KR20160038072A - Devices and methods for minimally invasive suturing - Google Patents

Abstract

An apparatus and method for minimally invasive suturing is disclosed. One sealing device for minimally invasive sutures includes a proximal section, a distal end and an intermediate portion therebetween. The apparatus includes a sealing head assembly having a sealing needle having a pointed end and a second end. The suture needle is rotatable about an axis substantially perpendicular to the longitudinal axis of the device and the pointed end of the suture needle is advanced by a drive mechanism having a needle driver for engaging and rotating the suture needle, In which it is arranged to guide the needles around the circular path and before the deployment of a suitable guide.

Description

≪ Desc / Clms Page number 1 > DEVICES AND METHODS FOR MINIMALLY INVASIVE SUTURING &

Cross-reference to related application

This application is a continuation-in-part of U.S. Patent Application No. 12 / 909,606, filed October 21, 2010 and filed on August 9, 2011, U.S. Patent No. 7,993,354, U.S. Patent Application No. 61 / 388,648, filed January 1, 2005). This application is also related to International Application No. PCT / US2009 / 006212, filed November 20, 2009, which claims priority to U.S. Provisional Application No. 61 / 200,180, filed November 25, 2008. This application is also related to U.S. Patent Application No. 11 / 231,135, filed September 20, 2005, which claims the benefit of U.S. Provisional Application No. 60 / 611,362, filed September 20, 2004. This patent application also relates to International Application No. PCT / US2008 / 06674, filed on May 23, 2008, and claims the benefit of priority of US Provisional Application No. 60 / 939,887, filed May 24, 2007 . This patent application also relates to U.S. Patent Application No. 12 / 175,442, filed July 17, 2008. Each of the foregoing applications is incorporated herein by reference in its entirety.

Technical field

Embodiments disclosed herein relate to medical devices for suturing tissue, and more particularly to devices for manipulating and controlling suturing needles during minimally invasive sutures, methods for making such devices, and methods for sealing such devices And a method of using the same.

Minimally invasive surgery (MIS) allows doctors to perform many surgical procedures with less pain and disability than conventional open surgery. Unlike conventional open surgery, which allows the surgeon to easily visualize and manipulate both the tissue and the device, by approaching the surgical site easily through a wide incision, the MIS can be a small hole ("keyhole surgery") or, , Requiring insertion of a device through a natural opening, including the esophagus or anus, and manipulation to allow the surgeon to perform the procedure remotely.

In MIS, small holes in the body are usually made. Insert the medical device through the cannula. The cannula typically has a small internal diameter of 5 to 10 millimeters (mm), sometimes exceeding 20 millimeters (mm). Many such cannulas can be inserted into the body during any given procedure. Minimally invasive surgical instruments are inevitably smaller and generally longer and more difficult to manipulate accurately.

Perhaps the most problematic surgical task at MIS is suturing. Sutures can be operated in harmony with both hands with small needles and sutures that are difficult to visualize (especially when only indirect 2D video images are available) and with a variety of devices commonly used for hand suturing (including needle drivers and pickup clamps) . In an environment characterized by limited space, limited visualization and limited mobility, many surgeons find that minimally invasive suturing by hand is extremely difficult, and is usually an unrealistically impossible surgical task.

In a preferred method of hand suturing, the surgeon uses this to hold a grasping clamp ("needle driver") in his hand and grip a curved needle near the tail of the needle. The pronation of the surgeon's wrist pushes the needle into the tissue. As the end of the curved needle comes out of the tissue, the surgeon releases the needle from the grip of the needle driver and holds it with another clamp ("pick-up"). The surgeon then pulls the curved needle by the needle tip into the circular path along the arc of the curvature of the needle along the most non-traumatic path, preferably throughout the tissue, until the full length of the needle leaves the tissue. Each time you make a stitch, push the curved needle about the full circle arc like this. After making each stitch, tie the suture and make each (stitch) stitch. Repeatedly repeatedly pushing the curved needles in a complete circular arc until a number of stitches and stitches of the desired length are made, creating a continuous (continuous) stitch. To make additional interrupted or continuous stitches, the surgeon must place the tip of the needle and hold the needle around the tail of the needle.

In the passive suturing technique described above, direct handling of the needles can lead to accidental needle sticking through the surgical or nurse's gloves to give the surgeon, nurse, staff and patient a potential infection risk, or to initiate infection at the suture site You can contaminate the needle with a pathogenic bacterium that can. There is also the risk that the needles will penetrate into internal organs or blood vessels and cause serious, and usually fatal, infections.

Various devices for stitching for MIS are described in U. S. Patent No. 5,643, 295 entitled "Methods and Apparatus for Suturing Tissue "; U.S. Patent No. 5,665,096 (entitled " Needle Driving Apparatus and Methods of Suturing Tissue "); U.S. Patent No. 5,665,109 entitled "Methods and Apparatus for Suturing Tissue "; U.S. Patent No. 5,759,188 entitled "Suturing Instrument with Rotatably Mounted Needle Driver and Catcher "; U.S. Patent No. 5,860,992 (entitled "Endoscopic Suturing Devices and Methods"); U.S. Patent No. 5,954,733 entitled "Suturing Instrument with Rotatably Mounted Needle Driver and Catcher "; U.S. Patent No. 6,719,763 (entitled "Endoscopic Suturing Device"); And U. S. Patent No. 6,755, 843 entitled "Endoscopic Suturing Device ", both of which are incorporated herein by reference in their entirety for teaching in these documents.

U.S. Patent No. 5,437,681, U.S. Patent No. 5,540,705, and U.S. Patent No. 6,923,819, assigned to the assignee, disclose a sealing apparatus having a thread management comprising a protective cartridge, a sealing needle and a needle rotation drive, Which is incorporated herein by reference. The devices described in the aforementioned patents and patent applications include a mechanism for pushing a protected needle, but the needle rotates about an axis parallel to the axis of the device. In addition, the orientation and size of the sealing device make it difficult for this device to be visible and cumbersome to use in MIS.

Thus, it is easily manipulated within the small diameter of the cannula; Function in an environment characterized by limited space, limited visualization and limited mobility; Mimic the preferred suturing method used by the surgeon; The surgeon fixes and binds the knot with a fast controlled tension; Making a continuous stitch; There remains a need in the art for a minimally invasive suturing device for protecting the user from accidental needle purging during needle manipulation and for protecting internal organs and blood vessels from accidental needle piercing.

Apparatus and methods for minimally invasive suturing of tissue within a body are disclosed herein.

According to an aspect illustrated herein, a medical device is provided for sealing an opening in a patient's body that closely mimics or simulates a passive sealing operation performed by a surgeon. The device provides several advantages over conventional methods used by surgeons to seal tissue during minimally invasive surgery in that the device provides a hand-held sealing device that does not require an external power source. The presently disclosed embodiment provides a relatively easy operation by only one hand of the surgeon.

According to an embodiment illustrated herein, the seal head assembly may be removably attached to an actuator mechanism of the seal apparatus. The diameter of the device is small enough to fit a 5 mm cannula in some embodiments, making operation and suturing extremely easy with the device during endoscopy or other MIS procedures. In the surgical procedure, it is preferable that a small incision is made and a small incision is made. Therefore, a device with reduced profile is very advantageous. The suture head assembly of the device is also suitable for use in endoscopic surgical procedures, including laparoscopy, thoracoscopy and arthroscopy, and other less invasive surgical procedures, to the left of the center, to the right of the center, Can be articulated to the inside, to the side.

The apparatus of the presently disclosed embodiments closely imitates or mimics the passive sealing action performed by the surgeon. For example, during passive suture by hand, the needle is fixed to the forceps and moves into the circular arc without interfering anywhere inside the arc. The design of the sealing device of the presently disclosed embodiment prevents interference in the center of the needle arc during sealing. That is, there is no center at the center of the circular arc of the suture needle. The entire area of the circular arc of the needle is not disturbed. This allows the user to better visualize during surgery, unlike current mechanical seal methods, while maintaining control over needle movement.

The advantage provided by the sealing device of the presently disclosed embodiment is that the device makes it possible to treat the sealing material through a tissue incision in a manner substantially similar to that of the surgeon's hand. In particular, some embodiments of the suturing device initially push the suture needle from the tail of the needle and push the end of the needle through the tissue. The device then follows the end of the needle that has passed through the tissue and pulls the suture needle attached to the suture needle through the tissue and the remainder of the suture. The suture needle is thus a preferred suturing method in most non-traumatic ways, which consistently follows the arc of the curve of the needle itself, which passes the needle through the tissue. An advantage provided by the sealing device of the presently disclosed embodiment is the ability of the sealing needle to pull the sealing tread through the entirely sealed tissue segment along each stitch. When using the sealing device of the presently disclosed embodiment, auxiliary devices or tools such as needle holders, pick-up forceps or the like are not required to complete the stitches. A forceps or grasping instrument can be used to tie the knot.

According to an aspect illustrated herein, embodiments of a sealing device including a sealing needle protected by a housing are provided, wherein the sealing needle is not directly exposed to the user or is not directly handled by the user, thereby preventing accidental needle sticking . Because the housing acts as a shield between the organ and the needle, the configuration of the sealing device of the presently disclosed embodiment also protects against accidental penetration of internal organs or blood vessels by the needle.

In one embodiment, a sealing apparatus having a sealing head is provided. The sealing head includes a housing defining the at least one passage therein and a deployed needle track. The deployed needle tracks are disposed within the housing and the needle tracks are moved from a storage or shrinkage condition (in which the needle tracks are arranged to extend substantially within the housing) or a deployment condition (in this condition the needle tracks extend outwardly from the housing) And is configured and adapted to form an arcuate needle track. The apparatus further comprises an arcuate or circular needle disposed in the deployed needle track, the needle having a first end, a second end and a generally annular shape. When the deployed needle track is in an unfolding condition, the apparatus further comprises a drive for advancing the needle about a 360 degree path around the needle track. The drive is configured and adapted to advance the needle in multi-turn 360 revolutions around the needle track when the deployed or expandable needle track is in the deployed or extended condition without removing the needle from the needle track. In order to advance the needle to about 360 ° rotation, the drive optionally engages the needle and unwinds from the needle.

According to a further aspect, the housing of the sealing device can be generally cylindrical and has an outer diameter of about 5.0 mm. The circular path of the needle track may have a diameter of about 10 mm. If desired, the needle may have a non-circular cross-section. Advantageously, the apparatus further comprises means for deploying the needle track from the storage condition to the deployment condition. The needle track can occupy about 270 [deg.] Of the 360 [deg.] Needle when the needle track is placed. However, it is understood that the present disclosure is directed to an apparatus with an expandable or each expandable needle track that can expand to a final extent of, for example, 270 degrees, in increments of 1 degree. For example, from about 180 ° to about 190 °, about 200 °, about 210 °, about 220 °, about 230 °, about 240 °, about 250 °, about 260 °, about 270 °, A needle track extending about 290, about 300, about 310, about 320 or about 300 may be provided. For example, depending on the diameter of the device and the dimensions of the needle track, the angular extent of the needle track may be varied from about 10 degrees, about 20 degrees, about 30 degrees, about 40 degrees, °, about 50 °, about 60 °, about 70 °, about 80 °, about 90 °, about 100 °, about 110 °, about 120 °, about 130 °, about 140 °, about 150 °, It may only be necessary to have a guide to guide the user. The drive may include a long soluble member that reciprocates along a long axis of the apparatus. The drive may advance along the needle track in engagement with the needle as the elongate flexible member is advanced proximally relative to the housing. The needles may include a first notch and a second notch along the inner surface of the needle for engaging with the opposite rotation mechanism disposed in the at least one housing and the deployed needle track. The needle may additionally include a notch on the top surface of the needle to engage the portion of the drive and the notch on the top surface of the needle intersects the notch disposed on the inside surface of the needle.

According to a preferred embodiment, the deployed needle track comprises at least one arcuate guide adapted to be deployed from the housing along the arcuate path. Preferably, the deployed needle track includes a pair of arcuate guides adapted to be deployed from the housing along the arcuate path. The pair of arcuate guides are preferably deployed from the housing along the arcuate path by pulling the first pair of pull wires and one pull wire is attached to each guide. The pair of guides is further preferably configured and adapted to pull the second pair of pull wires to the housing and pull one pull wire in the second pair of pull wires to each guide. The first pair of pull wires is preferably connected to a second pair of pull wires to form a pair of continuous mechanical loops, the loop being connected to the guide at the distal end and connected to the pair of handles at the proximal end, The guide moves.

The present disclosure also provides a suture needle having an arcuate body having a leading tip and a trailing end, the arcuate body having a first notch along an inner radial area needle and a second notch along an axis of the central curve of the needle Defining a second notch having a projection in a plane defined by the first notch and the second notch. If desired, the needles may additionally include a generally square cross-section. The needle body may include a portion having a round cross-section that separates a major portion of the needle having a generally square cross-section from a posterior portion having a generally square cross-section. The needle may further define a third notch for receiving a drive pawl portion in the needle proximate its trailing end. In addition, the needles can define an arcuate keel over its length to stabilize its movement in the sealing device.

According to an aspect illustrated herein, there is provided a method comprising: inserting a distal end of a suturing device having a suture needle having a pointed end into the body; Positioning the suture needles to extend into a plurality of discrete tissue segments; Actuating the actuator at a first time such that the pointed end of the sealing needle expands behind the protective housing of the cartridge to engage a plurality of discrete tissue segments; And actuating the actuator at a second time to allow the suture needle to complete the rotation and pull the suture extending from the suture needle over the plurality of discrete tissue segments to form the stitches. Is provided.

According to a further aspect, there is provided a sealing apparatus having a sealing head. The sealing head includes a housing defining at least one passage therein, the housing having a proximal end, a distal end and a distal end connecting the proximal end and the distal end. The head further comprises a deployed needle track disposed at least partially within the housing, the needle track extending from a storage condition (in this condition, the needle track is substantially disposed within the housing and has an angular extent of about 180 degrees) (In this condition, the needle track has an angular extent of greater than 180 degrees and extends outwardly from the distal end of the housing) to form an arcuate needle track in a plane parallel to the longitudinal axis of the housing. Preferably, the needle track extends at an angle along a circular path defining a path of movement of the needle such that the track extends at an angle around the circular path from the contraction condition to the expansion condition. The sealing head further comprises an arcuate needle disposed in the deployed needle track, the needle having a first end, a second end, and a generally annular surface. When the deployed needle track is in an unfolding condition, the sealing head further includes a drive for advancing the needle in multi-turn 360 rotation about the needle track, and the drive is selectively Engage the needle and release it from the needle.

According to a further aspect, the housing is generally cylindrical and has a diameter of about 5.0 mm, and the path of the needle track has a diameter of about 10 mm. However, it is understood that the diameter may be larger or smaller if desired. The needle can have a substantially circular cross-section, a circular cross-section, a non-circular cross-section, a square or triangular cross-section, or a cross-section that varies from one shape to another, for example from circular to square, . The apparatus preferably further comprises means for deploying the needle track from the storage condition to the deployment condition. When the needle track is deployed, the needle track preferably occupies about 270 [deg.] Out of the 360 [deg.] Needle path, but the angle of the track may be somewhat 270 [deg.

According to a further aspect, the drive preferably comprises a long flexible member which reciprocates along the longitudinal axis of the device. The drive engages the needle and advances along the needle track as the elongate flexible member advances proximally relative to the housing. The deployed needle track preferably includes at least one arcuate guide adapted to deploy from the housing along the arcuate path. The deployed needle track preferably includes a pair of suitable arcuate guides adapted to be deployed from the housing along the arcuate path. The pair of arcuate guides are preferably deployed from the housing along the arcuate path by pulling the first pair of pull wires and one pull wire is attached to each guide. The pair of arcuate guides are preferably configured and adapted to pull the second pair of pull wires to the housing and one pull wire in the second pair of pull wires is attached to each guide. The first pair of pull wires is preferably connected to a second pair of pull wires to form a pair of continuous mechanical loops, the loop being connected to the guide at the distal end and connected to the pair of handles at the proximal end, The guide moves.

In another embodiment, a sealing apparatus having a sealing head is provided. The sealing head includes a proximal end, a distal end, and a long housing having a distal end connecting the proximal end and the distal end, the housing defining a major axis from its proximal end to its distal end. The sealing head further comprises a deployed needle track at least partially disposed within the housing, wherein at least a portion of the needle track has a nonconductive condition (in this condition, the needle track has an arcuate extent of about 180 degrees and is substantially disposed within the housing (In this condition, the needle track has an arcuate degree of more than 180 degrees and the needle track is in a plane parallel to the longitudinal axis of the housing). The sealing head further comprises an arcuate needle disposed in the deployed needle track, the needle having a first end, a second end, and a generally annular surface. When the deployed needle track is in an unfolding condition, the sealing head also includes a drive for advancing the needle through multiple 360 [deg.] Rotations around the needle track, the drive selectively advancing the needle about 360 [ And released from the needle.

According to a further aspect, the housing may be generally cylindrical or straight, if desired. The deployed or extended needle track may include one or more arcuate guides suitable for deployment from the housing along the arcuate path. The deployed or extended needle track may include a pair of suitable arcuate guides adapted to deploy from the housing along the arcuate path. Thus, a pair of arcuate guides can be deployed from the housing along an arcuate path by pulling a first pair of pull wires, and one pull wire is attached to each guide. In one embodiment, when the needle track is in an expanding condition, the deployed or extended needle track occupies about 270 degrees in the 360 degree needle path, but the angular extent of the track is somewhat less than 270 degrees, .

These and other advantages of the presently disclosed embodiments are illustrated through the embodiments described below. The presently disclosed embodiments thus include features of the configurations illustrated in the following description, combinations of members, and arrangement of components.

The presently disclosed embodiments are further described with reference to the accompanying drawings, wherein like structure is referred to by like numerals throughout the several views. The drawings shown need not be scaled, but are instead generally emphasized when illustrating the principles of the presently disclosed embodiments:
BRIEF DESCRIPTION OF THE DRAWINGS Figures 1 to 3 generally show a sealing device made according to the present disclosure;
Figures 4 to 32 and Figures 47 (A) to 47 (D) illustrate aspects of a first embodiment of a sealing head of a sealing apparatus manufactured in accordance with the present disclosure;
33-37 illustrate aspects of an embodiment of a needle loader made in accordance with the present disclosure;
Figures 38-40 illustrate aspects of a first embodiment of a suture needle made in accordance with the present disclosure;
41-44 illustrate aspects of a second embodiment of a suture needle made in accordance with the present disclosure;
45 illustrates an embodiment of a third embodiment of a suture needle made in accordance with the present disclosure;
Figure 46 illustrates aspects of a fourth embodiment of a suture needle made in accordance with the present disclosure;
Figures 47 (E) - (55) illustrate aspects of a second embodiment of a sealing head of a sealing device manufactured in accordance with the present disclosure;
Figures 56-59 illustrate aspects of the middle portion of the sealing device illustrated in Figures 1-3;
Figs. 60 to 122 illustrate aspects of the handle portion of the sealing device illustrated in Figs. 1 to 3;
Figs. 123 to 131 are views illustrating operations of the sealing head of Figs. 4 to 32 and Figs. 47 (A) to 47 (D). Fig.
The drawings describe currently disclosed embodiments, but other embodiments are also contemplated as described in the discussion. This disclosure presents exemplary embodiments in a representative fashion without limitation. Various modifications and embodiments may be devised by those skilled in the art that are within the scope and spirit of the principles of the presently disclosed embodiments.

Reference can be made in detail to preferred embodiments of the present disclosure, examples of which are illustrated in the drawings. The method and corresponding steps of the disclosed embodiments are described in conjunction with the detailed description of the system.

In general, the present disclosure provides embodiments of a sealing device having features that allow the device to be configured on a small scale with a profile that is smaller than the embodiments described in the prior art and patent applications (incorporated herein by reference). do. In particular, an embodiment constructed to fit through a 5 mm trocar and constructed in accordance with this present disclosure is constructed. Advantageously, the embodiments still use relatively large suture needles to effectively suture by allowing substantial tissue capture during surgery.

For purposes of illustration and without limitation, as embodied herein, an exemplary embodiment of a sealing apparatus 1000 is illustrated in FIG. Apparatus 1000 includes three areas including seal head 100, intermediate section 500 and handle 600. Each of these areas is described in detail below. Figures 2-3 illustrate an apparatus 1000 with a particular portion removed. In particular, FIG. 2 illustrates apparatus 1000 from which a needle loader (described in further detail below) has been removed, and FIG. 3 illustrates apparatus 1000 from which a particular handle housing portion has been removed.

For purposes of illustration, and not by way of limitation, the sealing head 100 separated from the rest of the apparatus 1000 is illustrated in FIG. The sealing head 100 includes three main housing components 106, 108, 112 (not shown) that define a gap 110 for receiving a tissue of a patient that includes a proximal end 102, a distal end 104, ). The sealing head 100 is configured and adapted to direct the semicircular needles 300, 350, 400 around the semicircular track and across the gap 110 to form a series of seams over the tissue to be sealed.

Prior to advancing the needle over the gap 110, the sealing head 100 must be switched from the delivery configuration to the deployment configuration. As illustrated in FIGS. 4 and 5, the sealing head 100 is initially provided in a compressed form having a predetermined transverse dimension or diameter. This transverse dimension, [phi], can be any desired dimension, and is preferably about 5 millimeters. In particular, it is desirable to select the dimension (?) So that, for example, the suture head 100 can pass through the abdominal region of the patient via the standard 5 mm trocar during the laparoscopic surgical procedure. Figure 5 shows the sealing head 100 from a diagonal, as compared to Figure 4, including a pivot boss 114 that coincides with the middle portion 500 of the apparatus 1000.

The sealing head 100 is illustrated in an exploded configuration in FIG. As illustrated in Figure 6, in the deployed configuration, the proximal guide 120 and the distal guide 130 move outwardly from its seated position defined by the housing components 106, 108 described in more detail below. 6, guide 120, 130 defines a circular needle path or track 140 in the P-plane that is parallel to the longitudinal X-axis of apparatus 1000. As shown in FIG. As illustrated, is pulled by a detent 125 in a proximal guide 120 that engages a notch 306 disposed along the inner surface of the needle 300 described in detail below, Tip 302 slightly advances.

After the guides 120 and 130 are in the deployed condition and the needle track 140 is defined, the detent 160 can be advanced to its distal end along its reciprocating path to advance the needle 300 through the track . Figure 7 illustrates a needle 300 that spans the gap 110 wherein the needle 300 at an arcuate degree of about 180 is substantially spaced apart from the outer periphery of the enclosure defined by the housing segments 106, Located.

8 to 10 illustrate the function of the sealing head 110 from the diagonal angle of the head. Figure 8 illustrates a sealing head 100 of a delivery configuration in which guides 120, 130 are pulled. As can be seen, the locking pawl 160 is proximal to the needle 300 and the trailing end 304 of the needle 300 is visible. 9 illustrates a sealing head of a deployed configuration in which guides 120 and 130 are deployed. As shown in FIG. 9, the distal guide 130 defines an arcuate recess 135 that receives the detent 160 at the distal end of its reciprocating movement, which is best seen in FIG. 10, the notch 158 in the drive member 150 advances in the distal direction, as in detent 160. As shown in FIG.

Figs. 11A to 11D illustrate the structure of the fastening detent 160. Fig. The detent 160 includes a housing 166 attached (e.g., welded) to the distal end 154 of the drive member 150. The detent The housing 166 is preferably a metal tubular structure and houses a detent spring 164 biased between the movable pin 168 and the cap portion 162. It is preferred that the cap 162 be attached, e.g. welded, to the housing 166.

Figure 12 illustrates sealing head 100 with cover portion 106 removed, which shows a reciprocating guide path, followed by drive member 150 and detent 160, and guides 120 and 130. The guides 120 and 130 are advanced from the delivery configuration to the deployment configuration by advancing wires, cables or filaments 172, 174, 176 and 178 which are directed around a series of bosses in the housing portion 106 described below . In particular, each of the guides 120, 130 includes crimps 102a, 120b, 130a, 130b that integrally form the ends of the respective guides 120, 130. Each crimp includes a passage formed therein to receive the distal end of the wire 172-178. The wires 172-178 may take any suitable form and most preferably a multi-strand 300 series stainless steel cable with a diameter of 0.009 ". The guides 120 and 130 are pulled in and out of the sealing head 100 by applying tension to one wire in each pair attached to each guide.

Figure 13 illustrates the guides 120, 130 in the unfolding condition and does not show the wires 172-178 for simplicity. Figure 14 illustrates a drive member 150 having detents 160 that are ridden within grooves 135 at the side of guide 130 and at a level of complete distension of its travel path. The ridge 130e of the wall 130d can be increased and thickened to match the groove 135 to provide an increased bearing surface for the detent 160. [ The stop (not shown) is preferably provided in a raised surface configuration on the guides 120, 130, and the housing components help prevent the guides 120, 130 from falling off the seal head.

As is also clear, the groove 125 at the side of the guide 120 becomes accessible to the passage of the detent when the guide is in the deployed condition. As illustrated in FIG. 14, guide 150 traverses the arcuate path along the guide and follows the path of the needle. 15 illustrates the spatial relationship of the drive member 150 associated with the needle, where other device components have been removed. Figure 16 illustrates the relative position of the needle 300 with respect to the drive pin 168 and the counterrotating spring 115 housed within the detent 160. [ Figure 17 illustrates drive pin 168 in detail and pin 168 includes a distal face 168a in contact with the body of the needle, a generally cylindrical face 168b in the circumference (the distal end of which is at the needle 100, Or distal end 304 of the needle, a proximal face 168d in contact with the detent spring 164, an enlarged head portion 168c and a pin 168 from falling from the housing 166 Includes a circumferential distal surface (168e) that contacts a narrow portion of the housing (166) of the detent (160).

18-21 are additional views of sealing head 100 showing progressive removal of the components. Figures 19 to 20 show the sealing head 100 and the bosses in the housing portion 106 defining the support points (not shown) for the guide cables 172, 174, 176 and 178 106a, 106b, and 106c. The spacers 106d may also be provided to maintain a desired distance between the housing components 106 and 108 that allow movement of the components within the sealing head 100 and may be provided on the support surfaces & (Fig. 29). 20-21 illustrate removal of a guard 109 providing an inner support that the guides 120, 130 support. Guide 120, 130 rides on the arched channel defined by the cooperation of components 106, 108, and 109.

Figure 22 illustrates the same spatial relationship of the proximal and distal guides 120, 130 as in Figure 21. The views of the proximal guide 120 are shown in Figs. 23 (A) to 23 (B). The guides 120, 130 are preferably fabricated from a metallic material by assembling a series of metallic subcomponents, for example by laser welding, and once integrated, integrated and integral. The guide may be considered to have a "top surface" in contact with the drive member 150 and a "bottom surface" in contact with the housing portion 108. The proximal guide 120 defines a curved channel 125 at its top surface 122. The proximal guide 120 includes a lower surface 124 having an inner defined groove 124b therein, an inner surface 126 that supports the inner surface of the guard 109 and an outer surface 128 that supports the housing components 106 and 108 ) Is further defined. The distal guide 130 defines a curved channel 135 at its upper surface 132 to guide the detent 160, as illustrated in Figures 24 (A) -24 (B). The distal guide 130 includes a lower surface 134 having an inner defined groove 134b therein, an inner surface 136 that supports the inner surface of the guard 109 and an outer surface 138 that supports the housing components 106, ) Is further defined.

25-32 illustrate the cooperation between the wire / filament 172-178 and the guides 120,130. As shown in this figure, the wires / filaments 172, 174, 176 and 178 cooperate with the other components of the bosses 106a, 106b and 106c and the sealing head 100 so that the guides 120, To be pulled forward. The wire 178 terminates in the crimp 130b of the guide 130. [ Tension is applied to the wire 178 wound around the boss 106a (Fig. 28) so that the guide 120 advances from the sealing head 100. Fig. Conversely, tension is exerted on the wire 176 terminating in the crimp 130a of the guide 130 (Fig. 30), causing the guide 130 to be pulled by the sealing head 100. Fig. Similarly, tension is applied to the wire 172 wound around the boss 106c and attached to the guide 120 at the crimp 120b to cause the guide 120 to advance from the sealing head, Tension is applied to the wire 174 wound around the boss 106c at the attachment point in the crimp 120a to cause the guide 120 to fall back into the housing.

33-37 illustrate embodiments of the needle loader 180 configured to load the sealing needles 300, 350, 400 with the sealing head 100. The needle loader 180 includes two major components, including a main body portion 182 and an advancing portion 184. [ The forward portion of the pin 184a is received in the opening 182a of the main body portion 182. The main body portion 182 defines a groove 182f for receiving the sealing needles 300, 350, The main body portion 182 includes clip portions 182c and 182e and a central portion 182d that fit into the sealing head 100. [ If desired, the clip portions 182c and 182e may be adapted to mate with the sealing head 100. A distal stop plate 182b is provided to facilitate axial alignment between the loader 180 and the sealing head 100. [ The advancement portion 184 rotates within the opening 182a of the main body portion 182 and further includes a needle pushing arm 186. [ In operation, the needles are located in track 184f and the seal material is attached to the trailing edge as described herein. Then, the loader 180 is snapped to the sealing head. The arm 186 is preferably located proximate the trailing end of the needle at this time. Thereafter, the arm 186 is rotated so that the needles 300, 350, and 400 advance to the needle track 140. The needles 300,350 and 400 may be positioned on the needle loader 180 due to the fact that the arms 186 are dimensioned to pass through the grooves 124b and 134b of the distal guide 130 and the proximal guide 120, respectively, . ≪ / RTI >

38 to 40 illustrate a first embodiment of the sealing needle 300. Fig. The needle 300 includes an arcuate body defined by a leading edge 302, a trailing edge 304 and a generally annular surface 305. The needle 300 includes a plurality of notches 306,308,310 formed therein and an opening 312 at the trailing end 304 for receiving the length of the length of the sealing material 312a. The notches 306 and 308 are located in the inner radial area 322 of the needle and the notches 310 have protrusions within the P 'plane defined by the axis X' of the central curve of the needle. The notch 310 includes a first portion 310a that is generally perpendicular to the P 'surface and a portion 310b and a sloped portion 310c that are generally at the P' surface. The notches 306 and 308 have protrusions that are generally perpendicular to the P 'surface. The notches 308 and 306 have first portions 306a and 308a generally parallel to the transverse plane of the needle at this location and angled portions 306b and 306b tilted (e.g., at an angle of 60 degrees) , 308b. The notches 308, 310 intersect to facilitate the function of the particular embodiment of the sealing head 100, 100 'described herein.

Figs. 41-44 illustrate a second embodiment of the sealing needle 350. Fig. Needle 350 includes an arcuate body defined by a leading edge 352, a trailing edge 354 and a generally annular surface 355. Needle 350 includes a plurality of notches 356,358, 360 formed therein and an opening 362 at trailing end 354 for receiving the length of the length of seal material. The notches 356 and 358 are located in the inner radial area 372 of the needle and the notch 360 has protrusions within the P 'plane defined by the axis X' of the central curve of the needle. The notch 360 includes a first portion 360a that is generally perpendicular to the P 'face and a portion 360b and slope portion 360c that are generally in the P' face. Notches 356 and 358 have protrusions that are generally perpendicular to the P 'surface. The notches 358 and 356 have first portions 356a and 358a generally parallel to the transverse plane of the needle at this position and angled portions 356a and 358b tilted (e.g., at an angle of 60 degrees) , 358b. The notches 358, 360 intersect to facilitate the function of the particular embodiment of the sealing head 100, 100 'described herein. Needle 350 further includes a generally square cross-section 366 having a rounded portion and a trailing portion 364 also having a rounded cross-section. In another manner described, the needle body includes a portion 366 having a round cross-section that separates a major portion of the needle having a generally square cross-section from the trailing portion 364 having a generally square cross-section. It is believed that using a needle having a square cross section helps the needle 350 traverse the gap 110 of the sealing head and reentry into the sealing head with a superior alignment compared to the needle 300.

FIG. 45 illustrates a third embodiment of the sealing needle 400. Needle 400 includes an arcuate body defined by leading edge 402, trailing edge 404, and generally annular surface 405. The needle 400 includes a plurality of notches 406, 408, 410 formed therein and an opening 412 at the trailing end 404 for receiving the length of the length of the sealing material. The notches 406 and 408 are located in the inner radial area 422 of the needle and the notch 410 has protrusions within the P 'plane defined by the axis X' of the central curve of the needle. The notches 406, 408, 410 are generally similar to those described with respect to the needle 300. The main difference between needles 300 and 400 is the addition of additional notches 415 that are cut into needles near its trailing end 404. The notch 415 has a protrusion on the face P 'and is shaped to receive the housing 166 of the detent 160. It is believed that using a needle with a notch 415 helps the needle 400 traverse the gap 110 of the sealing head and re-enter the sealing head with a good alignment compared to the needle 300.

Figure 46 illustrates a fourth embodiment of the sealing needle 450. This is substantially the same as the needle 300, except that the needle 450 additionally includes an arcuate keel 475 or a raised surface over its length. The keel 475 is positioned in the groove 124b of the guides 120 and 130 to stabilize it as the needle 450 traverses the gap 110 of the sealing head and re- , 134b.

Figures 47 (f) - 55 illustrate aspects of an alternative embodiment of a sealing head 100 'made in accordance with the present disclosure. The main difference between the sealing head 100 and the sealing head 100 'lies in the path of travel of the drive member 150. [

Embodiments of the seal head 100 include a drive member 150 that defines a narrow or notch area 158, for example, as illustrated in FIG. In operation, when the detent 160 is located at the distal end of its travel range within the groove 135 of the distal guide 130, the notch area 158 is aligned with the bosses 106W, 108W 47 (D)). When in this position, the drive member 150 extends into the groove 125 of the proximal guide 120 (Figure 14). However, as tension is applied and the detent 160 (and the needle 300) become proximal along the needle track, the narrow area 158 of the drive member 150 will pass through the bosses 106W and 108W, The detent 160 moves over the lower leg of the passage 106T as it moves proximally through the boss 106W and out of the passageway and is ready to begin another cycle. The bosses 106W and 108W create a passage therebetween to allow the narrow area 158 to pass through (but not the rest of the member 150 or the detent 160). The narrow region 158 moves along the top path over the bosses 106W and 108W as the drive member 150 is advanced over the circle and the bosses 106W and 108W move as the region 158 aligns with the boss. Allowing drive member 150 and detent 160 to move proximally along a lower path beneath bosses 106W and 108W. The housing portion 112 is illustrated in Figure 47 (E).

Thus, it can be understood that the drive member 150 should ideally be a metal. Preferably, the member 150 is manufactured from hardened stainless steel heat treated with HR 900 and is available from ME-92 < RTI ID = 0.0 > (TM) < / RTI > West (815) 758-6691, Simmons Avenue, Such as an Armoloy ME 92 (TM) coating commercially available from West / Armoloy (R). Preferably, the member 150 is a 17-7 PH stainless steel with the condition "C ", which is then cured to a condition CH900 and then coated with the ME 92 (TM) coating. Preferably, the ME-92 (TM) coating is applied after 900 thermal treatments. The operating sequence for fabricating the members 150 may be 17-7 machined to size by any number of known methods (e.g., electrical discharge machining (EDM), shearing, milling, etc.) PH < / RTI > strip stock material. The drive ribbon is heat treated and then cleaned to remove the thermally treated surface oxide, and then the ME-92 (TM) coating is applied. In a further example, a 17-7 PH conditional "A" material can be heat treated with RH950. In another embodiment, the drive member 150 may be made from a shape memory material, such as a nickel-titanium alloy, such as, for example, sold under the trade name NITINOL TM. In another embodiment, member 150 is fabricated from a polymeric material. In one aspect, the member 150 may comprise a polyethylene terephthalate material or a high strength nylon material. If desired, laminates of plastic and metallic materials or a number of materials can be used. In a further exemplary embodiment, the member 150 may comprise a bundle of wires or filaments, a single wire or filament, or any material in any configuration that pushes the needles around the needle track.

Other components of the sealing head 100 including the needles 300 and the like are preferably made of various materials, preferably stainless steel, by metal injection molding (" MIM ") techniques known in the art. . According to a preferred embodiment, it is preferred to use 17-4 PH stainless steel alloys. Apparatus 1000 is preferably a disposable device and the handle components are preferably made from injection molded plastic whenever desired.

Additional embodiments of the sealing head 100 'are illustrated in Figures 47 (f) - (55). The main difference between the sealing head 100 'and the sealing head 100 is that the drive member 150 in the sealing head 100' follows a single path during reciprocation compared to the alternate path of embodiment 100. Figure 47 (f) illustrates a sealing head 100 'including a needle 300 having guides 120', 130 'in its deployed configuration. The guides 120 ' 130 ' are only partially visible and are not shown to include a crimp at their ends to conform to the deployment or traction cable as in the described embodiment 100 described above. Similar to the manner in which the sealing head 100 defines a guide path between the housing components 106 and 112 (FIG. 21), the sealing head 100 'includes a guide between the housing components 106' and 112 ' And defines a path 153 '(FIG. 48). Figure 48 shows the removal of the material 112a 'acting as a detent stop and the addition of the material 106'b acting as a new detent stop in the component 106' to remove the components 106 ', 112' To further illustrate alternate paths 1001 through which the drive member 150 ' can traverse. The end result is a different angle of incidence for the drive member 150.

Figure 49 illustrates a "left" housing component 108 'from various angles, and Figures 50 (A) -50 (E) illustrate "right" housing components from various angles. The path 153 'along which the drive member 150' and the detent 160 '(not shown) follow is clear from the drawing. Although the drive member 150'and the detents 160'can be substantially identical to the embodiments 150 and 160, a single path to the traversing of the detents 160 ' It is understood that it is not necessary to have the notch area 158 as defined by the cooperation of the " A detent 115 'is illustrated in Figures 51 (A) -51 (B), which helps prevent the needle (e. G., 300) from moving against the desired direction of travel. As shown in FIG. Figure 52 illustrates the spatial relationship of guides 120 ', 130' in relation to pin surface 168a 'and detents 160' at two respective locations thereof for illustrative purposes only. Figures 53 (A) -53 (D) illustrate various views of the housing portion 112 '. 54 to 55 illustrate the spatial orientation of the guides 120 ', 130' (substantially the same as the guides 120, 130) in relation to the detents 115 ' Further illustrates a guide stop 117 'which helps guide the guides 120', 130 'to stop.

FIGS. 56-59 illustrate aspects of the intermediate portion 500 of the apparatus 1000. FIG. The intermediate portion 500 includes a long, preferably metal tube 510 having a proximal and distal end 514. The distal end 514 of the tube 510 is attached to a knuckle assembly 520 and is eventually attached to the sealing head 110 in a rotational axis at the pivot 114. The pulley 515 is positioned on the pivot 114 to act as a support surface for adjacent articulation cables 532 and 534 and the cables 532 and 534 are preferably attached to the pulley 515 Thereby providing an influence for executing the articulation. The articulation cables 532 and 534 may take any suitable form, most preferably a diameter. Strand 300 series stainless steel cable of 020. The suture head 100 is articulated with respect to the intermediate portion 500 around the pivot 114. The knuckle 520 is a multi- A distal end 522 and a distal end 524 (in the form of yoke 524a, 524b for receiving the sealing head 100) separated by a proximal end 526. The intermediate portion 526 includes a drive member Member 150 is attached to the pull rod 151 in this region and the cross-sectional profile of the channel 528 is defined by the cross- The openings 523 are also defined to receive the members 532 and 534. In addition, the openings 525 and 527 may also be used to control the movement of the guides 120 and 130 177, 176, 178 for the tubular member 510. The tubular member 510 is provided to allow passage of the pull wires / cables 172, 174, 176, The distal end is attached to a rotissuation mechanism that rotates the tube 510 and the sealing head 100 relative to the handle 600 of the device described below The distal end 514a of the tube 510 is connected to a drive member Lt; RTI ID = 0.0 > 150 < / RTI >

For purposes of illustration, without limitation, the handle 600 of the apparatus 1000 is illustrated in Figs. The handle 600 includes a number of components and systems for manipulating the sealing head 100, 100 '. 61 illustrates a front view of the handle with the tube 510 removed and the relative rotational movement of the handle 620 with respect to the handle 600 illustrates the stitching head 100, 100 'To rotate about the handle 600. 60 shows a rear view of the handle 600. Fig. 62 shows a handle with the rotissuation handle 620 removed and shows a proximal cable guide 606, a left tube collar 634, and a right tube collar 632. FIG. The tubular collar portions 632 and 634 cooperate to capture the proximal end 512 of the tube 510, which may be, for example and without limitation, a stainless steel hypotube with a nominal 5 mm nominal diameter. There is also illustrated an articulation handle 630 that can articulate the sealing head 100 around its pivot point as described below. The housing 600 includes two major housing halves, including a right 612 and a left 614. 63 illustrates a handle 600 with tubular collars 632 and 634 removed. The proximal cable guide 606 is fixed within the hypotube by, for example, an interference pit. The longitudinal length (Figures 71-72) along the tube 510 between the distal disc 606b of the proximal cable guide 606 and the cable disc 648 is such that the sealing head is rotibalized with respect to the handle 600 When rotated, represents a twist region in which all of the cables extending across the tube 510 can rotate and twist relative to each other. The twist region is preferably about 3 inches to 6 inches in length, and most preferably about 4 inches in length. In a preferred embodiment, the sealing head has a total angular extent of movement of about 270 degrees, preferably about 135 degrees, relative to the handle 600 in both directions from the groove position illustrated in the figure. The detent (Fig. 64) in the rotissuation handle 620 is configured and adapted to engage a detent 614g received in the opening in the left handle portion 614 (Fig. 79 (A)).

The tube collar (Figures 66-67) is substantially mirror image of each other (over the vertical center plane of the device 1000) and defines a hollow, generally cylindrical interior for receiving the proximal end 512 of the tube 510 Cooperation. In particular, lugs 632a and 634a are provided to coincide with openings 518 around proximal end 512 of tube 510 (Figure 69). The tube collar also defines a radially oriented detent 632b, 634b along its proximal side to coincide with the raised portion 644b on the distal surface of the rotatory surface 644 (FIG. 68). The rotator surface 644 further includes a proximal portion 644c having a square cross-section for receiving the left and right housing side portions 612, 614.

The rotatory surface 644 is received in the housing 614 between adjacent ribs 614r (Figure 70), such as in the cable disc 648. [ The cable disc 648 (Figures 71-72) has a circumferential groove (not shown) around its periphery to conform to the lip 614r and the annular channel 648a at its distal face for receiving the rotator spring 646 648b. The spring 646 is configured and adapted to allow the rotatory surface to contact the detents 632b and 634b to facilitate stepwise rotational movement. The cable disc 648 further defines a plurality of openings 648c to allow passage of the cables / wires 172, 174, 176, 178, 532, 534 and 551. [

Cable path guide 650 is provided to direct cables 172, 174, 176, 178, 532, and 534 toward handle 600, as illustrated in Figures 73-74. In particular, guide 650 includes a first set of guides 654 for guiding cables 172, 174, 176 and 178 and a second set of guides 654 for guiding cables 532 and 534 towards handle 600. [ Guides or bosses 652 and 654 are provided. The groove 658 is provided in a guide 650 for receiving the lip 612r of the right housing portion 612 (Fig. 79 (D)).

75-76 illustrate cross-sectional views of the handle 600 where the right housing portion 612 is removed so that the internal components of the handle 600 can be seen. Figure 75 illustrates the trigger 700 in the locked position or actuator and Figure 76 illustrates the trigger 700 in the released position where the trigger is pulled to place a needle (e.g., 300) around the needle track 140 Can be advanced. As illustrated in Figures 75-76, the handle includes a trigger 700, a pull cable / ribbon 710, a trigger spring capsule 720, a trigger return spring 730, a pull cable 727, a pulley 750, And a brake handle 800 that prevents the articulation knob 810 from being rotated. The stop surface 614s is defined in the left housing 614 to define a stop for the trigger 700 when the trigger 700 is locked. The right housing 612 includes similar stop features 612s (Fig. 79 (D)). The articulation handle 810 (Figure 77 (E)) is configured to receive the handle portion 812, the long shaft 814 (Figure 83) and preferably the hex nut 886 for engaging the brake rotation fit- tings 830 Threaded distal portion 816 (Figure 90). The right and left handle cap portions 616 and 618 (Figures 77A-77D) are provided with bosses 616a and 618a for receiving and supporting the rim 835b of the brake spring 835 (Fig. 84). The bearing portion 835a of the brake spring 835 supports the brake rotation fitting 830 and eventually causes the brake rotation fitting 830 to oppose the shaft 814 of the handle 810. The portion 814 of the handle 810 preferably includes an elastic layer or coating capable of gripping the toothed portion 834 of the fitment 830 and the rotation of the handle 810 is connected to the fitting 830, (532, 534) advance along the proximal-distal direction relative to the device 1000 to articulate the sealing head 100, 100 '. 78 illustrates a handle 600 with the components 810, 616, and 618 removed. 79 (A) - 79 (D) illustrate the inner and outer views of the left and right handle portions 612, 614. 80-81 illustrate the inner workings of the handle 600 where the trigger 700 is respectively locked and unlocked and both handle portions 612 and 614 are removed. 82 illustrates an enlarged view of the inner workings of the handle 600 and shows the removed upper brake pads 820 and fully illustrates the position of the spring 835 and the spring 835 with the trigger 700 released. A knuckle pulley 842 rotatably supported by the knuckle pulley holder 840 is also illustrated which eventually leads to a guide spring 845 relative to the pedestal 870 to maintain tension on the cables 532, . 83 to 85 further illustrate the fitting 830, the spring 835 and the spring 845.

Figures 86 (A) - 86 (B) illustrate movement of a shuttle 888 that moves proximal when the trigger 700 is released (Figures 99 (A) - (B)). The proximal movement of the shuttle 888 prevents the handle 892r from being articulated and eventually prevents the guides 120 and 130 from falling into the seal head 100 and 100'and the trigger 700 is actuated to engage the circular needles & (E.g., 300) about track 140, 140 '. To better illustrate the lower brake pad 850, the components 830, 835 are removed in FIG. Brake pads 820, 850 are preferably made from an elastic and somewhat compressible material, such as silicon. Fig. 87 (A) further illustrates the lower brake pad 850, and Figs. 87 (B) to 87 (D) illustrate the brake pedestal 860. Fig. Pedestal 860 defines upper circular boss 862 for receiving lower brake pad 850 and brake handle components 882, 884 and 884a (FIG. Figures 88 to 89 (a) illustrate the remaining internal work of the handle with the brake pads removed (Figure 88) and the pulley holder 840 and brake pedestal 860 further removed. Figures 89 (a) - 89 (b) show a longitudinal section 872c having a narrow portion 872c that is wide enough to allow passage of cables 532 and 534 but not wide enough to allow passage of cable end 874 Further illustrating coupling knuckle 872 including opening 872a (FIG. 91). The opening 872b is large enough to allow the distal end 874 to pass through the knuckle 872 so that the cable 532 is bonded to the cable 534 and the articulation and braking control 800 facilitates articulation To provide a closed loop. The brake trigger 884 is pulled to move the upper portion of the handle component 882 (and its counterpart on the left side of the device) into contact with the lower brake pad 850 to create a camming effect , Brake pad 850 may cause component 830 to compress between upper and lower brake pads 820, 850.

92 to 102 illustrate aspects of the operation and control of the guides 120, 130 and the locking mechanism for the trigger 700. The handles 892 are rotated so that the guides 120 and 130 are unfolded or unfolded. The cables 172-178 are routed over a guide 885 fixed in place by housing components 612 and 614 and are divided into two pairs of wires and one set of wires is connected to a spring loaded pulley 174, 176, 178 are routed downwardly around the handle 894a, 896a and routed to the handle 192 where all four cables 172, 174, 176, 178 are tapered by the tapered pins 893, Fixed in place in opening 892b). Another pair of cables is routed around the guide 887 directly to the handle 892. [ 93 (B) is a generally curved planar member having a plurality of cable guides 885a, and cables 172-178 bear the upper surface thereof during routing thereof to handle 892. As shown in Fig. Figure 93 (A) illustrates guides 887 and 885 in place with respect to the other internal components of the handle 600. The guides 887 (Figures 93 (C) - 93 (D)) include a groove 887a defined by the boss 887a accommodating the housing portions 612 and 614 and a pin 887c for routing the cable / 887b. The handle 892 includes a grip 892a and a groove 892c and a channel 892d for directing the cable / wire to the opening 892b (Figures 94 (A) - 94 (E)). Both handles 892 are of substantially the same shape.

The guide handle 892 also serves to unlock the trigger lock 780 so that the trigger 700 actuates movement of the needle (e. G., 300). 95A-95B, the trigger lock 780 is attached to the cable at a ferrule 781 disposed in the opening 783 at the trigger pad 782 of the trigger lock (Figs. 95C-95D) . The trigger lock 780 is slidably disposed on the cylindrical rail 786 and is biased toward a locked position by a spring 787. The diverging point 784 at the opposite end of the trigger lock 780 is configured and adapted to engage the trigger 700. When the handle 892L is rotated so that the cable to which the ferrule 781 is attached is moved upward (Fig. 95B), the diverging point 784 of the trigger lock 780 is released from the trigger 700, causing the trigger to move freely. The handles 892L and 892R are disposed on the axle 891 in a rotating manner (Figs. 96 and 122). 97-101 further illustrate additional features of the actuation system for the guides 120, 130 where additional components are progressively removed to better understand the other components and their relative positions. Figure 102 further illustrates additional aspects and drawings of components 840, 894, 896. [

Figures 103 to 113 illustrate aspects of the operation of the reciprocating trigger mechanism 700. 103 illustrates the relative positions of the trigger 700, the pull cable / ribbon 710, the trigger spring capsule 720, the trigger return spring 730, the pull cable 727, and the pulley 750. Figure 103 shows a ferrule 752 secured to the distal end of pull cable 727 and within opening 701 in handle 700 by removing components 786 and 787 and handles 700 (Figure 105) . Trigger 700 is further illustrated in Figures 106 (A) - 106 (B) from two additional angles and shows a bifurcated yoke 702 proximate the upper end of trigger 700. The yoke cap 704 is received in the trigger handle 700 by securing the stud 704a to the hole 700a by interference pits and / or ultrasonic welding, adhesive or the like. The yoke 702 and the yoke cap 704 define internal openings 702a and 704a to receive the boss 888a of the shuttle link 888 (Fig. 99 (B)). FIG. 107A illustrates the interior of capsule 720 and shows clutch spring 724. FIG. Figures 107b-c illustrate a housing portion 720a that coincides with the housing portion 720b. Housing portion 720b is on the same mirror of portion 720a, only 720a being illustrated. The clutch spring 724 is removed in Figure 108 to clearly illustrate the pull cable 727, the clutch spring ferrules 723 and the clutch washers 726. 109 illustrates an assembly from which spring 730 and housing portion 720b have been removed. Figure 110 illustrates enlargement of the connection of the drive member 710 to the assembly 720 and illustrates that the tabs 711 and 712 are bent at the proximal end of the drive member 710 and the slots 721a in the washer plate 721, As shown in FIG. An O-ring 720, which may be silicon or other suitable material, is illustrated in Figs. O rings 729 provide a seal for the housing segments 612, 614. The ferrule 723 is fixed to the cable 727. Figures 111-113 provide an enlarged view of the proximal end of the ferrule 723, washer plate 721, and member 710, respectively.

Figures 114-120 further illustrate the connection between the drive member 710 and the drive member 150/551. 114, a proximal drive member that may include the ribbon member 150 described above affixed to the intermediate cable section 551 in the intermediate section 500 may be secured in place after the distal section 930 is attached Is received in the ferrule 910 and the cable / rod 551 is located in the cavity 922 in the coupling by passing through the slot 924 in the coupling 920. The rounded portion 932 of the distal end faces the circle, allowing movement between the member 551 and the coupling 920. As illustrated in Figures 115-117, distal portion 930 defines a passageway 936 for receiving cable 551 and defines a generally cylindrical proximal section 934. The ferrule 910 defines a passage 912 for receiving a cable 551 and a transverse opening 914 for receiving a ferrule in place in the cable 551, for example, brazing or brazing material or other material. do. The coupling 920 includes a proximal face 922a, a distal face 928 and a probing hole 922. [ 114, a threaded male fitting 940 is received within the threaded opening 922 of the coupling and receives the retaining hex nuts 950 above it do. The proximal end 943 of the fitting 940 faces proximal and defines an internal cavity 946 for receiving the distal tip 717 of the drive ribbon / cable 710. The tip 717 is inserted into the pupil 946 until the stop 719 is in contact with the proximal surface 943. The threads 942 and 952 are defined on the fitting 940 and the nut 950. The components 940 and 710 may be coupled by any suitable means, including, but not limited to, interference pits and / or welding, solder, brazing, adhesives, and the like. Figs. 121-122 illustrate its position with respect to the torsion spring 960 and guide spring 970, and other components within the handle 600. Figs. Springs 960 and 970 are parts of a control mechanism for deploying and traversing guides 120 and 130. Return springs 895 and 897 are illustrated in Figure 121 (C).

An exemplary operation method of the sealing head 100 is described in Figs. 123 to 131. Fig. Figure 123 illustrates a cross-sectional view of the sealing head 100 with the needles 300 disposed therein in a delivery configuration in which the guides 120, 130 are pulled. The needle 300 is fully contained within the apparatus 1000 and the detent spring 115b prevents the needle 300 from moving in a counterclockwise direction. Similarly, the detent spring 115a is biased against the inner circumferential surface 322 of the needle, tending to prevent the needle from moving in a clockwise direction. As described in Figures 123 to 131, when the needle track is in an unfolding condition, the drive system of the apparatus 1000 is configured and advanced to advance the needle 300 by multiple 360 ° rotations around the needle track, Do. It is furthermore clear that the angle of the needle track is about 180 degrees before deployment, and that the angle after deployment is greater than 180 degrees.

124 illustrates the initial deployment of the guide. The detent 115a is pulled along the surface 322 of the needle 300 until the needle is engaged with the notch 308 and the detent 115b engages the notch 306. [ The guide is then fully retracted in FIG. 125, and the detent 115a located in the guide 120 pulls the needle 300 clockwise to present the needles in the suture. The detent 160 advances along its arcuate track along the guides 120 and 130 to the farthest extent so that the notch 158 in the drive member 150 is aligned with the boss 108a and the detent 115b to support the surface 122 of the needle 300. The notch area 158 of the member 150 then pivots through the bosses 106a and 108a and the drive member 150 is moved in a direction that is partially defined by the passage 108T Falls into the lower passage. A further proximal movement of the drive member 150 causes the wider portion above the circle of the ribbon 150 to support the underside of the bosses 106a and 108a and the detent 160 to engage the trailing end of the needle 300 And the needle advances approximately 180 degrees as illustrated in Figure 126. [ Thereafter, the detent 160 is repeatedly moved to cause the detent 160 to engage with the notch 310 in the needle 300. Area 158 passes through bosses 106a and 108a as before and pulls detent 160 and leading edge tip 302 of the needle along the arcuate needle track 140 so that the needle Return to the starting point. Figure 129 illustrates the guides 120, 130 in partial traction and the needle moves counterclockwise until the notch 306 meets the detent 115b. 130 illustrates even further pulled guides 120,130 and how to pull detent 115a from notch 308 and pull along the surface 322 of the needle. Additional counterclockwise movement of the needle 300 is prevented by the detent 115b that is locked to the notch 306. [ FIG. 131 illustrates the sealing head 110 once again in a completely missing transfer or removal configuration of the guides 120, 130. Thus, an apparatus is provided herein that is capable of rotating the disclosed needle 180 degrees, 360 degrees, or any additional 180 degrees as desired. If desired, each increment of forward is incremented to somewhat 180 degrees if desired.

Laparoscopic cholecystectomy, Colonic resection, Laminectomy, Splenectomy, Paraesophageal hernia repair, Inguinal hernia repair, Ventral hernia repair, Nissen fundoplication, Liver resection a ligation device of the presently disclosed embodiment can be used in laparoscopic procedures including liver lobectomy, gastrectomy, small bowel resection, small bowel obstruction therapy, distal pancreatectomy, nephrectomy and gastric bypass surgery have. Those skilled in the art will appreciate that the presently disclosed embodiments may be utilized in other laparoscopic procedures.

In using the apparatus of the presently disclosed embodiment, the abdominal region is gas-sucked to create a working space for the user. Any gas known to those skilled in the art including, but not limited to, nitrogen or carbon dioxide may be used. Establish access ports using the trocar at a location appropriate for the particular surgical procedure. A variety of surgical instruments can then be inserted into the body via this access port / cannula. The user then introduces the distal end portion of the suture device into the cannula and then articulates the suture head assembly (e.g., 100, 100 '). Thereafter, the suture head assembly is positioned relative to the tissue / vessel to be sutured together, and preferably the user fixes the suture head assembly in place. Thereafter, the user places a plurality of discrete tissue segments into the opening defined in the distal end portion of the sealing head assembly, through manipulation of the sealing device. The user is able to actuate the handle close to the incision in a continuous suture while operating the device using only one hand and to accurately and evenly stitch along the length of the suture similar to sutures performed conventionally in a continuous suture You can relax individually. The user can use a single suture and extend the entire length of the incision or multiple sutures in a single suture. Thus, by placing the device that joins the dissected tissue segments and actuates the handle, the stitching device allows the user to make a continuous stitch or a stitch that is stitch close to the tissue incision in a time-effective manner. Those skilled in the art will appreciate that any conventional procedure for performing laparoscopic surgery may be employed by the device.

The minimized structural design of the suture head assembly allows the suture needle to be clearly seen unobstructed during advancement over the tissue segments during the suture operation procedure, allowing the suture device to be positioned precisely to provide uniform suture and to be close to the incision rim To prevent the risk of tearing the tissue. The suturing device then advances a short distance in accordance with the incision and repeats the procedure described above to produce another stitch comprising the suture material or tread.

The user may alternately advance and actuate the needle rotation around an axis parallel to the advancing direction to produce a continuous seal that can extend past the entire length of the incision or series of interrupted stitches, can do. After making each individual stitch, the stitches are tightened by applying a pulling force on the stitching material or tread, so that the uniformly created stitches are strained over the length of the incised tissue segment. Thus, hard segmented seams are achieved and tissue bleeding and tear are minimized. Once an appropriate amount of seal material or tread 246 is positioned, the user can use a needle grasper to tighten and knot the formed stitches.

All patents, patent applications and publications cited herein are incorporated herein by reference in their entirety. It is to be understood that the various disclosed and other features and functions or alternatives thereof may be advantageously combined with many other different systems or applications. Those skilled in the art will also be able to make various presently unexpected or unexpected alternatives, changes, modifications, or improvements herein that are also intended to be covered by this disclosure.

Claims (1)

A suturing needle having an arcuate body having a leading tip and a trailing end, said arcuate body being defined by a central notch of the first notch and needle along the inner radial area needle Defining a second notch having a projection in the face, and further wherein the first notch and the second notch intersect.

Images