Systems, devices, and methods for closing abdominal wall defects

Abstract

Systems and methods for closing tissue defects are disclosed. The system may include a subcutaneous guide disposed percutaneously between two skin access sites and a self-locking strap that may be advanced into the body through a first access site via a first needle and then delivered to a second needle. The strap may be withdrawn out of the body with a second needle through a second access site. The strap may be withdrawn from the first needle, thereby causing the strap to pass through two access sites and be placed across the defect. Upon withdrawal of the subcutaneous guide from the body, the subcutaneous guide pulls the captured strap such that both ends of the strap protrude from the first entry site, allowing the strap to tighten around the defect. Devices for closing tissue defects are also disclosed.

Description

[0001] This application is a divisional application of Chinese patent application 2018800060032 (PCT / US2018 / 013764) filed on January 16, 2018 and entitled “Systems, devices and methods for closing abdominal wall defects”.

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of and priority to U.S. Provisional Application Serial No. 62 / 446,029, filed on January 13, 2017, which is incorporated herein by reference in its entirety. Technical Field

[0004] The present disclosure relates generally to devices and methods for closing defects in tissue. More specifically, the present disclosure relates to methods and devices for performing ventral hernia repairs. Background Art

[0005] Hernia may occur in the muscle wall that has weakened or previously operated on. Although weakened abdominal muscles may cause abdominal hernia, more often abdominal hernia is an abdominal wall defect, which usually occurs after the failure of the closure of the midline incision of the previous abdominal open surgery and usually causes the abdominal tissue to push through the rift of the abdominal wall to form a bulge or hernial sac. In the U.S., 350,000-500,000 abdominal hernias are repaired every year. In large abdominal hernias, the defect may be greater than 10cm wide and 40cm or more long and extend downward to the pubic symphysis below the xiphoid process of the sternum. The defect may be located below the parenchyma layer of tissue, and the skin is the outermost layer. Under the skin, there may be 5-10cm of subcutaneous fat, outer fascia layer, rectus abdominis and another layer of fascia tissue. In abdominal hernia repair, it may be desirable to suture through all these layers of tissue to repair (close) the defect. These defects can be repaired by the conventional "open" method requiring a large incision or the laparoscopic surgery requiring a small abdominal incision.

[0006] Patients may develop ventral hernias after undergoing abdominal surgery. For example, when open abdominal surgery is completed, full-thickness abdominal wall closure is performed. Interrupted sutures are placed through the anterior rectus sheath, the rectus abdominis, and the posterior rectus sheath. These conventional repair techniques have a long-term failure rate of 41%-52%, which leads to ventral hernia formation. Poor tissue strength coupled with significant tension on the sutures leads to failure of the abdominal closure, requiring hernia repair.

[0007] In conventional laparoscopic repair, multiple trocar ports are inserted to place large pieces of prosthetic mesh to cover the defect. Because large abdominal incisions are avoided, the postoperative pain caused by this method is much less than that caused by the open method. However, the abdominal defect is usually not completely closed. On the contrary, a large prosthetic patch is nailed to the inner surface of the abdominal wall to cover the defect. The placement of large pieces of artificial materials leads to a high incidence of postoperative complications (including seroma formation). Then, the fluid of the seroma forms a small cavity that increases the possibility of infection of the mesh placed laparoscopically, which requires the removal of the mesh plus antibiotic treatment. Due to the implantation of large foreign body patches, intestinal adhesions are also potential complications.

[0008] It is desirable to partially or completely close the abdominal defect using laparoscopic techniques to significantly reduce the size of the prosthetic mesh required to repair the abdominal hernia or eliminate the use of mesh patches completely determined by the surgeon. The current method uses sutures that must be advanced into the body cavity through multiple layers of tissue containing the full-thickness abdominal wall, and therefore, the sutures are difficult to find and manipulate when inserted into the body cavity. After looping around the muscle, the two ends of the suture can be withdrawn from a single site, and a slipknot composed of two half structures is tied to the suture, and the suture is tensioned by holding it on one suture branch while the laparoscopic knot pusher is advanced along the opposite suture branch. Because the multiple sutures used in hernia repair are continuously tensioned to gradually close the large abdominal defect, the tension must be maintained on the slipknot. The tension can be maintained by applying a surgical clamp to the base of the knot. However, if the patient is overweight, it may be difficult or impossible to advance the jaws of the surgical clamp along the tiny skin puncture to reach the position of the knot for a distance of 5-10cm. In non-obese patients, the presence of a large number of surgical clips on the patient's abdominal wall makes it difficult for the surgeon to manipulate and function during the operation. After the suture array is continuously tensioned to close the abdominal wall defect, a series of at least five square knots must be tied on top of each slipknot on each individual suture, and eighty or more knots may be required to complete the repair. Each square knot requires maintaining tension on one suture branch while the laparoscopic knot pusher is advanced along the other suture branch to push the knot subcutaneously down to the anterior rectus sheath. This process is cumbersome because fifty or more knots need to be tied to complete the repair.

[0009] Other methods employ anchor delivery tools in which the tissue anchor is located within a needle hole. Since a relatively large diameter needle is required to deliver the anchor, since the outer diameter of the needle is larger than the diameter of the anchor, the anchor under continued tension has the potential to expand the needle bundle in the muscle formed by needle insertion, thereby causing the anchor to be pulled out through the expanded needle bundle. This scenario can be particularly observed in weakened or weakened tissues encountered by patients with ventral hernias.

[0010] It is desirable to have simple laparoscopic techniques and instruments that can penetrate the entire abdominal wall and quickly and easily place multiple interrupted fastening rings around the hernia defect so that the rings can be tensioned without cutting, pulling or tearing muscle tissue. Summary of the invention

[0011] The present disclosure relates to devices and methods for minimally invasive closure of surgical defects such as abdominal hernias using self-locking bands. These embodiments can provide fewer surgical steps, reduced complexity, smaller incision sites, reduced tissue pressure, and easier and faster continuous tensioning along the length of the defect. An embodiment of a system according to the present disclosure may include: a self-locking band with a locking head; a first needle having a lumen for delivering the self-locking band through a first incision site; a second needle having a hook on its distal end, the hook for engaging the self-locking band and pulling the band out of the body through a second incision site; and a guide having an orifice near its distal end, the orifice for passing the second needle therethrough and retaining the band after the second needle is removed from the orifice.

[0012] In other embodiments, the guide may be used to tunnel through the subcutaneous tissue from the first incision site to the second incision site, and the guide may have a hook near its distal end for engaging the self-locking band and pulling the band back through the subcutaneous tissue to the first incision site. In addition, the second needle may have a hook at its distal end, and the needle may be able to pass through the locking head and engage with the distal end of the self-locking band and pull the distal end of the band through the locking head and out of the body.

[0013] Embodiments of the system also include: a support tube for pushing the self-locking band while tensioning the band; a rotary cutter having at least one distal blade for severing the self-locking band adjacent the locking head; a linear cutter having an inner tube, an outer tube, and a radially flexing blade that is pressed into the lumen of the inner tube when engaged by the outer tube. The system may further include a tensioner having at least one movable locking head for incrementally tensioning the self-locking band; the tensioner may have a tension meter for measuring the tension on the band and an indicator for displaying the tension on the band. The tension meter may be a mechanical spring meter or a force transducer, and the tension meter may be capable of converting the tension into an electrical signal and sending the electrical signal to a display or receiving computer. The system may include a laparoscopic grasper for placing the self-locking band into engagement with the second needle; the laparoscopic grasper may have a robotic arm interface for robotic control. The self-locking band may include an attached locking head capable of receiving a single end of the band or a separate locking head capable of receiving both ends of the band. The self-locking band may have apertures at its proximal and distal ends or a ridge at its distal end for engaging with the second needle. The band may also have a plurality of apertures through which the band is passed to promote tissue ingrowth. The first needle may have a slot along its length for removing the self-locking band, and the guide may have a robotic interface secured to its distal end.

[0014] Embodiments of a method for closing a defect may include: positioning a guide beneath the skin between a first incision and a second incision on a patient's body such that the distal end of the guide resides near the second incision; inserting a first needle through the first incision; inserting a second needle through the second incision and an orifice in the guide; placing a distal end of a self-locking band through the first needle and into a body cavity. Next, a surgeon or a robotic arm may engage the second needle with the distal end of the band and pull the second needle through the guide and out of the body such that the band is captured by the orifice in the guide. The band may be released from the first needle and the guide may be pulled out of the body through the first incision such that the distal end of the self-locking band exits the first incision and the guide. To lock the band, a surgeon may place a locking head on the distal end of the self-locking band and advance the locking head along the self-locking band to tighten the self-locking band around the defect.

[0015] In other embodiments, the method may include: inserting a first needle through a first incision and into a body cavity on a first side of the defect; placing a distal end of a self-locking band through the first needle and into the body cavity; retracting the first needle from the body; and removing the first needle from the band while the band is inside the body. Next, a surgeon or robotic arm may place a guide through a second incision site on the opposite side of the defect and advance the guide subcutaneously to the first incision site; engage the proximal end of the band with the guide and pull the proximal end of the band subcutaneously across the defect to the second incision site. The second needle may be placed through the proximal end attached to the band and advanced into the body cavity to engage the distal end of the band. The second needle may be used to pull the distal end of the band through muscle tissue and out through the lock. Finally, the band may be tightened to close the defect.

[0016] In other embodiments, first, a guide needle may be placed through the skin and muscle tissue to determine the correct distance lateral to the defect for inserting surgical instruments. In addition, a laparoscopic grasper that can be controlled robotically is used to engage the second needle with the distal end of the band. The first needle may include a hook at its distal end for engaging the self-locking band, and the first needle may have a slot through which the self-locking band is withdrawn laterally from the needle. A support tube may be placed on the self-locking band so that the surgeon can pull the self-locking band while pushing the support tube to tighten the self-locking band. Next, the surgeon can tighten the self-locking band with a tensioner having at least one locking head to tighten the self-locking band incrementally. The tensioner may have a tension meter, which may be a mechanical spring meter or force transducer for measuring the tension on the band and displaying the tension, and the force signal may be converted into an electrical signal that can be transmitted to a display or receiving computer. Excess self-locking band may be cut inside the body adjacent to the locking head. In some embodiments, the band may include a plurality of apertures passing through the band to promote tissue ingrowth.

[0017] In another embodiment, a tensioner for tightening a self-locking band may include: a shaft; a plunger slidably disposed on the shaft; a fixed locking head located at a distal end of the plunger and attached to the shaft; and a movable locking head attached to the plunger and aligned with a first fixed shaft so that the band can pass through the two locking heads. The tensioner may also include: a frame slidably attached to the shaft and located at a distal end of the fixed locking head; and a compression spring compressed between the frame and the fixed locking head. An elongated tube may extend distally from the frame so that the tube abuts against the locking head of the self-locking band inside the human body.

[0018] The strap tensioner may further include a force transducer configured to read an amount of force on the strap held by the retaining lock when the elongated tube abuts the locking head of the strap. The tensioner may include a set of force markings located on a distal portion of the shaft, the set of force markings configured to read an amount of force on the strap held by the retaining lock.

[0019] In one embodiment, a self-locking belt having teeth on both sides may be provided. The belt may include: an elongated body having a distal end, a proximal end, a top side, and a bottom side; a first set of beveled teeth on the top side; and a second set of beveled teeth on the top side, the second set of beveled teeth having a slope direction opposite to the direction of the first set of teeth. The bottom side may have: a third set of beveled teeth having a slope direction that is the same as the direction of the first set of teeth; and a fourth set of beveled teeth on the bottom side, the fourth set of beveled teeth having a slope direction that is the same as the direction of the second set of teeth. The belt may have a separate locking head having an aperture that enables the distal end and the proximal end to pass simultaneously and opposing pawls that protrude into the aperture to engage with the distal end and the proximal end. The third set of beveled teeth may be longitudinally offset from the first set of beveled teeth and the fourth set of beveled teeth may be longitudinally offset from the second set of beveled teeth to provide the belt with a wider minimum cross-sectional thickness. In embodiments, the band may have a plurality of apertures therethrough to promote tissue ingrowth and a proximal end that is tapered having an aperture therethrough to engage a surgical instrument. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The foregoing will be apparent from the following more particular description of exemplary embodiments of the invention, as illustrated in the accompanying drawings, in which like reference numerals refer to the same parts throughout the different views. The drawings are not necessarily drawn to scale, emphasis instead being placed upon illustrating embodiments of the invention.

[0021] Figure 1 A system for closing a tissue defect is depicted.

[0022] Figures 2A-2J Various views of embodiments of a self-locking strap are shown.

[0023] Figures 3A-3G Various views of other embodiments of self-locking straps are shown.

[0024] Figures 4A-4E Various views of other embodiments of self-locking straps are shown.

[0025] Figure 5A-5B Various views of other embodiments of self-locking straps are shown.

[0026] Figure 6A-6BVarious views of another embodiment of a self-locking strap are shown.

[0027] Figures 7A-7K Various embodiments of a slotted needle that retains a band that can be laterally removed from the lumen of the slotted needle are shown.

[0028] Figures 8A-8C A crochet hook is shown for pulling the strap away from the body.

[0029] Figures 9A-9C A grasper for grasping the band in vivo is shown.

[0030] Figures 10A-10H Various embodiments of a subcutaneous guide for subcutaneous tunneling between two incision sites are shown.

[0031] Figures 11A-11C A tubular cutter is shown for cutting off excess length of the self-locking tape.

[0032] Figures 12A-12B A rotary cutter is shown for cutting off excess length of the self-locking strap.

[0033] Figures 13A-13B An embodiment of a belt tensioner is shown.

[0034] Figures 14A-14E The operation of the belt tensioner is shown.

[0035] Figures 15A-15E Various embodiments of releasable locking heads are shown.

[0036] Fig.16A Another embodiment of a belt tensioner is shown.

[0037] Figures 17A-17B The general anatomical layout used for the procedures described herein is shown.

[0038] Figure 18A-1 8K shows an example of a system for closing a tissue defect.

[0039] Figures 19A-19K Another embodiment of a system for closing a tissue defect is shown.

[0040] Figures 20A-20I Another embodiment of a system for closing a defect is shown.

[0041] Figures 21A-21C An embodiment device having a surgical robotic interface is shown. DETAILED DESCRIPTION

[0042] The following is a description of exemplary embodiments of the invention.

[0043] Systems and methods for closing tissue defects are described herein. Although the present disclosure describes systems and methods in the context of hernia repair, and particularly ventral hernia repair, the presently disclosed devices and methods can be used in surgical procedures to connect tissue, close tissue openings, or secure a device to or between two or more tissue portions.

[0044] In the midline of the patient, the left and right anterior and posterior rectus sheaths together form a single layer called the linea alba. Due to the opening of this layer, a ventral hernia defect may occur. The opening may be an opening extending through the posterior rectus sheath, the rectus abdominis muscle, and the anterior rectus sheath; or the opening may be an opening in the fascia lateral to the rectus abdominis. Although the present disclosure describes systems and methods in the context of laparoscopic surgery, the systems and methods may be applied to any other type of surgery, such as laparotomy or robotic surgery.

[0045] refer to Figure 1 , an embodiment of a system 1 for closing a fascial opening 40 (e.g., a ventral hernia) is shown with respect to a skin layer 1 and a defect 40 shown with reference to the anterior rectus sheath 37. The system can be used to deliver an implant for constraining tissue, such as a suture or band through minimally invasive surgery or laparoscopic surgery. By way of non-limiting example, the system 1 can include a self-locking band 10, a grooved needle 15, a hook needle 21, a subcutaneous guide 25, a tubular cutter 30, and a support tube 45. The inner tube 17 can reside inside the grooved needle 15. The tubular cutter 30 can include an outer tube 34 and an inner tube 31, the inner tube having a cutting blade 33 attached thereto. The above components are further described in detail in the present disclosure. Other components and devices, including those disclosed throughout the present application, can be included in the system and used in the methods disclosed herein, that is, the system 1 shown is not necessarily a complete surgical kit, and other devices and methods can replace or add to the system 1 to form other systems or embodiments within the scope of the invention disclosed herein. For example, various laparoscopic instruments, such as a laparoscope with a camera, may also be used during surgical procedures.

[0046] The present application discloses methods, systems and devices for placing a band around a defect to close a tissue defect. Typically, since the tension required to approach muscle tissue may be high, the band can be wider than a suture and have a flatter shape to apply less pressure on the tissue and reduce the risk of cutting the tissue. In the present application, the band refers to a "self-locking band", which means that when the band is pulled through its "locking head" and released, the band tends to stay in the same position without being retracted through the locking head. The self-locking band uses a mechanism so that when the band is pulled through the locking head, it will not slide back through the locking head. That is, the band can be pulled through the locking head in one direction, but the reverse movement of the band in the locking head is mechanically limited to achieve a locked position in a one-way manner. There are many types of mechanisms that perform this function, such as a tie-wrap mechanism (also known as a cable tie), a ratchet, a cam lock, and a ratchet and pawl mechanism. Some designs have features on the band such as teeth that interact with features such as pawls in the locking head, and the pawls are deflected or otherwise spring-biased to engage with features on the band. The strap may have a hole or slot with which a spring-loaded pawl feature engages. Other designs may have a smooth strap clamped by a cam-like feature, sharp teeth, or barbs that grip the strap primarily in one direction to prevent it from backing up through a locking head. Some self-locking straps may have an integrated locking head, for example, positioned near the end of the strap, while other self-locking straps may have a separate head that can be placed on the strap for locking. Such self-locking straps and variations thereof are within the scope of the present disclosure.

[0047] The use of self-locking bands in abdominal hernia surgery simplifies the surgery and saves time because the surgeon does not need to tie various suture knots or clamp and re-tighten partially tightened sutures or worry about the self-locking bands loosening. The self-locking function of the bands disclosed herein allows the surgeon to quickly and easily tighten the individual bands in succession to incrementally close the defect without tying permanent or releasable knots. This is because the surgeon can pull one or both ends of the band through the locking head and release the band at any time, and the band will maintain tension due to the ratchet effect of the band feature engaged with the locking head. Therefore, the surgeon can continue to other aspects of the surgical procedure, for example, tightening other bands incrementally along the defect without clamping the band or tying it to prevent sliding.

[0048] For the sake of brevity, several self-locking belt embodiments are disclosed in this application. However, other types of self-locking belts are within the scope of the invention described herein.

[0049] The size of the self-locking band should be set so that it has the strength to approach and retain muscle tissue, and is flexible enough to pass through the body and instrument operation. The self-locking band mentioned in this application can be made of any biocompatible material that can be implanted in the body. By way of non-limiting example, candidate materials include polymers such as PEEK, polypropylene, or nylon or metals such as nitinol or stainless steel.

[0050] Figure 2A Describe the embodiment of the self-locking band 10 that can be made of biocompatible materials suitable for implantation in human body or mammal body. The self-locking band 10 can include distal end 11 and proximal end 13, and as mentioned above, it can be made of polymeric materials such as polypropylene, PEEK or nylon or metal materials such as nitinol or stainless steel. The diameter of the self-locking band 10 can be any size that provides enough tensile strength to approach or hold tissue together, for example, in ventral hernia repair. In one embodiment, the self-locking band 10 can be made of polypropylene, and its diameter can be between 0.25mm and 2mm or, for example, a diameter of about 0.35mm, and its length can be about 100cm or any length suitable for the size of the patient. In another embodiment, the self-locking band 10 can be made of stainless steel, and its diameter can be about 0.10mm to 0.25mm and its length is about 100cm. The ridge 12 or other gripping feature may be permanently formed or attached near the distal end of the self-locking band 10, and it may be made of the same material as the self-locking band 10, or it may be made of a different polymeric or metallic material. The ridge 12 may be larger than the diameter of the band, or be approximately 0.5 mm to 0.75 mm in diameter, and may be, for example, spherical in shape or any other shape that allows it to be retained by the hook needle 21 or other grippers described elsewhere herein. In other embodiments, the ridge 12 may be a loop or orifice formed at the distal end 11 of the self-locking band 10 to facilitate gripping the self-locking band 10.

[0051] The self-locking strap 10 includes a distal end 11 at one end and a proximal end 13 at an opposite end. The self-locking strap 10 may have teeth 50 arranged along the strap to facilitate locking to a locking head, which may be attached to one end of the self-locking strap 10. The teeth 50 may be located on the entire self-locking strap or on a portion thereof, or in some embodiments, the entire strap may be smooth. By way of non-limiting example, in Figure 2A, an embodiment of a self-locking band 10 having teeth 50 on the portion of the band toward the proximal end 13 is shown. The self-locking band 10 can include a single polymeric or metallic material, such that the smooth end (distal end 11) and the toothed end (proximal end 13) are made into one component, for example, by extrusion or injection molding of the polymeric material. The major outer diameter of each tooth 50 can be 1 mm to 3 mm or about 2 mm. The tooth 50 can be any shape that allows it to engage with the lock head 14 to limit movement through the lock head 14 in a certain way. For example, in some embodiments, the shape of the tooth 50 can be like an ellipse, square, sphere, cone, wedge, step, tooth or hemispherical. The term "diameter" used herein refers to the major dimension or maximum dimension across the tooth 50. The length of the self-locking band 10 can be about 100 cm or any length that allows it to extend beyond the multi-layer abdominal tissue to take into account the huge changes in anatomical structure caused by, for example, changes in fat tissue.

[0052] exist Figure 2B The self-locking belt 10 is shown in an example of operation. Figure 2C A cross-sectional view is shown in FIG. 1 to illustrate how the tooth 50 interacts with the locking head 14. The locking head 14 may be attached to the proximal end 13 of the self-locking band 10 and include a locking feature, such as one or more pawls 51 that engage with the tooth 50. The pawl 51 may be two-dimensional, such as a beam, or may include a conical shape (axisymmetric), and it may be segmented to allow the pawl 51 to deform to allow the tooth 50 to pass through, while flexing back down behind the tooth 50 to lock the tooth from passing back through the locking head 14. Figure 2C As shown, due to the angled orientation of the pawl 51, the triangular or conical teeth 50 in this embodiment are constrained to pass only in the direction of the arrow 48 when the pawl 51 is flexed around the teeth 50 and close behind the teeth when the proximal end 13 is pulled through the lock head 14. This operation is an example of a one-way lock and those skilled in the art will recognize that the examples and embodiments described herein are for illustrative purposes only, and that various modifications or changes made therefrom will inspire those skilled in the art and will be included within the spirit and scope of the present application and the scope of the appended claims. The pawl 51 of the lock head 14 is made of a polymeric material such as polypropylene, PEEK or nylon, or it can be a metal such as stainless steel. The lock head 14 can be integrally formed with the proximal end 13 by, for example, injection molding, or it can be a separate element. In further embodiments, the lock head 14 can be a single ratchet pawl as used in cable ties or tie wires, which is designed to allow the belt to pass in one direction while locking the belt from moving in the opposite direction as described elsewhere in this disclosure.

[0053] Alternatively, the flexible member (ie, beam or pawl) may be located on the strap and the locking head may have a substantially fixed interface, still resulting in a one-way locking action. Figure 2D-2HExample embodiments of alternative locking features are shown. Figure 2D A toothed belt 60 with ball teeth 61 is shown, Figure 2E A toothed belt 62 having hemispherical teeth 63 is shown, and Figure 2F A toothed belt 64 is shown with conical teeth 65. Figure 2G and Figure 2H A flat belt embodiment is shown in side view, so the belt does not need to be axisymmetric. Figure 2G In the embodiment, the toothed belt 66 is flat and has semi-arc teeth 67, and Figure 2H A toothed belt 68 is shown that is flat and has angled teeth 69. It may be desirable to have holes through the self-locking belt to promote tissue ingrowth into and through the belt so that the belt is more adherent to the tissue along its entire length and less likely to pierce the abdominal wall and cause a fissure and abdominal hernia. The holes may be small holes distributed along the length through the thickness of the belt. For example, Fig.2I A portion of a self-locking strap 232 is shown having angled teeth 233 and a series of holes 234 perforating the strap. In other embodiments, the apertures may be as shown in FIG. Figure 2J The actual locking feature shown. The portion of the self-locking band 235 has a slot 236 through the band that can promote ingrowth, and if the lock head has a mating tab that projects into the slot 236, for example, the slot can be used for locking because the tab is biased by beam flexure or otherwise spring loaded.

[0054] Reference now Figures 3A-3D , which shows another embodiment of a self-locking strap 100 that can have a reduced maximum width due to the separation of the locking heads. For example, Figure 3A A self-locking band 100 is shown having an elongated body 106 and a substantially flat cross-sectional profile with proximal teeth 101 and distal teeth 102 located on the top side 103 of the self-locking band 100. The two sets of teeth, the proximal teeth 101 and the distal teeth 102, are oriented opposite to each other, that is, the teeth are angled to lock in opposite directions when the band is positioned in a straight line as shown. However, when the band is configured in a loop, the teeth 101 and 102 will be oriented to be in the same direction. The two sets of teeth 101 and 102 of the band can emanate from a center point 105 of the band 100, which can be located at the center of the band 100 or can be offset from the center, and the teeth 101 and 102 can be offset from the center point 105, although in the drawings, the sets of teeth emanate from near the center point 105, that is, the teeth are arranged symmetrically around the center of the band. This self-locking band embodiment has a separate locking head, as further described below. Because the locking head can generally have a larger diameter than the underlying band, the self-locking band 100 can fit into a needle with a smaller lumen when the locking head is disengaged.

[0055] Figure 3BA top view of a self-locking band 100 is shown with proximal teeth 101 and distal teeth 102 spaced apart about a center point 105. Apertures 107 and 108 may be located at one or both ends of the self-locking band and may have any shape or size that may engage with a surgical grasper or hook needle (not shown) within the body, as described below. The width w3 of band 100 may be small enough that band 100 may fit into a small gauge needle to facilitate minimally invasive surgery. For example, band insertion needle 7 (see Fig.18C ) can have an outer diameter of 11 gauge (3 mm) and a lumen diameter of approximately 2.4 mm. Thus, a ribbon having a width of approximately 1.7 mm to 2.0 mm or less can pass through the lumen.

[0056] Figure 3C A side view of a self-locking band 100 is shown. As with other band embodiments disclosed herein, the overall thickness t3 of the band should be large enough so that the band will withstand the tension required to approximate tissue in a given type of surgery while maintaining sufficient flexibility to form a loop to tighten around the anatomical structure. For reference purposes, in open abdominal closure surgery, sutures with a tensile strength of 10 lbs are typically used. The self-locking band 100 can also have swaged or flattened ends to facilitate in vivo handling and provide a flexible section for manipulating the self-locking band 100 in vivo and entering the lumen of a needle. Figure 3D The minimum thickness t3m of the band is shown in the detail view shown in , which shows the center point 105 and the proximal teeth 101 and distal teeth 102 located on either side. The minimum thickness t3m affects the overall stiffness and strength of the band, and therefore the depth of the teeth should be shallow enough so that the minimum thickness t3m is thick enough to provide sufficient tensile strength required for a given surgery, but also deep enough to engage with the pawl type features in the lock head without slipping under tensile loading. The self-locking band 100 can be made of a biocompatible material such as a polymer (e.g., polypropylene, PEEK, or nylon) or a metal material such as nitinol or stainless steel.

[0057] like Figure 3D As shown, the proximal teeth 101 slope downwardly toward the proximal portion of the belt, while the distal teeth 102 slope downwardly in the opposite direction toward the distal end of the belt. Figure 3E-3G An example of operation is shown in FIG.

[0058] refer to Figure 3E , the self-locking band 100 is shown in a loop configuration because it can be wrapped around tissue in the body (not shown). The self-locking band 100 is folded so that the bottom side 104 is on the inside of the loop because it will contact the body; at the end, the bottom side 104 is in contact with itself and the top side 103 faces outward, so that the distal and proximal ends of the band are adjacent. The locking head 109, shown in cross-section to illustrate the function, engages the end of the self-locking band 100 when it is advanced in the direction of arrow 116. As shown in FIG. Figure 3FAs shown, the ends of the self-locking strap 100 can be simultaneously pulled through the locking head 109 in the direction of arrow 117. This self-locking mechanism is Figure 3G The locking head may have a plurality of pawls 110 and 111 which flex open to allow the self-locking band 100 to pass through and then close to engage with the proximal teeth 101 and distal teeth 102, respectively, thereby preventing the self-locking band 100 from moving back through the locking head 109, i.e., Figure 3F 117 in the direction opposite to the direction of the arrow 117. The pawls 110 and 111 may have one or more teeth 112 to facilitate gripping the self-locking band 100, or the pawls 110 and 111 may have any other surface features that may facilitate gripping the self-locking band 100, such as serrations or surface roughness. Alternatively, the pawls 110 and 111 may be smooth, relying on the leading edges 114 and 115 of the pawls 110 and 111, respectively, to lock onto the proximal teeth 101 and distal teeth 102 on the self-locking band 100, such as a typical wire tie.

[0059] Figures 4A-4E Yet another embodiment is shown in FIG. A self-locking belt 120 is shown as having an elongated body 126 and a substantially flat cross-sectional profile having proximal teeth 121 and distal teeth 122 located on a top side 123 of the self-locking belt 120. Similar to the previously disclosed self-locking belt 100, the top side 123 of the self-locking belt 120 has two sets of teeth, a proximal tooth 121 located at a proximal end 118 and a distal tooth 122 located at a distal end 119, the two sets of teeth being oriented opposite to each other about a center point 125, that is, the two sets of teeth are angled to lock in opposite directions when the belt is a straight line as shown. However, the present self-locking belt 120 has teeth on both sides of the belt, the top side 123 and the bottom side 124. That is, the bottom side has bottom side proximal teeth 131 and bottom side distal teeth 132, which are arranged in a relative manner like the teeth on the top side 123. This two-sided tooth arrangement allows the self-locking strap 120 to lock into the locking head even if the strap is twisted as it is wrapped through the body.

[0060] Figure 4B 1 is a side view of the self-locking band 120. The overall thickness t4 of the band should be large enough so that the band will withstand the tension required to access tissue during and after surgery, yet should be flexible enough to form a loop and be able to be tightened around anatomical structures. The self-locking band 120 can have tapered ends as shown, and the thickness t4 can also be swaged or flattened at the end (not shown) to facilitate in vivo handling and provide a flexible section for manipulating the self-locking band 120 in vivo and entering the lumen of a needle. The minimum thickness t1 is between 1 and 20 mm. Figure 4C, which is a side view showing the proximal teeth 121 on the top side 123 and the bottom proximal teeth 131 on the bottom side 124. In the configuration shown, the two sides of the teeth are aligned because the root and tip of each tooth on the top side 123 are mirrored on the bottom side 124. As such, the minimum thickness t1 that affects the overall stiffness and strength of the band is indicated by the distance t1 between the upper tooth inner edge 133 and the lower tooth inner edge 134, as indicated by t1.

[0061] In another embodiment, the teeth can be staggered to increase the distance t1, thereby providing more cross-sectional area, which can increase the strength of the belt. Figure 4D It is shown in Figure 4D is with Figure 4C , however in this embodiment, the proximal teeth 141 are offset from the bottom proximal teeth 142 by a distance o, where o is less than the spacing p between the teeth. Staggering the teeth in this manner increases the minimum distance between the teeth to t2, providing an effectively thicker belt, where t2 is greater than t1 for a given belt thickness and tooth profile.

[0062] Figure 4E The self-locking band 120 operating with the locking head 109 is shown in a cross-sectional view to illustrate the one-way locking engagement. Similar to the previously described embodiments, the self-locking band 120 is shown passing through the locking head 109. The locking head may have a plurality of pawls 110 and 111 that flex open to allow the band to pass through and close to engage with the proximal teeth 121 and distal teeth 122, respectively, thereby preventing the band 120 from moving back through the locking head 109. If the distal end 119 of the band 120 happens to rotate (not shown) while the band passes through the body, the bottom distal teeth 132 will engage with the pawls 111 of the locking head 109. The pawls 110 and 111 may have one or more teeth 112 or clamping features that facilitate clamping the self-locking band 120 or any other surface features that facilitate retaining the self-locking band 120. Alternatively, pawls 110 and 111 may be smooth, relying on their leading edges to lock onto the proximal and distal teeth 101, 102 of a strap like a standard tie wire.

[0063] In some embodiments, the self-locking tape may have a smooth surface; Figure 5A An embodiment of a self-locking strap 150 without teeth inserted through the locking head 151 shown in the side cross-sectional view is shown. The self-locking strap 150 can have a relatively smooth top surface 154 and a relatively smooth bottom surface 158, that is, the cross-section of the self-locking strap 150 can be flat or round, and it can be locked in the locking head 151 even if the strap 150 is twisted because both the bottom surface 158 and the top surface 154 are configured to engage with the locking head 151. That is, if the self-locking strap 150 is twisted as it passes through the body, as shown in FIG. Figure 5A As shown, it will still lock because both sides of the strap engage the locking head 151 in the same manner. The surface of the self-locking strap 150 may not be completely smooth, as it may have a certain degree of surface texture or roughness to facilitate clamping in the locking head 151. The texture may be a small grid, irregular protrusions, a texture, or a general grit or surface roughness that can be imparted to the strap, such as by injection molding. The locking head 151 can have a set of pawls 152 and 153 that resiliently flex to open to accept the strap 150, and then tend to close, applying pressure to the strap 150 and probing into the top surface 154 and the bottom surface 158 to prevent the strap 150 from traveling back through the locking head 151, that is, in the opposite direction of arrow 162. The pawls 152 and 153 may also be referred to as tines, beams, or barbs by those skilled in the art. In Figure 5B , a self-locking band 150 is shown as another embodiment protruding through a locking head 159, the locking head having a barb 160 that impacts the band 150 to penetrate into the top surface 154 of the band 150 so that the band 150 can only travel in one direction. In an embodiment, the barb 160 can be made of a metal such as stainless steel, while the body 161 of the locking head can be made of plastic, rubber or an elastomeric material; the barb 160 can be insert molded into the body 161, or bonded therein, or integrally molded as part of the locking head.

[0064] Another type of split lock embodiment is a curling (not shown). That is, the extendable lock can be slid down to the ends of the strap and Figure 5A The method shown in is similar to that shown in , and then crimped in place with a tool such as pliers. The crimp design does not inherently produce a one-way lock, but the crimp can, for example, be partially closed until finally tightened and then fully crimped.

[0065] The self-locking band 150 can be made of biocompatible materials such as polymers (e.g., polypropylene, PEEK, or nylon) or metal materials such as stainless steel. In addition, since the self-locking band may remain in the body after surgery, the self-locking band can be made of a bioabsorbable material that absorbs or decomposes over time.

[0066] The patient can feel the geometric features such as bumps or protrusions of the implant that reside below the skin surface, that is, these features are palpable or produce a sensation when pressing on the tissue below the skin. Fig. 6A. The band 220 may have a locking head 221 having a slot 223 therethrough for receiving a distal tip 225, an elongated body 229, a proximal tip 222 having a proximal aperture 226, a distal aperture 227, and a plurality of teeth 224 arranged along the length of the body. The locking head 221 protrudes on the bottom side 238 and tends to embed into the fascia and muscle so that the self-locking band remains relatively flat on the top side 237, which may be adjacent to the skin. That is, the distal tip 225 of the band can pass from the bottom side 238 through the locking head 221 to the top side 237. As shown in FIG. Figure 6B As shown in the broken view in FIG. 2 , the lock head 221 can have a pawl 228 that engages with the teeth 224 or any other type of ratchet mechanism that provides one-way movement after the distal tip 225 is pulled through the lock head 221. A needle can be placed through the slot 223 so that the needle can engage with the distal tip 225 to pull the distal tip 225 back through the slot 223, thereby locking the band, as shown in FIG. Figures 18A-18I Further described in .

[0067] Reference now Fig. 7A , which shows an embodiment of a slotted needle 15 including a slot 16 that can extend from the heel of the needle to the proximal end of the needle where a handle 19 can reside. The outer diameter of the slotted needle 15 can be approximately 1.65 mm (16 gauge), the width of the slot 16 can be 0.25 mm to 0.75 mm or approximately 0.5 mm, and the length of the slotted needle 15 can be approximately 20 cm. Embodiments of the slotted needle 15 allow the needle to be inserted through the full thickness abdominal wall, such as the skin, the anterior rectus sheath, the abdominal wall, and the posterior rectus sheath without deforming, while providing a conduit for advancing the self-locking band into the body. To help retain the band, the inner lumen of the slotted needle 15 can include an inner tube 17, which can have a slot 18 that allows the band to be released. For clarity, to emphasize details or functions, this device and other devices disclosed herein may be shown not to scale in the drawings.

[0068] The slotted needle 15 can be used to deliver sutures or bands into the body minimally invasively while allowing the surgeon to extract the suture or band from the slotted needle 15 through the side of the needle rather than pulling it out through a lumen; this can result in a smaller size of the slotted needle 15, and therefore a smaller wound size. A band with an oversized feature such as a locking head can be passed through the slotted needle 15 and into the body, but if the locking head does not fit through the lumen, the band can be released through the side (slot 16) of the slotted needle 15. Figure 7B and Figure 7CThis manipulation is shown in the context of a self-locking band 10, but other embodiments of sutures or bands may be confined within and removed from the slotted needle 15 in this manner. As shown in 7B, a ridge 12 residing near the distal end 11 of the self-locking band 10 is located within the lumen near the tip of the slotted needle 15. Once the slotted needle 15 is introduced into the body cavity and through the desired tissue portion, the distal end 11 can be advanced through the lumen; a tamper or other actuator (not shown) can be used to push the self-locking band 10 through the lumen. Figure 7C , the distal end 11 has been pushed out of the slotted needle 15 so that the ridge 12 is located distal to the needle tip. The slotted needle 15 can then be peeled away from the distal end 11, as shown by the peeling site 20 at the intersection with the slotted needle 15. As the self-locking band 10 is pulled away from the slotted needle 15, generally in the direction indicated by the arrow 53, the peeling site 20 may move distally. Once the distal end 11 is introduced into the abdominal cavity and removed from the slotted needle 15, the slotted needle 15 can be retracted from the body, leaving at least the distal end 11 in the body cavity.

[0069] The band may be retained within the lumen of the slotted needle by a variety of methods. By way of non-limiting example, several slotted needle designs are Figure 7D-7H , which schematically show end views of a slotted needle. Fig.7D A slotted needle 70 is shown having a slot 72 and a band 71 disposed within the lumen. The diameter d1 of the band 71 can be less than, equal to, or slightly greater than the width of the slot Sw1, such that the band has clearance or a slight interference fit when passing through the slot 72. If the band diameter d1 is less than the slot width Sw1, the band can still be retained because the band should be aligned with the slot 72 along most of the entire length of the slot 72 to be removed, and therefore the band tends to continue to remain until pulled laterally to incrementally remove the band 71 from the slotted needle 70. As shown in FIG. Fig. 7E As shown, a band 77 having an elongated cross-section having a minimum width d2 and a maximum width w2 is shown; the band 77 is shown residing within the slotted needle 70. The band 77 will tend to remain captured in the needle 70 even if the minimum width d2 is less than the slot width sw1, because the band 77 will not generally align with the slot 72 unless the surgeon twists the band 77 and needle 70 into alignment in order to release the band.

[0070] Those skilled in the art will recognize that there are many ways to keep the band within the slotted needle while making it easy to move when needed. In some embodiments, the slotted needle may not be round, such as Figure 7FIn this embodiment, the slotted needle 90 is rectangular with a flat portion 92 having a slot 91 therethrough. The band 77 may also have an elongated cross-sectional shape that tends to stay within the lumen when the band 77 is pulled from the slotted needle 90 until the surgeon aligns its minimum band width d2 with the slot 91. In yet another embodiment, Figure 7G A slotted needle 70 is shown with an inner tube 17 within its lumen. The inner tube 17 may be made of any flexible material such as a polymer (e.g., polyethylene or nylon) or an elastic material such as rubber, silicone, or a thermoplastic elastomer. The inner tube 17 may have a slot 18 of width Sw3, which may be greater than, equal to, or less than the diameter d1 of the band 71, such that it provides some resistance to retain the band 71 within the lumen. The inner tube 17 may be made of a thin-walled membrane that deforms when the band 71 is peeled off from the lumen. The slot 18 may be an actual slot through the inner tube 17 that remains open or slightly closed until peeled off, or the slot may be a serrated line that opens with a small amount of force. The inner tube 17 may be bonded to or otherwise fitted to the inner lumen of the slotted needle 70, extending maximally from the root of the needle tip to the proximal end of the needle, close to the tip or anywhere in between with enough overlap with the slot 72 to retain the band 71. In yet another embodiment, the inner tube 93 may have a circumferential length such that it has an overlap 76 having a length d4 of about 0.5 mm to 2 mm, as shown in FIG. Figure 7H The inner tube 93 should have a wall thickness thin enough so that when the surgeon peels the band 71 from the grooved needle 70, the inner tube deforms and opens under the peeling pressure.

[0071] Figures 7I-7K Other embodiments of slotted needles are shown. Fig.7I , a slotted needle 95 is shown having a fixed handle 98 and a rotating handle 99, each handle having a slot - a fixed slot 84 and a rotating slot 85, respectively. When the slots are aligned, the band 71 can be passed through the slot 97 in the shaft 96 and through the fixed handle 98 and the drug to be removed from the slotted needle 95 or inserted into the rotating handle 99 of the slotted needle. However, when the fixed handle 98 and the rotating handle 99 are not aligned, such as Figure 7J As shown, the band 71 remains captured in the slotted needle 95. Those skilled in the art will recognize that this operation can also be achieved with a single slotted handle (not shown) that rotates about the shaft 96 of the slotted needle 95 to align / misalign the handle slot with the slot 97 on the shaft 96 as needed to hold or release the band 71. In yet another embodiment, the sleeve 113 can be placed on the slotted needle 96 to cover the slot 97, such as Figure 7KThe cannula may be as long as the slotted needle 96 or it may be less in length and it may have serrations or gaps (not shown) to facilitate removal or it may be cut and released from the slotted needle 96 by the surgeon to release the band 71 .

[0072] In some embodiments, the system may include a hook needle 21 for grasping the band from within the body cavity. For example, the hook needle 21 can be used as a needle or trocar to directly penetrate tissue without the need for an external trocar. Fig. 8A As shown, the hook 21 can have an open slot 22 and an oblique tip 8 that produce a channel 23 near its distal portion, so that the hook can pierce multiple layers of tissue. The width of the channel 23 can be 0.25mm to 1mm, or about 0.5mm, but usually its size is slightly larger than the width of the band. The outer diameter of the hook 21 can be about 1mm to 3mm or about 1.65mm (16 gauge). The size of the slot 22 and the channel 23 should be selected based on the size of the band and / or the size of any gripping features on the band. The hook 21 can be about 20cm long, or any length suitable for entering the body cavity of the anatomical structure of a given patient, and the hook can include a handle 24 attached to its proximal end. The hook 21 should be strong and hard enough so that it can be inserted through the multiple layers of tissue in the abdomen, that is, the full-thickness abdominal wall containing the anterior rectus sheath, the rectus abdominis, and the posterior rectus sheath, to grasp the distal end of the band so that it is pulled back through the tissue layers and pulled out of the body. As such, the hook needle 21 may have any cross-sectional shape that provides suitable stiffness and strength, including a circular or oval cross-section that may be solid or hollow, or a flat or rectangular cross-sectional shape.

[0073] Figure 8B The hook needle 21 is shown engaging the self-locking tape 10 through the open slot 22 near the ridge 12. The surgeon hooks the self-locking tape 10 with the open slot 22 and then pulls the tip of the hook needle 21 so that the ridge 12 sits against the side of the hook needle 21. Figure 8C As shown, the protuberance 12 is hooked in the channel 23 of the hook needle 21, thereby enabling the surgeon to grasp and manipulate the self-locking tape 10 through the hook needle 21. The self-locking tape 10 having the protuberance 12 at one end is shown as an example here, however, the hook needle 21 can be used to grasp any suture or tape or features thereon from within the body, such as a tape with a loop or having an aperture for engagement with the hook needle 21, such as the distal aperture 128 of the self-locking tape 120 described above.

[0074] The open slot 22 on the hook needle 21 can be any passive feature such as a slot, a hook, or a vertical hook latch, or an active gripping mechanism such as a claw, a jaw, or a clasp. Each of the mechanisms allows the hook needle 21 to grip a suture or band residing in the body. For example, it can be as Fig.9AThe use of a surgical grasper 135 is shown. The grasper 135 may have a handle 138 having a lever 147 that actuates a movable jaw 137 located near the distal end of the shaft 143. The movable jaw 137 may be hinged about a pivot so that it opens to allow access to the open slot 140, as shown. Fig. 9B shown. Fig. 9C A simulated partial view of the distal tip of another embodiment of a grasper 155 is shown having a sliding jaw 145 that slides in the direction of arrow 148 to expose an open slot 149. The grasper 155 may have a needle tip 136 that is sharp enough to allow the grasper 155 to penetrate multiple layers of tissue of the full-thickness abdominal wall to reach the intracorporeal band for retrieval. One skilled in the art will recognize that there are standard graspers with a handle that actuates the jaws or clamps at the distal end and may have a ratchet lock 139 ( Fig.9A ) and a ratchet release 146 for releasing the distal mechanism. Such a device can be used in this surgery and is within the scope of the present disclosure.

[0075] Once the self-locking band enters the body cavity through the hook 21 or similar instrument and pulls the self-locking band through the muscle, the surgeon needs to manipulate the self-locking band to tighten and lock it. When it is easier to directly see the self-locking band and manipulate it, the surgeon can pull it out of the body. Therefore, the surgeon can pull the end of the self-locking band out of the body from the hook 21 through the skin incision site on the opposite side of the defect to connect it with the opposite end of the band. In the absence of a subcutaneous guide, it is troublesome to find the band or needle below the skin surface, because the band is located below the skin surface and outside the field of vision, and since there is usually no camera in the subcutaneous layer, the surgeon may have to grope in the body to find the band by trial and error, which requires a considerable amount of time and energy. If the band is already captured when it is in the body, it is easier to pull the band out of the body. Since the band is already in the hook 21, if the hook 21 is contained by the subcutaneous guide that may be placed in the appropriate position in the body in advance, the subcutaneous guide automatically captures the band because when the hook 21 is withdrawn by the subcutaneous guide, the subcutaneous guide 25 has captured the band. The subcutaneous guide should be sufficiently rigid and able to resist axial, buckling and bending loads as well as torsion, since the subcutaneous tissue through which the subcutaneous guide must tunnel has fibrous interconnections interspersed with adipose tissue, and substantial forces may be required to perform blunt dissection over the defect between incision sites. Advancing the subcutaneous guide using an accompanying anterior-posterior rotational motion may be employed.

[0076] Figures 10A-10CA subcutaneous guide 25 is depicted that may have an elongated body 58, a handle 57, a distal tip 28, and one or more slots such as a distal slot 26. Because the distance between incision sites typically varies between patients, the subcutaneous guide 25 may have a series of slots (not shown) along its elongated body 58. The subcutaneous guide 25 is used to tunnel between two incisions located in the abdomen below the surface of the skin but above the muscle and fascia. Therefore, the subcutaneous guide must be strong enough to dissect tissue layers that may contain hard fibrofatty tissue without bending or buckling. Thus, in embodiments, to facilitate dissection, the shape of the distal tip 28 may be pointed and may be beveled or tapered. In other embodiments, the distal tip 28 may be sharp to facilitate sharp dissection, or it may be relatively blunt for blunt dissection. The elongated body 58 may have a tubular or solid cross-section, which may be shaped as an ellipse (e.g., Fig. 10B The distal groove 26 may be 20 mm (16 gauge) or any other cross-sectional shape that provides the necessary strength to tunnel subcutaneously through tissue. The major diameter may be small, such as about 3 mm or about 1 mm to 4 mm to facilitate tunneling. The length of the groove 26 may be 0.5 mm to 3 cm, for example, or about 2 cm long, and its width may be sized to accommodate the hook needle 21 or a similar instrument that may be introduced through the subcutaneous guide 25. For example, if the diameter of the hook needle 21 is 1.65 mm (16 gauge), the distal groove 26 should be wider than 1.65 mm so that the hook needle 21 can pass through the distal groove 26. The subcutaneous guide 25 may be made of any biocompatible material suitable for surgical use, such as a metal or plastic material that is strong enough to tunnel through the body, such as stainless steel. The subcutaneous guide 25 may be straight or its shape may be a gentle curve, such as Fig. 10C As shown. The curve of the subcutaneous guide 25 can allow it to more easily enter the skin incision on one side of the hernia defect, cross the defect area, and position the skin incision on the opposite side in some body types. In other anatomical body types, for example, if the abdomen has a significant curvature, a straight subcutaneous guide can be used.

[0077] Figures 10D-10G Another embodiment of a subcutaneous guide 164 is shown that may include an elongated body 165, a handle 163, and a distal tip 168 having a slot 166. This embodiment may have a circular cross-sectional shape through most of the elongated body 165, such as Fig.10E The body 165 is shown in the cross-sectional view of FIG. 1 , but can be expanded into a wider and flatter shape at the distal tip 168 to provide a larger target area for the hook needle 21. The body 165 can be tubular or solid, and should be thick enough to tunnel through the subcutaneous tissue of another embodiment of the subcutaneous guide 25 as described above. Figure 10GThe cross-sectional shape of the tip shown is an oval or flat shape, which can be formed by swaging, curling, or otherwise compressing the elongated body 165 to deform it into such a shape. The shape of the distal tip 168 can facilitate blunt dissection through tissue, and the flat and relatively wide platform of the distal tip 168 provides a large target area when the hook needle 21 is passed through the slot 166. This embodiment can additionally have the above-described Figures 10A-10D The same materials, sharpness and geometric properties of the embodiments described in .

[0078] Fig. 10H Yet another subcutaneous guide 184 is shown that may include an elongated body 185, a handle 183, and a distal tip 188 having a slot 186. This embodiment may have the same geometric and structural attributes of the subcutaneous guide described previously, but in addition, it may have a gap 187 for entering the slot 186. When tunneling the subcutaneous guide 184 across the subcutaneous tissue, the band or needle may pass through the gap 187 and into the slot 186 if the needle or band is already in the body.

[0079] Once the self-locking band 10 has been tightened and locked around tissue in the body, the excess band material can be removed. In order to limit the amount of excess band that may contact tissue in the body cavity, it is desirable to cut the excess band near the locking head, which may be deep in the body cavity and difficult to reach. One method of finding the locking head is to follow the excess band protruding out of the body cavity down into the body to the locking head; this excess band can be used as a guide to guide the cutting device down until the band reaches the desired cutting position. Figures 11A-11C An embodiment of a tubular cutter 30 is depicted for cutting excess remaining length of a self-ligating band after closure of a hernia defect. Fig.11A A perspective view of a tubular cutter 30 is shown, comprising an inner tube 31 having an opening 32 near its distal end and an outwardly spring-loaded cutting blade 33 attached to or integrated into the inner tube 31 proximate the opening 32 in the inner tube 31. An outer tube 34 is coaxial with the inner tube 31 and proximate the cutting blade 33. Fig. 11B and Fig. 11C The operation of tubular cutter 30 is schematically illustrated by a side cross-sectional view. Fig. 11B The surgeon uses the self-locking band 10 as a guide to push the tubular cutter 30 downward through the self-locking band 10 located within the lumen of the inner tube 31 to a desired distance, that is, a distance at which the cutting blade 33 meets a portion of the self-locking band 10. Fig. 11CAs shown, the surgeon can push the outer tube 34 distally as indicated by arrow 59 in the inner tube 31 so that the outer tube 34 contacts the cutting blade 33, forcing it to move radially into the lumen of the inner tube 31 as indicated by arrow 86 to cut the self-locking band 10. As the cutting blade 33 moves into the lumen, it intersects with the self-locking band 10, thereby cutting the self-locking band. Those skilled in the art will recognize that there are other methods of pushing the outer tube 34 to obtain more force or leverage, such as having an attached handle. In other embodiments, the tubular cutter 30 can have a threaded interface between the outer tube 34 and the inner tube 31, so that the outer tube 34 can be pushed forward by twisting the outer tube along the thread, so that when the outer tube 34 is screwed down until it presses the cutting blade 33, it can be pushed forward by the cutting blade. This design can provide a greater mechanical advantage to actuate the cutting blade 33 than directly pushing the outer tube 34.

[0080] In other embodiments, the surgeon may use conventional cutting tools, scissors, or laparoscopic cutting tools to cut the band and remove excess material. In some embodiments, a rotary cutter may be used. Fig. 12A , a rotary cutter 169 is shown having an elongated body 170 having a length capable of extending through an incision and into the body to a desired depth to cut the self-locking band 100 and an inner diameter size that will accommodate the band 100 passing therethrough. The rotary cutter 169 can be placed on the self-locking band 100 and advanced downwardly along the self-locking band 100 to a desired depth, i.e., a depth to which the cutter 169 can be used to cut through any excess band. In practice, the surgeon can advance the rotary cutter 169 along the self-locking band 100 until the surgeon touches its locking head (not shown) against the band 100, and the surgeon can then rotate the rotary cutter knowing that the rotary cutter 169 has reached the desired depth for cutting. The elongated body 170 can have a blade arrangement in its inner lumen. For example, the rotary cutter 169 has a cutting blade 171 mounted to the inner diameter and extending into the lumen so that the cutting edge 172 will intersect the self-locking band 10 when the body 170 is rotated, for example, in the direction of arrow 173. In Fig. 12BIn another embodiment shown, the rotary cutter 175 has a similar elongated body 176 but it has two cutting blades 177 and 178 extending into its lumen. The rotary cutter 175 can be passed downward by the self-locking belt 100 so that the belt 10 is between the cutting edge 180 and the relative cutting edge 181. For example, when the elongated body 176 rotates in the direction of the arrow 179, the cutting edges 180 and 181 will intersect with the self-locking belt 100, thereby cutting it off. Those skilled in the art will recognize that there are many blade arrangements that can be provided for cutting the band in the lumen of the tube when rotating, all of which are within the scope of the present disclosure. For these embodiments, the blade can be similar to a razor blade and can be made of steel, while the tube can be made of steel or polymeric material. The blade can be connected to the tube by any suitable metal connection process such as welding process, such as laser welding, or it can be bonded (potting), or curled in place by features on the tube. Alternatively, the blade can be bonded, hot melted or inserted into a polymer tube.

[0081] In a tissue approximation procedure using a self-locking band, a band tensioner may be employed to tighten the band against the locking head, which will be positioned to contact the anterior rectus sheath of the patient. The tensioner may have a small diameter (5 mm or less) distal tubular extension that allows the tensioner to be inserted through a small skin incision, and the tensioner may extend through the subcutaneous fatty connective tissue layer to rest adjacent to the locking head. For example, a simple version of the tensioner is a support tube 45 ( Figure 18I-1 8J), which can be advanced down to the locking head to allow the surgeon to push the locking head while pulling the band in the opposite direction. The tensioning device can impart a degree of mechanical advantage to the band tensioning manipulation to facilitate the process of placing multiple bands. In addition, the tensioning device can provide a measure of the tension applied by the band to the abdominal wall tissue during hernia repair surgery. Excessive tension applied to the tissue during abdominal closure, whether the abdominal closure is performed by conventional sutures or self-locking bands, can lead to tissue tears and recurrence of abdominal hernias.

[0082] Fig.13A1. An embodiment of a tensioning device 190 is shown in FIG. The device 190 may have a series of two ratchet locks (locks) that may be inter-converted in an axial manner. The fixed lock 191 is distal and fixed in that it is fixedly attached to the inner core 195 of the device 190. The movable lock 192 is proximal to the fixed lock 191 and is movable along the inner core 195. The two locks 191 and 192 are kept aligned with each other by attaching them to a plunger system having coaxial components, which may include a non-circular cross-section or a keyway feature that prevents relative rotation of the components during actuation. The locks 191 and 192 are shown in a cross-sectional view of the accompanying drawings; that is, the interior of the locks is visible, showing the pawl mechanism to clearly convey its orientation and operation. In some embodiments, the locks 191 and 192 may have at least one pawl 205 and 210, respectively. The pawl mechanism may have teeth, or it may be a single flexible beam that interacts with teeth or other features on the self-locking band (not shown) to cause the pawl to flex or otherwise bias or spring-load to deflect toward the self-locking band passing through the lock head. This type of ratchet mechanism is just one example of a one-way locking mechanism, and as described elsewhere in this disclosure, the locking mechanism may be any device that allows one-way movement when locked in the opposite direction by teeth or other features on the self-locking band that engage with a pawl or other feature in the lock head, or, for example, the locking mechanism may be a smooth band clamped by a spring-loaded beam, tines, wedges, or cams within the lock head. The lock heads 191 and 192 may have the same mechanism as the lock heads of the self-locking bands.

[0083] The plunger 197 is free to translate along the inner core 195, and it can be biased with the return spring 193 so that in its rest position, the two locking heads 191 and 192 are adjacent to each other, as shown in FIG. Fig.13A As shown. The elongated tube 199 is located distally of the fixed lock 191, in line with the inner channels of the locks 191 and 192; the elongated tube 199 can be connected to a frame 200 that slides along the inner core 195 of the device 190. The spring gauge 194 is located between the frame 200 and the fixed lock 191 to provide a gauge to measure the applied tension pulled on the self-locking band. The distal end of the inner core 195 can have an enlarged cross-section, tab or boss that keeps the frame from sliding off the inner core when it is usually loaded in the distal direction by the spring gauge 194. Or for example, the inner core 195 can have a core stopper 217 attached to its distal end on its outer surface to keep the frame 200 and the elongated tube 199 on the inner core 195. One or more transverse cutting blades 201 can be located near the distal tip and in the lumen of the elongated tube 199. When the device is rotated for a fixed indwelling self-locking band (not shown), the excess band can be cleanly cut near the lock. Fig. 13BAn end view of tensioner 190 is shown in FIG, wherein transverse cutting blade 201 is visible within the lumen of elongated tube 199 which is offset from inner core 195 by frame 200. In this embodiment, the sliding members have a square cross-section to prevent relative rotation therebetween.

[0084] Figures 14A-14E An example of the operation of the tensioning device 190 is shown in FIG. One end of the self-locking band 209 is inserted into the distal end of the elongated tube 199 and advanced through both locking heads 191 and 192 until the teeth or other features on the band 209 engage the pawls 205 and 210 on the locking heads 191 and 192 ( Fig.14A ).like Fig. 14B As shown, when the plunger 197 is pulled toward the core handle 196 in the direction of arrow 206, the attached movable lock head 192 and pawl 210 move therewith, and because the pawl 210 engages with the strap 209, the strap is also pulled in the direction of arrow 206. The strap 209 is free to slide through the fixed lock head 191 because the lock heads 191 and 192 are configured to restrict movement in the direction opposite to arrow 206. Fig. 14C As shown, when the plunger 197 is released, the movable lock 192 is free to slide back along the band 209 to meet the fixed lock 191. The fixed lock 191 holds the band 209 in place so that the band does not move back out of the elongated tube 199. Repeated depression of the plunger 197 stretches the length of the self-locking band 209 to be equal to the deflection length of the plunger 197 to incrementally advance the band 209. While the self-locking band 209 is loose on the anatomical structure, the tensioning device 190 can be held in place while the band is automatically advanced due to the action of the two locks 192 and 191. Once the band begins to have tension as it tightens around the anatomical structure, the tensioning device 190 will be pulled downward into the body as the surgeon actuates it until the elongated tube 199 contacts the lock of the self-locking band 209.

[0085] Fig.14DA self-locking band 209 is schematically shown encircling tissue 212 when tensioned. For clarity, tissue 212 is schematically indicated as a rectangular cross-section, which may represent any tissue engaged by the band, such as the rectus abdominis muscle. The tensioning device 190 abuts against the locking head 211 of the band 209 during tensioning, as the tensioning device 190 eventually pulls the band 209 downward as it is incrementally tightened. As described above, the surgeon depresses the plunger handle 198 in the direction opposite to arrow 218 to tighten the band by engaging the movable locking head 192. When the plunger handle 198 is released, the plunger 197 is free to move in the direction of arrow 218, that is, the movable locking head 192 will be released from the band 209. However, the fixed locking head 191 will engage the band 209, thereby preventing it from sliding back out of the elongated tube 199 and into the body. The band 209 pulls the retaining lock 191 distally, and because the retaining lock 191 is rigidly attached to the inner core 195, the retaining lock 191 is pulled by the band 209, causing it to compress the spring gauge 194. As the spring gauge 194 is compressed, the amount that the inner core 195 protrudes from the frame 200 is proportional to the force on the spring gauge 194 and therefore proportional to the tension on the band 209, because it is the band 209 that is pulling the retaining lock 191. This force can be displayed via the force readout 208 on the inner core 195. During this procedure, the surgeon can check the force readout to avoid placing too much tension on the abdominal wall during defect closure. After the band tensioning is completed, the tensioning device can be rotated to cut the band 209 at its interface with the lock 211, as shown in FIG. Fig.14E shown.

[0086] After partially tightening the self-locking band, the locks 191 and 192 on the tensioning device 190 may need to be removed from the self-locking band 209. This may be necessary during a surgical procedure, such as in an abdominal hernia repair, where multiple bands are required so that the surgeon can gradually close the tissue along the defect. After placing multiple self-locking bands along the abdominal wall defect, the surgeon can tighten the individual bands to the desired degree of tension as measured by the force readout 208 on the tensioning device 190. Then, during the closure process, the tensioning device 190 can be removed from the band 209 and applied to an adjacent band to close the abdominal hernia defect in stages without exceeding the amount of tension that would cause the band to cut through the abdominal wall tissue. The fixed locks 191 and movable locks 192 on the tensioning device 190 may include a release mechanism, such as Figures 15A-15D The fixed lock head 191 is shown as an example, however, the same principles can be incorporated into the movable lock head 192 via its release frame 203 and pawl 210. The release frame 202 can pass through the window 204 and attach to or abut against the pawl 205 of the fixed lock head 191. Fig. 15C As shown, when the release frame 202 is pressed down in the direction of arrow 213, the ratchet 205 moves along the direction of arrow 206 ( Fig.15D) direction to release the belt positioned inside the lock head 191.

[0087] To remove the tensioner 190 from the belt, the release frames 202 and 203 on the fixed lock 191 and the movable locks 192 and 192 can be pressed down simultaneously. Fig.15E As shown, to facilitate simultaneous depression of both release frames 202 and 203, a release frame extension 214 may rigidly protrude from one release frame 202 and extend just above the other release frame 203, such that when release frame extension 214 is depressed in the direction of arrow 215, both release frames 202 and 203 are depressed, thereby releasing the belt (not shown) from both lock heads 191 and 192. Alternatively, a release frame extension (not shown) may be rigidly mounted to release frame 202 on fixed lock head 191 and extend above release frame 203 on movable lock head 192.

[0088] Fig.16A Another embodiment of a tensioning device 239 is shown having a locking head 240 attached to a plunger 245 that slides on a core 243. The locking head can have any type of one-way mechanism, including a ratchet / pawl mechanism or, for example, a cam that locks onto the band when the core handle is pulled. A single locking head can have a ratchet and pawl mechanism, or it can have a cam that engages the band 209 when the plunger 245 is pulled toward the core handle 244 via the plunger handle 246. A return spring 241 tends to return the plunger 245 and its attached locking head 240 to release the cam and slide back toward the frame 248 fixedly attached to the core 243. The locking head 211 on the self-locking band 209 prevents the band from loosening after each pull and release by the plunger 245. An elongated tube 247 slides within the frame 248 and presses a spring gauge 242 at the proximal end of the elongated tube 247. When the plunger 245 is pulled to tension the band 209, the locking head 211 against the band 209 pulls the inner core 243 and the attached frame 248, and the spring gauge 242 is compressed because the elongated tube 247 abuts the locking head 211. A force indicator 251 attached to the elongated tube 247 translates on a force readout 250, which shows a force proportional to the displacement of the spring gauge 242 and therefore the compression force on the spring gauge 242. This force is related to the tension of the band 209. The band 209 can be severed by one or more transverse cutting blades 249 located at the distal end of the elongated tube 247, as described above.

[0089] Those skilled in the art will recognize that there are many different types of force transducers that can be integrated into a device for tightening a strap, and that such devices and methods are within the scope of the invention disclosed herein. For example, such a load cell can be placed on any member that is subject to mechanical tension, such as the support tube 45, the elongated tube 247 (or 199), the frame 248 (or 200), or the lock head 240 (or 192). By way of non-limiting example, a suitable load cell can include a strain gauge or piezoelectric sensor that converts stress into an electrical signal. Alternatively, for example, an electromagnetic sensor or a linear displacement sensor such as a potentiometer can be incorporated into the tensioning device 239 so that it measures the displacement of the force indicator 251 and converts it into an electrical signal. The generated electrical signal can be used to form a digital readout on the device or transmitted to a separate device, such as a computer or robotic system, via wired or wireless communication (e.g., Bluetooth or Bluetooth LE).

[0090] Various embodiments of methods or techniques and instruments for placing multiple intermittent fastening rings on each side of a hernia defect and maintaining tension on each ring while allowing continuous clamping of each ring to reset the edges of the defect will now be disclosed. The operation can be performed laparoscopically via multiple small incisions and trocar ports. The order of the steps and components described herein is for illustrative purposes only and is not intended to limit the scope of the invention, as various alternative combinations or arrangements of the order of the steps are contemplated. The described systems, devices, and methods can be used to repair hernia defects, and in some instances, can be used to repair hernias using a component separation method (CSM). For example, when a surgeon desires to offset a fascial opening toward the midline of the abdominal cavity, a laparoscopic CSM can be used, and the fascial opening may be offset from the midline. Once the defect is aligned, the systems and methods described herein can be used to close the defect.

[0091] Typically, the surgeon creates a small midline incision in the umbilicus87 and inserts a Veress needle to insufflate the abdomen with carbon dioxide gas, thereby creating a Fig.17A The pneumoperitoneum is removed and a trocar port is placed at the umbilicus for insertion of the laparoscope. A second trocar port may be placed lateral to the midline for insertion of laparoscopic instruments. Those skilled in the art will recognize that there are other surgical steps and preparatory steps for this surgical procedure. Fig. 17B Similarly, it is a cross-section through the human body. The following figures show the skin 2, the rectus abdominis muscle 38, and the fascia tissue 37 and 39, but for the sake of clarity, other types of tissue, such as muscle, connective tissue, and fat, are not shown in the figures. However, those skilled in the art will recognize that various tissue layers can exist between the skin 2 and the fascia tissue 37 and 39 and the muscle tissue 38. For simplicity, in the method figures, the self-locking belt is shown without details such as locking features (such as teeth).

[0092] Figure 18A-1 8K shows an example of a defect closure system that delivers a band to the defect site and then tensions the band to close the opening. Fig.18A , a guide needle 35 can be inserted through the skin entry site 36 and through the full-thickness abdominal wall, which is composed of the anterior rectus sheath 37, the rectus abdominis muscle 38, and the posterior rectus sheath 39 located on both sides of the hernia defect 40. The guide needle 35 can be long (about 15 mm or longer, depending on the patient's anatomy), such as an intravenous needle or spinal needle, and is approximately 18 gauge (1.27 mm in diameter). The guide needle 35 is used to determine the skin entry site 36 for subsequent needle placement to produce a desired tissue margin (e.g., in this embodiment, d is approximately 2 cm) lateral to the hernia defect 40 for subsequent placement of the self-locking band. The tissue margin can be directly visualized through an intraperitoneal laparoscope (not shown).

[0093] Based on the entry site of the guide needle 35, a first skin incision 41 and a second skin incision 42 may be formed. Fig.18B As shown. Skin incision 41 and skin incision 42 can be about 3 mm long and are located at the entry site of guide needle 35. Next, a subcutaneous guide 25 is placed, which spans from the first skin incision site 41 to the second skin incision site 42 on the opposite side of the hernia defect 40 as it cuts and / or tunnels through the intermediate tissue between the incision site 41 and the incision site 42. The subcutaneous guide 25 is advanced until the open portion of the slot 26 appears at the second skin incision site 42. As shown, the distal tip 28 of the subcutaneous guide 25 can protrude through the second skin incision site 42, or can reside below the surface of the skin.

[0094] The hook needle 21 can be placed through the distal slot 26 on the subcutaneous guide 25 at the second skin incision site 42, such as Fig.18C As shown. The hook needle 21 can then be advanced through the anterior rectus sheath 37, the rectus abdominis muscle 38, and the posterior rectus sheath 39. The slotted needle 15 with the self-locking band 10 in its lumen can be placed through the first incision site 41 and adjacent to the subcutaneous needle guide 25. Once the slotted needle 15 is in place, the self-locking band 10 can be advanced through the slotted needle 15 into the body cavity. Placing the self-locking band 10 into the body cavity via the slotted needle 15 avoids the use of another device and potentially another skin entry site to introduce the band 10 into the body.

[0095] In order to pull the self-locking band 10 through the opposing muscle, the self-locking band can be engaged by the hook needle 21. Fig.18DManually adjusting the angles of the slotted needle 15 and the hook needle 21 to bring their distal tips close to each other is shown. The self-locking band 10 is then pushed out of the slotted needle 15, exposing the ridge 12 at the distal end 11, thereby allowing the hook needle 21 to hook the distal end 11 near the ridge 12. Alternatively, a laparoscopic grasper (not shown) can be introduced into the body cavity through another access site; through the grasper, the surgeon can manually grasp the self-locking band 10 and attach it to the hook needle 21. Those skilled in the art will recognize that there may be other features, such as a loop or hole on the end of the self-locking band 10 that can be grasped by the hook needle 21, or the hook needle 21 may have a grasping feature, such as a snare, or a clamp or a claw near its distal tip, which is fixed to any part of the self-locking band 10, whether or not the self-locking band 10 has a grasping feature.

[0096] Fig.18E The hook needle 21 is shown being retracted from the patient's body as indicated by arrow 54, thereby also pulling the self-locking band 10 out of the body at the second skin incision site 42, as the self-locking band 10 is captured by the hook needle 21. Since the hook needle 21 is placed through the distal slot 26 of the subcutaneous guide 25, when the hook needle is withdrawn through the distal slot 26, the self-locking band 10 is also pulled through the slot 26, causing it to be captured by the subcutaneous guide 25. Both ends of the band now pass through the first skin incision site 41 and the second skin incision site 42 and exit from the body, as shown in FIG. Fig.18F The slotted needle 15 can be withdrawn from the body and then, as indicated by arrow 53, the self-locking band 10 can be peeled away from the needle 15 and out of the lumen.

[0097] In order to tighten the self-locking belt 10, both ends of the self-locking belt 10 should be withdrawn from the same skin incision or at least can be entered from the same skin incision so that the belt will reside in the body as a whole. This can be achieved by withdrawing the subcutaneous guide 25 from the patient's body through the first skin incision site 41, such as Figure 18G As indicated by the arrow 55 in FIG. Since the distal end 11 is positioned by the distal groove 26 of the subcutaneous guide 25, the distal end 11 is also pulled out of the body through the first skin incision site 41, so that the self-locking belt 10 passes through the rectus abdominis muscle 38 and is placed across the hernia defect 40, and the two ends of the self-locking belt 10 exit the body so that the self-locking belt 10 can be tightened. Fig.18H This configuration is shown, in which a traction force indicated by arrows 56 can be applied to the self-locking band 10 to pull the self-locking band through the full-thickness abdominal wall on both sides of the hernia defect 40 and out of the first skin incision site 41. Since the locking head 14 protrudes to the outside of the body near the first skin incision site 41, the distal end of the self-locking band 10 can be placed through the locking head 14 for unidirectional tightening.

[0098] Fig.18IThe self-locking band 10 is shown in a locked configuration when tightened as indicated by arrow 88. The support tube 45 can be advanced over the self-locking band 10 so that the self-locking band 10 extends through its lumen, and the distal end 78 of the support tube 45 can be placed in contact with the locking head 14 to provide counter traction during the tightening process. Thus, as indicated by arrow 57, the surgeon can pull the self-locking band 10 while pushing the support tube 45 in the opposite direction. The support tube 45 can be a tubular device made of any material so that it is strong enough to withstand the tension of pulling the self-locking band 10, such as a rigid polymer material, such as polycarbonate or nylon, or a metal (e.g., stainless steel).

[0099] FIG. 18J shows that the self-locking band 10 is fully tightened to close the ventral hernia defect 40 when pulled in the direction indicated by arrow 57. When the hernia defect is closed so that the self-locking band 10 falls firmly in place, the support tube 45 can push the locking head 14 through the first skin incision site 41 and make it contact with the anterior rectus sheath 37. The excess length of the self-locking band 10 can be removed by any suitable method or tool. For example, and with reference to FIG. 18K, the tubular cutter 30 can be advanced along the self-locking band 10 through the first skin incision site 41 to contact the locking head 14, at which point the outer tube 34 can be advanced downward on the inner tube 31 so that the cutting blade 33 is bent toward the self-locking band 10, thereby cutting the excess self-locking band 10. In other embodiments, other devices such as a rotary cutter 175 (not shown) can be used to cut off the excess band. In addition, the tubular cutter 30 or the rotary cutter 175 can also be used instead of the support tube 45 to lock the band and cut off the excess length. It will be apparent to those skilled in the art that other alternative methods of cutting excess tape exist without departing from the invention disclosed herein. By way of non-limiting example, this method may include cutting excess toothed self-locking tape 10 with a scalpel, scissors or tweezers.

[0100] Figures 19A-19KYet another embodiment of a system and method for accessing full-thickness abdominal tissue is shown, which shows an example of a defect closure system that delivers a band to a defect site and then tensions the band to close the opening. System 6 includes a self-locking band having a separate locking head that allows the band to be introduced into the body through a conventional small needle. After the band is placed in the abdominal cavity, the needle can be withdrawn from the patient's body without the additional step of stripping the band from the grooved needle. If the size of the locking head is suitable for a small needle, this method can also be adopted using a band with an attached locking head. By way of non-limiting example, system 6 can include a self-locking band 100, a band insertion needle 7, a hook needle 21, a subcutaneous guide 164, a laparoscopic grasper 73, and a support tube 45. Other components and devices, including those disclosed throughout this application, can be included in the system and used in the method disclosed herein, that is, the system 6 shown is not necessarily a complete surgical kit, and other devices and methods can replace or add to system 6 to form other systems or embodiments within the scope of the invention disclosed herein. For example, band cutting instruments may be included, and various laparoscopic instruments, such as a laparoscope with a camera, may also be used during surgery.

[0101] Reference Fig.19A , a guide needle 35 can be inserted through the skin access site 36 and through the full-thickness abdominal wall, which is composed of the anterior rectus sheath 37, the rectus abdominis muscle 38, and the posterior rectus sheath 39. The guide needle 35 can be long (about 15 mm), such as an intravenous needle or spinal needle, and is approximately 18 gauge (1.27 mm in diameter). The guide needle 35 is used to determine the skin entry site 36 for subsequent needle placement to produce a desired tissue margin (e.g., in this illustration, d=2 cm) laterally to the hernia defect 40 for subsequent placement of the self-locking band 100. The tissue margin can be directly visualized through an intraperitoneal laparoscope (not shown).

[0102] Based on the entry site of the guide needle 35, a first skin incision 41 and a second skin incision 42 may be formed. Fig.19B As shown. Skin incision 41 and skin incision 42 can be about 3 mm long and are located at the entry site of guide needle 35. Next, a subcutaneous guide 164 is placed, which spans from the first skin incision site 41 to the second skin incision site 42 on the opposite side of the hernia defect 40 as it cuts and / or tunnels through the intermediate tissue between the incision site 41 and the incision site 42. The subcutaneous guide 164 is advanced until the open portion of the slot 166 appears at the second skin incision site 42. As shown, the distal tip 167 of the subcutaneous guide 164 can protrude through the second skin incision site 42, or can reside below the surface of the skin.

[0103] The hook needle 21 can be placed in the second skin incision site 42 through the distal groove 166 on the subcutaneous guide 164, such as Fig.19C As shown. Then, the hook needle 21 can be advanced through the anterior rectus sheath 37, the rectus abdominis muscle 38 and the posterior rectus sheath 39. The band insertion needle 7 with the self-locking band 100 in its lumen can be passed through the first incision site 41 and placed adjacent to the subcutaneous guide 164. Once the band insertion needle 7 is in place, the self-locking band 100 can be advanced through the band insertion needle 7 into the body cavity. For simplicity, the self-locking band 100 is schematically shown as a line without details such as locking features (such as teeth).

[0104] To pull the band 100 through the opposing muscle, it can be hooked by the hook 21; if the hook 21 and the distal tip of the band insertion needle 7 are close together in the body cavity, it can be manipulated so that the hook 21 engages with the band 100 or a distal feature on the band (such as the distal orifice 108). Fig.19D As shown, a laparoscopic grasper 73 can be introduced into the body cavity through another entry site; through the grasper 73, the surgeon can manually grasp the band 100 or the distal orifice 108 and attach it to the hook needle 21. Only the distal end of the grasper 73 is shown. Those skilled in the art will recognize that there may be other features, such as loops, hooks, or ridges on the end of the band 100 that can be grasped by the hook needle 21, or the hook needle 21 may have a grasping feature, such as a snare near its distal tip, or a clamp or claw that holds onto any portion of the band 100, whether or not the band 100 has an engagement feature.

[0105] Fig.19E The hook needle 21 is shown being pulled out of the patient's body as indicated by arrow 54, thereby pulling the self-locking band 100 out of the body at the second skin incision site 42, as the band 100 is captured by the hook needle 21. Since the hook needle 21 is placed through the distal slot 166 of the subcutaneous guide 164, as the hook needle is withdrawn through the distal slot 166, the band 100 is also pulled through the slot 166, causing it to be captured by the subcutaneous guide 164. Both ends of the band are now outside the body, with the distal end of the band passing through the first skin incision site 41 and the proximal end of the band passing through the second skin incision site 42, as shown in FIG. Fig.19F The band insertion needle 7 can be withdrawn from the body and over the band 100, so that the band is withdrawn through the first skin incision site 41 without the band insertion needle 7.

[0106] In order to tighten the self-locking belt 10, both ends of the belt 100 should be withdrawn from the same skin incision or at least can be entered from the same skin incision. This can be achieved by withdrawing the subcutaneous guide 164 from the patient's body through the first skin incision site 41, such as Figure 19GAs the self-locking band 100 is positioned through the distal slot 166 of the subcutaneous guide 164, the self-locking band 100 is also pulled out of the body through the first skin incision site 41, so that the self-locking band 100 passes through the rectus abdominis muscle 38 and is placed across the hernia defect 40. As the two ends of the band 100 exit the body through the first skin incision site 42, the band 100 can be tightened. This Fig.19H 3 and 4 ), and as indicated by arrows 79, traction can be applied to both ends of the self-locking band 100 to tighten it through the full-thickness abdominal wall on both sides of the hernia defect 40.

[0107] Fig.19I The self-locking band 100 is shown in a locked configuration when tightened as indicated by arrow 79. The support tube 45 can be slid over the self-locking band 100 so that the band 100 extends through its lumen, and the distal end 78 of the support tube 45 can be placed in contact with the locking head 109 to provide counter traction during the tightening process. Thus, as indicated by arrow 79, the surgeon can pull the band 100 while pushing the support tube 45 in the opposite direction to tighten the self-locking band 100, as shown in FIG. Fig.19J As shown. The support tube 45 itself can be a tubular device made of any material that is strong enough to withstand the tension of pulling the band 100; the support tube 45 can be made of a rigid polymer material (such as polycarbonate) or a metal (e.g., stainless steel). Since the surgeon may wish to measure the tension applied, the support tube 45 can have a compression spring along its length connected to a plunger passing through its inner lumen, so that when the support tube 45 is pushed and the band 100 is pulled, the plunger extends, thereby showing an indication of force. Alternatively, the tensioning device 190 shown in Figures 13-16 can be used to tighten the band 100 while providing an indication of tension.

[0108] The excess length of the band 100 may be removed by any suitable method or tool. As described herein above (FIG. 18K), a tubular cutter 30 may be used. In other embodiments, other devices such as a rotary cutter 175 (FIG. 11) may be used to cut the excess band. Additionally, a tensioning device 190 may be used to cut the band 100, as the device 190 may have a transverse cutting blade 201 at its distal end. It will be apparent to one skilled in the art that other alternative methods of cutting the excess band exist without departing from the invention disclosed herein. By way of non-limiting example, such methods may include cutting the excess self-locking band 100 with a scalpel, scissors, or tweezers.

[0109] Figures 20A-20IYet another embodiment of a system and method for closing a ventral hernia is disclosed in the present disclosure. By way of non-limiting example, the system may include a self-locking band 220, a grooved needle 15, a hook needle 21, a subcutaneous guide 184, a tubular cutter 30, and a support tube 45. The tubular cutter 30 may have an outer tube 34 and an inner tube 31, the inner tube having a cutting blade 33 attached thereto. The above components are described in further detail in the present disclosure. Other components and devices, including those disclosed throughout the present application, may be included in the system disclosed herein and used in the method disclosed herein, that is, the system shown is not necessarily a complete surgical kit, and other devices and methods may be substituted or added to the system to form other systems or embodiments within the scope of the invention disclosed herein. For example, various laparoscopic instruments, such as a laparoscope with a camera, may also be used during a surgical procedure.

[0110] A guide needle 35 may be inserted through the skin access site 36 and through the full-thickness abdominal wall, which may be formed by a needle as described above, for example Fig.18A The anterior rectus sheath 37, the rectus abdominis muscle 38 and the posterior rectus sheath 39 shown and described in the figure are composed of the anterior rectus sheath 37, the rectus abdominis muscle 38 and the posterior rectus sheath 39. Based on the entry site of the guide needle 35, a Fig.18B The first skin incision 41 and the second skin incision 42 are shown and described in FIG.

[0111] To clearly illustrate the surgical procedure, the self-locking band 220 is schematically shown as a line diagram, omitting some details such as locking features (e.g., teeth). To introduce the self-locking band 220 into a body cavity, as shown in FIG. Fig. 20A As shown, a slotted needle 15 can be placed through the first incision site 41 and through the full-thickness abdominal wall to enter the body cavity below the posterior rectus sheath 39. Once the slotted needle 15 is in place, the self-locking band 220 can be advanced through the slotted needle 15 and into the body cavity, as shown in FIG. Fig. 20B As the band is introduced into the body cavity, the band can be removed from the slotted needle 15, as shown. Fig.20D Removing the band laterally from the slotted needle can allow the slotted needle to have a smaller diameter because the locking head 221 attached to the self-locking band 220 does not need to pass through the lumen of the slotted needle 15. However, if the locking head 221 can be made as small as the width of the elongated body 229 of the band 220 ( Fig. 6A), then a slot may not be needed because the locking head 221 can be pulled directly through the lumen of a conventional needle. Alternatively, if the diameter of the needle is large enough to accommodate the locking head 221, which may be larger than the width of the elongated body 229 of the self-locking band 220, a conventional needle without a slot can be used to pass the self-locking band 220 therethrough. That is, a needle with a larger diameter than the slotted needle 15 can be used, which is generally expected to have a smaller incision and a smaller needle bundle passing through the muscle associated with minimally invasive surgery. For example, if a large needle or cannula needle with a diameter of, for example, 10 mm is used, then a relatively large hole in the fascia will need to be closed with sutures to prevent local hernia. In addition, large bundles in the muscle may result in weaker tissue for placement of the band.

[0112] refer to Fig.20D , placing a subcutaneous guide 184 that spans from the first skin incision site 42 to the second skin incision site 41 on the opposite side of the hernia defect 40 as it cuts and / or tunnels through the intermediate tissue between the incision site 42 and the incision site 41. The subcutaneous guide 184 is advanced until the groove 186 appears at the first skin incision site 41. As shown, the distal tip 188 of the subcutaneous guide 164 can protrude through the second skin incision site 42, or can reside below the surface of the skin so that the surgeon can access it to engage the self-locking band 220. This can be achieved by, for example, placing the proximal tip 222 of the self-locking band 220 through the gap 187 on the distal tip 188 of the subcutaneous guide 184 (for example), so that the subcutaneous guide 184 hooks the distal orifice 227 of the self-locking band 220. Once engaged, the subcutaneous guide 184 can be pulled back through the second incision site 42, thereby retracting the locking head 221 across the defect, adjacent to or outside the second skin incision site 42. Those skilled in the art will recognize that there may be other features, such as loops, hooks, or ridges on the end of the band 220 that can be grasped by the subcutaneous guide 184, or the guide 184 may have a grasping feature, such as a snare near its distal tip, or a clamp or claw that is retained on any portion of the self-locking band 220, whether or not the band 220 has an engagement feature.

[0113] Fig.20E The subcutaneous guide 184 is shown being pulled out of the patient's body as indicated by arrow 230 , thereby pulling the self-locking band 220 out of the body at the second skin incision site 42 as the band 100 is captured by the hook 21 .

[0114] To tighten the self-locking band 220, both ends of the band 220 should exit from the same skin incision or at least be accessible from the same skin incision. This can be achieved by placing a hook needle 21 through a slot 223 on the locking head 221 and advancing the hook needle 21 through the full-thickness abdominal wall and into the body cavity, where the distal tip 225 of the self-locking band 220 resides in the body cavity, such as Fig.20F With the needle already placed through the same slot 223 through which the distal tip 225 in the locking head 221 will pass, the hook needle 21 can be withdrawn from the body, thereby passing through the full-thickness abdominal wall and pulling the self-locking band 220 through the locking head 221 to engage, as shown. Figure 20G As shown. Fig. 20H As shown, the self-locking band 220 can be tightened and the locking head 221 driven downward toward the anterior rectus sheath 37.

[0115] The support tube 45 can be advanced over the self-locking band 220 so that the band 220 extends through its lumen, and the distal end 78 of the support tube 45 can be placed in contact with the locking head 221 to provide countertraction during the tightening process. Thus, as indicated by arrow 231, the surgeon can pull on the band 220 while pushing the support tube 45 in the opposite direction to tighten the self-locking band 220, as shown in FIG. Fig.20I As shown. Since the surgeon may wish to measure the tension applied, the support tube 45 may have a compression spring along its length connected to a plunger passing through its inner lumen so that when the support tube 45 is pushed and the band 220 is pulled, the plunger extends, thereby showing a measurement of force. Alternatively, other tensioning devices may be used, such as the tensioning device 190 shown in FIGS. 12-14 , which may be used to tighten the band 220 while indicating tension.

[0116] The excess length of the band 220 may be removed by any suitable method or tool. As described herein above (FIG. 18K), a tubular cutter 30 may be used. In other embodiments, other devices such as a rotary cutter 175 (FIG. 12) may be used to cut the excess band. Additionally, the tensioning device 190 may be used to cut the band 220, as the device 190 may have a transverse cutting blade 200 at its distal end. It will be apparent to one skilled in the art that other alternative methods of cutting the excess band exist without departing from the invention disclosed herein. By way of non-limiting example, such a method may include cutting the excess self-locking band 220 with a scalpel, scissors, or tweezers.

[0117] The embodiments presented in this application are simple, less cumbersome, and require fewer steps than other minimally invasive techniques. In addition, the system provides the higher degree of tension required to close full-thickness abdominal wall defects. In embodiments of the present invention, no distinct bundle is formed, whereby the band can be pulled back through the wall. This reduces the likelihood of a failed defect closure; the bundle passing through the rectus abdominis muscle can be as small as the needle used in surgery. In addition, those skilled in the art will appreciate that the size of the self-locking band can be set to a diameter large enough to maintain the required tension and resist cutting through tissue, but small enough to fit through the slotted needle 15, compared to relatively thin sutures.

[0118] Systems and methods for closing fascial openings are described herein. Multiple bands can be delivered into the body, and this process can be repeated as needed multiple times to close the defect. Large defects may require several bands, which can be tightened in parallel and tightened incrementally to gradually repair the defect, thereby reducing the peak force on the tissue. Part or all of the system and device can be reused to deliver multiple bands, or part or all of the system and device can be discarded as a whole or in part, and a new set of systems and devices can be used for each band. Although the present disclosure describes the system and method in the context of hernia repair and especially in ventral hernia repair, the currently disclosed device and method can be used to connect tissues, close openings, or fasten the device to two or more tissue parts or fasten to surgical procedures therebetween. In addition, although the present disclosure describes the method in the context of laparoscopic surgery, the method can be applied to any other type of surgery such as laparotomy or laparotomy. In addition, the currently disclosed system and method can optionally include hernia meshes similar to those used in typical hernia repair surgery or any new mesh system or application methods that can be produced.

[0119] Laparoscopic ventral hernia repair techniques using self-locking bands can be performed with the assistance of robotic surgical techniques. Robotic assistance can enhance control over multiple steps in the manual techniques described herein. For example, the subcutaneous passage of the subcutaneous guide requires a large peeling force to drive the guide through tissue that may be fatty and fibrous; the use of a robotic arm can allow the needle guide to advance smoothly through the tissue, while the artificial passage in the fibrous tissue may cause the movement to be jerky, which may result in the guide being incorrectly inserted into the rectus abdominis or abdominal cavity. Thus, the proximal end of any of the devices used in the surgeries disclosed herein may include a connector for attaching the distal end of the robotic arm, which may have a standard or custom connection that interfaces with the connector. For example, Fig.21AA laparoscopic grasper 255 is shown, which includes an elongated shaft 258 supporting an end effector 256 and a robotic arm interface 257 attached to a surgical robotic arm (not shown). The robotic arm interface 257 can receive and transmit drive signals and motion between the robotic arm and the end effector 256, and can interface with the robotic system through a quick release mechanism. An articulated wrist joint 259 can provide two degrees of freedom of motion between the end effector 256 and the shaft 258, and the shaft 258 can be rotatable relative to the robotic arm interface 257, thereby creating three degrees of freedom of operation at the end effector 256. As an example, robotic assistance can be used during the transfer of the distal end of the self-locking band to the hook needle, as described above Fig.19D A laparoscopic grasper 255 may be inserted into the abdominal cavity to grasp the distal end of the band, maneuver it toward the hook and stabilize it after being secured by the hook.

[0120] Fig. 21B A subcutaneous guide 265 is shown with a slot 268 at the distal end 266. The subcutaneous guide 265 may have a robotic arm interface 267 at its proximal end, and robotic controls may be used to manipulate the subcutaneous guide during subcutaneous dissection, such as Fig. 21C As shown. The forces as indicated by arrow 270 can be better controlled by the surgical arm than by manual procedures because higher forces can be applied by the robotic system in a more controlled manner. Robotic assistance also facilitates movement of intraperitoneal instruments under laparoscopic visualization.

[0121] Although the present invention is specifically shown and described by reference to these exemplary embodiments, it will be appreciated by those skilled in the art that different changes in form and detail may be made therein without departing from the scope of the invention as encompassed by the appended claims. Although certain embodiments of the present invention are described above in full, various alternatives, modifications and equivalents may be used. The various devices and method steps of the embodiments disclosed herein may be combined or substituted with one another, and such alternative embodiments fall within the scope of the claimed invention. Therefore, the above description should not be viewed as limiting the scope of the present invention, which is defined by the appended claims.

Claims

1. A system for closing a tissue defect, the system comprising: Self-locking belt with locking head; a first needle having a lumen for delivering the self-locking band through the first incision site; a second needle having a hook on a distal end thereof for engaging the self-locking band and pulling the band out of the body through a second incision site; as well as A guide having an aperture near its distal end for passing the second needle therethrough and retaining the band after the second needle is removed from the aperture.

2. The system of claim 1, further comprising a support tube for urging the self-locking strap when tensioning the strap.

3. The system of claim 1, further comprising a rotary cutter having at least one distal blade for severing the self-locking band adjacent the locking head.

4. The system of claim 1 further comprising a linear cutter having an inner tube, an outer tube, and a radially flexing blade that is pressed into the lumen of the inner tube when engaged by the outer tube.

5. The system of claim 1, further comprising a tensioner having at least one movable locking head for incrementally tensioning the self-locking belt.

6. The system of claim 5, wherein the tensioner comprises a tension meter for measuring tension on the belt.

7. The system of claim 6, further comprising an indicator for displaying the tension on the belt.

8. The system of claim 6, wherein the tension meter is a mechanical spring meter.

9. The system of claim 6, wherein the strain gauge is a force transducer.

10. The system of claim 6, 7, 8 or 9, wherein the tensiometer is capable of converting the tension into an electrical signal and transmitting the electrical signal to a display or receiving computer.

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