Suture based closure device

Abstract

To provide a device for suturing tissue.SOLUTION: A medical device includes a mounting structure that is adapted to be secured to a distal end of an endoscope. A first suture arm is pivotably secured to the mounting structure and is adapted to releasably secure a needle that is adapted to puncture tissue while accommodating a suture. A second suture arm is pivotably secured to the mounting structure and is adapted to releasably secure the needle. The first suture arm and the second suture arm cooperate to pass the needle back and forth therebetween along an arcuate path.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to devices for suturing tissue, and more particularly to devices that cooperate with an endoscope or similar device for endoscopically suturing tissue. [Background technology]

[0002] Various endoscopic procedures may result in injuries (or wounds) that are too large for hemostatic clips to easily bridge and help close the injury. Examples of such endoscopic procedures include removal of large lesions, tunneling under the mucosal layer, full-thickness removal of tissue, treatment of other organs by passing outside the gastrointestinal tract, and repair of post-operative problems such as post-operative leakage, failed surgical staple lines, and anastomotic leakage. Endoscopic procedures also include bariatric revision procedures. Known devices and methods for endoscopically closing large injuries each have certain advantages and disadvantages. Summary of the Invention

[0003] The present disclosure relates to several alternative designs, materials, and methods of devices for endoscopically closing large lesions. In one example, the medical device includes a mounting structure adapted to be secured to a distal end of an endoscope. A first suturing arm is pivotally secured to the mounting structure via a first pivot point. The first suturing arm includes a first latch member at an end of the first suturing arm opposite the first pivot point and a first latch mechanism pivotally secured to the first latch member, the first latch mechanism being pivotable between a latched position in which a needle is secured between the first latch member and the first latch mechanism, and a released position. A second suturing arm is pivotally secured to the mounting structure via a second pivot point. The second suturing arm includes a second latch member at an end of the second suturing arm opposite the second pivot point and a second latch mechanism pivotally secured to the second latch member, the second latch mechanism pivotable between a latched position in which the needle is secured between the second latch member and a released position.

[0004] Alternatively or additionally, the medical device may further include a first control element operably coupled to the first suturing arm, such that pulling the first control element moves the first suturing arm toward the second suturing arm and pushing the first control element moves the first suturing arm away from the second suturing arm.

[0005] Alternatively or additionally, the medical device may further include a second control element operably coupled to the second suturing arm, such that pulling the second control element moves the second suturing arm toward the first suturing arm and pushing the second control element moves the second suturing arm away from the first suturing arm.

[0006] Alternatively or additionally, the medical device may further include a third control element operably coupled to the first latch mechanism for moving the first latch mechanism between its latched position and its released position, and a fourth control element operably coupled to the second latch mechanism for moving the second latch mechanism between its latched position and its released position.

[0007] Alternatively or additionally, the medical device may further include a first rounded pin secured to the first latch member, the first rounded pin adapted to engage a latch detent of the needle when the needle is disposed between the first latch member and the first latch mechanism, and a second rounded pin secured to the first latch mechanism, the second rounded pin adapted to engage the latch detent of the needle when the first latch mechanism is in its latched position.

[0008] Alternatively or additionally, the first latch member and the first latch mechanism may together define a first lumen adapted to receive a needle when the first latch mechanism is in its latched position, and the first rounded pin and the second rounded pin may extend partially into the first lumen.

[0009] Alternatively or additionally, the medical device may further include a third rounded pin fixed to the second latch member, the third rounded pin adapted to engage a needle latch detent when the needle is disposed between the second latch member and the second latch mechanism, and a fourth rounded pin fixed to the second latch mechanism, the fourth rounded pin adapted to engage a needle latch detent when the second latch mechanism is in its latched position.

[0010] Alternatively or additionally, the combination of the second latch member and the second latch mechanism may define a second lumen adapted to receive a needle when the second latch mechanism is in its latched position, and the third rounded pin and the fourth rounded pin may extend partially into the second lumen.

[0011] Alternatively or additionally, the first suturing arm may be adapted to pivot from a position approximately 45 degrees from vertical in an outward direction away from the second suturing arm to a horizontal position in an inward direction toward the second suturing arm.

[0012] Alternatively or additionally, the second suturing arm may be adapted to allow the first suturing arm to pivot through the second suturing arm when the first suturing arm approaches its horizontal position.

[0013] Alternatively or additionally, the second suturing arm may be adapted to pivot from a position about 45 degrees from the vertical in an outward direction away from the first suturing arm to a position about 45 degrees from the vertical in an inward direction toward the first suturing arm.

[0014] In another example, a medical device includes a mounting structure adapted to be secured to a distal end of an endoscope. A first suture arm is pivotally secured to the mounting structure, the first suture arm adapted to releasably secure a needle adapted to pierce tissue while receiving a suture, the first suture arm having a first width. A second suture arm is pivotally secured to the mounting structure, the second suture arm adapted to releasably secure the needle, the second suture arm having a second width greater than the first width such that the first suture arm can pivot through the second suture arm to capture a newly delivered needle. Both the first suture arm and the second suture arm are adapted to shuttle the needle between them along an arcuate path.

[0015] Alternatively or additionally, the first suturing arm may be adapted to pivot from a position approximately 45 degrees from vertical in an outward direction away from the second suturing arm to a horizontal position in an inward direction toward the second suturing arm.

[0016] Alternatively or additionally, the second suturing arm may be adapted to pivot from a position about 45 degrees from the vertical in an outward direction away from the first suturing arm to a position about 45 degrees from the vertical in an inward direction toward the second suturing arm.

[0017] Alternatively or additionally, the medical device may further include a first control element operably coupled to the first suturing arm, such that pulling the first control element moves the first suturing arm toward the second suturing arm and pushing the first control element moves the first suturing arm away from the second suturing arm.

[0018] Alternatively or additionally, the medical device may further include a second control element operably coupled to the second suturing arm, such that pulling the second control element moves the second suturing arm toward the first suturing arm and pushing the second control element moves the second suturing arm away from the first suturing arm.

[0019] Alternatively or additionally, the medical device may further include a third control element operably coupled to the first latch mechanism for moving the first latch mechanism between its latched position and its released position, and a fourth control element operably coupled to the second latch mechanism for moving the second latch mechanism between its latched position and its released position.

[0020] In another example, a medical device includes a mounting structure adapted to be secured to a distal end of an endoscope. A first suturing arm is pivotally secured to the mounting structure, the first suturing arm adapted to releasably secure a needle adapted to pierce tissue while housing a suture. A second suturing arm is pivotally secured to the mounting structure, the second suturing arm adapted to releasably secure a needle adapted to pierce tissue while housing a suture. The first suturing arm and the second suturing arm are each actuated to move toward and away from each other to reciprocate the needle along an arcuate path therebetween.

[0021] Alternatively or additionally, the first suturing arm may include a first latch member and a first latch mechanism pivotally secured to the first latch member, the first latch mechanism pivotable between a latched position in which the needle is secured between the first latch member and the first latch mechanism, and a released position.

[0022] Alternatively or additionally, the second suturing arm may include a second latch member and a second latch mechanism pivotally secured to the second latch member, the second latch mechanism pivotable between a latched position in which the needle is secured between the second latch member and the second latch mechanism, and a released position.

[0023] 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]

[0024] The present disclosure may be more fully understood from consideration of the following description in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a side view of an exemplary assembly including an exemplary suturing device secured to a distal end of an endoscope. [Diagram 2] FIG. 2 is an end view of the exemplary assembly of FIG. [Diagram 3] FIG. 3 is a perspective view of the exemplary assembly of FIG. 1 configured to reload a needle or suture. [Figure 4] FIG. 4 illustrates a pivot stop formed on one of the suture arms forming part of the exemplary assembly of FIG. [Figure 5A] 5A and 5B show a pivot stop formed on another of the suture arms forming part of the exemplary assembly of FIG. 1. [Figure 5B] 5A and 5B show a pivot stop formed on another of the suture arms forming part of the exemplary assembly of FIG. 1. [Figure 6] FIG. 6 is a partial cutaway view of an exemplary suture arm forming part of the exemplary assembly of FIG. [Figure 7A] 7A-7D are side views of the exemplary assembly of FIG. 1 showing the sequence of events for placing a suture. [Figure 7B] 7A-7D are side views of the exemplary assembly of FIG. 1 showing the sequence of events for placing a suture. [Figure 7C] 7A-7D are side views of the exemplary assembly of FIG. 1 showing the sequence of events for placing a suture. [Figure 7D] 7A-7D are side views of the exemplary assembly of FIG. 1 showing the sequence of events for placing a suture. [Figure 8] FIG. 8 is a perspective view of an exemplary assembly including an exemplary suturing device secured to a distal end of an endoscope. [Figure 9] FIG. 9 is a perspective view of an exemplary assembly including an exemplary suturing device secured to a distal end of an endoscope. [Figure 10] FIG. 10 is a perspective view of a needle that can be used with the exemplary assembly of FIGS. [Figure 11] FIG. 11 is a perspective view of an exemplary assembly including an exemplary suturing device secured to a distal end of an endoscope. [Figure 12] 12 is a partial cutaway side view of the exemplary assembly of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025] While the present disclosure is amenable to various modifications and alternative forms, details of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

[0026] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. Definitions of certain terms are provided below and shall apply, unless a different definition is given in the claims or elsewhere in this specification.

[0027] All numerical values ​​are assumed to be modified herein by the term "about", whether or not expressly indicated. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term "about" can be expressed as including numbers that are rounded to the nearest significant figure.

[0028] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions, ranges and / or values ​​for various components, features and / or specifications are disclosed, those skilled in the art inspired by this disclosure will understand that the desired dimensions, ranges and / or values ​​may deviate from those expressly disclosed.

[0029] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include or refer to both singular and plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used to include "and / or" unless the content clearly dictates otherwise.

[0030] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The detailed description and the drawings, which are not necessarily to scale, depict exemplary embodiments and are not intended to limit the scope of the disclosure. The illustrated exemplary embodiments are intended as examples only. Selected features of any exemplary embodiment may be incorporated into additional embodiments, unless expressly stated to the contrary.

[0031] The present disclosure relates to devices configured to be used in combination with an endoscope or similar delivery device to close wounds within the body. In some examples, the suturing devices described herein may be configured to be used in combination with a single or dual working channel endoscope within a single working channel or available channels of an endoscope, and in some cases may be operated by a single individual, although in some cases a second individual may be involved.

[0032] Figure 1 is a perspective view of an exemplary assembly 10 including an exemplary suturing device 12 secured to a distal end of an endoscope 14, while Figure 2 is an end view of the exemplary assembly 10. The suturing device 12 may be used in combination with a variety of different endoscopes 14, including, but not limited to, endoscopes 14 having a main working channel with a 2.8 millimeter (mm) diameter, a 3.2 mm diameter, or a 3.7 mm diameter. It will also be understood that the suturing device 10 may be used with any of endoscopes, colonoscopes, gastroscopes, duodenoscopes, bronchoscopes, ureteroscopes, catheters, medical devices, and the like.

[0033] As shown, the exemplary suturing device 12 includes an end cap 16 configured to secure the suturing device 12 relative to the endoscope 14. In general, a first device adapted to be secured relative to a second device includes a first device secured directly to the second device, and also includes a first device secured to the second device using one or more intervening structures. For example, the end cap 16 may be any over-the-scope connector. In some instances, the suturing device 12 may instead include other structures or mechanisms (not shown) adapted to secure the suturing device 12 relative to the endoscope 14. In some cases, as shown, the assembly 10 may include a tissue grasping device 18 that may be used to grasp tissue and draw tissue into the workspace 20 so that the suturing device 12 can be used to place one or more stitches in the tissue. In some embodiments, the tissue grasping device 18 may be a helical device. Although a helical tissue grasping device 18 is shown, in some cases other types of graspers may be used, so long as the grasper can fit through the main working channel of the endoscope 14 .

[0034] The suturing device 12 includes a first suturing arm 22 and a second suturing arm 24 configured to allow a needle 26 to be shuttled between the first suturing arm 22 and the second suturing arm 24. It will be appreciated that the movement of the first suturing arm 22 and the second suturing arm 24, as shown in Figures 7A-7D, may be considered to cause the needle 26 to move along an arcuate path. As the needle 26 passes through tissue, it pulls the suture 28 with it, thereby pulling the suture 28 through the tissue.

[0035] The first suturing arm 22 includes a first latch member 30 and a first latch mechanism 32. The second suturing arm 24 includes a second latch member 34 and a second latch mechanism 36. As described below, the first latch member 30 and the first latch mechanism 32 cooperate to releasably secure the needle 26 to the first suturing arm 22. Similarly, the second latch member 34 and the second latch mechanism 36 cooperate to releasably secure the needle 26 to the second suturing arm 24.

[0036] To move the first and second suturing arms 22, 24 as desired, the suturing device 12 includes a first control element 38 attached to a first clevis 40 secured to the first suturing arm 22 proximate a first pivot point 42. The first control element 38 may be, for example, a wire or other elongated structure having sufficient tensile strength to allow the first control element 38 to be pushed or pulled. When the first control element 38 is pushed distally, such as by a suitable handle mechanism (not shown), the first suturing arm 22 is pivoted away from the working space 20 and away from the second suturing arm 24. When the first control element 38 is pulled proximally, such as by a suitable handle mechanism (not shown), the first suturing arm 22 is pivoted into the working space 20 and toward the second suturing arm 24.

[0037] The suturing device 12 includes a second control element 44 attached to a second clevis 46 secured to the second suturing arm 24 proximate a second pivot point 48. The second control element 44 may be, for example, a wire or other elongated structure having sufficient tensile strength to be able to push or pull the second control element 38. When the second control element 44 is pushed distally, such as by a suitable handle mechanism (not shown), the second suturing arm 22 is pivoted away from the working space 20 and away from the first suturing arm 22. When the second control element 44 is pulled proximally, such as by a suitable handle mechanism (not shown), the second suturing arm 24 is pivoted into the working space 20 and towards the second suturing arm 22. In some cases, other actuation mechanisms are contemplated, such as the use of one or more gears in the handle mechanism. This is merely one example.

[0038] The first latch mechanism 32 is pivotally fixed to the first latch member 30 at a pivot point 50. A third control element may be used to open and close the first latch mechanism 32 relative to the first latch member 30, as will be described with respect to FIG. 6. The second latch mechanism 36 is pivotally fixed to the second latch member 34 at a pivot point 56. A fourth control element may be used to open and close the second latch mechanism 36 relative to the second latch member 34, as will be described with respect to FIG. 6.

[0039] 2, it can be seen that the first suture arm 20 and the second suture arm 22 are not identical. Rather, the first suture arm 20 can be seen as being narrow relative to the wider second suture arm 22. This size mismatch allows the first suture arm 20 to angle toward and actually pass through the second suture arm 22.

[0040] FIG. 3 shows the first suture arm 20 in a horizontal or substantially horizontal position in which it extends through the second suture arm 22. The first suture arm 20 is in a position in which it can capture the needle 26 as it is provided through the external tube 62. This may occur, for example, if the needle 26 needs to be replaced. In some cases, the needle 26 may be used to terminate the suture, meaning that the needle 26 may be left inside the patient near the tissue being sutured. This may mean that another needle 26 may be needed if there is another suture to be placed. In some cases, the assembly 10 is advanced towards the suture site with the needle 26 secured firmly between the first suture arm 20 and the second suture arm 22, but in some cases it may be desirable to advance the assembly 10 instead without the needle 26 and provide the needle 26 only once the assembly 10 has reached the suture site.

[0041] As will be appreciated, the first suture arm 20 and the second suture arm 22 are not freely pivotable to any position, but are configured to provide limitations to movement. In some cases, for example, the first suture arm 20 may be allowed to pivot from a position approximately 45 degrees from vertical in an outward direction away from the second suture arm 22 (approximately the position of the first suture arm 20 shown in FIG. 1) to a horizontal position in an inward direction toward the second suture arm 22 (approximately the position of the first suture arm 20 shown in FIG. 3). The second suture arm 22 may be allowed to pivot from a position approximately 45 degrees from vertical in an outward direction away from the vertical (approximately the position of the second suture arm 22 in FIG. 1) to a position approximately 45 degrees from vertical in an inward direction toward the first suture arm 20.

[0042] The first suturing arm 20 and the second suturing arm 22 include physical mechanisms for achieving these travel limitations. FIG. 4 illustrates a portion of the first suturing arm 20 relative to the end cap 16. The first suturing arm 20 can be seen to include a pivot pin 66 that interacts with a corresponding surface 68 formed on the end cap 16. A portion 70 of the surface 68 can be seen to be configured to limit how far the first suturing arm 20 can pivot in an outward direction, while a portion 72 of the surface 68 is configured to allow the pivot pin 66 to move across portion 68, allowing the first suturing arm 20 to pivot in an inward direction to a horizontal orientation.

[0043] 5A and 5B show a portion of the second suture arm 22 relative to the end cap 16. The second suture arm 22 can be seen to include a pivot pin 74 that interacts with a corresponding surface 76 formed on the end cap 16. A portion 78 of the surface 76 can be seen to be configured to limit how far the second suture arm 22 can pivot in an outward direction, while a portion 80 of the surface 76 is configured to limit how far the second suture arm 22 can pivot in an inward direction. As can be seen particularly in FIG. 5B, the second suture arm 22 includes pivot stops 82 and 84 that prevent the first suture arm 20 from pivoting past a horizontal position.

[0044] 6 is a partial cutaway view of a portion of a suturing arm 90, which may be considered to represent either the first suturing arm 20 or the second suturing arm 22. The suturing arm 90 includes a latch member 92 and a latch mechanism 94. The latch mechanism 94 is attached to the latch member 92 via a pivot point 96. It will be understood that the latch member 92 may be considered to represent either the first latch member 30 or the second latch member 34, and the latch mechanism 94 may be considered to represent either the first latch mechanism 32 or the second latch mechanism 36.

[0045] The control element 101 extends upward through the suture arm 90, through the opening 106 and into the opening 108. The control element 101 can be considered to represent either a third control element or a fourth element, depending on whether the suture arm 90 represents the first suture arm 20 or the second suture arm 22. The control element 101 can be, for example, a wire, and includes a plug portion 105 that secures the control element 101 within the opening 108. The plug portion 105 can represent, for example, a solder ball, or simply a wide portion of the control element 101 that is frictionally secured within the opening 108. Pressing the control element 101 can cause the latch mechanism 94 to open relative to the latch member 94, and pulling the control element 101 can cause the latch mechanism 94 to close relative to the latch member 94.

[0046] The latch member 92 includes a rounded pin 98 secured within an opening 100 formed in the latch member 92. The latch mechanism 94 includes a rounded pin 102 secured within an opening 103 formed in the latch mechanism 94. It will be appreciated that the rounded pin 98 and the rounded pin 102 are configured to releasably engage detents 104 formed near either end of the needle 26. When the latch mechanism 94 is in a closed or latched position (such as the latch mechanisms 32, 26 shown in FIG. 1 or FIG. 2), the rounded pins 98 and 102 engage one of the detents 104 to secure the needle 26 relative to the suturing arm 90. When the latch mechanism 94 is in an open or released position (as shown in FIG. 6), the needle 26 is not held in place and is therefore released. In some cases, openings 106 and 108 formed in latch member 92 and latch mechanism 94, respectively, allow a control element to pass up to and be secured relative to latch mechanism 94. However, this is not required in all cases. It will be appreciated that needle 26 includes a suture opening 110 through which a suture, such as suture 28, may be secured.

[0047] Comparing FIG. 6 with FIG. 1, it will be appreciated that the suturing device 12 may include a first rounded pin fixed relative to the first latch member 30 and adapted to engage a latch detent 104 of the needle 26 when the needle 26 is disposed between the first latch member 30 and the first latch mechanism 32, and a second rounded pin fixed relative to the first latch mechanism 32 and adapted to engage the latch detent 104 of the needle 26 when the first latch mechanism 32 is in its latched position. The first latch member 30 and the first latch mechanism 32 can be considered to together define a first lumen (such as lumen 112 shown in FIG. 6 ) adapted to receive the needle 26 when the first latch mechanism 32 is in its latched position, and the first rounded pin and the second rounded pin each extend partially into the first lumen.

[0048] The suturing device 12 may include a third rounded pin fixed relative to the second latch member 34, the third rounded pin adapted to engage a latch detent 104 of the needle 26 when the needle 26 is disposed between the second latch member 34 and the second latch mechanism 36, and a fourth rounded pin fixed relative to the second latch mechanism 36, the fourth rounded pin adapted to engage a latch detent 104 of the needle 26 when the second latch mechanism 36 is in its latched position. The second latch member 34 and the second latch mechanism 36 may be considered to together define a second lumen (such as lumen 112 shown in FIG. 6 ) adapted to receive the needle 26 when the second latch mechanism 36 is in its latched position, with the third rounded pin and the fourth rounded pin each extending partially into the second lumen.

[0049] As an example, the suturing device 12 may be secured to the end of the endoscope 14. A needle 26 and suture 28 may be loaded into the suturing device 12, with the needle 26 locked into both the first suturing arm 20 and the second suturing arm 22. The suture 28 extends through the outer tube 62, and the suturing device 12 (and endoscope 140) is passed to the area of ​​interest, such as, for example, the stomach or esophagus. In some cases, an overtube (not shown) may be used during intubation to protect the patient's esophagus. Once the suturing device 12 is properly positioned, a tissue grasping device, such as, but not limited to, the spiral tissue grasping device 18, may be advanced down the working channel of the endoscope 14. The first suturing arm 20 and the second suturing arm 22 may be moved to an open position in which both the first suturing arm 20 and the second suturing arm 22 are tilted away from the working space 24 to ensure clearance for the tissue grasping device. At this point, the needle 26 remains locked to either the first suture arm 20 or the second suture arm 22. The tissue gripping device can be advanced distally to engage the tissue. The tissue gripping device can then be pulled proximally to draw the tissue into the working space 24. The first suture arm 20 and the second suture arm 22 are rotated toward each other to a closed position where the needle 26 can engage both the first suture arm 20 and the second suture arm 22, thereby passing the needle 26 and suture 28 through the tissue. The needle 26 can be transferred from one suture arm to the other by unlocking the suture arm with the needle and locking the arm receiving the needle.

[0050] This is shown, for example, in Figures 7A-7D. In Figure 7A, the needle 26 is locked into the first suture arm 20 and the first and second suture arms 20, 22 are pivoted to an open position in which the first and second suture arms 20, 22 are tilted away from each other. A tissue gripping device, not shown, has a gap for gripping tissue and pulling the tissue in the workspace 24. In Figure 7B, the first and second suture arms 20, 22 are tilted toward each other and the second latch mechanism 36 is opened to allow the needle 26 to enter.

[0051] In Figure 7C, the first suture arm 20 and the second suture arm 22 are in a closed position where the first suture arm 20 and the second suture arm 22 are generally parallel to one another. The first latch mechanism 32 is open and the second latch mechanism 36 is closed. As a result, the needle 26 is secured to and released by the second suture arm 22. In Figure 7D, the second suture arm 22 is angled away from the first suture arm 20 and the needle 26 is secured to the second suture arm 22.

[0052] 8 is a perspective view of an exemplary assembly 120 including an exemplary suturing device 122 secured relative to an endoscope 14. The suturing device 122 may be used in combination with a variety of different endoscopes 14, including, but not limited to, endoscopes 14 having a main working channel with a diameter of 2.8 millimeters (mm), a diameter of 3.2 mm, or a diameter of 3.7 mm. As shown, the exemplary suturing device 122 includes an end cap 124 configured to secure the suturing device 122 relative to the endoscope 14. For example, the end cap 124 may be any over-the-scope connector. In some examples, the suturing device 122 may instead include other structures or mechanisms (not shown) adapted to secure the suturing device 122 relative to the endoscope 14.

[0053] The suturing device 122 includes a first suturing arm 126 and a second suturing arm 128. The first suturing arm 126 includes a first needle receiving mechanism 130 and the second suturing arm 128 includes a second needle receiving mechanism 132. Although not shown, the suturing device 122 may include a first control wire extending proximally from the first suturing arm 126 and a second control wire extending proximally from the second suturing arm 128, allowing a user to actuate the first suturing arm 126 and the second suturing arm 128 as desired. The first suturing arm 126 and the second suturing arm 128 may be locked to the needle 134 via separate control wires that pass through the center of each of the suturing arms 126, 128 and releasably engage corresponding openings formed in the needle 134. It will be appreciated that needle 134 includes a first opening positioned to receive a wire extending through first suture arm 126 and a second opening positioned to receive a wire extending through second suture arm 128. These openings are referenced with respect to FIG. 10. The wires which control the engagement of the needle are individually movable such that needle 134 can be locked to first suture arm 126, or locked to second suture arm 128, or released from either first suture arm 126 or second suture arm 128, as desired.

[0054] 9 is a perspective view of an exemplary assembly 140 including an exemplary suturing device 142 fixed relative to endoscope 14. Suturing device 142 is similar to suturing device 122, but with second suturing arm 128 replaced by a fixed suturing arm 144.

[0055] 10 is a perspective view of needle 134. Needle 134 includes a first opening 136 configured to accommodate, for example, a wire extending through first suture arm 126. Needle 134 includes a second opening 138 configured to accommodate, for example, a wire extending through second suture arm 128. Suture opening 140 allows a suture to be secured to needle 134.

[0056] FIG. 11 is a perspective view of an exemplary assembly 150 including an exemplary suturing device 152 fixed relative to an endoscope 14. FIG. 12 is a partial cross-sectional view of the exemplary assembly 150. The suturing device 152 may be used in combination with a variety of different endoscopes 14, including, but not limited to, endoscopes 14 having a main working channel with a diameter of 2.8 millimeters (mm), a diameter of 3.2 mm, or a diameter of 3.7 mm. The suturing device 152 includes one stationary arm 154 and one movable arm 156, which may be controlled using a control wire extending from the movable arm 156. The control wire may pivot or swing the movable arm 156 to shuttle the needle 158 between the stationary arm 154 and the movable arm 156. The needle 158 may be locked to the stationary arm 154 via an actuation lock mechanism 160 controlled at a proximal end by a user via the control wire. The needle 158 may be passively locked to the movable arm 156 via a spring force. In some cases, the actuation lock mechanism 160 may be configured to provide sufficient force to overcome the spring force.

[0057] It should be understood that a variety of different materials may be used in forming the devices described herein. In some cases, a variety of different metals may be used. Illustrative, but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt chrome, and the like. In some cases, the first control element 46 and the second control element may be made of Nitinol. In some embodiments, for example, the devices described herein may include any suitable polymeric material, including biocompatible materials such as polyurethane or silicone. Suitable polymers include PEEK (polyetheretherketone) and polycarbonate. Other suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., Polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers such as HYTREL® available from DuPont), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like.Atochem's CRISTAMID®), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, available, for example, under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimides (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfones, nylons, nylon-12 (e.g., EMS American Such materials include, but are not limited to, polyvinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like.

[0058] Those skilled in the art will recognize that the present disclosure may be manifested in a variety of forms other than the specific embodiments described and contemplated herein, and therefore changes may be made in form and detail without departing from the scope and spirit of the present disclosure as set forth in the appended claims. The technical ideas contained in this disclosure are described below as appendices. (Appendix 1) 1. A medical device comprising: a mounting structure adapted to be secured to a distal end of an endoscope; a first suture arm pivotally secured to the mounting structure via a first pivot point, a first latch member at an end of the first suture arm opposite the first pivot point; a first latch mechanism pivotally secured to the first latch member, the first latch mechanism pivotally movable between a latched position in which a needle is secured between the first latch member and the first latch mechanism and a released position; a first suture arm including: a second suture arm pivotally secured to the mounting structure via a second pivot point, a second latch member at an end of the second suture arm opposite the second pivot point; a second latch mechanism pivotally secured to the second latch member, the second latch mechanism pivotally movable between a latched position in which a needle is secured between the second latch member and the second latch mechanism and a released position; and a second suture arm including A medical device comprising: (Appendix 2) 2. The medical device of claim 1, further comprising a first control element operably coupled to the first suturing arm, wherein pulling the first control element causes the first suturing arm to move toward the second suturing arm and pushing the first control element causes the first suturing arm to move away from the second suturing arm. (Appendix 3) 3. The medical device of claim 1 or 2, further comprising a second control element operably coupled to the second suturing arm, wherein pulling the second control element moves the second suturing arm toward the first suturing arm and pushing the second control element moves the second suturing arm away from the first suturing arm. (Appendix 4) a third control element operatively coupled to the first latch mechanism for moving the first latch mechanism between its latched position and its released position; and a fourth control element operatively coupled to the second latch mechanism for moving the second latch mechanism between its latched position and its released position; and The medical device according to any one of claims 1 to 3, further comprising: (Appendix 5) a first rounded pin secured to the first latch member, the first rounded pin adapted to engage a latch detent of the needle when the needle is disposed between the first latch member and the first latch mechanism; a second rounded pin secured to the first latch mechanism, the second rounded pin adapted to engage the latch detent of the needle when the first latch mechanism is in its latched position; 5. The medical device of any one of claims 1 to 4, further comprising: (Appendix 6) 6. The medical device of any one of appendixes 1-5, wherein the first latch member and the first latch mechanism together define a first lumen adapted to receive the needle when the first latch mechanism is in its latched position, and the first rounded pin and the second rounded pin extend partially into the first lumen. (Appendix 7) a third rounded pin secured to the second latch member, the third rounded pin adapted to engage a latch detent of the needle when the needle is disposed between the second latch member and the second latch mechanism; a fourth rounded pin secured to the second latch mechanism, the fourth rounded pin adapted to engage the latch detent of the needle when the second latch mechanism is in its latched position; 7. The medical device of any one of claims 1 to 6, further comprising: (Appendix 8) 8. The medical device of any one of claims 1-7, wherein the combination of the second latch member and the second latch mechanism defines a second lumen adapted to receive the needle when the second latch mechanism is in its latched position, and the third rounded pin and the fourth rounded pin extend partially into the second lumen. (Appendix 9) 9. The medical device of any one of claims 1-8, wherein the second suturing arm is adapted to allow the first suturing arm to pivot through the second suturing arm when the first suturing arm approaches its horizontal position. (Appendix 10) 1. A medical device comprising: a mounting structure adapted to be secured to a distal end of an endoscope; a first suture arm pivotally secured to the mounting structure, the first suture arm adapted to releasably secure a needle adapted to pierce tissue while receiving a suture, the first suture arm having a first width; a second suture arm pivotally secured to the mounting structure, the second suture arm adapted to releasably secure the needle, the second suture arm having a second width greater than the first width such that the first suture arm can pivot through the second suture arm to capture a newly delivered needle; Equipped with A medical device, wherein the first suture arm and the second suture arm are both adapted to reciprocate the needle therebetween along an arcuate path. (Appendix 11) 11. The medical device of claim 10, wherein the first suturing arm is adapted to pivot from a position approximately 45 degrees from vertical in an outward direction away from the second suturing arm to a horizontal position in an inward direction toward the second suturing arm. (Appendix 12) 12. The medical device of claim 10 or 11, wherein the second suturing arm is adapted to pivot from a position about 45 degrees from vertical in an outward direction away from the first suturing arm to a position about 45 degrees from vertical in an inward direction toward the second suturing arm. (Appendix 13) 13. The medical device of any one of appendix 10-12, further comprising a first control element operably coupled to the first suturing arm, wherein pulling the first control element causes the first suturing arm to move toward the second suturing arm and pushing the first control element causes the first suturing arm to move away from the second suturing arm. (Appendix 14) 14. The medical device of any one of appendix 10-13, further comprising a second control element operably coupled to the second suturing arm, wherein pulling the second control element causes the second suturing arm to move toward the first suturing arm and pushing the second control element causes the second suturing arm to move away from the first suturing arm. (Appendix 15) a third control element operatively coupled to the first latch mechanism for moving the first latch mechanism between its latched position and its released position; a fourth control element operatively coupled to the second latch mechanism for moving the second latch mechanism between its latched position and its released position; and The medical device of any one of appendices 10 to 14, further comprising:

Claims

1. 1. A medical device comprising: a mounting structure adapted to be secured to a distal end of an endoscope; a first suture arm having a proximal end and a distal end; a second suture arm having a proximal end and a distal end; Equipped with the first suture arm is pivotally secured to the mounting structure via a first pivot point at the proximal end of the first suture arm; The first suture arm includes: a first latch member at the distal end of the first suture arm; a first latch mechanism pivotable relative to the first latch member between a latched position in which the needle is securable between the first latch member and the first latch mechanism by the first latch member and the first latch mechanism, and a released position; 4. A medical device comprising:

2. 10. The medical device of claim 1, further comprising a first control element operably coupled to the first suturing arm, wherein pulling the first control element moves the first suturing arm toward the second suturing arm and pushing the first control element moves the first suturing arm away from the second suturing arm.

3. The medical device of claim 1 or 2, wherein the second suture arm is pivotally secured to the mounting structure via a second pivot point.

4. 4. The medical device of claim 3, further comprising a second control element operably coupled to the second suturing arm, wherein pulling the second control element moves the second suturing arm toward the first suturing arm and pushing the second control element moves the second suturing arm away from the first suturing arm.

5. 3. The medical device of claim 1 or 2, further comprising a first latch mechanism control element operably coupled to the first latch mechanism for moving the first latch mechanism between its latched position and its released position.

6. a first rounded pin secured to the first latch member, the first rounded pin adapted to engage a latch detent of the needle when the needle is disposed between the first latch member and the first latch mechanism; a second rounded pin secured to the first latch mechanism, the second rounded pin adapted to engage the latch detent of the needle when the first latch mechanism is in its latched position; The medical device of claim 1 or 2, further comprising:

7. 7. The medical device of claim 6, wherein the first latch member and the first latch mechanism together define a first lumen adapted to receive the needle when the first latch mechanism is in its latched position, and the first rounded pin and the second rounded pin extend partially into the first lumen.

8. The first suturing arm is pivotable from a position away from the second suturing arm to a position where the needle can be transferred to the second suturing arm, the second suturing arm comprising: A second latch member; a second latch mechanism pivotable relative to the second latch member between a latched position in which the needle is secured between the second latch member and the second latch mechanism by the second latch member and the second latch mechanism, and a released position; The medical device of claim 6 .

9. The second suture arm includes: a third rounded pin secured to the second latch member, the third rounded pin adapted to engage a latch detent of the needle when the needle is disposed between the second latch member and the second latch mechanism; a fourth rounded pin secured to the second latch mechanism, the fourth rounded pin adapted to engage the latch detent of the needle when the second latch mechanism is in its latched position; The medical device of claim 8 , further comprising:

10. 10. The medical device of claim 9, wherein the combination of the second latch member and the second latch mechanism defines a second lumen adapted to receive the needle when the second latch mechanism is in its latched position, and the third rounded pin and the fourth rounded pin extend partially into the second lumen.

11. 2. The medical device of claim 1, wherein the second suturing arm is adapted to allow the first suturing arm to pivot through the second suturing arm when the first suturing arm approaches a position 90 degrees from a longitudinal axis of the mounting structure and in a direction closer to the second suturing arm.

12. The medical device of claim 11 , wherein the first suture arm has a first width and the second suture arm has a second width greater than the first width of the first suture arm.

13. 13. The medical device of claim 11 or 12, wherein the first suturing arm is pivotable to a horizontal position in which the distal end of the first suturing arm is adjacent to the distal end of the endoscope to capture a needle from the endoscope.

14. 13. The medical device of claim 11 or 12, wherein the first suturing arm is adapted to pivot from a position approximately 45 degrees from vertical in an outward direction away from the second suturing arm to a horizontal position in an inward direction toward the second suturing arm.

15. The medical device of claim 1 or 2, wherein the first latch mechanism is pivotally secured to the first latch member.

Images