Biodegradable stents, methods of manufacture, and uses thereof

Abstract

The instant disclosure provides a novel class of stents with improved performance and increased ease of manufacture and use. Disclosed embodiments comprise stents, for example flow-diversion stents, with reduced metal content as compared to current devices. This can reduce the risk of toxicity caused by metals degrading in the body, for example in the brain.

Description

[0001] BIODEGRADABLE STENTS, METHODS OF MANUFACTURE, AND USES THEREOF

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003]

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 553,819, filed February 15, 2024, the disclosure of which is incorporated herein by reference in its entirety.

[0004] FIELD

[0005]

[0002] The present specification relates to the production and use of biodegradable stents.

[0006] BACKGROUND

[0007]

[0003] An aneurysm is a '‘bulge” in a blood vessel caused by a weakness in the vessel wall, often where the vessel branches. As blood passes through the weakened vessel, blood pressure can cause a small area to bulge outwards like a balloon.

[0008]

[0004] A brain aneurysm can leak or rupture, causing bleeding into the brain (hemorrhagic stroke). Most often, a ruptured brain aneurysm occurs in the space between the brain and the thin tissues covering the brain. This type of hemorrhagic stroke is called a subarachnoid hemorrhage. A ruptured aneurysm can be lifethreatening and requires prompt medical treatment.

[0009]

[0005] However, preventative treatments can often limit further complications, and a common treatment for brain aneurysms can include the use of a stent (a flexible mesh tube). For example, “flow diversion” is a technique in which a surgeon uses a catheter to place a stent into a blood vessel where an aneurysm has formed. This process diverts the flow of blood away from the aneurysm itself. Rerouting the blood flow reduces pressure on the aneurysm, making it less likely to rupture. In time, new cells grow on the stent, sealing the aneurysm and healing the vessel. If the stent covers the opening of a branch leading off the vessel, normal flow of blood prevents cells growing on that portion of the stent and blocking the branch, so there is not a risk of the stent cutting off the blood supply to other areas of the brain.

[0006] While effective, current stent materials often include metals, because non- metallic components do not provide adequate mechanical support. However, metals and alloys are susceptible to corrosion, and corrosion of stents presents two main risks: release of metallic ions into tissue and deterioration of the mechanical properties of stents which may contribute to fracture. This diffusion can create toxicities. In addition, the metals used in implantable devices such as stents can pose manufacturing challenges in terms in terms of cost, effort, and environmental impact.

[0010]

[0007] Further, while stents can influence blood flow, their mesh flow diversion structure limits their ability to control blood flow.

[0011]

[0008] Thus, improved approaches are desired.

[0012] SUMMARY

[0013]

[0009] The instant disclosure provides a novel class of stents with improved performance and increased ease of manufacture and use. Disclosed embodiments comprise stents, for example flow-diversion stents, with reduced metal content as compared to current devices. This can reduce the risk of toxicity caused by metals degrading in the body, for example in the brain.

[0014]

[0010] In embodiments, metal content is reduced by replacing the metal(s) with biodegradable components whose degradation does not cause toxicity. For example, in embodiments, metals such as nitinol are replaced by biodegradable polymers such as polylactic acid (PLA). In embodiments, biodegradable metals can also be used. In embodiments, the metal content is replaced by a “shape-memory” polymer. The disclosed use of biodegradable polymers provides clear advantages to device manufacturers, doctors, and patients.

[0015]

[0011] Disclosed embodiments comprise methods of use of disclosed stents. For example, in embodiments, disclosed stents can be used in treatment of aneurysms. Disclosed stents can also be used in treatment of intracranial stenosis. In addition to the reduced toxicity benefits inherent to disclosed stents, they can also prevent, rather than merely limit, blood flow in a treatment area. Thus, disclosed embodiments provide doctors with improved devices; for example, the instant disclosure enables a practitioner to tailor the degradation time of disclosed devices to match patient needs such as aneurysm shrinkage.

[0016]

[0012] Further, disclosed methods and devices can improve patient outcomes by providing stents with mechanical properties (such as structural and degradation rates) that are specifically designed to achieve individual patient treatment goals, while reducing or eliminating the risk of stent-associated toxicity.

[0017]

[0013] Disclosed embodiments comprise methods of manufacture of disclosed stents. For example, in embodiments, disclosed stents can be manufactured using a “dip coating” process. Disclosed stents can also be manufactured by forming a layer of biodegradable polymer material and then “wrapping” this material around an expansion layer.

[0018]

[0014] Disclosed embodiments can reduce manufacturing time and cost along with reducing environmental impact as compared to traditional metal-based stent manufacturing. For example, devices comprising an expansion layer embedded within a biodegradable flow diversion layer eliminate the need for finely machined flow diversion components (as seen in FIG. 1 ).

[0019]

[0015] Disclosed embodiments comprise kits comprising disclosed stents. For example, in embodiments, disclosed stents can be sterilized and packaged with instructions for use.

[0020] BRIEF DESCRIPTION OF THE DRAWINGS

[0021]

[0016] FIG. 1 shows a conventional two-layer stent. The outer “expansion” component or layer 12 is a self-expanding spring which applies radial force to expand the stent once it is placed at the treatment area. The inner layer 15 acts as a flow diversion component, reducing “leakage” from the blood vessel in the case of aneurysm treatment, or maintaining artery diameter in the case of intracranial stenosis treatment.

[0017] FIG. 2 shows a tensile strength test of a thin film PLA polymer as used in disclosed embodiments. The test results demonstrate the ability of the biodegradable polymer to resist increasing strain before failure, and illustrates the polymer’s suitability for use with the self-expanding spring expansion layer.

[0022]

[0018] FIG. 3 shows a disclosed “layered” embodiment with the biodegradable polymer flow diversion component 32 layered around the radial force-providing expansion component 34 and the mandrel at 36.

[0023]

[0019] FIG. 4 shows a disclosed “embedded” embodiment with the biodegradable polymer flow diversion component 42 encasing the radial force-providing expansion component 44.

[0024]

[0020] FIG. 5 shows a cross-section of the stent of FIG. 3 with the biodegradable polymer flow diversion component 32 layered around the radial force-providing expansion component 34 as the flow diversion component 32 degrades over time. FIG. 5A shows the stent shortly after implantation, while FIG. 5B shows the flow diversion layer 32 reduced after a period of time, and FIG. 5C shows flow diversion layer 32 completely degraded.

[0025]

[0021] FIG. 6 shows a cross-section of the stent of FIG. 4 with the biodegradable polymer flow diversion component 42 encasing the radial force-providing expansion component 44 as the flow diversion component 42 degrades over time. FIG. 6A shows the stent shortly after implantation, while FIG. 6B shows the flow diversion layer 42 reduced after a period of time, and FIG. 6C shows flow diversion layer 42 completely degraded.

[0026]

[0022] FIG. 7 shows a deployed stent of FIG. 3 with the biodegradable polymer flow diversion component 32 layered around the radial force-providing expansion component 34 spanning an aneurysm 70 in a blood vessel 72 as the stent degrades over time. FIG. 7A shows the stent shortly after implantation, while FIG. 7B shows the flow diversion layer 32 reduced after a period of time, and FIG. 7C shows flow diversion layer 32 completely degraded. DETAILED DESCRIPTION

[0027]

[0023] Definitions:

[0028]

[0024] “Administration,” or “to administer” means the step of giving (i.e. administering) a material or active agent or both to a subject.

[0029]

[0025] “Expansion component” means the stent component that applies the radial force to open the stent after placement. This is typically the outer layer of a two-component stent.

[0030]

[0026] “Flow diversion component” means the stent component that delineates the desired flow path. This is typically the inner layer of a two-component stent.

[0031]

[0027] “Patient” means a human or non-human subject receiving medical or veterinary care.

[0032]

[0028] “Therapeutically effective amount” means the level, amount or concentration of an agent, material, or composition needed to treat a disease, disorder or condition without causing significant negative or adverse side effects.

[0033]

[0029] “Treat,” “treating,” or “treatment” means an alleviation or a reduction (which includes some reduction, a significant reduction, a near total reduction, and a total reduction), resolution or prevention (temporarily or permanently) of a symptom, disease, disorder or condition, so as to achieve a desired therapeutic or cosmetic result, such as by healing of injured or damaged tissue, or by altering, changing, enhancing, improving, ameliorating and / or beautifying an existing or perceived disease, disorder or condition. Treatment can include non-surgical intervention in the form of counseling or behavior modification.

[0034]

[0030] Stents

[0035]

[0031] As seen in FIG. 1 , many current stents are formed from separate components; typically an outer expansion layer (or component) 12 that applies a radial force to the stent (to aid in stent expansion), and an inner flow diversion layer (or component) 15 that directs blood flow (the inner flow diversion layer is a finer mesh than the outer expansion layer). These devices are typically made from metals, and as these metals degrade inside the body, they can create toxicities both in the tissue surrounding the treatment site as well as systemically.

[0036]

[0032] In contrast, disclosed embodiments comprise a reduced metal content, thereby reducing or eliminating this risk. For example, disclosed embodiments can comprise a metal content by mass of 10%, 20%, 30%, 40% 50%, 60%, 70%, 80%, 90%, or 100% less than current devices. In embodiments, the reduction in metal mass as compared to current devices is at least 10%, at least 20%, at least 30%, at least 40% at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or the like.

[0037]

[0033] Further, disclosed embodiments can comprise a metal content by volume of 10%, 20%, 30%, 40% 50%, 60%, 70%, 80%, 90%, or 100% less than current devices. In embodiments, the reduction in metal volume as compared to current devices is at least 10%, at least 20%, at least 30%, at least 40% at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or the like.

[0038]

[0034] In disclosed embodiments, the metals are replaced by a biodegradable component, for example a biodegradable polymer component. Disclosed embodiments can comprise any appropriate biodegradable polymer. For example, disclosed embodiments can comprise at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), polypropylene, and combinations thereof.

[0039]

[0035] For example, in disclosed two-layer stent embodiments, a metal expansion layer can surround a biodegradable polymer inner flow diversion layer. After placement, as the metal layer expands the attached biodegradable polymer expands with it, the providing a flow path. Disclosed embodiments can comprise at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), polypropylene, and combinations thereof. In embodiments, the metal expansion layer can comprise at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, and tantalum alloys.

[0040]

[0036] In disclosed three-layer embodiments, an outer biodegradable layer can surround a central expansion layer 34 which in turn surrounds a further inner biodegradable flow diversion layer 32 as seen in FIG. 3. FIG. 5 shows a cross-section of the stent of FIG. 3 as it degrades over time. FIG. 5A shows the stent shortly after implantation, while FIG. 5B shows the flow diversion layer 32 reduced after a period of time, and FIG. 5C shows flow diversion layer 32 completely degraded.

[0041]

[0037] Disclosed embodiments can comprise at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), polypropylene, and combinations thereof. In embodiments, the metal expansion layer can comprise at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, and tantalum alloys.

[0042]

[0038] While multi-layer devices are contemplated for use in disclosed embodiments, disclosed devices can also comprise a single-layer design, for example wherein the metal expansion component 44 is embedded within a biodegradable flow diversion layer 42 as seen in FIG. 4. Disclosed embodiments can comprise at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), polypropylene, and combinations thereof. In embodiments, the metal expansion component can comprise at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, and tantalum alloys.

[0043]

[0039] FIG. 6 shows a cross-section of the stent of FIG. 4 with the biodegradable polymer flow diversion component 42 encasing the radial force-providing expansion component 44 as the flow diversion component 42 degrades over time. FIG. 6A shows the stent shortly after implantation, while FIG. 6B shows the flow diversion layer 42 reduced after a period of time, and FIG. 6C shows flow diversion layer 42 completely degraded.

[0044]

[0040] FIG. 7 shows a deployed stent of FIG. 3 with the biodegradable polymer flow diversion component 32 layered around the radial force-providing expansion component 34 spanning an aneurysm 70 in a blood vessel 72 as the flow diversion component 32 degrades over time. FIG. 7A shows the stent shortly after implantation, while FIG. 7B shows the flow diversion layer 32 reduced after a period of time, and FIG. 7C shows flow diversion layer 32 completely degraded.

[0045]

[0041] In embodiments, the thickness of the biodegradable polymer layer can be, for example, 50 pm, 60 pm, 70 pm, 80 pm, 90 pm, 100 pm, or the like. In embodiments, the thickness of the biodegradable polymer layer can be, for example, at least 50 pm, at least 60 pm, at least 70 pm, at least 80 pm, at least 90 pm, at least 100 pm, or the like.

[0046]

[0042] In embodiments, the thickness of the biodegradable polymer layer can be, for example, not more than 50 pm, not more than 60 pm, not more than 70 pm, not more than 80 pm, not more than 90 pm, not more than 100 pm, or the like.

[0047]

[0043] Further embodiments can comprise a drug elution component.

[0048]

[0044] In embodiments, disclosed stents can degrade along a predetermined timeline. For example, in embodiments, the ratio of biodegradable polymer to metal (if present) can determine the degradation rate. Disclosed embodiments comprise adjusting the ratio of biodegradable polymer to metal (if present) to produce stents with a monthly degradation rate of, for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%.

[0049]

[0045] Methods of Manufacture

[0050]

[0046] Further disclosed embodiments relate to methods for producing a biodegradable stent according to the present disclosure. For example, a disclosed stent can be produced by embedding an expansion component to apply a radial force within a biodegradable polymer layer, which is then used to form the “tube” of the stent body. The force-applying expansion component can comprise a metal alloy such as nitinol, or can comprise a biodegradable polymer such as polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), polypropylene, and combinations thereof. In this manner, the device comprises a single layer.

[0051]

[0047] In embodiments, the biodegradable material can be applied to a metal expansion layer, for example by dip-coating. In further embodiments, the biodegradable material can be formed as a sheet, for example between 50 and 100 urn, then “wrapped” around the metal expansion layer.

[0052]

[0048] Disclosed methods can comprise manufacture of a stent designed to degrade at a predetermined rate. For example, in embodiments, the ratio of biodegradable polymer to metal (if present) can determine the degradation rate. Disclosed embodiments comprise adjusting the ratio of biodegradable polymer to metal (if present) to produce stents with a monthly degradation rate of, for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%.

[0053]

[0049] Methods of Use

[0054]

[0050] Methods of use of disclosed embodiments can comprise application to a site where direction of blood flow is to be modified or maintained. For example, disclosed methods comprise application of a disclosed device to a site where blood flow is desired to be reduced as described generally below: a. A surgeon inserts a small tube in the leg of an anesthetized patient and carefully guides a narrow, flexible catheter through the blood vessels of the body to the brain. b. The catheter system is like a telescope, narrowing the further it goes. The stent, which comes in a range of sizes, is loaded into the very end of the catheter. c. When the catheter reaches the brain, the surgeon positions it inside the blood vessel where the aneurysm is present without entering the fragile aneurysm sac. d. The stent is put in place and blood flow is immediately rerouted. The surgeon withdraws the catheter and monitors patient blood flow to ensure the stent is in proper position. e. The surgical team monitors the patient carefully over the next 12 - 24 months as new cells rebuild the blood vessel where the aneurysm occurred.

[0055]

[0051] Similarly, in treatment of intracranial stenosis, the stent can be positioned using a catheter to a location where artery diameter is to be maintained.

[0056]

[0052] Disclosed embodiments can further comprise the use of computerized tomography (CT), a cerebrospinal fluid test, magnetic resonance imaging (MRI), cerebral angiogram, and combinations thereof. Disclosed embodiments can further comprise counseling to encourage the discontinuation of drug use or smoking, as well as the adoption of an exercise program.

[0057]

[0053] Further disclosed methods of treatment can comprise the administration of drugs to aid in recovery or improve patient comfort. In embodiments, in addition to stent emplacement the patient is administered a therapeutically effective amount of a drug.

[0058]

[0054] Disclosed embodiments also provide more efficient flow diversion. For example, in embodiments, the solid biodegradable polymer flow diversion component provides increased flow diversion as compared to current mesh flow diversion components (see FIG. 1 ). Disclosed embodiments can provide flow diversion performance of 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% greater than that of current devices.

[0055] Disclosed methods can comprise use of a stent designed to degrade at a predetermined rate. For example, in embodiments, the ratio of biodegradable polymer to metal (if present) can determine the degradation rate. Disclosed embodiments comprise use of a stent with a specific ratio of biodegradable polymer to metal (if present) to produce a monthly degradation rate of, for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%. In embodiments, the degradation rate of the stent can be based upon the patient’s projected treatment duration.

[0059]

[0056] Thus, disclosed embodiments provide improved tools for treatment. These methods are further described in the following Examples.

[0060]

[0057] Commercial Products / Kits

[0061]

[0058] The present devices can be finished as a commercial product by the usual steps performed in the present field, for example by appropriate sterilization and packaging steps. For example, the present material may be treated by UV / vis irradiation (200-500 nm), for example using photo-initiators with different absorption wavelengths (e.g. Irgacure 184, 2959), preferably water-soluble initiators (Irgacure 2959). Such irradiation is usually performed for an irradiation time of 1 -60 min, but also longer irradiation times may be applied, depending on the specific method. The material according to the present disclosure can be finally sterile-wrapped so as to retain sterility until use and packaged (e.g. by the addition of specific product information leaflets) into suitable containers (boxes, etc.).

[0062]

[0059] According to further embodiments, disclosed devices can also be provided in kit form combined with other components necessary for administration of the device to the patient. The kits are designed in various forms based on the specific deficiencies they are designed to treat.

[0063] EXAMPLES

[0064]

[0060] The following non-limiting Examples are provided for illustrative purposes only in order to facilitate a more complete understanding of representative embodiments. This example should not be construed to limit any of the embodiments described in the present specification.

[0065] Example 1

[0066] Stent Manufacture

[0067]

[0061] The expansion component of a disclosed stent is dip coated in a PLA polymer. The coating formed is 100 pm thick and encases the metal expansion component.

[0068] Example 2

[0069] Stent Manufacture

[0070]

[0062] The expansion component of a disclosed stent is dip coated in a PCL polymer. The coating formed is 80 pm and encases the metal expansion component.

[0071] Example 3

[0072] Stent Manufacture

[0073]

[0063] The expansion component of a disclosed stent is “sandwiched” between two PLA polymer layers. The polymer layers are 100 pm thick.

[0074] Example 4

[0075] Treatment of Aneurysm

[0076]

[0064] A surgeon inserts a small tube in the leg of an anesthetized patient and carefully guides a narrow, flexible catheter through the blood vessels of the body to the brain. The catheter system is like a telescope, narrowing the further it goes. The dip-coated stent (with the PLA polymer encasing the nitinol expansion component; see FIG. 4) is loaded into the end of the catheter.

[0077]

[0065] When the catheter reaches the brain, the surgeon positions it inside the blood vessel where the aneurysm is present without entering the fragile aneurysm sac. The stent is put in place and blood flow is rerouted. The surgeon withdraws the catheter and monitors patient blood flow to ensure the stent is in proper position. The surgical team monitors the patient carefully over the next 12 - 24 months as new cells rebuild the blood vessel where the aneurysm occurred.

[0078] Example 5

[0079] Treatment of Aneurysm

[0080]

[0066] A surgeon inserts a small tube in the leg of an anesthetized patient and carefully guides a narrow, flexible catheter through the blood vessels of the body to the brain. The catheter system is like a telescope, narrowing the further it goes. The dip-coated stent (with the PCL polymer encasing the stainless steel expansion component; see FIG. 4) is loaded into the end of the catheter.

[0081]

[0067] When the catheter reaches the brain, the surgeon positions it inside the blood vessel where the aneurysm is present without entering the fragile aneurysm sac. The stent is put in place and blood flow is rerouted. The surgeon withdraws the catheter and monitors patient blood flow to ensure the stent is in proper position. The surgical team monitors the patient carefully over the next 12 - 24 months as new cells rebuild the blood vessel where the aneurysm occurred.

[0082] Example 6

[0083] Treatment of Aneurysm

[0084]

[0068] A surgeon inserts a small tube in the leg of an anesthetized patient and carefully guides a narrow, flexible catheter through the blood vessels of the body to the brain. The catheter system is like a telescope, narrowing the further it goes. The dip-coated stent (with the PLA polymer encasing the nitinol expansion component; see FIG. 4) is loaded into the end of the catheter.

[0085]

[0069] When the catheter reaches the brain, the surgeon positions it inside the blood vessel where the aneurysm is present without entering the fragile aneurysm sac. The stent is put in place and blood flow is rerouted. The surgeon withdraws the catheter and monitors patient blood flow to ensure the stent is in proper position.

[0086]

[0070] In closing, it is to be understood that although aspects of the present specification are highlighted by referring to specific embodiments, one skilled in the art will readily appreciate that these disclosed embodiments are only illustrative of the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is in no way limited to a particular methodology, protocol, and / or reagent, etc., described herein. As such, various modifications or changes to or alternative configurations of the disclosed subject matter can be made in accordance with the teachings herein without departing from the spirit of the present specification. Lastly, the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present disclosure, which is defined solely by the claims. Accordingly, embodiments of the present disclosure are not limited to those precisely as shown and described.

[0087]

[0071] Certain embodiments are described herein, comprising the best mode known to the inventor for carrying out the methods and devices described herein. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. Accordingly, this disclosure comprises all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described embodiments in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

[0088]

[0072] Groupings of alternative embodiments, elements, or steps of the present disclosure are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be comprised in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0089]

[0073] Unless otherwise indicated, all numbers expressing a characteristic, item, quantity, parameter, property, term, and so forth used in the present specification and claims are to be understood as being modified in all instances by the term “about.” As used herein, the term “about” means that the characteristic, item, quantity, parameter, property, or term so qualified encompasses a range of plus or minus ten percent above and below the value of the stated characteristic, item, quantity, parameter, property, or term. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the specification and attached claims are approximations that may vary. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical indication should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and values setting forth the broad scope of the disclosure are approximations, the numerical ranges and values set forth in the specific examples are reported as precisely as possible. Any numerical range or value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Recitation of numerical ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate numerical value falling within the range. Unless otherwise indicated herein, each individual value of a numerical range is incorporated into the present specification as if it were individually recited herein.

[0090]

[0074] The terms “a,” “an,” “the” and similar referents used in the context of describing the disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the disclosure and does not pose a limitation on the scope otherwise claimed. No language in the present specification should be construed as indicating any non-claimed element essential to the practice of embodiments disclosed herein.

[0091]

[0075] Specific embodiments disclosed herein may be further limited in the claims using consisting of or consisting essentially of language. When used in the claims, whether as filed or added per amendment, the transition term “consisting of” excludes any element, step, or ingredient not specified in the claims. The transition term “consisting essentially of” limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s). Embodiments of the present disclosure so claimed are inherently or expressly described and enabled herein.

Claims

CLAIMS1. A stent comprising an expansion component and a flow diversion component, said flow diversion component comprising a biodegradable material.

2. The stent of claim 1 , wherein said biodegradable material comprises at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3- hydroxyvalerate) (PHVB), polypropylene.

3. The stent of claim 2, wherein said flow diversion component surrounds said expansion component.

4. The stent of claim 2, wherein said flow diversion component is layered on said expansion component.

5. The stent of claim 2, wherein said expansion component comprises at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, and tantalum alloys.

6. The stent of claim 2, wherein said expansion component comprises at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3- hydroxyvalerate) (PHVB), polypropylene.

7. A method of directing blood flow in a vessel, comprising applying a stent comprising: an expansion component; anda flow diversion component, said flow diversion component comprising a biodegradable material; wherein said stent is applied to a location inside the vessel where blood flow is to be directed.

8. The method of claim 7, wherein said biodegradable material comprises at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate- co-3-hydroxyvalerate) (PHVB), polypropylene.

9. The method of claim 8, wherein said flow diversion component surrounds said expansion component.

10. The method of claim 8, wherein said flow diversion component is layered on said expansion component.

11. The method of claim 8, wherein said expansion component comprises at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, and tantalum alloys.

12. The method of claim 8, wherein said expansion component comprises at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate- co-3-hydroxyvalerate) (PHVB), polypropylene.

13. A kit comprising a stent comprising: an expansion component and a flow diversion component, said flow diversion component comprising a biodegradable material; and instructions for use.

14. The kit of claim 13, wherein said biodegradable material comprises at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3- hydroxyvalerate) (PHVB), polypropylene.

15. The kit of claim 13, wherein said flow diversion component surrounds said expansion component.

16. The kit of claim 13, wherein said flow diversion component is layered on said expansion component.

17. The kit of claim 13, wherein said expansion component comprises at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, and tantalum alloys.

18. A stent comprising an expansion component and means for flow diversion, said means for flow diversion comprising a biodegradable material.

19. The stent of claim 18, wherein said biodegradable material comprises at least one of polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate- co-3-hydroxyvalerate) (PHVB), polypropylene.

20. The stent of claim 18, wherein said expansion component comprises at least one of stainless steel (316L), cobalt-chromium alloys, nickel-titanium alloy (nitinol), platinum, tantalum alloys, polylactic acid (PLA), polyamide (PA), polybutylene adipate terephthalate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL),polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoate (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), polypropylene.

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