Apparatus and method for surgical suturing with thread management

The present invention relates to a surgical device for suturing tissue. In particular, the present invention relates to suturing devices that allow the operation and control of suturing needles and suturing materials during surgery, and how to use such tissue suturing devices.

Sutures are used in a variety of surgical applications, including closure of dehiscence or incised tissue, soft tissue binding, anastomosis, graft binding, and the like. Conventionally, suturing of dehiscence or incision tissue is performed, for example, on the incised tissue portion where the surgeon sutures the sharp tip of a curved suture needle with a suture attached to the blunt end opposite the needle. It is performed by passing the needle through the tissue portion and hanging the needle over the incision. The needle is then manually pulled out of the tissue portion, which causes the attached suture to follow the curved path of the needle. Usually, a knot is tied at the end of the suture to secure the first stitch. This operation is repeated until the entire incision is sewn with multiple stitches, pulling the needle to pull the entire suture through the subsequent stitches to the tissue.

For example, in conventional laparotomy, including obstetric and gynecological surgery such as cesarean delivery, a significant length (typically 8 inches (20.3 cm) or longer) of incision is formed in the fascia. .. In many orthopedic surgeries, such as total hip arthroplasty, a longer incision between the two layers of fascia must be closed. Fascial closure is the final stage of surgery and must be done carefully before skin closure. Closing the fascia by manual suturing is a routine (mechanical), repetitive and time-consuming task. Suturing a typical abdominal incision can take up to 20 minutes, and total hip arthroplasty can take even longer to close the fascia. Instead of manual suturing, mechanical suturing devices have been used in other applications, along with staplers, bone fixtures, and suture-based arterial closure devices. Manual suturing is redundant and the speed of the procedure is highly dependent on the skill of the surgeon. Manual suturing also involves handling and manipulating sharp suture needles with instruments such as needle holders, which can cause the needle to accidentally pierce the surgeon's or nurse's gloves due to slippage or carelessness. There is a risk of infecting surgeons, nurses, staff and patients. Also, handling the needle directly by hand can contaminate the needle with pathogens, which can initiate infection at the suture site. There is also the risk of needles sticking into internal organs, resulting in serious and often fatal infections.

However, suturing devices found in the art, designed to overcome these limitations, are inaccessible suture areas because they are too complex to design and economically feasible or relatively difficult to use. Not suitable for accurate operation in. For example, the device disclosed in US Pat. No. 4,557,265 must be held sideways with respect to the direction of the incision to be closed. Another limitation of prior art suturing devices is the inability to reliably control needles and threads during the suturing process. This can result in the formation of non-uniform sutures that are overly loose or overly tight, which can lead to excessive bleeding and the risk of tearing the treated tissue of the patient.

Suture devices that can maintain reliable control of the suture needle and provide uniform stitching are disclosed in US Pat. Nos. 5,437,681 and 5,540,705. The disclosed device requires a "scissors-like" grip operated by the surgeon's thumb and has an articulated drive mechanism. This drive mechanism rotates the linear drive shaft contained in the barrel so that the drive shaft moves forward the suture needle contained in the disposable (disposable) cartridge attached to the end of the barrel. Rotate and pass through the tissue. However, there is a limit to the efficient operation of this device. That is, (1) the direction of rotation of the needle and the drive shaft is perpendicular to the device operating handle, which makes the operation and control of the device relatively difficult. (2) With this device, the user cannot see the needle and the needle advancing through the tissue during the suturing operation. This is because the barrel containing the drive shaft leading to the needle cartridge is not an open structure that allows for such observations. It is difficult for the user to place the advancing needle very accurately along the junction of the incision tissue portion because the movement of the needle is blocked from the user's field of view due to this property of the instrument design. .. (3) The process of obtaining uniform needle rotation, tissue penetration and suturing, as the needle advancing speed and thus the stitch dimensions and uniformity are controlled essentially by the degree to which the user pushes down on the joint mechanism. It is difficult to move forward, and it depends on the skill of the user as a whole.

(Disclosure of Invention) The present invention provides a suturing device that is substantially comparable to, or mimics, a manual suturing procedure performed by a surgeon. The suturing device of the present invention is considerably easier to use than the mechanical suturing methods currently in use, allows the user to better view the procedure during operation of the device, and in all aspects of the suturing process. Continues to control needle movement, advancement, and suture processing, thereby preventing suture material entanglement during needle movement.

One benefit provided by the suturing device of the present invention is that the device allows the suturing material to be manipulated and passed through a tissue incision in much the same way as a surgeon would manually suture. Specifically, the suture device first pushes the suture needle through the tail of the needle to insert the tip of the needle into the tissue. The device then picks up the tip of the needle after the needle has penetrated the tissue, pulls the rest of the suture, and passes the suture attached to the suture through the tissue. Thus the suture needle always moves in an arc due to the curvature of the needle itself, which is the most undamaged and preferred suturing method for passing the needle through the tissue. One benefit provided by the suture device of the present invention is that the suture needle can pull the suture after each stitch and pass it completely through the closed tissue portion. The present invention also relates to a suturing device that includes a suture needle protected by a housing cartridge, whereby the suture needle is not exposed to the user and is not directly handled by the user and therefore accidentally pierces the needle. Is avoided. The structure of the suturing device of the present invention also prevents accidental needle penetration of internal organs. This is because the cartridge acts as a shield between the internal organs and the needle.

The suture needle of the present invention is configured to fit into a cartridge that is detachably attached to the distal end of the suture device. The present invention also comprises an actuating means and a shaft-drive assembly, which applies torque to the suture needle during the suture process to advance the needle into the tissue without accidental pullback. Let me.

The suturing apparatus of the present invention provides a hand-held suturing device with a relatively simple mechanical structure that does not require an external power source, with some advantages over the conventional tissue suturing method used by surgeons. Bring in doing. The present invention makes it relatively easy for the surgeon to operate with only one hand, thus allowing the surgeon to move obstructive tissue, necrotizing tissue pieces and biofluids from the suture site with the hand without the device. It can also be done without the need to use needle holders, pick-up forceps, and other instruments normally required for manual suturing. In addition, the suture devices of the present invention can be used for conventional open surgery, as well as minimally invasive surgery (MIS) and "non-invasive" surgery in terms of length, tip, needle, suture, and needle cartridge dimensions. For example, it can be configured to be used for surgery through an opening or small incision in the human body. Further, the suture head can be oriented in any preferred direction, fixed in a particular direction, or made movable in various directions by joint means.

These and other advantages of the present invention will be apparent by the embodiments described below. Accordingly, the present invention includes features of structures, component combinations and component placements exemplified in the detailed description below.

The surgical suturing device of the present invention is configured with a "pistol-shaped" grip for the user, which provides a barrel assembly and a handgrip extending from the proximal end of the barrel. Including. Barrel assemblies have linear or non-linear structures and include, but are not limited to, straight, curved, or angled shapes. The barrel assembly contains multiple hollow segments that can be connected to each other by one or more universal joints, which do not require permanent connection of these segments and the segments are individually pulled apart and separated. It makes it possible. A cartridge holder is detachably connected to the distal end of the barrel assembly by a plurality of support arms, and a disposable cartridge capable of accommodating a suture needle and a suture material is detachably attached to the cartridge holder.

The disposable cartridge has a substantially columnar housing with an opening at the distal end of the cartridge, i.e. the side wall of the housing at the working end. An arcuate suture needle with a sharp tip at one end is slidably attached to a circular track at the distal end of the housing facing the position of the opening. The needle is attached to the end of a suture material or thread that has a suture source, such as a spool assembly, and the suture source is either contained entirely inside the cartridge or outside the cartridge. The radius of the arc that defines the arcuate suture needle roughly corresponds to the housing circumference at the cartridge housing opening. The needle is typically in the "home" position of its trajectory, where the gap in the arcuate suture needle is aligned with the opening in the cartridge housing. The sharp tip of the needle is located on one side of the housing opening and is entirely within the range of the housing opening. Therefore, the tip is always protected by the cartridge housing. The blunt end of the suture attached to the suture is located opposite the opening. Thus, the sharp tip of the needle is completely contained within the cartridge and does not protrude and is not exposed to the user.

According to the present invention, the needle can be disengaged and disengaged by a drive means rotatably mounted within the barrel assembly so that it can rotate about 360 degrees from the home position about the central vertical axis of the cartridge. This rotational movement of the needle causes the sharp tip of the needle to advance across the cartridge housing and across the opening. Therefore, when the device is arranged such that the incised tissue portion to be sutured is located within the housing opening, the needle penetrates the tissue portion and crosses the incision between the tissue portions. Subsequent rotational movement of the needle causes the needle to return to its initial "home" position, which allows the suture attached to the needle to be drawn into the tissue and the thread inside at one side of the tissue incision. Enter in the direction and exit upward on the opposite side of the incision. Thus, the suture follows the curved path of the needle and closes the tissue by stitching the thread across the incision, similar to a manual suture by a surgeon. The needle is "pushed" from the tail by a drive mechanism and then pulled out from the tip. Preferably, a fixing means is provided at the end of the suture material to prevent the suture material from being completely pulled out of the tissue portion. For example, pre-tied (pretide) or welded loops, knots simply tied with sutures, or double-tipped loop sutures attached to suture needles can be used as fixing means.

The rotational movement of the needle in the needle cartridge is performed by the needle driver, who grips the pistol-shaped grip around the handle of the suturing device with one hand and activates the trigger lever with at least one finger of that hand. Can be manipulated by The suturing device includes a finger-operated trigger lever located near the handle. When the lever is moved, the lever operates the drive shaft contained in the universal joint barrel assembly via a drive mechanism, whereby the drive shaft is rotationally moved, whereby the suture needle is moved forward in a circular motion. Therefore, by arranging the device so that the needle cartridge opening spans the incision tissue portion and moving the trigger lever, the suturing device provides a running stitch (straight stitch) to allow the user to efficiently close the tissue incision. ) Or allows intermittent stitching.

The needle cartridge of the present invention is disposablely attached to a cartridge holder assembly detachably connected to the distal end of the universal joint barrel assembly. The cartridge holder assembly is supported by a plurality of support arms extending from the distal end of the universal joint barrel assembly. The structural design of the minimal support arm allows the user to clearly see the suture needle advancing through the tissue portion during the suturing procedure, thereby providing accurate placement of the suturing device. This allows for uniform suturing and also eliminates the risk of tissue tearing by placing the device too close to the edge of the incision. The suturing device of the present invention is then advanced a short distance along the incision and the above steps are repeated to form another stitch containing the suturing material. The suturing apparatus of the present invention automatically pulls the entire suturing material through the tissue under controlled tension and tightens the formed stitch without tearing the tissue, similar to the surgeon's manual suturing operation. You can also do it. Alternatively, the surgeon tightens the stitches that are hung over the incised tissue portion by the passage of the suture needle of the suture device of the present invention by simply pulling the thread by hand.

The user can operate the suturing device to advance the needle and rotate the needle about an axis substantially parallel to the advancing direction, thereby extending the entire length of the incision. A series of stitches, or a series of intermittent stitches, can be formed. After each stitch is placed, the stitches are tightened by pulling on the suture material, thus the resulting suture is orderly and evenly pulled along the length of the incision tissue portion. In this way, a tight closure of the incision is achieved and tissue bleeding and tearing is minimized.

As described in more detail below, the needle driver can be operated by the surgeon holding the instrument in one hand and using at least one finger in that hand. The suturing device includes a finger-operated lever, which is functionally connected to an internal gear and forms part of a handgrip located at one end of the device, where the surgeon performs a running stitch, a series Intermittent or non-intermittent stitches can be placed efficiently and effectively to allow the tissue incision to be closed in the shortest amount of time.

The suture device of the present invention can further include a related thread processing system, which works with a needle driver to control or process the suturing material or thread during rotation of the suture needle. For example, the thread processing roller pushes the thread out of the track to prevent the suture from being pinched by the needle when it reenters the track. Thus, the risk of thread entanglement or catching during the suturing procedure is minimized. The suture processing system can also include a mechanism by which the suturing material or suture is controlledly "fed out" during the suturing process.

With the suturing device of the present invention, it is not necessary to use ancillary instruments or tools such as needle holders, pickup forceps, etc. to perform suturing completely. The suturing device can also be configured with varying lengths and angles of universal joint barrels, angles between barrel segments and the number and shape of support arms. The dimensions and opening positions of needles, needle cartridges and cartridge openings are also incisions for performing procedures such as fascial closure, skin closure, soft tissue binding, anastomosis, and fixation of reticular tissue, grafts, and other artificial materials. Can be modified for use in surgery. The suturing device of the present invention is also designed to have a very small working or tip located at the end of a long rigid shaft or flexible shaft that can be directed in any preferred direction. The device can be used for minimally invasive surgery, such as laparoscopic surgery, thoracic surgery, endoscopic surgery including arthroscopic surgery, and suturing during non-invasive surgery.

In addition to providing all of the advantages discussed above, the suturing apparatus of the present invention is relatively easy to manufacture and cost effective. Therefore, this suturing device will be used for a wide range of suturing applications. They include single or continuous stitches, including spiral sutures, insert sutures, drawstring sutures, etc., which are required for tissue incision closure, graft attachment, etc.

The present invention will be further described with reference to the accompanying drawings. Throughout these figures, similar structures are numbered similarly. The drawings shown are not necessarily displayed on a constant scale and are generally expanded to show the principles of the invention.

Although the above identified drawings show preferred embodiments of the invention, other embodiments of the invention are also believed to be discussed in the text. This disclosure illustrates, but is not limited to, an exemplary embodiment of the invention as an explanation. Numerous other modifications and embodiments will be devised by those skilled in the art without departing from the scope and spirit of the principles of the invention.

The entire suturing apparatus of the present invention is shown by number 1 in FIG. With reference to FIG. 1, the suture device 1 of the present invention can be used to form continuous or intermittent stitches or sutures to allow closure of the incised tissue portion. The suturing device 1 includes an actuator handle 12 including a proximal end 6 and a distal end 8 and a trigger lever 16 that allow the user to grip the device 1 with a pistol grip. The actuator handle 12 is attached to the pusher 9 at the distal end of the handle 12. The pusher 9 includes a shaft barrel assembly 10, which contains a plurality of shaft segments (not shown) capable of accommodating a drive shaft (not shown) extending outward from the housing 14 at the distal end 8 of the actuator handle 12. Including. The shaft barrel assembly 10 is composed of at least two segments and is connected to each other by a universal joint coupler (not shown) to have a symmetrically connected assembly. The connected assembly is surrounded by a universal joint sleeve 18 so that the universal joint barrel forms an angle of approximately 30 degrees from the horizontal plane. A shaft segment 10 located farther from the actuator handle 12 is detachably attached to the support arm assembly 22. The support arm assembly 22 is composed of a pair of "skeletalized" arms extending along the axis of mutual diffusion, an opening through which the working end 19 of the device is visible during operation of the device. Brings 23. The working end 19 of the suturing device 1 includes a cartridge holder assembly 20 detachably attached to the support arm assembly 22, and the needle cartridge 24 is disposablely attached to the assembly 20.

FIGS. 2 to 13 show a detailed view of various parts of one embodiment of the suturing device 1 and a final assembly device that allows these parts to be operated by the described "side drive" mechanism. The method of being configured in is shown.

FIG. 2 shows the working end 19 of the suturing device 1, which includes the universal joint coupling sleeve 18, the universal joint segment more distal to the actuator handle (not shown), and the support arm assembly 22. A universal joint assembly (invisible) is encapsulated in a joint sleeve 18, including a "pusher" 9 and a cartridge holder assembly 20 to which a disposable needle cartridge 24 is attached.

3A and 3B are detailed partial views of the working end 19 of the suture device, illustrating the disposable needle cartridge 24 being removed and the curved suture needle 26 being separated from the needle cartridge 24, these parts. Is shown relative to the cartridge holder assembly 20, the pusher 9 including the support arm assembly 22, and the universal joint segment. FIG. 3A shows the connection state including the connection of the shaft segment 10 having the universal joint coupler (invisible). Figure 3B shows the connected shaft segment 10 contained within a coupling joint sleeve or "sweep" 18, which sweeps the cartridge mount 20 from the core (stem) to the actuator handle at approximately 30 degrees. Align. The sweep 18 can be preconfigured to provide a predetermined fixation angle (relative to the actuator handle) for the cartridge mount, or the user can set the cartridge mount angle to the optimum setting for a particular procedure. It may be configured to be adjustable so that it can be changed.

4A-C are enlarged views showing a hollow universal joint segment and a method of connecting two identical segments to each other. As shown in FIG. 4A, shaft segment 10 includes a hollow columnar barrel 28 with two open ends, with two sets of arched slots 32 and 34 at one end, one of the arched slots. The pair is narrower than the other pair. The joint segment also includes a plurality of circular openings 36 arranged in a columnar surface to accommodate a corresponding number of fixing pins of the same diameter in the universal joint sleeve (sweep) 18. Two shaft segments 10 having similarly arched slot structures 32 and 34 can be connected to each other using a universal joint coupler 38 (FIG. 4B). The universal joint coupler 38 includes a plurality of pins 40, whereby the coupler engages with the narrower set of slots 32 of the connecting joint 32 to provide a non-rigid connection connecting the two shaft segments 10. (Fig. 4C). Therefore, the angle formed by the connected segments 10 can be changed. The connected segment 10 provides a conduit for passing a drive shaft (not shown) for moving the needle.

FIG. 5 is a "perspective" view of a universal joint sleeve or "sweep" 18 containing a hollow tubular segment with two open ends 28, in which the tube axis of the sleeve 18 is bent at a predetermined angle. The sleeve 18 also includes a plurality of slots 30 arranged along the side wall, which can be engaged with the corresponding slot 36 of the shaft segment 10 properly positioned by a fixing bolt on the pin 38. it can. Therefore, the sweep 18 allows the angle of the connected shaft segments 10 to be "locked" to a preferred angle. The sleeve 18 may be configured with a fixed angle or may be configured with the adjustability to allow the user to adjust the angle to the preferred setting. In one embodiment, the sweep 18 provides an angle of about 30 degrees from the horizontal plane. The angle for the connected universal joint segment 10 determined by the sweep is then attached to the shaft segment 10 of the distal end 8 of the actuator handle 12 (via the support arm assembly 22) of the cartridge holder assembly. Determine 20 angles. The angle of the cartridge holder with respect to the actuator handle 12 determines the approaching ability of the suturing device 1 at the site of the suturing procedure. This depends on whether the treatment site is an open flat site or a non-flat narrow site and is important.

FIG. 6 is a detailed view of the pusher 9, which includes a cartridge holder assembly 20 attached to a support arm assembly that includes a pair of "framework" support arms 22, where the support arm assembly is a shaft segment. It is attached to the end of 10. An open structure with a relatively wide opening 23 of the minimally sized "framework" support arm 22 is an essential feature of the suturing device 1, which allows the user to use the suturing device 1 During operation, the needle cartridge and cartridge (not shown) holder assembly 20 can be directly viewed as the needle advances through the opening, tissue incision, and incision tissue. The embodiment shown in FIG. 6 has a plurality of support arms 22, but other examples include support arm assemblies that include a single support arm as shown in FIG. 11B. The improved visibility provided by the shape and structure of the support arm assembly 22 allows the device to be placed accurately on the incision and also allows the suture device to be uniformly advanced after each stitch of the suture to be uniform and symmetrical. Sutures are formed, thereby minimizing the risk of tissue tearing and bleeding due to placing the stitches too close to the edge of the incised tissue. The cartridge holder assembly 20 is composed of sterilizable medical grade materials, even if these materials are metal materials that allow reuse after sterilization after previous use, such as stainless steel. It may be a sterile medical grade plastic material that can be discarded or processed after a single use. The cartridge holder assembly 20 has a columnar structure with a distal edge 40 and a proximal edge 42, and an opening 45 with respect to the actuator handle (not shown) of the device, and the dimensions and position of the opening 45 are disposable needles. Matches approximately similar openings placed in the cartridge. The cartridge holder assembly 20 further includes a plurality of slots 44 diametrically opposed to each other along the distal edge 40, the slot 44 corresponding to which is the needle cartridge housing (not shown). Multiple placed in Can engage with the same holding clip. The cartridge holder assembly 20 further includes a columnar slot 46 located on the distal edge 40, which is associated with a correspondingly located positioning pin of the same diameter on the needle cartridge housing (not shown). Can be matched. The proximal edge 42 of the cartridge holder assembly is attached to the shaft segment 10 distal to the actuator handle 12 via a support assembly that includes at least one "framework" support arm 22.

7A and 7B show two different figures of one embodiment of the disposable suture needle cartridge 24 of the present invention, preferably provided in a sterile shielded package. The cartridge 24 includes a circular housing 48 that can be formed from a suitable rigid medical grade sterile metal or plastic material. The housing can be detachably held by a cartridge holder assembly 20 at the distal end 19 (working end) of the suturing device 1 using known means, such as multiple clips 50 (shown in FIG. 7A). The plurality of clips 50 may be arranged radially opposed to each other along the edge of the inner lip 52 and may engage with a plurality of identical slots arranged in the cartridge holder assembly 20 corresponding to these clips. it can. The cartridge 24 further includes a columnar positioning pin 54 located on the edge of the inner lip 52, which is associated with a corresponding columnar slot of the same diameter arranged on the cartridge holder assembly 20. Can be matched. The retaining clip 50 allows the cartridge to be held by the cartridge holder assembly 20 when engaged, while the positioning pin 54 opens the opening of the cartridge 24 when engaged with the slot, the cartridge holder assembly 20. Align to the corresponding opening in. The needle cartridge 24 further includes an opening 56 and a circular groove or "track" 58 provided on the inner surface of the housing 48, the groove 58 being perpendicular to both the longitudinal axes of the housing 48 and the suturing device 1. It extends to various aspects. As shown in FIG. 7A, the cartridge housing opening 56 interrupts track 58. An arcuate surgical suture needle 26 made of medical grade stainless steel or similar material is slidably placed within the track 58.

8A and 8B show embodiments of the arcuate suture needle 26 of the present invention. In one embodiment (FIG. 8A), the needle 26 is formed as a circular split ring with a gap 59, a sharp tip 60 and a blunt tip 62. The needle 26 further includes an opening for accommodating the front end of the suture material. In one embodiment, the opening is in the form of a needle hole 64 through which the front end of the suture material can be passed to attach the suture material to the needle 26. In the illustrated needle (FIG. 8A), the needle hole 64 is located near the blunt end 62. However, the needle hole 64 can be placed at any position along the arc between the top 61 and the blunt end 62 of the needle 26. In a preferred embodiment (FIG. 8B), the needle 26 comprises an opening in the form of a columnar bore 66 located at the blunt end 62 (FIG. 8B) and axially aligned with the needle 26. The front end of the suture material is inserted into the bore and secured by mechanical crimping. To allow the needle 26 to penetrate the tissue to the desired depth, the needle preferably has an arcuate portion that spans an angle greater than about 280 degrees to about 330 degrees, more preferably about 270 degrees. .. The needle 26 has two symmetrical notches 68 (inner notches) along the radial medial edge near the sharp tip 60 and blunt end 62 of the needle 26. The notches 68 are arranged so as to face each other directly, and each notch has a vertical (about 90 degrees) portion and an inclined portion at an angle of about 60 degrees with respect to the vertical portion. The inner notch 68 is engaged by a drive mechanism within the cartridge holder assembly 20 to allow the needle 26 to rotate during the actuation of the drive mechanism, whereby the needle penetrates the tissue and advances. A similar triangular notch 70 is located on the radial outer edge of the needle, near the inner notch 68 closer to the sharp tip 60 (outer notch). The outer notch 70 engages an "anti-rotation" pin located on the cartridge holder assembly 20 to prevent the needle 26 from rotating in the direction opposite to the forward direction, i.e., "needle reversion". .. Operation of suturing device 1

The width of the opening 56 of the cartridge housing 48 matches and corresponds to the width of the gap of the needle 26, and therefore when the needle 26 is in the "home" position (as shown in FIG. 7A), the needle 26 Does not substantially project into the opening 56. With such alignment, the needle is completely contained within the cartridge holder 20, thereby handling the cartridge 24 when placing the disposable needle cartridge 24 in the cartridge holder 20 or when processing the cartridge 24 after use. Also, during the operation of the suturing device 1, the sharp tip 60 is prevented from accidentally touching the user's finger. Such protection of the needle 26 in the suturing apparatus of the present invention prevents the occurrence of accidental "needle puncture", thereby contaminating the needle during use or before treatment after use. It substantially reduces the risk of infection by certain pathogenic bacteria or viruses. The needle 26 is rotated around the longitudinal axis of the suturing device 1 within the curved track 58 so that the sharp tip 60 first crosses the opening and then returns to the initial position of the needle, the home position. Can be advanced to. Since the suture material is attached to the needle 26, the suture material follows the path of the needle 26. The end of the suture material may include a knot or button to prevent the suture material from being pulled out of the sutured tissue during the placement of the first stitch. The suture material or thread is stored in an outer or inner sealed package relative to the needle cartridge housing 48 and can be withdrawn from that package prior to the placement of the first stitch in the suture process. In a preferred embodiment, the cartridge housing 48 includes a suture material or a suture needle 26 attached to the end of the thread, and all suture material of appropriate length is packaged in a medical packaging material whose end is sterile. ing.

FIG. 9 shows the thread processing roller 72 of the present invention. The thread processing roller 72 acts to push the thread out of the track so that the suture is not pinched by the needle when the needle reenters the track. The thread processing roller 72 includes a spring actuated stop pin 74. The stop pin 74 maintains a positive pressure on the suture material or thread, thereby holding the suture material in the thread holding slot of the suture needle and squeezing the thread out of the needle track so that the thread impedes the movement of the needle. Exclude that. Therefore, the stop pin 74 prevents the suture material from accidentally entering the needle slot in the needle cartridge 24 and obstructing the movement of the needle when the suture material is pulled forward by the forward movement of the needle 26.

FIG. 10 is an enlarged view of the anti-rotation pin 75. The anti-rotating pin 75 can engage the outer notch of the needle 26 to prevent rotation of the needle 26 and prevent "needle reversion", thereby deviating the needle 26 from a series of movements. To prevent that.

FIG. 11B is an enlarged view of the pusher assembly including the pusher 76 and the claw 78 (FIG. 11A) located at the tip of the pusher, with the claw 78 in the corresponding slot of the support arm 22 of the pusher assembly. It exists and is connected to the support arm 22 by a pivot pin 80. The needle 26 is moved in a circular path by a rigid arm (pusher) extending from a hub located in the center of the suturing device 1. The claw 78 at the tip of the pusher 76 can be fitted with a wedge-shaped notch located along the radial inner edge of the needle. The pusher 76 is activated when the user operates the actuator trigger of the actuator handle 12, and can move back and forth in an arc over an angle of about 280 degrees. The outer surface of the pusher 76 has a shape that accommodates a C-shaped spring (not shown) that presses the wedge-shaped claw 78 against the needle 26 to maintain close contact. The forward movement of the needle during operation of the needle 26 aligns the triangular slot 68 along the radial medial edge of the needle 26 with the wedge-shaped claw 78 of the pusher 76, thereby causing the claw 78 to become a C-shaped spring. The positive pressure applied to the pin engages slot 68 and "locks" it. Thus, the rotational forward movement of the needle 26 is controlled to occur continuously over about 280 degrees each time the needle is moved.

FIG. 12 is a cut-out partial view of the needle 26 at the home position in the cartridge (not shown) with respect to the stem cartridge holder assembly (not shown).

The relative positions of the claw 78, the thread processing roller 72, which engages the radial inner edge notch 68 of the needle 26, and the anti-rotating pin 75, which engages the radial outer edge notch 70 of the needle 26, are shown in FIG. It is shown in.

FIG. 13 is a cut-out view of the needle 26 in the cartridge (not shown) in the home position, aligning the needle opening with the corresponding opening of the needle cartridge holder 20, the needle 26 and the cartridge holder 20. And the position of the opening relative to the connected shaft segment 10 connected by the universal joint coupler 38 and maintained at a fixed angle by a restraint connecting sleeve or "sweep" (not shown).

14-20 show a detailed view of the parts of a preferred embodiment of the suturing apparatus of the present invention and a method of arranging these parts to enable the operation as described in the text.

FIG. 14 shows the working end of a preferred embodiment of the suturing device of the present invention. The working end includes a "pusher" 9 having a support arm assembly 80 and a cartridge holder assembly 82, to which the disposable needle cartridge 84 is attached. The "pusher" 9 is connected to the drive mechanism through a shaft segment 86, which is attached to the actuator handle 12 via a universal joint coupling that includes a universal joint assembly encapsulated in a sleeve (not shown). Is connected to a second shaft segment distal to the joint. The shaft segment 86 is attached to the universal joint assembly by a pin that engages slot 88 with the corresponding slot in the coupling assembly.

FIG. 15A is a partial view of the pusher assembly including the needle cartridge 84 engaged with the cartridge holder assembly 82. The cartridge 84 is attached to the cartridge holder assembly 82 via a mounting clip 90 located at the top of the arc of the cartridge holder assembly 82, the clip 90 being a corresponding complementary slot located at the top of the cartridge 84. At 92, it "locks" slidably in place. Both the cartridge holder assembly 82 and the cartridge 84 include openings 94, which are approximately the same size and are aligned with each other in a "locked" position. The cartridge 84 further includes a suture material processing cleat 98, which keeps the suture material 100 from entangled when the suture material enters the cartridge 84 during operation of the suture device.

FIG. 15B is a cut-out view of the pusher assembly with the suture needle 102 housed in the home position in the cartridge 84 (not shown) exposed, at which point the needle opening is the needle cartridge holder. Aligned with both the opening of assembly 82 and the opening of cartridge 84. The needle 102 is placed in the "home" position by engaging the cartridge 84 with the cartridge holder assembly 82 in the "lock" position, where the needle is proximal to the cartridge holder assembly 82 by the clip 104. The clip is constrained to engage a notch (not shown) located along the radial trailing edge of the needle. This is done by a corresponding pin located on a drive arm located within the cartridge holder assembly 82, which is part of a "rear drive" (rear drive) needle rotation drive operating mechanism.

FIG. 16 shows a preferred embodiment of the curved suture needle 102 of the present invention. The needle 102 is formed as a circular split ring with an opening (ie, a gap) 106, a sharp point 108 and an opposite end 110. A columnar bore 110 aligned axially with respect to the needle is arranged at the blunt end 110. The front end of the suture material is inserted into the bore and secured by mechanical crimping. Alternatively, the opening for accommodating the suture material may be in the form of a "needle hole" through which the front end of the suture material is passed to attach the suture material to the needle 102. To allow the needle 102 to penetrate the tissue to the desired depth, the needle 102 preferably has an arcuate portion over an angle of about 280 to about 330 degrees, more preferably greater than about 270 degrees. .. The needle 26 includes two symmetrical notches (posterior notches) 114 along the radial trailing edge, i.e., the edge closer to the cartridge holder 82, each of which is a sharp notch of the needle 102. It is located near the tip 108 and near the opposite blunt end 110. The posterior notches 114 are arranged so as to face each other directly, and each notch has a vertical (about 90 degrees) portion and an inclined portion at an angle of about 60 degrees with respect to the vertical portion. The posterior notch 114 is engaged by a drive mechanism within the cartridge holder assembly to allow the needle to rotate during the actuation of the drive mechanism, whereby the needle penetrates the tissue and advances. A similar triangular notch 116 is located on the radial outer edge of the needle, near the posterior notch 114 closer to the sharp tip 108 (outer notch). The outer notch 116 engages with an "anti-rotation" pin located in the cartridge holder assembly, which prevents the needle from rotating in the direction opposite to the forward direction, i.e., "needle reversion". Engagement of the outer notch 116 of the needle during operation prevents the needle from deviating from the suturing process.

17A and 17B are an external view and an internal view of the cartridge 84, respectively. The outer surface of the cartridge 84 (FIG. 17A) contains a suture material treated cleat 98 that can be held in place to prevent entanglement of the suture material. The cartridge 84 further includes a slot 92 located at the top of the arcuate edge, which slidably engages with the complementaryly placed pins on the cartridge holder assembly to "slip the pins in place. "Lock". The inner surface of the cartridge 84 includes the track 118, which allows the suture needle (not shown) housed inside the cartridge to rotate and move from the "home" position across the opening 106 during operation. To do. A radial slot 120 on the inner surface of the cartridge 84 engages a complementaryly placed pin on the cartridge holder assembly, which allows the needle to slide into the slot 120 when the pin engages. , Stays in track 118 and is moved along track 118.

FIG. 18 is an upper partial view of a preferred embodiment of the pusher 9 including the cartridge holder assembly 82 and the support arm 22. The cartridge holder assembly 82 includes a plurality of mounting clips 122 capable of receiving the cartridge 84, and a mounting clip 90 at the top of the radial edge, the clip 90 being attached to the cartridge that engages the cartridge holder assembly 82. It slidably engages with complementarily arranged slots, thereby engaging the drive mechanism within the assembly 82 with the suture needle housed within the cartridge. The cartridge holder assembly 82 further includes a gate assembly 124 that prevents the needle 102 from falling off the track and behind the cartridge holder assembly 82. The gate assembly 124 is maintained in a closed "home" position by the torque force applied by the spring 126 connected via the pin 128, thereby limiting the lateral movement of the needle 102. The gate assembly 124 opens each time the suturing device is activated to allow circular movement of the drive mechanism that engages the needle 102, closes shortly after passing the drive mechanism and returns to the home position, within the cartridge holder assembly 82. Prevents lateral movement and displacement of the needle 102.

19A, 19B and 19C are continuous views of a "rear drive" needle-operated drive mechanism operating within a cartridge holder 82 of a pusher assembly (not shown). The "rear drive" mechanism includes a driver arm 130 connected to a drive shaft 132, which moves circularly to "clean up" along the circular inner edge of the cartridge holder assembly 82, including the gate assembly 124. it can. The actuation of the device causes the drive shaft 132 to rotate clockwise, thereby moving the driver arm 130 circularly from the dormant "home" position and reaching the gate assembly 124, passing through the gate assembly 124, in the meantime. To open the gate (Figs. 19A and 19B). The driver arm 130 continues to move circularly until it returns to the "home" position and rests (Fig. 19C). The gate assembly 124 returns to the closed home position after passing through the driver arm 130, which allows the driver arm 130 to "drive" the needle 102 in a circular motion, and the needle 102 disengages from the track 118. To prevent. Thus, each time the suturing device 1 is activated, the driver arm 130 passes through the gate assembly 124, during which the gate assembly 124 is opened. The gate assembly 124 returns to the closed "home" position after passing through the driver arm 130, thus preventing lateral movement of the needle 102, thereby preventing the needle 102 from being misaligned and stuck during operation. ..

20A, 20B and 20C are three-dimensional views, perspective views and cross-sectional views of the ratchet assembly 134 of the present invention which is a part of the drive mechanism for the suturing device 1, respectively. As shown in FIG. 20A, the ratchet assembly 134 includes a ratchet ring 136, which has a generally arcuate outer surface portion 138 having a plurality of teeth 138 and an arcuate flat portion 140 having a flat surface. And have. The ratchet ring 136 includes a central circular bore (not shown) that allows the pinion gear 142, including the shaft 144, to be slidably fitted and attached to the gear 142 so that it does not move. The ratchet ring 136 further includes a plurality of wedge-shaped surfaces 139a and 139b near the flat portion 140. The ratchet assembly 134 is attached to a base 146 that includes a housing 148, which is mounted on a support bracket 152 by a claw (not visible) actuated by a coil spring (not shown) and multiple screws 153. Contains the installed shuttle 150. FIG. 20B is a detailed partial view of a ratchet ring 136 including a circular bore 154 that slidably accepts a shaft 144 of a pinion gear 142 (not shown) and can be attached to the shaft 144. The ratchet ring 136 is attached to the base 146 so that the teeth 138 of the ratchet ring 136 interact with the claw 156. The claw 156 is actuated by a coil spring (not shown), which applies positive pressure to the claw 156 to maintain close contact between the claw 156 and the teeth 138 of the ratchet ring 136. The shuttle 150 is attached to the base so as to rotate the ratchet ring 136 in a single direction (for example, clockwise), and this rotation is caused by the contact between the shuttle 150 and the first wedge-shaped surface 139a of the ratchet ring 136. It is done until it is stopped. After contact with the first wedge-shaped surface 139a, the shuttle 150 moves and the ratchet ring 136 shuts in the direction opposite to the initial rotation direction (eg, counterclockwise). Allows the wheel 150 to rotate until stopped by contacting the second wedge-shaped surface 139b. FIG. 20C is a cross-sectional perspective view of the ratchet ring 136 in which the teeth 138 of the ratchet ring 136 are engaged with the claw 156, and the claw 156 is in close contact with the teeth 138 due to the positive pressure applied by the action of the coil spring 158. Be maintained.

The ratchet assembly 134 of the present invention may be suitably positioned within the handle 12 of the suturing device 1. In a preferred embodiment, the ratchet assembly 134 is located at the distal end 8 of the actuator handle 12, whereby the shaft 144 of the ratchet assembly 134 is of a shaft segment 10 whose end is attached to the trigger mechanism of the suturing device 1. Become a part. By operating the trigger mechanism (not shown) via the trigger 16 of the actuator handle 12 and operating the suturing device 1, the shaft 144 of the ratchet mechanism 134, the attached ratchet ring 136 and the pinion gear 142 are unidirectionally operated. Rotating, the pinion gear 142 drives the shaft segment 10 connected to the driver arm 130 of the rear drive mechanism in the pusher 9, which rotates the engaged needle 102 in the same direction to bring the needle 102 into the incision structure. Penetrate and pull the suture material through with the needle. After the shaft has moved about 280 degrees, when the first wedge-shaped surface 139a comes into contact with the shuttle 150, the rotation of the shaft 144 is stopped, which is the end of the first operation step. The shuttle 150 can then rotate the shaft 144, along with the attached ratchet ring 136 and pinion gear 142, equidistantly in opposite directions until contact between the shuttle 150 and the second wedge-shaped surface 139b stops movement again. To. The advantage provided by the ratchet mechanism 134 of the present invention is that the operating step of the suturing device 1 is predetermined, that is, the ratchet assembly 134 is improper or incomplete due to the needle 102 being caught in the tissue. Prevents the user from performing imperfect actions that can result in suturing. Further, the ratchet assembly 134 can be operated by the trigger 16 regardless of the orientation of the ratchet assembly 134 with respect to the trigger 16 and the actuator handle 12, for example, upside down or sideways.

The actuating means of the suturing device 1 of the present invention may include trigger mechanisms known in the art, such as the trigger mechanisms disclosed in US Pat. Nos. 6,053,908 and 5,344,061. Both of these patents will be incorporated as part of the text. Alternatively, the actuating means may be a manually operable button or switch, or may be mechanically operable by an automatic electrical device or fuel drive, the latter being, for example, electrical, electromagnetic, compressed air. , An electric motor, an electromagnetic motor, or a pneumatic (pneumatic) motor powered by compressed gas, hydraulic, vacuum or hydrocarbon fuels.

To initiate suturing, one of the embodiments of the suturing apparatus 1 of the present invention is placed in the injured part or incision in the tissue so as to span the injured part or two tissue parts formed by the incision. Then, the suturing device 1 is operated by operating the actuator trigger 16 on the actuator handle 12. The detailed operation of the suturing apparatus 1 of the present invention is described with respect to a preferred embodiment, and this operation is similarly applied to all other embodiments of the present invention described and considered in the text. The claw 156 of the pusher mechanism of the suture device 1 engages with the blunt end of the suture needle 102, that is, the notch 114 arranged at the radial trailing edge near the "tail" to push the needle and push the needle over an arc of about 280 degrees. To move forward. The sharp tip 108 of the needle 102 crosses the opening 96 defined by the cartridge 84 and the cartridge holder 82, penetrates the first tissue portion located within the opening 96, and traverses the tissue portion. And re-enter the device on the opposite side of the opening 96. The pusher 9 then returns to its initial position, where the claw 156 engages a notch 114 located at the radial trailing edge 114 near the sharp tip of the needle 102. This pulls the needle 102 to which the suture material or thread is attached over an arc of about 280 degrees. This allows the blunt end 110 of the needle 102 and the suturing material to pass through the tissue sections and span these sections across the injured or incised section. The needle 102 is advanced along a perfect circle of about 360 degrees and then stops at the initial "home" position in the track of the cartridge holder 82. The needle 102, including the sharp tip 102, is kept fully contained within the cartridge 84. The suture material or thread can then be cut and secured in a suitable manner, such as tying, or additional stitches can be placed along the entire injury or incision by repeating the above process. it can. Each stitch can be similarly arranged in either a single stitch, an intermittent stitch, or a series of continuous running stitches. Shi

It has a separable suture cartridge 84 including a suture needle 102, a pusher 9 including a cartridge holder 82 and a support arm 80, a drive shaft assembly including a driver arm 130, and an actuator handle 12 including an actuating trigger 16 and a drive mechanism. Although the suturing device 1 has been described, the entire suturing device 1 can be designed as a single unit that can be reused or that is completely discarded after one use.

Therefore, from what has been clarified from the above description, it can be understood that the above-mentioned embodiment is effectively achieved by the suturing apparatus of the present invention. In addition, since some changes relating to the above description may be made without departing from the scope of the present invention, all matters included in the above description or shown in the accompanying drawings are not limited but exemplified. Should be interpreted as something like that.

<figref num="1">FIG. 1 is a diagram of the suturing device of the present invention, wherein the suturing device comprises the main parts of the cartridge, the cartridge holder assembly, the drive shaft segment, the universal coupling joint assembly and sleeve, and the actuator handle having the actuating trigger. Including.</figref><figref num="2">FIG. 2 is a partial view of a shaft-universal joint assembly attached to one embodiment of the working end of a suturing device, including a pusher, a cartridge assembly, and a cartridge that can be operated by a side drive mechanism.</figref><figref num="3">FIG. 3A is a partial view of the working end of the suturing device including the universal joint assembly without the universal joint sleeve attached, and FIG. 3B is the same view with the universal joint sleeve attached.</figref><figref num="4">4A, 4B, and 4C are enlarged views of a single universal joint, a joint coupler, and a pair of connected universal joints, respectively.</figref><figref num="5">FIG. 5 is an enlarged view of a universal joint sleeve configured with an angle of 30 degrees.</figref><figref num="6">FIG. 6 is a detailed view of an embodiment of a cartridge mount assembly that includes a pair of support arms and shaft segments.</figref><figref num="7">7A and 7B are two different views of one embodiment of the needle cartridge.</figref><figref num="8">8A and 8B are two embodiments of a curved suture needle having a suture material port that can be operated by a side drive mechanism.</figref><figref num="9">FIG. 9 is an enlarged view of the thread processing roller housed in the cartridge.</figref><figref num="10">FIG. 10 is an enlarged view of the "anti-rotation" pin housed inside the cartridge assembly.</figref><figref num="11">Figure 11A is an enlarged view of the nail, Fig. 11B, pawl cartridge holder supported disposed at a predetermined position is an enlarged view of a pusher including lifting arm.</figref><figref num="12">FIG. 12 is an exploded partial view showing the interaction points between the suture needle and the cartridge holder and the support arm component.</figref><figref num="13">FIG. 13 is a partial view showing the relative arrangement of the suture needle with respect to the cartridge holder.</figref><figref num="14">FIG. 14 is a partial view of the working end of a second embodiment of a suturing device operable by a rear drive mechanism, including a shaft segment, a pusher, a cartridge holder and a cartridge (shown part by part in FIGS. 15-19). ..</figref><figref num="15">FIG. 15A is a perspective view of a pusher having a cartridge holder assembly, to which a cartridge having a suture threading mechanism for restraining the suturing material is attached. FIG. 15B shows a pusher containing a cartridge holder assembly and a disassembled view of a cartridge containing a curved suture needle that can be operated by a rear drive mechanism.</figref><figref num="16">FIG. 16 is an enlarged view of a curved suture needle having a suture material port that can be operated by a rear drive mechanism.</figref><figref num="17">17A and 17B are front and rear views of the cartridge.</figref><figref num="18">FIG. 18 is a cut-out plan view of a pusher including a cartridge holder assembly having a locking gate.</figref><figref num="19">Figures 19A, 19B and 19C show the operation of the pusher arm in the cartridge assembly operating in rear drive mode, the pusher arm moves radially by opening the gate (Figure 19A) and the gate is in the closed position after passing the arm. It springs back to (Figs. 19B and 19C).</figref><figref num="20A">FIG. 20A is a three-dimensional view of the ratchet assembly of the present invention driven by a drive shaft to operate the pusher arm when the device is activated.</figref><figref num="20B">FIG. 20B is a partial view of the ratchet assembly of the present invention driven by a drive shaft to operate the pusher arm when the device is activated.</figref><figref num="20C">FIG. 20C is a cross-sectional view of the ratchet assembly of the present invention driven by a drive shaft to operate the pusher arm when the device is activated.</figref>