Biodegradable stents, methods of making the same, and uses thereof

Abstract

The present disclosure provides a novel class of stents with improved performance and increased ease of manufacture and use. Embodiments disclosed herein include stents, such as blood flow diverting stents, with reduced metal content compared to existing devices. This can reduce the risk of toxicity from metal degradation in the body, for example in the brain.

Description

[0001] Cross-references to related applications 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. Technical Field

[0002] This manual relates to the production and use of biodegradable scaffolds. Background Technology

[0003] An aneurysm is a "bulge" in a blood vessel caused by a weak point in the vessel wall (often at a branch point). When blood flows through a weak vessel, blood pressure can cause a small area to bulge outward like a balloon.

[0004] A cerebral aneurysm can leak or rupture, causing intracranial hemorrhage (hemorrhagic stroke). A ruptured cerebral aneurysm most commonly occurs in the space between the brain and the thin layer of tissue covering it. This type of hemorrhagic stroke is called a subarachnoid hemorrhage. A ruptured aneurysm can be life-threatening and requires immediate medical attention.

[0005] However, preventative treatment can often limit further complications, and common treatments for brain aneurysms include the use of a stent (a flexible mesh tube). For example, "flow diversion" is a technique where a surgeon uses a catheter to place a stent into the blood vessel where an aneurysm has formed. This process redirects blood flow away from the aneurysm itself. Rerouting the blood flow reduces pressure on the aneurysm, decreasing the likelihood of it rupturing. Over time, new cells grow on the stent, eventually closing the aneurysm and repairing the vessel. If the stent covers the opening of a branch extending from the vessel, normal blood flow prevents cells from growing on that part of the stent and blocking the branch, thus eliminating the risk of the stent cutting off blood supply to other areas of the brain.

[0006] While effective, current scaffold materials often contain metals because non-metallic components cannot provide sufficient mechanical support. However, metals and alloys are susceptible to corrosion, and corrosion of scaffolds poses two main risks: the release of metal ions into the tissue and the deterioration of the scaffold's mechanical properties, which can lead to fracture. This diffusion can be toxic. Furthermore, the use of metals in implantable devices such as scaffolds can present manufacturing challenges in terms of cost, workload, and environmental impact.

[0007] Furthermore, although the stent can affect blood flow, the stent's mesh-like blood flow guiding structure limits the stent's ability to control blood flow.

[0008] Therefore, improved methods are needed. Summary of the Invention

[0009] This disclosure provides a novel class of stents with improved performance and increased ease of manufacture and use. The embodiments disclosed herein include stents, such as flow-directing stents, which have a reduced metal content compared to existing devices. This can reduce the risk of toxicity from metal degradation in vivo, such as in the brain.

[0010] In embodiments, the metal content is reduced by replacing the metal with a biodegradable component, the degradation of which does not lead to toxicity. For example, in embodiments, metals (such as nitinol) are replaced by biodegradable polymers such as polylactic acid (PLA). Biodegradable metals may also be used in embodiments. In embodiments, the metal content is replaced by "shape memory" polymers. The use of the biodegradable polymers disclosed herein offers significant advantages to device manufacturers, physicians, and patients.

[0011] The embodiments disclosed herein include methods of using the stents disclosed herein. For example, in one embodiment, the stents disclosed herein can be used to treat aneurysms. The stents disclosed herein can also be used to treat intracranial arterial stenosis. In addition to the inherent reduced toxicity benefits of the stents disclosed herein, they can block, rather than simply restrict, blood flow in the treatment area. Therefore, the embodiments disclosed herein provide physicians with improved devices; for example, this disclosure enables practitioners to tailor the degradation time of the devices disclosed herein to match patient needs, such as aneurysm contraction.

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

[0013] The embodiments disclosed herein include methods for manufacturing the disclosed stent. For example, in one embodiment, the stent disclosed herein can be manufactured using a dip-coating process. Alternatively, the stent disclosed herein can be manufactured by forming a layer of biodegradable polymer material and then “wrapping” this material around an expansion layer.

[0014] Compared to the manufacture of traditional metal-based scaffolds, the embodiments disclosed herein can reduce manufacturing time and cost, as well as environmental impact. For example, devices comprising an expansion layer embedded within a biodegradable flow-guiding layer eliminate the need for finely machined flow-guiding components (such as in...). Figure 1 (As seen in the text).

[0015] The embodiments disclosed herein include kits containing the support structure disclosed herein. For example, in one embodiment, the support structure disclosed herein may be sterilized and packaged together with an instruction manual. Attached Figure Description

[0016] Figure 1 A conventional double-layer stent is shown. The outer "expansion" component, or layer 12, is a self-expanding spring that applies a radial force to expand the stent once it is placed in the treatment area. The inner layer 15 acts as a diversion component, thereby reducing "leakage" from the vessel in the case of aneurysm treatment, or maintaining the arterial diameter in the case of intracranial artery stenosis treatment.

[0017] Figure 2 Tensile strength tests of the thin-film PLA polymer used in the embodiments disclosed herein are shown. The test results demonstrate that the biodegradable polymer is able to resist increasing strain before failure, illustrating that the polymer is suitable for use with self-expanding spring expansion layers.

[0018] Figure 3 The “layered” implementation disclosed herein is shown, wherein the biodegradable polymer flow guide 32 is layered around the expansion member 34 and the mandrel 36 that provide radial force.

[0019] Figure 4 An “embedded” implementation disclosed herein is shown, wherein a biodegradable polymer flow guide 42 encloses an expansion member 44 that provides radial force.

[0020] Figure 5 illustrates the degradation of the biodegradable polymer flow guide 32 over time. Figure 3 The cross-sectional view of the support, wherein the flow guiding component 32 is stacked around the expansion component 34 that provides radial force. Figure 5A The stent was shown shortly after implantation, and Figure 5B It shows that the flow layer 32 decreases after a certain period of time, and Figure 5C This shows that the flow guide layer 32 has been completely degraded.

[0021] Figure 6 illustrates the degradation of the biodegradable polymer flow guide 42 over time. Figure 4 The cross-sectional view of the support, wherein the flow guide 42 encloses the expansion member 44 that provides radial force. Figure 6A The stent was shown shortly after implantation, and Figure 6B It shows that the flow layer 42 decreased after a certain period of time, and Figure 6C This shows that the flow guide layer 42 has completely degraded.

[0022] Figure 7 illustrates the degradation of the stent over time. Figure 3In the case of an expanded stent, a biodegradable polymer diversion component 32 is stacked around an expansion component 34 that provides radial force across an aneurysm 70 in a blood vessel 72. Figure 7A The stent was shown shortly after implantation, and Figure 7B It shows that the flow layer 32 decreases after a certain period of time, and Figure 7C This shows that the flow guide layer 32 has been completely degraded. Detailed Implementation

[0023] definition: "Administration" or "administer" refers to the procedure of giving (i.e., administering) a material or active agent, or both, to a subject.

[0024] An "expansion component" is a support component that applies radial force after placement to open the support. This is typically the outer layer of a two-component support.

[0025] A "flow diversion component" refers to a support component used to define the desired flow path. This is typically the inner layer of a two-component support.

[0026] "Patient" refers to a human or non-human subject receiving medical or veterinary care.

[0027] "Therapeutically effective amount" refers to the level, quantity, or concentration of a reagent, material, or composition required to treat a disease, ailment, or condition without causing significant negative or adverse side effects.

[0028] "Treatment" refers to the reduction or alleviation (including some reduction, significant reduction, near-complete reduction, and complete reduction), resolution, or prevention (temporary or permanent) of symptoms, diseases, ailments, or conditions to achieve a desired therapeutic or cosmetic outcome, such as by healing injured or damaged tissue, or by altering, modifying, enhancing, improving, alleviating, and / or beautifying existing or perceived diseases, ailments, or conditions. Treatment may include non-surgical interventions in the form of counseling or behavioral modification.

[0029] support As in Figure 1As seen in the diagram, many current stents are formed from separate components; typically an outer expansion layer (or component) 12 that applies radial force to the stent (to assist stent expansion), and an inner diversion layer (or component) 15 that guides blood flow (the inner diversion layer is a finer mesh than the outer expansion layer). These devices are typically made of metal, and when these metals degrade in the body, they can produce toxicity in the tissues surrounding the treatment site and throughout the body.

[0030] In contrast, the embodiments disclosed herein include reduced metal content, thereby reducing or eliminating this risk. For example, the embodiments disclosed herein may contain 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% less metal by weight than current equipment. In the embodiments, the reduction in metal mass compared to current equipment 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%, etc.

[0031] Furthermore, the embodiments disclosed herein may include a metal content that is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% less by volume than that of the current device. In the embodiments, the reduction in metal volume compared to the current device 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%, etc.

[0032] In the embodiments disclosed herein, the metal is replaced by a biodegradable component, such as a biodegradable polymer component. The embodiments disclosed herein may include any suitable biodegradable polymer. For example, the embodiments disclosed herein may include at least one of the following: 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.

[0033] For example, in the dual-layer scaffold embodiments disclosed herein, a metal expansion layer may surround an inner flow-guiding layer of biodegradable polymer. Upon placement, as the metal layer expands, the attached biodegradable polymer also expands, thereby providing a flow path. The embodiments disclosed herein may include at least one of the following: 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 an embodiment, the metal expansion layer may comprise at least one of the following: stainless steel (316L), cobalt-chromium alloy, nickel-titanium alloy (Nitinol), platinum, and tantalum alloy.

[0034] In the three-layer embodiment disclosed herein, the outer biodegradable layer may surround the central expansion layer 34, which in turn surrounds another inner biodegradable flow-guiding layer 32, as in Figure 3 As seen in Figure 5. Figure 3 The cross-section of the stent as it degrades over time. Figure 5A The stent was shown shortly after implantation, and Figure 5B It shows that the flow layer 32 decreases after a certain period of time, and Figure 5C This shows that the flow guide layer 32 has been completely degraded.

[0035] The embodiments disclosed herein may include at least one of the following: 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 may comprise at least one of the following: stainless steel (316L), cobalt-chromium alloy, nickel-titanium alloy (Nitinol), platinum, and tantalum alloy.

[0036] While multi-layer devices are contemplated for use in the embodiments disclosed herein, the devices disclosed herein may also include single-layer designs, such as those in which the metal expansion member 44 is embedded within the biodegradable flow guide layer 42, as in Figure 4The embodiments disclosed herein may include at least one of the following: 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 member may include at least one of the following: stainless steel (316L), cobalt-chromium alloy, nickel-titanium alloy (Nitinol), platinum, and tantalum alloy.

[0037] Figure 6 illustrates the degradation of the biodegradable polymer flow guide 42 over time. Figure 4 The cross-section of the support, wherein the flow guide 42 encloses the expansion member 44 that provides radial force. Figure 6A The stent was shown shortly after implantation, and Figure 6B It shows that the flow layer 42 decreased after a certain period of time, and Figure 6C This shows that the flow guide layer 42 has completely degraded.

[0038] Figure 7 shows the degradation of the flow guide component 32 over time. Figure 3 The unfolded stent, wherein a biodegradable polymer flow guide 32 is stacked around an expansion member 34 that provides radial force across an aneurysm 70 in a blood vessel 72. Figure 7A The stent was shown shortly after implantation, and Figure 7B It shows that the flow layer 32 decreases after a certain period of time, and Figure 7C This shows that the flow guide layer 32 has been completely degraded.

[0039] In some embodiments, the thickness of the biodegradable polymer layer can be, for example, 50 µm, 60 µm, 70 µm, 80 µm, 90 µm, 100 µm, etc. In other embodiments, the thickness of the biodegradable polymer layer can be, for example, at least 50 µm, at least 60 µm, at least 70 µm, at least 80 µm, at least 90 µm, at least 100 µm, etc.

[0040] In the embodiments, the thickness of the biodegradable polymer layer may be, for example, no more than 50 µm, no more than 60 µm, no more than 70 µm, no more than 80 µm, no more than 90 µm, no more than 100 µm, etc.

[0041] Another implementation may include a drug elution component.

[0042] In embodiments, the stents disclosed herein can degrade along a predetermined timeline. For example, in embodiments, the ratio of the biodegradable polymer to a metal (if present) can determine the degradation rate. Embodiments disclosed herein include adjusting the ratio of the biodegradable polymer to a metal (if present) to produce stents with monthly degradation rates of, for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%.

[0043] Manufacturing method Other disclosed embodiments relate to methods for producing biodegradable scaffolds according to this disclosure. For example, the scaffolds disclosed herein can be produced by embedding an expansion member for applying radial force within a biodegradable polymer layer, and then using the biodegradable polymer layer to form a "tube" of the scaffold body. The force-applying expansion component may comprise a metal alloy, such as nitinol, or may 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.

[0044] In one embodiment, a biodegradable material may be applied to the metal expansion layer, for example, by dip coating. In another embodiment, the biodegradable material may be formed as a sheet, for example, between 50 μm and 100 μm, and then “wrapped” around the metal expansion layer.

[0045] The methods disclosed herein may include manufacturing scaffolds designed to degrade at a predetermined rate. For example, in embodiments, the ratio of a biodegradable polymer to a metal (if present) can determine the degradation rate. Embodiments disclosed herein include adjusting the ratio of a biodegradable polymer to a metal (if present) to produce scaffolds with monthly degradation rates of, for example, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%.

[0046] How to use The methods of using the embodiments disclosed herein may include application to a site where the direction of blood flow needs to be changed or maintained. For example, the methods disclosed herein include applying the device disclosed herein to a site where blood flow needs to be reduced, as generally described below: a. The surgeon inserts a thin tube into the leg of an anesthetized patient and carefully guides the narrow, flexible catheter through the body's blood vessels to the brain.

[0047] b. The catheter system is like a telescope; it gets narrower as you go further in. A stent of a certain size is inserted into the very end of the catheter.

[0048] c. When the catheter reaches the brain, the surgeon will place it into the blood vessel containing the aneurysm, but not into the fragile aneurysm sac.

[0049] d. The stent is placed in the appropriate position, and blood flow is immediately redirected. The surgeon removes the catheter and monitors the patient's blood flow to ensure the stent is in the correct position.

[0050] e. Over the next 12 to 24 months, the surgical team will closely monitor the patient as new cells rebuild blood vessels at the site of the aneurysm.

[0051] Similarly, in treating intracranial arterial stenosis, a catheter can be used to position a stent at the location where the artery diameter needs to be maintained.

[0052] The embodiments disclosed herein may further include the use of computed tomography (CT), cerebrospinal fluid testing, magnetic resonance imaging (MRI), cerebral angiography, and combinations thereof. The embodiments disclosed herein may further include counseling to encourage cessation of medication use or smoking, and the adoption of exercise programs.

[0053] Other disclosed treatment methods may include administering medication to aid recovery or improve patient comfort. In this embodiment, in addition to stent placement, a therapeutically effective amount of medication is administered to the patient.

[0054] The embodiments disclosed herein also provide more efficient flow guidance. For example, in the embodiments, compared with current mesh flow guidance components (see...), Figure 1 Compared to conventional devices, solid biodegradable polymer flow-guiding components provide increased flow guidance. The embodiments disclosed herein can provide flow guidance performance that is 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% higher than current devices.

[0055] The methods disclosed herein may include using a stent designed to degrade at a predetermined rate. For example, in embodiments, the ratio of a biodegradable polymer to a metal (if present) can determine the degradation rate. Embodiments disclosed herein include using 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 stent degradation rate may be based on the patient's expected treatment duration.

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

[0057] Commercial products / kits The device of this invention can be manufactured as a commercial product through conventional steps performed in the art, such as appropriate sterilization and packaging steps. For example, the material of this invention can be treated with ultraviolet / visible radiation (200-500 nm), for example using photoinitiators with different absorption wavelengths (e.g., Irgacure 184, Irgacure 2959), preferably water-soluble initiators (Irgacure 2959). This irradiation is typically performed for 1-60 minutes, but longer irradiation times may be applied depending on the specific method. The material according to this disclosure can be finally aseptically packaged to remain sterile until use, and packaged (e.g., by adding specific product information instructions) into suitable containers (boxes, etc.).

[0058] According to another embodiment, the device disclosed herein may also be provided as a kit combined with other components necessary for applying the device to a patient. These kits are designed in various forms based on the specific defect that the kit is intended to treat.

[0059] Example The following non-limiting embodiments are provided for illustrative purposes only to help to provide a more comprehensive understanding of representative implementations. These embodiments should not be construed as limiting any of the implementations described in this specification.

[0060] Example 1 scaffold manufacturing The expansion component of the disclosed scaffold is dip-coated into a PLA polymer. The resulting coating is 100 µm thick and encapsulates the metal expansion component.

[0061] Example 2 scaffold manufacturing The expansion component of the disclosed scaffold is dip-coated in PCL polymer. The resulting coating is 80 µm thick and encapsulates the metal expansion component.

[0062] Example 3 scaffold manufacturing The expansion component of the disclosed scaffold is "clipped" between two PLA polymer layers. The polymer layers are 100 µm thick.

[0063] Example 4 Treatment of aneurysms The surgeon inserts a thin tube into the leg of an anesthetized patient and carefully guides the narrow, flexible catheter through the body's blood vessels to the brain. The catheter system acts like a telescope, narrowing as it goes deeper. A dip-coated stent (in which PLA polymer encapsulates nitinol expansion components; see...) is then inserted... Figure 4 Insert it into the end of the catheter.

[0064] Once the catheter reaches the brain, the surgeon places it inside the blood vessel containing the aneurysm, but not into the fragile aneurysm sac. A stent is then placed in the appropriate location, and blood flow is redirected. The surgeon removes the catheter and monitors the patient's blood flow to ensure the stent is in the correct position. For the next 12 to 24 months, the surgical team closely monitors the patient as new cells rebuild the blood vessel at the site of the aneurysm.

[0065] Example 5 Treatment of aneurysms The surgeon inserts a thin tube into the leg of an anesthetized patient and carefully guides the narrow, flexible catheter through the body's blood vessels to the brain. The catheter system acts like a telescope, narrowing as it goes deeper. A dip-coated stent (in which PCL polymer encapsulates stainless steel expansion components; see...) is then used. Figure 4 Insert it into the end of the catheter.

[0066] Once the catheter reaches the brain, the surgeon places it inside the blood vessel containing the aneurysm, but not into the fragile aneurysm sac. A stent is then placed in the appropriate location, and blood flow is redirected. The surgeon removes the catheter and monitors the patient's blood flow to ensure the stent is in the correct position. For the next 12 to 24 months, the surgical team closely monitors the patient as new cells rebuild the blood vessel at the site of the aneurysm.

[0067] Example 6 Treatment of aneurysms The surgeon inserts a thin tube into the leg of an anesthetized patient and carefully guides the narrow, flexible catheter through the body's blood vessels to the brain. The catheter system acts like a telescope, narrowing as it goes deeper. A dip-coated stent (in which PLA polymer encapsulates nitinol expansion components; see...) is then inserted... Figure 4 Insert it into the end of the catheter.

[0068] Once the catheter reaches the brain, the surgeon places it inside the blood vessel containing the aneurysm, but not into the fragile aneurysm sac. A stent is then placed in the correct position, and blood flow is redirected. The surgeon removes the catheter and monitors the patient's blood flow to ensure the stent is in the correct location.

[0069] Finally, it should be understood that although various aspects of this specification have been highlighted with reference to specific embodiments, those skilled in the art will readily understand that these disclosed embodiments merely illustrate the principles of the subject matter disclosed herein. Therefore, it should be understood that the disclosed subject matter is by no means limited to the specific methods, schemes, and / or reagents described herein. Consequently, various modifications, alterations, or alternative configurations can be made to the disclosed subject matter based on the teachings herein without departing from the spirit of this specification. Finally, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of this disclosure, which is defined only by the claims. Therefore, the embodiments of this disclosure are not limited to the exact embodiments shown and described.

[0070] This document describes certain embodiments, including the best mode known to the inventors for carrying out the methods and apparatus described herein. Of course, variations of these embodiments will become apparent to those skilled in the art upon reading the foregoing description. Therefore, this disclosure includes all modifications and equivalents of the subject matter described in the appended claims as permitted by applicable law. Furthermore, unless otherwise stated herein or clearly contradicted by the context, this disclosure covers any combination of all possible variations of the above embodiments.

[0071] The grouping of alternative embodiments, elements, or steps disclosed herein should not be construed as limiting. Each member of a group may be cited and claimed individually or in any combination with other members of the groups disclosed herein. It is anticipated that one or more members of a group may be included in or removed from the group for convenience and / or patentability reasons. When any such inclusion or removal occurs, the specification will be deemed to include the modified group, thereby satisfying the written description of all Markush groups as used in the appended claims.

[0072] Unless otherwise stated, all figures used in this specification and claims to represent characteristics, items, quantities, parameters, properties, terms, etc., shall be understood to be modified in all cases by the term "about". As used herein, the term "about" means that the characteristic, item, quantity, parameter, property, or term thus defined includes a range plus or minus 10% above or below the value of said characteristic, item, quantity, parameter, property, or term. Therefore, unless otherwise stated, the numerical parameters specified in the specification and appended claims are approximate values ​​that may vary. At least, and without attempt to limit the application of the doctrine of equivalence to the scope of the claims, each numerical indication should be interpreted at least according to the number of significant figures reported and by applying ordinary rounding techniques. Although the numerical ranges and values ​​listed in the broad scope of this disclosure are approximate, the numerical ranges and values ​​listed in the specific examples are reported as precisely as possible. However, any numerical range or value necessarily contains some error due to the standard deviation found in its corresponding test measurement. The listing of numerical ranges herein is intended only as a shorthand method for individually referring to each individual value falling within that range. Unless otherwise stated herein, each individual value within the numerical range is included in this specification as if it were listed separately in this specification.

[0073] The terms “a,” “an,” “the,” and similar designations used in the context of describing this disclosure (particularly in the context of the following claims) should be construed as encompassing both the singular and plural, unless otherwise stated herein or clearly contradicted by the context. All methods described herein may be performed in any suitable order unless otherwise stated herein or expressly provided by the context. The use of any example or exemplary language (e.g., “such as”) is intended only to better illustrate this disclosure and does not constitute a limitation on the scope of the claims. No language in this specification should be construed as indicating that any unclaimed element is essential to the practice of the embodiments disclosed herein.

[0074] The specific embodiments disclosed herein may be further limited in the claims by using the language of "consisting of" or "substantially consisting of". When used in the claims, whether in the original filing or as amended, the transitional term "consisting of" excludes any element, step, or component not specified in the claims. The transitional term "substantially consisting of" limits the scope of the claims to the specified materials or steps, and those materials or steps that do not substantially affect the basic and novel features. The embodiments of this disclosure thus claimed are inherently or explicitly described and implemented herein.

Claims

1. A stent comprising an expansion member and a flow guiding member, the flow guiding member comprising a biodegradable material.

2. The scaffold according to claim 1, wherein the biodegradable material comprises at least one of the following: polylactic acid (PLA), polyamide (PA), polybutylene adipate (PBAT), polybutylene succinate (PBS), polycaprolactone (PCL), polyethylene (PE), polyethylene terephthalate (PET), polyhydroxyalkanoates (PHA), poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHVB), and polypropylene.

3. The support according to claim 2, wherein the flow guiding member surrounds the expansion member.

4. The support according to claim 2, wherein the flow guiding component is stacked on the expansion component.

5. The bracket according to claim 2, wherein the expansion member comprises at least one of the following: stainless steel (316L), cobalt-chromium alloy, nickel-titanium alloy (Nitinol), platinum, and tantalum alloy.

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

7. A method for guiding blood flow within a blood vessel, the method comprising applying a stent, the stent comprising: Expansion components; and A flow guiding component, the flow guiding component comprising a biodegradable material; The stent is applied to the location within the blood vessel to guide blood flow.

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

9. The method of claim 8, wherein the flow guiding member surrounds the expansion member.

10. The method of claim 8, wherein the flow guiding component is stacked on the expansion component.

11. The method of claim 8, wherein the expansion member comprises at least one of the following: stainless steel (316L), cobalt-chromium alloy, nickel-titanium alloy (Nitinol), platinum, and tantalum alloy.

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

13. A kit, the kit including a support, the support comprising: An expansion component and a flow guiding component, wherein the flow guiding component comprises a biodegradable material; and Instruction manual.

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

15. The kit of claim 13, wherein the flow guiding member surrounds the expansion member.

16. The kit of claim 13, wherein the flow guiding component is stacked on the expansion component.

17. The kit of claim 13, wherein the expansion member comprises at least one of the following: stainless steel (316L), cobalt-chromium alloy, nickel-titanium alloy (Nitinol), platinum, and tantalum alloy.

18. A stent comprising an expansion member and a means for diverting fluid, the means for diverting fluid comprising a biodegradable material.

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

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

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