Apparatus, system and method for delivering a stent

Abstract

This disclosure generally relates to the field of medical devices. More specifically, this disclosure relates to the delivery of a variable-length stent within a patient's body. In one example, the stent may include a body comprising a coil in a generally helical pattern about a longitudinal axis of the stent and along the length of the stent between a proximal and distal end. The coil may define a lumen along a longitudinal axis passing through the center of the body. A distal tube may have a wall extending from the distal end of the body. A first orifice may extend through the wall of the distal tube into the lumen. A distal retaining member may extend from the distal tube. A distal suture may have an intermediate portion. The intermediate portion may extend through the first orifice.

Description

[0001] priority

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application Serial No. 62 / 890,832, filed August 23, 2019, entitled “Apparatus, System, and Method for Delivering Stents,” the disclosure of which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure generally relates to the field of medical devices. In particular, this disclosure relates to devices, systems, and methods for delivering a stent of variable length within a patient. Background Technology

[0004] Delivered stents of fixed length may be too short for the patient's anatomy and may need to be removed and replaced with a new stent, potentially prolonging the procedure and increasing the likelihood of complications. Delivered stents of fixed length that are too long for the patient's anatomy may cause irritation as the excess length must be accommodated within the body, such as in the case of a ureteral stent, within the bladder. Variable-length stents may present challenges related to delivery, positioning, repositioning, length adjustment, and disengagement, all of which are associated with the body length of the adjustable stent. For example, even if the expected length is correct when positioning the stent, a variable-length stent may unintentionally, prematurely, or inappropriately extend or compress its length during placement, repositioning, and / or removal.

[0005] Taking these factors into account, the improvements in this disclosure may be useful. Summary of the Invention

[0006] This disclosure generally relates in its various aspects to medical devices, and in particular to stents of variable length and means, systems, and methods for delivering such stents, such as ureteral stents. In one aspect, the stent may include a body comprising a coil about a longitudinal axis of the stent, the coil extending along the length of the stent in a generally helical pattern between a proximal end and a distal end. The coil may define a lumen along a longitudinal axis passing through the center of the body. A distal tube having walls may extend distally from the distal end of the body. The lumen may extend through the distal tube. A first orifice may extend through the wall of the distal tube into the lumen. A proximal tube having walls may extend proximally from the proximal end of the body. The lumen may extend through the proximal tube. A distal retaining member may extend distally from the distal tube. The lumen may extend through the distal retaining member. A proximal retaining member having walls may extend proximally from the proximal tube to the proximal end of the proximal retaining member. The lumen may extend through the proximal retaining member to the proximal end of the proximal retaining member. The distal suture may have a first end, a second end, and a middle portion. The middle portion may extend through the first hole.

[0007] In the various embodiments described herein or otherwise, a second hole may extend through the wall of the distal tube into the lumen, such that the first and second holes are aligned to form a suture axis offset from the longitudinal axis. A middle portion of the distal suture may extend through the second hole. A third hole may extend through the wall of the proximal retainer into the lumen. The proximal suture may have a first end, a second end, and a middle portion. This middle portion may extend through the third hole and the proximal end of the proximal retainer. A portion of the distal suture may adhere to the proximal tube. A fourth hole may extend through the wall of the distal tube into the lumen, such that the first and fourth holes are aligned parallel to the longitudinal axis. A middle portion of the distal suture may extend through the fourth hole. A fifth hole may extend through the wall of the distal tube into the lumen, such that the first and fifth holes are aligned to form a suture axis intersecting the longitudinal axis. A middle portion of the distal suture may extend through the fifth hole. The distal suture extends distally from the first end along the wall of the distal tube within the lumen, through the first orifice, along the outer surface of the distal tube wall, through the fifth orifice into the lumen, and extends proximally along the wall of the distal tube within the lumen to the second end. A preset gap can be between selected adjacent coils of the body. This gap can be configured such that the diameter of the lumen increases when the selected adjacent coils are compressed together along the longitudinal axis. Axial compression of the body can be controlled by applying proximal tension to the distal suture. The proximal and distal retaining members can be pigtail-shaped, J-shaped, Cope ring-shaped, spiral-shaped, helical, or plug-puller-shaped, or combinations thereof. The distal retaining member can have a tapered distal tip that gradually tapers distally.

[0008] In one aspect, the stent delivery system may include a stent delivery device. The stent delivery device may include a cannula having a proximal end, a distal end, and a cannula lumen therethrough. A handle may be located at the proximal end of the cannula. A pusher may be disposed on the cannula. The pusher may have a proximal end, a distal end, and a pusher lumen therethrough. A locking knob may be located at the proximal end of the pusher and reversibly coupled to the handle. The stent may include a body containing a coil and disposed on the cannula, the stent having a stent lumen extending through the length of the stent. The distal end of the cannula is reversibly engaged with a portion of the stent length.

[0009] In the various embodiments described herein or otherwise, the portion of the stent may be located near the annular portion disposed on the stent wall within the stent lumen. This portion of the stent may be located away from the distally tapering portion on the stent wall within the stent lumen. The cannula may have an outer diameter larger than the diameter of the stent lumen. A portion of the stent length may run along the proximal end of the stent. The cannula may have an outer diameter larger than the diameter of the stent lumen, and a portion of the stent length may run along the distal end of the stent. A guidewire may be disposed through the cannula lumen.

[0010] In one aspect, a method for positioning a stent may include inserting a guidewire into a target location within a patient's body. A stent, including a body containing a coil on the guidewire, may be inserted. The stent may be translated distally within the patient's body via the guidewire using a pusher. The stent may also be translated proximally within the patient's body via the guidewire using a first suture associated with the distal portion of the stent. Distal translation of the stent may include pushing the stent with a pusher. Proximal translation of the stent may be achieved by applying tension to the first suture.

[0011] In the various embodiments described herein or otherwise, the length of the stent can be adjusted within the patient by adjusting the gap between selected body winding coils of the stent. The stent can be removed from the patient by translating a second suture disposed through the proximal portion of the stent. Attached Figure Description

[0012] Non-limiting examples of this disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. In the drawings, each identical or substantially identical component shown is generally represented by the same number. For clarity, not every component is labeled in every figure, nor is every component shown in every embodiment of this disclosure, and such illustrations are not necessary for allowing those skilled in the art to understand this disclosure. In the figures:

[0013] Figure 1 is a view of a prior art ureteral stent positioned in the ureter between the kidney and the bladder;

[0014] Figure 2A The bracket according to an embodiment of the present disclosure is shown in a delivery configuration;

[0015] Figure 2B It shows Figure 2A The support shown is in its deployed configuration;

[0016] Figure 2C It shows Figure 2B The distal portion of the bracket shown;

[0017] Figure 3A The image shows a support in a transport configuration according to an embodiment of the present disclosure, the support having adjacent winding coil groups separated by gaps;

[0018] Figure 3B It shows Figure 3A The support shown is in a compression conveying configuration;

[0019] Figure 3C It shows Figure 3A and 3B The support shown is in its deployed configuration;

[0020] Figure 4 The distal portion of the stent according to an embodiment of the present disclosure is shown;

[0021] Figure 5 A portion of the bracket according to an embodiment of this disclosure is shown;

[0022] Figure 6 A portion of the bracket according to an embodiment of this disclosure is shown;

[0023] Figure 7A A support system according to an embodiment of the present disclosure is shown, wherein the support is in a transport configuration;

[0024] Figure 7B Show Figure 7A The support shown is in its deployed configuration;

[0025] Figure 8 A support system according to an embodiment of the present disclosure is shown, wherein the support is in a transport configuration;

[0026] Figure 9 A support system according to an embodiment of the present disclosure is shown, wherein the support is in a transport configuration;

[0027] Figure 10A This illustrates a support conveying device according to an embodiment of the present disclosure;

[0028] Figure 10B Illustrations of embodiments according to this disclosure Figure 10A The bracket conveying device shown is used for unfolding.

[0029] Figure 11 A support system according to an embodiment of the present disclosure is shown, wherein the support is in a transport configuration;

[0030] Figure 12 A support system according to an embodiment of the present disclosure is shown, wherein the support is in a transport configuration;

[0031] Figure 13 A support system according to an embodiment of the present disclosure is shown, wherein the support is in a transport configuration.

[0032] Note that the accompanying drawings are intended to depict only typical or exemplary embodiments of this disclosure. Therefore, the drawings should not be considered as limiting the scope of this disclosure. This disclosure will now be described in more detail with reference to the accompanying drawings. Detailed Implementation

[0033] This disclosure is not limited to the described embodiments. The terminology used herein is for the purpose of describing particular embodiments only 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 this disclosure pertains.

[0034] Although embodiments of this disclosure may be described with particular reference to ureteral stents, it should be understood that such devices, systems, and methods can be used with a variety of instruments and for a variety of other tissues, body pathways, organs, and / or cavities such as the vascular system, urogenital system, upper gastrointestinal system, lower gastrointestinal system, etc.

[0035] As used herein, the "proximal" end refers to the end of the device along the device that is closest to a healthcare professional when the device is introduced into the patient, and the "distal" end refers to the end of the device or object along the device that is furthest from a healthcare professional during implantation, positioning, or delivery.

[0036] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural references, unless otherwise expressly stated. As used in this specification and the appended claims, the term “or” is generally used to mean “and / or,” unless otherwise expressly stated.

[0037] Note that references to "one embodiment," "some embodiments," "other embodiments," etc., in the specification indicate that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such statements do not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in connection with an embodiment, it should be understood that, unless expressly objected, these features, structures, and / or characteristics may also be used in conjunction with other embodiments, whether explicitly described or not.

[0038] Whether explicitly stated or not, all numerical values ​​herein are assumed to be modified by the term "approximately". In the context of numerical values, the term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure. Unless otherwise stated, other uses of the term "approximately" (i.e., in contexts other than numerical values) may be considered to have their common and conventional definition, as understood from and consistent with the context of the specification. A range of numerical values ​​indicated 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).

[0039] As used herein, unless the context clearly indicates otherwise, the conjunction “and” includes each structure, component, part, etc. so combined, and unless the context clearly indicates otherwise, the conjunction “or” includes one or more structures, components, parts, etc. so combined, individually and in any combination and number.

[0040] The detailed description should be read with reference to the accompanying drawings, which are not necessarily drawn to scale, depict illustrative embodiments, and are not intended to limit the scope of the invention.

[0041] Stents can be delivered into a patient for various purposes, including implantation and drainage of lumens, pathways, vessels, and spaces within the body. For example, ureteral stents can be used to facilitate drainage of the upper urinary tract (e.g., from the kidney to the bladder), possibly after ureteroscopy, ureterotomy, and endoscopic pyelostomy, as well as in other situations where ureteral obstruction may occur or access to the kidney and / or ureter is required.

[0042] Figure 1 illustrates an exemplary stent 100 of this type. The stent 100 has a proximal end 100p and a distal end 100d. It is a tubular polymer extrusion having a shaft 102, a distal kidney retaining member (e.g., a kidney “pigtail” 104), and a proximal retaining member (e.g., a bladder “pigtail” 106). These retaining members 104, 106 prevent the stent 100 from shifting upward toward the kidney 110 or downward toward the bladder 112. Once properly deployed in the ureter 114, the stent 100 supports the ureter 114 and allows urine to flow through the stent 100, and also allows urine to flow around the stent 100 because the ureter 114 naturally expands around the foreign body.

[0043] In various embodiments of the stent described herein, or in other embodiments within the scope of this disclosure, the stent can be placed on a guidewire using a cystoscope, flexible ureteroscope, etc., and advanced to a position with a delivery device that can engage and release the stent. Once the distal end of the stent has been advanced into the kidney / calyx, the guidewire and / or delivery device are removed, thereby allowing the formation of a retention member, such as a pigtail, in the kidney and bladder. The distal retention member of the stent may be closed or taper at the end, depending on the insertion method (e.g., using a guidewire or other methods).

[0044] Delivered stents can cause patient discomfort or pain; for example, with ureteral stents, pain and / or discomfort in the bladder and hypochondrial region after insertion, especially if the delivered stent length is not well-suited to the patient's anatomy. Therefore, different applications and anatomical configurations can benefit from stents of varying diameters and lengths. For instance, the differences in ureteral anatomy necessitate different diameters and lengths between the end-holding components of the ureteral stent. Variable-length stents address various of these issues, but they also present their own challenges, such as the effective and accurate control of delivery, placement, and removal of stents that can extend and retract in length, such as stents with a body containing a coil.

[0045] refer to Figure 2A-2C The image shows a bracket 200 according to an embodiment of the present disclosure. Figure 2AIn this configuration, stent 200 is positioned on a guidewire 220 that extends through the lumen 206 of stent 200, thereby substantially extending (i.e., straightening) the distal retaining member 201 and the proximal retaining member 202. Guidewire 220 is sufficiently rigid to keep retaining members 201, 202 substantially straight along the longitudinal axis l during delivery through a patient's body cavity, for example, in a ureteral stent delivered within the ureter between a patient's kidney and bladder. Stent 200 includes a body 205 wound into a coil around the longitudinal axis l of stent 200. Body 205 extends along the length of stent 200 in a substantially helical pattern between a distal end 205d and a proximal end 205p. Various other patterns, shapes, widths, pitches, etc., of the coil can be used for specific applications as needed. Body 205 defines the lumen 206 along the longitudinal axis l passing through the center of the helical pattern. The distal end 203 extends from the distal end 205d of the body 205, and the proximal end 204 extends from the proximal end 205p of the body 205. Each of the distal end 203 and the proximal end 204 further extends a lumen 206 through the tubes 203 and 204. A distal retaining member 201 extends from the distal end 203, and a proximal retaining member 202 extends from the proximal end 204. Each retaining member 201, 202 further extends a lumen 206 through the retaining member 201, 202. The distal end 200d of the stent 200 has a wall that tapers distally, the diameter of which decreases, so that when the stent 200 is in a delivery configuration on the guidewire 220 or other delivery device, the distal end 200d can more easily navigate distally to the patient's anatomy. Other configurations for the tips of the distal and / or proximal retaining members 202 are contemplated. The stent 200 in Figure 2B and 2C The diagram shows an unfolded configuration in which guidewire 220 is removed from lumen 206, thereby allowing retaining members 201, 202 to form. A first aperture 211 and a second aperture 212 each extend through the wall of the distal tube 203 into lumen 206. A suture 221 extends along stent 200 and is configured for delivery, positioning, repositioning, removal, compression, or extension of stent 200 by a medical professional. A middle portion 221m of the suture 221 extends through the first aperture 211 and the second aperture 212. The first aperture 211 and the second aperture 212 are aligned to form a suture axis that is offset from (i.e., does not intersect) the longitudinal axis l. This results in minimal contact between the sutures 221 and the guidewire 220 compared to if the two axes intersect. In various embodiments, one or more sutures may extend within a channel extending along the stent wall, and / or one or more sutures may extend along a separate tubular channel independent of the stent lumen. The ends 221p of the sutures 221 are joined together, allowing a medical professional to more easily manipulate the ends 221p of the sutures 221 by applying or releasing tension on them (e.g., by the medical professional's hand, a device handle, etc.). In other embodiments, the ends of the sutures may be detachable.

[0046] The stent 200 and delivery device, such as a pusher (not shown), can be loaded onto a guidewire 220 outside the body. A distal retention member 201 can be substantially straightened and counter-loaded onto the proximal end of the guidewire 220. The stent 200 can be pushed distally (rather than pulled) onto the guidewire 220 to minimize stent 200 extension and / or attachment to the guidewire 220. For example, a medical professional can grasp the distal portion of the unloaded stent 200 with their thumb and forefinger and then push the stent 200 with controlled force to maintain the stent 200 in shape at the proximal end of the guidewire 220, or until the guidewire 220 is felt in the lumen 206. The thumb and forefinger can be repositioned proximally, e.g., “micro-moved,” on another unloaded portion of the stent 200 to further push the stent 200 onto the guidewire 220. Once the stent 200 is fully loaded onto the guidewire 220, the stent 200 can be held at its proximal end for further advancement along the guidewire 220. A healthcare professional can use one hand to push the stent 200 while using a second hand to stabilize the guidewire 220. The distal end of the pusher can be loaded onto the proximal end of the guidewire 220 by pushing or pulling it distally until its distal end abuts against the proximal end of the stent 200. To advance the stent 200, one hand can grasp the proximal end of the guidewire 220 while the second hand pushes the pusher to advance the stent 200 distally into the body, for example, into the kidney. The pusher compresses the body 205 while simultaneously translating the stent 200 distally along the guidewire 220 to maintain or increase the inner diameter of the stent lumen 206 at the body 205, thereby reducing the adhesion between the stent 200 and the guidewire 220. The distal retaining member 201 resists this distal translation of the stent 200 because it tends to partially form its deployed configuration away from alignment with the longitudinal axis l, thereby engaging the guidewire 220. To reposition the stent 200, for example, to position the distal retaining member 201 within the kidney, the stent 200 may need to be translated proximally by grasping the proximal end of the guidewire 220 with one hand while a second hand pulls the suture 221 proximally. When pulled proximally, the suture 221 compresses the body 205 to maintain or increase the inner diameter of the stent lumen 206, wherein the proximal retaining member 202 resists proximal translation of the stent 200 because it tends to partially form into its deployed configuration away from alignment with the longitudinal axis l, thereby engaging the guidewire 220. To form the distal retaining member 201, the stent 200 may first be translated distally and proximally on the guidewire 220 as needed to position the distal retaining member 201. Once the initial placement is satisfied, the pusher can be held stationary with one hand, and when the second hand moves the guide wire 220 proximally out of the distal retainer 201 to allow the distal retainer 201 to form, the pusher abuts the proximal end of the support 200.The formed distal retention member 201 can be positioned in the kidney by pulling the suture 221 proximally with a first hand and / or by pushing the stent 200 distally on the guidewire 220 with a pusher while holding the guidewire 220 with a second hand. To check the deployed length of the stent 200 (e.g., compared to the length of the ureter), one or more radiopaque markers can be observed under fluoroscopy, and their positions can be compared with other markers or anatomical structures, as described below. As the distal retention member 201 is formed, the guidewire 220 can still be straightened in the delivery configuration for the proximal retention member 202. The pusher can hold the proximal end of the stent 200 adjacent to it, and the distal suture 221 can be released from the stent 200. The proximal retention member 202 can be formed by pulling the guidewire 220 back from the lumen 206, whereby the pusher holds the proximal end of the stent 200 adjacent to it.

[0047] refer to Figures 3A-3C The image shows a bracket 300 according to an embodiment of the present disclosure. Figure 3A In this configuration, a support 300 is arranged on a guide wire 320 extending through a lumen 306 of the support 300, thereby substantially straightening the distal retainer 301 and the proximal retainer 302, which extend from the distal tube 303 and the proximal tube 304, respectively. The support 300 includes a body 305 wound into a coil around a longitudinal axis l of the support 300. The body 305 extends along the length of the support 300 in a substantially helical pattern between a distal end 305d and a proximal end 305p. The body 305 defines a lumen 306 along the longitudinal axis l passing through the center of the helical pattern. Pre-defined intervals 305g are located between every four adjacent coils of the body 305. The intervals 305g are configured such that when adjacent helical coils of the body 305 are compressed together substantially along the longitudinal axis l (e.g., ...), ... Figure 3BAs shown, the diameter of the lumen 306 increases. Compressing the helical coils together results in an increase in the inner diameter of the coils and the diameter of the lumen 306. Tensing the body 305, for example, pulling the coils apart, results in a decrease in the inner diameter of the coils and the diameter of the lumen 306. A larger diameter lumen 306 can help reduce the tendency of the support 300 to engage with the guide wire 320 and can help make the ability of the support 300 to translate along the guide wire 320 easier. Various parameters of the helical coils of the body 305, such as pitch, coil diameter, polymer diameter, number of windings, gap size, gap frequency, etc., can be adjusted to regulate the response of the body 305 to tension and / or compression. Although a gap 305g is shown between every four adjacent coils of the body 305, the gap 305g can be arranged at any point along the body 305 (e.g., between each coil, every other one, every two, every four, every seven, every nine coils, etc.). The coils are illustrated as stranded wires attached to each other, such as those strung together, polymer-coated, extruded, or in combination thereof, forming a flat strip. The number of helical coils used may be limited by parameters (such as the pitch of the helical coils). Support 300 in Figure 3CThe diagram shows an unfolded configuration in which guidewire 320 is removed from lumen 306, thereby allowing retaining members 301 and 302 to form. A first hole 311 and a second hole 312 each extend through the wall of the distal tube 303 into lumen 306. A distal suture 321 extends along the support 300, with the middle portion 321m of suture 321 extending through the first hole 311 and the second hole 312. A third hole 313 extends through the wall of the proximal tube 304 into lumen 306. A proximal suture 322 extends along the support 300, with the middle portion 321m of suture 321 extending through the third hole 313, through lumen 306, and through the proximal end 300p of the support 300. The distal ends 321p of the distal sutures 321 are joined together, and the proximal ends 322p of the proximal sutures 322 are joined together, allowing a medical professional to manipulate the ends 321p, 322p by applying or releasing tension on the sutures 321, 322 (e.g., by grasping a loop formed by the ends 321p, 322p, a handle of the device, etc., with the medical professional's fingers). A delivery device 324 surrounding the guidewire 320, such as a pusher, can aid in positioning the stent 300 and can provide a stop near the stent 300 during positioning or compression of the stent 300 (e.g., by pulling one or more of the sutures 321, 322 proximally against the delivery device 324). For example, when a medical professional pulls the sutures 321 proximally to position the stent 300, the delivery device 324 may not need to act as a stop because it prevents the stent 300 from translating proximally on the guidewire 320. The conveying device 324 can be used as a stop to compress and / or elastically or plastically shorten the length of the support 300. For example, the coil of the body 305 is reinforced with an annealed (e.g., stainless steel) material so that the body 305 maintains its shortened length.

[0048] In various embodiments, the stent 300 can be loaded onto the guidewire 320 and positioned within the body, substantially similar to the method described above with reference to the stent 200 and suture 221. To extend the body 305 (e.g., within the ureter), the guidewire 320 can be retracted proximally to the proximal retaining member 302, and the proximal suture 322 can be pulled proximally to also pull the proximal retaining member 302 proximally into the bladder (while the distal retaining member 301 remains in its deployed form, anchored in the kidney), thereby allowing the body 305 to extend (i.e., stretch) along the ureter to the desired length and possibly into the bladder. While one hand holds the proximal suture 322, extending the body 305, and the same hand also holds the pusher 302 adjacent to the proximal end 300p, a second hand can pull the guidewire 320 back from the lumen 306, thereby allowing the proximal retaining member 302 to form within the bladder. Alternatively, the guidewire 320 can be removed from the proximal pigtail member 302 before extending the body 305 with the proximal suture 322. The second suture 322 can be used for final adjustment of the stent 300's positioning by pulling the proximal suture 322 proximally. The proximal suture 322 can be released and removed from the stent 300, or it can be left (e.g., tied to the outside of the thigh or left in the bladder) for later stent retraction. The proximal suture 322 can be pulled proximally to substantially straighten the proximal retaining member 302 for stent 300 removal, as the distal retaining member 301 anchors the remainder of the stent 300 while the proximal retaining member 302 is straightened. The intermediate portion 322m of the proximal suture 322 within the lumen 306 can facilitate proximal guidance of the proximal suture 322 out of the stent 300 if needed.

[0049] In various embodiments, a medical professional may use one or more sutures and / or delivery devices to deliver, deploy, position, reposition, or pull back the stent. For example, during delivery, a medical professional may pull the distal suture to compress the body by using and abutting (or not using) the delivery device (e.g., pusher, cannula, catheter, sheath, etc.), or a medical professional may pull the proximal suture to extend the coiled body. During stent translation over the guidewire, the guidewire generates friction within the stent lumen, causing a portion of the body to be tensioned (e.g., stretched due to engagement with the guidewire) and the coils of the body to separate from each other, resulting in a reduction in the diameter of the stent lumen. A medical professional may reduce the effects of guidewire friction by longitudinally compressing the body during stent translation. For example, during delivery, the body may be compressed by the medical professional pulling the distal suture proximally, causing the stent to abut proximally against the delivery device (compressing the body) to translate the stent over the guidewire. Additionally or alternatively, a healthcare professional can orient or reorient the stent, such as the distal retainer, by twisting the body in the opposite direction to the coil direction (e.g., a clockwise spirally wound coil can be rotated counterclockwise so that the lumen diameter within the coil remains substantially constant). This orientation can be marked on the proximal portion of the stent, and the torsional force can be transferred directly to the stent by the healthcare professional's hand, or via a guidewire, cannula, pusher, sheath, or connected handle. The healthcare professional can also remove the stent from the patient using sutures located inside and / or outside the patient. For example, the professional may leave the proximal end or ends of the suture inside the patient or outside the body. The suture attached to the proximal end of the stent can be pulled proximally to straighten the proximal retainer in the bladder, allowing it to translate proximally through the urethra. As the proximal retainer translates through the urethra, the distal retainer can be straightened by the stent translating through the ureter. However, other methods and procedures for removing the stent in conjunction with distal sutures (with or without proximal sutures), guide wires, and pushers or other delivery devices have been considered. The sutures can be non-absorbable, absorbable, soluble, or biodegradable. The sutures can be monofilamentous, braided, and may contain hydrophilic coatings, etc. The suture length from the middle section to the proximal extension of the joint can be approximately 45 cm. The sutures can be different colors or include visual markings to make them identifiable to each other. The sutures can be sheathed or coated to prevent them from tangling with other sutures or devices.

[0050] In various embodiments, the distal or proximal tube may include one or more holes configured for the distal or proximal suture, the arrangement of which differs from those discussed above, for example, from... Figure 2A-3CThe holes are 211, 212, 311, and 312. The distal and / or proximal tubes of the stent embodiments described herein may alternatively or additionally include holes from another embodiment of the stent.

[0051] refer to Figure 4 The diagram shows the distal portion of a stent 400 according to an embodiment of the present disclosure in an unfolded configuration. The stent 400 has a body 405, a distal tube 403 extending from the body 405, and a distal retaining member 401 extending from the distal tube 403. The distal tube 403 includes a first hole 411 and a second hole 412 that extend through the wall of the distal tube 403 into a lumen 406, such that the first hole 411 and the second hole 412 are aligned parallel to a longitudinal axis l. A middle portion 421m of a distal suture 421 extends through the first and second holes 411, 412. The distal suture 421 extends through the lumen 406 of the stent 400, with only the middle portion 421m extending outside the stent 400 along the outer surface of the wall of the distal tube 403. Except for the central portion 421m, the distal suture 421 lies entirely within the lumen 406 along the length of the stent 400. This reduces the likelihood of the distal suture 421 contacting other devices or anatomical structures compared to a distal suture 421 that does not extend along the stent 400 within the lumen 406. The distal suture 421 does not intersect the longitudinal axis l, further reducing the likelihood of it contacting the guidewire within the lumen 406 compared to a distal suture 421 that does intersect the longitudinal axis l.

[0052] refer to Figure 5 The image shows the distal portion of a stent 500 according to an embodiment of the present disclosure. The stent 500 has a body 505 and a distal tube 503 extending from the body 505. The distal tube 503 includes a first hole 511 and a second hole 512, which extend through the wall of the distal tube 503 into a lumen 506 of the stent 500. The first hole 511 and the second hole 512 are aligned to form a suture axis intersecting the longitudinal axis l of the stent 500. The middle portion 521m of the distal suture 521 extends through holes 511 and 512, such that the distal suture 521 extends within the lumen 506 along the wall of the distal tube 503, through the first hole 511, along the outer surface of the wall of the distal tube 503, through the second hole 512 into the lumen 506, and extends within the lumen 506 along the wall of the distal tube 503. Except for the middle portion 521m, the distal suture 521 is entirely within the lumen 506 along the length of the stent 500. This reduces the likelihood of the distal suture 521 contacting other devices or anatomical structures outside the lumen 506 compared to a distal suture 521 that does not have a length along the stent 500 within the lumen 506. The distal suture 521 does not intersect the longitudinal axis l, which reduces the likelihood of the distal suture 521 contacting the guidewire within the lumen 506 compared to a distal suture 521 that does intersect the longitudinal axis l.

[0053] refer to Figure 6 The diagram illustrates the distal portion of a stent 600 according to an embodiment of the present disclosure. The stent 600 has a body 605 and a distal tube 603 extending from the body 605. The distal tube 603 includes a hole 611 extending through the wall of the distal tube 603 into a lumen 606 of the stent 600. A middle portion 621m of a distal suture 621 extends through the hole 611 such that the distal suture 621 extends along the outer surface of the wall of the distal tube 603 and along the lumen 606. The distal suture 621 does not intersect the longitudinal axis l, which reduces the likelihood of the distal suture 621 contacting a guidewire within the lumen 606 compared to a distal suture 621 that does intersect the longitudinal axis l.

[0054] refer to Figure 7A and 7B The image shows a bracket 700 according to an embodiment of the present disclosure. Figure 7A In this configuration, the stent 700 is arranged on a guide wire 720 extending through the lumen 706 of the stent 700, thereby substantially straightening the distal retaining member 701 and the proximal retaining member 702, which extend from the distal tube 703 and the proximal tube 704, respectively. The stent 700 includes a body 705 wound in a helical pattern around a longitudinal axis l of the stent 700. The body 705 defines the lumen 706 along the longitudinal axis l passing through the helical pattern. The stent 700 is in... Figure 7BThe diagram shows an unfolded configuration in which guidewire 720 is removed from lumen 706, thereby allowing retaining members 701, 702 to form. A first hole 711 and a second hole 712 each extend through the wall of the distal tube 703 into lumen 706. A suture 721 extends along support 700, with a central portion 721m of the suture 721 extending through the first hole 711 and the second hole 712. An adhesive 716 (e.g., heat shrink tubing, glue, molten material, etc.) may be disposed around the suture 721 and a portion of the proximal tube 704, securing the suture 721 near the body along support 700 for manipulation. The ends 721p of the distal suture 721 are joined together, allowing a medical professional to manipulate the ends 721p by applying or releasing tension on the suture 721 (e.g., via the medical professional's hand, a device handle, etc.). Because the adhesive 716 secures the suture 721 to the proximal tube 704, the length 723 of the suture 721 between the adhesive 716 and the holes 711, 712 limits the amount of extension of the body 705. The length 723 can be adjusted to limit the extension of the coil body 705 to such an extent that the body 705 does not substantially contact the guide wire 720. A delivery device 724 surrounding the guide wire 720 near the support 700 can aid in positioning the support 700 and can provide a stop during positioning or compression of the support 700 (e.g., pulling the suture 721 proximally against the delivery device 724).

[0055] refer to Figure 8 A stent 800 according to an embodiment of the present disclosure is shown in a delivery configuration on guidewire 820. The stent 800 has a first hole 811 through the wall of distal tube 803 and a second hole 812 through the wall of proximal tube 804, offset approximately 180° about the longitudinal axis l of the stent 800. A middle portion 821m of distal suture 821 extends through the first hole 811, and a proximal portion 822m of proximal suture 822 extends through the second hole 812. The offset holes 811, 812 allow the distal and proximal sutures 821, 822 to be arranged separately within the lumen 806 of the stent 800, such that they do not contact each other and become entangled. The distal suture 821 can be used to translate the stent 800 proximally or compress the body of the stent 800. The proximal suture 821 can be used to translate the stent 800 proximally, extend the stent body, or retract the stent 800.

[0056] refer to Figure 9A stent 900 according to an embodiment of the present disclosure is shown in a delivery configuration on a guidewire 920. The stent 900 includes an aperture 911 that passes through the wall of a distal tube 903 into a lumen 906 of the stent 900. A central portion 921m of a suture 921 extends through the aperture 911. The inner diameter of the lumen 906 can be various French sizes, such as 4, 5, 6, 7, 8 French, etc. For example, a 4 or 5 French size stent 900 has a lumen 906 slightly larger than the outer diameter of the guidewire 920, such that tensioning of the body 905 may cause the coil of the body 305 to deflect to a sufficiently small diameter, thereby reducing the diameter of the lumen 906 to bind the stent 900 to the guidewire 920. Due to shape memory retention, the lumen 906 within the retaining member has a frictional or interference fit with the guidewire 920. Medical professionals can use the guidewire 920 to extend the length of the body 905 of the stent 900. For example, a medical professional can use the delivery device 924 as a stop to position the distal end of the guidewire 920 within the lumen 906 of the proximal retaining member. Because the stent 900 and guidewire 920 have a frictional or interference fit with the retaining member(s), the medical professional can translate the guidewire 920 proximally to separate the coils of the body 905 from each other, thereby extending the length of the body 905, where the distal retaining member is formed in the kidney to resist proximal translation of the guidewire 920. The guidewire 920 can be removed from the lumen 906 by using the delivery device 924 as a stop. In some embodiments, the length of the body 905 can be adjusted to the length of the ureter, and the formed retaining member substantially maintains that length.

[0057] The stent 900 and pusher 924 can be loaded onto the guidewire 920 outside the patient by substantially straightening the distal holding member and reversing its loading onto the proximal end of the guidewire 920. The stent 900 can be pushed (rather than pulled) onto the guidewire 920 distally to minimize the adhesion between the stent 900 and the guidewire 920. One hand can push the stent 900, and a second hand can be used to stabilize the guidewire 920 distal to the stent 900 and / or stabilize the guidewire 920 at its proximal end when it exits the stent lumen 906. The distal end of the pusher 924 can be loaded onto the proximal end of the guidewire 920 by pushing or pulling the pusher 924 distally until the distal end of the pusher 924 abuts the proximal end of the stent 900. By grasping the proximal end of the guidewire 920 with one hand and translating the pusher 924 distally with the other hand to advance the stent 900 into the patient and kidney, the stent 900 can be translated distally. The pusher 924 compresses the body 905 to maintain or increase the inner diameter of the stent lumen 906, thereby reducing engagement with the guidewire 920, as the distal retaining member resists distal translation of the stent 900. This is because the distal retaining member tends to partially form an unfolded or bent configuration that is misaligned with its longitudinal axis l, thus engaging the guidewire 920. The stent 900 can be further positioned proximal to the distal retaining member in the kidney. One hand can grasp the proximal end of the guidewire 920 while the other hand pulls the suture 921 proximally, thereby compressing the body 905 to maintain or increase the inner diameter of the stent lumen 906. This is because the proximal retaining member resists proximal translation of the stent 900, as the proximal retaining member tends to partially form an unfolded configuration that is not aligned with the longitudinal axis l, thus engaging the guidewire 920. The stent 900 can be positioned along the guidewire 920 (e.g., within the kidney, ureter, and bladder) to the desired location. To unfold the distal retaining member, the pusher 924 can be held stationary with one hand, adjacent to the proximal end of the stent 900, while the second hand pulls the guidewire 920 proximally to allow the distal retaining member to form. The formed distal retaining member can be moved within the kidney by using the first hand to pull the suture 921 proximally and / or by using the pusher 924 to push the stent 900 distally on the guidewire 920 while the second hand grasps the guidewire 920. The adequacy of the stent length (e.g., reference to ureteral length) can be checked by referencing radiopaque markers of one or more ureteral orifices, bladder, kidneys, and ureters. By releasing the pusher 924 and releasing or pulling the guidewire 920 proximally, the length of the body 905 can be axially extended to the desired length, wherein the proximal retaining member engages with the guidewire 920 because it tends to partially form an unfolded configuration misaligned with the longitudinal axis l, thereby engaging the guidewire 920. The body 905 can be extended to the desired length. As the body 905 extends through the guidewire 920, the pusher 924 can retain the proximal end of the stent 900 adjacent to it.The guidewire 920 can be pulled back proximally, thereby compressing the body 905 attached to the guidewire 920, which helps to release the guidewire 920 from the lumen 906 and allows the proximal retaining member to form in the bladder.

[0058] refer to Figure 10A and 10B This illustration shows a stent delivery device according to an embodiment of the present disclosure, comprising a cannula 1030 having a proximal end 1030p, a distal end 1030d, and a cannula lumen 1031 passing therethrough. A handle 1032 is attached to the proximal end 1030p of the cannula 1030. A pusher 1034 is disposed on the cannula 1030. The pusher 1034 has a proximal end 1034p, a distal end 1034d, and a pusher lumen 1035 passing therethrough. A knob 1036 is attached to the proximal end 1034p of the pusher 1034. The knob 1036 is reversibly coupled to the handle 1032 and can be locked to prevent premature stent deployment. The cannula lumen 1031 is configured to receive a guidewire. Figure 10BIn this configuration, a support 1000 is mounted on a sleeve 1030. A pusher 1034 has an outer diameter of the same or substantially the same length as the outer diameter of the support 1000. The sleeve 1030 provides protection against friction between the guidewire and the support 1000, preventing the guidewire from contacting the portion of the support 1000 on the sleeve 1030. The support 1000 is in a partially deployed or loaded configuration, wherein a distal retaining member 1001 is ready to be reverse-loaded onto a guidewire to be straightened prior to delivery. The distal retaining member 1001 of the support is formed, and a proximal retaining member 1002 is straightened by the sleeve 1030 and the guidewire within the support 1000 (but near the distal retaining member 1001), such that the distal end 1030d of the sleeve 1030 lies between the distal retaining member 1001 and the body 1005. The stent 1000 can be deployed by unlocking the locking knob 1036 from the handle 1032 and translating the handle 1032 and the sleeve 1030 proximally relative to the locking knob 1036 and the pusher 1034. This movement causes the distal end 1034d of the pusher 1034 to abut against the stent 1000, allowing the sleeve 1030 to be removed from the stent 1000. The distal end 1034d of the pusher 1034 has a first opaque strip 1037, which can be visualized using, for example, fluoroscopy during operation of the stent delivery device and can be visually referenced, for example, to indicate that the proximal end of the stent 1000 abuts the pusher 1034. The sleeve 1030 includes a second opaque strip 1038 at the distal end 1030d and a third opaque strip 1039 adjacent to the second opaque strip 1038. The second and third opaque strips 1038, 1039 can be spaced apart from each other such that when the third opaque strip 1039 is pulled back from the locking knob 1036 towards the proximal end, the second opaque strip 1038 is positioned within the distal tube 1003, thereby indicating that the distal retaining member 1001 has been formed. Furthermore, for example, the opaque strips 1037, 1038, 1039 can be visualized relative to each other to indicate the length of the support 1000 before it has deployed (e.g., the distance between the second opaque strip 1038 and the first opaque strip 1037).

[0059] In various embodiments, one or more radiopaque markers may be disposed on the stent, cannula, actuator, sheath, and / or the like. The markers may be fluoroscopically identifiable bands or other shapes. The markers may be arranged at distances measured relative to each other, allowing measurement of anatomical structures and / or devices relative to the markers. One or more markers may be located at one end of a device component. One or more markers may be disposed at the location of a device indicating when a portion of the stent has deployed. For example, a marker may be placed on a cannula such that when the marker is pulled proximally and visualized in vitro or relative to another marker, the visualization indicates to a medical professional that the distal retention member has deployed.

[0060] refer to Figure 11 This illustration shows a stent delivery system according to an embodiment of the present disclosure. The stent delivery system includes a delivery device having a sleeve 1130 and a pusher 1134 disposed on the sleeve 1130. A guide wire 1120 extends within the lumen of the sleeve 1130. A stent 1100 is disposed on the sleeve 1130 in a delivery configuration. The stent 1100 includes an engagement portion 1110 at a distal tube 1103 along the wall of the stent 1100, the distal tube having an inner diameter approximately the same size as the outer diameter of the sleeve 1130. The sleeve 1130 is frictionally engaged with the engagement portion 1110 of the stent 1100, such that the sleeve 1130 can be translated proximally and distally, thereby also translating the stent 100 proximally and distally. The stent includes a taper 1108 along the wall of the stent 1100, which defines an inner diameter of the stent 1100 that decreases distally, such that the sleeve 1130 can be guided from the larger inner diameter of the stent 1100 near the engagement portion 1110 into the smaller inner diameter of the engagement portion 1110. The stent 1100 includes an annular portion 1109 disposed within the wall of the stent 1100. The annular portion 1109 has an inner diameter smaller than the outer diameter of the sleeve 1130. As the sleeve 1130 extends within the engagement portion 1110, the annular portion 1109 can abut the distal end 1130d of the sleeve 1130. The annular portion 1109 can prevent the sleeve 1130 from translating further distally beyond the engagement portion 1110. The annular portion 1109 also provides a surface for the sleeve 1130 to distally translate the support 1100 when an axial force is applied to translate the support 1100 at a location away from the body 1105, rather than translating the support within or near the body 1105, which could cause buckling of the body 1105 during delivery. The sleeve 1130 and / or guide wire 1120 can be pulled back from the support 1100, for example, to unfold, by abutting the pusher 1134 against the proximal end of the support 1100 and proximally translating the sleeve and / or guide wire 1120 relative to the pusher 1134.

[0061] Support delivery system (e.g.) Figure 11The stent 1100 (shown in the diagram) can be assembled with a pusher 1134, which is releasably locked to the sleeve 1130 via a handle. The stent 1100 can be loaded onto the sleeve 1130 by substantially straightening the proximal retaining member and inserting the sleeve 1130 through the lumen of the stent 1100. The proximal end of the stent 1100 can slide on the distal end 1130d of the sleeve 1130 (which can be angled to form a smaller distal tip outer diameter that extends proximally to the larger outer diameter of the sleeve 1130) by pushing (i.e., not pulling) the stent 1100 proximally onto the sleeve 1130 until the sleeve 1130 engages the smaller inner diameter of the engagement portion 1110 and can abut the annular portion 1109 of the stent 1100. The proximal end of the stent 1100 can abut the pusher 1134. Guidewire 1120 can be placed into the kidney using fluoroscopy (if it has not been placed in a previous surgical procedure, such as flexible ureteroscopy). To load the assembled stent 1100 and delivery device onto guidewire 1120, the distal retaining member can be substantially straightened and reverse-loaded onto the proximal end of guidewire 1120, and pushed distally using a handle or releasably locked pusher 1134. To prevent stent 1100 from dislodging from cannula 1130 (which could result in undesirable stretching or damage), pusher 1134 can be locked. A healthcare professional can push stent 1100 with one hand via pusher 1134 or handle while a second hand stabilizes guidewire 1120 distal to stent 1100, and then stabilize guidewire 1120 at a medical Luer interface at the proximal end of cannula 1130 to exit the proximal end of cannula 130 lumen. To advance the stent 1100 distally, one hand can grasp the proximal end of the guidewire 1120, and a second hand can advance the locked pusher 1134 to advance the stent 1100 distally via the guidewire 1120 into the kidney. The stent 1100 is at least partially supported by a cannula 1130. The cannula 1130 releasably engages the stent 1100 at an engagement portion 11110. The pusher 1134 abuts the proximal end of the stent 1100, thereby minimizing undesirable extension of the stent 1100 as it moves along the guidewire 1120. Friction between the tissue (e.g., the ureter) and the stent 1100 during distal translation may cause axial compression of the body 1105, thereby maintaining or increasing the inner diameter of the stent 1100 (reducing the engagement of the body 1105) because the distal retaining member resists distal translation relative to the guidewire 1120 due to the member's tendency to partially form an unfolded configuration. To position the distal retainer in the kidney, the stent 1100 may need to be translated proximally. This can be achieved by stabilizing the proximal end of the guidewire 1120 with one hand while pulling the pusher 1134 and the cannula 1130 proximally with a second hand.When the stent 1100 is pulled proximally along the guidewire 1120 while the cannula tip 1130d is still engaged with the engagement portion 1110, friction between the tissue (e.g., ureter) and the stent 1100 may cause axial compression of the body 1105 during proximal translation, thus maintaining or increasing the stent lumen diameter, thereby reducing the engagement of the stent 1100 while maintaining the engagement of the cannula 1130 with the engagement portion 1110. The distal retainer can be adjusted on the guidewire 1120 as needed. Once the desired position of the distal retainer has been achieved, the handle can be held with one hand while a second hand moves the guidewire 1120 to allow the distal retainer to form by grasping the proximal end and translating it proximally. During (or after) the deployment of the distal retainer, the handle can be rotated about its longitudinal axis (possibly under fluoroscopy) to reorient the distal retainer, for example, in the kidney. Guidewire 1120 can be removed from cannula 1130 to allow contrast agent, for example, to be supplied to the kidney for fluorescence imaging of the kidney via a path passing through a medical Luer interface, through cannula 1130, through a coil of body 1105, and exiting from the distal end of stent 1100. Stent 1100 can be moved by using a first hand to pull the handle proximally or push the handle distally over guidewire 1120 while a second hand holds and stabilizes the proximal end of guidewire 1120 (if guidewire 1120 is not removed). The memory-set curvature of the proximal retainer or body 1105 under axial tension can engage stent 1100 with the distal end 1130d of cannula 1130, such that pulling the handle proximally can extend body 1105 and can pull the proximal retainer proximally into the bladder. Once the desired length of the stent 1100 is reached, the first hand can grasp the handle, with the tip of the pusher 1134 abutting the proximal end of the stent 1100. The guidewire 1120 can be removed from the lumen of the cannula 1130 (if it has not already been removed). The locking knob of the pusher 1134 can be released from the handle of the cannula 1130 with the second hand and held stationary. The first hand can move the handle proximally, causing the engagement portion 1110 of the cannula 1130 and the stent 1100 to translate proximally, compressing the body 1105 to increased column strength, where further proximal translation axially forces the cannula end 1130d to release from the engagement portion 1110. As the cannula 1130 disengages from the engagement portion 1110, the cannula 1130 can be pulled proximally back from the stent 1100. As the cannula 1130 and guidewire 1120 are removed from the stent 1100, the proximal suture (similarly) is removed. Figure 10BA suture (or suture from another embodiment described herein) can be used to pull the proximal end of the stent 1100 proximally. The proximal suture may be located within the bladder and partially within the ureter. Pulling the proximal suture proximally can extend the body 1105 and can pull the proximal retaining member proximally into or already within the bladder to form an deployed configuration. Since the cannula 1130 is within the lumen of the stent 1100, near the proximal end of the body 1105, or only within the proximal retaining member, the proximal suture or cannula 1130 can be used to pull the proximal end of the stent 1100 proximally within the bladder.

[0062] refer to Figure 12 This illustration shows a stent delivery system according to an embodiment of the present disclosure. The stent delivery system includes a delivery device having a sleeve 1230 and a pusher 1234 disposed on the sleeve 1230. A guide wire 1220 extends within the lumen of the sleeve 1230. A portion of a proximal retaining member 1202 of the stent 1200 is disposed on the sleeve 1230 in a delivery configuration. The length of the portion of the proximal retaining member 1202 disposed on the sleeve 1230 can be, for example, about 6 mm, about 1 mm to about 10 mm, etc. The sleeve 1230 has an outer diameter larger than the inner diameter of the stent 1200 to create a frictional fit or interference fit between the distal end of the sleeve and the proximal end of the stent. The distal end 1230d of the sleeve 1230 has an outer diameter that decreases distally, allowing the stent 1130 to be guided onto the distal end 1230d of the sleeve 1230, from the smaller outer diameter of the distal end 1230d to the larger outer diameter of the remainder of the sleeve 1230. In a delivery configuration, the stent 1200 can be translated proximally or distally by translating the sleeve 1230 proximally or distally, wherein the sleeve 1230 engages with the proximal retaining member 1202. The stent 1200 can be deployed by distally unlocking relative to the sleeve 1230 and translating the proximal retaining member 1202 distally away from the sleeve 1230 by a translation actuator 1234.

[0063] Support delivery system (e.g.) Figure 12The stent 1200 (shown in the diagram) can be assembled with a pusher 1234, which is releasably locked to a handle via a knob. When unlocked from the handle, the knob may have a limited travel distance, for example, about 10 mm. The stent 1200 can be loaded by substantially straightening the proximal retaining member 1202 and placing the stent 1200 on the distal end 1230d of the cannula 1230 until the proximal end 1202p of the stent abuts the distal end of the pusher 1234. The guidewire 1220 can be translated distally into the kidney (if it has not been positioned from a previous surgical procedure, such as flexible ureteroscopy). To load the delivery system onto the guidewire 1220, the distal retaining member can be substantially straightened and reverse-loaded onto the proximal end of the guidewire 1220. The stent 1200 can be further pushed distally onto the guidewire 1220 (i.e., pulled to avoid engagement and possible disengagement of the stent 1200 from the cannula 1230). The proximal end of the guidewire 1220 can be introduced into the lumen of the cannula 1230 by pushing the stent 1200 distally with one hand via the pusher 1234 or the handle. A second hand can be used to stabilize the guidewire 1220 initially at the distal end of the stent 1200, and then stabilize the proximal end of the guidewire 1200 to withdraw it proximally from the cannula 1230, for example at the medical Luer interface of the handle. The stent 1200 can be translated distally by grasping the proximal end of the guidewire 1220 with one hand and pushing the pusher 1234 distally with the second hand. During distal translation, friction between body tissue (e.g., the ureter) and stent 1200 may axially compress the body 1205 to column strength, which maintains or increases the inner diameter of the lumen of stent 1200, thus reducing adhesion. This is because the distal retainer and proximal retainer 1202 resist distal translation relative to guidewire 1220 due to the retainer's tendency to partially form a deployment configuration misaligned with longitudinal axis l. The distal retainer can be deployed by pushing the distal retainer distally into the kidney. Once the healthcare professional is satisfied with the initial placement of the distal retainer, a handle (and pusher 1234) can be held with one hand such that the pusher 1234 abuts the proximal end 1202p of the stent when a second hand translates the guidewire 1220 proximally by grasping the proximal end of the guidewire 1220 to allow the distal retainer to form. During (or after) deployment of the distal retainer, the handle can be rotated about its longitudinal axis to transmit torque, thereby orienting the distal retainer in the kidney. Torque can be applied to the stent 1200 in the opposite direction to the winding of the body of the stent 1200 (e.g., clockwise torque for a counterclockwise body). The preferred direction of rotation can be marked on the handle or pusher 1234. When the guidewire 1220 is located within the body of the stent 1200 to support the column strength of the stent 1200, and by pushing the handle distally while grasping the proximal end of the guidewire 1220 with the other hand, the deployed distal retention member can be moved within the kidney.Guidewire 1220 can be pulled proximally from cannula 1230 to allow additional space for contrast agent supply, for example, along the stent and via a medical Luer interface into the kidney and ureter for fluoroscopic imaging of the kidney and ureter. Removing guidewire 1220 alleviates the problem of the stent body being bound to guidewire 1220. When cannula 1230 is engaged with the proximal end 1202p of stent 1200, stent 1200 can be moved to the desired position without guidewire 1220 by pulling the handle proximally. Under fluoroscopic guidance, the length of stent 1200 can be observed with reference to the lengths of the ureter, kidney, bladder, and various radiopaque markers along cannula 1230, actuator 1234, and / or stent 1200. The length of stent 1200 can be adjusted by pulling the handle proximally while monitoring the distal holding member anchored within the kidney. Stent 1200 can be repositioned, and the body can be extended to the desired length and position. When the desired position and length are reached, the first hand can grasp the handle of the sleeve 1230 to manipulate the locking knob of the pusher 1234 to unlock the knob and translate it distally (e.g., with the thumb) to translate the pusher 1234 distally to abut the proximal end 1202p of the support and push the support 1200 distally away from the sleeve 1230 so that it is no longer engaged with the sleeve 1230.

[0064] refer to Figure 13A stent delivery system according to an embodiment of the present invention is shown, the stent delivery system including a stent 1300 positioned on a guide wire 1320 in a delivery configuration, wherein retaining members 1301, 1302 are straightened. A sheath 1340 extends on the stent 1300. In the delivery configuration, the retaining members 1301, 1302 are shape-memory partially shaped such that they are not parallel to the longitudinal axis l of the stent 1300. This partial shaping of the retaining members 1301, 1302 applies a degree of radial force to the inner surface of the sheath 1340, thereby engaging the stent 1300 to the sheath 1340. Because the stent 1300 is slidably engaged in the sheath 1340, the stent 1300 can be translated on the guide wire 1320 by translating the sheath 1340. The sheath 1340 can be translated by manipulating a knob 1336 attached to the proximal end of the sheath 1340. A pusher 1334, having an outer diameter substantially matching that of the stent 1300, extends on a guidewire 1320 adjacent to the stent 1300. The pusher includes a radiopaque strip 1337 that can be visualized, for example, via fluoroscopy, to locate the proximal end of the stent 1300 and / or the distal end of the pusher 1337. The pusher 1334 can be used to deploy the stent 1300 from a sheath 1340 and / or a guidewire 1320. For example, the pusher 1334 can be abutted against the proximal end of the stent 1300, and the sheath 1340 can be translated proximally relative to the pusher 1334, such that the stent 1300 is pushed out of the sheath 1340 by the pusher 1334, which acts as a proximal stop. The pusher 1334 can be translated by manipulating a handle 1332 attached to the proximal end of the pusher 1334.

[0065] Support delivery system (e.g.) Figure 13(As shown) can be assembled by reverse-loading the stent delivery device and stent 1300 onto guidewire 1320 and pushing the system distally into the kidney. The tendency of the proximal retaining member 1302 to partially form integrates the stent 1300 into the interior of sheath 1340, thereby allowing translation of the stent 1300 by translating sheath 1340 or pusher 1334. The guidewire can be pulled proximally to allow the distal retaining member 1301 to form. The formed distal retaining member 1301 can also be translated along guidewire 1320 by translating the stent 1300. The length of the stent 1300 can be checked within the patient. While the handle 1332 and pusher 1334 remain stationary abutting the proximal end of the stent 1300 to deliver the stent 1300 into the ureter, the knob 1336 can be unlocked and the sheath 1340 can be pulled proximally back. When the proximal retaining member 1302 is engaged with the sheath 1340, the length of the stent 1300 (e.g., the body and / or retaining members 1301, 1302) can be adjusted by simultaneously pulling the sheath 1340 and the pusher 1334 proximally. When the pusher 1340 remains stationary to abut the proximal end of the stent 1300, thereby disengaging the stent 1300 from the sheath 1340, the extended body can be released by pulling the knob 1336 and the sheath 1340 proximally. When the retaining members 1301, 1302 are formed, and when the retaining members 1301, 1302 hold the stent 1300 in the kidney and bladder, the restoring force of the unfolded retaining members 1301, 1302 can adjust the length of the stent 1300 to substantially conform to the length of the ureter. One embodiment may include one or more sutures for positioning and retracting the stent 1300.

[0066] In various embodiments, the suture can be removed from the stent (e.g., after unfolding) by separating the ends of the suture, for example by cutting, breaking, untying, etc., and pulling the first end of the suture proximally, causing a length of suture to extend through one or more holes in the stent until the second end of the suture is removed from the stent. One or more sutures may remain attached to the stent in the patient after unfolding. A portion of the suture may extend outside the patient (e.g., outside the urethra) and may be temporarily adhered to the patient during use so that it can be subsequently manipulated to remove and / or reposition the stent (e.g., by translating the stent by pulling the suture proximally).

[0067] In various embodiments, the stent can be delivered antegradely into the patient using a guidewire placed in the kidney via a needle and possibly into the bladder via the ureter. The needle can be expanded to accommodate the stent and / or a sheath, which can be used around the needle and / or stent. The stent can be delivered in a similar manner as described herein, with a distal retaining member in the bladder and a proximal retaining member in the kidney. One or more sutures can extend out of the urethra and / or into an entry point in the flank through which the stent is delivered.

[0068] Various embodiments of this disclosure include controlled extension stents, particularly ureteral stents. Such stents may have a body comprising a single filament wound around an axis along the length of the stent, or multiple filaments wound in adjacent coil groups that define a lumen around the longitudinal axis of the stent. Adjacent coils of a single filament or adjacent coil groups of multiple filaments may be substantially in contact with other adjacent coils or adjacent adjacent groups in a non-extended state and may be separated in an extended state. In one or more embodiments, the controlled extension stent may have coils wound in groups or coils of a single filament that adhere together on contact lines created by the coils as they are wound along the length of the stent. The winding may be helical. When the coils are in contact with each other, adhesion can be achieved by heat setting above the softening point of the filament material, or by applying a permanent or soluble adhesive along one or more contact lines. The temperature range for achieving adhesion depends on the materials used. The strength of the adhesion varies with heating temperature and time. This can be achieved, for example, in an oven, a water bath, or by using a low-voltage RF generator. For example, for ethylene-vinyl acetate (EVA), heat setting parameters can include a heating temperature of 70-80°C and a setting time of 30 minutes to 4 hours. Adhesive bonding can be achieved using coating compositions such as polyvinylpyrrolidone (PVP). The dissolution time can vary based on adhesion to the substrate, the composition, and curing (crosslinking). Adhesive bonding can also be achieved via a hard candy shell coating made of sugar. Depending on the desired support structure, positioning can be formed on the contact lines along the entire length of the support or only in certain portions. The support along its length can include coil groups where some filaments are bonded together, while other coil groups are not bonded together. The body can have coil groups that are separated from adjacent groups in the extended state. In addition to this group separation, the coiled filaments within a group can separate from each other in the extended state of the support. Whether the coiled filaments separate from each other within or between groups may depend on whether the filaments or groups are bonded together, and if so, on the strength of the adhesive bond between the filaments. Stronger adhesion between filaments may result in a stent with greater resistance to tensile stress or bending, while weaker or non-existent adhesion may result in a stent that is more compliant when yielding to tensile stress or bending.

[0069] The manner in which the body extends is controlled by various factors in its design. The material chosen for each filament determines its amount of extension. Stiffer materials require greater tensile stress to extend, while softer materials extend more easily. The filament material, size, and processing are discussed in this disclosure and play a role in the amount of body extension and the flexibility of the support. For example, extension control can be determined by the thickness of each filament. Thicker filaments may resist tensile stress better than thinner filaments. The filament thickness can range, for example, from about 0.020 inches (0.508 mm) to about 0.037 inches (0.940 mm). Further control of body extension can be achieved by setting the pitch of the coils relative to the longitudinal axis of the support. A sharper pitch relative to the longitudinal axis of the support extends more easily than a more perpendicular pitch. Various ranges of pitch angles in this disclosure are discussed below. Extension control can also be determined by the processing and type of material to change the range of extension that may result under tensile stress on the support. The tension of the winding coils can also change the amount of extension. Examples of filaments may include variable cross-sections along their length, which may consist of a co-extruded inner core and outer core of different materials for additional control over elongation. Alternatively, the filaments may be solid or hollow, and the radial or circumferential strength of the coils can be adjusted to control elongation. Further control over body elongation can be achieved by the number of filaments clustered together along the support. A larger number of clustered filaments can provide greater resistance to tensile stress and thus reduce elongation. Furthermore, a body designed to have more surface contact between the coiled filaments can provide more friction against tensile stress, which leads to reduced body elongation.

[0070] Especially in the case of ureteral stents, the device may have an outer diameter of approximately 3 French, approximately 4.8 French, approximately 5 French, approximately 6 French, approximately 7 French, or approximately 9 French, including any half or all of this range, and the device may have an inner lumen diameter of approximately 0.038 inches (0.0965 cm) to accommodate the profile of a standard medical guidewire within the stent lumen. The embodiments of the ureteral stent disclosed herein may have a non-extended length of approximately 20 cm to approximately 35 cm, or approximately 10 cm to approximately 30 cm, or a similar range as measured between retaining members or between the proximal and distal tubes. Additional extendable length varies based on all the parameters previously discussed. Patient breathing may cause the ureter to extend by approximately 3 cm to approximately 5 cm. The maximum extension may be approximately 10 cm. Overextension may be undesirable during stent removal from the patient. If the stent extends to a length similar to removing a thin string rather than the controlled length of the body, the patient will experience additional discomfort during stent removal. The extension length of the body and / or stent can be maintained within the patient by one or more shaped retaining members. For example, a distal retaining member formed in the kidney and a proximal retaining member formed in the bladder can provide resistance, thereby maintaining the extension length of the body within the ureter and / or between the kidney and the bladder. The body of the stent may extend unevenly. For example, the proximal suture may be translated proximally, such that the coil of the proximal portion of the body extends while the rest of the body does not extend or extends less than the coil of the proximal portion of the body.

[0071] The body can be formed by winding one or more filaments around a mandrel to form coils that define lumens for guidewires, fluid channels, and / or tubular structures to support ureteral function. These coils can provide column strength to prevent tortuosity and oversight control within the patient. This strength can be further increased by bonding the coils and / or filaments together. However, the bonding of the coils can be broken with minimal force to provide controlled extension where needed during ureteral movement. The stent may include coils from one end to the other, or may contain coiled and uncoiled filament segments. For example, the ends of the stent may include straight filaments or retaining members, as discussed in the following disclosure.

[0072] During stent delivery, it may be desirable for the stent to be essentially straight and relatively rigid until it is properly positioned within the patient's body. Once in place, a softer stent may be desired to allow it to function comfortably while accommodating normal movement within the patient's anatomy. For example, the ureter may move by approximately 3 cm during breathing or body movement. Furthermore, ureteral length may vary from patient to patient, potentially requiring an extension length of up to approximately 10 cm. A coating may need to be added to the stent to achieve a transition from rigid to soft, and the aim is to deliver the stent more as a column and dissolve it, leaving a softer underlying stent.

[0073] The apparatuses, systems, and methods of this disclosure can be used alone or in conjunction with other apparatuses, systems, and methods for stent delivery. Exemplary apparatuses, systems, and methods that can implement embodiments of this disclosure include, but are not limited to, those described in U.S. Patent Application Serial No. 15 / 802,863, which is incorporated herein by reference in its entirety for all purposes. Exemplary embodiments, apparatuses, features, or other elements described therein may be combined with or incorporated into embodiments of this disclosure.

[0074] In various embodiments of this disclosure, the scaffold material may be a polymer. The polymeric material suitable for the filament embodiments may comprise any polymer or polymer blend suitable for use in implantable or insertable medical devices. The polymer may be selected from, for example, suitable components such as Percuflex. TM C- Polyethylene, polyurethane, nylon, polyolefins such as polyethylene (e.g., metallocene-catalyzed polyethylene), polypropylene, and polybutene; polyolefin copolymers, such as ethylene copolymers like ethylene vinyl acetate (EVA) copolymers, ethylene-methacrylic acid copolymers, and ethylene-acrylic acid copolymers, some of which have acid groups that can be neutralized by zinc or sodium ions (commonly referred to as ionomers); vinyl aromatic polymers such as polystyrene; vinyl aromatic copolymers, such as olefin and styrene or α-methylstyrene copolymers, such as butadiene-styrene copolymers and polyisobutylene and polystyrene or polymethylstyrene copolymers, such as polystyrene-polyisobutylene-polystyrene triblock copolymers; polyacetals ; chlorinated polymers such as polyvinyl chloride (PVC); fluoropolymers such as polytetrafluoroethylene (PTFE); polyesters such as polyethylene terephthalate; polyester ethers; polyamides such as nylon 6 and nylon 6,6; polyethers; polyamide ethers such as polyether block amides (PEBA), including (a) nylon blocks such as nylon 6, nylon 4 / 6, nylon 6 / 6, nylon 6 / 10, nylon 6 / 12, nylon 11 or nylon 12 blocks, and (b) polyether blocks such as poly(ethylene oxide), poly(trimethylene oxide), poly(propylene oxide) or poly(tetramethylene oxide) blocks, a specific example of which is poly(tetramethylene oxide)-b-polyamide-12 block copolymer, available from Elf Atochem as Polyoctenamers, such as those from Degussa in Parsipenny, New Jersey. It is a mixture of cyclic and linear polyoctene; elastomers and thermoplastic polyurethanes, including polyurethane copolymers (including block and random copolymers of polyether-based, polyester-based, polycarbonate-based, aliphatic-based, aromatic-based, and mixtures thereof), commercially available examples of which include and ); and vinyl aromatic polymers and copolymers; silicone; polycarbonate; and mixtures of any of the foregoing. The filament may consist of multiple material layers due to the properties of the material layers (e.g., anti-fogging, radiopaque, etc.). The filament may be composed of different materials, may include co-extensions of different materials, or may include an inner core of different materials and one or more outer layers. Choosing a support material with increased rigidity will increase the elastic modulus of the main coil, thereby increasing the main body's resistance to tensile forces.

[0075] EVA copolymers are a preferred group of polymers for use in ureteral stents. Examples include EVA copolymers with a vinyl acetate content of about 5% to about 40% (including 5% to 10% to 15% to 20% to 25% to 30% to 35% to 40%, of which 10-30% is typical). Increasing the vinyl acetate content generally results in a softer material, while decreasing the vinyl acetate content generally results in a harder material.

[0076] The stents of various embodiments of this disclosure may also contain one or more optional additives, such as those selected from therapeutic agents, radiopaque agents, colorants, other optional additives such as plasticizers and extrusion lubricants, and combinations thereof, in amounts effectively used for their intended purpose. When used in the apparatus of this disclosure, such optional additives may be present, for example, in a polymer material such as the aforementioned polymer material, or in a coating applied to a polymer material, or both.

[0077] Radiopaque reagents facilitate visualization of the stent at any time during insertion and implantation. Radiopaque reagents that can be used in the stents of this disclosure include bismuth salts such as bismuth subcarbonate, bismuth oxychloride, bismuth trioxide, barium sulfate, tungsten, and mixtures thereof. More specific examples of such radiopaque reagents include tungsten, platinum, tantalum, iridium, gold or other dense metals, barium sulfate, bismuth subcarbonate, bismuth trioxide, bismuth oxychloride, meglumine, iopamidol, sodium iodide, sodium iodamide, and meglumine. When present, the radiopaque reagent is typically present in amounts from about 10% to about 40% (including 10% to 15% to 20% to 25% to 30% to 35% to 40%, with 15-30% being more typical). Additionally or alternatively, the selection of polymeric or additive materials and extrusion techniques can be optimized to enhance device contrast using ultrasonic imaging. In addition to or as alternatives to radiopaque reagents, such as contrast beads or foams and other examples, the combination of ultrasound contrast agents facilitates visualization of the stent under ultrasound imaging at any time during device insertion and implantation. Those skilled in the art can readily determine the appropriate amounts of radiopaque reagents and ultrasound contrast agents to achieve the desired visibility. The described polymeric materials can be mixed with the aforementioned radiopaque reagents and / or ultrasound contrast agents or colorants. Colorants can be used by medical professionals as visual cues regarding the stent's position within the patient's body.

[0078] Drainage elements can be arranged along the exterior of the support and communicate with the lumen fluid generated by the support coils, facilitating fluid drainage along the interior and exterior of the device. If the filament is hollow, the element can be a hole or other shape. Furthermore, the spacing between the support coils can be configured for drainage. In addition to or as an alternative to drainage elements, channels can be included externally to increase the drainage capacity of the device. Channels can take various shapes and configurations, such as semicircular, triangular, rectangular, and trapezoidal cross-sections, as well as many other shapes. The above embodiments may also include segments of coiled filament alternating with segments of straightened filament. Additionally or alternatively, the filament can be formed with a braided pattern, the structure of which is sufficient to form a support but also loose enough to allow for some degree of controlled elongation. Even relatively tight braided patterns can allow for a certain degree of elongation of the filament material's elastic and / or plastic deformation.

[0079] Various retaining members of a stent according to one or more embodiments of this disclosure can be formed by winding one or more filaments of an elongated tubular body around a mandrel, shaping the end portions of the body in a specific form, and heat-setting it to give the end portions shape memory when unconstrained in the patient, thereby presenting the form of a retaining member. A retaining member (e.g., a kidney retaining member) may comprise a single pigtail-shaped piece wound in a plane offset from a plane parallel to the longitudinal axis of the middle portion of the stent. The polymer of the retaining member can be heat-set, for example, by transforming the polymer into a curved pigtail configuration with hot water to have shape memory, such that the retaining member can return to a curved configuration, for example, through a guidewire, when not extended. Other examples of retaining members for use with this or other embodiments of this disclosure include, for example, annular tails, spirals, helices, coils, puller shapes, Malecots, barbs, mushroom and hook-shaped ends, tapered shapes, curves, J-curves, etc. The retaining member at the distal end of the stent may be funnel-shaped or tapered, wherein the stent diameter gradually increases from the proximal end of the stent toward the distal end. The end portion forming the retaining member can be a filament extending along the support body, or the filaments can be fused together and then formed into the shape of the retaining member. One or more filaments can be formed into the desired shape by heating on a mandrel. Alternatively, filaments or groups of filaments can be placed in a plate having grooves cut into it to form the desired retaining member shape. Depending on the configuration of the grooves, the plate can be heated from below (e.g., with a heat lamp) to shape the filaments or support body into the retaining member shape. Two retaining members can be formed simultaneously using two adjacent plates, each plate having a groove for the retaining member at either end of the support. For example, if the two ends of the device are made of different materials and can be heated for the same or different durations, these plates can be heated to the necessary degree at different temperatures.

[0080] Radiopaque strips or ultrasound-contrast strips, fillers, or other markings that are part of the stent and / or delivery device allow medical professionals to view the stent and / or delivery device under a fluoroscope or using ultrasound. Furthermore, if the stent is radiopaque or ultrasound-visible, its placement in the patient can be confirmed by viewing the stent under a fluoroscope or using ultrasound.

[0081] In various embodiments, the delivery device components may include cannulas, actuators, catheters, sheaths, and / or Tuohy-borst or other adapters. These components may be reversibly coupled to each other, for example, using locking knobs, wing nuts, pawls, hooks, latches, cams, screws, handles, etc. These components may have lengths or distances between their ends that substantially match the length of the support, the length of the portion of the component that engages the support (e.g., about 5 mm, about 10 mm, etc.), or the length of the patient's anatomy. For example, the actuator may be about 40 cm long. The components may be made of various materials, such as polymers, nylon, polyethylene, polyurethane, etc. Polyetherimide, polyetheretherketone, polyethylene terephthalate, polypropylene, polycarbonate, stainless steel, alloys, etc. The distal portion of the part may be cut at an angle (e.g., so that the distal end of one part can be guided in the lumen of another part or in a support) or may be cut in a square (e.g., so that two parts or one part and a support can be adjacent to each other so that they can be translated posteriorly to each other).

[0082] Methods of treating a patient using embodiments of this disclosure can be performed by introducing a stent according to the above, additional, or alternative embodiments into the patient. A physician can use a cystoscope to locate the ureteral orifice from which urine flows into the bladder. This may or may not be performed on an already introduced flexible guidewire, wherein the stent can slide along the length of the stent lumen formed by a coil of one or more filaments. X-ray or fluoroscopic imaging can be used to monitor the guidewire and / or stent entering the ureteral orifice and ascending into the ureter. Contrast fluid can be injected to improve guidance. If a guidewire is used, the stent can be pushed past the guidewire and ascend along the guidewire into the kidney. Stent advancement can be performed using a delivery device. If a guidewire is used, the stent can be removed before or after it is in place. A retention member for the stent, if present at one or both ends of the stent, can be formed in the kidney and / or bladder. The stent can be positioned within the patient such that it extends cooperatively according to the length of the ureter and / or extends and retracts with the patient's body movement without dislodging.

[0083] A method for positioning a stent may include inserting a guidewire into a target location within a patient, such as the kidney. A stent, comprising a body with coils, may be inserted onto the guidewire and / or a cannula. The stent may be translated distally within the patient via a pusher on the guidewire. The stent may be translated proximally within the patient via a first suture associated with the distal portion of the stent on the guidewire. The stent can be positioned within the body by translating the pusher, cannula, sheath, and / or guidewire. Parts of the stent delivery system may be operated by one or more handles or knobs that can be reversibly locked to each other. The stent can be removed from the patient via translating a second suture disposed through the proximal portion of the stent. The stent can be translated distally by pushing it with a pusher. The stent can be translated proximally by applying tension to the first suture. The stent can be translated by compressing the gap between adjacent coils of the stent, thereby increasing the lumen diameter of adjacent coils around the guidewire. The length of the stent within the scope of the patent can be adjusted by adjusting the gap between the coils wound around a selected body of the stent. By adjusting the tension of multiple coils in the stent, the length of the stent can be adjusted in response to observation of its position within the patient's body. For example, a second suture can be pulled proximally to extend the stent's main body. The first suture can be cut and pulled back from the patient's body.

[0084] In addition to the various embodiments described herein, variations, modifications, and other implementations of this disclosure will occur to those skilled in the art. Therefore, this disclosure is not limited by the foregoing illustrative description but by the appended claims.

Claims

1. A stent, comprising: The body includes coils in a generally helical pattern around the longitudinal axis of the support and along the length of the support between the proximal and distal ends, the coils defining a lumen along the longitudinal axis passing through the center of the body; A distal tube having a wall extending distally from the distal end of the body, wherein the lumen extends through the distal tube; A first hole extends through the wall of the distal tube into the lumen; A proximal tube having a wall extending proximal to the proximal end of the body, wherein the lumen extends through the proximal tube; A distal retaining member extending distally from the distal tube, wherein the lumen extends through the distal retaining member; A proximal retaining member having a wall extending proximally from the proximal tube to a proximal end of the proximal retaining member, wherein the lumen extends through the proximal retaining member to the proximal end of the proximal retaining member; and A distal suture having a first end, a second end, and a middle portion, the middle portion extending through the first hole. The axial compression of the body can be controlled by applying proximal tension to the distal suture.

2. The stent of claim 1, further comprising a second hole extending through the wall of the distal tube into the lumen, such that the first hole and the second hole are aligned to form a suture axis offset from the longitudinal axis, and a middle portion of the distal suture extends through the second hole.

3. The bracket according to any one of claims 1 to 2, further comprising a predetermined gap between selected adjacent coils in the body, wherein, The gap is configured such that the diameter of the lumen increases when the selected adjacent coils are compressed together along the longitudinal axis.

4. The stent according to any one of claims 1 to 2, wherein, The proximal retaining member and the distal retaining member are pigtail-shaped, J-shaped curve, Cope ring, spiral, helical, or plug puller-shaped, or a combination thereof.

5. The stent according to any one of claims 1 to 2, wherein, The distal retaining member has a tapered distal tip that gradually tapers towards the distal end.

6. A stent, comprising: The body includes coils in a generally helical pattern around the longitudinal axis of the support and along the length of the support between the proximal and distal ends, the coils defining a lumen along the longitudinal axis passing through the center of the body; A distal tube having a wall extending distally from the distal end of the body, wherein the lumen extends through the distal tube; A first hole extends through the wall of the distal tube into the lumen; A proximal tube having a wall extending proximal to the proximal end of the body, wherein the lumen extends through the proximal tube; A distal retaining member extending distally from the distal tube, wherein the lumen extends through the distal retaining member; A proximal retaining member having a wall extending proximally from the proximal tube to a proximal end of the proximal retaining member, wherein the lumen extends through the proximal retaining member to the proximal end of the proximal retaining member; and The distal suture, having a first end, a second end, and a middle portion, the middle portion extending through the first hole, further includes: A third hole extends through the wall of the proximal retaining member into the lumen; A proximal suture having a first end, a second end, and a middle portion, the middle portion extending through the third hole and the proximal end of the proximal retaining member.

7. A stent, comprising: The body includes coils in a generally helical pattern around the longitudinal axis of the support and along the length of the support between the proximal and distal ends, the coils defining a lumen along the longitudinal axis passing through the center of the body; A distal tube having a wall extending distally from the distal end of the body, wherein the lumen extends through the distal tube; A first hole extends through the wall of the distal tube into the lumen; A proximal tube having a wall extending proximal to the proximal end of the body, wherein the lumen extends through the proximal tube; A distal retaining member extending distally from the distal tube, wherein the lumen extends through the distal retaining member; A proximal retaining member having a wall extending proximally from the proximal tube to a proximal end of the proximal retaining member, wherein the lumen extends through the proximal retaining member to the proximal end of the proximal retaining member; and A distal suture having a first end, a second end, and a middle portion, the middle portion extending through the first hole, wherein a portion of the distal suture adheres to the proximal tube.

8. A stent, comprising: The body includes coils in a generally helical pattern around the longitudinal axis of the support and along the length of the support between the proximal and distal ends, the coils defining a lumen along the longitudinal axis passing through the center of the body; A distal tube having a wall extending distally from the distal end of the body, wherein the lumen extends through the distal tube; A first hole extends through the wall of the distal tube into the lumen; A proximal tube having a wall extending proximal to the proximal end of the body, wherein the lumen extends through the proximal tube; A distal retaining member extending distally from the distal tube, wherein the lumen extends through the distal retaining member; A proximal retaining member having a wall extending proximally from the proximal tube to a proximal end of the proximal retaining member, wherein the lumen extends through the proximal retaining member to the proximal end of the proximal retaining member; and The distal suture has a first end, a second end, and a middle portion, the middle portion extending through the first hole, and further includes a fourth hole extending through the wall of the distal tube into the lumen, such that the first hole and the fourth hole are aligned parallel to the longitudinal axis, and the middle portion of the distal suture extends through the fourth hole.

9. A stent, comprising: The body includes coils in a generally helical pattern around the longitudinal axis of the support and along the length of the support between the proximal and distal ends, the coils defining a lumen along the longitudinal axis passing through the center of the body; A distal tube having a wall extending distally from the distal end of the body, wherein the lumen extends through the distal tube; A first hole extends through the wall of the distal tube into the lumen; A proximal tube having a wall extending proximal to the proximal end of the body, wherein the lumen extends through the proximal tube; A distal retaining member extending distally from the distal tube, wherein the lumen extends through the distal retaining member; A proximal retaining member having a wall extending proximally from the proximal tube to a proximal end of the proximal retaining member, wherein the lumen extends through the proximal retaining member to the proximal end of the proximal retaining member; and The distal suture has a first end, a second end, and a middle portion, the middle portion extending through the first hole and further including a fifth hole, the fifth hole extending through the wall of the distal tube into the lumen, such that the first hole and the fifth hole are aligned to form a suture axis intersecting the longitudinal axis, and the middle portion of the distal suture extending through the fifth hole, such that the distal suture extends distally from the first end within the lumen along the wall of the distal tube, through the first hole, along the outer surface of the wall of the distal tube, through the fifth hole into the lumen, and extends proximally within the lumen along the wall of the distal tube to the second end.

10. A support delivery system, comprising: The support conveying device includes: A cannula having a proximal end, a distal end, and a cannula lumen passing through it; The handle is located at the proximal end of the sleeve; An actuator disposed on the sleeve, the actuator having a proximal end, a distal end, and an actuator lumen passing through therethrough; A locking knob at the proximal end of the actuator, the locking knob being reversibly connected to the handle; and The bracket according to claim 1; The distal end of the sleeve is reversibly engaged with a portion of the length of the support.

11. The support conveying system according to claim 10, wherein, The portion of the support is an annular portion located on the wall of the support within the cavity of the support tube.

12. The support conveying system according to claim 11, wherein, The portion of the stent is located away from the portion on the wall of the stent that gradually tapers distally within the stent cavity.

13. The support conveying system according to claim 10, wherein, The outer diameter of the sleeve is larger than the diameter of the support lumen, and the length of the support extends along the proximal end of the support.

14. The support conveying system according to claim 10, wherein, The outer diameter of the sleeve is larger than the diameter of the support lumen, and a portion of the length of the support extends along the distal end of the support.

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