DEVICES, SYSTEMS, AND METHODS FOR URETERAL STENTS

Information

  • Patent Application
  • 20220387199
  • Publication Number
    20220387199
  • Date Filed
    May 31, 2022
    a year ago
  • Date Published
    December 08, 2022
    a year ago
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
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 of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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 and 1B illustrate an exemplary stent assembly 102 according to one or more embodiments disclosed hereby. More specifically, FIG. 1A illustrates a side view of stent assembly 102 and FIG. 1B illustrates a perspective view of stent assembly 102. Stent assembly 102 has a proximal end 108, a distal end 110, a longitudinal axis 120, and includes a stent 104, a band 116, and a suture loop 118. The stent 104 includes a distal retention member 112, a midportion 106, and a proximal retention member 114. In the illustrated embodiments, the band 116 is coupled between the stent 104 and the suture loop 118. In many embodiments, band 116 may facilitate safe and efficient removal of the stent 104 while improving patient comfort. In some embodiments, FIGS. 1A and 1B 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 of FIGS. 1A and 1B, 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 of FIGS. 1A and 1B, 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 to FIGS. 2A and 2B, the stent 104 may be positioned in a patient such that the distal retention member 112 extends into the kidney and the proximal retention member 114 extends into the bladder. In many embodiments, the band 116 may extend into the urethra. In many such embodiments, the length that the band 116 extends into the urethra may be adjustable, such as to accommodate a variety of anatomies. For example, only a portion of the band 116 may extend into the urethra with excess portions of the band 116 being left in the bladder. Accordingly, the effective length of stent assembly 102 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 member 112 comprises a pigtail and the proximal retention member 114 comprises a loop. However, the distal retention member 112 and/or the proximal retention member 114 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 the midportion 106 such that the cord ends cannot poke into tissue and cause irritation or pain. The illustrated embodiment of proximal retention member 114 includes a single loop. However, other embodiments may include one or more loops, such as two or three. Utilizing a loop for the proximal retention member 114, such as in place of a pigtail, can facilitate efficient removal of the stent 104. 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, the distal retention member 112 may include a guidewire passage that enables the stent 104 to be loaded onto a guidewire. For example, the pigtail of 112 may be straightened out and a guidewire may be inserted through a lumen of the stent 104. In one embodiment, the guidewire may exit the lumen of the stent 104 via an opening where the proximal retention member 114 couples to the midportion 106. In some embodiments, an opening to a guidewire passage may be disposed between where the one or more loops of the proximal retention member 114 are integrated into the midportion 106.


More generally, one or more portions of the stent assembly 102, such as the stent 104 or band 116, 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 the stent assembly 102 may have a layered construction. For example, stent 104 may include three layers of different blends of Percuflex™. In various embodiments, one or more portions of the stent 104 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, the stent 104, or portions thereof, may be available in different durometers, lengths, and configurations. For example, each of the distal retention member 112, midportion 106, and proximal retention member 114 may be available in different durometers, lengths, and configurations. For example, the stent 104 may be available in lengths between 6 centimeters (cm) and 34 cm. In some such examples, the stent 104 may be available in 2 cm increments between 10 cm and 30 cm. In one embodiment, the proximal retention member 114 may be available in a loop configuration (as illustrated) or a pigtail configuration (as distal retention member 112 is illustrated). In some embodiments, one or more portions of the stent 104 may be constructed from a radiopaque material. In some such embodiments, the placement of the stent 104 may be confirmed using imaging (e.g., via a fluoroscope and/or cystoscope).


In many embodiments, one or more components of the stent assembly 102, such as stent 104, may include one or more markers, which may be radiopaque (see e.g., markers 716a, 716b, 716c, 716d, 716e of FIG. 7A). For example, stent 104 may include a bladder marking and/or a kidney marking that will reside in the bladder and kidney, respectively, when the stent 104 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 the stent 104. In some embodiments, one or more portions of the stent assembly 102 may include a hydrophilic coating. In some such embodiments, the hydrophilic coating may be activatable. For example, the hydrophilic coating may be activated before the stent assembly 102 is inserted into a patient.


In various embodiments, the band 116 may be coupled (e.g., looped through) to the proximal retention member 114. In some embodiments, the band 116 may be attached to the proximal retention member 114 during manufacture of the stent assembly 102. For example, the band 116 may be looped into the proximal retention member 114 when the proximal retention member 114 is attached to the midportion 106. In several embodiments, the band 116 may be constructed from a different material than the stent 104. In some embodiments, the band 116 may have a predetermined durometer and/or shape that can be different than the rest of the stent assembly 102. For example, band 116 may comprise a bead or bead material. In many embodiments, the band 116 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 the band 116 may be positioned close the proximal end of the urethra without extending out of the urethra.


In several embodiments, the band 116 is atraumatic. For instance, the band 116 may have no loose ends, stepped transitions, seams, or transitions that may cause irritation within a patient. In one embodiment, the band 116 may comprise a seamless loop, such as an O-ring or a rubber band. In many embodiments, the band 116 may be molded, such as with an O-ring. In some embodiments, the band 116 may be crosscut from an elastic tube, such as a rubber band. In various embodiments, the band 116 may be a crosscut of a thin film polymer tube. In some embodiments, one or more portions of the band 116 may be constructed from a radiopaque material. In some such embodiments, the placement of the band 116 may be confirmed using imaging (e.g., via a fluoroscope and/or cystoscope). In many embodiments, the band 116 may include one or more markers, which may be radiopaque, to determine positioning. For example, band 116 may include a bladder marking that will reside just inside the bladder when the band is properly positioned. In another example, band 116 may include a marking that will reside in the penile urethra when the band 116 is properly positioned.


Further, the suture loop 118 may be coupled to (e.g., looped through) the band 116 and the ends may be knotted or crimped together (see e.g., crimp 720 of FIG. 7A). The suture loop 118 may be made of a polymer, a reinforced polymer, a thread, or the like. In various embodiments, the suture loop 118 may be used to assist in positioning of the stent 104 and band 116. For example, the suture loop 118 may be utilized to adjust the stent 104 proximally (e.g., pull the proximal retention member 114 back into the bladder or urethra). In another example, the suture loop 118 may be utilized to pull the band 116 into the urethra. Excess portions of the proximal retention member 114 may be left in the bladder. As described in more detail below, in many embodiments, the suture loop 118 may be removed after placement of the stent 104, such as to avoid patient discomfort.



FIGS. 2A and 2B 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 a stent 202 positioned within the patient and FIG. 2B illustrates various aspects of a band 220 positioned within the patient. In some embodiments, FIGS. 2A and 2B may include one or more components that are the same or similar to one or more other components of the present disclosure. For example, midportion 204 may be the same or similar to midportion 106. In another example, band 220 may be the same or similar to band 116. Further, one or more components of FIGS. 2A and 2B, 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 member 214 may be incorporated into stent 104 (e.g., by replacing proximal retention member 114) 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 of FIGS. 2A and 2B, without departing from the scope of this disclosure. For example, proximal retention member 114 may be incorporated into stent 202 (e.g., by replacing proximal retention member 214). Embodiments are not limited in this context.


Referring to FIG. 2A, the stent 202 includes a proximal end 210 with a proximal retention member 214, a distal end 208 with a distal retention member 206 midportion 204, and a midportion 204 connecting the proximal and distal retention members 214, 206. Additionally, a band 220 is coupled to the proximal retention member 214 and extends into the urethra 234. In the illustrated embodiment of FIG. 2A, the proximal retention member 214 is disposed in the bladder 212, the distal retention member 206 is disposed in the renal pelvis 232 of kidney 216, and the midportion 204 extends through the ureter 218. In various embodiments, the renal pelvis 232 may comprise an area proximate the center of the kidney 216 at which urine collects and is funneled into the ureter 218. In some embodiments, proximal retention member 214 and band 220 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 in FIG. 2A. The stent 202 has a proximal end 210 and a distal end 208. It may comprise a tubular polymer extrusion having a midportion 204 (or shaft), a distal retention member 206 (e.g., a renal “pigtail”), and a proximal retention member 214 (e.g., a bladder loop). These retention members 206, 214 prevent upward migration of the stent 202 toward the kidney 216 or downward migration of the stent 202 toward the bladder 212. Once properly deployed in the ureter 218, the stent 202 supports the ureter 218 and allows the passage of urine through the stent 202 and, because the ureter 218 naturally dilates around foreign bodies, allows urine to flow around the stent 202 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, and 10A-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 loop 118) 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 the ureter 218. 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., band 220) and/or a proximal retention member (e.g., proximal retention member 714 of FIG. 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 to FIG. 2B, various aspects of the band 220 positioned with a patient is illustrated. The band 220 may include a proximal end 228 and a distal end 230 coupled to the proximal retention member 214 of stent 202. The distal end 230 of band 220 may be positioned in the bladder 212. The band 220 may extend proximally past the prostate 222 and the bulbar urethra 224, finally ending with the proximal end 228 in the penile urethra 226. In some embodiments, the proximal end 228 of band 220 may be positioned proximate the proximal end of the urethra (i.e., near the exit). For example, the distal end 230 of band 220 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 the band 220, the proximal end of the proximal retention member may be positioned in the same manner as the band 220. 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 the band 220, or an extended proximal retention member, may be positioned within the bladder 212. For instance, the entire band 220, or extended proximal retention member, may be initially positioned within the bladder 212. Then the proximal end may be pulled into the urethra to the proper position, leaving the remainder of the band 220, or extended proximal retention member, in the bladder 212. The ability to leave excess material in the bladder 212 may enable a more adaptable stent 202 with an adjustable effective length, reducing the need for different size stents and stent assemblies. In many embodiments, the band 220, 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 the bulbar urethra 224 and the penile urethra 226, may be a tubular structure that provides a passageway between the bladder 212 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., band 220 or proximal retention member 714) in the urethra may simplify locating the stent assembly for removal. For example, when the proximal end 228 of the band 220 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 pull band 220 into the urethra, past the prostate 222, and past the bulbar urethra 224 to position the proximal end 228 in the penile urethra 226. In several embodiments, the proximal end 228 of the band 220 may be positioned proximal the bulbar urethra 224 to avoid patient pain or discomfort, such as during removal, because the bulbar urethra 224 is more sensitive than the penile urethra 226 in many patients.



FIG. 3 illustrates an exemplary band 302 according to one or more embodiments disclosed hereby. The band 302 may include a first portion 304a and a second portion 304b separated by a dashed line. In various embodiments, the band 302 may be utilized in a stent assembly (e.g., stent assembly 102) to facilitate extraction of the stent (e.g., stent 104). In the illustrated embodiment, the band 302 comprises a circle. In many embodiments, a proximal end of band 302 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, band 302 may be the same or similar to band 116, band 220, or band 916. Further, one or more components of FIG. 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, band 302 may be incorporated into stent assembly 102 (e.g., by replacing band 116) 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 of FIG. 3, without departing from the scope of this disclosure. For example, stent 202 may be incorporated with band 302 (e.g., by coupling band 302 to proximal retention member 214 in place of band 220). It will be appreciated that shapes described hereby, such as with respect to the bands in FIGS. 3-6, may be applied to the proximal retention member (e.g., proximal retention member 714 of FIG. 7A) without departing from the scope of this disclosure. Embodiments are not limited in this context.



FIG. 4 illustrates an exemplary band 402 according to one or more embodiments disclosed hereby. The band 402 may include a first portion 404a and a second portion 404b separated by a dashed line. Additionally, the band 402 may include a first straight portion 408a, a second straight portion 408b, a first curved portion 406a, and a second curved portion 406b. In various embodiments, the band 402 may be utilized in a stent assembly (e.g., stent assembly 102) to facilitate extraction of the stent (e.g., stent 104). 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, band 402 may be the same or similar to band 116, band 220, or band 916. Further, one or more components of FIG. 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, band 402 may be incorporated into stent assembly 102 (e.g., by replacing band 116) 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 of FIG. 4, without departing from the scope of this disclosure. For example, stent 202 may be incorporated with band 402 (e.g., by coupling band 402 to proximal retention member 214 in place of band 220). Embodiments are not limited in this context.


In various embodiments, the band 402 comprises an elliptical or racetrack shape. The elliptical or racetrack shape may provide a longer length to allow a proximal end of the band 402 to extend into the urethra, such as to the penile urethra 226, while a distal end of the band 402 remains in the bladder. In some embodiments, the narrower portion (i.e., portion 404b) may extend into the urethra and the wider portion (i.e., portion 404a) may extend into the bladder. In other embodiments, the wider portion (i.e., portion 404a) may extend into the urethra and the narrower portion (e.g., portion 404b) may extend into the bladder. In several embodiments, the proximal end of band 502 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 the band 402 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 an exemplary band 502 according to one or more embodiments disclosed hereby. The band 502 may include a first portion 504a and a second portion 504b separated by a dashed line. Additionally, the band 502 may include a first straight portion 508a, a second straight portion 508a, a first curved portion 506a, and a second curved portion 506b. In various embodiments, the band 502 may be utilized in a stent assembly (e.g., stent assembly 102) to facilitate extraction of the stent (e.g., stent 104). 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, band 502 may be the same or similar to band 116, band 220, or band 916. Further, one or more components of FIG. 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, band 502 may be incorporated into stent assembly 102 (e.g., by replacing band 116) 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 of FIG. 5, without departing from the scope of this disclosure. For example, stent 904 may be incorporated with band 502 (e.g., by coupling the second portion 504b of band 502 through proximal retention member 910 in place of band 916). Embodiments are not limited in this context.


In various embodiments, the band 502 includes a first end with curved portion 506a and a second end with curved portion 506b. The first and second curved portions 506a, 506b may be connected by the first and second straight portions 508a, 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 portion 506a) may extend into the bladder and the smaller curved portion (i.e., curved portion 506b) may extend into the urethra. In many embodiments, the proximal end of band 502 may be positioned in the urethra proximal of the bulbar urethra, such as in the penile urethra. In many embodiments, the proximal end of band 502 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 the band 502 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 an exemplary band 602 according to one or more embodiments disclosed hereby. The band 602 may include a first portion 604a and a second portion 604b separated by a dashed line. Additionally, the band 602 may include a first closed loop 606a and a second closed loop 606b connected by a straight portion 608. In various embodiments, the band 602 may be utilized in a stent assembly (e.g., stent assembly 102) to facilitate extraction of the stent (e.g., stent 104). 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, band 602 may be the same or similar to band 116, band 220, or band 916. Further, one or more components of FIG. 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, band 602 may be incorporated into stent assembly 102 (e.g., by replacing band 116) 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 of FIG. 6, without departing from the scope of this disclosure. For example, stent 104 may be incorporated with band 602 (e.g., by coupling the second portion 604b of band 602 through proximal retention member 114 in place of band 116). Embodiments are not limited in this context.


In various embodiments, the band 602 includes the first closed loop 606a connected to the second closed loop 606b by straight portion 608. In many embodiments, the closed loop 606a may be a thinner and larger circle and the closed loop 606b may be a thicker and smaller circle. In some embodiments, the closed loop 606a may be coupled to a proximal retention member of a catheter and positioned within a bladder. In some such embodiments, the closed loop 606b may be positioned in the urethra, such as proximal to the bulbar urethra. In various embodiments, the closed loop 606a may be constructed from a re-shapeable material, such as a polymer. In several embodiments, the closed loop 606b may be constructed from a molded, memory shaped, and/or heat set material such that the closed loop 606b will 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, the closed loop 606b may operate as a smooth surface anchor in the urethra to prevent migration of the band 602 into the bladder. In many embodiments, a suture loop connected to a proximal end of the band may be utilized to pull the band 602 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 and 7B illustrate an exemplary stent assembly 702 according to one or more embodiments disclosed hereby. More specifically, FIG. 7A illustrates a side view of stent assembly 702 and FIG. 7B illustrates a top view of stent assembly 702. Stent assembly 702 has a proximal end 708, a distal end 710, and includes a stent 704 and a suture loop 718. The stent 704 includes a distal retention member 712, a midportion 706 with markers 716a, 716b, 716c, 716d, 716e, and a proximal retention member 714. The suture loop 718 includes a crimp 720. In the illustrated embodiments, the proximal retention member 714 has extended length that facilitates positioning of the proximal end of the proximal retention member 714 within a urethra of a patient near the exterior opening of the urethra. In many embodiments, proximal retention member 714 may facilitate safe and efficient removal of the stent 704 while improving patient comfort. In some embodiments, FIGS. 7A and 7B may include one or more components that are the same or similar to one or more other components of the present disclosure. Distal retention member 712 may be the same or similar to distal retention member 112. Further, one or more components of FIGS. 7A and 7B, 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 member 714 may be incorporated into stent assembly 102 (e.g., by replacing band 116 and proximal retention member 114) 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 of FIGS. 7A and 7B, without departing from the scope of this disclosure. Embodiments are not limited in this context.


As shown in FIG. 7B, at least a portion of the extended length may result from stretching the shaped loop of the proximal retention member 714 out. In several embodiments, the shape of proximal retention member 714 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 of proximal retention member 714 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 the proximal retention member 714 to anchor in the bladder and/or a second portion of the proximal retention member 714 to anchor in the urethra (see e.g., shape of band 502 and/or band 602). In some embodiments, the proximal retention member 714 may take the form of one or more bands described herein, such as band 302, band 402, band 502, or band 602. In one embodiment, a tube, or similar, may be threaded onto the proximal retention member 714 to aid in maintaining the proximal retention member 714 in the urethra and/or allowing urine to pass.


In various embodiments, stent 704 includes markers 716a, 716b, 716c, 716d, 716e to assist in positioning the stent 704 within a body. In many embodiments, the markers 716a, 716b, 716c, 716d, 716e reflect 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 the stent 704. In some embodiments, marker 716a may comprise a bladder marking and/or marker 716e may comprise a kidney marking that will reside in the bladder and kidney, respectively, when the stent 704 is properly positioned. In many embodiments, markers 716b, 716c, 716d may comprise length indicators. For instance, markers 716b, 716c, 716d may be positioned between markers marker 716a, 716b in 5 cm increments.



FIG. 8 illustrates an exemplary stent 804 according to one or more embodiments disclosed hereby. In the illustrated embodiment, a proximal portion of the stent 804 is shown with proximal end 802, distal end 808, and including midportion 806 having guidewire passage 812 and proximal retention member 810. 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, midportion 806 may be the same or similar to midportion 106. Further, one or more components of FIG. 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 passage 812 may be excluded from stent 804 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 of FIG. 8, without departing from the scope of this disclosure. For example, distal retention member 206 may be incorporated into stent 804 without departing from the scope of this disclosure. It will be appreciated that shapes described hereby, such as with respect to proximal retention member 714 and/or proximal retention member 810 may be applied to one or more bands described hereby (e.g., band 220) without departing from the scope of this disclosure. Embodiments are not limited in this context.


The proximal retention member 810 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 the proximal retention member 810 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 the proximal retention member 810 during positioning.


In various embodiments, the proximal retention member 810 may be utilized to facilitate extraction of the stent 804. In many embodiments, the proximal end of proximal retention member 810 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 to proximal retention member 810. In various embodiments, a distal portion of proximal retention member 810 may anchor in the bladder and a proximal portion of proximal retention member 810 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 a stent assembly 902 in conjunction with a positioner 922 according to one or more embodiments disclosed hereby. More specifically, FIG. 9A illustrates a side view of stent assembly 902, FIG. 9B illustrates a top view of stent assembly 902 in conjunction with positioner 922, FIG. 9C illustrates a detail view of the coupling between proximal retention member 910 and band 916, and FIG. 9D illustrates the positioner 922. Stent assembly 902 has a distal end 912, a proximal end 914, and includes a stent 904, band 916, and suture loop 918. The stent 904 may include a distal retention member 906 connected to a proximal retention member 910 by a midportion 908. The positioner 922 has a distal end 924, a proximal end 926, and includes a tubular member 930 with a notch at the distal end 924. 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, stent 904 may be the same or similar to stent 104. In another example, band 916 may be the same or similar to band 220. Further, one or more components of FIGS. 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, positioner 922 may be utilized in conjunction with stent assembly 102 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 of FIGS. 9A-9D, without departing from the scope of this disclosure. For example, band 402 or band 502 may be incorporated into stent assembly 902 (e.g., by replacing band 916). Embodiments are not limited in this context.


In stent assembly 902, the band 916 may be joined to the proximal retention member 910 (e.g., stent loop) in such a way that the band 916 is slidable proximally along the length of the proximal retention member 910 when pulled. For example, the band 916 may slide proximally when pulled by suture loop 918 to allow the ureteral portion of the stent assembly 902 (e.g., band 916) to slide and extend into the urethra. Accordingly, stent assembly 902 may have an adjustable effective length. In many embodiments, excess portions of the band 916 may remain in the bladder after the proximal end of the band 916 is positioned in the urethra (e.g., near the external opening of the urethra). In various embodiments, the band 916 may be slidably coupled to the proximal retention member 910 by inserting the proximal retention member 910 into the inner perimeter of the band 916, and then the proximal portion 920a of band 916 may be inserted into the inner perimeter of the proximal retention member 910. In various such embodiments, the steps of inserting the proximal retention member 910 into the inner perimeter of the band 916, and then the proximal portion 920a of band 916 may be inserted into the inner perimeter of the proximal retention member 910 may be repeated one or more times to slidably couple the band 916 to the proximal retention member 910.


In various embodiments, the positioner 922 may slide over a guidewire during delivery. For example, the tubular member 930 may slide over the guidewire during delivery. The positioner 922 may include a notch 928. In several embodiments, the notch 928 may hold the distal end of the band 916 against the proximal end of the stent 904 during insertion of the stent assembly 902. After the stent 904 is positioned using the guidewire and the positioner 922, the guidewire may be removed with the positioner still abutted to the proximal end of the stent 904. In some embodiments, the suture loop 918 and the positioner 922 may be used to guide the band 916, or a portion thereof, into the urethra. Once the band 916 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 the notch 928. In various embodiments, at this point, the suture loop 918 may be removed (e.g., cut off). In many embodiments, the notch 928 has sufficient clearance to release the band 916 by backing the positioner 922 proximally away from the band 916 and out of the body. Aspects of placing the stent assembly 902 within a patient is described in more detail below with respect to FIGS. 10A-10C.



FIGS. 10A-10C illustrates various aspects of positioning a stent 1002 within a patient according to one or more embodiments disclosed hereby. More specifically, FIG. 10A illustrates insertion of the stent 1002 into a scope port 1012 of scope 1014 (e.g., a cystoscope), FIG. 10B illustrates positioning of the stent 1002 within a patient with guidewire 1008, FIG. 10C illustrates removal of the guidewire 1008. The illustrated portions of stent 1002 may include proximal retention member 1004a, proximal retention member 1004b, and midportion 1006. 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, guidewire 1008 may be the same or similar to positioner 922. In another example, proximal retention member 1004a and proximal retention member 1004b may be the same or similar to proximal retention member 114. Further, one or more components of FIGS. 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, scope 1014 may be utilized in conjunction with stent assembly 102 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 of FIGS. 10A-10C, without departing from the scope of this disclosure. For example, band 402 or band 502 may be incorporated into stent assembly 902 (e.g., by being coupled to proximal retention member 1004a and/or proximal retention member 1004b). Embodiments are not limited in this context.


Generally, positioning of the stent 1002 within a patient may include one or more of the following steps. A hydrophilic coating may be activated on the stent 1002. The stent 1002 may be loaded over a guidewire 1008 and advanced into the scope port 1012 of scope 1014. The stent 1002 may be advance until a portion of the midportion 1006 resides outside of the scope port 1012. The positioner 1018 may be advanced over the guidewire 1008 until the positioner 1018 abuts the midportion 1006 and the proximal retention members 1004a, 1004b lie over the positioner 1018 (see e.g., FIG. 10A). The stent 1002 may be advanced distally via the positioner 1018 through the scope 1014. The stent 1002 may be advanced until the stent 1002 is positioned with bladder mark 1020 at the ureteral orifice 1016 of bladder 1010 and proximal retention members 1004a, 1004b residing completely in the bladder 1010 (see e.g., FIG. 10B). The guidewire 1008 may be retracted and confirmation of the distal retention member pigtail curl in the renal pelvis may be confirmed. The guidewire 1008 wire may be removed from the patient along with the positioner 1018 once the position of stent 1002 is confirmed (see e.g., FIG. 10C). The correct stent size for the patient may be confirmed by ensuring that the bladder mark 1020 is positioned at the ureteral orifice 1016, the loops of proximal retention members 1004a, 1004b are residing in the bladder 1010, and the band (not shown in FIGS. 8A-8C) extends into the urethra past the bulbar urethra. The suture loop (not shown in FIGS. 8A-8C) may be cut and removed once the stent 1002 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
  • 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; anda suture looped through the band.
  • 2. The stent of claim 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 of claim 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 of claim 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 of claim 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 of claim 1, wherein the proximal retention member comprises at least one loop.
  • 7. The stent of claim 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; anda tubular member comprising a lumen along a length and a notch at a distal end of the tubular member.
  • 9. The system of claim 8, wherein the proximal retention member comprises at least one loop.
  • 10. The system of claim 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 of claim 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 of claim 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 of claim 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; andpositioning 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 of claim 14, further comprising positioning a suture coupled to the band into the urethra.
  • 16. The method of claim 15, further comprising removing the suture.
  • 17. The method of claim 14, further comprising using a tubular member with a lumen defined therein and guided over a guidewire to deliver the stent.
  • 18. The method of claim 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 of claim 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 of claim 14, wherein positioning the band comprises positioning a first portion of the band proximal of a bulbar urethra.
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.

Provisional Applications (2)
Number Date Country
63196325 Jun 2021 US
63196330 Jun 2021 US