Patent Description:
The fascial closure portion of any surgical case is critical. A well preformed minimally invasive surgery can result in a complication if this final portion of the case is neglected or done poorly. Any abdominal wall defect greater than <NUM> should be accompanied by a fascial closure to reduce the risk of incisional hernia. Incisional hernias can be very costly complications. They lead to increased hospital stays; increased patient pain and suffering; and most often times an ensuing operation. Incisional hernias can also be life-treating if the bowel becomes strangulated and ischemic. The rates of incisional hernia have been alarmingly high in single incision minimally invasive techniques and have prevented such techniques from becoming more widely adapted as the standard of care.

The current technologies and devices for port site fascial closure are antiquated and require an immense amount of skill to use. Therefore, the results are not widely reproducible even in the most talented hands. The embodiments described herein will allow the integration of computer aided surgery (robotics) into the fascial closure portion of a case. As computer aided surgery continues to progress, automation will become more accepted and adopted. With automation, surgery will become safer, more uniformly reproducible and efficient. This could potentially impact overall patient outcomes, access to surgical care; and reduce overall cost by eliminating human error from the surgical suite. The disclosed embodiments will help continue the progression and widespread integration of single incision minimally invasive surgery and computer aided surgical techniques. Suture management is a problematic technical skill for robotic surgeons in general surgical cases such as ventral and incisional hernia repair Suture management is crucial during robotic surgeries of the GI tract and abdominal wall. An efficient management of suture can lower the cost of each case by reducing console and overall operating room times. Currently, when the suture is introduced into the robotic surgical field, it is unorganized and tangled. The suture is at the risk of knotting, breaking or incidentally being cut while it is being organized to begin closing a ventral defect or affixing a mesh to the anterior abdominal wall. Sometimes to avoid this issue of unmanageable suture, surgeons will reduce the length of the suture. This prevents difficulty with suture management but often contributes to multiple lengths of suture introduced by an assistant throughout the case. This practice can be time consuming. This practice can also potentially have a higher risk of a retained foreign body or incorrect counts by using multiple needles to complete one case. Document <CIT> discloses a suture passer guide including an elongate member and a suture positioning member.

Certain optional features of the invention are defined in the dependent claims. The methods described herein do not form part of the invention and are only used for illustration purposes.

In one aspect of the disclosed embodiments, a device for assisting in suturing the fascial tissue after an abdominal surgery is provided. The device could also be utilized during robotic intraabdominal, thoracic and pelvic surgery as a suture carriage. The device includes a clam-shell housing that retains a spool of suture. The loose end of the suture is clamped and retained at an end of the device so that the suture extends through an eyelet between the end and the spool. The device is inserted into the abdomen through a surgical port. A suture grabber is inserted through a guide ring and grabs the suture in the eyelet of the device. The grabber pulls the suture through the fascial tissue to form a first end to be tied. The grabber than grabs another portion of the suture and pulls a second end to be tied through the fascial tissue. The device and port are removed and the two ends are tied.

In another aspect of the disclosed embodiments, a suturing device includes a clamshell body having a first side coupled to a second side by a hinge. The first side and the second side each have a clamping end opposite the hinge. A slot is formed in each of the first side and the second side. The slot in the first side is aligned with the slot in the second side when the clamshell body is closed to form a cavity. A spool is included having a rod extending from an end cap. The end cap is retained in the cavity and is rotatable relative to the clamshell body. A suture is wound around the rod of the spool. The clamping ends of the first side and the second side lock together to capture an end of the suture.

In some embodiments, each of the first side and the second side may include a first slot and a second slot. The first slots of the first side and the second side may form a first cavity to retain a first end cap of the spool. The second slots of the first side and the second side may form a second cavity to retain a second end cap of the spool. The rod of the spool may extend between the first end cap and the second end cap.

In some embodiments, an eyelet may extend between the ends of the first side. The suture may be accessible through the eyelet. An eyelet may extend between the ends of the second side. The suture may be accessible through the eyelet. An eyelet may be formed between the first side and the second side when the first side and the second side are coupled together. The suture may be accessible through the eyelet.

In some embodiments, the suture may extend between the spool and the clamping end of the clamshell body. The clamshell body may be configured to be retained by a robotic arm. The clamshell body may be sized to be extended through a trocar.

In some embodiments, a guide ring may be configured to couple to a trocar. The guide ring may be configured to receive a suture grabber that grabs the suture in the clamshell body. The guide ring may include a conical sidewall extending between a first end and a second end. The conical sidewall may be sized to position around a trocar. The first end of the guide ring may include a flange having a plurality of openings. The openings may be sized to receive a suture grabber. An opening defined by the flange may be sized to position around a trocar. The guide ring may include a first half and a second half that is separable from the first half. The first half may be coupled to the second half to couple the guide ring to the trocar. A needle may be attached to an end of the suture for a hernia closure procedure.

In yet another aspect of the disclosed embodiments, a method of suturing an abdominal cavity includes inserting a spool of suture in the abdominal cavity. The method also includes capturing a first portion of the suture and removing the first portion from the abdominal cavity. The method also includes capturing a second portion of the suture and removing the second portion from the abdominal cavity. The method also includes tying the first portion to the second portion outside of the abdominal cavity.

In some embodiments, the spool may be retained in a clamshell body. The method may also include inserting the clamshell body into the abdominal cavity. The method may also include capturing the first portion of the suture in an eyelet of the clamshell body. The method may also include capturing the second portion of the suture in the eyelet of the clamshell body. The method may also include capturing the first portion of the suture and the second portion of the suture with a suture grabber. The method may also include inserting the suture grabber through an opening of a guide ring.

The embodiments described herein can also be utilized during robotic intra-abdominal, thoracic and pelvic surgery as a suture and needle carriage with immediate application in abdominal wall reconstruction and intra-corporeal anastomosis.

While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, and alternatives falling within the scope of the invention as defined by the appended claims.

Referring to <FIG>, an automated surgery system <NUM> includes at least one robotic arm <NUM> having a plurality of fingers <NUM> to grab surgical instruments. The robotic arm <NUM> is positioned at a surgical site so that the robotic arm <NUM> can manipulate the instruments at the surgical site. A control panel <NUM> includes a plurality of controls <NUM>, e.g. a joystick, for a surgeon to manipulate the robotic arms <NUM> during surgery.

Referring to <FIG>, a suturing instrument <NUM> is configured to be used with the automated surgery system <NUM>. In some embodiments, the suturing instrument <NUM> is used manually and held by the surgeon using a manual arm. The suturing instrument <NUM> is configured to retain a spool <NUM> of suture thread <NUM>. The suturing instrument <NUM> is positioned with a surgical site under the patient's skin and tissue. The suture thread <NUM> is retained in an eyelet <NUM> of the suturing instrument <NUM> so that the suture thread is accessible to be grabbed by another surgical instrument, i.e. a suture passer. The suture passer is inserted into the surgical site and grabs a portion of the suture thread <NUM> positioned in the surgical site. The suture thread <NUM> is then pulled out of the surgical site with the suturing instrument <NUM> remaining is position in the surgical site. The suturing instrument <NUM> is then rotated and positioned for a second pass of the suture passer. The suture passer grabs a second portion of the suture thread <NUM> and pulls the second portion from the surgical site so that two ends of the suture thread <NUM> are positioned outside of the surgical site and a segment of the suture thread <NUM> between the two ends is positioned within the surgical site. The suturing instrument <NUM> can then be removed from the surgical site with the suture thread <NUM> is place. The ends of the suture thread <NUM> are then tied together to close the surgical site. As set forth above, the suturing instrument <NUM> may be operated by the automated surgery system <NUM> or may be operated manually by the surgeon.

Referring to <FIG>, a spool <NUM> includes a center post <NUM> and a pair of ends <NUM> on each end of the center post <NUM>. Each of the ends <NUM> is circular so the spool <NUM> can roll or rotate on the ends <NUM>. The ends <NUM> have a radius <NUM> that is greater than a radius <NUM> of the center post <NUM>. The center post <NUM> is configured to retain a strand of suture thread <NUM>. The strand of suture thread <NUM> is wound around the center post <NUM>. A loose end <NUM> of the suture thread <NUM> extends from the center post <NUM> so that the loose end <NUM> can be grabbed to unwind the strand of suture thread <NUM> from the center post <NUM>.

Referring to <FIG>, a suturing instrument <NUM> is configured to retain the spool <NUM> so that the spool <NUM> can rotate with respect to the device <NUM> to unwind the strand of suture <NUM>. The suturing instrument <NUM> includes a chassis <NUM> that is configured as a clamshell body. The chassis <NUM> is created from a single piece of polymer. The chassis <NUM> is designed with a hinge <NUM> to fold upon itself while encasing the spool <NUM> and locking the thread <NUM> in place. The chassis <NUM> includes a top end <NUM> and a bottom end <NUM> coupled to the top end <NUM> by the hinge <NUM>. A body <NUM> of the top end <NUM> includes a pair of grooves <NUM> that are each configured to retain one of the ends <NUM> of the spool <NUM> so that the spool <NUM> rotates within the groove <NUM>. A pair of arms <NUM> extends from the body <NUM> to an end <NUM> that is formed by a pair of angled arms <NUM> that join along a centerline <NUM> of the chassis <NUM>. A stabilizing post <NUM> is positioned on each arm <NUM>. An eyelet <NUM> is defined between the arms <NUM>, the arms <NUM> and the body <NUM>. A length of the eyelet <NUM> can be variable depending on the robotic arm <NUM> used and the best angles for fascial approximation. A body <NUM> of the bottom end <NUM> includes a pair of grooves <NUM> that are each configured to retain one of the ends <NUM> of the spool <NUM> so that the spool <NUM> rotates within the groove <NUM>. The grooves <NUM> are configured to align with the grooves <NUM> when the chassis <NUM> is closed. A pair of arms <NUM> extends from the body <NUM> to an end <NUM> that is formed by a pair of angled arms <NUM> that join along the centerline <NUM> of the chassis <NUM>. A stabilizing post <NUM> is positioned on each arm <NUM> and is configured to align with the stabilizing posts <NUM> when the chassis <NUM> is closed. An eyelet <NUM> is defined between the arms <NUM>, the arms <NUM> and the body <NUM>. A length of the eyelet <NUM> can be variable depending on the robotic arm <NUM> used and the best angles for fascial approximation.

Referring to <FIG>, the top end <NUM> includes a notch <NUM> that is configured to receive a finger <NUM> of a robotic arm <NUM> to retain the chassis <NUM> on the robotic arm <NUM>. Likewise, the bottom end <NUM> includes a notch <NUM> that receives a finger <NUM> of a robotic arm <NUM> to retain the chassis <NUM> on the robotic arm <NUM>. The chassis <NUM> is grabbed between the fingers <NUM> of the robotic arm <NUM> so that the chassis <NUM> is retained between the fingers <NUM>. The chassis <NUM> has a depth <NUM>, as illustrated in <FIG>.

Referring to <FIG>, the bodies <NUM> and <NUM> have angled walls <NUM> that extend from the hinge <NUM>. Another angled wall <NUM> extends from each angled wall <NUM>. Outer walls <NUM> extend opposite the angled walls <NUM> and <NUM>. When the chassis <NUM> is closed, the outer walls <NUM> extend at an angle <NUM> with respect to the centerline <NUM> of the chassis <NUM>. In some embodiments, the angle <NUM> is approximately <NUM>°. The angled walls <NUM> extend at an angle <NUM> relative to the centerline <NUM>. In some embodiments, the angle <NUM> is approximately <NUM>°. When closed, the chassis <NUM> has a height <NUM> that may be equal to the depth <NUM>. The stabilizing post <NUM> includes a tab <NUM> that inserts into an opening (not shown) of the stabilizing post <NUM> to secure the stabilizing post <NUM> to the stabilizing post <NUM>. Likewise, an end jaw <NUM> of the bottom end <NUM> includes a tab <NUM> that inserts into an opening (not shown) formed in an end jaw <NUM> of the top end <NUM> to secure the top end <NUM> to the bottom end <NUM>. The thread <NUM> extends from the spool <NUM> positioned between the bodies <NUM> and <NUM>, between the stabilizing posts <NUM>, <NUM>, and to the end jaws <NUM> and <NUM>. The loose end <NUM> of the thread <NUM> is secured between the end jaws <NUM> and <NUM> of the chassis <NUM>. As illustrated in <FIG>, the thread <NUM> extends through the eyelets <NUM>, <NUM> of the chassis <NUM>.

The chassis <NUM> may be manufactured in various sizes to accommodate different robotic arm <NUM> and port diameters. The chassis <NUM> can be directly grasped by an arm (either robotic or handheld) and inserted directly through a port site that will be closed. The suture type loaded on the spool <NUM> can be variable to account for different surgeon preference. The suture <NUM> is loaded on spool and the end <NUM> is grasped within the end jaws <NUM>, <NUM> of chassis <NUM>. The eyelets <NUM>, <NUM> of the chassis <NUM> are designed to optimize negative space while maintaining stability. This allows for ample space for a suture passer to access the suture <NUM>. The stabilizing posts <NUM>, <NUM> may be omitted if the material strength allows. If omitted the suture <NUM> can be accessed from all <NUM> sides of the chassis <NUM> with a suture passer. The chassis <NUM> may be manufactured with a needle on the end of the suture to allow intra-abdominal suturing.

Referring to <FIG>, a guide ring <NUM> includes a top end <NUM>, a bottom end <NUM>, and a sidewall <NUM> extending between the top end <NUM> and the bottom end <NUM>. The guide ring <NUM> is made from a polymer and can be disposable or re-useable. The sidewall <NUM> is frusto-conical in shape and narrows from a top diameter <NUM> at the top end <NUM> to a bottom diameter <NUM> at the bottom end <NUM>. The guide ring <NUM> is sized to position around a trocar <NUM> (described below). The guide ring <NUM> is a plastic ring that is affixed to the outside of the trocar <NUM>. Referring to <FIG>, the top end <NUM> has a lip <NUM> that extends inward from the sidewall <NUM>. A trocar aperture <NUM> is centered in the top end <NUM>. The lip <NUM> extends around the trocar aperture <NUM>. The trocar aperture <NUM> has a diameter <NUM> that is sized to be positioned around a trocar. The guide ring <NUM> is designed with markings for optimal suture spacing for varying sized trocars <NUM>. The guide ring <NUM> can have markings that line up with the skin incision or built in magnets to auto-orient to the arm's position within the patient. The lip <NUM> ensures that the dermis will not be included in fascial closure. Suture passer apertures <NUM> are positioned on the guide ring <NUM> on a rim of the lip <NUM>. In the illustrated embodiment, the guide ring <NUM> includes four suture passer apertures <NUM>. The suture passer apertures <NUM> are sized to receive the arm of a suture passer (described below). Referring to <FIG>, the bottom end <NUM> includes an exit aperture <NUM> that is sized to fit around the trocar <NUM>.

As seen in <FIG>, the guide ring <NUM> includes two halves or hemi-guide rings <NUM>. The hemi-guide rings <NUM> clip together to form the assembled guide ring <NUM>. Each hemi-guide ring <NUM> includes a post <NUM> extending from the lip <NUM>. Each hemi-guide ring <NUM> also includes an opening <NUM> extending into the lip <NUM>. The post <NUM> of a first hemi-guide ring <NUM> is configured to insert into the opening <NUM> of a second hemi-guide ring <NUM>, and the post <NUM> of the second hemi-guide ring <NUM> is configured to insert into the opening of the first hemi-guide ring <NUM> to clip the first hemi-guide ring <NUM> to the second hemi-guide ring <NUM> to form the guide ring <NUM>. In use the hemi-guide rings <NUM> are clipped around the trocar <NUM> to position the guide ring <NUM> onto the trocar <NUM>.

<FIG> illustrate a method for closing a surgical site utilizing the instrument <NUM>. Once the main critical portions of a minimally invasive surgical case are completed, the fascia must be closed (for trocars > <NUM>). An arm <NUM> (either computer aided arm or hand-held disposable arm) is loaded with the first instrument <NUM>. An appropriately sized guide ring <NUM> is attached to the trocar <NUM> and positioned with a lip <NUM> between the trocar <NUM> and the skin <NUM>, as illustrated in <FIG>.

As illustrated in <FIG>, the instrument <NUM> is advanced into the trocar <NUM> until full range of motion of the arm wrist is enabled. The instrument <NUM> is swiveled from a perpendicular position <NUM> to a parallel orientation in relation to the patient's fascial plane, as shown in <FIG>. This can be done with automation if computer aided; or under direct control by the surgeon if using a disposable arm. Based on the size of defect being closed, the instrument <NUM> is rotated into a first suture position <NUM> in correspondence to the guide ring markings. A suture passer <NUM> is advanced through a correlating aperture <NUM> on the guide ring <NUM>, as shown in <FIG>. The suture passer <NUM> can be disposable or reusable. The suture passer <NUM> may have built in depth stops on the needle to prevent intra-abdominal injuries if passed by assistant. The suture passer <NUM> could be an external robotic arm and automated.

The suture passer <NUM> enters the eyelets <NUM>, <NUM> of the instrument <NUM> and secures a segment <NUM> of the suture <NUM> so that the segment <NUM> can be pulled out through the guide ring <NUM>, as illustrated in <FIG>. A clamp <NUM> is placed on the suture loop <NUM>. In <FIG>, the instrument <NUM> is rotated to a corresponding position <NUM> for a second throw. The suture passer <NUM> is advanced through a correlating aperture <NUM> on the guide ring <NUM>, in <FIG>. The suture passer <NUM> grasps another segment <NUM> of the suture <NUM> and pulls the segment <NUM> of the suture <NUM> back out through the correlating aperture <NUM> in the guide ring <NUM>, in <FIG>. The suture <NUM> is allowed to be completely pulled off of spool through the aperture. In <FIG>, the loop of the suture <NUM> clamped. The suture <NUM> is then cut and held.

In <FIG>, the instrument <NUM> is rotated back to the perpendicular position <NUM>. In <FIG>, the instrument <NUM> is removed from the surgical site. The guide ring <NUM>, the arm <NUM>, and the trocar <NUM> are removed and the suture <NUM> is tied using a surgeons knot in a normal fashion, as illustrated in <FIG>. If the defect is larger, the process is repeated for each suture <NUM> until the desired number of sutures is placed. The sutures are always tied down after the trocar <NUM>, the arm <NUM>, and the guide ring <NUM> have been removed from the patient.

<FIG> illustrate a method for utilizing the guide ring <NUM> during the procedure described above. The assembled guide ring <NUM> is placed around the laparoscopic trocar <NUM> at the end of the operation. The trocar aperture <NUM> is oriented distal to the abdominal cavity and the exit aperture <NUM> is oriented proximal to the abdominal cavity. The sidewall <NUM> of the guide ring <NUM> is thin and flexible yet strong enough to not be penetrated by the suture grabber <NUM>. The sidewall <NUM> terminates in the exit aperture <NUM>. The exit aperture <NUM>, when in use, is placed below the dermis in the incision. The suture passer apertures <NUM> for the grabber <NUM> are located on the top end <NUM> of the guide ring <NUM> outside the skin. The exit aperture <NUM> is on the bottom end <NUM> of the guide ring <NUM>. The grabber <NUM> passes out of the guide ring <NUM> through the exit aperture <NUM> between the trocar <NUM> and the bottom end <NUM>. An axis of orientation <NUM> is the line of the interfaces of the hemi-guide rings <NUM>. A gamma (γ) angle is the angle between the axis of orientation <NUM> and a line of orientation <NUM>. A gamma prime (γ') is the angle between the axis of orientation <NUM> and a line of orientation prime <NUM>. The gamma (γ) and gamma prime (γ') angles are equal.

Initially, the guide ring <NUM> is aligned with the axis of the line of orientation <NUM> in parallel with the incision. The guide ring <NUM> is aligned as to pass the grabber <NUM> through the fascia opposite to the side of the incision in which it was inserted. After the instrument <NUM> is inserted and parallel with the facia, the grabber <NUM> is inserted through an aperture <NUM> to retrieve suture <NUM>. Once the suture <NUM> is secured, the grabber <NUM> is inserted into an aperture <NUM> and suture <NUM> is re-grasped and pulled through. The instrument <NUM> is then changed and the method is repeated for apertures <NUM> and <NUM> to form the suture configuration shown in <FIG>.

Referring to <FIG>, for even larger size trocar closures (e.g. ><NUM>), the guide ring <NUM> position is dynamic to facilitate positioning additional sutures <NUM> for fascial closure. The first two sutures <NUM> are passed through the fascia following the above sequence. A third instrument <NUM> is then inserted and aligned parallel with the facia. The same sequence of grabber <NUM> passes are again made; however, before each pass is made, the corresponding guide ring line of orientation <NUM> is lined up in parallel to the incision before the grabber <NUM> is passed into the corresponding apertures <NUM>, <NUM>, <NUM>, <NUM> in the guide ring <NUM>. Repeating this method for each of the aperture <NUM>, <NUM>, <NUM>, <NUM> positions produces four sutures in the fascia, as illustrated in <FIG>. The method can be extrapolated for even larger defects or used to create a woven pattern of suture <NUM>.

The suture grabber <NUM> may be automated to move with the guide ring <NUM> and instrument <NUM> to optimize suture spacing. Alternatively, the suture grabber <NUM> could be oriented manually by the surgeon. The instrument <NUM> is compatible with a robotic arm (or a handheld device if a strictly laparoscopic case). The method can be automated and observed with direct surgeon vision and override control at a console. This allows the surgeon to tie the suture closure knot and close the skin once scrubbed in to close the patient. The instrument <NUM> can be used through the trocar it is closing without removal of the trocar.

The spool <NUM> is a pre-loaded swiveling internal spool of suture that eliminates the steps of loading suture and passing it through the abdominal wall. The suture on the spool may be manufactured with a needle for intra-abdominal suturing. The suture <NUM> is positioned reproducibly within the pertioneal cavity to ensure optimal suture spacing and tissue approximation leading to reduced incisional hernia rates in larger (><NUM>) laparoscopic defects. This allows single port site minimally invasive abdominal surgery to become more widespread and eventually the standard of care. Surgeons are able to guide an internal spool from the console while the bedside assistant can make safe, reliable passes under direct vision of the surgeon. Additionally, the guide ring <NUM> provides templates for optimal fascial suture spacing.

The instrument <NUM> is a disposable and there is potential for multiple suture passes in each instrument <NUM>. Defects would require one instrument <NUM> per <NUM>-<NUM> in trocar diameter to optimize closure strength. The guide rings could be specifically manufactured for varying defect sizes. The instrument <NUM> can be scaled to fit varying sizes and brands of robotic arms. Spools can be preloaded and sold in varying package quantities.

The instrument <NUM> can be applied/modified to work in conjunction with current and future computer aided surgical devices. The instrument <NUM> allows the suture <NUM> to be within the peritoneal cavity. This offers a much simpler design and method for closing fascia on a widespread scale. The instrument <NUM> is adaptable for future use with surgical artificial intelligence. The instrument <NUM> can be used by all specialties that perform minimally invasive abdominal, thoracic or pelvic surgery. The instrument <NUM> can offer increased level of safety, precision, and ease of use.

In one aspect of the disclosed embodiments, a device for assisting in suturing the fascial tissue after an abdominal surgery is provided. The device includes a clam-shell housing that retains a spool of suture. The loose end of the suture is clamped and retained at an end of the device so that the suture extends through an eyelet between the end and the spool. The device is inserted into the abdomen through a surgical port. A suture grabber is inserted through a guide ring and grabs the suture in the eyelet of the device. The grabber pulls the suture through the fascial tissue to form a first end to be tied. The grabber than grabs another portion of the suture and pulls a second end to be tied through the fascial tissue. The device and port are removed and the two ends are tied.

Any theory, mechanism of operation, proof, or finding stated herein is meant to further enhance understanding of principles of the present disclosure and is not intended to make the present disclosure in any way dependent upon such theory, mechanism of operation, illustrative embodiment, proof, or finding. It should be understood that while the use of the word preferable, preferably or preferred in the description above indicates that the feature so described can be more desirable, it nonetheless cannot be necessary and embodiments lacking the same can be contemplated as within the scope of the disclosure, that scope being defined by the claims that follow.

In reading the claims it is intended that when words such as "a," "an," "at least one," "at least a portion" are used there is no intention to limit the claim to only one item unless specifically stated to the contrary in the claim. When the language "at least a portion" and/or "a portion" is used the item can include a portion and/or the entire item unless specifically stated to the contrary.

Claim 1:
A suturing device (<NUM>) comprising:
a clamshell body (<NUM>) having a first side coupled to a second side by a hinge (<NUM>), the first side and the second side each having a clamping end (<NUM>, <NUM>) opposite the hinge (<NUM>);
a slot (<NUM>, <NUM>) formed in each of the first side and the second side, the slot (<NUM>, <NUM>) in the first side being aligned with the slot (<NUM>, <NUM>) in the second side when the clamshell body (<NUM>) is closed to form a cavity;
characterized in that the suturing device (<NUM>) further comprises
a spool (<NUM>) having a rod (<NUM>) extending from an end cap (<NUM>), the end cap (<NUM>) retained in the cavity and rotatable relative to the clamshell body (<NUM>); and
a suture wound around the rod (<NUM>) of the spool (<NUM>); and
an eyelet (<NUM>, <NUM>) extending between the clamping end (<NUM>, <NUM>) and the hinge (<NUM>) of at least one of the first side and the second side, the suture being accessible through the eyelet (<NUM>, <NUM>),
wherein the clamping ends (<NUM>, <NUM>) of the first side and the second side lock together and capture an end of the suture in a fixed position between the clamping ends (<NUM>, <NUM>).