Suturing device and method of use thereof
Patent Information
- Application Number
- JP2024515446
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2022-09-07
- Publication Date
- 2025-09-17
AI Technical Summary
Existing surgical methods for urinary incontinence and pelvic organ prolapse, such as mesh repair and native tissue repair, are invasive and difficult, requiring extensive abdominal or transvaginal surgeries.
A suturing device with fixed and movable jaws, a needle transport mechanism, and a loading apparatus that allows for precise suturing and secure needle transfer between jaws, enabling minimally invasive procedures.
Facilitates accurate and efficient suturing within hard-to-reach surgical areas, reducing invasiveness and improving procedural ease while maintaining precision.
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Abstract
Description
[Technical Field]
[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of and priority to National Patent Application No. 2021 / 014052, filed September 7, 2021, the entire contents of which are incorporated herein by reference.
[0002] FIELD OF THE DISCLOSURE The present disclosure relates to suturing devices used in surgical procedures, suture loading apparatus for loading sutures into suturing devices, and methods of their use. [Background technology]
[0003] Urinary incontinence (UI) refers to the unintentional loss of urine. The condition is classified into three different forms: stress UI, urge UI, and mixed UI. The most common is stress UI, which occurs when physical movements or activities such as coughing, blowing, running, or heavy lifting put pressure (e.g., stress) on the bladder.
[0004] Abdominal vaginal stump repair based on natural tissue repair for stress UI is based on elevation of the vaginal wall toward bilateral strong pelvic floor support structures, such as the arcus tendineus fascia pelvis (ATFP) and iliac ligaments. However, natural tissue repair is invasive and difficult because it is an intensive and extensive (abdominal) surgical procedure. Transvaginal surgery is based on mesh repair for SUI. This involves the placement of a tension-free mesh (sling). This method often involves the placement of an artificial implant, such as a synthetic sling or mesh.
[0005] Pelvic organ prolapse refers to the prolapse (fall) of the pelvic organs from their normal positions. The pelvic organs include the vagina, cervix, uterus, bladder, urethra, and rectum.
[0006] Surgical treatment for POP can be performed through the abdomen or vagina. Abdominal surgery to repair POP can be performed either based on natural tissue repair or by placing an artificial mesh. Transvaginal surgery can also be performed either based on natural tissue repair or by placing an artificial mesh. Natural tissue repair performed through the vagina is based on elevation of the vaginal wall or cervix toward strong pelvic floor support structures such as the sacrospinous ligaments, sacrouterine ligaments, and arcus tendineus fasciae pelvis (ATFP) (if the patient's uterus has been removed for another reason). Summary of the Invention [Means for solving the problem]
[0007] In some aspects, the techniques described herein involve a suturing device comprising a fixed arm 7 integral with a fixed jaw 5 including a first gripping slot 103 configured to receive a needle 201; a movable jaw 6 including a second gripping slot 104 configured to receive a needle 201, the movable jaw 6 being configured to pivot about a reference location on and relative to the fixed arm 7 while the fixed jaw 5 remains immovable; and a movable arm 8 coupled to the movable jaw 6, the movable arm 8 being configured to pivot about a reference location on the fixed arm 7 while the fixed arm 7 remains immovable. The present invention relates to a suturing device including: a movable arm (8) configured to pivot about a sub-location and relative to a fixed arm (7), configured to pivot away from the fixed arm (7) and move a movable jaw (6) away from the fixed jaw (5), and configured to pivot toward the fixed arm (7) and move the movable jaw (6) toward the fixed jaw (5) until a needle (201) is positioned within the first gripping slot (103) or the second gripping slot (104); and a needle transport mechanism (4) configured to secure the needle (201) within the first gripping slot (103) or the second gripping slot (104).
[0008] In some aspects, the techniques described herein relate to a suturing device, wherein the fixed arm 7 further includes an arm joint 101 located within a reference location, the arm joint 101 being coupled to a movable arm 8, the movable arm 8 being configured to pivot about the arm joint 101 and relative to the fixed arm 7.
[0009] In some aspects, the techniques described herein relate to a suturing device, wherein the fixed arm 7 further includes a jaw joint 100 located within a reference location, the jaw joint 100 being coupled to a movable jaw 6, and the movable jaw 6 being configured to pivot about the jaw joint 100 and relative to the fixed jaw 5.
[0010] In some aspects, the techniques described herein relate to a suturing device that further includes a connection joint 102 located within a reference location, the connection joint 102 configured to connect a movable arm 8 and a movable jaw 6, and the movable arm 8 configured to move the connection joint 102 and pivot the movable jaw 6 about the jaw joint 100.
[0011] In some aspects, the techniques described herein relate to a suturing device that further includes an attachment member 1105 configured to be attached to a fixed jaw 5 or a movable jaw 6, the attachment member 1105 including a needle 201.
[0012] In some aspects, the techniques described herein relate to a suturing device, wherein the needle transport mechanism 4 further includes a first control bar 505A disposed within the first gripping slot 103 and configured to advance toward the first notch 207A of the needle 201 to grip the needle 201 within the first gripping slot 103 or retract from the first notch 207A to release the needle 201 from the first gripping slot 103, and a second control bar 505B disposed within the second gripping slot 104 and configured to advance toward the second notch 207B of the needle 201 to grip the needle 201 within the second gripping slot 104 or retract from the second notch 207B to release the needle 201 from the second gripping slot 104.
[0013] In some aspects, the techniques described herein are directed to a suturing device, wherein the needle transport mechanism 4 is further configured to advance the first gripping member 510A toward the first notch 207A of the needle 201 disposed within the first gripping slot 103 to grip the needle 201 within the first gripping slot 103, or to retract the first gripping member 510A from the first notch 207A to release the needle 201 from the first gripping slot 103. and a second control bar (505B) disposed within the second gripping slot (104) and configured to advance a second gripping member (510B) toward a second notch (207B) of the needle (201) to grip the needle (201) within the second gripping slot (104) or retract the second gripping member (510B) from the second notch (207B) to release the needle (201) from the second gripping slot (104).
[0014] In some aspects, the techniques described herein include a suturing device, wherein the needle transport mechanism 4 further includes a first cable 3001A configured to advance and release a first spring 3002A, advance a first piston 3003A toward a first notch 207A of the needle 201 disposed in the first gripping slot 103, and grip the needle 201 in the first gripping slot 103, and further configured to retract the first piston 3003A, compress the first spring 3002A, retract the first piston 3003A from the first notch 207A, and release the needle 201 from the first gripping slot 103. and a second cable 3001B configured to advance and release a second spring 3002B and advance a second piston 3003B toward a second notch 207B of the needle 201 disposed in the second gripping slot 104 to grip the needle 201 in the second gripping slot 104, and further configured to retract the second piston 3003B, compressing the second spring 3002B, retracting the second piston 3003B from the second notch 207B, and releasing the needle 201 from the second gripping slot 104.
[0015] In some aspects, the techniques described herein relate to a suturing device further including a lever 3 configured to move between a first position 110A for advancing a first control bar 505A to grip a needle 201 in a first gripping slot 103 and retracting a second control bar 505B to release the needle 201 from the second gripping slot 104, a second position 110B for retracting the first control bar 505A to release the needle 201 from the first gripping slot 103 and retracting the second control bar 505B to release the needle 201 from the second gripping slot 104, and a third position 110C for retracting the first control bar 505A to release the needle 201 from the first gripping slot 103 and advancing the second control bar 505B to grip the needle 201 in the second gripping slot 104.
[0016] In some aspects, the techniques described herein include a suturing device having a first position 110A for advancing a first cable 3001A, releasing a first spring 3002A, advancing a first piston 3003A, grasping a needle 201 in a first gripping slot 103, retracting a second cable 3001B, retracting a second piston 3003B, compressing a second spring 3002B, retracting a second piston 3003B, and releasing the needle 201 from a second gripping slot 104; and a third position 110C for retracting the first cable 3001A, retracting the first piston 3003A, compressing the first spring 3002A, retracting the first piston 3003A, releasing the needle 201 from the first gripping slot 103, advancing the second cable 3001B, releasing the second spring 3002B, advancing the second piston 3003B, and gripping the needle 201 within the second gripping slot 104.
[0017] In some aspects, the techniques described herein include a suturing device having a first position 110A for advancing a first cable 3001A, releasing a first spring 3002A, advancing a first piston 3003A, gripping a needle 201 in a first gripping slot 103, retracting a second cable 3001B, retracting a second piston 3003B, compressing a second spring 3002B, and retracting a second piston 3003B to release the needle 201 from a second gripping slot 104; and a third position 110C for retracting the first cable 3001A, retracting the first piston 3003A, compressing the first spring 3002A, retracting the first piston 3003A, releasing the needle 201 from the first gripping slot 103, advancing the second cable 3001B, releasing the second spring 3002B, advancing the second piston 3003B, and gripping the needle 201 in the second gripping slot 104.
[0018] In some aspects, the techniques described herein relate to a suturing device that further includes a cover 108 that is partially positioned over a lever 3 and includes indicators that correspond to movement of the lever 3 to a first position 110A, a second position 110B, and a third position 110C.
[0019] In some aspects, the techniques described herein relate to a suturing device further including a switching joint 106 coupled to the first control bar 505A and the second control bar 505B.
[0020] In some aspects, the techniques described herein relate to a suturing device, wherein a lever 3 is coupled to a switching joint 106, and the lever 3 is configured to rotate the switching joint 106 and move a first control bar 505A and a second control bar 505B.
[0021] In some aspects, the techniques described herein relate to a suturing device, the suturing device further including a switching joint 106 coupled to the first cable 3001A and the second cable 3001B.
[0022] In some aspects, the techniques described herein relate to a suturing device, wherein a lever 3 is coupled to a switching joint 106, and the lever 3 is configured to rotate the switching joint 106 and pull or advance a first cable 3001A and a second cable 3001B.
[0023] In some aspects, the techniques described herein relate to a suturing device, wherein the movable arm 8 includes a stop 605, and the second control bar 505B includes a safety member 610 configured to interlock with the stop 605 when the lever 3 is in the second position 110B, preventing the movable arm 8 from moving and preventing the needle 201 from falling out.
[0024] In some aspects, the techniques described herein relate to a suturing device in which a stop 605 is configured to slide into an activated position on a movable arm 8, locking the stop 605 adjacent to a safety member 610 and allowing the stop 605 and safety member 610 to interlock.
[0025] In some aspects, the techniques described herein relate to a suturing device where a stop 605 is configured to slide into a deactivated position on the movable arm 8, securing the stop 605 away from the safety member 610 and preventing the stop 605 and the safety member 610 from interlocking.
[0026] In some aspects, the techniques described herein relate to a loading device 10 including a first loading slot 13 disposed within the loading device 10, the first loading slot 13 configured to receive a fixed jaw 5, and a slider 12 including a slot 15 configured to hold a needle 201, the slider 12 configured to move within a loading channel 320 and move the slot 15 holding the needle 201 toward the first loading slot 13 and into the first gripping slot 103 of the fixed jaw 5.
[0027] In some aspects, the techniques described herein relate to a loading device 10 that further includes a pulley 11 that includes a thread 16 coupled to a needle 201, the pulley 11 being configured to rotate to move the thread 16 when the first gripping slot 103 of the fixed jaw 5 exits the first loading slot 13.
[0028] In some aspects, the techniques described herein relate to a loading device 10 that further includes a second loading slot 14 disposed within the loading device 10, the second loading slot 14 configured to receive the movable jaw 6, and the slider 12 configured to move within the loading channel 320 and move the slot 15 that holds the needle 201 toward the second loading slot 14 and into the second gripping slot 104 of the movable jaw 6.
[0029] In some aspects, the techniques described herein are methods, including the steps of: moving a movable arm 8 of a suturing device away from a fixed arm 7 of the suturing device and about a reference location on the fixed arm 7 while the fixed arm 7 remains immovable, the moving the movable arm 8 away pivoting a movable jaw 6 of the suturing device about the reference location and moving the movable jaw 6 away from a fixed jaw 5 extending from the fixed arm 7, which remains immovable and in contact with the cavity tissue; and moving a needle 201 secured in the fixed jaw 5 until the needle 201 is positioned within the movable jaw 6. moving the movable arm 8 about the reference location and toward the fixed arm 7 and pivoting the movable jaw 6 about the reference location and toward the fixed jaw 5 until the needle 201 punctures through the target tissue between the fixed jaw 5 and the movable jaw 6 at the reference location; actuating the needle transport mechanism 4 of the suturing device to transfer the needle 201 from the fixed jaw 5 to the movable jaw 6; moving the movable arm 8 about the reference location and away from the fixed arm 7 and pivoting the movable jaw 6 with the needle 201 about the reference location and away from the fixed jaw 5 to move the needle 201 through the target tissue.
[0030] In some aspects, the techniques described herein relate to methods, wherein pivoting the movable arm 8 relative to the fixed arm 7 and about an arm joint 101, the arm joint 101 being coupled to the movable arm 8 and located in a reference location, and wherein pivoting the movable arm 8 further includes pivoting the movable jaw 6 relative to the fixed jaw 5 and about a jaw joint 100, the jaw joint 100 being coupled to the fixed arm 7 and located in a reference location.
[0031] In some aspects, the techniques described herein relate to methods that further include the steps of moving the movable arm 8, moving a connection joint 102 configured to couple the movable arm 8 and the movable jaw 6, and pivoting the movable jaw 6 about the jaw joint 100.
[0032] In some aspects, the techniques described herein relate to a method further comprising the step of attaching an attachment member 1105 to the fixed jaw 5 or the movable jaw 6, where the attachment member 1105 includes a needle 201.
[0033] In some aspects, the techniques described herein relate to a method, wherein actuating the needle transport mechanism 4 includes retracting a first control bar 505A from a first notch 207A of the needle 201, which is disposed in a first gripping slot 103 of the fixed jaw 5, to release the needle 201 from the first gripping slot 103 of the fixed jaw 5, and advancing a second control bar 505B toward a second notch 207B of the needle 201, which is disposed in a second gripping slot 104 of the movable jaw 6, to grip the needle 201 in the second gripping slot 104 of the movable jaw 6.
[0034] In some aspects, the techniques described herein relate to methods that, following the step of moving a needle 201 secured within the movable jaw 6 through a target tissue, further include the steps of advancing a first control bar 505A toward a first notch 207A of the needle 201 disposed within a first gripping slot 103 of the fixed jaw 5 to grip the needle 201 within the first gripping slot 103 of the fixed jaw 5, and retracting a second control bar 505B from a second notch 207B of the needle 201 disposed within a second gripping slot 104 of the movable jaw 6 to release the needle 201 from the second gripping slot 104 of the movable jaw 6.
[0035] In some aspects, the techniques described herein are methods, including the steps of: moving a lever 3 of a suturing device to a first position 110A, advancing a first control bar 505A from a first notch 207A of a needle 201 disposed in a first gripping slot 103 of a fixed jaw 5 to grip the needle 201 in the first gripping slot 103; retracting a second control bar 505B from a second notch 207B of the needle 201 disposed in a second gripping slot 104 of a movable jaw 6 to release the needle 201 from the second gripping slot 104; and moving a lever 3 of the suturing device to a second position 110B, advancing a first control bar 505A from a first notch 207A of the needle 201 disposed in the first gripping slot 103 of a fixed jaw 5 to grip the needle 201 in the first gripping slot 103. and moving the lever 3 of the suturing device to a third position 110C to retract the first control bar 505A from the first notch 207A of the needle 201 disposed in the first gripping slot 103 of the fixed jaw 5, releasing the needle 201 from the first gripping slot 103, and retracting the second control bar 505B from the second notch 207B of the needle 201 disposed in the second gripping slot 104 of the movable jaw 6, releasing the needle 201 from the second gripping slot 104.
[0036] In some aspects, the techniques described herein relate to a method further including a switching joint 106 coupled to the first control bar 505A and the second control bar 505B, wherein the lever 3 is coupled to the switching joint 106, and the lever 3 is configured to rotate the switching joint 106 and retract or advance the first control bar 505A and the second control bar 505B.
[0037] In some aspects, the techniques described herein relate to methods that further include sliding a stop 605 on the movable arm 8 into an activated position on the movable arm 8 and securing the stop 605 adjacent a safety member 610 of the second control bar 505B that is configured to interlock with the stop 605 when the lever 3 is in the second position 110B, prevent the movable arm 8 from moving, and prevent the needle 201 from falling out.
[0038] In some aspects, the techniques described herein relate to methods that further include pivoting stop 605 into a deactivated position on movable arm 8 and securing stop 605 away from safety member 610 to prevent stop 605 and safety member 610 from interlocking.
[0039] In some aspects, the techniques described herein relate to methods, wherein actuating the needle transport mechanism 4 includes retracting the first control bar 505A and retracting the first gripping member 510A from the first notch 207A of the needle 201, which is disposed in the first gripping slot 103 of the fixed jaw 5, to release the needle 201 from the first gripping slot 103 of the fixed jaw 5, and advancing the second control bar 505B and advancing the second gripping member 510B towards the second notch 207B of the needle 201, which is disposed in the second gripping slot 104 of the movable jaw 6, to grip the needle 201 in the second gripping slot 104 of the movable jaw 6.
[0040] In some aspects, the techniques described herein relate to methods, wherein actuating the needle transport mechanism 4 includes: retracting a first cable 3001A, retracting a first piston 3003A, compressing a first spring 3002A, and retracting the first piston 3003A from a first notch 207A of the needle 201 disposed in a first gripping slot 103 of the fixed jaw 5, releasing the needle 201 from the first gripping slot 103 of the fixed jaw 5; and advancing a second cable 3001B, releasing a second spring 3002B, and advancing the second piston 3003B toward a second notch 207B of the needle 201 disposed in a second gripping slot 104 of the movable jaw 6, to grip the needle 201 in the second gripping slot 104 of the movable jaw 6.
[0041] In some aspects, the techniques described herein are methods comprising the steps of moving a lever 3 of a suturing device to a first position 110A, advancing a first cable 3001A, releasing a first spring 3002A, advancing a first piston 3003A, grasping a needle 201 in a first gripping slot 103 of a fixed jaw 5, retracting a second cable 3001B, retracting a second piston 3003B, compressing a second spring 3002B, retracting a second piston 3003B, releasing a needle 201 from a second gripping slot 104 of a movable jaw 6; and moving a lever 3 of the suturing device to a second position 110B, retracting a first cable 3001A, retracting a first piston 3003A, semi-compressing a first spring 3002A, and semi-retracting a first piston 3003A. retracting the second spring 3002B, releasing the needle 201 from the first gripping slot 103, retracting the second cable 3001B, retracting the second piston 3003B, semi-compressing the second spring 3002B, semi-retracting the second piston 3003B, releasing the needle 201 from the second gripping slot 104; and moving the lever 3 of the suturing device to a third position 110C and retracting the first cable 3001A. and advancing the second cable 3001B, releasing the second spring 3002B, and advancing the second piston 3003B to grip the needle 201 in the second gripping slot 104.
[0042] In some aspects, the techniques described herein relate to a method further including a switching joint 106 coupled to the first cable 3001A and the second cable 3001B, wherein the lever 3 is coupled to the switching joint 106, and the lever 3 is configured to rotate the switching joint 106 and pull or advance the first cable 3001A and the second cable 3001B.
[0043] In some aspects, the techniques described herein are methods comprising the steps of moving a lever 3 of a suturing device to a first position 110A, advancing a first cable 3001A, releasing a first spring 3002A, advancing a first piston 3003A, grasping a needle 201 in a first gripping slot 103 of a fixed jaw 5, retracting a second cable 3001B, retracting a second piston 3003B, compressing a second spring 3002B, retracting a second piston 3003B, releasing a needle 201 from a second gripping slot 104 of a movable jaw 6; and moving a lever 3 of the suturing device to a second position 110B, partially retracting the first cable 3001A, retracting a first piston 3003A, partially compressing a first spring 3002A, and partially retracting a first piston 3003A. retracting the second cable 3001B, gripping the needle 201 in the first gripping slot 103, partially retracting the second cable 3001B, retracting the second piston 3003B, partially compressing the second spring 3002B, partially retracting the second piston 3003B, gripping the needle 201 in the second gripping slot 104; and moving the lever 3 of the suturing device to a third position 110C and retracting the first cable 3001A. retracting the first cable 3001B, retracting the first piston 3003A, compressing the first spring 3002A, retracting the first piston 3003A, releasing the needle 201 from the first gripping slot 103, advancing the second cable 3001B, releasing the second spring 3002B, advancing the second piston 3003B, and gripping the needle 201 in the second gripping slot 104.
[0044] In some aspects, the techniques described herein relate to a method further including a switching joint 106 coupled to the first cable 3001A and the second cable 3001B, wherein the lever 3 is coupled to the switching joint 106, and the lever 3 is configured to rotate the switching joint 106 and pull or advance the first cable 3001A and the second cable 3001B.
[0045] In some aspects, the techniques described herein relate to methods that further include inserting a fixed jaw 5 of a suturing device into a first loading slot 13 disposed in a loading apparatus 10, and moving a slider 12, which includes a slot 15 configured to hold a needle 201 in a loading channel 320 of the loading apparatus 10, to move the slot 15 holding the needle 201 toward the first loading slot 13 and into the first gripping slot 103 of the fixed jaw 5.
[0046] In some aspects, the techniques described herein relate to methods that further include, in response to actuating the needle transport mechanism 4, removing the suturing device and raising the curved needle 18 attached to a first end of the thread 16 opposite the second end of the thread 16 attached to the needle 201.
[0047] In some aspects, the techniques described herein relate to a method that, following the steps of moving movable arm 8 away from fixed arm 7 and pivoting movable jaw 6 away from fixed jaw 5 to move needle 201 through the target tissue, the method further includes the steps of moving movable arm 8 about a reference location and toward fixed arm 7 and pivoting movable jaw 6 about the reference location and toward fixed jaw 5 until needle 201 secured within movable jaw 6 pierces through a different section of the target tissue until needle 201 is disposed within fixed jaw 5; and actuating needle transport mechanism 4 to transfer needle 201 from movable jaw 6 to fixed jaw 5.
[0048] In some aspects, the techniques described herein provide a system including a mesh 2302 extending between a first positioning thread 16A and a second positioning thread 16B, where the first positioning thread 16A is attached to a first positioning needle 201A and the second positioning thread 16B is attached to a second positioning needle 201B; a first loading slot 13A and a second loading slot 13B disposed within a sling loader 2315, where the first loading slot 13A and the second loading slot 13B are configured to receive a fixed jaw 5 of a suturing device; and a first slider 12A attached to the sling loader 2315, where the first slot 15A is configured to hold the first positioning needle 201A. and a second slider 12B attached to the sling loader 2315, the second slider 12B including a second slot 15B configured to hold the second positioning needle 201B, the second slider 12B being configured to move within the second loading channel 320B of the sling loader 2315 and to move the second slot 15B holding the second positioning needle 201B toward the second loading slot 13B and into the first gripping slot 103 of the fixed jaw 5.
[0049] In some aspects, the techniques described herein relate to a system further including a first adjusting thread 2308A, a second adjusting thread 2308B, and a third adjusting thread 2308C, each extending from mesh 2302, wherein second adjusting thread 2308B extends between first adjusting thread 2308A and third adjusting thread 2308C.
[0050] In some aspects, the techniques described herein relate to a system in which each end of a first adjusting thread 2308A includes a first curved needle 2310A and a second curved needle 2310B, each end of the second adjusting thread 2308B includes a third curved needle 2310C and a fourth curved needle 2310D, and each end of the third adjusting thread 2308C includes a fifth curved needle 2310E and a sixth curved needle 2310F.
[0051] In some aspects, the techniques described herein are methods, including the steps of moving a first slider 12A of a loading apparatus 2315 within a first sliding channel 320A of a first loading slot 13A and moving a first needle 201A disposed in a first slot 15A of the first slider 12A into a first gripping slot 103 of a fixed jaw 5 extending from a fixed arm 7 of a suturing device loaded into the first loading slot 13A, the first needle 201A being attached to a first thread 16A attached to a mesh 2302; activating lever 3 of the device to secure first needle 201A within first gripping slot 103; moving movable arm 8 of the suturing device away from fixed arm 7 and about a reference location on fixed arm 7 while fixed arm 7 remains immovable, wherein moving movable arm 8 away pivots movable jaw 6 of the suturing device about a reference location and moves it away from fixed jaw 5 while fixed jaw 5 remains immovable; moving the movable arm 8 about the reference location and toward the fixed arm 7 and pivoting the movable jaw 6 about the reference location and toward the fixed jaw 5 until the attached first needle 201A pierces through a first portion of the tissue to be palpated between the fixed jaw 5 and the movable jaw 6 and the first needle 201A is received within the second gripping slot 104 of the movable jaw 6; removing the suturing device from the pelvic cavity 2208, activating the needle transport mechanism 4 of the suturing device to release the first needle 201A from the second gripping slot 104; moving the second slider 12B of the loading device 2315 within the second sliding channel 320B of the second loading slot 13B of the second slider 12B to move the second needle 201B disposed in the second slot 15B of the second slider 12B into the first gripping slot 103 of the fixed jaw 5 loaded in the second loading slot 13B, the second needle 201B being attached to the second thread 16B attached to the mesh 2302; and actuating the lever 3 of the suturing device to fix the second needle 201B in the first gripping slot 103;moving the movable arm 8 about the reference location and toward the fixed arm 7 and pivoting the movable jaw 6 about the reference location and toward the fixed jaw 5 until the second needle 201B secured in the first gripping slot 103 pierces through a second portion of the tissue to be palpated on the other side of the first portion of the tissue to be palpated between the fixed jaw 5 and the movable jaw 6 and is received in the second gripping slot 104 to place the mesh 2302 in the pelvic cavity 2208; removing the suturing device from the pelvic cavity 2208 and severing the first thread 16A, the second thread 16B, and a portion of the mesh 2302; and attaching the first adjusting suture 2305A, the second adjusting suture 2305B, and the third adjusting suture 2305C to the mesh 2302, wherein the first adjusting suture 2305A and the a first adjusting suture 2305A and a third adjusting suture 2305C are attached to each end of the mesh 2302 for tension adjustment, and a second adjusting suture 2305B is attached to the center of the mesh 2302 for relaxing the mesh 2302; severing curved needles 2310 associated with each of the adjusting sutures 2305, creating a knot 2720 in the thread 2308 of the adjusting sutures 2305, forming a loop, and placing the knot 2720 within the housing 2725, leaving the knot 2720 anchored within the housing 2725 inside the patient's vaginal cavity 2205, closing the incision 2206 within the vaginal cavity 2205; and pulling up the adjusting sutures 2305 associated with the mesh 2302, and adjusting the tension of the mesh 2302 during an early post-operative examination of the patient in an office setting without the need for a new surgery.
[0052] In some aspects, the techniques described herein relate to a method, wherein pulling the adjustment suture 2305 includes pulling a knot 2720 disposed within a housing 2725 attached to the adjustment suture 2305 to adjust the tension of the mesh 2302, and once the tension adjustment is complete, cutting the loop and removing the housing 2725 and the adjustment suture 2305. [Brief explanation of the drawings]
[0053] The present disclosure is further described in the detailed description that follows with reference to the several drawings, which are set forth by way of non-limiting examples of illustrative embodiments, in which like reference numerals represent similar parts throughout the several views of the drawings.
[0054] [Figure 1] 1A and 1B depict one embodiment of a suturing device.
[0055] [Figure 2] 2A and 2B depict one embodiment of a grasping slot of a suturing device.
[0056] [Figure 3-1] 3A and 3B depict an embodiment of a suturing device that includes movement of a movable arm and movable jaw while a needle is secured within the fixed jaw.
[0057] [Figure 3-2] 3C and 3D depict an embodiment of a suturing device that includes a needle transport mechanism for transporting a needle.
[0058] [Figure 3-3] FIG. 3E depicts an embodiment of a suturing device that includes movement of a movable arm and movable jaw while a needle is secured within the movable jaw.
[0059] [Figure 4] 4A, 4B, and 4C depict an embodiment of a suturing device that includes articulations to facilitate movement of the movable arms and jaws.
[0060] [Figure 5-1] FIG. 5A depicts one embodiment of a concave needle for a suturing device.
[0061] [Figure 5-2] 5B, 5C, 5D, and 5E depict one embodiment of a straight needle for a suturing device.
[0062] [Figure 5-3] 5F, 5G, 5H, and 5I depict an embodiment of a needle having an open channel feature-based needle and thread joint.
[0063] [Figure 5-4] FIG. 5J depicts an embodiment of a suturing device that includes a mechanism for locking and releasing needles.
[0064] [Figure 5-5] 5K, 5L, and 5M depict exploded views of certain embodiments of the control bar and gripping members.
[0065] [Figure 5-6] 5N, 5O, and 5P depict an embodiment of a suturing device that includes a mechanism for locking and releasing the needle. [Figure 5-7] 5N, 5O, and 5P depict an embodiment of a suturing device that includes a mechanism for locking and releasing the needle.
[0066] [Figure 6] 6A, 6B, and 6C depict an embodiment of a suturing device that includes a stop in an activated position.
[0067] [Figure 7] 7A and 7B depict an embodiment of a suturing device that includes an activated stop and a safety member that prevents movement of the movable arm and movable jaw when the needle is not secured.
[0068] [Figure 8-1] 8A and 8B depict an embodiment of a suturing device that includes an activated stop that allows movement of the movable arm and movable jaw once a needle is secured within the first grasping slot.
[0069] [Figure 8-2] 8C and 8D depict an embodiment of a suturing device that includes an activated stop that allows movement of the movable arm and movable jaw once a needle is secured within the second grasping slot.
[0070] [Figure 9A] FIG. 9A depicts an embodiment of a suturing device that includes a stop that transitions from an active position to a deactivated position.
[0071] [Figure 9B] 9B and 9C depict exploded views of the stop and movable arm. [Figure 9C] 9B and 9C depict exploded views of the stop and movable arm.
[0072] [Figure 9D] 9D and 9E depict an embodiment of a suturing device including a stop in a deactivated position. [Figure 9E] 9D and 9E depict an embodiment of a suturing device including a stop in a deactivated position.
[0073] [Figure 10] 10A and 10B depict an embodiment of a suturing device that includes a stop in a deactivated position to allow the movable arm to move even when the needle is not secured.
[0074] [Figure 11A] FIG. 11A depicts an exploded view of an embodiment of a suturing device.
[0075] [Figure 11B] 11B and 11C depict an embodiment of a suturing device with attachment members. [Figure 11C]11B and 11C depict an embodiment of a suturing device with attachment members.
[0076] [Figure 12A] 12A and 12B depict embodiments of the shape of a suturing device. [Figure 12B] 12A and 12B depict embodiments of the shape of a suturing device.
[0077] [Figure 13A] 13A and 13B depict an embodiment of a suturing device. [Figure 13B] 13A and 13B depict an embodiment of a suturing device.
[0078] [Figure 13C] FIG. 13C depicts an exploded view of an embodiment of a suturing device.
[0079] [Figure 14] 14A, 14B, and 14C depict one embodiment of a loading device and needle.
[0080] [Figure 15] FIG. 15 depicts a rear view of an embodiment of a loading device.
[0081] [Figure 16] FIG. 16 depicts one embodiment of a loading device with thread.
[0082] [Figure 17] FIG. 17 depicts an embodiment of a suturing device in which the thread is loaded from a loading apparatus.
[0083] [Figure 18] FIG. 18 depicts a flow chart of a method for using a suturing device and loading apparatus.
[0084] [Figure 19] FIG. 19 depicts an embodiment of a suturing device loaded onto a loading fixture.
[0085] [Figure 20-1] 20A-20I depict the use of a loading apparatus to load sutures into a suturing device. [Figure 20-2] 20A-20I depict the use of a loading apparatus to load sutures into a suturing device.
[0086] [Figure 21] FIG. 21 depicts a suturing device securing a needle that is loaded by a loading apparatus.
[0087] [Figure 22A] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity. [Figure 22B] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity. [Figure 22C] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity. [Figure 22D] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity. [Figure 22E] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity. [Figure 22F] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity. [Figure 22G] 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict operation of the suturing device within the cavity.
[0088] [Figure 22DD] FIG. 22DD depicts one embodiment of a surgeon holding a suturing device for palpation during the suturing action.
[0089] [Figure 23] 23A and 23B depict one embodiment of a miniature sling.
[0090] [Figure 24] FIG. 24 depicts a close-up view of an embodiment of a miniature sling including an adjustable suture.
[0091] [Figure 25] FIG. 25 depicts one embodiment of a sling loader for a miniature sling.
[0092] [Figure 26] FIG. 26 depicts one embodiment of a miniature sling mounted on a sling loader.
[0093] [Figure 27A] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27B] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27C] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27D] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27E] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27F] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27G] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27H]27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27I] 27A-27J depict one embodiment of the step of inserting a mini sling. [Figure 27J] 27A-27J depict one embodiment of the step of inserting a mini sling.
[0094] While the above-identified drawings set forth embodiments of the presently disclosed subject matter, other embodiments are also contemplated as described in the discussion. The present disclosure presents illustrative embodiments by way of expression, not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed subject matter. Name List 1A-B Suture device 2A First Handle 2B Second handle 3 Lever 4 Needle transfer mechanism 5 Fixed jaws 6 Movable jaws 7 Fixed Arm 8 Movable Arm 10 Loading device 11 Pulley 12 Slider 12A First Slider 12B Second slider 13 First Loading Slot 14 Secondary Loading Slot 15 slots 15A 1st slot 15B Second Slot 16 Thread 16A First Thread 16B Second Thread 17 Fixed wall 18 Curved needle 100 Temporomandibular joint 101 Arm joint 102 Connecting joints 103 First Gripping Slot 104 Secondary Grasping Slot 105 Arm movement 106 Switching Joint 107 Jaw Movement 108 Cover 110A 1st position 110B Second position 110C 3rd position 112A-BC Safety position 121A-B Safety notch 122A-B notch 123A-B Protrusion 201 needles 201A First Needle 201B Second Needle 201C-DE Embodiments of needle 201 207A First notch 207B Second notch 208 holes 209 channels 301A-B First Fastener 302A-B Second Fastener 320 Loading Channel 505A First Control Bar 505B Second Control Bar 510A First Gripping Member 510B Second gripping member 515A-BC Safety Notch 605 Stop part 606 Lid 607 Flap 608 Protrusion 610 Safety Components 615 Base area 616A-B Notch 617 Sliding Channel 1105A-B Mounting material 1205A-B Length 1800 methods 1802 Steps of the method 1800 1804 Steps of the method 1800 1806 Method 1800 Steps 1808 Method 1800 Steps 1810 Method 1800 Steps 1812 Method 1800 Steps 1814 Method 1800 Steps 2205 Vaginal cavity 2206 Incision 2207 Vaginal wall 2208 Pelvic cavity 2208A Pelvic cavity 2208B Pelvic cavity 2209A-BCDEF Puncture Point 2210 Stop area 2211 index finger 2300 Ultra Small Sling 2302 mesh 2305A-BC Adjustable Suture 2308A-BC Adjustable Suture Thread 2310A-BCDEF Curved needle 2315 Sling Loader 2705 Urethra 2710 Surplus 2720A-BC Knot 2725A-BC Housing 3001A-B Cable 3002A-B Spring 3003A-B Piston 3004A-B stub 3005A-B Geometric Features 3006A-B Geometric Features 3007A-B Geometric Features 3008A-B Mechanical Elements DETAILED DESCRIPTION OF THE INVENTION
[0095] Detailed Description The present disclosure includes an improved suturing device, suture loader, tension-free mid-urethral sling, and methods for their use. The suture loader can load a threaded needle into the suturing device. The suturing device can be inserted into the cavity to access the tissue to be sutured. The suturing device can include a fixed jaw and a movable jaw between which the tissue is positioned for suturing. The fixed jaw remains in a fixed position while the movable jaw moves the threaded needle and sutures the tissue. The suturing device includes a needle transport mechanism that passes the needle between the jaws while suturing the tissue. A stop and safety member can control the movement of the movable jaw as the needle is transported between the jaws and prevent the needle from falling out. Once suturing is complete, the suturing device can be removed from the cavity along with the needle. Section A: Suturing Devices
[0096] 1A and 1B, suturing device 1A can be scissor-shaped and ergonomically sized to reach target tissue in tight spaces. Suturing device 1A can include a fixation arm 7 that is integral with fixation jaw 5. In some embodiments, the distal end of fixation arm 7 includes fixation jaw 5. Suturing device 1A can include a movable arm 8 that is coupled to movable jaw 6.
[0097] The fixed jaw 5 and the movable jaw 6 are capable of both receiving and grasping a needle, and the suturing device 1A may also include a needle transfer mechanism 4 for transferring the needle between the fixed jaw 5 and the movable jaw 6. The needle transfer mechanism 4 may include a lever 3 for controlling the transfer of the needle between the fixed jaw 5 and the movable jaw 6. In some embodiments, the lever 3 extends from the fixed arm 7.
[0098] In some embodiments, suturing device 1A can include a first handle 2A coupled to fixed arm 7 and a second handle 2B coupled to movable arm 8. Handle 2A and handle 2B can assist a user in moving movable arm 8 relative to fixed arm 7. Handle 2A and handle 2B can be located on an end of suturing device 1A that remains outside the cavity during surgery so that the surgeon can control suturing device 1A.
[0099] 2A and 2B depict certain embodiments of a suturing device 1A. In some embodiments, the fixed jaw 5 includes a first gripping slot 103 that can receive a needle 201 (further described with reference to FIG. 5B). In some embodiments, the movable jaw 6 includes a second gripping slot 104 that can receive a needle 201. In some embodiments, the gripping slot is a channel that is sized and shaped to receive the needle. For example, the gripping slot can define a rounded channel or a rounded hole for receiving and gripping the needle.
[0100] In some embodiments, the needle transport mechanism 4 can transport the needle between the first gripping slot 103 and the second gripping slot 104. To do so, the needle transport mechanism can secure the needle in or release the needle from the first gripping slot 103 or the second gripping slot 104.
[0101] 3A-3E show one embodiment of a mechanism for moving and pivoting the movable arm 8 relative to the fixed arm 7 and for pivoting the movable jaw 6 relative to the fixed jaw 5. As shown in FIG. 3A, the movable arm 8 can have an arm movement 105 along which the movable arm 8 pivots away from or toward the fixed arm 7. For example, the arm movement 105 can be triggered by the surgeon's manual movement of the handle 2A to open and close the device 1A. This control can be advantageous while operating within a blind area to ensure that the movement of the device 1A can be under the surgeon's control. In some embodiments, the arm movement 105 can be triggered by an additional mechanical force element, such as a spring.
[0102] The fixed arm 7 can remain immovable relative to the movable arm 8 while the movable arm 8 moves. The movable arm 8 can pivot relative to the fixed arm 7, causing the movable jaw 6 to pivot relative to the fixed jaw 5. Movement of the movable arm 8 relative to the fixed arm 7 can allow the movable jaw 6 to have a jaw movement 107 along which the movable jaw 6 can pivot away from or towards the fixed jaw 5. The fixed jaw 5 can remain immovable relative to the movable jaw 6 while the movable jaw 6 moves. In some embodiments, the movable arm 8 and the movable jaw 6 move relative to the fixed arm 7. In some embodiments, the movable arm 8 and the movable jaw 6 move relative to the fixed jaw 5. In some embodiments, the movable arm 8 and the movable jaw 6 move relative to each other. In some embodiments, the fixed arm 7 and the fixed jaw 5 do not move. In some embodiments, the fixed jaw 5 cannot move independently of the fixed arm 7 because the fixed arm 7 is integral with the fixed jaw 5.
[0103] The fixed jaw 5 can be more easily operated safely in tight spaces because allowing the fixed jaw 5 to remain stationary relative to the target tissue allows the suture to be placed while remaining within a safe area. For example, as the surgeon moves the movable jaw 6 relative to the fixed jaw 5, the surgeon will know the location of the fixed jaw 5. When the target tissue is referenced with the fixed jaw 5 in a surgical location that is difficult to see or not visible at all, the fixed jaw 7 allows the suture to pass through the targeted tissue. The fixed jaw 5 and the movable jaw 6 can be united in a constant or predictable location relative to the tissue so that the location and distance do not need to be constantly predicted to center the tissue. Thus, the fixed jaw 5 allows suturing in areas that are difficult to see.
[0104] 3B, in some embodiments, the movable arm 8 is pivoted relative to the fixed arm 7, allowing the movable jaw 6 to pivot relative to the fixed jaw 5. The movable arm 8 can pivot the movable jaw 6 relative to the fixed jaw 5 until the needle 201 is received in both the first gripping slot 103 and the second gripping slot 104, exchanging the needle between the slots.
[0105] 3A-3E, in some embodiments, lever 3 can move between first position 110A, second position 110B, or third position 110C to control the locking and release of both first gripping slot 103 and second gripping slot 104. For example, lever 3 can be a biaser, gripper, or switch that can be moved by the surgeon. In first position 110A, needle 201 is locked in first gripping slot 103 of fixed jaw 5. As shown in FIG. 3A, when movable arm 8 is moved or released, needle transfer mechanism 4 can grip needle 201 in fixed jaw 5 while keeping the grip inactive in movable jaw 6. As shown in FIG. 3B, when the movable arm 8 is adjacent to the fixed arm 7, the needle transfer mechanism 4 can grasp the needle 201 in the fixed jaw 5 while keeping the grip inactive in the movable jaw 6 by keeping the lever 3 in the first position 110A.
[0106] As shown in Figure 3C, lever 3 can then be moved to second position 110B so that needle 201 is released from first gripping slot 103 while still not secured within second gripping slot 104. As shown in Figure 3C, needle transfer mechanism 4 is inactive in both fixed jaw 5 and movable jaw 6, allowing needle 201 to be released.
[0107] 3D , in the third position 110C, the needle 201 is secured within the second gripping slot 104. As shown in FIG. 3D , the needle transfer mechanism 4 can grip the needle 201 within the movable jaw 6 while keeping the grip inactive within the fixed jaw 5. As shown in FIG. 3E , when the movable jaw 6 is pivoted away from the fixed jaw 5 by movement of the movable arm 8, the needle is secured within the movable jaw 6, thus completing the transfer of the needle between the fixed jaw 5 and the movable jaw 6. As shown in FIG. 3E , when the movable arm 8 is moved or opened, the needle transfer mechanism 4 can grip the needle 201 within the movable jaw 6 while keeping the grip inactive within the fixed jaw 5.
[0108] 3A-3E, in some embodiments, suturing device 1A further includes a cover 108 disposed partially over lever 3. Lever 3 can move between positions to define first position 110A, second position 110B, or third position 110C. In some embodiments, cover 108 includes markings, indentations, or indicators corresponding to movement of lever 3 to first position 110A, second position 110B, or third position 110C.
[0109] 4A-4C depict one embodiment mechanism of suturing device 1A for movement of movable arm 8 relative to fixed arm 7, allowing movable jaw 6 to have jaw translation 107 along which movable jaw 6 pivots away from or toward fixed jaw 5. In some embodiments, fixed arm 7 can include arm joint 101 for coupling fixed arm 7 to movable arm 8. For example, arm joint 101 can be a mechanical joint for connecting two components and allowing them to move relative to one another. In some embodiments, arm joint 101 allows movement of movable arm 8 relative to fixed arm 7. For example, movable arm 8 can pivot about arm joint 101 and relative to fixed arm 7. In another example, arm joint 101 can allow movable arm 8 to pivot relative to fixed arm 7 in one degree of freedom. In yet another embodiment, the arm joint 101 can limit some movement of the movable arm 8, such as to prevent the movable arm 8 from breaking or applying excessive force on the movable jaw 6, slot, or any other component described herein.
[0110] In some embodiments, the fixed arm 7 includes a jaw joint 100. In some embodiments, the fixed jaw 5 includes a jaw joint 100. The jaw joint 100 is coupled to the movable jaw 6 such that the movable jaw 6 can pivot relative to the fixed jaw 5. For example, the jaw joint 100 can be a mechanical joint that connects two components and allows them to move relative to one another. In some embodiments, the movable jaw 6 can pivot about the jaw joint 100 and relative to the fixed jaw 5. For example, the jaw joint 100 can allow the movable jaw 6 to pivot relative to the fixed jaw 5 in one degree of freedom. In another example, the jaw joint 100 can limit some movement of the movable jaw 6, such as to prevent the movable jaw 6 from breaking or applying excessive force on the fixed jaw 5, a slot, or any other component described herein.
[0111] In some embodiments, the suturing device 1A further includes a connection joint 102 coupled to the movable arm 8 and the movable jaw 6. The connection joint 102 can be positioned between the jaw joint 100 and the arm joint 101 such that the jaw joint 100 and the arm joint 101 are decoupled and mechanically independent from one another. The connection joint 102 can allow movement of the movable arm 8 to pivot the movable jaw 6. For example, the connection joint 102 can be a mechanical joint that connects the two components and allows them to move relative to one another. In some embodiments, the movable arm 8 can physically move the connection joint 102 to pivot the movable jaw 6 about the jaw joint 100. Movement of the movable arm 8 can move the connection joint 102, causing the movable jaw 6 to pivot about the jaw joint 100. For example, as shown in FIGS. 4B and 4C , movement of the movable arm 8 away from the fixed arm 7 moves the connection joint 102 across the width of the fixed arm 7. The connecting joint 102 raises the movable jaw 6 , which causes the movable jaw 6 to pivot about the jaw joint 100 and away from the fixed jaw 5 .
[0112] In some embodiments, the connection joint 102 can limit some movement of the movable jaw 6 and the movable arm 8, such as to prevent them from disconnecting or applying excessive force to the slot or any other components described herein. For example, the connection joint 102 can be limited to moving along the width of the fixed arm 7, which would prevent the movable jaw 6 and the movable arm 8 from moving excessively. In some embodiments, the portion of the fixed arm 7 between the jaw joint 100 and the arm joint 101 can remain in a fixed position while the movable jaw 6 moves inside the pelvic cavity and the movable arm 8 moves outside the vaginal cavity. Such movement can advantageously reduce the profile of the movable jaw 6 and the movable arm 8.
[0113] In some embodiments, the fixed arm 7 includes a reference location comprising a jaw joint 100, an arm joint 101, and a connecting joint 102. Pivoting movement of the movable arm 8 and the movable jaw 6 about the reference location allows the suturing device 1A to move like a scissors-type mechanism. For example, the suturing device 1A can be comprised of three rigid metal parts (e.g., (1) the fixed jaw 7, which is integral with the fixed jaw 5; (2) the movable arm 8; and (3) the movable jaw 6) attached to one another using three joints 100-102. The movable jaw 6 and the movable arm 8 can move relative to one another and relative to the fixed arm 7 and the fixed jaw 5 about the reference location in 2D space, as described above. In some embodiments, the movable arm 8 pivots about the reference location and relative to the fixed arm 7. In some embodiments, the movable jaw 6 pivots about the reference location and relative to the fixed arm 5.
[0114] For example, during operation of suturing device 1A inside the pelvic cavity, its outer contour can be designed accordingly to perform suturing in the correct location; fixed arm 7 can be aligned with and remain fixed relative to the specific area of the pelvic cavity, while jaw joint 100, arm joint 101, and connection joint 102 allow the surgeon to move handle 2A, move movable arm 8, and move movable jaw 6. By keeping fixed arm 7 fixed in place, jaws 5 and 6 can be accurately positioned for suturing.
[0115] 5A-5I depict embodiments of needles 201. Needles 201C, 201D, and 201E (generally referred to as needles 201) can include a first notch 207A and a second notch 207B. The location of first notch 207A and second notch 207B on needle 201 allows needle 201 to be grasped in first gripping slot 103, second gripping slot 104, or both. For example, first notch 207A can be attached to fixed jaw 5, and second notch 207B can be attached to movable jaw 6.
[0116] As shown in FIG. 5A, needle 201 can be needle 201C, which has a concave shape. FIGS. 5B, 5C, 5D, and 5E depict an embodiment of needle 201D, which has a straight shape. In some embodiments, needle 201C and needle 201D can include a hole 208. In some embodiments, hole 208 can be used for needle-thread joining by drilling a hole in the center of needle 201C or needle 201D, inserting a thread (e.g., thread 16) into hole 208, and deforming hole 208 with the aid of a suitable die geometry attached to a press. In some embodiments, needle 201 and thread 16 can be joined by using a suitable adhesive instead of deforming hole 208.
[0117] 5F, 5G, 5H, and 51 depict an embodiment of a needle 201E that includes a channel 209. The channel 209 can be an open-channel feature-based joint of the needle 201 and the thread 16. The channel 209 can be open in a central region of the needle 201E. The thread can be placed in the channel 209, and the channel 209 can be deformed onto the thread with the aid of a suitable die geometry attached to a press machine. In some embodiments, the needle 201 and the thread 16 can be joined by using a suitable adhesive instead of deforming the channel 209.
[0118] 5J depicts one embodiment of a needle transport mechanism 4 of suturing device 1A. Needle transport mechanism 4 can allow needle 201 to be retained in or released from jaws 5 and 6 with the aid of alternatingly moving flexible plates (e.g., first and second control bars 505A and 505B, and / or first and second gripping members 510A and 510B). These plates can be pulled or pushed by control levers (e.g., lever 3) attached to the plates. In some embodiments, first control bar 505A, second control bar 505B, first gripping member 510A, and second gripping member 510B can be located within fixed arm 7. In some embodiments, first control bar 505A, second control bar 505B, first gripping member 510A, and second gripping member 510B can be located within fixed jaw 5 and fixed arm 7.
[0119] 5J, needle transport mechanism 4 includes a first control bar 505A and a second control bar 505B. In some embodiments, first control bar 505A and second control bar 505B extend into separate channels in fixed arm 7. In some embodiments, first control bar 505A extends into the channel through fixed jaw 5. In some embodiments, second control bar 505B extends into the channel through movable jaw 6.
[0120] The control bars can independently advance or retract within their respective channels. In some embodiments, the first control bar 505A can advance toward the first gripping slot 103 and toward the first notch 207A or second notch 207B of the needle 201 disposed within the first gripping slot 103 to secure the needle 201 within the first gripping slot 103. In some embodiments, the first control bar 505A can retract from the first gripping slot 103 and the first notch 207A or second notch 207B to release the needle 201 from the first gripping slot 103. In some embodiments, the second control bar 505B can advance toward the second gripping slot 104 and toward the first notch 207A or the second notch 207B of the needle 201 disposed within the second gripping slot 104 to secure the needle 201 within the second gripping slot 104. In some embodiments, the second control bar 505B can retract from the second gripping slot 104 and the first notch 207A or the second notch 207B to release the needle 201 from the second gripping slot 104. For example, the control bars can be retracted within their respective channels.
[0121] The needle transport mechanism 4 can include a switch joint 106 coupled to the lever 3, the first control bar 505A, and the second control bar 505B. In some embodiments, the switch joint 106 is disposed on the fixed arm 7. Movement of the lever 3 can cause movement of the switch joint 106, which in turn causes movement of the first control bar 505A and the second control bar 505B, to secure or release the needle 201 within the first gripping slot 103 or the second gripping slot 104. For example, the switch joint 106 can be a mechanical joint for connecting two components and allowing them to move relative to each other.
[0122] In some embodiments, the lever 3 can rotate or move the switching joint 106, thereby moving the first control bar 505A and the second control bar 505B. For example, the lever 3 can pivot the switching joint 106, and thus push or pull the control bars connected to the switching joint 106. In this manner, movement of the lever 3 can advance the first control bar 505A toward the first gripping slot 103 while retracting the second control bar 505B from the second gripping slot 104, or can retract the first control bar 505A away from the first gripping slot 103 while advancing the second control bar 505B toward the second gripping slot 104. For example, the switching joint 106 is rotated clockwise by the lever 3 such that the first control bar 505A is retracted away from the first gripping slot 103 and the second control bar 505B is advanced toward the second gripping slot 104. In another embodiment, the switching joint 106 is rotated counterclockwise by the lever 3 such that the first control bar 505A is advanced towards the first gripping slot 103 and the second control bar 505B is retracted away from the second gripping slot 104.
[0123] 5K, 5L, and 5M depict exploded views of certain embodiments of first and second control bars 505A, 505B, and first and second gripping members 510A, 510B. In some embodiments, first and second gripping members 510A, 510B extend into separate channels in fixed arm 7. In some embodiments, first gripping member 510A extends into a channel in fixed jaw 5. In some embodiments, first gripping member 510A extends into a channel in movable jaw 6.
[0124] In some embodiments, the control bars are coupled or overmolded onto separate gripping members. For example, the first control bar 505A and the first gripping member 510A can be one bar, such that the first gripping member 510A is an extension of the first control bar 505A. Although not shown, in another example, it is envisioned that the first control bar 505A and the first gripping member 510A can be separate bars, such that the first gripping member 510A is coupled to the first control bar 505A. As shown in FIG. 5M, the first gripping member 510A (or the second gripping member 510B) can flex relative to the first control bar 505A (or the second control bar 505B). The highly elastic nature of the first gripping member 510A and the second gripping member 510B allows them to move and function within the angled channels of the jaws 5 and 6.
[0125] 5J , in some embodiments, the first control bar 505A can advance the first gripping member 510A toward the first notch 207A or the second notch 207B of the needle 201, which is disposed within the first gripping slot 103, to secure the needle 201 within the first gripping slot 103. For example, the first control bar 505A can be pushed toward the first gripping slot 103. In this manner, the movement of the first control bar 505A can cause the first gripping member 510A to grip the first notch 207A or the second notch 207B and grip the needle 201 within the first gripping slot 103.
[0126] In some embodiments, the first control bar 505A can retract the first gripping member 510A from the first notch 207A or the second notch 207B, releasing the needle 201 from the first gripping slot 103. For example, the first control bar 505A can be pulled away from the first gripping slot 103. In this manner, movement of the first control bar 505A can cause the first gripping member 510A to release the first notch 207A or the second notch 207B, releasing the needle 201 from the first gripping slot 103.
[0127] In some embodiments, the second control bar 505B can advance the second gripping member 510B toward the first notch 207A or the second notch 207B of the needle 201, which is disposed in the second gripping slot 104, to grip the needle 201 within the second gripping slot 104. For example, the second control bar 505B can be pushed toward the second gripping slot 104. In this manner, movement of the second control bar 505B can cause the second gripping member 510B to grip the first notch 207A or the second notch 207B of the needle 201 and grip the needle 201 within the second gripping slot 104.
[0128] In some embodiments, the second control bar 505B can retract the second gripping member 510B from the first notch 207A or the second notch 207B, releasing the needle 201 from the second gripping slot 104. For example, the second control bar 505B can be pulled away from the second gripping slot 104. In this manner, movement of the second control bar 505B can cause the second gripping member 510B to release the first notch 207A or the second notch 207B, releasing the needle 201 from the second gripping slot 104. In some embodiments, the control bars or gripping members have different lengths. For example, the first gripping member 510A or the first control bar 505A can be longer than the second gripping member 510B or the second control bar 505B because it must extend a greater distance to reach the first gripping slot 103. In another embodiment, the second gripping member 510B or the second control bar 505B can be longer than the first gripping member 510A or the first control bar 505A because it must be able to bend together with the movable jaw 6 that has the second gripping slot 104.
[0129] The lever 3 can move to the first position 110A, move the switching joint 106, advance the first control bar 505A, advance the first gripping member 510A, and grip the needle 201 in the first gripping slot 103, and retract the second control bar 505B, retract the second gripping member 510B, and release the needle 201 from the second gripping slot 104. For example, as shown in FIG. 5J , the lever 3 can rotate the switching joint 106 counterclockwise and move into the first position 110A. In some embodiments, the lever 3 can move to the first position 110A, move the switching joint 106, advance the first control bar 505A, and advance the first gripping member 510A, and grip the needle 201 in the first gripping slot 103. 5J , by moving lever 3 to first position 110A, switching joint 106 can be rotated counterclockwise, which can advance first control bar 505A to the left and retract second control bar 505B to the right, such that first control bar 505A causes first gripping member 510A to grip needle 201 in first gripping slot 103 and second control bar 505B causes second gripping member 510B to release needle 201 from second gripping slot 104. Lever 3 can include a safety notch 515A on suturing device 1 to maintain lever 3 in first position 110A so that lever 3 is not accidentally moved to a different position during use (e.g., during a surgical procedure).
[0130] The lever 3 can move to the second position 110B, move the switching joint 106, retract the first control bar 505A, retract the first gripping member 510A, and release the needle 201 from the first gripping slot 103, and retract the second control bar 505B, retract the second gripping member 510B, and release the needle 201 from the second gripping slot 104. In some embodiments, the lever 3 can move to the second position 110B, move the switching joint 106, retract the first control bar 505A, retract the first gripping member 510A, and release the needle 201 from the first gripping slot 103.
[0131] For example, as shown in FIG. 5J, when the lever 3 is moved from the first position 110A to the second position 110B, the switching joint 106 can be rotated in a clockwise direction, which can cause the first control bar 505A to be partially retracted to the right and the second control bar 505B to be partially advanced to the left so that the first control bar 505A and the second control bar 505B are in an inactive position that prevents the first gripping slot 103 and the second gripping slot 104 from gripping the needle 201.
[0132] 5J , when the lever 3 is moved from the third position 110C to the second position 110B, the switching joint 106 can be rotated counterclockwise, which can partially advance the first control bar 505A to the left and partially retract the second control bar 505B to the right so that the first and second control bars 505A, 505B are in an inactive position that prevents the first and second gripping slots 103, 104 from gripping the needle 201. The lever 3 can include a safety notch 515B on the suturing device 1 to maintain the lever 3 in the second position 110B so that the lever 3 is not accidentally moved to a different position during use (e.g., during a surgical procedure).
[0133] The lever 3 can be moved to the third position 110C, moving the switching joint 106, advancing the second control bar 505B, advancing the second gripping member 510B, gripping the needle 201 in the second gripping slot 104, and retracting the first control bar 505A, retracting the first gripping member 510A, releasing the needle from the first gripping slot 103. In some embodiments, the lever 3 can be moved to the third position 110C, moving the switching joint 106, advancing the second control bar 505B, advancing the second gripping member 510B, gripping the needle in the second gripping slot 104. 5J , by moving the lever 3 from the second position 110B to the third position 110C, the switching joint 106 can be rotated in a clockwise direction, which can retract the first control bar 505A to the right and advance the second control bar 505B to the left, such that the first control bar 505A causes the first gripping member 510A to release the needle 201 from the first gripping slot 103 and the second control bar 505B causes the second gripping member 510B to grip the needle 201 in the second gripping slot 104. The lever 3 can include a safety notch 515C on the suturing device 1 to maintain the lever 3 in the third position 110C so that the lever 3 is not accidentally moved to a different position during use (e.g., during a surgical procedure).
[0134] 5N, 5O, and 5P, in some embodiments, needle transport mechanism 4 includes cable 3001A, cable 3001B, spring 3002A, and spring 3002B. Cable 3001A and cable 3001B can be attached to lever 3 using stubs 3004A and 3004B at the ends of cables 3001A and 3001B. In some embodiments, cables 3001A and 3001B extend into separate channels in fixed arm 7. In some embodiments, cable 3001A extends into a channel in fixed jaw 5. In some embodiments, cable 3001B extends into a channel in movable jaw 6. In some embodiments, spring 3002A is located in fixed jaw 5. In some embodiments, spring 3002B is located in movable jaw 6.
[0135] Lever 3 can be rotated along switching joint 106. There can be three distinct positions into which lever 3 can be rotated. Lever 3 can be designed so that a predetermined amount of user-applied force is required to change the position of lever 3. In some embodiments, the predetermined amount of user-applied force is based on the tension in cables 3001A and 3001B. Geometric features 3005A, 3005B, 3007A, 3007B, 3006A, and 3006B of fixed arm 7 can be used to route cables 3001A and 3001B in an optimal path. Springs 3002A and 3002B can be mounted on cylindrical pistons 3003A and 3003B and retained by mechanical elements, which can include structural features such as rings, pins, etc., or protrusions (e.g., mechanical element 3008B retains spring 3002B). In some embodiments, the cylindrical piston 3003A is located within the fixed jaw 5. In some embodiments, the cylindrical piston 3003B is located within the movable jaw 6.
[0136] In some embodiments, the proximal ends of pistons 3003A and 3003B (e.g., proximal to the surgeon) are attached to cables 3001A and 3001B, respectively. In some embodiments, the distal ends of pistons 3003A and 3003B can be designed and shaped to engage and grip needle 201. In some embodiments, the distal end of piston 3003A can be advanced to engage and grip needle 201 within fixed jaw 5. In some embodiments, the distal end of piston 3003A can be retracted to disengage and release needle 201 within fixed jaw 5. In some embodiments, the distal end of piston 3003B can be advanced to engage and grip needle 201 within movable jaw 6. In some embodiments, the distal end of piston 3003B can be retracted to disengage and release needle 201 within movable jaw 6.
[0137] In some embodiments, lever 3 can be in a center position (e.g., similar to second position 110B), as shown in FIGS. 5N and 5O. In the center position, cables 3001A and 3001B can both be half-retracted, springs 3002A and 3002B can both be half-compressed, and pistons 3003A and 3003B can both be half-retracted. In some embodiments, when pistons 3003A and 3003B are half-retracted, pistons 3003A and 3003B disengage from needle 201 such that needle 201 can be released from both fixed jaw 5 and movable jaw 6. In some embodiments, when pistons 3003A and 3003B are half-retracted, pistons 3003A and 3003B engage needle 201 such that needle 201 is secured in both fixed jaw 5 and movable jaw 6. In some embodiments, when jaws 5 and 6 are in a closed position (e.g., movable jaw 6 has moved toward fixed jaw 5), needle 201 can be retained by both jaws 5 and 6 and the suturing device (e.g., device 1A or 1B) can be locked.
[0138] In some embodiments, lever 3 can be in a forward position (e.g., similar to first position 110A). In the forward position, lever 3 can cause spring 3002A corresponding to fixed jaw 5 to be fully released by cable 3001A, which can move piston 3003A forward from the spring force, and needle 201 can be retained within fixed jaw 5. At the same time, lever 3 can cause spring 3002B corresponding to movable jaw 6 to be pulled by cable 3001B and fully compressed, which can pull piston 3003B by cable 3001B and release needle 201 from movable jaw 6.
[0139] In some embodiments, lever 3 can be in a rearward position (e.g., similar to third position 110C). In the rearward position, lever 3 can fully release spring 3002B corresponding to movable jaw 6 via cable 3001B, which can move piston 3003B forward from the spring force, and needle 201 can be retained by movable jaw 6. At the same time, lever 3 can fully compress spring 3002A corresponding to fixed jaw 5 via cable 3001A, which can move piston 3003A via cable 3001A, and release needle 201 from fixed jaw 5.
[0140] 6A, 6B, and 6C depict an embodiment of suturing device 1A including a stop 605 in the activated position. From a safety perspective, if movable jaw 6 moves when lever 3 is in second position 110B, needle 201 may fall out because it is not secured in either first gripping slot 103 or second gripping slot 104. To address this issue, suturing device 1A includes stop 605 to control, based on the position of lever 3, when movable arm 8, and therefore movable jaw 6, may move. For example, stop 605 can physically block movable arm 8 from moving, preventing needle 201 from falling out.
[0141] 6A and 6B, stop 605 may be located on movable arm 8 to control when movable arm 8 may move relative to fixed arm 7. For example, stop 605 may grip or secure fixed arm 7, preventing movable arm 8 from moving and preventing needle 201 from falling out. Stop 605 may be located on movable arm 8 and adjacent lever 3 on fixed arm 7 to control movable arm 8 based on the position of lever 3. In some embodiments, stop 605 is covered by lid 606 to protect stop 605.
[0142] The stop 605 can slide on the movable arm 8 between an activated position and a deactivated position. The stop 605 can control the movement of the movable arm 8 when the stop 605 is in the activated position. In the activated position, the stop 605 is positioned closer to the movable arm 8 and is adjacent to the fixed arm 7, gripping a portion of the fixed arm 7 and can control the movement of the movable arm 8 relative to the fixed arm 7.
[0143] The stop 605 can slide on the movable arm 8 from an activated position to a deactivated position in which the stop 605 does not control the movement of the movable arm 8. For example, the stop 605 can be a plastic or metal cap that slides on the movable arm 8. In the deactivated position, the stop 605 is positioned farther away from the movable arm 8 and can avoid gripping the fixed arm 7 and therefore controlling the movement of the movable arm 8 relative to the fixed arm 7. The stop 605 can slide on the movable arm 8 towards the fixed arm 7 and into the activated position to grip the fixed arm 7 and control the movable arm 8.
[0144] 6B and 6C, the stop 605 can include a flap 607 for securing the stop 605 in the activated position. For example, the flap 607 can be a bendable extension of the stop 605. The flap 607 can snap onto and over an edge of the movable arm 8 to secure the stop 605 in the activated position. The flap 607 can bend away from the movable arm 8 to release the stop 605 from the activated position. As shown in FIG. 6C, the surgeon can bend the flap 607 to release the stop 605 from the activated position.
[0145] 7A and 7B depict an embodiment of suturing device 1A including stop 605 in an activated position that prevents movement of movable arm 8 and movable jaw 6 when lever 3 is in second position 110B and thus needle 201 is not secured, and safety member 610. In some embodiments, FIG. 7A shows a cross-sectional view of stop 605 without lid 606. In some embodiments, stop 605 does not have a lid.
[0146] The stop 605 is located on the movable arm 8 so that the stop 605 will move when the movable arm 8 moves. The safety member 610 is located on the fixed arm 7 so that the stop 605 will move relative to the safety member 610 when the movable arm 8 moves. The interlock of the safety member 610 and the stop 605 will therefore prevent the stop 605 from moving, and therefore the movable arm 8 from moving, and the needle 201 from falling out.
[0147] The safety member 610 and the stop 605 can interlock when the stop 605 protrudes relative to the safety member 610. In the activated position, the stop 605 is positioned to interlock with the safety member 610. For example, the stop 605 can block or grip the safety member 610. In some embodiments, when the lever 3 is in the second position 110B (e.g., the needle 201 is not secured) and the jaws are closed, the stop 605 and the safety member 610 interlock and prevent the movable jaw 8 from opening. In some embodiments, when the lever 3 is in the first position 110A or the third position 110C (the needle 201 is secured) and the jaws are open, the stop 605 and the safety member 610 can interlock and prevent the lever 3 from moving to the second position 110B and releasing the needle 201.
[0148] By positioning the stop 605 and safety member 610 to interlock when the lever 3 is in the second position 110B and the jaws are closed, the needle 201 will not fall out when not secured in either the first or second gripping slot 103, 104, but the movable arm 8 may move when the needle 201 is secured in either the first or second gripping slot 103, 104. The safety member 610 and stop 605 can interlock because the stop 605 in the activated position protrudes against the safety member 610 when the lever 3 is in the second position 110B. By protruding against the stop 605, the safety member 610 prevents the movable arm 8, and therefore the movable jaw 6, from moving when the lever 3 is in the second position 110B, preventing the needle 201 from falling out.
[0149] The safety member 610 can be positioned on the second control bar 505B to interlock the stop 605 and the safety member 610 based on the position of the lever 3. As the lever 3 moves the second control bar 505B, the position of the lever 3 determines the position of the safety member 610. The lever 3 in the second position 110B causes the safety member 610 to be in the safety position 112A such that the safety member 610 interlocks with the stop 605, preventing the movable arm 8 from moving relative to the fixed arm 7 and preventing the needle 201 from falling out.
[0150] 8A and 8B depict an embodiment of a suturing device 1A including a stop 605 in an activated position that allows movement of the movable arm 8 and movable jaw 6 when the needle 201 is secured within the first grasping slot 103, and a safety member 610. Lever 3 in first position 110A causes safety member 610 to reside in safety position 112B, which will allow safety member 610 to bypass stop 605 so that movable arm 8 may move.
[0151] 8B depicts the movable arm 8 moving when the lever 3 is in the first position 110A. In the activated position, when the movable arm 8 and movable jaw 6 are open, the stop 605 can prevent the lever 3 from moving from the first position 110A (with the needle 201 secured therein) to the second position 110B (without the needle 201 secured therein) and prevent the needle 201 from falling out.
[0152] 8C and 8D depict an embodiment of suturing device 1A including stop 605 in an activated position that allows movement of movable arm 8 and movable jaw 6 when needle 201 is secured within second gripping slot 104. Lever 3 in third position 110C causes safety member 610 to reside in safety position 112C, which will allow safety member 610 to bypass stop 605 so that movable arm 8 may move.
[0153] 8D depicts the movable arm 8 moving when the lever 3 is in the third position 110C. In the activated position, when the movable arm 8 and movable jaw 6 are open, the stop 605 can prevent the lever 3 from moving from the third position 110C (with the needle 201 secured therein) to the second position 110B (without the needle 201 secured therein) and prevent the needle 201 from falling out.
[0154] 9A, the stop 605 transitions from the activated position to the deactivated position. The surgeon can flex the flap 607 to release the stop 605 from the activated position. The surgeon can pull the stop 605 away from the safety member 610. The stop 605 can slide on the movable arm 8 away from the fixed arm 7 and into the deactivated position. In some embodiments, the surgeon can continue to slide the stop 605 until it is removed from the movable arm 8.
[0155] 9B and 9C depict exploded views of the stop 605 and the movable arm 8. As shown in FIG. 9B , the movable arm 8 can include a base region 615. The base region 615 can be integral with the movable arm 8. The base region 615 can be aligned with the lever 3 or the switching joint 106. The position of the stop 605 relative to the base region 615 can determine whether the stop 605 is in an activated position or a deactivated position. In the activated position, the stop 605 is positioned closer to the movable arm 8 and adjacent to the fixed arm 7, and can grip a portion of the fixed arm 7 or interlock with the safety member 610 to control the movement of the movable arm 8 relative to the fixed arm 7. In the deactivated position, the stop 605 is positioned farther away from the movable arm 8 and avoids gripping the fixed arm 7 and therefore avoiding controlling the movement of the movable arm 8 relative to the fixed arm 7.
[0156] Base region 615 can include notch 616A and notch 616B positioned within sliding channel 617 configured to receive stop 605. Notch 616A and notch 616B can be indentations or cutouts on base region 615. Notch 616A can secure stop 605 in the activated position, and notch 616B can secure stop 605 in the deactivated position. Notch 616A is positioned away from the side edge of movable arm 8 to secure stop 605 closer to movable arm 8 in the activated position. Notch 616B is positioned closer to the side edge of movable arm 8 to secure stop 605 further away from movable arm 8 in the deactivated position.
[0157] 9C , stop 605 can include a protrusion 608 that can be secured within notch 616A or notch 616B. For example, protrusion 608 can be a ridge or a tube that protrudes from stop 605. Protrusion 608 can slide or snap into notch 616A or notch 616B to be secured. Protrusion 608 can slide into notch 616A to secure stop 605 in the activated position. Protrusion 608 can slide into notch 616B to secure stop 605 in the deactivated position.
[0158] 9D and 9E, in the deactivated position, stop 605 is positioned away from locking arm 7 and safety member 610 such that stop 605 and safety member 610 cannot interlock. Regardless of the position of lever 3, and therefore safety member 610, safety member 610 can be positioned so that it does not protrude against stop 605 when stop 605 is in the deactivated position.
[0159] 10A and 10B depict an embodiment of a suturing device 1A including a stop 605 in a deactivated position to allow the movable arm 8 to move even when the needle 201 is not secured. When the stop 605 is in the deactivated position, the movable arm 8 can move when the lever 3 is in the second position 110B and the needle 201 is not secured in either the first gripping slot 103 or the second gripping slot 104. By allowing the movable arm 8 to move when the lever 3 is in the second position 110B, the needle 201 can be released, such as at the end of a suturing operation. In the deactivated position, the stop 605 can allow the lever 3 to move from the first position 110A or the third position 110C to the second position 110B to load, unload, reload, and the like, the needle 201 into the loading apparatus 10, as described below.
[0160] 11A depicts an embodiment of a suturing device 1 A. In some embodiments, a first handle 2A is coupled to a movable arm 8 using a first set of fasteners 301A and 301B. In some embodiments, a second handle 2B is coupled to a stationary arm 7 using a second set of fasteners 302A and 302B.
[0161] 11B and 11C depict an embodiment of a suturing device 1A with mounting member 1105A and mounting member 1105B. In some embodiments, mounting member 1105A or 1105B is already pre-loaded with a needle 201. As shown in FIG. 11B, mounting member 1105A can be configured to be attached to movable jaw 6, which is configured to receive mounting member 1105A. As shown in FIG. 11C, mounting member 1105B can be configured to be attached to fixed jaw 5, which is configured to receive mounting member 1105B. For example, instead of having to load needle 201 into second gripping slot 104, mounting member 1105A with needle 201 can be attached to movable jaw 6 of suturing device 1A. In another example, instead of having to load a needle 201 into the first grasping slot 103, an attachment member 1105B with a needle 201 can be attached to the fixed jaw 5 of the suturing device 1A. In some embodiments, upon completion of the suturing operation, the attachment member 1105A or attachment member 1105B can be removed along with the needle 201, and another attachment member 1105A or attachment member 1105B with a replacement needle 201 can be attached to the fixed jaw 5 or the movable jaw 6. In some embodiments, the surgeon can use the same needle 201 to suturing for more than one suture. For example, if the procedure so requires, the surgeon can also use the same needle 201 to perform suture after suture (sequentially), which is called a Z suture or figure-of-eight suture.
[0162] 12A and 12B depict embodiments of the shape of a suturing device (e.g., suturing device 1A or suturing device 1B). The suturing devices can be of various sizes, shapes, and angles that are optimized based on the anatomy for which the suturing device will be used. The suturing devices can have sizes and angles that are optimized for positional accuracy and for safely repairing pelvic floor disorders in a minimally invasive manner.
[0163] The size and angle of the devices can be selected according to the target ligament each device is designed to reach and the passageway each device must navigate to reach the target ligament. For example, the passageway may have obstacles, such as hard and soft tissue. The size and angle can ensure that the surgical method for using the suturing device can maneuver the suturing device through the passageway so that the device can be delivered to the target ligament in a minimally invasive manner. For example, the area of the passageway may be within the pelvic cavity, which can be very similar between patients with minimal standard deviation. Therefore, calculations can be accurate across patients, even though the patients may have different physical parameters (e.g., height, weight, etc.). The size and angle can be selected according to the target ligament. For example, once the device is delivered to the target ligament, the outer contour of the fixation jaw 5 can be used for positional accuracy.
[0164] The suturing device can have a length such that handles 2A and 2B can be positioned outside the cavity during operation of the suturing device, while the length defines a portion of the suturing device that can be positioned inside the cavity. For example, the suturing device can have a length and angle for a transvaginal approach or procedure. As shown in FIG. 12A , the fixation jaw 5 can extend at an angle of 77.2 degrees relative to the fixation arm 7. The length 1205A can be measured from the tip of the fixation jaw 5 and fixation arm 7. As shown in FIG. 12B , the fixation arm 7 can have a distal portion that extends at an angle of 15.88 degrees relative to the proximal portion. The fixation jaw 5 can extend at an angle of 130 degrees relative to the fixation arm 7. The fixation jaw 5 and fixation arm 7 can have a length 1205B. It is envisioned that the suturing device can be modified to modify the size, shape, and angle to optimize the suturing device for a particular cavity and operation.
[0165] 13A, 13B, and 13C depict an embodiment of suturing device 1B. Suturing device 1B can be similar to suturing device 1A, but differs in that its components have different angles, sizes, and shapes to optimize suturing device 1B for the anatomical structure for which suturing device 1B will be used. FIG. 13C depicts an exploded view of an embodiment of suturing device 1B. In some embodiments, first handle 2A is coupled to stationary arm 7 using a first set of fasteners 301A-301B. In some embodiments, second handle 2B is coupled to movable arm 8 using a second set of fasteners 302A-302B. In some embodiments, suturing device 1B can use attachment member 1105A or attachment member 1105B, as described with reference to FIGS. 11B and 11C. For example, mounting member 1105A can be configured to be attached to movable jaw 6, which is configured to receive mounting member 1105A. In another embodiment, mounting member 1105B can be configured to be attached to fixed jaw 5, which is configured to receive mounting member 1105B. Section B: Suture Loader
[0166] 14A-14C, 15, and 16 depict embodiments of a loading apparatus 10 for loading a needle 201 into a suturing device 1A or 1B in a practical and standardized manner. FIG. 15 depicts the back side of an embodiment of the loading apparatus 10. In some embodiments, the loading apparatus 10 includes a first loading slot 13 disposed within the loading apparatus 10. In some embodiments, the first loading slot 13 can receive a fixed jaw 5. For example, the first loading slot 13 can form a channel within the loading apparatus 10. The channel can be sized and angled to receive the fixed jaw 5 such that the fixed jaw 5 can fit securely within the first loading slot 13 and receive the needle 201. The channel can be defined by one or more sidewalls within which the fixed jaw 5 can be positioned. The fixed wall 17 may enable the fixed jaw 5 to maintain its position within the first loading slot 13 of the loading device 10 while receiving the needle 201 .
[0167] 14C , in some embodiments, the loading device 10 includes a slider 12 that includes a slot 15 for holding a needle 201. The slot 15 can be sized and shaped to hold the needle 201. For example, the slot 15 can include a rounded hole or define a channel sized to receive the needle 201. The needle 201 can be placed in the slot 15, securing the needle 201 therein. The slider 12 can move the needle 201 within the slot 15 while the needle 201 remains coupled to the thread 16.
[0168] The slider 12 can insert the needle 201 into the first gripping slot 103. In some embodiments, the slider 12 can move within the loading channel 320 to move the slot 15 holding the needle 201 toward the first loading slot 13 and into the first gripping slot 103 of the fixed jaw 5. For example, the loading channel 320 can define a space within which the slider 12 can move. The loading channel 320 and slider 12 can be sized so that the slider 12 slides within the loading channel 320 but does not fall out of the channel. For example, the slider 12 can be moved to two distinct positions for the needle 201 to engage the fixed jaw 5: one for advancing the needle 201 into the first gripping slot 103, and another for retracting the slider 12 after the needle 201 is secured within the first gripping slot 103.
[0169] In some embodiments, the loading apparatus 10 includes a pulley 11 that includes a thread 16 that is coupled to the needle 201. The thread 16 can be wound or wrapped around the pulley 11. In some embodiments, the pulley 11 can rotate such that the thread 16 moves when the first gripping slot of the fixed jaw 6 exits the first loading slot 13. For example, the pulley 11 can be shaped like a wheel with a grooved periphery around which the thread 16 is wound. In some embodiments, the thread 16 can be wound around the pulley 11 for loading the needle 201 back into the loading apparatus 10 after being loaded into the suturing device 1A or suturing device 1B. This feature may be useful in many instances during a procedure, such as when, after passing a first suture, the surgeon decides to perform a Z-stitch using the same needle 201 and may therefore be able to load it back into the loading apparatus 10, from which the needle 201 may be loaded into the suturing device 1A or suturing device 1B.
[0170] In some embodiments, the loading apparatus 10 includes a second loading slot 14 disposed therein. In some embodiments, the second loading slot 14 can receive the movable jaw 6. The second loading slot 14 can form a channel within the loading apparatus 10. The channel can be sized and angled to receive the movable jaw 6 such that the movable jaw 6 can fit securely into the second loading slot 14 while the fixed jaw 6 is in the first loading slot 13. For example, the loading channel 320 can be defined by one or more sidewalls within which the fixed jaw 5 can be positioned. Although not shown, in some embodiments, the slider 12 can move within the loading channel 320 to move the slot holding the needle 201 toward the second loading slot 14 and into the second gripping slot 104 of the movable jaw 6. For example, slider 12 can be moved to two distinct positions: one for advancing needle 201 into second gripping slot 104, and another for retracting slider 12 after needle 201 is secured in second gripping slot 104. In another example, slider 12 can be moved to three distinct positions: one for advancing needle 201 into second gripping slot 104, another for retracting slider 12 after needle 201 is secured in second gripping slot 104, and another for advancing needle 201 into first gripping slot 103. In some embodiments, pulley 11 can rotate such that thread 16 moves through second loading slot 14 as second gripping slot 104 of movable jaw 6 exits second loading slot 14.
[0171] FIG. 17 depicts one embodiment of a thread 16 with a curved needle 18 for securing the thread 16 in the loading apparatus 10. The thread 16 can be coupled to a needle 201 at one end, and the curved needle 18 can be at the other end of the thread 16. The curved needle 18 can be replaced if necessary. For example, the thread 16 can be tethered or untethered from the curved needle 18. The curved needle 18 can have a sharp end that hooks onto, attaches to, or wraps around a pulley 11 to secure the curved needle 18. The curved needle 18 can be mounted on a pulley 11 to allow the pulley 11 to wind the thread 16. The pulley 11 allows the thread 16 to unwind in a controlled manner after the suturing device 1 is removed from the loading apparatus 10, preventing the thread 16 from relaxing and forming knots or clumps. Section C: Method
[0172] FIG. 18 depicts a flowchart of a method 1800 for using suturing device 1A and loading apparatus 10 for suturing. Method 1800 may include the step of providing suturing device 1A or suturing device 1B (step 1802). It is envisioned that method 1800 may be practiced with any other embodiment of a suturing device. The shape of the suturing device and the angle between the jaws and arms may be optimized for a particular procedure or ligament. For example, the angle may be optimized for safety to prevent injury to other tissues, such as the bladder. The surgeon may select suturing device 1A or suturing device 1B based on the treatment site to be sutured. For example, the surgeon may select from among the suturing devices based on the ligament to be sutured.
[0173] Method 1800 may include inserting suturing device 1A or 1B into loading device 10 (step 1804). Lever 3 is pulled toward handle 2 to be in second position 110B, allowing needle 201 to be received within fixed jaw 5. Prior to placing suturing device 1A in loading apparatus 10, stop 605 may be moved to a deactivated position to allow lever 3 to move from first position 110A or third position 110C to second position 110B. As shown in FIG. 19 , movable jaw 6 of suturing device 1A may be opened relative to fixed jaw 5. Suturing device 1A may be placed on suture loading apparatus 10 in such a way that fixed jaw 5 fits into first loading slot 13 and movable jaw 6 fits into second loading slot 14.
[0174] Method 1800 can include loading a needle 201 into suturing device 1A (step 1806). Figure 20A is a front view of slider 12 in an initial (e.g., default) position when needle 201 is loaded into slider 12, and Figure 20B is a rear view thereof. Figure 20C is a front view of slider 12 being moved along loading channel 320 to move needle 201 into fixed jaw 5, and Figure 20D is a rear view thereof. The needle slider 12 can be moved toward fixed jaw 5. The slider 12 can be driven within loading channel 320 to load needle 201 into fixed jaw 5. The needle 201 can be loaded into first gripping slot 103.
[0175] As shown in FIGS. 20A-20I, in some embodiments, slider 12 includes safety notches 121A-122B in loading channel 320 and protrusions 123A-123B on slider 12 to create a clicking effect to notify the surgeon that needle 201 is successfully loaded. Safety notches 121A-122B and protrusions 123A-123B can provide a clicking effect that notifies the surgeon that needle 201 has been successfully loaded based on notches 121A and 121B or successfully unloaded based on notches 122A and 122B. FIGS. 20E and 20F show closer views of slider 12 shown in FIGS. 20B and 20D, respectively. FIGS. 20G, 20H, and 20I show details of slider 12 from different views. Figure 20I shows a front view of the slider 12 according to Figure 20E. Figure 20G shows a rear view of the slider according to Figure 20E. Figure 20H shows a perspective view of the slider 12 according to Figure 20E.
[0176] FIG. 21 shows a needle 201 from the loading device 10 secured in the first gripping slot 103 of the fixed jaw 5. After the slider 12 loads the needle 201 into the first gripping slot 103, the lever 3 can be moved to the first position 110A to grip the needle 201 in the first gripping slot 103 of the fixed jaw 5. As shown in FIG. 21 , the lever 3 can be pulled upward and into the first position 110A. For example, the lever 3 can be moved from the second position 110B to the first position 110A. The stop 605 can be in a deactivated position to allow the lever 3 to be moved from the first position 110A or the third position 110C to the second position 110B. After securing the needle 201 in the first gripping slot of the fixed jaw 5, the slider 12 can be moved away from the fixed jaw 5 while the needle 201 remains secured in the first gripping slot of the fixed jaw 5.
[0177] After receiving the needle 201, the suturing device 1A can be separated from the loading apparatus 10, and the needle 201 will pull up the thread 16 wound onto the pulley 11. The suture thread 16 can be pulled from the pulley 11 and therefore from the loading apparatus 10. One end of the thread 16 can remain attached to the curved needle 18, which remains attached to the pulley 11.
[0178] In some embodiments, instead of steps 1804 and 1806, mounting member 1105A or mounting member 1105B, already pre-loaded with needle 201, can be attached to suturing device 1A or 1B. The mounting can be attached to fixed jaw 5 or movable jaw 6, as shown in FIGS. 11B and 11C. For example, instead of having to load needle 201 with loading apparatus 10, the surgeon can attach the mounting to suturing device 1A or 1B for suturing with the mounting. Upon completion of the suturing operation, the mounting can be removed along with needle 201, and another mounting with a replacement needle 201 can be attached to fixed jaw 5 or movable jaw 6.
[0179] The method 1800 may include a step of moving the suturing device 1A into the vaginal cavity (step 1808). As shown in FIG. 22A , the suturing device 1A may be inserted into the vaginal cavity 2205. The surgeon may make an incision 2206 (e.g., a 3 cm incision) in the wall of the vagina and insert the suturing device 1A through the incision 2206 to reach the pelvic cavity 2208 (e.g., Retzius's space) where the suturing operation is performed (e.g., the ATFP is in the vaginal cavity) and the suture is delivered to the pelvic cavity. As shown in FIG. 22B , the suturing device 1A may be inserted into the vaginal cavity 2205. As shown in FIG. 22C , the suturing device 1A may be inserted into the pelvic cavity 2208 through the vaginal cavity 2205 so as not to open any incisions in the abdomen, and the suturing device 1A may be inserted. The surgeon can move the suturing device 1A into the vaginal cavity 2205 while the movable jaw 6 is closed against the fixed jaw 5.
[0180] As shown in FIG. 22D , the surgeon can move the suturing device 1A until the fixed jaw 5 or the movable jaw 6 touches the target tissue inside the pelvic cavity 2208, which allows the surgeon to safely position the suturing device 1A. For example, the surgeon can determine the placement geographic location of the target tissue (e.g., the ATFP for an SUI procedure) by palpating the target tissue, and then the surgeon can move the suturing device 1A until the fixed jaw 5 or the movable jaw 6 touches the palpated ligament in the closed position. Once the fixed jaw 5 or the movable jaw 6 touches the palpated tissue, the surgeon can infer that the suturing device 1A is properly positioned. For example, the suturing device 1A can be inserted into the pelvic cavity 2208, which may be the surgical site, through an incision 2206 made in the wall of the vagina.
[0181] The suturing device 1A can be designed based on the length of the cavity into which the suturing device 1A is expected to be inserted. The area of the point on the suturing device 1A that remains outside the cavity when the surgeon stops inserting the suturing device 1A can be understood as the stop area 2210. For example, the stop area 2210 can be near the arm joint 101. In another embodiment, during operation of the suturing device 1A, the arm joint 101 can be positioned outside the vaginal cavity 2205, while a portion of the suturing device 1A can be positioned inside the vaginal cavity 2205. In another embodiment, the stop area 2210 is closer to the handle 2A and the handle 2B so that the suturing device 1A is inserted further into the vaginal cavity 2205.
[0182] As shown in FIG. 22DD, in some embodiments, the shape of the suturing device 1B can be advantageous for palpation during the suturing operation. During the POP operation, the surgeon can use their index finger 2211 to locate the ligament where the suture will be placed and determine a safe area on the ligament where the suture should be placed. The surgeon can bring the suturing device 1B to this safe area and pass the suture. In some embodiments, the shape of the suturing device 1B can match the shape of the index finger 2211 during palpation, and the size of the suturing device 1B can be adapted to interface with the surgeon's index finger 2211 during palpation. The shape and size of the fixed suturing device 1B and fixed jaws 5 allow the surgeon to place the suturing device 1B, palpate, and pass the suture under their index finger 2211 and in one step. The suturing device 1B, with its size, shape and fixed jaw 5, is able to conform to the shape of the index finger 2211 and cooperate harmoniously with the index finger 2211 of the surgeon.
[0183] 18 , method 1800 can include the step of opening movable arm 8 relative to fixed arm 7 and unwrapping movable jaw 6 (step 1810) until tissue within pelvic cavity 2208 is between fixed jaw 5 and movable jaw 6. As shown in FIG. 22E , the surgeon can retract suturing device 1A away from the tissue to create a safe distance for opening movable jaw 6 relative to fixed jaw 5. After opening movable jaw 6, the surgeon can position fixed jaw 5 over the tissue to be sutured.
[0184] The expansion of suturing device 1A, caused by the opening of handles 2A and 2B, can remain outside of the vaginal cavity 2205. Movement of movable arm 8 within the vaginal cavity 2205 can cause movable jaw 6 to pivot about jaw joint 100 inside the pelvic cavity 2208. Because movable arm 8 can move movable jaw 6 while fixed jaw 5 and fixed arm 7 can be in the same position, the surgeon can predict where needle 201 will be sutured, which allows the surgeon to more safely suture tissue that is difficult to see or not visible at all.
[0185] Method 1800 may include the step of closing movable arm 8 relative to fixed arm 7, closing movable jaw 6, and moving needle 201 through tissue (step 1812). As shown in FIGS. 22E and 22F , fixed jaw 5 can provide a fixed reference while movable jaw 6 moves, and tissue inside pelvic cavity 2208 to be sutured can be positioned between fixed jaw 5 and movable jaw 6. By moving movable jaw 6 relative to fixed jaw 5, needle 201 is passed through the tissue. Although the location where suturing is required may be narrow, deep, and in an area that is difficult or not visible at all to the surgeon, needle 201 can be sutured at the desired location because the movement of movable jaw 6 is predictable and precise while fixed jaw 5 remains stationary relative to the target tissue. As shown in FIG. 22F, the surgeon can close the movable arm 8 against the fixed arm 7 and close the movable jaw 6 against the fixed jaw 5.
[0186] Method 1800 may include the step of actuating needle transport mechanism 4 to transport needle 201 from fixed jaw 5 to movable jaw 6 and pass suture (step 1814). The surgeon may move lever 3 to transport needle 201 from fixed jaw 5 to movable jaw 6. By pulling lever 3 toward handle 2 and into third position 110C, needle 201 is transported and secured within movable jaw 6. Needle 201 may be transported from first gripping slot 103 of fixed jaw 5 to second gripping slot 104 of movable jaw 6. Having fixed jaw 5 in a fixed location while transporting needle 201 may allow for safe transport of needle 201 when tissue is difficult to see or not visible at all.
[0187] As shown in FIG. 22G, the needle 201 has been transferred to the movable jaw 6. The movable jaw 6 moves away with the needle 201, opening it up against the fixed jaw 5 so that it can be positioned for another suture. As shown in FIGS. 22A-22G, the needle 201 was first loaded into the fixed jaw 5, so that the needle 201 was transferred from the fixed jaw 5 to the movable jaw 6. However, it is envisioned that the needle 201 may be first loaded into the movable jaw 6 (e.g., second gripping slot 104). The movable jaw 6 and needle 201 can pierce through tissue and move toward the fixed jaw 5 until the needle 201 is positioned within the fixed jaw 5 (e.g., first gripping slot 103).
[0188] Because the suturing devices described herein are capable of transferring needle 201 between the jaws, the surgeon can use the same device to reach and suture a treatment site instead of relying on one device to manipulate the treatment site and another device to suture. Transferring needle 201 between the jaws also allows for sequential suturing. For example, if the procedure so requires, the surgeon can also use the same needle 201 to place suture after suture (sequentially), which is called a Z-suture or figure-of-eight suture.
[0189] After performing the sutures, the suturing device 1A can be removed from the pelvic cavity 2208. The stop 605 can be moved into a deactivated position and the lever 3 can be moved into a second position 110B to release the needle 201 from both the fixed jaw 5 and the movable jaw 6. Because the needle 201 is attached to the thread 16, which is itself attached to the curved needle 18, the surgeon can release the needle 201 and remove the suturing device 1A, but keep the thread 16 sutured within the pelvic cavity 2208.
[0190] For example, for stress urinary incontinence surgery, the surgeon can load the device four times to pass four sutures using needle 201. Two of these sutures can be placed on the left ATFP and two on the right ATFP. For example, there are two ATFPs in the pelvis that are symmetrically placed, one on the left side of the pelvis and the other on the right side. These sutures can be placed by inserting the suturing device into the pelvic cavity 2208 through an incision 2206 in the vaginal cavity 2205 and by turning the jaws of the device to the right and left, respectively. It is envisioned that the procedure can be performed using two sutures or a different number of sequential sutures, depending on the procedure, the suturing device, and the surgeon's preference. For example, a procedure using suturing device 1B can use one suture or two sutures on the same side.
[0191] After each suture is completed, the surgeon can move the suturing device 1A out of the pelvic cavity 2208. The surgeon can release the used needle 201, with the thread 16 attached to the curved needle 18, from the suturing device 1A so that the thread 16 remains sutured within the pelvic cavity 2208. The surgeon can reload another needle into the suturing device 1A until four such sutures have been passed. After four sutures have been placed, the four threads 16 and their respective curved needles 18 remain attached and protruding from the pelvic cavity 2208.
[0192] After completing the four sutures using the needles 201, the surgeon can pass or withdraw the four sutures by withdrawing the curved needles 18 attached to each thread 16. These sutures can form loops with the sutures placed on the vaginal wall and passed over the ATFP using the needles 201. For example, the surgeon can pull the ends of each suture toward each other, which has the effect of bringing the vaginal wall closer to the ATFP on both sides (e.g., left and right) and elevating the vaginal wall, bladder, and urethra, thus restoring their anatomical positions. The surgeon can tie each loop (e.g., four in total) with a knot and cut off the excess thread 16, and thus the needles 201 and curved needles 18.
[0193] In some embodiments, the surgeon can create the loop without using the curved needle 18 attached to the other end of the thread 16. For example, the surgeon can pull up the needle 201 to pass the suture through the vaginal tissue in the vaginal cavity 2205, pull up the thread 16, and use the thread 16 to connect the loop.
[0194] The surgeon can use standard sutures to close the incision 2206 that was opened to place the suturing device 1A into the cavity. For example, the surgeon can use standard sutures in conjunction with a standard suturing device, such as a needle holder and thumb forceps. In another example, the surgeon can use a needle holder and thumb forceps to perform a suturing pattern.
[0195] In some embodiments, suturing device 1A and suturing device 1B can be used for natural tissue repair without synthetic implants (e.g., by using a sling or mesh, or in place of mid-urethral sling surgery for SUI or mesh surgery for POP). For example, the suturing device can also be used to aid in the placement of an "adjustable single-incision sling" (e.g., a miniature sling that can tighten and relax as needed to treat stress urinary incontinence) within the pelvic cavity 2208. Each end of the miniature sling can include a needle 201, which can be loaded into a specialized loading device to form a kit for placing the miniature slings. The suturing device can load each needle, suture each needle to a different end of the pelvic cavity 2208, and place the miniature sling 2300 along the pelvic cavity 2208.
[0196] FIG. 23A depicts one embodiment of a mini sling 2300. The mini sling 2300 can be an adjustable, tension-free, single-incision mid-urethral sling. The mini sling 2300 can have a rectangular shape that tapers toward the edges, allowing for atraumatic placement. The suturing device can be for placement of an adjustable, tension-free "single-incision mid-urethral sling (mini sling)" in addition to the suture placement described in this patent. The tension of the mini sling 2300 can be adjustable. The mini sling 2300 can be tension-free by not needing to be secured to tissue with anchors. This can be advantageous over slings that allow only the surgeon to adjust the tension of the sling during surgery, meaning that once the tension is adjusted, the mini sling is secured in the tissue using anchors.
[0197] The ultra-small sling 2300 can include a mesh 2302 that narrows from the center to the edges. For example, the mesh 2302 (e.g., a rectangular portion) can be 6 cm long. One edge is attached to thread 16A, which is itself attached to needle 201A, and another edge is attached to thread 16B, which is itself attached to needle 201B. FIG. 23B depicts a close-up view of needle 201B. The surgeon can use needles 201A and 201B to load the ultra-small sling 2300 into suturing device 1A or suturing device 1B and deliver the ultra-small sling 2300 into the pelvic cavity 2208 for placement. Because needles 201A and 201B are positioned at both ends, needles 201A and 201B can allow each end of micro-sling 2300 to be loaded into suturing device 1A or 1B, which can then move micro-sling 2300 to a target location for placement of micro-sling 2300 within pelvic cavity 2208.
[0198] 24 depicts a close-up view of an embodiment of a micro sling 2300 including adjusting sutures 2305A-2305C. For example, the micro sling 2300 can include three adjusting sutures 2305A-2305C. Although not shown, the micro sling 2300 can include fewer or additional adjusting sutures. Each of the adjusting sutures 2305A-2305C can include a thread 2308A-2308C. Each of the threads 2308A-2308C can be attached to the mesh 2302 by the surgeon after placing the mesh 2302 in the pelvic cavity 2208. Each of the adjusting sutures 2305A-2305C can include a curved needle 2310A-2310F attached to each end of the thread 2308A-2308C such that the curved needles 2310A-2310F extend from outside the mesh 2302 and the pelvic cavity 2208 after the adjusting sutures 2305A-2305C are attached to the mesh 2302 by the surgeon. The curved needles 2310A-2310F can be pulled up outside the pelvic cavity 2208 to allow adjustment of the tension in the mesh 2302 of the mini sling 2300.
[0199] Adjustment suture 2305B can be placed in the center of mesh 2302 to relax mesh 2302. Adjustment suture 2305A and adjustment suture 2305B can be placed towards the ends of mesh 2302 (e.g., the points where mesh 2302 was cut at each end) to tighten mesh 2302. Curved needles 2310A-2310F can be brought into vaginal cavity 2205 by puncturing through vaginal wall 2207 and cut off. The remaining threads 2308A-2308C can be tied into knots and stored in the housing for later use for adjustment.
[0200] 25 depicts one embodiment of a sling loader 2315 for a mini sling 2300. The sling loader 2315 can be similar to and include functionality of the loading device 10, however, the sling loader 2315 can be specifically designed for the mini sling 2300. In some embodiments, the mini sling 2300 can be preloaded into the sling loader 2315. For example, the mini sling 2300 and the sling loader 2315 can be a kit. The sling loader 2315 can include first loading slots 13A and 13B configured to receive the fixed jaw 5. The sling loader 2315 can include second loading slots 14A and 14B configured to receive the movable jaw 6.
[0201] The sling loader 2315 can receive both the needle 201A and the needle 201B of the micro-sling 2300 and can load the micro-sling 2300 into the suturing device 1A. The sling loader 2315 can include a slider 12A disposed in a slot 15A that can hold the needle 201A of the micro-sling 2300. The ring loader 2315 can include a slider 12B disposed in a slot 15B that can hold the needle 201B of the micro-sling 2300.
[0202] 26 and 27A-27J depict an embodiment of using a micro-sling 2300 to treat urinary incontinence. For example, the micro-sling 2300 can be positioned so that the mesh 2302 is positioned under the urethra 2705 to treat urinary incontinence. The micro-sling 2300 can be positioned by using a suturing device 1A to pass needles 201A and 201B through the target tissue in the pelvic cavity 2208 (where the ATFP attaches to the pubic bone) as described herein in a mesh repair. The threads 16A and 16B of the micro-sling 2300 can be passed through an incision 2206 in the vaginal cavity 2205 (e.g., the vaginal wall). The threads 16A and 16B on the ends of the micro-sling 2300 can be pulled simultaneously to position the mesh 2302 of the micro-sling 2300. In some embodiments, it is envisioned that the suturing device 1B may be used to position the ultra-small sling 2300.
[0203] 26, the micro-sling 2300 can be loaded into a sling loader 2315. In some embodiments, slider 12A and slider 12B are symmetrically positioned to symmetrically load the needles 201A and 201B of the micro-sling 2300. The micro-sling 2300 can be loaded end-on with needles 201A and 201B into suturing device 1A or 1B via sling loader 2315. As shown in FIG. 27A, needle 201A is loaded into suturing device 1A by sling loader 2315.
[0204] As shown in FIG. 27B and described in FIGS. 22A-22G, suturing device 1A can be used to pass needle 201A through target tissue in pelvic cavity 2208A and place one end of miniature sling 2300. Needle 201A can be inserted into vaginal cavity 2205 and through incision 2206 to reach pelvic cavity 2208A. For example, sharp and blunt dissection (e.g., a 3 cm incision) is advanced under the vesicovaginal fascia toward the junction of the pubic ramus and pubic symphysis, and the arcus tendineus of the pelvic fascia is detected. Thread 16A follows needle 201A through incision 2206, and mesh 2302 follows thread 16A into pelvic cavity 2208A so that mesh 2302 can be positioned within pelvic cavity 2208.
[0205] 27C and described in FIGS. 22A-22G, suturing device 1A can be used to pass needle 201B through target tissue in pelvic cavity 2208B and place the other end of ultra-small sling 2300. For example, suturing device 1A can release needle 201A, and then needle 201B can be loaded into suturing device 1A by sling loader 2315. Ultra-small sling 2300 can thus be positioned relative to urethra 2705 by using suturing device 1A to pass needle 201A through pelvic cavity 2208A and needle 201B through pelvic cavity 2208B. Threads 16A and 16B of ultra-small sling 2300 can be passed through incision 2206 (e.g., vaginal wall) in vaginal cavity 2205.
[0206] Device 1A can position thread 16A and thread 16B to position miniature sling 2300 at the location where it is to be placed within pelvic cavity 2208A and 2208B, respectively. Device 1A can pass needle 201 through tissue at the target geographic location such that thread 16A is not tied to knot 2720A, but simply passes through the tissue to pass the end of miniature sling 2300 through the tissue, but no suturing is performed. For example, the ends (e.g., 16A and 16B) of miniature sling 2300 are not secured by suturing because miniature sling 2300 is placed without tension.
[0207] 27D, threads 16A and 16B on the ends of the micro sling 2300 can be pulled simultaneously with the step of positioning the mesh 2302 relative to the urethra 2705. For example, after delivering the micro sling 2300, the mesh 2302 can be elevated upward toward the urethra 2705 so that both ends of the micro sling 2300 can be pulled by threads 16A and 16B. For example, both threads 16A and 16B can be pulled simultaneously. The mesh 2302 of the micro sling 2300 can rise below and toward the urethra 2705 as threads 16A and 16B are pulled.
[0208] 27E, threads 16A and 16B can be pulled so that mesh 2302 can be placed in the pelvic cavity 2208 in a tension-free state instead of being secured in tissue with anchors. Threads 16A and 16B can be pulled until threads 16A and 16B attached to mesh 2302 are visible to the surgeon through incision 2206. For example, threads 16A and 16B can be pulled out of the incision toward vaginal cavity 2205 so that the surgeon can cut them and any excess mesh 2302 at their ends to ensure that only the targeted length of mesh 2302 is present in the pelvic cavity 2208.
[0209] 27F, in some embodiments, excess portion 2710, which may include excess ends of mesh 2302 attached to threads 16A and 16B with needles 201A and 201B, can be cut off after positioning mesh 2302. As shown in FIG. 27G, mesh 2302 can be positioned within pelvic cavities 2208A and 2208B after excess portion 2710, containing mesh 2302 attached to threads 16A and 16B and needles 201A and 201B attached thereto, is cut off.
[0210] 27H, after positioning mesh 2302, if the surgeon decides to make post-operative adjustments, the surgeon can attach adjustment sutures 2305A-2305C to mesh 2302 during surgery. For example, the surgeon can insert adjustment sutures 2305A-2305C through incision 2206 in the vagina. Adjustment sutures 2305A-2305C can each include a curved needle 2310A-2310F attached to each end of threads 2308A-2308C.
[0211] The surgeon can attach adjusting sutures 2305A and 2305C towards the ends of mesh 2302 (e.g., at the points where mesh 2302 was cut at each end) to tension mesh 2302. In some embodiments, the curved needles of adjusting sutures 2305A and 2305C can be inserted through incision 2206 and then brought out by puncturing the vaginal wall 2207 and bringing them back into vaginal cavity 2205. The surgeon can attach adjusting suture 2305B to the center of mesh 2302 to relax mesh 2302.
[0212] In some embodiments, after the surgeon attaches the adjusting sutures 2305A-2305C to the mesh 2302, each end of the adjusting threads 2308A-2308C, which are attached to a respective curved needle 2310A-2310F, can be brought into the vaginal cavity 2205 by puncturing through the vaginal wall 2207 with the curved needles 2310A-2310F attached to each end of the adjusting thread 2308.
[0213] 271, in some embodiments, curved needles 2310A-2310F puncture through the vaginal wall 2207 at puncture points 2209A-2209F. For example, six curved needles 2310A-2310F can create six puncture points 2209A-2209F through which the six ends of three adjusting sutures 2308A-2308C can be pulled out of the pelvic cavity 2208 and into the vaginal cavity 2205. The curved needles 2310A-2310F can be pulled to pull the adjusting sutures 2305A-2305C through the puncture points 2209A-2209F. For example, the adjusting strings 2308A-2308C each have two ends with curved needles 2310A-2310F attached to either end, and each end of the adjusting strings 2308A-2308C can be brought through the vaginal wall 2207 into the vaginal cavity 2205.
[0214] 271, the surgeon can sever a portion of the thread 2308A-2308C and remove the curved needles 2310A-2310F from the treatment site. In some embodiments, the curved needles 2310A-2310F can be removed by bringing them out of the incision 2206 (e.g., without passing through the incision 2206) and cutting the curved needles 2310A-2310F. For example, the mesh 2302 can remain positioned against the urethra 2705, and the curved needles 2310A-2310C attached thereto can be detached.
[0215] After the curved needles 2310A-2310F are separated, the surgeon can tie knots 2720A-2720C in the respective ends of the threads 2308A-2308C. The surgeon can use the knots 2720A-2720C to adjust the tension of the mesh 2302, as the remaining threads 2308A-2308C remain attached to the mesh 2302. The surgeon can separate the curved needles 2310A-2310F and tie knots 2720A-2720C in the remaining threads 2308, forming loops and securing the knots 2720A-2720C within the housings 2725A-2725C. The knots 2720A-2720C, threads 2308, and housings 2725 do not protrude from the vagina. For example, during the post-operative period, they are not visible to the patient as they reside within the vaginal cavity 2205.
[0216] As shown in FIG. 27J, the knots 2720A-2720C can be stored within housings 2725A-2725C. The housings 2725A-2725C can be containers or enclosures for the knots 2720A-2720C. The housings 2725A-2725C can be used to secure the knots 2720A-2720C within the patient's vaginal cavity 2205 after surgery until the patient's post-operative examination for adjustment. The housings 2725A-2725C can keep the knots 2720A-2720C intact and protect them from contamination during this period of time. By maintaining the knots 2720A-2720C within the housings 2725A-2725C, the surgeon can adjust the tension of the mesh 2302 against the urethra 2705 after the procedure. For example, knots 2720A-2720C can be kept in housings 2725A-2725C for one week following surgery in case adjustment of mesh 2302 is needed. In another example, one week after surgery, a patient may report difficulty urinating or incontinence, both of which can be corrected by adjusting the tension of mesh 2302 against urethra 2705. After tension is readjusted post-operatively, adjustment sutures 2305A-2305C can be detached from mesh 2302 and removed. This ability to adjust mesh 2302 after surgery is advantageous by avoiding the need for a second surgery to reinsert mesh 2302 or additional adjustment sutures.
[0217] After surgery (e.g., one week), when the surgeon checks the patient for an adjustment, the surgeon reaches into the knots 2720A-2720C secured within the housing 2725 within the patient's vaginal cavity 2205 and adjusts the tension of the mesh 2302. For example, this adjustment can be made after surgery and can be done in an outpatient clinic or office setting without requiring a new surgery. The surgeon can pull the knots 2720A-2720C and pull the threads 2308A-2308C attached to the mesh 2302.
[0218] In some embodiments, during a post-operative examination performed in an office setting or outpatient clinic, the surgeon can pull up on knots 2720A-2720C of adjusting sutures 2305A and 2305C, pulling mesh 2302 toward urethra 2705 and tightening mesh 2302. For example, the surgeon can pull up on knots 2720A-2720C secured within housings 2725A-2725C of adjusting sutures 2305A and 2305C, pulling mesh 2302 toward urethra 2705 and tightening mesh 2302. In some embodiments, the surgeon can pull on knots 2720A and 2720C to increase tension in mesh 2302. For example, knots 2720A and 2720C on the sides of mesh 2302 can be used to increase tension after surgery. The surgeon can retract the knots 2720A and 2720C at the edges, pulling the mesh 2302 towards the urethra 2705 and causing the mesh 2302 to contract.
[0219] In some embodiments, the surgeon can pull on the knot 2720B to loosen the mesh 2302. The surgeon can pull on the knot 2720B in the center to pull the mesh 2302 away from the urethra 2705 and loosen the mesh 2302. In some embodiments, the surgeon can pull on the knot 2720B secured within the housing 2725B of the adjusting suture 2305B to pull the mesh 2302 away from the urethra 2705 and loosen the mesh 2302. For example, the surgeon can pull on the knot 2720B secured within the housing 2725B of the adjusting suture 2305B in the center of the mesh 2302 to pull the mesh 2302 away from the urethra 2705 and loosen the mesh 2302. After the surgeon has completed the adjustment, the surgeon can cut the loop, discard the housing 2725, pull up the adjustment string 2308, and remove the string.
[0220] Reference will now be made generally to suturing device 1A and suturing device 1B. The suturing device can be used for the treatment of pelvic floor disorders, such as the treatment of SUI and POP. For example, the suturing device can be angled for transvaginal approaches or procedures. In another example, the suturing device can be a minimally invasive surgical device for vaginal wall or uterine prolapse in women. The suturing device can include various sizes, shapes, and angles calculated and optimized based on the pelvic anatomical structure for which the suturing device will be used. The optimal size and shape allows the suturing device to safely access the target tissue for its prescribed surgical procedure. The angled design of the suturing device allows the tip of the device to reach the target pelvic structure and be sutured via the vaginal route. The angled design and size prevent unintended contact with other tissue. The shape of the suturing device can improve performance by preventing unintended tissue injury, providing safety and ease of access to the target tissue. The suturing device can be minimally invasive, disposable, sterile, and for single use.
[0221] The suturing device can be a transvaginal device for placing sutures in tissue at a surgical site during pelvic floor surgery in women (e.g., to treat stress urinary incontinence or pelvic organ prolapse, which is the bulging of pelvic organs such as the bladder, rectum, and uterus into the vagina and beyond the vaginal opening). The suturing device can be a transvaginal device used in conjunction with a single incision, which can be advantageous over abdominal and multiple incisions. The suturing device can be used for consistent placement of sutures in difficult-to-access locations, such as those that are narrow and not visible. The suturing device can be a one-step suturing device with an operating mechanism that allows a needle to be safely captured in opposing jaws.
[0222] The suturing device can suture defined ligaments to the level of the bladder neck and elevate the bladder outlet to its normal position. The suturing device is ergonomic and can be shaped to perform vaginal natural tissue repair procedures for stress urinary incontinence. The suturing device is designed for the surgical treatment of stress urinary incontinence in women and can facilitate consistent placement of sutures in difficult-to-access locations (small and not visible). The suturing device can be designed for anterior vaginal support or transvaginal vaginal stumppexy procedures. The suturing device can be used in general suturing applications that are difficult to access during urological procedures, including, but not limited to, stress urinary incontinence procedures, to assist in the placement of sutures at surgical sites.
[0223] The suturing device can enable the surgeon to perform surgery via the vagina (e.g., a transvaginal route, as opposed to abdominal surgery) in a minimally invasive manner (e.g., only a single vaginal incision). The suturing device can be used for single vaginal incision natural tissue repair via suturing the vaginal wall to the pelvic floor support structures (to assist in the placement of sutures within the ligaments onto the pelvic floor support structures). The suturing device can be used in conjunction with sensory and / or direct visual control by the surgeon (e.g., surgeon). The suturing device can be designed to enable the surgeon to perform natural tissue repair without the placement of artificial implants (as opposed to mid-urethral sling techniques, which require the placement of synthetic slings / meshes or transvaginal mesh surgery).
[0224] The suturing device can be designed to be safely inserted into the cavity. The safety of the suturing device can be derived from the length of the suturing device. For example, the length (of arms 7 and 8 and jaws 5 and 6) and the angle of the suturing device can contribute to the safety results described herein, and therefore the length and angle can be designed to avoid damaging the vagina or incision. In another example, the entry point of the suturing device into the body is through an incision made in the vaginal wall, so the surgeon can insert the suturing device into the pelvic cavity where the ATFP is located. For example, for stress incontinence surgery performed with a suturing device, the suturing device does not need to be inserted beyond the ATFP, which is the anatomical landmark used to determine the length of the suturing device. Even when the suturing device is positioned in the vagina beyond the arm joint 101, the length of the suturing device allows the widening of the suturing device caused by the release of the handle to not affect the incision.
[0225] The suturing device can facilitate consistent, sequential placement of sutures onto pelvic floor structures in locations that are difficult to access during pelvic floor surgery (e.g., placing multiple sutures with the same needle, also known as Z-sutures or figure-of-eight sutures). The suturing device can be designed to facilitate consistent placement of sutures in locations that are difficult to access during transvaginal prolapse surgery (as opposed to abdominal surgery) (deep, narrow, and non-visible procedure sites). The suturing device can suture defined ligaments to the apical vaginal wall or cervix to provide elevation of the vaginal apex.
[0226] The suturing device can be used for transvaginal minimally invasive procedures. The suturing device can be designed for vaginal wall or uterine prolapse surgery based on natural tissue repair in women suffering from pelvic organ prolapse (loosening of pelvic organs such as the bladder, uterus, or bowel into the vagina). The suturing device can be designed to enable the surgeon to perform natural tissue repair without the placement of artificial implants (as opposed to surgeries requiring the placement of synthetic mesh). The suturing device can enable the surgeon to perform surgery through the vagina in a minimally invasive manner using only a single incision, etc. The suturing device can be used in general suturing applications that are difficult to access during urological procedures, including, but not limited to, pelvic organ prolapse procedures, to assist in the placement of sutures at the surgical site. The suturing device can be used in conjunction with sensory and / or direct visual control.
[0227] Suturing devices 1A and 1B can be used for positioning a tension-free single-incision mid-urethral sling (mini sling 2300) whose tension can be adjusted post-operatively.
[0228] While one or more embodiments of the present disclosure have been described, it should be understood that these embodiments are illustrative only and not limiting, and that numerous modifications may become apparent to those skilled in the art, including that the inventive methodologies, illustrative systems and platforms, and illustrative devices described herein may be utilized in any combination with one another. Still further, the various steps may be performed in any desired order (and any desired steps may be added and / or any desired steps may be eliminated).
Claims
1. A suturing device, comprising: a fixation arm integral with a fixation jaw having a first gripping slot configured to receive a needle, the fixation arm further comprising an arm joint; a movable arm movably coupled to the movable jaw, the movable arm including a second gripping slot configured to receive the needle, the movable arm configured to pivot relative to the fixed arm at the arm joint; a needle transport mechanism configured to secure the needle within the first gripping slot or the second gripping slot and release the needle from the first gripping slot or the second gripping slot, the needle transport mechanism configured to selectively engage the needle while the needle is positioned within the first gripping slot or the second gripping slot; A suturing device comprising:
2. A suturing device as described in claim 1, wherein the movable jaw is connected to the fixed arm at a temporomandibular joint, and the movable jaw is configured to pivot about the temporomandibular joint and relative to the fixed jaw.
3. The suturing device of claim 2 further comprises a connecting joint configured to connect the movable arm and the movable jaw, and the movable arm is configured to move the connecting joint and pivot the movable jaw around the jaw joint.
4. The suturing device of claim 1, further comprising an attachment member configured to be attached to the fixed jaw portion or the movable jaw portion, the attachment member comprising the needle.
5. The suturing device of claim 1, wherein the needle transport mechanism comprises a first cable and a second cable.
6. A suturing device as described in claim 5, wherein the first and second cables are configured to couple to a first piston and a second piston, and the first and second pistons are configured to selectively engage the needle while the needle is positioned within the first gripping slot or the second gripping slot.
7. A suturing device as described in claim 6, further comprising a first spring positioned within the fixed jaw and a second spring positioned within the movable jaw, wherein the first cable is configured to move the first spring, move the first piston, and grip the needle within the first gripping slot or release the needle from the first gripping slot, and the second cable is configured to move the second spring, move the second piston, and grip the needle within the second gripping slot or release the needle from the second gripping slot.
8. Further comprising a lever, a first position for advancing the first cable to release the first spring and advance the first piston to grip the needle in the first gripping slot and retracting the second cable to retract the second piston to compress the second spring and retract the second piston to release the needle from the second gripping slot; a second position for partially retracting the first cable to retract the first piston, partially compressing the first spring, and partially retracting the first piston to grip the needle in the first gripping slot, and partially retracting the second cable to retract the second piston, partially compressing the second spring, and partially retracting the second piston to grip the needle in the second gripping slot; a third position for retracting the first cable to retract the first piston to compress the first spring and retract the first piston to release the needle from the first gripping slot, and advancing the second cable to release the second spring and advance the second piston to grip the needle in the second gripping slot; The suturing device of claim 7 , configured to move between
9. The suturing device of claim 1, wherein the needle transfer mechanism comprises a first plate and a second plate configured to move the needle between the first gripping slot in the fixed jaw and the second gripping slot in the movable jaw.
10. The first plate includes a first control bar configured to advance a first gripping member toward a first notch of the needle disposed in the first gripping slot to grip the needle in the first gripping slot, or configured to retract the first gripping member from the first notch to release the needle from the first gripping slot; 10. The suturing device of claim 9, wherein the second plate includes a second control bar configured to advance a second gripping member toward a second notch of the needle disposed in the second gripping slot to grip the needle in the second gripping slot, or to retract the second gripping member from the second notch to release the needle from the second gripping slot.
11. The first plate includes a first control bar configured to advance toward a first notch of the needle disposed in the first gripping slot to grip the needle in the first gripping slot, or configured to retract from the first notch to release the needle from the first gripping slot; 10. The suturing device of claim 9, wherein the second plate includes a second control bar configured to advance toward a second notch of the needle disposed in the second gripping slot to grip the needle in the second gripping slot, or to retract from the second notch to release the needle from the second gripping slot.
12. Further comprising a lever, the lever comprising: a first position in which the needle transport mechanism grips the needle in the first gripping slot and releases the needle from the second gripping slot; a second position in which the needle transport mechanism grips the needle within the first gripping slot and the second gripping slot; a third position in which the needle transport mechanism releases the needle from the first gripping slot and grips the needle in the second gripping slot; and The suturing device of claim 1 , configured to move between
13. A suturing device as described in claim 12, further comprising a cover positioned partially over the lever, the cover comprising indicators corresponding to movement of the lever to the first position, the second position, and the third position.
14. A suturing device as described in claim 12, further comprising a switching joint coupled to the needle transport mechanism.
15. A suturing device as described in claim 14, wherein the lever is coupled to the switching joint, and the lever is configured to rotate the switching joint and move the needle transport mechanism.
16. A suturing device as described in claim 12, wherein the movable arm includes a stop portion and the needle transport mechanism includes a safety member, the safety member configured to interlock with the stop portion.
17. The suturing device of claim 16, wherein the stop is configured to slide into an activated position on the movable arm, securing the stop adjacent to the safety member and allowing the stop and the safety member to interlock.
18. The suturing device of claim 16, wherein the stop is configured to slide into a deactivated position on the movable arm, securing the stop away from the safety member and preventing the stop and the safety member from interlocking.
19. The suturing device of claim 1, wherein the needle further comprises a channel configured to receive a thread, the channel being deformable to splice the thread to the needle.
20. The suturing device of claim 1, wherein the needle further comprises a channel configured to receive a thread, and the thread and needle are joined within the channel using an adhesive.
21. A suturing device comprising: a fixation arm integral with a fixation jaw having a first gripping slot configured to receive a needle, the fixation arm further comprising an arm joint; a movable arm movably coupled to a movable jaw, the movable arm including a second gripping slot configured to receive the needle, the movable jaw configured to pivot about a reference location on the fixed arm and relative to the fixed jaw, the movable arm configured to pivot relative to the fixed arm at the arm joint; a needle transport mechanism configured to secure the needle within the first gripping slot or the second gripping slot and release the needle from the first gripping slot or the second gripping slot, the needle transport mechanism configured to selectively engage the needle while the needle is positioned within the first gripping slot or the second gripping slot; A suturing device comprising:
22. A suturing device comprising: a fixation arm integral with a fixation jaw having a first gripping slot configured to receive a needle, the fixation arm further comprising an arm articulation at a reference location; a movable arm movably coupled to the movable jaw, the movable arm including a second gripping slot configured to receive the needle, the movable arm configured to pivot about the arm joint at the reference location on the fixed arm and relative to the fixed arm; a needle transport mechanism configured to secure the needle within the first gripping slot or the second gripping slot and release the needle from the first gripping slot or the second gripping slot, the needle transport mechanism configured to selectively engage the needle while the needle is positioned within the first gripping slot or the second gripping slot; A suturing device comprising:
23. 1. A suturing device comprising: a locking arm integral with a locking jaw having a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm, the movable jaw including a second gripping slot configured to receive the needle, the movable jaw configured to pivot about a reference location on the fixed arm and relative to the fixed jaw; a needle transport mechanism comprising a first plate and a second plate, the needle transport mechanism configured to secure the needle within the first gripping slot or the second gripping slot and release the needle from the first gripping slot or the second gripping slot, the first and second plates configured to selectively engage the needle while the needle is positioned within the first gripping slot or the second gripping slot, the fixed arm further comprising an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm at the arm joint; A suturing device comprising:
24. The suturing device of claim 23, wherein the fixed arm further comprises an arm joint coupled to the movable arm, the movable arm configured to pivot about the arm joint and relative to the fixed arm.
25. 24. The suturing device of claim 23, wherein the fixed arm further comprises a jaw joint located within the reference location, the jaw joint coupled to the movable jaw, the movable jaw configured to pivot about the jaw joint and relative to the fixed jaw.
26. 26. The suturing device of claim 25, further comprising a connecting joint configured to couple the movable arm and the movable jaw, the movable arm configured to move the connecting joint and pivot the movable jaw about the jaw joint.
27. The suturing device of claim 23, further comprising an attachment member configured to be attached to the fixed jaw or the movable jaw, the attachment member comprising the needle.
28. the first plate includes a first control bar configured to advance a first gripping member toward a first notch of the needle disposed in the first gripping slot to grip the needle in the first gripping slot, or to retract the first gripping member from the first notch to release the needle from the first gripping slot; 24. The suturing device of claim 23, wherein the second plate includes a second control bar configured to advance a second gripping member toward a second notch of the needle disposed in the second gripping slot to grip the needle in the second gripping slot, or to retract the second gripping member from the second notch to release the needle from the second gripping slot.
29. the first plate includes a first control bar configured to advance toward a first notch of the needle disposed in the first gripping slot to grip the needle in the first gripping slot, or to retract from the first notch to release the needle from the first gripping slot; 24. The suturing device of claim 23, wherein the second plate includes a second control bar configured to advance toward a second notch of the needle disposed in the second gripping slot to grip the needle in the second gripping slot, or to retract from the second notch to release the needle from the second gripping slot.
30. Further comprising a lever, the lever comprising: a first position for advancing the first control bar to grip the needle in the first gripping slot and retracting the second control bar to release the needle from the second gripping slot; a second position for retracting the first control bar to release the needle from the first gripping slot and for retracting the second control bar to release the needle from the second gripping slot; a third position for retracting the first control bar to release the needle from the first gripping slot and advancing the second control bar to grip the needle in the second gripping slot; and The suturing device of claim 29, configured to move between
31. The suturing device of claim 30, further comprising a cover disposed partially over the lever, the cover comprising an indicator corresponding to movement of the lever to the first position, the second position, and the third position.
32. The suturing device of claim 30, further comprising a switching joint coupled to the first control bar and the second control bar.
33. The suturing device of claim 32, wherein the lever is coupled to the switch joint, the lever configured to rotate the switch joint and move the first control bar and the second control bar.
34. 31. The suturing device of claim 30, wherein the movable arm includes a stop and the second control bar includes a safety member configured to interlock with the stop when the lever is in the second position to prevent the movable arm from moving and the needle from falling out.
35. 35. The suturing device of claim 34, wherein the stop is configured to slide into an activated position on the movable arm to secure the stop adjacent to the safety member and allow the stop and safety member to interlock.
36. 35. The suturing device of claim 34, wherein the stop is configured to slide into a deactivated position on the movable arm, securing the stop away from the safety member and preventing the stop and the safety member from interlocking.