balloon 5100 and the prehub cover 5104 for discharging the liquid adhesive. The base balloon 5100 that expands under pressure distributes the adhesive as a thin layer so as to cover at least a part of the raised element. The base balloon 5100 that expands under pressure distributes the adhesive as a thin layer so as to cover at least a part of the belt-like body. The base balloon 5100 that expands under pressure can distribute the adhesive as a thin layer and dispose it between the base balloon 5100 and the prehub cover 5104. The adhesive can be cured and form an integral structure between the base balloon 5100 and the prehub cover 5104.

[0218] In some embodiments, the design of the base balloon 5100 has a high expansion ratio that reduces the balloon's compliance within the nominal pressure range intended during the procedure. The base balloon 5100 can be a non-compliant balloon. The base balloon 5100 can be a semi-compliant balloon. The base balloon 5100 can facilitate control of the maximum expansion diameter of the balloon. The base balloon 5100 can expand to a specific diameter or to a specific diameter within a certain tolerance range. The base balloon 5100 can apply a specific pressure to the vessel wall without additional radial expansion. In some embodiments, the prehub cover 5104 is designed to have a high compliance or a low expansion ratio and is intended to minimize surface tearing due to serrated elements, existing disease (e.g., calcified atherosclerosis), or other external penetration sources. The prehub cover 5104 can be compliant. The combination of a low-compliance base balloon 5100 and a high-compliance prehub cover 5104 has several of the advantages described herein. The design features function as a system for effectively retaining the strip. The design features function to minimize the possibility that the prehub cover will tear between parts of the strip, such as between angioplasty devices. The design features function to minimize the possibility that the strip or plaque will penetrate the preformed coating and the base balloon. The design features function to allow good pressure retention throughout the procedure.

[0219] One way to reduce the compliance of the base balloon 5100 or increase the compliance of the prehub cover 5104 is to change the manufacturing process in the balloon tube extrusion process and / or the balloon forming process. The base balloon 5100 can be formed from an extruded tube that is blow molded during the balloon forming process. The prehub cover 5104 can be formed from an extruded tube that is blow molded during the balloon forming process. The compliance can be changed during the manufacture of the base balloon 5100 and / or the prehub cover 5104. In some embodiments, manufacturing methods that change the molecular orientation of the polymer chains are applied. The molecular orientation of the polymer chains of the base balloon 5100 can be changed. The molecular orientation of the polymer chains of the prehub cover 5104 can be changed. By changing the extrusion or raw material manufacturing process, the molding process, or the balloon forming process used to manufacture the base balloon 5100 or the prehub cover 5104, the molecules can be promoted to biaxial orientation. The molecular orientation of the polymer chains of the base balloon 5100 can be made biaxial orientation. The molecular orientation of the polymer chains of the prehub cover 5104 can be made biaxial orientation. In some methods, biaxial orientation produces a material with tear resistance or a property that limits or improves the compliance of the material. The biaxial orientation of the base balloon 5100 contributes to reducing the compliance of the base balloon 5100. The biaxial orientation of the base balloon 5100 contributes to improving the compliance of the prehub cover 5104. The biaxial orientation of the base balloon 5100 contributes to improving the tear resistance.

[0220] To affect the properties of the base balloon 5100 and / or the prehub cover 5104, changes in blow molding parameters and / or extrusion parameters are conceivable, but are not limited to these areas of the manufacturing process or the parameters described herein. Changes in the balloon forming method that can be used to affect the behavior of the base balloon 5100 or the prehub cover 5104 include four blow moldings for affecting the desired properties Parameters: Include changes to the temperature of the heating joe, changes to the pre-pressure / warm-up time, changes to the forming pressure / form time, and / or changes to the distal / proximal stretching load. These blow molding parameters can promote the desired molecular orientation. By changing any of these parameters, the performance characteristics of the base balloon 5100 or the prehub cover 5104 can be made slightly different. Further, changes to the extrusion parameters that can be used to affect the behavior of the base balloon 5100 or the prehub cover 5104 include changes to the distance between the extrusion tool and the cooling bath and changes to the speed of the gear pump during the extrusion process. Changes to these parameters affect the performance characteristics of the base balloon 5100 or the prehub cover 5104.

[0221] Other characteristics considered to obtain the desired characteristics of the base balloon 5100 or the prehub cover 5104 include the inner and outer diameters of the extrusion, the draw ratio and die head of the extrusion, and / or the final molecular orientation of the polymer chain. Changes to the balloon-in-balloon design can provide many advantages. The base balloon 5100 can be designed to have low compliance, such that the base balloon does not expand radially even as the pressure increases. The prehub cover 5104 can be designed to have high compliance, such that the prehub cover 5104 can be prevented from bursting.

[0222] In some methods, the modification of the prehub cover 5102 can be facilitated by applying heat and / or force. In some methods, heat and / or force can be applied to the strip 5102 when the strip 5102 is in contact with the prehub cover 5104. A heat source such as a heating iron can be rotated over the tip of the strip 5102. In a method of applying heat to the tip of the strip, the heat from a heat source such as a heating iron can melt or liquefy the prehub cover 5104. The heat source can be used to melt the material around each tip of the strip 5102. When the material of the prehub cover 5104 melts in the region of the tip of the strip 5102, the tip of the strip 5102 can protrude through the melted opening of the prehub cover 5104. The tip of the strip 5102 can rise above the outer surface of the prehub cover 5104. The melted material of the prehub cover 5104 quickly re-hardens in the region surrounding the tip of the strip 5102 when the heat is removed. The re-hardened material provides a thicker, more durable, and more resilient layer of the prehub cover 5104. The melted and re-hardened material of the prehub cover 5104 surrounds the tip of the strip 5102. The additional material around each tip of the strip 5102 increases the resistance of the prehub cover 5104 to tearing. The material added around the perimeter of each tip of the strip 5102 limits the prehub cover 5104 from tearing at the gap between the strips.

[0223] In some embodiments, the prehub cover 5104 is melted along the unhoned surface of the scalpel. The strip 5102 can have a longitudinal space between adjacent scalpels along a single strip. The prehub cover 5104 can be melted only along the unhoned surface such that only the individual scalpels extend through the openings of the prehub cover 5104. The prehub cover 5104 can remain intact along the longitudinal space between adjacent scalpels. The prehub cover 5104 can remain in its original state along the circumferential space between adjacent scalpels. The recuring material can surround the scalpel extending through the prehub cover 5104. The recuring material can extend longitudinally along the inclined surface of the scalpel. The recuring material can extend laterally along the proximal edge and / or distal edge of the scalpel. The recuring material can reinforce the prehub cover 5104 in the vicinity of the scalpel. In some methods, the scalpel can extend through the prehub cover 5104 only under the application of a force and / or heat that forms an opening in the prehub cover 5104. The unhoned surface cannot break through the prehub cover 5104 until heat or force is applied, and the prehub cover -5104 extends under pressure from base balloon 5104. By the application of force and / or heat, the prehub cover 5104 weakens in the vicinity of the angioplasty device. The prehub cover 5104 melts around the angioplasty device, forming a thickened material around the angioplasty device. The force and / or heat enables the angioplasty device to extend through the prehub cover 5104. The force and / or heat reinforce the prehub cover 5104 near the angioplasty device, preventing or reducing tearing of the prehub cover 5104. The re-hardened material is more resistant to tearing between each angioplasty device. The re-hardened material is more resistant to splitting in the vicinity of the angioplasty device. The re-hardened material is more resistant to splitting in the most vulnerable areas. The method of melting the material of the prehub cover 5104 around the extrusion tip of the strip 5102 increases the tear resistance in the areas most vulnerable to tearing, thus increasing the robustness and durability of the system.

[0224] The prehub cover 5104 can facilitate the retention of the strip 5102 with respect to the base balloon 5100. The prehub cover 5104 can reinforce the attachment of the strip 5102. One important feature of the prehub cover 5104 is to prevent the strip 5102 from falling freely from the balloon during an intravascular procedure. The strip 5102 can be subject to large forces within the vasculature during expansion and interaction with plaque. The prehub cover 5104 provides a retention layer between the strip 5102 and the base balloon 5100. For example, the method of assisting the protrusion of the tip by applying force and / or heat to weaken the prehub cover 5104 can have the additional advantage of locally thickening the material in the vicinity of the angioplasty device. The material thickening of the prehub cover 5104 can be designed to increase the functional effect of the prehub cover 5104 as a strip retention function.

[0225] As shown in panel 5, the serrated inner base balloon 5100 expands. The angioplasty device extends through the opening of the prehub cover 5104. The opening of the prehub cover 5104 surrounds the individual angioplasty devices. The prehub cover 5104 is continuous between the individual angioplasty devices. The opening of the prehub cover 5104 can have a thickened wall surrounding the angioplasty device. In some ways, an adhesive can be dispensed into the opening of the prehub cover 5104. The adhesive can form a thin layer between the cured and thickened material of the prehub cover 5104 and the angioplasty device.

[0226] In some embodiments, the entire space between the base balloon 5100, the strip having the angioplasty device 5102, and the outer prefabrication cover 5104 is adhered. The adhesive can form a thin layer between the base balloon 5100, the strip including the angioplasty device 5102, and the outer prehub cover 5104. The base balloon 5100, the strip including the angioplasty device 5102, and the outer prehub cover 5104 can be exposed to UV light to cure the adhesive. The final balloon-in-balloon structure 5199 can be seen in panel 6. The adhesion of the two layers is generally performed using, for example, a UV-curable adhesive or other adhesive that is uniformly applied to the surface of the inner base balloon 5100 before sliding the outer prehub cover material 5104 over the inner base balloon 5100, as shown in panels 3 and 4. Then, as shown in panel 5, the inner base balloon is inflated to a high pressure (e.g., about 5 atmospheres, 6 atmospheres, 7 atmospheres, 8 atmospheres, or more), and irradiated with UV light to cure. The contact of the two surfaces of the base balloon 5100 and the prehub cover 5104 under pressure load causes the adhesive to be uniformly dispersed. The contact and pressure between the base balloon 5100 and the prehub cover 5104 can form a uniform coating thickness on the surface of the balloon body and the cone of the balloon before the curing cycle. The final balloon-in-balloon structure 5199 can be pleated. The final balloon-in-balloon structure 5199 can be utilized in any of the methods described herein. The final balloon-in-balloon structure 5199 is a serrated balloon. Strip The angioplasty device 5102 of 5102 can rotate from a tangential direction to a perpendicular direction within the blood vessel. The prehub cover 5104 and the base balloon 5100 can function integrally to form lobes that contact the blood vessel wall. The prehub cover 5104 and the base balloon 5100 can function integrally to rotate the strip in a perpendicular direction. The prehub cover 5104 and the base balloon 5100 can function integrally to apply a tensile force to the blood vessel wall to form a linear separation line.

[0227] The final balloon-in-balloon structure 5199 has several advantages. The strip 5102 can be attached to the base balloon 5100. The prehub cover 5104 can functionally reinforce the attachment of this strip. An adhesive can be applied to the pleats of the base balloon 5100. This adhesive can function as a lubricant for sliding the base balloon 5100 onto the prehub cover 5104. The strip 5102 can rotate within the prehub cover 5104 as the base balloon 5100 expands. The strip 5102 can rotate vertically within the prehub cover 5104. Even when pressure is applied from the base balloon 5100, the wedge cutting device does not pierce through the prehub cover 5104. The prehub cover 5104 can be made of a durable and flexible material. The prehub cover 5104 can be penetrated by the wedge cutting device by applying heat. The heat interacts with the prehub cover 5104 to melt the prehub cover 5104 in the vicinity of the wedge cutting device. The wedge cutting device penetrates through the prehub cover 5104 under the application of heat, and a bulge is formed from the softened material of the prehub cover 5104 around the wedge cutting device. The prehub cover 5104 surrounds the individual wedge cutting devices. The unpolished surface extends from the prehub cover 5104. Most of the height of the wedge cutting device is exposed. The prehub cover 5104 can be made into a thin layer such that most of the height of the wedge cutting device extends from the prehub cover 5104. When the heat is removed, the prehub cover 5104 forms a hardened bulge around the wedge cutting device. The adhesive previously applied to the pleats of the base balloon 5100 can be distributed through the space between the wedge cutting device and the hardened bulge of the prehub cover 5104. The balloon-in-balloon structure 5199 can be exposed to light to cure the adhesive. The final balloon-in-balloon configuration 5199 can be a new serrated balloon. The final balloon-in-balloon structure 5199 advantageously includes a prehub cover 5104 that forms a thin layer over the base balloon 5100 and over the longitudinal space between the wedge cutting devices of the strip 5102.The prehub cover 5104 can be a thin and durable layer. In some embodiments, the prehub cover 5104 can better support the strip 5102 attached to the base balloon 5100 than only the adhesive layer between the base balloon 5100 and the strip 5102. In some embodiments, the prehub cover 5104 can reinforce the connection between the strip 5102 and the balloon 5100 to maintain the strip 5102 in a predetermined position. In some ways, the mechanics of the arterial shape can act to remove the strip 5102 from the base balloon 5100. Such dynamics can be overcome by the prehub cover 5104 that reinforces the connection between the strip 5102 and the base balloon 5100. The prehub cover 5104 extends uniformly over the base balloon 5100 and between the angiotomy devices, and only the angiotomy device can be exposed from the opening of the prehub cover 5104. The prehub cover 5104 can provide consistent retention of the strip 5102.

[0228] As shown in FIG. 41A, a strip 3500 including a plurality of strips (e.g., two identical strips) whose tips contact only the tip 4100 can be made on the angiotomy device frame or carrier 4110. This angiotomy device frame 4110 can be created via a mechanical removal process such as chemical etching. In some embodiments, the strip 3500 can be easily and cleanly peeled from the frame 4110 and the mirror image strip via mechanical force or other means without modifying the shape of the angiotomy device of the strip 3500. In some embodiments, the frame or carrier 4110 can remain attached to the strip 3500 until the surface of the strip facing the base portion of the angiotomy device is adhered or otherwise attached to the surface of the balloon, as described elsewhere herein.

[0229] Figures 41B and 41C show that in some embodiments, a plurality of strips 4100 can be bent or folded into a bent configuration 4120, leaving the tip 4100, to create an A-frame 4130 having a gap or well in a plane facing radially outward of the combined A-frame wedge dissection instrument 3510 assembly.

[0230] Figures 41D and 41E show an alternative embodiment having a serrated tip 4160 that includes a plurality of pointed surfaces having a central concave segment 4150 therebetween (compared to the central flat segment 4140 of FIGS. 41B and 41C). The strip 3500 having the serrated tip 4160 can be bent leaving the serrated tip 4160 to form an A-frame having an open gap or well with the serrated tip 4160.

[0231] In some embodiments, the distance between adjacent base strips at the base portion is from about 30 μm to about 260 μm, from about 60 μm to about 190 μm, or from about 90 μm to about 130 μm. In some embodiments, the dimension of the gap, such as the width, at the apex of the "A" of the A-frame can be, for example, from about 10 μm to about 150 μm, from about 25 μm to about 100 μm, or from about 50 μm to about 75 μm. In some embodiments, the angle that makes up the apex of the "A" of the A-frame defined by the intersection of the distal portions of the two wedge dissection instruments can be, for example, from about 5 degrees to about 45 degrees, for example, from about 10 degrees to about 30 degrees, or from about 15 degrees to about 22 degrees.

[0232] FIG. 42 is a series of explanatory diagrams showing a stack of ribbons 4200 connected to a disposable blank or carrier 4300 at any point in the ribbon attachment process (before placement on the balloon, during balloon placement, or after adhesion of the ribbon to the balloon). This process aids in the automation of ribbon pickup and placement and improves the accuracy of ribbon and balloon alignment. The radially distal tip 4210 can contact a continuous free end 4220 or other continuous or discontinuous surface to allow for easy peeling of the ribbon. In some embodiments, a carrier system for attaching a wedge cutting device to a medical balloon can include a ribbon that includes a plurality of wedge cutting devices spaced longitudinally along the surface of the ribbon. Each wedge cutting device has a length between a base surface facing the ribbon directly adjacent to the first surface of the ribbon and the proximal end of the radially outward facing surface and the distal end of the radially outward facing surface, defining the height of each wedge cutting device, an unhoned radially outward facing surface, and a side surface between the base surface facing the ribbon and the radially outward facing surface. The ribbon can also include a second surface opposite the first surface of the ribbon and a ribbon carrier including a free end. The unhoned radially outward facing surface of each wedge cutting device can be reversibly attached to the free edge of the ribbon carrier in the attachment region. The regions between the attachment regions can define voids and can be configured to be separated upon application of a mechanical force. In some embodiments, the second surface of the ribbon is attached to the surface of the medical balloon and the ribbon carrier can be separated from the ribbon after the second surface of the ribbon is attached to the medical balloon. In some embodiments, the ribbon carrier can be integrally formed with the ribbon and is created using a process such as chemical etching. The ribbon carrier is formed from the same material or a different material than the ribbon.

[0233] FIG. 43 shows an example of an enlarged view of the attachment of a surface 4325 facing radially outward of a wedge cutting tool 4100 to a free edge 4220 of a blank or carrier 4300. Also shown is a gap 4280 between attachment regions 4328 where the base surface of the strip does not contact the corresponding free end 4420 of the blank or carrier. In some embodiments, each gap or all gaps 4280 have a surface area that is about 110%, about 120%, about 130%, about 140%, about 150%, about 160%, about 170%, about 180%, about 190%, about 200%, about 250%, about 300% or more of the surface area of each strip-shaped wedge cutting tool or each wedge cutting tool. In some embodiments, the proximal free edge 4420 of the blank or carrier 4300 contacts the distal most edge or surface of the wedge cutting tool 4325 such that the intersection or contact point between the strip / wedge cutting tool 4100 and the blank 4300 follows only a straight line (e.g., is the only contact edge), and there is no or substantially no overlap in dimensions such as the height dimension as shown in FIG. 43 between any part of the strip or the strip-shaped wedge cutting tool and the blank or carrier. In some embodiments, this can advantageously allow for easy peeling of the strip and associated wedge cutting tool from the carrier. In other embodiments, there may be an overlap in one or more dimensions between the attachment region of the carrier and the strip and associated wedge cutting tool, for example, via a slot or groove at the free end of the blank. In other embodiments, the attachment region need not be along the continuous free edge of the blank or carrier, but rather is at an interval separating the space between a protrusion of the blank or carrier and the wedge cutting tool. The protrusion may be a mirror image of the wedge cutting tool or another pattern.

[0234] Figures 44A and 44B illustrate an example of a manufacturing process for producing a serratoplasty forming strip, a cutting member, or a wedge incision instrument 3510 using a reel of a suitable material such as a stock 4410 of metal, for example, stainless steel material. The stock 4410 can be shaped or ground regardless of whether it has a polished (honed) edge. The polished (honed) edge 4430 is formed with single or multiple facets (small flat surfaces) on the edge and is polished so that the tip becomes fine (e.g., honing) or the side surfaces are polished so that they are narrow but flat (e.g., without honing). Cross-sectional views of the polished (honed) stock 4430 in some embodiments can be shaped like a triangle having potentially multiple slopes on the rising side of the slope of an equilateral triangle.

[0235] In addition to the material grinding techniques described above, the manufacture of a stainless steel serrated blade can be achieved by other bulk processing techniques.

[0236] Therefore, grinding, stamping, etching, electrochemical machining, and electrical discharge machining or combinations of these processes are mass processing techniques that are envisioned to be used alone or in combination to manufacture serrated tips at low cost.

[0237] The description of the manufacturing steps that can be included in chemical etching can, in some embodiments, include some or all of the following.

[0238] A mask or mask set 4400 containing information and design details for manufacturing a series of serrated blades, cutting members, or wedge incision instruments can be placed on the light-resistant layer 4420. Each mask 4400 is a series of openings for allowing light to pass through the mask 4400. The mask set 4400 can be the same or slightly different from each other so as to be able to partially etch one side of the stainless steel material 4410.

[0239] Chemical etching of stainless steel reels or sheets 4410 using masks, photoresists, and etching materials can be advantageously applied to enable etching large quantities of material at low cost.

[0240] Mass production of highly reproducible and low-cost parts by bulk chemical etching is possible. Conventionally, chemical etching produces rounded edges with gently sloping sidewalls that penetrate the material at an angle approaching 90 degrees. To achieve a more gentle angle of inclination, grayscale masking was investigated, but the results were not satisfactory. A new masking technique, instead of grayscale, utilized patterns such as relatively narrow holes and slits and succeeded in controlling the etching rate. By controlling the flow of the etching material through the resist layer, an angle of a structure like a blade was achieved.

[0241] By double-sided mask exposure, etching can be performed from both sides of the material. With double-sided exposure, the edge profile generates a larger control mirror imaging profile on both sides of the stainless steel material.

[0242] Figure 45B shows that the strip 3500 can be placed over the through-hole 4500 embedded in the balloon wall 4510. This through-hole can be a hole extruded prior to the manufacture of the balloon, and thus can provide a conduit through which a therapeutic agent(s) can pass and be delivered to serrated tissue. Similar to Figure 45A, in some embodiments, the strip 3500 is placed over a series of through-holes 4520 formed by laser cutting or other means for puncturing the balloon wall 4510, leading to another conduit produced in an extrusion process, and thus can provide a conduit through which a therapeutic agent(s) can pass and be delivered to serrated tissue.

[0243] FIG. 46 shows that in some embodiments, a series of a plurality of A-frame strips 3500 (or non-A-frame strips having a wedge cutting device as disclosed herein), such as four A-frame strips, can be disposed over through holes 4600 embedded in balloon wall 4610. The A-frame strips 3500 can be regularly spaced as illustrated, or irregularly spaced in other embodiments.

[0244] 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 each base portion, each strip including a wedge cutting device 3510 having a radially outer facing surface with a periphery. The wedge cutting devices 3510 of the first strip 3510 and the second strip 3520 contact each other at a portion of the periphery of each radially outer facing surface, and there is a top gap at a position where the wedge cutting device 3510 of the first strip 3510 and the wedge cutting device 3510 of the second strip 3520 do not contact each other, and the gap is configured to receive a drug reservoir hole 4500 therein.

[0245] FIG. 47 shows an example (also shown enlarged) of a row of strips 3500 on a mask 4700 set before chemical etching. Each row of strips 3500 can include a peelable region 4710 between adjacent wedge cutting devices 3510.

[0246] Figure 48A shows the strip array 3500. Figure 48B shows a detailed enlarged view of an adjacent wedge cutting device 3510 having a detachable region 4710. Figure 48C shows the serration strip 3500 reversibly connected to the strip carrier 4810 for ease of alignment, control, placement, and manufacture. Three chemical etching variations of the connection between the strip carrier 4810 and the strip 3500 having different shapes are shown in Etching I 4820, Etching II 4830, and Etching III 4840. The close-up shows how the side wedge cutting device 3510 is connected to the strip carrier 4810. Figure 48D shows another embodiment of the strip carrier 4480 reversibly attached to the wedge cutting device of the strip 4890. The strip carrier 4880 can have any suitable shape and may in some cases have rounded or other tabs 4882, openings 4884, lateral tabs 4886, or other features for ease of alignment, control, placement, and manufacture. In some embodiments, the strip carrier can include protrusions that are mirror images of the wedge cutting device of the strip to facilitate removal, such as after the strip has been adhered or otherwise fixed to a balloon (not shown).

[0247] FIG. 49 above shows an illustration of an example of an entire system for manufacturing a seratoplasty, showing a series of serrated or scored wedge cutting devices 3510 provided on the outer diameter of a balloon 3316 attached to a catheter 3310 having a guide wire hub 4900 and a balloon inflation hub 4910. FIGS. 49A - 49J show additional views of an example of a seratoplasty system.

[0248] Figure 50 schematically shows a balloon blown from an extruded article having ridges of a set of longitudinally oriented materials according to some embodiments. The material of the ridges may be the same as or different from the material of the balloon. The number and position of the ridges typically correspond to the position of the tip of the strip when lying over the pleat position and the compression (crimp) position. The ridges provide a region that is thicker than the region of the balloon without ridges. This thicker region functions as a buffer region or a pillow to limit and prevent accidental rupture of the balloon by the strip held on the balloon surface.

[0249] Figure 51 schematically shows a set of strips disposed in a balloon blow mold prior to the balloon blow process according to some embodiments. In this design, the strips provide the ability to be accurately positioned within the mold set by including alignment elements integrated into the carrier portion for the strips. The mold (e.g., multiple, such as the three separate segments shown) allows for proper positioning of the strips such that the sufficient height of the base portion of the strip coincides with a position that tends to allow the strip to be embedded in the balloon matrix during the heating and balloon blow processes.

[0250] Figure 52 schematically shows an extrusion including optical markers to assist in the orientation of the extrusion in the balloon blow process according to some embodiments. As shown, in some embodiments, there are three regions (highlighted) used as optical reference planes for orienting the extrusion in the balloon blow process to enable proper positioning such that the strips are aligned for the ridges that are accurately positioned as the pillow (e.g., protection) region of the balloon during the pleat and folding processes.

[0251] Figure 53 shows an embodiment in which the extruded article used for blow molding the balloon has a second holding layer with a glass transition temperature slightly lower than that of the balloon itself. This second layer provides an effective area of a slightly more forgiving material that allows the strip to be embedded therein. When the extruded article is heated and blown into the balloon mold, the upper holding layer easily flows into the cavity designed in the mold of the balloon mold, and a space for enclosing the strip is secured as shown. Even with this design, since the depth of the strip can be controlled by the design of the mold and the strip carrier, the strip can be arranged more effectively with a high tolerance range and minimal control effort.

[0252] Figure 54 schematically shows a perspective view of a mold (shown only partially and transparently) with a series of strips clamped to an improved balloon blowing machine according to some embodiments. The partial and transparent mold is shown in three sections covering approximately 120 degrees per section of the balloon surface. The strip carrier has a series of features such as holes and cutouts in the center of the carrier. These features are designed to accurately align and assist the strip in a narrow range of positions aligned with the area of the balloon surface during the blow cycle.

[0253] Figure 55 schematically shows a strip and a bonding material surrounding the base of the strip In this cross-sectional view, the bonding material is a single material, but it can be one or more materials such as two layers, three layers, or more layers. The bonding material is designed to provide effective strip retention for the balloon. Therefore, the material is designed to provide the flexibility and durability of strip retention under various force loading conditions of the system during delivery, inflation, destruction of diseased tissue, and retrieval.

[0254] FIG. 56 is a cross-sectional view schematically showing how a strip and a strip holding material are arranged on one side of a single balloon blow mold according to some embodiments. Note that the shape of the mold for the balloon blow system can be matched to the shape of the taper of the strip. Designing the mold in this way makes it possible to control the position of the strip on the balloon by alignment and reduces the likelihood of the holding material flowing beyond the tip of the strip.

[0255] FIG. 57 schematically shows three strips incorporated within a set of three molds spaced 120 degrees apart from each other according to some embodiments. Prior to the balloon blow process, the strips are placed within the dye cavity and the holding material protrudes into the balloon blow cavity. In other embodiments, two strips at 180-degree intervals, four strips at 90-degree intervals, or strips at irregular intervals can be included.

[0256] FIG. 58 schematically shows an enlarged view of a strip and a holding material captured between two sides of a balloon mold according to some embodiments. The balloon mold is contoured to allow the holding material to flow in. When the mold is heated to enable balloon forming, the holding material is also heated. The heating can be high enough to be near or above the glass transition temperature of both the balloon material and the holding material, causing the materials to flow effectively into a single composite material.

[0257] FIG. 59 schematically shows a cross-section of a balloon removed from a balloon blowing machine with a belt-like body and a holding material adhered thereto. Here, the belt-like body is effectively adhered to the balloon surface, and the holding material is adhered or fused to the outer surface of the balloon. It should be noted that the balloon and the holding material can be composed of multiple layers. In some cases, the outermost layer of the holding material and the outermost layer of the balloon are made of the same material, or are formed from materials designed to effectively fuse at the blowing temperature of the balloon. The design of the holding layer can include multiple layers, where one layer has higher elasticity and the other layer is more inelastic. By combining the elastic layer and the inelastic layer, the holding layer can enhance the holding force for both highly elastic balloons and highly inelastic belt-like bodies.

[0258] FIG. 60 schematically shows how three belt-like bodies are adhered to the balloon surface by a holding layer according to some embodiments. At this step, the carrier is removed, the balloon is fully inflated, and the orientation of the belt-like body during deployment is shown.

[0259] FIG. 61 schematically shows an enlarged view of the belt-like body after the holding layer is adhered to the balloon surface according to some embodiments. The holding layer is shown to be wrapped around the belt-like body under the belt-like body and extends on both sides of the belt-like body by a sufficient distance so that when folded, the belt-like body is laid on the holding layer.

[0260] FIG. 62 schematically shows a perspective view of three belt-like bodies with a holding layer adhered thereto, showing the minimum surface area that the holding layer covers the entire balloon surface on the outer surface of the balloon.

[0261] FIG. 63 schematically shows a top view of the holding layer shown on the outside of a part of the balloon surface such that the holding layer covers the upper part of the belt-like body, covers between each of the wedge cutting instruments, and a footing is formed on the balloon to assist in holding the belt-like body. According to some embodiments, the height of the holding layer is typically minimum above the belt-like body.

[0262] Figure 64 schematically shows a retention layer with minimized footprints on both sides of the strip along the balloon surface. In this embodiment, two or more additional rows of material, whether the same as or different from the retention layer, are envisioned to run horizontally with respect to the strip at a distance that allows for a protective region (pillow region) in the area where the tip of the strip lies on the balloon when pleated and folded.

[0263] Figure 65 schematically shows the pillow portions adjacent to the retention portion of the strip in a dotted line pattern similar to the spacing of the tips of the strip. These individual pillow portions provide a retention region of minimal surface area for protecting the balloon while minimizing the additional volume with respect to the balloon.

[0264] Figure 66 schematically shows a cross-sectional view of a retention strip having a retention layer with a minimal amount of retention material and a pair of balloon-protecting pillow portions attendant on both sides as a protective region for minimizing puncturing of the strip of the balloon.

[0265] Figure 67 schematically shows an embodiment with only a single pillow portion as shown in the area where the strip lies and no pillow portion on the opposite side.

[0266] Figure 68 schematically shows a variation of the same concept for the minimal retention region of the strip, showing an example where the pillow region on one side contains less material than the pillow region on the opposite side of the strip.

[0267] Figure 69 schematically shows a variation of the same concept for the minimal retention region of the strip, with additional material shown at the proximal end of the strip. The additional region of material provides a more structured retention region than is typically seen at the end of the strip.

[0268] Figure 70 schematically shows variations of a method in which a protective region (raised pillow region) integrated into a balloon provides protection for the balloon during folding and compression (crimping) of the balloon. These design variations, in some embodiments, can provide the ability to tightly fold and compress (crimp) a series of micro wedges onto the balloon while minimizing the possibility of holes opening in the balloon from the sharp edges of the individual micro wedges. In each figure, the strip can be disposed inside the pleat of the balloon. In Variation A, one short pillow is disposed on the folded-over material of the balloon, and two short pillows are disposed on the inner circumference of the fold of the balloon to protect the balloon from puncturing. In Variation B, one long pillow is disposed on the folded-back portion of the balloon, and one long pillow is disposed on the inner circumference of the folded-back portion of the balloon to protect the balloon from puncturing. In Variation C, one long pillow is disposed on the folded-back portion of the balloon, and one short pillow is disposed on the inner circumference of the folded-back portion of the balloon to protect the balloon from puncturing. To protect the balloon from puncturing, pillows including any variation in the length and number of pillows can be provided either on the folded-back portion of the balloon or on the inner circumference of the folded-back portion of the balloon.

[0269] Figure 71 schematically shows an embodiment having four wedge dissection instruments connected by gaps following a base, a row of another set of four wedge dissection instruments, and a row of small strip sections. This design variation can have any number of lengths of wedge dissection instruments joined together and separated from adjacent rows. For example, five, six, or more rows, or two or three rows are envisioned. The designs of the holding portion and the pillow can follow any of the design patterns described above.

[0270] Figure 72 schematically shows an embodiment in which the individual wedge cutting devices are not connected. In some embodiments, some regions of the balloon have wedge cutting devices that are not connected, while other regions of the balloon may be connected as shown on the right side of the illustration. The designs of the holding portion and the pillow portion can follow any of the design patterns described above.

[0271] Figure 73 schematically shows a side view of a strip integrated on the balloon surface. An additional holding area is formed on the last wedge cutting device closest to the conical body of the balloon. It is generally known in the field of balloon blowing that the conical body of the balloon may be subject to more stress during delivery and contraction, and may also have a gentle slope in the region near the conical end. For this reason and other reasons not enumerated herein, it may be advantageous to dispose additional material on the most distal wedge cutting device, regardless of whether the strips are adhesively bonded together.

[0272] Figures 74A - 74E are a series of diagrams showing a mechanism for the serrated strip element 200 to change direction vertically without covering in a very narrow stenotic lesion from the tangential direction under the wing of the balloon material. This series of diagrams shows the delivery configuration of the balloon and its subsequent expansion. Briefly, the strip 200 rotates during the expansion of the balloon 100. The strip 200 is delivered in the tangential direction. The strip 200 can be at least partially or completely covered by the balloon 100 during delivery. The strip 200 lies flat during delivery. Due to the inflation of the balloon, the strip 200 can change its orientation from the tangential direction to the vertical direction. Further, due to the contraction of the balloon, the strip 200 can be rotated from the vertical direction to the tangential direction. The strip 200 can rotate within a blood vessel with a very small diameter. The strip 200 can rotate within a small-diameter stenotic lesion. The mechanics of the ex...

Claims

1. A balloon configured to reversibly expand and contract within a blood vessel, A band-shaped body having multiple raised features, each of which has an unpolished tip, the band-shaped body having spaces between adjacent raised features, and the balloon is configured to expand by moving the band-shaped body radially outward and applying force to the blood vessel wall, thereby forming serrations, depressions and / or microperforations in the blood vessel wall. An energy source used in combination with the aforementioned multiple raised feature portions, An intravascular device equipped with the following features.

2. The intravascular device according to claim 1, characterized in that a hydraulic shock wave is applied to the plaque.

3. The intravascular device according to claim 2, characterized in that the intravascular device has the ability to break down the plaque into smaller particles, thereby enabling more effective vasodilation.

4. The intravascular device according to claim 1, characterized in that the energy source is separate from the balloon and the catheter having the plurality of raised features.

5. The intravascular device according to claim 1, characterized in that the energy source is integrated with the balloon and the catheter having the plurality of raised features.

6. The intravascular device according to claim 1, characterized in that vibrational energy is transmitted using vibrations directed in the radial direction.

7. The intravascular device according to claim 1, characterized in that energy is transmitted through a liquid used to fill the balloon.

8. The intravascular device according to claim 1, characterized in that energy is transmitted through the gas used to fill the balloon.

9. The intravascular device according to claim 1, characterized in that the energy source includes a pneumatic pump.

10. The intravascular device according to claim 1, characterized in that the energy source includes a hydraulic pump.

11. The intravascular device according to claim 1, characterized in that energy supply becomes more effective when combined with the cracked areas provided by the plurality of raised features.

12. The intravascular device according to claim 1, characterized in that the plurality of raised features concentrate energy supply.

13. The intravascular device according to claim 1, characterized in that cracks propagate more easily or faster by supplying energy in combination with the aforementioned multiple raised features.

14. The intravascular device according to claim 1, characterized in that the energy source is configured to reduce the layer of sediment and decrease the height to the medial layer.

15. The intravascular device according to claim 1, characterized in that the thickness through which the plurality of raised feature portions penetrate is reduced by pressure-induced fracture of the calcium layer.

16. The intravascular device according to claim 1, characterized in that the energy source is configured to selectively cleave deposits in the intima layer.

17. The intravascular device according to claim 1, characterized in that the energy source is configured to selectively crack deposits in the medial layer.

18. The intravascular device according to claim 1, characterized in that the energy source is configured to selectively crack deposits within the blood vessel wall.

19. The intravascular device according to claim 1, characterized in that the energy source is configured to modify a highly calcified region.

20. The intravascular device according to claim 1, characterized in that the energy source is configured to generate waves that propagate through soft vascular tissue.

Images