Stents and stent systems in which one or more features can be selectively modified as a part of the deployment process are described herein.
Although stents may be used for a variety of blood vessels, stents may also be used in many different body lumens, such as, e.g., the bile duct, ureter, pancreatic duct, vascular locations, esophagus, or any other body lumen.
The stents described herein include one or more features that can be selectively modified at the point of use, i.e., in the surgical suite, etc. The selectively modifiable features may take a variety of forms such as, e.g., length, the presence of flaps, voids, etc.
Selectively modifiable stents may provide the user with a product that may better suit the needs of a particular patient while not requiring that the health care facility maintain a large stock of stents that have different combinations of features that may be obtained by point-of-care selective modification.
In one aspect, some embodiments of an implantable stent as described herein include a body comprising a wall; a lumen extending through the body from a first end of the body to a second end of the body, wherein the wall comprises an interior surface facing the lumen and an exterior surface facing away from the lumen, wherein the interior surfaces and the exterior surfaces are constructed of biocompatible materials; and a predetermined line of separation provided in the wall, wherein separating the line of separation forms an opening in the wall between the interior surface of the wall and the exterior surface of the wall.
In some embodiments of an implantable stent as described herein the line of separation comprises a plurality of perforations formed through the wall between the interior surface and the exterior surface.
In some embodiments of an implantable stent as described herein the wall comprises a reduced thickness along the line of separation as compared to a wall thickness on opposite sides of the line of separation.
In some embodiments of an implantable stent as described herein the portion of the wall occupied by the line of separation is formed of a first material, and the portion of the wall that is not occupied by the stent is formed of a second material that is different than the first material. In some embodiments, the first material is soluble in a first solvent and wherein the second material is not appreciably soluble in the first solvent.
In some embodiments of an implantable stent as described herein the line of separation comprises a series of mechanically interlocking fingers distributed along the line of separation.
In some embodiments of an implantable stent as described herein the line of separation comprises a separation element embedded in the wall, wherein removal of the separation element separates the wall along the line of separation. In some embodiments, the separation element comprises a filament embedded in a polymeric material that forms the stent.
In some embodiments of an implantable stent as described herein the line of separation extends around a circumference of the body, wherein separation of the line of separation separates the stent into two discrete smaller bodies, wherein each smaller body of the two discrete smaller bodies comprises a lumen extending through the smaller body from a first end to a second end.
In some embodiments of an implantable stent as described herein the line of separation comprises a shape that creates a flap attached at one end to the body when the wall is separated along the line of separation.
In some embodiments of an implantable stent as described herein the line of separation is in the form of a closed figure such that separation of the line of separation forms a void in the wall of the body in the shape of the closed figure.
In some embodiments of an implantable stent as described herein the stent comprises two or more discrete lines of separation.
In another aspect, some embodiments of an implantable stent system as described herein include a first body and a second body; wherein the first body comprises a wall and a lumen extending through the first body from a first end of the first body to a second end of the first body, wherein the wall comprises an interior surface facing the lumen and an exterior surface facing away from the lumen, wherein the interior surfaces and the exterior surfaces are constructed of biocompatible materials; wherein the second body comprises a wall and a lumen extending through the second body from a first end of the second body to a second end of the second body, wherein the wall comprises an interior surface facing the lumen and an exterior surface facing away from the lumen, wherein the interior surfaces and the exterior surfaces are constructed of biocompatible materials; wherein the second end of the first body comprises external threads on the exterior surface of the wall of the first body and the first end of the second body comprises internal threads on the interior surface of the wall of the second body, wherein the external threads and the internal threads are complementary such that the first body and the second body can be connected by screwing the first body and the second body together using the external threads and the internal threads.
In some embodiments of an implantable stent system as described herein the first end of the first body comprises internal threads on the interior surface of the wall of the first body.
In some embodiments of an implantable stent system as described herein the second end of the second body comprises external threads on the exterior surface of the wall of the second body.
In some embodiments of an implantable stent system as described herein the first end of the first body comprises internal threads on the interior surface of the wall of the first body, and the second end of the second body comprises external threads on the exterior surface of the wall of the second body.
In another aspect, some embodiments of an implantable stent system as described herein include a first body and a second body; wherein the first body comprises a wall and a lumen extending through the first body from a first end of the first body to a second end of the first body, wherein the wall comprises an interior surface facing the lumen and an exterior surface facing away from the lumen, wherein the interior surfaces and the exterior surfaces are constructed of biocompatible materials; wherein the second body comprises a wall and a lumen extending through the second body from a first end of the second body to a second end of the second body, wherein the wall comprises an interior surface facing the lumen and an exterior surface facing away from the lumen, wherein the interior surfaces and the exterior surfaces are constructed of biocompatible materials; wherein the second end of the first body comprises one or more external annular grooves on the exterior surface of the wall of the first body and the first end of the second body comprises one or more internal annular grooves on the interior surface of the wall of the second body, wherein the external annular grooves and the internal annular grooves are complementary such that the first body and the second body can be connected by advancing the external annular grooves of the first body and the internal annular grooves of the second body towards each other.
In some embodiments of an implantable stent system as described herein the second of the first body comprises two or more external annular grooves on the exterior surface of the wall of the first body and the first end of the second body comprises two or more internal annular grooves on the interior surface of the wall of the second body.
In some embodiments of an implantable stent system as described herein the first end of the first body comprises one or more internal annular grooves on the interior surface of the wall of the first body.
In some embodiments of an implantable stent system as described herein the second end of the second body comprises one or more external annular grooves on the exterior surface of the wall of the second body.
In some embodiments of an implantable stent system as described herein the first end of the first body comprises one or more internal annular grooves on the interior surface of the wall of the first body, and the second end of the second body comprises one or more external annular grooves on the exterior surface of the wall of the second body.
In some embodiments of an implantable stent system as described herein the first body comprises a predetermined line of separation provided in the wall, wherein separating the line of separation forms an opening in the wall between the interior surface of the wall and the exterior surface of the wall. In some embodiments, the line of separation comprises a plurality of perforations formed through the wall between the interior surface and the exterior surface. In some embodiments, the wall comprises a reduced thickness along the line of separation as compared to a wall thickness on opposite sides of the line of separation. In some embodiments, the portion of the wall occupied by the line of separation is formed of a first material, and the portion of the wall that is not occupied by the stent is formed of a second material that is different than the first material (in some embodiments, the first material is soluble in a first solvent and wherein the second material is not appreciably soluble in the first solvent). In some embodiments, the line of separation comprises a series of mechanically interlocking fingers distributed along the line of separation. In some embodiments, the line of separation comprises a separation element embedded in the wall, wherein removal of the separation element separates the wall along the line of separation (in some embodiments, the separation element comprises a filament embedded in a polymeric material that forms the stent). In some embodiments, the line of separation extends around a circumference of the first body, wherein separation of the line of separation separates the first body into two discrete smaller bodies, wherein each smaller body of the two discrete smaller bodies comprises a lumen extending through the smaller body from a first end to a second end. In some embodiments, the line of separation comprises a shape that creates a flap attached at one end to the body when the wall is separated along the line of separation. In some embodiments, the line of separation is in the form of a closed figure such that separation of the line of separation forms a void in the wall of the body in the shape of the closed figure. In some embodiments, the first body comprises two or more discrete lines of separation.
The words “preferred” and “preferably” refer to embodiments that may afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the invention.
As used herein, “a,” “an,” “the,” “at least one,” and “one or more” are used interchangeably. Thus, for example, a line of separation may be used to refer to one, two, three or more lines of separation.
The term “and/or” means one or all of the listed elements or a combination of any two or more of the listed elements.
The above summary is not intended to describe each embodiment or every implementation of the present invention. Rather, a more complete understanding of the invention will become apparent and appreciated by reference to the following Description of Illustrative Embodiments and claims in view of the accompanying figures of the drawing.
The present invention will be further described with reference to the figures of the drawing, wherein:
In the following description of illustrative embodiments, reference is made to the accompanying figures of the drawing which form a part hereof, and in which are shown, by way of illustration, specific embodiments of stents and stent systems. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.
The stents described herein may be manufactured using a wide variety of materials. For those stents that include a line of separation, the material(s) selected for the stent may need to be chosen based on the ability of the material(s) to provide the functionality (e.g., separability) described herein. Reference may be had to the one or more of the following patents for further details regarding potentially suitable techniques for construction, manufacturing, and/or deployment of stents: U.S. Pat. Nos. 4,733,665; 4,739,762; 5,195,984; 5,401,257; 5,725,572; 5,735,871; 5,755,781; 5,853,419; 5,861,027; 6,007,573; 6,059,810; 6,099,561; 6,132,471; 6,200,337; 6,206,916; and 7,338,530; as well as in U.S. Patent Application Publications US 2010/0114325; US 2010/0049328; and US 2008/0249457; etc.
Some materials that may potentially be used to manufacture the stents described herein may include, but are not limited to: SOF-FLEX, a type of polyether urethane, silicone, block co-polymers, urethanes, polyethylene, polystyrene, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP) and the like, and combinations thereof. Some specific examples may also include TEFLON (a polytetrafluoroethylene) which is discussed for use in stents in U.S. Pat. No. 6,132,471, and PELLETHANE (a biocompatible thermoplastic polyurethane elastomer available from Dow Corning and that has been approved by the Food and Drug Administration for implantation) which is discussed for use with stents in U.S. Pat. No. 7,338,530.
One illustrative embodiment of a stent as described herein is depicted in the perspective view of
The stent 10 includes a lumen 16 that extends through the stent for the first end 12 to the second end 14. The lumen 16 is defined by the wall 20 of the stent 10. The wall 20 includes an interior surface facing the lumen 16 and an exterior surface facing away from the lumen 16. The materials used to construct the interior surfaces and the exterior surfaces of the stents described herein are preferably biocompatible materials. As used herein, “biocompatible materials” are materials that can be implanted within a living body for an extended period of time, e.g., weeks, months and/or years.
The stent 10 of
In connection with
The lines of separation provided in connection with the stents described herein may, in some embodiments, preferably be separable without requiring the use of tools such as blades, scissors, etc. to cut the stent walls. It may be further preferred that, in at least some embodiments, the stent walls be separable along the lines of separation by manipulating the stents to produce tension across the line of separation.
The lines of separation provided in connection with the stents described herein may take many different forms, some illustrative embodiments of which are described in connection with
Referring to
Referring to
In at least some embodiments, the first material of the section 232 may be soluble in a first solvent while the second material forming the wall around the line of separation 230 is not appreciably soluble in the same solvent. As used herein, “not appreciably soluble” means that exposure of the second material to the solvent used to promote separation of the first material (under the same conditions) does not weaken the second material to a degree that accurate separation of the stent wall 220 along the line of separation 230. Such differential solubility may be used advantageously to facilitate separation of the wall 220 along the line of separation 230 during and/or after exposure of the section 232 to the solvent.
The lines of separation provided in the stents described herein may take a variety of different configurations or shapes, some illustrative examples of which are depicted in
In still other embodiments, portions of the stent could be made stiffer than surrounding portions (by, e.g., the addition of an extra layer of material, etc.) to assist in the separation of the stent walls. For example, the tip regions of the flaps 540 depicted in
Yet another optional feature is depicted in
Another optional feature that is depicted in connection with the embodiment of stent 510 in
The stent 610 depicted in
The stent 710 depicted in
In connection with the stent 710 of
Although different variations in the construction, configuration, etc. of the lines of separation that may be provided in the stents described herein may be illustrated individually in
The stents as described herein may also include multiple bodies that can be connected along lines of separation that are formed by, e.g., complementary threads such that two or more stent bodies can be connected by threading them together.
Although only two bodies 910a and 910b are depicted in
Yet another variation of the stent system depicted in
In still other embodiments that may provide for separation of stent body into two or more segments, a first stent body may include internal grooves or other depressions while a second stent body includes one or more balls or other structures resiliently supported such that the internal grooves or other depressions receive and retain the ball or other structure in a manner similar to ball detent mechanism to retain the stent segments together, but allow for separation if so desired.
In some embodiments, only one end of a stent body may include annular grooves (external and/or internal). In still another variation, the same stent body may include two ends with internal annular grooves or two ends with external annular grooves. Further still, the lines of separation described in connection with
The complete disclosure of the patents, patent documents, and publications cited in the Background, the Description of Illustrative Embodiments, and elsewhere herein are incorporated by reference in their entirety as if each were individually incorporated.
Illustrative embodiments of this invention are discussed and reference has been made to possible variations within the scope of this invention. These and other variations and modifications in the invention will be apparent to those skilled in the art without departing from the scope of the invention, and it should be understood that this invention is not limited to the illustrative embodiments set forth herein. Accordingly, the invention is to be limited only by the claims provided below and equivalents thereof.
The present application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/254,378, filed on Oct. 23, 2009 and titled PATIENT-SPECIFIC MODIFIABLE STENTS, which is hereby incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US2010/053671 | 10/22/2010 | WO | 00 | 7/3/2012 |
Number | Date | Country | |
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61254378 | Oct 2009 | US |