Electrolytic reshaping of chronic clots

Abstract

The present disclosure relates generally to the use of medical instruments for treating chronic venous disease and collagenous scar tissue. In particular, the present disclosure provides methods and systems for remodeling collagen obstructions using energy and expandable catheters.

Description

[0001] Cross Reference to Related Applications

[0002] None. TECHNICAL FIELD

[0003] The present disclosure relates generally to the use of medical devices for the treatment of chronic venous disease and collagenous scar tissue. In particular, the present disclosure provides methods and systems for remodeling collagen obstructions using energy and expandable catheters. BACKGROUND

[0004] Chronic venous disease is a condition in which clots form and remain in the venous circulation system, particularly in the lower extremities, such as the lower part of the leg below the knee. In a healthy person, young clots in arteries or veins, also known as venous thrombi, are primarily composed of fibrin and typically resolve via natural solubilizers in the circulatory system and normal physical activity. However, the longer the clot persists, the more likely it is to cause harm, particularly in the case where it develops into an embolus and travels through the bloodstream or becomes a chronic clot and wedges into the vein like a scar. When a clot persists for more than about 30 days, its composition changes from primarily fibrin, which can be dissolved via natural solubilizers, to cross-linked collagen. Cross-linked collagen is rubbery, elastic, and tenacious, and chronic clots can strongly attach to the vein wall via tendrils called adhesions. Once formed, chronic clots greatly reduce venous blood flow, causing significant negative symptoms. Conventional intervention techniques, such as angioplasty balloon dilation, debulking, and stent placement, are ineffective in the treatment of cross-linked collagen in chronic clots, as it is difficult to remove the clot without damaging the vein wall to which it is attached.

[0005] Cross-linked collagen is also formed as part of the accumulation of venous scar tissue that hinders inferior vena cava (IVC) filter removal. In such treatments, an IVC filter is a device placed within the inferior vena cava, a vein that carries blood from the lower extremities back to the heart. When chronic collagen clots in the veins of the legs and pelvis do become detached from the vein wall and travel to the lungs, they cause pulmonary embolism or blockage. IVC filters are implanted to help reduce the risk of pulmonary embolism by capturing large collagen clots and preventing them from reaching the heart and lungs. However, at the point where the IVC filter contacts the vein wall, collagen clot scar tissue accumulates, making it difficult and even impossible to remove the IVC filter without damaging the vein wall to which they are attached.

[0006] Cross-linked collagen also forms part of the accumulation of venous scar tissue that hinders pacemaker and / or implantable cardioverter-defibrillator (ICD) removal. In such treatments, a pacemaker or ICD is implanted into a patient and leads are attached to the patient's heart. These leads deliver electrical shocks from a pulse generator directly to the heart when needed. However, when the leads need to be removed, the collagen clot-based scar tissue that has accumulated around the leads makes it difficult, if not impossible, to remove the ICD without damaging the vein walls to which they are attached. The inability to remove the leads percutaneously can result in the need for surgery.

[0007] It would be desirable to make improvements to one or more aspects of the foregoing. SUMMARY

[0008] Chronic clots and collagenous scar tissue are tough and resilient obstructions found in the vasculature. The physical size and properties of these tissues resist routine efforts to remove them and / or effectively open the lumen within their structure without disturbing the surrounding vein. Attempts to place a stent over a chronic clot often result in in-stent thrombosis (IST) or re-occlusion. Conventional techniques have not been widely explored and doing so can be costly. Surgical removal of chronic clots can be damaging to surrounding tissue and still result in vascular scarring.

[0009] Methods and systems according to the present disclosure generally involve remodeling collagenous obstructions using energy and an expandable catheter. In contrast to using conventional techniques, these methods result in reduced complications, faster obstruction removal, and shorter recovery times. These and other advantages will be apparent from the disclosure of aspects, examples, and configurations contained herein.

[0010] The present disclosure provides a method for treating a collagenous obstruction within a vasculature of a subject, the method comprising: introducing a catheter into the vasculature of the subject, the catheter comprising an expandable member and an electrically conductive element proximal to the expandable member; positioning the catheter proximal to the collagenous obstruction within the vasculature of the subject; supplying energy to the electrically conductive element, whereby the energy reacts with water within the vasculature of the subject and generates hydrogen ions that at least partially disrupt cross-links within the collagenous obstruction; and expanding the expandable member as the cross-links are disrupted. In some aspects, the method further comprises inserting a guidewire through the collagenous obstruction.

[0011] In some examples of the method, the collagenous obstruction is a chronic clot or venous scar tissue.

[0012] In some examples of the method, the expandable member is a balloon catheter. In other examples, the expandable member is an expandable sheath.

[0013] In some examples of the method, supplying the energy occurs prior to expanding the expandable member. In other examples of the method, supplying the energy occurs concurrently with expanding the expandable member. In some examples of the method, supplying the energy occurs over a predetermined time interval. In some examples of the method, the energy is an electrical current or ultrasound waves.

[0014] The present disclosure also provides a system for treating a collagen obstruction within a vasculature of a subject, the system comprising a catheter comprising: an expandable member and an electrically conductive element proximal to the expandable member; a generator coupled to the electrically conductive element; a control unit coupled to the generator and / or the electrically conductive element and the catheter, wherein the control unit is configured to supply energy to the electrically conductive element and cause expansion or contraction of the expandable member, wherein the control unit comprises a non-transitory computer readable medium containing instructions that, when executed, cause one or more processors to provide 5-20 volts over a period of 1-5 minutes.

[0015] In some examples of the system, the expandable member is a balloon catheter. In some examples of the system, the expandable member is an expandable sheath.

[0016] In some examples, the system further comprises an inflation source coupled to the control unit, wherein the control unit comprises a non-transitory computer readable medium containing instructions that, when executed, cause one or more processors to cause the generator to supply energy to the electrically conductive element prior to instructing the inflation source to expand the expandable member.

[0017] In some examples of the system, the non-transitory computer readable medium contains instructions that, when executed, cause one or more processors to cause the generator to supply energy to the electrically conductive element concurrently with instructing the inflation source to expand the expandable member.

[0018] In some examples, the system further comprises an inflation source coupled to the control unit, wherein the control unit comprises a non-transitory computer readable medium containing instructions that, when executed, cause one or more processors to cause the generator to supply energy to the electrically conductive element concurrently with instructing the inflation source to expand the expandable member.

[0019] The foregoing is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither extensive nor exhaustive of the disclosure and its various aspects, examples, and configurations. It is intended to neither identify key or essential elements of the disclosure nor delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, examples, and configurations of the disclosure can utilize one or more of the features set forth above or in the detailed description below in separate or combinable ways. BRIEF DESCRIPTION OF DRAWINGS

[0020] The accompanying drawings are incorporated into the specification and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the present disclosure. The drawings simply illustrate preferred and alternative examples of how the present disclosure can be made and used, and should not be construed as limiting the present disclosure to only the illustrated and described examples. Additional features and advantages will be apparent to those skilled in the art from the following detailed description of various aspects, examples, and configurations of the present disclosure, as illustrated in the drawings.

[0021] Figures 1A-1C is a schematic view of collagen: Figure 1A depicts a collagen molecule; Figure 1B depicts a collagen fibril; Figure 1C depicts a collagen fiber; and Figure 1D is a photographic representation of cross-linked collagen clots in the vasculature;

[0022] Figure 2 is a flowchart of a method for treating collagen obstructions according to examples of the present disclosure;

[0023] Figures 3A-3C is a schematic view of a balloon system used according to examples of the present disclosure;

[0024] Figure 4 is a schematic view of an expandable catheter according to examples of the present disclosure; and

[0025] Figure 5 is a schematic view of a system for treating collagen obstructions according to embodiments of the present disclosure. DETAILED DESCRIPTION

[0026] Methods and systems according to the present disclosure generally relate to treating collagen obstructions by remodeling collagen clots or scar tissue using energy and an expandable catheter.

[0027] As used herein, “at least one,” “one or more,” and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together. When each of the above expressions is recited where A, B, and C refer to elements, such as X, Y, and Z, or classes of elements such as X1-Xn, Y1-Ym, and Z1-Zp, then the elements or classes of elements are to be taken individually for each occurrence of the expression. For example, if each of A, B, and C refers to elements, then “at least one of A, B, and C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together. n , Y1-Y m , and Z1-Z o) is intended to mean a single element from X, Y, and Z, a combination of elements from the same class (e.g., X1 and X2) and a combination of elements from two or more classes (e.g., Y1 and Z o

[0028] It should be noted that the terms "a" or "an" entity refer to one or more of that entity. As such, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. It is also to be noted that the terms "comprising", "comprise" and "including" can be used interchangeably.

[0029] The terms "vasculature" and "vessel" as used herein refer to any part of the circulatory system of a subject, including peripheral and non-peripheral arteries and veins. Vessel material found within the vasculature can consist of both biological materials (e.g., nucleic acids, amino acids, carbohydrates, polysaccharides, lipids, etc.) and non-biological materials (e.g., fatty deposits, fibrous tissue, calcium deposits, remnants of dead cells, cellular debris, etc.).

[0030] A "catheter" is a tube that can be inserted into a body lumen, duct, lumen, or vessel, such as the vasculature. In most uses, a catheter is a relatively thin, flexible tube ("soft" catheter), but in some uses it can be a larger, less solidly flexible - but possibly still flexible - catheter ("hard" catheter).

[0031] The term "balloon catheter" as used herein generally refers to various types of angioplasty catheters that carry a balloon for performing angioplasty. Balloon catheters can also have a wide variety of internal structures, such as different lumen designs, with at least three basic types: triple lumen, dual lumen, and coaxial lumen. By use of the term "balloon catheter" herein is meant to include all of the various internal structures and design variations.

[0032] The term "electrically conductive" as used herein generally refers to a material that has a measurable level of electrical conductivity or the ability to support the movement of charged particles.

[0033] It should be understood that every maximum numerical limitation given throughout this disclosure is deemed to include each and every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is deemed to include each and every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is deemed to include each and every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0034] ​Chronic venous disease is a condition in which clots form in the venous circulatory system, particularly in the lower extremities. Chronic clots, as used herein, refer to clots that exist within the vasculature for a prolonged period of time (greater than about 30 days). Chronic clots, like acute clots, can cause occlusion of a blood vessel or thrombosis. In some cases, a subject with a chronic clot, such as a deep vein thrombosis (DVT), can harbor a clot that has been re-cannulated, allowing blood flow through the vein. Chronic clots are primarily formed of collagen fibers.

[0035] Collagen is the major structural protein in the extracellular matrix of various connective tissues and forms the basic structure of blood vessels. It is also a major component of wound healing. Referring now to Figures 1A-1D , in particular Figure 1A , a collagen molecule 105 is structurally formed of a triple helix of amino acids 110. The collagen molecule 105 is arranged such that the triple helix 110 is connected via a series of intramolecular crosslinks 135, three helices 110 generating a single collagen molecule 105. As Figure 1B depicted, multiple collagen molecules 105 can be arranged together to form elongate collagen fibrils 120. In some configurations, the collagen molecules 105 are bound together via intermolecular crosslinks 130. As Figure 1C depicted, multiple collagen fibrils 120 can be arranged together to form elongate collagen fibers 140. In some instances, the collagen fibrils 120 are bound together via intermolecular crosslinks 130. These crosslinks 130 can take the form of ionic bonds, covalent bonds, disulfide bonds, and / or isopeptide bonds. The crosslinks increase the stiffness of the collagen fibrils 120 and collagen fibers 140, and any resulting collagen clot. As Figure 1D depicted, the crosslinked collagen can form a collagen clot 160 within a peripheral vein of a vasculature 150. The collagen clot 160 can be attached to the vasculature 150 via an adhesion 165.

[0036] While the physicochemical properties of collagen can be influenced by - among other factors - temperature, pH, salinity, and collagen concentration, generally at near neutral or neutral pH (e.g., pH 6-8), collagen molecules 105 self-assemble into collagen fibrils 120, which themselves self-assemble into collagen fibers 140 via a series of intramolecular crosslinks 135 and intermolecular crosslinks 130 Figure 1A → Figure 1B → Figure 1C However at acidic pH (e.g., pH < 6), these collagen crosslinks 130 are disrupted by hydrogen ions, causing a breakdown Figure 1C → Figure 1B → Figure 1A from collagen fibers 140 to collagen fibrils 120 to collagen molecules 105. Such acidic pH values can be generated in tissue via electrolysis of water, as detailed below.

[0037] The five most common types of collagen in the human body are called type I, type II, type III, type IV, and type V collagen. These groups are classified according to the structures they form, although all types of collagen contain at least one triple helix. Water is a component of collagen and contributes up to 60% of its composition (by weight). Collagen can attach to other types of collagen molecules, such as collagen fibers, clots, and scar tissue, during the formation of collagen fibers, clots, and scar tissue. Figure 1C The described proteins, as well as other proteins, including but not limited to fibrin, glycoproteins, and / or proteoglycans, are involved. Collagen blockages can attach to the vein wall via adhesion and / or fibronectin, laminin, fibrin, and / or integrin molecules.

[0038] This disclosure provides methods and systems for the minimally invasive interventional treatment of collagen blockages, including collagen clots or scar tissue. The method typically involves using a conductive element within a catheter to target and deliver a controlled amount of hydrogen ions to the collagen blockage. The generation of a high local concentration of hydrogen ions within the collagen at the surface of the inserted electrode minimizes the exposure of this acidic environment to the rest of the vascular system or local anatomy. Such a high local concentration of hydrogen ions can generate a pH range of 2–4. The rubbery, tough structure of the collagen blockage softens upon interaction with the hydrogen ions, ultimately disrupting collagen cross-links and leaving more ductile, partially or completely uncross-linked collagen fibers and / or fibrils. The softened tissue can then be physically remodeled using an expandable catheter (in the case of clots), or the IVC filter or pacemaker / ICD lead can be completely removed (in the case of scar tissue). Remodeling or removal results in the reopening of the lumen of the vein.

[0039] Once the conductive element stops supplying energy, hydrogen ions are no longer delivered to the treatment site, and the natural buffering capacity within the vascular system causes the collagen and surrounding tissue to return to a normal, balanced pH level. After the remaining collagen returns to a normal pH level, it will reassemble into cross-links and become rubbery and elastic, but in a remodeled structure rather than as a blockage.

[0040] refer to Figure 2 The flowcharts in this disclosure, along with specific materials and methods, include the use of energy and expandable catheters to remodel collagen clots and / or collagen scar tissue. This disclosure includes method 200 for treating an object with vascular collagen obstructions using examples of the catheters described herein. Although it is not described in detail... Figure 2 The diagram in the middle shows that, however, it is expected that during execution... Figure 2 The method described herein previously used plaque resection devices, such as ablation devices, including laser catheters, to ablate at least a portion of the vascular collagen blockage in the target vessel, and / or during the execution of Figure 2The laser catheter is used before, during, and / or after any of the steps set forth in the method to ablate at least a portion of the vascular collagen occlusion in the blood vessel.

[0041] Figure 2 The method 200 in includes a step 210 of locating a vascular collagen occlusion in a blood vessel of a subject 210. The method 200 can optionally include a step 215 of inserting a guidewire through the collagen occlusion. The next step 220 includes positioning a catheter on the guidewire and adjacent to the vascular collagen occlusion. As will be discussed in greater detail below, the catheter will include an expandable member and a conductive element. The method 200 next includes a step 230 of supplying energy to the conductive element coupled to the catheter to disrupt at least a portion of the cross-linking within the vascular collagen occlusion 230. It can be desirable for the conductive element to generate 5-20 volts of electrical power over a period of 5 minutes. For example, the voltage can be 5 volts, 6 volts, 7 volts, or 20 volts. For example, the cumulative time period over which the electrical energy is applied can be about 1 minute, 2 minutes, 3 minutes, 4 minutes, or 5 minutes. In other words, the electrical energy can be applied continuously over a 1 to 5 minute time window, or the electrical energy can be applied over a series of smaller time windows that cumulatively add up to a 1-5 minute period. For example, the electrical energy can be applied over a cumulative period of 1-5 minutes in sub-intervals of 30 seconds, 1 minute, 90 seconds, 2 minutes, or 180 seconds. Supplying this amount of electrical power over this time period reduces the pH of the collagen to a pH level below 6, and in some cases to about pH 2 to pH 4. The amount of electrical power applied to the tissue and the duration depends on the depth of penetration of the local concentration of hydrogen ions into the tissue, and in some examples, the hydrogen ions can be located 1 mm from the anode. Once the desired pH is obtained, it is desirable to maintain the reduced pH level for a particular period of time. Thus, the cumulative time period(s) discussed above achieves this goal.

[0042] The method 200 also includes a next step 240 that includes expanding the expandable member of the catheter. After completing steps 230 and / or 240, the catheter can optionally be repositioned within the vasculature. After completing step 240, step 230 can optionally be repeated. When the desired therapeutic result is obtained, the method 200 can end at step 250, or repeat any of 210-240 as can be necessary to treat the subject having a vascular collagen occlusion.

[0043] In some examples, the supplying of energy in step 230 occurs prior to the expanding of the expandable member of the catheter in step 240. In other examples, the supplying of energy in step 230 occurs simultaneously with the expanding of the expandable member of the catheter in step 240. In such examples, the amount of electrical power supplied can be variable or can be constant such that the pH of the collagen is reduced to and / or maintained at pH < 6.

[0044] In some examples, the disclosed method 200 can be used to deliver a controlled amount of hydrogen ions to a collagen obstruction located within the peripheral vasculature. For example, the disclosed method can be applied to any blood vessel having a chronic clot, a compressive disease, an IST, or an implant with undesirable scar tissue buildup. For example, the collagen obstruction can be located in a vein of the leg, foot, arm, or hand. In other specific examples, the disclosed method can be used to deliver a controlled amount of hydrogen ions to scar tissue on an IVC filter to allow easier / less forceful removal of the IVC filter. In other examples, the disclosed method can be used to deliver a controlled amount of hydrogen ions to scar tissue on a pacemaker / ICD lead to allow easier / less forceful removal of the pacemaker / ICD lead.

[0045] In some examples, the disclosed method includes positioning a vasculature collagen obstruction in a subject and percutaneously positioning a conductive element adjacent to the collagen obstruction using a technique similar to angioplasty. In some examples, the disclosed method includes using venography and / or ultrasound.

[0046] In some examples, the conductive element can have a first electrode, a second electrode, and an insulating layer between the first electrode and the second electrode. The electrodes can be made of a material capable of withstanding the high voltage levels and intense mechanical forces generated during use (e.g., approximately 1000-2000 psi or 20-200 ATM in a few microseconds). For example, the electrodes can be made of stainless steel, tungsten, nickel, iron, steel, etc. The insulating layer can be made of any material with a high breakdown voltage, such as Kapton, ceramic, polyimide, or Teflon.

[0047] In some examples, the conductive element can be an ultrasound-activated wire guide designed to provide a passageway within the collagenous obstruction. In some examples, a current return electrode can be located on the skin or at some internal site. Alternatively, the negative (-) of the system can involve the uninsulated portion of the working guide wire or the exposed portion of the conductive procedure sheath / guide.

[0048] In some examples, electrical energy can be supplied to the conductive element. For example, a DC current can be used. In some aspects, the DC current can interact with water present in the collagen and generate hydrogen ions (also known as protons or denoted as H+ herein) via anodic electrolysis at the surface of the conductive element via the following reaction: H2O→ O2+ 4H + + 4e -In other examples, AC current can be used. In some examples, the electrical energy can be precisely controlled by the amount of current applied from a constant current device. For example, the constant current device can be an IOMED Phoresor DC power supply. In other examples, the dose of hydrogen ions can be precisely controlled by the amount of current applied from a variable current device.

[0049] In some examples, after the expandable member is expanded 240, the method can further include the optional step of reversing the polarity of the current, such that the current produces hydroxyl ions, which will neutralize the previously produced hydrogen ions to form water and restore collagen cross-linking. In some examples, this restoration of cross-linking can accelerate or otherwise enhance the reformation of remodeled collagen.

[0050] In some examples, after the procedure is ended 250, a stent or other physical device can be used to provide additional radial strength to the remodeled collagen. For example, certain compressed anatomic regions or disease profiles can benefit from such a device, including but not limited to May-Thurner syndrome.

[0051] In some examples, the conductive element can be supplied with ultrasonic energy. For example, the pressure waves of ultrasound can be used as the energy source in step 230. In other examples, the pressure waves of ultrasound can be used concurrently with the electrical energy in step 230, such that the ultrasonic energy is used to drive the H+ ions deeper into the clot. This can increase the effectiveness of the method 200, as the pressure waves destroy the luminal as well as the inner (tissue layers of the vessel wall) vessel obstruction (e.g., calcium deposits), thereby creating a path for the energy to enter the collagen and break the cross-linking. In some aspects, high frequency ultrasound can further relax the collagen through its mechanical destruction. In some aspects, the electrolysis of water at the surface combined with the ultrasonic vibrations can help distribute / diffuse the hydrogen ions into the collagen, thereby more fully enhancing the effect.

[0052] In some examples, the energy can be applied for a predetermined period of time. In some examples, the energy can be applied in intermittent periods. For example, the energy can be pulsed on and off in pulses lasting approximately 1 second, with cumulative times not exceeding a few minutes. For example, the energy can be applied for one or more periods lasting between 30 seconds and 10 minutes. In some aspects, the energy is applied for a cumulative time of at least about 1 minute, 2 minutes, 3 minutes, 4 minutes, 5 minutes, 6 minutes, 7 minutes, 8 minutes, 9 minutes, or 10 minutes.

[0053] The energy can be applied at a predetermined rate. For example, the energy can be a voltage or a current, and can be applied at a low level. The energy can be applied at any value between 5-20 volts. Alternatively, in some examples, the energy can be applied at any voltage greater than the minimum voltage required to electrolyze water (~1.23V), depending on temperature and impurities in the water.

[0054] In some examples, the expandable member can be integrally formed with the electrically conductive element, such that the expandable member itself is electrically charged and / or capable of delivering energy, and serves as an anode in the production of hydrogen ions into the collagen obstruction. Use of such a device can allow for increased wall apposition by allowing the expandable member to intrude or sink into the collagen obstruction.

[0055] In other examples, the expandable member can physically press an electrically conductive element or another electrically conductive material against another electrically conductive material that has already come into contact with the collagen obstruction. In such examples, the disclosed methods can be used to induce an electrical potential between the electrically conductive material that has already come into contact with the collagen obstruction and another electrode (either inside or outside the vessel) to drive the production of hydrogen ions into the collagen obstruction. For example, the electrically conductive material that has already come into contact with the collagen obstruction can be a stent. In other examples, the electrically conductive material that has already come into contact with the collagen obstruction can have undesirable scarring tissue buildup. For example, the electrically conductive material can be an IVC filter, a pacemaker / ICD lead, etc.

[0056] Several non-limiting examples of expandable members of the present disclosure are further described in FIGS. 3-4.

[0057] In some examples, the expandable member can be a balloon catheter. Referring now to Figures 3A-3C The balloon catheter 300 of the present disclosure includes a shaft 305 coupled to an inflatable balloon 310 and, optionally, an expandable shell or cage 315. The inflatable balloon 310 is located at the distal end of the catheter shaft 305 and is configured to receive inflation media from an inflation lumen in the shaft 305. In this way, the balloon 310 can be alternated from a collapsed or non-inflated configuration (as shown in Figure 3A ) to a fully inflated configuration (as shown in Figure 3B ). The expandable cage 315 can be disposed circumferentially around the exterior of the inflatable balloon 310, such that the expandable cage 315 expands when the balloon 310 is inflated, as shown in Figure 3B , and self-closes over the balloon, as shown in the collapsed configuration of Figure 3A The expandable cage 315 is typically formed of a highly elastic metal, such as stainless steel, tantalum, platinum, cobalt-chromium alloy, elgiloy alloy, or nitinol alloy, and can typically be formed by laser cutting of hypotube.

[0058] Balloon catheter 300 also includes an electrically conductive element 370, which is or is coupled to expandable cage 315. The elongate tubular body of balloon catheter 300 defines an internal lumen 308, which can be configured and dimensioned to contain electrically conductive element 370 and, in some examples, guidewire 310. At its proximal end and / or the proximal end of catheter 300, electrically conductive element 370 can be coupled to a power generator 530 and / or control unit 575, which is used to supply energy to break at least portions of crosslinks within collagen obstructions. In some examples, balloon catheter 300 is not inflated during positioning of the catheter in the vasculature, and can thereafter be expanded to a partially or fully inflated capacity, such that it expands to a functional diameter. In the functional diameter, it can achieve the desired therapeutic effect of physically remodeling collagen while breaking collagen crosslinks.

[0059] In some examples, balloon catheter 300 can be expanded by inflating balloon 310 with a liquid medium. For example, balloon 310 can be inflated with a liquid medium to a pressure of greater than 0 atmospheres to about 20.0 atmospheres. Different degrees of force can be used or required to remodel different sizes of collagen obstructions at different locations within the vasculature. Based on the present disclosure, one of ordinary skill in the art will appreciate the degree of force required to remodel each collagen obstruction or each collagen obstruction after breaking crosslinks. Use of an expanding balloon catheter at low pressures can reduce the potential for damaging healthy vasculature tissue during a procedure, and can facilitate treatment of a greater range and type of vascular obstructions.

[0060] In some examples, balloon catheter 300 can be made of an electrically insulating material, which can be rigid (e.g., PET, etc.), semi-rigid (e.g., PBAX, nylon, PEBA, polyethylene, etc.), or flexible (e.g., polyurethane, silicone, etc.).

[0061] In some examples, the expandable member can be an expandable catheter. Referring now to Figure 4 , Figure 4 One embodiment of a catheter 400 used in the disclosed systems and methods is illustrated. In Figure 4In some examples, the expandable catheter can be expanded at a pressure greater than 0 atmospheres to about 20.0 atmospheres. Different degrees of force can be used or required to remodel different sized collagen obstructions at different locations within the vasculature. Based on the present disclosure, one of ordinary skill in the art will appreciate the degree of force required to remodel each particular collagen obstruction or each particular collagen obstruction after the cross-linking is disrupted.

[0062] In some examples, the expandable catheter can be expanded at a pressure greater than 0 atmospheres to about 20.0 atmospheres. Different degrees of force can be used or required to remodel different sized collagen obstructions at different locations within the vasculature. Based on the present disclosure, one of ordinary skill in the art will appreciate the degree of force required to remodel each particular collagen obstruction or each particular collagen obstruction after the cross-linking is disrupted.

[0063] Referring now to Figure 5 The methods disclosed herein can be used as part of a catheter system 500 for treating collagen obstructions in a subject 510. The catheter system 500 includes a catheter 520 coupled to a generator 530 controlled by a control unit 575. The generator 530 and / or control unit 575 include controls to allow an operator to position a collagen obstruction in the subject 510 and adjust the position of the catheter 520 within the subject 510. The generator 530 and / or control unit 575 include controls to allow an operator to adjust the voltage, the amplitude of the current, the duration of the voltage, and thereby the duration and flow of hydrogen ions. The generator 530 and / or control unit 575 also include controls to allow an operator to adjust the expansion and contraction of the expandable member.

[0064] The control unit 575 can be internal or external to the generator 530, which can generate electrical pulses and / or charges. The control unit 575 can include one or more computing devices programmed to control the generator 530. The generator 530 and / or the control unit 575 can include a non-transitory computer-readable medium (e.g., memory) containing instructions that, when executed, cause one or more processors to control the generator 530 and / or other components of the catheter system 500. For example, the non-transitory computer-readable medium should include instructions instructing the generator 530 to apply electrical power having a selected voltage to the conductive elements 370, 470 for the interval time window and / or the cumulative and / or continuous period of time discussed above. The control unit 575 can also be logically coupled to an inflation source (not shown) to inflate the expandable member. If so, the non-transitory computer-readable medium can also include instructions for instructing the generator 530 to apply electrical power to the conductive elements 370, 470 before, during, and / or after the control unit 575 instructs the inflation source to inflate or expand the expandable member.

[0065] The control unit 575 can include one or more input devices to receive input from an operator. For example, the input devices include keys, buttons, touchscreens, dials, switches, mice, and trackballs, which can provide user control of the control unit 575. The control unit 575 can also include one or more output devices to provide feedback or information to an operator. For example, the output devices include displays, lights, audio devices, which can provide user feedback or information.

[0066] The present disclosure includes, in various aspects, examples, and configurations, components, methods, processes, systems, and / or apparatuses substantially as herein described and depicted, including various aspects, examples, configurations, subcombinations, and subsets thereof. Those skilled in the art will understand how to make and use various aspects, aspects, examples, and configurations after understanding the present disclosure. The present disclosure includes, in various aspects, examples, and configurations, providing apparatuses and processes without items not depicted and / or described herein or in various aspects, examples, and configurations herein, including without such items as can have been used in previous apparatuses or processes, for example, to improve performance, to enable ease of use, and / or to reduce implementation costs.

[0067] Moreover, although the description of the present disclosure has included description of one or more aspects, examples, or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the present disclosure, e.g., as can be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, examples, and configurations to the full extent of the allowed range, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are expressly disclosed herein, and without intending to publicly dedicate any patentable subject matter.

Claims

1. A system for treating collagen blockages within the vascular system of a subject, the system comprising: A catheter comprising an expandable member and a conductive element adjacent to the expandable member, wherein the conductive element of the catheter is configured to be positioned adjacent to the collagen blockage within the vascular system of the object; A generator coupled to the conductive element; and A control unit coupled to the generator, wherein the control unit is configured to control the energy supply from the generator to the conductive element, whereby the energy reacts with water within the vascular system of the object to generate hydrogen ions that disrupt at least a portion of the cross-linked structures within the collagen blockage. The control unit includes a non-transient computer-readable medium containing instructions that, when executed, cause one or more processors to supply 5-20 volts to the conductive element over a period of 1-5 minutes.

2. The system according to claim 1, wherein, The expandable component is a balloon catheter.

3. The system according to claim 1, wherein, The expandable component is an expandable sheath.

4. The system of claim 1, further comprising an expansion source coupled to the control unit, wherein, The control unit includes a non-transient computer-readable medium containing instructions that, when executed, cause one or more processors to supply energy to the conductive element from the generator before instructing the expansion source to expand the expandable member.

5. The system according to claim 4, wherein, The non-transient computer-readable medium contains instructions that, when executed, cause one or more processors to instruct the expansion source to expand the expandable member while simultaneously causing the generator to supply energy to the conductive element.

6. The system of claim 1, further comprising an expansion source coupled to the control unit, wherein, The control unit includes a non-transient computer-readable medium containing instructions that, when executed, cause one or more processors to instruct the expansion source to expand the expandable member while simultaneously causing the generator to supply energy to the conductive element.

Images