Suture-based closure device for use with endoscope

Abstract

A suturing device for use in conjunction with a delivery system having a lumen extending therethrough includes a needle operable to carry a suture, a distal shuttle configured to releasably secure the needle, a sleeve disposed on the distal shuttle, wherein the distal shuttle is movable relative to the sleeve between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle. The shaft is operably coupled to the sleeve and the control line is operably coupled to the distal shuttle. The needle may include a needle cap.

Description

[0001] This application is a divisional application of application number 202080050802.7, application date 2020.5.15, and application title “Suture-based closure device for use with an endoscope”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims priority to U.S. Provisional Application Serial No. 62 / 848,985, filed May 16, 2019, the entire contents of which are incorporated herein by reference. Technical Field

[0004] The present disclosure relates to devices for suturing tissue, and more particularly, to devices for endoscopic suturing of tissue that work in conjunction with an endoscope or similar device. Background Art

[0005] Various endoscopic treatments may result in a defect (or wound) that is too large for known closure methods. Examples of such endoscopic treatments include removal of large lesions, burrowing beneath the mucosal layer, full thickness removal of tissue, treatment of other organs by passing outside the gastrointestinal tract, and post-operative repair, such as post-operative leaks. Endoscopic treatments also include bariatric repair procedures. Of the known devices and methods for endoscopically closing large defects, each has certain advantages and disadvantages. Summary of the invention

[0006] The present disclosure relates to several alternative designs, materials and methods of devices for endoscopically closing large defects. One example is a suturing device used in conjunction with an endoscope. The suturing device includes a needle configured to carry a suture, the needle having a distal end. The needle cap is configured to releasably fit over the distal end of the needle.

[0007] Another example is a suturing device used in conjunction with an endoscope having a working channel and a distal end. The suturing device includes a needle configured to carry a suture, the needle including a distal end and a distal ratchet proximal to the distal end. The needle cap is configured to releasably fit over the distal end of the needle. The distal shuttle is configured to releasably secure the needle. The cannula is disposed on the distal shuttle and is movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle.

[0008] Alternatively or additionally, the needle cap may be formed from a biocompatible polymer.

[0009] Alternatively or additionally, the needle cap may be formed from a bioabsorbable polymer.

[0010] Alternatively or additionally, the needle cap may include a cylindrical needle cap body and an atraumatic distal tip, the cylindrical needle cap body defining a void configured to fit over a needle.

[0011] Alternatively or additionally, the needle cap may further comprise one or more elongated slots extending axially within the cylindrical needle cap body.

[0012] Alternatively or additionally, the needle cap may further include one or more raised protrusions extending into the void, the one or more raised protrusions being configured to fit in the distal detent of the needle.

[0013] Alternatively or additionally, the needle cap may be configured to be pushed off the needle by moving the cannula distally.

[0014] Another example is a suturing device for use in conjunction with an endoscope having a working channel and a distal end. The suturing device includes a translation assembly configured to translate axially within the working channel and includes a needle configured to carry a suture, a distal shuttle configured to releasably secure the needle, and a sleeve disposed on the distal shuttle. The sleeve is movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle, the sleeve including an elongated groove extending axially along the sleeve, the elongated groove configured to accommodate a suture extending therethrough. The suturing device includes a distal end cap that is securable to the distal end of the endoscope and is configured to engage the needle when the needle is advanced distally into the distal end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

[0015] Alternatively or additionally, the distal shuttle may include: a distal needle opening configured to accommodate the needle when the distal shuttle is advanced distally over the needle; one or more support ball openings arranged orthogonally to the distal needle opening such that when the needle is secured to the distal shuttle, the one or more support ball openings are aligned with a proximal detent of the needle; and one or more support balls disposed within the one or more support ball openings, disposed within the proximal detent when the needle is secured to the distal shuttle.

[0016] Alternatively or additionally, the cannula may include one or more cannula openings having a smaller diameter than the one or more bearing balls. When in the locked position, the one or more cannula openings are misaligned with the one or more bearing ball openings such that the one or more bearing balls engage the proximal detents of the needle, and when in the unlocked position, the one or more cannula openings are aligned with the one or more bearing ball openings such that the one or more bearing balls can move radially outward a distance sufficient to allow the one or more bearing balls to leave the proximal detents of the needle.

[0017] Another example is a suturing device used in conjunction with a delivery system including an inner cavity extending therethrough. The suturing device includes a suture translation assembly configured to be axially translated within the inner cavity of the delivery system, the suture translation assembly including a needle that can be used to carry a suture and a distal shuttle configured to releasably secure the needle. A sleeve can be disposed on the distal shuttle and can be moved relative to the sleeve between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle. A suturing catheter is operably coupled to the sleeve and a control line is operably coupled to the distal shuttle. The distal end cap is configured to be fixed to the distal end of the delivery system and to releasably engage and disengage the needle, the end cap being configured to engage the needle when the needle is advanced distally into the end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

[0018] Alternatively or additionally, moving the control wire proximally may cause the distal shuttle to move proximally relative to the cannula, thereby locking the needle to the distal shuttle.

[0019] Alternatively or additionally, moving the control wire distally may cause the distal shuttle to move distally relative to the cannula, thereby releasing the needle from the distal shuttle.

[0020] Alternatively or additionally, the needle may include a distal region and a proximal region, the distal region including a distal detent for releasably engaging the distal end cap, and the proximal region including a proximal detent for releasably engaging the distal shuttle.

[0021] Alternatively or additionally, the distal shuttle may include: one or more bearing ball openings, which are arranged to be aligned with the proximal pawl when the needle is secured to the distal shuttle; and one or more bearing balls disposed in the one or more bearing ball openings, which may be disposed within the proximal pawl when the needle is secured to the distal shuttle.

[0022] Alternatively or additionally, the cannula may include one or more cannula openings having a smaller diameter than the one or more bearing balls. When in the locked position, the one or more cannula openings are misaligned with the one or more bearing ball openings such that the one or more bearing balls engage the proximal detents of the needle, and when in the unlocked position, the one or more cannula openings are aligned with the one or more bearing ball openings such that the one or more bearing balls can move radially outward a distance sufficient to allow the one or more bearing balls to leave the proximal detents of the needle.

[0023] Alternatively or additionally, the suturing device may further include a yoke operably coupled to the control wire, the yoke connecting the control wire to the distal shuttle via a pin extending through the yoke and translating along a pair of slots formed in the cannula.

[0024] Alternatively or additionally, the suturing catheter may include a coil, and the coil may be operably coupled to the cannula.

[0025] Alternatively or additionally, the sleeve may be welded to the coil.

[0026] Alternatively or additionally, the control line may extend through the suture catheter.

[0027] Alternatively or additionally, the suturing device may further include a user interface operably coupled to the suturing catheter and the control wire, the user interface configured to allow a user to move the control wire relative to the suturing catheter, thereby moving the distal shuttle.

[0028] Another example is a suturing device used in conjunction with a delivery system including an inner cavity extending therethrough. The suturing device includes a needle that can be used to carry a suture and a distal shuttle configured to releasably secure the needle. A cannula can be disposed on the distal shuttle, and the distal shuttle can be moved relative to the cannula between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle. A shaft is operably coupled to the cannula, and a control line extends through the shaft and is operably coupled to the distal shuttle. The distal end cap is configured to be securable to the distal end of the delivery system and to releasably engage and disengage the needle, the end cap being configured to engage the needle when the needle is advanced distally into the end cap, and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

[0029] Alternatively or additionally, the suturing device may further include a user interface configured to allow a user to manipulate the control wire relative to the shaft to move the distal shuttle between its locked position and its unlocked position.

[0030] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The present disclosure may be more fully understood upon consideration of the following description in conjunction with the accompanying drawings, in which:

[0032] Figure 1 is a perspective view of an illustrative suturing device according to an example of the present disclosure;

[0033] Figure 2 is formed Figure 1 A perspective view of a distal assembly of a portion of an illustrative suturing device, shown in an extended position;

[0034] Figure 3 yes Figure 2 a stereoscopic view of the mid-distal assembly, shown in the retracted position;

[0035] Figure 4 yes Figure 2 a cross-sectional view of the mid-distal assembly taken along line 4-4;

[0036] Figure 5 is formed Figure 1an exploded view of a portion of a suture translation assembly of a portion of an illustrative suturing device;

[0037] Figure 6 is a side view of a distal shuttle and a member forming part of a suture translation assembly, wherein the member is shown extended in a locked position;

[0038] Figure 7 yes Figure 6 a side view of the mid-distal shuttle and member, with the member shown retracted in an unlocked position;

[0039] Figure 8 According to the examples disclosed herein, it can be used Figure 1 A side view of a distal component in a suturing device;

[0040] Fig. 9 yes Figure 8 a side view of the mid-distal assembly in combination with the attached flexible lumen;

[0041] Fig.10 According to the examples disclosed herein, it can be used Figure 1 A side view of a distal assembly in a suturing device of , shown with an attached lumen;

[0042] Fig.11 and 12 According to the examples disclosed herein, Figure 1 and 8 A view of a tissue release mechanism used in conjunction with a distal assembly;

[0043] Fig.13 According to the examples disclosed herein, it can be used Figure 1 A perspective view of a distal component in a suturing device;

[0044] Fig.14 According to the examples disclosed herein, it can be used Figure 1 A stereoscopic view of a suture translation assembly in a suturing device;

[0045] Fig.15 According to the example of this disclosure Fig.14 A partially exploded perspective view of the center seam translation assembly;

[0046] Fig.16 It is formed according to the example of the present disclosure Fig.14 A perspective view of the internal components of a portion of the mid-seam translation assembly:

[0047] Fig.17 According to the example of this disclosure Fig.14 a perspective view of a portion of a midline translation assembly, shown in a locked configuration;

[0048] Fig.18 According to the example of this disclosure Fig.14 a perspective view of a portion of a center seam translation assembly, shown in an unlocked configuration;

[0049] Fig.19 According to the examples disclosed herein, it can be used Figure 1 A stereoscopic view of a suture translation assembly in a suturing device;

[0050] Fig. 20 According to the example of this disclosure Fig.19 a perspective view of a center suture translation assembly with some components removed to show internal structure, the suture translation assembly is shown in a locked configuration;

[0051] Fig.21 According to the example of this disclosure Fig.19 A side view of a portion of a suture translation assembly showing how a locking member engages an internal member of the suture translation assembly and a Fig. 20 Pins in the locking configuration shown;

[0052] Fig. 22 According to the example of this disclosure Fig.19 a perspective view of the center seam translation assembly, shown in an unlocked configuration;

[0053] Fig.23 is a perspective view of a cannula that may be used as part of a suture translation assembly;

[0054] Fig.24 According to the example of this disclosure, Fig.23 The middle casing can be used for Figure 1 A perspective view of a distal component in a suturing device;

[0055] Fig.25 is a view of a needle with a needle cap according to an example of the present disclosure;

[0056] Fig.26 yes Fig.25 A cross-sectional view of the middle needle and needle cap taken along line 26-26;

[0057] Fig. 27 is a perspective view of an example suture translation assembly according to the present disclosure, wherein the needle is in an unlocked position;

[0058] Fig.28 According to the example of this disclosure Fig. 27 a perspective view of the suture translation assembly with the needle in the locked position;

[0059] Fig.29 yes Fig.28 A cross-sectional view of the midline translation assembly taken along line 29-29; and

[0060] Fig.30 yes Fig.28Partial exploded view of the midline translation assembly.

[0061] Although the present disclosure is susceptible to various modifications and alternative forms, the details thereof have been shown in the drawings by way of example and will be described in detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present disclosure. DETAILED DESCRIPTION

[0062] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0063] Definitions of certain terms are provided below and shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0064] It is assumed herein that all numerical values ​​are modified by the term "about", whether or not explicitly stated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the value (i.e., having the same function or result). In many cases, the term "about" may be meant to include numbers rounded to the nearest significant figure.

[0065] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0066] Although some suitable sizes, ranges and / or values ​​are disclosed in relation to various components, features and / or specifications, those skilled in the art, in light of this disclosure, will appreciate that the desired sizes, ranges and / or values ​​may vary from what is explicitly disclosed.

[0067] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or otherwise refer to singular as well as plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0068] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are marked with the same number. The detailed description and the drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the present disclosure. The illustrative embodiments depicted are intended to be examples only. Unless expressly stated to the contrary, selected features of any illustrative embodiment may be incorporated into additional embodiments.

[0069] The present disclosure relates to a device configured to be used in conjunction with an endoscope or similar delivery device to close a wound in the body. In some cases, the suturing devices described herein may be configured so that they can be used in a single working or available channel of an endoscope, and in some embodiments can be operated by a single person, although in some embodiments a second person may be involved. In some embodiments, the suturing devices described herein may be considered to be operated along a single operating line. The device itself can be translated distally and proximally in the working channel, and the handle portion itself can be translated distally and proximally along the same operating line to lock and unlock the needle, thereby being able to pass the needle back and forth between the active portion of the suturing device and the passive portion of the suturing device. The device can be configured to enable the needle to be selectively locked to one of the more distal positions or the more proximal positions, and the device itself can be translated distally or proximally with the needle locked in place so as to move the needle relative to the repaired tissue, thereby moving the suture.

[0070] Figure 1 is a stereoscopic view of a suturing device 10, which may be considered to be configured for use in conjunction with a delivery system including an inner cavity extending therethrough. For example, the delivery system may be an endoscope having a working channel. The delivery system may also be a catheter. It should be understood that the proportions are changed on either side of the fracture line shown. In some embodiments, the suturing device 10 may be considered to include a suture translation assembly 12 configured to be axially translatable within the cavity of the delivery system and a distal assembly 14 configured to be fixed to the distal end of the delivery system. The suture translation assembly 12 extends into the distal assembly 14 and includes a needle 16 that can be used to carry sutures and a distal shuttle 18 configured to releasably fix the needle 16.

[0071] The member 20 may be disposed on the distal shuttle 18 and, as shown in subsequent figures, may be movable between a locked position in which the needle 16 is secured to the distal shuttle 18 and an unlocked position in which the needle 16 may be released from the distal shuttle 18. In some embodiments, for example, the member 20 may be a cannula 20. The user interface may extend proximally from the distal shuttle 18 and the cannula 20 and may be configured to move the cannula 20 between the locked position and the unlocked position. The shaft 28 may extend distally to the suture translation assembly 12 and may be particularly coupled to the cannula 20. The user interface may take a variety of different forms. For example, the user interface may be as described in U.S. Patent Application Publication No. 2018 /

[0072] 0235604, which is incorporated herein by reference in its entirety. In some embodiments, the user interface may be as described in Provisional Application No. 62 / 794,075, filed on January 18, 2019, entitled "Endoscopic Suturing Control Handle," which is incorporated herein by reference in its entirety. In some cases, the user interface may be as described in Provisional Application No. 62 / 794,075, filed on January 18, 2019, entitled "Endoscopic Suturing Control Handle," which is incorporated herein by reference in its entirety. These are just examples.

[0073] In some embodiments, the distal assembly 14 includes a body 29 having a proximal connector 30 that can be configured to couple to the distal end of an endoscope or other delivery system. In some embodiments, as shown, the proximal connector 30 can include a securing feature 401. As discussed with respect to subsequent figures, the securing feature 401, which in some embodiments is viewed as a securing flange 401, facilitates securing the distal assembly 14 to the distal end of an endoscope or other delivery system using a split ring attachment mechanism.

[0074] The body 29 includes an arm 32 that extends to an end cap 34. As will be discussed, the end cap 34 can be configured to releasably engage and disengage the needle 16. In some embodiments, for example, the end cap 34 can be configured to engage the needle 16 when the needle 16 is advanced distally into the end cap 34, and release the needle 16 when the needle 16 is locked in the distal shuttle 18 (as will be discussed) and the distal shuttle 18 is withdrawn proximally. The distal assembly 14 can be considered to include a guide member 36 that can be fixed to the body 29 or formed integrally with the body 29 and can allow the suture translation assembly 12 to extend through and translate relative to the guide member 36. In some embodiments, the body 29 can include a hole 27 that can enable other devices to be inserted therethrough. In some cases, as will be discussed with respect to subsequent figures, the hole 27 can be configured to accommodate a side saddle lumen attachment element. In some embodiments, aperture 27 may include one or more of pin hole 31a and pin hole 31b, which may be used, for example, to mount the aforementioned side saddle lumen attachment element, or possibly other features.

[0075] Figure 2 and Figure 3 The suture translation assembly 12 is shown extending through the guide member 36 and into the distal assembly 14. Figure 2 , the suture translation assembly 12 is shown in an extended position, with the needle 16 extending into the end cap 34, and in Figure 3, the suture translation assembly 12 is shown in a retracted position, wherein the needle 16 has been withdrawn proximally from the end cap 34. In some embodiments, as seen, the end cap 34 includes a proximal needle opening 37, which is configured to help guide the needle 16 into the proximal needle opening 37 and to accommodate the needle 16 as the needle 16 is advanced distally into the end cap 34. In some embodiments, the proximal needle opening 37 may extend all the way through the end cap 34, while in other cases, the proximal needle opening 37 may not extend all the way through the end cap 34. In some cases, as shown, the proximal needle opening 37 can be considered to be aligned with the longitudinal axis 38 of the needle 16 (e.g., Figure 3 shown).

[0076] One or more fixing openings 40 may be arranged orthogonally to the proximal needle opening 37 and one or more fixing members 42 configured to be disposed within the one or more fixing openings 40 and configured to releasably engage a distal detent (as will be discussed) of the needle 16. In some embodiments, there may be a pair of fixing openings 40, one on each side of the end cap 34. In some embodiments, there may be a pair of fixing members 42, one of which is disposed within each of the pair of fixing openings 40. In some embodiments, although schematically shown, the one or more fixing members 42 may be, for example, a spring or a coil.

[0077] Figure 4 is a cross-sectional view of the distal assembly 14 with the suture translation assembly 12 disposed within the distal assembly 14 . Figure 5 is an exploded view of the suture translation assembly 12. The needle 16 can be considered to include a distal region 44 and a proximal region 46. In some embodiments, the distal region 44 can include a distal detent 48 for releasably engaging the end cap 34, and the proximal region 46 can include a proximal detent 50 for releasably engaging the distal shuttle 18. As shown, the needle 16 can include an aperture 52 for receiving a suture therethrough.

[0078] In some embodiments, the distal shuttle 18 may be considered to include a distal needle opening 54 configured to receive the needle 16 and to align with the longitudinal axis 38 of the needle 16 when the distal shuttle 18 is advanced distally over the needle 16. One or more bearing ball openings 56 may be arranged orthogonally to the distal needle opening 54 such that the one or more bearing ball openings 56 are aligned with the proximal detent 50 when the needle 16 is secured to the distal shuttle 18. In some embodiments, one or more bearing balls 58 may be disposed within the one or more bearing ball openings 56 and may be configured to be disposed within the proximal detent 50 when the needle is secured to the distal shuttle 18.

[0079] In some embodiments, the distal shuttle 18 includes an internal void 60 and a cannula capture member 62 slidably disposed within the internal void 60. In some embodiments, the cannula capture member 62 can be coupled to a cable 64 that extends distally within the shaft 28 into a cable hole 66 and is secured via a crimp or other mechanical connection 68. In some embodiments, the cannula capture member 62 can be coupled to the cannula 20 via a pin 70 that extends through first and second cannula connection holes 72, 74 and a corresponding hole 76 that extends through the cannula capture member 62 and through the internal void 60.

[0080] In some embodiments, the sleeve 20 includes one or more sleeve openings 80, which may have a diameter or width that is smaller than the diameter of one or more bearing balls 58. In some embodiments, the sleeve 20 may include a pair of sleeve openings 80 corresponding to a pair of bearing ball openings 56 and a pair of bearing balls 58. When the sleeve 20 is in the locked position, for example Figure 6 As shown, the one or more sleeve openings 80 are not aligned or aligned with the one or more bearing ball openings 56, so the one or more bearing balls 58 engage the proximal detent 50 of the needle 16. The sleeve 20 prevents the one or more bearing balls 58 from being pushed out of the proximal detent 50.

[0081] In contrast, when the sleeve 20 is in the unlocked position, e.g. Figure 7 As shown, one or more sleeve openings 80 are aligned with one or more bearing ball openings 56. This allows one or more bearing balls 58 to move radially outward into one or more sleeve openings 80 a distance sufficient to allow one or more bearing balls 58 to clear the proximal pawl 50 of the needle 16 in response to the force applied to the one or more bearing balls 58 by the needle 16. Figure 4 Although the suture translation assembly 12 is shown advanced into the distal assembly 14 , the cannula 20 is in an unlocked position relative to the distal shuttle 18 and thus the one or more bearing balls 58 may be seen as partially extending into the one or more cannula openings 80 .

[0082] In some cases, the suturing device 10 will have a proximal handle (not shown) that allows the user to create relative motion between the cannula 20 and the distal shuttle 18. The proximal handle can provide the user with an indication of the relative position of the cannula 20 and the distal shuttle 18. In some cases, the proximal handle can include a soft detent or other features that inform the user when the needle 16 is locked relative to the distal shuttle 18 and when the needle 16 is unlocked relative to the distal shuttle 18.

[0083] In some cases, the cannula 20 and the distal shuttle 18 may be modified to provide a more reliable indication of when the needle 16 is locked to the distal shuttle 18 and when the needle 16 is not locked to the distal shuttle 18. Figure 5In some cases, the sleeve opening 80 may be relative to Figure 5 18. In some cases, the internal void 60 formed in the distal shuttle 18 may be shortened. In combination, these two changes may provide a more reliable indication of when the needle 16 is locked to the distal shuttle 18 and when the needle 16 is not locked to the distal shuttle 18. Moving the cannula 20 completely in one direction means that the needle 16 is locked to the distal shuttle 18. Moving the cannula 20 completely in the opposite direction means that the needle 16 is not locked to the distal shuttle 18. This may provide a simple two-state locked / unlocked indication to the user.

[0084] In some embodiments, it will be appreciated that the combination of the distal shuttle 18 and cannula 20 provides an active connection to the needle 16, while the distal end cap 34 provides a passive connection to the needle 16. If the needle 16 moves distally into the distal end cap 34, the distal end cap 34 will grip onto the needle 16, with the one or more retainers 42 engaging the distal detents 48. If the needle 16 is subsequently moved proximally, the applied axial force overcomes any resistance provided by the one or more retainers 42, and the needle 16 is able to move proximally. In contrast, the active connection to the needle 16 provided by the distal shuttle 18 and cannula 20 requires action to move the cannula 20 between the locked position and the unlocked position relative to the distal shuttle 18. The user interface provides a mechanism for positively moving the cannula 20 between the locked position and the unlocked position.

[0085] Figure 8 is a side view of the distal assembly 14a, which may be used, for example, Figure 1 1. The distal assembly 14a is similar to the distal assembly 14 shown in the previous figures, but includes a side saddle lumen attachment element 120 connected to the body 29 of the distal assembly 14a. In some embodiments, the side saddle lumen attachment element 120 may include one or two pegs 122 that fit into the pin holes 31a and 31b (pin hole 31a is visible in this view) so that the side saddle lumen attachment element 120 can pivot relative to the body 29 of the distal assembly 14a. In some embodiments, the side saddle lumen attachment element 120 includes a ring 124 (the pegs 122 extend from the ring 124), a distal region 126, and a body 128 having a curvature thereto in some cases.

[0086] In some embodiments, the distal region 126 and the body 128 have a semicircular profile to accommodate a lumen, such as a flexible lumen 130, which can be inserted into the distal region 126 and the body 128. Fig. 9 The friction or compression fit shown is engaged within the side saddle lumen attachment element 120. The flexible lumen 130 can be polymeric or metallic. For example, after the flexible lumen 130 has been placed relative to the side saddle lumen attachment element 120, the polymer lumen can be expanded to full working size by extending a mandrel through the flexible lumen 130.

[0087] In some embodiments, the side saddle attachment element 120 (and the accompanying flexible lumen 130) can be used as an auxiliary working channel and can include sutures used in surgery. In some embodiments, it can be large enough to accommodate auxiliary tools used in tissue collection or manipulation, thereby allowing the use of auxiliary tools, but does not require a dedicated dual-channel delivery system, such as a dual-channel endoscope. If necessary, a dual-channel delivery system can be used to provide more options in surgery. The side saddle attachment element 120 can have an outlet in the distal component 14a so that the auxiliary tool extends along an axis suitable for tissue manipulation. The axis can intersect with the axis of the suture bearing element, thereby allowing the auxiliary tool to pull the tissue into the projected path of the suture bearing element. For example, this can be used to pull the tissue to align it with the needle to help drive the needle 16 through the tissue. Keeping the tension of the suture through the side saddle attachment element 120 can prevent the suture from interfering with the surgery.

[0088] Fig.10 31a, 31b, is a perspective view of a distal assembly 14b that includes a shorter side saddle lumen attachment element 120a that can be pivotally secured to the body 29 via one or more pegs 122a that extend into the pin holes 31a, 31b. Lumen 130a is coupled to the side saddle lumen attachment element 120a to provide a working channel through which a suture or other tool can extend.

[0089] Fig.11 and Fig.12 1 is a view of a tissue release mechanism 150 that may be mounted on arm 32. In some embodiments, tissue release mechanism 150 may assist in surgery by helping to remove tissue that may otherwise become stuck on needle 16. In some cases, tissue release mechanism 150 may be spring loaded to engage needle 16, or may be separately and independently actuated. In some cases, tissue release mechanism 150 includes crossbar 152 that provides an additional surface from which tissue may be pushed out of needle 16.

[0090] When preparing the suturing device 10 for use, the distal assembly 14 can be fixed to a delivery device such as an endoscope. In some embodiments, an attachment actuator, such as a flexible silicone tube, can be deployed along the delivery device to hold the distal assembly 14 in place and prevent the distal assembly 14 from rotating relative to the delivery device. In some embodiments, if desired, a side saddle lumen attachment element 120 (or 120a) can be fixed to the distal assembly 14. The suture can be passed through the needle 16 and fed back toward the user interface. The device 10 can be extended through the body to reach the defect site.

[0091] Fig.13 is a perspective view of a distal assembly 14c, which may be used, for example, Figure 110. The distal assembly 14c is similar to the distal assembly 14 shown in the previous figures, but includes some modifications that may be useful, particularly in bariatric revision procedures. Bariatric surgery generally refers to surgery that can surgically reduce the effective available volume of a patient's stomach to achieve long-term weight loss in the patient, and can be performed laparoscopically. Bariatric revision surgery is a surgery performed under endoscopy in which changes can be made to what was initially done to the patient's stomach. In some embodiments, the distal assembly 14c can also be used for other suturing procedures, such as but not limited to full tissue thickness repair and / or partial tissue thickness repair.

[0092] The distal assembly 14c may include a body 29a having a proximal connector 30a, which may be configured, for example, to connect to the distal end of an endoscope or other delivery system. In some embodiments, as shown, the proximal connector 30a may include a fixing feature such as a fixing flange 401. The body 29a includes an arm 32a extending to the end cap 34a. In some embodiments, the body 29a, including the arm 32a, may be similar to the body 29 and arm 32 previously mentioned with respect to the distal assembly 14, the distal assembly 14a, and the distal assembly 14b. However, in some cases, the body 29a and the arm 32a may be adapted to accommodate thicker tissue, for example, which may mean a change in the overall shape of the body 29a and / or the arm 32a relative to the body 29 and / or the arm 32. In some embodiments, the body 29a and / or the arm 32a may simply be larger to accommodate thicker tissue. The distal assembly 14c can be considered to include a guide member 36a that can be fixed to or integrally formed with the body 29a and can be configured to allow the suture translation assembly (e.g., Figures 14 to 18 The suture translation assembly 12, suture translation assembly 12a, or Figures 19 to 22 The suture translation assembly 12b) is shown extending through the guide member 36a and translating relative to the guide member 36a.

[0093] In some embodiments, as shown, guide member 36a includes channel 300. In some embodiments, channel 300 allows suture to pass between suture translation assembly 12, 12a, 12b and the working channel of an endoscope or other delivery device to which distal assembly 14c is attached. For example, channel 300 may be designed to include a guide that helps align suture with channel 300 as suture translation assembly 12, 12a, 12b passes through the working channel of an endoscope or other delivery device. In some embodiments, it may be desirable to load suture prior to suture translation assembly 12, 12a, 12b passing through the working channel of an endoscope or other delivery device.

[0094] In some cases, the distal assembly 14c includes a guide structure 27a attached to or integrally formed with the body 29a. In some embodiments, the guide structure 27a may be alternatively pivotally attached to the body 29a. The guide structure 27a may be configured to accommodate a polymer tubular member attached thereto so as to guide a tool through the endoscope into a position relative to the working site. In some cases, the guide structure 27a may be configured to accommodate a metal tubular member attached thereto. In some embodiments, for example, the guide structure 27a and the accompanying tubular member (not shown) may accommodate a grasper or similar tool that allows a user to grasp the tissue and pull it into place so that the needle 16 can pass through the tissue. In some embodiments, the relative position or offset of the guide structure 27a relative to the relative position or offset shown with respect to the distal assembly 14, the distal assembly 14a or the distal assembly 14b may be greater to provide more space for the tool and / or accommodate a larger and thicker tissue portion.

[0095] The end cap 34a includes one or more fixed openings 40a, which, as can be seen, can be arranged orthogonally to the proximal needle opening (not shown), for example Figure 3 14. The proximal needle opening 37 shown in FIG. One or more fixing members 42a can be disposed in the one or more fixing openings 40a, respectively. In some embodiments, the one or more fixing members 42a can be a coil spring disposed in the one or more fixing member openings 40a. The fixing member 42a can releasably engage a pawl on the needle 16, as discussed with respect to the distal assembly 14.

[0096] In some embodiments, the diameter of the fixed opening 40a may be greater than the total diameter of the fixture 42a, and the fixed opening 40a may taper to a diameter on the opposite side (not seen) that is approximately equal to the diameter of the fixture 42a. In some embodiments, the fixture 42a may be welded, brazed, adhesively fixed or otherwise attached to the left side of the fixed opening 40a and may be slightly free to move on the right side of the fixed opening 40a. In some cases, the distal assembly 14c may include an opening 302 orthogonal to the fixed opening 40a. The opening 302 may be threaded so as to threadably engage the positioning screw 304. In some embodiments, as shown, the opening 302 may be offset closer to the right side of the fixed opening 40a, away from the fixed end of the fixture 42a, so that the positioning screw 304 can be considered to support the free end of the fixture 42a. Rotating the positioning screw 304 in a first direction (e.g., clockwise) can cause the positioning screw 304 to translate toward the fixture 42a, thereby increasing the interference between the fixture 42a and the needle 16 and increasing the retention force that can be applied to the needle 16. Conversely, rotating the set screw in a second direction (eg, counterclockwise) may translate the set screw 304 away from the fixture 42a, thereby reducing the retention force that may be applied to the needle 16. This may, for example, help to adjust for manufacturing tolerances.

[0097] As noted, the distal assembly 14c may be used with, for example, the Figure 5 The distal assembly 14c can also be used in conjunction with the suture translation assembly 12 discussed above. Figures 14 to 18 The suture translation assembly 12a shown and Figures 19 to 22 The suture translation assembly 12b is shown for use with the suture translation assembly 12b. Fig.14 is a perspective view of the suture translation assembly 12a, shown holding the needle 16, and Fig.15 1 is a partially exploded view of the suture translation assembly 12a. Fig.15 , the suture translation assembly 12a includes an inner member 310 that retains the needle 16. A locking member 312 is slidably disposed on the inner member 310. It can be seen that the inner member 310 includes a pin 314 that extends radially outward from the inner member 310 and extends through a corresponding slot 316 formed in the locking member 312. The pin 314 is used to prevent relative rotation between the inner member 310 and the locking member 312. The pin 314 is also used to limit translation of the locking member 312 relative to the inner member 310.

[0098] The control member 318 is fixed relative to the proximal end 320 of the locking member 312 and extends distally to a handle, such as a translation handle. Thus, the locking member 312 can translate distally and / or proximally relative to the inner member 310. Fig.14 As shown, the suture translation assembly 12a includes an outer sleeve 330, which can be fixed to the inner member 310 via a pin 314. For example, the outer sleeve 330 can be coupled to the coil 332. In some embodiments, the outer sleeve 330 can be a single tubular member. In some embodiments, for example, Fig.15 As shown, the outer sleeve 330 may actually include one or more of an outer sleeve 334, a slotted sleeve 336, and an inner and outer sleeve 338. The slotted sleeve 336 may be configured to allow sutures to pass through. This is merely illustrative and is not intended to be limiting in any way.

[0099] The inner member 310 includes a plurality of arms 322, such as Fig.16 1, which shows a distal portion of the inner member 310, the arm 322 includes a curved tab 324 that is configured to engage a corresponding detent in the needle 16. Although a total of four arms 322 are shown, it should be understood that the inner member 310 may include any number of arms 322. It should be understood that the length of the arm 322 is relatively long and therefore can be considered relatively flexible. As the locking member 312 extends distally to the locked configuration, for example, Fig.17 As shown, locking member 312 prevents arm 322 from moving outward. As a result, curved tab 324 remains engaged with a corresponding detent of needle 16, and needle 16 remains locked to suture translation assembly 12a. As locking member 312 is retracted proximally to an unlocked configuration, such as Fig.18As shown, the arms 322 are free to move radially outward, thereby releasing the bent tabs 324 from the detents in the needle 16 and allowing the needle 16 to move distally relative to the inner member 310.

[0100] Fig.19 is a perspective view of a suture translation assembly 12b that may be used in combination with any of distal assemblies 14, 14a, 14b, and / or 14c. Fig. 20 is a perspective view of the suture translation assembly 12b, wherein the external portion such as the external sleeve 350 ( Fig.19 ) is removed to expose the inner member 340 holding the needle 16a. In some embodiments, the outer sleeve 350 can be a single tubular member. In some cases, the outer sleeve 350 can include several components, such as the outer sleeve 330 ( Fig.15 ) described.

[0101] In some embodiments, as shown, needle 16a has a distal detent 342 and a proximal detent 344 (at Fig.21 16 ), which are shaped differently from the corresponding detents in the needle 16. The suture translation assembly 12b includes a locking member 346 that is slidably disposable relative to the inner member 340. A pin 352 is attached to the inner member 340 and extends through a corresponding slot 354 formed in the locking member 342. The pin 352 limits translation of the locking member 342 relative to the inner member 340 and also prevents relative rotational movement of the locking member 342. The locking member 342 is fixed to the control member 318, which extends distally to a handle such as a translation handle. As a result, the locking member 342 can be translated distally and / or proximally relative to the inner member 340.

[0102] In some embodiments, the outer sleeve 350 may define a slot 370 that includes an axially extending slot portion 372 and a shorter radially extending slot portion 374. In some embodiments, the axially extending slot portion 372 allows the pin 352 to move within the axially extending slot portion 372 to allow the needle 16a to be fully retracted into the suture translation assembly 12b for advancement through an endoscope or other delivery device. Once the suture translation assembly 12b has been advanced through an endoscope or other delivery device, the inner member 340 and the locking member 342 may be advanced distally through the outer sleeve 350 until the pin 352 is aligned with the radially extending slot portion 374. By rotating the translation handle, the pin 352 may be rotated to a position within the radially extending slot portion 374 so that the locking member 342 may be translated relative to the inner member 340.

[0103] In some embodiments, as shown, the locking member 342 includes a pair of arms 358 extending distally from the locking member 342. For example, Fig.21As shown, arm 358 includes a tab 360 that is formed when suture translation assembly 12b is in a position such as Fig. 20 and 21 In the illustrated locking configuration, the projection 360 extends through a slot 362 formed in the inner member 340. As a result, the tab 360 is able to extend through the slot 362 and engage the proximal detent 344 of the needle 16a. Although a pair of arms 358 are shown, it should be understood that the locking member 342 may include any number of arms 358, and of course a corresponding number of slots 362.

[0104] To move the suture translation assembly 12b to the unlocked configuration, for example Fig. 22 As shown, locking member 342 can move distally relative to inner member 340. Fig. 22 As can be seen in FIG. 3 , the tab 360 has been removed from the slot 362 (only one slot 362 is seen), and the needle 16a is free to move relative to the suture translation assembly 12b. As the locking member 342 moves distally, the angled surface 364 pushes against the slot 362 and moves outward.

[0105] In some embodiments, and with respect to Fig.13 , guide member 36a includes a channel 300 configured to allow suture to pass between the suture translation assembly 12, 12a, 12b and a working channel of an endoscope or other delivery device to which distal assembly 14c is attached. For example, channel 300 may be designed to include a guide that helps align the suture with channel 300 as the suture translation assembly 12, 12a, 12b passes through the working channel of an endoscope or other delivery device. In some embodiments, it may be desirable to load the suture before the suture translation assembly 12, 12a, 12b passes through the working channel of an endoscope or other delivery device.

[0106] In some cases, such as Fig.23 As shown, rather than providing a channel 300 in the guide member 36a, the suture translation assembly 12, 12a, 12b may be modified to accommodate a suture passing along the suture translation assembly 12, 12a, 12b. Fig.23 is a perspective view of a sleeve 20a that may be used to form a portion of a suture translation assembly 12, 12a, 12b. As can be seen, the sleeve 20a includes a groove 20b that extends the length of the sleeve 20a. Fig.24 Cannula 20a is shown extending through guide member 36a with suture 299 extending through groove 20b.

[0107] In some embodiments, it may be desirable to protect the distal end of needle 16 while advancing suture translation assembly 12, 12a, 12b through a delivery system such as an endoscope. In some embodiments, for example, needle 16 may otherwise damage the working channel of an endoscope. In some cases, it may be desirable to protect needle 16 itself from damage. In some embodiments, covering needle 16 and distal shuttle 18 ( Figure 1-5 ) cannula 20, 20a may be displaced proximally during loading, resulting in possible exposure of needle 16. In some embodiments, when cannula 20, 20a extends over needle 16, it may be difficult to load through a bend in the working channel of an endoscope.

[0108] Fig.25 and 26 An example is shown in which a needle cap 500 has been placed over the distal region 44 of the needle 16 . Fig.25 is a side view, and Fig.26 is along Fig.25 26-26. In some embodiments, the needle cap 500 can be removed from outside the patient's body after the suture translation assembly 12, 12a, 12b has been loaded into the endoscope but before the endoscope is inserted into the patient. In some embodiments, the needle cap 500 can be pushed away from the needle 16 in the patient's body. When performing a procedure using multiple needles and sutures, such as but not limited to endoscopic sleeve gastroplasty, it may be necessary to remove the needle cap 500 endoscopically in the patient, thereby eliminating the need to remove and insert the endoscope multiple times. In some embodiments, the needle cap 500 can be pushed away from the needle 16 by moving the sleeve 20, 20a distally. In some embodiments, the needle cap 500 can be configured to split when the needle cap 500 contacts the distal end cap 14, 14a, 14b, 14c.

[0109] The needle cap 500 includes a cylindrical needle cap body 503 that defines a void 501 configured to fit the needle 16. The needle cap 500 also includes an atraumatic tip 505 that is integrally molded with or otherwise attached to the cylindrical needle cap body 503. In some embodiments, the needle cap 500 includes one or more elongated slots 509 that extend axially along the cylindrical needle cap body 503 and provide sufficient flexibility to allow the needle cap 500 to be fully bent to be advanced onto the needle 16. In some embodiments, there may be two slots 509, although in Fig.25 and 26 Only one is visible. Needle cap 500 includes one or more raised protrusions 520 configured to fit into distal detents 48 of needle 16. Although cylindrical needle cap body 503 is shown as having parallel sides, in some cases, needle cap 500 may have an expanded side that is compressible for delivery. Extending needle 16 distally may allow the expanded side of needle cap 500 to expand. The needle may then be withdrawn proximally to push needle cap 500 away from needle 16.

[0110] Figures 27 to 30 Another way of protecting the needle 16 is shown to prevent damage to the interior of the endoscope or to prevent itself from being damaged. Figures 27 to 30 5 are various views of a suture translation assembly 530 that provides a reduced overall length for ease of loading into an endoscope. In some cases, the suture translation assembly 530 is short enough to allow easy passage through the endoscope with the cannula in place over the needle. In some embodiments, the controls of the suture translation assembly 530 are reversed relative to the suture translation assembly 12, 12a, 12b described with respect to the previous figures. Fig. 27 The suture translation assembly 530 is shown in an unlocked position in which the needle 16 is unlocked relative to the distal shuttle and can be advanced to the distal end cap 14, 14a, 14b, 14c. Fig.28 The suture translation assembly 530 is shown in a locked position, wherein the needle 16 is locked to the distal shuttle. As shown, the suture translation assembly 530 includes a sleeve 518 and a suture guide 590. In some embodiments, as shown, the suture guide 590 is a coil. The sleeve 518 has a pair of slots 560 (only one slot 560 is visible in the illustrated orientation) to accommodate the movement of the distal shuttle, as will be discussed. The sleeve 518 also includes a pair of sleeve openings 580 (only one is visible) that allow the bearing ball 58 (not shown) to move in and out relative to the distal shuttle, thereby locking and unlocking the needle 16.

[0111] The internal structure of the suture translation assembly 530 is Fig.29 and Fig.30 It is better to see Fig.29 is along Fig.28 A cross-sectional view taken along the center line 29-29, Fig.30 yes Fig.28 As can be seen, the control line 592 extends through the suture catheter 590 and terminates within the yoke 604. The sleeve 518 is coupled to the suture catheter 590 via the coupler 602. In some embodiments, the sleeve 518 can be welded to the suture catheter 590 directly or by welding to the coupler 602. As a result, the sleeve 518 does not move relative to the suture catheter 590.

[0112] The pin 570 extends through the yoke 602 and into the hole 606 formed in the distal shuttle 600, thereby operably coupling the control line 592 to the distal shuttle 600. The pin 570 extends to and is guided by a pair of slots 560 formed in the sleeve 518. This prevents the distal shuttle 600 from rotating relative to the sleeve 518. In some embodiments, the distal shuttle 600 includes a groove 610 that allows the suture to extend from the needle 16 and extend axially through the sleeve 518.

[0113] The distal shuttle 600 also includes a pair of bearing ball openings 608. As previously described, when the bearing ball openings 608 are aligned with the cannula openings 580, the bearing balls 58 (not shown) are able to move radially outwardly sufficiently freely to clear the proximal detents 50 of the needle 16, thereby unlocking the needle 16 from the distal shuttle 600. Conversely, when the bearing ball openings 608 are misaligned with the cannula openings 580, the bearing balls 58 (not shown) cannot clear the proximal detents 50 of the needle 16, and the needle 16 remains locked to the distal shuttle 600. Therefore, moving the control wire 592 in the proximal direction moves the distal shuttle 600 in the proximal direction relative to the cannula 518. This causes the cannula opening 580 to be misaligned with the bearing ball openings 608 and locks the needle 16 to the cannula 518. Conversely, moving the control wire 592 in the distal direction moves the distal shuttle 600 distally relative to the cannula 518.

[0114] It should be understood that a variety of different materials can be used to form the devices described herein. In some embodiments, a variety of different metals can be used. Illustrative but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt chromium, etc. For example, in some embodiments, the devices described herein may include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Other suitable polymers include, but are not limited to, polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, such as available from DuPont ), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., available from DSM Engineering Plastics ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer or available from Elf Atochem ), elastomeric polyamides, block polyamide / ether, polyether block amide (PEBA, for example, available under the trade name Available), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g., ), polysulfone, nylon, nylon-12 (e.g. available from EMS American Grilon ), perfluoro(propyl vinyl ether)

[0115] (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers thereof, polymer / metal composites, etc.

[0116] Those skilled in the art will recognize that the present disclosure may be embodied in a variety of forms other than the specific embodiments described and contemplated herein. Therefore, departures in form and detail may be made without departing from the scope and spirit of the present disclosure as described in the appended claims.

Claims

1. A suturing device for use in combination with an endoscope having a working channel and a distal end, the suturing device comprising: a needle configured to carry a suture, the needle having a distal end and a distal detent proximate the distal end thereof; a protective needle cap configured to releasably fit over the distal end of the needle, the needle cap comprising an atraumatic distal tip and a cylindrical needle cap body defining a void configured to fit over the needle, wherein the protective needle cap is formed of a bioabsorbable polymer; a distal shuttle configured to releasably secure the needle; and a cannula disposed on the distal shuttle, the cannula being movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle; wherein the protective needle cap is configured to be pushed away from the needle within the patient's body by moving the cannula distally; A distal end cap is configured to be fixed to the distal end of the endoscope, the distal end cap being configured to releasably engage and disengage the needle, the end cap being configured to engage the needle when the needle is advanced distally into the distal end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

2. A suturing device for use in conjunction with a delivery system having a lumen extending therethrough, the suturing device comprising: A suture translation assembly configured to translate axially within the lumen of the delivery system, the delivery system having a distal end, the suture translation assembly comprising: a needle that can be used to carry sutures; a distal shuttle configured to releasably secure the needle; a cannula disposed on the distal shuttle, the distal shuttle being movable relative to the cannula between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle; a suture catheter operably coupled to the cannula via a coupler; a control wire operably coupled to the distal shuttle and terminating in a yoke, the yoke coupling the control wire to the distal shuttle; and A distal end cap is configured to be fixed to the distal end of the delivery system, the distal end cap is configured to releasably engage and disengage the needle, the distal end cap is configured to engage the needle when the needle is advanced distally into the distal end cap, and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally.

3. A suturing device according to claim 2, wherein the needle includes a distal region and a proximal region, the distal region including a distal pawl for releasably engaging the distal end cap, and the proximal region including a proximal pawl for releasably engaging the distal shuttle.

4. The suturing device according to claim 3, wherein the distal shuttle comprises: one or more bearing ball openings arranged to align with the proximal pawl when the needle is secured to the distal shuttle; as well as One or more bearing balls disposed within the one or more bearing ball openings are disposed within the proximal pawl when the needle is secured to the distal shuttle.

5. A suturing device for use in conjunction with an endoscope having a lumen extending therethrough, the suturing device comprising: a needle that can be used to carry sutures; a distal shuttle configured to releasably secure the needle; a cannula disposed on the distal shuttle, the distal shuttle moving relative to the cannula between a locked position in which the needle is locked to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle; a shaft operably coupled to the sleeve; a control wire extending through the shaft and operably coupled to the distal shuttle via a yoke; a distal end cap configured to be securable to a distal end of the endoscope, the distal end cap configured to releasably engage and disengage the needle, the distal end cap configured to engage the needle when the needle is advanced distally into the distal end cap and to release the needle when the needle is locked to the distal shuttle and the distal shuttle is withdrawn proximally; and A user interface is configured to allow a user to manipulate the control wire relative to the shaft to move the distal shuttle between its locked and unlocked positions.

6. A suturing device for use in combination with a delivery device having a delivery lumen and a distal end, the suturing device comprising: a needle configured to carry a suture, the needle having a distal-most end; a protective needle cap configured to releasably fit over the distal-most end of the needle, the needle cap having an atraumatic distal tip configured to extend over the distal-most end of the needle to protect the distal-most end of the needle and a needle cap body defining a void configured to receive the needle therein; Wherein the protective needle cap is configured to be pushed away from the needle within the patient's body by moving the cannula distally.

7. The suturing device according to claim 6 further includes a sleeve arranged on the suture translation assembly, and the sleeve can be moved between a locked position in which the needle is fixed to the suture translation assembly and an unlocked position in which the needle is released from the suture translation assembly.

8. A method for delivering a suturing device to close a tissue defect in a patient, the method comprising: extending a suturing device into a patient, the suturing device comprising a needle configured to carry a suture and having a protective needle cap releasably positioned over a distal-most end of the needle, the protective needle cap having an atraumatic distal tip configured to extend over the distal-most end of the needle to cover and protect the distal-most end of the needle, and The protective needle cap is moved away from the needle while the suturing device is in a patient.

9. A suturing device for use in conjunction with an endoscope having a working channel and a distal end, the suturing device comprising: A suture translation assembly configured to translate axially within a working channel of the endoscope, the suture translation assembly comprising: a needle configured to carry a suture, the needle having a distal end and a distal detent proximate the distal end; a distal shuttle configured to releasably secure the needle; and a cannula disposed on the distal shuttle, the cannula being movable between a locked position in which the needle is secured to the distal shuttle and an unlocked position in which the needle is released from the distal shuttle; a distal assembly configured to be secured to a distal end of the endoscope, the distal assembly having a distal end cap, wherein the suture translation assembly extends into the distal assembly; The suturing device also includes a needle cap configured to releasably fit over the distal end of the needle, the needle cap configured to be pushed away from the needle within the patient's body.

10. The suturing device of claim 9, wherein the needle cap comprises an atraumatic distal tip and a cylindrical needle cap body defining a void configured to fit over the needle.

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