Suture-based closure devices

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 a device for suturing tissue, and more particularly to a device that collaborates with an endoscope or similar device for endoscopically suturing tissue.

Background Art

[0002] Various endoscopic treatments can result in injuries (or wounds) that are too large for hemostatic clips to easily bridge and close the damage. Examples of such endoscopic procedures include removal of large lesions, tunneling under the mucosal layer, removal of the entire tissue layer, treatment of other organs by passing through the outside of the gastrointestinal tract, and repair of postoperative problems such as postoperative leakage, failed surgical staple lines, and anastomotic leakage. Endoscopic treatments also include obesity correction procedures. Known devices and methods for endoscopically closing large injuries each have specific 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 injuries. In one example, a medical device includes an attachment structure adapted to be fixed to the distal end of an endoscope. A first suturing arm is pivotally fixed to the attachment 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 fixed to the first latch member, the first latch mechanism being pivotable between a latch position where a needle is fixed between the first latch member and the first latch mechanism and a release position. A second suturing arm is pivotally fixed to the attachment 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 fixed to the second latch member, the second latch mechanism being pivotable between a latch position where a needle is fixed between the second latch member and the second latch mechanism and a release position.

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

[0005] Alternatively or additionally, the medical device may further include a second control element operably coupled to the second suture arm, the second suture arm moving toward the first suture arm by pulling the second control element, and the second suture arm moving toward the first suture arm by pushing the second control element.

[0006] Alternatively or additionally, the medical device may further include a third control element operably coupled to a 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 a 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 fixed to a first latching member, which is adapted to engage with a latch return of the needle when the needle is positioned between the first latching member and the first latching mechanism, and a second rounded pin fixed to the first latching mechanism, which is adapted to engage with a latch return of the needle when the first latching mechanism is in its latched position.

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

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

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

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

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

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

[0014] In another example, the medical device includes a mounting structure adapted to be fixed to the distal end of an endoscope. A first suture arm is pivotably fixed to the mounting structure and is adapted to releasably fix a needle adapted to puncture tissue while accommodating a suture, and the first suture arm has a first width. A second suture arm is pivotably fixed to the mounting structure and is adapted to releasably fix a needle, and the second suture arm has a second width greater than the first width so that the first suture arm can pivot through the second suture arm to capture a newly delivered needle. Both the first and second suture arms are adapted to reciprocate the needle between them along an arc-shaped path.

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

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

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

[0018] Alternatively or additionally, the medical device may further include a second control element operably coupled to the second suture arm, the second suture arm moving toward the first suture arm by pulling the second control element, and the second suture arm moving toward the first suture arm by pushing the second control element.

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

[0020] In another example, the medical device includes a mounting structure adapted to be fixed to the distal end of an endoscope. A first suturing arm is pivotably fixed to the mounting structure and is adapted to releasely fix a needle adapted to puncture tissue while containing a suture. A second suturing arm is pivotably fixed to the mounting structure and is adapted to releasely fix a needle adapted to puncture tissue while containing a suture. The first and second suturing arms are each actuated to move toward and away from each other in order to reciprocate the needle between them along an arc-shaped path.

[0021] Alternatively or additionally, the first suturing arm may include a first latch member and a first latch mechanism pivotably fixed to the first latch member, the first latch mechanism being pivotable between a latched position in which the needle is fixed 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 pivotably fixed to the second latch member, the second latch mechanism being pivotable between a latched position in which the needle is fixed 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 all implementations of this disclosure. The following drawings and detailed description illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0024] This disclosure may be more fully understood by considering the following description in connection with the accompanying drawings. [Figure 1] FIG. 1 is a side view of an exemplary assembly including an exemplary suturing device fixed to the distal end of an endoscope. [Figure 2] FIG. 2 is an end view of the exemplary assembly of FIG. 1. [Figure 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 is a view showing a pivot stop formed in one of a plurality of suturing arms forming a part of the exemplary assembly of FIG. 1. [Figure 5A] FIGS. 5A and FIGS. 5B are views showing a pivot stop formed in the other of a plurality of suturing arms forming a part of the exemplary assembly of FIG. 1. [Figure 5B] FIGS. 5A and FIGS. 5B are views showing a pivot stop formed in the other of a plurality of suturing arms forming a part of the exemplary assembly of FIG. 1. [Figure 6] FIG. 6 is a partial cutaway view of an exemplary suturing arm forming a part of the exemplary assembly of FIG. 1. [Figure 7A] FIGS. 7A - 7D are side views of the exemplary assembly of FIG. 1 showing a series of events for placing a suture. [Figure 7B] FIGS. 7A - 7D are side views of the exemplary assembly of FIG. 1 showing a series of events for placing a suture. [Figure 7C] FIGS. 7A - 7D are side views of the exemplary assembly of FIG. 1 showing a series of events for placing a suture. [Figure 7D] FIGS. 7A - 7D are side views of the exemplary assembly of FIG. 1 showing a series of events for placing a suture. [Figure 8] FIG. 8 is a perspective view of an exemplary assembly including an exemplary suturing device fixed to the distal end of an endoscope. [Figure 9] Figure 9 is a perspective view of an exemplary assembly including an exemplary suturing device fixed to the distal end of an endoscope. [Figure 10] Figure 10 is a perspective view of the needle as it can be used with the exemplary assemblies shown in Figures 8 and 9. [Figure 11] Figure 11 is a perspective view of an exemplary assembly including an exemplary suturing device fixed to the distal end of an endoscope. [Figure 12] Figure 12 is a partial cross-sectional side view of the exemplary assembly shown in Figure 11. [Modes for carrying out the invention]

[0025] This disclosure follows various modifications and alternative forms, the details of which are shown in the drawings as examples and described in detail. However, it should be understood that the intent is not to limit the invention to any particular embodiment described. On the contrary, the invention encompasses all modifications, equivalents, and alternative forms that fall within the technical concept and scope of this disclosure.

[0026] The terms defined below shall apply unless otherwise given in the claims or elsewhere in this specification. Definitions of specific terms are provided below and shall apply unless different definitions are given in the claims or elsewhere in this specification.

[0027] All numerical values ​​herein are assumed to be modified by the term “approximately,” whether expressly indicated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to (i.e., having the same function or result as) the stated value. Often, the term “approximately” can be expressed as a number rounded to the nearest significant figure.

[0028] Numerical ranges specified by endpoints include all numbers within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). While several appropriate dimensions, ranges, and / or values ​​relating to various components, features, and / or specifications are disclosed, a person skilled in the art, inspired by this disclosure, will understand that desired dimensions, ranges, and / or values ​​may deviate from those expressly disclosed.

[0029] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include or refer to singular and plural referents unless the content clearly indicates otherwise. As used herein and in the appended claims, the term “or” is generally used to include “and / or” unless the content clearly indicates otherwise.

[0030] The following detailed description should be read with reference to the drawings, where similar elements in different drawings are numbered the same. The detailed description and drawings, which are not necessarily to scale, illustrate exemplary embodiments and are not intended to limit the scope of this disclosure. The illustrated exemplary embodiments are intended for illustrative purposes only. Selected features of any exemplary embodiment may be incorporated into additional embodiments unless expressly stated otherwise.

[0031] This disclosure relates to a device configured for use in combination with an endoscope or similar delivery device to close an internal wound. In some examples, the suturing devices described herein may be configured to be used in combination with a single-working-channel endoscope or a dual-working-channel endoscope within a single working channel or available channel of an endoscope, and in some cases may be operated by a single person, but in some cases a second person may be involved.

[0032] Figure 1 is a perspective view of an exemplary assembly 10, including an exemplary suturing device 12 fixed to the 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 various different endoscopes 14, including but not limited to endoscopes 14 having a main working channel of 2.8 mm, 3.2 mm, or 3.7 mm in diameter. It is also understood that the suturing device 10 may be used with any of the following: endoscopes, colonoscopes, gastroscopes, duodenoscopes, bronchoscopes, ureteroscopes, catheters, medical devices, etc.

[0033] As shown in the figure, the exemplary suturing device 12 includes an end cap 16 configured to secure the suturing device 12 to the endoscope 14. Generally, the first device adapted to be fixed to a second device includes the first device which is directly fixed to the second device, and also the first device which is fixed 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 examples, the suturing device 12 may instead include other structures or mechanisms (not shown) adapted to secure the suturing device 12 to the endoscope 14. In some cases, as shown, the assembly 10 may include a tissue grasping device 18 which can be used to grasp tissue and pull the tissue into the working space 20 so that one or more stitches can be placed in the tissue using the suturing device 12. In some embodiments, the tissue grasping device 18 may be a helical device. A spiral tissue grasping device 18 is shown, but in some cases other types of grasping devices may be used, as long as the grasping device can pass 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, which are configured to move the needle 26 back and forth between the first and second suturing arms 22 and 24. As shown in Figures 7A to 7D, it will be understood that the movement of the first and second suturing arms 22 and 24 causes the needle 26 to move along an arc-shaped path. As the needle 26 passes through the tissue, the needle 26 pulls the suture thread 28 together with the needle 26, thereby pulling the suture thread 28 through the tissue.

[0035] The first suture arm 22 includes a first latch member 30 and a first latch mechanism 32. The second suture arm 24 includes a second latch member 34 and a second latch mechanism 36. As will be described later, the first latch member 30 and the first latch mechanism 32 work together to releasably secure the needle 26 to the first suture arm 22. Similarly, the second latch member 34 and the second latch mechanism 36 work together to releasably secure the needle 26 to the second suture arm 24.

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

[0037] The suturing device 12 includes a second control element 44 attached to a second clevis 46 fixed to the second suturing arm 24 in proximity to a second pivot point 48. The second control element 44 may be, for example, a wire or another elongated structure having sufficient tensile strength to push or pull the second control element 38. When the second control element 44 is pushed distally 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 proximal by a suitable handle mechanism (not shown), the second suturing arm 24 is pivoted inward into the working space 20 and toward the second suturing arm 22. In some cases, other actuation mechanisms are intended, such as the use of one or more gears in a handle mechanism. This is just one example.

[0038] The first latch mechanism 32 is pivotably fixed to the first latch member 30 at a pivot point 50. As illustrated with reference to Figure 6, the first latch mechanism 32 can be opened and closed relative to the first latch member 30 using a third control element. The second latch mechanism 36 is pivotably fixed to the second latch member 34 at a pivot point 56. As illustrated with reference to Figure 6, the second latch mechanism 36 can be opened and closed relative to the second latch member 34 using a fourth control element.

[0039] In particular, with respect to Figure 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 relatively narrower than the wider second suture arm 22. This size mismatch allows the first suture arm 20 to tilt toward the second suture arm 22 and actually pass through the second suture arm 22.

[0040] Figure 3 shows the first suture arm 20 in a horizontal or substantially horizontal position, extending through the second suture arm 22. The first suture arm 20 is positioned to capture the needle 26 when it is supplied through the external tube 62. This may occur, for example, when the needle 26 needs to be replaced. In some cases, the needle 26 may also be used to terminate the suture, meaning that the needle 26 may be left in the patient's body 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 toward the suture site with the needle 26 firmly fixed 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 without the needle 26 instead, and only provide the needle 26 after the assembly 10 has reached the suture site.

[0041] As can be understood, the first suture arm 20 and the second suture arm 22 are not capable of freely pivoting to any arbitrary position, but are configured to provide limitations on their movement. In some cases, for example, the first suture arm 20 may be capable of pivoting from a position approximately 45 degrees from the vertical in an outward direction away from the second suture arm 22 (approximately the position of the first suture arm 20 shown in Figure 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 Figure 3). The second suture arm 22 may be capable of pivoting from a position approximately 45 degrees from the vertical in an outward direction (approximately the position of the second suture arm 22 in Figure 1) to a position approximately 45 degrees from the vertical in an inward direction toward the first suture arm 20.

[0042] The first suture arm 20 and the second suture arm 22 include physical mechanisms to achieve these movement limitations. Figure 4 shows a portion of the first suture arm 20 relative to the end cap 16. It can be seen that the first suture arm 20 includes a pivot pin 66 that interacts with a corresponding surface 68 formed on the end cap 16. It can be seen that portion 70 of the surface 68 is configured to limit how far the first suture arm 20 can pivot outward, while portion 72 of the surface 68 is configured to allow the pivot pin 66 to move across portion 68, allowing the first suture arm 20 to pivot inward to a horizontal orientation.

[0043] Figures 5A and 5B show portions of the second suture arm 22 relative to the end cap 16. It can be seen that the second suture arm 22 includes a pivot pin 74 that interacts with a corresponding surface 76 formed on the end cap 16. It can be seen that portion 78 of the surface 76 is configured to limit how far the second suture arm 22 can pivot outward, while portion 80 of the surface 76 is configured to limit how far the second suture arm 22 can pivot inward. Particularly as seen in Figure 5B, the second suture arm 22 includes pivot stop portions 82 and 84 that prevent the first suture arm 20 from pivoting beyond the horizontal position.

[0044] Figure 6 is a partial cross-section of a suture arm 90, which is thought to represent either the first suture arm 20 or the second suture arm 22. The suture 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 can be considered to represent either the first latch member 30 or the second latch member 34, and the latch mechanism 94 can 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, passes through the opening 106, and enters the opening 108. Depending on whether the suture arm 90 represents a first suture arm 20 or a second suture arm 22, the control element 101 can be considered to represent either a third or a fourth control element. The control element 101 may 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 may represent, for example, a solder ball, or simply a wide portion of the control element 101 that is frictionally secured within the opening 108. By pushing the control element 101, the latch mechanism 94 can be opened relative to the latch member 94, and by pulling the control element 101, the latch mechanism 94 can be closed relative to the latch member 94.

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

[0047] Comparing Figure 6 with Figure 1, it will be understood that the suturing device 12 may include a first rounded pin fixed to the first latch member 30, which is adapted to engage with the latch stopper 104 of the needle 26 when the needle 26 is positioned between the first latch member 30 and the first latch mechanism 32, and a second rounded pin fixed to the first latch mechanism 32, which is adapted to engage with the latch stopper 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 Figure 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 partially extend within the first lumen.

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

[0049] For example, the suturing device 12 may be fixed to the end of the endoscope 14. A needle 26 and suture thread 28 may be loaded into the suturing device 12, and the needle 26 is locked in both the first suturing arm 20 and the second suturing arm 22. The suture thread 28 extends through an external tube 62, and the suturing device 12 (and the endoscope 140) is passed through a region of interest, such as 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 a spiral tissue grasping device 18, may be advanced through 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, inclined so that both the first suturing arm 20 and the second suturing arm 22 are away from the working space 24, in order 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 grasping device can be advanced distally and engaged with the tissue. The tissue grasping device can then be pulled proximal 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 in which the needle 26 can engage with both the first suture arm 20 and the second suture arm 22, thereby allowing the tissue to pass through the needle 26 and suture 28. The needle 26 can be moved from one suture arm to the other by unlocking the suture arm with the needle and locking the arm that receives the needle.

[0050] This is shown, for example, in Figures 7A to 7D. In Figure 7A, the needle 26 is locked in the first suture arm 20, and the first suture arm 20 and the second suture arm 22 are pivoted in an open position so that the first suture arm 20 and the second suture arm 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 working space 24. In Figure 7B, the first suture arm 20 and the second suture arm 22 are tilted toward each other, and the second latch mechanism 36 is open 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, with the first suture arm 20 and the second suture arm 22 being substantially parallel to each other. The first latch mechanism 32 is open, and the second latch mechanism 36 is closed. As a result, the needle 26 is fixed to the second suture arm 22 and released by the second suture arm 22. In Figure 7D, the second suture arm 22 is tilted away from the first suture arm 20, and the needle 26 is fixed to the second suture arm 22.

[0052] Figure 8 is a perspective view of an exemplary assembly 120 including an exemplary suturing device 122 fixed 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 those having a main working channel of 2.8 mm, 3.2 mm, or 3.7 mm in diameter. As shown, the exemplary suturing device 122 includes an end cap 124 configured to fix the suturing device 122 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 fix the suturing device 122 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 proximal to the first suturing arm 126 and a second control wire extending proximal to the second suturing arm 128, thereby allowing the 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 can be locked to the needle 134 via separate control wires that pass through the centers of each of the suturing arms 126 and 128 and releasably engage with corresponding openings formed in the needle 134. It will be understood that the needle 134 includes a first opening positioned to receive a wire extending through the first suture arm 126 and a second opening positioned to receive a wire extending through the second suture arm 128. These openings are referenced in relation to Figure 10. The wires controlling the needle engagement are individually movable, and therefore the needle 134 can be locked to the first suture arm 126 or to the second suture arm 128, or released from either the first suture arm 126 or the second suture arm 128, as desired.

[0054] Figure 9 is a perspective view of an exemplary assembly 140, including an exemplary suturing device 142 fixed to an endoscope 14. The suturing device 142 is similar to the suturing device 122, except that the second suturing arm 128 is replaced by a fixed suturing arm 144.

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

[0056] Figure 11 is a perspective view of an exemplary assembly 150, including an exemplary suturing device 152 fixed to an endoscope 14. Figure 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 those having a main working channel of 2.8 mm, 3.2 mm, or 3.7 mm in diameter. The suturing device 152 includes one stationary arm 154 and one movable arm 156, the movable arm 156 of which may be controlled using a control wire extending from the movable arm 156. The control wire can pivot or swing the movable arm 156 to reciprocate a 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 locking mechanism 160 controlled by the user via the control wire at its proximal end. The needle 158 may also be passively locked to the movable arm 156 via a spring force. In some cases, the operating lock mechanism 160 may be configured to provide sufficient force to overcome the spring force.

[0057] It should be understood that various different materials may be used when forming the devices described herein. In some cases, various different metals may be used. Exemplary but non-limiting examples of suitable metals include titanium, stainless steel, magnesium, cobalt-chromium, 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 polymer material, including biocompatible materials such as polyurethane or silicone. Suitable polymers include PEEK (polyether ether ketone) and polycarbonate. Other suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluoroethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), and polyamides (e.g., DURETHAN® or Elf available from Bayer).CRISTAMID® (available from Atochem), elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, available under trade names such as PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., EMS American This includes, but is not limited to, GRILAMID® (available from Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, 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 thereof.

[0058] Those skilled in the art will recognize that this disclosure may appear in various forms other than the specific embodiments described and intended herein. Accordingly, the forms and details may be modified without departing from the scope and technical concept of this disclosure as set forth in the appended claims. The technical concepts included in this disclosure are described below as an addendum. (Note 1) It is a medical device, A mounting structure adapted to be fixed to the distal end of the endoscope, A first suture arm pivotably fixed to the mounting structure via a first pivot point, A first latch member located at the end of the first suture arm opposite the first pivot point, A first latch mechanism pivotably fixed to the first latch member, wherein the needle is pivotable between a latch position in which it is fixed between the first latch member and the first latch mechanism and a release position. Including the first suture arm, A second suture arm pivotably fixed to the mounting structure via a second pivot point, A second latch member located at the end of the second suture arm opposite the second pivot point, A second latch mechanism pivotably fixed to the second latch member, wherein the needle is pivotable between a latch position in which it is fixed between the second latch member and the second latch mechanism and a release position. Including the second suture arm and A medical device equipped with the following features. (Note 2) The medical device according to Appendix 1, further comprising a first control element operably coupled to the first suture arm, wherein pulling the first control element causes the first suture arm to move toward the second suture arm, and pushing the first control element causes the first suture arm to move toward the second suture arm. (Note 3) The medical device according to Appendix 1 or 2, further comprising a second control element operably coupled to the second suture arm, wherein pulling the second control element causes the second suture arm to move toward the first suture arm, and pushing the second control element causes the second suture arm to move toward the first suture arm. (Note 4) To move the first latch mechanism between its latched position and its released position, a third control element is operably coupled to the first latch mechanism, A fourth control element is operably coupled to the second latch mechanism in order to move the second latch mechanism between its latched position and its released position. A medical device further comprising any one of the appendices 1 to 3. (Note 5) A first rounded pin fixed to the first latch member, the first rounded pin being adapted to engage with the latch return stopper of the needle when the needle is positioned between the first latch member and the first latch mechanism, A second rounded pin fixed to the first latch mechanism, the second rounded pin being adapted to engage with the latch stopper of the needle when the first latch mechanism is in its latched position. A medical device further comprising any one of the appendices 1 to 4. (Note 6) The medical device according to any one of Appendix 1 to 5, wherein the first latching member and the first latching mechanism together define a first lumen adapted to receive the needle when the first latching mechanism is in its latched position, and the first rounded pin and the second rounded pin partially extend into the first lumen. (Note 7) A third rounded pin fixed to the second latch member, the third rounded pin being adapted to engage with the latch return stopper of the needle when the needle is positioned between the second latch member and the second latch mechanism, A fourth rounded pin fixed to the second latch mechanism, the fourth rounded pin being adapted to engage with the latch stopper of the needle when the second latch mechanism is in its latched position. A medical device further comprising any one of the appendices 1 to 6. (Note 8) The medical device according to any one of the appendices 1 to 7, wherein the combination of the second latching member and the second latching mechanism defines a second lumen adapted to receive the needle when the second latching mechanism is in its latched position, and the third rounded pin and the fourth rounded pin partially extend into the second lumen. (Note 9) The medical device according to any one of the appendices 1 to 8, wherein the second suture arm is adapted to allow the first suture arm to pivot through the second suture arm when the first suture arm approaches its horizontal position. (Note 10) It is a medical device, A mounting structure adapted to be fixed to the distal end of the endoscope, A first suture arm pivotably fixed to the mounting structure, the first suture arm having a first width, and being adapted to releasely fix a needle adapted to puncture tissue while containing a suture thread, A second suture arm pivotably fixed to the mounting structure, wherein the second suture arm is adapted to releasably secure the needle, and the second suture arm has 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 in which the first suture arm and the second suture arm are both fitted to move the needle back and forth between them along an arc-shaped path. (Note 11) The medical device as described in Appendix 10, wherein the first suture arm is adapted to pivot from a position approximately 45 degrees from the vertical in an outward direction away from the second suture arm to a horizontal position in an inward direction toward the second suture arm. (Note 12) The medical device according to Appendix 10 or 11, wherein the second suture arm is adapted to pivot from a position approximately 45 degrees from the perpendicular in an outward direction away from the first suture arm to a position approximately 45 degrees from the perpendicular in an inward direction toward the second suture arm. (Note 13) The medical device according to any one of appendices 10 to 12, further comprising a first control element operably coupled to the first suture arm, wherein pulling the first control element causes the first suture arm to move toward the second suture arm, and pushing the first control element causes the first suture arm to move toward the second suture arm. (Note 14) The medical device according to any one of appendices 10 to 13, further comprising a second control element operably coupled to the second suture arm, wherein the second suture arm moves toward the first suture arm by pulling the second control element, and the second suture arm moves toward the first suture arm by pushing the second control element. (Note 15) A third control element operably coupled to the first latch mechanism is used to move the first latch mechanism between its latched position and its released position. A fourth control element is operably coupled to the second latch mechanism in order to move the second latch mechanism between its latched position and its released position. A medical device further comprising any one of the appendices 10-14.

Claims

1. It is a medical device, A mounting structure adapted to be fixed to the distal end of the 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 pivotably fixed to the mounting structure via a first pivot point located at the proximal end of the first suture arm. The first suturing arm is, The first latch member located at the distal end of the first suture arm, A first latch mechanism wherein the needle is pivotable relative to the first latch member between a latched position in which the needle can be fixed between the first latch member and the first latch mechanism by the first latch member and the first latch mechanism, and a released position. Medical devices, including those mentioned above.

2. The medical device according to claim 1, further comprising a first control element operably coupled to the first suture arm, wherein pulling the first control element causes the first suture arm to move toward the second suture arm, and pushing the first control element causes the first suture arm to move toward the second suture arm.

3. The medical device according to claim 1 or 2, wherein the second suturing arm is pivotably fixed to the mounting structure via a second pivot point.

4. The medical device according to claim 3, further comprising a second control element operably coupled to the second suture arm, wherein pulling the second control element causes the second suture arm to move toward the first suture arm, and pushing the second control element causes the second suture arm to move toward the first suture arm.

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

6. A first rounded pin fixed to the first latch member, the first rounded pin being adapted to engage with the latch return stopper of the needle when the needle is positioned between the first latch member and the first latch mechanism, A second rounded pin fixed to the first latch mechanism, the second rounded pin being adapted to engage with the latch stopper of the needle when the first latch mechanism is in its latched position. The medical device according to claim 1 or 2, further comprising:

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

8. The first suture arm is pivotable from a position away from the second suture arm to a position where the needle can be transferred to the second suture arm, and the second suture arm is The second latch member, A second latch mechanism wherein the needle is pivotable relative to the second latch member between a latched position in which the needle is fixed between the second latch member and the second latch mechanism by the second latch member and the second latch mechanism, and a released position. A medical device according to claim 6, including the medical device described in claim 6.

9. The second suture arm is, A third rounded pin fixed to the second latch member, the third rounded pin being adapted to engage with the latch return stopper of the needle when the needle is positioned between the second latch member and the second latch mechanism, A fourth rounded pin fixed to the second latch mechanism, the fourth rounded pin being adapted to engage with the latch stopper of the needle when the second latch mechanism is in its latched position. The medical device according to claim 8, further comprising:

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

11. The medical device according to claim 1, wherein the second suture arm is adapted to allow the first suture arm to pivot through the second suture arm when the first suture arm is positioned at a 90-degree angle from the longitudinal axis of the mounting structure and approaches the second suture arm in a direction closer to the second suture arm.

12. The medical device according to claim 11, wherein the first suture arm has a first length in the direction extending between the proximal end and the distal end of the first suture arm and a first width intersecting the first length, and the second suture arm has a second length in the direction extending between the proximal end and the distal end of the second suture arm and a second width intersecting the second length, wherein the second width is greater than the first width.

13. The medical device according to claim 11 or 12, wherein the first suturing arm is pivotable so that its distal end is adjacent to the distal end of the endoscope in order to capture a needle from the endoscope.

14. The medical device according to claim 11 or 12, wherein the first suture arm is adapted to pivot from a position about 45 degrees from the perpendicular in an outward direction away from the second suture arm to a position 90 degrees from the longitudinal axis of the mounting structure in an inward direction toward the second suture arm.

15. The medical device according to claim 1 or 2, wherein the first latch mechanism is pivotably fixed to the first latch member.

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