Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06066—Needles, e.g. needle tip configurations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/0482—Needle or suture guides
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06004—Means for attaching suture to needle
  • A61B2017/06047—Means for attaching suture to needle located at the middle of the needle
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
  • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
  • A61B17/06066—Needles, e.g. needle tip configurations
  • A61B2017/0609—Needles, e.g. needle tip configurations having sharp tips at both ends, e.g. shuttle needle alternately retained and released by first and second facing jaws of a suturing instrument

Definitions

• Suturing instruments for assisting a medical practitioner in placing stitches during surgical procedures are useful, particularly in surgical procedures requiring the placement of secure and accurate sutures in difficult to access regions of the body, including internal body regions. Instruments and methods for suturing remotely are especially important in minimally invasive surgical procedures such as laproscopic and endoscopic procedures. In addition to helping to access remote regions of the body requiring suturing, suturing instruments may also allow the efficient manipulation of very small needles and the formation of small and precise sutures
• a suture is attached to the center of a double-ended needle and can be passed between the two jaws. At least one end of the needle protrudes from one or the other jaw at all times. The protruding needle may become caught in tissue, a problem that is exacerbated in difficult to access regions and regions offering limited maneuverability, such as the subacromial space of the jaw. Similar devices are described in US 5,814,054, US 5,645,552, US 5,389,103, US 5,645,552, and US 5,571,090.
• the diameter of the distal end of the device is less than 12 mm, less than 10 mm, less than 8 mm, or less than 6 mm.
• the jaws at the distal end of the device may be appropriately scaled.
• the first and second jaws may be less than about 30 mm long, less than 27 mm long, less than 25 mm, less than 20 mm long, etc.
• the elongate neck region may have a diameter that is less than the diameter of the closed first and second jaws.
• the jaws in the distal region are typically oriented so that they open and close perpendicular to the long axis of the device, however alternative configurations are possible.
• the control may be biased (e.g., by a spring) so that return of the control to the relaxed position causes return of the tissue penetrator to the retracted position.
• the tissue penetrator is triggered and fully extends after triggering, and returns automatically to the retracted position.
• the tissue penetrator is controlled by the jaw control. For example, when the jaw control is activated to close tissue between the jaws, the tissue penetrator is activated. In some variations the tissue penetrator is extended when the pressure applied to the jaw control exceeds some threshold.
• the tissue penetrator may be extended when the force applied to the jaw control exceeds about 2 lbs, about 5 Ib, about 81b, about 10 Ib, about 121b, about 151b, about 201b, etc.
• the tissue penetrator movement is linked to additional pressure on the jaw control, so that continuing to squeeze the jaw control further extends tissue penetrator.
• the tissue penetrator is "triggered” and fully extends after triggering, regardless of the amount of pressure applied to the jaw control above the threshold to trigger. Return of the tissue penetrator from the extended (tissue piercing) configuration to the contracted (at least partly within the jaw) configuration may be automatic or controlled (e.g., by decreasing the pressure on the jaw control).
• the handle of a suture passer may include additional controls that can control other aspects of the device, such as the angle of deflection of the distal end of the device.
• the distal end of the device e.g., including the jaws or a portion of the jaws
• the handle includes a distal tip deflector control that is configured to control deflection of the distal end of the device.
• the suture passer devices described herein may also be configured so that they are compatible with surgical visualization techniques.
• the first jaw and/or the second jaw may include a suture passage to at least partially guide the suture.
• the tissue penetrator and/or the suture shuttle dock may include a suture passage to at least partially guide the suture when the suture shuttle is engaged with the tissue penetrator.
• the suture passage (which may be a channel or guide, and may therefore be referred to as a suture channel or suture guide) may be open (e.g., an open channel) or at least partially enclosed.
• tissue clamping region having two jaws
• handle including a jaw control to manipulate at least one jaw
• tissue penetrator configured to form a channel through the tissue through which a suture shuttle may be passed.
• the tissue penetrator may be configured to be substantially retractable into the first jaw (e.g., the distal tip of the tissue penetrator may be retracted into the first jaw).
• the tissue clamping region typically includes a first jaw having first tissue-contacting surface, and a second jaw having a second tissue-contacting surface, wherein the tissue-contacting surfaces of the first and second jaws are substantially parallel when the tissue clamping region is opened.
• the device may also include a suture shuttle dock functionally connected to the second jaw and configured to releasably secure the suture shuttle. Any of the features previously described (alone or in combination) may be included as part of these continuous suture passers.
• kits including a suture passer as described herein and instructions for use.
• the suture attachment region of the suture shuttle comprises a loop, a hook, a passage, or a channel.
• a suture may be passed through the suture attachment region, and may be tied, glued, welded, or otherwise affixed to the suture attachment region.
• the suture may be attached or connected to the suture attachment region "on the fly", so that a suture that has already been passed through the tissue may be connected to the suture shuttle and used with a suture passer as described herein.
• the suture shuttle body region may be made of a polymer, a metal, or a ceramic.
• the system may include a continuous suture passer and a suture shuttle.
• the continuous suture passer may have a first jaw and a second jaw, a handle including a jaw control configured to manipulate at least one jaw, and an extendable tissue penetrator configured to form a channel through the tissue (wherein the tissue penetrator is configured to be substantially retracted into the first jaw).
• the suture shuttle may include a suture attachment region configured to secure to the distal portion of a surgical suture, and a shuttle body that is configured to engage the tissue penetrator.
• the system may also include a suture attached to the suture attachment region of the shuttle.
• the suture passer may be a continuous suture passer that includes a suture shuttle dock functionally connected to the second jaw and configured to releasably secure the suture shuttle.
• the continuous suture passer used as part of the system may include a tissue clamping region including a first tissue-contacting surface on the first jaw and a second tissue-contacting surface on the second jaw, wherein the tissue- contacting surfaces of the first and second jaws are substantially parallel when the tissue clamping region is opened.
• Also described herein are methods of passing a suture that include the steps of positioning a tissue between a first jaw and a second jaw of a suture passer (wherein the suture passer included an extendable tissue penetrator functionally connected with the first jaw and a suture shuttle dock functionally connected with the second jaw, and wherein a suture shuttle is releasably held by either the suture shuttle dock or the retractable tissue penetrator), extending the tissue penetrator through the tissue from a retracted position, transferring the suture shuttle between the suture shuttle dock and the retractable tissue penetrator, retracting the tissue penetrator through the tissue, repositioning the tissue between the first jaw and the second jaw of the suture passer, extending the tissue penetrator through the tissue, and transferring the suture shuttle between the suture shuttle dock and the retractable tissue penetrator.
• This method may also include the steps of securing the tissue between the first jaw and the second jaw before extending the tissue penetrator through the tissue.
• a suture shuttle may be loaded into the suture passer before beginning this method (or as a first step).
• the suture is first loaded into the suture passer.
• the first and second jaws are separated so that the first and second jaws are substantially parallel.
• Also described herein are methods of passing a suture that include the steps of expanding a tissue clamping region of a suture passer (wherein the tissue clamping region has a first jaw with a first tissue-contacting surface and a second jaw with a second tissue- contacting surface) so that the first tissue-contacting surface and the second tissue-contacting surface are substantially parallel, positioning a tissue between the first and second jaws, clamping the tissue between the first and second jaws, extending a retractable tissue penetrator into the tissue from the first jaw after clamping the tissue between the first and second jaws, engaging a suture shuttle with the tissue penetrator, and retracting the tissue penetrator and pulling the suture shuttle through the tissue.
• FIG. 1 is one variation of a suture passer as described herein.
• FIG. 2 is another variation of a suture passer.
• FIG. 3 is another variation of a suture passer.
• FIG. 6 A is one variation of the distal end of a suture passer.
• FIG. 6B is a perspective view of the lower jaw of the suture passer of FIG. 6A
• FIGS. 6C-6G are side views of the front, back, side, top, and bottom (respectively) of the same lower jaw.
• FIGS. 7A-7C illustrate the operation of a tissue penetrator coupled to a first jaw.
• FIGS. 10A-10E illustrate the operation of one variation of a suture passer passing a suture through relatively thick tissue.
• FIGS. 12A-12D illustrate the distal region of a suture passer.
• FIG. 14 is one variation of a suture shuttle.
• FIG. 15A is another variation of a suture shuttle
• FIGS. 15B and 15C are perspective and side views of the suture shuttle as described herein.
• FIG. 18C is another variation of a suture shuttle.
• FIGS. 19A-19C illustrate attachment of a suture to one variation of a suture shuttle.
• FIGS. 24C and 24D illustrate the conjugate motion of the handle to operate the jaws.
• FIG. 27 A is one variation of a continuous suture passer.
• FIG. 27B is one variation of tissue penetrator.
• FIGS. 28 A and 28B show side perspective views of the distal end of another variation of a suture passer.
• FIG. 33 is another cross-section through one variation of a suture passer.
• FIGS. 34A-34C illustrate the operation of another variation of a suture passer.
• FIGS. 37A and 37B are side perspective and side views (respectively) of the distal end of another variation of a suture passer.
• suture passers for passing a suture through tissue, as well as systems including suture passers, and methods of passing sutures through tissue.
• the suture passers described herein are continuous suture passers that are configured to pass a suture back and forth through a tissue without having to reload the device.
• these devices may be used for continuous stitching of tissue.
• the distal end of the suture passer 10 shown in FIG. 1 has two jaws 12, 12' that are shown in the closed position.
• the opening and closing of the jaws may be controlled by handle 18.
• This handle 18 is configured to be grasped and manipulated by a subject's hand.
• the handle 18 also includes a jaw control lever 17 that may be moved to open and close the jaws 12, 12' of the device.
• the handle shown in FIG. 1 also includes a tissue penetrator control 16, which is can manipulate a tissue penetrator and to pass the suture between the jaws, as described in more detail below.
• the tissue penetrator control 16 is a switch or lever.
• the handle may include any appropriate control, one or more locks, including locks for locking the jaws, locking the tissue penetrator, locking the suture passer, etc.
• These controls may be switches, levers, buttons, sliders, dials, triggers, etc.
• FIG. 2 shows another variation of a suture passer.
• the distal end of the suture passer has two jaws 22, 22', which are shown in an open configuration.
• the upper jaw 22 remains in the plane of the intermediate section 25 while the lower jaw 22' opens.
• the distal end of the device also includes a hinge region 23, along which the jaws are opened.
• a suture 24 is also included, and is shown passing through the upper jaw 22 while the distal end of the suture (connected to a suture shuttle) is held within the lower jaw 22'.
• the proximal end of the device includes a handle 27.
• the device also includes a jaw control 29 that may be used to open and close the jaws.
• FIG. 3 Another example of a continuous suture passer is shown in FIG. 3.
• the handle region is shown in skeletonized view, meaning that components (including an outer cover), are not shown, but may be used as part of the handle.
• a cover may include additional grasping surface area for the user, and may also help protect the device, and particularly any moving components, which are shown as visible in FIG. 3.
• the distal end of the device includes two jaws 32, 32' that are shown in partial cut-away view so that the tissue penetrator 34 is visible, retracted in the upper jaw. The relative motions of the upper and lower jaws 32, 32' and the tissue penetrator are described in greater detail below. As described above, the jaw movement may be controlled by the jaw control 39.
• the inner (tissue-contacting) surfaces of the jaws are shown as parallel over the length of the jaw, meaning the tissue contacting surface of the jaws are separated by approximately the same distance over the length of the jaws.
• the jaws are substantially parallel even when the distance between the surfaces of the jaws varies slightly over the length of the jaws.
• the jaws may be substantially parallel even when the distance between the jaws in the proximal end of the tissue contacting surface is less than about 5%, less than about 10%, less than about 20%, less than about 40%, the distance between the jaws in the distal end of the tissue contacting surface.
• substantially parallel does not require that the jaws be strictly parallel.
• the motion of the jaws as they open and close may be coordinated so that features of the upper and lower jaws remain in alignment as the jaws are opened or closed.
• the alignment of features between the upper and lower jaw may be achieved by configuring the first and/or second jaws so that they move with compound motion.
• one or both jaws may be configured for compound motion when opening and closing.
• Compound motion in this context may refer to combinations of simple motions (e.g., straight translation, rotation, helical, etc.).
• the tissue-contacting surface of the first jaw 52' is moved away from the tissue-contacting surface of the second jaw 51 in FIG. 5B and 5C, the second jaw 51 is also moved inwards (proximally). This is apparent in FIGS.
• FIGS. 6 A to 6G illustrate additional details of the first and second jaw shown in FIG. 5.
• FIG. 6A shows a line drawing of the first 62 and second 62' jaws of a suture passer similar to that shown in FIGS. 5A-5C.
• the tissue penetrator 65 and suture shuttle dock 66 are both visible on the first 62 and second 62' jaws, respectively.
• FIGS. 6B-6G show side and perspective views of the lower jaw 62'.
• the lower jaw 62' includes a textured tissue-contacting surface 68 that may help grasp tissue.
• an opening into the suture shuttle dock 66 is visible, as is a suture passage or guide, which is shown as a notch in the lower jaw through which the suture may extend when the suture shuttle is held within the suture shuttle dock.
• the tissue penetrator also includes a suture passage to at least partially guide the suture when the suture shuttle is engaged with the tissue penetrator.
• the suture passage (or suture guide) may help control the direction and orientation of the suture when the suture shuttle is held by the tissue penetrator (or suture shuttle dock).
• FIGS. 7B and 7C illustrate one variation of a tissue penetrator.
• FIG. 7A is one variation of a jaw 72 having a passage 74 into which a tissue penetrator 75 may fit, as shown in FIGS. 7B and 7C.
• FIG. 7B the tissue penetrator 76 is shown retracted into the jaw 72.
• the tissue penetrator is curved, so that it extends from the jaw at an angle.
• the distal end of the tissue penetrator in FIG. 7B is fully retracted into the jaw 72, causing the more proximal end of the tissue penetrator 76 to extend slightly from the jaw in the proximal direction.
• the tissue penetrator may be extended from the jaw so that it can extend distally and penetrate tissue held between the jaws.
• FIG. 7C shows a tissue penetrator 76 extended at least partially from the jaw 72.
• the tissue penetrator 76 and the jaw 72 both include a suture passage 77, 77' to guide the suture when the suture shuttle is held within the device. This suture passage is shown as a notch 77, 77' in both the tissue penetrator 76 and the jaw 72.
• FIGS. 8A-8C show the tissue penetrator of FIGS. 7B and 7C in a side (FIG.
• the distal end of the tissue penetrator 89 may include an edge to assist in penetrating the tissue.
• the suture passage 87 is visible.
• the edges of the suture passage are curved or blunted so that the suture is not damaged (or cut) when guided by the suture passage.
• the suture passage is coated with a material (including friction-reducing materials) that help prevent damage to suture or help the suture to slide through the suture passage.
• the distal region end of the tissue penetrator may include one or more linkages for linking the tissue penetrator a tissue penetrator control.
• the tissue penetrator may be connected to a wire or other pusher/puller for moving the tissue penetrator.
• the tissue penetrator may include gears or gear teeth (or voids to mate with gear teeth) so that the tissue penetrator can be extended and retracted.
• FIG. 9 is a three-dimensional view of a tissue penetrator 96 retracted within a jaw 92.
• This variation of a tissue penetrator is a curved needle or tube having a hollow region (at least at the distal tip) forming the suture shuttle engagement region 98.
• the distal end of the tissue penetrator 99 is configured to pierce tissue.
• the distal end 99 may be sufficiently sharp so that it can penetrate biological tissue.
• the tissue penetrator shown in FIG. 9 is curved so that as it is extended from the jaw it will pass through any tissue between the jaws and contact the opposite jaw to transfer a suture shuttle. In some variations the tissue penetrator is bendable or flexible.
• the tissue penetrator may be made of a shape-memory material (e.g., a nickel titanium alloy), or it may be hinged or otherwise shaped to bend.
• the tissue penetrator may include cut out regions that allow it to bend or compress in a predetermined direction.
• the tissue penetrator 96 includes voids 95 for mating with a gear (e.g., a worm gear) along the tissue penetrator.
• a gear e.g., a worm gear
• a gear e.g., a spur gear, a helical gear, etc.
• a gear may be included within the jaw to move the device.
• FIGS. 10A- 10E and 11 A- 11 E illustrate the operation of one example of a continuous suture passer.
• a suture passer lOl may be inserted into a subject's body using any appropriate technique.
• a suture passer may be inserted into the body percutaneously using laproscopic or endoscopic techniques.
• the suture passer When used as part of a laproscopic/endoscopic procedure, the suture passer may be dimensioned and configured for insertion through a catheter, introducer, or other small diameter structure.
• the diameter referred to is typically the diameter with the jaws in the "closed" position, taken perpendicularly through the long axis of the device.
• the jaws open in parallel (as described above), which may allow the jaws to access regions of the tissue that are relatively distant from the edge of the tissue. Also, the jaws may be opened wider than suture passers whose jaws open scissor-like or otherwise form an angled opening. This is particularly useful for thick tissue, as shown in FIG. 10A- 10E, but is also useful for thin tissues, as illustrated in FIGS. 11A-11F.
• the tissue can be pierced by the tissue penetrator, as shown in FIG. 10C.
• the tissue is first clamped between the jaws of the suture passer (as illustrated in FIG. 11C), which may stabilize the tissue between the jaws of the suture passer.
• the tissue penetrator may be moved to extend from the jaw or to retract back into the jaw.
• the tissue penetrator may be retracted or extended by any means, including a worm gear, a push/pull wire or rod, a magnetic actuator (e.g., solenoid), a pneumatic actuator, etc.
• the suture passer can then be repositioned to pass another suture through the tissue by extending the tissue penetrator through the tissue, engaging the lower jaw, causing the shuttle engagement region to release the suture shuttle back into the lower jaw's shuttle dock.
• the suture passer can be withdrawn from the tissue after completing the single suture pass, and the suture can be tied, or again passed through the tissue.
• FIG. 11 shows the same suture passer being used to suture a substantially thinner tissue.
• the exemplary suture passer shown in these figures is configured so that as the jaws move, the relative positions of the tissue penetrator on the first jaw and the suture shuttle dock on the second jaw are substantially the same regardless of the position of the jaws. Thus, when the tissue penetrator is extended from the first jaw, it meets the shuttle dock on the second jaw. As described above, this may be accomplished by coordinating the compound motion of the jaws as they are opened and closed.
• FIGS. 12A-12D illustrate this coordinated motion in one variation of a suture passer.
• the distal end of the tissue penetrator 1215 can be completely retracted into the upper jaw, as shown in FIG. 12A-12C.
• the device may be positioned in the tissue without having the tissue engage the tissue penetrator until the tissue penetrator is activated. This may prevent damage to the tissue, and make the device easier to manipulate with respect to the tissue.
• a reciprocating mechanical means may include one or more triggers that can toggle (open/closed) the shuttle lock in the shuttle dock of the lower jaw and/or a shuttle lock in the shuttle engagement region of the tissue penetrator.
• opening the shuttle lock in the lower jaw may close the shuttle lock in the upper jaw (tissue penetrator), and vice versa, allowing the shuttle to be transferred between the two. This toggling may occur when the two regions (the tissue penetrator and the shuttle dock of the lower jaw) contact or when the shuttle contacts both of these regions.
• a shuttle lock may be any mechanism that prevents or helps to prevent the shuttle from leaving the shuttle dock (or shuttle engagement region).
• a shuttle lock may be a mechanical lock (as shown in FIG. 12C) that mechanically engages or surrounds the shuttle, or it may be a magnetic lock.
• the shuttle lock is a pressure lock (e.g., that applies suction to retain the shuttle).
• a suture shuttle may be used with any of the devices or systems described herein.
• a suture shuttle include a suture attachment region that is configured to secure to a surgical suture, a shuttle body, and a shuttle retainer region that is configured to engage the suture passer.
• the suture shuttle e.g., the body region
• the suture shuttle is substantially blunt.
• the suture shuttle does not itself penetrate the tissue, but relies on the tissue piercer of the suture passer to pierce the tissue.
• the outer surface of the suture shuttle may be smooth or soft.
• the size and shape of the suture shuttle may be related to the suture passer that it is to be used with, since the suture shuttle engages the suture passer (e.g., the tissue penetrator and the shuttle dock).
• the suture passer is configured to be used with suture shuttles having different shapes and/or a range of different dimensions.
• the shuttle dock and shuttle engagement regions of the suture passer may be oversized and include a size adapter.
• a size adapter may be, for example, a spring-biased holder that secures the suture shuttle within the shuttle dock regardless of the size of the shuttle.
• the shuttle lock is spring biased and acts as this holder.
• the suture attachment region of the suture shuttle is typically configured to secure a suture to the suture shuttle.
• the suture attachment region is a passage or opening through the shuttle (or a region of the shuttle) through which the suture can be passed and secured.
• the suture attachment region is an outer surface of the suture shuttle to which the suture is attached.
• the suture shuttle compresses the suture between one or more surfaces of the suture shuttle to secure the suture therein.
• the suture attachment region may be a passage through the suture shuttle that can be crimped or otherwise clamped around the suture.
• the suture is secured to the suture attachment region by a glue or adhesive.
• the suture may also be attached to the shuttle by knotting, tying, etc.
• the suture attachment region may also be a loop or hook.
• the suture may be preloaded to connect to the suture shuttle.
• a suture that has already been implanted may be connected to a shuttle.
• the suture may be connected by a hook or loop that can be threaded with the suture after the suture has been implanted into the subject's body.
• the suture may be attached (e.g., threaded) to a suture shuttle that is held by a suture passer as described herein, or it may be attached manually or by a separate suture threading device.
• a suture shuttle may be made of any material or combination of materials, particularly biocompatible materials.
• the suture shuttle may be made of a metal, plastic, polymer, ceramic, etc.
• the suture shuttle is made of a hard plastic.
• the suture shuttle comprises a bioabsobable/biodegradable material.
• the suture shuttle comprises an elastic (e.g., rubber, silicone, etc.) material. Any appropriate suture may be used with the suture shuttle and suture passers described herein, including commercially available sutures (suture material and suture thickness may vary).
• FIG. 15A shows another example of a spherical suture shuttle attached to a suture.
• FIGS. 15B and ISC are perspective views of a suture shuttle similar to the shuttle in FIG. 14, having a channel around the perimeter for aligning and interacting with a suture passer.
• the suture shuttle body may be any appropriate shape, including spherical, capsular, elongate, lobular, pyramidal, etc.
• FIG. 16 a suture shuttle having a cylindrical shape is shown. The suture is connected to the cylindrical shuttle.
• the suture is attached perpendicular to the long axis of the cylinder, however, the suture shuttle may also be attached to the long axis of the cylinder.
• FIGS. 17A and 17B illustrate the interaction between a cylindrical shuttle such as the one shown in FIG. 16 and a tissue penetrator adapted for use with a cylindrical shuttle.
• the tissue penetrator may engage a shuttle dock on the opposite jaw, and a shuttle lock that holds the suture shuttle in the shuttle dock may hold the shuttle therein while the tissue penetrator is retracted, leaving the suture shuttle in the shuttle dock.
• the tissue penetrator may be a solid needle or a cannicular needle (e.g. having an opening therein), as illustrated in FIG. 18D.
• a ring or coil suture shuttle may be particular useful with small, solid (e.g., needle-like) tissue penetrators.
• the tissue penetrator 1817 may include a suture shuttle dock region (or shuttle engagement region) configured as a notch or ring 1821 along an outer surface of the tissue penetrator (e.g., slightly proximal to the distal tip of the tissue penetrator) that the suture shuttle may engage with.
• FIG. 18E the suture shuttle is shown releasably attached to the tissue penetrator of FIG. 18D.
• the suture shuttle is connected to the shuttle body by an extension (e.g., a wire, string, etc.).
• the suture attachment region 1815 (described in more detail below) in this variation is a clip or loop through which a suture 1819 may be passed, having a progressively narrow opening for the suture.
• FIG. 19A-19C illustrates another method of attaching a suture to a suture shuttle.
• the suture shuttle 1900 includes cylindrical shuttle body 1901, as well as a suture attachment region 1903 that is connected to suture shuttle body 1901 by an extension 1904.
• the extension may be a wire, string, or the like, and may be part of the shuttle body, or it may be a separately attached region.
• the suture attachment region 1903 includes a channel into which the suture may pass.
• the suture attachment regions secures the suture so that it does not readily slide once it is held by the suture attachment region.
• a suture may be connected to a suture shuttle as indicated in FIGS. 19A-19C.
• the suture 1905 may be pulled through the channel in the suture attachment region 1903 until it is secured within the larger diameter region of the suture attachment region 1903.
• both ends of the suture 1905 extend from the suture shuttle. This may allow a suture to be passed while both ends of the suture passer remain behind.
• one end of the suture passer may be knotted, or the suture may be tied, glued, crimped, etc. to the suture passer to prevent the suture from slipping out of the suture shuttle.
• FIG. 19D shows another example of a suture attachment region 1903' of a suture shuttle 1900', configured as a pinched loop or clip.
• the suture shuttle attachment region 1903' is a loop of material that is compressed closed at one end (e.g., the distal end). As the suture is drawn towards the pinched distal ends, the suture may become pinched by the loop, thereby securing the suture therein.
• the suture shuttle attachment region includes ends that may be opened to release the suture if the force exceeds some threshold force. This may allow the suture to release from the suture shuttle before the force of pulling on the suture can damage the tissue.
• FIG. 2OA shows a suture shuttle having a protruding suture attachment region
• FIGS.20E and 2OF show another variation of a suture shuttle in which the suture attachment region is a channel 2031 through the body of the suture shuttle.
• the suture may be threaded through the channel, and then secured within the suture shuttle.
• FIGS. 2OG and 2OH illustrate two different methods of securing a suture within the suture shuttle.
• FIG. 2OG the suture is secured within the channel by compressing the outer perimeter of the suture shuttle to crimp it, compressing the suture within the channel and preventing it from exiting.
• FIG. 2OH illustrates another variation, in which the suture is passed through the device and then knotted 2040 after passing through the suture attachment region.
• FIGS. 21A and 21B illustrate another variation of a suture shuttle.
• the suture shuttle is not blunt, but is pointed at either end, so that the suture shuttle may be the tissue penetrator (or may be part of the tissue penetrator) for a suture passer.
• a variation of a suture passer implementing a sharp suture shuttle is described in greater detail below.
• the suture attachment region 2103 is located in the center of the suture shuttle.
• the suture attachment region includes a slot having a narrow channel and wider opening region, as described previously in FIG. 17 A and 17B.
• a suture 2105 may be attached to the shuttle by first knotting the suture (or otherwise forming a larger region of the suture), and sliding the suture into the channel until it reaches the larger diameter opening. The suture 210S can then be pulled until the end of the suture (knot or larger region) is secured. This is illustrated in the side view of FIG. 21B.
• the suture shuttle may include an orientation feature for orienting the suture.
• the suture passer may include one or more suture passage or suture guide for directing the suture extending from the suture shuttle.
• a suture passage may include a channel into which the suture may reside, to protect the suture from interfering with the device.
• a suture channel may guide the suture as is exits the distal end of the device (as described above).
• a suture channel may also be included in the intermediate region of the device (e.g., the region between the distal end and the proximal end.
• a suture channel may be included as a channel along the side of the intermediate region of the device.
• FIG. 22 shows one variation of a suture channel 2201 that may be included as part of the intermediate region 2202 of the device.
• the suture channel is an open channel that may extend at least partially along the length of the device.
• the channel is open along the distal-proximal axis of the device, so that the suture may be inserted into the channel during operation of the device.
• a suture channel can both guide the suture and protect the suture, allowing it to move smoothly during operation of the device.
• a suture channel may be particularly useful for suture passers that are used as part of a laproscopic or endoscopic procedure, in which the suture passer is inserted into a cannula or introducer that might otherwise inhibit the free motion of the suture.
• FIGS. 23 A and 23B are schematic illustrations of different handles that may be used.
• the handle is configured as a hand grip having a jaw control and a tip deflection control.
• the jaws may be opened or closed by applying pressure to squeeze the handle 2301 in the large grip region 2303.
• the jaw control 2301 is a proportional control.
• the control may be biased (e.g., by a spring 2307) to return the jaws to the closed (or open) configuration, or to increase the force necessary to open or close the jaws.
• the same control may be used for both the jaw control and the tissue penetrator control.
• tissue penetrator controller 2311 is used, rather than a combined jaw control 2301 ' and tissue penetrator control 2311.
• the index and middle finger may be used to control the tissue penetrator control 2311.
• the tissue penetrator is deployed by triggering, which automatically extends the tissue penetrator, exchanges that suture shuttle, and retracts the tissue penetrator.
• the tissue penetrator is be deployed in a proportional manner, similar to the opening/closing of the jaws described above.
• the handle may also include a control for ejecting the suture shuttle from the device, or for loading the suture shuttle into the device.
• a control may be used to disengage the shuttle lock of a shuttle dock or shuttle engagement region (e g in a tissue penetrator).
• the handle may also include controls for reloading a suture shuttle into the distal end of the device.
• the device may be configured so that a cartridge of suture shuttles (either with or without sutures attached) may be used.
• a plurality of suture shuttles may be included as part of a cartridge that is loaded into one of the jaws. As a suture shuttle is passed, it may be ejected, and a new suture shuttle may be presented into the shuttle dock to take its place.
• the handle may include a handle housing.
• the housing may cover the inner workings of the handle and controls.
• FIGS. 24 A and 24B illustrate one variation of the device in which the controls and the mechanism for operating the controls are visible.
• the jaw control may regulate the reciprocal movement of the jaws by connecting the handle control 2401 to the first (upper) and second (lower) jaws using gears and a cable or pusher (not visible).
• FIGS. 25A and 25B also illustrate this.
• FIGS. 25A and 25B show some of the components illustrated in FIGS. 24A and 24B, particularly those components used to open and close the jaws as previously described.
• the mechanisms illustrated in FIGS. 24A and 24B also include the mechanisms used to extend and retract the tissue penetrator.
• the tissue penetrator may be retracted completely into the upper jaw.
• a separate tissue penetrator control 2404 may be used to extend or retract the tissue penetrator.
• the gearing for extending and retracting the tissue penetrator is configured (within the handle) to be moved with the jaw control gearing, so that the motion of the tissue penetrator may be coordinated with the motion of the jaws as they open and close.
• the motion of the tissue penetrator is mediated at least in part by a pusher or cable.
• the motion of the tissue penetrator is mediated by a worm screw.
• the handle housing may also include a control mechanism for regulating the passage of the suture shuttle between the jaws.
• the suture shuttle is releasably secured in either the first or second jaw (e.g., the tissue penetrator or the shuttle dock) by a shuttle lock holding the suture shuttle within the shuttle dock.
• the shuttle lock By coordinating the shuttle lock so that it engages the shuttle in the shuttle dock on every other complete motion of the tissue penetrator, the shuttle can be passed between the shuttle dock and the tissue penetrator.
• the lock (or locks) securing the suture shuttle may be controlled to alternatively engage or disengage.
• the suture passer may also include a manual over ride (e.g., on the handle) to eject the suture shuttle from the device.
• the handle may also house additional mechanisms, including tip deflecting mechanisms (e.g., one or more cables or pushers for deflecting the distal end of the device), lighting sources/cameras (which may be used to help visualize the distal end of the device), fluid channels or adding/removing fluid, or the like.
• tip deflecting mechanisms e.g., one or more cables or pushers for deflecting the distal end of the device
• lighting sources/cameras which may be used to help visualize the distal end of the device
• fluid channels or adding/removing fluid or the like.
• the tissue penetrator includes logic or controllers for regulating the activation of various aspects of the device, including the jaws, the suture shuttle location, and the tissue penetrator.
• a controller may be an electronic controller, and may include software or hardware (or both).
• the tissue penetrator may include a controller for regulating the force applied by the jaws on the tissue.
• a controller may also regulate the motion of the tissue penetrator.
• the maximum threshold of force applied to the tissue may be regulated by a controller.
• a controller e.g., a micro-controller chip
• one or more force sensors may be included.
• FIG. 25 A-25E illustrates one variation of a method for making a stitch in tissue using the devices described herein. This example illustrates the forming of a modified Mason- Allen stitch.
• the suture passer device is first positioned near the tissue, and the jaws are opened so that the tissue may be fit between them. The jaws of the suture passer may be closed (e.g. clamped) onto the tissue, and the tissue penetrator (not shown) may be passed through the tissue.
• the suture passer is first loaded with a suture shuttle and suture in the lower jaw.
• the interaction between the tissue penetrator and the shuttle dock triggers the lock holding the suture shuttle within the shuttle dock to open, and the shuttle may be engaged (via a friction fit) to the with the suture passer's shuttle engagement region, and withdrawn through the passage formed by the tissue penetrator, as shown in FIG. 25B.
• the suture passer may then be repositioned, as shown, and the suture and suture shuttle again passed back to the lower jaw, as seen in FIG. 25C.
• the suture shuttle and suture are passed, via the tissue penetrator, through the tissue and into the second (lower) jaw and in close proximity to the shuttle dock.
• FIG. 2SE which shows the last step in making a modified Mason-Allen stitch, also suggests one way in which the suture passer may be used to form a knot by passing the suture over another region of the suture and drawing the suture taut.
• This process is also described in FIG. 26A-26C, in an example in which the suture is passed even when tissue is not present between the jaws.
• the jaws are first be locked into position so that there is a separation between the jaws.
• a jaw lock may be used to hold the jaws in the partially-opened configuration. If the user would like to form a knot, the suture passer may be positioned so that the suture shuttle and attached suture will be passed behind the rest of the length of the suture.
• FIGS. 27A-35 illustrate different variations of the suture passer devices described herein. As mentioned, any of the elements or features described in these examples may be used with any of the other embodiments described herein.
• the proximal end of the tissue penetrator includes one or more attachment sites for manipulators that can extend or retract the tissue penetrator.
• the tissue penetrator 2715 is connected to two cables that extend proximally and may be coupled to a tissue penetrator control to extend or retract the tissue penetrator.
• the tissue penetrator also includes one or more guides for guiding the motion of the tissue penetrator as it extends or retracts. In FIG.
• the tissue penetrator includes a guide configured as two pegs that stick out from the sides of the distal end of the tissue penetrator and can engage with a track or rail in the first jaw to guide (or limit) the motion of the tissue penetrator.
• a tissue penetrator may be any appropriate length.
• the tissue penetrator may be is slightly longer than the opening width of the jaws (in variations have two jaws). Thus, the tissue penetrator may be long enough to penetrate tissue even when the jaws are open.
• the jaws may be opened to approximately twice the diameter of the closed jaw. For example, the jaws may be opened so that the space between the jaws is greater than 10 mm, greater than 15 mm, greater than 20 mm, greater than 25 mm, greater than 30 mm, or greater than 40 mm.
• FIG. 27C illustrates the scale of one variation of a suture passer similar to the example shown in FIG. 27 A.
• the suture passer has two jaws that project distally from the end of the device. When the jaws are closed (as shown), they have a maximum diameter of approximately 5 mm. The jaws are approximately 20 mm long.
• a suture passer may have a larger or smaller diameter, and the length of the jaw (or jaws) may be smaller or longer than 20 mm.
• the distal end of the device may have a maximum diameter of between about 20 mm and about 3mm. In some variations, the diameter of the distal end of the device is less than about 15 mm when the device is closed.
• FIGS. 27D-27G illustrate the operation of a suture passer that is similar to the suture passer shown in FIG. 27A, in that the jaws open and close from a single pivot point (e. g., the jaws do not remain substantially parallel to eachother as they open and close).
• the suture passer is shown in substantially closed position, with the tissue penetrator 2715 ' retracted.
• the tissue penetrator includes one or more guides for guiding the motion of the tissue penetrator as it leaves the upper jaw.
• the tissue penetrator includes a post that is movable in a channel in the side of the upper jaw.
• FIG. 27E the jaws have been opened, so that the space between the jaws is greater than about 11 mm.
• the jaws are opened by retracting the upper jaw from the lower jaw.
• FIG. 27F the tissue penetrator 2715' is extended from upper jaw towards the lower jaw.
• this tissue penetrator is curved or bendable, so that the sharp tip of the tissue penetrator may extend towards the lower jaw (and particularly the shuttle dock in the lower jaw where a suture shuttle may be seated).
• the tissue penetrator may be jointed to bend.
• the tissue penetrator is made at least partially of a shape memory material so that it can assume a bend shape upon leaving the upper jaw.
• the tissue penetrator is rotated as it is extended, so that the tip of the tissue penetrator is moved towards the lower jaw.
• the tissue penetrator is shorter than the 11 mm length that the jaws are opened.
• the upper jaw maybe closed to bring the tissue penetrator in proximity to the shuttle dock in the lower jaw, as shown in FIG. 27G.
• the interaction of the tissue penetrator and the shuttle dock (as well as the suture shuttle) may pass the suture shuttle between the jaws, as previously described.
• the suture shuttle 2805 in FIG. 28A-28D is a tissue-penetrating suture shuttle, similar to that shown in FIG. 21 A and 2 IB.
• the tissue-penetrating suture shuttle is sharp on both ends, and includes a central suture attachment region 2819 that is visible in FIG. 27C.
• both the upper and lower jaws include a suture shuttle dock that is configured to secure the suture shuttle.
• the suture shuttle may be passed by compressing the jaws of the suture passer to alternately engage and disengage the sharp suture passer between each jaw.
• the suture passer protrudes from the jaws in this variation, which may interfere with ability to grasp the tissue, the parallel-opening of the jaws may permit the jaws to be opened widely.
• FIG. 28D shows one variation of a handle for the device, including a jaw control lever 2840.
• the handle in FIG. 28D also shows a portion of a shuttle lock alternator 2835 that can control the alternating gasping/releasing of the suture shuttle as the device is closed and opened.
• tissue penetrator that does not itself penetrate the tissue. Instead, the tissue penetrator secures a tissue penetrating suture shuttle at the distal end of the tissue penetrator.
• the tissue penetrator is extended from the jaw of the suture shuttle when the suture shuttle is held therein, so that it can penetrate the tissue and hand the tissue penetrating suture shuttle to another tissue penetrator on the opposite jaw.
• the tissue penetrator including the tissue-penetrating suture shuttle is extended to meet with the tissue penetrator on the opposite jaw.
• FIGS. 3OA and 30B show another variation of a tissue penetrating suture shuttle 3001.
• the suture shuttle 3001 has tissue-penetrating ends at both ends of the shuttle
• a suture attachment region 3005 is located in the approximate center of the suture shuttle (shown here as a hole or passage through the suture shuttle).
• the openings may be configured to mate with a pin or other mechanism so that the movement and/or position of the suture shuttle may be controlled by the suture passer. In some variations these openings are pits or indentations.
• the elongated suture shuttle of FIGS. 30A and 3OB may be bent or curved (or configured to bend or curve), as shown in FIG. 3OB.
• FIG. 31 shows the suture passer of FIGS. 30A and 30B retracted within a jaw of the device.
• the tissue penetrating suture shuttle 3001 is adjacent to a shuttle dock at the distal end of the jaw 3010; in this example the shuttle dock is a cavity or passage in the distal end of the jaw.
• the jaw may also include a suture passage (or suture guide) to control the location of the suture when the suture shuttle is located within the jaw.
• the suture passage may be a channel or opening in the side of the jaw, as previously described.
• the suture passer with an attached suture may be secured by a shuttle lock 3013 that includes a pin 3013' or other attachment mechanism.
• the attachment mechanism is a retractable pin.
• the pin maybe spring loaded, so that it extends from the lock body into the opening through the suture shuttle previously mentioned (3003, 3003' in FIG. 3OA, above).
• the shuttle lock is connected to a wire or pusher 3012 and may be driven in and out of the distal region of the jaw (e.g., the shuttle dock), thereby extending or retracting the tissue penetrating suture shuttle.
• the distal end of the jaw (the shuttle dock) includes a stopper 3005 that acts as a lock engager or lock disengager.
• the stopper 3005 is ramped on the same side as the attachment mechanism. As the shuttle lock 3013 is moved into the stopper region 3005, the ramp compresses the spring-loaded stopper 3013', so that it does not extend from the shuttle lock 3013.
• the lock If the lock is engaged to a suture shuttle 3001 it this will disengaging the lock from the shuttle, allowing it to be transferred to the shuttle dock in the opposite side. If the shuttle lock 3013 is held within the stopper 3005, as the wire or pusher 3012 withdraws the shuttle lock 3013 from the stopper, the lock will extend from the body of the shuttle lock and may engage the suture shuttle (e.g., an opening in the suture shuttle 3003, 3003') as previously described. In some variations this wire or pusher 3012 is linked to the wire or pusher in the opposite jaw (e.g., FIG. 29A) so that the movement of the wire or pusher in each jaw is complimentary (pulling one wire occurs simultaneously with pushing the wire in the opposite jaw). As mentioned above, a wire or pusher maybe flexible or stiff, and a wire may be a "push" wire so that the wire has sufficient columnar strength to push as well as pull without substantially buckling. In some variations the pusher is a rod.
• FIG. 32 is another example of a suture passer that may use a tissue-penetrating suture shuttle such as the one shown in FIGS. 3OA and 30B.
• the shuttle lock of FIG. 32 is attached to a wire or pusher 3212.
• the shuttle lock is a flexible collet 3213, 3213 'that has arms that are biased to expand open if the inner diameter of the shuttle dock region is large enough to permit the collet to expand open.
• the distal end of each shuttle dock region 3205 of the jaws 3201, 3203 is sufficiently large to allow the collet 3213' to expand open when the collet is positioned at the distal end of the shuttle dock.
• the collet When the collet is opened it does not engage the suture shuttle, however when the collet is compressed closed (e.g., the upper jaw collet 3213 in FIG. 32), the collet may secure the suture passer so that it can be extended or retracted.
• the jaws 3201, 3203 of the suture passer in FIG. 32 are shown closed, as they might be when tissue is present between the jaws so that the suture shuttle may be passed between the jaws.
• the jaws are sharp (e.g., pointed, serrated, etc.).
• the jaws may be closed so that the tissue between them is penetrated by the jaws, and the suture shuttle may be passed.
• FIG. 34B illustrates the jaws in the closed position, forming a complete passage through the tissue for the suture shuttle.
• the jaws are configured to mate with each other in the closed position.
• the jaws are tubular or cannicular.
• the jaws are curved, as shown in FIGS. 34A-34C. In some variations only one jaw is tissue- penetrating, as described below in FIGS. 37A-37B.
• FIGS. 35A and 35B show a variation of a suture passer in which the distal ends of the jaws are tissue-penetrating and each jaw includes a shuttle dock therein so that a suture shuttle may be passed between the jaws.
• FIG. 35 A a piece of tissue 3507 is positioned between the tissue penetrating jaws 3501, 3503.
• a suture shuttle (not shown) may be held within either of the jaws shuttle docks so that it may be transferred between the jaws. For example, after the jaws have been closed through the tissue, as shown in FIG.
• the suture shuttle may be transferred from one jaw to the other.
• the shuttle may be transferred by any appropriate method, including those described above.
• a pusher or wire may be included in each shuttle dock to extend or retract the suture shuttle so that it can be transferred.
• the shuttle dock may also include a shuttle lock for securing the shuttle in the shuttle dock.
• FIG. 36 shows an example of a tissue penetrating jaw 3603 that includes a shuttle lock 3601 and a pusher 3605 that may be used. By coordinating the locking and unlocking of the shuttle within the shuttle dock, as well as the motion of the wire or pusher, the suture shuttle may be passed between the jaws. The variation shown in FIG.
• each jaw 35A and 35B may also include any of the suture control features (e.g., suture channels or guides) described above.
• each jaw may include a cut-out region in the side of the jaw at the distal end of each jaw, into which the suture may be positioned as it is transferred from jaw to jaw.
• 35B may engage with each other after they have penetrated the tissue, as shown in FIG. 35B.
• the jaws may be aligned so that they form a channel though which the suture shuttle may pass.
• FIG. 37A-37B are side and perspective views, respectively of a variation of a suture passing device having a single tissue-penetrating arm.
• the tissue-penetrating arm is configured as a tissue penetrator that can hold and pass the suture shuttle (particularly dull or non-tissue penetrating suture shuttles).
• the upper jaw is a tissue penetrator 3701.
• the upper and lower arms are kinematically linked, so that the tissue penetrator will mate with the shuttle dock on the lower jaw as the upper and lower jaws are opened and closed.
• the tissue penetrating upper jaw 3701 is configured to extend upwards, as shown in FIG.
• the suture passer may include a shield or protector, as shown in FIG. 32. This shield may mount under the opposite jaw to prevent the tissue penetrator from damaging tissue below the opposite jaw.
• any of the devices described herein may be part of a system or kit for passing a suture.
• any of the suture passers described herein may be included with a suture shuttle as a system for suturing tissue.
• the suture shuttle may be loaded with a suture (e.g. preloaded), or it may be unloaded.
• the suture shuttle may be threaded with a sterile surgical-grade suture.
• a kit for suturing may include any of the suture passers described herein, as well as a suture shuttle, and a suture.
• the devices, systems, kits, and methods described herein may be used to repair any appropriate type of tissue.
• the devices described herein may be used during arthroscopic rotator cuff repair, open or mini-open rotator cuff repair, arthroscopic labral repair (e.g., Bankart repair or anterior-inferior labral repair, SLAP or superior labrum anterior posterior repair, hip labral repair, etc.), arthroscopic biceps tenodesis, arthroscopic capsular plication, rotator interval closure, capsular shift, arthroscopic capsular repair or reconstruction, arthroscopic meniscus repair or reconstruction, open tendon, ligament and muscle suturing, Achilles tendon repair, ACL repair, or the like.
• arthroscopic labral repair e.g., Bankart repair or anterior-inferior labral repair, SLAP or superior labrum anterior posterior repair, hip labral repair, etc.
• arthroscopic biceps tenodesis e.g., Bank
• FIG. 39 is a schematic illustration of a rotator cuff tendon, showing the dimensions of the space into which the suture passer may fit. If the tendon 3901 is torn, a suture passer may fit in the space between the bones 3903 and 3905 to access the tendon, and apply stitches.
• FIG. 39A shows a tendon in the correct position, when the tendon has been torn, it may be even more difficult to access, as shown in FIG. 39B. There is approximately 25-30 mm of space to work in after traction has been applied to the arm.
• This region has been traditionally very difficult to access, and to repair. Even if the area is accessed, the practitioner (e.g., surgeon or other medical expert) has had to use a simple or horizontal mattress-type suture stitch, because of the difficulty in access and reliable passing of the suture or a needle holding the suture. However, a high failure rate has been associated with this type of arthroscopic repair of the rotator tendon cuff. It may be desirable to use other types of stitches, such as a modified Mason- Allen stitch, that has been shown to have superior strength when compared with simple and horizontal mattress stitches.
• the modified Mason- Allen stitch has been commonly used in open rotator cuff repairs, but the easier-to-perform simple and horizontal stitches have been commonly used in arthroscopic rotator cuff repairs because of the technical difficulty of placing the modified Mason- Allen stitch arthroscopically.
• the continuous suture passers described herein may be readily used to perform a modified Mason- Allen stitch by placing the tissue between the jaws of the device, closing the jaws of the device, passing the suture shuttle through the tissue and between the jaws of the device, and repeatedly repositioning the tissue within the jaws of the device and passing the suture shuttle between the repositioned jaws.
• the modified Mason- Allen stitch involves placing a basic mattress stitch followed by placing one additional pass beyond the depth of and perpendicular to the mattress stitch.
• FIGS. 25 A - 25E is a depiction of a modified Mason- Allen stitch).
• the tissue penetrator may be triggered to penetrate the tissue and form a passage for the suture shuttle.
• the user may push a Thumb trigger to deploy the suture shuttle through the tissue.
• the tissue penetrator may latch or engage the opposite jaw.
• the suture shuttle When the suture shuttle is initially in the second jaw, the suture shuttle disengages from the shuttle dock in the second jaw and is engaged to the shuttle dock on the tissue penetrator of the first jaw.
• the tissue penetrator may then be retracted, pulling a suture attached to the suture shuttle with the suture shuttle through the tissue.
• the jaw may then be opened and the tissue repositioned between the jaws, and the entire procedure repeated to again pass the suture through the tissue.
• the suture passer has two jaws and a tissue penetrator retractably connected to the first jaw.
• the handle of the device includes an upper trigger that is the jaw control, which controls grasping of the jaws independent of a lower control that deploys the tissue penetrator.
• the tissue can be grasped as hard as desired, and the tissue penetrator can be passed at any time.
• the tissue penetrator (configured as a hollow needle that includes a shuttle engagement region) hits the lower jaw, the pressure in the second trigger (the tissue penetrator control) increases, which opens the suture shuttle lock (a lever that holds the suture shuttle). This lever operates in an alternating fashion, so that every other time it is activated it will let the shuttle free from the lower jaw.
• the suture shuttle is passed between the upper (first) and lower (second) jaws.

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