Deployment of multiple biliary stents

Abstract

A catheter (220) having: a guidewire engagement portion (222) at a distal portion (260) thereof; a first stent (54) surrounding the catheter, the first stent being capable of being advanced together with the catheter into a lumen of a subject; a guidewire (12) arranged to (i) enter the catheter from a distal end (320) opening of the catheter, (ii) be disposed in the guidewire engagement portion, and (iii) exit the catheter proximal to the guidewire engagement portion; and a second stent (54) proximal to the first stent, the second stent surrounding the proximal portion (240) of the catheter and the guidewire. The first stent is capable of being slidably deployed from the distal end of the catheter when the guidewire has laterally exited the guidewire engagement portion, and the second stent is capable of being slidably deployed from the distal end of the catheter after deployment of the first stent without moving the guidewire proximally. Other applications are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to US 62 / 691,329, filed on June 28, 2018 by Einav et al., entitled “Deployment of multiple biliary stents.”

[0003] This application is a continuation-in-part application of U.S. patent application 16 / 064,843, which is a national phase application of PCT application No. PCT / IL2016 / 051368, entitled “Deployment of Multiple Biliary Stents,” filed by Einav on December 22, 2016, and published as WO2017 / 109783. The PCT application claims priority to GB patent application No. 1522683.0, entitled “Deployment of Multiple Biliary Stents,” filed by Einav on December 22, 2015.

[0004] Each of the above patent applications is incorporated herein by reference. Field of the Invention

[0005]

[0014] Embodiments of the present invention relate generally to medical devices, and more particularly to methods and apparatus for deploying a plurality of stents within a lumen of a subject. Background Art

[0006] Stents are often deployed within a lumen of a subject's body for a variety of reasons. In some cases, they are deployed to widen a narrowed section of the lumen. For example, biliary stents are inserted into the bile duct to treat blockages and strictures that occur there. Several malignant and benign conditions can cause bile duct strictures. Pancreatic cancer is a common malignant cause of bile duct strictures. Non-cancerous causes of bile duct strictures may include bile duct injury during cholecystectomy surgery and pancreatitis.

[0007] Biliary stents are typically tubular structures used to support the stricture of the bile duct and prevent the stricture from re-forming. Summary of the Invention

[0008] According to some applications of the present invention, there are provided devices and methods for deploying more than one stent (e.g., two stents) in the lumen of a subject. For example, two or more stents are deployed in the common bile duct of a subject to treat biliary strictures and obstructions. Typically, two or more stents, such as two, three or four stents, are deployed side by side in the common bile duct to help alleviate biliary strictures. Typically, a catheter is used to deploy stents (e.g., a first stent and a second stent) in the lumen of a subject. In this context, in the specification and in the claims, "proximal" means closer to the orifice through which the catheter or stent is initially placed in the body, and "distal" means further away from this orifice.

[0009] For some applications, the catheter is shaped to define a guidewire engaging portion, such as a slit, extending proximally from the distal end of the catheter along the wall of the catheter. The proximal end of the slit is typically located distal to the proximal end of the catheter. Alternatively, the catheter is shaped to define a hole through the wall of the catheter, the hole being located proximal to the proximal end of the guidewire engaging portion and distal to the proximal end of the catheter. Typically, the proximal end of the slit is located distal to the hole.

[0010] During delivery to the subject's lumen, the first stent surrounds the catheter and is advanced into the subject's lumen together with the catheter. Typically, the first stent is arranged along the catheter so that, before insertion into the subject's body, the proximal end of the first stent is arranged distal to the hole in the wall of the catheter, while the distal end of the first stent is arranged proximal to the guidewire engagement portion. When positioned at the desired location in the subject's lumen, the first stent is slidably deployed from the distal end of the catheter, i.e., advanced from the distal end and deployed in the lumen.

[0011] Also before insertion into the subject's body, a second stent is disposed proximally of the first stent, surrounding the proximal portion of the catheter. (The proximal portion of the catheter is referred to as the "proximal portion" because it is close to the more distal portion of the catheter around which the first stent is disposed. The proximal portion of the catheter, and the second stent surrounding the proximal portion of the catheter, are introduced into the subject's body as described herein.) The second stent is shaped and sized to be advanced over the catheter and from the distal end of the catheter into the subject's lumen. After the first stent is deployed from the distal end of the catheter, the second stent is placed side by side with the first stent.

[0012] According to some applications of the present invention, the first stent and the second stent are delivered to the inner cavity of the subject without removing the catheter or guidewire used during the procedure from the subject's body after deploying the first stent and before deploying the second stent. As provided by some applications of the present invention, the first stent and the second stent are both pre-mounted on the catheter and advanced into the subject's body in a single advancement procedure to be subsequently deployed within the inner cavity of the subject as described herein.

[0013] According to some applications of the present invention, there is provided a device comprising:

[0014] a catheter shaped to (a) define a guidewire engagement portion at a distal portion of the catheter, the guidewire engagement portion having a proximal end distal to the proximal end of the catheter, and (b) define an aperture in a wall of the catheter, the aperture being proximal to the proximal end of the guidewire engagement portion and distal to the proximal end of the catheter;

[0015] a first stent, the first stent surrounding the catheter so as to be advanceable together with the catheter into an inner lumen of a subject, the first stent being slidable along the catheter such that a proximal end of the first stent is disposed distally of the aperture and a distal end of the first stent is disposed proximal of the guidewire engagement portion, the first stent being slidably deployable from the distal end of the catheter; and

[0016] A second stent proximal to the first stent surrounds a proximal portion of the catheter and is shaped and sized to be advanceable along the catheter and deployable from the distal end of the catheter into the lumen and positioned alongside the first stent after the first stent is deployed from the distal end of the catheter.

[0017] For some applications, the distal end of the second stent is disposed proximal to the aperture.

[0018] For some applications, the device also includes a guidewire configured to (i) enter the lumen of the catheter from the distal opening of the catheter, (ii) exit the lumen of the catheter at the guidewire engagement portion of the catheter, and (iii) enter the lumen of the catheter through the hole, and the first stent is (i) constrained from moving distally past the guidewire engagement portion when the guidewire is disposed in the guidewire engagement portion, and (ii) constrained from moving proximally past the hole when the guidewire is disposed in the hole.

[0019] For some applications, the first stent is slidably deployable from the distal end of the catheter when the guidewire is not disposed within the guidewire engagement portion.

[0020] For some applications, no holes are present in the wall of the catheter within 10 mm of the distal end of the catheter.

[0021] For some applications, no holes having a diameter less than 1 cm are present in the wall of the catheter within 10 mm of the distal end of the catheter.

[0022] For some applications, the apparatus further comprises a guidewire that (i) enters the lumen of the catheter from the distal opening of the catheter, (ii) exits the lumen of the catheter at the guidewire engagement portion of the catheter, and (iii) enters the lumen of the catheter through the aperture, and

[0023] The first stent (a) has an outer surface that is positioned against the guidewire, and (b) is configured to be advanced into the lumen of the subject when the outer surface is positioned against the guidewire,

[0024] And the second stent surrounds the guidewire and is configured to be advanced over the guidewire into the lumen of the subject.

[0025] For some applications, the distance between the distal end of the catheter and the aperture is 4-18 cm.

[0026] For some applications, the guidewire engaging portion is shaped to define a slit extending proximally from the distal end of the catheter along the wall of the catheter, the slit having a length of 1 mm-7 cm.

[0027] For some applications, the slit has a length of 2.5-3 cm.

[0028] For some applications, the guidewire engaging portion is shaped to define a weak point configured to tear in response to a force applied to the weak point by the guidewire.

[0029] According to some applications of the present invention, a device is further provided, comprising:

[0030] a catheter shaped to define a proximal end and a distal end of the catheter;

[0031] a first stent surrounding the catheter so as to be advanceable along with the catheter into a lumen of a subject and slidably deployable from the distal end of the catheter;

[0032] a second stent proximal to the first stent, the second stent surrounding a proximal portion of the catheter and being shaped and sized to be advanceable along the catheter into the lumen;

[0033] a first lock that prevents the first stent from moving proximally past a position at least 1 mm from a distal end of the second stent; and

[0034] A second lock prevents distal movement of the second stent past a position at least 1 mm near the proximal end of the first stent.

[0035] For some applications, the catheter is shaped to define two holes in a lateral wall of the catheter, and the first lock includes a locking wire passing through the two holes.

[0036] For some applications:

[0037] the second bracket being shaped to define a hole in a portion of the second bracket,

[0038] The device further includes a push tube disposed proximal to the second stent and configured to push the second stent away from the catheter.

[0039] The push tube is shaped to define a hole in a portion of the push tube, and

[0040] The second lock includes a locking wire that passes through the hole in the portion of the second bracket and through the hole in the portion of the push tube.

[0041] For some applications, the first locking feature includes a first locking line, and the second locking feature includes a second locking line.

[0042] For some applications, a distance between the proximal end of the first stent and the distal end of the second stent is a fixed distance.

[0043] For some applications, a distance between the proximal end of the first stent and the distal end of the second stent is 2-80 mm.

[0044] For some applications, the distance between the proximal end of the first stent and the distal end of the second stent is at least 5 mm.

[0045] For some applications, the distance between the proximal end of the first stent and the distal end of the second stent is less than 25 mm.

[0046] For some applications, the first lock is configured to prevent distal movement of the first stent during advancement of the first stent over the catheter into the lumen of the subject.

[0047] For some applications, the device further comprises a guide wire,

[0048] The catheter is further configured to (a) define a guidewire engagement portion at a distal portion of the catheter, the proximal end of the guidewire engagement portion being distal to the proximal end of the catheter, and (b) define an aperture in a wall of the catheter, the aperture being proximal to the proximal end of the guidewire engagement portion and distal to the proximal end of the catheter,

[0049] The first stent is (i) constrained from distal movement through the guidewire engagement portion when the guidewire is disposed within the guidewire engagement portion, and (ii) constrained from proximal movement through the aperture when the guidewire is disposed within the aperture, and

[0050] The first lock is not arranged to prevent distal movement of the first stent using the guidewire.

[0051] According to some applications of the present invention, a device is further provided, comprising:

[0052] a catheter shaped to define a proximal end and a distal end of the catheter;

[0053] a first stent surrounding the catheter so as to be advanceable along with the catheter into a lumen of a subject and slidably deployable from the distal end of the catheter;

[0054] a second stent proximal to the first stent, the second stent surrounding a proximal portion of the catheter and shaped and sized to be advanceable along the catheter into the lumen; and

[0055] a lock that prevents the second stent from moving distally beyond the proximal end of the first stent while the first stent is being slidably deployed from the distal end of the catheter and is unlockable to allow the second stent to be deployed from the catheter after the first stent is deployed from the distal end of the catheter.

[0056] For some applications:

[0057] the second bracket being shaped to define a hole in a portion of the second bracket,

[0058] The device further includes a push tube disposed proximal to the second stent and configured to push the second stent away from the catheter.

[0059] The push tube is shaped to define a hole in a portion of the push tube, and

[0060] The second lock includes a locking wire that passes through the hole in the portion of the second bracket and through the hole in the portion of the push tube.

[0061] According to some applications of the present invention, a method is also provided, comprising:

[0062] Use equipment, the equipment comprising:

[0063] a catheter shaped to define a proximal end and a distal end of the catheter;

[0064] a first stent surrounding a distal portion of the catheter, and

[0065] a second stent proximal to the first stent, the second stent surrounding a proximal portion of the catheter;

[0066] The device is advanced to a desired position within a lumen of a subject, with: (a) the first stent being constrained from proximally moving past a position at least 1 mm from a distal end of the second stent, and (b) the second stent being constrained from distally moving beyond a position at least 1 mm near the proximal end of the first stent.

[0067] For some applications:

[0068] After said advancing of said device, and while said second stent is constrained from distal movement, withdrawing said catheter relative to said first stent until said first stent is deployed from said distal end of said catheter into said lumen;

[0069] After deploying the first stent from the distal end of the catheter, releasing the second stent so that the second stent is unconstrained and can move distally;

[0070] The second stent is then advanced along the catheter into the lumen of the subject and deployed from the distal end of the catheter alongside the first stent.

[0071] According to some applications of the present invention, a device is further provided, comprising:

[0072] a catheter shaped to define a guidewire engagement portion at a distal portion of the catheter, the guidewire engagement portion having a proximal end distal to the proximal end of the catheter;

[0073] a first stent, the first stent surrounding the catheter so as to be advanceable together with the catheter into an inner lumen of a subject, the first stent being slidable along the catheter such that a distal end of the first stent is disposed proximal to the guidewire engaging portion of the catheter;

[0074] a guidewire arranged to (i) enter the lumen of the catheter from a distal opening of the catheter, (ii) be disposed in the guidewire engagement portion, and (iii) exit the lumen of the catheter proximal to the guidewire engagement portion of the catheter, such that the first stent is constrained from distal movement past the guidewire engagement portion due to the guidewire being disposed within the guidewire engagement portion; and

[0075] a second stent proximal to the first stent, the second stent surrounding a proximal portion of the catheter and the guidewire and being shaped and sized to be advanceable along the catheter; and

[0076] (i) the guidewire is positioned to exit the guidewire engagement portion laterally without being advanced distally or proximally,

[0077] (ii) the first stent is slidably deployable from the distal end of the catheter when the guidewire has exited the guidewire engagement portion without moving the guidewire proximally after the guidewire exits the guidewire engagement portion, and

[0078] (iii) the second stent is slidably deployable from the distal end of the catheter after the first stent is deployed from the distal end of the catheter and is positionable alongside the first stent without moving the guidewire proximally after the guidewire exits the guidewire engagement portion.

[0079] For some applications, the first stent (a) has an outer surface that is positioned against the guidewire and (b) is configured to be advanced into a lumen of a subject when the outer surface is positioned against the guidewire.

[0080] For some applications, the guidewire engaging portion is shaped to define a slit extending proximally along a wall of the catheter from a distal end of the catheter, the slit having a length of 1-70 mm.

[0081] For some applications, the slit is shaped to define two slit lips that contact each other without any force applied to the slit lips to define a closed slit configuration and can be disengaged from each other by applying a force to the lips to define an open slit configuration.

[0082] For some applications, the slit is shaped to define two slit lips that contact one another to define a closed slit configuration and can be disengaged from one another to define an open slit configuration, and

[0083] Also included is a locking member, the locking member:

[0084] pressing the slit lips against each other in the closed slit configuration when the guidewire is disposed in the guidewire engagement portion to inhibit the lateral exit of the guidewire from the guidewire engagement portion, and

[0085] The lateral exit of the guidewire from the guidewire engaging portion is permitted in the open slit configuration when the locking member is not pressing the slit lips against each other.

[0086] For some applications, the guidewire engagement portion is formed to define a weak point that is configured to (i) tear in response to a force applied to the weak point by the guidewire when the distal portion of the catheter is withdrawn into the first stent, and (ii) be shaped and sized to allow the guidewire to pass therethrough in its torn state.

[0087] For some applications, the apparatus further comprises:

[0088] a first lock that prevents the first stent from moving proximally past a position at least 1 mm from a distal end of the second stent; and

[0089] A second lock prevents distal movement of the second stent past a position at least 1 mm near the proximal end of the first stent.

[0090] For some applications, the catheter is shaped to define two holes in a lateral wall of the catheter, and wherein the first lock comprises a locking wire passing through the two holes.

[0091] For some applications:

[0092] the second bracket being shaped to define a hole in a portion of the second bracket,

[0093] The device further includes a push tube disposed proximal to the second stent and configured to push the second stent away from the catheter.

[0094] The push tube is shaped to define a hole in a portion of the push tube, and

[0095] The second lock includes a locking wire that passes through the hole in the portion of the second bracket and through the hole in the portion of the push tube.

[0096] For some applications, the first locking feature includes a first locking wire, and wherein the second locking feature includes a second locking wire.

[0097] For some applications, the first lock is configured to prevent distal movement of the first stent during advancement of the first stent over the catheter into the lumen of the subject.

[0098] The present invention will be more fully understood from the following detailed description of its application in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0099] Figure 1 is a schematic diagram of a catheter for deploying a first stent and a second stent within a lumen of a subject according to some applications of the present invention;

[0100] Figure 2 is a schematic diagram of an apparatus for delivering and deploying a first stent and a second stent in an internal lumen of a subject according to some applications of the present invention;

[0101] Figures 3A to 3H is a schematic diagram illustrating a general overview of a method for deploying a first stent and a second stent in an internal lumen of a subject according to some applications of the present invention;

[0102] Figure 4 is a schematic diagram of additional configurations of a catheter for deploying a first stent and a second stent within a lumen of a subject according to some applications of the present invention;

[0103] Figures 5A to 5B is a schematic diagram of additional configurations of a distal portion of a catheter according to some applications of the present invention;

[0104] Figures 6A to 6B is a schematic diagram of an apparatus for delivering and deploying a first stent and a second stent in an internal lumen of a subject according to some applications of the present invention;

[0105] Figures 7A to 7H is a schematic diagram illustrating a general overview of a method for deploying a first stent and a second stent in an internal lumen of a subject according to some applications of the present invention;

[0106] Figures 8A to 8B is a schematic diagram of a locking mechanism comprising a locking member configured to prevent movement of a first stent relative to a catheter; and

[0107] 9A to 9D is a schematic diagram of a locking mechanism including a first locking member and a second locking member configured to prevent movement of a first stent and a second stent, respectively, relative to a catheter. DETAILED DESCRIPTION

[0108] A catheter is provided for facilitating the deployment of more than one stent (e.g., a first stent and a second stent) in a lumen of a subject. According to some applications of the present invention, various configurations of the catheter are described herein. Specifically, according to some applications of the present invention, Figures 1 to 4 The catheter 22 is shown, and FIG. 5 to FIG. Figure 9DCatheter 220 is shown. It should be noted that both catheter 22 and catheter 220 are configured to deliver the first stent and the second stent into the lumen of a subject without removing catheters 22 and 220 or the guidewire used during the procedure from the subject's body after deploying the first stent and before installing the second stent. As will be described herein below, the first stent and the second stent are typically mounted on catheters 22 and 220 prior to the procedure and then advanced into the subject's body for deployment within the subject's lumen.

[0109] This detailed description begins with a description of a catheter 22 for deploying a plurality of stents within a lumen of a subject, according to some applications of the present invention.

[0110] right Figure 1 and Figure 2 For reference.

[0111] Figure 1 is a schematic diagram of a catheter 22 according to some applications of the present invention. As shown, the catheter 22 is shaped to define a proximal end 30 at the proximal portion 24 of the catheter 22 and a distal end 32 at the distal portion 26 of the catheter 22.

[0112] The catheter 22 is further shaped to define a guidewire engagement portion 122, which is shown as a hole 40 extending through the wall 36 of the catheter 22 at the distal portion 26 of the catheter. The catheter 22 is further shaped to define a slit 28 extending proximally from the distal end 32 of the catheter along the wall 36 of the catheter 22. The proximal end 29 of the slit 28 is located distal to the proximal end 30 of the catheter 22. Additionally, the proximal end 29 of the slit 28 is located proximal to the hole 40.

[0113] Typically, the holes 40 are disposed at an offset angle α of 90 to 180 degrees (e.g., 180 degrees) relative to the central longitudinal axis A1 of the catheter from the slit 28. Alternatively, a smaller angle α (e.g., Figure 2 ( An angle α of approximately 60 degrees is shown in the figure). As used in this application, including in the claims, the "central longitudinal axis" of an elongated structure is the set of all centroids of the structure's transverse cross-sectional segments along the structure. Thus, the cross-sectional segments are locally perpendicular to the central longitudinal axis extending along the structure. (If the structure has a circular cross-section, the centroid corresponds to the center of the circular cross-sectional segment.) The central longitudinal axis of a curved elongated structure is curved, not straight.

[0114] Typically, the distance D1 between the center of the hole 40 and the distal end 32 of the catheter 22 is at least 5 mm and / or less than 200 mm, such as between 5 and 200 mm.

[0115] In some applications, the aperture 40 is shaped to define an elliptical aperture having a major axis W1 that is generally oriented parallel to the longitudinal axis A1 of the catheter 22. The major axis is generally 1.5 to 4 times longer than the minor axis W2 of the aperture 40. For example, the aperture 40 has a major axis W1 that is 5-10 mm in length and a minor axis W2 that is 0.5-1.0 mm in length.

[0116] The slit 28 defines two slit edges 27 that are parallel to the central longitudinal axis A1 of the catheter 22. A distance D2 between a first one of the slit edges and a second one of the slit edges is typically 0.45-0.9 mm. For some applications, when the catheter 22 is viewed from the distal end 32 of the catheter 22, an angle θ of 10 to 80 degrees, such as 20 to 70 degrees, is formed, the angle θ being defined by: (a) a first line extending from the central longitudinal axis to the first one of the slit edges, and (b) a second line extending from the central longitudinal axis to the second one of the slit edges.

[0117] Still Figure 1 and Figure 2 For reference. Figure 2 is a schematic diagram of apparatus 20 for delivering and deploying a first stent 52 and a second stent 54 within an internal lumen of a subject, according to some applications of the present invention.

[0118] For some applications, apparatus 20 includes a catheter 22 (as described above with reference to Figure 1 4 and 5. The first and second brackets 52 and 54 are shown as being arranged to surround the catheter 22, with the second bracket 54 being positioned proximal to the first bracket 52 and surrounding the proximal portion 24 of the catheter 22. The first bracket 52 is generally positioned above the catheter 22 such that the proximal end 53 of the first bracket 52 is positioned distal to the proximal end 29 of the slit 28 of the catheter 22, and the distal end 55 of the first bracket 52 is positioned proximal to the hole 40.

[0119] The first stent 52 is shaped to define a proximal flap 524 and a distal flap 522, and the second stent 54 is shaped to define a proximal flap 540 and a distal flap 542. The flaps are generally configured to help anchor the stent to the lumen in which the stent is deployed.

[0120] For some applications, distal end 59 of second bracket 54 is disposed proximal to proximal end 29 of slit 28 . For other applications, distal end 59 of second bracket 54 is disposed distal to proximal end 29 of slit 28 .

[0121] The first stent 52 is slidably deployed from the distal end 32 of the catheter 22. Additionally, the second stent 54 is also shaped and sized to generally be able to be advanced over the catheter 22 after the first stent 52 is deployed from the distal end 32 of the catheter 22.

[0122] For some applications, first bracket 52 and second bracket 54 each have a length L1 of 5-15 cm, and slit 28 also has a length L2 of 5-15 cm. Typically, the length of slit 28 is greater than the length of first bracket 52. For some applications, the length of slit 28 is: (a) greater than the length of first bracket 52, and (b) less than the sum of the lengths of first bracket 52 and second bracket 54.

[0123] Device 20 is typically advanced into a lumen of a subject, and catheter 22 facilitates placement of first stent 52 and second stent 54 within the lumen of the subject.

[0124] Now Figures 3A to 3H Reference is now made to a general overview of a method for deploying a first stent 52 and a second stent 54 in a lumen of a subject using apparatus 20 according to some applications of the present invention. Typically, stents 52 and 54 are deployed in a lumen of a subject, such as a common bile duct of the subject, to treat a stenosis of the lumen. According to some applications of the present invention, apparatus 20 is configured such that first stent 52 is advanced into the lumen of the subject against a guidewire, and second stent 54 is advanced into the lumen over (i.e., surrounding) the guidewire.

[0125] right Figure 3A According to some applications of the present invention, the device 20 (as described above with reference to Figure 2 As described, a catheter 22 and a first stent 52 and a second stent 54 are used in conjunction with a guidewire 12 to deploy the stents 52 and 54 side by side in the lumen. The guidewire 12 is typically passed through the catheter 22 such that after passing:

[0126] (a) The guide wire 12 enters the lumen of the catheter 22 from the distal end 32 opening of the catheter 22,

[0127] (b) the guide wire 12 exits the lumen of the catheter 22 through the hole 40 of the catheter 22,

[0128] (c) Since the guide wire 12 is disposed in the hole 40 , the first stent 52 is constrained and cannot move distally through the hole 40 of the catheter 22 .

[0129] (d) The guide wire 12 enters the lumen of the catheter 22 through the proximal end 29 of the slit 28, and

[0130] (e) Because the guidewire 12 is disposed within the slit 28 , the first stent 52 is constrained from moving proximally past the proximal end 29 of the slit 28 .

[0131] After the guide wire 12 passes through the catheter 22 as described above, Figure 3A As shown, the device 20 is advanced into the body of the subject, for example, into the small intestine, and into the lumen 4 of the common bile duct. As shown, the first stent 52 is advanced distally over the catheter 22 and against the guidewire 12 (i.e., the outer surface of the first stent 52 is disposed against the guidewire 12). Due to the passage of the guidewire 12 as described above, the stent 52 is advanced distally in the lumen 4 while being constrained from distal movement through the hole 40 of the catheter 22. The constrained movement of the stent 52 (particularly due to the guidewire 12 being disposed within the hole 40) generally allows the stent 52 to be advanced to the desired deployment site within the lumen 4 in a controlled manner (i.e., inhibiting uncontrolled distal movement of the stent 52, thereby allowing the physician to safely perform implantation at the desired deployment site).

[0132] Additionally, because the guidewire 12 is disposed within the slit 28 , the first stent 52 is constrained from moving proximally past the proximal end 29 of the slit 28 , thereby allowing the physician to advance the stent 52 in a controlled manner.

[0133] Now Figures 3B to 3H For reference.

[0134] When the first stent 52 reaches the desired deployment position in the lumen 4, as shown in FIG. Figure 3B As shown, the guide wire 12 is removed from the bore 40 of the catheter 22 by pulling the guide wire 12 proximally in the direction indicated by arrow 11. Then, generally as indicated by arrow 13 ( Figure 3C ) is indicated by advancing the guidewire 12 distally within the lumen 4. Thus, the guidewire 12 is maintained within the lumen 4 at this stage and is not removed from the lumen 4. Removing the guidewire 12 from the hole 40 typically releases the first stent 52 and allows the catheter 22 to be pulled proximally in the direction indicated by the arrow until the catheter 22 is removed from the stent 52 and the stent 52 can be deployed within the lumen 4 ( Figure 3D As the catheter 22 is pulled proximally in the direction indicated by arrow 15, the guidewire 12 slides through the slit 28 of the catheter 22 and is thus centered within the lumen of the catheter ( Figure 3E Centering of the guidewire 12 within the catheter 22 facilitates deployment of the second stent 54 within the lumen 4 using the guidewire 12. Positioning the guidewire 12 within the catheter 22 using the slit 28 allows the second stent 54 to be advanced over the guidewire 12 while the first stent 52 is advanced against (but not simultaneously around) the guidewire 12.

[0135] like Figure 3FAs shown, and indicated by arrow 17, the second stent 54 is advanced distally in lumen 4 over the catheter 22 and over the guidewire 12 (which is the lumen of the catheter 22). Figure 3G As shown, the second stent 54 continues to advance distally in the lumen 4 (as indicated by arrow 19) until it reaches the desired deployment site alongside the first stent 52 ( Figures 3F to 3G Once the second bracket 54 is deployed side by side with the first bracket 52, as shown in FIG. Figure 3H As indicated by arrow 21 in FIG. 1 , the catheter 22 and the guidewire 12 are retracted by pulling in the proximal direction.

[0136] like Figures 3A to 3H As illustrated, use of the device 20 according to some applications of the present invention allows for deployment of the second stent 54 after deployment of the first stent 52 while maintaining the guidewire 12 within the lumen 4. Additionally, the device 20 allows for deployment of the second stent 54 after deployment of the first stent 52 without requiring the device 20 to be removed from the subject's body after deployment of the first stent 52 in order to install the second stent 54. Notably, the first stent 52 and the second stent 54 are typically disposed simultaneously on the catheter 22 as they are advanced into the subject's body (also as shown in FIG. Figure 2 ), for deployment within a lumen using the techniques described herein.

[0137] right Figures 1 to 9D It should be noted that for some applications, first stent 52 and second stent 54 comprise self-expanding stents.

[0138] It should also be noted that stents are described by way of illustration and not limitation. The scope of the present invention includes the use of any other stent or tubular structure configured to relieve stenosis of a lumen of a subject.

[0139] Now Figures 3A to 4 For reference. Figure 4 is a schematic diagram of an additional configuration of a catheter 22 for deploying a first stent 52 and a second stent 54 within a lumen of a subject, according to some applications of the present invention. Figures 1 to 3H As depicted, the guidewire engaging portion 122 embodied as the aperture 40 is configured to engage the guidewire 12 in a manner such that, because the guidewire 12 is engaged by the portion 122 (e.g., disposed within the aperture 40), the guidewire engaging portion inhibits distal movement of the first stent 52 past the guidewire engaging portion 122 of the catheter 22. By way of illustration and not limitation, the guidewire engaging portion 122 is configured to engage the guidewire 12 in a manner such that, because the guidewire 12 is engaged by the portion 122 (e.g., disposed within the aperture 40), the guidewire engaging portion inhibits distal movement of the first stent 52 past the guidewire engaging portion 122 of the catheter 22. Figures 1 to 3H40. It should be noted that the guidewire engaging portion 122 can be shaped to define any other configuration suitable for engaging the guidewire 12 in a manner such that it grips or otherwise holds the guidewire 12, thereby inhibiting distal movement of the first stent 52 past the guidewire engaging portion 122 as the stent 52 is advanced distally against the guidewire 12. Figures 3A to 3H The described technique is also applicable to Figure 4 The guidewire engaging portion 122 is shown.

[0140] like Figure 4 As shown, for some applications, the edges 27 of the slits 28 are shaped to define a guidewire engagement portion 122. Typically, a distance D2 between a first one of the slit edges and a second one of the slit edges is 0.45-0.9 mm. However, at the guidewire engagement portion 122, the distance D3 between the slit edges 27 is less than the distance D2, such that, for example, D2 is 2 to 5 times greater than D3. Typically, the distance D3 between the slit edges 27 is 0.09 mm-0.45 mm, e.g., greater than 0.15 mm and / or less than 0.4 mm. Typically, Figure 4 The length of the guidewire engaging portion 122 shown is 5 to 10 times longer than D3, for example 0.45 mm to 4.5 mm, for example greater than 1 mm and / or less than 3.5 mm. Figure 4 As shown, the guidewire 12 is generally engaged by and locked into the narrow region in the slit 28, which defines a guidewire engagement portion 122. Engaging the guidewire 12 by the guidewire engagement portion 122 generally allows the first stent 52 to be advanced to the desired deployment site within the lumen of the subject in a controlled manner (i.e., inhibiting uncontrolled distal movement of the stent 52 as the stent 52 is advanced distally against the guidewire 12, thereby allowing the physician to safely perform implantation at the desired deployment site).

[0141] In other words, when the guidewire 12 (i) is at least partially disposed within the lumen of the catheter 22, (ii) passes through the opening at the distal end 32 of the catheter 22, (iii) passes through the guidewire engagement portion 122 of the catheter 22, and (iv) passes through the proximal end 29 of the slit 28, the first stent 52 (i) is constrained from moving distally past the guidewire engagement portion 122 and (ii) is constrained from moving proximally past the proximal end 29 of the slit 28. Additionally, when the guidewire 12 (i) is at least partially disposed within the lumen of the catheter 22, (ii) passes through the opening at the distal end 32 of the catheter 22, (iii) passes through the guidewire engagement portion 122 of the catheter 22, and (iv) passes through the proximal end 29 of the slit 28, the second stent 54 is constrained from moving distally past the proximal end of the slit.

[0142] Once the first stent 52 is at the desired deployment site in the lumen of the subject, the guidewire 12 is released from the guidewire engagement portion 122 by pulling on the guidewire 12. Removing the guidewire 12 from the guidewire engagement portion 122 generally releases the first stent 52 and allows for the stent to be deployed in the position indicated by arrow 15 (e.g., Figure 3D The catheter 22 is pulled proximally in the direction indicated by the guide 24 (shown) until the catheter 22 is removed from the stent 52 and the stent 52 can be deployed in the lumen of the subject.

[0143] It should be noted that for other applications, the guidewire engaging portion 122 may include a clip or any other device suitable for engaging the guidewire 12 .

[0144] Now Figures 5A to 5B and Figures 6A to 6B For reference.

[0145] Figures 5A to 5B and Figures 6A to 6B is a schematic diagram of a catheter 220 according to some applications of the present invention. Unless otherwise indicated, catheter 220 is substantially the same as catheter 22.

[0146] As shown, the catheter 220 has a distal portion 260 and a proximal portion 240 proximal thereto. The catheter 220 is further formed to define a guidewire engagement portion 222 at the distal portion 260 of the catheter 220. Typically, the proximal end 262 of the guidewire engagement portion 222 is located distal to the proximal end 300 of the catheter 220.

[0147] Typically, the catheter 220 is further formed to define a hole 400 in the wall of the catheter 220, the hole 400 being located proximal to the proximal end 262 of the guidewire engagement portion 222 and distal to the proximal end 300 of the catheter. Typically, the distance between the distal end 320 of the catheter 220 and the hole 400 is at least 4 cm and / or less than 18 cm (e.g., 4-18 cm). Typically, no holes are present in the wall of the catheter 220 within 10 mm of the distal end 320 of the catheter. (More typically, no holes having a diameter less than 1 cm are present in the wall of the catheter 220 within 10 mm of the distal end 320 of the catheter.)

[0148] For some applications, the guidewire engaging portion 222 is shaped to define a slit 280 extending proximally along the wall of the catheter 220 from the distal end 320 of the catheter. The slit 280 typically has a length of at least 1 mm and / or less than 70 mm (e.g., 1-70 mm). For example, the slit can have a length of at least 25 mm and / or less than 30 mm (e.g., 25-30 mm). The proximal end 262 of the slit 280 is located distal to the proximal end 300 of the catheter 220. Additionally, the proximal end 262 of the slit 280 is located distal to the hole 400. Typically, the proximal end 262 of the slit 280 is located 5-40 mm away from the distal end 320 of the catheter.

[0149] For some applications, the slit 280 is formed to define two lips 282 (hereinafter referred to as "slit lips 282") that contact each other in the absence of any force applied to the slit lips 282 to define a closed slit configuration and are typically capable of being disengaged from each other by applying a force to the slit lips 282 to define an open slit configuration.

[0150] Optionally, the guidewire engaging portion 222 is shaped to define a weak point 284, such as a cleavable portion, configured to be responsive to (e.g., as described below in Figure 7B The force applied by the guide wire 12 to the weak point 284 is shown to tear. It should be noted that Figure 5A and Figures 6A to 6B Two options are shown (as indicated by double arrow A1) where the guidewire engaging portion 222 is shaped to define either a slit 280 or a weak point 284. This is illustrative and not restrictive; it should be noted that with respect to Figure 5B , the guidewire engaging portion 222 can be formed to define a slit 280 .

[0151] Still Figures 5A to 5B and Figures 6A to 6B As shown, the catheter 220 is in a collapsed configuration (at Figure 6A 94, 95, 96 and 97, and in Figure 5A Optionally, the catheter 220 may exhibit varying diameters along the length of the catheter, such as a smaller diameter in the portion of the catheter 220 generally proximal to the guidewire engagement portion 222 and distal to the aperture 400 (shown in exploded view as box 98). Figure 5B 100, and in Figure 6B 102, 104, and 106). For some applications, there may be a single portion of the catheter 220 having a smaller diameter extending from the guidewire engagement portion 222 to the aperture 400 (such as Figures 6A to 6B ). Optionally, for some applications, the diameter of the catheter 220 may be smaller in two separate portions of the catheter 220: (i) near the guidewire engagement portion 222, close to the guidewire engagement portion 222, and (ii) near the hole 400, away from the hole 400. Between these two portions, the catheter 220 may assume its larger diameter. Optionally, for some applications, the catheter 220 may have a substantially constant diameter along substantially the entire length of the catheter 220. Typically, the catheter 220 is configured for use with the guidewire 12, and the collapsed configuration or variable diameter configuration of the catheter 220 allows the guidewire to generally enter and exit the lumen of the catheter 220.

[0152] Still Figures 5A to 5B and Figures 6A to 6B For reference. Figures 6A to 6B is a schematic diagram of an apparatus 200 for delivering and deploying a first stent 52 and a second stent 54 within an internal lumen of a subject, according to some applications of the present invention.

[0153] As shown, the apparatus 200 includes a catheter 220 (as described above with reference to Figures 5A to 5B and Figures 6A to 6B 400 ). As shown in the figure, the first stent 52 and the second stent 54 surround the catheter 220, and the second stent 54 is disposed proximally to the first stent 52 and surrounds the proximal portion 240 of the catheter 220. The first stent 52 is generally disposed above the catheter 220 so that the distal end 55 of the first stent 52 is disposed proximally to the proximal end 262 of the guidewire engagement portion 222, and the proximal end 53 of the first stent 52 is disposed distally to the hole 400.

[0154] Typically, the distal end 59 of the second stent 54 is disposed proximal to the first stent 52 and proximal to the aperture 400 .

[0155] First stent 52 is slidably deployable from distal end 320 of catheter 220. Additionally, second stent 54 is also shaped and sized to generally be capable of being advanced over catheter 220 after first stent 52 is deployed from distal end 320 of catheter 220. Apparatus 200 is generally advanced into a lumen of a subject, and catheter 220 facilitates placement of first stent 52 and second stent 54 within the lumen of the subject.

[0156] Reference Figures 7A to 7H, which shows an overall overview of a method for using device 200 to deploy a first stent 52 and a second stent 54 in an inner cavity of a subject according to some applications of the present invention. Typically, stents 52 and 54 are deployed in an inner cavity of a subject, such as a common bile duct of the subject, in order to treat a stenosis of the inner cavity. According to some applications of the present invention, similar to device 20, as shown in the figure, device 200 is configured so that the first stent 52 is advanced into the inner cavity of the subject against a guidewire 12, and the second stent 54 is advanced into the inner cavity over the guidewire 12 (i.e., surrounding the guidewire).

[0157] First of all, Figure 7A According to some applications of the present invention, the device 200 (as described above with reference to Figures 5A to 5B and Figures 6A to 6B As described, a catheter 220 and a first stent 52 and a second stent 54 are used in conjunction with a guidewire 12 to deploy the stents 52 and 54 so that the stents are placed side by side in the lumen. The guidewire 12 is typically passed through the catheter 220 so that after passing through:

[0158] (a) The guide wire 12 enters the inner cavity of the catheter 220 from the distal end 320 opening of the catheter 220,

[0159] (b) the guidewire 12 exits the lumen of the catheter 220 at the guidewire engagement portion 222 and is disposed against the outer surface of the first stent 52,

[0160] (c) Since the guidewire 12 is disposed in the guidewire engagement portion 222 , the first stent 52 is constrained from moving distally past the guidewire engagement portion 222 of the catheter 220 .

[0161] (d) The guide wire 12 enters the lumen of the catheter 220 through the hole 400 proximal to the first stent 52, so that the guide wire 12 is surrounded by the catheter 220 and the second stent 54, and

[0162] (e) When the guidewire 12 is disposed within the hole 400 , the first stent 52 is constrained from moving proximally through the hole 400 .

[0163] It should be noted that Figure 7A The exploded view in the form of frame 110 in FIG. 1 only shows that the guidewire engaging portion 222 is shaped to define the slit 280. This is illustrative and not restrictive; alternatively, the guidewire engaging portion 222 can be shaped to define the weak point 284. Similarly, it should be noted that Figure 7A The exploded view in the form of frame 112 in FIG. 1 shows only the collapsed configuration of the portion of the catheter 220 proximal to the guidewire engaging portion 222. Optionally, this portion of the catheter 220 may be utilized as shown. Figure 5B and Figure 6B Varying diameter configurations shown.

[0164] After the guide wire 12 passes through the catheter 220 as described above, Figure 7A As shown, the device 200 is advanced into the body of the subject, for example, into the small intestine, and into the lumen 4 of the common bile duct. As shown, the first stent 52 is advanced distally over the catheter 220 and against the guidewire 12 (i.e., the outer surface of the first stent 52 is disposed against the guidewire 12). Due to the passage of the guidewire 12 as described above, the stent 52 is advanced distally in the lumen 4 while being constrained from distal movement past the guidewire engagement portion 222. The constrained movement of the stent 52 generally allows the stent 52 to be advanced to the desired deployment site within the lumen 4 in a controlled manner (i.e., inhibiting uncontrolled distal movement of the stent 52, thereby allowing the physician to safely perform implantation at the desired deployment site).

[0165] Additionally, because the guidewire 12 is disposed within the aperture 400 , the first stent 52 is constrained from moving proximally through the aperture 400 , thereby allowing the physician to advance the stent 52 in a controlled manner.

[0166] Now 7B to 7H For reference.

[0167] When the first stent 52 reaches the desired deployment position in the lumen 4, as shown in FIG. Figure 7B As shown, the guidewire 12 is typically passed through, i.e., exited from, the guidewire engagement portion 222 of the catheter 220 by pulling the catheter 220 proximally, thereby causing the guidewire 12 to exit laterally through the guidewire engagement portion 222. The guidewire 12 is shown as exiting the lumen of the catheter 220 at the guidewire engagement portion 222 by leaving the slit lip 282. It should be noted that the guidewire engagement portion 222 is shown as a slit for purposes of illustration and not limitation. For some applications, such as those described herein with reference to Figures 5A to 5B and Figures 6A to 6B As depicted, the guidewire engaging portion 222 is shaped to define a weak point 284, and the guidewire 12 exits the lumen of the catheter by tearing the weak point.

[0168] like Figure 7B As shown, the guidewire 12 exits the guidewire engagement portion 222 laterally without advancing distally or proximally. (This is in contrast to Figure 3B and Figure 3C In contrast to the application described in Figure 3B As shown, the guide wire 12 is removed from the guide wire engagement portion in the distal portion of the catheter by pulling the guide wire 12 proximally in the direction indicated by arrow 11. The guide wire 12 is then typically removed as indicated by arrow 13 (shown in FIG. Figure 3C ) is advanced distally in lumen 4 to facilitate subsequent deployment of stent 52). Figure 7BAs shown, the guidewire engaging portion 222 is arranged to allow the guidewire 12 to leave the guidewire engaging portion 222 without having to pull the guidewire proximally to release the guidewire from the catheter. Instead, the guidewire 12 "pops out" the guidewire engaging portion 222 in a lateral direction, for example, in response to pulling the catheter 220 proximally back.

[0169] Relative to Figure 7B It should also be noted that according to some applications of the present invention, due to the locking of the second bracket 54, the first bracket 52 and the second bracket 54 (not shown) Figure 7B There is a fixed distance of at least 1 mm and / or less than 80 mm (e.g., 1-80 mm) between the first stent 52 and the second stent so that the second stent is prevented from moving distally before the first stent 52 is deployed. 9A to 9D Examples of such locking mechanisms are described.For some applications, the fixed distance is at least 5 mm, and for some applications, the fixed distance is less than 25 mm.

[0170] right Figure 7C After the guidewire 12 is removed from the guidewire engagement portion 222, the guidewire 12 is maintained within the lumen 4 and does not advance proximally or distally within the lumen. Figure 7B As shown, removal of the guidewire 12 from the guidewire engagement portion 222 typically allows for subsequent deployment of the first stent 52 by proximally withdrawing the catheter 220. In particular, the catheter 220 is typically pulled proximally in the direction indicated by arrow A3 until the catheter 220 is removed from the stent 52 and the stent 52 is thereby deployed within the lumen 4. It should be noted that during deployment of the first stent 52, the guidewire 12 is maintained within the lumen 4 and is not advanced proximally or distally therein.

[0171] After the first stent 52 is deployed, the second stent 54 is advanced over the catheter 220 and over the guidewire 12. Optionally, the catheter 220 is positioned at the position indicated by arrow A4 ( Figure 7D ) in the direction indicated by the distal end. Figures 7E to 7F As shown, second stent 54 is advanced distally in lumen 4 over catheter 220 and over guidewire 12 (which is in the lumen of catheter 220) as indicated by arrow A5. It should be noted that during deployment of second stent 54, guidewire 12 is maintained within lumen 4 and is not advanced proximally or distally therein.

[0172] like Figure 7F As shown, the second stent 54 continues to advance distally in the lumen 4 until it reaches the desired deployment site alongside the first stent 52. Once the second stent 54 is positioned side by side with the first stent 52 ( Figure 7F ),like Figures 7G to 7HAs shown, the guidewire 12 is pulled in the proximal direction to retract the guidewire (and catheter 22, if present) and out of the subject's body.

[0173] like Figures 7A to 7H As shown, use of the device 200 according to some applications of the present invention allows for deployment of the second stent 54 after deployment of the first stent 52 while maintaining the guidewire 12 in a generally constant position within the lumen 4. Additionally, the device 200 allows for deployment of the second stent 54 after deployment of the first stent 52 without requiring the device 200 to be removed from the subject's body after deployment of the first stent 52 in order to install the second stent 54. Notably, the first stent 52 and the second stent 54 are typically simultaneously installed on the catheter 220 (e.g., when the first stent 52 and the second stent 54 are advanced into the subject's body). Figures 6A to 6B ), for deployment within a lumen using the techniques described herein.

[0174] Now Figures 8A to 8B and 9A to 9D Reference is made to FIG, which is a schematic diagram of a locking mechanism configured to prevent movement of the first stent 52 and the second stent 54 relative to the catheter. The locking mechanism is typically employed to allow the first stent 52 and the second stent 54 to be advanced together over the catheter into the lumen of the subject in a controlled manner. Once the physician removes each locking mechanism, the corresponding stent can be deployed into the lumen from the distal end of the catheter. It should be noted that reference is made herein to FIG. Figures 8A to 8B and 9A to 9D The locking mechanism described can be applied to Figures 1 to 7H The stent 52 and the second stent 54 are shown, as well as the catheters 22 and 220. By way of illustration and not limitation, Figures 8A to 8B and 9A to 9D Reference is made to catheter 220. It will be understood that reference Figures 8A to 8B and 9A to 9D The locking mechanism described may also be used with catheter 22 .

[0175] like Figures 8A to 8B 、 Figure 9A and Figure 9D 2. Referring first to the first locking member 600 for preventing the first stent 52 from moving proximally and distally relative to the catheter 220, reference is made. Typically, the first locking member 600 is configured to prevent the first stent 52 from moving proximally past a position at least 1-80 mm (e.g., 2-80 mm, e.g., 5-80 mm, e.g., 5-25 mm) away from the distal end 59 of the second stent 54. Additionally, the first locking member 600 is configured to prevent the stent 52 from moving distally so that the stent does not fall off the distal end of the catheter 220 while the stent 52 is being advanced within the lumen of the subject until it reaches the desired implantation location and the first locking member 600 is removed by the physician.

[0176] Generally, the first locking member 600 includes a first locking wire 610 and a locking ring 620 .

[0177] The locking ring 620 is typically looped through two lateral holes 614 ( Figure 9A and Figure 9D ) ring and fastened to the catheter 220.

[0178] The first locking wire 610 typically comprises a thin metal wire having a diameter of 0.1-0.35 mm, for example 0.2 mm. The first locking wire 610 typically extends from the proximal portion of the device 200 between the catheter 220 and the inner surfaces of the first and second stents 52, 54, and passes through the locking ring 620 (typically accessed via a hole in the wall of the first stent 52).

[0179] The first locking wire 610 exits the first stent 52 through the distal end 55 of the stent 52 and is disposed adjacent to the side of the catheter 220 away from the distal end 55. For some applications, such as Figure 8A and Figure 9A As shown, the locking wire 610 passes through a lateral hole 612 in the side of the catheter 220, travels across the catheter 220, and exits the catheter 220 via an additional lateral hole 612 in the opposite side. The locking wire 610 then extends proximally along the inner surface of the first stent 52 outside the catheter 220. This locks the first stent 52 in place and prevents the stent from moving distally or proximally. Additionally, when the first locking wire 610 passes through the lateral hole 612, the slit lips 282 come into contact with each other to maintain the slit 280 in a closed state.

[0180] Alternatively, such as Figure 8B and Figure 9D As shown, after locking wire 610 passes through locking ring 620 , locking wire 610 continues to extend distally outside of catheter 220 .

[0181] Once the stent 52 is in the desired position within the lumen of the subject, the physician pulls the first locking wire 610 proximally, thereby releasing the lock on the first stent 52 by disengaging the locking wire 610 from the locking ring 620. This disengagement allows the catheter 220 to move proximally, thereby deploying the first stent 52 distally from the catheter 220. It should be noted that for clarity, Figures 8A to 8B and 9A to 9D The distal wing 542 of the first bracket 52 is not shown.)

[0182] like Figures 9B to 9C Referring now to the second locking member, the second locking member includes a locking wire 640 for preventing distal movement of the second stent 54 relative to the catheter 220 .

[0183] like Figure 9B As shown, for some applications, the second stent 54 is formed to define a hole 544 in a portion of the second stent 54 (e.g., in the wing 540). Additionally, a push tube 700 disposed proximal to the second stent 54 and configured to push the second stent 54 away from the catheter 220 is formed to define a hole 706 in a portion of the push tube (e.g., in the distal extension 702 of the push tube).

[0184] Second locking wire 640 is passed through hole 544 in the portion of second stent 54 and through hole 706 in portion 702 of push tube 700 to prevent distal movement of stent 54. After first stent 52 is deployed, second locking wire 640 is removed from holes 544 and 706, thereby releasing second stent 54 from locking. Subsequently, second stent 54 is deployed from the distal end of catheter 220.

[0185] For some applications, such as Figure 9B As shown, after passing through holes 544 and 706 , second locking wire 640 loops back toward push tube 700 and then extends proximally along the inner surface of push tube 700 outside of catheter 220 .

[0186] Optionally, for some applications, such as Figure 9C As shown, after passing through holes 544 and 706 , the second locking wire 640 continues to extend distally along the inner surface of the second stent 54 outside the catheter 220 .

[0187] Still Figures 8A to 8B and 9A to 9D It should be noted that the first locking member 600 is not arranged to prevent the first stent 52 from moving distally or proximally using the guidewire 12. It should also be noted that the locking wire 640 is not arranged to prevent the second stent 54 from moving distally using the guidewire 12.

[0188] Referenced above Figures 8A to 8B and 9A to 9D In the overview of the application of the present invention described, both the first stent 52 and the second stent 54 are locked to the catheter 220 pre-operatively, ie, before the catheter 220 is inserted into the body of the subject.

[0189] right Figure 9A and Figure 9D For some applications, locking wires 610 and 640 are disposed in corresponding lumens in the wall of push tube 700 .

[0190] right Figures 1 to 9D It should be noted that for some applications, devices 20 and 200 are configured to deploy more than two stents, such as three or four stents, into a lumen of a subject (configuration not shown).

[0191] Still Figures 1 to 9D Reference is made. It should be noted that, by way of illustration and not limitation, devices 20 and 200 are described with reference to the lumen 4 of the common bile duct. The scope of the present invention includes using devices 20 and 200 in any suitable lumen to deploy multiple stents, tubes, or other devices in the lumen. For example, the techniques and devices described herein can be used in the urethra, and / or ureters, and / or pancreatic ducts, and / or esophagus, and / or trachea of ​​a subject. Additionally or alternatively, the techniques and devices described herein can be used to deploy two or more prostate stents.

[0192] Those skilled in the art will appreciate that the present invention is not limited to those specifically shown and described above. On the contrary, the scope of the present invention includes both combinations and sub-combinations of the various features described above, as well as changes and modifications thereof that are not in the prior art and that would occur to those skilled in the art after reading the foregoing description.

Claims

1. A medical device for deploying a stent, the medical device comprising: a catheter shaped to define a proximal end and a distal end of the catheter and further shaped to define a guidewire engagement portion at the distal portion of the catheter, the guidewire engagement portion extending proximally from the distal end of the catheter along the wall of the catheter and shaped to define a slit or weak point, the slit being shaped to define two slit lips that contact one another in the absence of any force applied to the slit lips to define a closed slit configuration and are disengageable from one another by application of a force to the lips to define an open slit configuration, the weak point including a splittable portion configured to tear in response to a force applied to the weak point by a guidewire, and the weak point being shaped and sized to allow the guidewire to pass therethrough in its torn state, the proximal end of the guidewire engagement portion being distal to the proximal end of the catheter; a first stent, the first stent surrounding the catheter so as to be advanceable together with the catheter into an inner lumen of a subject, the first stent being slidable along the catheter such that a distal end of the first stent is disposed proximal to the guidewire engaging portion of the catheter; a guidewire arranged to (i) enter the lumen of the catheter from a distal opening of the catheter, (ii) be disposed in the guidewire engagement portion, and (iii) exit the lumen of the catheter proximal to the guidewire engagement portion of the catheter, such that the first stent is constrained from distal movement past the guidewire engagement portion due to the guidewire being disposed within the guidewire engagement portion; as well as a second stent proximal to the first stent, the second stent surrounding a proximal portion of the catheter and the guidewire and being shaped and sized to be advanceable along the catheter, and in: (i) the guidewire is positioned to exit the guidewire engagement portion laterally without being advanced distally or proximally, (ii) the first stent is slidably deployable from the distal end of the catheter when the guidewire has exited the guidewire engagement portion without requiring proximal movement of the guidewire after the guidewire exits the guidewire engagement portion, and (iii) the second stent is slidably deployable from the distal end of the catheter after the first stent is deployed from the distal end of the catheter and is positionable alongside the first stent without moving the guidewire proximally after the guidewire exits the guidewire engagement portion.

2. The medical device of claim 1 , wherein the first stent (a) has an outer surface that is positioned against the guidewire, and (b) is configured to be advanced into the lumen of the subject when the outer surface is positioned against the guidewire.

3. The medical device according to any one of claims 1 to 2, wherein the slit has a length of 1-70 mm.

4. The medical device according to claim 3, further comprising a first locking member, the first locking member comprising a locking ring and a first locking wire passing through the locking ring, wherein the first locking wire is secured to the catheter by passing through two opposing lateral holes in the catheter so as to press the slit lips against each other in the closed slit configuration and inhibit the lateral exit of the guidewire from the guidewire engagement portion when the guidewire is disposed in the guidewire engagement portion, and The lateral exit of the guidewire from the guidewire engaging portion is permitted in the open slit configuration when the first locking wire is not pressing the slit lips against each other.

5. The medical device of any one of claims 1 to 2, wherein the weak point is configured to tear in response to a force applied to the weak point by the guidewire when the distal portion of the catheter is withdrawn into the first stent.

6. The medical device according to any one of claims 1 to 2, further comprising: a first locking member comprising a locking ring and a first locking wire passing through the locking ring, the first locking wire being secured to the catheter by passing through two opposing lateral holes in the catheter, effectively preventing the first stent from moving proximally past a position at least 1 mm from a distal end of the second stent; as well as and a second locking member comprising a second locking wire, the second locking wire passing through a hole in the second stent and through a hole in a push tube disposed proximal to the second stent and configured to push the second stent away from the catheter, effectively preventing the second stent from moving distally past a position at least 1 mm near the proximal end of the first stent. 7 . The medical device of claim 6 , wherein the first lock is configured to prevent distal movement of the first stent during advancement of the first stent over the catheter into the lumen of the subject.

Images