Improved temporary vascular scaffolding using auxiliary energy delivery

Abstract

Devices and methods for treating target sites within body tubular lumenes are provided. The medical devices include a stent-like structure comprising multiple scoring and non-scoring filaments woven together alternately. Generally, stent-like structures have more non-scoring filaments than scoring filaments, providing greater structural support and potentially limiting scoring forces to only a select few areas. The stent-like structure expands within the target site, scoring the target site and providing temporary structural support while the target site is injected with a therapeutic agent. Such therapeutic agent injection occurs using the use of a drug-eluting or drug-coated balloon placed within the stent-like structure, or by occluding the target site and introducing the drug into the occluded target site, where it remains for a period of time.

Description

Background Art

[0001] (Cross-reference) This application claims the benefit of U.S. Provisional Application No. 63 / 466,546, filed May 15, 2023, which is hereby incorporated by reference in its entirety.

[0002] (Background of the Invention) Balloon angioplasty has been a common method for treating vascular occlusions since 1976. In plain balloon angioplasty (POBA), there is a significant subset of patients with immediate sub-optimal results related to trauma to the vasculature, including, among other things, vessel dissection, incomplete plaque compression, low lumen gain, and acute elastic recoil of the vessel. Due to these sub-optimal immediate results, which occur in 40 - 60% or more of cases, other means for treating vascular stenosis have been developed. Intravascular stents are widely used and address the acute problems of angioplasty, reducing the restenosis rate from 50 - 60% in the case of POBA to 30 - 35% in the case of these bare metal stents (BMS).

[0003] The restenosis rate of BMS is usually unacceptable, so drug-eluting stents (DES) are used to inhibit restenosis. These devices reduce the restenosis rate to about 20% or less in coronary circulation. However, DES are very expensive and can lead to thrombosis, which can be proven to be fatal. In addition, DES are not particularly effective in peripheral circulation. The cost of drug-eluting stents has led to a leap in the overall cost of insured medical care in the United States. Finally, stents are not only costly, but expensive and potentially harmful drugs are regularly used for at least one year after stent implantation.

[0004] Restenosis is a weakness of all vascular intervention therapies, ranging from angioplasty to stent placement and even surgery. Various drugs can prevent restenosis. The main question is the best way to deliver the drug in the most cost-effective manner available while bringing about good patient outcomes and preventing complications.

[0005] Due to the variable plaque morphology and composition, the stress provided by conventional POBA can be unpredictable, and often high-pressure balloon inflation is required to successfully provide sufficient stress to crack the plaque. When the plaque is compressed at high pressure, the balloon expands very rapidly to its full dimensions, often remarkably instantaneously (1 / 10th of a second), and expands the vascular wall very rapidly, which can rupture smooth muscle cells. Dissociation often occurs, as the smooth muscle cells do not have the opportunity to gradually stretch and deform in order to maintain their integrity, resulting in irreparable damage to the smooth muscle cells.

[0006] Many blood vessels are significantly calcified, which prevents compression and the expected lumen acquisition. The term “calcified matrix” refers to compressive-resistant calcification, whether it is within the arterial media, arterial intima, or plaque, or any of these locations, as used hereafter.

[0007] Therefore, methods and devices that reduce pressure, allowing plaque or calcified matrix to be fractured, would result in slower and more gradual stretching of the arterial wall. Such slower stretching can reduce the degree of trauma to the blood vessel. Methods and devices that enable slow, gradual dilation and prolonged opening of the vascular wall may allow plastic deformation of the tissue to occur while the opening is present, preventing elastic rebound of the blood vessel.

[0008] Sometimes, a wire or multiple wires running along the outside of the angioplasty balloon, sometimes called a buddy wire, can create a localized stress area approximately 120 times larger than that of a conventional balloon surface. The stress pattern from the external wire can extend into the plaque rather than concentrating on the surface, as with conventional balloons. The stress pattern is typically less dependent on the plaque's morphology and composition than with conventional balloons. In other words, the stress is more predictable, concentrated, and may require lower balloon pressure to compress the plaque. Clinical studies have confirmed that, compared to conventional POBA catheters, the buddy wire technique compresses plaque at lower balloon pressures, results in less dissection, has less elastic rebound, and exhibits greater lumen gain and a lower restenosis rate tendency.

[0009] Subsequently, extending these concepts, dissection and scoring balloons have been introduced. One such balloon uses several razor-type blades along the edge of the balloon. Scoring balloons can utilize several 0.005–0.007-inch supports placed across the balloon or other scoring elements placed on the surface of the balloon. Both balloon types have been commercially successful. They are typically used in the treatment of complex lesions or plaque displacement. Scoring balloons have been shown to achieve 50% more lumen acquisition than POBA when used as pre-inflation before stent implantation. This procedure can significantly reduce the number of dissections compared to POBA. Scoring balloons have also been shown not to slip away from the lesion, which is a problem with POBA. Scoring balloons may also be more effective than POBA in soft, fibrous, and calcified plaques and are recommended as a plaque displacement strategy when treating complex lesions. The use of scoring balloons therefore results in very few occurrences of unintentional or unplanned stent placements, commonly referred to as salvage stent placements.

[0010] Both slow, gradual balloon inflation and prolonged balloon inflation improve the immediate outcomes of POBA, along with less dissection, fewer further interventions such as stent placement, and less restenosis. Other studies, however, have not shown improvement in long-term outcomes with prolonged inflation time, possibly because their prolonged inflation is a consequence of dissection treatment. Currently, no studies evaluating both plaque displacement and gradual inflation / prolonged dilation have been conducted or published.

[0011] While these mechanical strategies have resulted in measurable improvements in acute complications of POBA, drug-coated balloons (DCBs) have emerged as a promising advance in POBA. DCBs are POBA balloons coated with antiproliferative drugs such as paclitaxel or sirolimus. The drugs are delivered during the relatively short balloon inflation period and have been shown to remain present in smooth muscle cells for up to 6 days. Drugs from DCBs essentially cover 100% of the plaque / vascular wall, compared to only 15-20% with drug-eluting stents. The use of DCBs has dramatically reduced restenosis rates, at least in coronary and above-knee peripheral vascular interventions.

[0012] Therefore, both mechanical and pharmacological strategies demonstrate advantages when treating vascular lesions with balloon angioplasty. Mechanical strategies effectively address acute or immediate problems with minimal damage to the blood vessels, while pharmacological strategies using drug-coated balloons significantly reduce restenosis.

[0013] In U.S. Patent No. 5,449,372, Schmaltz et al. describe a temporary stent that may be used for support after lesion dilation. In U.S. Patents No. 6,450,989 and No. 7,011,654, William R. Dubrul and Richard E. Fulton describe an inflatable and support device with a disease inhibitor and its use. In U.S. Patent No. 7,232,432, William R. Dubrul and Richard E. Fulton describe a porous braided structure for angioplasty and drug delivery. The following U.S. patents and publications, namely U.S. Patents No. 8,454,636, No. 7,494,497, No. 7,279,002, No. 6,808,531, No. 5,797,935, and No. 5,766,203, and U.S. Publications No. 2013 / 0041391, No. 2011 / 0082483, and No. 2005 / 0080478, may also be of interest. Those patents and applications are incorporated herein by reference.

[0014] This disclosure provides a novel method that utilizes not only new improvements to prior inventions, but also both prior inventions and new improvements thereto. [Prior art documents] [Patent Documents]

[0015] [Patent Document 1] U.S. Patent No. 5,449,372 [Overview of the Initiative] [Means for solving the problem]

[0016] (Brief summary of the invention) To address the problem of methods for treating lesions in the most cost-effective manner available, while resulting in favorable patient outcomes and preventing complications, the medical device industry has focused on developing methods and devices that prevent the vascular response (restenosis) to injury, as opposed to developing devices that cause less injury, and therefore less restenosis. One aspect of the present invention concerns devices and methods that both cause less injury to the vascular system by using special scaffold dilation across balloons. The devices and methods provided herein can cause less dissection and more uniform plaque fragmentation at lower pressures. The devices and methods provided herein can deliver drugs deep into the vascular wall while providing means for prolonged vascular dilation that will improve acute lumen acquisition and reduce vascular rebound. Thus, less initial injury and less elastic rebound may result in less restenosis, and drug delivery may further reduce or prevent restenosis. Furthermore, although many of the above features are described in previous patents, additional structural improvements and additions to the aforementioned technology, along with novel methods utilizing the prior art and the improved invention, can be revealed.

[0017] Typically, the delayed outcome after vascular intervention therapy is determined by the immediate results of the intervention therapy (immediate lumen diameter and immediate residual percentage stenosis). Many embodiments of the present invention are designed to improve these two factors. Optimal outcomes in percutaneous intervention therapy may depend on 1) obtaining superior acute angiographic results with less intimal tearing, dissection, and elastic rebound; 2) avoiding damage to the distal vascular bed from debris released during the procedure (in contrast to debris released in atherectomy); and 3) reducing smooth muscle cell proliferation by causing less injury and through pharmacological intervention therapy. Aspects of the present invention address all three areas.

[0018] Many embodiments of the present invention relate to a method for treating a target site in a vascular channel of the body using a catheter assembly, the catheter assembly comprising a stent or scaffold-like structure mounted over an inflatable balloon. A method of performing an interventional treatment at a target site using such a device may include inserting the device into the target site and slowly and gradually inflating the inflatable balloon element to a pressure in the range of 5 to 6 atm over a time period of at least 1 minute, preferably over 2 to 3 minutes. Inflating the inflatable balloon allows the scaffold to expand against the wall to a desired diameter. The method may further include deflating the balloon over a longer period of time exceeding 5 minutes while the scaffold remains expanded. During this time, plastic deformation of the plaque and tissue occurs, which can increase lumen acquisition and reduce vascular rebound. The method may further include deflating the scaffold over the already deflated balloon and removing the entire device.

[0019] In short, the prior art method involves expanding an expandable element, such as a balloon and a temporary stent structure covering the balloon, against the inner wall of a vascular channel. In some embodiments, the balloon is collapsed, leaving the stent structure expanded against the inner wall for a time period of at least 3 minutes, and the collapsed balloon and collapsed stent structure are removed from the vascular channel during a stent structure removal step. The improved method for treating a target site includes, in addition to the steps of the prior art method, one or more of the following: slow, incremental expansion of the expandable element for at least 90 seconds, in which pressure fluctuation pulses are added to the incremental expansion; plaque / vascular scoring using a special scoring element; delivery of an auxiliary energy source to induce structural instability within the calcified matrix; delivery of catheter or scaffold movement to weaken the calcified matrix; and rapid pressure changes to the vascular wall to weaken the calcified matrix and more completely compress the plaque and calcified matrix.

[0020] In many embodiments, the balloon stent assembly comprises a catheter assembly having a proximal portion and a distal portion. The catheter assembly may include first and second extension members. The temporary stent (or scaffold (as used herein synonymously)) may have proximal and distal ends, the proximal end being fixed to a first position along the first extension member, and the distal end being fixed to a second position along the second extension member. The temporary stent may be installed in a deflated state by moving the first and second positions of the extension members so as to be separated from each other. The assembly may also include an inflatable balloon mounted on the distal portion of the catheter assembly at the location surrounded by the temporary stent. The balloon may be installed in an inflated state, thereby installing the temporary stent in an expanded and collapsed state. The temporary stent may be free to remain in an expanded state when the balloon moves to a collapsed state. The temporary stent may include a scoring member. Energy delivery means may be provided within the device or be separate from the device and configured to be inserted coaxially into the device. Means for providing motion to a catheter, guidewire, or scaffold may be provided. Means for rapidly altering the pressure on a blood vessel may also be provided.

[0021] Alternatively, the scaffold (or stent) may be a sock-like structure such that, after the scaffold is placed within the target site, the expandable element is inserted into the lumen of the expanded scaffold. In this configuration, the scaffold is not fixedly attached to any component of the expandable element. Depending on the clinical situation and the configuration of the target lesion, the expandable element may be an angioplasty balloon catheter, an endovascular lithotripsy (IVL) balloon catheter, a drug-coated or drug-eluting balloon, or an expandable element with other functions. A preferred method may involve a single procedure utilizing different balloon catheters with different therapeutic effects sequentially within the same unattached scaffold. This method, therefore, may include at least some of the following actions: The device is inserted and deployed proximal to the target site to provide support for distal navigation to the target site. During distal navigation, the self-expandable scaffold may expand against the vascular wall to provide support for distal navigation. Next, the scaffold is retrieved by the outer sheath and repositioned at the target site, where the expandable element is slowly and gradually expanded to a pressure in the range of 5-6 atm over a time period of at least 90 seconds, preferably over 2-3 minutes. This action will expand the scaffold to a desired diameter relative to the wall. The expandable element may be an IVL balloon catheter, and acoustic pulses may be delivered to the vascular wall. The expandable element is then collapsed to restore blood flow, allowing the scaffold to remain supporting the expanded vascular vessel for a longer period exceeding 5 minutes. In some embodiments, the expandable element can be removed from the scaffold after collapse. In some embodiments, the expandable element may then be replaced with a second expandable element comprising a drug-coated balloon. The second expandable element is expanded for a specified amount of time to deliver the active substance to the vascular wall, and then can be collapsed (and removed) while the scaffold remains expanded. Next, the scaffolding is crushed and removed.

[0022] By using a balloon to expand a temporary stent (or scaffold), not only is the balloon pressure applied to the obstruction, but (i) its positive effect, e.g., the ability to gradually expand an occlusive lesion in a controlled manner by gradually increasing the pressure, can be improved, and (ii) its negative effect, e.g., the tendency for the balloon to expand uncontrollably in a sudden and abrupt manner, producing injury and dissection, and the tendency for the unfolding of the balloon folds during expansion to cause intimal rupture and dehiscence (both of which can easily lead to restenosis and vascular rebound), can be reduced by the covering temporary stent structure and the method of using it. The wires of the temporary stent or a separate scoring member can provide a localized force area on the plaque, which would allow the plaque or obstruction to be expanded with less pressure, producing controlled expansion compared to the uncontrolled rupture and dissection frequently seen in POBA. The scaffold essentially protects the vascular wall from injury caused by balloon defolding while preventing localized, rapid dilation that could damage the vascular wall. More gradual stretching and deformation of smooth muscle cells may occur, and they may have the opportunity to adapt to this stretch and maintain their integrity rather than being irreversibly damaged, as is frequently the case with POBA. Furthermore, once the scaffold is placed over the expandable element, the defolding of the folds of the expandable element cannot cause intimal rupture, dehiscence, or damage as it expands, because the scaffold protects the intima from contact with the expandable element (as is frequently the case with POBA). This is an important aspect of this method, as intimal rupture and damage are precursors to dissection and reparative cell proliferation processes (both of which make patients more susceptible to restenosis). This method, which combines slow, incremental dilation over at least 90 seconds with intimal injury protection provided by a removable scaffold from intimal injury due to the unfolding of expandable elements, along with the application of localized force and dilation using less pressure, may induce less damage to the vascular wall and therefore a less reparative neointimal hyperplasia response that leads to restenosis.

[0023] Thus, an expandable element, such as a balloon, can perform two distinct functions: 1) it can expand a plaque or obstruction (in a more consistent manner due to the overlying temporary stent structure), and 2) it can expand the temporary stent structure more effectively, using more force and involving more lumen acquisition, than can be achieved without balloon assistance. The overlying temporary stent structure also protects the vasculature from damage by the expandable element, such as a balloon.

[0024] Thus, using the method with an expandable element, such as a balloon, and a temporary stent structure can effectively and safely expand the vasculature and then, following expansion, support the expanded vasculature over an appropriate time period to promote plastic modulation and remodeling of tissue, resulting in a consistent and sustainable lumen acquisition that is not achievable using current methods of revascularization.

[0025] In some embodiments, the first elongating member comprises an outer actuator sleeve and the second elongating member comprises an inner balloon catheter shaft on which a balloon can be mounted. In some embodiments, the temporary stent comprises a porous braided stent structure. In some embodiments, the temporary stent structure comprises a laser-cut stent.

[0026] Treating progressive vascular disease is one of the largest healthcare costs borne by society. Many simpler and less expensive interventional treatment methods, such as POBA, may not be effective at high frequencies, necessitating the use of more complex and expensive alternatives such as stent placement and surgery, which cost billions of dollars annually.

[0027] The method of the present invention is expected to improve the results of POBA, reduce or avoid the need for stenting and / or surgery by preventing restenosis by first causing less vascular injury, preventing elastic recoil, which requires stenting frequently, and at the same time administering a non-proliferative agent. The procedures, performed in accordance with many embodiments of the present invention, are expected to cost significantly less than the various devices and operations designed to correct POBA and the complications of POBA.

[0028] An aspect of the present invention provides a medical device for treating a target site within a body lumen. Often, the target site would be an area of ​​a blood vessel occluded by plaque. The medical device may comprise a stent-like structure, which may comprise a plurality of scoring filaments or elements and a plurality of non-scoring filaments or elements. The scoring filaments and non-scoring filaments may or may not be woven alternately with each other. Alternatively, or in combination, at least some of the scoring and non-scoring filaments may not be woven alternately with each other. For example, the filaments may be supports for a laser cutting scaffold. The plurality of non-scoring filaments may be configured to radially support the body lumen after the stent-like structure has been extended therein. The stent-like structure may comprise more non-scoring filaments than scoring filaments. By providing more non-scoring filaments or elements than scoring filaments or elements, greater structural strength and improved scoring by the stent-like structure can be provided. Scoring of a lesion or occlusion within a body lumen may depend, for example, on providing localized force on and to one or more areas within the plaque. If there are too many filaments that are scoring filaments, the localized force may be diluted or fragmented throughout the filaments, neither of which may be dominant in directing the force into the plaque and causing the plaque to rupture directly beneath the scoring filaments. Therefore, only a limited number of scoring filaments or elements may be required to produce the desired result of localization over a certain area to rupture plaque present in a body lumen such as a blood vessel. In some embodiments, the scoring filaments or elements may be substantially flat and not radially protrude from the scaffold when the stent-like structure is in a collapse configuration. In some embodiments, the scoring filaments or elements may not score the vascular wall when the stent-like structure is navigated to the target site.In some embodiments, scoring filaments or elements can be deformed substantially perpendicular to the vascular wall when the stent-like structure is expanded, thereby providing scoring to the plaque or lesion. In some embodiments, the stent-like structure may not include scoring elements.

[0029] A stent-like structure typically has an expandable configuration and a compressible configuration. In the expandable configuration, the stent-like structure may be compressible into the compressible configuration. In the expandable configuration, the stent-like structure can be compressed into the compressible configuration by shortening the stent-like structure in the axial direction.

[0030] The medical device may further include an expandable element. The stent-like structure may be positioned across the expandable element, or the expandable element may be inserted into the lumen of the stent-like structure. The expandable element may be expandable to press the stent-like structure radially outward against the inner wall of the body lumen. The expandable element may include an inflatable balloon. The expandable element may be independently collapsible from the stent-like structure. The expandable element may or may not be fixedly attached to the stent-like structure. The expandable element may have an outer surface coated with a therapeutic substance or material. The expandable element may have one or more pores for releasing the therapeutic substance or material.

[0031] The medical device may further include a catheter shaft, and the expandable element may be positioned along the catheter shaft.

[0032] Another aspect of the present invention provides a method for treating a target region (or site) within a body lumen. Often, the target site would be a region of a blood vessel occluded with plaque. A medical device, such as a catheter assembly disclosed herein, may be positioned in or near the target region within a body lumen. The expandable element of the catheter assembly may be expanded to (i) expand a stent-like structure (or scaffold) positioned across the expandable element, and (ii) press both the expandable element and the stent-like structure against the inner wall of the target region. In some embodiments, the inner wall of the body lumen may also be scored using one or more of the stent-like structure or expandable element. The therapeutic agent may be released from the outer surface of the expandable element for injection into the inner wall. Alternatively, or in combination, the therapeutic agent may be released from one or more of the pores of the expandable element, the stent-like structure (or scaffold), or the scoring elements of the stent-like structure (or scaffold) for injection into the inner wall. In some cases, the expandable element may comprise an energy delivery means / device or an energy generating device. The expandable element may be crushed, leaving the stent-like structure expanded against the inner wall and supporting it radially. The stent-like structure remains expanded against the inner wall for at least a time period of three minutes, and may cause one or more of the following: (i) preventing elastic rebound of the inner wall, (ii) allowing a therapeutic agent to be injected into the inner wall, (iii) preventing or minimizing flow-limited dissociation, or (iv) transmitting energy or motion to the inner wall. After a time period, the stent-like structure is crushed across the crushed expandable element, and the entire medical device may be removed from the body lumen.

[0033] Alternatively, the expandable elements do not need to be fixedly attached to a stent-like structure so that different expandable elements, each with a different therapeutic effect, can be inserted individually or sequentially to provide one or more of the following: vascular dilation, endovascular lithotripsy, delivery of some other energy source, or drug / substance delivery.

[0034] (Integrated by reference) All publications, patents, and patent applications referenced herein are incorporated herein by reference to the same extent as each individual publication, patent, or patent application is incorporated by specific and individual reference. [Brief explanation of the drawing]

[0035] The novel features of the present invention are specifically described in the appended claims. A deeper understanding of the features and advantages of the present invention will be obtained by referring to the following detailed description and accompanying drawings, which describe illustrative embodiments in which the principles of the present invention are utilized.

[0036] Figures 1-6 illustrate exemplary devices and procedures according to many embodiments of the prior art invention.

[0037] [Figure 1] Figure 1 is a side view of a stent-like temporary scaffold or structure according to many embodiments of the prior art invention.

[0038] [Figure 2] Figure 2 is an enlarged top view of alternating woven filaments of a stent-like temporary scaffold or structure according to many embodiments of the prior art invention.

[0039] [Figure 3] Figure 3 is an enlarged perspective view of a non-scoring filament, which is made of alternating weave and is received within a notch in a stent-like temporary scaffold or scoring filament within a structure, according to many embodiments of the prior art invention.

[0040] [Figure 4] Figure 4 is a side view of a scoring filament having multiple notches for receiving multiple non-scoring filaments within a stent-like temporary scaffold or structure, according to many embodiments of the prior art invention.

[0041] [Figure 5] Figures 5A-5C are side views of multiple scoring members of scoring filaments within a stent-like structure according to many embodiments of the prior art invention.

[0042] [Figure 6A] Figure 6A is a cross-sectional view of an occluded blood vessel prior to treatment, according to many embodiments of the prior art invention.

[0043] [Figure 6B] Figures 6B-6D are cross-sectional views of stent-like temporary scaffolds or structures, arranged across expandable elements, as used to treat vascular occlusion in Figure 6A, according to many embodiments of the prior art invention. [Figure 6C] Figures 6B-6D are cross-sectional views of stent-like temporary scaffolds or structures, arranged across expandable elements, as used to treat vascular occlusion in Figure 6A, according to many embodiments of the prior art invention. [Figure 6D] Figures 6B-6D are cross-sectional views of stent-like temporary scaffolds or structures, arranged across expandable elements, as used to treat vascular occlusion in Figure 6A, according to many embodiments of the prior art invention.

[0044] [Figure 6E] Figure 6E is a cross-sectional view of the occluded blood vessel in Figure 6A after treatment in Figures 6B-6D, according to many embodiments of the prior art invention.

[0045] [Figure 7] Figure 7 shows perspective views of the scoring and non-scoring elements.

[0046] [Figure 8A] Figures 8A and 8B show the strain curves of the device and the energy means associated with it. [Figure 8B] Figures 8A and 8B show the strain curves of the device and the energy means associated with it.

[0047] [Figure 9A] Figures 9A-9D illustrate the present invention and the insertion of energy means into it. [Figure 9B] Figures 9A-9D illustrate the present invention and the insertion of energy means into it. [Figure 9C] Figures 9A-9D illustrate the present invention and the insertion of energy means into it. [Figure 9D] Figures 9A-9D illustrate the present invention and the insertion of energy means into it.

[0048] [Figure 10] Figure 10 demonstrates an energy delivery device integrated into the device.

[0049] [Figure 11] Figure 11 illustrates a method of utilizing the present invention, including options for inserting and utilizing energy means to improve suboptimal results.

[0050] [Figure 12] Figure 12 illustrates the present invention and its connection to a controller, which may be a programmable pump for inflating / deflating the balloon and / or rapidly changing the pressure, a controller for delivering energy to the device or scaffolding, or both.

[0051] [Figure 13A] Figures 13A-13D illustrate exemplary stent-like structures with damped or non-damped components. [Figure 13B] Figures 13A-13D illustrate exemplary stent-like structures with damped or non-damped components. [Figure 13C] Figures 13A-13D illustrate exemplary stent-like structures with damped or non-damped components. [Figure 13D] Figures 13A-13D illustrate exemplary stent-like structures with damped or non-damped components. [Modes for carrying out the invention]

[0052] (Detailed description of the invention) The following description will typically refer to specific structural embodiments and methods. It should be understood that the invention is not intended to limit itself to the specifically disclosed embodiments and methods, and that the invention may be practiced using other features, elements, methods, and embodiments. Preferred embodiments are described to illustrate the invention, not to limit the scope defined by the claims. Those skilled in the art will recognize various equivalent modifications relating to the following description. Similar elements in various embodiments are generally referred to by similar reference numbers.

[0053] The prior art, apart from the prior art of the present inventors, does not address removable balloon stent devices that dilate plaque and, after plaque dilation, support the wall. Lashinski, et al., U.S. Patent No. 6,773,519, describes a stent-like device that is deployed and then removed, and a removable connector that is part of the device but is not a removable stent. Tsugita, U.S. Patent No. 6,652,505, describes an inductive filter that is used to deliver a stent and can be removed, but is not a removable stent. Kahmann, U.S. Patent No. 5,879,380, describes a device and method for re-covering a damaged or removed vascular cross-section, but is not a device for both dilating a lesion and preventing elastic rebound, as is the case with many embodiments of the present invention discussed below. Those patents and applications are incorporated herein by reference.

[0054] At least five distinct but complementary actions of the disclosure and methods can be achieved on the inner surface of a blood vessel. The methods, devices, and systems provided herein can provide a proven balloon action for effectively opening an occlusion. The methods, devices, and systems provided herein provide a scaffold across the balloon to prevent intimal rupture (caused by balloon unfolding) and prevent rapid expansion (both of which facilitate dissociation from excessive reparative hyperplasia processes and the resulting restenosis). As disclosed herein, scoring members can apply stress more uniformly over the plaque, allowing expansion at lower pressures and thus causing less dissociation and injury. As disclosed herein, a scaffold acting independently of the balloon acts as a transiently removable stent, reducing acute elastic rebound. The methods, devices, and systems provided herein, when combined with, for example, drug delivery, can prevent restenosis. Prior art devices and methods, provided by many embodiments of the present invention, do not possess the mechanical advantages, i.e., scaffolds with scoring members generate crevices that allow plaque to be compressed more homogeneously with lower pressure and less injury, while providing channels for antiproliferative or other active materials to perfuse into the media of the blood vessel. The ability of the scaffolds to be used as transient, temporary, or removable stents reduces the incidence of acute elastic rebound and flow-limited dissociation, working in conjunction with active materials to prevent restenosis. Drug-eluting and drug-coated balloons may offer a significant improvement over simple balloon angioplasty (POBA) by reducing the incidence of restenosis from 40-60% to 10-15%. However, restenosis from neointima-hyperplasia is only one of three main problems associated with POBA. The other two, namely acute elastic rebound and flow-limited dissociation, are not addressed by drug-eluting and drug-coated balloons.Therefore, in current practice, there is still a need to place stents when these two main problems occur, and they occur in up to 40-50% of cases in some studies. In the majority of these cases, stent placement, which is not "rescue" or intended, will be necessary to address the acute rebound and flow-limited dissection that occur. Rebound and dissection phenomena are so common that many practitioners actually proceed directly to stent placement rather than attempting to perform angioplasty alone before determining the need for stent placement, saving time and completing the intervention with good results. This adds cost to the procedure and may leave a metallic structure in the patient, which can lead to other problems such as delayed stent thrombosis, in-stent restenosis, stent rupture, stent incomplete closure, and others. These sequelae of stent placement can often be very difficult to deal with once they occur. Therefore, drug-eluting and drug-coated balloons are only a partial solution to the dilemma. However, utilizing them in conjunction with embodiments of the present invention and methods can provide a complete solution to the three main drawbacks of POBA. Furthermore, improvements may include the addition of auxiliary energy generation / delivery and transmission means to enhance the mechanical action and weaken the "calcified matrix" (calcification within plaque or vascular walls, which will hereafter be referred to as such), as provided herein by the devices, systems, and methods.

[0055] Aspects of the methods and devices disclosed herein can address all three major drawbacks of POBA without the need for stent placement or permanent placement of foreign body material within the vascular space to maintain a channel for blood flow. Restenosis is addressed by providing delivery of a drug or other substance to prevent restenosis, whether by a drug-eluting balloon or a drug-coated balloon, or by using a drug coated on a stent-like structure or a scoring element of a stent-like structure, such as a drug-eluting or drug-coated balloon. Many embodiments of the present invention support the vascular wall after dilation, preventing or significantly reducing the occurrence of flow-limited dissection. Many embodiments of the present method also support the wall while the drug acts on smooth muscle cells, relaxing them, and thus preventing acute elastic rebound. By performing these three actions, the need for stent placement will be significantly reduced, if not eliminated, in most cases. This is not the case when using drug-eluting or drug-coated balloons, which do not involve the present invention. In addition, auxiliary energy delivery means, which are not present in the prior art versions of the present invention, may be combined with other features to destabilize the structure of the calcified substrate.

[0056] For reference, Figure 9C demonstrates the dual shaft of the device and the fully expanded expandable balloon element with the scaffold covering it. The balloon stent assembly 140 includes a balloon catheter shaft 104 with a balloon 102 at its distal end and an actuator sleeve 144 surrounding the balloon catheter shaft 104. A radially expandable temporary stent (e.g., braided) 142 can be positioned across the balloon 102. The balloon 102 and temporary stent 142 are shown expanded in Figure 9C. The distal end 146 of the temporary stent 142 may be fixed to the distal end of the balloon catheter shaft 104, while the proximal end 148 of the temporary stent 142 may be fixed to the distal end of the actuator sleeve 144. The temporary stent 142 can be removed from the patient following the procedure.

[0057] Figure 9B illustrates the collapsed balloon and the scaffold, which remains expanded to provide opening to the vascular wall. By moving the actuator sleeve 144 distally in the direction of arrow 150, the temporary stent 142 can be expanded over the collapsed balloon 102, as shown in Figure 9B, and may remain expanded when the balloon 102 is deinflated and collapsed. The temporary stent 142 is fixed distally to the catheter shaft 104 but not to the balloon 102. In the fully expanded state of the temporary stent 142 and the collapsed state of the balloon 102, the temporary stent may act as a stent-like structure, allowing blood flow to be restored.

[0058] Figure 9A demonstrates a scaffold that will be collapsed over the collapsed balloon element for insertion into and removal from the target site. By moving the actuator sleeve 144 proximal in the direction of arrow 152, the braid 142 can be deflated relative to the deinflated and collapsed balloon 102, and may further help to make the outer shape of the collapsed balloon thinner. In this deflated state, the balloon assembly 140 is typically inserted and removed. The scaffold is normally expanded with the balloon, but when the balloon is deflated or collapsed, allowing distal blood flow to resume, the scaffold can be locked into the expanded configuration by manipulating the catheter shaft 104 and actuator sleeve 144 with one finger. By keeping the scaffold expanded for several minutes while blood flow is restored distally, this method may allow the smooth muscle to adapt to the stretching of the angiogenesis. This may reduce the incidence of acute elastic rebound, which is one of the main acute-phase problems of POBA. Indeed, prolonged dilation of the vascular tissue has this desired effect. However, the time a balloon can remain inflated is limited because ischemia can develop as the balloon obstructs blood flow to distal tissues. Current methods would involve using a stent-like structure to support the dilated vessel and provide distal blood flow to prevent ischemia from developing during the dilation phase.

[0059] Figure 1 shows an exemplary scaffold of a prior art device comprising scoring wires 200 and support wires 201, 202. Figure 2 shows an enlarged cross-section of a braided device containing only support wires 201, 202. To save space, the cut or scoring wires or members 200 have a maximum radial dimension or height to the vertex of a triangle of 0.005 to 0.009 inches and are all oriented in the same direction (scoring members do not intersect with other scoring members), while the support non-scoring members 201, 202 may have a maximum radial dimension or height of only 0.001 to 0.005 inches. This allows thicker cut or scoring wires or members to overlap only with thinner support wires or members. Figure 3 demonstrates an enlarged cross-section of Figure 1 in which two relatively flat support members 201 are woven alternately with the scoring members 200. The flat support members 201 are located within the notches 203 described above. Figure 4 illustrates a cross-section obtained along the direction of travel of one scoring braid member 200. It can be understood that the scoring member 200 may intersect with other support members 201, and may be intersected by other support members 201. Figure 4 shows that, in order to accommodate the intersecting members 201, rounded recesses or other configurations (not shown) may be present within the scoring member 200 instead of sharp notches. A series of notches creates a serrated configuration at the relatively sharp end of the scoring member between the notches. The serrated edge formed by a series of notches would score lesions / vasculars more easily and completely than a round or rectangular scoring member.

[0060] The number of filament members in the braid will affect not only the radial strength, but also the number of wires per inch (number of wire crossing areas per inch), the size of the central mandrel, the rate of mandrel advancement, and other factors. Therefore, any number of combinations of wire or filament type, wire or filament shape and dimensions, relative stiffness of wire or filament, number of wire or filament types, total number of wires or filaments, total number of structurally important wires or filaments, mandrel size, braid density, number of wires per inch, orientation of thicker and thinner members, and other factors can be considered and will contribute to the size, strength, and functionality of the scaffold. By utilizing these variables, it is possible to optimize the cutting or scoring characteristics, the strength of the device, and limit its size, all of which are important goals.

[0061] In both non-braided and braided scaffolding, including laser-cut scaffolding, some of the scaffolding struts may be constructed such that, when the device is contracted or compressed for insertion, almost all of the struts are configured in a substantially cylindrical orientation, but depending on the expansion, some of the struts, including the apex, may be configured to be oriented substantially perpendicular to the vascular wall. These substantially perpendicular struts, i.e., members of the stent, will act as scoring elements when compressed into the plaque by the balloon expansion into the stent. When contracted or compressed for removal, these struts or parts of the struts may return to a substantially cylindrical shape. Other struts or parts of the struts may be consistently oriented in a conventional cylindrical pattern to provide strength to the scaffolding.

[0062] Figures 6A-6E show cross-sections of blood vessel 210 with a partially occluded plaque 211 and the vascular lumen 300.

[0063] Paclitaxel relaxes smooth muscle cells by acting on the cytoskeleton or microtubules within them, thereby improving polymerization. While other cellular effects certainly exist, dysfunctional microtubules are thought to be the reason why smooth muscle cells relax rather than contract as a result of exposure to a certain drug. Sirolimus acts on the potassium channel mechanism and similarly inhibits the contraction of smooth muscle cells. Existing methods do not maintain the blood vessel in a dilated state for a sufficient time period to allow the drug or substance to be administered by the components of this device, delivered to the vascular wall, penetrate through the vascular wall into the tunica media, act on smooth muscle cells, and inhibit contraction. Most methods of drug delivery use a POBA balloon to dilate the lesion relatively quickly (less than 90 seconds), then keep the balloon inflated for a further 90 seconds, and then deflate and remove the balloon. A drug-coated balloon can then be inserted and expanded over short periods (typically 1 minute or less) to deliver the drug from the balloon surface to the intima, and then removed. Therefore, there is no time available for both to maintain the vascular dilation while the drug penetrates from the vascular wall into the media, and to act on the smooth muscle cells to prevent them from contracting and rebounding to a smaller lumen diameter. The administered drug may prevent neointima hyperplasia, which contributes to restenosis, but it does little to prevent or inhibit acute vascular rebound. In some embodiments, employing a temporary stent by a temporary scaffold 142 (Figure 9A-9C) can prolong vascular dilation after drug delivery (for at least 3 minutes, preferably 8-12 minutes, and possibly for several hours or days). In some embodiments, the temporary stent may be combined with paclitaxel or sirolimus or other drugs / substances to provide sufficient time for the drug or substance to act on the cytoskeleton and microtubules for prolonged vascular dilation, so that smooth muscle cells cannot contract in response to the removal of the temporary stent.Many embodiments and methods of the present invention may utilize paclitaxel or other antiproliferative drugs or substances through the use of a scaffold 142 (or other stent structure) that acts as a temporary stent so as not to deflate when the temporary stent is removed, providing the primary action of prolonged dilation and allowing the drug or substance to act on cells. Without prolonged dilation, the drug may not have sufficient time to act on cellular components and relax smooth muscle cells. The extra time provided by a temporary stent that is dilated while blood is flowing through its surface can result in reduced elastic rebound of the blood vessel and better prolonged patency, along with drug uptake and action.

[0064] Each scoring filament may have one or more of the following shapes: pointed, triangular, or rectangular. Figures 5A-5C show exemplary shapes of multiple scoring members of scoring filaments within a stent-like structure.

[0065] As disclosed herein, there may be means such that, when expanded, the scoring tip of the scoring member is oriented substantially perpendicular to the longitudinal orientation of the scaffolding, but when the scaffolding is crushed, it is oriented substantially parallel to the longitudinal axis of the scaffolding. These means may include a shape within the base or notch of the scoring element that, in response to the expansion of the expandable balloon element, changes the orientation of the scoring element from a non-scoring orientation substantially parallel to the scaffolding surface and the longitudinal axis of the scaffolding to a scoring orientation substantially perpendicular to the scaffolding surface and the longitudinal axis of the scaffolding. This may be accomplished by constructing a base of the scoring element with a rounded edge or with an additional fan shape extending into the base so that the scoring element can be rotated by about 90 degrees from its stationary position under pressure. The non-scoring element may also have a fan-shaped edge that can allow the base of the scoring element to be rotated from an orientation perpendicular to the surface of the scaffolding to a relatively flat position when there is no pressure on the scaffolding member when the scaffolding is contracted or crushed. The notches in the scoring elements may also be configured with waists, i.e., cross-sectional dimensions thinner than the base, which would facilitate the rotation of the scoring members relative to the non-scoring members. In short, when there are no outward radial forces on the scaffolding, the scoring members are configured to be oriented such that their major axes and vertices are flat and substantially coplanar with the non-scoring filaments or members. In response to the expansion of the expandable elements and the resulting pressure acting on the non-scoring members, compressing the bases of the scoring members from the opposite side, the scoring members respond to the compression by rotating so that they are oriented substantially perpendicular to the major axes of the scaffolding and the non-scoring members, and the vertices of the scoring members are directed away from the scaffolding.

[0066] As demonstrated in Figure 7, each scoring filament or member 200 may have a base portion 252 configured such that when an expandable element is inflated and expands the scaffold, it rotates the orientation of the scoring member and compresses the base portion of the scoring member. The scoring filament 200 may comprise a tip or apex 251 and two substantially flat surfaces, e.g., 254 (opposing surfaces not shown). When the expandable element is not inflated or expanded, the scoring filament 200 may be oriented such that the surface 254 is substantially parallel to the surface of the scaffold, and therefore the scoring tip 251 does not face the vascular wall. This can eliminate any scoring or contact of the scoring member with the vascular wall. The scoring member 200 may be configured with a recess or fan-shaped cutout 250 that allows rotation or bending of the scoring member 200 in relation to a support member 201 (e.g., a non-scoring member). When the scaffold or stent is retracted and there is no outward pressure on the stent by the expandable member, the scoring filaments or members are positioned such that the long axis of each scoring member is substantially coplanar with the supporting or non-scoring member of the stent-like structure. In Figure 7, the scoring member 200 may be configured with a curved or fan-shaped or waisted portion, e.g., 250, within a notch area 253, which is configured to receive a non-scoring filament, e.g., 201, when the pressure of the expandable element is not provided on the non-scoring or supporting member. This can serve two purposes: 1) when not expanded, the scoring element of the scoring filament 200, e.g., the vertex 251, cannot be directed outward, thus reducing the overall shape of the device; and 2) when navigating or positioning the device, the potential for damage to blood vessels from unintentional exposure of the scoring element can be minimized. Other configurations (not shown) have also been considered, and the embodiments herein represent possibilities.

[0067] As shown in Figure 7, the notches 253 in the base of the scoring member 200 may be configured so that the scoring member can be compressed by the non-scoring member 201 when the non-scoring filaments of the scaffolding are under tension at the scaffolding position where they are expanded or in the process of being expanded. In some cases, the non-scoring member may be woven alternately above and below the scoring member. In other cases, the non-scoring member may not be woven alternately above and below the scoring member. The base 252 of the scoring member 200 may be asymmetrically rounded in such a way that compression applied to the base asymmetrically rounded by the expandable element can rotate the scoring member from a thin orientation where the long axis of the scoring element is relatively flat to a larger outer orientation where the scoring element protrudes at the scoring position away from the scaffolding. Therefore, means to facilitate the change in orientation of scoring members from a thin to a vertical scoring position may include one or more of the following: the base of the scoring element, a notch within the scoring element, a non-scoring element, thermal solidification of any element, outward radial pressure from an expandable element, expansion of the internal dimensions of the scaffold, or translation of the internal and external shafts to compress the scaffold. In the latter case, compressing the braided scaffold can change the intersection angle as the filaments or members of the braid expand radially. Means within non-scoring members, the base of the scoring filaments, or notches in the scoring filaments may be present to change the orientation of the scoring filaments regardless of the pressure applied thereto when the scaffold is compressed or shortened.

[0068] Shallow notches within the non-scoring member 250 may also be present to receive the scoring member and facilitate changes in the orientation of the scoring member.

[0069] Alternatively, the non-scoring filaments do not have to intersect the scoring filaments above or below them, nor do they have to be received by or permanently housed within the notches. In other words, the non-scoring filaments or elements do not have to intersect the scoring filaments or be received within their notches in other configurations. In this alternative embodiment, the scoring and non-scoring filaments do not have to be related to each other. In this alternative configuration, which may exist when the scaffold is laser-cut or a non-braided stent-like structure, the base of the scoring element may be configured as in Figure 7. In this case, the pressure of the expansion element can change the orientation of the scoring element. In some cases, the temporary stent may not have any scoring elements at all.

[0070] Improvements to the prior art would result in the devices of the present invention, comprising novel means and methods for slowly expanding the expandable element and temporary stent-like structure using one or more auxiliary methods, including pressure modification, vascular lithotripsy, laser, or other energy delivery to the vascular wall, during or after the gradual expansion occurs. This differs from current methods, which expand the lesion before delivering energy to the vascular wall. Simultaneous energy delivery to the vascular wall while the expandable element and scaffold are expanding, with or without scoring means, would be more effective in fragmenting and rearranging calcified plaque and medial calcification for greater lumen acquisition. Furthermore, after the temporary scaffold has supported the vascular wall for several minutes, the method of delivering pulses of energy to the vascular wall would improve the creep phenomenon, which relies on applying strain over a certain time period. Simply put, the addition of auxiliary energy means to deposit energy as a “strain jump” within the calcified plaque and vascular wall will accelerate tertiary creep and fracture / cracking of the calcified material, causing the calcified area to fracture more quickly and easily than with constant force alone. This phenomenon, known as a strain jump, generates structural instability within the strained material, leading to fracture with a shorter duration of strain. This is illustrated in Figures 8A and 8B. Figure 8A demonstrates the accumulation of strain over time and the creep phenomenon that occurs until the material eventually loses structural integrity and causes fracture. In this case, the material may be a calcified matrix. In Figure 8B, the auxiliary energy deposit may occur either intermittently or at specific times during the opening-expansion cycle or during the expansion-support cycle when the balloon is normally collapsed. In the latter case, the balloon may be expanded and the energy source delivered if necessary. Instead of a constant force supplied over a time period by either an expandable element or a scaffold with a scoring element, as in the prior art, the improvements in these embodiments would include additional means and methods of energy delivery such that a constant force exists but is amplified by an additional force administered either intermittently or at specific intervals.In Figure 8B, the expected strain curve, with the addition of strain jumps, is superimposed on the strain curve in Figure 8A, demonstrating the addition of auxiliary energy or strain jumps, a new secondary creep phase (A), and a new tertiary creep. The time to fracture or crack, representing compressive instability within the calcified matrix, is significantly reduced after the addition of strain jumps from the administration of auxiliary energy.

[0071] The auxiliary energy may consist of one or more of several forms of energy. One form utilizes a means of energy propagation in a solution to expand a balloon-expandable element. A method of treating a target site utilizing a removable balloon-expandable scaffold is claimed, which uses microbubbles, substances, dissolved gases, or nanoparticles as cavitation nuclei in the solution used to inflate the balloon, administers sound waves or other energy to the solution, and generates cavitation and subsequent pressure waves that are transmitted to the vascular wall, thereby weakening the integrity of the calcified matrix by cavitation and the resulting pressure waves, in combination with one or more other means of inducing instability within the calcified matrix, including scoring elements, generation of strain jumps using auxiliary energy delivery or modification, longitudinal movement of the catheter or scaffold, prolonged strain on the vascular wall with prolonged expansion, or physical motion. Fast pulses of laser energy may also be used to deliver energy to the median and generate structural instability within the calcified matrix.

[0072] Recent advances in endovascular lithotripsy (IVL) represent a welcome improvement to vascular interventional therapy. However, this method has several drawbacks, typically requiring pre-IVL angioplasty and / or drug-coated balloon (DCB) angioplasty and stent placement prior to IVL device placement and activation. Furthermore, despite the multiple steps in the procedure, IVL lacks a means to counteract vascular rebound. The balloon folds can unfold against the arterial intima, still potentially leading to intimal tearing and rupture, which has the potential to evolve into dissection or trigger a neointimal hyperplasia-restenosis chain reaction. Therefore, improvements are needed to correct the shortcomings of IVL and the multi-step process that results in plaque alteration.

[0073] In one embodiment of the improved device of the present invention, the advantages of temporary scaffolding (no intimal tearing, no / limited rebound, time for plastic deformation to occur, less damage to blood vessels, etc.) are combined with the advantages of IVL (fragmentation of calcified material for better compression of plaque and calcified vascular walls and the resulting improved responsiveness).

[0074] Finally, the stent-like structure may be collapsed after a predetermined time period, and the complete catheter assembly, including the collapsed balloon and the collapsed stent-like structure, may then be removed from the target area.

[0075] Figure 8A illustrates the effect of applying a constant strain to a somewhat rigid object (such as a calcified matrix). This is the expected result of prolonged dilation of a vessel by a removable scaffold. In most cases, fracture or cracking of the calcified matrix is ​​likely to occur.

[0076] Figure 8B illustrates the effect of adding auxiliary energy delivery, including motion, to the system in addition to applying a constant strain to a somewhat rigid object (e.g., a calcified matrix). Fracture or cracking will occur earlier with the use of auxiliary energy, as the added auxiliary energy will enhance and accelerate the strain effect of the expandable elements and scaffold. Therefore, the addition of auxiliary energy means, in one or another form, will be beneficial to the compression process, even in severely calcified blood vessels. Both atherectomy, with its potential for distal embolism, and multi-step endovascular lithotripsy processes, which require a series of actions consisting of pre-opening, energy deposition, post-energy deposition, and separate application of a drug-coated balloon, and which can damage the blood vessel, can be avoided because all the necessary actions for lumen acquisition will be incorporated into the device of the present invention.

[0077] The sum of these advantages—namely, the mechanical advantage of slowly expanding the balloon, less pressure, less dissociation, and less injury—along with the braiding and scoring elements in plaque dilation, combined with integrated drug elution to prevent restenosis, combined with energy deposition to enhance other effects, providing prolonged dilation, and overcoming vascular rebound, would significantly improve patient outcomes.

[0078] Furthermore, temporary stents may be used in combination with other modalities other than energy or drugs, such as stem cell transplantation and exosomes, plant-derived materials, minerals, radiofrequency, lithotripsy, electroporation, heat, atherectomy, gene therapy, cryotherapy, electrical pulses and currents, radiation, iontophoresis, other pharmacological agents and substances, and their equivalents. This concept employs multiple modalities that can directly or indirectly affect or weaken the calcified matrix and other components of plaque and / or vascular walls, thereby preventing compression of these structures and the resulting expected lumen acquisition. Other modalities incorporated within this method or device can affect other components of the plaque or vascular wall, preventing intimal rupture, dissection, vascular injury, vascular rebound, vascular responsiveness, and restenosis. By incorporating multiple different effective modes of action that specifically target different components of the problem within a single device, more complete and effective results can be obtained. Vascular responsiveness can be maintained after treatment, which is not the case with stent placement or incomplete compression of the calcified matrix. The use of multiple different devices can be avoided, which would improve the procedure in terms of safety profile, procedure time, patient risk, and cost to the healthcare system.

[0079] Prior art devices consisted of scoring, temporary stent placement, and prolonged dilation and simultaneous drug delivery. This improvement comprises, in a novel manner, means and methods for gradually and incrementally expanding an expandable member to gradually dilate the lumen, novel means and methods for delivering auxiliary energy means to weaken calcified matrix, novel methods and operations for delivering motion, stress, and strain to a target site to weaken calcified matrix, and the use of scaffolds for delivering energy or substance to weaken calcified matrix, or to prevent rebound and restenosis, or both. Novel means for depositing energy into the vascular wall may also be used in conjunction with the temporary stent structure to weaken plaque and calcified matrix and other structures within the vascular wall. These means, in particular, include acoustic generators, endovascular lithotripsy, electrical generators, radial pressure wave generators, and one or more of the following means: vibration, electrohydraulic, iontophoresis, reversible or irreversible electroporation, electromagnetic, piezoelectric, compression, and impact means, which enhance pressure by balloon and / or temporary stent structures. Combining energy deposition means with the inherent advantages of current devices can further improve effectiveness and overcome the problems and drawbacks of energy application alone. For example, endovascular lithotripsy (IVL) uses a semi-responsive balloon to dilate plaque / vascular tissue. This process exposes the intima to intimal tearing from shear forces caused by the unfolding of the balloon during dilation, which frequently forms the basis for dissection. Also, typically, gradual balloon dilation is not available, nor are there any means for prolonged vascular dilation to avoid vascular rebound. Scoring is not provided with IVL, and drug delivery must be delivered by a separate application via a standalone drug-coated balloon after the IVL has opened the lesion, rather than being integrated into the dilating device. Therefore, while standalone IVL may succeed in weakening the calcified matrix, it presents unaddressed problems and is an incomplete solution.

[0080] A method is also claimed for utilizing the present invention after IVL or atherectomy to completely compress the calcified matrix that has already been weakened or partially removed, respectively, and to achieve maximum lumen acquisition. This would involve inserting the present invention to a target site after IVL or atherectomy, expanding the expandable element and scaffold over a certain time period, collapsing the expandable element, leaving the scaffold expanded and supporting the vascular wall over a second time period, collapsing the scaffold and removing the entire device. A drug may be delivered during the expansion of the expandable element step, during the time the scaffold is expanded, or both. Vascular rebound would be prevented by prolonged vascular dilation, drug delivery, or both. Vascular restenosis would be prevented by drug, energy delivered, lack of injury to the vascular, prolonged dilation, or a combination of two or more of these features.

[0081] A preferred embodiment of the present disclosure may include an energy delivery device incorporated within an expandable element. The energy delivery device may comprise a plurality of energy generating means. The energy delivery device may be installed within a cavity of the expandable element or attached to the shaft of the expandable element. The method may include advancing the device to a target site, gradually and incrementally expanding the expandable element to contact the vascular wall, and expanding the scaffold and the vascular wall. Supplementary energy may then be delivered to the vascular wall at a selected time before, during, or after the expansion step. The expandable element may be an integral part of the device, i.e., fixedly attached to the scaffold, or a separate device configured to be inserted into a partially expanded scaffold. The energy delivery device may be an endovascular lithotripsy device.

[0082] A second preferred device configuration and method of this disclosure may include separate expandable elements and scaffolds that are not fixedly attached to each other. The expandable elements may be configured to be inserted into the lumen of a self-expanding scaffold that is at least partially expanded. The method may include advancing the scaffold to a target site, at least partially expanding the self-expanding scaffold at the target site, inserting an expandable element, which may comprise a balloon and an energy delivery device, into the lumen of a self-expanding scaffold, expanding the expandable element, delivering energy to the vascular wall before, during, and / or after the expansion step, and crushing the expandable element while keeping the scaffold expanded against the wall for at least 3 minutes, preferably 8 to 12 minutes, potentially over a time period of several hours to several days, and crushing the scaffold. The expandable element, together with the energy delivery device, may be removed at any time after expansion and energy delivery in the method.

[0083] To incorporate an energy generating means (or energy delivery device / means) into other configurations of the devices disclosed herein, one configuration may include a separate energy generating means inserted into the inner lumen of the expandable element and positioned as an add-on device for optimal energy delivery. A method to do so may involve placing the device at a target site, inflating the expandable element at least partially, inserting an energy delivery device into the lumen of the expandable element before or after partial inflation, delivering some form of energy from the energy delivery device to the vascular wall, collapsing the expandable element, leaving the scaffold expanded for a time period of at least 3 minutes, collapsing the scaffold, and removing the entire device from the patient.

[0084] The method may include delivering energy at any stage of the gradual expansion of the expandable element, particularly during specific times in later stages, and / or in response to the complete expansion of the expandable element. Therefore, in some cases, the energy deposition means may not be an integral part of the device, but may be inserted into the device and activated during and after the gradual expansion of the device. This is demonstrated in Figures 9A-9D. As in Figure 9D, an energy delivery device 900 comprising an energy generating means 901 may be sized to fit into the inner lumen of the expandable element and positioned in a suitable location prior to energy delivery. A conductive medium may be inserted between the shaft of the energy generating means and the inner surface of the inner shaft of the catheter. This location inside the outer catheter requires that the energy delivery means transmit or release sufficient energy for the energy delivery means to pass through the shaft of the covering catheter, and the shaft is made of a material that enables or facilitates energy transmission. However, frequently, the catheter material necessary for the catheter to function properly may not readily transmit energy. In this case, the energy-conducting material (structural hydrogel, polyurethane, other polymers, metals, conductive materials, and equivalents) may be inserted into a specific location within the catheter wall through a “window” or plug, which allows the generated energy to propagate through these energy-transmission windows in the reconstructed catheter shaft covering it into the fluid-filled, expanded balloon, where one of the following will be generated and transmitted into the vascular wall: evaporation, cavitation, shock wave-type force, or sound pressure wave. The energy wave will thereby enhance the mechanical expansion action of the expandable element or the calcium-crushing action of the scoring element of the temporary scaffold, or both. By combining these means, namely mechanical scoring and mechanical pressure waves, in one device and in one method, more complete and homogeneous plaque and calcified matrix compression will occur, resulting in easier and more complete compression by the expandable member, and thus better lumen acquisition with less pressure and less vascular damage.In the case of acoustic or energy-transmitting material windows installed within the two catheter shafts of the present invention, a section of the catheter wall may be removed and replaced with a different material, or the different material may be initially installed in a specific location depending on the extrusion molding of the shaft. These windows (not shown) may be circumferential around the catheter shaft, or they may represent only a “cutout” occupying one-third or less of the circumference. They may be any desired shape and size that allows energy to be transmitted through the window without compromising the integrity of the catheter shaft. The length of the transmittance window may be as little as 1 cm and may be sized to fit across only one energy-generating / delivering component, or to fit across all of the energy-generating / delivering components. In the case of localized acoustic windows within the catheter wall, they may be positioned across each energy-generating / delivering component. In the present invention, since there are two shafts of the catheter, the windows or acoustic cutouts will be installed within each inner and outer shaft so as to be aligned when the two shafts are positioned for sub-maximum or maximum expansion of the expandable elements. Water, saline solution, or some other energy-conducting material may be placed between multiple catheter shafts to enhance energy conduction. If the catheter can be constructed from a material that transmits the desired energy, windows or special means to ensure transmission may not be necessary.

[0085] A method for treating a vascular channel may include inserting an energy delivery device into the inner lumen of a temporary stent device comprising a scaffold and an expandable element; positioning the energy delivery device adjacent to an acoustic window in a catheter shaft capable of delivering energy; expanding the expandable element and the scaffold at least partially; activating the energy delivery device over a defined time period; delivering energy to the vascular wall; fully expanding the expandable element; collapsing the expandable element; keeping the scaffold expanded for at least 3 minutes; and collapsing the scaffold.

[0086] Modification of energy transmitted by scaffolding or stent-like structures can, in some cases, be problematic. The stent itself cannot directly attenuate shock waves during lithotomy. Instead, the presence of a stent within a blood vessel can have a secondary effect on shock wave propagation due to its interaction with surrounding tissues and fluids.

[0087] When endovascular lithotripsy shock wave therapy encounters an intravascular stent, several factors are involved.

[0088] Reflection and Scattering: The presence of a stent can cause reflection and scattering of shock waves. Depending on the material and design of the stent, some of the shock wave energy may be reflected back towards the source or scattered in various directions. This affects the distribution and intensity of the shock waves reaching the target area and can potentially alter the therapeutic effect.

[0089] Acoustic impedance mismatch: Stents can generate acoustic impedance mismatches at the interface between the stent and the surrounding tissue or fluid. These mismatches can lead to partial reflection of shock waves and alterations in wave propagation patterns, affecting the distribution and attenuation of shock wave energy.

[0090] Interference with targeting: In some cases, the presence of a stent can make it more difficult to accurately target and deliver shock waves to the intended treatment site. Stents can block the shock wave pathway or cause a shadowing effect, potentially affecting treatment outcomes.

[0091] Overall, while stents themselves cannot directly attenuate shock waves in lithotripsy procedures, their presence can influence shock wave propagation through secondary effects such as reflection, scattering, and acoustic impedance mismatch. Understanding these interactions is crucial for optimizing lithotripsy treatment in patients with stents. The composition of the stent or scaffold is important to prevent any modification of the shock waves, whether it enhances or blocks their effects, due to their physical properties and interaction with acoustic energy. Scaffolds or stents may consist of different materials that block or attenuate shock waves. Scaffolds or stents may comprise metals such as stainless steel, titanium, and nitinol, which can be used in stents, clips, and prosthetic implants. These metals can attenuate shock waves through mechanisms such as reflection, absorption, and scattering. The degree of attenuation depends on factors such as the type of metal, its thickness, and its acoustic properties. Scaffolds or stents may comprise polymers, including various plastics and synthetic materials. Polymers can attenuate shock waves through absorption and scattering mechanisms. The composition, density, and thickness of polymer materials affect their ability to attenuate shock waves. Scaffolds or stents may comprise ceramics such as alumina (aluminum oxide) and zirconia, due to their biocompatibility and mechanical properties. Ceramics can attenuate shock waves through absorption, scattering, and reflection. The composition and microstructure of ceramic materials affect their acoustic properties and attenuation characteristics. Scaffolds or stents may comprise composite materials, which consist of a combination of different substances such as fibers, resins, and fillers that can be tissue-engineered to have specific acoustic properties. Composite materials used in medical devices or implants can attenuate shock waves through a combination of absorption, scattering, and reflection mechanisms. Scaffolds or stents may comprise hydrogels. Hydrogels are water-absorbing polymer materials that can be used in a variety of medical applications, including tissue engineering and drug delivery.Hydrogels can attenuate shock waves through absorption and scattering mechanisms because their water content and structure influence their acoustic properties.

[0092] Overall, the attenuation of shock waves by materials in lithotripsy procedures depends on factors such as the composition, density, thickness, and acoustic properties of the materials involved, as well as the size of the cells or spaces between the stent's supports or structural components. Closed-cell stents, characterized by a small free cell area between the supports and cells, are frequently surrounded by supports, while open-cell stents have larger exposed gaps, and the cells are open areas that cannot be completely surrounded by supports.

[0093] Regardless of the location of the energy delivery device (or energy generating means / device), i.e., whether it is incorporated into the scaffolding device as a separate component inserted into the lumen of at least partially expanded scaffolding, or as a separate component inserted into the lumen of the shaft of expandable member, the energy generated and transmitted toward the vascular wall may be significantly attenuated or shielded by the scaffolding placed between the expandable element and the vascular wall. Thus, the effective energy delivered to the vascular wall and calcified matrix may often be reduced by the covering scaffolding, or the energy delivery may not be uniform or in the desired pattern. To overcome the drawbacks of installing scaffolding over energy-delivering expandable elements, one or more of the scaffolding configurations may include: 1) an open cell stent pattern that minimizes the structural components of the scaffolding and maximizes the open area, causing little to no attenuation; 2) a scaffolding of energy-transmitting material without significant attenuation of energy; 3) windows or openings within the scaffolding for energy to be transmitted through them without attenuation; and 4) a pattern of un-attenuated windows within the scaffolding, oriented to provide maximum energy transfer through them, with intentional attenuation means within other areas of the scaffolding, so that energy can be applied to the vascular wall in a desired pattern, each having both maximum and minimum energy delivery areas within the vascular wall adjacent to the windows and attenuation components, respectively. The attenuation means cannot completely attenuate the energy, but the relative difference between the areas of maximum and minimum transfer may be significant. Similar to the aforementioned explanation of localized forces in scoring, applying an energy source locally, i.e., in a localized pattern, to the vascular wall and calcified matrix is ​​more effective than applying a generalized force or energy source that can be relatively homogeneous to the entire vascular wall and the substantially cylindrical calcified matrix, which can cause the calcified matrix to expand substantially concentrically, absorb energy pulses, and lead to structural instability or fracture of the calcified matrix only in much more concentrated, frequent, or repetitive energy deposits.Therefore, windows or openings created within the scaffold of this disclosure may be configured to deliver energy in a pattern that maximizes the energy delivered to one or more areas of the vascular wall and minimizes the energy delivered to other areas of the vascular wall. The differences and variations in energy delivery using the device and method of use to different cross-sections of the wall and matrix may be more effective in inducing structural instability within the plaque and calcified matrix than delivering homogeneous energy force to the vascular wall. Thus, by using the device and technique disclosed herein, pulse intensity may be reduced (potentially safer), fewer pulses may be required (saving time and cost), and patterns that induce predictable fracture patterns within the calcified matrix allow for easier and more predictable vascular expansion than with random energy delivery. While most scaffolds may have areas without any damping material (between braided filaments or stent supports), the closed-cell configuration of the scaffold may limit energy transfer. A predictable fracture pattern can generate fragments of the calcified matrix, which are more easily expandable and then more easily oriented with other fragments. Simply put, a random fracture pattern using IVL (and potentially other energy delivery devices) randomly fractures the calcified matrix, generating shock waves that resist expansion without further damaging the vessel, leaving some larger fragments intact. The scaffold of this disclosure is designed to maximize energy deposition in a pattern that promotes substantially uniformly sized fragments, allowing the vessel to expand more easily and maintain this expansion after the temporary scaffold is removed.

[0094] In some cases, it may be beneficial to simply limit the size and configuration of the struts to minimize shadowing, reflection, scattering, impedance mismatch, targeted interference, and / or attenuation of transferable energy, and to maximize open space free of any material to improve energy transfer through it. Examples of patterns of attenuated and non-attenuated components of the scaffold are detailed in Figures 13A–13D. In some embodiments, the struts of the stent may be flat to cover more space and attenuate energy, or they may be thicker to intentionally minimize energy delivery in a given area.

[0095] Figure 13A demonstrates a stent structure comprising thin struts 401 that cannot significantly block energy transfer and a large open area 402 that can allow energy transfer without blocking it. This may be a preferred embodiment when the present invention is used with various forms of energy delivery devices. Figure 13A shows a closed cell configuration comprising braided filaments, e.g., 401 and the open area 402. In some embodiments, the stent may be in an open cell configuration.

[0096] In some embodiments, the scaffold may include attenuation means that can intentionally limit energy transfer to a certain area of ​​the vascular wall, while allowing complete energy transfer to the vascular wall through an open opening designed to rupture the calcified matrix. The difference in energy deposition caused by this configuration can cause the calcified matrix to rupture more easily and in a substantially predictable pattern, rather than exposing the entire vascular to a uniform energy deposition in which there is no control over the location or degree to which the calcified matrix can rupture. This configuration can provide a localized area of ​​more concentrated energy force deposition adjacent to an area of ​​reduced energy force deposition, which can limit the intensity, duration, or number of energy pulses required to rupture the calcified matrix into fragments, allowing the calcified matrix and vascular to become more expandable and compressible. The following description is merely an example of a potential configuration designed to deliver energy in a pattern or arrangement that ruptures the calcified plaque in a otherwise more clinically beneficial manner. Figure 13B demonstrates a tubular braided stent consisting of one of wide and / or high-density braided members 201, 401, and 202, where the density of threads per inch blocks energy transfer, and the open area 402 is generated by omitting an opposing member in one spiral braiding direction. Figure 13B also shows a closed cell configuration with a scoring member 200, but where an enlarged cell is generated by omitting one braided filament 202. This generates a spiral array of larger open windows 402 for unsuppressed energy transfer through it. Support members 201 and 202 may also be configured with wider widths (not shown) and other properties, which blocks energy transfer and thereby prevents energy transfer and deposition in the remainder of the vascular directly beneath the scaffold structure, while providing a spiral pattern of maximum energy deposition. Figure 13C demonstrates a tubular braided stent consisting of one of the wide and / or high-density braided members 201 and 202, where the density of threads per inch prevents energy transfer, and the open areas 402 and 404 are created by omitting opposing members in both braided spiral directions.Figure 13D demonstrates an open-cell laser-cut type stent comprising the cross-section or area of ​​an energy-blocking scaffolding component or support, combined with the area of ​​a cutout or the absence of a scaffolding component or support, which allows energy to be freely transferred to the vascular wall in a desired pattern, providing the area of ​​minimum energy transfer and the area of ​​maximum energy transfer to the vascular wall, respectively.

[0097] In some embodiments, an open area (e.g., 402) can be created by increasing the distance between adjacent support members or filaments. In some embodiments, an open area can be created by removing support members or filaments. In some cases, the support members or filaments may comprise a material that vibrates in response to energy transfer, and the vibrational energy is transferred to the vascular wall, further causing structural instability and other effects within the calcified matrix and other components of the vascular wall.

[0098] When a scaffold is braided tubularly from a braiding machine consisting of 16 carriers, one configuration in which the scaffold is optimized to deliver an energy pulse pattern involves removing two opposing filaments from each of the eight right-handed and eight left-handed filaments. This would produce an intersecting spiral configuration with a maximum energy deposition area. Utilizing a closed-cell or open-cell laser-cut stent or mesh braid as a scaffold would produce a small rhomboid maximum energy delivery. In some cases, a closed-cell stent, minimizing the free cell area, may adequately deliver the desired pattern. In some cases, a scaffold with an area of ​​full energy transfer and an area attenuated to have no energy transfer may be more effective in expanding the calcified matrix following energy deposition. A smaller area of ​​energy deposition through open cells between the scaffold supports may augment a larger area of ​​energy deposition through a window pattern created within the scaffold.

[0099] In some cases, the energy delivery device (or energy generating means / device) may be physically incorporated into or part of the device disclosed herein. In this embodiment, the energy delivery device may be an integral part of the expandable element, and the energy generating means may be incorporated into the device so as to be installed on or inside a shaft that is directly adjacent to and surrounded by the interior of the expandable element. In this example, the energy delivery means may be installed directly adjacent to the cavity of the expandable element, as shown in Figure 10. Figure 10 illustrates a removable scaffold in which the energy delivery device is incorporated into the expandable element. Once the energy delivery device is incorporated into the device, it cannot be seen from the outside. For illustrative purposes, Figure 10 shows a portion of the scaffold being removed and the energy delivery device being incorporated. The energy delivery device 1001, comprising an energy generating means, e.g., 1002, can be inserted into the expandable element 102 after the expandable element 102 has been expanded and a temporary stent or scaffold 142 has been expanded by the expandable element. The energy delivery device 1001 can be inserted through the inner lumen of the shaft 104. 144 indicates the actuator sleeve of the shaft 104. 148 indicates the proximal end of the temporary stent or scaffold 142.

[0100] Furthermore, a method is also disclosed in which a target site or lesion is first treated using a device comprising an expandable element and a temporary stent (or scaffold) without any auxiliary energy delivery device, the outcome is assessed, and then the lesion is retreated by inserting an energy delivery means into the internal catheter lumen, thereby expanding the expandable element and scaffold, and treatment is performed while either the expandable element or the scaffold is expanded, or both are expanded. This method reserves expensive energy delivery components for those cases with potentially suboptimal outcomes, and the method would essentially be a “rescue” procedure rather than a primary intervention treatment. Thus, savings for the healthcare system can be achieved while providing better patient care. This schematic is illustrated in Figure 11. Figure 11 demonstrates a method for treating a target site. The method may include the process of inserting a removable device comprising an expandable element and a scaffold, and positioning the device at the target site in the blood vessel. The method may include process 1102, i.e., gradually or incrementally expanding the expandable element over a time period. In some embodiments, the time period may be at least about 2 minutes. The method may also include process 1103, i.e., leaving the expanded element expanded over a time period, e.g., at least about 1 minute. The method may also include process 1104, i.e., collapsing the expandable element and leaving the scaffold expanded, which may open the vessel over a time period, e.g., at least about 5 minutes. The method may also include process 1105, i.e., collapsing the scaffold over the collapsed expandable element and assessing the treatment outcome. If the outcome is satisfactory, the method may include process 1106, i.e., removing the removable device. If the outcome is unsatisfactory, the method may include process 1107, i.e., inserting an energy delivery device into the lumen of the removable device, re-expanding the expandable element, and delivering energy from the energy delivery device.The method may include process 1108, namely crushing the expandable elements and leaving the scaffold expanded for a certain time period, for example, for at least about 5 minutes. The method may also include process 1109, namely crushing the scaffold and removing the energy delivery device and the removable device.

[0101] In this example, the method may involve positioning the energy delivery means across a conductive window within the catheter shaft, as discussed above. In some cases, the method may include a sock-like stent structure that is separate from and not fixedly attached to the expandable element. In some cases, energy delivery may be performed during or after the expansion of the expandable element.

[0102] In some embodiments, the present disclosure provides a method for reducing rebound and restenosis at a target site within a blood vessel, the method comprising (a) advancing a medical device to a target site, the medical device being (i) a stent-like structure comprising a plurality of scoring members and a plurality of non-scoring members, wherein the plurality of non-scoring members is greater than the plurality of scoring members; (ii) expandable elements capable of expanding the stent-like structure against the wall of a body blood vessel, wherein the plurality of scoring members are configured to score and penetrate plaque and / or walls of a blood vessel using localized force; and (iii) an inner and outer shaft, wherein the distal end of the stent-like structure is attached to the distal end of the inner shaft. The invention comprises an inner and outer shaft, the proximal end of which is attached to an outer shaft, and an expandable element located within the inner shaft and operably coupled thereto, wherein parallel movement of the inner and outer shafts includes: (b) crushing the stent-like structure over the crushed expandable element for removal from a body vascular vessel; (c) gradually inflating the expandable element to press the stent-like structure against the vascular wall and dilate the vessel; (d) applying an auxiliary energy source; (e) crushing the expandable element to provide blood flow distally; (f) keeping the stent-like structure expanded and supporting the vascular wall above 3 / 4; (g) crushing the stent-like structure; and (g) removing the expandable element and the stent-like structure.

[0103] In some embodiments, the present disclosure provides a method for reducing rebound and restenosis at a target site within a blood vessel, the method comprising (a) providing a self-expanding stent-like structure or scaffold comprising a plurality of scoring members and a plurality of non-scoring members, wherein the stent-like structure comprises more non-scoring members than scoring members, the scaffold is attached only to a proximal delivery shaft member and, when deployed in an expanded configuration, provides a lumen for the expandable members to be inserted into and positioned within the lumen of the scaffold, the expandable elements are capable of expanding the stent-like structure against the wall of the body lumen, and the scoring members use localized force to break down plaque and / or blood vessels (b) scoring the wall and configuring it to penetrate therein, (c) inflating the expandable element to press the stent-like structure against the vascular wall and expand the body lumen, (d) applying auxiliary energy and / or a drug / substance source which can induce structural instability within the calcified matrix, (e) collapsing the expandable element to provide distal blood flow, (f) leaving the stent-like structure expanded and supporting the vascular wall for more than 3 minutes, (g) collapsing the stent-like structure, and (g) removing both the expandable element and the stent-like structure from the blood vessel.

[0104] In some embodiments, the inner shaft may include an energy delivery device. In some embodiments, the energy delivery device may be mounted on the inner shaft adjacent to or within the cavity of the expandable element. In some embodiments, the energy delivery device may not be enclosed within the inner shaft. In some embodiments, the energy delivery device may be a standalone device that can be inserted into the inner shaft during treatment. In some embodiments, the energy delivery device may be inserted coaxially into the inner lumen of the inner shaft of the medical device.

[0105] In some embodiments, the inner and outer shaft walls may have a localized area of ​​the material insert that is capable of transmitting sufficient energy from the inner lumen of the inner shaft to the cavity of the expandable element, thereby generating one or more of the following: (1) evaporating the fluid within the expandable element, and (2) generating sonic pressure waves that are further transmitted through the soft tissue, acting on the calcified components and causing them to break down.

[0106] In some embodiments, the stent-like structure may comprise one or more materials capable of blocking energy transfer from an energy delivery device. In some embodiments, the energy delivery device is an endovascular lithotomy device.

[0107] In some embodiments, the methods disclosed herein may include applying a drug or substance from a drug-coated expandable element or stent-like structure or a scoring element of a stent-like structure.

[0108] In some embodiments, the method may further include removing the expandable element while leaving the stent-like structure expanded. In some embodiments, the method may further include inserting a second expandable element having a different therapeutic modality and expanding the second expandable element within the lumen of the scaffold for a sufficient number of cycles to deliver the therapy. In some embodiments, the method may further include collapsing the second expandable element. In some embodiments, the second expandable element may comprise either a drug delivery balloon or a balloon capable of delivering an energy source to the vascular wall.

[0109] In some embodiments, the stent-like structure includes scoring members. In some embodiments, the stent-like structure includes non-scoring members or support members.

[0110] In some embodiments, the stent-like structure does not include a scoring member.

[0111] In some embodiments, the inflation of the expandable element is gradual and incremental. In some embodiments, inflation may take at least 90 seconds to inflate the expandable element to a target size or a pressure of at least 5 atm. In some embodiments, incremental inflation is performed by a pump capable of gradually increasing the inflation pressure to a desired level, abruptly altering the pressure, and thereby transmitting strain jumps to the vascular wall and components. In some embodiments, the pump may be controlled by a controller.

[0112] In some embodiments, the scaffold comprises an acoustic window without any attenuating material for transmitting acoustic pressure changes to the vascular wall. In some embodiments, the stent-like structure comprises a material capable of blocking the transmission of acoustic pulses to the vascular wall by causing one or more of the following: reflection, scattering, acoustic impedance mismatch, shadowing, and interference to the targeting of acoustic pulses. In some embodiments, the material comprises one or more of the following: metals, polymers, ceramics, composite materials, and hydrogels. In some embodiments, the acoustic window is configured in shape and size to deliver maximum energy deposition through it to the vascular wall. In some embodiments, the relative placement of the blocking components of the acoustic window and stent-like structure is configured to provide an area of ​​maximum energy transfer adjacent to an area of ​​minimum or reduced energy transfer, creating a localized area of ​​energy deposition adjacent to a localized area of ​​energy preservation, and generating structural instability within the tissue affected by the acoustic pulse.

[0113] In some embodiments, the stent-like structure comprises: 1) an open-cell stent pattern that minimizes structural damping components of the stent-like structure and maximizes the undamped open area; 2) a scaffold of material that transmits energy without significant energy attenuation; 3) a scaffold having windows or openings through which energy can be transmitted without attenuation; and 4) a pattern of undamped windows within the stent-like structure oriented to provide maximum energy transmission through it, with intentional damping means within other areas of the stent-like structure. In some embodiments, energy is applied to the vascular wall in a desired pattern that provides both maximum and minimum energy delivery areas within the vascular wall adjacent to the windows and damping components.

[0114] In addition, all methods utilizing a self-expanding, non-expandable stent-like structure configuration may include an additional step of deploying the stent-like structure at a site in the vessel proximal to the target lesion to provide stability and anchoring function, thereby assisting distal navigation of guidewires and other devices through the target lesion and distal vascular tree. In some cases, the target lesion may be stenotic or completely occluded, which can cause difficulties when traversing the target lesion with a guidewire or therapeutic device, thereby creating difficulties regarding lesion access. Stabilization, achieved by temporarily expanding the stent-like structure against the arterial / vascular wall proximal to the target lesion in the compartment to be navigated, can allow for improved pushability of wires and devices through tortuous or stenotic vessels, assisting their passage. In some cases, this additional method may be employed solely to cross the target lesion or stenosis using a guidewire, by temporarily deploying the stent-like structure proximal to the intended target, crossing the lesion using a guidewire, collapsing the self-expanding stent-like structure, advancing the stent-like structure to the target site, deploying the stent-like structure at the target site, and widening the stenosis according to at least one of the methods listed above. Alternatively, after performing the support steps in the above method, another therapeutic device may be inserted through the internal lumen of the stent-like structure while the stent-like structure is deployed in an anchoring configuration. This may include POBA, atherectomy, laser treatment, plaque correction, IVL, or other modalities. After the therapeutic treatment has been administered into the vascular system, the therapeutic device may be removed. The stent-like structure may be collapsed and repositioned within the target lesion for further treatment. An expandable element may be inserted and expand the stent-like structure, as in the above method. The expandable element may be compressed, and the stent-like structure may remain expanded against the vascular wall for a time period of at least 5 minutes. Supplemental energy or an active substance may be administered at some point.When using this additional step, a stent-like structure that either has scoring elements or does not rotate to a scoring position may be desirable because scoring of the vascular wall proximal to the target site may be avoidable when it is detrimental and therefore feasible.

[0115] Furthermore, alternative methods utilizing devices for embolic protection may include positioning a stent-like structure and expandable elements proximal to the lesion, expanding the expandable elements to occlude blood flow, performing therapy at the target site, aspirating any debris released from the therapeutic procedure, and collapsing the expandable elements to restore blood flow.

[0116] Furthermore, additional means and methods may be employed to reduce the integrity of the calcified matrix, making it more compressible for lumen acquisition and more permeable to the delivered drug or substance. While the energy delivery means described herein may be effective, the technology may be expensive and require specialized non-disposable equipment to assist in energy generation and delivery. Other methods and means may be simpler and less expensive and may involve operations that generate longitudinal or rotational micromovements of one or more of the device, expandable elements, guidewires, or scaffolds. The method may be carried out by manual operation or by a mechanism (not shown) attached to the catheter shaft or guidewire. Sustained strain from prolonged dilation is amplified not only by these micromovements but also by a scoring action, and by utilizing the method, microfractures will be generated within the calcified matrix. These methods may be used in conjunction with other methods, including energy delivery.

[0117] Figure 12 demonstrates a programmable controller module 1201 comprising a pump 101 programmed to inflate / deinflate an expandable element at a specified pressure and time. The controller may also comprise means for delivering an additional energy source to the vascular wall, or coordinate with at least a separate energy delivery system. The controller may, in some cases, comprise only means for energy delivery. Inflation of the expandable element may be manual. The programmable controller module 1201 may comprise an external power supply 160 and a computer-based controller 162 via a wire 164. The pump may inflate the expandable element 102, so that the stent-like structure 142 of the device 140 is expanded and can contact the plaque. The device may comprise a guide wire 122 and a shaft 104. The pump can deliver pressure to the expandable element through the shaft 104.

[0118] The controller module may include a programmed balloon inflation pump that gradually and automatically inflates the balloon to at least 4 atm in a series of steps, including gradually and incrementally increasing the overall pressure inside the balloon over a period of at least 90 seconds, preferably over 2 to 3 minutes. The programmable pump may inflate the inflatable element using either incrementally repeating pressure pulses or sustained pressure increases over a time period of at least 90 seconds, preferably at least 2 minutes, to achieve a target pressure of 6 to 7 atmospheres (atm) inside the inflatable element. The method for expanding a lesion may include connecting a selected configuration of the current device to a programmable controller module, programming the controller to inflate the inflatable element to a pressure of 7 atm or less over a period of at least 90 seconds using either sustained inflation or intermittent pressure pulses, inflating the inflatable element within a scaffold, keeping the scaffold expanded for at least 3 minutes, preferably over 8 to 12 minutes, while deflating the inflatable element, and deflating the scaffold. When using a program for pulsed, intermittent increases in pressure, generally, periods of stagnation may exist between pulses, during which there is no overall pressure or pressure pulse increase.

[0119] Furthermore, the controller module may be programmed to provide intermittently variable high-speed pulses of different pressures, including the absence of positive pressure. The modified pressure troughs and peaks, in the form of strain jumps, will induce gradually compressive radial micromotions within the tissue, exposing the calcium matrix to abruptly reduced forces, followed immediately by rebound and a subsequent increase in force above the original baseline, thereby enhancing the localized force scoring components and / or energy delivery.

[0120] By utilizing the action of pressure pulses and scaffolding on the plaque, in addition to gradually increasing pressure, localized force scoring is provided, giving normal tissue an opportunity to adapt to tissue / plaque stretching and plastic deformation over a relatively long period of time of at least several minutes, and the lesion / vascular system will open with lower pressure, less injury, and less rebound.

[0121] Such a programmable balloon inflation pump is an essential part of the system of this disclosure. The pump is connected to a Luer catheter fitting and is configured to pump fluid into the catheter shaft to inflate the balloon and, optionally, to withdraw the fluid from the balloon. It is programmed to gradually and incrementally inflate an angioplasty-type balloon over a period of 1 to 5 minutes, typically 2 to 3 minutes (in this case, it would inflate the covering scaffold). The incremental pressure changes may be linear or nonlinear and sustained or non-sustained and may have intermittent episodes of pressure dips and recoveries, designed to generate strain jumps, as shown in Figure 8B, which reduce the integrity of the calcified matrix and allow for more complete and homogeneous compression of the plaque. A controller module may also be programmed to provide longitudinal or rotational micromovement of the device or scaffold, energy delivery, electrical pulses, and equivalents, which generate strain jumps, thereby dampening the mechanical effects of the expandable element.

[0122] Also requested is a method that uses a pump to inflate an expandable member and gradually expands the temporary stent to the point of full expansion using intermittent pressure changes above 0.1 atm. The motion caused by the rapid change in pressure will be transmitted to the calcified matrix and modified / weakened by the scoring member and scaffold. Therefore, this novel method of inflating the expandable device using strain jump insertion is designed to weaken plaque or structures within the vascular wall that resist compression by conventional methods of balloon expansion and prevent or inhibit optimal lumen acquisition.

[0123] In some cases, manual longitudinal micromovement of the catheter shaft may cause slight micro-longitudinal movement of the expanded scaffold. This would further serve to break up the calcium matrix and provide more complete lumen acquisition. Methods for providing longitudinal micromovement may include positioning the invention at a target site, expanding the covering scaffold, inflating the expandable element, and providing manual longitudinal micromovement of the catheter during inflation, upon completion of inflation using the expandable element and with the scaffold fully expanded, or after the expandable element has collapsed and the scaffold remains expanded against the vascular wall. In some cases, several automated methods for providing longitudinal or rotational movement to the catheter and / or scaffold may be provided.

[0124] In some cases, the controller module may include a generator element that provides an electrical current to a scaffold, which acts on at least some of the smooth muscle cells to prevent them from contracting by inducing apoptosis or controlled cytotoxicity. Applying this current to the lesion may be part of other methods.

[0125] In many embodiments of the present invention, balloon stent assemblies can both perform both the controlled dilation of plaque using a balloon, in contrast to known temporary stents, causing little to no vascular damage, and provide auxiliary energy deposition means in addition to supporting the vascular with a temporary stent over long periods. Known temporary stents are generally intended to support the vascular only after something unexpected has occurred during the procedure, namely rebound, dissection, vasospasm, or vasoconstriction. Some are also designed primarily to facilitate drug delivery to the arterial media. In many embodiments of the present invention, all functions (protection against intimal injury, gradual dilation and long-term support function, scoring, energy or mechanical force delivery, and drug delivery) occur substantially simultaneously, thus preventing dissection, vasospasm, vasoconstriction, and / or rebound by supporting the vascular wall during and immediately after the interventional treatment, which is a significant improvement over prior art devices. In many cases, using the present invention, there is virtually no time when radial force is not applied to the vascular wall, and therefore there is no time when unexpected events occur. Thus, employing multiple effective modes of action virtually simultaneously is simpler, less risky, and less expensive with better results than the typical multi-step procedural strategy of treating with POBA, then a plaque correction device, and then a drug-coated balloon or drug-coated stent. By using a collapsed expandable element and an expanded stent-like structure, the vascular can maintain an open configuration while blood flows through the stent-like structure and distal tissue, preventing ischemia that may occur if the vascular structure is obstructed.

[0126] Also claimed is a method for treating a target site within a vascular channel and removing the device using a single device comprising an expandable element, a removable scaffold that provides prolonged dilation of the vascular channel for more than 3 minutes, a scoring element, and an auxiliary energy delivery means capable of weakening the integrity of the calcified matrix. In some cases, the scoring element may not be present in the device.

[0127] The above description may use terms such as upper, lower, top, bottom, upper side, and lower side. These terms may be used in the description and claims to aid in understanding the present invention and are not intended to be restrictive.

[0128] Preferred embodiments of the present invention are shown and described herein, but it will be apparent to those skilled in the art that such embodiments are provided only as examples. Numerous modifications, alterations, and substitutions will be conjured upon those skilled in the art without departing from the present invention. It should be understood that various alternatives to the embodiments of the present invention described herein may be adopted in practicing the present invention. The following claims define the scope of the present invention, and methods and structures within the scope of these claims, as well as their equivalents, are intended to be covered thereby.

Claims

1. A method for reducing rebound and restenosis at a target site within a blood vessel, (a) advancing a medical device to the target site, wherein the medical device is (i) A stent-like structure comprising a plurality of scoring members and a plurality of non-scoring members, wherein the plurality of non-scoring members is greater than the plurality of scoring members, (ii) An expandable element that can expand the stent-like structure into the wall of a body blood vessel, wherein the plurality of scoring members are configured to score the plaque and / or wall of the blood vessel using localized force and to penetrate into the plaque and / or wall of the blood vessel, (iii) Inner and outer shafts, wherein the distal end of the stent-like structure is attached to the distal end of the inner shaft, and the proximal end of the stent-like structure is attached to the outer shaft, and the expandable element is located within the inner shaft and operably coupled to the inner shaft. Equipped with, The parallel movement of the inner and outer shafts crushes the stent-like structure across the crushed expandable element for removal from the body's blood vessels, (b) By gradually expanding the expandable element, the stent-like structure is pressed against the wall of the blood vessel, thereby expanding the blood vessel, (c) Applying an auxiliary energy source, (d) To compress the expandable element and provide blood flow distally, (e) keeping the stent-like structure expanded and supporting the vascular wall by more than 3 minutes, (f) Crushing the stent-like structure, (g) Removing the expandable element and the stent-like structure Methods that include...

2. The method according to claim 1, wherein the inner shaft comprises an energy delivery device.

3. The method according to claim 2, wherein the energy delivery device is mounted on the inner shaft adjacent to or within the cavity of the expandable element.

4. The method according to claim 2, wherein the energy delivery device is inserted coaxially into the inner lumen of the inner shaft of the medical device.

5. The method according to claim 1, wherein the inner and outer shaft walls are capable of transmitting sufficient energy from the inner lumen of the inner shaft to the cavity of the expandable element, thereby causing one or more of the following: evaporating the fluid within the expandable element; and generating sonic pressure waves that are further transmitted through soft tissue, act on calcified components, and fracture the calcified components.

6. The method according to claim 1, wherein the stent-like structure comprises one or more materials capable of blocking energy transfer from the energy delivery device.

7. A method for reducing rebound and restenosis at a target site within a blood vessel, To provide a self-expanding stent-like structure or scaffold comprising a plurality of scoring members and a plurality of non-scoring members, wherein the stent-like structure comprises more non-scoring members than scoring members, the scaffold is attached only to a proximal delivery shaft member and, when deployed in an expanded configuration, provides a lumen into which expandable members are inserted and positioned, the expandable elements are capable of expanding the stent-like structure against the wall of a body lumen, and the scoring members are configured to score plaque and / or vascular walls using localized force and to penetrate into the plaque and / or vascular walls. By expanding the expandable element, the stent-like structure is pressed against the vascular wall, thereby expanding the body lumen. Applying auxiliary energy, or applying a drug / substance source, or both, which can induce structural instability within the calcified matrix, To compress the expandable element and provide blood flow distally, The stent-like structure is kept expanded and the vascular wall is supported by more than 3 / 4 of it. The stent-like structure is crushed, To remove both the expandable element and the stent-like structure from the blood vessel. A method provided by [the company / organization].

8. The method according to any of the prior claims, wherein the expandable element comprises an energy delivery device.

9. The method according to any one of the preceding claims, wherein the energy delivery device is an endovascular lithotomy device.

10. The method according to any of the preceding claims, comprising applying a drug or substance from a drug-coated expandable element or the stent-like structure or the scoring element of the stent-like structure.

11. The method according to any of the prior claims, further comprising removing the expandable element.

12. The method according to claim 11, further comprising inserting a second expandable element having a different therapeutic modality, and expanding the second expandable element within the lumen of the scaffold for a period of time sufficient to deliver the therapy.

13. The method according to claim 12, further comprising crushing the second expandable element.

14. The method according to claim 11, wherein the second expandable element comprises either a drug delivery balloon or a balloon capable of delivering an energy source to the vascular wall.

15. The method according to any of the preceding claims, wherein the stent-like structure does not include a scoring member.

16. The method according to any of the preceding claims, wherein the expansion of the expandable element is gradual and incremental, taking at least 90 seconds to expand to a target size or a pressure of 5 atm.

17. The method according to claim 16, wherein the gradual expansion is carried out by a pump capable of gradually increasing the expansion pressure to a desired level, abruptly altering the pressure, and thereby transmitting strain jumps to the vascular wall and components.

18. The method according to any of the preceding claims, wherein the scaffolding comprises an acoustic window without any attenuating material for transmitting acoustic pressure changes to the vascular wall.

19. The method according to any of the preceding claims, comprising a material capable of preventing the transmission of the acoustic pulse to the vascular wall by causing one or more of the following: reflection, scattering, acoustic impedance mismatch, shadowing, and interference with the targeting of the acoustic pulse.

20. The method according to claim 19, wherein the material comprises one or more of metals, polymers, ceramics, composite materials, and hydrogels.

21. The method according to claim 18 or 19, wherein the acoustic window is configured in shape and size to deliver the maximum energy deposition through the acoustic window to the vascular wall.

22. The method according to claim 21, wherein the relative placement of the acoustic window and the blocking component of the stent-like structure is configured to provide an area of ​​maximum energy transfer adjacent to an area of ​​minimum or reduced energy transfer, thereby generating a localized area of ​​energy deposition adjacent to a localized area of ​​energy preservation, and generating structural instability within the tissue affected by the acoustic pulse.

23. The method according to any of the preceding claims, wherein the stent-like structure comprises: 1) an open-cell stent pattern that minimizes structural damping components of the stent-like structure and maximizes the undamped open area; 2) a scaffold of material that transmits the energy without significant damping of the energy; 3) a scaffold having windows or openings through which the energy is transmitted without damping; and 4) a pattern of undamped windows within the stent-like structure oriented to provide maximum energy transmission through which it is transmitted, and having intentional damping means within other areas of the stent-like structure.

24. The method according to claim 23, wherein the energy is applied to the vascular wall in a desired pattern that includes both the maximum and minimum energy delivery areas within the vascular wall adjacent to the window and the attenuation component.

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