US20220387199A1 - Devices, systems, and methods for ureteral stents - Google Patents

Abstract

The disclosure relates to a stent assembly for placement of a stent within a ureter. In many embodiments, the stent assembly includes a band coupled to a proximal end of the stent. In many such embodiments, the band may extend into the urethra and facilitate removal of the catheter without the help of a medical professional or requiring a portion of the stent assembly (e.g., suture loop) to extend outside of the patient. In various embodiments, the band may include one or more features that promote patient comfort while the stent is positioned within a body, such as by being atraumatic and/or seamless.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of priority of U.S. Provisional Application No. 63/196,325, filed Jun. 3, 2021, the entire disclosure of which is hereby incorporated by reference herein for all purposes.
• This application also claims the benefit of priority to U.S. Provisional Patent application titled “Devices, Systems, and Methods for Extracting a Ureteral Stent”, U.S. Patent Application No. 63/196,330, filed Jun. 3, 2021, the entire disclosure of which is hereby incorporated by reference herein for all purposes.
FIELD
• The present disclosure relates generally to the field of medical devices. In particular, the present disclosure relates to devices, systems, and methods for ureteral stents.
BACKGROUND
• In medicine, a stent is typically a tube inserted into the lumen of an anatomic vessel or duct in order to keep the passageway open. There is a variety of stents that are utilized for different purposes. One type of stent, a ureteral stent, includes a tube inserted into the ureter to prevent or treat obstruction of urine flow from the kidney to the bladder. A stent is usually inserted by a doctor with the aid of a cystoscope. After a period of time the patient no longer needs the stent to keep the passageway open and the stent is removed. Sometimes a stent is removed using a piece of suture attached to the stent that is left hanging out of a patient. However, oftentimes the piece of suture may be removed when the stent is placed to avoid patient discomfort. In such times, a doctor may use a cystoscope in conjunction with one or more tools to retrieve the stent.
BRIEF SUMMARY
• This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.
• In one aspect, the present disclosure relates to a stent comprising a midportion, a distal retention member, a proximal retention member, a band, and a suture. The midportion may extend along a longitudinal axis between a proximal end and a distal end. The distal retention member may extend distally from the distal end of the midportion. The proximal retention member may extend proximally from the proximal end of the midportion. The band may include first and second portions and extend about and proximally from the proximal retention member. The suture may be looped through the band.
• In some embodiments, the first portion of the band has a radius larger than a radius of the second portion of the band. In various embodiments, the second portion of the band comprises a shape-memory material and the first portion of the band comprises a filament. In several embodiments, the first portion of the band comprises a first half of a closed loop and the second portion of the band comprises a second half of the closed loop. In many embodiments, the first portion of the band comprises a first closed loop and the second portion of the band comprises a second closed loop. In some embodiments, the proximal retention member comprises at least one loop. In various embodiments, the first portion of the band extends about the at least one loop and the second portion of the band extends through the at least one loop. In several embodiments, at least one of the proximal retention member and the distal retention member comprises a shape of a pigtail, a J-shaped curve, a loop, a cope loop, a spiral shape, a helical shape, or a cork screw, or a combination thereof. In many embodiments, a portion of the suture is adhered to the second portion of the band. In some embodiments, the first portion of the band is slidable with respect to the proximal retention member. In various embodiments, the band is seamless. In several embodiments, the band is molded. In many embodiments, the band comprises a portion of a tubular extrusion. In some embodiments, the band comprises a compound shape. In various embodiments, the band comprises at least two straight portions and at least two curved portions.
• In another aspect, the present disclosure relates to a system comprising a stent, a band, a suture, and a tubular member. The stent may extend along a longitudinal axis and have a proximal end and a distal end and a midportion therebetween. The stent may include a proximal retention member extending proximally from the proximal end. The band may extend about the proximal retention member and include a first portion and a second portion. The suture may be looped through the second portion of the band. The tubular member may include a lumen along a length and a notch at a distal end of the tubular member.
• In various embodiments, the proximal retention member comprises at least one loop. In various such embodiments, the first portion of the band extends about the at least one loop and the second portion of the band extends through the at least one loop. In some embodiments, the notch is configured to reversibly mate with the first portion of the band and the proximal end of the stent. Many embodiments include a guidewire extending through the lumen of the tubular member. In many such embodiments, the tubular member is configured to advance the stent along at least a portion of the guidewire. In several embodiments, the first portion of the band is slidable with respect to the proximal retention member.
• In yet another aspect, the present disclosure relates to a method of delivering a stent. The method may include delivering a stent into a ureter. The method may include positioning a proximal retention member of the stent into a bladder. The method may include positioning a proximal end of a band in a urethra. A distal end of the band may be coupled to the proximal retention member.
• In various embodiments, the method includes positioning a suture coupled to the band into the urethra. In some embodiments, the method includes removing the suture. In many embodiments, the method includes using a tubular member with a lumen defined therein and guided over a guidewire to deliver the stent. In several embodiments, the band is slidably coupled to the proximal retention member such that an effective length of the band is adjustable. In several such embodiments, positioning the band comprises adjusting the effective length of the band between a proximal end of the proximal retention member and the second portion of the band. In various embodiments, positioning the band comprises positioning a first portion of the band proximal of a bulbar urethra.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
• Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying figures, which are schematic and not intended to be drawn to scale. In the figures, each identical or nearly identical component illustrated is typically represented by a single numeral. In will be appreciated that various figures included in this disclosure may omit some components, illustrate portions of some components, and/or present some components as transparent to facilitate illustration and description of components that may otherwise appear hidden. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment shown where illustration is not necessary to allow those of ordinary skill in the art to understand the disclosure. In the figures:
• FIG.1A illustrates a side view of a stent assembly according to one or more embodiments disclosed hereby.
• FIG.1B illustrates a perspective view of the stent assembly ofFIG.1A according to one or more embodiments disclosed hereby.
• FIG.2A illustrates various aspects of a stent positioned within a patient according to one or more embodiments disclosed hereby.
• FIG.2B illustrates various aspects of a band positioned within a patient according to one or more embodiments disclosed hereby.
• FIG.3 illustrates an exemplary band according to one or more embodiments disclosed hereby.
• FIG.4 illustrates an exemplary band according to one or more embodiments disclosed hereby.
• FIG.5 illustrates an exemplary band according to one or more embodiments disclosed hereby.
• FIG.6 illustrates an exemplary band according to one or more embodiments disclosed hereby.
• FIG.7A illustrates a side view of a stent assembly according to one or more embodiments disclosed hereby.
• FIG.7B illustrates a top view of the stent assembly ofFIG.7A according to one or more embodiments disclosed hereby.
• FIG.8 illustrates an exemplary stent according to one or more embodiments disclosed hereby.
• FIG.9A illustrates a side view of a stent assembly according to one or more embodiments disclosed hereby.
• FIG.9B illustrates a top view of the stent assembly ofFIG.9A in conjunction with a positioner according to one or more embodiments disclosed hereby.
• FIG.9C illustrates a detail view of a portion of the stent assembly ofFIG.9A according to one or more embodiments disclosed hereby.
• FIG.9D illustrates an exemplary positioner according to one or more embodiments disclosed hereby.
• FIGS.10A-10C illustrates various aspects of positioning a stent within a patient according to one or more embodiments disclosed hereby.
DETAILED DESCRIPTION
• The present disclosure relates generally to devices, systems and methods for ureteral stent assemblies, such as for maintaining fluid flow between a kidney and a bladder, for instance. Some embodiments are particularly directed to a band coupled to a proximal end of the stent, or a proximal retention member of the stent, that is configured to assist in removal of the stent. For example, the stent and/or band may be designed such that a proximal retention member of the stent, or a proximal end of the band, is positionable within the urethra to facilitate removal of the stent. In many embodiments, the effective length of the stent and/or band that extends into the urethra may be adjustable to allow the proximal end to be positioned between the proximal end of the urethra and the bulbar urethra. However, the present disclosure is not limited to the embodiments described. The terminology used herein is only for the purpose of describing particular embodiments and is not intended to be limiting. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.
• Although embodiments of the present disclosure may be described with specific reference to ureteral stents, it should be appreciated that such devices, systems, and methods may be used with a variety of instruments and for a variety of other tissues, body passageways, organs and/or cavities, such as the vascular system, urogenital system, upper gastrointestinal system, lower gastrointestinal system, and the like.
• As used herein, a “proximal” end refers to the end of a device that lies closest to the medical professional along the device when introducing the device into a patient, and a “distal” end refers to the end of a device or object that lies furthest from the medical professional along the device during implantation, positioning, or delivery.
• As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
• It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etcetera, indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used in connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
• All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified. The recitation of numerical ranges by endpoints includes all numbers within that range, including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
• As used herein, the conjunction “and” includes each of the structures, components, portions, or the like, which are so conjoined, unless the context clearly indicates otherwise, and the conjunction “or” includes one or the others of the structures, components, portions, or the like, which are so conjoined, singly and in any combination and number, unless the context clearly indicates otherwise.
• The detailed description should be read with reference to the drawings, which are not necessarily to scale, depict illustrative embodiments, and are not intended to limit the scope of the invention.
• Reference is now made to the drawings, wherein like reference numerals are used to refer to like elements throughout. In the following description, for purpose of explanation, numerous specific details are set forth in order to provide a thorough understanding thereof. It may be evident, however, that the novel embodiments can be practiced without these specific details. In other instances, well known structures and devices are shown in block diagram form to facilitate a description thereof. The intention is to cover all modification, equivalents, and alternatives within the scope of the claims.
• FIGS.1A and1B illustrate anexemplary stent assembly102 according to one or more embodiments disclosed hereby. More specifically,FIG.1A illustrates a side view ofstent assembly102 andFIG.1B illustrates a perspective view ofstent assembly102.Stent assembly102 has aproximal end108, adistal end110, alongitudinal axis120, and includes astent104, aband116, and asuture loop118. Thestent104 includes adistal retention member112, amidportion106, and aproximal retention member114. In the illustrated embodiments, theband116 is coupled between thestent104 and thesuture loop118. In many embodiments,band116 may facilitate safe and efficient removal of thestent104 while improving patient comfort. In some embodiments,FIGS.1A and1B may include one or more components that are the same or similar to one or more other components of the present disclosure. Further, one or more components ofFIGS.1A and1B, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. Further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIGS.1A and1B, without departing from the scope of this disclosure. Embodiments are not limited in this context.
• As will be described in more detail below, such as with respect toFIGS.2A and2B, thestent104 may be positioned in a patient such that thedistal retention member112 extends into the kidney and theproximal retention member114 extends into the bladder. In many embodiments, theband116 may extend into the urethra. In many such embodiments, the length that theband116 extends into the urethra may be adjustable, such as to accommodate a variety of anatomies. For example, only a portion of theband116 may extend into the urethra with excess portions of theband116 being left in the bladder. Accordingly, the effective length ofstent assembly102 may be adjustable. Generally, stent assembly may refer to a stent in conjunction with other components, such as a band and/or suture loop. However, as will be appreciated, sometimes the term stent may be used in place of stent assembly to refer to the stent in conjunction with one or more other components such as a band and/or suture loop.
• In the illustrated embodiment,distal retention member112 comprises a pigtail and theproximal retention member114 comprises a loop. However, thedistal retention member112 and/or theproximal retention member114 may be shaped like a pigtail, a J-shaped curve, a loop, a cope loop, a spiral shape, a helical shape, or a corkscrew, or a combination thereof. The one or more loops may be made of a cord material. In various embodiments, the two ends of the cord material may be integrated into themidportion106 such that the cord ends cannot poke into tissue and cause irritation or pain. The illustrated embodiment ofproximal retention member114 includes a single loop. However, other embodiments may include one or more loops, such as two or three. Utilizing a loop for theproximal retention member114, such as in place of a pigtail, can facilitate efficient removal of thestent104. For example, unlike a loop, when a pigtail is hooked by a removal tool, the removal force may cause the pigtail to straighten, resulting in the removal tool detaching from the stent. In various embodiments, each loop may be 1 French (Fr) and made of a polymer material. In several embodiments, thedistal retention member112 may include a guidewire passage that enables thestent104 to be loaded onto a guidewire. For example, the pigtail of112 may be straightened out and a guidewire may be inserted through a lumen of thestent104. In one embodiment, the guidewire may exit the lumen of thestent104 via an opening where theproximal retention member114 couples to themidportion106. In some embodiments, an opening to a guidewire passage may be disposed between where the one or more loops of theproximal retention member114 are integrated into themidportion106.
• More generally, one or more portions of thestent assembly102, such as thestent104 orband116, may be constructed using various biocompatible materials, such as one or more of polymer, ethylene vinyl acetate, bismuth, bismuth subcarbonate, Percuflex™, Elvax™. In some embodiments, one or more portions of thestent assembly102 may have a layered construction. For example,stent104 may include three layers of different blends of Percuflex™. In various embodiments, one or more portions of thestent104 may be stiff or semi-stiff during placement and may soften as they rise to body temperature. In various such embodiments, this may promote patient tolerability. In many embodiments, thestent104, or portions thereof, may be available in different durometers, lengths, and configurations. For example, each of thedistal retention member112,midportion106, andproximal retention member114 may be available in different durometers, lengths, and configurations. For example, thestent104 may be available in lengths between 6 centimeters (cm) and 34 cm. In some such examples, thestent104 may be available in 2 cm increments between 10 cm and 30 cm. In one embodiment, theproximal retention member114 may be available in a loop configuration (as illustrated) or a pigtail configuration (asdistal retention member112 is illustrated). In some embodiments, one or more portions of thestent104 may be constructed from a radiopaque material. In some such embodiments, the placement of thestent104 may be confirmed using imaging (e.g., via a fluoroscope and/or cystoscope).
• In many embodiments, one or more components of thestent assembly102, such asstent104, may include one or more markers, which may be radiopaque (see e.g.,markers716a,716b,716c,716d,716eofFIG.7A). For example,stent104 may include a bladder marking and/or a kidney marking that will reside in the bladder and kidney, respectively, when thestent104 is properly positioned. As will be described in more detail below, bismuth and/or bismuth subcarbonate may be utilized to form one or more radiopaque markers in thestent104. In some embodiments, one or more portions of thestent assembly102 may include a hydrophilic coating. In some such embodiments, the hydrophilic coating may be activatable. For example, the hydrophilic coating may be activated before thestent assembly102 is inserted into a patient.
• In various embodiments, theband116 may be coupled (e.g., looped through) to theproximal retention member114. In some embodiments, theband116 may be attached to theproximal retention member114 during manufacture of thestent assembly102. For example, theband116 may be looped into theproximal retention member114 when theproximal retention member114 is attached to themidportion106. In several embodiments, theband116 may be constructed from a different material than thestent104. In some embodiments, theband116 may have a predetermined durometer and/or shape that can be different than the rest of thestent assembly102. For example,band116 may comprise a bead or bead material. In many embodiments, theband116 may be available in different lengths. For example, the male urethra may be approximately 20 cm and the female urethra may be approximately 4 cm. Accordingly, a longer band may be used for males than females. In some embodiments, the proximal end of theband116 may be positioned close the proximal end of the urethra without extending out of the urethra.
• In several embodiments, theband116 is atraumatic. For instance, theband116 may have no loose ends, stepped transitions, seams, or transitions that may cause irritation within a patient. In one embodiment, theband116 may comprise a seamless loop, such as an O-ring or a rubber band. In many embodiments, theband116 may be molded, such as with an O-ring. In some embodiments, theband116 may be crosscut from an elastic tube, such as a rubber band. In various embodiments, theband116 may be a crosscut of a thin film polymer tube. In some embodiments, one or more portions of theband116 may be constructed from a radiopaque material. In some such embodiments, the placement of theband116 may be confirmed using imaging (e.g., via a fluoroscope and/or cystoscope). In many embodiments, theband116 may include one or more markers, which may be radiopaque, to determine positioning. For example,band116 may include a bladder marking that will reside just inside the bladder when the band is properly positioned. In another example,band116 may include a marking that will reside in the penile urethra when theband116 is properly positioned.
• Further, thesuture loop118 may be coupled to (e.g., looped through) theband116 and the ends may be knotted or crimped together (see e.g., crimp720 ofFIG.7A). Thesuture loop118 may be made of a polymer, a reinforced polymer, a thread, or the like. In various embodiments, thesuture loop118 may be used to assist in positioning of thestent104 andband116. For example, thesuture loop118 may be utilized to adjust thestent104 proximally (e.g., pull theproximal retention member114 back into the bladder or urethra). In another example, thesuture loop118 may be utilized to pull theband116 into the urethra. Excess portions of theproximal retention member114 may be left in the bladder. As described in more detail below, in many embodiments, thesuture loop118 may be removed after placement of thestent104, such as to avoid patient discomfort.
• FIGS.2A and2B illustrate various aspects of a stent assembly positioned within a patient according to one or more embodiments disclosed hereby. More specifically,FIG.2A illustrates various aspects of astent202 positioned within the patient andFIG.2B illustrates various aspects of aband220 positioned within the patient. In some embodiments,FIGS.2A and2B may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,midportion204 may be the same or similar tomidportion106. In another example,band220 may be the same or similar toband116. Further, one or more components ofFIGS.2A and2B, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,proximal retention member214 may be incorporated into stent104 (e.g., by replacing proximal retention member114) without departing from the scope of this disclosure. Further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIGS.2A and2B, without departing from the scope of this disclosure. For example,proximal retention member114 may be incorporated into stent202 (e.g., by replacing proximal retention member214). Embodiments are not limited in this context.
• Referring toFIG.2A, thestent202 includes aproximal end210 with aproximal retention member214, adistal end208 with adistal retention member206midportion204, and amidportion204 connecting the proximal anddistal retention members214,206. Additionally, aband220 is coupled to theproximal retention member214 and extends into theurethra234. In the illustrated embodiment ofFIG.2A, theproximal retention member214 is disposed in thebladder212, thedistal retention member206 is disposed in therenal pelvis232 ofkidney216, and themidportion204 extends through theureter218. In various embodiments, therenal pelvis232 may comprise an area proximate the center of thekidney216 at which urine collects and is funneled into theureter218. In some embodiments,proximal retention member214 andband220 may be replaced with a proximal retention member comprising an extended loop (see e.g.,FIG.7A).
• More generally, stents may be delivered into patients for various purposes including stenting, drainage, etc., of lumens, tracts, vessels, and cavities within the body. As an example, ureteral stents may be used to facilitate drainage in the upper urinary tract (e.g., drainage from the kidney to the bladder), possibly following ureteroscopy, endourerotomies, and endopyelotomy, as well as in other instances where ureteral obstruction may occur or access to the kidney and/or ureter is otherwise warranted.
• An exemplary stent of this type is illustrated in conjunction with patient anatomy inFIG.2A. Thestent202 has aproximal end210 and adistal end208. It may comprise a tubular polymer extrusion having a midportion204 (or shaft), a distal retention member206 (e.g., a renal “pigtail”), and a proximal retention member214 (e.g., a bladder loop). Theseretention members206,214 prevent upward migration of thestent202 toward thekidney216 or downward migration of thestent202 toward thebladder212. Once properly deployed in theureter218, thestent202 supports theureter218 and allows the passage of urine through thestent202 and, because theureter218 naturally dilates around foreign bodies, allows urine to flow around thestent202 as well.
• In various embodiments of a stent described hereby and otherwise within the scope of the present disclosure, a stent may be placed over a guidewire, through a cystoscope, a flexible ureteroscope, or the like, and advanced into a position with a delivery device that may engage and may release the stent (see e.g.,FIGS.9B,9D, and10A-10C). Once the distal end of the stent is advanced into the kidney/renal calyx, the guidewire and/or delivery device are removed, allowing retention members, such as pigtails to form in the kidney and/or bladder. The distal retention member of a stent may be closed or tapered on the end, which may depend on the method of insertion (e.g., the use of a guidewire or otherwise).
• A delivered stent may cause patient discomfort or pain, for example, regarding ureteral stents, pain and/or discomfort in the bladder and flank area after insertion. For example, many stents have an extraction suture loop (e.g., suture loop118) attached to the proximal end of the stent. Typically, the suture loop is a length of suture with the ends tied or crimped together. The suture loop may be extended external to the patient such that the stent can be removed from the body by pulling the suture loop. However, having a portion of the stent assembly extending outside of the body can lead to leakage. Inadvertent or undesired pulling of the suture loop can cause pain to the patient, and can lead to dislodgement of the stent, which can cause urine to cease flowing through theureter218. However, leaving the suture loop inside the body can cause pain and irritation to the urinary tract, such as due to the tied or crimped ends of the suture loop irritating the urethra. For these and other reasons, some medical professionals prefer to not use the suture loop. Accordingly, they may remove the suture loop after placement of the stent, such as by cutting it off.
• Further complexities are associated with removing the suture loop after placement of the stent. For example, ureteral stents are typically placed after urological procedures, such as a flexible ureteroscopy, to provide or maintain urine drainage from the kidney to the bladder. After a period of time (e.g., less than a year), the stent has served its purpose and needs to be removed from the patient. Typically, without an external suture loop end, the patient has an appointment with a medical professional to remove the stent. The medical professional may utilize a cystoscope, a retrieval device, and pain medication for the patient to remove the stent. Removal of the stent by a medical profession is time consuming and resource demanding. For example, removal of the stent can be time consuming for a doctor and require considerable resources for the medical equipment, room, labor, and stocking/reprocessing of the cystoscope.
• Accordingly, many embodiments may include a band (e.g., band220) and/or a proximal retention member (e.g.,proximal retention member714 ofFIG.7A) that facilitates removal of the catheter without the help of a medical professional or requiring a portion of the stent assembly (e.g., suture loop) to extend outside of the patient. For example, the extraction may be performed without visualization using a single-use extraction tool. In several embodiments, the band may be utilized in conjunction with the extraction tool described in U.S. Provisional Patent application titled “Devices, Systems, and Methods for Extracting a Ureteral Stent”, attorney docket number 8150.0788Z, filed even date herewith, the entirety of which is incorporated herein by reference. In various embodiments, the band may include one or more features that promote patient comfort while the stent is positioned within a body, such as by being atraumatic and/or seamless.
• Referring toFIG.2B, various aspects of theband220 positioned with a patient is illustrated. Theband220 may include aproximal end228 and adistal end230 coupled to theproximal retention member214 ofstent202. Thedistal end230 ofband220 may be positioned in thebladder212. Theband220 may extend proximally past theprostate222 and thebulbar urethra224, finally ending with theproximal end228 in thepenile urethra226. In some embodiments, theproximal end228 ofband220 may be positioned proximate the proximal end of the urethra (i.e., near the exit). For example, thedistal end230 ofband220 may be positioned as close as possible to the exterior opening of the urethra without extending outside of the patient. In embodiments in which an extended proximal retention member (e.g., a loop) is utilized in place of theband220, the proximal end of the proximal retention member may be positioned in the same manner as theband220. In several embodiments, positioning a proximal end of the stent assembly outside of the body can lead to leakage, however, by leaving the proximal end of the stent assembly within the body, leakage may be avoided. In various embodiments, any excess length of theband220, or an extended proximal retention member, may be positioned within thebladder212. For instance, theentire band220, or extended proximal retention member, may be initially positioned within thebladder212. Then the proximal end may be pulled into the urethra to the proper position, leaving the remainder of theband220, or extended proximal retention member, in thebladder212. The ability to leave excess material in thebladder212 may enable a moreadaptable stent202 with an adjustable effective length, reducing the need for different size stents and stent assemblies. In many embodiments, theband220, or extended proximal retention member, may be formed from a thin material that will not be pulled back into the bladder by returning to an original shape (see e.g.,FIGS.3-7B).
• More generally, the urethra, which includes thebulbar urethra224 and thepenile urethra226, may be a tubular structure that provides a passageway between thebladder212 and the exterior of the body. Accordingly, the urethra enables urine to be excreted from the body. In several embodiments described hereby, placing a portion of the stent assembly (e.g.,band220 or proximal retention member714) in the urethra may simplify locating the stent assembly for removal. For example, when theproximal end228 of theband220 is confined to the tubular passage of the urethra near the outside of the body makes it more accessible than if it was positioned within the bladder. In various embodiments, a suture loop may be utilized to pullband220 into the urethra, past theprostate222, and past thebulbar urethra224 to position theproximal end228 in thepenile urethra226. In several embodiments, theproximal end228 of theband220 may be positioned proximal thebulbar urethra224 to avoid patient pain or discomfort, such as during removal, because thebulbar urethra224 is more sensitive than thepenile urethra226 in many patients.
• FIG.3 illustrates anexemplary band302 according to one or more embodiments disclosed hereby. Theband302 may include afirst portion304aand asecond portion304bseparated by a dashed line. In various embodiments, theband302 may be utilized in a stent assembly (e.g., stent assembly102) to facilitate extraction of the stent (e.g., stent104). In the illustrated embodiment, theband302 comprises a circle. In many embodiments, a proximal end ofband302 may be positioned in the urethra proximal of the bulbar urethra, such as in the penile urethra. In some embodiments,FIG.3 may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,band302 may be the same or similar toband116,band220, orband916. Further, one or more components ofFIG.3, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,band302 may be incorporated into stent assembly102 (e.g., by replacing band116) without departing from the scope of this disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIG.3, without departing from the scope of this disclosure. For example,stent202 may be incorporated with band302 (e.g., by couplingband302 toproximal retention member214 in place of band220). It will be appreciated that shapes described hereby, such as with respect to the bands inFIGS.3-6, may be applied to the proximal retention member (e.g.,proximal retention member714 ofFIG.7A) without departing from the scope of this disclosure. Embodiments are not limited in this context.
• FIG.4 illustrates anexemplary band402 according to one or more embodiments disclosed hereby. Theband402 may include afirst portion404aand asecond portion404bseparated by a dashed line. Additionally, theband402 may include a firststraight portion408a, a secondstraight portion408b, a firstcurved portion406a, and a secondcurved portion406b. In various embodiments, theband402 may be utilized in a stent assembly (e.g., stent assembly102) to facilitate extraction of the stent (e.g., stent104). In some embodiments,FIG.4 may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,band402 may be the same or similar toband116,band220, orband916. Further, one or more components ofFIG.4, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,band402 may be incorporated into stent assembly102 (e.g., by replacing band116) without departing from the scope of this disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIG.4, without departing from the scope of this disclosure. For example,stent202 may be incorporated with band402 (e.g., by couplingband402 toproximal retention member214 in place of band220). Embodiments are not limited in this context.
• In various embodiments, theband402 comprises an elliptical or racetrack shape. The elliptical or racetrack shape may provide a longer length to allow a proximal end of theband402 to extend into the urethra, such as to thepenile urethra226, while a distal end of theband402 remains in the bladder. In some embodiments, the narrower portion (i.e.,portion404b) may extend into the urethra and the wider portion (i.e.,portion404a) may extend into the bladder. In other embodiments, the wider portion (i.e.,portion404a) may extend into the urethra and the narrower portion (e.g.,portion404b) may extend into the bladder. In several embodiments, the proximal end ofband502 may be positioned in the urethra proximal of the bulbar urethra, such as in the penile urethra. In many embodiments, a suture loop connected to a proximal end of the band may be utilized to pull theband402 out of the bladder and into the urethra. In many such embodiments, the suture loop may be removed after positioning of the stent assembly. It will be appreciated that a variety of elliptical or racetrack shapes may be utilized without departing from the scope of this disclosure. For example, an oval or an egg shape may be used.
• FIG.5 illustrates anexemplary band502 according to one or more embodiments disclosed hereby. Theband502 may include afirst portion504aand asecond portion504bseparated by a dashed line. Additionally, theband502 may include a first straight portion508a, a second straight portion508a, a firstcurved portion506a, and a secondcurved portion506b. In various embodiments, theband502 may be utilized in a stent assembly (e.g., stent assembly102) to facilitate extraction of the stent (e.g., stent104). In some embodiments,FIG.5 may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,band502 may be the same or similar toband116,band220, orband916. Further, one or more components ofFIG.5, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,band502 may be incorporated into stent assembly102 (e.g., by replacing band116) without departing from the scope of this disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIG.5, without departing from the scope of this disclosure. For example,stent904 may be incorporated with band502 (e.g., by coupling thesecond portion504bofband502 throughproximal retention member910 in place of band916). Embodiments are not limited in this context.
• In various embodiments, theband502 includes a first end withcurved portion506aand a second end withcurved portion506b. The first and secondcurved portions506a,506bmay be connected by the first and secondstraight portions508a,508b. In some embodiments, the straight portions may be positioned at the intersection of the bladder and the urethra. In some such embodiments, the larger curved portion (i.e.,curved portion506a) may extend into the bladder and the smaller curved portion (i.e.,curved portion506b) may extend into the urethra. In many embodiments, the proximal end ofband502 may be positioned in the urethra proximal of the bulbar urethra, such as in the penile urethra. In many embodiments, the proximal end ofband502 may be positioned in the urethra proximal of the bulbar urethra, such as in the penile urethra. In many embodiments, a suture loop connected to a proximal end of the band may be utilized to pull theband502 out of the bladder and into the urethra. In many such embodiments, the suture loop may be removed after positioning of the stent assembly.
• FIG.6 illustrates anexemplary band602 according to one or more embodiments disclosed hereby. Theband602 may include afirst portion604aand asecond portion604bseparated by a dashed line. Additionally, theband602 may include a firstclosed loop606aand a secondclosed loop606bconnected by astraight portion608. In various embodiments, theband602 may be utilized in a stent assembly (e.g., stent assembly102) to facilitate extraction of the stent (e.g., stent104). In some embodiments,FIG.6 may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,band602 may be the same or similar toband116,band220, orband916. Further, one or more components ofFIG.6, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,band602 may be incorporated into stent assembly102 (e.g., by replacing band116) without departing from the scope of this disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIG.6, without departing from the scope of this disclosure. For example,stent104 may be incorporated with band602 (e.g., by coupling thesecond portion604bofband602 throughproximal retention member114 in place of band116). Embodiments are not limited in this context.
• In various embodiments, theband602 includes the firstclosed loop606aconnected to the secondclosed loop606bbystraight portion608. In many embodiments, theclosed loop606amay be a thinner and larger circle and theclosed loop606bmay be a thicker and smaller circle. In some embodiments, theclosed loop606amay be coupled to a proximal retention member of a catheter and positioned within a bladder. In some such embodiments, theclosed loop606bmay be positioned in the urethra, such as proximal to the bulbar urethra. In various embodiments, theclosed loop606amay be constructed from a re-shapeable material, such as a polymer. In several embodiments, theclosed loop606bmay be constructed from a molded, memory shaped, and/or heat set material such that theclosed loop606bwill recover to nominal dimensions when not subjected to a sufficient external force. In several such embodiment, the force exerted by the urethra would not be sufficient to reshape. Accordingly, theclosed loop606bmay operate as a smooth surface anchor in the urethra to prevent migration of theband602 into the bladder. In many embodiments, a suture loop connected to a proximal end of the band may be utilized to pull theband602 out of the bladder and into the urethra. In many such embodiments, the suture loop may be removed after positioning of the stent assembly.
• FIGS.7A and7B illustrate anexemplary stent assembly702 according to one or more embodiments disclosed hereby. More specifically,FIG.7A illustrates a side view ofstent assembly702 andFIG.7B illustrates a top view ofstent assembly702.Stent assembly702 has aproximal end708, adistal end710, and includes astent704 and asuture loop718. Thestent704 includes adistal retention member712, amidportion706 withmarkers716a,716b,716c,716d,716e, and aproximal retention member714. Thesuture loop718 includes acrimp720. In the illustrated embodiments, theproximal retention member714 has extended length that facilitates positioning of the proximal end of theproximal retention member714 within a urethra of a patient near the exterior opening of the urethra. In many embodiments,proximal retention member714 may facilitate safe and efficient removal of thestent704 while improving patient comfort. In some embodiments,FIGS.7A and7B may include one or more components that are the same or similar to one or more other components of the present disclosure.Distal retention member712 may be the same or similar todistal retention member112. Further, one or more components ofFIGS.7A and7B, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,proximal retention member714 may be incorporated into stent assembly102 (e.g., by replacingband116 and proximal retention member114) without departing from the scope of this disclosure. Further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIGS.7A and7B, without departing from the scope of this disclosure. Embodiments are not limited in this context.
• As shown inFIG.7B, at least a portion of the extended length may result from stretching the shaped loop of theproximal retention member714 out. In several embodiments, the shape ofproximal retention member714 may enable the proximal end to extend into the urethra and proximate to the external opening of the urethra. In several such embodiments, the shape ofproximal retention member714 may cause excess length to be retained in the bladder as the proximal end is positioned in the urethra. In various embodiments, the shape of the proximal retention member may cause a first portion of theproximal retention member714 to anchor in the bladder and/or a second portion of theproximal retention member714 to anchor in the urethra (see e.g., shape ofband502 and/or band602). In some embodiments, theproximal retention member714 may take the form of one or more bands described herein, such asband302,band402,band502, orband602. In one embodiment, a tube, or similar, may be threaded onto theproximal retention member714 to aid in maintaining theproximal retention member714 in the urethra and/or allowing urine to pass.
• In various embodiments,stent704 includesmarkers716a,716b,716c,716d,716eto assist in positioning thestent704 within a body. In many embodiments, themarkers716a,716b,716c,716d,716ereflect imaging energy (e.g., from intraoperative imaging) in a characteristic and/or unique manner, such as by being radiopaque. In several embodiments, bismuth and/or bismuth subcarbonate may be utilized to form one or more radiopaque markers in thestent704. In some embodiments,marker716amay comprise a bladder marking and/ormarker716emay comprise a kidney marking that will reside in the bladder and kidney, respectively, when thestent704 is properly positioned. In many embodiments,markers716b,716c,716dmay comprise length indicators. For instance,markers716b,716c,716dmay be positioned betweenmarkers marker716a,716bin 5 cm increments.
• FIG.8 illustrates anexemplary stent804 according to one or more embodiments disclosed hereby. In the illustrated embodiment, a proximal portion of thestent804 is shown withproximal end802,distal end808, and includingmidportion806 havingguidewire passage812 andproximal retention member810. In some embodiments,FIG.8 may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,midportion806 may be the same or similar tomidportion106. Further, one or more components ofFIG.8, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,guidewire passage812 may be excluded fromstent804 without departing from the scope of this disclosure. Still further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIG.8, without departing from the scope of this disclosure. For example,distal retention member206 may be incorporated intostent804 without departing from the scope of this disclosure. It will be appreciated that shapes described hereby, such as with respect toproximal retention member714 and/orproximal retention member810 may be applied to one or more bands described hereby (e.g., band220) without departing from the scope of this disclosure. Embodiments are not limited in this context.
• Theproximal retention member810 may comprise a double helical shape. In many embodiments, each helix of the double helical shape may be bonded together. In many such embodiments, the bond may be perforated or scored, such as to allow the double helix to be pulled apart to extend theproximal retention member810 to a length that is able to reach into the urethra a targeted length (e.g., a measured length from a first point to a second point of the anatomy). In some embodiments, only a portion of the bond between each helix may be perforated or scored, such as to control how or where the double helix pulls apart. For example, a proximal portion may be perforated or scored and a distal portion may not be perforated or scored. In such examples, the distal portion will remain in a tubular coiled shape when the proximal portion is pulled apart to adjust the overall length of theproximal retention member810 during positioning.
• In various embodiments, theproximal retention member810 may be utilized to facilitate extraction of thestent804. In many embodiments, the proximal end ofproximal retention member810 may be positioned in the urethra proximal of the bulbar urethra, such as in the penile urethra. In several embodiments a suture loop (not shown) may be coupled toproximal retention member810. In various embodiments, a distal portion ofproximal retention member810 may anchor in the bladder and a proximal portion ofproximal retention member810 may extend into and/or anchor in the urethra, such as near an external opening of the urethra.
• FIGS.9A-9D illustrates various aspects of astent assembly902 in conjunction with apositioner922 according to one or more embodiments disclosed hereby. More specifically,FIG.9A illustrates a side view ofstent assembly902,FIG.9B illustrates a top view ofstent assembly902 in conjunction withpositioner922,FIG.9C illustrates a detail view of the coupling betweenproximal retention member910 andband916, andFIG.9D illustrates thepositioner922.Stent assembly902 has adistal end912, aproximal end914, and includes astent904,band916, andsuture loop918. Thestent904 may include adistal retention member906 connected to aproximal retention member910 by amidportion908. Thepositioner922 has adistal end924, aproximal end926, and includes atubular member930 with a notch at thedistal end924. In some embodiments,FIGS.9A-9D may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,stent904 may be the same or similar tostent104. In another example,band916 may be the same or similar toband220. Further, one or more components ofFIGS.9A-9D, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,positioner922 may be utilized in conjunction withstent assembly102 without departing from the scope of this disclosure. Further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIGS.9A-9D, without departing from the scope of this disclosure. For example,band402 orband502 may be incorporated into stent assembly902 (e.g., by replacing band916). Embodiments are not limited in this context.
• Instent assembly902, theband916 may be joined to the proximal retention member910 (e.g., stent loop) in such a way that theband916 is slidable proximally along the length of theproximal retention member910 when pulled. For example, theband916 may slide proximally when pulled bysuture loop918 to allow the ureteral portion of the stent assembly902 (e.g., band916) to slide and extend into the urethra. Accordingly,stent assembly902 may have an adjustable effective length. In many embodiments, excess portions of theband916 may remain in the bladder after the proximal end of theband916 is positioned in the urethra (e.g., near the external opening of the urethra). In various embodiments, theband916 may be slidably coupled to theproximal retention member910 by inserting theproximal retention member910 into the inner perimeter of theband916, and then theproximal portion920aofband916 may be inserted into the inner perimeter of theproximal retention member910. In various such embodiments, the steps of inserting theproximal retention member910 into the inner perimeter of theband916, and then theproximal portion920aofband916 may be inserted into the inner perimeter of theproximal retention member910 may be repeated one or more times to slidably couple theband916 to theproximal retention member910.
• In various embodiments, thepositioner922 may slide over a guidewire during delivery. For example, thetubular member930 may slide over the guidewire during delivery. Thepositioner922 may include anotch928. In several embodiments, thenotch928 may hold the distal end of theband916 against the proximal end of thestent904 during insertion of thestent assembly902. After thestent904 is positioned using the guidewire and thepositioner922, the guidewire may be removed with the positioner still abutted to the proximal end of thestent904. In some embodiments, thesuture loop918 and thepositioner922 may be used to guide theband916, or a portion thereof, into the urethra. Once theband916 is positioned in the urethra (e.g., with the proximal end extending past the bulbar urethra), the distal portion of the band may still be supported by thenotch928. In various embodiments, at this point, thesuture loop918 may be removed (e.g., cut off). In many embodiments, thenotch928 has sufficient clearance to release theband916 by backing thepositioner922 proximally away from theband916 and out of the body. Aspects of placing thestent assembly902 within a patient is described in more detail below with respect toFIGS.10A-10C.
• FIGS.10A-10C illustrates various aspects of positioning astent1002 within a patient according to one or more embodiments disclosed hereby. More specifically,FIG.10A illustrates insertion of thestent1002 into ascope port1012 of scope1014 (e.g., a cystoscope),FIG.10B illustrates positioning of thestent1002 within a patient withguidewire1008,FIG.10C illustrates removal of theguidewire1008. The illustrated portions ofstent1002 may includeproximal retention member1004a,proximal retention member1004b, andmidportion1006. In some embodiments,FIGS.10A-10C may include one or more components that are the same or similar to one or more other components of the present disclosure. For example,guidewire1008 may be the same or similar topositioner922. In another example,proximal retention member1004aandproximal retention member1004bmay be the same or similar toproximal retention member114. Further, one or more components ofFIGS.10A-10C, or aspects thereof, may be incorporated into other embodiments of the present disclosure, or excluded from the described embodiments, without departing from the scope of this disclosure. For example,scope1014 may be utilized in conjunction withstent assembly102 without departing from the scope of this disclosure. Further, one or more components of other embodiments of the present disclosure, or aspects thereof, may be incorporated into one or more components ofFIGS.10A-10C, without departing from the scope of this disclosure. For example,band402 orband502 may be incorporated into stent assembly902 (e.g., by being coupled toproximal retention member1004aand/orproximal retention member1004b). Embodiments are not limited in this context.
• Generally, positioning of thestent1002 within a patient may include one or more of the following steps. A hydrophilic coating may be activated on thestent1002. Thestent1002 may be loaded over aguidewire1008 and advanced into thescope port1012 ofscope1014. Thestent1002 may be advance until a portion of themidportion1006 resides outside of thescope port1012. Thepositioner1018 may be advanced over theguidewire1008 until thepositioner1018 abuts themidportion1006 and theproximal retention members1004a,1004blie over the positioner1018 (see e.g.,FIG.10A). Thestent1002 may be advanced distally via thepositioner1018 through thescope1014. Thestent1002 may be advanced until thestent1002 is positioned withbladder mark1020 at theureteral orifice1016 ofbladder1010 andproximal retention members1004a,1004bresiding completely in the bladder1010 (see e.g.,FIG.10B). Theguidewire1008 may be retracted and confirmation of the distal retention member pigtail curl in the renal pelvis may be confirmed. Theguidewire1008 wire may be removed from the patient along with thepositioner1018 once the position ofstent1002 is confirmed (see e.g.,FIG.10C). The correct stent size for the patient may be confirmed by ensuring that thebladder mark1020 is positioned at theureteral orifice1016, the loops ofproximal retention members1004a,1004bare residing in thebladder1010, and the band (not shown inFIGS.8A-8C) extends into the urethra past the bulbar urethra. The suture loop (not shown inFIGS.8A-8C) may be cut and removed once thestent1002 is properly positioned.
• The foregoing discussion has broad application and has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be clear to those skilled in the art that principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and with other elements, materials, and components, without departing from the concept, spirit, or scope, or characteristics thereof. For example, various features of the disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of the certain aspects, embodiments, or configurations of the disclosure may be combined in alternate aspects, embodiments, or configurations. While the disclosure is presented in terms of embodiments, it should be appreciated that the various separate features of the present subject matter need not all be present in order to achieve at least some of the desired characteristics and/or benefits of the present subject matter or such individual features. One skilled in the art will appreciate that the disclosure may be used with many modifications or modifications of structure, arrangement, proportions, materials, components, and otherwise, used in the practice of the disclosure, which are particularly adapted to specific environments and operative requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be constructed of multiple parts or elements shown as multiple parts may be integrally formed, the operation of elements may be reversed or otherwise varied, the size or dimensions of the elements may be varied. Similarly, while operations or actions or procedures are described in a particular order, this should not be understood as requiring such particular order, or that all operations or actions or procedures are to be performed, to achieve desirable results. Additionally, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the claimed subject matter being indicated by the appended claims, and not limited to the foregoing description or particular embodiments or arrangements described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and can be claimed separately or in combination with features of that embodiment or any other embodiment, the scope of the subject matter being indicated by the appended claims, and not limited to the foregoing description.
• In the foregoing description and the following claims, the following will be appreciated. The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a”, “an”, “the”, “first”, “second”, etc., do not preclude a plurality. For example, the term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and/or the like) are only used for identification purposes to aid the reader's understanding of the present disclosure, and/or serve to distinguish regions of the associated elements from one another, and do not limit the associated element, particularly as to the position, orientation, or use of this disclosure. Connection references (e.g., attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another.
• The following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term “comprises/comprising” does not exclude the presence of other elements or steps. Additionally, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion in different claims does not imply that a combination of features is not feasible and/or advantageous. In addition, singular references do not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and shall not be construed as limiting the scope of the claims in any way.
• All of the devices and/or methods disclosed and claimed hereby can be made and executed without undue experimentation in light of the present disclosure. While the devices and methods of this disclosure have been described in terms of preferred embodiments, it may be apparent to those of skill in the art that variations can be applied to the devices and/or methods and in the steps or in the sequence of steps of the method disclosed hereby without departing from the concept, spirit and scope of the disclosure. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the disclosure as defined by the appended claims.

Claims (20)

1. A stent, comprising:

a midportion extending along a longitudinal axis between a proximal end and a distal end;

a distal retention member extending distally from the distal end of the midportion;

a proximal retention member extending proximally from the proximal end of the midportion;

a band extending about and proximally from the proximal retention member, the band comprising a first portion and a second portion; and

a suture looped through the band.

2. The stent ofclaim 1, wherein the first portion of the band has a radius larger than a radius of the second portion of the band.

3. The stent ofclaim 1, wherein the second portion of the band comprises a shape-memory material and the first portion of the band comprises a filament.

4. The stent ofclaim 1, wherein the first portion of the band comprises a first half of a closed loop and the second portion of the band comprises a second half of the closed loop.

5. The stent ofclaim 1, wherein the first portion of the band comprises a first closed loop and the second portion of the band comprises a second closed loop.

6. The stent ofclaim 1, wherein the proximal retention member comprises at least one loop.

7. The stent ofclaim 1, wherein the first portion of the band extends about the at least one loop and the second portion of the band extends through the at least one loop.

8. A system comprising:

a stent extending along a longitudinal axis and having a proximal end and a distal end and a midportion therebetween, the stent comprising a proximal retention member extending proximally from the proximal end;

a band extending about the proximal retention member, the band comprising a first portion and a second portion;

a suture looped through the second portion of the band; and

a tubular member comprising a lumen along a length and a notch at a distal end of the tubular member.

9. The system ofclaim 8, wherein the proximal retention member comprises at least one loop.

10. The system ofclaim 9, wherein the first portion of the band extends about the at least one loop and the second portion of the band extends through the at least one loop.

11. The system ofclaim 8, wherein the notch is configured to reversibly mate with the first portion of the band and the proximal end of the stent.

12. The system ofclaim 8, comprising a guidewire extending through the lumen of the tubular member, wherein the tubular member is configured to advance the stent along at least a portion of the guidewire.

13. The system ofclaim 8, wherein the first portion of the band is slidable with respect to the proximal retention member.

14. A method of delivering a stent, the method comprising:

delivering a stent into a ureter;

positioning a proximal retention member of the stent into a bladder; and

positioning a proximal end of a band in a urethra, wherein a distal end of the band is coupled to the proximal retention member.

15. The method ofclaim 14, further comprising positioning a suture coupled to the band into the urethra.

16. The method ofclaim 15, further comprising removing the suture.

17. The method ofclaim 14, further comprising using a tubular member with a lumen defined therein and guided over a guidewire to deliver the stent.

18. The method ofclaim 14, wherein the band is slidably coupled to the proximal retention member such that an effective length of the band is adjustable

19. The method ofclaim 18, wherein positioning the band comprises adjusting the effective length of the band between a proximal end of the proximal retention member and the second portion of the band.

20. The method ofclaim 14, wherein positioning the band comprises positioning a first portion of the band proximal of a bulbar urethra.

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