Suturing device and method of use
The suturing device with electrically controlled wires and image sensors provides a minimally invasive solution for precise suturing of native tissues, addressing the challenges of invasive procedures and mesh-related complications in urinary incontinence and pelvic organ prolapse.
Patent Information
- Application Number
- JP2025552241
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-03-15
- Filing Date
- 2024-03-06
- Publication Date
- 2026-03-06
AI Technical Summary
Current surgical procedures for urinary incontinence and pelvic organ prolapse are invasive and often require synthetic meshes, posing safety concerns and complications, while minimally invasive techniques using native tissue repair are challenging due to difficult suturing locations.
A suturing device with a first and second jaw, each with a gripping slot, and a needle transport mechanism using electrically controlled wires to securely hold and release needles, allowing precise suturing of native tissues without meshes, facilitated by image sensors and energy sources for enhanced precision.
Enables safe, minimally invasive suturing of native tissues with improved precision and reduced complications, effectively addressing urinary incontinence and pelvic organ prolapse without the need for synthetic meshes.
Smart Images

Figure 2026507919000001_ABST
Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 452,301, filed March 15, 2023, Turkish Patent Application No. 2023 / 002908, filed March 15, 2023, and Turkish Patent Application No. 2023 / 002475, filed March 6, 2023, the entire contents of each of which are incorporated herein by reference.
[0002] FIELD OF THE DISCLOSURE The present disclosure relates to suturing devices used in surgical procedures, suture loading devices for loading sutures into suturing devices, and methods of use thereof. [Background technology]
[0003] Urinary incontinence refers to the involuntary or unintentional loss of urine. The condition has three different forms: stress urinary incontinence, urge urinary incontinence, and mixed urinary incontinence. The most common is stress urinary incontinence (SUI), which is the involuntary loss of urine during physical activities that result in increased abdominal pressure (stress) and / or bladder pressure, such as coughing, sneezing, laughing, heavy lifting, and exercise.
[0004] Transabdominal bladder neck lift procedures based on native tissue repair for stress-induced UI are based on elevating the vaginal wall toward the bilaterally strong pelvic floor support structures, such as the arcus tendineus fascia pelvis (ATFP) and iliopectineal ligament. However, native tissue repair is intensive, major (abdominal surgery), highly invasive, and difficult. Transvaginal procedures are based on mesh repair for SUI, which involves the placement of tension-free mesh (slings). This method often involves the placement of artificial implants, such as synthetic slings or meshes.
[0005] Pelvic organ prolapse refers to the prolapse (descension) of the pelvic organs, including the vagina, cervix, uterus, bladder, urethra, and rectum, from their normal positions.
[0006] Surgical treatment for POP can be performed through the abdomen or vagina. Abdominal surgery to repair POP can be based on natural tissue repair or by placing a synthetic mesh. Transvaginal surgery can similarly be based on natural tissue repair or by placing a synthetic mesh. Vaginal natural tissue repair is based on elevating the vaginal wall or cervix (if the patient's uterus has been removed for other reasons) toward the strong supporting pelvic floor structures, such as the sacrospinous ligaments, uterosacral ligaments, and arcus tendineus fasciae pelvis (ATFP).
[0007] Many surgical procedures have been developed over time to address these issues. Current surgical treatment options for SUI include native tissue repair, such as transabdominal bladder neck suspension, in which the bladder neck is supported by sutures. This can involve the use of sling procedures, in which support is provided by either tissue surgically removed from another part of the patient's body (autologous slings), tissue donated by another person (allograft slings), or tissue donated by an animal (xenograft slings). Sling procedures can also be performed with materials such as surgical mesh (mesh slings). In contrast to transabdominal bladder neck suspension, sling procedures are performed through the vagina. These can be performed using three incisions in two ways: retropubic or transobturator. Other procedures include "mini-sling" procedures, which can be performed with only a single incision. The most common procedures for treating SUI are transabdominal bladder neck suspension, which can be challenging because it is performed through the abdomen, and midurethral sling surgery (MUS), which uses surgical mesh and carries safety concerns due to mesh erosion and associated complications.
[0008] The arcus tendineus-bladder neck suspension (VACS) procedure introduces a minimally invasive, transvaginal technique for the repair of native tissue. The arcus tendineus pelvic fascia (ATFP), which is more difficult to reach transabdominally, can be easily palpated through the vaginal sidewall. However, the pubic portion of the ATFP, which requires suturing for VACS, is located posterior to the pubic bone, making its location unsuitable for suturing.
[0009] Therefore, there remains a need for safe and effective surgical procedures for urinary incontinence that are minimally invasive and use natural tissue repair techniques. Summary of the Invention
[0010] The present disclosure relates to a suturing device including a first jaw including a first gripping slot configured to receive a needle, a second jaw including a second gripping slot configured to receive the needle, and a needle transport mechanism, the needle transport mechanism including a first gripping member disposed in the first jaw and selectively extendable within the first gripping slot, a first wire coupled to the first gripping member and configured to change in length in response to an electric current applied thereto, a second gripping member disposed in the second jaw, and a second wire coupled to the second gripping member and configured to change in length in response to an electric current applied thereto, the first gripping member configured to be releasably coupled to the needle, and the second gripping member configured to be releasably coupled to the needle.
[0011] The present disclosure relates to an overall system, the suturing system including a suturing device and an energy source, the suturing device including a first jaw including a first gripping slot configured to receive a needle, a second jaw including a second gripping slot configured to receive the needle, and a needle transport mechanism, the needle transport mechanism including a first gripping member disposed in the first jaw, a first wire coupled to the first gripping member and configured to change in length in response to an electric current applied thereto, a second gripping member disposed in the second jaw, and a second wire coupled to the second gripping member and configured to change in length in response to an electric current applied thereto, the first gripping member configured to releasably couple with the needle, the second gripping member configured to releasably couple with the needle, and an energy source coupled to the first wire and the second wire and configured to supply an electric current to the first wire and the second wire.
[0012] The present disclosure relates to a method, the method comprising opening a second jaw of a suturing device relative to a first jaw of a suturing device, the first jaw including a first gripping slot configured to receive a needle and a first gripping member configured to removably couple to the needle to hold the needle in the first gripping slot, the second jaw including a second gripping slot configured to receive the needle and a second gripping member configured to removably couple to the needle to hold the needle in the second gripping slot, the needle being coupled to the first gripping member and held within the first gripping slot of the first jaw. opening a second jaw held in the slot; closing the second jaw against the first jaw, optionally with a suturing device positioned such that the target tissue is between the first and second jaws before closing the second jaw; and transferring the needle from a first gripping slot of the first jaw to a second gripping slot of the second jaw, wherein transferring the needle includes supplying an electric current to a first wire coupled to the first gripping member and changing the length of the first wire to separate the first gripping member from the needle.
[0013] The present disclosure relates to a transport mechanism for a suturing device, the transport mechanism including a wire coupled to a needle, the wire coupled to an energy source configured to supply an electric current to the wire, the wire configured to change length in response to the electric current being supplied thereto, the wire configured to move the needle from a first position to a second position upon the supply of the electric current. In some embodiments, the present disclosure further includes a potential energy member configured to transition between a first configuration and a second configuration, the potential energy member configured to move the needle from the second position to the first position upon transitioning from the second configuration to the first configuration.
[0014] The present disclosure relates to a transport mechanism for a suturing device, the transport mechanism for the suturing device including a wire, the wire coupled to a gripping member, the wire coupled to an energy source configured to supply an electric current to the wire, the wire configured to change length in response to the electric current being applied thereto, the wire configured to move the gripping member from a first position to a second position upon application of the electric current, the gripping member configured to couple to a needle at the first position and to decouple from the needle at the second position. In some embodiments, the present disclosure further includes a potential energy member configured to transition between a first configuration and a second configuration, the potential energy member configured to move the gripping member from the second position to the first position upon transitioning from the second configuration to the first configuration.
[0015] The present disclosure relates to a suturing device including a needle transport mechanism and one or more image sensors including one or more optical wires extending through the suturing device, the one or more image sensors configured to generate image data of a surgical site of the suturing device.The present disclosure relates to a suturing device including a needle transport mechanism and a fiber optic image sensor, for example, a fiber optic camera including an optical wire extending through the suturing device, the fiber optic camera configured to generate image data of a surgical site of the suturing device.
[0016] The present disclosure relates to a suturing device including a needle transport mechanism and one or more electric field sensors disposed on a surface of the suturing device and configured to locate nerves at and around a surgical site of the suturing device.The present disclosure relates to a suturing device including a needle transport mechanism and one or more electric field sensors disposed on a surface of the suturing device and configured to locate nerves at and around a surgical site of the suturing device.
[0017] The present disclosure relates to a suturing device including a first jaw including a first gripping slot configured to receive a needle, a second jaw including a second gripping slot configured to receive a needle, and one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw and configured to vibrate the at least one of the first jaw or the second jaw.The present disclosure relates to a suturing device including a first jaw including a first gripping slot configured to receive a needle, a second jaw including a second gripping slot configured to receive a needle, and one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw and configured to vibrate the at least one of the first jaw or the second jaw.
[0018] The present disclosure relates to a suturing device including an elongate body, a needle, and a needle transport mechanism including a wire coupled to the needle and an energy source, the wire configured to change length in response to an electric current being supplied thereto, the wire configured to move the needle when an electric current is supplied thereto.
[0019] The present disclosure relates to a suturing device including: a fixed arm integral with a fixed jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive a needle and configured to pivot relative to the fixed jaw about a datum on the fixed arm; and a needle transport mechanism, the needle transport mechanism including a first gripping member configured to secure and release the needle from the first gripping slot, the first gripping member selectively engaging the needle while the needle is disposed in the first gripping slot. a first gripping member configured to selectively engage the needle while it is disposed in the first gripping slot; a first wire coupled to the first gripping member, the first wire configured to vary in length in response to an electric current applied thereto; a second gripping member configured to secure the needle in the second gripping slot and release the needle from the second gripping slot, the second gripping member configured to selectively engage the needle while it is disposed in the first gripping slot; and a second wire coupled to the second gripping member, the second wire configured to vary in length in response to an electric current applied thereto.
[0020] In some embodiments, the present disclosure relates to a suturing device, wherein the fixed arm further includes an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm about the arm joint. In some embodiments, the present disclosure relates to a suturing device, wherein the fixed arm further includes a jaw joint disposed on a datum, the jaw joint coupled to the movable jaw, the movable jaw configured to pivot relative to the fixed jaw about the jaw joint. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a connection joint configured to connect the movable arm and the movable jaw, the movable arm configured to move the connection joint to pivot the movable jaw about the jaw joint.
[0021] The present disclosure relates to a suturing device including: a fixed arm integral with a fixed jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a reference on the fixed arm; and a needle transport mechanism including a first wire and a second wire configured to secure the needle in the first gripping slot or the second gripping slot, the first wire and the second wire configured to change length depending on current supplied to the first wire and the second wire, respectively, and configured to control the first gripping member and the second gripping member to hold and release the needle from the first gripping slot and the second gripping slot.
[0022] The present disclosure relates to a suturing device including: a needle configured to include a channel for threading a suture; a fixed arm integral with a fixed jaw including a first gripping slot configured to receive the needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a reference on the fixed arm; and a needle transport mechanism including first and second needle securement members configured to secure the needle in the first or second gripping slot, wherein the first and second needle securement members are coupled to first and second wires and configured to engage one or more features on the needle and selectively retain and release the needle from the first and second gripping slots in response to electrical current supplied to the first and second wires.
[0023] The present disclosure relates to a suturing device including a first jaw including a first gripping slot configured to receive a needle, a second jaw including a second gripping slot configured to receive a needle, and a needle transport mechanism, the needle transport mechanism including a first gripping member disposed in the first jaw and selectively extendable within the first gripping slot, a first wire coupled to the first gripping member and configured to change in length in response to an electric current applied thereto, a first potential energy member configured to transition between a first configuration and a second configuration to apply a force to the first gripping member, a second gripping member disposed in the second jaw, a second wire coupled to the second gripping member and configured to change in length in response to an electric current applied thereto, and a second potential energy member configured to transition between the first configuration and the second configuration to apply a force to the second gripping member,
[0024] The present disclosure relates to a suturing device including: a fixed arm integral with a fixed jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive a needle and configured to pivot relative to the fixed jaw about a reference on the fixed arm; a needle transport mechanism, the needle transport mechanism configured to secure and release the needle in the first gripping slot and to selectively engage the needle while the needle is disposed in the first gripping slot; and a wire coupled to the first gripping member, the wire having a length that varies in response to an electric current supplied thereto. a first wire configured to selectively engage the needle while it is disposed in the first gripping slot; a first potential energy member configured to transition between a first configuration and a second configuration to apply a force to the first gripping member; a second gripping member configured to secure and release the needle in the second gripping slot and to selectively engage the needle while it is disposed in the first gripping slot; a second wire coupled to the second gripping member, the second wire configured to change length in response to an electric current supplied thereto; and a second potential energy member configured to transition between the first configuration and the second configuration to apply a force to the second gripping member.
[0025] The present disclosure relates to a suturing device including an elongate body, a fixed jaw body extending from the elongate body and including a linear guide, a fixed jaw fixedly coupled to the fixed jaw body and extending from the fixed jaw body, a movable jaw coupled to the fixed jaw body at the linear guide and configured to move linearly relative to the fixed jaw within the linear guide, and a drive mechanism, the drive mechanism including a wire configured to move the movable jaw along the linear guide, the wire configured to change length in response to an electric current supplied thereto. In some embodiments, the disclosure relates to a suturing device, wherein the drive mechanism further includes a potential energy member, the wire configured to move the movable jaw along the linear guide in a first direction, and the potential energy member configured to move the movable jaw along the linear guide in a second direction opposite the first direction.
[0026] The present disclosure relates to a suturing device including an elongate body, a fixed jaw body extending from the elongate body and including a jaw joint, a fixed jaw fixedly coupled to the fixed jaw body and extending from the fixed jaw body, a movable jaw coupled to the fixed jaw body and configured to pivot about the jaw joint relative to the fixed jaw, and a drive mechanism, the drive mechanism including a wire configured to rotate the movable jaw about the jaw joint, the wire configured to change length in response to an electric current supplied thereto. In some embodiments, the present disclosure relates to a suturing device, wherein the drive mechanism further includes a potential energy member, the wire configured to rotate the movable jaw about the jaw joint in a first direction, and the potential energy member configured to rotate the movable jaw about the jaw joint in a second direction opposite the first direction.
[0027] The present disclosure relates to a suturing device comprising: a needle; a first needle retaining member including a first port configured to receive the needle; a second needle retaining member including a second port configured to receive the needle and aligned with the first needle retaining member; and a needle transport mechanism at least partially disposed within the first needle retaining member, the needle transport mechanism including a wire coupled to the needle, the wire configured to change length in response to an electric current supplied thereto, the needle transport mechanism configured to move the needle from the first port of the first needle retaining member to the second port of the second needle retaining member. In some embodiments, the present disclosure relates to a suturing device in which the first needle retaining member and the second needle retaining member are fixed relative to each other.
[0028] The present disclosure relates to a suturing device comprising: a first jaw including a first gripping slot configured to receive a needle; a second jaw including a second gripping slot configured to receive the needle and movable relative to the first jaw; and a needle transport mechanism configured to secure the needle to the first gripping slot or the second gripping slot and release the needle from the first gripping slot or the second gripping slot, the needle transport mechanism including a wire configured to change length in response to an electric current supplied thereto.
[0029] In some embodiments, the present disclosure relates to a suturing device, wherein the needle transport mechanism includes a first gripping member disposed in the first jaw and selectively extendable within a first gripping slot, a first wire coupled to the first gripping member, the first wire configured to vary in length in response to an electric current supplied to the first wire, a second gripping member disposed in the second jaw and selectively extendable within a second gripping slot, and a second wire coupled to the second gripping member, the second wire configured to vary in length in response to an electric current supplied to the second wire, wherein the first gripping member is configured to releasably couple with the needle, and the second gripping member is configured to releasably couple with the needle. In some embodiments, the present disclosure relates to a suturing device, wherein a first wire is configured to move a first gripping member from a first position to a second position upon application of an electric current to the wire, the first gripping member configured to couple to the needle at the first position and the first gripping member configured to decouple from the needle at the second position. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a first potential energy member configured to transition between a first configuration and a second configuration, the first potential energy member configured to move the first gripping member from the second position to the first position upon transitioning from the second configuration to the first configuration. In some embodiments, the present disclosure relates to a suturing device, wherein a second wire is configured to move a second gripping member from a first position to a second position when an electric current is supplied to the wire, the second gripping member being configured to couple to the needle at the first position and the second gripping member being configured to decouple from the needle at the second position.In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a second potential energy member configured to transition between a first configuration and a second configuration, the second potential energy member configured to move a second gripping member from the second position to the first position when transitioning from the second configuration to the first configuration. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including an input configured, when actuated, to cause an energy source coupled to the first wire and the second wire to stop applying power to the first wire and to apply power to the second wire. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including an input configured, when actuated, to cause an energy source coupled to the first wire and the second wire to stop applying power to the second wire and to apply power to the first wire. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including an input configured, upon actuation, to cause an energy source coupled to the first wire and the second wire to stop supplying power to one of the first or second wire coupled to one of the first or second gripping member that was not coupled to the needle prior to actuation of the input, and configured, upon actuation of the input, to supply power to one of the first or second wire coupled to one of the first or second gripping member that was previously coupled to the needle. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a first input and a second input, wherein the first input is configured, once actuated, to cause an energy source coupled to the first wire and the second wire to stop supplying power to the first wire and to start supplying power to the second wire, and the second input is configured, once actuated, to cause the energy source coupled to the first wire and the second wire to stop supplying power to the second wire and to start supplying power to the first wire.In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a first handle, a second handle, and a force sensor, the force sensor configured to detect contact and closure force between the first handle and the second handle when the first handle and the second handle are closed, the force sensor configured to cause an energy source coupled to the first wire and the second wire to stop supplying power to the first wire and to start supplying power to the second wire upon detecting a threshold force. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a force sensor configured to cause the energy source to stop supplying power to the second wire and to start supplying power to the first wire upon detecting the threshold force. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a first handle, a second handle, and a force sensor, the force sensor configured to detect contact and closure force between the first handle and the second handle when the first handle and the second handle are closed, the force sensor configured to, upon detecting a threshold force, cause an energy source coupled to the first wire and the second wire to stop supplying power to one of the first wire or the second wire coupled to one of the first gripping member or the second gripping member that is not coupled to the needle prior to detecting the threshold force, and the force sensor configured, upon detecting the threshold force, to cause an energy source coupled to the first wire and the second wire to supply power to one of the first wire or the second wire coupled to one of the first gripping member or the second gripping member that is coupled to the needle prior to detecting the threshold force. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a fixed arm integral with the first jaw and a movable arm movably coupled to the second jaw configured to pivot relative to the fixed jaw about a datum on the fixed arm, In some embodiments, the present disclosure relates to a suturing device, the suturing device further including an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm about the arm joint.In some embodiments, the present disclosure relates to a suturing device, wherein the fixed arm further includes a jaw joint disposed on the datum, the jaw joint coupled to a second jaw, the second jaw configured to pivot relative to the first jaw about the jaw joint. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a connection joint configured to couple the movable arm and the second jaw, the movable arm configured to move the connection joint to pivot the second jaw about the jaw joint. In some embodiments, the present disclosure relates to a suturing device including a fixed jaw body including a linear guide, a first jaw fixedly coupled to the fixed jaw body and extending from the fixed jaw body, a second jaw coupled to the fixed jaw body at the linear guide and configured to move linearly relative to the first jaw within the linear guide, and a drive mechanism, the drive mechanism including a wire configured to move the second jaw along the linear guide, the wire configured to change length in response to a current supplied to the wire. In some embodiments, the present disclosure relates to a suturing device, the drive mechanism further including a potential energy member, the wire configured to move the second jaw along the linear guide in a first direction, and the potential energy member configured to move the second jaw along the linear guide in a second direction opposite the first direction. In some embodiments, the present disclosure relates to a suturing device including a fixed jaw body including a jaw joint, a first jaw fixedly coupled to and extending from the fixed jaw body, a second jaw coupled to the fixed jaw body and configured to pivot about the jaw joint relative to the first jaw, and a drive mechanism, the drive mechanism including a wire configured to rotate the second jaw about the jaw joint, the wire configured to change length in response to an electric current supplied to the wire.In some embodiments, the present disclosure relates to a suturing device, wherein the drive mechanism further includes a potential energy member, and the wire is configured to rotate the second jaw about the jaw joint in a first direction, and the potential energy member is configured to rotate the second jaw about the jaw joint in a second direction opposite the first direction. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a fixed arm integral with the first jaw, a first handle coupled to a proximal end of the fixed arm, a movable arm movably coupled to the second jaw configured to pivot relative to the fixed jaw about a datum on the fixed arm, and a second handle coupled to the proximal end of the movable arm. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a single handle. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a fiber optic camera including an optical wire extending through the suturing device, the fiber optic camera configured to generate image data of a surgical site for the suturing device. In some embodiments, the present disclosure relates to a suturing device further including an electric field sensor disposed on a surface of the suturing device and configured to locate nerves at and around a surgical site of the suturing device.In some embodiments, the present disclosure relates to a suturing device further including a piezoelectric film disposed on a surface of at least one of the first jaw or the second jaw and configured to vibrate the at least one of the first jaw or the second jaw.
[0030] The present disclosure relates to a suturing device including: a fixed arm integral with a fixed jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a reference on the fixed arm; a needle transport mechanism including first and second plates configured to secure and release the needle from the first or second gripping slot, the first and second plates configured to selectively engage the needle while the needle is disposed in the first or second gripping slot; and at least one of a fiber optic camera, an electric field sensor, or a piezoelectric film.
[0031] In some embodiments, the present disclosure relates to a suturing device, wherein a first plate includes a first control bar configured to advance a first gripping member toward a first receptacle of a needle placed in the first gripping slot to grip the needle in the first gripping slot or retract the first gripping member from the first receptacle to release the needle from the first gripping slot, and a second plate includes a second control bar configured to advance a second gripping member toward a second receptacle of a needle placed in the second gripping slot to grip the needle in the second gripping slot or retract the second gripping member from the second receptacle to release the needle from the second gripping slot. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a lever configured to move between a first position in which the first control bar is advanced to grip the needle in the first gripping slot and the second control bar is retracted to release the needle from the second gripping slot, a second position in which the first control bar is retracted to release the needle from the first gripping slot and the second control bar is retracted to release the needle from the second gripping slot, and a third position in which the first control bar is retracted to release the needle from the first gripping slot and the second control bar is advanced to grip the needle in the second gripping slot. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a cover partially disposed over the lever, the cover including indicators corresponding to movement of the lever to the first position, the second position, and the third position. In some embodiments, the present disclosure relates to a suturing device, the suturing device further including a switch joint coupled to the first control bar and the second control bar. In some embodiments, the present disclosure relates to a suturing device, wherein a lever is coupled to a switch joint, the lever configured to rotate the switch joint to move the first control bar and the second control bar. In some embodiments, the present disclosure relates to a suturing device, wherein the fixed arm further includes an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm about the arm joint.In some embodiments, the present disclosure relates to a suturing device, wherein the fixed arm further includes a jaw joint disposed on a datum, the jaw joint coupled to the movable jaw, the movable jaw configured to pivot relative to the fixed jaw about the jaw joint. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a connecting joint configured to couple the movable arm and the movable jaw, the movable arm configured to move the connecting joint to pivot the movable jaw about the jaw joint. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes a fiber optic camera including an optical wire extending through the suturing device, the fiber optic camera configured to generate image data of a surgical site of the suturing device. In some embodiments, the present disclosure relates to a suturing device, wherein the suturing device further includes an electric field sensor disposed on a surface of the suturing device and configured to identify the location of a nerve at and around the surgical site of the suturing device. In some embodiments, the present disclosure relates to a suturing device, the suturing device including a piezoelectric film disposed on a surface of at least one of a first jaw or a second jaw, the piezoelectric film configured to vibrate at least one of the first jaw or the second jaw.
[0032] The present disclosure relates to a suturing method, the suturing method including: forming an incision in a vaginal wall to access a patient's pelvic cavity; positioning a first suturing device through the incision adjacent to a first target tissue within the pelvic cavity, the first target tissue being a first arcus tendineus fasciae pelvis (ATFP) within the pelvic cavity; using the first suturing device, placing at least one suture in the first ATFP; placing at least one suture in the vesicovaginal fascia, wherein the at least one suture in the vesicovaginal fascia is connected to the at least one suture in the first ATFP; and pulling the at least one suture in the first ATFP and the at least one suture in the vesicovaginal fascia to form a loop, thereby approximating the vaginal wall to the first ATFP.
[0033] In some embodiments, the present disclosure relates to a method in which the vaginal wall, bladder neck, and urethra are lifted by tensioning at least one suture in the ATFP and at least one suture in the vesicovaginal fascia. In some embodiments, the present disclosure relates to a method, further comprising: placing a suturing device through an incision adjacent to a second target tissue within the pelvic cavity, the second target tissue being a second ATFP within the pelvic cavity; placing at least one suture in the second ATFP; placing at least one suture in the vesicovaginal fascia, the at least one suture in the vesicovaginal fascia being connected to the at least one suture in the second ATFP; and tensioning the at least one suture in the second ATFP and the at least one suture in the vesicovaginal fascia to form a loop, thereby approximating the vaginal wall to the second ATFP. In some embodiments, the present disclosure relates to a method for repairing the anatomical location of at least one of the vaginal wall, bladder neck, or urethra within the pelvic cavity. In some embodiments, the present disclosure relates to a method for repairing the anatomical location of each of the vaginal wall, bladder neck, and urethra within the pelvic cavity. In some embodiments, the present disclosure relates to a method for repairing the physiological function of at least one of the vaginal wall, bladder neck, or urethra within the pelvic cavity. In some embodiments, the present disclosure relates to a method for repairing the physiological function of each of the vaginal wall, bladder neck, and urethra within the pelvic cavity. In some embodiments, the present disclosure relates to a method for repairing the physiological function of each of the vaginal wall, bladder neck, and urethra within the pelvic cavity. In some embodiments, the present disclosure relates to a method for repairing the physiological function of at least one ... at least one suture formed from at least one of a thread, fiber, filament, and wire. In some embodiments, the present disclosure relates to a method for repairing the at least one suture formed from an absorbable material. In some embodiments, the present disclosure relates to a method for repairing the at least one suture formed from a non-absorbable material. In some embodiments, the present disclosure relates to a method, in which at least one suture in a first ATFP or a second ATFP is positioned in an anterior-posterior portion of the first ATFP or the second ATFP.In some embodiments, the present disclosure relates to a method, wherein at least one suture in a first ATFP or a second ATFP is placed at the junction of the pubic ramus and the pubic symphysis. In some embodiments, the present disclosure relates to a method, wherein at least one suture in a first ATFP or a second ATFP includes a first suture and a second suture, wherein the first suture is placed in an anterior-posterior portion of the first ATFP or the second ATFP, and the second suture is placed in a mediolateral pubic portion of the first ATFP or the second ATFP, 0.5 to 1 cm posterior-inferior to the first suture. In some embodiments, the present disclosure relates to a method, wherein after forming an incision in the vaginal wall and before placing a suturing device inside the pelvic cavity, the method further includes forming a dissection from above the vesicovaginal fascia toward the junction of the pubic ramus and the pubic symphysis. In some embodiments, the present disclosure relates to a method, wherein the repair is performed using only sutures, without the use of a mesh. In some embodiments, the present disclosure relates to a method, wherein bilateral approximation of the vesicovaginal fascia to the ATFP restores the connection between the pelvic floor structures and the urethra and bladder neck. In some embodiments, the present disclosure relates to a method, wherein at least one suture in the vesicovaginal fascia is placed with a second suturing device. In some embodiments, the present disclosure relates to a method, further comprising palpating tissue to identify a target tissue within the pelvic cavity.
[0034] The present disclosure relates to a suturing method, the suturing method including: making a transverse incision in the vaginal wall to access the patient's pelvic cavity; positioning a suturing device through the incision adjacent to a target tissue within the pelvic cavity, the target tissue being the sacrospinous ligament within the pelvic cavity; placing a plurality of sutures in the target tissue; placing a plurality of sutures in the cervical or vaginal cuff; and tensioning the plurality of sutures to form loops with the sutures passing through the sacrospinous ligament and the cervical or vaginal cuff to correct vaginal cuff prolapse.
[0035] The present disclosure relates to a suturing method, the suturing method including: forming an incision in a vaginal wall to access a patient's pelvic cavity; placing a suturing device into the pelvic cavity through the incision, the suturing device including a movable jaw and a fixed jaw; opening the movable jaw relative to the fixed jaw so that target tissue within the pelvic cavity is located between the movable jaw and the fixed jaw, the target tissue being each arcus tendineus of fascia pelvis (ATFP) within the pelvic cavity; placing a plurality of sutures in the target tissue, the plurality of sutures being placed in each arcus tendineus of fascia pelvis (ATFP); placing the plurality of sutures in the vesicovaginal fascia; and optionally pulling the plurality of sutures in any order to form loops with the sutures that have passed through the ATFP and the vesicovaginal fascia to approximate the vaginal wall to both ATFPs and elevate the vaginal wall, bladder neck, and urethra to restore their respective anatomical and physiological positions within the pelvic cavity.
[0036] In some embodiments, the present disclosure relates to a method, further comprising creating a dissection above the vesicovaginal fascia toward the junction of the pubic ramus and the pubic symphysis. In some embodiments, the present disclosure relates to a method, further comprising palpating tissue to locate a target tissue within the pelvic cavity. In some embodiments, the present disclosure relates to a method, further comprising withdrawing the suturing device from the target tissue, creating a distance between the suturing device and the target tissue and opening the movable jaw relative to the fixed jaw. In some embodiments, the present disclosure relates to a method, wherein the suturing device further comprises: a fixed jaw integral with a distal end of a fixed arm and including a first gripping slot configured to receive a needle; and a movable jaw movably coupled to the distal end of the movable arm and including a second gripping slot configured to receive a needle, the movable jaw configured to pivot relative to the fixed jaw about a datum on the fixed arm. In some embodiments, the present disclosure relates to a method, wherein the distal ends of the fixed arm and the movable arm are angled to precisely reach the target tissue in the pelvic cavity to be sutured through the vaginal incision. In some embodiments, the present disclosure relates to a method, wherein the suturing device further includes a fixed jaw integral with the distal end of the fixed arm and including a first gripping slot configured to receive a needle, and a movable jaw movably coupled to the distal end of the movable arm and including a second gripping slot configured to receive a needle, the movable jaw configured to move linearly relative to the fixed arm.
[0037] The present disclosure relates to a suturing method, the suturing method including: placing a suturing device into a patient's pelvic cavity through an incision in a vaginal wall, the suturing device including a movable jaw and a fixed jaw; opening the movable jaw relative to the fixed jaw such that a target tissue within the pelvic cavity is located between the movable jaw and the fixed jaw, the target tissue being an arcus tendineus fasciae pelvis (ATFP); and placing a plurality of sutures in the target tissue using the suturing device. In some embodiments, the disclosure relates to a method, the method further including palpating tissue to identify the location of the target tissue within the pelvic cavity.
[0038] The present disclosure relates to a suturing method, the suturing method including: placing a suturing device inside a patient's pelvic cavity, the suturing device including a movable jaw and a fixed jaw; opening the movable jaw relative to the fixed jaw so that target tissue in the pelvic cavity is located between the movable jaw and the fixed jaw; suturing the target tissue with the suturing device, placing a plurality of sutures in the target tissue to suture the target tissue to a vaginal wall stump or a cervix, thereby treating pelvic organ prolapse, the target tissue being in the form of a ligament in the pelvic cavity, and suturing the ligament to the vaginal wall stump or the cervix to elevate the vaginal apex. In some embodiments, the disclosure relates to a method, the method further including palpating tissue to locate the target tissue inside the pelvic cavity.
[0039] The present disclosure relates to a suturing method, the suturing method including: placing a suturing device inside a patient's pelvic cavity through an incision in a vaginal wall, the suturing device including a movable jaw, a fixed jaw, and a needle; opening the movable jaw relative to the fixed jaw so that target tissue in the pelvic cavity is located between the movable jaw and the fixed jaw; operating the movable jaw relative to the fixed jaw, wherein the movable jaw moves toward the fixed jaw and a needle disposed on at least one of the movable jaw and the fixed jaw moves through the target tissue to apply a suture to the target tissue, optionally the suturing device is sized and shaped to be received through the vaginal wall into said pelvic cavity, and placing sutures to elevate the vaginal wall, bladder neck, and urethra to restore their anatomical and physiological positions within the pelvic cavity.
[0040] In some embodiments, the present disclosure relates to a method, further comprising palpating tissue to locate a target tissue within the pelvic cavity. In some embodiments, the present disclosure relates to a method, wherein the suturing device further comprises: a fixed jaw integral with a distal end of a fixed arm and including a first gripping slot configured to receive a needle; and a movable jaw movably coupled to the distal end of the movable arm and including a second gripping slot configured to receive a needle, the movable jaw configured to pivot relative to the fixed jaw about a reference position on the fixed arm while the fixed jaw remains stationary. In some embodiments, the present disclosure relates to a method, wherein the distal ends of the fixed arm and the movable arm are angled to precisely reach the target tissue within the pelvic cavity to be sutured through the vaginal wall.
[0041] The present disclosure relates to a suturing device including a handle; an elongate arm connected to the handle at a proximal end and having a first movable jaw and a second fixed jaw disposed at a distal end, the first jaw being movable and including a first gripping slot configured to receive a needle, and the second jaw being fixed and including a second gripping slot configured to receive a needle; and a mandrel mechanism configured to connect the handle to the elongate arm such that the first and second jaws at the distal end of the elongate arm rotate about a longitudinal axis of the elongate arm, allowing the first and second jaws to assume any angular position while the handle is fixed.
[0042] In some embodiments, the mandrel mechanism includes a user-operated button configured to move a spring-loaded pin disposed within the mandrel mechanism into one of at least one recesses disposed along the angular path of the mandrel mechanism, In some embodiments, the position of the spring-loaded pin within one of the at least one recesses is configured to set the angular position of the first jaw and the second jaw.
[0043] In some embodiments, the suturing device further includes a lever mechanism configured to move the first jaw relative to the second jaw on the linear guide, hi some embodiments, the lever mechanism has a distal position in which the first and second jaws are fully closed and a proximal position in which the first and second jaws are fully open.
[0044] In some embodiments, the suturing device further includes a needle transport mechanism configured to transport a needle between a first gripping slot of the first jaw and a second gripping slot of the second jaw to apply a suture to the target tissue. In some embodiments, the needle transport mechanism includes a toggle switch configured to move between a distal position and a proximal position to transport the needle between the first jaw and the second jaw using a first cable and a second cable, wherein in the distal position of the toggle switch, pulling the first cable transports the needle from the first jaw to the second jaw, and in the proximal position of the toggle switch, pulling the second cable transports the needle from the second jaw to the first jaw.
[0045] In some embodiments, the suturing device further includes one or more image sensors including one or more optical wires extending through the suturing device, the one or more image sensors configured to generate image data of the surgical site of the suturing device. In some embodiments, the suturing device further includes one or more electric field sensors disposed on a surface of the suturing device and configured to identify the location of nerves at and around the surgical site of the suturing device. In some embodiments, the suturing device includes one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw and configured to vibrate at least one of the first jaw or the second jaw.
[0046] In some embodiments, the suturing device further includes a dual action needle unload button located at the proximal end of the handle, the dual action needle unload button configured to unload the needle while the first jaw and the second jaw are open.
[0047] The present disclosure relates to a suturing device comprising: a handle; and an elongate arm connected to the handle at a proximal end and having a first jaw and a second jaw disposed at a distal end, the first jaw including a first gripping slot configured to receive a needle, the second jaw including a second gripping slot configured to receive a needle, the first jaw and the second jaw having a locking opening therebetween, the distal end of the elongate arm being angled relative to the proximal end to reach target tissue to be sutured.
[0048] In some embodiments, the first jaw and the second jaw rotate between 60° and 90° relative to the elongate arm.
[0049] In some embodiments, the suturing device further includes one or more image sensors including one or more optical wires extending through the suturing device, the one or more image sensors configured to generate image data of the surgical site of the suturing device. In some embodiments, the suturing device further includes one or more electric field sensors disposed on a surface of the suturing device and configured to identify the location of nerves at and around the surgical site of the suturing device. In some embodiments, the suturing device further includes one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw and configured to vibrate at least one of the first jaw or the second jaw.
[0050] The present disclosure relates to a suture needle including an elongate body having a proximal end and a distal end, a first circumferential slot disposed at the proximal end of the elongate body and a second circumferential slot disposed at the distal end of the elongate body, the first circumferential slot and the second circumferential slot configured to interface with a suturing device, and a thread slot formed in an intermediate portion of the elongate body between the proximal and distal ends thereof, the thread configured to receive a thread, wherein the thread is forcibly deformed into the thread slot and coupled to the suture needle, creating a desired retention force between the thread and the suture needle.
[0051] In some embodiments, the thread slot has at least one of the following cross-sectional shapes: rectangular, triangular, angled, straight, linear, or circumferential.
[0052] The present disclosure will be further described in the following detailed description, by way of non-limiting examples of illustrative embodiments, with reference to several drawings in which like reference numerals represent like parts throughout the several views of the drawings. [Brief explanation of the drawings]
[0053] [Figure 1] 1 is a cross-sectional view of a suturing device, according to some embodiments herein. [Figure 2] 1 is a cross-sectional view of a suturing device, according to some embodiments herein. [Figure 3A] 1 illustrates an embodiment of a suturing device, according to some embodiments herein. [Figure 3B] 1 illustrates an embodiment of a suturing device, according to some embodiments herein. [Figure 4A] 12A-12C illustrate an embodiment of a grasping slot of a suturing device, according to some embodiments herein. [Figure 4B] 12A-12C illustrate an embodiment of a grasping slot of a suturing device, according to some embodiments herein. [Figure 5A] 1A-1C illustrate an embodiment of a suturing device including movable arm and jaw movement and needle transport, according to some embodiments herein. [Figure 5B] 1A-1C illustrate an embodiment of a suturing device including movable arm and jaw movement and needle transport, according to some embodiments herein. [Figure 5C] 1A-1C illustrate an embodiment of a suturing device including movable arm and jaw movement and needle transport, according to some embodiments herein. [Figure 5D]1A-1C illustrate an embodiment of a suturing device including movable arm and jaw movement and needle transport, according to some embodiments herein. [Figure 6A] 1A-1C illustrate an embodiment of a suturing device including a joint for facilitating movement of a movable arm and a movable jaw, according to some embodiments herein. [Figure 6B] 1A-1C illustrate an embodiment of a suturing device including a joint for facilitating movement of a movable arm and a movable jaw, according to some embodiments herein. [Figure 6C] 1A-1C illustrate an embodiment of a suturing device including a joint for facilitating movement of a movable arm and a movable jaw, according to some embodiments herein. [Figure 7A] 14A-14D illustrate curved needles of a suturing device, according to some embodiments herein. [Figure 7B] 1 illustrates a straight needle of a suturing device, according to some embodiments herein. [Figure 7C] 1 illustrates a straight needle of a suturing device, according to some embodiments herein. [Figure 7D] 1 illustrates a straight needle of a suturing device, according to some embodiments herein. [Figure 7E] 1 illustrates a straight needle of a suturing device, according to some embodiments herein. [Figure 7F] 1A-1C illustrate an embodiment of a needle having an open channel feature based needle-to-thread coupling, according to some embodiments herein. [Figure 7G] 1A-1C illustrate an embodiment of a needle having an open channel feature based needle-to-thread junction, according to some embodiments herein. [Figure 7H] 1A-1C illustrate an embodiment of a needle having an open channel feature based needle-to-thread junction, according to some embodiments herein. [Figure 7I] 1A-1C illustrate an embodiment of a needle having an open channel feature based needle-to-thread junction, according to some embodiments herein. [Figure 7J]1 is a cross-sectional view of a suturing device illustrating one embodiment of a needle transport mechanism, according to some embodiments herein. [Figure 7K] 1 is a cross-sectional view of a suturing device illustrating one embodiment of a needle transport mechanism, according to some embodiments herein. [Figure 7L] 1 is a cross-sectional view of a suturing device illustrating one embodiment of a needle transport mechanism, according to some embodiments herein. [Figure 7M] 1 is a cross-sectional view of a suturing device illustrating one embodiment of a needle transport mechanism, according to some embodiments herein. [Figure 7MM] 1 is a cross-sectional view of a suturing device illustrating one embodiment of a needle transport mechanism, according to some embodiments herein. [Figure 7N] 1 is a cross-sectional view of a suturing device illustrating one embodiment of a needle transport mechanism, according to some embodiments herein. [Figure 7O] FIG. 10 is a cross-sectional view of a needle transport mechanism according to some embodiments herein. [Figure 7P] FIG. 10 is a cross-sectional view of a needle transport mechanism according to some embodiments herein. [Figure 8A] 1 illustrates a suturing device including a user interface, according to some embodiments herein. [Figure 8B] 1 illustrates a suturing device including a user interface, according to some embodiments herein. [Figure 8C] 1 illustrates a suturing device and a loading device, according to some embodiments herein. [Figure 9A] 12A-12C illustrate an external unit that couples to a suturing device, according to some embodiments herein. [Figure 9B] 12A-12C illustrate an external unit that couples to a suturing device, according to some embodiments herein. [Figure 10A] 1A-1C illustrate embodiments of a suturing device including a force sensor, according to some embodiments herein. [Figure 10B] 1A-1C illustrate embodiments of a suturing device including a force sensor, according to some embodiments herein. [Figure 10C] 1A-1C illustrate embodiments of a suturing device including a force sensor, according to some embodiments herein. [Figure 11A] 1 illustrates a suturing device having an attachment member, according to some embodiments herein. [Figure 11B] 1 illustrates a suturing device having an attachment member, according to some embodiments herein. [Figure 12A] 1A-1C illustrate an embodiment of a shape of a suturing device, according to some embodiments herein. [Figure 12B] 1A-1C illustrate an embodiment of a shape of a suturing device, according to some embodiments herein. [Figure 13A] 1 illustrates a suturing device, according to some embodiments herein. [Figure 13B] 1 illustrates a suturing device, according to some embodiments herein. [Figure 13B] 1 illustrates a suturing device, according to some embodiments herein. [Figure 14A] 1 is a flowchart of an exemplary method of operating a suturing device, according to some embodiments herein. [Figure 14B] 1 is a flowchart of an exemplary method of operating a suturing device, according to some embodiments herein. [Figure 14C] 1 is a flowchart of an exemplary method of operating a suturing device, according to some embodiments herein. [Figure 14D] 1 is a flowchart of an exemplary method of operating a suturing device, according to some embodiments herein. [Figure 14E] 1 is a flowchart of an exemplary method of operating a suturing device, according to some embodiments herein. [Figure 15A] 1 illustrates a curved needle, according to some embodiments herein. [Figure 15B] 1 illustrates a curved needle, according to some embodiments herein. [Figure 15C] 1 illustrates a curved needle, according to some embodiments herein. [Figure 16A] 1 illustrates a suturing device, according to some embodiments herein. [Figure 16B] 1 illustrates a suturing device, according to some embodiments herein. [Figure 16C] 1 illustrates a suturing device, according to some embodiments herein. [Figure 16D] 1 illustrates a suturing device, according to some embodiments herein. [Figure 17A] FIG. 1 illustrates a straight needle, according to some embodiments herein. [Figure 17B] FIG. 1 illustrates a straight needle, according to some embodiments herein. [Figure 17C] FIG. 1 illustrates a straight needle, according to some embodiments herein. [Figure 17D] FIG. 1 illustrates a straight needle, according to some embodiments herein. [Figure 18A] 1A-1C illustrate an embodiment of a suturing device and the linear movement (translation) of a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 18B] 1A-1C illustrate an embodiment of a suturing device and the linear movement (translation) of a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 18C] 1A-1C illustrate an embodiment of a suturing device and the linear movement (translation) of a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 18D] 1A-1C illustrate an embodiment of a suturing device and the linear movement (translation) of a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 19A] FIG. 1 is a partial exploded view of a suturing device, according to some embodiments herein. [Figure 19B] FIG. 1 is a partial exploded view of a suturing device and actuator, according to some embodiments herein. [Figure 20A] FIG. 10 is a perspective view of a fixed jaw body of a suturing device, according to some embodiments herein. [Figure 20B]1 is a cross-sectional view of a fixed jaw body, jaws, and actuator of a suturing device, according to some embodiments herein. [Figure 20C] 10A-10C illustrate a drive mechanism for linearly moving a movable jaw, according to some embodiments herein. [Figure 20D] 10A-10C illustrate a drive mechanism for linearly moving a movable jaw, according to some embodiments herein. [Figure 20E] 10A-10C illustrate a drive mechanism for linearly moving a movable jaw, according to some embodiments herein. [Figure 20F] 10A-10C illustrate a drive mechanism for linearly moving a movable jaw, according to some embodiments herein. [Figure 21] 1 is a perspective view of a suturing device, according to some embodiments herein. [Figure 22A] 1 illustrates a suturing device with an optical camera, according to some embodiments herein. [Figure 22B] 1 illustrates a suturing device with an optical camera, according to some embodiments herein. [Figure 22C] 1 illustrates a suturing device with an optical camera, according to some embodiments herein. [Figure 23A] 1 illustrates a suturing device having an electric field sensor, according to some embodiments herein. [Figure 23B] 1 illustrates a suturing device having an electric field sensor, according to some embodiments herein. [Figure 24A] 10A-10C illustrate a foot pedal for use with a suturing device, according to some embodiments herein. [Figure 24B] 10A-10C illustrate a foot pedal for use with a suturing device, according to some embodiments herein. [Figure 25] 10A-10C illustrate piezoelectric films on the jaws of a suturing device, according to some embodiments herein. [Figure 26A] 1 illustrates a suturing device, according to some embodiments herein. [Figure 26B] FIG. 26B is a cross-sectional view of the suturing device of FIG. 26A according to some embodiments herein. [Figure 26C] 1 illustrates an embodiment of a suturing device, according to some embodiments herein. [Figure 27A] 1 illustrates a suturing device, according to some embodiments herein. [Figure 27B] 1 illustrates a suturing device, according to some embodiments herein. [Figure 28A] 10A-10C illustrate a drive mechanism for rotating a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 28B] 10A-10C illustrate a drive mechanism for rotating a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 28C] 10A-10C illustrate a drive mechanism for rotating a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 28D] 10A-10C illustrate a drive mechanism for rotating a movable jaw relative to a fixed jaw, according to some embodiments herein. [Figure 29A] 1 illustrates one embodiment of a suturing device. [Figure 29B] 1 illustrates one embodiment of a suturing device. [Figure 30A-30B] 10A-10C illustrate an embodiment of a grasping slot of a suturing device. [Figure 31A] 10A-10C illustrate an embodiment of a suturing device that includes movement of a movable arm and movable jaw while a needle is secured to the fixed jaw. [Figure 31B] 10A-10C illustrate an embodiment of a suturing device that includes movement of a movable arm and movable jaw while a needle is secured to the fixed jaw. [Figure 31C] 1A-1C illustrate an embodiment of a suturing device including a needle transport mechanism for transporting a needle. [Figure 31D] 1A-1C illustrate an embodiment of a suturing device including a needle transport mechanism for transporting a needle. [Figure 31E]10A-10C illustrate an embodiment of a suturing device that includes movement of a movable arm and movable jaw while a needle is secured to the movable jaw. [Figure 32A] 1A-1C illustrate an embodiment of a suturing device including a joint to facilitate movement of the movable arm and movable jaw. [Figure 32B] 1A-1C illustrate an embodiment of a suturing device including a joint to facilitate movement of the movable arm and movable jaw. [Figure 32C] 1A-1C illustrate an embodiment of a suturing device including a joint to facilitate movement of the movable arm and movable jaw. [Figure 33A] 1A-1C illustrate an embodiment of a curved needle of a suturing device. [Figure 33B] 1A-1C illustrate an embodiment of a straight needle of a suturing device. [Figure 33C] 1A-1C illustrate an embodiment of a straight needle of a suturing device. [Figure 33D] 1A-1C illustrate an embodiment of a straight needle of a suturing device. [Figure 33E] 1A-1C illustrate an embodiment of a straight needle of a suturing device. [Figure 33F] 13A-13D illustrate an embodiment of a needle having an open channel feature based interface with a thread. [Figure 33G] 10A-10C illustrate an embodiment of a needle having an open channel feature based junction between the needle and thread. [Figure 33H] 10A-10C illustrate an embodiment of a needle having an open channel feature based junction between the needle and thread. [Figure 33I] 10A-10C illustrate an embodiment of a needle having an open channel feature based junction between the needle and thread. [Figure 33J] 1A-1C illustrate an embodiment of a suturing device that includes a mechanism for locking and releasing needles. [Figure 33K] FIG. 10 is an exploded view of one embodiment of a control bar and gripping member. [Figure 33L] FIG. 10 is an exploded view of one embodiment of a control bar and gripping member. [Figure 33M] FIG. 10 is an exploded view of one embodiment of a control bar and gripping member. [Figure 33N] 1A-1C illustrate an embodiment of a suturing device that includes a mechanism for locking and releasing needles. [Figure 33O] 1A-1C illustrate an embodiment of a suturing device that includes a mechanism for locking and releasing needles. [Figure 33P] 1A-1C illustrate an embodiment of a suturing device that includes a mechanism for locking and releasing needles. [Figure 34A] 1A-1C illustrate an embodiment of a suturing device including a stopper in an activated position. [Figure 34B] 1A-1C illustrate an embodiment of a suturing device including a stopper in an active position. [Figure 34C] 1A-1C illustrate an embodiment of a suturing device including a stopper in an active position. [Figure 35A] 10A-10C illustrate an embodiment of a suturing device including an activated stop and a safety member that prevents movement of the movable arm and jaw when the needle is unlocked. [Figure 35B] 10A-10C illustrate an embodiment of a suturing device including an activated stop and a safety member that prevents movement of the movable arm and jaw when the needle is unlocked. [Figure 36A] 10A-10C illustrate an embodiment of a suturing device that includes an actuation stop that allows movement of the movable arm and movable jaw while the needle is secured in the first grasping slot. [Figure 36B] 10A-10C illustrate an embodiment of a suturing device that includes an actuation stop that allows movement of the movable arm and movable jaw while the needle is secured in the first grasping slot. [Figure 36C] 10A-10C illustrate an embodiment of a suturing device that includes an actuation stop that allows movement of the movable arm and movable jaw while the needle is secured in the second grasping slot. [Figure 36D] 10A-10C illustrate an embodiment of a suturing device that includes an actuation stop that allows movement of the movable arm and movable jaw while the needle is secured in the second grasping slot. [Figure 37A]1A-1C illustrate an embodiment of a suturing device including a stopper that transitions from an activated position to a deactivated position. [Figure 37B] FIG. 2 is an exploded view of the stopper and the movable arm. [Figure 37C] FIG. 2 is an exploded view of the stopper and the movable arm. [Figure 37D] 10A-10C illustrate an embodiment of a suturing device including a stopper in a disabled position. [Figure 37E] 10A-10C illustrate an embodiment of a suturing device including a stopper in a disabled position. [Figure 38A] 10A-10C illustrate an embodiment of a suturing device including a stopper in a disabled position that allows movement of the movable arm even when the needle is not secured. [Figure 38B] 10A-10C illustrate an embodiment of a suturing device including a stopper in a disabled position that allows movement of the movable arm even when the needle is not secured. [Figure 39A] FIG. 1 is an exploded view of one embodiment of a suturing device. [Figure 39B] 1A-1C illustrate an embodiment of a suturing device having an attachment member. [Figure 39C] 1A-1C illustrate an embodiment of a suturing device having an attachment member. [Figure 40A] 1A-1C illustrate one embodiment of the shape of the suturing device. [Figure 40B] 1A-1C illustrate one embodiment of the shape of the suturing device. [Figure 41A] 1 illustrates one embodiment of a suturing device. [Figure 41B] 1 illustrates one embodiment of a suturing device. [Figure 41C] FIG. 1 is an exploded view of one embodiment of a suturing device. [Figure 42A] 1 illustrates one embodiment of a loading device and needle. [Figure 42B] 1 illustrates one embodiment of a loading device and needle. [Figure 42C] 1 illustrates one embodiment of a loading device and needle. [Figure 43]FIG. 1 is a rear view of an embodiment of a loading device. [Figure 44] FIG. 1 illustrates an embodiment of a loading device including thread. [Figure 45] 1 illustrates one embodiment of a suturing device loaded with thread from a loading device. [Figure 46] 1 is a flow chart of a method of using the suturing device and loading device. [Figure 47] 1 illustrates one embodiment of a suturing device attached to a loading device. [Figure 48A] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48B] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48C] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48D] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48E] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48F] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48G] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48H] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 48I] 10A-10C illustrate the loading of suture into the suturing device using a loading device. [Figure 49] 13A-13C show a suturing device securing a needle loaded by a loading device. [Figure 50] 1 illustrates an embodiment of a suturing device, according to some embodiments herein. [Figure 51A] FIG. 10 illustrates an embodiment of a suturing device, according to some embodiments herein, showing a mandrel mechanism for rotating opposing jaws. [Figure 51B]FIG. 10 illustrates an embodiment of a suturing device, according to some embodiments herein, showing a mandrel mechanism for rotating opposing jaws. [Figure 51C] FIG. 10 illustrates an embodiment of a suturing device, according to some embodiments herein, showing a mandrel mechanism for rotating opposing jaws. [Figure 51D] FIG. 10 illustrates an embodiment of a suturing device, according to some embodiments herein, showing a mandrel mechanism for rotating opposing jaws. [Figure 52A] 1A-1C illustrate an embodiment of a suturing device having a lever mechanism for opening and closing the jaws, according to some embodiments herein. [Figure 52B] 1A-1C illustrate an embodiment of a suturing device having a lever mechanism for opening and closing the jaws, according to some embodiments herein. [Figure 52C] 1A-1C illustrate an embodiment of a suturing device having a lever mechanism for opening and closing the jaws, according to some embodiments herein. [Figure 52D] 1A-1C illustrate an embodiment of a suturing device having a lever mechanism for opening and closing the jaws, according to some embodiments herein. [Figure 52E] 1A-1C illustrate an embodiment of a suturing device having a lever mechanism for opening and closing the jaws, according to some embodiments herein. [Figure 52F] 1A-1C illustrate an embodiment of a suturing device having a lever mechanism for opening and closing the jaws, according to some embodiments herein. [Figure 53A] 10A-10C illustrate an embodiment of a suturing device having a toggle switch for transferring needles between jaws, according to some embodiments herein. [Figure 53B] 10A-10C illustrate an embodiment of a suturing device having a toggle switch for transferring needles between jaws, according to some embodiments herein. [Figure 53C] 10A-10C illustrate an embodiment of a suturing device having a toggle switch for transferring needles between jaws, according to some embodiments herein. [Figure 53D] 10A-10C illustrate an embodiment of a suturing device having a toggle switch for transferring needles between jaws, according to some embodiments herein. [Figure 53E] 10A-10C illustrate an embodiment of a suturing device having a toggle switch for transferring needles between jaws, according to some embodiments herein. [Figure 53F] 10A-10C illustrate an embodiment of a suturing device having a toggle switch for transferring needles between jaws, according to some embodiments herein. [Figure 54A] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54B] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54C] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54D] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54E] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54F] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54G] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 54H] 1 illustrates an embodiment of a suturing device having a dual action needle removal button, according to some embodiments herein. [Figure 55A] 51 illustrates an embodiment of a suturing device having needles for use with the device shown in FIG. 50, according to some embodiments herein. [Figure 55B]51 illustrates an embodiment of a suturing device having needles for use with the device shown in FIG. 50, according to some embodiments herein. [Figure 55C] 51 illustrates an embodiment of a suturing device having needles for use with the device shown in FIG. 50, according to some embodiments herein. [Figure 55D] 51 illustrates an embodiment of a suturing device having needles for use with the device shown in FIG. 50, according to some embodiments herein. [Figure 55E] 51 illustrates an embodiment of a suturing device having needles for use with the device shown in FIG. 50, according to some embodiments herein. [Figure 56A] 1 illustrates an embodiment of a suturing device having a needle transport mechanism, according to some embodiments herein. [Figure 56B] 1 illustrates an embodiment of a suturing device having a needle transport mechanism, according to some embodiments herein. [Figure 56C] 1 illustrates an embodiment of a suturing device having a needle transport mechanism, according to some embodiments herein. [Figure 56D] 1 illustrates an embodiment of a suturing device having a needle transport mechanism, according to some embodiments herein. [Figure 57] 1 illustrates an embodiment of a suturing device, according to some embodiments herein. [Figure 58A] 1 shows a suturing device operating intraluminally. [Figure 58B] 1 shows a suturing device operating intraluminally. [Figure 58C] 1 shows a suturing device operating intraluminally. [Figure 58D] 1 shows a suturing device operating intraluminally. [Figure 58E] 10A-10C illustrate one embodiment of an operator holding a suturing device for palpation during a suturing procedure. [Figure 58F] 1 shows a suturing device operating intraluminally. [Figure 58G] 1 shows a suturing device operating intraluminally. [Figure 58H] 1 shows a suturing device operating intraluminally. [Figure 59A] 1A-1C illustrate an embodiment of a mini sling. [Figure 59B] 1A-1C illustrate an embodiment of a mini sling. [Figure 60] FIG. 10 is a close-up view of one embodiment of a mini-sling including an adjusting suture. [Figure 61] 1A-1C illustrate an embodiment of a sling loader for a mini-sling. [Figure 62] FIG. 10 illustrates one embodiment of a mini-sling placed on a sling loader. [Figure 63A] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63B] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63C] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63D] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63E] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63F] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63G] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63H] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63I] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 63J] FIG. 10 illustrates one embodiment of inserting a mini-sling. [Figure 64A] 1 is an exemplary schematic diagram of the pelvic cavity. [Figure 64B] FIG. 1 illustrates an exemplary embodiment of multiple sutures placed within the pelvic cavity, representing a VACS procedure. [Figure 64C] FIG. 1 illustrates an exemplary embodiment of multiple sutures placed within the pelvic cavity, representing a VACS procedure. DETAILED DESCRIPTION OF THE INVENTION
[0054] While the above-described drawings illustrate embodiments of the present disclosure, other embodiments are contemplated, as described below. The present disclosure presents exemplary embodiments for purposes of illustration and not limitation. Those skilled in the art can devise many other modifications and embodiments that fall within the scope and spirit of the principles of the embodiments of the present disclosure.
[0055] The present disclosure includes improved suturing devices and methods for their use. The suturing devices of the present disclosure may be inserted into a cavity to access the tissue to be sutured.
[0056] In some embodiments, a suturing device, a suture loader, a tension-free mid-urethral sling, and methods of use thereof are provided. The suture loader can load a needle with a suture into the suturing device. The suturing device can be inserted into the cavity to access the tissue to be sutured. The suturing device includes a fixed jaw and a movable jaw, between which the tissue is positioned for suturing. The fixed jaw remains in place, while the movable jaw moves the needle with the suture to suture the tissue. The suturing device includes a needle transport mechanism that moves the needle between the jaws as the tissue is sutured. A stop and safety member can control the movement of the movable jaw to prevent the needle from slipping out as it moves between the jaws. Once suturing is complete, the suturing device, along with the needle, can be removed from the cavity.
[0057] Any of the embodiments of the suturing devices described herein can have a variety of sizes, shapes, and angles, which are optimized based on the anatomy in which the suturing device will be used. The suturing device can have a size and angle optimized for safe, minimally invasive repair of pelvic floor disorders with positional precision. The suturing device can also have a size and angle optimized for minimally invasive use in surgical sites that are deep, narrow, or invisible to the naked eye. The size and angle of the device can be selected depending on the target tissue that each device is designed to reach for suturing and the path that each device must travel to reach the target tissue. For example, the path may contain obstacles such as hard and soft tissue. The size and angle allow the suturing device to be maneuvered along the path during a surgical procedure using the suturing device to minimally invasively reach each target tissue. For example, the area of the path may be located within the pelvic cavity, which may be very similar between patients with minimal standard deviation. Therefore, calculations can be performed accurately between patients, even if physical parameters (e.g., height, weight, etc.) vary between patients. Additionally, any of the suturing devices described herein may have a length that allows the handle to be positioned outside the cavity during operation of the suturing device, and that length may define the portion of the suturing device that may be positioned inside the cavity. For example, the suturing device may have a length and angle suitable for a transvaginal approach or transvaginal procedure.
[0058] As used herein, the terms "distal" and "proximal" may be used to describe the relative location of one or more elements. "Distal" is the direction toward or closest to the surgical site within the patient. "Proximal" is the direction opposite the distal direction.
[0059] In some embodiments, the suturing devices described herein include a needle (suture needle) for passing through the tissue of interest. In some embodiments, the suturing devices described herein include a mechanism for moving or acting on the needle. Such a mechanism may be referred to as a "needle transfer mechanism." For example, with reference to FIG. 1 , a suturing device 100 is shown. The suturing device 100 generally includes an elongate body 102 and a needle transfer mechanism 112. In some embodiments, the needle 104 extends from the elongate body 102 and is configured to suture the tissue 120. In some embodiments, the needle transfer mechanism 112 includes a muscle wire 108 coupled to the needle 104. In some embodiments, the muscle wire 108 is directly coupled to the needle 104. In some embodiments, the muscle wire 108 is indirectly coupled to the needle 104 (e.g., via one or more components disposed between the muscle wire 108 and the needle 104). In some embodiments, muscle wire 108 is extendable proximally through at least a portion of elongate body 102. In some embodiments, muscle wire 108 may be coupled to energy source 110 configured to supply an electric current to muscle wire 108. In some embodiments, needle transport mechanism 112 includes potential energy member 106. Potential energy member 106 may be coupled to needle 104. In some embodiments, potential energy member 106 may be directly coupled to needle 104. In some embodiments, potential energy member 106 is indirectly coupled to needle 104 (e.g., via one or more components disposed between potential energy member 106 and needle 104). Alternatively, in some embodiments, potential energy member 106 is positioned such that it can apply a force to needle 104.
[0060] Continuing to refer to FIG. 1 , in some embodiments, muscle wire 108 can be configured to change length based on the application of electrical current to muscle wire 108. For example, when energy source 110 applies electrical current to muscle wire 108, muscle wire 108 shortens, and when electrical current is no longer applied to muscle wire 108, muscle wire 108 can return to its original, extended length. In some embodiments, when muscle wire 108 shortens, muscle wire 108 can apply a pulling or pushing force (directly or indirectly, e.g., via one or more intervening components) to needle 104, causing needle 104 to move. In some embodiments, potential energy member 106 can move from a first shape or configuration to a second shape or configuration when muscle wire 108 shortens. In the second shape or configuration, potential energy member 106 can store energy. When muscle wire 108 is stretched, potential energy member 106 releases its stored energy and returns to the first shape or configuration, thereby applying a pushing or pulling force (directly or indirectly, e.g., via one or more intervening components) to needle 104, causing needle 104 to move.
[0061] Referring to FIG. 2 , a suturing device 200 is shown. The suturing device 200 can include an elongate body 202. In some embodiments, a first jaw 204 and a second jaw 206 extend from the elongate body 202 toward tissue 220 to be sutured. The first jaw 204 and the second jaw 206 can be configured to move a needle 208 of the suturing device 200 between the jaws 204, 206. The suturing device 200 can include a needle transport mechanism 230. In some embodiments, the needle transport mechanism 230 can include a first gripping member 232 in the first jaw 204 that can be moved to grip or release the needle 208. In some embodiments, the needle transport mechanism 230 includes a muscle wire 234 coupled to the first gripping member 232. In some embodiments, the muscle wire 234 is directly coupled to the first gripping member 232. In some embodiments, muscle wire 234 is indirectly coupled to first gripping member 232 (e.g., via one or more components disposed between muscle wire 234 and first gripping member 232). In some embodiments, muscle wire 234 is extendable proximally through at least a portion of elongate body 202. In some embodiments, muscle wire 234 may be coupled to energy source 210 configured to supply electrical current to muscle wire 234. In some embodiments, needle transport mechanism 230 includes potential energy member 236. Potential energy member 236 may be coupled to first gripping member 232. In some embodiments, potential energy member 236 may be directly coupled to first gripping member 232. In some embodiments, potential energy member 236 is indirectly coupled to first gripping member 232 (e.g., via one or more components disposed between potential energy member 236 and first gripping member 232). Alternatively, in some embodiments, the potential energy member 236 is positioned such that it can apply a force to the first gripping member 232 .
[0062] 2 , in some embodiments, muscle wire 234 can be configured to change length based on the application of electrical current to muscle wire 234. For example, when energy source 210 applies electrical current to muscle wire 234, muscle wire 234 shortens, and when electrical current is no longer applied to muscle wire 234, muscle wire 234 can return to its original, extended length. In some embodiments, when muscle wire 234 shortens, muscle wire 234 can apply a pulling or pushing force (directly or indirectly, e.g., through one or more intervening components) to first gripping member 232, causing first gripping member 232 to move. In some embodiments, potential energy member 236 can move from a first shape or configuration to a second shape or configuration when muscle wire 234 shortens. In the second shape or configuration, potential energy member 236 can store energy. When muscle wire 234 is stretched, potential energy member 236 may release its stored energy and return to the first shape or configuration, thereby exerting a pushing or pulling force (directly or indirectly, e.g., via one or more intervening components) on first gripping member 232 to cause first gripping member 232 to move.
[0063] 2 , needle transport mechanism 230 can include a second gripping member 242 in second jaw 206, a muscle wire 244 coupled (directly or indirectly) to second gripping member 242 and coupled to energy source 210, and a potential energy member 246 coupled (directly or indirectly) to second gripping member 242 or otherwise positioned to apply a force to second gripping member 242. Muscle wire 244 and potential energy member 246 can operate similarly to muscle wire 234 and potential energy member 236 to move second gripping member 242. Movement of first gripping member 232 and second gripping member 242 can control movement of needle 208 between jaws 204 and 206 to suture tissue 220.
[0064] While the device shown in FIG. 2 has a relatively straight elongate body, a portion of the distal end of the elongate body may be angled relative to the remainder of the elongate body. For example, the angle of the distal end of the elongate body relative to the remainder of the elongate body may be in the range of approximately 10-20°. For example, the elongate body may have a distal portion extending at an angle of approximately 16° relative to the proximal portion. For example, the elongate body may have a distal portion extending at an angle of 15.88° relative to the proximal portion. It is contemplated that suturing devices may be improved by modifying the size, shape, and angle to optimize the suturing device for a particular cavity and procedure.
[0065] 3A and 3B, in some embodiments, suturing device 2001A can be scissor-shaped and ergonomically sized to reach target tissue in tight spaces. Suturing device 2001A can include a fixed arm 2007 integral with a fixed jaw 2005. In some embodiments, the distal end of fixed arm 2007 includes fixed jaw 2005. Suturing device 2001A can include a movable arm 2008 coupled to a movable jaw 2006.
[0066] The fixed jaw 2005 and the movable jaw 2006 can release and grasp a needle, and the suturing device 2001A can also include a needle transfer mechanism 2004 that transfers the needle between the fixed jaw 2005 and the movable jaw 2006. The needle transfer mechanism 2004 is described in more detail below.
[0067] In some embodiments, suturing device 2001A can include a first handle 2002A coupled to movable arm 2008 and a second handle 2002B coupled to fixed arm 2007. Handle 2002A and handle 2002B can assist a user in moving movable arm 2008 relative to fixed arm 2007. Handle 2002A and handle 2002B can be located at the end of suturing device 2001A that remains outside the patient's cavity during surgery to allow an operator to control suturing device 2001A. Handle 2002A and handle 2002B can be located at the proximal end of suturing device 2001A.
[0068] 4A and 4B show one embodiment of suturing device 2001A. In some embodiments, fixed jaw 2005 includes a first gripping slot 2103 capable of receiving needle 2201 (described separately with reference to FIGS. 7A-7I). In some embodiments, movable jaw 2006 includes a second gripping slot 2104 capable of receiving needle 2201. In some embodiments, the gripping slot is a channel sized and shaped to receive the needle. For example, the gripping slot can define a circular channel or hole for receiving and gripping the needle.
[0069] 3A-4B, in some embodiments, the needle transport mechanism 2004 can move (transport) the needle between the first gripping slot 2103 and the second gripping slot 2104. As such, the needle transport mechanism 2004 can secure the needle to the first gripping slot 2103 and / or the second gripping slot 2104 and / or release the needle from the first gripping slot 2103 or the second gripping slot 2104.
[0070] 5A-5D illustrate one embodiment of a mechanism for pivoting movable arm 2008 relative to fixed arm 2007 and movable jaw 2006 relative to fixed jaw 2005. As shown in FIGS. 5A and 5B, movable arm 2008 can have arm movement 2105, pivoting toward or away from fixed arm 2007. For example, arm movement 2105 can be triggered by manual movement of handle 2002A by the surgeon to open or close device 2001A. This control can be advantageous during surgery in areas where visibility is limited, allowing the movement of device 2001A to be under operator control. In some embodiments, arm movement 2105 can be triggered by an additional potential energy member, such as a spring.
[0071] In some embodiments, the fixed arm 2007 can remain stationary relative to the movable arm 2008 while the movable arm 2008 is moving. The movable arm 2008 can pivot relative to the fixed arm 2007, causing the movable jaw 2006 to pivot relative to the fixed jaw 2005. Movement of the movable arm 2008 relative to the fixed arm 2007 causes the movable jaw 2006 to produce a jaw movement 2107 along which the movable jaw 2006 can pivot away from or towards the fixed jaw 2005. The fixed jaw 2005 can remain stationary relative to the movable jaw 2006 while the movable jaw 2006 is moving. In some embodiments, the movable arm 2008 and the movable jaw 2006 move relative to the fixed arm 2007. In some embodiments, the movable arm 2008 and the movable jaw 2006 move relative to the fixed jaw 2005. In some embodiments, movable arm 2008 and movable jaw 2006 move relative to one another. In some embodiments, fixed arm 2007 and fixed jaw 2005 do not move. In some embodiments, fixed jaw 2005 cannot move independently of fixed arm 2007. In some embodiments, fixed arm 2007 is integral with fixed jaw 2005, so that fixed jaw 2005 cannot move independently of fixed arm 2007.
[0072] The fixed jaw 2005 can facilitate safe operation in tight spaces because, by maintaining the fixed jaw 2005 stationary (fixed) relative to the target tissue, the suture can be placed in a safe area. For example, even if the operator moves the movable jaw 2006 relative to the fixed jaw 2005, the operator can still know the position of the fixed jaw 2005. When the target tissue is referenced using the fixed jaw 2005 in a surgical site where visualization is difficult or impossible, the fixed jaw 2005 allows the suture to pass through the target tissue. Because the fixed jaw 2005 and movable jaw 2006 can come together in a fixed or predictable position relative to the tissue, there is no need to continually predict position and distance. Thus, the fixed jaw 2005 allows suturing in areas where visualization is difficult.
[0073] 5B , in some embodiments, the movable arm 2008 can pivot the movable jaw 2006 relative to the fixed jaw 2005 by pivoting relative to the fixed arm 2007. The movable arm 2008 can transfer the needle 2201 between the first gripping slot 2103 and the second gripping slot 2104 by pivoting the movable jaw 2006 relative to the fixed jaw 2005 until the needle 2201 is received in both the first gripping slot 2103 and the second gripping slot 2104.
[0074] 5A-5D, the needle transfer mechanism 2004 can control the locking and release of both the first gripping slot 2103 and the second gripping slot 2104. The needle transfer mechanism 2004 can receive one or more inputs or commands to control the locking and release of the first gripping slot 2103 and the second gripping slot 2104. For example, in a first state, the needle 2201 can be locked in the first gripping slot 2103 of the fixed jaw 2005. As shown in FIG. 5A, when the movable arm 2008 is moving or open, the needle transfer mechanism 2004 can grip the needle 2201 in the fixed jaw 2005 while disabling the grip in the movable jaw 2006. As shown in FIG. 5B, when the movable arm 2008 is adjacent to the fixed arm 2007, the needle transfer mechanism 2004 can grasp the needle 2201 in the fixed jaw 2005 while disabling the grip in the movable jaw 2006.
[0075] As shown in FIG. 5C , needle transfer mechanism 2004 can secure needle 2201 in second gripping slot 2104 and then release needle 2201 from first gripping slot 2103. That is, in FIG. 5C , needle transfer mechanism 2004 can grip needle 2201 with movable jaw 2006 while disabling gripping at fixed jaw 2005. As shown in FIG. 5D , when movable jaw 2006 pivots away from fixed jaw 2005 due to movement of movable arm 2008, needle transfer (handover) between fixed jaw 2005 and movable jaw 2006 is completed because needle 2201 is secured to movable jaw 2006. As shown in FIG. 5D , when movable arm 2008 is moving or open, needle transfer mechanism 2004 can grip needle 2201 with movable jaw 2006 while disabling gripping at fixed jaw 2005.
[0076] 5 5A-5D , in some embodiments, the needle transport mechanism 2004 of the suturing device 2001A can include a cover 2108 partially disposed over at least a portion of the needle transport mechanism 2004. In some embodiments, as described in more detail below, the cover 2108 can include one or more buttons for accepting user inputs or commands. In some embodiments, as described in more detail below, the cover 2108 can include one or more indicators corresponding to the operational state (enabled (e.g., gripping) or disabled (e.g., not gripping)) of the needle transport mechanism 2004 in the movable jaw 2006 and / or the fixed jaw 2005.
[0077] 6A-6C illustrate a mechanism for one embodiment of suturing device 2001A, which allows relative movement of movable arm 2008 with respect to fixed arm 2007 to cause movable jaw 2006 to perform jaw action 2107, pivoting movable jaw 2006 away from or toward fixed jaw 2007. In some embodiments, fixed arm 2007 can include an arm joint 2101 for coupling fixed arm 2007 to movable arm 2008. For example, arm joint 2101 can be a mechanical joint that connects two components to allow movement relative to one another. In some embodiments, arm joint 2101 allows movement of movable arm 2008 relative to fixed arm 2007. For example, movable arm 2008 can pivot relative to fixed arm 2007 about arm joint 2101. In some embodiments, the arm joint 2101 allows the movable arm 2008 to pivot with one degree of freedom relative to the fixed arm 2007. In some embodiments, the arm joint 2101 can limit the movement of the movable arm 2008 to prevent the movable arm 2008 from breaking or from exerting excessive force on the movable jaw 2006, slot, or any other component described herein.
[0078] In some embodiments, the fixed arm 2007 includes a jaw joint 2100. In some embodiments, the fixed jaw 2005 includes a jaw joint 2100. The jaw joint 2100 is coupled to the movable jaw 2006 and allows the movable jaw 2006 to pivot relative to the fixed jaw 2005. For example, the jaw joint 2100 can be a mechanical joint that connects two components and allows movement relative to one another. In some embodiments, the movable jaw 2006 can pivot relative to the fixed jaw 2005 about the jaw joint 2100. In some embodiments, the jaw joint 2100 allows the movable jaw 2006 to pivot with one degree of freedom relative to the fixed jaw 2005. In some embodiments, the jaw joint 2100 can limit the movement of the movable jaw 2006 to prevent the movable jaw 2006 from breaking or exerting excessive force on the fixed jaw 2005, the slot, or any other component described herein.
[0079] In some embodiments, the suturing device 2001A further includes a connection joint 2102 coupled to the movable arm 2008 and the movable jaw 2006. The connection joint 2102 can be disposed between the jaw joint 2100 and the arm joint 2101 such that the jaw joint 2100 and the arm joint 2101 are decoupled and mechanically independent from one another. The connection joint 2102 can cause the movable jaw 2006 to pivot upon movement of the movable arm 2008. For example, the connection joint 2102 can be a mechanical joint that connects two components to allow them to move relative to one another. In some embodiments, the movable arm 2008 can physically move the connection joint 2102 to pivot the movable jaw 2006 about the jaw joint 2100. Movement of the movable arm 2008 can move the connection joint 2102 to pivot the movable jaw 2006 about the jaw joint 2100. 6B and 6C, as the movable arm 2008 moves away from the fixed arm 2007, the connecting joint 2102 moves across the width of the fixed arm 2007. As the connecting joint 2102 pulls on the movable jaw 2006, the movable jaw 2006 pivots about the jaw joint 2100 and moves away from the fixed jaw 2005.
[0080] In some embodiments, the movement of the movable jaw 2006 and the movable arm 2008 can be limited to prevent them from disengaging or from exerting excessive force on the slots or any other components described herein. For example, the connecting joint 2102 can be limited to movement along the width of the fixed arm 2007, thereby preventing excessive movement of the movable jaw 2006 and the movable arm 2008. In some embodiments, the portion of the fixed arm 2007 between the jaw joint 2100 and the arm joint 2101 can remain in a fixed position while the movable jaw 2006 moves inside the pelvic cavity and the movable arm 2008 moves outside the vaginal cavity. Such movement can advantageously reduce the profile of the movable jaw 2006 and the movable arm 2008.
[0081] In some embodiments, the suturing device 2001A is comprised of three rigid metal components (e.g., (1) a fixed arm 2007 integral with a fixed jaw 2005, (2) a movable arm 2008, and (3) a movable jaw 2006) that are attached to one another at three joints 2100, 2101, and 2102. In some embodiments, the fixed arm can at least partially define a datum that includes a jaw joint 2100 and an arm joint 2101. The movable jaw 2006 and the movable arm 2008 can move relative to one another and relative to the fixed arm 2007 and the fixed jaw 2005 in a 2D plane about the datum. In some embodiments, the movable arm 2008 pivots relative to the datum about the arm joint 2101. In some embodiments, the movable jaw 2006 pivots relative to the datum about the jaw joint 2100.
[0082] For example, when manipulating suturing device 2001A inside the pelvic cavity, fixed arm 2007, which may have an appropriately designed profile to properly position the suture, is aligned and fixed to a specific area of the pelvic cavity, and jaw joint 2100, arm joint 2101, and connecting joint 2102 allow the operator to move handle 2002A, which moves movable arm 2008 and thus movable jaw 2006. By maintaining fixed arm 2007 in place, jaws 2005 and 2006 can be properly positioned for suturing.
[0083] 7A-7I, 15A-15C, and 17A-17D illustrate embodiments of needles 2201. Needles 2201A, 2201B, 2201C, 2201D, and 2201E (collectively referred to as needles 2201) can include a first receptacle 2207A and a second receptacle 2207B. Receptacles 2207A, 2207B can be notches, holes, recesses, cutouts, indentations, barbs, or other features in the surface of needles 2201A-2201E that allow needles 2201A-2201E to be gripped in first gripping slot 2103 and / or second gripping slot 2104, as described below. Depending on the location of the first receptacle 2207A and the second receptacle 2207B on the needle 2201, the needle 2201 may be grasped in the first gripping slot 2103, the second gripping slot 2104, or both. For example, the first receptacle 2207A may be grasped and coupled to the fixed jaw 2005, and the second receptacle 2207B may be grasped and coupled to the movable jaw 2006.
[0084] As shown in FIG. 7A, needle 2201 can be a curved needle 2201A. FIGS. 7B, 7C, 7D, and 7E show an embodiment of a straight needle 2201B. In some embodiments, needle 2201A and needle 2201B can include a hole 2208. In some embodiments, hole 2208 can be used to bond the needle and thread by drilling a hole in needle 2201A or needle 2201B, inserting a thread (e.g., thread 2301) into hole 2208, and deforming hole 2208 with an appropriate die shape attached to a press. In some embodiments, needle 2201 and thread can be bonded using a suitable adhesive instead of deforming hole 2208.
[0085] 7F, 7G, 7H, and 71 show one embodiment of needle 2201C including channel 2209. Channel 2209 allows for an open-channel-shaped base bond between needle 2201 and thread 2301. Channel 2209 can then be drilled into needle 2201C, thread 2301 placed within channel 2209, and a suitable die shape attached to a press can deform channel 2209 to cover thread 2301. In some embodiments, needle 2201 and thread 2301 can be bonded using a suitable adhesive instead of deforming channel 2209.
[0086] 15A-15C show an embodiment of needle 2201D having a concave shape and holes as first receptacles 2207A and second receptacles 2207B. Receptacles 2207A and 2207B may include countersunk shapes at the front of the receptacles 2207A and 2207B. The countersunk shapes allow the gripping members to more precisely grip needle 2201D. FIGS. 17A-17D show an embodiment of straight needle 2201E having holes as first receptacles 2207A and second receptacles 2207B. Receptacles 2207A and 2207B of needle 2201E include countersunk shapes at the front of the receptacles 2207A and 2207B.
[0087] 7J, 7K, 7L, 7M, 7MM, 7N, 7O, and 7P, an embodiment of needle transport mechanism 2004 of suturing device 2001A is shown. Needle transport mechanism 2004 can retain needle 2201 in and release needle 2201 from jaws 2005 and 2006 with the aid of muscle wires (e.g., first muscle wire 2027A and second muscle wire 2027B). In some embodiments, muscle wires 2027A and 2027B can be shape memory alloy wires. In some embodiments, muscle wires 2027A and 2027B can be made of one or more materials that transition from a reference length to a deformed length when current is applied thereto and from the deformed length to the reference length when current flow is interrupted (i.e., when current flow through the muscle wires is stopped). In some embodiments, the reference length can be longer than the deformation length. That is, in some embodiments, muscle wires 2027A, 2027B shorten when an electric current is applied. In some embodiments, muscle wires 2027A, 2027B are made of a Nitinol smart material.
[0088] In some embodiments, first muscle wire 2027A and second muscle wire 2027B can be disposed within stationary arm 2007. In some embodiments, first muscle wire 2027A and second muscle wire 2027B extend within respective channels in stationary arm 2007. For example, first muscle wire 2027A can extend within first channel 2028A, and second muscle wire 2027B can extend within second channel 2028B. First channel 2028A and second channel 2028B can be separated by divider 2030. Divider 2030 can prevent shorting of first muscle wire 2027A and / or second muscle wire 2027B. In some embodiments, first muscle wire 2027A extends within a channel that passes through stationary jaw 2005. In some embodiments, the second muscle wire 2027B extends within a channel through the movable jaw 2006 .
[0089] In some embodiments, electrical connectors 2029A and 2029B can be disposed at the proximal ends of muscle wires 2027A, 2027B (i.e., the ends closest to the handle of suturing device 2001A). A first electrical connector 2029A can be disposed at the proximal end of first muscle wire 2027A, and a second electrical connector 2029B can be disposed at the proximal end of second muscle wire 2027B. Each electrical connector 2029A, 2029B can electrically couple the respective muscle wire 2027A, 2027B on which it is disposed to an energy source, as described in more detail below. In some embodiments, electrical connectors 2029A, 2029B can supply electrical current to the proximal ends of first muscle wire 2027A and second muscle wire 2027B by coupling the proximal ends of first muscle wire 2027A and second muscle wire 2027B to a first point on a respective conductor wire (e.g., passing through cable 2602 (FIG. 6A)) that is coupled to an energy source. In some embodiments, electrical connectors 2029A, 2029B can be disposed in recess 2031 that includes a first opening 2032A to first channel 2028A and a second opening 2032B to second channel 2028B. Electrical connectors 2029A, 2029B and openings 2032A, 2032B can be sized such that electrical connectors 2029A, 2029B cannot move distally (i.e., toward the jaws) through the openings into channels 2028A, 2028B. Thus, the proximal ends of muscle wires 2027A, 2027B, including electrical connectors 2029A, 2029B, can be held substantially stationary within recesses 2031 as muscle wires 2027A, 2027B transition to their respective deformed lengths (i.e., shorten from their respective nominal lengths). In other words, electrical connectors 2029A, 2029B can secure the proximal ends of muscle wires 2027A, 2027B as current flows through muscle wires 2027A, 2027B. This causes the length transitions of muscle wires 2027A, 2027B to cause movement (e.g., toward the jaws) at the distal ends of muscle wires 2027A, 2027B.In some embodiments, the divider 2030 can extend at least partially through the recess 2031 to separate the first electrical connector 2029A and the second electrical connector 2029B.
[0090] In some embodiments, the distal ends of muscle wires 2027A, 2027B can be coupled to pull wires 2021A and 2021B, respectively. The distal end of first muscle wire 2027A can be coupled to first pull wire 2021A via a first ferrule 2026A or connector, and the distal end of second muscle wire 2027B can be coupled to second pull wire 2021B via a second ferrule 2026B. In some embodiments, first ferrule 2026A and second ferrule 2026B can couple the distal end of first muscle wire 2027A to first pull wire 2021A and the distal end of second muscle wire 2027B to second pull wire 2021B by crimping. In some embodiments, ferrules 2026A, 2026B can couple the distal ends of first muscle wire 2027A and second muscle wire 2027B to distal points of respective insulated conductor wires 2033A, 2033B that are coupled to an energy source. First insulated conductor wire 2033A can pass through first opening 2032A in the wall defining the distal end of recess 2031, pass through first channel 2028A, and be coupled to the distal end of first muscle wire 2027A with ferrule 2026A to supply electrical current to the distal end of first muscle wire 2027A. Second insulated conductor wire 2033B passes through second opening 2032B in the wall defining the distal end of recess 2031, passes through second channel 2028bB, and is coupled to the distal end of second muscle wire 2027B with ferrule 2026B to provide electrical current to the distal end of second muscle wire 2027B. In some embodiments, first seal ring 2025A can be positioned at the distal end of first channel 2028A through which first pull wire 2021A extends, and second seal ring 2025B can be positioned at the distal end of second channel 2028B through which second pull wire 2021B extends. Seal rings 2025A, 2025B can prevent blood and other fluids from entering channels 2028A, 2028B and contacting muscle wires 2027A, 2027B. Thus, the seal rings 2025A, 2025B can help prevent short circuits.
[0091] In some embodiments, a first pull wire 2021A can extend through at least a portion of the fixed jaw 2005, and a second pull wire 2021B can extend through at least a portion of the movable jaw 2006. In some embodiments, a distal end of the first pull wire 2021A can be coupled to a first gripping member 2024A disposed in the fixed jaw 2005, and a distal end of the second pull wire 2021B can be coupled to a second gripping member 2024B disposed in the movable jaw 2006. Geometric features, such as feature 2020B, can be used to route a pull wire, such as pull wire 2021B of FIG. 7M, in an optimal path through the suturing device 2001A and the jaws. The pull wires 2021A, 2021B may be non-conductive to insulate the fixed jaw 2005 (and its internal components) and the movable jaw 2006 (and its internal components) from the muscle wires 2027A, 2027B, so that in embodiments, the non-conductive pull wires 2021A, 2021B can prevent short circuits, for example, caused by blood or tissue contacting the muscle wires 2027A, 2027B.
[0092] It will be appreciated that in some embodiments, the muscle wires 2027A, 2027B can be directly coupled to the gripping members 2024A, 2024B. In some embodiments, the muscle wires 2027A, 2027B can be indirectly coupled to the gripping members 2024A, 2024B via one or more components (e.g., pull wires 2021A, 2021B) between the muscle wires 2027A, 2027B and the gripping members 2024A, 2024B.
[0093] The needle 2201 can be grasped and held in the fixed jaw 2005 by the first gripping member 2024A, and can be grasped and held in the movable jaw 2006 by the second gripping member 2024B. More specifically, the first gripping member 2024A can hold the needle 2201 in the fixed jaw 2005 when pressed into the first receptacle 2207A or the second receptacle 2207B of the needle 2201, and the second gripping member 2024B can hold the needle 2201 in the movable jaw 2006 when pressed into the first receptacle 2207A or the second receptacle 2207B of the needle 2201. The first gripping member 2024A and the second gripping member 2024B can be removably coupled to the needle 2201. The first and second gripping members 2024A, 2024B may be pins, clips, protrusions, or any other members sized to be pressed into the first and / or second receptacles 2207A, 2207B.
[0094] In some embodiments, needle transfer mechanism 2004 can include a first spring 2022A and a second spring 2022B. First spring 2022A can be disposed near and coupled to first gripping member 2024A in fixed jaw 2005. Second spring 2022B can be disposed near and coupled to second gripping member 2024B in movable jaw 2006. In some embodiments, springs 2022A, 2022B can be retained in fixed jaw 2005 and movable jaw 2006, respectively, by mechanical elements such as rings, pins, etc., or by structural features such as protrusions. For example, second spring 2022B can be retained in movable jaw 2006 by mechanical element 2023B.
[0095] It will be understood that in some embodiments, the springs 2022A, 2022B can be directly coupled to the gripping members 2024A, 2024B. In some embodiments, the springs 2022A, 2022B can be indirectly coupled to the gripping members 2024A, 2024B via one or more components between the springs 2022A, 2022B and the gripping members 2024A, 2024B. In some embodiments, the springs 2022A, 2022B need not be directly or indirectly coupled to the gripping members 2024A, 2024B. Other arrangements of the springs 2022A, 2022B (and other potential energy members described herein) are possible that allow the springs 2022A, 2022B to exert a force on the gripping members 2024A, 2024B and / or vice versa. For example, spring 2022A, gripping member 2024A (including feature 2024AA of gripping member 2024A), and mechanical element 2023 may each be sized such that a distal end of spring 2022A is maintained in contact with at least a portion of gripping member 2024A (such as feature 2024AA) or another element in contact with gripping member 2024A (e.g., an element disposed between spring 2022A and gripping member 2024A), thereby enabling spring 2022A to apply a distal force to gripping member 2024A. Similarly, spring 2022A, gripping member 2024A (including feature 2024AA of gripping member 2024A), and mechanical element 2023 may each be sized such that the distal end of spring 2022A is maintained in contact with at least a portion of gripping member 2024A (such as feature 2024AA) or another element in contact with gripping member 2024A (e.g., an element disposed between spring 2022A and gripping member 2024A), thereby enabling gripping member 2024A to apply a proximal force to spring 2022A.
[0096] Muscle wires 2027A, 2027B can transition between their respective nominal and deformed lengths independently within their respective channels 2028A, 2028B. In some embodiments, first muscle wire 2027A can be at or transition to its nominal or extended length, at which first gripping member 2024A advances into first gripping slot 2103 and toward first receptacle 2207A or second receptacle 2207B of needle 2201 in first gripping slot 2103 to secure needle 2201 in first gripping slot 2103. In some embodiments, the first muscle wire 2027A is at or can transition to a deformed length that is shorter than its reference length, at which the first gripping member 2024A retracts from the first gripping slot 2103 and from the first receptacle 2207A or the second receptacle 2207B to release (unlock) the needle 2201 from the first gripping slot 2103.
[0097] In some embodiments, the second muscle wire 2027B is at or can transition to its reference length or extended length, at which length the second gripping member 2024B advances toward the second gripping slot 2104 and toward the first receptacle 2207A or second receptacle 2207B of the needle 2201 in the second gripping slot 2104 to secure the needle 2201 in the second gripping slot 2104. In some embodiments, the second muscle wire 2027B can be at an extended length shorter than its reference length or transition to its deformed length, at which length the second gripping member 2024B retracts from the second gripping slot 2104 and from the first receptacle 2207A or the second receptacle 2207B to release (unlock) the needle 2201 from the second gripping slot 2104.
[0098] For example, and by way of example only with respect to first muscle wire 2027A, shortening of first muscle wire 2027A in first channel 2028A (i.e., transitioning to its deformed length) can cause the distal end of first muscle wire 2027A to move proximally in first channel 2028A. Accordingly, first muscle wire 2027A can exert a proximal force on pull wire 2021A and first gripping member 2024A, causing first gripping member 2024A to retract from first gripping slot 2103 and first receptacle 2207A or second receptacle 2207B of needle 2201, releasing needle 2201 from first gripping slot 2103. In some embodiments, proximal movement, or retraction, of first gripping member 2024A fully compresses first spring 2022A to a loaded state. Figure 7P shows first gripping member 2024A retracted from first gripping slot 2103 and fully compressed first spring 2022A. As described above, first muscle wire 2027A can be shortened when an electric current is passed through first muscle wire 2027A.
[0099] When the current to first muscle wire 2027A is interrupted or stops flowing through first muscle wire 2027A, first muscle wire 2027A transitions to its nominal length, and the distal end of first muscle wire 2027A moves distally within first channel 2028A. When the current to first muscle wire 2027A is interrupted and the proximal retraction force on the distal ends of muscle wire 2027A, pull wire 2021A, and first gripping member 2024A is removed, first spring 2022A transitions from a loaded state to a semi-compressed state (shown in FIG. 7O), and a distal force is applied to first gripping member 2024A, pull wire 2021A, and first muscle wire 2027A. Thus, as first spring 2022A transitions to the semi-compressed state, first gripping member 2024A advances toward first gripping slot 2103. As shown in FIG. 7O, when first muscle wire 2027A is at its nominal length and first gripping member 2024A moves distally toward and / or through first gripping slot 2103, a mechanical element (such as mechanical element 2023B described with respect to second muscle wire 2027B) can maintain first spring 2022A in the semi-compressed state. In the semi-compressed state, the first spring 2022A can apply and maintain a distal force to the first gripping member 2024A such that the first gripping member 2024A is forced into the first receptacle 2207A or the second receptacle 2207B of the needle 2201 with sufficient force to grip and hold the needle 2201.
[0100] For example, selective application of electrical current to first muscle wire 2027A, and thus selectively lengthening or shortening first muscle wire 2027A, can selectively transition first gripping member 2024A between the positions shown in Figures 7O and 7P to grip or release needle 2201 relative to jaw 2005.
[0101] While first muscle wire 2027A has been described in detail above, it will be understood that second muscle wire 2027B may similarly operate in conjunction with second pull wire 2021B and second gripping member 2024B. In some embodiments, first muscle wire 2027A and second muscle wire 2027B may operate independently.
[0102] 8A and 8B, a user interface 2605 for controlling the needle transport mechanism 2004 is shown. In some embodiments, the user interface 2605 includes a circuit board and microcontroller embedded in the suturing device 2001A. In some embodiments, the user interface 2605 can include one or more inputs 2604 for controlling the operation of the needle transport mechanism 2004 and / or other components of the suturing device 2001A. The one or more inputs 2604 can include an input 2604A, such as a button. In some embodiments, the user interface can include two or more buttons. While buttons are specifically described herein as the one or more inputs, it will be understood that the inputs of the user interface 2605 can include any user-operable element, such as a switch, dial, knob, etc. The one or more inputs 2604 can be disposed along a surface of the suturing device 2001A for access by the user. One or more inputs 2604 allow for user control of needle transport mechanism 2004, and in particular, user control of first and second muscle wires 2027A, 2027B. One or more inputs 2604 allow for independent energization of first muscle wire 2027A and second muscle wire 2027B (i.e., first muscle wire 2027A can be energized while second muscle wire 2027B is de-energized, or vice versa). In some embodiments, one or more inputs 2604 allow for dependent energization of first muscle wire 2027A and second muscle wire 2027B (i.e., energizing one muscle wire 2027A, 2027B automatically de-energizes the other muscle wire 2027A, 2027B).In some embodiments, one or more inputs 2604 allow for independent powering of first muscle wire 2027A and second muscle wire 2027B (i.e., powering one muscle wire 2027A, 2027B does not automatically result in powering down the other muscle wire 2027A, 2027B). In some embodiments, one or more inputs 2604 can control a power source, which in some embodiments may be a battery or adapter, coupled to user interface 2605 and / or user interface 2705 (FIG. 9A) and providing power to one or more outputs 2606 of user interface 2605 and / or one or more outputs 2713 of user interface 2705 (FIG. 9A), as described in more detail below. In some embodiments, the power source may be internal to suturing device 2001A. For example, in some embodiments, the power source may be located within cover 2108. In some embodiments, the power source may be external to the suturing device 2001A and coupled to the user interface 2605 via one or more electrical connectors that extend from the suturing device (e.g., through the second handle 2002B) to the power source.
[0103] In some embodiments, the user interface 2605 can include one or more outputs 2606 for indicating information regarding the operation of the suturing device 2001A, such as power status, operation of the needle transport mechanism 2004, error conditions (low battery), etc. The outputs 2606 can include a first indicator 2606A and a second indicator 2606B. The indicators can be LED lights, microphones, buzzers, etc. The first indicator 2606A and the second indicator 2606B can provide visual, audible, and / or tactile outputs that indicate to the user, for example, information regarding the operation of the suturing device 2001A and the needle transport mechanism 2004 (e.g., the first indicator 2606A can indicate that a needle is grasped in the fixed jaw 2005, and the second indicator 2606B can indicate that a needle is grasped in the movable jaw 2006). Although two indicators 2606A and 2606B are shown, it will be understood that the suturing device 2001A may include more or fewer indicators and outputs 2606. One or more outputs 2606 may be coupled to a surface of the suturing device 2001A for interaction with a user (e.g., visual, auditory, tactile).
[0104] The elements of user interface 2605 (e.g., input 2604 and output 2606) may be located anywhere along suturing device 2001A. In some embodiments, the elements of user interface 2605 may be located on cover 2108. In some embodiments, the elements of user interface 2605 may be located along suturing device 2001A such that they are visible and / or accessible during use of suturing device 2001A. In some embodiments, the elements of user interface 2605 may be located on suturing device 2001A such that they remain outside the patient's cavity during surgery.
[0105] 8A, 8B, 9A, and 9B, the supply of electrical current to first muscle wire 2027A and second muscle wire 2027B will be described. In some embodiments, suturing device 2001A includes a cable 2602 extending from suturing device 2001A. In some embodiments, cable 2602 extends from second handle 2002B, which is coupled to fixation arm 2007. In some embodiments, cable 2602 extends from port 2600 in second handle 2002B. In some embodiments, cable 2602 incorporates two separate leads or conductor wires, each coupled to one of first muscle wire 2027A or second muscle wire 2027B. In some embodiments, multiple cables extend from the second handle 2002B, and each cable can be electrically coupled to one of the first muscle wire 2027A or the second muscle wire 2027B. In some embodiments, the cable 2602 is coupleable to an external unit 2700, which can include an energy source. In particular, in some embodiments, the cable 2602 can be coupled to the external unit 2700's energy source via a socket 2706 and a cable 2708 extending from a port 2710 of the external unit 2700. In some embodiments, the external unit 2700 includes a battery pack and analog and / or digital circuitry coupled to the user interface elements 2604, 2606 of the suturing device 2001A. The analog and / or digital circuitry allows for control of the operation of the suturing device 2001A and / or the external unit 2700 through user manipulation of one or more inputs 2604. That is, in some embodiments, cable 2602 and cable 2708 allow control signals from one or more inputs 2604 of user interface 2605 of suturing device 2001A to be transmitted to external unit 2700.
[0106] In some embodiments, the external unit 2700 includes a user interface 2705. In some embodiments, the user interface 2705 can include one or more inputs 2711. In some embodiments, the user interface 2705 can include one or more outputs 2713 that indicate to a user the operation of the suturing device 2001A and / or the external unit 2700 (e.g., the operation of an energy source of the external unit 2700). In some embodiments, the one or more inputs 2711 of the user interface 2705 can operate in addition to or as an alternative to the one or more inputs 2604 of the user interface 2605. In some embodiments, the one or more inputs 2711 of the user interface 2705 can operate to control the same functions as those described with respect to the one or more inputs 2604 of the user interface 2605 above. In some embodiments, the one or more inputs 2711 of the user interface 2705 can operate to control different or separate functions from those described with respect to the one or more inputs 2604 of the user interface 2605 above. In some embodiments, the one or more outputs 2713 of the user interface 2705 may indicate the same indicia as those described above with respect to the one or more outputs 2606 of the user interface 2605. In some embodiments, the one or more outputs 2713 of the user interface 2705 may indicate different or separate indicia from those described above with respect to the one or more outputs 2606 of the user interface 2605 with respect to the operation of the suturing device 2001A and / or the external unit 2700. Analog and / or digital circuitry of the external unit 2700 allows for control of the operation of the suturing device 2001A and / or the external unit 2700 by user manipulation of the one or more inputs 2711.That is, in some embodiments, cable 2602 and cable 2708 allow control signals from one or more inputs 2711 of user interface 2705 of external unit 2700 to be transmitted to suturing device 2001A.
[0107] The inputs 2711 of the user interface 2705 may be buttons, switches, dials, knobs, etc. The one or more outputs 2713 of the user interface 2705 may be LED lights, microphones, buzzers, etc. The one or more inputs 2711 and / or one or more outputs 2713 may be disposed along a surface of the external unit 2700 for access by a user. In some embodiments, the one or more inputs 2711 of the user interface 2705 can control a power source, which in some embodiments may be a battery or an adapter, coupled to the user interface 2705 and / or the user interface 2605 and provides power to one or more outputs 2606 of the user interface 2605 and / or one or more outputs 2713 of the user interface 2705, as described in more detail below. In some embodiments, the one or more inputs 2711 include input 2711A, which may be a button or other actuator, for powering on / off the external unit 2700 and / or the electronics and user interface 2605 of the suturing device 2001A. In some embodiments, the one or more inputs 2711 include input 2711B, which may be a switch or other actuator, for selecting an operating mode of the suturing device 2001A, as described below. In some embodiments, the one or more inputs 2711 include input 2711C, which may be a knob or other actuator, for setting a threshold force in an automatic mode of the suturing device 2001A, as described below. In some embodiments, the one or more outputs 2713 include indicator 2713A, which may indicate a power-on or power-off state of the suturing device 2001A and / or the external unit 2700.
[0108] In some embodiments, the system may include only the user interface 2605 of the suturing device 2001A for control of the suturing device 2001A and / or the external unit 2700. In some embodiments, the system may include only the user interface 2705 of the external unit 2700 for control of the suturing device 2001A and / or the external unit 2700. In some embodiments, the system may include the user interface 2605 of the suturing device 2001A and the user interface 2705 of the external unit 2700 for control of the operation of the suturing device 2001A and / or the external unit 2700.
[0109] The external unit 2700, and in particular the energy source of the external unit 2700, can be used to supply electrical current to the first muscle wire 2027A and / or the second muscle wire 2027B via the cable 2602. In some embodiments, the external unit 2700 supplies electrical current to the muscle wires 2027A and / or 2027B via insulated conductor wires 2033A, 2033B coupled to the distal ends of the first muscle wire 2027A and the second muscle wire 2027B. Supplying electrical current to the muscle wires 2027A, 2027B controls the shortening or lengthening of the muscle wires 2027A, 2027B.
[0110] In some embodiments, the suturing device 2001A is not coupled to the external unit 2700 for purposes of providing electrical current. In such embodiments, the suturing device 2001A can include an internal energy source (not shown). The internal energy source can be located in the first handle 2002A or the second handle 2002B. In some embodiments, the internal energy source eliminates the need for one or more wires or cables extending from the suturing device 2001A. Operation and control of the internal energy source (e.g., through the user interface 2605 of the suturing device 2001A) is generally the same as that described for the external unit 2700. The external unit 2700 energy source and / or the internal energy source may be collectively referred to herein as the energy source.
[0111] 10A-10C, in some embodiments, the suturing device 2001A includes a force sensor 2804. The force sensor 2804 may be a force-sensing resistor, piezoelectric film, capacitive sensor, inductive sensor, Hall Effect sensor, etc. configured to measure the contact force of the handles 2002A, 2002B and / or one or more other characteristics associated with the contact force of the handles 2002A, 2002B. In some embodiments, the force sensor 2804 may be disposed on an inner surface 2806 of the first handle 2002A or the second handle 2002B. That is, the force sensor 2804 may be disposed on a surface of the first handle 2002A or the second handle 2002B such that it is sandwiched between the first handle 2002A and the second handle 2002B when the first handle 2002A and the second handle 2002B are closed or joined together. In some embodiments, the suturing device 2001A can include multiple force sensors disposed on both the first handle 2002A and the second handle 2002B. In some embodiments, the force sensor 2804 can be disposed rearward of the flexible contact surface 2802 on the inner surface 2806 of the first handle 2002A and / or the second handle 2002B. The force sensor 2804 can detect contact and closure force between the first handle 2002A and the second handle 2002B when the first handle 2002A and the second handle 2002B are closed. The force sensor 2804 can be electrically coupled to an energy source (e.g., the external unit 2700 or the internal energy source described above), for example, via one or more control units. In some embodiments, the force sensor 2804 can be coupled to the external unit 2700 via the cable 2602. When the force sensor 2804 detects and measures a force (ie, when the first handle 2002A and the second handle 2002B are closed), it can communicate an electrical signal or feedback to the controller.In response, the controller can control the energy source to supply or cut off electrical energy to the first muscle wire 2027A and supply or cut off electrical energy to the second muscle wire 2027B to move the needle between the jaws 2005, 2006, as described in more detail below.
[0112] In some embodiments, the force sensor 2804, the input 2604 of the user interface 2605, the input 2711 of the user interface 2705 (e.g., buttons 2604A-2604C), the output 2606 of the user interface 2605, the output 2713 of the user interface 2705, and the energy source (e.g., in the internal or external unit 2700) may each be coupled to one or more processors or controllers, such as a microprocessor of the user interface 2605, configured to process information from and control the operation of the force sensor 2804, the inputs 2604, 2711, the outputs 2606, 2713, and the energy source. The one or more processors or controllers of the suturing system may be configured to execute instructions encoded on at least one non-transitory computer-readable storage medium to perform any of the functions and methods described above or below.
[0113] In some embodiments, the suturing device 2001A can include one or more additional sensors, such as one or more image sensors (e.g., fiber optic visual sensors or cameras (including ultraviolet, infrared, and / or visible light sensors / cameras)), one or more temperature sensors, and / or one or more electrodes. The one or more additional sensors can be electrically coupled to, for example, the external unit 2700. The one or more additional sensors can be used to detect various tissues near the suturing device 2001A, such as nerves, veins, arteries, etc. The one or more additional sensors can be coupled to an energy source through and / or via specific cables or leads extending from the suturing device 2001A. In some embodiments, the one or more additional sensors can be electrically coupled to a processor of the suturing device 2001A to send and receive signals to and from the processor. In some embodiments, the one or more additional sensors can be electrically coupled to its own external processor. In some embodiments, operation of one or more of the inputs 2606, 2711 can control the operation of the one or more additional sensors. In some embodiments, operation of one or more of the outputs 2606, 2713 can indicate information regarding the operation of one or more sensors. For example, the one or more image sensors can be one or more of visible light sensors, infrared sensors, and ultraviolet sensors and can be used for image processing. In some embodiments, the one or more image sensors can be one or more ultrasound imaging probes that can be used for additional visualization.
[0114] While an embodiment in which the transport mechanism 2004 includes a first spring 2022A and a second spring 2022B has been described in detail, it should be understood that this is a non-limiting example. Instead of the springs 2022A, 2022B, the transport mechanism 2004 can include any desired potential energy member. As used herein, a potential energy member can generally refer to an element that stores energy based on a change in shape or position and can independently release energy and return to a low-energy shape or position without requiring an external stimulus to return the potential energy member to the low-energy shape or position. For example, the springs 2022A, 2022B can store energy when compressed. When the power supply to the muscle wires 2027A, 2027B is removed, the springs 2022A, 2022B can automatically transition to a low-energy position (e.g., a semi-compressed position) to advance the gripping members 2024A, 2024B. The transition to the low energy position is accomplished by the energy stored in the spring without the need for an additional external stimulus to apply energy to the spring. Potential energy members that can be used in the transfer mechanism include, for example, torsion springs, leaf springs, elastomers, and the like.
[0115] For example, referring to FIG. 7MM, another embodiment of suturing device 2001A is shown that includes elastomers 2019A and 2019B instead of springs 2022A and 2022B. Elastomers 2019A and 2019B can have similar mechanical connections (e.g., to gripping members 2024A and 2024B) as springs 2022A and 2022B described above. Mechanical elements such as 2023B can then hold and position elastomers 2019A and 2019B in jaws 2005 and 2006. When muscle wires 2027A and 2027B are energized, a proximal force is exerted on elastomers 2019A and 2019B, causing them to compress into a stressed shape. When the muscle wires 2027A, 2027B are de-energized, the elastomers 2019A, 2019B transition to an unstressed or low-stress state, allowing the gripping members 2024A, 2024B to advance distally. Similar to the springs 2022A, 2022B, the elastomers 2019A, 2019B may be maintained in a semi-compressed state by mechanical elements within the jaws 2005, 2006, so that when the muscle wires 2027A, 2027B are de-energized, the elastomers provide a continuous distal force to the gripping members 2024A, 2024B.
[0116] 7N, another embodiment of suturing device 2001A is shown that includes leaf springs 2017A and 2017B instead of springs 2022A and 2022B. Leaf springs 2017A and 2017B can have similar mechanical connections (e.g., to gripping members 2024A and 2024B) as springs 2022A and 2022B described above. Mechanical elements such as 2023B and retention features 2018AA, 2018AB, 2018BA, and 2018BB can then retain and position leaf springs 2017A and 2017B in jaws 2005 and 2006. When the muscle wires 2027A, 2027B are energized, a proximal force acts on the leaf springs 2017A, 2017B, causing them to bend or arch into a stressed shape. When the muscle wires 2027A, 2027B are de-energized, the leaf springs 2017A, 2017B transition to an unstressed or low-stress state, allowing the gripping members 2024A, 2024B to advance distally. Like springs 2022A, 2022B, leaf springs 2017A, 2017B may be maintained in a semi-stressed, or bent, state by mechanical elements in jaws 2005, 2006 so that when power is removed from muscle wires 2027A, 2027B, leaf springs 2017A, 2017B continuously exert a distal force on gripping members 2024A, 2024B.
[0117] To use the suturing device 2001A, a user must first load the needle 2201 into the suturing device 2001A. To load the needle 2201 into the suturing device 2001A, a user may first power on the suturing device 2001A and / or the external unit 2700 by manipulating (actuating) one or more of the inputs 2604 and / or 2711. In some embodiments, a user may power on the external unit 2700 and elements of the suturing device 2001A by manipulating the input 2711A of the user interface 2705. Once powered on, the indicator 2713A may change behavior (e.g., light up) to indicate that the system is powered on.
[0118] When the system is powered on, a user can select a load / unload mode using one or more of inputs 2604 and / or 2711. In some embodiments, a user can select the load / unload mode by actuating input 2711B of user interface 2705. In the load-unload mode, the force sensor 2804 is released and one or more of the needle transport buttons of inputs 2604, 2711 are actuable when handles 2002A, 2002B are open and no force is being applied to force sensor 2804. A user can open jaws 2005, 2006 by manipulating handles 2002A, 2002B. A user can load a needle 2201 into fixed jaw 2005 or movable jaw 2006. For illustrative purposes only, the following describes an example in which a needle 2201 is loaded into fixed jaw 2005. In some embodiments, needle 2201 can be loaded using loader 2347 (FIG. 8C). In some embodiments, needle 2201 can be loaded manually.
[0119] A user can check one or more of outputs 2606 and / or 2713 to determine the energized or de-energized state of muscle wires 2027A, 2027B. In some embodiments, when indicator 2606A is off, first muscle wire 2027A is energized, first muscle wire 2027A has its deformed length, and first gripping member 2024A is retracted. In some embodiments, when indicator 2606B is off, second muscle wire 2027B is energized, second muscle wire 2027B has its deformed length, and second gripping member 2024B is retracted. Needle 2201 can be positioned in either jaw 2005, 2006 with the respective gripping member 2024A, 2024B retracted. By way of example only, the following describes an embodiment in which needle 2201 is loaded into fixed jaw 2005. Once needle 2201 is positioned in first gripping slot 2103, a user can grasp needle 2201 in the first gripping slot of fixed jaw 2005 by manipulating one or more of inputs 2604, 2711 to de-energize first muscle wire 2027A. In some embodiments, a user can actuate input 2604A of user interface 2605 to de-energize first muscle wire 2027A. This causes first muscle wire 2027A to begin extending to its nominal length, removing the proximal force on first gripping member 2024A and causing first spring 2022A to transition and hold first gripping member 2024A through first gripping slot 2103 and into the receptacle (e.g., receptacles 2207A, 2207B) of needle 2201, retaining needle 2201 in first gripping slot 2103 of fixed jaw 2005. Indicators 2606A, 2606B change with operation of input 2604A. For example, indicator 2606A can change behavior (e.g., light on) to indicate that power has been removed from first muscle wire 2027A, while indicator 2606B can remain off (light off) to indicate that power is still being applied to second muscle wire 2027B.Once the needle 2201 is loaded and gripped, the suturing device 2001A may be removed from the loader 2347 (FIG. 8C), if used.
[0120] Once the needle 2201 is loaded, the suturing device 2001A is ready for use. In some embodiments, the transport mechanism 2004 of the suturing device 2001A can function in a semi-automatic mode. In the semi-automatic mode, a user can control the needle transport through an input (e.g., one or more of inputs 2604, 2711). In the semi-automatic mode, a user can only activate the needle transport mechanism 2004 when the handles 2002A, 2002B are fully closed. To prevent user error, the force sensor 2804 acts like a safety switch, preventing needle transport and alerting the user if the user attempts to activate the needle transport when the handles 2002A, 2002B are not fully closed.
[0121] To use the suturing device, a user can operate one or more of the inputs 2604, 2711 to place the transport mechanism 2004 in semi-automatic mode. In some embodiments, a user can actuate (operate) the input 2711B to enter the semi-automatic mode from the load-unload mode. Once the semi-automatic mode is initiated, the force sensor 2804 is enabled. If a threshold force is detected by the force sensor 2804, the processor can determine that the handles 2002A, 2002B are fully closed. If the threshold force is not detected by the force sensor 2804, the processor can determine that the handles 2002A, 2002B are not fully closed.
[0122] In some embodiments, the semi-automatic mode allows for needle transfer between the jaws 2005, 2006 to be controlled by use of a single input from the one or more inputs 2604, 2711. In some embodiments, this single input can be input 2604A. Such an embodiment may be referred to as a single-button semi-automatic mode. To suture tissue in the single-button semi-automatic mode, a user places target tissue between the open jaws 2005, 2006 and closes the jaws 2005, 2006 by closing the handles 2002A, 2002B, thereby causing the needle 2201 secured to the fixed jaw 2005 to enter the grasping slot 2104 of the movable jaw 2006. The user can then operate a single input from the one or more inputs 2604, 2711 to transfer the needle 2201 between the jaws 2005, 2006. In some embodiments, this single input may be input 2604A (sometimes referred to as a needle transfer button). In some embodiments, actuation of needle transfer button 2604A results in transfer of needle 2201 between jaws 2005, 2006 only if force sensor 2804 measures a force indicating that handles 2002A, 2002B are closed. If the force sensor measures a force indicating that handles 2002A, 2002B are not closed, or if no force is measured, the processor locks or disables needle transfer button 2604A so that actuation of needle transfer button 2604A by the user does not result in needle transfer between jaws 2005, 2006, and needle 2201 remains gripped by the jaws 2005, 2006 that was gripping it before the user actuated needle transfer button 2604A. When force sensor 2804 measures a force indicating that handles 2002A, 2002B are closed and needle transport button 2604A is actuated, power is applied to one muscle wire 2027A, 2027B and power is not applied to the other muscle wire 2027A, 2027B. For example, if needle 2201 is loaded into fixed jaw 2005, actuation of needle transport button 2604A disconnects second muscle wire 2027B, connected to second gripping member 2024B, from the energy source.Thus, the muscle wire 2027B does not apply a proximal force to the second gripping member 2024B, and the second spring 2022B holds the second gripping member 2024B through the second gripping slot 2104 and into the receptacle (e.g., receptacles 2207A, 2207B) of the needle 2201, thereby holding the needle 2201 in the second gripping slot 2104 of the movable jaw 2006. The energy source then supplies current to first muscle wire 2027A, shortening it to its deformed length and applying a proximal force (e.g., via first pull wire 2021A) to first gripping member 2024A, retracting first gripping member 2024A from the receptacle of needle 2201 and first gripping slot 2103, releasing needle 2201 from fixed jaw 2005. Thus, actuation of needle transfer button 2604A de-energizes second muscle wire 2027B and energizes first muscle wire 2027A, transferring needle 2201 from fixed jaw 2005 to movable jaw 2006.
[0123] The user then opens jaws 2005, 2006, moves suturing device 2001A to a new position, and closes jaws 2005, 2006, once again transferring needle 2201 between jaws 2005, 2006. That is, when force sensor 2804 detects that handles 2002A, 2002B are closed, needle transfer button 2604A is operated to stop power supply to first muscle wire 2027A and to apply power to second muscle wire 2027B, transferring needle 2201 from movable jaw 2006 to fixed jaw 2005. Each time the jaws 2005, 2006 are closed and the needle transfer button 2604A is operated, the muscle wires associated with the jaws 2005, 2006 (e.g., the first jaw) that were not holding the needle 2201 before the needle transfer button 2604A was operated are de-energized to grasp and hold the needle 2201 in the first jaw, and the muscle wires associated with the jaws 2005, 2006 (e.g., the second jaw) that were holding the needle 2201 before the needle transfer button 2604A was operated are energized to release the needle 2201 from the second jaw.
[0124] In some embodiments, in semi-automatic mode, needle transfer between jaws 2005, 2006 can be controlled through the use of more than one of one or more inputs 2604, 2711. In some embodiments, needle transfer between jaws 2005, 2006 can be controlled through the use of two separate inputs 2604 of user interface 2605. Such an embodiment may be referred to as a dual-button semi-automatic mode. For example, actuation of a first button (e.g., a first needle transfer button) of one or more inputs 2604 can apply power to first muscle wire 2027A and remove power from second muscle wire 2027B, and actuation of a second button (e.g., a second needle transfer button) of one or more inputs 2604 can remove power from first muscle wire 2027A and apply power to second muscle wire 2027B.
[0125] To suture tissue in the dual button semi-automatic mode, the user places the target tissue between the open jaws 2005, 2006 and closes the jaws 2005, 2006 by closing the handles 2002A, 2002B, thereby causing the needle 2201 secured to the fixed jaw 2005 to enter the grasping slot 2104 of the movable jaw 2006. The user can then operate the first needle advancement button to de-energize the second muscle wire 2027B connected to the second grasping member 2024B. Thus, the second muscle wire 2027B does not apply a proximal force to the second gripping member 2024B, and the second spring 2022B holds the second gripping member 2024B through the second gripping slot 2104 and into the receptacle (e.g., receptacles 2207A, 2207B) of the needle 2201, thereby holding the needle 2201 in the second gripping slot 2104 of the movable jaw 2006. A single actuation of the first needle transport button then energizes first muscle wire 2027A connected to first gripping member 2024A, shortening first muscle wire 2027A to its deformed length and applying a proximal force (e.g., via first pull wire 2021A) to first gripping member 2024A, retracting first gripping member 2024A from the receptacle of needle 2201 and first gripping slot 2103 and releasing needle 2201 from fixed jaw 2005. Thus, actuation of the first needle transport button transfers needle 2201 from fixed jaw 2005 to movable jaw 2006.
[0126] The user can then open jaws 2005, 2006, move suturing device 2001A to a new position, and close jaws 2005, 2006, again transferring needle 2201 between jaws 2005, 2006. That is, when force sensor 2804 detects that handles 2002A, 2002B have closed, the user can actuate second needle transport button to stop powering first muscle wire 2027A associated with fixed jaw 2005. Thus, the muscle wire 2027A does not apply a proximal force to the first gripping member 2024A, and the first spring 2022A pushes and holds the first gripping member 2024A through the first gripping slot 2103 and into the receptacle (e.g., receptacles 2207A, 2207B) of the needle 2201, holding the needle 2201 in the first gripping slot 2103 of the fixed jaw 2005. A single actuation of the second needle transport button then energizes the second muscle wire 2027B associated with the movable jaw 2006, shortening the second muscle wire 2027B to its deformed length and applying a proximal force (e.g., via the second pull wire 2021B) to the second gripping member 2024B, retracting the second gripping member 2024B from the receptacle of the needle 2201 and the second gripping slot 2104 and releasing the needle 2201 from the movable jaw 2006.
[0127] Each time the jaws 2005, 2006 are closed, the needle 2201 can be transferred between the jaws 2005, 2006 by actuation of the first or second needle transport button described above. As with the single button semi-automatic mode, the processor can lock or disable any actuation of the muscle wire 2027A, 2027B via the first and second needle transport buttons until the force sensor 2804 detects a force indicating that the handles 202A, 202B are closed.
[0128] It should be appreciated that in the single-button and dual-button semi-automatic modes, outputs 2606, 2713 can change throughout the suturing operation to indicate the current state of muscle wires 2027A, 2027B. For example, when first muscle wire 2027A is energized (and needle 2201 is not grasped by fixed jaw 2005), indicator 2606A can be off, and when first muscle wire 2027A is deenergized (and needle 2201 is grasped by fixed jaw 2005), indicator 2606A can be on. Similarly, when power is applied to the second muscle wire 2027B (and the needle 2201 is not gripped by the movable jaw 2006), the indicator 2606B can be off, and when power is removed from the second muscle wire 2027B (and the needle 2201 is gripped by the movable jaw 2006), the indicator 2606B can be on.
[0129] Once the needle 2201 is loaded, the suturing device 2001A is ready for use. In some embodiments, the transport mechanism 2004 of the suturing device 2001A can function in an automatic mode. In automatic mode, a user does not need to operate either of the inputs 2604, 2711 to operate the needle transport mechanism 2004 and transfer the needle 2201 between the jaws 2005, 2006. In automatic mode, the processor can automatically initiate needle transport based on the force measured by the force sensor 2804. In some embodiments, the force measured by the force sensor 2804 to initiate needle transport is a threshold force that indicates that the handles 2002A, 2002B are fully closed. In some embodiments, the force measured by the force sensor 2804 to initiate needle transport is a threshold force that is greater than the force that indicates that the handles 2002A, 2002B are fully closed. In other words, needle delivery may be initiated when the user closes the handles 2002A, 2002B and then applies additional force to the handles 2002A, 2002B to reach a needle delivery force threshold.
[0130] As described above, once the needle is loaded, to use the suturing device, the user can operate one or more of the inputs 2604, 2711 to place the transport mechanism 2004 in automatic mode. In some embodiments, the user can operate input 2711B to enter automatic mode from the load-unload mode. Once automatic mode is initiated, the force sensor 2804 is enabled. The user can use one or more of the inputs 2604, 2711 to set a threshold force that must be measured by the force sensor 2804 for needle transport to begin. In some embodiments, this threshold force can be set by operating input 2711C. The processor can be configured so that automatic mode needle transport occurs only if the threshold force set by the user is greater than the expected force required to close the handles 2002A, 2002B.
[0131] As described above, once automatic mode is initiated, the user can transfer the needle 2201 between the jaws 2005, 2006 without manipulating any of the inputs 2604, 2711. To suture tissue in automatic mode, the user places the target tissue between the open jaws 2005, 2006 and closes the jaws 2005, 2006 by closing the handles 2002A, 2002B, thereby closing the jaws 2005, 2006 so that the needle 2201, secured to the fixed jaw 2005, enters the grasping slot 2104 of the movable jaw 2006. In some embodiments, the user must apply additional force after the handles 2002A, 2002B are closed to reach a threshold force to initiate needle transfer. Once the threshold force is measured by the force sensor 2804, the processor can begin transferring the needle 2201 between the jaws 2005, 2006. In particular, the processor can operate the energy source to energize one muscle wire and not the other. More specifically, the energy source can operate to de-energize the muscle wires 2027A, 2027B associated with the jaws 2005, 2006 that were not holding the needle 2201 before the jaws 2005, 2006 were closed. Thus, in the present example where the needle 2201 is loaded into the fixed jaw 2005, once the threshold force is measured by the force sensor 2804, the second muscle wire 2027B connected to the second gripping member 2024B is disconnected from the energy source. Thus, muscle wire 2027B does not exert a proximal force on second gripping member 2024B, and second spring 2022B urges and holds second gripping member 2024B through second gripping slot 2104 and into a receptacle (e.g., receptacle 2207A, 2207B) of needle 2201, retaining needle 2201 in second gripping slot 2104 of movable jaw 2006. An energy source then supplies current to muscle wire 2027A, 2027B associated with jaw 2005, 2006 that was holding needle 2201 before handles 2002A, 2002B were closed.Thus, in this example, energizing first muscle wire 2027A shortens first muscle wire 2027A to its deformed length and applies a proximal force (e.g., via first pull wire 2021A) to first gripping member 2024A, retracting first gripping member 2024A from the receptacle of needle 2201 and first gripping slot 2103, releasing needle 2201 from fixed jaw 2005. Thus, applying a threshold force to handles 2002A, 2002B deenergizes second muscle wire 2027B and energizes first muscle wire 2027A, transferring needle 2201 from fixed jaw 2005 to movable jaw 2006.
[0132] The user can then open jaws 2005, 2006, move suturing device 2001A to a new position, and close jaws 2005, 2006, again transferring needle 2201 between jaws 2005, 2006. That is, when force sensor 2804 again measures the threshold force, the processor operates needle transport mechanism 2004 and the energy source to transfer needle 2201 from movable jaw 2006 to fixed jaw 2005 by de-energizing first muscle wire 2027A and energizing second muscle wire 2027B. Each time the jaws 2005, 2006 are closed (and thus the handles 2002A, 2002B are closed) and the force sensor 2804 measures a threshold force, de-energizing the muscle wires associated with the jaw 2005, 2006 (e.g., the first jaw) that was not holding the needle 2201 before the handles were closed will cause the needle 2201 to be grasped and held in the first jaw, and de-energizing the muscle wires associated with the jaw 2005, 2006 (e.g., the second jaw) that was holding the needle 2201 before the handles were closed will release the needle 2201 from the second jaw.
[0133] It should be appreciated that in automatic mode, outputs 2606, 2713 can change throughout the suturing operation to indicate the current state of muscle wires 2027A, 2027B. For example, when first muscle wire 2027A is energized (and needle 2201 is not gripped by fixed jaw 2005), indicator 2606A can be off, and when first muscle wire 2027A is deenergized (and needle 2201 is gripped by fixed jaw 2005), indicator 2606A can be on. Similarly, when second muscle wire 2027B is powered (and needle 2201 is not grasped by movable jaw 2006), indicator 2606B can be off, and when second muscle wire 2027B is de-powered (and needle 2201 is grasped by movable jaw 2006), indicator 2606B can be on. After each transfer of needle 2201 between jaws 2005, 2006, one or more of outputs 2606, 2713 can indicate successful completion of needle transfer. For example, one or more of outputs 2606, 2713 can produce an audio or visual signal indicating successful completion of needle transfer.
[0134] The automatic mode allows for one-handed operation of the suturing system: specifically, a user can control the relative movement of the arms and jaws of the suturing device 2001A and needle delivery by grasping the handles 2002A, 2002B with one hand and applying the required threshold force to initiate needle delivery.
[0135] After completing suturing in one of the above modes (automatic, single-button semi-automatic, or dual-button semi-automatic), the user can remove the needle 2201 from the suturing device 2001A. To do so, the user can enter a load-removal mode by manipulating one or more inputs 2604, 2711. In some embodiments, the user can exit a needle transfer mode (e.g., one of the automatic, single-button semi-automatic, or dual-button semi-automatic modes) and enter the load-removal mode by manipulating input 2711B. In the load-removal mode, the muscle wire enable (needle transfer) button 2604 can be activated when the force sensor 2804 is disengaged and the handles 2002A, 2002B are open. With the jaws 2005, 2006 open, the user can release the needle 2201 from the jaws 2005, 2006 in which it is held by manipulating one or more of the inputs 2604, 2711. In some embodiments, a user can operate input 2604A to release needle 2201 from jaws 2005, 2006 in which needle 2201 is held. In some embodiments, a user can operate input 2604A of user interface 2605 to de-energize muscle wires 2027A, 2027B associated with jaws 2005, 2006 in which needle 2201 is held, thereby releasing needle 2201 from jaws 2005, 2006. The user can then manually remove needle 2201 from suturing device 2001A. In some embodiments, using loader 2347 (FIG. 8C), suturing device 2001A is placed into loader 2347 with jaws 2005, 2006 open, and the user can then release and remove needle 2201 by activating needle transport mechanism 2004 as described above.
[0136] After the needle is removed, the user can power off the suturing device 2001A and / or the external unit 2700 by operating one or more of the inputs 2604, 2711. In some embodiments, the user can power off the external unit 2700 and elements of the suturing device 2001A by operating the input 2711A of the user interface 2705. When powered off, the indicator 2713A can change behavior (e.g., light off) to indicate that the system is powered off. It should be understood that the system is powered on during the needle transport and suturing operations described above (e.g., automatic mode, single button semi-automatic mode, dual button semi-automatic mode).
[0137] During use of the suturing device 2001A, one or more outputs 2606, 2713 can indicate to the user information regarding the operational status of the suturing device 2001A. For example, in some embodiments, the processor can control one or more of the outputs to indicate the mode in which the suturing device is operating (e.g., load-unload, single-button semi-automatic, dual-button semi-automatic, automatic). In some embodiments, the processor can control one or more of the outputs (e.g., indicator 2713A) to indicate whether the system is powered on or off. In some embodiments, the processor can control one or more of the outputs (e.g., indicators 2606A, 2606B) to indicate the energy state (e.g., powered or unpowered) of the first muscle wire 2027A and / or the second muscle wire 2027B. In some embodiments, the processor can control one or more of the outputs to indicate the force threshold set by the user on the force sensor for initiation of automatic needle transport. In some embodiments, the processor can control one or more of the outputs to indicate whether the force measured by the force sensor is above or below a set threshold, hi some embodiments, the processor can control one or more of the outputs to indicate error and alarm conditions such as low battery, not reaching a threshold force, etc.
[0138] 11A and 11B show one embodiment of a suturing device 2001A having an attachment member 2106A and an attachment member 2106B. In some embodiments, the attachment member 2106A or 2106B is pre-loaded with a needle 2201. As shown in FIG. 11A, the attachment member 2106A can be configured to be attached to a movable jaw 2006 configured to receive the attachment member 2106A. As shown in FIG. 11B, the attachment member 2106B can be configured to be attached to a fixed jaw 2005 configured to receive the attachment member 2106B. For example, instead of loading the needle 2201 into the second grasping slot 2104, the attachment member 2106A with the needle 2201 can be attached to the movable jaw 2006 of the suturing device 2001A. In another example, instead of loading needle 2201 into first grasping slot 2103, attachment member 2106B having needle 2201 can be attached to fixed jaw 2005 of suturing device 2001A. In some embodiments, at the end of a suturing procedure, attachment member 2106A or attachment member 2106B can be removed along with needle 2201, and another attachment member 2106A or attachment member 2106B having a replacement needle 2201 can be attached to fixed jaw 2005 or movable jaw 2006. In some embodiments, the operator can use the same needle 2201 to sew two or more sutures. For example, if the procedure requires it, the operator can repeatedly (sequentially) suture using the same needle 2201, which is referred to as a Z suture or a figure-of-eight suture.
[0139] 12A and 12B illustrate embodiments of the shape of a suturing device (e.g., suturing device 2001A or suturing device 2001B (FIGS. 13A and 13B)). These suturing devices can be of various sizes, shapes, and angles optimized based on the anatomy in which the suturing device will be used. The suturing devices can have sizes and angles optimized for positional precision to perform pelvic floor disorder repair in a safe, minimally invasive manner. The suturing devices can also have sizes and angles optimized for minimally invasive use in surgical sites that are deep, narrow, or invisible to the naked eye.
[0140] The size and angle of the device can be selected depending on the target tissue each device is designed to reach and the path each device must follow to reach the target tissue. For example, this path may contain obstacles such as hard and soft tissue. According to the size and angle, during a surgical procedure using the suturing device, the suturing device can be manipulated along the path to deliver the device to each target tissue in the least invasive manner. For example, the path may be within the pelvic cavity, which is very similar between patients and minimizes standard deviation. This allows for accurate calculations even when physical parameters (e.g., height, weight, etc.) vary between patients. The size and angle can be selected depending on the target tissue so that the outer contour of the fixed jaw 5 can be used for positional accuracy after the device is delivered to the target tissue.
[0141] Any of the suturing devices described herein can have a length that allows the handles (e.g., handles 2002A, 2002B, and handle 2306) to be positioned outside the cavity during operation of the suturing device, while the length defines the portion of the suturing device that can be positioned inside the cavity. For example, the suturing device can have a length and angle for a transvaginal approach or transvaginal surgery. For example, as shown in FIG. 12A , the fixed jaw 2005 is extendable at an angle 2550 relative to the fixed arm 2007 ranging from 0 to 165 degrees. In some embodiments, the fixed jaw 2005 is extendable at an angle 2550 relative to the fixed arm 2007 ranging from approximately 60 to 90 degrees. In some embodiments, the fixed jaw 2005 is extendable at an angle of approximately 77 degrees relative to the fixed arm 2007. In some embodiments, the fixed jaw 2005 is extendable at an angle of 77.2 degrees relative to the fixed arm 2007. Length 2205A can be measured from the tip of fixed jaw 2005 to fixed arm 2007. As shown in FIG. 12B, fixed arm 2007 can have a distal portion extending at an angle 2551A ranging from 0 to 90 degrees relative to the proximal portion. In some embodiments, fixed arm 2007 can have a distal portion extending at an angle 2551A ranging from approximately 10 to 20 degrees relative to the proximal portion. In some embodiments, fixed arm 2007 can have a distal portion extending at an angle of approximately 16 degrees relative to the proximal portion. In some embodiments, fixed arm 2007 can have a distal portion extending at an angle of 15.88 degrees relative to the proximal portion. Fixed jaw 2005 can be extendable at an angle 2551B ranging from 90 to 180 degrees relative to the fixed arm 2007. In some embodiments, the fixed jaw 2005 is extendable at an angle 2551B in the range of approximately 120-140 degrees relative to the fixed arm 2007. In some embodiments, the fixed jaw 2005 is extendable at an angle of 130 degrees relative to the fixed arm 2007. As shown in FIG. 12B, in some embodiments, the fixed arm 2007 can have multiple corners 2553, 2554. It will be understood that any sharp corners or edges of the devices described herein can instead have a smooth curvature.The fixed jaw 2005 and the fixed arm 2007 can have a length 2205B. It is contemplated that the suturing device can be improved by modifications of size, shape, and angle to optimize the suturing device for a particular cavity and surgery.
[0142] 13A and 13B illustrate one embodiment of suturing device 2001B. Suturing device 2001B is similar to suturing device 2001A described above and may operate similarly, except that its components have different angles, sizes, and shapes to optimize suturing device 2001B for the anatomical structure in which it will be used. It should be understood that suturing device 2001B differs from suturing device 2001A only in its size and angles, and that any of the embodiments described above or below (including variations in needle transport mechanisms, jaw movement, and / or handle design) may also be employed with suturing device 2001B. In some embodiments, suturing device 2001B can use attachment member 2106A or attachment member 2106B as described with reference to FIGS. 11A and 11B. For example, the mounting member 2106A can be configured to be attached to a movable jaw 2006 configured to receive the mounting member 2106A. In another example, the mounting member 2106B can be configured to be attached to a fixed jaw 2005 configured to receive the mounting member 2106B.
[0143] 16A-16D, another suturing device 2001C is shown. The suturing device 2001C includes a handle 2306 and a body 2302 extending distally from the handle 2306. The handle 2306 may be ergonomically designed for one-handed operation by a user. In some embodiments, the handle 2306 includes one or more inputs. The inputs may be buttons, knobs, switches, dials, etc. In some embodiments, the handle 2306 includes an input 2303. The input 2303 may be used to enter a load / unload mode in which the needle 2201 is released or grasped in both grasping slots of the jaws 2005A, 2006A. The input 2303 may be a button. In some embodiments, the handle 2306 includes an input 2304. The input 2304 may be used to actuate the linear movement of the movable jaw 2006A, as described separately below. Input 2304 may be a button. In some embodiments, handle 2306 includes input 2307. Input 2307 may be used to select which jaw 2005A, 2006A will grip or release needle 2201. Input 2307 may be a rotary switch. In some embodiments, handle 2306 includes one or more outputs. The outputs may generally indicate to the user which jaw 2005A, 2006A currently grips needle 2201. In some embodiments, handle 2306 includes output 2308A. Output 2308A may indicate the status of fixed jaw 2005A. In particular, output 2308A may indicate when the gripping mechanism in fixed jaw 2005A is active and therefore when needle 2201 is gripped by fixed jaw 2005A. In some embodiments, output 2308A may be an LED. In some embodiments, the handle 2306 includes an output 2308B. The output 2308B can indicate the status of the movable jaw 2006A. In particular, the output 2308B can indicate when the gripping mechanism in the movable jaw 2006A is active and thereby gripping the needle 2201 in the movable jaw 2006A. In some embodiments, the output 2308B can be an LED.In some embodiments, the handle 2306 includes a protrusion 2309 on its upper surface. The protrusion 2309 may provide a tactile gripping reference for the user, indicating where to place the thumb when using the suturing device 2001C. In some embodiments, a cable 2305 extends from the proximal end of the handle 2306. The cable 2305 may extend from the handle 2306 similarly to and function similarly to the cable 2602 (FIG. 8A) described above with respect to the suturing device 2001A. In some embodiments, the cable 2305 is electrically connected to an external unit similar to (including all of the functionality of) the external unit 2700 (FIG. 9A) described with respect to the suturing device 2001A. In some embodiments, a fiber optic wire 2310 extends from the proximal end of the handle 2306. In some embodiments, the fiber optic wire 2310 is optically connected to the same external unit as the cable 2305 or to a different external unit.
[0144] In some embodiments, body 2302 can be rigid. In some embodiments, body 2302 can be bendable at multiple points. In some embodiments, body 2302 can be flexibly deformed to multiple positions and can maintain a set shape in a first position until bent or deformed to a second position. Body 2302 can be configured to enter a cavity in a patient. Body 2302 is generally an elongated member that is easy to manipulate in the patient and can be inserted into the patient in a minimally invasive manner. The handle 2306 is generally configured to remain outside the patient's cavity during operation for user grasping and interaction via the inputs and outputs of the handle 2306. Figure 16D schematically illustrates the ergonomic shape of the handle 2306 for ease of grasping by the user.
[0145] 18A-18D, fixed jaw 2005A and movable jaw 2006A are shown in more detail. Fixed jaw 2005A and movable jaw 2006A can include gripping slots such as gripping slots 2103, 2104 (FIGS. 4A and 4B) described with reference to suturing device 2001A. In some embodiments, fixed jaw 2005A is coupled to fixed jaw body 2345. Fixed jaw body 2345 can be generally L-shaped. Fixed jaw 2005A can be disposed at the distal end of fixed jaw body 2345. In some embodiments, fixed jaw 2005A is unitary with fixed jaw body 2345. Fixed jaw body 2345 is coupled to the distal end of body 2302. In particular, the proximal end of fixed jaw body 2345 can be disposed at the distal end of body 2302. In some embodiments, the fixed jaw body 2345 is integral with the body 2302 .
[0146] In some embodiments, the fixed jaw body 2345 can include a linear guide 2337. In some embodiments, the linear guide 2337 can be positioned substantially perpendicular to the fixed jaw 2005A. The linear guide 2337 provides a track for linear movement of the movable jaw 2006A relative to the fixed jaw 2005A. In some embodiments, movable jaw 2006A is substantially parallel to fixed jaw 2005A, and jaws 2006A, 2005A do not rotate relative to one another as movable jaw 2006A moves. In some embodiments, movable jaw 2006A may move in a direction substantially perpendicular to fixed jaw 2005A within linear guide 2337. Figures 18A-18D generally illustrate the movement of movable jaw 2006A within linear guide 2337 relative to fixed jaw 2005A and the transfer of needle 2201E between jaws 2005A, 2006A.
[0147] 19A , a partial exploded view of fixed jaw body 2345, fixed jaw 2005A, and movable jaw 2006A is shown. In some embodiments, an actuator 2312A is disposed within fixed jaw 2005A. In some embodiments, actuator 2312A is extendable through a portion of fixed jaw body 2345. Actuator 2312A is generally configured to actuate gripping member 2316A of fixed jaw 2005A. In some embodiments, fixed jaw body 2345 includes a removable cover 2313 for inserting actuator 2312A into fixed jaw 2005A. In some embodiments, actuator 2312B is disposed within movable jaw 2006A. In some embodiments, actuator 2312B is extendable through a portion of fixed jaw body 2345. Actuator 2312B is generally configured to actuate gripping member 2316B of movable jaw 2006A. In some embodiments, the movable jaw 2006A includes a protrusion 2338. The protrusion 2338 is located on the proximal end of the movable jaw 2006A. The protrusion 2338 is sized and shaped to be received in a linear guide 2337 such that the protrusion 2338 of the movable jaw 2006A is coupled to the fixed jaw body 2345 and can slide within the linear guide 2337. The actuators 2312A, 2312B can each include a muscle wire and an elastomeric element therein, as described in more detail below. The actuators 2312A and 2312B are then included in a needle transport mechanism 2380 of the suturing device 2001C. The needle actuators 2312A and 2312B can also be independently referred to as needle transport mechanisms.
[0148] 19B, 20A, and 20B, actuators 2312A and 2312B will be described in more detail. FIG. 19B is an exploded view of actuator 2312A. FIG. 20A is a perspective view of fixed jaw body 2345, fixed jaw 2005A, and movable jaw 2006A. FIG. 20B is a cross-sectional view of fixed jaw body 2345, jaws 2005A, 2006A, and actuators 2312A, 2312B. Referring to actuator 2312A associated with fixed jaw 2005A, actuator 2312A includes muscle wire 2320A. Muscle wire 2320A may be similar in design and function to muscle wires 2027A, 2027B described above. In some embodiments, the proximal end of muscle wire 2320A is crimped to the distal end of insulated wire 2314A by ferrule 2324A. The insulated wire 2314A can prevent short circuits. In some embodiments, the insulated wire 2314A can extend through the fixed jaw body 2345 and the main wire 2333, which extends proximally through the body 2302. The insulated wire 2314A typically supplies electrical current to the muscle wire 2320A. In particular, the insulated wire 2314A can provide an electrical connection at the proximal end of the muscle wire 2320A. In some embodiments, an insulating sleeve 2323A is disposed on the outside of the ferrule 2324A. The insulating sleeve 2323A can be any suitable insulating material and can prevent short circuits. In some embodiments, the actuator 2312A includes an insulated wire 2314B. In some embodiments, the distal end of the muscle wire 2320A is crimped to the distal end of the insulated wire 2314B. The insulation of the insulated wire 2314B can prevent short circuits. In some embodiments, the insulated wire 2314B can extend through the fixed jaw body 2345 and the main wire 2333 that extends proximally through the body 2302. The insulated wire 2314B typically supplies electrical current to the muscle wire 2320A. In particular, the insulated wire 2314B can provide an electrical connection at the distal end of the muscle wire 2320A.In some embodiments, the proximal end of gripping member 2316A is crimped to the distal end of muscle wire 2320A and the distal end of insulated wire 2314B to form a mechanical bond therebetween, and in some embodiments, an insulating sleeve 2322A is disposed on the proximal end of gripping member 2316A to insulate gripping member 2316A from the distal electrical connection with muscle wire 2320A and insulated wire 2314B.
[0149] In some embodiments, the actuator 2312A can include an elastomeric member 2318A disposed around the proximal end of and coupled to the gripping member 2316A. The elastomeric member 2318A can be any natural or synthetic polymer having elasticity. As shown in FIG. 18B , when the muscle wire 2320A is at its nominal or extended length, the elastomeric member 2318A can be held in a semi-compressed state by one or more mechanical elements (e.g., 2317A, 2319A) of the actuator 2312A or the fixed jaw 2005A. When energized, the muscle wire 2320A transitions to a shortened or deformed length, applying a proximal force to the gripping member 2316A and retracting it from the gripping slot of the fixed jaw 2005A. The gripping member 2316A can also retract from a needle receptacle disposed in the gripping slot of the fixed jaw 2005A. As the gripping member 2316A retracts from the gripping slot of the fixed jaw 2005A, the elastomeric member 2318A can be fully compressed. In some embodiments, the actuator 2312A includes a washer 2317A disposed around the gripping member 2316A and at the distal end of the elastomeric member 2318A. The washer 2317A is movable with the gripping member 2316A, and as the gripping member 2316A retracts, the washer 2317A can also move proximally to assist in fully compressing the elastomeric member 2318A.
[0150] In some embodiments, actuator 2312A includes bushing 2319A. Gripping member 2316A, insulating sleeve 2322A, muscle wire 2320A, insulated wire 2314B, insulating sleeve 2323A, and / or ferrule 2324A are at least partially disposed in and / or can move at least partially through an annular recess in bushing 2319A. Bushing 2319A is aligned with and positioned proximally of elastomeric member 2318A to support elastomeric member 2318A and provide a surface against which elastomeric member 2318A can be fully compressed.
[0151] When power is removed, the muscle wire 2320A begins to transition to its nominal or extended length, thereby removing the proximal retraction force applied to the gripping member 2316A and the elastomeric member 2318A. When the proximal retraction force is removed, the elastomeric member 2318A transitions from a fully compressed state to a semi-compressed state, allowing the gripping member 2316A to move distally into the gripping slot of the fixed jaw 2005A and into the receptacle of a needle disposed in the gripping slot of the fixed jaw 2005A.
[0152] As with the other potential energy members described above, the elastomeric members 2318A, 2318B need not be directly or indirectly coupled to the gripping members 2316A, 2316B. The elastomeric members 2318A, 2318B can be alternatively arranged to allow the elastomeric members 2318A, 2318B to exert a force on the gripping members 2316A, 2316B and / or vice versa. For example, elastomer 2318A, gripping member 2316A, and mechanical elements 2317A, 2319A may each be sized such that a distal end of elastomeric member 2318A is maintained in contact with at least a portion of gripping member 2316A or another element in contact with gripping member 2316A (e.g., an element located between elastomeric member 2318A and gripping member 2316A, such as washer 2317A), allowing elastomeric member 2318A to apply a distal force to gripping member 2316A. Similarly, elastomeric member 2318A, gripping member 2316A, and mechanical elements 2317A, 2319A may each be sized such that a distal end of elastomeric member 2318A is maintained in contact with at least a portion of gripping member 2316A or another element in contact with gripping member 2316A (e.g., an element located between elastomeric member 2318A and gripping member 2316A), allowing gripping member 2316A to apply a proximal force to elastomeric member 2318A.
[0153] While actuator 2312A has been described in detail above, it should be understood that the same description also applies to actuator 2312B. For example, actuator 2312B can include gripping member 2316B, washer 2317B, elastomeric member 2318B, insulating sleeve 2322B, bushing 2319B, muscle wire 2320B, insulating sleeve 2323B, and ferrule 2324B, which can be similarly arranged and operate similarly to like-numbered and named elements for actuator 2312A. Actuator 2312B can further include insulated wire 2315A, similar to insulated wire 2314A described above. That is, the proximal end of muscle wire 2320B can be crimped to the distal end of insulated wire 2315A by ferrule 2324B, and insulated wire 2315A can extend through fixed jaw body 2345 and main wire 2333 extending proximally through body 2302. Insulated wire 2315A typically supplies electrical current to the proximal end of muscle wire 2320B. Actuator 2312B can further include insulated wire 2315B similar to insulated wire 2314B described above. That is, the distal end of insulated wire 2315B can be crimped to the distal end of muscle wire 2320B to provide an electrical connection at the distal end of muscle wire 2320B. Insulated wire 2315B can extend through fixed jaw body 2345 and main wire 2333 extending proximally through body 2302. Additionally, the default state of muscle wires 2320A, 2320B may be de-energized, so that muscle wires 2320A, 2320B may default to their respective nominal lengths, or extended lengths. Thus, in the default state, gripping members 2316A, 2316B are positioned distally by elastomeric members 2318A, 2318B into the gripping slots of jaws 2005A, 2006A and into the receptacle of the needle (if positioned in the gripping slot of jaws 2005A, 2006A).
[0154] 20B, 20C, 20D, 20E, and 20F, suturing device 2001C includes a drive mechanism 2350 for moving movable jaw 2006A relative to fixed jaw 2005A within linear guide 2337. Drive mechanism 2350 can include a muscle wire 2327 and a pull wire 2325. Muscle wire 2327 can function similarly to the muscle wires described above, shortening when electrical current is applied to muscle wire 2327 and lengthening when electrical current to muscle wire 2327 is removed. Muscle wire 2327 and pull wire 2325 can be crimped together by ferrule 2326. In some embodiments, ferrule 2326 has an insulating sleeve 2339 inserted therein. In some embodiments, ferrule 2326 is inserted into and coupled to movable jaw 2006A. In particular, in some embodiments, the ferrule 2326 is inserted into and coupled to the protrusion 2338 of the movable jaw 2006A. This coupling allows the movable jaw 2006A to move integrally with the ferrule 2326. In some embodiments, a muscle wire 2327 extends proximally through the fixed jaw body 2345 and the body 2302. The muscle wire 2327 can be connected to an energy source for providing electrical current to the muscle wire 2327. In some embodiments, a pull wire 2325 extends proximally through the fixed jaw body 2345 and the body 2302. In some embodiments, the pull wire 2325 extends within the handle 2306, and the proximal end of the pull wire 2325 can be coupled to the distal end of the elastomeric member 2335. The proximal end of the elastomeric member 2335 can be coupled to the interior 2336 of the handle 2306. In some embodiments, drive mechanism 2350 can include one or more mechanical features, such as mechanical feature 2328, mechanical feature 2329, and / or mechanical feature 2330. The mechanical features can provide guides for muscle wire 2327 and pull wire 2325. In some embodiments, mechanical feature 2328, muscle wire 2327, and pull wire 2325 form a pulley system.When a force is applied to the pulley system, such as by energizing the muscle wire 2327 or by transitioning (e.g., stretching or compressing) the elastomeric member 2335, the ferrule 2326 moves proximally or distally. As the ferrule 2326 moves proximally or distally, the permanent bond between the ferrule 2326 and the protrusion 2338 on the movable jaw 2006A causes the movable jaw 2006A to move distally (towards the fixed jaw 2005A) within the linear guide 2337, closing the jaws 2005A, 2006A, or proximally (away from the fixed jaw 2005A), opening the jaws 2005A, 2006A.
[0155] The default position of the movable jaw 2006A is fully open, due to the elastomeric member 2335 located at the proximal end of the pull wire 2325. To close the jaws 2005A, 2006A (i.e., move the movable jaw 2006A distally), current can be applied to the muscle wire 2327, causing it to transition from its nominal, extended length to its shortened, deformed length. This causes the muscle wire 2327 to move around the mechanical feature 2328, causing the distal end of the muscle wire 2327 to apply a distal pulling force to the ferrule 2326 (and therefore the protrusion 2338), moving the movable jaw 2006A distally along the linear guide 2337 toward the fixed jaw 2005A, as shown in FIG. 20C. The distal pulling force applied to the ferrule 2326 also applies a distal pulling force to the pull wire 2325 coupled to the ferrule 2326, which pulls the elastomeric member 2335 distally at its proximal end, causing the elastomer to transition to a stressed or stretched shape. To open the jaws 2005A, 2006A, the power to the muscle wire 2327 can be removed, thereby removing the distal pulling force on the ferrule 2326, pull wire 2325, and elastomeric member 2335. When the distal pulling force is removed, the elastomeric member 2335 can transition from a stressed shape to an unstressed or shortened shape, thereby applying a proximal pulling force to the pull wire 2325, which in turn can apply a proximal pulling force to the ferrule 2326 and movable jaw 2006A, which is coupled to the ferrule 2326 by the protrusion 2338. The proximal pulling force therefore causes the movable jaw 2006A to move proximally within the linear guide 2337, opening the jaws 2005A, 2006A, as shown in FIG. 20D .
[0156] It should be understood that in embodiments, muscle wire 2327 may be coupled directly or indirectly to movable jaw 2006A such that it can directly or indirectly apply a distal pulling force to movable jaw 2006A. Similarly, it should be understood that in embodiments, elastomeric member 2335 may be coupled directly or indirectly to movable jaw 2006A such that it can directly or indirectly apply a proximal pulling force to movable jaw 2006A.
[0157] It should be understood that in embodiments, muscle wire 2327 may be coupled directly or indirectly to movable jaw 2006A such that it can directly or indirectly apply a proximal pulling force to movable jaw 2006A. Similarly, it should be understood that in embodiments, elastomeric member 2335 may be coupled directly or indirectly to movable jaw 2006A such that it can directly or indirectly apply a distal force to movable jaw 2006A.
[0158] 20E, 20F, and 21, the electrical and mechanical connections of the suturing device 2001C are described in further detail. As mentioned above, the main wire 2333 can be a proximal continuation of the insulated wires 2314A, 2314B, 2315A, and 2315B, which can be bundled together as the main wire 2333. As mentioned above, the cable 2305 can extend from the proximal end of the handle 2306 and be coupled to an energy source and / or a control unit that provides user commands to control the operation of the suturing device 2001C. In some embodiments, the main wire 2333 and / or the cable 2305 can be coupled to an electrical circuit board 2334. In some embodiments, the muscle wire 2327 can be coupled to the electrical circuit board 2334. In some embodiments, the electrical circuit board 2334 is disposed within the handle 2306. In some embodiments, the electrical circuit board 2334 is disposed external to the handle 2306. The electrical circuit board 2334 can include the hardware and software components necessary to collect user commands from the inputs 2303, 2304, 2307, and / or one or more inputs external to the handle 2306 (e.g., on an external unit such as external unit 2700) and, based on these commands, selectively power the muscle wires 2320A, 2320B, 2327. The electrical circuit board 2334 can include the hardware and software components necessary to control the outputs 2308A and 2308B based on the operation of the suturing device 2001C.
[0159] The operation of suturing device 2001C will now be briefly described. Similar to the use of suturing device 2001A, with jaws 2005A, 2006A open, a user can load a needle, such as needle 2201E or any of the other needles described above, into one of jaws 2005A, 2006A, either manually or by use of loader 2347 (FIG. 8C). To load the needle, a user can enter a load-unload mode by manipulating an input, such as input 2303, which is designed to resist accidental activation, in which power is applied to both muscle wires 2320A and 2320B to apply a proximal force to gripping members 2316A and 2316B, retracting them from the gripping slots of jaws 2005A, 2006A. The needle 2201 can then be placed in the gripping slot of the desired jaw 2005A, 2006A. An example of loading the needle 2201 into the fixed jaw 2005A is described below. With the needle 2201 placed in the gripping slot of the fixed jaw 2005A, an input such as input 2307 can be operated to de-energize the muscle wire 2320A, thereby removing the proximal force on the gripping member 2316A and causing the elastomeric member 2318A to transition from a fully compressed state to a partially compressed state, thereby advancing the gripping member 2316A distally into the gripping slot of the fixed jaw 2005A and into the receptacle for the needle 2201, thereby retaining the needle in the fixed jaw 2005A.
[0160] Once the needle 2201 is loaded, the suturing device 2001C can be placed on the desired tissue to be sutured with the jaws 2005A, 2006A open. The user can then close the jaws 2005A, 2006A by advancing the movable jaw 2006A distally toward the fixed jaw 2005A within the linear guide 2337. More specifically, the user can move the movable jaw 2006A distally by manipulating an input, such as input 2304. Manipulation of input 2304 energizes the muscle wire 2327, applying a distal force to the ferrule 2326 and therefore the movable jaw 2006A, thereby moving the jaw 2006A distally. When the jaws 2005A, 2006A are closed, the needle 2201 can enter a grasping slot in the movable jaw 2006A. The user can then operate input 2307, which first de-energizes muscle wire 2320B, removing the proximal force on gripping member 2316B and causing elastomeric member 2318B to transition from a fully compressed state to a partially compressed state, advancing gripping member 2316B distally into the gripping slot of movable jaw 2006A and into the needle receptacle, thereby retaining the needle in movable jaw 2006A. Operation of input 2307 then energizes muscle wire 2320A, which then applies a proximal force to gripping member 2316A, retracting gripping member 2316A from the gripping slot of fixed jaw 2005A, thereby transferring the needle from fixed jaw 2005A to movable jaw 2006A. That is, by operating input unit 2307 once, it is possible to both stop the supply of power to muscle wire 2320B and supply power to muscle wire 2320A.
[0161] After needle delivery, jaws 2005A, 2006A can be opened by manipulating input 2304. Manipulation of input 2304 de-energizes muscle wire 2327, removing the distal force on movable jaw 2006A, transitioning elastomeric member 2335 to an unstressed / semi-stressed state, and a proximal force can be applied to pull wire 2325 and movable jaw 2006A to move movable jaw 2006A proximally, away from fixed jaw 2005A. Suturing device 2001C can then be moved to the desired tissue, and jaws 2005A, 2006A can be closed as described above. With the jaws 2005A, 2006A closed, the user can transfer the needle from the movable jaw 2006A to the fixed jaw 2005A in a manner similar to that described above for transferring the needle from the fixed jaw 2005A to the movable jaw 2006A. Once the suturing is complete, the user can again operate the input 2303 to enter the removal mode and release the needle from either jaw 2005A, 2006A by energizing both muscle wires 2320A, 2320B.
[0162] It should be appreciated that during use of the suturing device, the outputs 2308A and 2308B can change operation based on the energization or de-energization of the needle transport mechanism of the suturing device 2001C and / or the respective muscle wires in the drive mechanism 2350 of the suturing device 2001C.
[0163] While embodiments of suturing device 2001C have been described as including elastomeric member 2335, elastomeric member 2318A, and elastomeric member 2318B, it should be understood that any or all of the elastomeric members may be replaced with different types of potential energy members. For example, elastomeric member 2335, elastomeric member 2318A, and / or elastomeric member 2318B may be replaced by torsion springs or leaf springs. It should be understood that if different types of potential energy members are included, they may be positioned and mechanically connected similarly to elastomeric members 2335, 2318A, and 2318B.
[0164] It should be appreciated that the suturing device 2001C can include one or more internal (e.g., disposed within the handle 2306) or external processors that control the operation of the inputs and outputs of the suturing device 2001C, as well as the power supply to the muscle wires of the suturing device 2001C. In particular, the one or more processors are configured to execute instructions encoded on at least one non-transitory computer-readable storage medium, thereby causing the one or more processors to perform any or all of the functions and methods described above.
[0165] 27A, 27B, 28A, 28B, 28C, and 28D, a suturing device 2001E is shown. The suturing device 2001E may be generally similar to the suturing device 2001C, and therefore the same reference numbers are used to designate similar parts in both the suturing device 2001C and 2001E. The suturing device 2001E may include a fixed jaw 2005B, a movable jaw 2006B, and a fixed jaw body 2545. The suturing device 2001E differs from the suturing device 2001C in that the movable jaw 2006B is configured to pivot relative to the fixed jaw 2005B. In particular, the fixed jaw body 2545 may include a jaw joint 2100 about which the movable jaw 2006B pivots. 27A, 27B, 28A, 28B, 28C, and 28D, it should be understood that suturing device 2001E can include a needle transport mechanism similar to needle transport mechanism 2380 of suturing device 2001C. For example, fixed jaw 2005B can include actuator 2312A (FIGS. 19A-20B), and movable jaw 2006B can include actuator 2312B (FIGS. 19A-20B).
[0166] The suturing device 2001E includes a drive mechanism 2500 for moving the movable jaw 2006B about the jaw joint 2100 relative to the fixed jaw 2005B. The drive mechanism 2500 may include a muscle wire 2527 and a pull wire 2525. The muscle wire 2527 may function similarly to the muscle wire described above, shortening when an electric current is applied and lengthening when the electric current is removed. The muscle wire 2527 and the pull wire 2525 may be crimped together by a ferrule 2520. In some embodiments, the ferrule 2520 is inserted into and coupled to the movable jaw 2006B. In particular, in some embodiments, the ferrule 2520 is inserted into and coupled to a protrusion 2522 of the movable jaw 2006B located proximally of the jaw joint 2100. This coupling allows the movable jaw 2006B to move together with the ferrule 2520. In some embodiments, the muscle wire 2527 extends proximally through the fixed jaw body 2545 and the body 2302, similar to the muscle wire 2327 described above with respect to the suturing device 2001C. The muscle wire 2527 can be connected to an energy source for supplying electrical current to the muscle wire 2527. In some embodiments, the pull wire 2525 extends proximally through the fixed jaw body 2545 and the body 2302, similar to the pull wire 2325 described above with respect to the suturing device 2001C. In some embodiments, the pull wire 2525 extends within the handle 2306, and the proximal end of the pull wire 2525 can be coupled to the distal end of the elastomeric member 2535. The proximal end of the elastomeric member 2535 can be coupled to the interior 2536 of the handle 2306. In some embodiments, drive mechanism 2500 can include one or more mechanical features, such as mechanical feature 2501, mechanical feature 2502, mechanical feature 2503, and / or mechanical feature 2504. The mechanical features can provide guides for muscle wires 2527 and pull wires 2525. In some embodiments, the mechanical features, muscle wires 2527, and pull wires 2525 form a pulley system.When a force is applied to the pulley system, such as by energizing the muscle wire 2527 or by transitioning (e.g., stretching or compressing) the elastomeric member 2535, the ferrule 2520 moves laterally (e.g., substantially leftward or rightward relative to the jaw joint 2100, as shown in FIG. 28C ). Due to the permanent coupling between the ferrule 2520 and the protrusion 2522 on the movable jaw 2006B, rightward movement of the ferrule 2520 causes the movable jaw 2006B to pivot about the jaw joint 2100 away from the fixed jaw 2005B, opening the jaws 2005B, 2006B. Leftward movement of the ferrule 2520 causes the movable jaw 2006B to pivot about the jaw joint 2100 toward the fixed jaw 2005B, closing the jaws 2005B, 2006B. The default position of the movable jaw 2006B is the fully open position (shown in FIG. 28C ) because the elastomeric member 2535 is disposed at the proximal end of the pull wire 2525. To close the jaws 2005B, 2006B (i.e., to pivot the movable jaw 2006B toward the fixed jaw 2005B), current can be supplied to the muscle wire 2527 to transition the muscle wire 2527 from its nominal, extended length to its shortened, deformed length. This allows the muscle wire 2527 to move around the mechanical features 2503, 2504, causing the distal end of the muscle wire 2527 to apply a leftward pulling force to the ferrule 2520 (and thus the protrusion 2522), causing the movable jaw 2006B to pivot about the jaw joint 2100 toward the fixed jaw 2005B, as shown in FIG. 28B . The leftward pulling force applied to the ferrule 2520 also applies a leftward pulling force to the pull wire 2525, which is also coupled to the ferrule 2520, which pulls the elastomeric member 2535 distally at its proximal end, causing the elastomer 2535 to transition to a stressed or extended configuration. To open the jaws 2005B, 2006B, the leftward pulling force on the ferrule 2520, pull wire 2525, and elastomeric member 2535 can be removed by de-energizing the muscle wire 2527.When the leftward pulling force is removed, the elastomeric member 2535 transitions from its stressed shape to its unstressed or shortened shape and can apply a proximal pulling force to the pull wire 2525, which in turn applies a rightward pulling force to the ferrule 2520 and the movable jaw 2006B, which is coupled to the ferrule 2520 at the protrusion 2522. This rightward pulling force causes the movable jaw 2006B to pivot relative to the fixed jaw 2005B about the jaw joint 2100 away from the fixed jaw 2005B, as shown in FIG.
[0167] It should be understood that in embodiments, muscle wire 2527 may be coupled directly or indirectly to movable jaw 2006B such that it can directly or indirectly apply a leftward pulling force to movable jaw 2006B. Similarly, it should be understood that in embodiments, elastomeric member 2535 may be coupled directly or indirectly to movable jaw 2006B such that it can directly or indirectly apply a rightward pulling force to movable jaw 2006B.
[0168] It should be understood that in embodiments, muscle wire 2527 may be coupled directly or indirectly to movable jaw 2006B such that it can directly or indirectly apply a rightward pulling force to movable jaw 2006B. Similarly, it should be understood that in embodiments, elastomeric member 2535 may be coupled directly or indirectly to movable jaw 2006B such that it can directly or indirectly apply a leftward pulling force to movable jaw 2006B.
[0169] It should be understood that the operation of suturing device 2001E is generally the same as suturing device 2001C described above. While embodiments of suturing device 2001E have been described as including elastomeric member 2535, it should be understood that elastomeric member 2535 can be replaced with a different type of potential energy member. For example, elastomeric member 2535 can be replaced by a torsion spring or a leaf spring. It should be understood that if a different type of potential energy member is included, it can be positioned and mechanically connected in a similar manner to elastomeric member 2535.
[0170] It should be appreciated that the suturing device 2001E can include one or more internal (e.g., disposed within the handle 2306) or external processors that control the operation of the inputs and outputs of the suturing device 2001E, as well as the power supply to the muscle wires of the suturing device 2001E. In particular, the one or more processors are configured to execute instructions encoded on at least one non-transitory computer-readable storage medium, thereby causing the one or more processors to perform any or all of the functions and methods described above.
[0171] 20B, 21, and 22A-22C, embodiments of suturing device 2001C that include one or more image sensors, such as one or more fiber optic cameras 2311, are described below. In some embodiments, fiber optic camera 2311 can enable visualization of an otherwise unseen surgical site. Fiber optic camera 2311 generally includes one or more fiber optic wires 2310. Fiber optic wire 2310 can generally be configured to collect images or input data at its distal end and transmit these images to its proximal end. In some embodiments, fiber optic wire 2310 is disposed within guide or channel 2332. Guide 2332 can extend through fixed jaw body 2345. The distal end of guide 2332 can terminate in opening 2331 in fixed jaw body 2345, which is disposed between fixed jaw 2005A and movable jaw 2006A. Opening 2331 can accommodate the distal end of fiber optic wire 2310. An optical window 2340 may be disposed in the opening 2331. The optical window 2340 may be a suitable material, such as protective glass, and in some embodiments, may be an optical lens that provides a desired angle of view. In some embodiments, the optical window 2340 prevents contamination of the fiber optic wire 2310 with blood, tissue, etc., to maintain a clear view of the surgical site. In some embodiments, a wiper 2341 may be coupled to the surface of the movable jaw 2006A, protruding from the movable jaw 2006A toward the fixed jaw 2005A. The wiper 2341 may be configured to clean the optical window 2340 as the movable jaw 2006A moves toward and away from the fixed jaw 2005A. The wiper 2341 may be constructed of or coated with a biocompatible material. The fiber optic wire 2310 can extend through the guide 2332 in the fixed jaw body 2345, the body 2302, and the handle 2306 or portions thereof. The fiber optic wire 2310 can be coupled to one or more processors and / or one or more display devices for processing and displaying data or images collected from the fiber optic wire 2310.In particular, the one or more processors are configured to execute instructions encoded on at least one non-transitory computer-readable storage medium, which may cause the one or more processors to control the operation of the fiber optic camera 2311, collect and analyze data or images from the fiber optic wire 2310, and display the data or images. In particular, although not shown, it should be understood that the fiber optic camera 2311 may further include external units including sensors, processing units, light sources, and displays.
[0172] While the above describes an image sensor in the form of a fiber optic camera 2311, it should be understood that the fiber optic camera 2311 may be replaced with any suitable imaging device for imaging tissues such as muscles, veins, nerves, and arteries toward and around the jaws 2005A, 2006A. For example, in some embodiments, the image sensor may be replaced with a fiber optic infrared sensor / camera, a fiber optic visible light sensor / camera, a fiber optic ultraviolet sensor / camera, and / or an ultrasound probe to generate infrared images of the surgical site. In some embodiments, ultrasound images of the surgical site may be generated through the use of one or more ultrasound sensors / probes. In some embodiments, multiple sensors of each of the above types may be deployed in any combination.
[0173] While an image sensor in the form of a fiber optic camera 2311 has been specifically described in connection with suturing device 2001C, it should be understood that any of the suturing devices described herein may similarly include the image sensors described herein. For example, suturing devices 2001A, 2001B, and / or 2001E may include one or more image sensors, such as fiber optic camera 2311, in fixed jaw 2005 and / or fixed arm 2007 for imaging the surgical site.
[0174] 23A and 23B, in some embodiments, the suturing device 2001C can include one or more electric field sensors 2343. The electric field sensor 2343 can be incorporated into the fixed jaw 2005A. In some embodiments, the electric field sensor 2343 is detachable from the suturing device 2001C. In some embodiments, the electric field sensor 2343 is disposed at the distal end of the fixed jaw 2005A. The electric field sensor 2343 and one or more input and output cables for the electric field sensor 2343 can be disposed in or extend through a channel 2342 in the fixed jaw 2005A. The one or more input and output cables can extend proximally through the body 2302 and handle 2306 and be coupled to one or more processors and / or one or more display devices. In some embodiments, the one or more input and output cables can be coupled to the electrical circuit board 2334. The electric field sensor 2343 can sense and locate nerves at and around the surgical site. In some embodiments, the electric field sensor 2343 operates similarly to an electrocardiogram (ECG), electromyography (EMG), or electroencephalography (EEG), but has higher resolution. Placing the electric field sensor 2343 at the distal end of the fixed jaw 2005A, which is the palpation point of the suturing device 2001C, can distinguish between tissue to be sutured and tissue not to be sutured, improving utilization of the sensor 2343. The electric field sensor 2343 may be coupled to one or more processors and / or one or more display devices for processing and displaying data collected from the electric field sensor 2343. In particular, the one or more processors are configured to execute instructions encoded on at least one non-transitory computer-readable storage medium, thereby causing the one or more processors to control operation of the electric field sensor 2343, collect and analyze data from the electric field sensor 2343, and display the data collected from the electric field sensor 2343.
[0175] While electric field sensor 2343 has been specifically described in connection with suturing device 2001C, it should be understood that electric field sensor 2342 may similarly be included in any of the suturing devices described herein. For example, suturing device 2001A, suturing device 2001B, and / or suturing device 2001E may include electric field sensor 2343 in fixed jaw 2005 and / or fixed arm 2007 to collect data regarding the surgical site.
[0176] In some embodiments, the data (e.g., images) obtained from the fiber optic camera 2311 and the electric field sensor 2343 are processed by image processing algorithms to indicate correct suture placement in the target tissue, the location of nerves to avoid, excessive bleeding, and / or other features or conditions of interest. For example, through the use of machine learning algorithms, the processed images from the fiber optic camera 2311 and / or the electric field sensor 2343 may be displayed on a screen including graphics such as a green square that can indicate correct suture placement in the target tissue. Also, in some embodiments, the surgeon can select the target tissue of interest on the screen or in the data displayed in one or more user interfaces to lock onto and track the target tissue as the suturing device is moved through the surgical site. In some embodiments, various anatomical features or conditions identified in the data or images may be labeled with unique markers on the display screen. For example, nerves to avoid may be indicated by a yellow square and excessive bleeding may be indicated by a red square on the screen. As another example, each anatomical feature or condition may be indicated by any unique auditory and / or visual indicator. The one or more processors of the system are configured to execute instructions encoded on at least one non-transitory computer-readable storage medium, thereby causing the one or more processors to perform some or all of the image and data processing described above.
[0177] 24A and 24B, a foot pedal 2344 is shown. In some embodiments, the foot pedal 2344 can be connected to any of the suturing devices described above. For example, the foot pedal 2344 can be connected to the suturing device 2001A via cable 2602, or to the suturing device 2001C or 2001E via cable 2305. A user can provide one or more operational inputs to the suturing device via the foot pedal 2344. For example, operation of the foot pedal 2344 can control the power supply to any of the muscle wires described above and / or the operation of any of the muscle wires described above. The suturing device can include one or more processors, including one or more processors configured to execute instructions encoded on at least one non-transitory computer-readable storage medium, thereby causing the one or more processors to perform some or all of the functions and methods described above based on input from the foot pedal 2344.
[0178] 25 , in some embodiments, the suturing device can include one or more piezoelectric films 2346. The piezoelectric film 2346 can be incorporated into any of the suturing devices described herein. The piezoelectric film 2346 can be disposed on one or more surfaces of the fixed jaw 2005, 2005A and / or the movable jaw 2006, 2006A. The piezoelectric film 2346 can induce vibrations of a desired frequency, phase, and amplitude. One or more electrical connections can extend proximally from the piezoelectric film 2346 to an energy source and a controller that controls the operation of the piezoelectric film 2346 based on input or commands from a user. The vibrations applied to one or more jaws by the piezoelectric film 2346 can reduce the force required to pass the needle 2201 through tissue. Additionally, the vibrations applied to one or more jaws by the piezoelectric film 2346 can reduce stress between the needle 2201 and the tissue, resulting in less trauma to the tissue being sutured, which can result in a faster healing outcome. Additionally, vibrations applied to one or more jaws by the piezoelectric film 2346 may improve engagement of the needle 2201 between the jaws.
[0179] It should be understood that the needle transfer mechanisms contemplated herein are not limited to needle transfer mechanisms for transferring a needle between a pair of jaws, as described above. Rather, the needle transfer mechanisms herein may be designed for use in suturing devices having a single jaw or that do not include jaws. For example, the needle transfer mechanisms described herein may be designed and used to advance a needle from a first position to a second position, and may also be used to move the needle from the second position to the first position. Such movement may occur between or originate from any suitable hardware components based on the design of a given suturing device. Thus, the term "needle transfer mechanism" as used herein is not limited to a mechanism for transferring a needle between two separate hardware components (e.g., jaws). Rather, the term "needle transfer mechanism" as used herein may refer to any mechanism designed to move a needle from a first position to a second position, regardless of optional release and / or capture of the needle in various hardware components. Also, as used herein, "needle transport mechanism" may refer to any mechanism designed to apply a force to or engage with a needle. For example, actuator 2312A (FIG. 20A) itself may be described as a needle transport mechanism because actuator 2312A selectively moves gripping member 2316A (FIG. 20B) into engagement with needle 2201. As used herein, "needle transport mechanism" may refer to any mechanism that moves a needle. As used herein, "needle transport mechanism" may refer to any mechanism that includes one or more moving parts that act on a needle.
[0180] 26A and 26B, a distal end 2402 of a suturing device 2001D is shown. The distal end 2402 can include a needle holding member 2403. The needle holding member 2403 can include a port 2405. The suturing device 2001D can include a needle 2404 and a needle transport mechanism 2406. The port 2405 can be an opening that receives the needle 2402, through which the needle 2404 can move. The needle transport mechanism 2406 is shown schematically but generally includes a muscle wire 2408, similar to the muscle wires described above, and a potential energy member 2410. The muscle wire 2408 can be directly or indirectly coupled to the needle 2404 such that a force can be applied to the needle 2404. In some embodiments, the muscle wire 2408 applies a proximal pulling force to the needle 2404. The potential energy member 2410 may be directly or indirectly coupled to or otherwise positioned relative to the needle 2404 such that it can apply a force to the needle 2404. In some embodiments, the potential energy member 2410 applies a distal force to the needle 2404. The potential energy member 2410 may be a torsion spring, a leaf spring, an elastomer, or the like. The muscle wire 2408 may be connected to an energy source and, when energized, shortens to apply a proximal pulling force to the needle 2404, moving and holding the needle 2404 to the first position shown in FIG. 26B . In the first position, the needle 2404 may be substantially or completely retracted in the distal end 2402 and needle holding member 2403 of the suturing device 2001D. Moving the needle 2404 to the first position and / or energizing and shortening the muscle wire 2408 applies a force to the potential energy member 2410, causing it to transition to a loaded configuration (e.g., a compressed spring). When the muscle wire 2408 is de-energized, it begins to transition back to its nominal or extended length, eliminating the proximal pulling force.Thus, the potential energy member 2410 changes and transitions to a relaxed shape (e.g., a semi-compressed state of a spring) and applies a distal force to the needle 2404, moving the needle 2404 to the second position shown in FIG. 26A. In the second position, the needle 2404 can extend a greater distance from the distal end 2402 of the suturing device 2001D, and particularly from the port 2405 of the needle holding member 2403, than in the first position. Depending on the design of the needle 2404 and the suturing device 2001D, the needle 2404 can move linearly and / or rotationally between the first and second positions. In both the first and second positions, the needle 2404 can be coupled to or retained by the distal end 2402 of the suturing device 2001D.
[0181] The embodiments shown in Figures 26A and 26B can be modified to transfer a needle from a first position on the suturing device to a second position on the suturing device. For example, Figure 26C shows an embodiment of a suturing device 2001D that includes the same transfer mechanism 2406 described and shown in Figures 26A and 26B. In the embodiment shown in Figure 26C, the suturing device 2001D includes a first port 2435 disposed on the first needle retaining member 2403 and a second port 2436 disposed on the second needle retaining member 2407, and the needle 2404 is movable from the first port 2435 of the suturing device 2001D to the second port 2436 of the suturing device 2001D. In other words, the needle 2404 can be transferred between the ports 2435, 2436 by the muscle wire 2408 and the potential energy member 2410. In some embodiments, first needle holding member 2403 and second needle holding member 2407 can be fixed relative to one another. In some embodiments, ports 2435, 2436 can be located in the jaws of suturing device 2001D. In some embodiments, ports 2435, 2436 can be located in the jaws of suturing device 2001D, but are fixed relative to one another because they are non-movable. It should be understood that in some embodiments, similar to those described above, muscle wire 2408 ( FIG. 26B ) and potential energy member 2410 ( FIG. 26B ) can be arranged to apply a force to needle 2404 directly or indirectly. For example, muscle wire 2408 ( FIG. 26B ) and potential energy member 2410 ( FIG. 26B ) can be arranged to apply a force to needle 2404 indirectly, such as via a needle carrier (not shown) coupled to needle 2404.
[0182] It should be understood that the features of any of the above-described embodiments of suturing devices and suturing systems may be combined in any desired manner. For example, any of the above-described embodiments of suturing devices may include a muscle wire as an actuator for the needle transport mechanism. Any of the above-described embodiments of suturing devices may include a muscle wire as an actuator for the jaw movement. Any of the above-described embodiments of suturing devices may include a fiber optic camera. Any of the above-described embodiments of suturing devices may include an electric field sensor. Any of the above-described embodiments of suturing devices may also include a piezoelectric film. Any of the above-described embodiments of suturing devices may also include any combination of a muscle wire as an actuator for the needle transport mechanism, a muscle wire as an actuator for the jaw movement, a fiber optic camera, an electric field sensor, and / or a piezoelectric film. It should be understood that a muscle wire as an actuator for the needle transport mechanism, a muscle wire as an actuator for the jaw movement, a fiber optic camera, an electric field sensor, and / or a piezoelectric film (alone or together in any combination) may be incorporated into a suturing device including a needle transport mechanism similar to that described in PCT Application No. PCT / TR2022 / 050959. It should be understood that muscle wire as an actuator for the needle transport mechanism, muscle wire as an actuator for jaw movement, fiber optic cameras, electric field sensors, and / or piezoelectric film (alone or together in any combination) can be incorporated into suturing devices that include a needle transport mechanism that does not transport the needle between two jaws, such as suturing device 2001D. It should be understood that muscle wire as an actuator for the needle transport mechanism, muscle wire as an actuator for jaw movement, fiber optic cameras, electric field sensors, and / or piezoelectric film (alone or together in any combination) can be incorporated into suturing devices such as those disclosed in U.S. Patent No. 7,048,749, U.S. Patent No. 6,475,135, U.S. Patent No. 11,369,365, U.S. Patent No. 8,034,060, and U.S. Patent No. 8,545,521.
[0183] FIG. 14A is a flowchart of a method 2900 of using suturing device 2001A or 2001B. In step 2902, method 2900 may include providing suturing device 2001A or 2001B. It is contemplated that method 2900 may be performed by any embodiment of a suturing device described herein. The shape of the suturing device and the angle between the jaws and arms may be optimized for a particular procedure or tissue. For example, the angle may be optimized for safety reasons to avoid injury to other tissue, such as the bladder. An operator may select suturing device 2001A or suturing device 2001B based on the procedure site to be sutured. For example, an operator may select a suturing device from among multiple suturing devices based on the tissue to be sutured.
[0184] At step 2904 of method 2900, a user can load needle 2201 into suturing device 2001A. In some embodiments, as described above, a user can selectively enter a load-unload mode, for example, by actuating input 2711B, and actuate first muscle wire 2027A or second muscle wire 2027B via one or more inputs (e.g., button 2604A) to load needle 2201 into suturing device 2001A. In some embodiments, a user can connect attachment member 2106A or attachment member 2106B, which is pre-loaded with needle 2201, to suturing device 2001A. Needle 2201 can be loaded into first gripping slot 2103 of fixed jaw 2005 or second gripping slot 2104 of movable jaw 2006. For example, to hold needle 2201 in first gripping slot 2103 of fixed jaw 2005, first muscle wire 2027A is not energized with current so that first gripping member 2024A is held in a receptacle (e.g., receptacle 2207A) of needle 2201.
[0185] In step 2906 of method 2900, a user may move suturing device 2001A into a cavity of a patient. In some embodiments, the cavity may be the vaginal cavity. In some embodiments, the cavity is the pelvic cavity. In some embodiments, a user may move suturing device 2001A into the cavity with movable jaw 2006 of suturing device 2001A closed against fixed jaw 2005 of suturing device 2001A.
[0186] In step 2908 of method 2900, a user can open movable jaw 2006 by opening movable arm 2008 relative to fixed arm 2007 until tissue within the cavity is between fixed jaw 2005 and movable jaw 2006. After opening movable jaw 2006, a user can position fixed jaw 2005 on the tissue to be sutured. It should be appreciated that handles 2002A and 2002B of suturing device 2001A can remain extracavitary during manipulation to facilitate user manipulation of handles 2002A, 2002B. Movement (operation) of movable arm 2008 within the cavity can cause movable jaw 2006 to pivot about jaw joint 2100 within the cavity. The movable arm 2008 can move the movable jaw 2006 while the fixed jaw 2005 and fixed arm 2007 can remain in the same position, allowing the user to predict the location where the needle 2201 will suture, making it possible to more safely suture tissue that is difficult or impossible to see.
[0187] In step 2910 of method 2900, a user can pass the needle 2201 through tissue by closing the movable jaw 2006. While the movable jaw 2006 moves, the fixed jaw 2005 can provide a fixed reference so that tissue within the cavity to be sutured can be positioned between the fixed jaw 2005 and the movable jaw 2006. Moving the movable jaw 2006 relative to the fixed jaw 2005 causes the needle 2201 to pass (penetrate) the tissue. Even if the location where the suture is required is in a narrow, deep area and difficult or impossible for the operator to visualize, the predictable and accurate movement of the movable jaw 2006 while the fixed jaw 2005 remains stationary relative to the target tissue allows the needle 2201 to suture at the desired location. A user can close the movable jaw 2006 against the fixed jaw 2005 by closing the movable arm 2008 against the fixed arm 2007.
[0188] In step 2912 of method 2900, a user can actuate needle transport mechanism 2004 to transfer needle 2201 from fixed jaw 2005 to movable jaw 2006 and transfer the suture. A user can operate needle transport mechanism 2004 according to any of the modes of operation described above.
[0189] 14B, the suturing device is shown performing the substeps of step 2912 of method 2900. Operation of needle transport mechanism 2004 is shown in a single-button semi-automatic mode. At step 2914, a user may actuate an input (e.g., button 2604A). Actuation of button 2604A selectively energizes or de-energizes muscle wire 2027A, 2027B based on which jaw 2005, 2006 holds needle 2201 prior to actuation of button 2604A. In this example, a single operation of the input unit first de-energizes second muscle wire 2027B, stretching second muscle wire 2027B and causing second spring 2022B to transition to a semi-compressed state, causing second gripping member 2024B to extend into second gripping slot 2104 of movable jaw 2006 and push into receptacle 2207B of needle 2201. Needle 2201 is then gripped and held in second gripping slot 2104. A single actuation of the input then energizes first muscle wire 2027A, which is coupled to first pull wire 2021A and first gripping member 2024A in fixed jaw 2005, shortening first muscle wire 2027A and applying a proximal pulling force to first pull wire 2021A and first gripping member 2024A. This force retracts first gripping member 2024A from receptacle 2207A of needle 2201, releasing needle 2201 from first gripping slot 2103 of fixed jaw 2005.
[0190] 14C, the suturing device is shown performing the substeps of step 2912 of method 2900. Operation of needle transport mechanism 2004 in a dual-button semi-automatic mode is shown. In step 2916, a user can actuate one of multiple inputs 2604. Specifically, with needle 2201 initially grasped in fixed jaw 2005, the user selects the input to transfer needle 2201 from fixed jaw 2005 to movable jaw 2006. Actuating the input once first de-energizes second muscle wire 2027B, stretching second muscle wire 2027B and transitioning second spring 2022B to a semi-compressed state, causing second gripping member 2024B to extend (enter) second gripping slot 2104 of movable jaw 2006 and press into receptacle 2207B of needle 2201. The needle 2201 is then grasped and held in the second grasping slot 2104. A single actuation of the input then energizes the first muscle wire 2027A coupled to the first pull wire 2021A and the first grasping member 2024A in the fixed jaw 2005, shortening the first muscle wire 2027A and applying a proximal pulling force to the first pull wire 2021A and the first grasping member 2024A. This force retracts the first grasping member 2024A from the receptacle 2207A of the needle 2201 and releases the needle 2201 from the first grasping slot 2103 of the fixed jaw 2005.
[0191] 14D, the suturing device is shown performing the substeps of step 2912 of method 2900. Operation of needle transport mechanism 2004 in automatic mode is shown. In step 2918, with the handles 2002A, 2002B closed, the user can apply additional force to the handles 2002A, 2002B until the force sensor 2804 measures a threshold force, which selectively applies or removes power from the muscle wire 2027A, 2027B based on which jaw 2005, 2006 the needle 2201 was held in before the threshold force was applied. In this example, upon measuring the threshold force, power to second muscle wire 2027B is stopped, causing second muscle wire 2027B to elongate, transitioning second spring 2022B to a semi-compressed state, and second gripping member 2024B to extend into second gripping slot 2104 of movable jaw 2006 and push into receptacle 2207B of needle 2201, which then grasps and holds needle 2201 in second gripping slot 2104. Power is then applied to first muscle wire 2027A, which is coupled to first pull wire 2021A and first gripping member 2024A in fixed jaw 2005, shortening first muscle wire 2027A and applying a proximal pulling force to first pull wire 2021A and first gripping member 2024A. This force retracts the first gripping member 2024A from the receptacle 2207A of the needle 2201 and releases the needle 2201 from the first gripping slot 2103 of the fixed jaw 2005.
[0192] 14A , steps 2908, 2910, and 2912 of method 2900 may be repeated sequentially as many times as desired. For example, following step 2912 described above, jaws 2005, 2006 of suturing device 2001A may be opened, moved to a second position, and closed, and a user may actuate needle transport mechanism 2004, via actuation steps similar to those described with respect to step 2912, to release needle 2201 from gripping slot 2104 of movable jaw 2006 and to grasp and retain needle 2201 in the gripping slot of fixed jaw 2005.
[0193] 14E, a flowchart of a method 2920 of using the suturing device 2001C or 2001E is shown. In step 2922, the method 2920 may include providing a suturing device. It is contemplated that the method 2920 may be performed with any embodiment of the suturing device 2001C or 2001E described herein. The shape of the suturing device 2001C or 2001E may be optimized for a particular procedure or anatomy. For example, the angle of the body 2302 and / or the angle of the jaws 2005A, 2006A or 2005B, 2006B relative to the body 2302 may be optimized for safety reasons to avoid injury to other tissue, such as the bladder.
[0194] In step 2924, the user can load needle 2201 into suturing device 2001C or suturing device 2001E. In some embodiments, as described above, the user can selectively enter a load-unload mode, for example, by operating input 2303, and load needle 2201 into suturing device 2001C or 2001E by applying power to muscle wire 2320A and / or muscle wire 2320B. In some embodiments, the user can connect attachment member 2106A or attachment member 2106B, with needle 2201 pre-loaded, to suturing device 2001C or suturing device 2001E. Needle 2201 can be loaded into the gripping slot of fixed jaw 2005A, 2005B or the gripping slot of movable jaw 2006A, 2006B. For example, no current is supplied to muscle wire 2320A so that gripping member 2316A is held in a receptacle (eg, receptacle 2207A) on needle 2201 to hold needle 2201 in the gripping slots of fixed jaws 2005A, 2005B.
[0195] In step 2926 of method 2920, a user may move suturing device 2001C or suturing device 2001E into a cavity of a patient. In some embodiments, the cavity may be the vaginal cavity. In some embodiments, the cavity is the pelvic cavity. In some embodiments, a user may move suturing device 2001C into the cavity with movable jaw 2006A of suturing device 2001C closed against fixed jaw 2005A of suturing device 2001C. In some embodiments, a user may move suturing device 2001E into the cavity with movable jaw 2006B of suturing device 2001E closed against fixed jaw 2005B of suturing device 2001E.
[0196] In step 2928 of method 2920, a user can open movable jaws 2006A, 2006B until tissue within the cavity is between fixed jaws 2005A, 2005B and movable jaws 2006A, 2006B. More specifically, with reference to suturing device 2001C, a user can manipulate an input, such as input 2304, to de-energize muscle wire 2327 and move movable jaw 2006A proximally, i.e., away from fixed jaw 2005A. With reference to suturing device 2001E, a user can manipulate an input, such as input 2304, to de-energize muscle wire 2327 and rotate movable jaw 2006B away from fixed jaw 2005B. After opening the movable jaws 2006A, 2006B, the user can position the fixed jaws 2005A, 2005B on the tissue to be sutured. It should be appreciated that the handle 2306 of the suturing device 2001C or suturing device 2001E can remain extraluminal during manipulation to facilitate user manipulation of the suturing device 2001C or suturing device 2001E. Because the movable jaw 2006A moves linearly within the linear guide 2337 and the fixed jaw 2005A remains stationary, the user can predict where the needle 2201 will suture, allowing for safer suturing of tissue that is difficult or impossible to visualize. Similarly, because the movable jaw 2006B rotates relative to the jaw joint 2100 and the fixed jaw 2005B remains stationary, the user can predict where the needle 2201 will suture, allowing for safer suturing of tissue that is difficult or impossible to visualize.
[0197] In step 2930 of method 2920, a user can close movable jaws 2006A, 2006B and pass needle 2201 through tissue. In particular, with respect to suturing device 2001C, a user can manipulate an input, such as input 2304, to energize muscle wire 2327 to move movable jaw 2006A distally along linear guide 2337 toward fixed jaw 2005A. With respect to suturing device 2001E, a user can manipulate an input, such as input 2304, to energize muscle wire 2327 to pivot movable jaw 2006B toward fixed jaw 2005B. While the movable jaws 2006A, 2006B move, the fixed jaws 2005A, 2005B can provide a fixed reference so that the tissue within the cavity to be sutured can be positioned between the fixed jaws 2005A, 2005B and the movable jaws 2006A, 2006B. By moving the movable jaws 2006A, 2006B relative to the fixed jaws 2005A, 2005B, the needle 2201 passes through the tissue. Even if the location to be sutured is in a narrow, deep area and is difficult or impossible for the operator to visualize, the movement of the movable jaws 2006A, 2006B can be tracked and rotated precisely along the linear guide 2337 or about the jaw joint 2100 while keeping the fixed jaws 2005A, 2005B stationary relative to the target tissue, allowing the needle 2201 to suture at the desired location.
[0198] In step 2932 of method 2920, a user can actuate a needle transport mechanism to transport needle 2201 from fixed jaws 2005A, 2005B to movable jaws 2006A, 2006B to transfer the suture. In particular, a user can actuate an input (e.g., input 2307) to transport needle 2201. A single actuation of the input first removes power from muscle wire 2302B, stretches muscle wire 2320B, transitions elastomeric member 2318B to a semi-compressed state, and extends gripping member 2316B into the gripping slot of movable jaws 2006A, 2006B and pushes it into receptacle 2207B of needle 2201. The gripping slot of movable jaws 2006A, 2006B then grasps and retains needle 2201. A single actuation of the input then energizes muscle wire 2320A coupled to gripping member 2316A in fixed jaws 2005A, 2005B, causing muscle wire 2320A to shorten and exert a proximal pulling force on gripping member 2316A, which retracts gripping member 2316A from receptacle 2207A of needle 2201 and releases needle 2201 from the gripping slot of fixed jaws 2005A, 2005B.
[0199] Steps 2928, 2930, and 2932 of method 2920 may be repeated sequentially as many times as desired. For example, following step 1612 described above, jaws 2005A, 2006A of suturing device 2001C or jaws 2005B, 2006B of suturing device 2001E may be opened, moved to a second position, and closed, and a user may actuate the needle transport mechanism, via actuation steps similar to those described with respect to step 2932, to release needle 2201 from the gripping slot of movable jaw 2006A, 2006B, and to grasp and retain needle 2201 in the gripping slot of fixed jaw 2005A, 2005B.
[0200] Suturing devices 2001A, 2001B, and 2001C will now be generally described. These suturing devices may be used to treat pelvic floor disorders, such as those for treating SUI and POP. For example, the suturing devices may be angled for transvaginal approaches or transvaginal procedures. In another example, the suturing devices may be minimally invasive surgical devices for female vaginal wall or uterine prolapse. The suturing devices may include a variety of sizes, shapes, and angles, which are calculated and optimized based on the pelvic anatomy in which the suturing device will be used. The optimal size and shape allows the suturing device to safely access the target tissue for the procedure specified for each device. The angled design of the suturing device allows the tip of the device to reach the target pelvic structure to be sutured transvaginally. The angled design and size also prevent unintended contact with other tissue. These suturing device shapes improve performance, prevent unintended tissue damage, and allow for safe and easy access to the target tissue. The suturing device may be minimally invasive, disposable or non-disposable, sterile, single use or multi-use.
[0201] The suturing device may be a transvaginal device that places sutures in tissue at a surgical site during female pelvic floor surgery (e.g., for the treatment of stress urinary incontinence or pelvic organ prolapse, in which pelvic organs such as the bladder, rectum, and uterus protrude beyond the vaginal opening into the vagina). The suturing device may also be a transvaginal device used through a single incision, which may be advantageous over transabdominal and multiple incisions. The suturing device may also be used to consistently place sutures in difficult-to-access locations, such as narrow, non-visible locations. The suturing device may also be a single-step suturing device with an operating mechanism that allows a needle to be safely captured in opposing jaws.
[0202] The suturing device can suture specific tissue to the vesicovaginal fascia at the level of the bladder neck to elevate the bladder outlet to its normal position. The suturing device can be ergonomically shaped to perform native vaginal tissue repair procedures for stress urinary incontinence. The suturing device can be designed to facilitate consistent suture placement in difficult-to-access (narrow, non-visible) locations for surgical treatment of female stress urinary incontinence. The suturing device can be designed for restoration of anterior vaginal support or transvaginal bladder neck augmentation. The suturing device can also be used in common suturing applications that are difficult to access during gynecological urological surgery, including, but not limited to, stress urinary incontinence procedures, to assist in the placement of sutures at surgical sites.
[0203] These suturing devices allow an operator to perform transvaginal procedures (e.g., transvaginal procedures as opposed to transabdominal procedures) in a minimally invasive manner (e.g., only a single vaginal incision). The suturing devices may be used for native tissue repair through a single vaginal incision by suturing the vaginal wall to the pelvic floor support structures (thereby assisting in the placement of ligamentous sutures to the pelvic floor support structures). The suturing devices may be used by an operator (e.g., a surgeon) with sensory and / or direct visual control. The suturing devices may be designed to allow an operator to perform native tissue repair without the placement of an artificial implant (as opposed to mid-urethral sling techniques or transvaginal mesh procedures, which require the placement of a synthetic sling / mesh).
[0204] The suturing device may be designed for safe insertion into a cavity. The safety of the suturing device may be derived from the length of the suturing device. For example, the length and angle of the suturing device (arms 2007 and 2008 and jaws 2005 and 2006) may contribute to the safety described herein and may be designed to avoid trauma to the vagina or incision. In another example, the entry point of the suturing device into the body is the vagina, but entry to the surgical site is via an incision made in the vaginal wall, allowing the operator to insert the suturing device into the pelvic cavity where the ATFP is located. For example, in stress incontinence procedures using a suturing device, it is not necessary to insert the suturing device beyond the ATFP, which is an anatomical landmark used to determine the length of the suturing device. Even if the suturing device is placed into the vagina beyond the arm joint, the length of the suturing device may prevent the suturing device from affecting the incision when the handles are opened, allowing the suturing device to expand.
[0205] The suturing device may facilitate consistent, sequential placement of sutures (e.g., placing multiple sutures with the same needle, also known as Z-sutures or figure-of-eight sutures) into difficult-to-access pelvic floor structures during pelvic floor surgery. The suturing device may be designed to facilitate consistent placement of sutures in difficult-to-access locations (deep, narrow, non-visible surgical sites) during transvaginal organ prolapse surgery (as opposed to transabdominal surgery). The suturing device can suture specific tissue to the stump vaginal wall or cervix for vaginal apex elevation.
[0206] The suturing device may be used in transvaginal minimally invasive surgery. The suturing device may be designed for vaginal wall or uterine prolapse surgery based on natural tissue repair in women with pelvic organ prolapse (the hanging of pelvic organs, such as the bladder, uterus, or bowel, into the vagina). The suturing device may be designed to allow the operator to perform natural tissue repair without placing an artificial implant (as opposed to surgery requiring the placement of a synthetic mesh). These suturing devices may allow the operator to perform transvaginal surgery in a minimally invasive manner, such as using only a single incision. The suturing device may be used in common suturing applications that are difficult to access during gynecological urological surgery, to assist in the placement of sutures at surgical sites, including, but not limited to, transvaginal pelvic organ prolapse surgery. The suturing device may be used with sensory control and / or direct visual control.
[0207] While one or more embodiments of the present disclosure have been described above, it should be understood that these embodiments are illustrative and not limiting, and that many modifications will be apparent to those skilled in the art, and that, for example, various embodiments of the methods, exemplary systems and platforms, and exemplary devices described herein may be used in any combination with one another. Furthermore, various steps may be performed in any desired order (and any desired steps may be added and / or any desired steps may be omitted).
[0208] 29A and 29B, the suturing device 4001A can be scissor-shaped and ergonomically sized to reach target tissue in tight spaces. The suturing device 4001A can include a fixed arm 4007 integral with a fixed jaw 4005. In some embodiments, the distal end of the fixed arm 4007 includes the fixed jaw 4005. The suturing device 4001A can include a movable arm 4008 coupled to a movable jaw 4006.
[0209] Both the fixed jaw 4005 and the movable jaw 4006 are capable of receiving and grasping a needle, and the suturing device 4001A may also include a needle transfer mechanism 4004 that transfers the needle between the fixed jaw 4005 and the movable jaw 4006. The needle transfer mechanism 4004 may include a lever 4003 for controlling the transfer of the needle between the fixed jaw 4005 and the movable jaw 4006. In some embodiments, the lever 4003 extends from a fixed arm 4007.
[0210] In some embodiments, the suturing device 4001A can include a first handle 4002A coupled to the fixed arm 4007 and a second handle 4002B coupled to the movable arm 4008. The handle 4002A and the handle 4002B can assist a user in moving the movable arm 4008 relative to the fixed arm 4007. The handle 4002A and the handle 4002B can be located on an end of the suturing device 4001A that remains outside the cavity during surgery to allow an operator to control the suturing device 4001A.
[0211] 30A and 30B show one embodiment of a suturing device 4001A. In some embodiments, the fixed jaw 4005 includes a first gripping slot 4103 capable of receiving a needle 4201 (described separately with reference to FIG. 33B). In some embodiments, the movable jaw 4006 includes a second gripping slot 4104 capable of receiving the needle 4201. In some embodiments, the gripping slot is a channel sized and shaped to receive the needle. For example, the gripping slot can define a circular channel or a circular hole for receiving and gripping the needle.
[0212] In some embodiments, the needle transport mechanism 4004 can transport the needle between the first gripping slot 4103 and the second gripping slot 4104. As such, the needle transport mechanism can secure the needle in either the first gripping slot 4103 or the second gripping slot 4104 and / or release the needle from either the first gripping slot 4103 or the second gripping slot 4104.
[0213] 31A-31E illustrate one embodiment of a mechanism for moving a movable arm 4008 to pivot relative to a fixed arm 4007, thereby pivoting the movable jaw 4006 relative to the fixed jaw 4005. As shown in FIG. 31A, the movable arm 4008 can have arm movement 4105 that pivots away from or toward the fixed arm 4007. For example, arm movement 4105 can be caused by a surgeon manually moving a handle 4002A to open or close the device 4001A. This control can be advantageous when performing surgery in areas where visibility is limited, ensuring the operator has control over the movement of the device 4001A. In some embodiments, arm movement 4105 can be caused by an additional mechanical force element, such as a spring.
[0214] The fixed arm 4007 may remain stationary relative to the moving movable arm 4008. The movable arm 4008 may pivot relative to the fixed arm 4007, causing the movable jaw 4006 to pivot relative to the fixed jaw 4005. Movement of the movable arm 4008 relative to the fixed arm 4007 causes the movable jaw 4006 to exhibit a jaw movement 4107 along which the movable jaw 4006 may pivot away from or towards the fixed jaw 4005. The fixed jaw 4005 may remain stationary relative to the moving movable jaw 4006. In some embodiments, the movable arm 4008 and the movable jaw 4006 move relative to the fixed arm 4007. In some embodiments, the movable arm 4008 and the movable jaw 4006 move relative to the fixed jaw 4005. In some embodiments, the movable arm 4008 and the movable jaw 4006 move relative to each other. In some embodiments, the fixed arm 4007 and the fixed jaw 4005 do not move. In some embodiments, the fixed arm 4007 is integral with the fixed jaw 4005, so that the fixed jaw 4005 cannot move independently of the fixed arm 4007.
[0215] The fixed jaw 4005 may facilitate safe operation in tight spaces because maintaining the fixed jaw 4005 stationary relative to the target tissue allows the placement of the suture to remain in a safe area. For example, when the operator moves the movable jaw 4006 relative to the fixed jaw 4005, the operator knows the position of the fixed jaw 4005. When the fixed jaw 4005 is the reference for the target tissue at a surgical site where visualization is difficult or impossible, the fixed jaw 4005 allows the suture to pass through the target tissue. The fixed jaw 4005 and the movable jaw 4006 can come together in a fixed or predictable position relative to the tissue, allowing the tissue to be centered without the need for continuous prediction of their location and distance. In this manner, the fixed jaw 4005 allows suturing in areas that are difficult to see.
[0216] 31B, in some embodiments, the movable arm 4008 can pivot the movable jaw 4006 relative to the fixed jaw 4005 by pivoting relative to the fixed arm 4007. The movable arm 4008 can pivot the movable jaw 4006 relative to the fixed jaw 4005 until the needle 4201 is received in both the first gripping slot 4103 and the second gripping slot 4104, thereby swapping the needle between the slots.
[0217] The lever 4003 can move between one or more positions to control the function of the first and second gripping slots. As shown in FIGS. 31A-31E , in some embodiments, the lever 4003 can move between a first position 4110A, a second position 4110B, and a third position 4110C to control the locking and release of both the first gripping slot 4103 and the second gripping slot 4104. For example, the lever 4003 can be a shifter, grip, or switch that can be moved by an operator. In the first position 4110A, the needle 4201 is locked in the first gripping slot 4103 of the fixed jaw 4005. As shown in FIG. 31A , when the movable arm 4008 is moved or open, the needle transfer mechanism 4004 can grip the needle 4201 in the fixed jaw 4005 while disabling the grip in the movable jaw 4006. As shown in FIG. 31B, when the movable arm 4008 is adjacent to the fixed arm 4007, the needle transfer mechanism 4004 can grasp the needle 4201 in the fixed jaw 4005 while disabling the grip in the movable jaw 4006 by holding the lever 4003 in the first position 4110A.
[0218] 31C, the lever 4003 can then be moved to a second position 4110B, releasing the needle 4201 from the first gripping slot 4103 but still securing it in the second gripping slot 4104. As shown in FIG. 31C, the needle transfer mechanism 4004 can be disabled in both the fixed jaw 4005 and the movable jaw 4006, releasing the needle 4201.
[0219] 31D , in the third position 4110C, the needle 4201 is secured in the second gripping slot 4104. As shown in FIG. 31D , the needle transfer mechanism 4004 can grip the needle 4201 in the movable jaw 4006 while disabling the grip in the fixed jaw 4005. As shown in FIG. 31E , when the movable jaw 4006 pivots away from the fixed jaw 4005 due to movement of the movable arm 4008, the needle is secured to the movable jaw 4006, and the transfer of the needle between the fixed jaw 4005 and the movable jaw 4006 is complete. As shown in FIG. 31E , when the movable arm 4008 is moved or open, the needle transfer mechanism 4004 can grip the needle 4201 in the movable jaw 4006 while disabling the grip in the fixed jaw 4005.
[0220] 31A-31E, in some embodiments, the suturing device 4001A further includes a cover 4108 partially disposed over the lever 4003. The lever 4003 is movable between a plurality of positions defining a first position 4110A, a second position 4110B, or a third position 4110C. In some embodiments, the cover 4108 includes markings, indentations, or indicators corresponding to movement of the lever 4003 to the first position 4110A, the second position 4110B, or the third position 4110C.
[0221] 32A-32C illustrate the mechanics of one embodiment of a suturing device 4001A that allows for jaw movement 4107, in which the movable arm 4008 moves relative to the fixed arm 4007 and the movable jaw 4006 pivots away from or toward the fixed jaw 4005. In some embodiments, the fixed arm 4007 can include an arm joint 4101 to couple the fixed arm 4007 to the movable arm 4008. For example, the arm joint 4101 can be a mechanical joint that connects two components and allows them to move relative to one another. In some embodiments, the arm joint 4101 allows the movable arm 4008 to move relative to the fixed arm 4007. For example, the movable arm 4008 can pivot relative to the fixed arm 4007 about the arm joint 4101. In another example, the arm joint 4101 allows the movable arm 4008 to pivot with one degree of freedom relative to the fixed arm 4007. In yet another example, the arm joint 4101 can limit the movement of the movable arm 4008 to prevent the movable arm 4008 from breaking or applying excessive force to the movable jaw 4006, the slot, or any other component described herein.
[0222] In some embodiments, the fixed arm 4007 includes a jaw joint 4100. In some embodiments, the fixed jaw 4005 includes the jaw joint 4100. The jaw joint 4100 is coupled to the movable jaw 4006 and allows the movable jaw 4006 to pivot relative to the fixed jaw 4005. For example, the jaw joint 4100 can be a mechanical joint that connects two components and allows them to move relative to one another. In some embodiments, the movable jaw 4006 can pivot relative to the fixed jaw 4005 about the jaw joint 4100. For example, the jaw joint 4100 allows the movable jaw 4006 to pivot with one degree of freedom relative to the fixed jaw 4005. In another example, the jaw joint 4100 can limit the movement of the movable jaw 4006 to prevent the movable jaw 4006 from breaking or applying excessive force to the fixed jaw 4005, the slot, or any other component described herein.
[0223] In some embodiments, the suturing device 4001A further includes a connecting joint 4102 coupled to the movable arm 4008 and the movable jaw 4006. The connecting joint 4102 can be disposed between the jaw joint 4100 and the arm joint 4101 such that the jaw joint 4100 and the arm joint 4101 are decoupled and mechanically independent from one another. The connecting joint 4102 allows the movable jaw 4006 to pivot upon movement of the movable arm 4008. For example, the connecting joint 4102 can be a mechanical joint that connects two components and allows them to move relative to one another. In some embodiments, the movable arm 4008 can physically move the connecting joint 4102 to pivot the movable jaw 4006 about the jaw joint 4100. Movement of the movable arm 4008 can move the connecting joint 4102 to pivot the movable jaw 4006 about the jaw joint 4100. 32B and 32C, movement of the movable arm 4008 away from the fixed arm 4007 causes the connecting joint 4102 to move across the width of the fixed arm 4007. As the connecting joint 4102 pulls on the movable jaw 4006, the movable jaw 4006 pivots about the jaw joint 4100 and moves away from the fixed jaw 4005.
[0224] In some embodiments, the connecting joint 4102 can limit the movement of the movable jaw 4006 and the movable arm 4008 to prevent them from disengaging or applying excessive force to the slots or any other components described herein. For example, the connecting joint 4102 can be limited to movement along the width of the fixed arm 4007, thereby preventing excessive movement of the movable jaw 4006 and the movable arm 4008. In some embodiments, the portion of the fixed arm 4007 between the jaw joint 4100 and the arm joint 4101 can remain in a fixed position while the movable jaw 4006 moves within the pelvic cavity and the movable arm 4008 moves outside the vaginal cavity. Such movement can advantageously reduce the profile of the movable jaw 4006 and the movable arm 4008.
[0225] In some embodiments, the fixed arm 4007 includes a reference position (or datum) 4009 that includes a jaw joint 4100, an arm joint 4101, and a connecting joint 4102. Pivoting of the movable arm 4008 and the movable jaw 4006 about the reference position 4009 allows the suturing device 4001A to move like a scissors-style mechanism. For example, the suturing device 4001A may be comprised of three rigid metal parts (e.g., (1) the fixed jaw 4005 integral with the fixed jaw 4005, (2) the movable arm 4008, and (3) the movable jaw 4006) attached to each other at three joints 4100-4102. The movable jaw 4006 and the movable arm 4008 can move relative to each other and, as described above, relative to the fixed arm 4007 and the fixed jaw 4005 about the reference position 4009 in 2D space. In some embodiments, the movable arm 4008 pivots relative to the fixed arm 4007 about a reference position 4009. In some embodiments, the movable jaw 4006 pivots relative to the fixed arm 4005 about a reference position 4009.
[0226] For example, while manipulating the suturing device 4001A inside the pelvic cavity, the fixed arm 4007, whose outer contour may be appropriately designed to place the suture in the correct position, may be aligned with and fixed to a specific area of the pelvic cavity, while the jaw joint 4100, arm joint 4101, and connecting joint 4102 allow the operator to move the handle 4002A to move the movable arm 4008 and thus the movable jaw 4006. By keeping the fixed arm 4007 fixed in place, the jaws 4005 and 4006 may be properly positioned for suturing.
[0227] 33A-33I show embodiments of needles 4201. Needle 4201C, needle 4201D, and needle 4201E (collectively referred to as needles 4201) can include a first notch 4207A and a second notch 4207B. Depending on the location of the first notch 4207A and the second notch 4207B on needle 4201, needle 4201 can be gripped by first gripping slot 4103, second gripping slot 4104, or both. For example, first notch 4207A can be attached to fixed jaw 4005, and second notch 4207B can be attached to movable jaw 4006.
[0228] As shown in FIG. 33A, needle 4201 can be a curved needle 4201C. FIGS. 33B, 33C, 33D, and 33E show an embodiment of a straight needle 4201D. In some embodiments, needle 4201C and needle 4201D can include a hole 4208. In some embodiments, hole 4208 can be used to connect the needle and thread by drilling a hole in the center of needle 4201C or needle 4201D, inserting a thread (e.g., thread 4016) into hole 4208, and deforming hole 4208 using an appropriate die shape attached to a press. In some embodiments, needle 4201 and thread 4016 can be connected using an appropriate adhesive instead of deforming hole 4208.
[0229] 33F, 33G, 33H, and 33I show one embodiment of a needle 4201E that includes a channel 4209. It will be understood that other needles described herein (including straight and curved needles), such as needle 4201C and needle 4201D, can also include a channel. The channel 4209 allows for an open-channel-shaped based connection between the needle 4201 and the thread 4016. The channel 4209 can be opened in a central region of the needle 4201E. The thread can be placed in the channel 4209, and an appropriate die shape attached to a press can deform the channel 4209 to cover the thread. In some embodiments, the needle 4201 and the thread 4016 can be connected using a suitable adhesive instead of deforming the channel 4209.
[0230] 33J shows one embodiment of the needle transport mechanism 4004 of the suturing device 4001A. The needle transport mechanism 4004 can retain and release the needle 4201 in and from the jaws 4005 and 4006 with the aid of flexible plates (e.g., first and second control bars 4505A and 4505B and / or first and second gripping members 4510A and 4510B) that move back and forth. The plates can be pulled or pushed by a control lever (e.g., lever 4003) attached to the plates. In some embodiments, the first control bar 4505A, second control bar 4505B, first gripping member 4510A, and second gripping member 4510B can be disposed on a stationary arm 4007. In some embodiments, the first control bar 4505A, the second control bar 4505B, the first gripping member 4510A, and the second gripping member 4510B can be disposed on the fixed jaw 4005 and the fixed arm 4007.
[0231] 33J, the needle transport mechanism 4004 includes a first control bar 4505A and a second control bar 4505B. In some embodiments, the first control bar 4505A and the second control bar 4505B extend within respective channels in the fixed arm 4007. In some embodiments, the first control bar 4505A extends within a channel through the fixed jaw 4005. In some embodiments, the second control bar 4505B extends within a channel through the movable jaw 4006.
[0232] The control bars are independently advanceable and retractable within their respective channels. In some embodiments, the first control bar 4505A can advance toward the first gripping slot 4103 and advance toward the first notch 4207A or the second notch 4207B of the needle 4201 disposed in the first gripping slot 4103 to secure the needle 4201 in the first gripping slot 4103. In some embodiments, the first control bar 4505A can retract from the first gripping slot 4103 and retract from the first notch 4207A or the second notch 4207B to release the needle 4201 from the first gripping slot 4103. In some embodiments, the second control bar 4505B can advance toward the second gripping slot 4104 and toward the first notch 4207A or the second notch 4207B of the needle 4201 disposed in the second gripping slot 4104 to secure the needle 4201 in the second gripping slot 4104. In some embodiments, the second control bar 4505B can retract from the second gripping slot 4104 and retract from the first notch 4207A or the second notch 4207B to release the needle 4201 from the second gripping slot 4104. For example, the control bars can be pulled within their respective channels.
[0233] The needle transport mechanism 4004 can include a switch joint 4106 coupled to the lever 4003, the first control bar 4505A, and the second control bar 4505B. In some embodiments, the switch joint 4106 is disposed on a locking arm 4007. Movement of the lever 4003 moves the switch joint 4106, which in turn moves the first control bar 4505A and the second control bar 4505B to lock or release the needle 4201 from the first gripping slot 4103 or the second gripping slot 4104. For example, the switch joint 4106 can be a mechanical joint that connects two components to allow movement relative to one another.
[0234] In some embodiments, the lever 4003 can rotate or translate the switch joint 4106 to move the first control bar 4505A and the second control bar 4505B. For example, the lever 4003 can rotate the switch joint 4106 to push or pull the control bars connected to the switch joint 4106. In this manner, movement of the lever 4003 can advance the first control bar 4505A toward the first gripping slot 4103 while retracting the second control bar 4505B from the second gripping slot 4104, or can advance the second control bar 4505B toward the second gripping slot 4104 while retracting the first control bar 4505A from the first gripping slot 4103. For example, clockwise rotation of the switch joint 4106 by the lever 4003 causes the first control bar 4505A to retract away from the first gripping slot 4103 and the second control bar 4505B to advance towards the second gripping slot 4104. In another example, counterclockwise rotation of the switch joint 4106 by the lever 4003 causes the first control bar 4505A to advance towards the first gripping slot 4103 and the second control bar 4505B to retract away from the second gripping slot 4104.
[0235] 33K, 33L, and 33M are exploded views of one embodiment of the first and second control bars 4505A, 4505B and the first and second gripping members 4510A, 4510B. In some embodiments, the first and second gripping members 4510A, 4510B extend within respective channels of the fixed arm 4007. In some embodiments, the first gripping member 4510A extends within a channel of the fixed jaw 4005. In some embodiments, the first gripping member 4510A extends within a channel of the movable jaw 4006.
[0236] In some embodiments, the control bars are coupled to or overmolded with each gripping member. For example, the first control bar 4505A and the first gripping member 4510A can be a single bar, with the first gripping member 4510A being an extension of the first control bar 4505A. Although not shown, in another example, the first control bar 4505A and the first gripping member 4510A can be separate bars, with the first gripping member 4510A coupled to the first control bar 4505A. As shown in FIG. 33M, the first gripping member 4510A (or the second gripping member 4510B) can bend relative to the first control bar 4505A (or the second control bar 4505B). The high resilience of first and second gripping members 4510A and 4510B allows them to move and function within the angled channels of jaws 4005 and 4006.
[0237] 33J , in some embodiments, the first control bar 4505A can advance the first gripping member 4510A toward the first notch 4207A or the second notch 4207B of the needle 4201 disposed in the first gripping slot 4103 to secure the needle 4201 in the first gripping slot 4103. For example, the first control bar 4505A can be pushed toward the first gripping slot 4103. In this manner, movement of the first control bar 4505A can cause the first gripping member 4510A to grip the first notch 4207A or the second notch 4207B to grip the needle 4201 in the first gripping slot 4103.
[0238] In some embodiments, the first control bar 4505A can retract the first gripping member 4510A from the first cutout 4207A or the second cutout 4207B, releasing the needle 4201 from the first gripping slot 4103. For example, the first control bar 4505A can be pulled away from the first gripping slot 4103. In this manner, movement of the first control bar 4505A can release the first gripping member 4510A from the first cutout 4207A or the second cutout 4207B, releasing the needle 4201 from the first gripping slot 4103.
[0239] In some embodiments, the second control bar 4505B can advance the second gripping member 4510B toward the first notch 4207A or the second notch 4207B of the needle 4201 disposed in the second gripping slot 4104 to grip the needle 4201 in the second gripping slot 4104. For example, the second control bar 4505B can be pushed toward the second gripping slot 4104. In this manner, movement of the second control bar 4505B can cause the second gripping member 4510B to grip the first notch 4207A or the second notch 4207B of the needle 4201 to grip the needle 4201 in the second gripping slot 4104.
[0240] In some embodiments, the second control bar 4505 can retract the second gripping member 4510B from the first cutout 4207A or the second cutout 4207B, releasing the needle 4201 from the second gripping slot 4104. For example, the second control bar 4505B can be pulled away from the second gripping slot 4104. In this manner, movement of the second control bar 4505B can release the second gripping member 4510B from the first cutout 4207A or the second cutout 4207B, releasing the needle 4201 from the second gripping slot 4104. In some embodiments, the first and second control bars or first and second gripping members can have different lengths. For example, the first gripping member 4510A or first control bar 4505A can be longer than the second gripping member 4510B or second control bar 4505B because it needs to extend a greater distance to reach the first gripping slot 4103. In another example, the second gripping member 4510B or second control bar 4505B can be longer than the first gripping member 4510A or first control bar 4505A because it needs to bend at the movable jaw 4006 that includes the second gripping slot 4104.
[0241] The lever 4003 can move to a first position 4110A to actuate the switch joint 4106, advancing the first control bar 4505A to advance the first gripping member 4510A, thereby gripping the needle 4201 in the first gripping slot 4103, and can retract the second control bar 4505B to retract the second gripping member 4510B, thereby releasing the needle 4201 from the second gripping slot 4104. For example, as shown in FIG. 33J , the lever 4003 can rotate the switch joint 4106 counterclockwise to move to the first position 4110A. In some embodiments, the lever 4003 can move to the first position 4110A to actuate the switch joint 4106, advancing the first control bar 4505A to advance the first gripping member 4510A, thereby gripping the needle 4201 in the first gripping slot 4103. 33J, moving the lever 4003 to the first position 4110A can rotate the switch joint 4106 in a counterclockwise direction, which advances the first control bar 4505A to the left and retracts the second control bar 4505B to the right, causing the first control bar 4505A to cause the first gripping member 4510A to grip the needle 4201 into the first gripping slot 4103 and the second control bar 4505B to cause the second gripping member 4510B to release the needle 4201 from the second gripping slot 4104. The lever 4003 can include a protective cutout 4515A on the suturing device 4001 that maintains the lever 4003 in the first position 4110A to prevent it from being accidentally moved to a different position during use (e.g., during surgery).
[0242] The lever 4003 can be moved to a second position 4110B to actuate the switch joint 4106, retracting the first control bar 4505A and retracting the first gripping member 4510A to release the needle 4201 from the first gripping slot 4103, and can be moved to a second position 4110B to actuate the switch joint 4106, retracting the first control bar 4505A and retracting the first gripping member 4510A to release the needle 4201 from the second gripping slot 4104. In some embodiments, the lever 4003 can be moved to a second position 4110B to actuate the switch joint 4106, retracting the first control bar 4505A and retracting the first gripping member 4510A to release the needle 4201 from the first gripping slot 4103.
[0243] For example, as shown in FIG. 33J, when the lever 4003 moves from the first position 4110A to the second position 4110B, the switching joint 4106 rotates in a clockwise direction, partially retracting the first control bar 4505A to the right and partially advancing the second control bar 4505B to the left, thereby placing the first control bar 4505A and the second control bar 4505B in an inactive position and preventing the first gripping slot 4103 and the second gripping slot 4104 from gripping the needle 4201.
[0244] 33J, when the lever 4003 moves from the third position 4110C to the second position 4110B, the switch joint 4106 rotates in a counterclockwise direction, partially advancing the first control bar 4505A to the left and partially retracting the second control bar 4505B to the right, causing the first control bar 4505A and the second control bar 4505B to be in an inactive position, preventing the first gripping slot 4103 and the second gripping slot 4104 from gripping the needle 4201. The lever 4003 may include a protective cutout 4515B on the suturing device 4001 that maintains the lever 4003 in the second position 4110B to prevent it from being accidentally moved to a different position during use (e.g., during surgery).
[0245] The lever 4003 can be moved to a third position 4110C to actuate the switch joint 4106, advancing the second control bar 4505B to advance the second gripping member 4510B to grip the needle 4201 in the second gripping slot 4104, and can be moved to retract the first control bar 4505A to retract the first gripping member 4510A to release the needle from the first gripping slot 4103. In some embodiments, the lever 4003 can be moved to a third position 4110C to actuate the switch joint 4106, advancing the second control bar 4505B to advance the second gripping member 4510B to grip the needle in the second gripping slot 4104. 33J, movement of the lever 4003 from the second position 4110B to the third position 4110C rotates the switch joint 4106 in a clockwise direction, retracting the first control bar 4505A to the right and advancing the second control bar 4505B to the left, causing the first control bar 4505A to cause the first gripping member 4510A to release the needle 4201 from the first gripping slot 4103 and the second control bar 4505B to cause the second gripping member 4510B to grip the needle 4201 into the second gripping slot 4104. The lever 4003 can include a protective cutout 4515C on the suturing device 4001 that maintains the lever 4003 in the third position 4110C to prevent accidental movement to a different position during use (e.g., during surgery). In some embodiments, a lever having first and second indicators may be used rather than the three indicators described above. For example, the lever may include only positions 4110A and 4110C. In all positions of the lever between positions 4110A and 4110C, the needle will remain gripped in both gripping slots, and a stop will prevent needle transfer between the jaws unless the handle is fully closed. It will be understood that any number of positions for the lever may be used. In some embodiments, the stop may be optional.
[0246] 33N, 33O, and 33P, in some embodiments, the needle transport mechanism 4004 includes a cable 4019A, a cable 4019B, a spring 4021A, and a spring 4021B. Cables 4019A and 4019B may be attached to the lever 4003 via stubs 4025A and 4025B at the ends of cables 4019A and 4019B. In some embodiments, cables 4019A and 4019B extend within respective channels in the fixed arm 4007. In some embodiments, cable 4019A extends within a channel in the fixed jaw 4005. In some embodiments, cable 4019B extends within a channel in the movable jaw 4006. In some embodiments, spring 4021A is disposed within the fixed jaw 4005. In some embodiments, spring 4021B is disposed within the movable jaw 4006.
[0247] Lever 4003 can rotate along switching joint 4106. Lever 4003 can rotate to three different positions. Lever 4003 can be designed so that a predetermined amount of force is required by the user to change the position of lever 4003. In some embodiments, the predetermined amount of force applied by the user is based on the tension in cables 4019A and 4019B. Geometric features 4027A, 4027B, 4031A, 4031B, 4029A, and 4029B of fixed arm 4007 can also be used to route cables 4019A and 4019B in an optimal path. Springs 4021A and 4021B are positioned on cylindrical pistons 4023A and 4023B and can be held by mechanical elements such as rings or pins or structural features such as protrusions (e.g., mechanical element 4033B holds spring 4021B). In some embodiments, the cylindrical piston 4023A is disposed within the fixed jaw 4005. In some embodiments, the cylindrical piston 4023B is disposed within the movable jaw 4006.
[0248] In some embodiments, the proximal ends (e.g., proximal to the operator) of pistons 4023A and 4023B are attached to cables 4019A and 4019B, respectively. In some embodiments, the distal ends of pistons 4023A and 4023B can be designed and shaped to engage and grip needle 4201. In some embodiments, the distal end of piston 4023A can advance to engage and grip needle 4201 in fixed jaw 4005. In some embodiments, the distal end of piston 4023A can retract to disengage and release needle 4201 in fixed jaw 4005. In some embodiments, the distal end of piston 4023B can advance to engage and grip needle 4201 in movable jaw 4006. In some embodiments, the distal end of piston 4023B can retract to disengage and release needle 4201 in movable jaw 4006.
[0249] In some embodiments, as shown in FIGS. 33N and 33O, the lever 4003 can be in a center position (e.g., similar to the second position 4110B). In this center position, both cables 4019A and 4019B can be half-tensioned, both springs 4021A and 4021B can be half-compressed, and both pistons 4023A and 4023B can be half-retracted. In some embodiments, when the pistons 4023A and 4023B are half-retracted, they are disengaged from the needle 4201, so that the needle 4201 can be released from both the fixed jaw 4005 and the movable jaw 4006. In some embodiments, when the pistons 4023A and 4023B are half-retracted, they are engaged with the needle 4201, so that the needle 4201 is secured to both the fixed jaw 4005 and the movable jaw 4006. In some embodiments, when jaws 4005 and 4006 are in a closed position (e.g., movable jaw 4006 has moved toward fixed jaw 4005), needle 4201 can be held by both jaws 4005 and 4006, thereby locking the suturing device (e.g., device 4001A or 4001B).
[0250] In some embodiments, lever 4003 may be in a forward position (e.g., similar to first position 4110A), in which lever 4003 may cause spring 4021A corresponding to fixed jaw 4005 to be fully released by cable 4019A, causing piston 4023A to move forward under spring force, retaining needle 4201 in fixed jaw 4005. At the same time, lever 4003 may cause spring 4021B corresponding to movable jaw 4006 to be fully compressed by cable 4019B, causing piston 4023B to be pulled by cable 4019B, releasing needle 4201 from movable jaw 4006.
[0251] In some embodiments, lever 4003 can be in a rearward position (e.g., similar to third position 4110C), in which lever 4003 can fully release spring 4021B associated with movable jaw 4006 via cable 4019B, causing piston 4023B to move forward via spring force and retain needle 4201 in movable jaw 4006. At the same time, lever 4003 can fully compress spring 4021A associated with fixed jaw 4005 via cable 4019A, causing piston 4023A to be pulled by cable 4019A, releasing needle 4201 from fixed jaw 4005.
[0252] 34A, 34B, and 34C illustrate an embodiment of a suturing device 4001A including a stopper 4605 in an active position. From a safety perspective, movement of the movable jaw 4006 when the lever 4003 is in the second position 4110B could result in the needle 4201 falling out because the needle 4201 is not secured in either the first or second gripping slot 4103 or 4104. To address this issue, the suturing device 4001A includes a stopper 4605 that controls when the movable arm 4008, and therefore the movable jaw 4006, can move based on the position of the lever 4003. For example, the stopper 4605 could physically block movement of the movable arm 4008 to prevent the needle 4201 from falling out.
[0253] 34A and 34B, a stopper 4605 can be disposed on the movable arm 4008 to control when the movable arm 4008 can move relative to the fixed arm 4007. For example, the stopper 4605 can grip or fix the fixed arm 4007 to prevent movement of the movable arm 4008 and prevent the needle 4201 from falling out. The stopper 4605 can be disposed on the movable arm 4008 adjacent to a lever 4003 on the fixed arm 4007 and can control the movable arm 4008 based on the position of the lever 4003. In some embodiments, the stopper 4605 is covered by a lid 4606 that protects the stopper 4605.
[0254] The stopper 4605 is slidable between an active position and an inactive position on the movable arm 4008. When the stopper 4605 is in the active position, it can control the movement of the movable arm 4008. In the active position, the stopper 4605 is positioned adjacent to the fixed arm 4007 near the movable arm 4008, thereby grasping a portion of the fixed arm 4007 and controlling the movement of the movable arm 4008 relative to the fixed arm 4007.
[0255] The stopper 4605 is slidable on the movable arm 4008 from an active position to an inactive position, in which it does not control the movement of the movable arm 4008. For example, the stopper 4605 may be a plastic or metal cap that slides on the movable arm 4008. In the inactive position, the stopper 4605 is positioned away from the movable arm 4008 to avoid gripping the fixed arm 4007 and therefore controlling the movement of the movable arm 4008 relative to the fixed arm 4007. The stopper 4605 can slide on the movable arm 4008 toward the fixed arm 4007 to the active position, thereby gripping the fixed arm 4007 and controlling the movable arm 4008.
[0256] 34B and 34C, the stopper 4605 can include a flap 4607 that secures the stopper 4605 in the active position. For example, the flap 4607 can be a bendable extension of the stopper 4605. The flap 4607 can secure the stopper 4605 in the active position by snapping onto or over the edge of the movable arm 4008. The flap 4607 can be bent away from the movable arm 4008 to release the stopper 4605 from the active position. As shown in FIG. 34C, an operator can release the stopper 4605 from the active position by bending the flap 4607.
[0257] 35A and 35B show an embodiment of a suturing device 4001A including a stopper 4605 and a safety member 4610 in an effective position to prevent movement of the movable arm 4008 and movable jaw 4006 when the lever 4003 is in the second position 4110B, thereby unlocking the needle 4201. In some embodiments, FIG. 35A shows a cross-sectional view of the stopper 4605 without the lid 4606. In some embodiments, the stopper 4605 does not have a lid.
[0258] Because stopper 4605 is disposed on movable arm 4008, stopper 4605 moves when movable arm 4008 moves. Because safety member 4610 is disposed on fixed arm 4007, stopper 4605 moves relative to safety member 4610 when movable arm 4008 moves. Therefore, the interlocking of safety member 4610 and stopper 4605 prevents movement of stopper 4605 and therefore movement of movable arm 4008, thereby preventing needle 4201 from falling out.
[0259] When the stopper 4605 protrudes relative to the safety member 4610, the safety member 4610 and the stopper 4605 can interlock. In the active position, the stopper 4605 is positioned to interlock with the safety member 4610. For example, the stopper 4605 can block or grip the safety member 4610. In some embodiments, when the lever 4003 is in the second position 4110B (e.g., the needle 4201 is not secured) and the jaws are closed, the interlocking of the stopper 4605 and the safety member 4610 prevents the movable jaw from opening. In some embodiments, when the lever 4003 is in the first position 4110A or the third position 4110C (e.g., the needle 4201 is secured) and the jaws are open, the interlocking of the stopper 4605 and the safety member 4610 can prevent the lever 4003 from moving to the second position 4110B and releasing the needle 4201.
[0260] The arrangement of the stopper 4605 and safety member 4610 to interlock when the lever 4003 is in the second position 4110B and the jaws are closed prevents the needle 4201 from falling out even when it is not secured in either the first or second gripping slot 4103 or 4104. However, the movable arm 4008 may move when the needle 4201 is secured in either the first or second gripping slot 4103 or 4104. The interlocking of the safety member 4610 and the stopper 4605 is possible because the stopper 4605 in its active position protrudes relative to the safety member 4610 when the lever 4003 is in the second position 4110B. By protruding against the stopper 4605, the safety member 4610 can prevent the movement of the movable arm 4008 and therefore the movable jaw 4006 when the lever 4003 is in the second position 4110B, thereby preventing the needle 4201 from falling out.
[0261] Due to the arrangement of the stopper 4605 and safety member 4610 such that they interact based on the position of the lever 4003, the safety member 4610 can be positioned on the second control bar 4505B. Because the lever 4003 moves the second control bar 4505B, the position of the lever 4003 determines the position of the safety member 4610. With the lever 4003 in the second position 4110B, the safety member 4610 is in the safety position 4112A, which in turn interacts with the stopper 4605 to prevent movement of the movable arm 4008 relative to the fixed arm 4007 and prevent the needle 4201 from slipping out.
[0262] 36A and 36B show an embodiment of a suturing device 4001A including a stopper 4605 and a safety member 4610 in an active position that allows movement of the movable arm 4008 and movable jaw 4006 when the needle 4201 is secured in the first grasping slot 4103. The lever 4003 in a first position 4110A places the safety member 4610 in a safety position 4112B, allowing the safety member 4610 to bypass the stopper 4605 and allow movement of the movable arm 4008.
[0263] 36B shows the movable arm 4008 moving when the lever 4003 is in the first position 4110A. In the active position where the movable arm 4008 and movable jaw 4006 are open, the stopper 4605 can prevent the lever 4003 from moving from the first position 4110A (needle 4201 secured) to the second position 4110B (needle 4201 not secured), thereby preventing the needle 4201 from falling out.
[0264] 36C and 36D show an embodiment of a suturing device 4001A including a stop 4605 in an active position that allows movement of the movable arm 4008 and movable jaw 4006 when the needle 4201 is secured in the second grasping slot 4104. The lever 4003 in a third position 4110C places the safety member 4610 in a safety position 4112C, thereby allowing the safety member 4610 to bypass the stop 4605 and allow movement of the movable arm 4008.
[0265] 36D shows the movable arm 4008 moving when the lever 4003 is in the third position 4110C. In the active position where the movable arm 4008 and movable jaw 4006 are open, the stopper 4605 can prevent the lever 4003 from moving from the third position 4110C (needle 4201 secured) to the second position 4110B (needle 4201 not secured), thereby preventing the needle 4201 from falling out.
[0266] 37A, the stopper 4605 transitions from the enabled position to the disabled position. An operator can bend the flap 4607 to release the stopper 4605 from the enabled position. The operator can also pull the stopper 4605 away from the safety member 4610. The stopper 4605 can slide on the movable arm 4008 away from the fixed arm 4007 to the disabled position. In some embodiments, the operator can maintain the slide until the stopper 4605 is removed from the movable arm 4008.
[0267] 37B and 37C are exploded views of the stopper 4605 and the movable arm 4008. As shown in FIG. 37B, the movable arm 4008 can include a base region 4615. The base region 4615 can be integral with the movable arm 4008. The base region 4615 can be aligned with the lever 4003 or the switching joint 4106. The position of the stopper 4605 relative to the base region 4615 can determine whether the stopper 4605 is in an active position or an inactive position. In the active position, the stopper 4605 is positioned adjacent to the fixed arm 4007 near the movable arm 4008, allowing the stopper 4605 to grip a portion of the fixed arm 4007 or to interact with the safety member 4610 to control the movement of the movable arm 4008 relative to the fixed arm 4007. In the disabled position, the stopper 4605 is positioned far away from the movable arm 4008 to avoid grasping the fixed arm 4007 and therefore controlling the movement of the movable arm 4008 relative to the fixed arm 4007.
[0268] The base region 4615 may include a notch 4616A and a notch 4616B disposed within a slide channel 4617 configured to receive the stopper 4605. The notch 4616A and the notch 4616B may be recesses or notches on the base region 4615. The notch 4616A may secure the stopper 4605 in the active position, and the notch 4616B may secure the stopper 4605 in the inactive position. The notch 4616A may be located away from a side edge of the movable arm 4008 to secure the stopper 4605 close to the movable arm 4008 in the active position. The notch 4616B may be located closer to the side edge of the movable arm 4008 to secure the stopper 4605 farther from the movable arm 4008 in the inactive position.
[0269] 37C , the stopper 4605 can include a protrusion 4608 that can be secured in the cutout 4616A or the cutout 4616B. For example, the protrusion 4608 can be a ridge or a tubular portion that protrudes from the stopper 4605. The protrusion 4608 can slide or snap into the cutout 4616A or the cutout 4616B. The protrusion 4608 can secure the stopper 4605 in the active position by sliding into the cutout 4616A. The protrusion 4608 can secure the stopper 4605 in the inactive position by sliding into the cutout 4616B.
[0270] 37D and 37E, in the disabled position, the stopper 4605 is positioned away from the fixed arm 4007 and the safety member 4610, and the stopper 4605 and the safety member 4610 cannot move together. Regardless of the position of the lever 4003 and therefore the safety member 4610, when the stopper 4605 is in the disabled position, the safety member 4610 can be positioned so as not to protrude relative to the stopper 4605.
[0271] 38A and 38B show an embodiment of a suturing device 4001A including a stopper 4605 in a disabled position that allows movement of the movable arm 4008 when the needle 4201 is not secured. When the stopper 4605 is in the disabled position, the movable arm 4008 is able to move even when the lever 4003 is in the second position 4110B and the needle 4201 is not secured in either the first or second gripping slot 4103 or 4104. By allowing movement of the movable arm 4008 when the lever 4003 is in the second position 4110B, the needle 4201 may be released, such as at the end of a suturing operation. In the disabled position, the stopper 4605 allows the lever 4003 to move from the first position 4110A or the third position 4110C to the second position 4110B, thereby allowing the needle 4201 to be loaded, removed, reloaded, etc. in the loading device 4010 described below.
[0272] 39A shows one embodiment of a suturing device 4001 A. In some embodiments, a first handle 4002A is coupled to a movable arm 4008 by a pair of first fasteners 4301A and 4301B. In some embodiments, a second handle 4002B is coupled to a stationary arm 4007 by a pair of second fasteners 4302A and 4302B.
[0273] 39B and 39C show an embodiment of a suturing device 4001A having an attachment member 4035A and an attachment member 4035B. In some embodiments, the attachment member 4035A or 4035B is pre-loaded with a needle 4201. As shown in FIG. 39B, the attachment member 4035A can be configured to be attached to a movable jaw 4006 configured to receive the attachment member 4035A. As shown in FIG. 39C, the attachment member 4035B can be configured to be attached to a fixed jaw 4005 configured to receive the attachment member 4035B. For example, instead of loading the needle 4201 into the second gripping slot 4104, the attachment member 4035A having (loaded with) the needle 4201 can be attached to the movable jaw 4006 of the suturing device 4001A. In another example, instead of loading the needle 4201 into the first grasping slot 4103, an attachment member 4035B having (loaded with) the needle 4201 can be attached to the fixed jaw 4005 of the suturing device 4001A. In some embodiments, upon completion of the suturing procedure, the attachment member 4035A or attachment member 4035B can be removed along with the needle 4201, and another attachment member 4035A or attachment member 4035B having a replacement needle 4201 can be attached to the fixed jaw 4005 or the movable jaw 4006. In some embodiments, the operator can use the same needle 4201 to sew two or more sutures. For example, if the procedure requires, the operator can use the same needle 4201 to sequentially perform sutures, which is referred to as a Z suture or a figure-of-eight suture.
[0274] 40A and 40B illustrate embodiments of the shape of a suturing device (e.g., suturing device 4001A or suturing device 4001B). The size, shape, and angle of these suturing devices can vary and are optimized based on the anatomy in which the suturing device is to be used. The suturing device can have an optimized size and angle to allow for positional precision in a safe and minimally invasive manner to repair pelvic floor disorders.
[0275] The size and angle of the device can be selected depending on the target ligament that each device is designed to reach for suturing and the path that each device must follow to reach the target ligament. For example, this path may contain obstacles such as hard and soft tissue. According to the size and angle, during a surgical procedure using the suturing device, the suturing device can be manipulated along the path to deliver the device to each target ligament in the least invasive manner. For example, the path may be within the pelvic cavity, which is very similar between patients and may minimize standard deviation. This allows for accurate calculations even when physical parameters (e.g., height, weight, etc.) vary between patients. The size and angle can be selected depending on the target ligament. For example, when the device is delivered to the target ligament, the outer contour of the fixed jaw 4005 can be used for positional accuracy.
[0276] The suturing device can have a length that allows the handles 4002A and 4002B to be positioned outside the cavity during operation of the suturing device, while the length defines the portion of the suturing device that can be positioned inside the cavity. For example, the suturing device can have a length and angle for a transvaginal approach or transvaginal surgery. As shown in FIG. 40A , the fixed jaw 4005 can be extended at an angle of 77.2° relative to the fixed arm 4007. The length 4037A can be measured from the tip of the fixed jaw 4005 to the fixed arm 4007. As shown in FIG. 40B , the fixed arm 4007 can have a distal portion that extends at an angle of 15.88° relative to the proximal portion. The fixed jaw 4005 can be extended at an angle of 130° relative to the fixed arm 4007. The fixed jaw 4005 and the fixed arm 4007 can have a length 4037B. It is contemplated that the suturing device may be modified by modifying the size, shape, and angle to optimize the suturing device for a particular cavity and procedure.
[0277] FIGS. 41A, 41B, and 41C illustrate one embodiment of a suturing device 4001B. The suturing device 4001B may be similar to the suturing device 4001A, except that its components have different angles, sizes, and shapes to optimize the suturing device 4001B for the anatomy in which it will be used. FIG. 41C is an exploded view of one embodiment of the suturing device 4001B. In some embodiments, a pair of first fasteners 4301A and 4301B couple a first handle 4002A to a fixed arm 4007. In some embodiments, a pair of second fasteners 4302A and 4302B couple a second handle 4002B to a movable arm 4008. In some embodiments, the suturing device 4001B can use an attachment member 4035A or an attachment member 4035B as described with reference to FIGS. 39...
Claims
1. 1. A suturing device comprising: a first jaw including a first gripping slot configured to receive a needle; a second jaw including a second gripping slot configured to receive the needle; a needle transport mechanism; The needle transport mechanism includes: a first gripping member disposed on the first jaw and selectively extendable within the first gripping slot; a first wire coupled to the first gripping member and configured to change length in response to an applied current; a second gripping member disposed on the second jaw; the second wire coupled to the second gripping member and configured to change length in response to an applied current; Including, the first gripping member is configured to releasably couple with the needle; the second gripping member is configured to releasably couple with the needle. Suturing device.
2. 1. A suturing system comprising: a suturing device and an energy source; The suturing device comprises: a first jaw including a first gripping slot configured to receive a needle; a second jaw including a second gripping slot configured to receive the needle; a needle transport mechanism; The needle transport mechanism includes: a first gripping member disposed on the first jaw; a first wire coupled to the first gripping member and configured to change length in response to an applied current; a second gripping member disposed on the second jaw; a second wire coupled to the second gripping member and configured to change length in response to an applied current; Including, the first gripping member is configured to releasably couple with the needle; the second gripping member is configured to releasably couple with the needle; the energy source is coupled to the first wire and the second wire and configured to supply an electric current to the first wire and the second wire; Suture system.
3. 1. A method comprising: opening a second jaw of the suturing device relative to a first jaw of the suturing device, the first jaw includes a first gripping slot configured to receive a needle and a first gripping member configured to removably couple with the needle to retain the needle in the first gripping slot; the second jaw includes a second gripping slot configured to receive the needle and a second gripping member configured to removably couple with the needle to retain the needle in the second gripping slot; the needle is coupled to the first gripping member and held within the first gripping slot of the first jaw; closing the second jaw against the first jaw, optionally positioning the suturing device such that target tissue is between the first and second jaws before closing the second jaw; transferring the needle from the first gripping slot of the first jaw to the second gripping slot of the second jaw, the transfer including applying an electric current to a first wire coupled to the first gripping member to change a length of the first wire to separate the first gripping member from the needle; A method comprising:
4. A transport mechanism for a suturing device, comprising: including wires, the wire is coupled to a needle; the wire is coupled to an energy source configured to provide an electrical current to the wire; The wire is configured to change length in response to the supply of an electric current; The wire is configured to move the needle from a first position to a second position when an electric current is applied to the wire. Transfer mechanism.
5. further comprising a potential energy member; the potential energy member is configured to transition between a first configuration and a second configuration; the potential energy member is configured to move the needle from the second position to the first position when transitioning from the second configuration to the first configuration. The transfer mechanism of claim 4 .
6. A transport mechanism for a suturing device, comprising: including wires, the wire is coupled to a gripping member; the wire is coupled to an energy source configured to provide an electrical current to the wire; The wire is configured to change length in response to the supply of an electric current; the wire is configured to move the gripping member from a first position to a second position when an electric current is applied to the wire; the gripping member is configured to couple to the needle in the first position; The gripping member is configured to separate from the needle in the second position. Transfer mechanism.
7. further comprising a potential energy member; the potential energy member is configured to transition between a first configuration and a second configuration; the potential energy member is configured to move the gripping member from the second position to the first position when transitioning from the second configuration to the first configuration. The transfer mechanism of claim 6 .
8. 1. A suturing device comprising: a needle transport mechanism; a fiber optic camera including an optical wire extending through the suturing device, the fiber optic camera configured to generate image data of a surgical site of the suturing device; 1. A suturing device comprising:
9. 1. A suturing device comprising: a needle transport mechanism; an electric field sensor disposed on a surface of the suturing device and configured to identify the location of nerves at and around a surgical site of the suturing device; 1. A suturing device comprising:
10. 1. A suturing device comprising: a first jaw including a first gripping slot configured to receive a needle; a second jaw including a second gripping slot configured to receive the needle; a piezoelectric film disposed on a surface of at least one of the first jaw and the second jaw and configured to vibrate the at least one of the first jaw and the second jaw; 1. A suturing device comprising:
11. 1. A suturing device comprising: A long, slender body and Needles and a needle transport mechanism including a wire coupled to the needle and an energy source; Including, The wire is configured to change length in response to the supply of an electric current; The wire is configured to move the needle when an electric current is applied to the wire. Suturing device.
12. 1. A suturing device comprising: a locking arm integral with the locking jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a datum on the fixed arm; a needle transport mechanism; The needle transport mechanism includes: a first gripping member configured to secure and release the needle in the first gripping slot and to selectively engage the needle while the needle is disposed in the first gripping slot; the first wire coupled to the first gripping member and configured to change length in response to an electric current supplied thereto; a second gripping member configured to secure the needle in and release the needle from the second gripping slot and configured to selectively engage the needle while the needle is disposed in the first gripping slot; the second wire coupled to the second gripping member and configured to change length in response to an applied current; Including, Suturing device.
13. The suturing device of claim 12, wherein the fixed arm further includes an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm about the arm joint.
14. 14. The suturing device of claim 13, wherein the fixed arm further includes a jaw joint disposed on the datum, the jaw joint coupled to the movable jaw, the movable jaw configured to pivot relative to the fixed jaw about the jaw joint.
15. 15. The suturing device of claim 14, further comprising a connection joint configured to couple the movable arm and the movable jaw, the movable arm configured to move the connection joint to pivot the movable jaw about the jaw joint.
16. 1. A suturing device comprising: a locking arm integral with the locking jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a datum on the fixed arm; a needle transport mechanism including a first wire and a second wire configured to secure the needle in the first gripping slot or the second gripping slot; Including, The first wire and the second wire are The length of each of the electrodes is changed depending on the current supplied thereto. configured to control a first gripping member and a second gripping member to hold the needle in the first gripping slot and the second gripping slot and to release the needle from the first gripping slot and the second gripping slot; Suturing device.
17. 1. A suturing device comprising: a needle configured to include a channel for threading a suture; a locking arm integral with a locking jaw including a first gripping slot configured to receive the needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a datum on the fixed arm; a needle transport mechanism including a first needle securement member and a second needle securement member configured to secure the needle in the first gripping slot or the second gripping slot; Including, the first and second needle securement members are coupled to first and second wires and configured to engage one or more features on the needle and selectively retain and release the needle relative to the first and second gripping slots in response to current supplied to the first and second wires; Suturing device.
18. 1. A suturing device comprising: a first jaw including a first gripping slot configured to receive a needle; a second jaw including a second gripping slot configured to receive the needle; a needle transport mechanism; The needle transport mechanism includes: a first gripping member disposed on the first jaw and selectively extendable within the first gripping slot; a first wire coupled to the first gripping member and configured to change length in response to an applied current; a first potential energy member configured to transition between a first configuration and a second configuration to apply a force to the first gripping member; a second gripping member disposed on the second jaw; a second wire coupled to the second gripping member and configured to change length in response to an applied current; a second potential energy member configured to transition between a first configuration and a second configuration to apply a force to the second gripping member; Including, the first gripping member is configured to releasably couple with the needle; the second gripping member is configured to releasably couple with the needle. Suturing device.
19. 1. A suturing device comprising: a locking arm integral with the locking jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a datum on the fixed arm; a needle transport mechanism; Including, The needle transport mechanism includes: a first gripping member configured to secure and release the needle in the first gripping slot and to selectively engage the needle while the needle is disposed in the first gripping slot; a first wire coupled to the first gripping member and configured to change length in response to an applied current; a first potential energy member configured to transition between a first configuration and a second configuration to apply a force to the first gripping member; a second gripping member configured to secure the needle in and release the needle from the second gripping slot and configured to selectively engage the needle while the needle is disposed in the first gripping slot; a second wire coupled to the second gripping member and configured to change length in response to an applied current; a second potential energy member configured to transition between a first configuration and a second configuration to apply a force to the second gripping member; Including, Suturing device.
20. 1. A suturing device comprising: A long, slender body and a fixed jaw body extending from the elongate body and including a linear guide; a fixed jaw fixedly coupled to and extending from the fixed jaw body; a movable jaw coupled to the fixed jaw body in the linear guide and configured to move linearly within the linear guide relative to the fixed jaw; A drive mechanism; Including, The drive mechanism includes a wire configured to move the movable jaw along the linear guide, the wire being configured to change length in response to a current supplied thereto. Suturing device.
21. the drive mechanism further includes a potential energy member; the wire is configured to move the movable jaw in a first direction along the linear guide; the potential energy member is configured to move the movable jaw along the linear guide in a second direction opposite the first direction.
21. The suturing device of claim 20.
22. 1. A suturing device comprising: A long, slender body and a fixed jaw body extending from the elongate body and including a jaw joint; a fixed jaw fixedly coupled to and extending from the fixed jaw body; a movable jaw coupled to the fixed jaw body and configured to pivot relative to the fixed jaw about the jaw joint; A drive mechanism; Including, the drive mechanism includes a wire configured to rotate the movable jaw about the jaw joint, the wire configured to change length in response to an electric current supplied thereto; Suturing device.
23. the drive mechanism further includes a potential energy member; the wire is configured to rotate the movable jaw about the jaw joint in a first direction; the potential energy member is configured to rotate the movable jaw about the jaw joint in a second direction opposite the first direction.
23. The suturing device of claim 22.
24. 1. A suturing device comprising: Needles and a first needle retaining member including a first port configured to receive the needle; a second needle retaining member aligned with the first needle retaining member, the second needle retaining member including a second port configured to receive the needle; a needle transport mechanism disposed at least partially within the first needle holding member; Including, the needle transport mechanism includes a wire coupled to the needle; The wire is configured to change length in response to a supplied current; the needle transport mechanism is configured to move the needle from the first port of the first needle holding member to the second port of the second needle holding member. Suturing device.
25. The suturing device of claim 24, wherein the first needle retaining member and the second needle retaining member are fixed relative to one another.
26. 1. A suturing device comprising: a first jaw including a first gripping slot configured to receive a needle; a second jaw movable relative to the first jaw, the second jaw including a second gripping slot configured to receive the needle; a needle transport mechanism configured to secure the needle to the first gripping slot or the second gripping slot and to release the needle from the first gripping slot or the second gripping slot; Including, the needle transport mechanism includes a wire, the wire configured to change length in response to an electric current applied thereto; Suturing device.
27. The needle transport mechanism includes: a first gripping member disposed on the first jaw and selectively extendable within the first gripping slot; a first wire coupled to the first gripping member and configured to change length in response to an applied current; a second gripping member disposed on the second jaw and selectively extendable within the second gripping slot; a second wire coupled to the second gripping member and configured to change length in response to an applied current; Including, the first gripping member is configured to releasably couple with the needle; 27. The suturing device of any one of claims 24 to 26, wherein the second gripping member is configured to releasably couple with the needle.
28. the first wire is configured to move the first gripping member from a first position to a second position when an electric current is applied to the first wire; the first gripping member is configured to couple to the needle in the first position; 28. The suturing device of any one of claims 24 to 27, wherein the first gripping member is configured to separate from the needle in the second position.
29. further comprising a first potential energy member; the first potential energy member is configured to transition between a first configuration and a second configuration; 29. The suturing device of any one of claims 24 to 28, wherein the first potential energy member is configured to move the first gripping member from the second position to the first position when transitioning from the second configuration to the first configuration.
30. the second wire is configured to move the second gripping member from a first position to a second position when an electric current is applied to the second wire; the second gripping member is configured to couple to the needle in the first position; 30. The suturing device of any one of claims 24 to 29, wherein the second gripping member is configured to separate from the needle at the second position.
31. further comprising a second potential energy member; the second potential energy member is configured to transition between a first configuration and a second configuration; 31. The suturing device of any one of claims 24 to 30, wherein the second potential energy member is configured to move the second gripping member from the second position to the first position when transitioning from the second configuration to the first configuration.
32. 32. The suturing device of any one of claims 24 to 31, further comprising an input configured, once actuated, to cause an energy source coupled to the first wire and the second wire to cease supplying power to the first wire and to supply power to the second wire.
33. 33. The suturing device of any one of claims 24 to 32, further comprising an input configured, once actuated, to cause an energy source coupled to the first wire and the second wire to cease supplying power to the second wire and to supply power to the first wire.
34. and an input, which, once activated, transmits to an energy source coupled to the first wire and the second wire: before operating the input unit, stopping the supply of power to one of the first wire or the second wire coupled to one of the first gripping member or the second gripping member that is not coupled to the needle; and Before the input unit is operated, power is supplied to one of the first wire and the second wire coupled to one of the first gripping member and the second gripping member coupled to the needle. It is configured as follows:
34. The suturing device of any one of claims 24 to 33.
35. further comprising a first input portion and a second input portion; the first input is configured, once activated, to cause an energy source coupled to the first wire and the second wire to stop supplying power to the first wire and to supply power to the second wire; the second input is configured, once activated, to cause the energy source coupled to the first wire and the second wire to stop supplying power to the second wire and to supply power to the first wire.
35. The suturing device of any one of claims 24 to 34.
36. A first handle; A second handle; a force sensor; further comprising the force sensor is configured to detect contact and a closing force between the first handle and the second handle when the first handle and the second handle are closed; The force sensor is configured to cause an energy source coupled to the first wire and the second wire to stop applying power to the first wire and to apply power to the second wire upon detecting a threshold force.
36. The suturing device of any one of claims 24 to 35.
37. 37. The suturing device of any one of claims 24 to 36, wherein the force sensor is configured to cause the energy source to stop supplying power to the second wire and to supply power to the first wire upon detecting the threshold force.
38. A first handle; A second handle; a force sensor; further comprising the force sensor is configured to detect contact and a closing force between the first handle and the second handle when the first handle and the second handle are closed; the force sensor is configured to, upon detecting a threshold force, cause an energy source coupled to the first wire and the second wire to stop supplying power to one of the first wire or the second wire coupled to one of the first gripping member or the second gripping member that is not coupled to the needle before detecting the threshold force; 38. The suturing device of any one of claims 24 to 37, wherein the force sensor is configured, upon detecting the threshold force, to cause the energy source coupled to the first wire and the second wire to supply power to one of the first wire or the second wire that is coupled to one of the first gripping member or the second gripping member that is coupled to the needle prior to detecting the threshold force.
39. a fixed arm integral with said first jaw; a movable arm movably coupled to the second jaw; further comprising the second jaw is configured to pivot relative to the fixed jaw about a datum on the fixed arm; 39. The suturing device of any one of claims 24 to 38.
40. 40. The suturing device of any one of claims 24 to 39, wherein the fixed arm further includes an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm about the arm joint.
41. 41. The suturing device of any one of claims 24 to 40, wherein the stationary arm further includes a jaw joint disposed on the datum, the jaw joint coupled to the second jaw, the second jaw configured to pivot relative to the first jaw about the jaw joint.
42. 42. The suturing device of any one of claims 24 to 41, further comprising a connection joint configured to couple the movable arm and the second jaw, the movable arm configured to move the connection joint to pivot the second jaw about the jaw joint.
43. a fixed jaw body including a linear guide; the first jaw fixedly coupled to and extending from the fixed jaw body; the second jaw coupled to the fixed jaw body in the linear guide and configured to move linearly within the linear guide relative to the first jaw; A drive mechanism; further comprising The drive mechanism includes a wire configured to move the second jaw along the linear guide, the wire being configured to change length in response to an electric current supplied thereto.
43. The suturing device of any one of claims 24 to 42.
44. the drive mechanism further includes a potential energy member; the wire is configured to move the second jaw in a first direction along the linear guide; the potential energy member is configured to move the second jaw along the linear guide in a second direction opposite the first direction.
44. The suturing device of any one of claims 24 to 43.
45. a fixed jaw body including a jaw joint; the first jaw fixedly coupled to and extending from the fixed jaw body; the second jaw coupled to the fixed jaw body and configured to pivot relative to the first jaw about the jaw joint; A drive mechanism; Further includes the drive mechanism includes a wire configured to rotate the second jaw about the jaw joint, the wire configured to change length in response to an electric current supplied thereto.
45. The suturing device of any one of claims 24 to 44.
46. the drive mechanism further includes a potential energy member; the wire is configured to rotate the second jaw about the jaw joint in a first direction; the potential energy member is configured to rotate the second jaw about the jaw joint in a second direction opposite the first direction.
46. The suturing device of any one of claims 24 to 45.
47. a fixed arm integral with said first jaw; a first handle coupled to a proximal end of the stationary arm; a movable arm movably coupled to the second jaw configured to pivot relative to the fixed jaw about a datum on the fixed arm; a second handle coupled to a proximal end of the movable arm; 47. The suturing device of any one of claims 24 to 46, further comprising:
48. 48. The suturing device of any one of claims 24 to 47, further comprising a single handle.
49. 49. The suturing device of any one of claims 1 to 48, further comprising a fiber optic camera including an optical wire extending through the suturing device, the fiber optic camera configured to generate image data of a surgical site of the suturing device.
50. 50. The suturing device of any one of claims 1 to 49, further comprising an electric field sensor disposed on a surface of the suturing device and configured to identify the location of nerves at and around a surgical site of the suturing device.
51. 51. The suturing device of any one of claims 1 to 50, further comprising a piezoelectric film disposed on a surface of at least one of the first jaw or the second jaw, the piezoelectric film configured to vibrate the at least one of the first jaw or the second jaw.
52. 1. A suturing device comprising: a locking arm integral with the locking jaw including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a movable arm including a second gripping slot configured to receive the needle and configured to pivot relative to the fixed jaw about a datum on the fixed arm; a needle transport mechanism including a first plate and a second plate configured to secure the needle in the first gripping slot or the second gripping slot and release the needle from the first gripping slot or the second gripping slot, the first plate and the second plate configured to selectively engage the needle while the needle is disposed in the first gripping slot or the second gripping slot; at least one of a fiber optic camera, an electric field sensor, or a piezoelectric film; 1. A suturing device comprising:
53. the first plate includes a first control bar configured to advance the first gripping member toward a first receptacle of the needle disposed in the first gripping slot to grip the needle in the first gripping slot or to retract the first gripping member from the first receptacle to release the needle from the first gripping slot; the second plate includes a second control bar configured to advance the second gripping member toward a second receptacle for the needle disposed in the second gripping slot to grip the needle in the second gripping slot or to retract the second gripping member from the second receptacle to release the needle from the second gripping slot; 53. The suturing device of claim 52.
54. Further comprising a lever, said lever comprising: a first position in which the first control bar is advanced to grasp the needle in the first grasping slot and the second control bar is retracted to release the needle from the second grasping slot; a second position in which the first control bar is retracted to release the needle from the first gripping slot and the second control bar is retracted to release the needle from the second gripping slot; a third position in which the first control bar is retracted to release the needle from the first gripping slot and the second control bar is advanced to grip the needle in the second gripping slot; configured to move between 54. The suturing device of claim 52 or 53.
55. 55. The suturing device of any one of claims 52 to 54, further comprising a cover partially positioned over the lever, the cover including indicators corresponding to movement of the lever to the first position, the second position, and the third position.
56. 56. The suturing device of any one of claims 52 to 55, further comprising a switch joint coupled to the first control bar and the second control bar.
57. 57. The suturing device of any one of claims 52 to 56, wherein the lever is coupled to the switch joint, the lever configured to rotate the switch joint to move the first control bar and the second control bar.
58. 58. The suturing device of any one of claims 52 to 57, wherein the fixed arm further includes an arm joint coupled to the movable arm, the movable arm configured to pivot relative to the fixed arm about the arm joint.
59. 59. The suturing device of any one of claims 52 to 58, wherein the fixed arm further includes a jaw joint disposed on the datum, the jaw joint coupled to the movable jaw, the movable jaw configured to pivot relative to the fixed jaw about the jaw joint.
60. 60. The suturing device of any one of claims 52 to 59, further comprising a connection joint configured to couple the movable arm and the movable jaw, the movable arm configured to move the connection joint to pivot the movable jaw about the jaw joint.
61. 61. The suturing device of any one of claims 52 to 60, further comprising one or more image sensors including one or more optical wires extending through the suturing device, the one or more image sensors configured to generate image data of a surgical site of the suturing device.
62. 62. The suturing device of any one of claims 52 to 61, further comprising one or more electric field sensors disposed on a surface of the suturing device and configured to identify the location of nerves at and around a surgical site of the suturing device.
63. 63. The suturing device of any one of claims 52 to 62, further comprising one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw, the one or more piezoelectric films configured to vibrate the at least one of the first jaw or the second jaw.
64. A suturing method comprising: forming an incision in the vaginal wall to access the patient's pelvic cavity; placing a first suturing device through the incision adjacent to a first target tissue within the pelvic cavity, the first target tissue being a first arcus tendineus fasciae pelvis (ATFP) within the pelvic cavity; placing at least one suture within the first ATFP using the first suturing device; placing at least one suture in the vesicovaginal fascia, wherein the at least one suture in the vesicovaginal fascia is connected to at least one suture in the first ATFP; pulling at least one suture in the first ATFP and at least one suture in the vesicovaginal fascia to form a loop, thereby approximating the vaginal wall to the first ATFP; A suturing method comprising:
65. 65. The method of claim 64, wherein the vaginal wall, bladder neck, and urethra are lifted by pulling at least one suture in the first ATFP and at least one suture in the vesicovaginal fascia.
66. positioning the first suturing device through the incision adjacent to a second target tissue within the pelvic cavity, the second target tissue being a second ATFP within the pelvic cavity; placing at least one suture within the second ATFP; placing at least one suture in the vesicovaginal fascia, wherein at least one suture in the vesicovaginal fascia is connected to at least one suture in the second ATFP; pulling at least one suture in the second ATFP and at least one suture in the vesicovaginal fascia to form a loop, thereby approximating the vaginal wall to the second ATFP; 66. The method of claim 64 or 65, further comprising:
67. 67. The method of any one of claims 64 to 66, wherein at least one anatomical location of the vaginal wall, bladder neck, or urethra within the pelvic cavity is repaired.
68. 68. The method of claim 67, wherein the anatomical location of the vaginal wall, bladder neck, or urethra, respectively, within the pelvic cavity is restored.
69. 69. The method of any one of claims 64 to 68, wherein at least one physiological function of the vaginal wall, bladder neck, or urethra in the pelvic cavity is restored.
70. 70. The method of claim 69, wherein the physiological function of the vaginal wall, bladder neck, or urethra in the pelvic cavity, respectively, is restored.
71. 65. The method of claim 64, wherein the at least one suture is formed from at least one of a thread, a fiber, a filament, and a wire.
72. 65. The method of claim 64, wherein the at least one suture is formed from an absorbable material.
73. 65. The method of claim 64, wherein the at least one suture is formed from a non-absorbable material.
74. 72. The method of any one of claims 64 to 71, wherein at least one suture in the first ATFP or the second ATFP is positioned in an anterior-posterior portion of the first ATFP or the second ATFP.
75. 75. The method of claim 74, wherein at least one suture in the first ATFP or the second ATFP is placed at the junction of the pubic ramus and pubic symphysis.
76. 76. The method of claim 74 or 75, wherein at least one suture in the first ATFP or the second ATFP comprises a first suture and a second suture, the first suture being positioned in an anterior-posterior portion of the first ATFP or the second ATFP, and the second suture being positioned in a medial-lateral pubic portion of the first ATFP or the second ATFP, 0.5 to 1 cm posterior-inferior to the first suture.
77. 77. The method of any one of claims 64 to 76, further comprising, after forming the incision in the vaginal wall and before placing the suturing device within the pelvic cavity, forming a dissection above the vesicovaginal fascia toward the junction of the pubic ramus and pubic symphysis.
78. 78. The method of any one of claims 64 to 77, wherein the repair is performed using only the sutures without the use of a mesh.
79. 71. The method of any one of claims 64 to 70, wherein approximation of the vesicovaginal fascia to the bilateral ATFP restores the connection between the pelvic floor structures and the urethra and bladder neck.
80. 65. The method of claim 64, wherein the at least one suture in the vesicovaginal fascia is placed with a second suturing device.
81. 65. The method of claim 64, further comprising palpating tissue to locate a target tissue within the pelvic cavity.
82. A suturing method comprising: forming a transverse incision in the vaginal wall to access the patient's pelvic cavity; placing a suturing device through the incision adjacent to a target tissue within the pelvic cavity, the target tissue being a sacrospinous ligament within the pelvic cavity; placing a plurality of sutures into the target tissue; placing a plurality of sutures in the cervical or vaginal stump; tensioning the plurality of sutures to form loops with the sutures passing through the sacrospinous ligament and the cervix or vaginal stump to correct the vaginal stump prolapse; A suturing method comprising:
83. A suturing method comprising: forming an incision in the vaginal wall to access the patient's pelvic cavity; placing a suturing device within the pelvic cavity through the incision, the suturing device including a movable jaw and a fixed jaw; opening the movable jaw relative to the fixed jaw so that a target tissue within the pelvic cavity is located between the movable jaw and the fixed jaw, the target tissue being each arcus tendineus fascia pelvis (ATFP) within the pelvic cavity; placing a plurality of sutures in the target tissue, the plurality of sutures being placed in each arcus tendineus fasciae pelvis (ATFP); placing a plurality of sutures in the vesicovaginal fascia; pulling the sutures to form loops with the sutures passing through the ATFP and the vesicovaginal fascia, approximating the vaginal wall to the ATFP on both sides and elevating the vaginal wall, bladder neck, and urethra to restore their respective anatomical and physiological positions within the pelvic cavity; A suturing method comprising:
84. 84. The method of claim 83, further comprising creating a dissection above the vesicovaginal fascia toward the junction of the pubic ramus and pubic symphysis.
85. 84. The method of claim 83, further comprising palpating tissue to identify a location of a target tissue within the pelvic cavity.
86. 84. The method of claim 83, further comprising pulling the suturing device away from the target tissue to create a distance between the suturing device and the target tissue and opening the movable jaw relative to the fixed jaw.
87. The suturing device comprises: a locking jaw integral with the distal end of the locking arm and including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a distal end of the movable arm, the movable jaw including a second gripping slot configured to receive the needle, the movable jaw configured to pivot relative to the fixed jaw about a datum on the fixed arm; 84. The method of claim 83, further comprising:
88. 88. The method of claim 87, wherein the distal end of the fixed arm and the distal end of the movable arm are angled to precisely reach the target tissue within the pelvic cavity to be sutured through the vaginal incision.
89. The suturing device comprises: a locking jaw integral with the distal end of the locking arm and including a first gripping slot configured to receive a needle; a movable jaw movably coupled to a distal end of the movable arm, the movable jaw including a second gripping slot configured to receive the needle, the movable jaw configured to move linearly relative to the fixed arm; 84. The method of claim 83, further comprising:
90. The suturing device comprises: The handle and an elongate arm connected at a proximal end to the handle and having a first jaw and a second jaw disposed at a distal end, the first jaw being movable and including a first gripping slot configured to receive a needle, and the second jaw being fixed and including a second gripping slot configured to receive the needle; a mandrel mechanism configured to connect the handle to the elongate arm such that the first and second jaws at the distal end of the elongate arm rotate about a longitudinal axis of the elongate arm, allowing the first and second jaws to assume any angular position while the handle remains fixed; and 84. The method of claim 83, further comprising:
91. The suturing device The handle and an elongate arm connected at a proximal end to the handle and having a first jaw and a second jaw disposed at a distal end, the first jaw including a first gripping slot configured to receive a needle, the second jaw including two gripping slots configured to receive the needle, and a locking opening provided between the first and second jaws; 84. The method of claim 83, further comprising:
92. A suturing method comprising: placing a suturing device within the patient's pelvic cavity through an incision in the vaginal wall, the suturing device including a movable jaw and a fixed jaw; opening the movable jaw relative to the fixed jaw so that a target tissue within the pelvic cavity is located between the movable jaw and the fixed jaw, the target tissue being the arcus tendineus fascia pelvis (ATFP); placing a plurality of sutures into the target tissue by performing Z-stitches with the suturing device; A suturing method comprising:
93. 93. The method of claim 92, further comprising palpating tissue to locate a target tissue within the pelvic cavity.
94. A suturing method comprising: placing a suturing device within a patient's pelvic cavity, said suturing device including a movable jaw and a fixed jaw; opening the movable jaw relative to the fixed jaw so that a target tissue within the pelvic cavity is positioned between the movable jaw and the fixed jaw; treating pelvic organ prolapse by suturing the target tissue with the suturing device and placing a plurality of sutures in the target tissue to suture the target tissue to a vaginal wall stump or a cervix, wherein the target tissue is in the form of a ligament within the pelvic cavity, and suturing the ligament to the vaginal wall stump or the cervix elevates the vaginal apex; A suturing method comprising:
95. 95. The method of claim 94, further comprising palpating tissue to locate a target tissue within the pelvic cavity.
96. A suturing method comprising: placing a suturing device into the patient's pelvic cavity through an opening in the vaginal wall, the suturing device including a movable jaw, a fixed jaw, and a needle; opening the movable jaw relative to the fixed jaw so that a target tissue within the pelvic cavity is positioned between the movable jaw and the fixed jaw; operating the movable jaw relative to the fixed jaw, wherein the movable jaw moves toward the fixed jaw and a needle disposed in at least one of the movable jaw and the fixed jaw moves through the target tissue to apply a suture to the target tissue; Including, Optionally, the suturing device is sized and shaped to be received through the vaginal wall into the pelvic cavity and to place sutures to elevate the vaginal wall, bladder neck, and urethra to restore their anatomical and physiological positions within the pelvic cavity. Suture method.
97. 97. The method of claim 96, further comprising palpating tissue to locate a target tissue within the pelvic cavity.
98. The suturing device comprises: a locking jaw integral with the distal end of the locking arm and including a first gripping slot configured to receive a needle; a movable jaw operably coupled to a distal end of the movable arm and including a second gripping slot configured to receive the needle; and wherein the movable jaw is configured to pivot relative to the fixed jaw about a reference position on the rigid arm while the fixed jaw remains stationary.
97. The method of claim 96.
99. 99. The method of claim 98, wherein the distal end of the fixed arm and the distal end of the movable arm are angled to precisely reach the target tissue within the pelvic cavity to be sutured through the vaginal wall.
100. 1. A suturing device comprising: The handle and an elongate arm connected at a proximal end to the handle and having a first jaw and a second jaw disposed at a distal end, the first jaw being movable and including a first gripping slot configured to receive a needle, and the second jaw being fixed and including a second gripping slot configured to receive the needle; a mandrel mechanism configured to connect the handle to the elongate arm such that the first and second jaws at the distal end of the elongate arm rotate about a longitudinal axis of the elongate arm, allowing the first and second jaws to assume any angular position while the handle remains fixed; and 1. A suturing device comprising:
101. 101. The suturing device of claim 100, wherein the mandrel mechanism includes a user-operated button configured to move a spring-loaded pin disposed within the mandrel mechanism into one of at least one recess disposed along an angular path of the mandrel mechanism.
102. 102. The suturing device of claim 101, wherein the position of the spring-loaded pin within one of the at least one recess is configured to set an angular position of the first jaw and the second jaw.
103. 101. The suturing device of claim 100, further comprising a lever mechanism configured to move the first jaw relative to the second jaw on a linear guide.
104. 104. The suturing device of claim 103, wherein the lever mechanism has a distal position in which the first and second jaws are fully closed and a proximal position in which the first and second jaws are fully open.
105. 101. The suturing device of claim 100, further comprising a needle transport mechanism configured to transport a needle between a first grasping slot of the first jaw and a second grasping slot of the second jaw to apply a suture to a target tissue.
106. The needle transport mechanism includes: a toggle switch configured to move between a distal position and a proximal position to transfer the needle between the first jaw and the second jaw using a first cable and a second cable; a distal position of the toggle switch pulling the first cable to transfer the needle from the first jaw to the second jaw; In the proximal position of the toggle switch, pulling the second cable transfers the needle from the second jaw to the first jaw.
106. The suturing device of claim 105.
107. 107. The suturing device of any one of claims 100 to 106, further comprising one or more image sensors including one or more optical wires extending through the suturing device, the one or more image sensors configured to generate image data of a surgical site of the suturing device.
108. 107. The suturing device of any one of claims 100 to 106, further comprising one or more electric field sensors disposed on a surface of the suturing device and configured to identify the location of nerves at and around a surgical site of the suturing device.
109. 107. The suturing device of any one of claims 100 to 106, further comprising one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw, the one or more piezoelectric films configured to vibrate the at least one of the first jaw or the second jaw.
110. 101. The suturing device of claim 100, further comprising a dual action needle ejection button disposed at a proximal end of the handle, the dual action needle ejection button configured to eject the needle while the first jaw and the second jaw are open.
111. 1. A suturing device comprising: The handle and an elongate arm connected at a proximal end to the handle and having a first jaw and a second jaw disposed at a distal end, the first jaw including a first gripping slot configured to receive a needle, the second jaw including a second gripping slot configured to receive the needle, the first jaw and the second jaw having a locking opening therebetween; Including, the distal ends of the elongate arms are angled relative to the proximal ends to reach the target tissue to be sutured; Suturing device.
112. 112. The suturing device of claim 111, wherein the first jaw and the second jaw rotate between 60° and 90° relative to the elongate arm.
113. 112. The suturing device of claim 111, comprising one or more image sensors including one or more optical wires extending through the suturing device, the one or more image sensors configured to generate image data of a surgical site of the suturing device.
114. 112. The suturing device of claim 111, further comprising one or more electric field sensors disposed on a surface of the suturing device and configured to identify the location of nerves at and around a surgical site of the suturing device.
115. 112. The suturing device of claim 111, further comprising one or more piezoelectric films disposed on a surface of at least one of the first jaw or the second jaw, the one or more piezoelectric films configured to vibrate the at least one of the first jaw or the second jaw.
116. A suture needle, an elongate body having a proximal end and a distal end; a first circumferential slot disposed at the proximal end of the elongate body and a second circumferential slot disposed at the distal end of the elongate body, the first circumferential slot and the second circumferential slot configured to cooperate with a suturing device; a thread slot formed in an intermediate portion of the elongate body between the proximal end and the distal end of the elongate body and configured to receive a thread; Including, the thread is forcibly deformed into the thread slot and coupled to the suture needle, creating a desired retention force between the thread and the suture needle; suture needle.
117. 117. The suture needle of claim 116, wherein the thread slot has at least one of the following cross-sectional shapes: rectangular, triangular, angled, straight, linear, or circumferential.