CN118159203A

CN118159203A - Suturing device and method of using the same

Info

Publication number: CN118159203A
Application number: CN202280070361.6A
Authority: CN
Inventors: A·O·耶尼尔; O·比尔格; S·赛利克; S·特美尔; O·S·格尔米雅; Y·卡德尔; A·阿尔坎; M·O·阿克巴斯
Original assignee: Solanus R&d And Consulting Services Industry Trading Co ltd
Current assignee: Solanus R&d And Consulting Services Industry Trading Co ltd
Priority date: 2021-09-07
Filing date: 2022-09-07
Publication date: 2024-06-07

Abstract

The present disclosure includes a suturing device comprising: a fixed arm having a fixed jaw including a first gripping slot configured to receive a needle; a movable arm coupled to the movable jaw, the movable jaw including a second gripping slot configured to receive a needle, the movable arm configured to pivot relative to the fixed arm to pivot the movable jaw relative to the fixed jaw until the needle is received in the first gripping slot and the second gripping slot; and a needle transfer mechanism configured to grasp the needle in the first grasping groove or the second grasping groove. In some aspects, the suturing device includes a safety member configured to control when the movable arm moves. The present disclosure includes a loading device including a loading slot configured to receive a fixed jaw and a slider configured to move a needle toward the fixed jaw.

Description

Suturing device and method of using the same

RELATED APPLICATIONS

The present application claims the benefit and priority of turkish patent application No. 2021/014052 filed on 7, 9, 2021, which is hereby incorporated by reference in its entirety.

Technical Field

The present disclosure relates to suturing devices for use in surgical procedures, suture loading apparatus for loading sutures into suturing devices, and methods of their use.

Background

Urinary Incontinence (UI) refers to an unintentional loss of urine. There are three different forms of this disease: pressure UI, impulse UI, and hybrid UI. Most commonly, a pressure UI occurs when physical movements or activities such as coughing, sneezing, running or lifting weight exert pressure (e.g., stress) on the bladder.

Abdominal vaginal suspension based on natural tissue repair for compressive UI is based on elevation of the vaginal wall toward a bilaterally strong pelvic floor support structure such as the pelvic fascia (ATFP), ilio-pubic ligament, and the like. However, natural tissue repair is invasive and difficult because it is intensive and a major surgery (abdomen). Transvaginal surgery is a SUI (compressive UI) based mesh repair. It involves placing a tension-free net (sling). Such methods typically involve placement of an artificial implant, such as a synthetic sling or mesh.

Pelvic organ prolapse refers to the prolapse (drop) of a pelvic organ from its normal position. Pelvic organs include vagina, cervix, uterus, bladder, urethra, and rectum.

Surgical treatment of POP (pelvic organ prolapse) can be performed through the abdomen or vagina. Abdominal procedures to repair POP may be based on natural tissue repair or by placement of artificial mesh. Transvaginal surgery can also be accomplished based on natural tissue repair or by placement of artificial mesh. Primary tissue repair accomplished through the vagina is based on elevation of the vaginal wall or cervix (if the patient's uterus is resected for other reasons) toward firm pelvic floor support structures such as the sacrospinous ligament, and the pelvic fascia (ATFP).

Disclosure of Invention

In some aspects, the technology described herein relates to a suturing device comprising: a fixed arm 7 integral with the fixed jaw 5, the fixed jaw comprising a first gripping slot 103 configured to receive the needle 201; a movable jaw 6 comprising a second gripping slot 104 configured to receive a needle 201, the movable jaw 6 being configured to pivot about a reference position on the fixed arm 7 and relative to the fixed jaw 5, while the fixed jaw 5 remains stationary; a movable arm 8 coupled to the movable jaw 6, the movable arm 8 being configured to pivot about a reference position and relative to the fixed arm 7 while the fixed arm 7 remains stationary, the movable arm 8 being configured to pivot away from the fixed arm 7 to move the movable jaw 6 away from the fixed jaw 5, the movable arm 8 being configured to pivot toward the fixed arm 7 to move the movable jaw 6 toward the fixed jaw 5 until the needle 201 is disposed in the first grip slot 103 and the second grip slot 104; and a needle transfer mechanism 4 configured to fix the needle 201 in the first grip groove 103 or the second grip groove 104.

In some aspects, the techniques described herein relate to a suturing device, wherein the fixed arm 7 further comprises an arm joint 101 in a reference position, wherein the arm joint 101 is coupled to the movable arm 8, and wherein the movable arm 8 is configured to pivot about the arm joint 101 and relative to the fixed arm 7.

In some aspects, the techniques described herein relate to a suturing device, wherein the fixed jaw 7 further comprises a jaw joint 100 in a reference position, wherein the jaw joint 100 is coupled to the movable jaw 6, and wherein the movable jaw 6 is configured to pivot about the jaw joint 100 and relative to the fixed jaw 5.

In some aspects, the technology described herein relates to a suturing device, wherein the suturing device further comprises a connection joint 102 in a reference position, wherein the connection joint 102 is configured to connect the movable arm 8 and the movable jaw 6, wherein the movable arm 8 is configured to move the connection joint 102 to pivot the movable jaw 6 about the jaw joint 100.

In some aspects, the technology described herein relates to a suturing device, wherein the suturing device further comprises an attachment member 1105 configured to attach to the fixed jaw 5 or the movable jaw 6, the attachment member 1105 comprising a needle 201.

In some aspects, the technology described herein relates to a suturing device wherein the needle transfer mechanism 4 further comprises: a first control rod 505A configured to advance toward the first notch 207A of the needle 201 disposed in the first grip groove 103 to grip the needle 201 in the first grip groove 103 or retract from the first notch 207A to release the needle 201 from the first grip groove 103; and a second control rod 505B configured to advance toward the second notch 207B of the needle 201 disposed in the second grip groove 104 to grip the needle 201 in the second grip groove 104 or retract from the second notch 207B to release the needle 201 from the second grip groove 104.

In some aspects, the technology described herein relates to a suturing device wherein the needle transfer mechanism 4 further comprises: a first control lever 505A configured to advance the first grip member 510A toward the first recess 207A of the needle 201 disposed in the first grip slot 103 to grip the needle 201 in the first grip slot 103, or retract the first grip member 510A from the first grip slot 103 to release the needle 201 from the first grip slot 103; and a second control rod 505B configured to advance the second gripping member 510B toward the 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 or retract the second gripping member 510B from the second notch 207B to release the needle 201 from the second gripping slot 104.

In some aspects, the technology described herein relates to a suturing device wherein the needle transfer mechanism 4 further comprises: the first cable 3001A configured to advance to release the first spring 3002A to advance the first piston 3003A toward the first recess 207A of the needle 201 disposed in the first grip slot 103 to grip the needle 201 in the first grip slot 103, the first cable 3001A also configured to pull the first piston 3003A to compress the first spring 3002A to retract the first piston 3003A from the first recess 207A to release the needle 201 from the first grip slot 103; and a second cable 3001B configured to advance to release the second spring 3002B to advance the second piston 3003B toward the second recess 207B of the needle 201 disposed in the second grip slot 104 to grip the needle 201 in the second grip slot 104, the second cable 3001B further configured to pull the second piston 3003B to compress the second spring 3002B to retract the second piston 3003B from the second recess 207B to release the needle 201 from the second grip slot 104.

In some aspects, the technology described herein relates to a suturing device, further comprising a lever 3 configured to move between: a first position 110A for advancing the first control rod 505A to grasp the needle 201 in the first grasping slot 103 and retracting the second control rod 505B to release the needle 201 from the second grasping slot 104; a second position 110B for retracting the first control rod 505A to release the needle 201 from the first grip slot 103 and retracting the second control rod 505B to release the needle 201 from the second grip slot 104; and a third position 110C for retracting the first control rod 505A to release the needle 201 from the first grip slot 103 and advancing the second control rod 505B to grip the needle 201 in the second grip slot 104.

In some aspects, the technology described herein relates to a suturing device, further comprising a lever 3 configured to move between: a first position 110A for advancing the first cable 3001A to release the first spring 3002A, advancing the first piston 3003A to grip the needle 201 in the first grip slot 103, and pulling the second cable 3001B to pull the second piston 3003B, compressing the second spring 3002B to retract the second piston 3003B to release the needle 201 from the second grip slot 104; a second position 110B for pulling the first cable 3001A to pull the first piston 3003A, thereby semi-compressing the first spring 3002A to semi-retract the first piston 3003A to release the needle 201 from the first grip slot 103, and pulling the second cable 3001B to pull the second piston 3003B, thereby semi-compressing the second spring 3002B to semi-retract the second piston 3003B to release the needle 201 from the second grip slot 104; and a third position 110C for pulling the first cable 3001A to pull the first piston 3003A, thereby compressing the first spring 3002A to retract the first piston 3003A to release the needle 201 from the first grip slot 103, and advancing the second cable 3001B to release the second spring 3002B, thereby advancing the second piston 3003B to grip the needle 201 in the second grip slot 104.

In some aspects, the technology described herein relates to a suturing device, further comprising a lever 3 configured to move between: a first position 110A for advancing the first cable 3001A to release the first spring 3002A, advancing the first piston 3003A to grip the needle 201 in the first grip slot 103, and pulling the second cable 3001B to pull the second piston 3003B, compressing the second spring 3002B to retract the second piston 3003B to release the needle 201 from the second grip slot 104; a second position 110B for half-pulling the first cable 3001A to pull the first piston 3003A, thereby half-compressing the first spring 3002A to half-retract the first piston 3003A to grip the needle 201 in the first grip slot 103, and half-pulling the second cable 3001B to pull the second piston 3003B, thereby half-compressing the second spring 3002B to half-retract the second piston 3003B to grip the needle 201 in the second grip slot 104; and a third position 110C for pulling the first cable 3001A to pull the first piston 3003A, thereby compressing the first spring 3002A to retract the first piston 3003A to release the needle 201 from the first grip slot 103, and advancing the second cable 3001B to release the second spring 3002B, thereby advancing the second piston 3003B to grip the needle 201 in the second grip slot 104.

In some aspects, the technology described herein relates to a suturing device that further includes a cover 108 disposed partially over the lever 3, the cover including indicators corresponding to movement of the lever 3 to the first, second, and third positions 110A, 110B, 110C.

In some aspects, the technology described herein relates to a suturing device further comprising a switch joint 106 coupled to the first and second control levers 505A, 505B.

In some aspects, the technology described herein relates to a suturing device wherein a lever 3 is coupled to the switch joint 106, wherein the lever 3 is configured to rotate the switch joint 106 to move the first and second control levers 505A, 505B.

In some aspects, the technology described herein relates to a suturing device that further includes a switch joint 106 coupled to the first cable 3001A and the second cable 3001B.

In some aspects, the technology described herein relates to a suturing device wherein a lever 3 is coupled to the switch joint 106, wherein the lever 3 is configured to rotate the switch joint 106 to pull the first cable 3001A and the second cable 3001B or advance the first cable 3001A and the second cable 3001B.

In some aspects, the technology described herein relates to a suturing device wherein the movable arm 8 includes a stop 605, and wherein the second control rod 505B includes a safety member 610 configured to interlock with the stop 605 when the lever 3 is in the second position 110B to prevent movement of the movable arm 8, thereby preventing the needle 201 from falling.

In some aspects, the technology described herein relates to a suturing device in which the stop 605 is configured to slide into an activated position on the movable arm 8 to secure the stop 605 near the safety member 610, thereby enabling the stop 605 to interlock with the safety member 610.

In some aspects, the technology described herein relates to a suturing device in which the stop 605 is configured to slide into a deactivated position on the movable arm 8 to secure the stop 605 away from the safety member 610, thereby preventing the stop 605 from interlocking with the safety member 610.

In some aspects, the technology described herein relates to a loading device 10 comprising: a first loading slot 13 provided in the loading device 10, configured to receive the fixed jaw 5; and a slider 12 including a slot 15 configured to hold the needle 201, the slider 12 being configured to move within the loading channel 320 such that the slot 15 holding the needle 201 moves toward the first loading slot 13 and into the first gripping slot 103 of the fixed jaw 5.

In some aspects, the technology described herein relates to a loading device 10 that further includes a pulley 11 that includes a wire 16 coupled to the needle 201, wherein the pulley 11 is configured to rotate such that the wire 16 moves when the first gripping slot 103 of the fixed jaw 5 exits the first loading slot 13.

In some aspects, the technology described herein relates to a loading device 10 that further includes a second loading slot 14 disposed in the loading device 10 that is configured to receive the movable jaw 6, wherein the slider 12 is configured to move within the loading channel 320 to move the slot 15 holding the needle 201 toward the second loading slot 14 and into the second gripping slot 104 of the movable jaw 6.

In some aspects, the technology described herein relates to a method comprising: moving the movable arm 8 of the suturing device away from the fixed arm 7 of the suturing device and around a reference position on the fixed arm 7, while the fixed arm 7 remains stationary, moving the movable arm 8 away from the movable jaw 6 causing the suturing device to pivot around the reference position and away from the fixed jaw 5 extending from the stationary fixed arm 7 and contacting luminal tissue; moving the movable arm 8 around the reference position and toward the fixed arm 7 to pivot the movable jaw 6 around the reference position and toward the fixed jaw 5 until the needle 201 fixed in the fixed jaw 5 pierces the target tissue between the fixed jaw 5 and the movable jaw 6 until the needle 201 is disposed within the movable jaw 6; actuating the needle transfer mechanism 4 of the suturing device to transfer the needle 201 from the fixed jaw 5 to the movable jaw 6; and moving the movable arm 8 about the reference position and away from the fixed arm 7 to pivot the movable jaw 6 with the needle 201 about the reference position and away from the fixed jaw 5 to move the needle 201 through the target tissue.

In some aspects, the technology described herein relates to a method that further includes pivoting the movable arm 8 relative to the fixed arm 7 and about an arm joint 101 that is coupled to the movable arm 8 and that is in a reference position, pivoting the movable arm 8 causing the movable jaw 6 to pivot relative to the fixed jaw 5 and about a jaw joint 100 that is in the reference position and that is coupled to the fixed arm.

In some aspects, the technology described herein relates to a method further comprising moving the movable arm 8 to move the connection joint 102 configured to connect the movable arm 8 and the movable jaw 6 to pivot the movable jaw 6 about the jaw joint 100.

In some aspects, the technology described herein relates to a method further comprising attaching an attachment member 1105 to the fixed jaw 5 or the movable jaw 6, the attachment member 1105 comprising the needle 201.

In some aspects, the technology described herein relates to a method wherein actuating the needle transfer mechanism 4 comprises: retracting the first control lever 505A from the first notch 207A of the needle 201 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 rod 505B toward the second notch 207B of the needle 201 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.

In some aspects, the technology described herein relates to a method wherein, after the needle 201 secured in the movable jaw 6 is moved through the target tissue, further comprising: advancing the first control rod 505A toward the first notch 207A of the needle 201 disposed in the first gripping groove 103 of the fixed jaw 5 to grip the needle 201 in the first gripping groove 103 of the fixed jaw 5; and retracting the second control rod 505B from the second notch 207B of the needle 201 disposed in the 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.

In some aspects, the technology described herein relates to a method, further comprising: moving the lever 3 of the suturing device to the first position 110A to advance the first control rod 505A from the first notch 207A of the needle 201 disposed in the first gripping slot 103 of the fixed jaw 5 to grip the needle 201 in the first gripping slot 103 and retracting the second control rod 505B from the second notch 207B of the needle 201 disposed in the second gripping slot 104 of the movable jaw 6 to release the needle 201 from the second gripping slot 104; moving lever 3 of the suturing device to second position 110B to retract first control rod 505A from first notch 207A of needle 201 disposed in first gripping slot 103 of fixed jaw 5 to release needle 201 from first gripping slot 103 and to retract second control rod 505B from second notch 207B of needle 201 disposed in second gripping slot 104 of movable jaw 6 to release needle 201 from second gripping slot 104; and moving the lever 3 of the suturing device to the third position 110C to retract the first control rod 505A from the first notch 207A of the needle 201 disposed in the first gripping slot 103 of the fixed jaw 5 to release the needle 201 from the first gripping slot 103 and to retract the second control rod 505B from the second notch 207B of the needle 201 disposed in the second gripping slot 104 of the movable jaw 6 to release the needle 201 from the second gripping slot 104.

In some aspects, the technology described herein relates to a method further comprising a switch joint 106 coupled to the first and second control levers 505A, 505B, wherein the lever 3 is coupled to the switch joint 106, and wherein the lever 3 is configured to rotate the switch joint 106 to pull the first and second control levers 505A, 505B or to advance the first and second control levers 505A, 505B.

In some aspects, the technology described herein relates to a method that further includes sliding the stop 605 on the movable arm 8 to an activated position on the movable arm 8 to secure the stop 605 near the safety member 610 of the second control lever 505B, the safety member configured to interlock with the stop 605 when the lever 3 is in the second position 110B to prevent movement of the movable arm 8, thereby preventing the needle 201 from falling.

In some aspects, the techniques described herein relate to a method that further includes sliding the stop 605 to a deactivated position on the movable arm 8 to secure the stop 605 away from the safety member 610, thereby preventing the stop 605 from interlocking with the safety member 610.

In some aspects, the technology described herein relates to a method wherein actuating the needle transfer mechanism 4 comprises: retracting the first control lever 505A from the first notch 207A of the needle 201 disposed in the first gripping slot 103 of the fixed jaw 5 to retract the first gripping member 510A to release the needle 201 from the first gripping slot 103 of the fixed jaw 5; and advancing the second control rod 505B toward the second notch 207B of the needle 201 disposed in the second gripping slot 104 of the movable jaw 6 to advance the second gripping member 510B to grip the needle 201 in the second gripping slot 104 of the movable jaw 6.

In some aspects, the technology described herein relates to a method wherein actuating the needle transfer mechanism 4 comprises: pulling the first cable 3001A to pull the first piston 3003A, thereby compressing the first spring 3002A to retract the first piston 3003A from the first recess 207A of the needle 201 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 cable 3001B to release the second spring 3002B, thereby advancing the second piston 3003B toward the second recess 207B of the needle 201 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.

In some aspects, the technology described herein relates to a method, further comprising: moving the lever 3 of the suturing device to the first position 110A to advance the first cable 3001A to release the first spring 3002A, to advance the first piston 3003A to grasp the needle 201 in the first grasping slot 103 of the fixed jaw 5, and to pull the second cable 3001B to pull the second piston 3003B to compress the second spring 3002B to retract the second piston 3003B to release the needle 201 from the second grasping slot 104 of the movable jaw 6; moving the lever 3 of the suturing device to the second position 110B to pull the first cable 3001A to pull the first piston 3003A, thereby semi-compressing the first spring 3002A to semi-retract the first piston 3003A to release the needle 201 from the first grip slot 103, and pulling the second cable 3001B to pull the second piston 3003B, thereby semi-compressing the second spring 3002B to semi-retract the second piston 3003B to release the needle 201 from the second grip slot 104; and moving the lever 3 of the suturing device to the third position 110C for pulling the first cable 3001A to pull the first piston 3003A, thereby compressing the first spring 3002A to retract the first piston 3003A to release the needle 201 from the first grasping slot 103, and advancing the second cable 3001B to release the second spring 3002B, thereby advancing the second piston 3003B to grasp the needle 201 in the second grasping slot 104.

In some aspects, the technology described herein relates to a method further comprising a switch joint 106 coupled to the first cable 3001A and the second cable 3001B, wherein the lever 3 is coupled to the switch joint 106, and wherein the lever 3 is configured to rotate the switch joint 106 to pull the first cable 3001A and the second cable 3001B or advance the first cable 3001A and the second cable 3001B.

In some aspects, the technology described herein relates to a method, further comprising: moving the lever 3 of the suturing device to the first position 110A to advance the first cable 3001A to release the first spring 3002A, to advance the first piston 3003A to grasp the needle 201 in the first grasping slot 103 of the fixed jaw 5, and to pull the second cable 3001B to pull the second piston 3003B to compress the second spring 3002B to retract the second piston 3003B to release the needle 201 from the second grasping slot 104 of the movable jaw 6; moving the lever 3 of the suturing device to the second position 110B to half-pull the first cable 3001A to pull the first piston 3003A, thereby half-compressing the first spring 3002A to half-retract the first piston 3003A to grasp the needle 201 in the first grasping slot 103, and half-pull the second cable 3001B to pull the second piston 3003B, thereby half-compressing the second spring 3002B to half-retract the second piston 3003B to grasp the needle 201 in the second grasping slot 104; and moving the lever 3 of the suturing device to the third position 110C for pulling the first cable 3001A to pull the first piston 3003A, thereby compressing the first spring 3002A to retract the first piston 3003A to release the needle 201 from the first grasping slot 103, and advancing the second cable 3001B to release the second spring 3002B, thereby advancing the second piston 3003B to grasp the needle 201 in the second grasping slot 104.

In some aspects, the technology described herein relates to a method, further comprising: inserting the fixed jaw 5 of the suturing device into a first loading slot 13 provided in the loading apparatus 10; and moving the slider 12 including the slot 15, the slot 15 being configured to retain the needle 201 within the loading channel 320 of the loading device 10 such that the slot 15 retaining the needle 201 moves toward the first loading slot 13 and into the first gripping slot 103 of the fixed jaw 5.

In some aspects, the techniques described herein relate to a method that further includes, upon actuation of the needle transfer mechanism 4, removing the suturing device and pulling the curved needle 18 attached to a first end of the wire 16 opposite a second end of the wire 16 attached to the needle 201.

In some aspects, the technology described herein relates to a method wherein, after moving the movable arm 8 away from the fixed arm 7 to pivot the movable jaw 6 away from the fixed jaw 5, the needle 201 is moved through the target tissue, the method further comprising: moving the movable arm 8 around the reference position and towards the fixed arm 7 to pivot the movable jaw 6 around the reference position and towards the fixed jaw 5 until the needle 201 fixed in the movable jaw 6 pierces a different section of the target tissue until the needle 201 is disposed in the fixed jaw 5; and actuating the needle transfer mechanism 4 to transfer the needle 201 from the movable jaw 6 to the fixed jaw 5.

In some aspects, the technology described herein relates to a system comprising: a mesh 2302 extending between a first positioning wire 16A and a second positioning wire 16B, the first positioning wire 16A attached to the first positioning needle 201A and the second positioning wire 16B attached to the second positioning needle 201B; a first loading slot 13A and a second loading slot 13B disposed within sling loading piece 2315, the first loading slot 13A and the second loading slot 13B configured to receive a fixed jaw 5 of a suturing device; a first slider 12A attached to the sling loader 2315, the first slider 12A including a first slot 15A configured to hold the first positioning needle 201A, the first slider 12A configured to move within the first loading channel 320A of the sling loader 2315 to move the first slot 15A to hold and retain the first positioning needle 201A in the first gripping slot 103 of the fixed jaw 5 toward the first loading slot 13A; 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 configured to move within the second loading channel 320B of the sling loader 2315 such that the second slot 15B holding the second positioning needle 201B moves toward the second loading slot 13B and into the first gripping slot 103 of the fixed jaw 5.

In some aspects, the technology described herein relates to a system that further includes a first adjustment line 2308A, a second adjustment line 2308B, and a third adjustment line 2308C each extending from the web 2302, the second adjustment line 2308B extending between the first adjustment line 2308A and the third adjustment line 2308C.

In some aspects, the technology described herein relates to a system wherein each end of the first adjustment wire 2308A includes a first curved needle 2310A and a second curved needle 2310B, each end of the second adjustment wire 2308B includes a third curved needle 2310A and a fourth curved needle 2310D, and each end of the third adjustment wire 2308C includes a fifth curved needle 2310E and a sixth curved needle 2310F.

In some aspects, the technology described herein relates to a method comprising: moving the first slider 12A of the loading device 2315 within the first sliding channel 320A of the first loading channel 13A to move the first needle 201A disposed in the first channel 15A of the first slider 12A into the first gripping channel 103 of the fixed jaw 5 extending from the fixed arm 7 of the suturing device loaded in the first loading channel 13A, the first needle 201A being attached to the first wire 16A, the first wire being attached to the web 2302; actuating lever 3 of the suturing device to secure first needle 201A within first grip slot 103; moving the movable arm 8 of the stapling device away from the fixed arm 7 and around a reference position on the fixed arm 7 while the fixed arm 7 remains stationary, moving the movable arm 8 away from the movable jaw 6 which caused the stapling device to pivot around the reference position and away from the fixed jaw 5 while the fixed jaw 5 remains stationary; moving the movable arm 8 about the reference position and towards the fixed arm 7 to pivot the movable jaw 6 about the reference position and towards the fixed jaw 5 until the first needle 201A fixed in the first grasping slot 103 pierces a first portion of the palpated tissue between the fixed jaw 5 and the movable jaw 6 and the first needle 201A is received in the second grasping slot 104 of the movable jaw 6; removing the suturing device from the pelvic cavity 2208 and actuating the needle transfer mechanism 4 of the suturing device to release the first needle 201A from the second grasping 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 loading device 2315 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 attached to the second wire 16B attached to the web 2302; actuating lever 3 of the suturing device to secure second needle 201B within first grip slot 103; moving movable arm 8 about the reference position and toward fixed arm 7 to pivot movable jaw 6 about the reference position and toward fixed jaw 5 until second needle 201B secured in first grasping slot 103 pierces a second portion of the palpated tissue on the other side of the palpated tissue between fixed jaw 5 and movable jaw 6 and is received in second grasping slot 104 to place mesh 2302 in pelvic cavity 2208; removing the suturing device from the pelvic cavity 2208 and severing the first wire 16A, the second wire 16B, and a portion of the mesh 2302; attaching a first adjustment suture 2305A, a second adjustment suture 2305B, and a third adjustment suture 2305C to the mesh 2302, the first adjustment suture 2305A and the third adjustment suture 2305C attached to each end of the mesh 2302 for tensioning, the second adjustment suture 2305B attached to the middle of the mesh 2302 for loosening the mesh 2302; severing the curved needle 2310 coupled to each adjustment suture 2305 to form the knot 2720 of the wire 2308 of the adjustment suture 2305 to form a loop and placing the knot 2720 into the housing 2725 and leaving the knot 2720 secured in the housing 2725 inside the vaginal cavity 2205 of the patient and closing the incision 2206 in the vaginal cavity 2205; and pulling the adjustment suture 2305 coupled to the mesh 2302 to adjust the tension of the mesh 2302 during a post-operative early examination of the patient in a clinic setting without requiring a new procedure.

In some aspects, the techniques described herein relate to a method in which pulling the adjustment suture 2305 includes pulling a knot 2720 disposed in a housing 2725 attached to the adjustment suture 2305 to adjust the tension of the mesh 2302, and once tensioning is complete, severing the loop and removing the housing 2725 and the adjustment suture 2305.

Drawings

The present disclosure is further described in the detailed description that follows, by way of non-limiting examples of exemplary embodiments, with reference to the noted plurality of drawings, in which like reference numerals represent similar parts throughout the several views of the drawings, and wherein:

Fig. 1A and 1B depict an embodiment of a suturing device.

Fig. 2A and 2B depict an embodiment of a gripping slot of a suturing device.

Fig. 3A and 3B depict an embodiment of a suturing device including movement of a movable arm and movable jaw when a needle is secured in a fixed jaw.

Fig. 3C and 3D depict embodiments of suturing devices including a needle transfer mechanism that transfers a needle.

Fig. 3E depicts an embodiment of a suturing device including movement of a movable arm and movable jaw when a needle is secured in the movable jaw.

Fig. 4A, 4B, 4C depict an embodiment of a stapling apparatus including a joint for facilitating movement of a movable arm and movable jaw.

Fig. 5A depicts an embodiment of a female needle for a suturing device.

Fig. 5B, 5C, 5D and 5E depict embodiments of a straight needle for a suturing device.

Fig. 5F, 5G, 5H, 5I depict an embodiment of a joined needle having an open channel feature based on a needle and a wire.

Fig. 5J depicts an embodiment of a suturing device including a mechanism for securing and releasing a needle.

Fig. 5K, 5L and 5M depict exploded views of embodiments of a control lever and grip member.

Fig. 5N, 5O and 5P depict embodiments of suturing devices including a mechanism for securing and releasing a needle.

Fig. 6A, 6B, and 6C depict an embodiment of a suturing device including a stop in an activated position.

Fig. 7A and 7B depict an embodiment of a suturing device including an activated stop and a safety member that prevents movement of the movable arm and movable jaw when the needle is not secured.

Fig. 8A and 8B depict embodiments of suturing devices that include an activated stop that allows movement of the movable arm and movable jaw when the needle is secured in the first grasping slot.

Fig. 8C and 8D depict embodiments of suturing devices that include an activated stop that allows movement of the movable arm and movable jaw when the needle is secured in the second grasping slot.

Fig. 9A depicts an embodiment of a suturing device including a stop transitioning from an active position to a deactivated position.

Fig. 9B and 9C depict exploded views of the stopper and movable arm.

Fig. 9D and 9E depict embodiments of suturing devices including a stop in a deactivated position.

Fig. 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 fixed.

Fig. 11A depicts an exploded view of an embodiment of a suturing device.

Fig. 11B and 11C depict an embodiment of a suturing device having an attachment member.

Fig. 12A and 12B depict an embodiment of the shape of a suturing device.

Fig. 13A and 13B depict an embodiment of a suturing device.

Fig. 13C depicts an exploded view of an embodiment of a suturing device.

Fig. 14A, 14B and 14C depict embodiments of a loading device and needle.

Fig. 15 depicts a rear view of an embodiment of a loading device.

Fig. 16 depicts an embodiment of a loading device with a line.

Fig. 17 depicts an embodiment of a suturing apparatus loaded with wires from a loading device.

FIG. 18 depicts a flow chart of a method of using the suturing apparatus and loading device.

Fig. 19 depicts an embodiment of the suturing apparatus loaded onto a loading device.

Figures 20A-20I depict the loading of a suture into a suturing apparatus using a loading apparatus.

Fig. 21 depicts a suturing apparatus that secures a needle loaded by a loading device.

Fig. 22A, 22B, 22C, 22D, 22E, 22F, and 22G depict a suturing device maneuvered within a lumen.

Fig. 22DD depicts an embodiment in which the operator holds the suturing device for palpation during a suturing operation.

Fig. 23A and 23B depict an embodiment of a mini-harness.

FIG. 24 depicts a close-up view of an embodiment of a mini-harness that includes an adjustment suture.

Fig. 25 depicts an embodiment of a harness loading piece for a mini-harness.

Fig. 26 depicts an embodiment of a mini-harness placed on a harness loader.

FIGS. 27A-27J depict an embodiment of inserting a mini-harness.

While the above-identified drawing figures set forth the presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. The present disclosure presents illustrative embodiments by way of representation and 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 embodiments.

List of reference numerals

1A-B suture device

2A first handle

2B second handle

3. Lever

4. Needle transfer mechanism

5. Fixed jaw

6. Movable jaw

7. Fixing arm

8. Movable arm

10. Loading device

11. Pulley wheel

12. Sliding piece

12A first slide

12B second slider

13. First loading groove

14. Second loading groove

15. Groove(s)

15A first groove

15B second groove

16. Wire (C)

16A first line

16B second line

17. Fixed wall

18. Curved needle

100. Jaw joint

101. Arm joint

102. Connecting joint

103. First gripping groove

104. Second gripping groove

105. Arm movement

106. Switching joint

107. Jaw movement

108. Covering piece

110A first position

110B second position

110C third position

112A-B-C secure location

121A-B safety notch

122A-B notch

123A-B protrusion

201. Needle

201A first needle

201B second needle

201C-D-E needle 201 embodiment

207A first recess

207B second recess

208. Hole(s)

209. Channel

301A-B first fastener

302A-B second fastener

320. Loading channel

505A first control lever

505B second control lever

510A first gripping member

510B second gripping member

515A-B-C fixation notch

605. Stop block

606. Cover for a container

607. Wing panel

608. Protrusions

610. Safety component

615. Base region

616A-B recess

617. Sliding channel

1105A-B attachment member

1205A-B length

1800. Method of

1802. Steps of method 1800

1804. Steps of method 1800

1806. Steps of method 1800

1808. Steps of method 1800

1810. Steps of method 1800

1812. Steps of method 1800

1814. Steps of method 1800

2205. Vaginal cavity

2206. Incision

2207. Vaginal wall

2208. Bone pelvic cavity

2208A pelvic cavity

2208B pelvic cavity

2209A-B-C-D-E-F puncture site

2210. Stop zone

2211. Indexing finger

2300. Mini sling

2302. Net

2305A-B-C modulating suture

2308A-B-C suture

2310A-B-C-D-E-F curved needle

2315. Sling loading piece

2705. Urethra tube

2710. Excess part

2720A-B-C junction

2725A-B-C shell

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 element

Detailed Description

The present disclosure includes improved suturing devices, suture loading members, tensionless mid-urethra slings, and methods of use thereof. The suture loading member may load the needle with the thread into the suturing device. A suturing device may be inserted into the cavity to reach the tissue to be sutured. The stapling apparatus can include a fixed jaw and a movable jaw between which tissue is placed for stapling. The fixed jaw remains in place while the movable jaw moves the needle of the tape wire to suture tissue. The suturing device includes a needle transfer mechanism that passes a needle between the jaws when suturing tissue. The stop and safety member may control movement of the movable jaws to prevent the needle from falling off when transferring between the jaws. When suturing is complete, the suturing device may be removed from the lumen along with the needle.

Part a: suturing device

Referring now generally to fig. 1A and 1B, the suturing device 1A may be scissor-shaped and ergonomically sized to reach a target tissue in a small space. The suturing device 1A may comprise a fixation arm 7 integrally formed with the fixation jaw 5. In some embodiments, the distal end of the fixation arm 7 includes a fixation jaw 5. The stapling device 1A can include a movable arm 8 coupled to the movable jaw 6.

Both the fixed jaw 5 and the movable jaw 6 may receive and grasp a needle, and the suturing device 1A may further include a needle transfer mechanism 4 to transfer 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 a needle between the fixed jaw 5 and the movable jaw 6. In some embodiments, the lever 3 extends from the fixed arm 7.

In some embodiments, the suturing device 1A may include a first handle 2A coupled to a fixed arm 7 and a second handle 2B coupled to a movable arm 8. The handles 2A and 2B may assist the user in moving the movable arm 8 relative to the fixed arm 7. The handles 2A and 2B may be provided at one end of the suturing device 1A that remains outside the cavity during operation so that an operator may control the suturing device 1A.

Fig. 2A and 2B depict an embodiment of a suturing device 1A. In some embodiments, the fixed jaw 5 includes a first gripping slot 103 (further described with reference to fig. 5B) that can receive the needle 201. In some embodiments, the movable jaw 6 includes a second gripping slot 104 that can receive the needle 201. In some embodiments, the channel of the grip slot is sized and shaped to receive a needle. For example, the grip slot may define a circular channel or circular aperture for receiving and gripping a needle.

In some embodiments, the needle transfer mechanism 4 may transfer the needle between the first grip slot 103 and the second grip slot 104. To this end, the needle transfer mechanism may secure the needle in the first grip slot 103 or the second grip slot 104, or release the needle from the first grip slot 103 or the second grip slot 104.

Fig. 3A-3E illustrate an embodiment of a mechanism for moving the movable arm 8 to pivot relative to the fixed arm 7 to pivot the movable jaw 6 relative to the fixed jaw 5. As shown in fig. 3A, movable arm 8 may have an arm motion 105 along which movable arm 8 pivots away from or toward fixed arm 7. For example, arm movement 105 may be caused by a surgeon manually moving handle 2A to open and close device 1A. Such control may be advantageous when operating in the invisible region to ensure that the movement of the device 1A may be under the control of the operator. In some embodiments, arm movement 105 may be caused by additional mechanical force elements, such as springs.

The fixed arm 7 may remain stationary relative to the movable arm 8 when the movable arm 8 moves. The movable arm 8 can pivot relative to the fixed arm 7 to pivot the movable jaw 6 relative to the fixed jaw 5. Movement of the movable arm 8 relative to the fixed arm 7 may cause the movable jaw 6 to effect a jaw movement 107 along which the movable jaw 6 may be pivoted away from or toward the fixed jaw 5. The fixed jaw 5 may remain stationary relative to the movable jaw 6 as 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.

The fixation jaw 5 may make it easier to work safely in a narrow space, as keeping the fixation jaw 5 stationary relative to the target tissue allows the suture to be placed while resting in a safe area. For example, when the operator moves the movable jaw 6 relative to the fixed jaw 5, the operator will know the position of the fixed jaw 5. The fixation jaw 7 enables the suture to pass through the target tissue when the target tissue is referenced with the fixation jaw 5 in an operative position that is difficult to see or not visible at all. The fixed jaw 5 and the movable jaw 6 may meet at a constant or predictable position relative to the tissue such that continuous predicted positions and distances are not required to center the tissue. Thus, the fixed jaw 5 can be stitched in an area that is difficult to see.

As shown in fig. 3B, in some embodiments, the movable arm 8 can pivot relative to the fixed arm 7 to pivot the movable jaw 6 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 the first grip slot 103 and the second grip slot 104 to exchange the needle between the slots.

As shown in fig. 3A-3E, in some embodiments, the lever 3 may be movable between a first position 110A, a second position 110B, or a third position 110C to control the securing and releasing of both the first grip slot 103 and the second grip slot 104. For example, the lever 3 may be a displacement member, a clamp or a switch movable by an operator. In the first position 110A, the needle 201 is fixed in the first gripping groove 103 of the fixed jaw 5. As shown in fig. 3A, when movable arm 8 is moved or opened, needle transfer mechanism 4 may grasp needle 201 in fixed jaw 5 while maintaining the grasp in movable jaw 6 inactive. As shown in fig. 3B, when movable arm 8 approaches fixed arm 7, needle transfer mechanism 4 can grasp needle 201 in fixed jaw 5 while maintaining the grasp in movable jaw 6 inactive by holding lever 3 in first position 110A.

As shown in fig. 3C, the lever 3 may then be moved to the second position 110B, whereby the needle 201 is released from the first grip slot 103 while still unsecured in the second grip slot 104. As shown in fig. 3C, the needle transfer mechanism 4 may be in an inactive state in both the fixed jaw 5 and the movable jaw 6 to release the needle 201.

As shown in fig. 3D, in the third position 110C, the needle 201 is secured in the second grip slot 104. As shown in fig. 3D, the needle transfer mechanism 4 can grasp the needle 201 in the movable jaw 6 while keeping the grasp in the fixed jaw 5 inactive. As shown in fig. 3E, when the movable jaw 6 is pivoted away from the fixed jaw 5 by the movement of the movable arm 8, the needle is fixed in the movable jaw 6, thereby completing the transfer of the needle 201 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 grasp the needle 201 in the movable jaw 6 while keeping the grasp inactive in the fixed jaw 5.

Referring generally to fig. 3A-3E, in some embodiments, suturing device 1A further includes a cover 108 disposed partially over lever 3. The lever 3 is movable between positions to set the first position 110A, the second position 110B or the third position 110C. In some embodiments, the cover 108 includes a marking, indentation, or indicator corresponding to movement of the lever 3 to the first, second, or third positions 110A, 110B, 110C.

Fig. 4A-4C depict an embodiment mechanism of the stapling apparatus 1A for movement of the movable arm 8 relative to the fixed arm 7 to enable the movable jaw 6 to have a jaw movement 107 along which the movable jaw 6 can be pivoted away from or toward the fixed jaw 5. In some embodiments, the fixed arm 7 may include an arm joint 101 to couple the fixed arm 7 to the movable arm 8. For example, arm joint 101 may be a mechanical joint for connecting two components and allowing them to move relative to each other. In some embodiments, the arm joint 101 enables the movable arm 8 to move relative to the fixed arm 7. For example, movable arm 8 may pivot about arm joint 101 and relative to fixed arm 7. In another example, arm joint 101 may allow movable arm 8 to pivot in one degree of freedom relative to fixed arm 7. In yet another example, the arm joint 101 may limit some movement of the movable arm 8, such as to prevent the movable arm 8 from breaking or exerting excessive force on the movable jaw 6, the slot, or any other component described herein.

In some embodiments, the securing arm 7 includes a jaw connector 100. In some embodiments, the fixed jaw 5 includes a jaw connector 100. The jaw joint 100 is coupled to the movable jaw 6 such that the movable jaw 6 is pivotable relative to the fixed jaw 5. For example, the jaw connector 100 may be a mechanical connector for connecting two components and allowing 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 connector 100 may allow the movable jaw 6 to pivot in one degree of freedom relative to the fixed jaw 5. In another example, the jaw connector 100 may limit some movement of the movable jaw 6, such as to prevent the movable jaw 6 from breaking or exerting excessive force on the fixed jaw 5, a slot, or any other component described herein.

In some embodiments, the suturing device 1A further comprises a connection joint 102 coupled to the movable arm 8 and the movable jaw 6. The connection joint 102 may be positioned between the jaw joint 100 and the arm joint 101 such that the jaw joint 100 and the arm joint 101 are separated and mechanically independent of each other. The connection joint 102 may allow the movable arm 8 to move to pivot the movable jaw 6. For example, the connection joint 102 may be a mechanical joint for connecting two components and allowing them to move relative to each other. 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 to pivot the movable jaw 6 about the jaw joint 100. For example, as shown in fig. 4B and 4C, movement of the movable arm 8 away from the fixed arm 7 causes the connection joint 102 to move across the width of the fixed arm 7. The connection joint 102 pulls the movable jaw 6, which causes the movable jaw 6 to pivot about the jaw joint 100 and away from the fixed jaw 5.

In some embodiments, the connection joint 102 may limit some movement of the movable jaw 6 and movable arm 8, such as to prevent them from disconnecting or exerting excessive force on the slot or any other component described herein. For example, the connection joint 102 may be limited to movement along the width of the fixed arm 7, which will prevent excessive movement of the movable jaw 6 and movable arm 8. In some embodiments, the portion of the fixed arm 7 between the jaw connector 100 and the arm connector 101 may remain in a fixed position as the movable jaw 6 moves within the pelvic cavity and the movable arm 8 moves outside the vaginal cavity. This movement can advantageously reduce the profile of the movable jaw 6 and the movable arm 8.

In some embodiments, the fixed arm 7 includes a reference position that includes the jaw connector 100, the arm connector 101, and the connection connector 102. The pivotal movement of the movable arm 8 and the movable jaw 6 about the reference position enables the stapling apparatus 1A to move like a scissor mechanism. For example, the suturing device 1A may be constructed of 3 rigid metal components (e.g., (1) a fixed jaw 7 integrally formed with the fixed jaw 5, (2) a movable arm 8, and (3) a movable jaw 6) attached to each other by three joints 100-102. As described above, the movable jaw 6 and the movable arm 8 are movable relative to each other and the fixed arm 7 and the fixed jaw 5 around a reference position in 2D space. In some embodiments, movable arm 8 pivots about a reference position and relative to fixed arm 7. In some embodiments, the movable jaw 6 pivots about a reference position and relative to the fixed arm 5.

For example, during operation of the suturing device 1A within the pelvic cavity, in order to perform suturing in the correct position, the fixed arm 7, whose outer contour may be designed accordingly, may be aligned with and fixed relative to a specific region of the pelvic cavity, while the jaw joint 100, arm joint 101 and connection joint 102 enable an operator to move the handle 2A to move the movable arm 8, and thus the movable jaw 6. By holding the securing arm 7 in place, the jaws 5 and 6 can be properly positioned for stapling.

Fig. 5A-5I depict an embodiment of a needle 201. The needles 201C, 201D, and 201E (commonly referred to as needles 201) may include a first notch 207A and a second notch 207B. The first notch 207A and the second notch 207B on the needle 201 are positioned such that the needle 201 can be gripped within either the first grip slot 103 or the second grip slot 104, or both. For example, a first notch 207A may be attached to the fixed jaw 5, while a second notch 207B may be attached to the movable jaw 6.

As shown in fig. 5A, the needle 201 may be a needle 201C having a concave shape. Fig. 5B, 5C, 5D and 5E depict an embodiment of a needle 201D having a straight shape. In some embodiments, needles 201C and 201D may include holes 208. In some embodiments, the holes 208 may be used to needle-line join by drilling in the middle of the needle 201C or the needle 201D, inserting a wire (e.g., wire 16) into the holes 208, and deforming the holes 208 with a suitable mold geometry attached to a press. In some embodiments, needle 201 and wire 16 may be joined by using a suitable adhesive rather than deforming aperture 208.

Fig. 5F, 5G, 5H, and 5I depict an embodiment of a needle 201E that includes a channel 209. Channel 209 may be an open channel feature based junction of needle 201 and wire 16. The channel 209 may be open in the middle region of the needle 201E. The wire may be placed within the channel 209 and the channel 209 may be deformed onto the wire with the aid of a suitable die geometry attached to the press. In some embodiments, needle 201 and wire 16 may be joined by using a suitable adhesive rather than deforming channel 209.

Fig. 5J depicts an embodiment of the needle transfer mechanism 4 of the suturing device 1A. The needle transfer mechanism 4 can enable the needle 201 to be held in the jaws 5 and 6 or released from the jaws 5 and 6 with the aid of flexible plates (e.g., first and second control levers 505A and 505B and/or first and second gripping members 510A and 510B) that move back and forth. These plates may be pulled or pushed by a control rod (e.g., lever 3) attached to the plates. In some embodiments, the first control rod 505A, the second control rod 505B, the first grip member 510A, and the second grip member 510B may be located within the stationary arm 7. In some embodiments, the first control rod 505A, the second control rod 505B, the first gripping member 510A, and the second gripping member 510B can be located within the fixed jaw 5 and the fixed arm 7.

Referring to fig. 5J, the needle transfer mechanism 4 includes a first control lever 505A and a second control lever 505B. In some embodiments, the first and second control rods 505A, 505B extend within respective channels in the fixed arm 7. In some embodiments, the first control rod 505A extends within a channel through the fixed jaw 5. In some embodiments, the second control rod 505B extends within a channel through the movable jaw 6.

The control rods can be independently advanced or retracted within their respective channels. In some embodiments, the first control rod 505A may be advanced toward the first grip slot 103 and toward the first notch 207A or the second notch 207B of the needle 201 disposed in the first grip slot 103 to secure the needle 201 in the first grip slot 103. In some embodiments, first control rod 505A may be retracted from first grip slot 103 and first notch 207A or second notch 207B to release needle 201 from first grip slot 103. In some embodiments, the second control rod 505B may be advanced toward the second grip slot 104 and toward the first notch 207A or the second notch 207B of the needle 201 disposed in the second grip slot 104 to secure the needle 201 in the second grip slot 104. In some embodiments, second control rod 505B may be retracted from second grip slot 104 and first notch 207A or second notch 207B to release needle 201 from second grip slot 104. For example, the control rods may be pulled within their respective channels.

The needle transfer mechanism 4 may include a switch joint 106 coupled to the lever 3, the first control rod 505A, and the second control rod 505B. In some embodiments, the switching joint 106 is provided on the fixed arm 7. Movement of the lever 3 may cause movement of the switch joint 106, which may cause movement of the first and second control rods 505A, 505B to secure or release the needle 201 in the first or second grip slots 103, 104. For example, the switching joint 106 may be a mechanical joint for connecting two components and allowing them to move relative to each other.

In some embodiments, lever 3 may rotate or move switching joint 106 to move first and second control rods 505A and 505B. For example, the lever 3 may rotate the switching joint 106, pushing or pulling a control rod connected to the switching joint 106. In this way, movement of the lever 3 may advance the first control rod 505A toward the first grip slot 103 while retracting the second control rod 505B from the second grip slot 104, or may retract the first control rod 505A away from the first grip slot 103 while advancing the second control rod 505B toward the second grip slot 104. For example, the switching joint 106 is rotated clockwise by the lever 3 such that the first control rod 505A is retracted away from the first grip groove 103, and the second control rod 505B is advanced toward the second grip groove 104. In another example, the switch joint 106 is rotated counterclockwise by the lever 3 such that the first control rod 505A advances toward the first grip slot 103 and the second control rod 505B retracts away from the second grip slot 104.

Fig. 5K, 5L, and 5M depict exploded views of embodiments of first and second control levers 505A and 505B and first and second grip members 510A and 510B. In some embodiments, the first and second gripping members 510A, 510B extend within respective channels in the stationary arm 7. In some embodiments, the first gripping member 510A extends within a channel in the fixed jaw 5. In some embodiments, the first gripping member 510A extends within a channel in the movable jaw 6.

In some embodiments, the control lever is connected or over-molded to the corresponding gripping member. For example, the first control rod 505A and the first grip member 510A may be one rod such that the first grip member 510A is an extension of the first control rod 505A. Although not shown, in another example, it is contemplated that the first control rod 505A and the first grip member 510A may be separate rods such that the first grip member 510A is coupled to the first control rod 505A. As shown in fig. 5M, the first grip member 510A (or the second grip member 510B) may be bent with respect to the first control lever 505A (or the second control lever 505B). The highly resilient nature of the first and second gripping members 510A, 510B allows them to move and function in the angled channels of the jaws 5, 6.

Referring back to fig. 5J, in some embodiments, the first control rod 505A may advance the first grip member 510A toward the first notch 207A or the second notch 207B of the needle 201 disposed in the first grip slot 103 to secure the first grip member 510A in the first grip slot 103. For example, the first control lever 505A may be pushed toward the first grip slot 103. In this manner, movement of the first control rod 505A may cause the first gripping member 510A to grip the first notch 207A or the second notch 207B to grip the needle 201 in the first gripping slot 103.

In some embodiments, first lever 505A may retract first grip member 510A from first notch 207A or second notch 207B to release needle 201 from first grip slot 103. For example, first control rod 505A may be pushed away from first grip slot 103. In this manner, movement of first control rod 505A may cause first grip member 510A to release first notch 207A or second notch 207B to release needle 201 from first grip slot 103.

In some embodiments, the second control rod 505B may advance the second gripping member 510B toward the first notch 207A or the 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. For example, the second control rod 505B may be pushed toward the second grip slot 104. In this way, movement of the second control rod 505B may cause the second gripping member 510B to grip the first notch 207A or the second notch 207B to grip the needle 201 in the second gripping slot 104.

In some embodiments, the second control rod 505B may retract the second grip member 510B from the first notch 207A or the second notch 207B to release the needle 201 from the second grip slot 104. For example, the second control rod 505B may be pushed away from the second grip slot 104. In this manner, movement of the second control rod 505B may cause the second grip member 510B to release the first notch 207A or the second notch 207B to release the needle 201 from the second grip slot 104. In some embodiments, the control rods or gripping members have different lengths. For example, the first grip member 510A or the first control rod 505A may be longer than the second grip member 510B or the second control rod 505B, as they have to extend a greater distance to reach the first grip slot 103. In another example, the second gripping member 510B or the second control rod 505B can be longer than the first gripping member 510A or the first control rod 505A, as they must be capable of bending with the movable jaw 6 including the second gripping slot 104.

The lever 3 can be moved to the first position 110A to move the switching joint 106, thereby advancing the first control rod 505A to advance the first gripping member 510A to grip the needle 201 in the first gripping slot 103 and retracting the second control rod 505A to retract the second gripping member 510B to release the needle 201 from the second gripping slot 104. For example, as shown in fig. 5J, lever 3 may rotate toggle joint 106 counterclockwise to move to first position 110A. In some embodiments, lever 3 may be moved to first position 110A to move switching joint 106 to advance first control rod 505A to advance first gripping member 510A to grip needle 201 in first gripping slot 103. For example, as shown in fig. 5J, by moving the lever 3 to the first position 110A, the switch joint 106 may be rotated in a counterclockwise direction, which may advance the first control rod 505A to the left and retract the second control rod 505B to the right, such that the first control rod 505A causes the first grip member 510A to grip the needle 201 in the first grip slot 103 and the second control rod 505B causes the second grip member 510B to release the needle 201 from the second grip slot 104. The lever 3 may include a safety notch 515A of the suturing device 1 to maintain the lever 3 in the first position 110A such that the lever 3 does not accidentally move to a different position during use (e.g., during surgery).

The lever 3 can be moved to the second position 110B to move the switch joint 106 to retract the first control rod 505A to retract the first grip member 510A to release the needle 201 from the first grip slot 103 and retract the second control rod 505A to retract the second grip member 510B to release the needle 201 from the second grip slot 104. In some embodiments, lever 3 may be moved to second position 110B to move switching joint 106, such that retraction retracts first control rod 505A to retract first grip member 510A to release needle 201 from first grip slot 103.

For example, as shown in fig. 5J, if lever 3 is moved from first position 110A to second position 110B, switching joint 106 may be rotated in a clockwise direction, which may partially retract first control rod 505A to the right and partially advance second control rod 505B to the left, such that first control rod 505A and second control rod 505B are in an inactive position preventing first grip slot 103 and second grip slot 104 from gripping needle 201.

In another example, as shown in fig. 5J, if lever 3 is moved from third position 110C to second position 110B, switching joint 106 may be rotated in a counterclockwise direction, which may partially retract first control rod 505A to the left and partially advance second control rod 505B to the right, such that first control rod 505A and second control rod 505B are in an inactive position preventing first grip slot 103 and second grip slot 104 from gripping needle 201. The lever 3 may include a safety notch 515B of the suturing device 1 to maintain the lever 3 in the second position 110B such that the lever 3 does not accidentally move to a different position during use (e.g., during surgery).

The lever 3 can be moved to the third position 110C to move the switching joint 106, thereby advancing the second control rod 505B to advance the second grip member 510B to grip the needle 201 in the second grip slot 104 and retracting the first control rod 505A to retract the first grip member 510A to release the needle from the first grip slot 103. In some embodiments, lever 3 may be moved to third position 110C to move switching joint 106 to advance second control rod 505B to advance second gripping member 510B to grip needle 201 in second gripping slot 104. For example, as shown in fig. 5J, by moving the lever 3 from the second position 110B to the third position 110C, the switch joint 106 may be rotated in a clockwise direction, which may retract the first control rod 505A to the right and advance the second control rod 505B to the left, such that the first control rod 505A causes the first grip member 510A to release the needle 201 from the first grip slot 103 and the second control rod 505B causes the second grip member 510B to grip the needle 201 in the second grip slot 104. The lever 3 may include a safety notch 515C of the suturing device 1 to maintain the lever 3 in the third position 110C such that the lever 3 does not accidentally move to a different position during use (e.g., during surgery).

Referring now to fig. 5N, 5O, and 5P, in some embodiments, the needle transfer mechanism 4 includes a cable 3001A, a cable 3001B, a spring 3002A, and a spring 3002B. The cables 3001A and 3001B may be attached to the lever 3 with stubs 3004A and 3004B located at the ends of the cables 3001A and 3001B. In some embodiments, cables 3001A and 3001B extend within respective channels in fixed arm 7. In some embodiments, the cable 3001A extends within a channel in the stationary jaw 5. In some embodiments, the cable 3001B extends within a channel in the movable jaw 6. In some embodiments, the spring 3002A is positioned within the stationary jaw 5. In some embodiments, the spring 3002B is located within the movable jaw 6.

The lever 3 can be rotated along the switching joint 106. There may be 3 different positions in which the lever 3 can be rotated. The lever 3 may be designed such that a predetermined amount of user-applied force is required to change the position of the lever 3. In some embodiments, the predetermined amount of user-applied force is based on the tension of cable 3001A and cable 3001B. The geometric features 3005A, 3005B, 3007A, 3007B, 3006A, and 3006B of the securing arm 7 may be used to route cable 3001A and cable 3001B in an optimal path. The springs 3002A and 3002B may be placed on the cylindrical piston 3003A and 3003B and retained by machine elements (e.g., machine element 3008B retains springs 3002B), which may include rings, pins, etc., or structural features such as protrusions. In some embodiments, a cylindrical piston 3003A is located within the stationary jaw 5. In some embodiments, a cylindrical piston 3003B is located within the movable jaw 6.

In some embodiments, the proximal ends of the pistons 3003A and 3003B (e.g., near the operator) are attached to the cables 3001A and 3001B, respectively. In some embodiments, the distal ends of the pistons 3003A and 3003B may be designed and shaped to engage and grip the needle 201. In some embodiments, the distal end of the piston 3003A may be advanced to engage and grip the needle 201 in the stationary jaw 5. In some embodiments, the distal end of the piston 3003A may be retracted to disengage and release the needle 201 in the fixed jaw 5. In some embodiments, the distal end of the piston 3003B may be advanced to engage and grip the needle 201 in the movable jaw 6. In some embodiments, the distal end of the piston 3003B may be retracted to disengage and release the needle 201 in the movable jaw 6.

In some embodiments, the lever 3 may be in an intermediate position (e.g., similar to the second position 110B), as shown in fig. 5N and 5O. In the neutral position, both cables 3001A and 3001B may be half-pulled, both springs 3002A and 3002B may be half-compressed, and both pistons 3003A and 3003B may be half-retracted. In some embodiments, when the pistons 3003A and 3003B are semi-retracted, the pistons 3003A and 3003B are disengaged from the needle 201, enabling the needle 201 to be released from both the fixed jaw 5 and the movable jaw 6. In some embodiments, when the pistons 3003A and 3003B are semi-retracted, the pistons 3003A and 3003B engage the needle 201 such that the needle 201 is secured in both the fixed jaw 5 and the movable jaw 6. In some embodiments, with jaws 5 and 6 in the closed position (e.g., movable jaw 6 moving toward fixed jaw 5), needle 201 may be held by jaws 5 and 6 and the suturing device (e.g., device 1A or 1B) may be locked.

In some embodiments, the lever 3 may be in a forward position (e.g., similar to the first position 110A). In the forward position, the lever 3 may cause the spring 3002A corresponding to the fixed jaw 5 to be fully released by the cable 3001A, which may cause the piston 3003A to move forward under the force of the spring, and the needle 201 may remain in the fixed jaw 5. At the same time, the lever 3 can cause the spring 3002B corresponding to the movable jaw 6 to be pulled by the cable 3001B and fully compressed, which can cause the piston 3003B to be pulled by the cable 3001B and the needle 201 to be released from the movable jaw 6.

In some embodiments, the lever 3 may be in a rearward position (e.g., similar to the third position 110C). In the rearward position, the lever 3 may cause the spring 3001B corresponding to the movable jaw 6 to be fully released via the cable 3002B, which may cause the piston 3003B to move forward under the force of the spring, and the needle 201 may remain in the movable jaw 6. At the same time, the lever 3 can cause the spring 3002A corresponding to the fixed jaw 5 to be pulled by the cable 3001A and fully compressed, which can cause the piston 3003A to be pulled by the cable 3001A and the needle 201 to be released from the fixed jaw 5.

Fig. 6A, 6B and 6C depict an embodiment of a suturing device 1A including a stop 605 in an activated position. For safety, if the movable jaw 6 moves when the lever 3 is in the second position 110B, the needle 201 may fall off because the needle 201 is not fixed in either the first grip slot 103 or the second grip slot 104. To address this problem, the stapling device 1A includes a stop 605 to control when the movable arm 8, and thus the movable jaw 6, can move based on the position of the lever 3. For example, stop 605 may physically prevent movable arm 8 from moving to prevent needle 201 from falling.

As shown in fig. 6A and 6B, a stop 605 may be provided on the movable arm 8 to control when the movable arm 8 may move relative to the fixed arm 7. For example, stop 605 may grip or secure fixed arm 7 to prevent movement of movable arm 8, thereby preventing needle 201 from falling. The stop 605 may be provided on the movable arm 8 adjacent to the lever 3 on the fixed arm 7 to control the movable arm 8 based on the position of the lever 3. In some embodiments, the stop 605 is covered by a cover 606 to protect the stop 605.

Stop 605 is slidable on movable arm 8 between an activated position and a deactivated position. When the stop 605 is in the activated position, the stop 605 may control the movement of the movable arm 8. In the activated position, stop 605 may be positioned closer to movable arm 8to be adjacent to fixed arm 7, thereby grasping a portion of fixed arm 7 to control movement of movable arm 8 relative to fixed arm 7.

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 may be a plastic or metal cap that slides over the movable arm 8. In the deactivated position, the stop 605 may be positioned farther from the movable arm 8 to avoid grasping the fixed arm 7 and thereby avoiding controlling movement of the movable arm 8 relative to the fixed arm 7. The stop 605 may slide on the movable arm 8 towards the fixed arm 7 and into an activated position to grip the fixed arm 7 to control the movable arm 8.

As shown in fig. 6B and 6C, the stop 605 may include a tab 607 to secure the stop 605 in the activated position. For example, the tab 607 may be a bendable extension of the stop 605. The tab 607 may snap onto and over the edge of the movable arm 8 to secure the stop 605 in the activated position. The tab 607 may be bent away from the movable arm 8 to release the stop 605 from the activated position. As shown in fig. 6C, the operator may bend the tab 607 to release the stop 605 from the activated position.

Fig. 7A and 7B depict an embodiment of the suturing device 1A comprising a stop 605 in the activated position and a safety member 610, the safety member 610 preventing movement of the movable arm 8 and the movable jaw 6 when the needle 201 is not fixed, because the lever 3 is in the second position 110B. In some embodiments, fig. 7A shows a cross-sectional view of the stop 605 without the cover 606. In some embodiments, stop 605 does not have a cover.

Since the stopper 605 is provided on the movable arm 8, the stopper 605 moves when the movable arm 8 moves. Since the safety member 610 is provided on the fixed arm 7, the stopper 605 moves relative to the safety member 610 when the movable arm 8 moves. Thus, the interlocking of the safety member 610 and the stop 605 will prevent the stop 605 from moving, thereby preventing the movable arm 8 from moving, thereby preventing the needle 201 from falling.

If the stop 605 protrudes against the safety member 610, the safety member 610 and the stop 605 may interlock. In the activated position, stop 605 is positioned to interlock with safety member 610. For example, the stop 605 may block or grip the security member 610. In some embodiments, when lever 3 is in second position 110B (e.g., needle 201 is not fixed) and the jaws are closed, stop 605 and safety member 610 interlock to prevent movable jaw 8 from opening. In some embodiments, when lever 3 is in either first position 110A or third position 110C (needle 201 is secured) and the jaws are open, stop 605 and safety member 610 may interlock to prevent lever 3 from moving to second position 110B to release needle 201.

By positioning the stop 605 and the safety member 610 to interlock when the lever 3 is in the second position 110B and the jaws are closed, the needle 201 does not fall when the needle 201 is not secured in the first grip slot 103 or the second grip slot 104, and the movable arm 8 can move when the needle 201 is secured in the first grip slot 103 or the second grip slot 104. The safety member 610 and the stop 605 may 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 thus the movable jaw 6 from moving when the lever 3 is in the second position 110B, preventing the needle 201 from falling.

To position the stop 605 and the safety member 610 to interlock based on the position of the lever 3, the safety member 610 may be provided on the second control rod 505B. Since the lever 3 moves the second control rod 505B, the position of the lever 3 determines the position of the safety member 610. The lever 3 in the second position 110B brings the safety member 610 to the safety position 112A, such that the safety member 610 interlocks with the stop 605 to prevent the movable arm 8 from moving relative to the fixed arm 7, thereby preventing the needle 201 from falling.

As shown in fig. 8A and 8B, an embodiment of the suturing device 1A includes a stop 605 in an activated position and a safety member 610, the safety member 610 allowing movement of the movable arm 8 and movable jaw 6 when the needle 201 is secured in the first grasping slot 103. The lever 3 in the first position 110A brings the safety member 610 to the safety position 112B, which will enable the safety member 610 to bypass the stop 605, thereby enabling the movable arm 8 to move.

Fig. 8B depicts the movable arm 8 moving when the lever 3 is in the first position 110A. In the activated position, when movable arm 8 and movable jaw 6 are open, stop 605 may prevent lever 3 from moving from first position 110A (where needle 201 is fixed) to second position 110B (where needle 201 is not fixed) to prevent needle 201 from falling.

Fig. 8C and 8D depict an embodiment of the suturing device 1A that includes 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 in the second gripping slot 104. The lever 3 in the third position 110C brings the safety member 610 to the safety position 112C, which will enable the safety member 610 to bypass the stop 605, thereby enabling the movable arm 8 to move.

Fig. 8D depicts the movable arm 8 moving when the lever 3 is in the third position 110C. In the activated position, when movable arm 8 and movable jaw 6 are open, stop 605 may prevent lever 3 from moving from third position 110C (where needle 201 is fixed) to second position 110B (where needle 201 is not fixed) to prevent needle 201 from falling.

As shown in fig. 9A, the stop 605 transitions from the activated position to the deactivated position. The operator may bend the tab 607 to release the stop 605 from the activated position. The operator may pull the stop 605 away from the safety member 610. The stop 605 can slide on the movable arm 8 and away from the fixed arm 7 and into the inactive position. In some embodiments, the operator may keep the stop 605 sliding until it is removed from the movable arm 8.

Fig. 9B and 9C depict exploded views of the stopper 605 and the movable arm 8. As shown in fig. 9B, movable arm 8 may include a base region 615. The base region 615 may be integrally formed with the movable arm 8. The base region 615 may be aligned with the lever 3 or the switch joint 106. The position of the stop 605 relative to the base region 615 may determine whether the stop 605 is in an activated or deactivated position. In the activated position, stop 605 may be positioned closer to movable arm 8 to be adjacent to fixed arm 7, thereby grasping a portion of fixed arm 7 or interlocking with safety member 610 to control movement of movable arm 8 relative to fixed arm 7. In the deactivated position, the stop 605 may be positioned farther from the movable arm 8 to avoid grasping the fixed arm 7 and thereby avoiding controlling movement of the movable arm 8 relative to the fixed arm 7.

The base region 615 may include a recess 616A and a recess 616B positioned in the sliding channel 617 that are configured to receive the stop 605. Recesses 616A and 616B may be recesses or cutouts in base region 615. Notch 616A may secure stop 605 in the activated position and notch 616B may secure stop 605 in the deactivated position. Recess 616A may be disposed away from a side edge of movable arm 8 to secure stop 605 closer to movable arm 8 in the activated position. Recess 616B may be disposed closer to a side edge of movable arm 8 to secure stop 605 further away from movable arm 8 in the deactivated position.

As shown in fig. 9C, the stop 605 may include a protrusion 608 that may be secured in a recess 616A or a recess 616B. For example, the projection 608 may be a bump or a tube protruding from the stop 605. The projection 608 may slide or snap into the recess 616A or the recess 616B to be secured. The projection 608 may slide into the recess 616A to secure the stop 605 in the activated position. The projection 608 may slide into the recess 616B to secure the stop 605 in the deactivated position.

As shown in fig. 9D and 9E, in the deactivated position, the stop 605 is positioned away from the fixed arm 7 and the safety member 610 such that the stop 605 and the safety member 610 cannot interlock. Regardless of the position of the lever 3 and thus the safety member 610, the safety member 610 may be positioned so as not to protrude against the stop 605 when the stop 605 is in the deactivated position.

Fig. 10A and 10B depict an embodiment of suturing device 1A that includes a stop 605 in a deactivated position to allow movable arm 8 to move even when needle 201 is not fixed. When the stop 605 is in the deactivated position, the movable arm 8 may move when the lever 3 is in the second position 110B and the needle 201 is not fixed in the first grip slot 103 or the second grip slot 104. By allowing the movable arm 8 to move when the lever 3 is in the second position 110B, the needle 201 may be released, such as at the end of a suturing operation. In the deactivated position, stop 605 may allow lever 3 to move from first position 110A or third position 110C to second position 110B, thus loading, unloading, and reloading needle 201 into loading device 10 as described below.

Fig. 11A depicts an embodiment of a suturing device 1A. In some embodiments, the first handle 2A is coupled to the movable arm 8 by a set of first fasteners 301A and 301B. In some embodiments, the second handle 2B is coupled to the fixed arm 7 by a set of second fasteners 302A and 302B.

Fig. 11B and 11C depict an embodiment of a suturing device 1A having an attachment member 1105A and an attachment member 1105B. In some embodiments, the attachment member 1105A or 1105B has the needle 201 already preloaded. As shown in fig. 11B, the attachment member 1105A may be configured to attach to a movable jaw 6 configured to receive the attachment member 1105A. As shown in fig. 11C, the attachment member 1105B may be configured to attach to a fixed jaw 5 configured to receive the attachment member 1105B. For example, the attachment member 1105A with the needle 201 may be attached to the movable jaw 6 of the suturing device 1A without having to load the needle 201 into the second grasping slot 104. In another example, the attachment member 1105B with the needle 201 may be attached to the fixed jaw 5 of the suturing device 1A without having to load the needle 201 into the first grasping slot 103. In some embodiments, at the end of the suturing operation, the attachment member 1105A or the attachment member 1105B may be removed with the needle 201, and the other attachment member 1105A or the attachment member 1105B with the replacement needle 201 may be attached to the fixed jaw 5 or the movable jaw 6. In some embodiments, the operator may use the same needle 201 to stitch more than one suture. For example, if the procedure (or operation) requires, the operator may also perform a stitch (sequence) once again with the same needle 201, which is referred to as a Z-stitch or 8-stitch.

Fig. 12A and 12B depict an embodiment of the shape of a suturing device (e.g., suturing device 1A or suturing device 1B). The suturing device may have various sizes, shapes and angles that are optimized based on the anatomy in which the suturing device is to be used. Because of its precise location and in a minimally invasive manner, the suturing device can be of optimized size and angle for safely repairing pelvic floor disease.

The size and angle of the devices may be selected based on the target ligament each device is designed to reach for suturing and the path each device needs to travel in order to reach the target ligament. For example, the path may have obstructions such as hard bone tissue and soft tissue. The size and angle may ensure that a surgical procedure using the suturing device may maneuver the suturing device through the path such that the device is delivered to its target ligament in a minimally invasive manner. For example, the area of the path may be in the pelvic cavity, which may be very similar from patient to patient, with minimal standard deviation. Thus, even though the patients may have different physical parameters (e.g., height, weight, etc.), the calculations may be accurate from patient to patient. The size and angle may be selected based on the target ligament. For example, once the device is delivered to the target ligament, the outer profile of the fixed jaw 5 may be used for positional accuracy.

The suturing device may have a length such that during operation of the suturing device, the handles 2A and 2B may be positioned outside the lumen, while the length defines the portion of the suturing device that may be positioned inside the lumen. For example, the suturing device may have a length and angle for a transvaginal approach or procedure. As shown in fig. 12A, the fixed jaw 5 may extend at an angle of 77.2 degrees with respect to the fixed arm 7. Length 1205A can be measured from the end of fixed jaw 5 and fixed arm 7. As shown in fig. 12B, the fixation arm 7 may have a distal portion that extends at an angle of 15.88 degrees relative to the proximal portion. The fixed jaw 5 may extend at an angle of 130 degrees with respect to the fixed arm 7. The fixed jaw 5 and the fixed arm 7 may have a length 1205B. It is contemplated that the suturing device may be modified to modify the size, shape, and angle to optimize the suturing device for a particular lumen and procedure.

Fig. 13A, 13B and 13C depict an embodiment of a suturing device 1B. Suturing device 1B may be similar to suturing device 1A, but with the exception that its components have different angles, sizes, and shapes to optimize suturing device 1B for the anatomy in which suturing device 1B is to be used. Fig. 13C depicts an exploded view of an embodiment of suturing device 1B. In some embodiments, the first handle 2A is coupled to the fixed arm 7 by a set of first fasteners 301A-301B. In some embodiments, the second handle 2B is coupled to the movable arm 8 by a set of second fasteners 302A-302B. In some embodiments, the suturing device 1B may use an attachment member 1105A or an attachment member 1105B as described with reference to fig. 11B and 11C. For example, the attachment member 1105A may be configured to attach to a movable jaw 6 configured to receive the attachment member 1105A. In another example, the attachment member 1105B may be configured to attach to a fixed jaw 5 configured to receive the attachment member 1105B.

Part B: suture loading piece

Fig. 14A-14C, 15 and 16 depict an embodiment of a loading device 10 for loading a needle 201 into a suturing apparatus 1A or 1B in a practical and standardized manner. Fig. 15 depicts a rear view of an embodiment of the loading device 10. In some embodiments, the loading device 10 includes a first loading slot 13 provided in the loading device 10. In some embodiments, the first loading slot 13 can receive a fixed jaw. For example, the first loading slot 13 may form a channel in the loading device 10. The channel may be sized and angled to receive the fixed jaw 5 such that the fixed jaw 5 may fit securely into the first loading slot 13 to receive the fixed jaw 5. The channel is defined by one or more side walls, and the fixed jaw 5 can be positioned within the channel. The fixed wall 17 may allow the fixed jaw 5 to maintain its position in the first loading slot 13 of the loading device 10 while receiving the needle 201.

As shown in fig. 14C, in some embodiments, the loading device 10 includes a slider 12 that includes a slot 15 for holding the needle 201. The slot 15 may be sized and shaped to hold the needle 201. For example, slot 15 may include a circular hole or define a channel sized to receive needle 201. Needle 201 may be placed into slot 15 to secure needle 201 in slot 15. Slider 12 may move needle 201 in slot 15 while needle 201 remains coupled to wire 16.

The slider 12 may insert the needle 201 into the first grip 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 of the fixed jaw 5 and into the first grasping slot 103. For example, the loading channel 320 may define a space in which the slider 12 may move. The loading channel 320 and the slider 12 may be sized such 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 separate positions to engage the needle 201 with the fixed jaw 5: one position for advancing the needle 201 into the first grip slot 103 and the other position for retracting the slider 12 after the needle 201 is fixed in the first grip slot 103.

In some embodiments, loading device 10 includes a pulley 11 that includes a wire 16 coupled to a needle 201. The wire 16 may be wound or coiled around the pulley 11. In some embodiments, the pulley 11 can be rotated such that the wire 16 moves when the first gripping groove of the fixed jaw 6 exits the first loading groove 13. For example, the pulley 11 may be shaped as a wheel with a grooved edge around which the wire 16 is wound. In some embodiments, wire 16 may be wound around pulley 11 to load needle 201 back into loading apparatus 10 after loading needle 201 into suturing device 1A or suturing device 1B. For example, this feature may be useful in many cases during the procedure, e.g., after passing the first suture, the operator may decide to make a Z-shaped suture with the same needle 201, thus being able to load it back into the loading apparatus 10 and load the needle 201 therefrom to the suturing device 1A or 1B.

In some embodiments, the loading device 10 includes a second loading slot 14 disposed in the loading device 10. In some embodiments, the second loading slot 14 can receive the movable jaw 6. The second loading slot 14 may form a channel in the loading device 10. The channel may be sized and angled to receive the movable jaw 6 such that the movable jaw 6 may be securely fitted into the second loading slot 14 when the fixed jaw 6 is positioned in the first loading slot 13. For example, the loading channel 320 can be defined by one or more sidewalls, and the fixed jaw 5 can be positioned within the channel. Although not shown, in some embodiments, the slider 12 can move within the loading channel 320 to move the slot 15 holding the needle 201 toward and into the second loading slot 14 of the movable jaw 6 and into the second loading slot 104. For example, the slider 12 may be moved to two separate positions: one position for advancing the needle 201 into the second grip slot 104 and the other position for retracting the slider 12 after the needle 201 is secured in the second grip slot 104. In another example, the slide 12 may be moved to three separate positions: one for advancing the needle 201 into the second grip slot 104, another for retracting the slider 12 after the needle 201 is secured in the second grip slot 104, and yet another for advancing the needle 201 into the first grip slot 103. In some embodiments, the pulley 11 can be rotated such that the wire 16 moves through the second loading slot 14 as the second gripping slot 104 of the movable jaw 6 exits the second loading slot 14.

Fig. 17 depicts an embodiment of the wire 16 having a curved needle 18 to secure the wire 16 into the loading device 10. The wire 16 may be coupled to the needle 201 at one end and the curved needle 18 may be at the other end of the wire 16. The curved needle 18 may be replaced if desired. For example, the wire 16 may be tied or untwisted from the curved needle 18. The curved needle 18 may have a sharp end to hook, attach or wrap around the pulley 11 to secure the curved needle 18. The curved needle 18 may be mounted on the pulley 11 such that the curved needle 18 enables the pulley 11 to wind up the wire 16. After the suturing device 1 is removed from the loading apparatus 10, the pulley 11 allows the wire 16 to unwind in a controlled manner to prevent the wire 16 from loosening and forming knots or clusters.

Part C: method of

Fig. 18 depicts a flowchart of a method 1800 of suturing using the suturing apparatus 1A and the loading device 10. Method 1800 may include providing suturing device 1A or suturing device 1B (step 1802). It is contemplated that method 1800 may be performed with any other embodiment of a suturing device. The shape of the stapling device and the angle between the jaws and arms may be optimal for certain procedures or ligaments. For example, the angle may be optimized for safety to prevent injury to other tissues such as the bladder. The operator may select either the suturing device 1A or the suturing device 1B based on the treatment site to be sutured. For example, the operator may choose among suturing devices based on the ligament to be sutured.

Method 1800 may include inserting suturing apparatus 1A or 1B into loading device 10 (step 1804). The lever 3 can be pulled toward the handle 2 to be in the second position 110B to receive the needle 201 in the fixed jaw 5. Prior to placing suturing device 1A into loading apparatus 10, stop 605 may be moved to a deactivated position to enable lever 3 to be moved from first position 110A or third position 110C to second position 110B. As shown in fig. 19, the movable jaw 6 of the suturing device 1A can be opened relative to the fixed jaw 5. The suturing device 1A can be placed on the suture loading apparatus 10 such that the fixed jaw 5 fits into the first loading slot 13 and the movable jaw 6 fits into the second loading slot 14.

Method 1800 may include loading needle 201 into suturing device 1A (step 1806). Fig. 20A is a front view and fig. 20B is a rear view of slider 12 in an initial (e.g., default) position when needle 201 is loaded into slider 12. Fig. 20C is a front view and fig. 20D is a rear view of the slider 12 moving along the loading channel 320 to move the needle 201 into the fixed jaw 5. The needle slider 12 can be moved in the direction of the fixed jaw 5. The slider 12 can be driven in the loading channel 320 to load the needle 201 into the fixed jaw 5. The needle 201 may be loaded into the first grip slot 103.

As shown in fig. 20A-20I, in some embodiments, slider 12 includes safety notches 121A-122B in loading channel 320 and protrusions 123A-123B on slider 12 for creating a clicking effect to inform the operator that needle 201 has been loaded successfully. The safety notches 121A-122B and the protrusions 123A-123B may provide a clicking effect to inform the operator of successful loading of the needle 201 based on the notches 121A and 121B or successful unloading based on the notches 122A and 122B. Fig. 20E and 20F show close-up views of the slider 12 shown in fig. 20B and 20D, respectively. Fig. 20G, 20H, and 20I show details of the slider 12 from different views. Fig. 201 shows a front view of the slider 12 according to fig. 20E. Fig. 20G shows a rear view of the slider according to fig. 20E. Fig. 20H shows a perspective view of the slider 12 according to fig. 20E.

Fig. 21 shows that the needle 201 from the loading device 10 is fixed in the first gripping groove 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 may be pulled upward and into the first position 110A. For example, the lever 3 may be moved from the second position 110B to the first position 110A. The stop 605 may be in a deactivated position to enable the lever 3 to move from the first position 110A or the third position 110C to the second position 110B. After the needle 201 is fixed in the first gripping groove of the fixed jaw 5, the slider 12 can be moved away from the fixed jaw 5, while the needle 201 is fixed in the first gripping groove of the fixed jaw 5.

After receiving needle 201, suturing device 1A may be separated from loading apparatus 10, and needle 201 pulls wire 16 wound on pulley 11. Suture 16 may be pulled from pulley 11 and thus from loading device 10. One end of the wire 16 may remain attached to the curved needle 18, which remains attached to the pulley 11.

In some embodiments, instead of step 1804 and step 1806, an attachment member 1105A or an attachment member 1105B with an already preloaded needle 201 may be attached to the suturing device 1A or the suturing device 1B. As shown in fig. 11B and 11C, the attachment may be attached to the fixed jaw 5 or the movable jaw 6. For example, instead of having to load needle 201 with loading device 10, an operator may also attach an attachment to suturing device 1A or suturing device 1B to utilize the attachment for suturing. At the end of the suturing operation, the attachment may be removed together with the needle 201, and another attachment with a replacement needle 201 may be attached to the fixed jaw 5 or the movable jaw 6.

The method 1800 may include moving the suturing device 1A into the vaginal cavity (step 1808). As shown in fig. 22A, suturing device 1A may be inserted into vaginal cavity 2205. An operator may make an incision 2206 (e.g., a 3cm incision) in the vaginal wall to insert a suturing device 1A through the incision 2206 to reach the pelvic cavity 2208 (e.g., retzius space) where a suturing operation is to be performed (e.g., ATFP is located in the cavity) and the suture is delivered to the pelvic cavity. As shown in fig. 22B, suturing device 1A may be inserted into vaginal cavity 2205. As shown in fig. 22C, the suturing device 1A can be inserted through the vaginal cavity 2205 into the bone pelvic cavity 2208 such that an incision is not opened in the abdomen to insert the suturing device 1A. While the movable jaw 6 is closed relative to the fixed jaw 5, the operator can move the stapling apparatus 1A into the vaginal cavity 2205.

As shown in fig. 22D, the operator can move the suturing device 1A until the fixed jaw 5 or the movable jaw 6 contacts the target tissue within the bone pelvis 2208, which allows the operator to safely position the suturing device 1A. For example, the operator may determine the location of the target tissue (e.g., ATFP for SUI procedures) by palpating the target tissue, and then the operator may move the stapling apparatus 1A until the fixed jaw 5 or the movable jaw 6 in the closed position contacts the palpating ligament. Once the fixed jaw 5 or the movable jaw 6 is in contact with the palpated tissue, the operator can infer that the suturing device 1A has been properly positioned. For example, suturing device 1A can be inserted into pelvic cavity 2208, which can be a manipulation site, through an incision 2206 that opens at the vaginal wall.

The suturing device 1A may be designed based on the length of the cavity into which the suturing device 1A is intended to be inserted. When the operator stops inserting the suturing device 1A, the area of the point on the suturing device 1A that remains outside the lumen may be referred to as a stop area 2210. For example, stop region 2210 may be located near arm joint 101. In another example, during operation of suturing device 1A, arm joint 101 may be positioned outside of vaginal cavity 2205, while a portion of suturing device 1A may be positioned inside of vaginal cavity 2205. In another example, stop region 2210 is closer to handles 2A and 2B, such that suturing device 1A is further inserted into vaginal cavity 2205.

As shown in fig. 22DD, in some embodiments, the shape of the suturing device 1B may facilitate palpation during suturing operations. During POP operation, the operator can use their index finger 2211 to locate the ligament where the suture is to be placed and to determine the safe area on which to place the suture on the ligament. The operator can bring the suturing device 1B to the safe area and pass the suture. In some embodiments, the shape of the suturing device 1B may match the shape of the index finger 2211 during palpation, and the size of the suturing device 1B may move with the index finger 2211 of the operator during palpation. The shape and size of the fixed fixation jaw 5 and suturing device 1B enable an operator to place the suturing device 1B under their index finger 2211 and complete palpation and suture penetration in one step. The suturing device 1B and its size, shape, and fixation jaw 5 may conform to the shape of an operator's index finger 2211 and may work cooperatively with the operator's index finger 2211.

Referring back to fig. 18, the method 1800 can include opening the movable arm 8 relative to the fixed arm 7 to open the movable jaw 6 until tissue in the pelvic cavity 2208 is located between the fixed jaw 5 and the movable jaw 6 (step 1810). As shown in fig. 22E, the operator can pull the stapling device 1A away from tissue to create a safe distance to open the movable jaw 6 relative to the fixed jaw 5. After opening the movable jaw 6, the operator can position the fixed jaw 5 on the tissue to be stapled.

Widening of suturing device 1A caused by opening of handles 2A and 2B may remain outside of vaginal cavity 2205. Movement of the movable arm 8 within the vaginal cavity 2205 can cause the movable jaw 6 to pivot about the jaw joint 100 inside the pelvic cavity 2208. Since the movable arm 8 can cause the movable jaw 6 to move while the fixed jaw 5 and the fixed arm 7 can stay in the same position, the operator can predict where the needle 201 will suture, which allows the operator to more safely suture tissue that is difficult to see or not visible at all.

Method 1800 may include closing movable arm 8 relative to fixed arm 7 to close movable jaw 6, thereby moving needle 201 through tissue (step 1812). As shown in fig. 22E and 22F, the fixed jaw 5 can provide a fixed reference while the movable jaw 6 is moving, and tissue within the pelvic cavity 2208 to be sutured can be placed between the fixed jaw 5 and the movable jaw 6. By moving the movable jaw 6 relative to the fixed jaw 5, the needle 201 passes through tissue. Although the location where suturing is desired may be in a narrower, deeper, difficult-to-see area or not at all seen by the operator, the needle 201 may be sutured in a desired location because the movement of the movable jaw 6 is predictable and accurate while the fixed jaw 5 remains stationary relative to the target tissue. As shown in fig. 22F, the operator can close the movable arm 8 with respect to the fixed arm 7 to close the movable jaw 6 with respect to the fixed jaw 5.

The method 1800 may include actuating the needle transfer mechanism 4 to transfer the needle 201 from the fixed jaw 5 to the movable jaw 6 to pass the suture (step 1814). The operator can move the lever 3 to transfer the needle 201 from the fixed jaw 5 to the movable jaw 6. By pulling the lever 3 in the direction of the handle 2 and pulling it to the third position 110C, the needle 201 is transferred and fixed in the movable jaw 6. The needle 201 can be transferred from the first gripping slot 103 of the fixed jaw 5 to the second gripping slot 104 of the movable jaw 6. Leaving the fixed jaw 5 in a fixed position while transferring the needle 201 enables safe transfer of the needle 201 when the tissue is difficult to see or not visible at all.

As shown in fig. 22G, the needle 201 has been transferred to the movable jaw 6. The movable jaw 6 can be moved away with the needle 201 and opened relative to the fixed jaw 5 to be positioned for another suture. As shown in fig. 22A-22G, the needle 201 is first loaded into the fixed jaw 5, and thus the needle 201 is transferred from the fixed jaw 5 to the movable jaw 6. However, it is contemplated that the needle 201 may be loaded into the movable jaw 6 (e.g., the second gripping slot 104) first. The movable jaw 6 and needle 201 can pierce tissue and move toward the fixed jaw 5 until the needle 201 is disposed in the fixed jaw 5 (e.g., the first grasping slot 103).

Because the suturing device described herein can transfer the needle 201 between jaws, an operator can reach the treatment site and suture with the same device, rather than relying on one device to manipulate the treatment site and another device to suture. In addition, the transfer of needle 201 between the jaws enables sequential suturing. For example, if the procedure requires, the operator may also perform a further stitch (sequence) with the same needle 201, which is referred to as a Z-stitch or a 8-stitch.

After suturing, the suturing device 1A may be removed from the pelvic cavity 2208. Stop 605 can be moved to a deactivated position and lever 3 can be moved to second position 110B to release needle 201 from both fixed jaw 5 and movable jaw 6. Since needle 201 is attached to wire 16, and wire 16 itself is attached to curved needle 18, the operator can release needle 201 to remove suturing device 1A, but leave wire 16 sutured in pelvic cavity 2208.

For example, for a stress urinary incontinence operation, the operator may load the device four times to pass four sutures with needle 201. Two of these sutures may be on the left ATFP and two sutures may be on the right ATFP. For example, there are 2 ATFPs in the pelvis, which are symmetrically distributed; one on the left side of the pelvis and the other on the right side of the pelvis. These sutures can be made by inserting the suturing device into the pelvic cavity 2208 through an incision 2206 in the vaginal cavity 2205 and by rotating the jaws of the device to the right and left, respectively. It is contemplated that the procedure may be performed with 2 sutures or a different number of consecutive sutures, depending on the procedure, the suturing device, and the preferences of the operator. For example, an operation using the suturing device 1B may use only 1 suture or 2 sutures on the same side.

After each suture is completed, the operator can move the suturing device 1A out of the basin 2208. The operator can release the used needle 201 from the suturing device 1A, wherein the wire 16 is attached to the curved needle 18 such that the wire 16 remains sutured in the pelvic cavity 2208. The operator may reload the suturing device 1A with another needle until four sutures are passed. After completion of the four sutures, the four wires 16 and their respective curved needles 18 remain attached and extend out of the pelvic cavity 2208.

After completing 4 sutures with the needle 201, the operator may pass or pull 4 sutures by pulling the curved needle 18 attached to each wire 16. These sutures may be placed on the vaginal wall to form a loop and the sutures passed over the ATFP with needle 201. For example, the operator may pull the ends of each suture toward each other, which has the effect of bringing the vaginal wall closer to the ATFP on each side (e.g., left and right) and lifting the vaginal wall, bladder, and urethra to restore their anatomical position. The operator may tie each loop (e.g., 4 total) with knots and cut off the excess wire 16, thereby cutting off the needle 201 and the curved needle 18.

In some embodiments, the operator may make the loop without attaching the curved needle 18 to the other end of the wire 16. For example, an operator may pass a suture from vaginal tissue in vaginal cavity 2205 by pulling needle 201 to pull wire 16 and tying a loop with wire 16.

The operator may use standard sutures to close the incision 2206, which is opened to place the suturing device 1A into the cavity. For example, the operator may use standard sutures and standard suturing devices, such as needle holders and thumbs. In another example, an operator may use a needle holder and thumb grip to perform a suturing pattern.

In some embodiments, suturing device 1A and suturing device 1B may be used for natural tissue repair without the need for a synthetic implant (e.g., by using a sling or mesh or instead of mid-urethral sling procedures for SUI, mesh procedures for POP). For example, the suturing device can also be used to assist in placing an "adjustable single incision sling" in the pelvic cavity 2208 (e.g., a mini-sling that can be tightened and loosened as needed to treat stress urinary incontinence). Each end of the mini-harness may include a needle 201, and the needle 201 may be loaded into a dedicated loading device to form a kit for placement of the mini-harness. The suturing apparatus can use a specialized loading device to load each needle and suture each needle at a different end of the pelvic cavity 2208 to place the mini-sling 2300 along the pelvic cavity 2208.

Fig. 23A depicts an embodiment of a mini-harness 2300. Mini-sling 2300 may be an adjustable, tensionless, single incision mid-urethra sling. The mini-harness 2300 may have a rectangular shape that tapers to an edge to allow atraumatic placement. In addition to the placement of sutures described in this patent, the suturing device can also be used to place an adjustable, tension-free "single incision mid-urethra sling (mini-sling)". The tension of the mini-harness 2300 may be adjusted. Mini-harness 2300 may be tensionless in that it does not have to be secured to tissue by anchors. This is advantageous over harnesses that only allow the operator to adjust the harness tension during operation, which means that once the tension is adjusted, the mini-harness is secured in the tissue with an anchor.

Mini-harness 2300 may include a web 2302 narrowing from the middle toward the edge. For example, web 2302 (e.g., rectangular portion) may be 6cm long. One edge is attached to wire 16A, wire 16A itself is attached to needle 201A, and the other edge is attached to wire 16B, wire 16B itself is attached to needle 201B. Fig. 23B depicts a close-up view of needle 201B. An operator can use needles 201A and 201B to load mini-sling 2300 into suturing device 1A or suturing device 1B to deliver mini-sling 2300 into bone pelvic cavity 2208 for placement. Because the needles 201A and 201B are disposed at opposite ends, the needles 201A and 201B may enable each end of the mini-sling 2300 to be loaded into the suturing device 1A or 1B, after which the suturing device 1A or 1B may move the mini-sling 2300 to a target location for placement of the mini-sling 2300 in the pelvic cavity 2208.

Fig. 24 depicts a close-up view of an embodiment of a mini-harness 2300 that includes adjustment sutures 2305A-2305C. For example, mini-harness 2300 may include 3 adjustment sutures 2305A-2305C. Although not shown, the mini-harness 2300 may include fewer or additional adjustment sutures. Each of the adjustment sutures 2305A-2305C may include a wire 2308A-2308C. After placing mesh 2302 in pelvic cavity 2208, the operator may attach each of wires 2308A-2308C to mesh 2302. Each of the adjustment sutures 2305A-2305C may include a curved needle 2310A-2310F attached to each end of the wire 2308A-2308C such that after the operator attaches the adjustment suture 2305A-2305C to the mesh 2302, the curved needles 2310A-2310F extend from the mesh 2302 and out of the pelvic cavity 2208. The curved needles 2310A-2310F can be pulled outside of the pelvic cavity 2208 to enable adjustment of the tension of the mesh 2302 of the mini-harness 2300.

An adjustment suture 2305B may be provided in the middle of the mesh 2302 for loosening the mesh 2302. Adjustment suture 2305A and adjustment suture 2305B may be provided toward the ends of web 2302 (e.g., the points at each end of web 2302 are cut) to tighten web 2302. Curved needles 2310A-2310F can enter vaginal cavity 2205 and be severed by piercing vaginal wall 2207. The remaining wires 2308A-2308C may be knotted and stored in the housing for later adjustment.

Fig. 25 depicts an embodiment of a harness loading piece 2315 for a mini-harness 2300. The sling loader 2315 may be similar to the loading device 10 and include the functionality of the loading device 10, but the sling loader 2315 may be specifically designed for the mini-sling 2300. In some embodiments, mini-harness 2300 may be preloaded into harness loader 2315. For example, mini-harness 2300 and harness loader 2315 may be a kit. Strap loading piece 2315 can include first loading slots 13A and 13B configured to receive fixed jaw 5. Strap loading piece 2315 can include second loading slots 14A and 14B configured to receive movable jaw 6.

The sling loading piece 2315 may receive both the needles 201A and 201B of the mini-sling 2300 to load the mini-sling 2300 into the suturing device 1A. The harness loading piece 2315 may include a slider 12A disposed in the slot 15A that may hold the needle 201A of the mini-harness 2300. The harness loading piece 2315 may include a slider 12B disposed in the slot 15B that may hold the needle 201B of the mini-harness 2300.

Fig. 26 and 27A-27J depict an embodiment of using mini-sling 2300 to treat urinary incontinence. For example, mini-sling 2300 may be positioned such that mesh 2302 is positioned under urethra 2705 to treat urinary incontinence. Mini-sling 2300 may be positioned by using suturing device 1A to pass needle 201A and needle 201B through target tissue in pelvic cavity 2208 (where ATFP adheres to the pubic bone), as described herein in mesh repair. Wires 16A and 16B of mini-sling 2300 may be passed through incision 2206 (e.g., vaginal wall) in vaginal cavity 2205. Wires 16A and 16B on the ends of mini-harness 2300 may be pulled simultaneously to position net 2302 of mini-harness 2300. In some embodiments, it is contemplated that the suturing device 1B may be used to position the mini-harness 2300.

As shown in fig. 26, mini-harness 2300 may be loaded into harness loader 2315. In some embodiments, slider 12A and slider 12B are symmetrically positioned to symmetrically load needle 201A and needle 201B of mini-harness 2300. The ends of mini-sling 2300 may be loaded into suturing device 1A or suturing device 1B by needle 201A and needle 201B via sling loader 2315. As shown in FIG. 27A, needle 201A has been loaded into suturing device 1A by sling loading member 2315.

As shown in fig. 27B and as described in fig. 22A-22G, suturing device 1A can be used to place an end of mini-sling 2300 by passing needle 201A through target tissue in bone pelvic cavity 2208A. Needle 201A can be inserted into vaginal cavity 2205 and through incision 2206 to pelvic cavity 2208A. For example, sharp and blunt dissection (e.g., a 3cm incision) is advanced from below the vaginal fascia of the bladder toward the junction of the pubic ramus and pubic symphysis, and pelvic arcus fascia is detected. Wire 16A follows needle 201A through incision 2206, and mesh 2302 follows wire 16A into pelvic cavity 2208A, such that mesh 2302 may be positioned in pelvic cavity 2208.

As shown in fig. 27C and as described in fig. 22A-22G, suturing device 1A can be used to pass needle 201B through target tissue in bone pelvis 2208B to place the other end of mini-sling 2300. For example, suturing device 1A may release needle 201A and then needle 201B may be loaded into suturing device 1A via sling loader 2315. Mini-sling 2300 may 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. Wires 16A and 16B of mini-sling 2300 may be passed through incision 2206 (e.g., vaginal wall) in vaginal cavity 2205.

Device 1A can position wires 16A and 16B to position mini-harness 2300 to the positions where it should be placed in pelvic cavities 2208A and 2208B, respectively. The device 1A can pass the needle 201 through tissue at the target site, but without suturing, such that the wire 16A is not tied into a knot 2720A, but only through tissue to pass the end of the mini-sling 2300 through tissue. For example, the ends (e.g., 16A and 16B) of the mini-harness 2300 are not secured by stitching, as the mini-harness 2300 is placed tension-free.

As shown in fig. 27D, wires 16A and 16B on the end of mini-sling 2300 can be pulled simultaneously to position mesh 2302 relative to urethra 2705. For example, after delivering mini-sling 2300, mesh 2302 can be raised toward urethra 2705 as both ends of mini-sling 2300 can be pulled by wires 16A and 16B. For example, wires 16A and 16B may be pulled simultaneously. When wires 16A and 16B are pulled, mesh 2302 of mini-sling 2300 can be lifted under urethra 2705 and toward urethra 2705.

As shown in fig. 27E, the wires 16A and 16B can be pulled so that the mesh 2302 can be placed into the pelvic cavity 2208 without tension, rather than being anchored in tissue with anchors. The wires 16A and 16B may be pulled until the wires 16A and 16B attached to the mesh 2302 are visible to the operator through the incision 2206. For example, wires 16A and 16B can be pulled from the incision toward vaginal cavity 2205 to enable the surgeon to cut them and the extra portion of mesh 2302 at its end and ensure that only the target length of mesh 2302 remains in bone pelvic cavity 2208.

As shown in fig. 27F, in some embodiments, excess portions 2710, which may include each excess end of mesh 2302 attached to wires 16A and 16B with needles 201A and 201B, may be cut after positioning mesh 2302. As shown in fig. 27G, after the excess portion 2710 comprising mesh 2302 attached to wires 16A and 16B and the needles 201A and 201B attached thereto are severed, mesh 2302 may be positioned in pelvic cavities 2208A and 2208B.

After positioning mesh 2302, the operator may attach adjustment sutures 2305A-2305C to mesh 2302 during operation if the operator decides to make a post-operative adjustment, as shown in fig. 27H. For example, an operator may insert adjustment sutures 2305A-2305C through incision 2206 in the vagina. Each of the adjustment sutures 2305A-2305C may include a curved needle 2310A-2310F attached to each end of the wires 2308A-2308C.

The operator may attach adjustment suture 2305A and adjustment suture 2305C toward the ends of web 2302 (e.g., the points at which web 2302 is cut at each end) to tension web 2302. In some embodiments, the curved needles of adjustment suture 2305A and adjustment suture 2305C can be inserted through incision 2206 and then brought out by piercing vaginal wall 2207 to bring them back into vaginal cavity 2205. An operator may attach an adjustment suture 2305B in the middle of the mesh 2302 for loosening the mesh 2302.

In some embodiments, after an operator attaches adjustment sutures 2305A-2305C to mesh 2302, each end of adjustment wires 2308A-2308C attached to respective curved needles 2310A-2310F may be brought into vaginal cavity 2205 by puncturing vaginal wall 2207 with curved needles 2310A-2310F attached to each end of adjustment wire 2308.

As shown in FIG. 27I, in some embodiments, curved needles 2310A-2310F pierce vaginal wall 2207 at piercing points 2209A-2209F. For example, 6 curved needles 2310A-2310F may create 6 puncture points 2209A-2209F through which 6 ends of 3 adjustment wires 2308A-2308C may be pulled out of the pelvic cavity 2208 and into the vaginal cavity 2205. The curved needles 2310A-2310F may be pulled to pull the adjustment sutures 2305A-2305C through the puncture points 2209A-2209F. For example, each of the adjustment wires 2308A-2308C has 2 ends, and curved needles 2310A-2310F are attached to both ends, and both ends of each of the adjustment wires 2308A-2308C can be brought to the vaginal cavity 2205 through the vaginal wall 2207.

As shown in FIG. 27I, the operator may sever a portion of the wires 2308A-2308C to remove the curved needle 2310A-2310F from the operating site. In some embodiments, curved needles 2310A-2310F may be brought from outside incision 2206 (e.g., not through incision 2206) by piercing vaginal wall 2207 to be removed by cutting curved needles 2310A-2310F. For example, mesh 2302 can remain positioned relative to urethra 2705 and curved needles 2310A-2310C attached thereto can be severed.

After the curved needles 2310A-2310F are severed, the operator may tie knots 2720A-2720C at their respective ends of the wires 2308A-2308C. The operator can use the knots 2720A-2720C to adjust the tension of the web 2302 because the remaining wires 2308A-2308C remain attached to the web 2302. The operator may cut the curved needles 2310A-2310F and tie the remaining wires 2308 to the knots 2720A-2720C to form loops and secure the knots 2720A-2720C in the housings 2725A-2725C. Knots 2720A-2720C, wire 2308 and housing 2725 do not extend out of the vagina. For example, during the post-operative period, they are not visible to the patient because they reside in the vaginal cavity 2205.

As shown in fig. 27J, knots 2720A-2720C may be stored in housings 2725A-2725C. The housings 2725A-2725C may be containers or enclosures for the knots 2720A-2720C. The housings 2725A-2725C may be used to secure the knots 2720A-2720C in the patient's vaginal cavity 2205 after surgery until the patient performs a post-operative examination for adjustment. The housings 2725A-2725C may keep the knots 2720A-2720C intact and prevent them from being contaminated during this time. By maintaining the knots 2720A-2720C in the housings 2725A-2725C, the operator can adjust the tension of the mesh 2302 relative to the urethra 2705 after the procedure. For example, the knots 2720A-2720C may remain in the housing 2725A-2725C for one week after surgery in case the mesh 2302 is needed. In another example, one week after surgery, the patient may report difficulty or incontinence, and both may be remedied by adjusting the tension of mesh 2302 relative to urethra 2705. After re-tensioning after surgery, the adjustment sutures 2305A-2305C may be severed and removed from the mesh 2302. This possibility of adjusting the mesh 2302 after surgery is advantageous because the need for a second operation to reinsert the mesh 2302 or additional adjustment sutures is avoided.

After surgery (e.g., 1 week), when the operator examines the patient for adjustment, the operator reaches the knot 2720A-2720C in the housing 2725 secured in the patient's vaginal cavity 2205 and adjusts the tension of the mesh 2302. For example, such adjustments may be made after surgery, without requiring new procedures, and may be made at an outpatient or clinic setting. An operator may pull on the knots 2720A-2720C to pull on the wires 2308A-2308C attached to the mesh 2302.

In some embodiments, during a post-operative examination conducted in a clinic environment or clinic, an operator can pull on the adjustment suture 2305A and the knots 2720A-2720C of the adjustment suture 2305C to pull the mesh 2302 toward the urethra 2705 to tighten the mesh 2302. For example, the operator can pull on knots 2720A-2720C secured in adjustment suture 2305A and housing 2725A-2725C of adjustment suture 2305C to pull mesh 2302 toward urethra 2705 to tighten mesh 2302. In some embodiments, the operator may pull on the knots 2720A and 2720C to increase the tension of the web 2302. For example, knots 2720A and 2720C on the sides of web 2302 may be used to increase tension after surgery. The operator can pull on knots 2720A and 2720C at the edges to pull the mesh 2302 toward the urethra 2705 to tighten the mesh 2302.

In some embodiments, the operator may pull on knot 2720B to loosen mesh 2302. The operator can pull on the intermediate knot 2720B to pull the mesh 2302 away from the urethra 2705 to loosen the mesh 2302. In some embodiments, the operator can pull on knot 2720B secured in housing 2725B of adjustment suture 2305B to pull mesh 2302 away from urethra 2705 to loosen mesh 2302. For example, the operator can pull on knot 2720B located in the middle of mesh 2302, secured in housing 2725B of adjustment suture 2305B, to pull mesh 2302 away from urethra 2705 to loosen mesh 2302. After the operator completes the adjustment, the operator may sever the loop, discard the housing 2725, and pull the adjustment wire 2308 to remove the wire.

Reference is now made generally to suturing device 1A and suturing device 1B. The suturing device may be used for treatment of pelvic floor disorders such as SUI and POP. For example, the suturing device may be angled for use in a transvaginal method or procedure. In another example, the suturing device may be a minimally invasive surgical device for female vaginal wall or uterine prolapse. The suturing device can include various sizes, shapes, and angles that are calculated and optimized based on the pelvic anatomy in which the suturing device is to be used. The optimal size and shape enables the suturing devices to safely access the target tissue of each device for a given procedure. The angled design of the suturing device enables the distal end of the device to reach the target pelvic structure to be sutured via the vaginal route. The angled design and dimensions prevent accidental contact with other tissues. The shape of the suturing device may improve performance and provide safety and the ability to easily reach the target tissue by preventing accidental tissue injury. The suturing device may be minimally invasive, disposable, sterile, and disposable.

The suturing device may be a transvaginal device to place sutures in tissue at the surgical site during female pelvic floor surgery (e.g., to treat stress urinary incontinence or pelvic organ prolapse, which is a bulge of pelvic organs such as the bladder, rectum, and uterus, into the vagina and through the vaginal orifice). The suturing device may be a transvaginal device for use with a single incision, which is more advantageous than abdominal incisions and multiple incisions. Suture devices may be used to consistently place sutures in difficult to access locations, such as those that are narrow and invisible. The suturing device may be a one-step suturing device having an operating mechanism that enables the needle to be safely captured at the opposing jaws.

The suturing device may suture the designated ligament to the bladder vaginal fascia at the bladder neck level to raise the bladder outlet to its normal position. The suturing device may be ergonomic and shaped to perform a vaginal primary tissue repair procedure directed to stress urinary incontinence. Suturing devices may be designed for surgical treatment of female stress urinary incontinence to facilitate consistent placement of sutures in difficult to access locations (narrow and invisible). The suturing device can be designed to restore anterior vaginal support or vaginal suspension procedures. Suturing devices may be used in general suturing applications that are difficult to access during urology and gynecology procedures, including but not limited to stress urinary incontinence procedures, to assist in the placement of sutures at the surgical site.

The suturing device may enable an operator to perform a procedure via the vagina in a minimally invasive manner (e.g., only a single vaginal incision) (e.g., a transvaginal approach as opposed to an abdominal procedure). The suturing device can be used to perform single vaginal incision natural tissue repair via suturing the vaginal wall to the pelvic floor support structure (to assist in placing sutures in the ligament onto the pelvic floor support structure). The suturing device may be used by an operator (e.g., a surgeon) through sensory and/or direct visual control. The suturing device may be designed to enable the operator to perform natural tissue repair without the need for placement of a manual implant (as opposed to mid-urethral sling techniques that require placement of a synthetic sling/mesh or transvaginal mesh procedure).

The suturing device may be designed to be safely inserted into the cavity. The safety of the suturing device may be derived from the length of the suturing device. For example, the length and angle (of arms 7 and 8 and jaws 5 and 6) of the suturing device may contribute to the safety results described herein, and thus the length and angle may be designed so as not to damage the vagina or incision. In another example, the operator can insert the suturing device into the pelvic cavity where the ATFP is located, as the entry point of the suturing device into the body is through the vagina and the entry to the surgical site is through an incision made in the vaginal wall. For example, for stress incontinence procedures performed using a suturing device, the suturing device need not be inserted beyond the ATFP, which is an anatomical landmark used to determine the length of the suturing device. Even if the suturing device is positioned in the vagina beyond the arm joint 101, the length of the suturing device is such that widening of the suturing device due to opening of the handle does not affect the incision.

The suturing device can facilitate consistent and sequential placement of sutures on pelvic floor structures (e.g., multiple sutures with the same needle; also referred to as Z-shaped sutures or 8-shaped sutures) that are in inaccessible locations during pelvic floor surgery. Suture devices may be designed to facilitate consistent placement of sutures in difficult-to-access locations (deep, narrow, and invisible surgical sites) during transvaginal prolapse surgery (as opposed to abdominal surgery). The suturing device may suture the prescribed ligament to the vaginal tip end wall or cervix to provide vaginal tip elevation.

The suturing device may be used in transvaginal minimally invasive surgery. Suturing devices can be designed for vaginal wall or uterine prolapse procedures based on the repair of primary tissue of women with pelvic organs (pelvic organs such as bladder, uterus or bowel prolapse to the vagina). The suturing device may be designed to enable an operator to perform natural tissue repair without the need to place a manual implant (as opposed to the procedure requiring placement of a synthetic mesh). The suturing device may allow an operator to perform a procedure via the vagina in a minimally invasive manner, such as with only one incision. Suturing devices may be used in general suturing applications that are difficult to access during urology and gynecology procedures, including but not limited to transvaginal pelvic organ prolapse procedures, to assist in the placement of sutures at the surgical site. The suturing device may be used with sensory and/or direct visual control.

Suturing devices 1A and 1B can be used for positioning of a tensionless single incision mid-urethra sling (mini-sling 2300), the tension of which can be adjusted post-operatively.

While one or more embodiments of the present disclosure have been described, it should be understood that these embodiments are merely illustrative and not limiting, and that many modifications will be apparent to those of ordinary skill in the art, including the various embodiments of the inventive methods, illustrative systems and platforms and illustrative devices described herein may be used in any combination with one another. 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 fixed arm (7) integral with a fixed jaw (5) comprising a first gripping slot (103) configured to receive a needle (201);

-a movable jaw (6) comprising a second gripping slot (104) configured to receive the needle (201), the movable jaw (6) being configured to pivot about a reference position on the fixed arm (7) and relative to the fixed jaw (5) while the fixed jaw (5) remains stationary;

-a movable arm (8) coupled to the movable jaw (6), the movable arm (8) being configured to pivot about a reference position and relative to the fixed arm (7) while the fixed arm (7) remains stationary, the movable arm (8) being configured to pivot away from the fixed arm (7) to move the movable jaw (6) away from the fixed jaw (5), the movable arm (8) being configured to pivot towards the fixed arm (7) to move the movable jaw (6) towards the fixed jaw (5) until the needle (201) is disposed in the first and second gripping slots (103, 104); and

-A needle transfer mechanism (4) configured to secure the needle (201) in the first grip slot (103) or the second grip slot (104).

2. The suturing device of claim 1, wherein the fixed arm (7) further comprises an arm joint (101) in the reference position, wherein the arm joint (101) is coupled to the movable arm (8), and wherein the movable arm (8) is configured to pivot about the arm joint (101) and relative to the fixed arm (7).

3. The suturing device of claim 2, wherein the stationary arm (7) further comprises a jaw joint (100) in the reference position, wherein the jaw joint (100) is coupled to the movable jaw (6), and wherein the movable jaw (6) is configured to pivot about the jaw joint (100) and relative to the stationary jaw (5).

4. The suturing device of claim 3, further comprising a connection joint (102) in the reference position, wherein the connection joint (102) is configured to connect the movable arm (8) and the movable jaw (6), wherein the movable arm (8) is configured to move the connection joint (102) to pivot the movable jaw (6) about the jaw joint (100).

5. The suturing device of claim 1, further comprising an attachment member (1105) configured to be attached to the fixed jaw (5) or the movable jaw (6), the attachment member (1105) comprising the needle (201).

6. The suturing device according to any one of claims 1-5, wherein the needle transfer mechanism (4) further comprises:

a first control lever (505A) configured to advance toward a first recess (207A) of the needle (201) provided in the first grip groove (103) to grip the needle (201) in the first grip groove (103), or to retract from the first recess (207A) to release the needle (201) from the first grip groove (103); and

-A second control lever (505B) configured to advance towards a second recess (207B) of the needle (201) provided in the second grip slot (104) to grip the needle (201) in the second grip slot (104), or to retract from the second recess (207B) to release the needle (201) from the second grip slot (104).

7. The suturing device according to any one of claims 1-5, wherein the needle transfer mechanism (4) further comprises:

A first control lever (505A) configured to advance a first grip member (510A) toward a first recess (207A) of the needle (201) provided in the first grip groove (103) to grip the needle (201) in the first grip groove (103), or retract the first grip member (510A) from the first recess (207A) to release the needle (201) from the first grip groove (103); and

A second control lever (505B) configured to advance a second grip member (510B) toward a second recess (207B) of the needle (201) provided in the second grip groove (104) to grip the needle (201) in the second grip groove (104), or retract the second grip member (510B) from the second recess (207B) to release the needle (201) from the second grip groove (104).

8. The suturing device according to any one of claims 1-5, wherein the needle transfer mechanism (4) further comprises:

-a first cable (3001A) configured to advance to release a first spring (3002A) to advance a first piston (3003A) towards a first recess (207A) of the needle (201) provided in the first grip groove (103) to grip the needle (201) in the first grip groove (103), the first cable (3001A) further configured to pull the first piston (3003A) to compress the first spring (3002A) to retract the first piston (3003A) from the first recess (207A) to release the needle (201) from the first grip groove (103); and

-A second cable (3001B) configured to advance to release a second spring (3002B) to advance a second piston (3003B) towards a second recess (207B) of the needle (201) provided in the second grip groove (104) to grip the needle (201) in the second grip groove (104), the second cable (3001B) further configured to pull the second piston (3003B) to compress the second spring (3002B) to retract the second piston (3003B) from the second recess (207B) to release the needle (201) from the second grip groove (104).

9. The suturing device of claim 6, further comprising a lever (3) configured to move between:

A first position (110A) for advancing the first lever (505A) to grip the needle (201) in the first grip slot (103) and retracting the second lever (505B) to release the needle (201) from the second grip slot (104),

A second position (110B) for retracting the first lever (505A) to release the needle (201) from the first grip slot (103) and retracting the second lever (505B) to release the needle (201) from the second grip slot (104), and

A third position (110C) for retracting the first lever (505A) to release the needle (201) from the first grip slot (103) and advancing the second lever (505B) to grip the needle (201) in the second grip slot (104).

10. The suturing device of claim 8, further comprising a lever (3) configured to move between:

A first position (110A) for advancing the first cable (3001A) to release the first spring (3002A), thereby advancing the first piston (3003A) to grip the needle (201) in the first grip slot (103), and pulling the second cable (3001B) to pull the second piston (3003B), thereby compressing the second spring (3002B) to retract the second piston (3003B) to release the needle (201) from the second grip slot (104),

A second position (110B) for pulling the first cable (3001A) to pull the first piston (3003A) to half compress the first spring (3002A) to half retract the first piston (3003A) to release the needle (201) from the first grip slot (103), and pulling the second cable (3001B) to pull the second piston (3003B) to half compress the second spring (3002B) to half retract the second piston (3003B) to release the needle (201) from the second grip slot (104), and

A third position (110C) for pulling the first cable (3001A) to pull the first piston (3003A), thereby compressing the first spring (3002A) to retract the first piston (3003A) to release the needle (201) from the first grip slot (103), and advancing the second cable (3001B) to release the second spring (3002B), thereby advancing the second piston (3003B) to grip the needle (201) in the second grip slot (104).

11. The suturing device of claim 8, further comprising a lever (3) configured to move between:

-a first position (110A) for advancing the first cable (3001A) to release the first spring (3002A), thereby advancing the first piston (3003A) to grip the needle (201) in the first grip slot (103), and pulling the second cable (3001B) to pull the second piston (3003B), thereby compressing the second spring (3002B) to retract the second piston (3003B) to release the needle (201) from the second grip slot (104);

A second position (110B) for half-pulling the first cable (3001A) to pull the first piston (3003A), thereby half-compressing the first spring (3002A) to half-retract the first piston (3003A) to grip the needle (201) in the first grip slot (103), and half-pulling the second cable (3001B) to pull the second piston (3003B), thereby half-compressing the second spring (3002B) to half-retract the second piston (3003B), thereby gripping the needle (201) in the second grip slot (104), and

12. The suturing device of claim 9, further comprising a cover (108) disposed partially over the lever (3), the cover (108) including indicators corresponding to movement of the lever (3) to the first (110A), second (110B) and third (110C) positions.

13. The suturing device of claim 9, further comprising a switch joint (106) coupled to the first control rod (505A) and the second control rod (505B).

14. The suturing device of claim 13, wherein the lever (3) is coupled to the switch joint (106), wherein the lever (3) is configured to rotate the switch joint (106) to move the first and second control levers (505A, 505B).

15. The suturing device of claim 10, further comprising a switch (106) coupled to the first cable (3001A) and the second cable (3001B).

16. The suturing device of claim 15, wherein the lever (3) is coupled to the switch joint (106), wherein the lever (3) is configured to rotate the switch joint (106) to pull the first cable (3001A) and the second cable (3001B) or advance the first cable (3001A) and the second cable (3001B).

17. The suturing device of claim 9, wherein the movable arm (8) includes a stop (605), and wherein the second control rod (505B) includes a safety member (610) configured to interlock with the stop (605) when the lever (3) is in the second position (110B) to prevent movement of the movable arm (8) to prevent the needle (201) from falling.

18. The suturing device of claim 17, wherein the stop (605) is configured to slide into an activated position on the movable arm (8) to secure the stop (605) adjacent the safety member (610) such that the stop (605) is capable of interlocking with the safety member (610).

19. The suturing device of claim 17, wherein the stop (605) is configured to slide into a deactivated position on the movable arm (8) to secure the stop (605) away from the safety member (610) to prevent the stop (605) from interlocking with the safety member (610).

20. A loading device (10), comprising:

-a first loading slot (13) provided in the loading device (10), the first loading slot (13) being configured to receive a fixed jaw (5); and

A slider (12) comprising a slot (15), the slot (15) being configured to hold a needle (201), the slider (12) being configured to move within a loading channel (320) such that the slot (15) holding the needle (201) moves towards the first loading slot (13) and into a first gripping slot (103) of the fixed jaw (5).

21. The loading device (10) of claim 20, further comprising a pulley (11) comprising a wire (16) coupled to the needle (201), wherein the pulley (11) is configured to rotate such that the wire (16) moves when the first gripping groove (103) of the fixed jaw (5) exits the first loading groove (13).

22. The loading device (10) of claim 20, further comprising a second loading slot (14) disposed in the loading device (10) configured to receive a movable jaw (6), wherein the slider (12) is configured to move within the loading channel (320) such that the slot (15) holding the needle (201) moves toward the second loading slot (14) and into a second gripping slot (104) of the movable jaw (6).

23. A method, comprising:

Moving a movable arm (8) of a suturing device away from a fixed arm (7) of the suturing device and around a reference position on the fixed arm (7) while the fixed arm (7) remains stationary, moving the movable arm (8) away from a pivot that causes a movable jaw (6) of the suturing device to pivot around the reference position and away from a fixed jaw (5) extending from the fixed arm (7) that remains stationary and contacting luminal tissue;

-moving the movable arm (8) around the reference position and towards the fixed arm (7) to pivot the movable jaw (6) around the reference position and towards the fixed jaw (5) until a needle (201) fixed in the fixed jaw (5) pierces a target tissue between the fixed jaw (5) and the movable jaw (6) until the needle (201) is arranged in the movable jaw (6);

actuating a needle transfer mechanism (4) of the suturing device to transfer the needle (201) from the fixed jaw (5) to the movable jaw (6); and

-Moving the movable arm (8) around the reference position and away from the fixed arm (7) to pivot the movable jaw (6) with the needle (201) around the reference position and away from the fixed jaw (5) to move the needle (201) through the target tissue.

24. The method of claim 23, further comprising pivoting the movable arm (8) relative to the fixed arm (7) and about an arm joint (101) coupled to the movable arm (8) and located in the reference position, pivoting the movable arm (8) causing the movable jaw (6) to pivot relative to the fixed jaw (5) and about a jaw joint (100) located in the reference position and coupled to the fixed arm (7).

25. The method of claim 24, further comprising moving the movable arm (8) to move a connection joint (102) configured to connect the movable arm (8) and the movable jaw (6) to pivot the movable jaw (6) about the jaw joint (100).

26. The method of claim 23, wherein an attachment member (1105) is attached to the fixed jaw (5) or the movable jaw (6), the attachment member (1105) comprising the needle (201).

27. The method according to any one of claims 23-26, wherein actuating the needle transfer mechanism (4) comprises:

Retracting a first control lever (505A) from a first recess (207A) of the needle (201) provided in a first gripping groove (103) of the fixed jaw (5) to release the needle (201) from the first gripping groove (103) of the fixed jaw (5); and

Advancing a second control rod (505B) towards a second recess (207B) of the needle (201) provided in a second gripping groove (104) of the movable jaw (6) to grip the needle (201) in the second gripping groove (104) of the movable jaw (6).

28. The method according to any one of claims 23-26, further comprising, after the needle (201) secured in the movable jaw (6) is moved through the target tissue:

Advancing a first control rod (505A) towards a first recess (207A) of the needle (201) provided in a first gripping groove (103) of the fixed jaw (5) to grip the needle (201) in the first gripping groove (103) of the fixed jaw (5); and

-Retracting a second control rod (505B) from a second recess (207B) of the needle (201) provided in a second gripping groove (104) of the movable jaw (6) to release the needle (201) from the second gripping groove (104) of the movable jaw (6).

29. The method of claims 23-26, further comprising:

Moving a lever (3) of the suturing device to a first position (110A) to advance a first control rod (505A) from a first recess (207A) of the needle (201) provided in a first gripping slot (103) of the stationary jaw (5) to grip the needle (201) in the first gripping slot (103), and retracting a second control rod (505B) from a second recess (207B) of the needle (201) provided in a second gripping slot (104) of the movable jaw (6) to release the needle (201) from the second gripping slot (104);

Moving the lever (3) of the suturing device to a second position (110B) to retract the first control rod (505A) from the first recess (207A) of the needle (201) provided in the first gripping slot (103) of the fixed jaw (5) to release the needle (201) from the first gripping slot (103) and to retract the second control rod (505B) from the second recess (207B) of the needle (201) provided in the second gripping slot (104) of the movable jaw (6) to release the needle (201) from the second gripping slot (104); and

-Moving the lever (3) of the suturing device to a third position (110C) to retract the first control rod (505A) from the first recess (207A) of the needle (201) provided in the first gripping groove (103) of the fixed jaw (5) to release the needle (201) from the first gripping groove (103), and to retract the second control rod (505B) from the second recess (207B) of the needle (201) provided in the second gripping groove (104) of the movable jaw (6) to release the needle (201) from the second gripping groove (104).

30. The method of claim 29, further comprising a switch joint (106) coupled to the first control rod (505A) and the second control rod (505B), wherein the lever (3) is coupled to the switch joint (106), and wherein the lever (3) is configured to rotate the switch joint (106) to pull the first control rod (505A) and the second control rod (505B) or advance the first control rod (505A) and the second control rod (505B).

31. The method of claim 29, further comprising sliding a stop (605) on the movable arm (8) to an activated position on the movable arm (8) to secure the stop (605) near a safety member (610) of the second control lever (505B), the safety member configured to interlock with the stop (605) when the lever (3) is in the second position (110B) to prevent movement of the movable arm (8) to prevent the needle (201) from falling.

32. The method of claim 31, further comprising sliding the stop (605) to a deactivated position on the movable arm (8) to secure the stop (605) away from the safety member (610) to prevent the stop (605) from interlocking with the safety member (610).

33. The method according to any one of claims 23-26, wherein actuating the needle transfer mechanism (4) comprises:

retracting a first control lever (505A) from a first recess (207A) of the needle (201) provided in a first gripping groove (103) of the fixed jaw (5) to retract a first gripping member (510A) to release the needle (201) from the first gripping groove (103) of the fixed jaw (5); and

Advancing a second control rod (505B) towards a second recess (207B) of the needle (201) provided in a second gripping groove (104) of the movable jaw (6) to advance a second gripping member (510B) to grip the needle (201) in the second gripping groove (104) of the movable jaw (6).

34. The method according to any one of claims 23-26, wherein actuating the needle transfer mechanism (4) comprises:

Pulling a first cable (3001A) to pull a first piston (3003A) to compress a first spring (3002A) to retract the first piston (3003A) from a first recess (207A) of the needle (201) provided in a first gripping slot (103) of the stationary jaw (5) to release the needle (201) from the first gripping slot (103) of the stationary jaw (5); and

Advancing a second cable (3001B) to release a second spring (3002B) to advance a second piston (3003B) toward a second recess (207B) of the needle (201) provided in a second gripping groove (104) of the movable jaw (6) to grip the needle (201) in the second gripping groove (104) of the movable jaw (6).

35. The method of any one of claims 23-26, further comprising:

Moving a lever (3) of the suturing device to a first position (110A) to advance a first cable (3001A) to release a first spring (3002A), to advance a first piston (3003A) to grasp the needle (201) in a first grasping slot (103) of the stationary jaw (5), and to pull a second cable (3001B) to pull a second piston (3003B) to compress a second spring (3002B) to retract the second piston (3003B) to release the needle (201) from a second grasping slot (104) of the movable jaw (6);

Moving the lever (3) of the suturing device to a second position (110B) to pull the first cable (3001A) to pull the first piston (3003A) to half compress the first spring (3002A) to half retract the first piston (3003A) to release the needle (201) from the first grip slot (103) and to pull the second cable (3001B) to pull the second piston (3003B) to half compress the second spring (3002B) to half retract the second piston (3003B) to release the needle (201) from the second grip slot (104); and

-Moving the lever (3) of the suturing device to a third position (110C) for pulling the first cable (3001A) to pull the first piston (3003A), thereby compressing the first spring (3002A) to retract the first piston (3003A) to release the needle (201) from the first grip slot (103), and advancing the second cable (3001B) to release the second spring (3002B), thereby advancing the second piston (3003B) to grip the needle (201) in the second grip slot (104).

36. The method of claim 35, further comprising a switch joint (106) coupled to the first cable (3001A) and the second cable (3001B), wherein the lever (3) is coupled to the switch joint (106), and wherein the lever (3) is configured to rotate the switch joint (106) to pull the first cable (3001A) and the second cable (3001B) or advance the first cable (3001A) and the second cable (3001B).

37. The method of any one of claims 23-26, further comprising:

Moving the lever (3) of the suturing device to a second position (110B) to half-pull the first cable (3001A) to pull the first piston (3003A), to half-compress the first spring (3002A) to half-retract the first piston (3003A) to grasp the needle (201) in the first grasping slot (103), and to half-pull the second cable (3001B) to pull the second piston (3003B), to half-compress the second spring (3002B) to half-retract the second piston (3003B) to grasp the needle (201) in the second grasping slot (104); and

38. The method of claim 37, further comprising a switch joint (106) coupled to the first cable (3001A) and the second cable (3001B), wherein the lever (3) is coupled to the switch joint (106), and wherein the lever (3) is configured to rotate the switch joint (106) to pull the first cable (3001A) and the second cable (3001B) or advance the first cable (3001A) and the second cable (3001B).

39. The method as recited in claim 23, further comprising:

Inserting the fixed jaw (5) of the suturing device into a first loading slot (13) provided in a loading apparatus (10); and

-Moving a slider (12) comprising a slot (15), the slot (15) being configured to hold the needle (201) within a loading channel (320) of the loading device (10) such that the slot (15) holding the needle (201) moves towards the first loading slot (13) and into a first gripping slot (103) of the fixed jaw (5).

40. The method of claim 39, further comprising removing the suturing device and pulling a curved needle (18) attached to a first end of a wire (16) opposite a second end of the wire (16) attached to the needle (201) upon actuation of the needle transfer mechanism (4).

41. The method of claim 23, wherein after moving the movable arm (8) away from the fixed arm (7) to pivot the movable jaw (6) away from the fixed jaw (5) to move the needle (201) through a target tissue, the method further comprises:

-moving the movable arm (8) around the reference position and towards the fixed arm (7) to pivot the movable jaw (6) around the reference position and towards the fixed jaw (5) until the needle (201) fixed in the movable jaw (6) pierces a different section of the target tissue until the needle (201) is arranged in the fixed jaw (5); and

Actuating the needle transfer mechanism (4) to transfer the needle (201) from the movable jaw (6) to the fixed jaw (5).

42. A system, comprising:

A mesh (2302) extending between a first positioning wire (16A) and a second positioning wire (16B), the first positioning wire (16A) being attached to a first positioning needle (201A) and the second positioning wire (16B) being attached to a second positioning needle (201B);

A first loading slot (13A) and a second loading slot (13B) disposed within the sling loading piece (2315), the first loading slot (13A) and the second loading slot (13B) for receiving a fixed jaw (5) of a suturing device;

A first slider (12A) attached to the sling loader (2315), the first slider (12A) including a first slot (15A) configured to retain the first positioning needle (201A), the first slider (12A) configured to move within a first loading channel (320A) of the sling loader (2315) to move the first slot (15A) to retain and retain the first positioning needle (201A) in a first gripping slot (103) of the fixed jaw (5) toward the first loading slot (13A); and

-A second slider (12B) attached to the sling loader (2315), the second slider (12B) comprising a second slot (15B) configured to hold the second positioning needle (201B), the second slider (12B) being configured to move within a second loading channel (320B) of the sling loader (2315) such that the second slot (15B) holding the second positioning needle (201B) moves towards the second loading slot (13B) and into the first gripping slot (103) of the fixed jaw (5).

43. The system of claim 42, further comprising a first adjustment line (2308A), a second adjustment line (2308B), and a third adjustment line (2308C) each extending from the web (2302), the second adjustment line (2308B) extending between the first adjustment line (2308A) and the third adjustment line (2308C).

44. The system of claim 43, wherein each end of the first adjustment wire (2308A) comprises a first curved needle (2310A) and a second curved needle (2310B), each end of the second adjustment wire (2308B) comprises a third curved needle (2310A) and a fourth curved needle (2310D), and each end of the third adjustment wire (2308C) comprises a fifth curved needle (2310E) and a sixth curved needle (2310F).

45. A method, comprising:

Moving a first slider (12A) of a loading device (2315) within a first sliding channel (320A) of a first loading slot (13A) to move 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), the fixed jaw (5) extending from a fixed arm (7) of a suturing device loaded in the first loading slot (13A), the first needle (201A) attached to a first wire (16A) attached to a web (2302);

Actuating a lever (3) of the suturing device to secure the first needle (201A) within the first grip slot (103);

Moving a movable arm (8) of the suturing device away from the fixed arm (7) and around a reference position on the fixed arm (7) while the fixed arm (7) remains stationary, moving the movable arm (8) away from a position that causes a movable jaw (6) of the suturing device to pivot around the reference position and away from the fixed jaw (5) while the fixed jaw (5) remains stationary;

-moving the movable arm (8) around the reference position and towards the fixed arm (7) to pivot the movable jaw (6) around the reference position and towards the fixed jaw (5) until the first needle (201A) fixed in the first grasping slot (103) pierces a first portion of palpated tissue between the fixed jaw (5) and the movable jaw (6) and the first needle (201A) is received in a second grasping slot (104) of the movable jaw (6);

Removing the suturing device from the pelvic cavity (2208) and actuating a needle transfer mechanism (4) of the suturing device to release the first needle (201A) from the second grasping slot (104);

Moving a second slider (12B) of the loading device (2315) within a second sliding channel (320B) of a second loading slot (13B) of the loading device (2315) to move a second needle (201B) disposed in a 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) attached to a second wire (16B) attached to the web (2302);

Actuating the lever (3) of the suturing device to secure the second needle (201B) within the first grip slot (103);

Moving the movable arm (8) about the reference position and towards the fixed arm (7) to pivot the movable jaw (6) about the reference position and towards the fixed jaw (5) until the second needle (201B) secured in the first grasping slot (103) pierces a second portion of the palpated tissue on the other side of the palpated tissue between the fixed jaw (5) and the movable jaw (6) and is received in the second grasping slot (104) to place the mesh (2302) in the pelvic cavity (2208);

Removing the suturing device from the pelvic cavity (2208) and severing a portion of the first wire (16A), the second wire (16B), and the mesh (2302);

Attaching a first adjustment stitch (2305A), a second adjustment stitch (2305B), and a third adjustment stitch (2305C) to the web (2302), the first adjustment stitch (2305A) and the third adjustment stitch (2305C) being attached to each end of the web (2302) for tensioning, the second adjustment stitch (2305B) being attached to the middle of the web (2302) for loosening the web (2302);

severing a curved needle (2310) coupled to each adjustment suture (2305) to form a knot (2720) of a thread (2308) of the adjustment suture (2305) to form a loop, and placing the knot (2720) into a housing (2725) and leaving the knot (2720) secured in the housing (2725) inside a vaginal cavity (2205) of a patient and closing an incision (2206) in the vaginal cavity (2205); and

The adjustment suture (2305) coupled to the mesh (2302) is pulled to adjust the tension of the mesh (2302) during post-operative early examination of a patient in a clinic setting without requiring a new procedure.

46. The method of claim 45, wherein pulling the adjustment suture (2305) includes pulling the knot (2720) disposed in the housing (2725) attached to the adjustment suture (2305) to adjust the tension of the mesh (2302), and once tensioning is complete, severing the loop and removing the housing (2725) and the adjustment suture (2305).