US20150282922A1 - Partially coated stents - Google Patents
Partially coated stents Download PDFInfo
- Publication number
- US20150282922A1 US20150282922A1 US14/680,593 US201514680593A US2015282922A1 US 20150282922 A1 US20150282922 A1 US 20150282922A1 US 201514680593 A US201514680593 A US 201514680593A US 2015282922 A1 US2015282922 A1 US 2015282922A1
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- United States
- Prior art keywords
- stent
- middle portion
- end portion
- biodegradeable
- biodegradable filament
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- Abandoned
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions
- the present disclosure pertains to medical devices, systems, and methods for using medical devices. More particularly, the present disclosure pertains to a partially coated stent.
- Stents are typically tubular endoprostheses used for supporting a diseased or traumatized lumen.
- stents may be used in body vessels such as in coronary or peripheral vasculature, an esophagus, trachea, bronchi, colon, biliary tract, urinary tract, prostate, brain, or in other bodily locations.
- stents can be permanent or temporary depending on the treatment requirements. Stents may be permanently retained in a patient's body, for example, or for an indeterminate amount of time. Further, some stents are designed to remain in a patient's body temporarily.
- stents migrate from the treatment location, for example, due to exposure to flow of bodily fluids or peristalsis.
- stents may be partially covered or uncovered, allowing tissue ingrowth into the stent.
- a stent comprises at least one biodegradable filament and a non-biodegradeable coating.
- the at least one biodegradable filament forms a stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion.
- the middle portion extends between the first and second end portions.
- the non-biodegradeable coating encapsulates the at least one biodegradable filament along the middle portion of the stent body.
- the non-biodegradeable coating forms a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion.
- the first and second end portions are uncoated.
- a stent comprises at least one biodegradable monofilament, a non-biodegradeable coating, and at least one retrieval loop.
- the at least one biodegradable monofilament forms a braided stent body.
- the braided stent body has a first end portion, a middle portion, and a second end portion opposite the first end portion.
- the middle portion extends between the first and second end portions.
- the non-biodegradeable coating encapsulates the at least one biodegradable monofilament along the middle portion of the braided stent body and forms a barrier such that non-biodegradeable coating prevents degradation of at least one biodegradable monofilament along the middle portion.
- the first and second end portions are uncoated.
- the retrieval loop is threaded through at least a portion of the middle portion of the braided stent body.
- FIG. 1 is a side-view of an embodiment of a stent in an expanded configuration.
- FIG. 2 is a side-view of the embodiment of FIG. 1 in an unexpanded configuration.
- FIG. 3 shows a side-view of an embodiment of a stent in an expanded configuration.
- references herein to “an embodiment,” “some embodiments,” “other embodiments,” etc., indicate that an embodiment includes a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment (or more embodiments), it should be understood that such feature, structure, or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless clearly evidenced or stated to the contrary.
- FIG. 1 is a side-view of a stent 100 that can be implanted in a body lumen (e.g., esophagus, vessel, trachea, bronchi, colon, biliary tract, urinary tract, prostate, brain, duodenum, or other tubular lumen or location) to treat various conditions.
- a body lumen e.g., esophagus, vessel, trachea, bronchi, colon, biliary tract, urinary tract, prostate, brain, duodenum, or other tubular lumen or location
- the stent 100 includes a stent body 102 having a first end portion 104 , a second end portion 106 , and a middle portion 108 extending between the first end portion 104 and the second portion 106 .
- the stent body 102 has a hollow, tubular structure defining a central lumen through which body fluid, such as mucus or blood, can pass.
- the stent 100 has an expanded configuration 202 and an unexpanded configuration 204 ( FIG. 2 ).
- the stent 100 In the unexpanded configuration 204 , the stent 100 has a radially reduced profile; in the expanded configuration 202 , the stent 100 has a radially increased profile which can conform to the geometry of a body lumen and, in some embodiments, expand the body lumen.
- the stent 100 may be delivered to a treatment location through an introducer sheath, endoscope, guide catheter, exterior tube, or via any other suitable delivery device. Further, the stent 100 can be delivered over a guide wire. During delivery, in at least some embodiments, the stent 100 is in the unexpanded configuration 204 .
- the stent 100 may assume the expanded configuration 202 within the body lumen.
- a cross-sectional area of at least a portion of the stent body 102 is greater than a cross-sectional area of at least a portion of the middle portion 108 .
- the cross-sectional area of either the first end portion 104 or the second end portion 106 is greater than at least a portion of the middle portion 108 .
- one or more of the first end portion 104 , the second end portion 106 , and the middle portion 108 have varying cross-sectional area.
- the stent 100 has one or more flared portions, for example flared ends.
- a first flared portion 118 extends along the entire length of first end portion 104 and along a portion of the middle portion 108 .
- a second flared portion 120 extends along the entire length of the second end portion 106 and along a portion of the middle portion 108 .
- the one or more flared portions may have an abrupt transition of cross-section or smooth transition.
- a physician may transition the stent 100 between the expanded configuration 202 and the unexpanded configuration 204 using an actuation mechanism, e.g., push-pull mechanism or balloon.
- an actuation mechanism e.g., push-pull mechanism or balloon.
- the stent 100 is self-expanding.
- the stent body 102 is formed by braiding one or more biodegradable filaments 110 .
- the one or more biodegradable filaments 110 have a monofilament structure.
- the biodegradable filaments 110 comprise a multi-filament structure.
- the biodegradable filaments 110 are braided in a helical pattern, although other arrangements are also suitable.
- the braiding pattern includes interstices 114 in between the biodegradable filaments 110 . The interstices 114 allow tissue ingrowth and thereby prevent or resist migration.
- the biodegradable filaments 110 may be formed using a suitable biodegradable material, particularly materials that may be formed into fibers or filaments. Further, in some embodiments, the biodegradable filaments 110 are flexible to allow formation of patterns or braiding, but also have suitable radial strength. Examples of such materials include, for example, poly(lactic-co-glycolic)acid, polyglycolic acid, polylactic acid, or the like. Such materials may degrade, disintegrated, or be absorbed in the body within a few weeks to few months, for example, 3, 4, 5, 6, 10, 12, 18 months.
- the stent 100 includes a non-biodegradeable coating 112 disposed on the filaments 110 of the middle portion 108 , encapsulating the biodegradable filaments 110 therealong.
- the non-biodegradeable coating 112 forms a barrier to prevent the biodegradable filaments 110 from degrading or being absorbed within the body.
- the non-biodegradeable coating 112 covers the biodegradable filaments 110 both on an outer surface and inner surface of the stent body 102 such that bodily fluids cannot readily degrade the filaments 110 along the middle portion 108 of the stent body 102
- the non-biodegradeable coating 112 is disposed such that the first and second end portions 104 , 106 of the stent body 102 remain uncoated.
- the stent 100 prior to implantation, is a partially coated stent.
- tissue is permitted to ingrow into these portions. The tissue ingrowth secures the stent 100 within the body lumen, preventing migration of the stent 100 .
- the uncoated first and second end portions 104 , 106 may biodegrade within the body lumen over a period of time, leaving behind a fully coated stent (e.g., the middle portion 108 ).
- the remaining stent 100 (e.g., the middle portion 108 ) does not have tissue grown into the interstices 114 and, consequently, a physician can retrieve and remove the stent 100 from the body lumen.
- the non-biodegradeable coating 112 can be disposed on the stent 100 in any desirable way.
- the entirety of the stent 100 is coated with the non-biodegradeable coating 112 except for the first flared portion 118 .
- the entirety of the stent 100 is coated with the non-biodegradeable coating 112 except for the second flared portion 120 .
- the entirety of the stent 100 is coated with the non-biodegradeable coating 112 except for the first flared portion 118 and the second flared portion 120 , for example as shown in FIG. 3 .
- the flared portions 118 , 120 degrade, leaving the remaining portion of the stent 100 (e.g., middle portion 108 ) behind.
- the non-biodegradeable coating 112 can be formed using any suitable technique, for example spray coating, dip coating, vapor deposition coating, extrusion, or a combination of these techniques.
- the non-biodegradeable coating 112 is applied and secured to the stent body 102 by adhesive bonding, conformal coating, or any suitable combination of these techniques, including a combination of adhesive bonding and conformal coating.
- the non-biodegradeable coating 112 is formed from a suitable biocompatible material.
- the non-biodegradeable coating 112 is an impermeable material that creates a barrier, preventing bodily fluid from coming into contact with encapsulated biodegradable filament 110 , thereby preventing biodegradation of middle portion 108 of the stent 100 .
- the non-biodegradeable coating 112 not only forms a barrier around the filament but also acts as a covering over the interstices 114 , thereby preventing tissue ingrowth and also preventing degradation of the 110 by bodily fluids. In this way, the middle portion 108 of the stent remains intact after degradation of the first and second ends 104 , 106 such that it can be removed from the body lumen.
- suitable materials for the non-biodegradeable coating 112 may include, but are not limited to, polyurethane (PU), polyethylene (PE), polytetrafluoroethylene (PTFE), or expanded polytetrafluoroethylene (ePTFE), polyolefins such as high density polyethylene (HDPE) and polypropylene (PP), polyolefin copolymers and terpolymers, polyethylene terephthalate (PET), polyesters, polyamides, polyurethaneureas and polycarbonates, polyvinyl acetate, thermoplastic elastomers including polyether-polyester block copolymers, polyvinyl chloride, polystyrene, polyacrylate, polymethacrylate, polyacrylonitrile, polyacrylamide, silicone resins, combinations and copolymers thereof.
- PU polyurethane
- PE polyethylene
- PTFE polytetrafluoroethylene
- ePTFE expanded polytetrafluoroethylene
- polyolefins
- the stent 100 includes one or more retrieval loops 116 a, 116 b to facilitate easy retrieval of non-degraded portion of the stent 100 .
- the retrieval loop(s) are routed through a portion of the middle portion 108 of the stent 100 , for example adjacent to the first or second end portion 104 , 106 .
- the retrieval loop(s) 116 a, 116 b may be gripped and pulled to retrieve the stent 100 from the body lumen.
- the retrieval loop(s) 116 a, 116 b may be pulled using a device such as, forceps (e.g., rat tooth foreceps). Any other suitable retrieval device can also be used.
- the first retrieval loop 116 a is longitudinally offset from the second retrieval loop 116 b.
- the stent 100 can be retrieved from either end.
- the retrieval loop(s) 116 a, 116 b are secured to an outer surface of the stent 100 or non-biodegradeable coating 112 , for example via an adhesive. In some embodiments, however, one or more retrieval loops 116 a, 116 b are routed through one or more of the interstices 114 . Further, in some embodiments, a portion of the retrieval loop(s) 116 a, 116 b may be braided into the structure of the stent 100 , forming an integral part of the stent structure. In some embodiments, one or more retrieval loop(s) 116 a, 116 b are formed from a biomaterial.
- one or more retrieval loop(s) 116 a, 116 b are formed from a non-biodegradable material. In some embodiments, one or more retrieval loop(s) 116 a, 116 b are formed from a shape memory material, such as a shape memory metal, for example a nickel-titanium alloy.
- a stent comprising:
- the stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion, the middle portion extending between the first and second end portions;
- non-biodegradeable coating encapsulating the at least one biodegradable filament along the middle portion of the stent body and forming a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion, wherein the first and second end portions are uncoated and biodegradeable.
- Statement 2 The stent of statement 1, wherein the at least one biodegradable filament is a monofilament.
- Statement 3. The stent of any one of the preceding statements, wherein the stent has an unexpanded configuration and an expanded configuration; in the expanded configuration, at least one of the first end portion and second end portion has a cross-sectional area greater than the cross-sectional area of at least a portion of the middle portion.
- Statement 4. The stent of statement 3, wherein, in the expanded configuration, at least a portion of the first end portion and at least a portion of the second end portion has a cross-sectional area greater than at least a portion of the cross-sectional area of the middle portion.
- the at least one biodegradable filament is formed from poly(lactic-co-glycolic) acid (PLGA), polylactic acid (PLA), polyglycolic acid (PGA), poly(ortho ester) (POE), poly(epsilon-caprolactone) (PCL), and polyhydroxybutyrate-valerate (PHBV), or polydioxanone (PDO).
- PLGA poly(lactic-co-glycolic) acid
- PLA polylactic acid
- PGA polyglycolic acid
- POE poly(ortho ester)
- PCL poly(epsilon-caprolactone)
- PHBV polyhydroxybutyrate-valerate
- PDO polydioxanone
- non-biodegradeable coating is formed from a silicone polymer, silicone copolymer, polyurethane, polystyrene-polyethylene/butylene-polystyrene (SEBS) copolymer, acrylate polymer, acrylate copolymer, methacrylate polymer, methacrylate copolymer, fluorinated polymer, (modified) ethylene-tetrafluoroethylene copolymer (ETFE) polymer, polytetrafluoroethylene (PTFE), poly(tetrafluoroethylene-co-hexafluoropropene) (FEP), polyvinylidene fluoride (PVDF), and combinations thereof.
- a silicone polymer silicone copolymer, polyurethane, polystyrene-polyethylene/butylene-polystyrene (SEBS) copolymer, acrylate polymer, acrylate copolymer, methacrylate polymer, methacrylate copolymer
- Statement 7. The stent of any one of the preceding statements further comprising at least one retrieval loop.
- Statement 8. The stent of statement 7, wherein at least a portion of the retrieval loop is routed through at least a portion of the middle portion.
- Statement 9. The stent of statement 7 further comprising a plurality of retrieval loops.
- Statement 10. The stent of statement 9, wherein the plurality of retrieval loops comprises a first retrieval loop and a second retrieval loop, the second retrieval loop threaded through at least a portion of the middle portion, the second retrieval loop being longitudinally offset from the first retrieval loop.
- Statement 11. The stent of statement 7, 8, 9, or 10 wherein the at least one retrieval loop is formed from a shape memory material.
- Statement 13 The stent of any one of the preceding statements further being an esophageal stent.
- Statement 14 The stent of any one of the preceding statements, wherein the at least one biodegradable filament is braided to form the stent body.
- Statement 15. The stent of any one of the preceding statements, wherein the stent body defines a plurality of interstices, the interstices being covered by the non-biodegradeable coating along the middle portion of the stent body, thereby preventing tissue ingrowth therealong.
- the stent body comprises a first flared portion, a portion of the first flared portion being coated with the non-biodegradeable coating and a portion of the flared portion being uncoated.
- Statement 17 The stent of statement 16, wherein the stent body comprises a second flared portion, a portion of the second flared portion being coated with the non-biodegradeable coating and a portion of the second flared portion being uncoated.
- Statement 18 The stent of statement 16, wherein the first and second flared portions are uncoated.
Abstract
A medical product comprises a biodegradable filament and a non-biodegradeable coating. The biodegradable filament forms a stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion. The middle portion extends between the first and second end portions. The non-biodegradeable coating encapsulates the at least one biodegradable filament along the middle portion of the stent body. The non-biodegradeable coating forms a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion. The first and second end portions are uncoated. After implantation, the end portions of the stent may biodegrade. The middle portion will not biodegrade due to its encapsulation by the non-biodegradeable coating.
Description
- This Application claims the benefit of and priority to U.S. Provisional Application No. 61/976,764, filed Apr. 8, 2014, the entire contents of which are herein incorporated by reference.
- The present disclosure pertains to medical devices, systems, and methods for using medical devices. More particularly, the present disclosure pertains to a partially coated stent.
- Stents are typically tubular endoprostheses used for supporting a diseased or traumatized lumen. For example, stents may be used in body vessels such as in coronary or peripheral vasculature, an esophagus, trachea, bronchi, colon, biliary tract, urinary tract, prostate, brain, or in other bodily locations.
- Generally, stents can be permanent or temporary depending on the treatment requirements. Stents may be permanently retained in a patient's body, for example, or for an indeterminate amount of time. Further, some stents are designed to remain in a patient's body temporarily.
- After implantation, in some cases, stents migrate from the treatment location, for example, due to exposure to flow of bodily fluids or peristalsis. In order to counteract migration, stents may be partially covered or uncovered, allowing tissue ingrowth into the stent.
- As discussed above, on occasion it may be useful to retrieve the stent previously deployed in a body lumen. In covered or partially covered stents, however, tissue ingrowth takes places and hence it becomes challenging to remove the stent from the body.
- Therefore, there remains a need for a stent that is less likely to migrate and can also be removed easily, as needed.
- In at least one embodiment, a stent comprises at least one biodegradable filament and a non-biodegradeable coating. The at least one biodegradable filament forms a stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion. The middle portion extends between the first and second end portions. The non-biodegradeable coating encapsulates the at least one biodegradable filament along the middle portion of the stent body. The non-biodegradeable coating forms a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion. The first and second end portions are uncoated.
- In at least one embodiment, a stent comprises at least one biodegradable monofilament, a non-biodegradeable coating, and at least one retrieval loop. The at least one biodegradable monofilament forms a braided stent body. The braided stent body has a first end portion, a middle portion, and a second end portion opposite the first end portion. The middle portion extends between the first and second end portions. The non-biodegradeable coating encapsulates the at least one biodegradable monofilament along the middle portion of the braided stent body and forms a barrier such that non-biodegradeable coating prevents degradation of at least one biodegradable monofilament along the middle portion. The first and second end portions are uncoated. The retrieval loop is threaded through at least a portion of the middle portion of the braided stent body.
- The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures and Detailed Description, which follow, more particularly exemplify these embodiments.
- A detailed description of the invention is hereafter described with specific reference being made to the drawings.
-
FIG. 1 is a side-view of an embodiment of a stent in an expanded configuration. -
FIG. 2 is a side-view of the embodiment ofFIG. 1 in an unexpanded configuration. -
FIG. 3 shows a side-view of an embodiment of a stent in an expanded configuration. - While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
- Definitions are provided for the following defined terms. It is intended that these definitions be applied, unless the context indicates otherwise.
- The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
- As used herein, the singular forms “a”, “an”, and “the” include plural references unless the context clearly indicates otherwise. As used herein, the term “or” is generally employed in its sense including “and/or” unless the context clearly evidences or indicates otherwise.
- References herein to “an embodiment,” “some embodiments,” “other embodiments,” etc., indicate that an embodiment includes a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment (or more embodiments), it should be understood that such feature, structure, or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless clearly evidenced or stated to the contrary.
- The following detailed description should be read with reference to the drawing(s). The drawing(s), which is/are not necessarily to scale, depict one or more illustrative embodiments and is/are not intended to limit the scope of the disclosure.
-
FIG. 1 is a side-view of astent 100 that can be implanted in a body lumen (e.g., esophagus, vessel, trachea, bronchi, colon, biliary tract, urinary tract, prostate, brain, duodenum, or other tubular lumen or location) to treat various conditions. As shown, thestent 100 includes astent body 102 having afirst end portion 104, asecond end portion 106, and amiddle portion 108 extending between thefirst end portion 104 and thesecond portion 106. In some embodiments, thestent body 102 has a hollow, tubular structure defining a central lumen through which body fluid, such as mucus or blood, can pass. - The
stent 100 has an expandedconfiguration 202 and an unexpanded configuration 204 (FIG. 2 ). In theunexpanded configuration 204, thestent 100 has a radially reduced profile; in the expandedconfiguration 202, thestent 100 has a radially increased profile which can conform to the geometry of a body lumen and, in some embodiments, expand the body lumen. Thestent 100 may be delivered to a treatment location through an introducer sheath, endoscope, guide catheter, exterior tube, or via any other suitable delivery device. Further, thestent 100 can be delivered over a guide wire. During delivery, in at least some embodiments, thestent 100 is in theunexpanded configuration 204. - After
stent 100 is delivered to the treatment location, thestent 100 may assume the expandedconfiguration 202 within the body lumen. In some embodiments, in the expandedconfiguration 202, a cross-sectional area of at least a portion of the stent body 102 (for example, both thefirst end portion 104 and the second end portion 106) is greater than a cross-sectional area of at least a portion of themiddle portion 108. In some embodiments, the cross-sectional area of either thefirst end portion 104 or thesecond end portion 106 is greater than at least a portion of themiddle portion 108. In some embodiments, one or more of thefirst end portion 104, thesecond end portion 106, and themiddle portion 108 have varying cross-sectional area. In some embodiments, thestent 100 has one or more flared portions, for example flared ends. In some embodiments, for example as shown inFIG. 1 , a firstflared portion 118 extends along the entire length offirst end portion 104 and along a portion of themiddle portion 108. Further, in some embodiments, a second flaredportion 120 extends along the entire length of thesecond end portion 106 and along a portion of themiddle portion 108. The one or more flared portions may have an abrupt transition of cross-section or smooth transition. - To deploy the
stent 100, a physician may transition thestent 100 between the expandedconfiguration 202 and theunexpanded configuration 204 using an actuation mechanism, e.g., push-pull mechanism or balloon. In some embodiments, thestent 100 is self-expanding. - In some embodiments, the
stent body 102 is formed by braiding one or morebiodegradable filaments 110. In some embodiments, the one or morebiodegradable filaments 110 have a monofilament structure. Alternatively, in some embodiments, thebiodegradable filaments 110 comprise a multi-filament structure. In some embodiments, thebiodegradable filaments 110 are braided in a helical pattern, although other arrangements are also suitable. Also, the braiding pattern includesinterstices 114 in between thebiodegradable filaments 110. Theinterstices 114 allow tissue ingrowth and thereby prevent or resist migration. - The
biodegradable filaments 110 may be formed using a suitable biodegradable material, particularly materials that may be formed into fibers or filaments. Further, in some embodiments, thebiodegradable filaments 110 are flexible to allow formation of patterns or braiding, but also have suitable radial strength. Examples of such materials include, for example, poly(lactic-co-glycolic)acid, polyglycolic acid, polylactic acid, or the like. Such materials may degrade, disintegrated, or be absorbed in the body within a few weeks to few months, for example, 3, 4, 5, 6, 10, 12, 18 months. - In some embodiments, the
stent 100 includes anon-biodegradeable coating 112 disposed on thefilaments 110 of themiddle portion 108, encapsulating thebiodegradable filaments 110 therealong. In at least some embodiments, thenon-biodegradeable coating 112 forms a barrier to prevent thebiodegradable filaments 110 from degrading or being absorbed within the body. To this end, thenon-biodegradeable coating 112 covers thebiodegradable filaments 110 both on an outer surface and inner surface of thestent body 102 such that bodily fluids cannot readily degrade thefilaments 110 along themiddle portion 108 of thestent body 102 - Additionally, in some embodiments, the
non-biodegradeable coating 112 is disposed such that the first andsecond end portions stent body 102 remain uncoated. In this way, prior to implantation, thestent 100 is a partially coated stent. As thefirst end portion 104 and thesecond end portion 106 remain uncoated, tissue is permitted to ingrow into these portions. The tissue ingrowth secures thestent 100 within the body lumen, preventing migration of thestent 100. Further, the uncoated first andsecond end portions non-biodegradeable coating 112, in some embodiments, the remaining stent 100 (e.g., the middle portion 108) does not have tissue grown into theinterstices 114 and, consequently, a physician can retrieve and remove thestent 100 from the body lumen. - The
non-biodegradeable coating 112 can be disposed on thestent 100 in any desirable way. For example, in some embodiments, the entirety of thestent 100 is coated with thenon-biodegradeable coating 112 except for the first flaredportion 118. Further, in some embodiments, the entirety of thestent 100 is coated with thenon-biodegradeable coating 112 except for the second flaredportion 120. And, in some embodiments, the entirety of thestent 100 is coated with thenon-biodegradeable coating 112 except for the first flaredportion 118 and the second flaredportion 120, for example as shown inFIG. 3 . In such an embodiments, the flaredportions - The
non-biodegradeable coating 112 can be formed using any suitable technique, for example spray coating, dip coating, vapor deposition coating, extrusion, or a combination of these techniques. In some embodiments, thenon-biodegradeable coating 112 is applied and secured to thestent body 102 by adhesive bonding, conformal coating, or any suitable combination of these techniques, including a combination of adhesive bonding and conformal coating. In some embodiments, thenon-biodegradeable coating 112 is formed from a suitable biocompatible material. In some embodiments, thenon-biodegradeable coating 112 is an impermeable material that creates a barrier, preventing bodily fluid from coming into contact with encapsulatedbiodegradable filament 110, thereby preventing biodegradation ofmiddle portion 108 of thestent 100. In some embodiments, thenon-biodegradeable coating 112 not only forms a barrier around the filament but also acts as a covering over theinterstices 114, thereby preventing tissue ingrowth and also preventing degradation of the 110 by bodily fluids. In this way, themiddle portion 108 of the stent remains intact after degradation of the first and second ends 104, 106 such that it can be removed from the body lumen. - Examples of suitable materials for the
non-biodegradeable coating 112 may include, but are not limited to, polyurethane (PU), polyethylene (PE), polytetrafluoroethylene (PTFE), or expanded polytetrafluoroethylene (ePTFE), polyolefins such as high density polyethylene (HDPE) and polypropylene (PP), polyolefin copolymers and terpolymers, polyethylene terephthalate (PET), polyesters, polyamides, polyurethaneureas and polycarbonates, polyvinyl acetate, thermoplastic elastomers including polyether-polyester block copolymers, polyvinyl chloride, polystyrene, polyacrylate, polymethacrylate, polyacrylonitrile, polyacrylamide, silicone resins, combinations and copolymers thereof. - In some embodiments, the
stent 100 includes one ormore retrieval loops stent 100. In some embodiments, the retrieval loop(s) are routed through a portion of themiddle portion 108 of thestent 100, for example adjacent to the first orsecond end portion stent 100 from the body lumen. The retrieval loop(s) 116 a, 116 b may be pulled using a device such as, forceps (e.g., rat tooth foreceps). Any other suitable retrieval device can also be used. - As shown for example in
FIG. 1 , thefirst retrieval loop 116 a is longitudinally offset from thesecond retrieval loop 116 b. As a result of having tworetrieval loops stent 100 can be retrieved from either end. - In some other embodiments, the retrieval loop(s) 116 a, 116 b are secured to an outer surface of the
stent 100 ornon-biodegradeable coating 112, for example via an adhesive. In some embodiments, however, one ormore retrieval loops interstices 114. Further, in some embodiments, a portion of the retrieval loop(s) 116 a, 116 b may be braided into the structure of thestent 100, forming an integral part of the stent structure. In some embodiments, one or more retrieval loop(s) 116 a, 116 b are formed from a biomaterial. In some embodiments, one or more retrieval loop(s) 116 a, 116 b are formed from a non-biodegradable material. In some embodiments, one or more retrieval loop(s) 116 a, 116 b are formed from a shape memory material, such as a shape memory metal, for example a nickel-titanium alloy. - A description of some embodiments of the heat treatments is contained in one or more of the following numbered statements:
- Statement 1. A stent comprising:
- at least one biodegradable filament forming a stent body, the stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion, the middle portion extending between the first and second end portions; and
- a non-biodegradeable coating, the non-biodegradeable coating encapsulating the at least one biodegradable filament along the middle portion of the stent body and forming a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion, wherein the first and second end portions are uncoated and biodegradeable.
- Statement 2. The stent of statement 1, wherein the at least one biodegradable filament is a monofilament.
Statement 3. The stent of any one of the preceding statements, wherein the stent has an unexpanded configuration and an expanded configuration; in the expanded configuration, at least one of the first end portion and second end portion has a cross-sectional area greater than the cross-sectional area of at least a portion of the middle portion.
Statement 4. The stent of statement 3, wherein, in the expanded configuration, at least a portion of the first end portion and at least a portion of the second end portion has a cross-sectional area greater than at least a portion of the cross-sectional area of the middle portion.
Statement 5. The stent of any one of the preceding statements, wherein the at least one biodegradable filament is formed from poly(lactic-co-glycolic) acid (PLGA), polylactic acid (PLA), polyglycolic acid (PGA), poly(ortho ester) (POE), poly(epsilon-caprolactone) (PCL), and polyhydroxybutyrate-valerate (PHBV), or polydioxanone (PDO).
Statement 6. The stent of any one of the preceding statements, wherein the non-biodegradeable coating is formed from a silicone polymer, silicone copolymer, polyurethane, polystyrene-polyethylene/butylene-polystyrene (SEBS) copolymer, acrylate polymer, acrylate copolymer, methacrylate polymer, methacrylate copolymer, fluorinated polymer, (modified) ethylene-tetrafluoroethylene copolymer (ETFE) polymer, polytetrafluoroethylene (PTFE), poly(tetrafluoroethylene-co-hexafluoropropene) (FEP), polyvinylidene fluoride (PVDF), and combinations thereof.
Statement 7. The stent of any one of the preceding statements further comprising at least one retrieval loop.
Statement 8. The stent of statement 7, wherein at least a portion of the retrieval loop is routed through at least a portion of the middle portion.
Statement 9. The stent of statement 7 further comprising a plurality of retrieval loops.
Statement 10. The stent of statement 9, wherein the plurality of retrieval loops comprises a first retrieval loop and a second retrieval loop, the second retrieval loop threaded through at least a portion of the middle portion, the second retrieval loop being longitudinally offset from the first retrieval loop.
Statement 11. The stent of statement 7, 8, 9, or 10 wherein the at least one retrieval loop is formed from a shape memory material.
Statement 12. The stent of statement 11, wherein the shape memory material is a nickel-titanium alloy.
Statement 13. The stent of any one of the preceding statements further being an esophageal stent.
Statement 14. The stent of any one of the preceding statements, wherein the at least one biodegradable filament is braided to form the stent body.
Statement 15. The stent of any one of the preceding statements, wherein the stent body defines a plurality of interstices, the interstices being covered by the non-biodegradeable coating along the middle portion of the stent body, thereby preventing tissue ingrowth therealong.
Statement 16. The stent of any of the preceding statements, wherein the stent body comprises a first flared portion, a portion of the first flared portion being coated with the non-biodegradeable coating and a portion of the flared portion being uncoated.
Statement 17. The stent of statement 16, wherein the stent body comprises a second flared portion, a portion of the second flared portion being coated with the non-biodegradeable coating and a portion of the second flared portion being uncoated.
Statement 18. The stent of statement 16, wherein the first and second flared portions are uncoated. - It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (20)
1. A stent comprising:
at least one biodegradable filament forming a stent body, the stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion, the middle portion extending between the first and second end portions; and
a non-biodegradeable coating, the non-biodegradeable coating encapsulating the at least one biodegradable filament along the middle portion of the stent body and forming a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion, wherein the first and second end portions are uncoated and biodegradeable.
2. The stent of claim 1 , wherein the at least one biodegradable filament is a monofilament.
3. The stent of claim 1 further comprising a retrieval loop.
4. The stent of claim 3 , wherein at least a portion of the retrieval loop is routed through at least a portion of the middle portion.
5. The stent of claim 1 , wherein the stent has an unexpanded configuration and an expanded configuration; in the expanded configuration, at least one of the first end portion and second end portion has a cross-sectional area greater than the cross-sectional area of at least a portion of the middle portion.
6. The stent of claim 5 , wherein, in the expanded configuration, at least a portion of the first end portion and at least a portion of the second end portion has a cross-sectional area greater than at least a portion of the cross-sectional area of the middle portion.
7. The stent of claim 1 , wherein the at least one biodegradable filament is formed from poly(lactic-co-glycolic) acid (PLGA), polylactic acid (PLA), polyglycolic acid (PGA), poly(ortho ester) (POE), poly(epsilon-caprolactone) (PCL), and polyhydroxybutyrate-valerate (PHBV), or polydioxanone (PDO).
8. The stent of claim 1 , wherein the non-biodegradeable coating is formed from a silicone polymer, silicone copolymer, polyurethane, polystyrene-polyethylene/butylene-polystyrene (SEBS) copolymer, acrylate polymer, acrylate copolymer, methacrylate polymer, methacrylate copolymer, fluorinated polymer, (modified) ethylene-tetrafluoroethylene copolymer (ETFE) polymer, polytetrafluoroethylene (PTFE), poly(tetrafluoroethylene-co-hexafluoropropene) (FEP), polyvinylidene fluoride (PVDF), and combinations thereof.
9. The stent of claim 1 further comprising a plurality of retrieval loops.
10. The stent of claim 1 , wherein the at least one biodegradable filament is braided to form the stent body.
11. The stent of claim 1 further being an esophageal stent.
12. The stent of claim 1 , wherein the stent body comprises a first flared portion, a portion of the first flared portion being coated with the non-biodegradeable coating and a portion of the flared portion being uncoated.
13. The stent of claim 12 , wherein the stent body comprises a second flared portion, a portion of the second flared portion being coated with the non-biodegradeable coating and a portion of the second flared portion being uncoated.
14. A stent comprising:
at least one biodegradable filament forming a braided stent body, the braided stent body having a first end portion, a middle portion, and a second end portion opposite the first end portion, the middle portion extending between the first and second end portions;
a non-biodegradeable coating, the non-biodegradeable coating encapsulating the at least one biodegradable filament along the middle portion of the braided stent body and forming a barrier such that the non-biodegradeable coating prevents degradation of the at least one biodegradable filament along the middle portion, wherein the first and second end portions are uncoated and biodegradeable; and
at least one retrieval loop threaded through at least a portion of the middle portion of the braided stent body.
15. The stent of claim 14 , wherein the at least one retrieval loop comprises a first retrieval loop and a second retrieval loop, the second retrieval loop threaded through at least a portion of the middle portion, the second retrieval loop being longitudinally offset from the first retrieval loop.
16. The stent of claim 14 , wherein the stent has an unexpanded configuration and an expanded configuration; in the expanded configuration, at least one of the first end portion and second end portion has a cross-sectional area greater than the cross-sectional area of at least a portion of the middle portion.
17. The stent of claim 16 , wherein, in the expanded configuration, at least a portion of the first end portion and at least a portion of the second end portion has a cross-sectional area greater than the cross-sectional area of at least a portion of the middle portion.
18. The stent of claim 14 , wherein the at least one biodegradable filament is formed from poly(lactic-co-glycolic) acid (PLGA), polylactic acid (PLA), polyglycolic acid (PGA), poly(ortho ester) (POE), poly(epsilon-caprolactone) (PCL), and polyhydroxybutyrate-valerate (PHBV), or polydioxanone (PDO).
19. The stent of claim 18 , wherein the non-biodegradeable coating is formed from a silicone polymer, silicone copolymer, polyurethane, polystyrene-polyethylene/butylene-polystyrene (SEBS) copolymer, acrylate polymer, acrylate copolymer, methacrylate polymer, methacrylate copolymer, fluorinated polymer, (modified) ethylene-tetrafluoroethylene copolymer (ETFE) polymer, polytetrafluoroethylene (PTFE), poly(tetrafluoroethylene-co-hexafluoropropene) (FEP), polyvinylidene fluoride (PVDF), and combinations thereof.
20. The stent of claim 19 , wherein the stent body defines a plurality of interstices, the interstices being covered by the non-biodegradeable coating along the middle portion of the stent body, thereby preventing tissue ingrowth therealong.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/680,593 US20150282922A1 (en) | 2014-04-08 | 2015-04-07 | Partially coated stents |
US15/612,981 US9907644B2 (en) | 2014-04-08 | 2017-06-02 | Partially coated stents |
Applications Claiming Priority (2)
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EP (1) | EP3128960A1 (en) |
JP (1) | JP6356262B2 (en) |
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WO (1) | WO2015157281A1 (en) |
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US11173027B2 (en) | 2019-03-14 | 2021-11-16 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
US11076956B2 (en) | 2019-03-14 | 2021-08-03 | Vdyne, Inc. | Proximal, distal, and anterior anchoring tabs for side-delivered transcatheter mitral valve prosthesis |
US11202706B2 (en) | 2019-05-04 | 2021-12-21 | Vdyne, Inc. | Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus |
US11712335B2 (en) | 2019-05-04 | 2023-08-01 | Vdyne, Inc. | Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus |
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US11166814B2 (en) | 2019-08-20 | 2021-11-09 | Vdyne, Inc. | Delivery and retrieval devices and methods for side-deliverable transcatheter prosthetic valves |
US11331186B2 (en) | 2019-08-26 | 2022-05-17 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
US11337807B2 (en) | 2019-08-26 | 2022-05-24 | Vdyne, Inc. | Side-deliverable transcatheter prosthetic valves and methods for delivering and anchoring the same |
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Also Published As
Publication number | Publication date |
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US9907644B2 (en) | 2018-03-06 |
KR20160145072A (en) | 2016-12-19 |
CN106456309A (en) | 2017-02-22 |
KR101846769B1 (en) | 2018-04-06 |
WO2015157281A1 (en) | 2015-10-15 |
US20170265981A1 (en) | 2017-09-21 |
JP2017513582A (en) | 2017-06-01 |
EP3128960A1 (en) | 2017-02-15 |
JP6356262B2 (en) | 2018-07-11 |
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