System for treating a patient

Abstract

A method and a system for performing a medical procedure including a scaffold for implanting in a hollow structure of a mammalian patient. The system includes a delivery device configured to deliver the scaffold to an implant location within the hollow structure. The scaffold, or one or more portions of scaffold, can be configured to bioabsorb, biodegrade, and / or otherwise decompose after implantation in a patient. The bioabsorption can occur over a period of time, such as a predetermined time period.

Description

[0001] SYSTEM FOR TREATING A PATIENT

[0002] DESCRIPTION

[0003] Related Applications

[0004]

[0001] This application claims benefit of United States Provisional Application Serial Number 63 / 503,729 (Docket No. STL-001-PR1), titled “System for Treating a Patient”, filed May 23, 2023, the content of which is incorporated by reference in its entirety for all purposes.

[0005] FIELD OF THE PRESENT INVENTIVE CONCEPTS

[0006]

[0002] The present invention relates generally to medical systems, and in particular, systems for treating a hollow structure of a patient.

[0007] BACKGROUND

[0008]

[0003] Numerous surgical, laparoscopic, interventional, and other products are used to perform a medical procedure on a mammalian patient. There is a need for improved systems, devices, and methods to perform these procedures.

[0009] BRIEF SUMMARY

[0010]

[0004] According to an aspect of the present inventive concepts, a system for treating a hollow structure of a patient comprises: a scaffold for implanting in a hollow structure of the patient; and a delivery device configured to deliver the scaffold to an implant location within the hollow structure.

[0011]

[0005] In some embodiments, the scaffold is configured to bioabsorb over a time period. The scaffold can be configured to be effectively bioabsorbed within a time period of no more than: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year. The scaffold can be configured to remain effectively in place for a time period of at least: 1 hour;

[0012] 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year, after which the scaffold is configured to be effectively bioabsorbed.

[0013]

[0006] In some embodiments, the scaffold comprises a first portion that is configured to bioabsorb over a time period, and a second portion that is configured to not bioabsorb.

[0007] In some embodiments, the scaffold comprises a first portion that is configured to bioabsorb over a time period and at a first bioabsorption rate, and a second portion that is configured to bioabsorb over a time period and at a second bioabsorption rate, and the second bioabsorption rate is greater than the first bioabsorption rate.

[0014]

[0008] In some embodiments, the system is configured to provide a temporary scaffolding force to the hollow structure at the implant location. The hollow structure can comprise an artery or a vein, and the system can be configured to provide the temporary scaffolding force to a luminal wall portion of the artery or vein, such as to maintain patency and / or to provide a healing effect. The implant location can comprise a segment of a vein including one or more venous valves. The one or more venous valves can have been previously disrupted and / or otherwise previously treated. The implant location can comprise a vein segment that is in one or more of the following conditions: spasm; tom; disrupted; perforated; and / or damaged. The system can be configured to reduce the likelihood of a stricture at or otherwise proximate the implant location. The stricture can comprise a stricture that might occur due to a subsequent clinical procedure. The subsequent clinical procedure can comprise a procedure performed at, or proximate, the implant location.

[0015]

[0009] In some embodiments, the system is configured to provide at least temporary incompetence of one or more venous valves located at the implant location. The one or more venous valves can comprise at least one venous valve that has been previously disrupted and / or otherwise treated. The system can be configured to provide chronic incompetence of one of the one or more venous valves located at the implant location. The chronic incompetence can comprise incompetence of the one or more venous valves for at least 1 month, 3 months, and / or 6 months.

[0016]

[0010] In some embodiments, the hollow structure comprises a blood vessel. The blood vessel can have been previously treated at a previous treatment location that is at and / or at least proximate the implant location of the scaffold. The previous treatment can comprise a treatment selected from the group consisting of: treatment with a cutting balloon; treatment with a cutting sheath; treatment with an atherectomy device; treatment with a lithotripsy device; treatment with a cryoplasty balloon; treatment that achieves a lumen improvement; treatment that does not achieve a lumen improvement; treatment of vascular calcification; and / or combinations thereof. The blood vessel can comprise a vein. The blood vessel can comprise an artery. [Oi l] In some embodiments, the hollow structure comprises a hollow body organ. The hollow body organ can be treated at a location proximate to the implant location of the scaffold, and the scaffold can be configured to provide a scaffolding force for a limited time period, and the scaffolding force, and / or the scaffold itself, can be configured to support and / or promote healing of the hollow body organ. The hollow body organ can comprise a tear duct. The hollow body organ can comprise an eustachian tube. The hollow body organ can comprise a fallopian tube. The hollow body organ can comprise a biliary structure. The biliary structure can comprise an intra and / or extrahepatic duct structure. The hollow body organ can comprise a urinary structure. The urinary structure can comprise the ureter, urethra, and / or intra prostatic urethra. The hollow body organ can comprise a gastrointestinal structure. The gastrointestinal structure can comprise the esophagus, stomach, small intestine, large intestine, and / or colon. The hollow body organ can comprise a structure of the pulmonary system, such as the bronchus.

[0017]

[0012] In some embodiments, the hollow structure comprises an aneurysm. The scaffold can be configured for placement across a neck of the aneurysm, and the scaffold can be configured to bioabsorb over a time period. The system can further comprise an embolic coil, an embolic fluid, and / or other embolic component configured to be placed within the aneurysm.

[0018]

[0013] In some embodiments, the hollow structure comprises a diseased and / or damaged hollow structure. The diseased and / or damaged hollow structure can comprise a focal tissue issue. The focal tissue issue can comprise a bum, ischemia, laceration, tissue disruption, and / or tumor. The diseased and / or damaged hollow structure can comprise a perforation of the hollow structure. The diseased and / or damaged hollow structure can comprise at least a partial transection of the hollow structure. The at least a partial transection can comprise a full transection.

[0019]

[0014] In some embodiments, the hollow structure comprises a tubular structure, and the scaffold is configured to allow remodeling and / or healing of the tubular structure at and / or otherwise proximate the implant location, and the scaffold is configured to bioabsorb over time.

[0020]

[0015] In some embodiments, the scaffold is configured to cause a desired response within the hollow structure. The desired response can comprise a remodeling of the hollow structure. The desired response can comprise a reendothelialization of a wall portion of the hollow structure.

[0016] In some embodiments, the scaffold comprises one or more natural materials, one or more synthetic materials, or at least one natural material and at least one synthetic material.

[0021]

[0017] In some embodiments, at least a portion of the scaffold is configured to be removed after delivery of the scaffold to the implant location. The entire scaffold can be configured to be removed after delivery of the scaffold to the implant location. The scaffold can be configured to be removed within 1 day of the delivery of the scaffold to the implant location. The scaffold can be configured to be removed within 1 week of the delivery of the scaffold to the implant location. The scaffold can be configured to be removed within 1 month of the delivery of the scaffold to the implant location. The scaffold can be configured to be removed after at least 1 day of the delivery of the scaffold to the implant location. The scaffold can be configured to be removed after at least 1 week of the delivery of the scaffold to the implant location. The scaffold can be configured to be removed after at least 1 month of the delivery of the scaffold to the implant location.

[0022]

[0018] In some embodiments, the scaffold comprises at least one self-expanding portion.

[0023]

[0019] In some embodiments, the scaffold comprises at least one plastically-deformable portion.

[0024]

[0020] In some embodiments, the scaffold comprises at least one self-expanding portion and at least one plastically-deformable portion.

[0025]

[0021] In some embodiments, the scaffold comprises a weave construction.

[0026]

[0022] In some embodiments, the scaffold comprises a lattice construction.

[0027]

[0023] In some embodiments, the scaffold comprises a circular cross section.

[0028]

[0024] In some embodiments, the scaffold comprises a non-circular cross section.

[0029]

[0025] In some embodiments, the scaffold comprises a varying diameter along its length.

[0030]

[0026] In some embodiments, the scaffold is configured to be delivered to an implant location that is proximate a damaged area of the hollow structure. The damaged area can comprise an area of perforated tissue. The perforated tissue can comprise perforated tissue of a bowel. The system can be configured to prevent further injury and / or to promote healing. The system can be configured to promote healing via ingrowth of tissue adjacent the implant location.

[0031]

[0027] In some embodiments, the scaffold further comprises an agent that is configured to be delivered over time. The scaffold can further comprise a coating that surrounds the agent, and the coating can be configured to bioabsorb over time, and the delivery of the agent can be configured to begin after the coating is effectively bioabsorbed. The agent can comprise two or more different agents. The agent can be impregnated within the scaffold. The agent can comprise a coating on a surface the scaffold. The scaffold can be configured to bioabsorb within a first time period, and the agent can be configured to be fully delivered within the first time period. The agent can comprise a pharmaceutical drug. The agent can comprise a pharmaceutical drug selected from the group consisting of chemotherapeutic; anti-coagulant; anti-infective; anti-fungal; anti-inflammatory; an agent configured to decrease cellular activity; an agent configured to increase cellular activity; and combinations thereof. The agent can comprise a radioactive agent. The agent can comprise a genetic therapy agent. The agent can comprise a small molecule agent. The agent can be configured to enhance healing. The agent can be configured to reduce stenosis. The agent can be configured to inhibit tissue growth. The agent can be configured to provide a focal tumor treatment.

[0032]

[0028] In some embodiments, the delivery device comprises a percutaneous delivery device. The percutaneous delivery device can comprise a catheter.

[0033]

[0029] In some embodiments, the delivery device comprises a surgical delivery device and / or a laparoscopic delivery device.

[0034]

[0030] In some embodiments, the delivery device comprises an endoscope.

[0035]

[0031] In some embodiments, the delivery device comprises an expandable element configured to expand and / or dilate the scaffold.

[0036]

[0032] In some embodiments, the system further comprises a dilation assembly configured to dilate the hollow structure and / or the scaffold prior to, during, and / or after the delivery of the scaffold to the implant location. The delivery device can comprise the dilation assembly. The dilation assembly can comprise a balloon catheter. The dilation assembly can comprise a device including a radially expandable element, and the radially expandable element can be configured to expand to dilate the hollow structure and / or scaffold. The radially expandable element can comprise a structure selected from the group consisting of mesh net; mallicot; expandable cage; unfurlable element; and combinations thereof. The dilation assembly can be configured to perform a low-pressure dilation. The dilation assembly can comprise an energy delivery element. The dilation assembly can comprise a cutting element, a sonic disruption element, and / or a lithotripsy element.

[0037]

[0033] In some embodiments, the system further comprises a scoring device configured to score the hollow structure prior to, during, and / or after the delivery of the scaffold to the implant location. The scoring device can comprise a device selected from the group consisting of: scoring sheath; cutting sheath; cutting balloon; and combinations thereof. The scoring device can be configured to treat the hollow structure if the hollow structure comprises a lumen with a stenosis of at least 7mm, and / or if the hollow structure comprises a stenosis of at least 50% (e.g., when compared to normal vessel or viscus).

[0038]

[0034] In some embodiments, the system further comprises a lumen altering device configured to increase and / or decrease the cross-sectional area of a lumen of the hollow structure. The hollow structure can be a hollow body organ. The lumen altering device can comprise a surgical device and / or laparoscopic device. The lumen altering device can comprise a dilation device. The dilation device can comprise a balloon catheter device.

[0039]

[0035] In some embodiments, the system further comprises a lithotripsy device configured to disrupt and / or destroy tissue and / or other material within the hollow structure. The lithotripsy device can be configured to perform the disruption and / or destruction of tissue prior to the delivery of the scaffold.

[0040]

[0036] In some embodiments, the system further comprises a space occluding device configured to reduce space within at least one portion of the hollow structure. The hollow structure can comprise an aneurysm. The space occluding device can be configured to deliver an occlusive agent and / or an occlusive coil. The space occluding device can be configured to modify the flow of fluid through the hollow structure. The modification of flow can comprise a reduction in flow. The hollow structure can comprise a TIPS shunt. The hollow structure can comprise an arteriovenous fistula, and the space occluding device can be configured to stop flow through the arteriovenous fistula. The hollow structure can comprise a portion of the GI tract, and the space occluding device can be configured to reduce flow through the portion of the GI tract to treat dumping syndrome. The space occluding device can comprise one or more space occluding elements that can be configured to bioabsorb over a time period. The space occluding device can be configured to modify flow through the hollow structure for a limited period of time. The one or more space occluding elements can be configured to be effectively bioabsorbed within a time period of no more than: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year. The one or more space occluding elements can be configured to remain effectively in place for a time period of at least: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year, after which the scaffold is configured to be effectively bioabsorbed.

[0041]

[0037] In some embodiments, the system further comprises a controller and a memory storage component coupled to the controller, and the memory storage component is configured to store instructions for the controller to perform an algorithm, and the algorithm is configured to determine a value for a target procedural parameter. The algorithm can comprise an Al algorithm.

[0042]

[0038] In some embodiments, the system further comprises a console. The console can comprise a controller including a memory storage component configured to store instructions for the controller to perform an algorithm.

[0043]

[0039] In some embodiments, the system further comprises one, two, or more functional elements. The one, two, or more functional elements can comprise one, two, or more sensors and / or one, two, or more transducers.

[0044]

[0040] In some embodiments, the system further comprises a lumen altering device configured to treat the hollow structure in a first treatment, and the scaffold is implanted in the hollow structure in a second treatment, subsequent to the first treatment. The lumen altering device can comprise a device selected from the group consisting of an angioplasty balloon; a cutting balloon; a cryoplasty balloon; an atherectomy device; a device configured to treat a vascular calcification; a lithotripsy device; and combinations thereof. The lumen altering device can be configured to perform a procedure selected from the group consisting of balloon angioplasty; balloon angioplasty in which the balloon is inflated beyond a nominal pressure, such as when inflated to at least 110% of nominal pressure; balloon angioplasty that is performed multiple times at a single anatomical location; balloon angioplasty in which the balloon is maintained expanded for a period of at least 5 minutes; atherectomy including multiple passes of the atherectomy element through the same anatomical location; and combinations thereof. In some embodiments, the scaffold is implanted only if the outcome of the first treatment is below a desired result, such as a desired result of residual stenosis being less than 30%.

[0045]

[0041] In some embodiments, the system comprises a sensor, such as an implantable sensor. The sensor can be configured to produce a signal, and the system can be configured to produce data based on the sensor signal. The system can be configured to analyze the data to determine a system parameter (e.g., a scaffold parameter and / or a treatment parameter). The scaffold can comprise the sensor.

[0046]

[0042] According to another aspect of the present inventive concepts, a method of treating a hollow structure of a patient comprises: selecting a patient for treatment; and delivering a scaffold at an implant location in the hollow structure of the patient using the system as described herein.

[0043] In some embodiments, the scaffold is configured to bioabsorb over a time period.

[0047]

[0044] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

[0048] INCORPORATION BY REFERENCE

[0049]

[0045] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.

[0050] BRIEF DESCRIPTION OF THE DRAWINGS

[0051]

[0046] Fig. 1 illustrates a schematic view of a medical system comprising an implantable scaffold and other components, consistent with the present inventive concepts.

[0052]

[0047] Fig. 1A illustrates a flow chart of a method of performing a medical procedure, consistent with the present inventive concepts.

[0053] DETAILED DESCRIPTION OF THE DRAWINGS

[0054]

[0048] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0055]

[0049] It will be understood that the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”) or “containing” (and any form of containing, such as “contains” and “contain”) when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0056]

[0050] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0057]

[0051] It will be further understood that when an element is referred to as being “on”, “attached”, “connected” or “coupled” to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being “directly on”, “directly attached”, “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[0058]

[0052] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled” and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of: electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and / or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of: power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0059]

[0053] It will be further understood that when a first element is referred to as being “in”, “on” and / or “within” a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0054] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g., a target tissue location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0055] Spatially relative terms, such as “beneath,” “below,” “lower,” “above,” “upper” and the like may be used to describe an element and / or feature’s relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as “below” and / or “beneath” other elements or features would then be oriented “above” the other elements or features. The device can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0056] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention” shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0060]

[0057] The term “and / or” where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example “A and / or B” is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0061]

[0058] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0062]

[0059] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0060] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

[0063]

[0061] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and / or values greater than 1 and less than 10.

[0064]

[0062] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0065]

[0063] As used herein, the terms “about” or “approximately” shall refer to ±20% of a stated value.

[0066]

[0064] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0065] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[0067]

[0066] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross sectional area as the cross section of the component being described.

[0068]

[0067] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0069]

[0068] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor, a transducer, or both. In some embodiments, a functional element is configured to deliver energy, deliver a therapeutic treatment, and / or otherwise perform a function. Alternatively or additionally, a functional element (e.g., a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0070]

[0069] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb), sound (e.g., a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g., an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g., different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g., a transducer comprising a tissue manipulating element); sound energy to tissue (e.g., a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0070] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0071]

[0071] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0072]

[0072] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0073]

[0073] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[0074]

[0074] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0075]

[0075] Provided herein are systems for performing a medical procedure, such as a procedure comprising a diagnostic procedure, a therapeutic procedure (also referred to as a “treatment procedure”), or both. The systems of the present inventive concepts comprise a scaffold for implanting in a blood vessel, tubular tissue segment, and / or other hollow structure of a mammalian patient. In use of the system of the present invention, a human or other mammalian patient is selected for treatment, and a medical procedure is performed in which a scaffold is implanted in a hollow structure of the patient.

[0076]

[0076] Referring now to Fig. 1, a system for performing a medical procedure is illustrated, consistent with the present inventive concepts. System 10 comprises scaffold 100, a device for implanting in a hollow structure HS of the patient. System 10 can comprise delivery device 200, a device configured to deliver scaffold 100 to an implant location, location ILOC, within hollow structure HS.

[0077]

[0077] Scaffold 100, or one or more portions of scaffold 100, can be configured to bioabsorb, biodegrade, and / or otherwise decompose after implantation in a patient (any one or more, “bioabsorb” herein). The bioabsorption can occur over a period of time, such as a predetermined time period. In some embodiments, the entire scaffold 100 is configured to be effectively bioabsorbed (“bioabsorbed” or “effectively bioabsorbed”), such that no significant portion of the scaffold 100 remains in its original form, and / or is providing its original function (e.g., no longer providing a scaffolding force to tissue). Scaffold 100, and / or one or more portions of scaffold 100, can be configured to be effectively bioabsorbed within a time period of no more than: 1 hour, 8 hours, 1 day, 1 week, 1 month, 3 months, 6 months, and / or 1 year. Alternatively or additionally, scaffold 100, and / or one or more portions of scaffold 100, can be configured to remain effectively in place for a time period of at least: 1 hour, 8 hours, 1 day, 1 week, 1 month, 3 months, 6 months, and / or 1 year, after which the scaffold can be configured to be effectively bioabsorbed. In some embodiments, scaffold 100 comprises a first portion that is configured to bioabsorb over time, and a second portion that is configured to not bioabsorb. In some embodiments, scaffold 100 comprises a first portion that is configured to bioabsorb over time at a first bioabsorption rate, and a second portion that is configured to bioabsorb at a second bioabsorption rate, and the second bioabsorption rate is greater than the first bioabsorption rate.

[0078]

[0078] Scaffold 100 can comprise one or more coatings, coating 110 shown. Coating 110 can be configured to bioabsorb over a time period.

[0079]

[0079] Scaffold 100 can comprise one or more agents, agent 150 shown. In some embodiments, coating 110 comprises agent 150. In some embodiments, agent 150 comprises at least two agents, such as agents 150a and 150b as shown.

[0080]

[0080] In some embodiments, scaffold 100 further comprises an agent 150 that is configured to be delivered over time. Scaffold 100 can further comprise a coating 110 that surrounds agent 150, and coating 110 can be configured to bioabsorb over time, such that delivery of agent 150 can be configured to begin after coating 110 is effectively bioabsorbed. Agent 150 can comprise two or more different agents (e.g., agents 150a and 150b shown). Agent 150 can be impregnated within scaffold 100. Agent 150 can comprise a coating on a surface of scaffold 100 (e.g., coating 110). Scaffold 100 can be configured to bioabsorb within a first time period, and an included agent 150 can be configured to be fully delivered within the first time period. Agent 150 can comprise a pharmaceutical drug, such as a pharmaceutical drug selected from the group consisting of: chemotherapeutic; anti -coagulant; anti-infective; anti-fungal; anti-inflammatory; an agent configured to decrease cellular activity; an agent configured to increase cellular activity; and combinations thereof. Agent 150 can comprise a radioactive agent. Agent 150 can comprise a genetic therapy agent. Agent 150 can comprise a small molecule agent. Agent 150 can be configured to enhance healing, reduce stenosis, and / or inhibit tissue growth. The agent can be configured to provide a focal treatment, such as a focal tumor treatment. Agent 150 can be configured to be delivered in a “bolus” arrangement (absorbs to a point at which the agent is released), or over time (e.g., a slow release). Agent 150 can be configured for local delivery (e.g., to tissue surrounding scaffold 100), and / or it can be configured to migrate (e.g., migrate downstream from scaffold 100).

[0081]

[0081] In some embodiments, scaffold 100 is configured to cause a desired response within hollow structure HS. The desired response can comprise a remodeling of hollow structure HS. Alternatively or additionally, the desired response can comprise a reendothelialization of a wall portion of hollow structure HS.

[0082]

[0082] In some embodiments, scaffold 100 comprises one or more natural materials, one or more synthetic materials, or at least one natural material and at least one synthetic material.

[0083]

[0083] In some embodiments, at least a portion of scaffold 100 is configured to be removed after delivery of scaffold 100 to implant location ILOC. The entire scaffold 100 can be configured to be removed after delivery of the scaffold to the implant location. Scaffold 100 can be configured to be removed within 1 day, 1 week, and / or 1 month of the delivery of scaffold 100 to implant location ILOC. Scaffold 100 can be configured to be removed after at least 1 day, 1 week, and / or 1 month of the delivery of scaffold 100 to implant location ILOC.

[0084]

[0084] In some embodiments, scaffold 100 comprises at least one self-expanding portion.

[0085]

[0085] In some embodiments, scaffold 100 comprises at least one plastically-deformable portion.

[0086] In some embodiments, scaffold 100 comprises at least one self-expanding portion and at least one plastically-deformable portion.

[0086]

[0087] In some embodiments, scaffold 100 comprises a weave construction. In some embodiments, scaffold 100 comprises a lattice construction.

[0087]

[0088] In some embodiments, scaffold 100 comprises a circular cross section. In some embodiments, scaffold 100 comprises a non-circular cross section.

[0088]

[0089] In some embodiments, scaffold 100 comprises a varying diameter along its length.

[0089]

[0090] In some embodiments, scaffold 100 is configured to be delivered to an implant location ILOC that is proximate a damaged area of hollow structure HS. The damaged area can comprise an area of perforated tissue. The perforated tissue can comprise perforated tissue of a bowel. In these embodiments, system 10 can be configured to prevent further injury and / or to promote healing. System 10 can be configured to promote healing via ingrowth of tissue adjacent the implant location.

[0090]

[0091]

[0091]

[0092] System 10 can further comprise delivery device 200 as shown, and delivery device 200 can be configured to deliver scaffold 100 to implant location ILOC. In some embodiments, delivery device 200 comprises a radially expandable element, expandable element 250 shown (e.g., a balloon, a mesh net, a mallicot, an expandable cage, and / or an unfurlable element), which can be configured to expand and apply a force to scaffold 100 (e.g., when scaffold 100 is implanted) and / or to another component of system 10. Alternatively or additionally, expandable element 250 can be configured to expand and apply a force to tissue of the patient, such as force applied to location ILOC of hollow structure HS (during and / or after delivery of scaffold 100 to location ILOC).

[0092]

[0093] In some embodiments, delivery device 200 comprises a percutaneous delivery device, such as a catheter configured to be percutaneously introduced into a patient.

[0093]

[0094] In some embodiments, delivery device 200 comprises a surgical delivery device and / or a laparoscopic delivery device.

[0094]

[0095] In some embodiments, delivery device 200 comprises an endoscope.

[0095]

[0096] In some embodiments, system 10 further comprises dilation assembly 300, which can include a radially expandable element, expandable element 350, each as shown. Similar to expandable element 250 of delivery device 200, expandable element 350 can be configured to expand and apply a force to scaffold 100 (e.g., when scaffold 100 is implanted) and / or to another component of system 10. Alternatively or additionally, expandable element 350 can be configured to expand and apply a force to tissue of the patient, such as force applied to location ILOC of hollow structure HS (during and / or after delivery of scaffold 100 to location ILOC). Force applied to tissue by dilation assembly 300 at or otherwise proximate implant location ILOC can be applied prior to, during, and / or after implantation of scaffold 100 at location ILOC. In some embodiments, delivery device 200 comprises dilation assembly 300 (e.g., expandable elements 250 and 350 are the same component).

[0096]

[0097] Dilation assembly 300 can comprise a balloon catheter. Dilation assembly 300 can be configured to perform a low-pressure dilation. Dilation assembly 300 (e.g., expandable element 350) can comprise an energy delivery element, a sonic disruption element, a lithotripsy element, and / or a cutting element.

[0097]

[0098] In some embodiments, system 10 further comprises console 500, as shown. Console 500 can comprise a device which operatively connects to delivery device 200 and / or one or more other components of system 10. Console 500 can comprise a controller, controller 510 shown. Controller 510 can comprise one or more electronic elements, electronic assemblies, and / or other electronic components, such as components selected from the group consisting of: memory storage components; analog-to-digital converters; rectification circuitry; state machines; microprocessors; microcontrollers; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and combinations thereof. In some embodiments, controller 510 comprises a memory storage component, memory 515, which can be coupled to other components of controller 510. Memory 515 can store or otherwise include instructions, such as instructions used by controller 510 to perform one or more algorithms, algorithm 550 shown. Algorithm 550 can comprise a machine learning algorithm, a neural network, and / or other artificial intelligence algorithm (“Al algorithm” herein). In some embodiments, algorithm 550 is configured to produce a procedural parameter related to a procedure of the present inventive concepts (e.g., a medical procedure performed using system 10).

[0098]

[0099] In some embodiments, system 10 further comprises one or more accessory devices, accessory device 600 shown. Accessory device 600 can comprise one or more devices that are configured to score tissue (e.g., score vessel wall tissue), scoring device 610 shown. Accessory device 600 can comprise one or more devices configured to expand, stretch, deform, and / or otherwise modify a lumen of the patient, lumen altering device 620 shown. Lumen altering device 620 can comprise an angioplasty balloon, a cutting balloon, a cryoplasty balloon, an atherectomy device, and / or a device configured to treat a vascular calcification. Accessory device 600 can comprise one or more devices configured to perform a lithotripsy procedure, lithotripsy device 630 shown. Lumen altering device 620 can comprise device 630 (e.g., lumen altering device 620 can comprise a lithotripsy device).

[0099] Accessory device 600 can comprise one or more devices configured to occlude a space within a patient, space occluding device 640 shown. Each accessory device 600 can comprise one or more devices configured to access an internal location of a patient percutaneously. Each accessory device 600 can comprise one or more devices configured to be advanced through an endoscope, a laparoscopic port, and / or a vascular introducer.

[0100]

[0100] Scoring device 610 can be configured to score hollow structure HS prior to, during, and / or after the delivery of scaffold 100 to the implant location ILOC. Scoring device 610 can comprise a device selected from the group consisting of scoring sheath; cutting sheath; cutting balloon; and combinations thereof. Scoring device 610 can be configured to treat the hollow structure HS if the hollow structure HS comprises a lumen with a stenosis of at least 7mm, and / or if hollow structure HS comprises a stenosis of at least 50% (e.g., when compared to normal vessel or viscus).

[0101]

[0101] Lumen altering device 620 can comprise a device configured to increase and / or decrease the cross sectional area of a lumen of hollow structure HS. Hollow structure HS can be a hollow body organ. Lumen altering device 620 can comprise a surgical device and / or laparoscopic device. Lumen altering device 620 can comprise a dilation device, such as a balloon catheter device.

[0102]

[0102] Lithotripsy device 630 can comprise a lithotripsy device configured to disrupt and / or destroy tissue and / or other material within hollow structure HS. The lithotripsy device can be configured to perform the disruption and / or destruction of tissue (e.g., tissue at or proximate implant location ILOC) prior to the delivery of scaffold 100.

[0103]

[0103] Space occluding device 640 can comprise a device configured to reduce space within at least one portion of hollow structure HS. Space occluding device 640 can comprise one, two, or more space occluding elements, such as occlusive coils, occlusive agents (e.g., fluids), and / or covered stents. Space occluding device 640 can comprise a delivery device, such as a delivery device configured to deliver one or more space occluding elements of device 640. In these embodiments, hollow structure HS can comprise an aneurysm, and space occluding device 640 can be configured to deliver one or more occlusive elements. In some embodiments, space occluding device 640 is configured to modify the flow of fluid through hollow structure HS (e.g., via delivery of occlusive elements that partially or fully occlude a lumen of hollow structure HS). The modification of flow can comprise a reduction in flow. In these embodiments, hollow structure HS can comprise a TIPS shunt that is modified by device 640. Hollow structure HS can comprise an arteriovenous fistula, and space occluding device 640 can be configured to stop flow through the arteriovenous fistula (e.g., via the delivery of a covered stent and / or occlusive agents in or proximate the fistula). Hollow structure HS can comprise a portion of the GI tract, and space occluding device 640 can be configured to reduce flow through the portion of the GI tract, such as to treat dumping syndrome. Space occluding device 640 can comprise one or more occlusive elements that can be configured to bioabsorb over time. Space occluding device 640 can be configured to modify flow through hollow structure HS for a limited period of time (e.g., by the delivery of one or more occlusive elements that bioabsorb over a time period). The one or more occlusive elements of device 640 can be configured to be effectively bioabsorbed within a time period, such as a time period of no more than: 1 hour, 8 hours, 1 day, 1 week, 1 month, 3 months, 6 months, and / or 1 year. The one or more space occluding elements of device 640 can be configured to remain effectively in place for a time period, such as a time period of at least: 1 hour, 8 hours, 1 day, 1 week, 1 month, 3 months, 6 months, and / or 1 year (e.g., after which scaffold 100 can be configured to be effectively bioabsorbed).

[0104]

[0104] System 10 can comprise one or more functional elements, such as functional element 99, functional element 199 of scaffold 100, functional element 299 of delivery device 200, functional element 399 of dilation assembly 300, functional element 599 of console 500, and / or functional element 699 of accessory device 600, each as shown in Fig.

[0105] 1. Functional elements 99, 199, 299, 399, 599, and / or 699 (any one or more of these, “functional element 99 / 199 / 299 / 399 / 599 / 699” herein) can comprise one, two, or more sensors, one, two or more transducers, and / or one, two, or more other functional elements.

[0106]

[0105] Functional element 199, and / or another functional element of system 10, can comprise a sensor, such as an implantable sensor. The sensor can be configured to produce a signal, and system 10 can be configured to produce data based on the sensor signal. System 10 can be configured to analyze the data to determine a system parameter (e.g., a scaffold 100 parameter and / or a treatment parameter). Scaffold 100 can comprise the sensor (e.g., functional element 199 comprises the sensor).

[0107]

[0106] System 10 can be configured to treat hollow structure HS in a percutaneous procedure, in a minimally invasive procedure, in an open surgical procedure, and / or in a procedure including a combination of two or more of these clinical techniques. In some embodiments, the treatment is performed without image guidance. Alternatively, image guidance can be used (e.g., as described herein). System 10 can be configured to treat a hollow structure HS in a clinical procedure in which the hollow structure HS is prepared or otherwise treated (e.g., as described herein) prior to the implantation of scaffold 100. This treatment performed prior to implantation of scaffold 100 can comprise a treatment procedure selected from the group consisting of expansion of tissue; constraining of tissue; perforation of tissue (e.g., for anchoring of scaffold 100 and / or absorption of agent 150 or other agent); and combinations of these. System 10 can be configured to treat a blood vessel (e.g., a vein, an artery, or both) and / or other hollow structure HS, where the treatment comprises an initial treatment (e.g., a treatment using lumen altering device 620 or otherwise) and a secondary treatment that includes implantation of scaffold 100, as described herein. The first treatment and the second treatment can be performed in the same clinical procedure. Alternatively, the first treatment can be performed in a first clinical procedure, and the second treatment can be performed in a second clinical procedure, such as a second clinical procedure that is performed at least 1 day, 1 week, or 1 month after the first clinical procedure. In some embodiments, the first treatment procedure can comprise use of lumen altering device 620, such as when device 620 is configured to perform: balloon angioplasty; balloon angioplasty in which the balloon is inflated beyond a nominal pressure, such as when inflated to at least 110% of nominal pressure; balloon angioplasty that is performed multiple times at a single anatomical location; balloon angioplasty in which the balloon is maintained expanded for a period of at least 5 minutes; atherectomy including multiple passes of the atherectomy element through the same anatomical location; and combinations of these. In these embodiments, the second treatment procedure comprises implantation of scaffold 100 (e.g., a scaffold configured to bioabsorb over time, and / or be removed after a pre-determined implantation duration, as described herein). In some embodiments, scaffold 100 is implanted only if the outcome of the first treatment is below a desired result, such as a desired result of residual stenosis being less than 30% (e.g., when determined using IVUS, angiography or other imaging technology).

[0108]

[0107] System 10 can be configured to treat a hollow structure HS via a first treatment procedure in which the hollow structure is treated with lumen altering device 620 or other component of system 10, and a second treatment procedure, performed after the first treatment procedure, in which scaffold 100 is implanted. In some embodiments, the system 10 components used in the first treatment procedure are configured to cause hollow structure HS to accurately “match” the scaffold 100 (e.g., accurately match the dimensions of scaffold 100, such as to create a void or an imprint into which scaffold 100 is positioned). In some embodiments, the system 10 components used in the first treatment procedure deposit an agent (e.g., agent 150) and / or a structure (e.g., a functional element 99) into, through, and / or on the wall of the hollow structure HS. In these embodiments, the agent and / or structure can be configured as a guide, an anchor, and / or a “lock and key” mechanism for scaffold 100. In some embodiments, a functional element 199 (e.g., of scaffold 100) and / or a functional element 99 comprises a component that is implanted at the implant location, and is configured to deliver one or more of radiation; an agent (e.g., an agent 150 comprising a chemotherapeutic agent; a contrast agent; and / or a bio-active agent).

[0109]

[0108] Referring additionally to Fig. 1A, a method of performing a medical procedure is illustrated, consistent with the present inventive concepts. Method 1000 of Fig. 1 A can comprise a medical procedure in which scaffold 100 is implanted using one or more other products of system 10.

[0110]

[0109] In STEP 1100, a patient is selected for treatment using the systems and methods of the present inventive concepts. In some embodiments, the patient has received a medical procedure in which an undesired condition has resulted, and method 1000 is performed to improve that undesired condition.

[0111]

[0110] In STEP 1200, an “implantation step” is performed. The implantation procedure includes implanting scaffold 100 at an implant location ILOC of a hollow structure HS of the patient. In some embodiments, delivery device 200 is used for the implantation of scaffold 100.

[0111] In STEP 1300, an optional “diagnostic step” can be performed, such as a procedure in which the efficacy (e.g., current or predicted future efficacy) of the implantation of scaffold 100 at implant location ILOC is assessed.

[0112]

[0112] In STEP 1400, an optional “scaffold modification step” can be performed, such as a procedure in which scaffold 100 is expanded, contracted, moved, and / or otherwise modified.

[0113]

[0113] Method 1000 can comprise additional procedures, such as one, two, or more treatment and / or diagnostic procedures (e.g., pharmaceutical treatment procedures, surgical procedures, interventional procedures, physical therapy procedures, and / or other medical procedures).

[0114]

[0114] In some embodiments, system 10 is configured (e.g., scaffold 100 and / or one or more other components of system 10 are configured) to provide a temporary scaffolding force to a hollow structure HS at the implant location ILOC.

[0115]

[0115] In some embodiments, hollow structure HS treated using system 10 comprises a blood vessel. The blood vessel can comprise a vein and / or an artery. The blood vessel can comprise a blood vessel that has been previously treated, at a previous treatment location, such as a previous treatment location that can be at and / or at least proximate the implant location ILOC of scaffold 100. The previous treatment can comprise a treatment selected from the group consisting of treatment with a cutting balloon; treatment with a cutting sheath; treatment with an atherectomy device; treatment with a lithotripsy device; treatment that achieves a lumen improvement; treatment that does not achieve a lumen improvement; treatment of a vascular calcification; and / or combinations thereof.

[0116]

[0116] In some embodiments, hollow structure HS can comprise an artery or a vein, and system 10 can be configured to provide a temporary scaffolding force to a luminal wall portion of the artery or vein. The implant location ILOC can comprise a segment of a vein including one or more venous valves. The one or more venous valves can comprise valves that have been previously disrupted and / or otherwise previously treated. The implant location ILOC can comprise a vein segment that is in one or more of the following conditions: spasm; torn; disrupted; perforated; and / or damaged. System 10 can be configured to reduce the likelihood of a stricture forming at or otherwise proximate the implant location ILOC. The stricture can comprise a stricture that might occur due to a subsequent clinical procedure (e.g., wherein the procedure performed using system 10 is performed as a preventative measure to potentially prevent or at least reduce the future stricture formation). The subsequent clinical procedure can comprise a procedure that is to be performed at or proximate the implant location ILOC.

[0117]

[0117] In some embodiments, system 10 is configured (e.g., scaffold 100 and / or one or more other components of system 10 are configured) to provide at least temporary incompetence of one or more venous valves located at the implant location ILOC. The one or more venous valves can comprise at least one venous valve that has been previously disrupted and / or otherwise treated (e.g., in a previous clinical procedure performed just prior, or at least 1 day prior to the system 10 procedure). System 10 can be configured to provide chronic incompetence of one of the one or more venous valves located at the implant location. The chronic incompetence can comprise incompetence of the one or more venous valves for at least 1 month, 3 months, and / or 6 months.

[0118]

[0118] In some embodiments, hollow structure HS treated using system 10 comprises a hollow body organ. The hollow body organ can be treated at a location proximate to the implant location ILOC of scaffold 100. Scaffold 100 can be configured to provide a scaffolding force for a limited time period (e.g., limited due to the bioabsorption of scaffold 100). The scaffolding force provided by scaffold 100, and / or scaffold 100 itself, can be configured to support and / or promote healing of the hollow body organ (e.g., at or otherwise proximate the implant location ILOC). The hollow body organ can comprise a tear duct, an eustachian tube, and / or a fallopian tube. The hollow body organ can comprise a biliary structure. The biliary structure can comprise an intra and / or extrahepatic duct structure. The hollow body organ can comprise a urinary structure. The urinary structure can comprise the ureter, urethra, and / or intra prostatic urethra. The hollow body organ can comprise a gastrointestinal structure. The gastrointestinal structure can comprise the esophagus, stomach, small intestine, large intestine, and / or colon. The hollow body organ can comprise a structure of the pulmonary system, such as the bronchus.

[0119]

[0119] In some embodiments, hollow structure HS treated using system 10 comprises an aneurysm. Scaffold 100 can be configured for placement across a neck of the aneurysm. In these embodiments, scaffold 100 can be configured to bioabsorb over a time period. System 10 can further comprise an embolic coil, an embolic fluid, and / or other embolic component configured to be placed within the aneurysm.

[0120] In some embodiments, hollow structure HS treated using system 10 comprises a diseased and / or damaged hollow structure. The diseased and / or damaged hollow structure HS can comprise a focal tissue issue. The focal tissue issue can comprise a bum, ischemia, laceration, tissue disruption, and / or tumor. The diseased and / or damaged hollow structure HS can comprise a perforation of the hollow structure HS. The diseased and / or damaged hollow structure HS can comprise at least a partial transection of hollow structure HS. The at least a partial transection can comprise a full transection.

[0120]

[0121] In some embodiments, hollow structure HS treated using system 10 comprises a tubular structure, and scaffold 100 is configured to allow remodeling and / or healing of the tubular structure at and / or otherwise proximate the implant location ILOC. The scaffold can be configured to bioabsorb over time.

[0121]

[0122] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which is defined in the accompanying claims.

Claims

WHAT IS CLAIMED IS:

1. A system for treating a hollow structure of a patient, the system comprising: a scaffold for implanting in a hollow structure of the patient; and a delivery device configured to deliver the scaffold to an implant location within the hollow structure.

2. A system as claimed in any one or more claims herein, wherein the scaffold is configured to bioabsorb over a time period.

3. The system according to claim 2 and / or any other one or more claims herein, wherein the scaffold is configured to be effectively bioabsorbed within a time period of no more than: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year.

4. The system according to claim 2 and / or any other one or more claims herein, wherein the scaffold is configured to remain effectively in place for a time period of at least: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year, after which the scaffold is configured to be effectively bioabsorbed.

5. A system as claimed in any one or more claims herein, wherein the scaffold comprises a first portion that is configured to bioabsorb over a time period, and a second portion that is configured to not bioabsorb.

6. A system as claimed in any one or more claims herein, wherein the scaffold comprises a first portion that is configured to bioabsorb over a time period and at a first bioabsorption rate, and a second portion that is configured to bioabsorb over a time period and at a second bioabsorption rate, and wherein the second bioabsorption rate is greater than the first bioabsorption rate.

7. A system as claimed in any one or more claims herein, wherein the system is configured to provide a temporary scaffolding force to the hollow structure at the implant location.

8. The system according to claim 7 and / or any other one or more claims herein, wherein the hollow structure comprises an artery or a vein, and wherein the system is configured to provide the temporary scaffolding force to a luminal wall portion of the artery or vein.

9. The system according to claim 7 and / or any other one or more claims herein, wherein the implant location comprises a segment of a vein including one or more venous valves.

10. The system according to claim 9 and / or any other one or more claims herein, wherein the one or more venous valves have been previously disrupted and / or otherwise previously treated.

11. The system according to claim 7 and / or any other one or more claims herein, wherein the implant location comprises a vein segment that is in one or more of the following conditions: spasm tom; disrupted; perforated; and / or damaged.

12. The system according to claim 7 and / or any other one or more claims herein, wherein the system is configured to reduce the likelihood of a stricture at or otherwise proximate the implant location.

13. The system according to claim 12 and / or any other one or more claims herein, wherein the stricture comprises a stricture that might occur due to a subsequent clinical procedure.

14. The system according to claim 13 and / or any other one or more claims herein, wherein the subsequent clinical procedurecomprises a procedure performed at, or proximate, the implant location.

15. The system as claimed in any one or more claims herein, wherein the system is configured to provide at least temporary incompetence of one or more venous valves located at the implant location.

16. The system according to claim 15 and / or any other one or more claims herein, wherein the one or more venous valves comprise at least one venous valve that has been previously disrupted and / or otherwise treated.

17. The system according to claim 15 and / or any other one or more claims herein, wherein the system is configured to provide chronic incompetence of one of the one or more venous valves located at the implant location.

18. The system according to claim 17 and / or any other one or more claims herein, wherein the chronic incompetence comprises incompetence of the one or more venous valves for at least 1 month, 3 months, and / or 6 months.

19. A system as claimed in any one or more claims herein, wherein the hollow structure comprises a blood vessel.

20. The system according to claim 19 and / or any other one or more claims herein, wherein the blood vessel has been previously treated at a previous treatment location that is at and / or at least proximate the implant location of the scaffold.

21. The system according to claim 19 and / or any other one or more claims herein, wherein the previous treatment comprises a treatment selected from the group consisting of treatment with a cutting balloon; treatment with a cutting sheath; treatment with an atherectomy device; treatment with a lithotripsy device; treatment with a cryoplasty balloon; treatment that achieves a lumen improvement; treatment that does not achieve a lumenimprovement; treatment of vascular calcification; and / or combinations thereof.

22. The system according to claim 19 and / or any other one or more claims herein, wherein the blood vessel comprises a vein.

23. The system according to claim 19 and / or any other one or more claims herein, wherein the blood vessel comprises an artery.

24. A system as claimed in any one or more claims herein, wherein the hollow structure comprises a hollow body organ.

25. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ is treated at a location proximate to the implant location of the scaffold, wherein the scaffold is configured to provide a scaffolding force for a limited time period, and wherein the scaffolding force, and / or the scaffold itself, is configured to support and / or promote healing of the hollow body organ.

26. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ comprises a tear duct.

27. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ comprises an eustachian tube.

28. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ comprises a fallopian tube.

29. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ comprises a biliary structure.

30. The system according to claim 29 and / or any other one or more claims herein, wherein the biliary structure comprises an intra and / or extrahepatic duct structure.

31. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ comprises a urinary structure.

32. The system according to claim 31 and / or any other one or more claims herein, wherein the urinary structure comprises the ureter, urethra, and / or intra prostatic urethra.

33. The system according to claim 24 and / or any other one or more claims herein, wherein the hollow body organ comprises a gastrointestinal structure and / or a structure of the pulmonary system such as the bronchus.

34. The system according to claim 33 and / or any other one or more claims herein, wherein the gastrointestinal structure comprises the esophagus, stomach, small intestine, large intestine, and / or colon.

35. A system as claimed in any one or more claims herein, wherein the hollow structure comprises an aneurysm.

36. The system according to claim 35 and / or any other one or more other claims herein, wherein the scaffold is configured for placement across a neck of the aneurysm, and wherein the scaffold is configured to bioabsorb over a time period.

37. The system according to claim 36, further comprising an embolic coil, an embolic fluid, and / or other embolic component configured to be placed within the aneurysm.

38. A system as claimed in any one or more claims herein, wherein the hollow structure comprises a diseased and / or damaged hollow structure.

39. The system according to claim 38 and / or any other one or more claims herein, wherein the diseased and / or damaged hollow structure comprises a focal tissue issue.

40. The system according to claim 39 and / or any other one or more claims herein, wherein the focal tissue issue comprises a bum, ischemia, laceration, tissue disruption, and / or tumor.

41. The system according to claim 38 and / or any other one or more claims herein, wherein the diseased and / or damaged hollow structure comprises a perforation of the hollow structure.

42. The system according to claim 38 and / or any other one or more claims herein, wherein the diseased and / or damaged hollow structure comprises at least a partial transection of the hollow structure.

43. The system according to claim 42 and / or any other one or more claims herein, wherein the at least a partial transection comprises a full transection.

44. A system as claimed in any one or more claims herein, wherein the hollow structure comprises a tubular structure, wherein the scaffold is configured to allow remodeling and / or healing of the tubular structure at and / or otherwise proximate the implant location, and wherein the scaffold is configured to bioabsorb over time.

45. A system as claimed in any one or more claims herein, wherein the scaffold is configured to cause a desired response within the hollow structure.

46. The system according to claim 45 and / or any other one or more claims herein, wherein the desired response comprises a remodeling of the hollow structure.

47. The system according to claim 45 and / or any other one or more claims herein, wherein the desired response comprises a reendothelialization of a wall portion of the hollow structure.

48. A system as claimed in any one or more claims herein, wherein the scaffold comprises one or more natural materials, one or more synthetic materials, or at least one natural material and at least one synthetic material.

49. A system as claimed in any one or more claims herein, wherein at least a portion of the scaffold is configured to be removed after delivery of the scaffold to the implant location.

50. The system according to claim 49 and / or any other one or more claims herein, wherein the entire scaffold is configured to be removed after delivery of the scaffold to the implant location.

51. The system according to claim 49 and / or any other one or more claims herein, wherein the scaffold is configured to be removed within 1 day of the delivery of the scaffold to the implant location.

52. The system according to claim 49 and / or any other one or more claims herein, wherein the scaffold is configured to be removed within 1 week of the delivery of the scaffold to the implant location.

53. The system according to claim 49 and / or any other one or more claims herein, wherein the scaffold is configured to be removed within 1 month of the delivery of the scaffold to the implant location.

54. The system according to claim 49 and / or any other one or more claims herein, wherein the scaffold is configured to be removed after at least 1 day of the delivery of the scaffold to the implant location.

55. The system according to claim 49 and / or any other one or more claims herein, wherein the scaffold is configured to be removed after at least 1 week of the delivery of the scaffold to the implant location.

56. The system according to claim 49 and / or any other one or more claims herein, wherein the scaffold is configured to be removed after at least 1 month of the delivery of the scaffold to the implant location.

57. A system as claimed in any one or more claims herein, wherein the scaffold comprises at least one self-expanding portion.

58. A system as claimed in any one or more claims herein, wherein the scaffold comprises at least one plastically-deformable portion.

59. A system as claimed in any one or more claims herein, wherein the scaffold comprises at least one self-expanding portion and at least one plastically-deformable portion.

60. A system as claimed in any one or more claims herein, wherein the scaffold comprises a weave construction.

61. A system as claimed in any one or more claims herein, wherein the scaffold comprises a lattice construction.

62. A system as claimed in any one or more claims herein, wherein the scaffold comprises a circular cross section.

63. A system as claimed in any one or more claims herein, wherein the scaffold comprises a non-circular cross section.

64. A system as claimed in any one or more claims herein, wherein the scaffold comprises a varying diameter along its length.

65. A system as claimed in any one or more claims herein, wherein the scaffold is configured to be delivered to an implant location that is proximate a damaged area of the hollow structure.

66. The system according to claim 65 and / or any other one or more claims herein, wherein the damaged area comprises an area of perforated tissue.

67. The system according to claim 66 and / or any other one or more claims herein, wherein the perforated tissue comprises perforated tissue of a bowel.

68. The system according to claim 65 and / or any other one or more claims herein, wherein the system is configured to prevent further injury and / or to promote healing.

69. The system according to claim 68 and / or any other one or more claims herein, wherein the system is configured to promote healing via ingrowth of tissue adjacent the implant location.

70. A system as claimed in any one or more claims herein, wherein the scaffold further comprises an agent that is configured to be delivered over time.

71. The system according to claim 70 and / or any other one or more claims herein, wherein the scaffold further comprises a coating that surrounds the agent, wherein the coating is configured to bioabsorb over time, and the delivery of the agent is configured to begin after the coating is effectively bioabsorbed.

72. The system according to claim 70 and / or any other one or more claims herein, wherein the agent comprises two or more different agents.

73. The system according to claim 70 and / or any other one or more claims herein, wherein the agent is impregnated within the scaffold.

74. The system according to claim 70 and / or any other one or more claims herein, wherein the agent comprises a coating on a surface the scaffold.

75. The system according to claim 70 and / or any other one or more claims herein, wherein the scaffold is configured to bioabsorb within a first time period, and wherein the agent is configured to be fully delivered within the first time period.

76. The system according to claim 70 and / or any other one or more claims herein, wherein the agent comprises a pharmaceutical drug.

77. The system according to claim 76 and / or any other one or more claims herein, wherein the agent comprises a pharmaceutical drug selected from the group consisting of: chemotherapeutic; anticoagulant; anti -infective; anti-fungal; anti-inflammatory; an agent configured to decrease cellular activity; an agent configured to increase cellular activity; and combinations thereof.

78. The system according to claim 70 and / or any other one or more claims herein, wherein the agent comprises a radioactive agent.

79. The system according to claim 70 and / or any other one or more claims herein, wherein the agent comprises a genetic therapy agent.

80. The system according to claim 70 and / or any other one or more claims herein, wherein the agent comprises a small molecule agent.

81. The system according to claim 70 and / or any other one or more claims herein, wherein the agent is configured to enhance healing.

82. The system according to claim 70 and / or any other one or more claims herein, wherein the agent is configured to reduce stenosis.

83. The system according to claim 70 and / or any other one or more claims herein, wherein the agent is configured to inhibit tissue growth.

84. The system according to claim 83 and / or any other one or more claims herein, wherein the agent is configured to provide a focal tumor treatment.

85. A system as claimed in any one or more claims herein, wherein the delivery device comprises a percutaneous delivery device.

86. A system according to claim 85 and / or any other one or more claims herein, wherein the percutaneous delivery device comprises a catheter.

87. A system as claimed in any one or more claims herein, wherein the delivery device comprises a surgical delivery device and / or a laparoscopic delivery device.

88. A system as claimed in any one or more claims herein, wherein the delivery device comprises an endoscope.

89. A system as claimed in any one or more claims herein, wherein the delivery device comprises an expandable element configured to expand and / or dilate the scaffold.

90. A system as claimed in any one or more claims herein, further comprising a dilation assembly configured to dilate the hollow structure and / or the scaffold prior to, during, and / or after the delivery of the scaffold to the implant location.

91. The system according to claim 90 and / or any other one or more claims herein, wherein the delivery device comprises the dilation assembly.

92. The system according to claim 90 and / or any other one or more claims herein, wherein the dilation assembly comprises a balloon catheter.

93. The system according to claim 90 and / or any other one or more claims herein, wherein the dilation assembly comprises a device including a radiallyexpandable element, wherein the radially expandable element is configured to expand to dilate the hollow structure and / or scaffold.

94. The system according to claim 93 and / or any other one or more claims herein, wherein the radially expandable element comprises a structure selected from the group consisting of: mesh net; mallicot; expandable cage; unfurlable element; and combinations thereof.

95. The system according to claim 90 and / or any other one or more claims herein, wherein the dilation assembly is configured to perform a low-pressure dilation.

96. The system according to claim 90 and / or any other one or more claims herein, wherein the dilation assembly comprises an energy delivery element.

97. The system according to claim 90 and / or any other one or more claims herein, wherein the dilation assembly comprises a cutting element, a sonic disruption element, and / or a lithotripsy element.

98. A system as claimed in any one or more claims herein, further comprising a scoring device configured to score the hollow structure prior to, during, and / or after the delivery of the scaffold to the implant location.

99. The system according to claim 98 and / or any other one or more claims herein, wherein the scoring device comprises a device selected from the group consisting of: scoring sheath; cutting sheath; cutting balloon; and combinations thereof.

100. The system according to claim 98 and / or any other one or more claims herein, wherein the scoring device is configured to treat the hollow structure if the hollow structure comprises a lumen with a stenosis of at least 7mm and / or a stenosis of at least 50%.

101. A system as claimed in any one or more claims herein, further comprising a lumen altering device configured to increase and / or decrease the cross-sectional area of a lumen of the hollow structure.

102. The system according to claim 101 and / or any other one or more claims herein, wherein the hollow structure is a hollow body organ.

103. The system according to claim 101 and / or any other one or more claims herein, wherein the lumen altering device comprises a surgical device and / or laparoscopic device.

104. The system according to claim 101 and / or any other one or more claims herein, wherein the lumen altering device comprises a dilation device.

105. The system according to claim 104 and / or any other one or more claims herein, wherein the dilation device comprises a balloon catheter device.

106. A system as claimed in any one or more claims herein, further comprising a lithotripsy device configured to disrupt and / or destroy tissue and / or other material within the hollow structure.

107. The system according to claim 106 and / or any other one or more claims herein, wherein the lithotripsy device is configured to perform the disruption and / or destruction of tissue prior to the delivery of the scaffold.

108. A system as claimed in any one or more claims herein, further comprising a space occluding device configured to reduce space within at least one portion of the hollow structure.

109. The system according to claim 108 and / or any other one or more claims herein, wherein the hollow structure comprises an aneurysm.

110. The system according to claim 108 and / or any other one or more claims herein, wherein the space occluding device is configured to deliver an occlusive agent and / or an occlusive coil.

111. The system according to claim 108 and / or any other one or more claims herein, wherein the space occluding device is configured to modify the flow of fluid through the hollow structure.

112. The system according to claim 111 and / or any other one or more claims herein, wherein the modification of flow comprises a reduction in flow.

113. The system according to claim 111 and / or any other one or more claims herein, wherein the hollow structure comprises a TIPS shunt.

114. The system according to claim 111 and / or any other one or more claims herein, wherein the hollow structure comprises an arteriovenous fistula, and wherein the space occluding device is configured to stop flow through the arteriovenous fistula.

115. The system according to claim 111 and / or any other one or more claims herein, wherein the hollow structure comprises a portion of the GI tract, and wherein the space occluding device is configured to reduce flow through the portion of the GI tract to treat dumping syndrome.

116. The system according to claim 108 and / or any other one or more claims herein, wherein the space occluding device comprises one or more space occluding elements that are configured to bioabsorb over a time period.

117. The system according to claim 116 and / or any other one or more claims herein, wherein the space occluding device is configured to modify flow through the hollow structure for a limited period of time.

118. The system according to claim 116 and / or any other one or more claims herein, wherein the one or more space occluding elements are configured to be effectively bioabsorbed within a time period of no more than: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year.

119. The system according to claim 116 and / or any other one or more claims herein, wherein the one or more space occluding elements are configured to remain effectively in place for a time period of at least: 1 hour; 8 hours; 1 day; 1 week; 1 month; 3 months; 6 months; and / or 1 year, after which the scaffold is configured to be effectively bioabsorbed.

120. A system as claimed in any one or more claims herein, further comprising a controller and a memory storage component coupled to the controller, wherein the memory storage component is configured to store instructions for the controller to perform an algorithm, and wherein the algorithm is configured to determine a value for a target procedural parameter.

121. The system according to claim 120 and / or any other one or more claims herein, wherein the algorithm comprises an Al algorithm.

122. A system as claimed in any one or more claims herein, further comprising a console.

123. The system according to claim 122 and / or any other one or more claims herein, wherein the console comprises a controller including a memory storage component configured to store instructions for the controller to perform an algorithm.

124. A system as claimed in any one or more claims herein, further comprising one, two, or more functional elements.

125. The system according to claim 124 and / or any other one or more claims herein, wherein the one, two, or more functional elements comprises one, two, or more sensors and / or one, two, or more transducers.

126. A system as claimed in any one or more claims herein, further comprising a lumen altering device, wherein the lumen altering device is configured to treat the hollow structure in a first treatment, and wherein the scaffold is implanted in the hollow structure in a second treatment, subsequent to the first treatment.

127. The system according to claim 126 and / or any other one or more claims herein, wherein the lumen altering device comprises a device selected from the group consisting of: an angioplasty balloon; a cutting balloon; a cryoplasty balloon; an atherectomy device; a device configured to treat a vascular calcification; a lithotripsy device; and combinations thereof.

128. The system according to claim 126 and / or any other one or more claims herein, wherein the lumen altering device is configured to perform a procedure selected from the group consisting of: balloon angioplasty; balloon angioplasty in which the balloon is inflated beyond a nominal pressure, such as when inflated to at least 110% of nominal pressure; balloon angioplasty that is performed multiple times at a single anatomical location; balloon angioplasty in which the balloon is maintained expanded for a period of at least 5 minutes; atherectomy including multiple passes of the atherectomy element through the same anatomical location; and combinations thereof.

129. The system according to claim 126 and / or any other one or more claims herein, wherein the scaffold is implanted only if the outcome of the first treatment is below a desired result, such as a desired result of residual stenosis being less than 30%.

130. The system claimed in any one or more claims herein, comprising a sensor configured to produce a signal.

131. The system according to claim 130 and / or any other one or more claims herein, wherein the sensor comprises an implantable sensor.

132. The system according to claim 130 and / or any other one or more claims herein, wherein the system is configured to produce data based on the sensor signal.

133. The system according to claim 132 and / or any other one or more claims herein, wherein the system is configured to analyze the data to produce a scaffold parameter, a treatment parameter, and / or other system parameter.

134. The system according to claim 130 and / or any other one or more claims herein, wherein the scaffold comprises the sensor.

126. A method of treating a hollow structure of a patient, comprising: selecting a patient for treatment; and delivering a scaffold at an implant location in the hollow structure of the patient using the system according to any one or more claims herein.

127. The method according to any one or more claims herein, wherein the scaffold is configured to bioabsorb over a time period.

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