MXPA06003581A - Suturing device - Google Patents

Abstract

A medical apparatus and method useful for suturing tissue is disclosed. The medical apparatus can include a curved needle and an apparatus suitable for providing endoscopic suturing. The apparatus can include a needle drive for driving the curved needle about a generally arcuate path. The curved needle can be deformed to form a closed needle structure.

Description

SUTURA DEVICE FIELD OF THE INVENTION The present invention relates generally to medical devices and very particularly to devices useful in endoscopic suturing.

BACKGROUND OF THE INVENTION The use of needle and suture in closing tissue defects or tissue fixation in another manner is known in the art. For example, the patent of E.U.A. 3,910,281 discloses a suture anchor that can be used with a needle and suture material. The use of suture methods in endoscopic applications is also known. For example, US 6,454,778 discloses a surgical instrument for applying sutures to tissue, including a needle deployment mechanism. However, scientists and engineers continue to look for improved devices and methods to secure tissue, including devices and methods that can be used endoscopically and / or in open procedures.

BRIEF DESCRIPTION OF THE INVENTION In one embodiment, the present invention provides a needle for use in suturing. The needle has a generally arched C-shaped configuration extending through an arc of at least about 180 degrees, and the needle is deformable from a first configuration, such as an open C-shape, to a second configuration, such as a closed configuration. In another embodiment, a suture method is provided. The method comprises providing a deformable needle from a first configuration (such as an open configuration) to a second configuration (tai as a closed configuration); provide suture material associated with the needle; passing the needle at least once through the tissue; and deforming the needle of the first configuration to the second configuration. In another embodiment, the invention provides a needle drive assembly for receiving a generally arcuate needle and urging the needle along a generally arcuate path. The drive assembly can provide 360 ° movement of the C-shaped suture needle with a generally curved, curved guidewire so that multiple suture passes can be made, without oscillatory movement, where the needle is driven by two cogwheels more. The impeller assembly can provide one-handed operation, which releases the operator's other hand for tissue manipulation. The drive assembly includes an element, such as a slidable plunger to deform the needle. In one embodiment, once the needle is closed on itself, the smaller form of the closed needle allows the needle to be discharged from the driver assembly such that the needle can remain attached to the suture material at the first end and serve as an anchor on the first end of it. The present invention provides a useful apparatus and method for suturing body tissue. In one embodiment, the invention provides a suture mechanism such as an end effector removably attached to an inserted end of a flexible endoscope for use within a patient's alimentary canal to stop bleeding, to close a wound or any of numerous surgical applications for suture, well known in the art, without having to surgically enter the body cavity.

BRIEF DESCRIPTION OF THE FIGURES Figure 1 is a perspective view of a suture mechanism showing a housing, generally a circular needle rail and drive train. Figure 2 is a perspective view of a modality of a C-shaped needle. Figure 3 is a side elevational view of the needle of Figure 2, showing suture material housed within the needle.

Figure 4 is another side elevation view of Figure 2, showing the needle collapsed to form a closed circular anchor. Figure 5 is a perspective view of an endoscope showing control of a fixed suture mechanism. Figure 6 is a cross-sectional elevation view of a suture mechanism removably attached to an endoscope by means of a transparent cover. Fig. 7 is a cross-section elevation view of a first step in a suture method showing the penetration of a folded portion of body tissue by the needle, which leaves an anchor button at the entrance to the needle hole. Figure 8 is a cross-sectional elevation view of a second step in a suture method showing suture material carried through a first fold. Figure 9 is a cross-sectional elevation view of a third step in a suture method showing the suction of a second fold in the suture element. Figure 10 is a cross-section elevation view of another step in a suture method showing the termination of the suture of a third fold. Figure 11 is a cross-section elevation view of another step in the suture method showing deformation of the circular needle to form another anchor.

Figure 12 is a cross-sectional elevation view of another step of a suture method showing the termination of the multiple-folds suture with the needle closed. Figure 13 is an elevation view in cross section of another step in a suture method showing the removal of the endoscope. Figure 14 is an illustration of a second endoscope that is advanced in the gastrointestinal tract. Fig. 15 is a cross-sectional elevational view of a final step in a suture method showing the second endoscope that collects the suture plies when pulling a stippled end of the suture through a tight fitting hole in the suture. the button anchor. Figure 16 is a perspective view of a suture mechanism shown attached to a handle through a flexible joint. Figure 17 is a perspective view of a pincer mechanism for forming a C-shaped suture needle to a closed circular anchor.

DETAILED DESCRIPTION OF THE INVENTION Figures 1-4 show one embodiment of a suture mechanism in accordance with the present invention. In one embodiment, the suture mechanism 2 can include a housing 4, a driving sprocket 30, a driven sprocket 40, a driving belt 50, a flexible drive cable 60, a needle 70 (which can be a needle generally in the form of C, arcuate, malleable), a suture material 100, an anchor of sliding suture material 110, a pull wire 118 and a plunger 120. As shown in Figure 1, the housing 4 may have an arcuate groove in it. the same, forming a needle rail 6. The rail 6 may be sized to contain a C-shaped needle 70 shown in Figures 2-3. The rail 6 may have an open V, U-shaped, rectangular, trapezoidal or other suitable shape, and the rail 6 may extend circumferentially around a needle portion 70. In one embodiment, the rail 6 may extend circumferentially around the rail. the needle 70 through an angle of no more than about 180 degrees. The housing 4 can have a first surface 8 and a second surface 10 defining an open end 12 in the rail 6 that provides clearance between the surface 8 and the surface 10. The housing 4 can be made of stainless steel of the series 300 by machining methods commonly known in the manufacturing art, such as casting, turning, milling and electro-discharge machining (EDM): Alternatively, the housing 4 may be formed of other suitable biocompatible materials, including biocompatible mechanical and non-mechanical materials. The housing 4 can be approximately 1.87 cm long, approximately 0.635 cm wide and approximately 1.39 cm high. The needle rail 6 may be approximately 1.27 cm in diameter at its root and may have a groove depth of approximately 0.04 cm. The open end 12 may be approximately 0.635 cm wide. The housing 4 may also have a first slot 14 and a second slot 16 for receiving the driving sprocket 30 and the driven sprocket 40 (the sprockets 30 and 40 may be the same size or different sizes), respectively, and the drive belt 50. The gear 30 can be associated with an axle 32, whether the axle 32 is fixed by grooving and / or press fit therethrough, and the gear 40 can be associated with an axle 42. , either fixed by grooving and / or adjusted by pressure through it. The axial clearance holes 18 and 20 can be formed on one or both sides of the housing 4, and the axes 32 and 42 can extend through the slots 14 and 16, respectively. The axes 32 and 42 can be substantially parallel to one another. The driving gear 30 has a first set of equally spaced teeth 34 and a second adjacent set of equally spaced teeth 36 that extend around its circumference. The gear 40 has a first set of equally spaced teeth 44 and a second set of equally spaced teeth 46 that extend around its circumference. Teeth 34 and 44 may have a common pitch. Teeth 36 and 46 can also have a common step, which may or may not be different from the pitch of the teeth 34 and 44. The sprockets 30 and 40 may each be individual unitary parts, or each of the sprockets 30 and 40 may be formed of two components wedged together to ease of formation of rows of individual teeth. The sprockets 30 and 40 can be made of stainless steel of the 300 series and the teeth 34, 36, 44 and 46 can be formed by a wire EDM process. Each cogwheel can be approximately 0.38 cm in diameter at the root of the tooth. The axes 32 and 42 can be made of stainless steel of the 300 series and can be approximately 0.195 cm in diameter and approximately 0.825 cm in length. The platforms on each side of the axes 32 and 42 can be used to define a channel shape or other non-circular shape that fits into non-circular holes similarly configured in the sprockets 30 and 40. The drive belt 50 can be a continuous band fixed around the sprockets 30 and 40. The driving band 50 can use openings 52 equally spaced along the length thereof. The openings 52 can have the same pitch as the teeth 36 and 46, so that when the driving sprocket 30 is rotated, the driving belt 50 positively rotates the driven sprocket 40 by the same amount. The driving band 50 can be made of any suitable biocompatible material, including without limitation a non-metallic material or a metallic material such as stainless steel of the series 300. In one embodiment, the driving belt can have a thickness of about 0.005 cm, a width of approximately 0.182 cm and a length of approximately 4.191 cm. Figure 1 shows a flexible, twisted cable 60 positioned to cooperate with the axis 32 of the driving wheel 30. The cable 60 may include a collar 62, which is removably attached to the shaft 32 for assembly purposes, but is rotatably fixed thereto. when it is assembled, such as by pin, channel or snap fit, so that when the wire 60 rotates about its axis, the shaft 32 rotates, causing the sprocket 30 to rotate, thereby urging the web 50 to rotate the sprocket 40 in the same direction and speed as the sprocket 30. The cable 60 can have a diameter of about 0.228 cm, and can be formed of any suitable material, including without limitation stainless steel wire of the 300 series similar to a Speedometer cable, being relatively low in bending stiffness but relatively high in torsional rigidity. The lubrication of the rotating and sliding parts in the housing 4 can be achieved with any suitable lubricant, including without limitation Teflon coating, soap or petroleum jelly. Figures 2-4 illustrate a generally arcuate C-shaped suture needle 70 in accordance with one embodiment of the present invention. The needle 70 is shown in the form of a generally curved hollow tube having a generally circular cross section having equally spaced openings 72 through an outer circumference 74 thereof. The needle 70 has a tip end 76 and a rear end 78 spaced apart by a space 80. The openings 72 can have the same pitch as the teeth 34 and 44, such that the driving and driving sprockets 30 and 40 engage both the apertures 72 of the needle 70 to cause it to rotate inside the rail 6. Two sprockets engage the needle 70, so that a sprocket is always engaged when the arcuate space 80 passes to the other sprocket. Accordingly, the spacing of the sprockets 30 and 40 may be greater than the space 80. The space 80 may be approximately 60 degrees of needle circumference, or in one embodiment, approximately 0.635 cm. The needle 70 can have an outer diameter of approximately 1.27 cm Figure 3 shows the needle 70 having an internal circumference 82. Around the inner circumference 82 are the substantially parallel spaced grooves 84 which generally extend radially outwards. The slots 84 can be separated between the openings 72 in a stepped manner to provide a substantially uniform bending stiffness along the needle 70. The needle 70 can be formed to have a global bending stiffness that allows it to penetrate the body tissue under a tangential force 86 with minimum deflection, but when desired may be permanently deformed to a closed circle 90 when a radial force 88 is applied, as shown in Figure 4. The slots 84 may be sized and configured in such a way that they are substantially closed as the needle 70 is deformed to a closed circle 90. Some slots 84 may be closed before other slots 84 are closed. In one embodiment, the slots 84 can be closed in a sequential manner generally one at a time, such as when a slot is closed, the stiffness at that point in the needle increases and the adjacent slots successively close. The needle curvature, needle material, thickness of its tubular wall, size and gap separation can be varied as desired to provide a desired overall stiffness of the needle 70. When a needle is deformed to a closed circle 90, it forms a suture anchor, as described here. In one embodiment, the needle 70 may have a generally tubular cross section of approximately 0.08 cm in diameter and may be formed of a stainless steel sheet material of the 300 series having a thickness of about 0.005 cm. The sheet material can be wrapped, enroled or otherwise formed to provide a tube with blunt edges 92 on the inner circumference 82, as best seen in Figure 2. In the embodiment shown, the blunt edges 92 are not welded or otherwise fixed. The openings 72 and the slots 84 can be formed in the needle 70 by a wire EDM method. The slots 84 may be from about 0.0025 to about 0.025 cm wide and have a depth from about 0.025 to about 0.050 cm. In one embodiment, the slots 84 are approximately 0.005 cm wide and have a depth of approximately 0.040 cm. For needle assembly for suture mechanism 2, the needle 70 can be slightly twisted to form a spiral shape in order to progressively feed into the rail 6, without permanently deforming the needle 70. Figure 3 shows the needle 70 having a length of approximately 2.54 cm of suture material 100 inside its hollow tubular body. The material 100 can be, for example, a 0.0127 cm diameter polypropylene monofilament or a woven strand folded back on itself one or more times. The material 100 may include an anterior end 102 and a posterior end 104 and a fold 106. The anterior end 102 may be folded to the needle 70 by a bent flap 94 of the needle 70 after the material 100 has been inserted into the needle. needle 70. Needle 70 may include another tab 96 bent inward approximately 45 degrees towards the tip of needle 76 and near rear end 78. Tab 96 may be sized and configured to capture an opening 72 (such as the opening more near needle tip 76 as shown in Figure 4) to prevent needle tip 76 from retracting from back end 78 when needle 70 is collapsed to closed circle 90. Rear end 104 may be associated with an anchor of slidable button 110, with a button anchor 110 slid over the rear end 104 and a knot 108 tied at the rear end 104 just outside the slidable anchor 110. The knot 108 holds the anchor 110 against the trailing end 78 of the needle 70 as the needle 70 slides into the rail 6 of the housing 4. The anchor 110 may be configured to allow it to pass through the rail 6 with the needle 70. The anchor 110 may be formed of stainless steel series 300 with a thickness of approximately 0.076 cm. The anchor 110 may include a hole 112 through which the suture material 100 passes. The hole 112 may be configured to provide movement in a sense of suture material 100. For example, the hole 112 may be configured to provide an adjustment tight around the suture material 100, or alternatively, the hole 112 can include an inward taper to a sharp edge 114 on a side 1 6 of the anchor 110 so that the material 100 can slide through the anchor 110 in one direction only, to the side 116 on the side opposite of the anchor 110. This allows the anchor 110 to collect the folds of body tissue, as described below. The housing 4 can be provided with openings extending in the rail 6 through which several of the teeth 34 and 44 of the sprockets 30 and 40 extend to engage the openings 72 of the needle 70. The housing 4 also has an outer outer surface 26 and a radially extending opening 29 extending from the end 26 to the needle rail 6. The opening 29 may have a rectangular (or other non-circular) shape to serve as a guide for a plunger 120 having an arrow with a rectangular (or other non-circular) cross section, to prevent the plunger 120 from rotating in the hole 29. Alternatively, the hole 29 may be circular with a lock, and the plunger 120 may have a round arrow with projection from a key to a lock. The plunger 120 may include a first end 122 and a second T-shaped end 124. The first end 122 may include a concave groove configured similar to the needle rail 6, such that when the plunger 120 is in its retracted position, the end 122 can be aligned with and serve as a rail portion 6. The T-shaped end 124 can be connected to a cable 118, which can be pulled to drive the plunger 120 from its retracted position to where a force is applied radial to close the needle 70, as described below. The plunger 120 can be formed of a stainless steel of the 300 series. In one embodiment, the plunger 120 can be supported to move approximately 0.635 cm from the retracted position to an extended position by the stainless steel pull cable 118. The cable 118 may be approximately 0.030 cm in diameter and may comprise a conventional woven pull cord designed for tension loading. For load balancing, the cable 118 may include a split or split wire portion to be fixed to any two ends of the T-shaped end 124, with the split halves of the pull cable 118 directed along sides opposite the housing 4 as shown in Figure 1. The housing 4 can include an annular depression at the end 26, the depression centered around the hole 29. The annular depression can accommodate a compression spring 126. The compression spring 126 can being arranged around the plunger 120 to deflect the plunger 120 in a retracted position when the pull cable 118 is not pulled. If desired, a portion of the T-shaped end 124 can act as a stop (such as when leaning against a portion of the receiving end 26) when the cable 118 is pulled, so that the needle 70 is not deformed more than as desired to form a closed circle 90. Figure 4 shows the needle 70 deformed to form the closed circle 90. The indicated end 76 is shown disposed at the end 78 of the tubular needle 70. The thickness of the wall of the material of which the tubular needle 70 is formed can be selected such that the tubular needle 70 is sufficiently flexible to allow widening of the edges 92 near the end 78, to accommodate the tapered outer surface of the tip end 76. Accordingly, the end tip 76 is housed inside end 78, and body tissue is protected against posterior contact with tip end 78. The anterior end 102 of suture 100 remains folded to needle 70 j UST below the lodged tip end 78, and the closed circle 90, still connected to the suture material 100, forms an anchor at the anterior end 102 of the suture material 00. Referring to Figures 5-13, an endoscope 130 is shown equipped with suture mechanism 2, and a method for using endoscope 130 is illustrated. Figure 5 shows endoscope 130 extending a handle 132, a flexible body 134 with a distal end 136, a lumen 138, a twisted cable cover 140, a vacuum source 141, a pull cable cover 142, a chamber 143 and a transparent cover 160. The flexible body 134 may include four separate passages therethrough. At the distal end 136 a first passage 144 is seen, which is a working channel; a second passage 146, a third passage 148 and a fourth passage 150. The twisted cable cover 140 can extend from a position adjacent to the handle 132 and extends through the first passage 144 of the flexible body 134 to the distal end 136 where ends. A twisted wire 60 fixedly connected to the shaft 32 of the driving sprocket 30 can extend through the cover 140 to a twisted handle 152. The twisted handle 152 can be removably connected to the wire 60 to manually operate the driving sprocket 30 of the suture mechanism 2. The pull cable cover 142 can extend from a position adjacent to a handle 132 through a first passage 144 of flexible body 134 along the side cover 140 to the distal end 136 in where it ends The pull cable 118 can extend through the cover 142 to a pull handle 154. The pull handle 154 can be removably connected to the cable 118 to manually operate the plunger 120 of the suture mechanism 2. The light can be transmitted from light 138 by one or more optical fibers extending through second and third passages 146 and 148. Chamber 143 may be located at distal end 136 and may be operatively connected to a cable extending from the handle 132 through the fourth passage 150, A vacuum source 141 can provide vacuum at the distal end 136, such as by communication through one or more passages in the endoscope. For example, a vacuum source 142 may be in fluid communication with the first passage 144. 7 The endoscope 130 may have a length of at least about 101.6 cm and a diameter of about 1.39 cm. The transparent cover 160 may be formed of clear polycarbonate and may have an outer diameter of approximately 1.90 cm and a length of approximately 5.08 cm. The protective cover 160 may be adapted to be releasably attached to the end of the endoscope 130, such as by pressure adjustment to prevent the cover from rotating with respect to the endoscope. Alternatively, a silicone rubber washer fitted between the cover and the endoscope can be used. The protective cover 160 has an opening 162 located near the open end 12 of the rail 6 of the suture mechanism 2. When the vacuum source 141 is activated, suction occurs in the aperture 162 to allow a fold of body tissue to be pulled towards the trajectory of the needle 70 for suturing. The opening 162 may be approximately 0.635 cm wide (as measured parallel to the longitudinal axis of the endoscope) and the opening 162 may extend approximately 120 degrees around the circumference of the protective cover 160. The protective cover 160 may be formed of a transparent material so that the light 138 illuminates the area of the body to be sutured and the camera 143 transmits that view to the operator of the endoscope. Figure 6 shows a cross-sectional view of the protective cover 160 and suture mechanism 2. This view shows the needle 70 in the rail 6 engaged by sprockets 30 and 40 to rotate the needle past the opening 162 in the protective cover 160. The mechanism 2 can be supported by the protective cover 160 on the gearwheel arrows 32 and 42. For example, the arrows 32 and 42 can be supported on supports formed in the protective cover 160. plunger 120 is shown in its retracted position, supporting an inner surface of a distal tip of protective cover 160. Figures 7-13 show a method for suturing body tissue in a human alimentary canal 170 using endoscope 130 and suture mechanism 2 Figure 7 shows a first step of sucking a first fold 172 of body tissue towards the opening 162. Figure 8 shows a second actuation step of the twisted wire 60 for driving r the needle 70 almost at a 360 degree rotation through the fold 172, leaving an anchor button 110 at an entry point 174 of the fold 172, while the suture material 100 is shown partially retracted from the needle 70. The figure 9 shows a third step of moving the endoscope 130 to an adjacent area of the alimentary canal 170, wherein a second fold 180 is sucked into opening 162 to initiate a second suture. The anchor 110 remains at the point 174 of the first sutured fold 172, and the suture 100 is shown retracted from the needle 70. Figure 10 shows another step of the suture method in which the third fold of body tissue is sucked towards the opening 162, after which the needle 70 is rotated about the third rail 6 to pull the suture material 100 through the third fold 190. Figure 11 shows another step in which the plunger 120 is actuated by pulling the cable 118 for moving the plunger 120 to close the needle 70 on itself to form a closed circle 90. In the process of closing the notches 84 of the needle 70, the suture material 100 can be pinched into the slot of which it has been withdrawn. As a result, no additional material 100 can be removed, and the closed circle 90 becomes an anchor at one end of the suture material 100. The needle 70 can be collapsed regardless of its rotational position within the needle rail 6. Therefore , it can be collapsed while it is still hooking the tissue or after it has passed through the tissue. In these figures, the closed circle 90 is shown formed outside the body tissue. Alternatively, the needle 70 can be closed with the needle still engaging the tissue, at the discretion of the surgeon. Figure 12 shows another step of the suture method in which the plunger is retracted. Once the needle 70 is closed on itself to form a needle circle 90, its size is reduced sufficiently so that the needle circle 90 will fall out of the open end 12 of the rail 6 and the opening 162 of the cover protection 160. The closed circle 90 can be approximately 0.635 cm in diameter. It can also be discharged laterally from the suture mechanism 2. When the pull cable 118 is released, the spring 126 returns the plunger 120 to its reset position. Figure 13 shows the endoscope 130 removed from the alimentary canal 170 and closed circle 90 at one end of the suture material 100, and the anchor button 110 at the other end, and the suture material 00 passing loosely through three folds 172 , 180 and 190, which tend to flatten and cause the knot 108 to look inward in the alimentary canal 170. Figure 14 shows a final step of collecting three folds by introducing a second endoscope 200, having a distal end 202 and conventional fasteners. 210. The fasteners 210 are connected to an operating handle by one or more pull wires or cables. The fasteners 210 can be operated to hold the knot 108 at the rear end 104 of the suture material 100, and to retract the knot 108 through a channel in the endoscope 200 while the anchor button 110 is held in place by the distal end 202 of endoscope 200. To prevent the anchor button 110 from entering the channel in endoscope 200, the anchor button 110 may be sized to prevent the button 110 from passing through the channel through which the fasteners operate. When the knot 108 and the anchor button 110 are released, the anchor button remains in position with the folds collected due to a tight fit between the hole 112 of the anchor button 110 and the suture material 100. Alternatively, a Sharp edge 114 on the side 116 of the anchor button 110 engages the material 100 and thus prevents reverse movement of the material 100 through the button 110. Referring now to Figure 16, it is shown a suture mechanism 212 fixed to a handle 214 by a rotating union 216.

The manual operation of a suture mechanism at the end of a handle allows a surgeon to controllably place an arcuate needle in the body tissue. The surgeon can also push the needle backwards so that if it is partially penetrated in the tissue, it can be retracted and relocated in the tissue if desired. The handle 214 may be formed of a rigid medical grade plastic or stainless steel of the 300 series. The rotating union 216 is made of surgical grade stainless steel. The suture mechanism 212 has a housing 218, a driving sprocket 230, a driven sprocket 240, a driving belt 250, a flexible twisting rope driver 260, a malleable C-shaped needle 270, suture material 300 and a slidable suture material anchor 310. The suture mechanism 212 is similar to the suture mechanism 2, except that there is no needle lock plunger 120 and there is no vacuum source 141 to lift the tissue in the path of the suture. needle 270. The C-shaped needle 270 is similar to needle 70, except that a tip end 276 and a rear end 278 are separated by a larger space 280, as explained below. The size of the suture mechanism 212 is not as contracted when it is attached to the handle 214 as is the suture mechanism 2 when used with the endoscope 130. In Figure 16, the housing 218 has an arcuate groove therein, forming a needle rail 220. The rail 220 is dimensioned to contain the C-shaped needle 270, similar to the rail 6 containing the needle 70. The housing 218 has an open end 222 on the rail 220, similar to the open end 12 in the rail 6, which provides clearance for the tissue to enter the path of the needle 270. The housing 218 may be formed of 300 series stainless steel by equalization procedures commonly known in the manufacturing art such as casting, turning, milling and machining by electro-discharge (EDM). The housing 218 may be approximately 1.87 cm long, approximately 0.635 cm wide and approximately 1.39 cm high. The needle rail 220 may be approximately 1.27 cm in diameter at its root and may have a groove depth of approximately 0.040 cm. The open end 222 may be approximately 0.635 cm wide. The gear 230 can have a shaft 232 fixed by crimping and / or press fit therethrough, and the gear 240 can have a shaft 242 fixed by crimping and / or press fitting therethrough. The axes 232 and 242 can be substantially parallel to one another. The driving gear 230 can have a first set of equally spaced teeth 234 and a second adjacent set of equally spaced teeth 236 extending around its circumference. The driven gear 240 may have a first set of equally spaced teeth 244 and a second adjacent set of equally spaced teeth 246 extending around its circumference. The teeth 234 and 244 may have a common pitch and the teeth 236 and 246 may also have a common pitch, which may or may not be different from the pitch of the teeth 234 and 244. The sprockets 230 and 240 may be individual parts or two components wedged together for easy formation of rows of individual teeth. The sprockets 230 and 240 can be formed of 300 series stainless steel and the teeth 234, 236, 244 and 246 can be formed by a wire EDM process. Each cogwheel can be approximately 0.38 cm in diameter at the root of the teeth. The axes 232 and 242 may be formed of stainless steel of the 300 series and may be approximately 0.195 cm in diameter and approximately 0.825 cm in length. The driving belt 250 may be a continuous band extending around the sprockets 230 and 240. The driving belt 250 may include equally spaced openings 252 along the length thereof. The openings 252 can have the same pitch as the teeth 236 and 246 so that when the driving sprocket 230 is rotated, the driving belt 250 positively rotates the driven gear 240 in the same amount. The driving band 250 may be formed of stainless steel of the series 300 and may have a thickness of about 0.005 cm, a width of about 0.182 cm and a length of about 4,191 cm. Figure 16 shows flexible twisted wire 260 positioned to engage the shaft 232 of the driving sprocket 230. The wire 260 may include a collar 262, which can be removably attached to the shaft 232 for assembly purposes, but is rotatably fixed thereto. when it is assembled, such as by pin, channel or snap fit, so that when the cable 260 is twisted, the shaft 232 rotates, causing the sprocket 230 to rotate, thereby urging the web 250 to rotate the sprocket 240 in the same direction and speed as the sprocket 230. The cable 260 can have a diameter of approximately 0.228 cm, and can be formed of stainless steel wire of the 300 series similar to a speedometer wire, low in bending stiffness but relatively high in torsional rigidity. The lubrication of rotating and sliding stainless steel parts in the housing 218 can be achieved with any suitable lubricant, including without limitation Teflon coating, soap or Vaseline brand materials. Figure 15 also shows C-shaped suture needle 270. Needle 270 may be in the form of a hollow, curved tubular structure having a generally circular cross-section having equally spaced openings 272 through an outer circumference 274 thereof. . The needle 270 has a tip end 276 and a second opposite end 278 separated from the tip end 276 by a space 280. The openings 272 can have the same pitch as the teeth 234 and 244, so that the driving sprockets driven 230 and 240 engage the apertures 272 of the needle 270 to cause it to rotate inside with the rail 220. Two sprockets engage the needle 270 so that one sprocket is always engaged when the space 280 passes to the other sprocket. The angular spacing of the sprockets 230 and 240 along the rail 220 is greater than the space 280. The space 280 may be approximately 60 degrees of needle circumference, or approximately 0.635 cm. The needle 270 can be approximately 1.27 cm in outer diameter. The housing 218 has a rotating union 216 fixedly attached thereto. The rotating union 216 has a spherical or hemispherical or cylindrical surface 215, as is commonly known in the art, with correspondingly shaped matching surface 217 engaging the surface 215 to allow sliding therebetween, preferably with adjustable friction, to allow a rotational position once it is established. The rotating union 216 is also fixedly attached to the handle 214 such that the suture mechanism 212 is rotatable relative to the handle 214. The rotation is achieved either manually before contact with the body tissue or by pressing the mechanism of suture 212 against body tissue while manually twisting and / or tilting handle 214. Alternatively, a control lever or other suitable mechanism may be associated with handle 214 to vary the orientation of the suture mechanism relative to handle 214 The cable 260 can be directed through the rotating union 21 and into the handle 214, if desired, or it can be rotated along the handle 214 as shown in Figure 16. The operation of the suture mechanism 212 is similar to that of suture mechanism 2 in the steps illustrated in Figures 8-10, except that no vacuum is used. Instead of vacuum to lift the tissue at the open end 222, a surgeon can manually lift the tissue at the open end 222, or alternatively, the open end 222 of the housing 218 can be pressed against the body tissue to place the tissue inside the tissue. the trajectory of the needle 270. The wire 260 can be manually twisted while the handle 214 is held by the surgeon to place the needle 270. The needle 270 is similar in construction to the needle 70. However, because it is designed for use outside the alimentary canal, where access to suture material is readily available, a length of suture material 100 may or may not be contained within needle 270. Also, needle 270 may or may not be not be collapsed to form a closed circle. Instead, the needle can be removed and the suture material can be tied manually. In one embodiment, needle 270 is similar to needle 70 and is designed to close to form an anchor. In this embodiment, the needle 270 has slots that extend radially outwardly between the internal circumference similar to the needle 70, which allows the needle 270 to be collapsed. However, instead of the plunger 120 in the suture material 2, separate manually operated tweezers 320, as shown in Figure 17, can be used to form the needle 270 to a closed circle 330 after the needle 270 is removed from the suture mechanism 212. The non-collapsed needle 270 can be "pulled out" or otherwise slightly deformed by the surgeon to remove it from the lane 220 of the suture mechanism 212. In another embodiment, the needle 270 may have a length of approximately 2.54 cm of suture material 300 inside its hollow tube body. The material 300 can be a polypropylene monofilament of about 0.0127 cm in diameter or a woven strand folded back on itself one or more times. The material 300 may include an anterior end connected to the needle 270 similar to the material 100 folded and connected to the needle 70. the material 300 may include a trailing end on which is placed a slidable button anchor 310, with a knot tied at the rear end just outside slidable anchor 310 similar to the anchor button 110 and material 100 with the knot 108. The anchor 310 may be configured to allow it to pass around the rail 220 with the needle 270. The anchor 310 may be formed of steel stainless steel of the 300 series with a thickness of approximately 0.076 cm. The anchor 310 may include a hole adapted to generally allow passage in a direction of suture material 300. Although the present invention has been illustrated by the description of various embodiments, the applicant does not intend to restrict or limit the spirit and scope of the appended claims to said detail. Numerous other variations, changes and substitutions will occur to one skilled in the art without departing from the scope of the invention. Moreover, the structure of each element associated with the present invention can alternatively be described as a means to provide the function performed by the element. It is understood that the foregoing description is provided by way of example and that other modifications may occur to one skilled in the art without departing from the scope and spirit of the appended claims.

Claims (19)

NOVELTY OF THE INVENTION CLAIMS

1. - A needle for use in suture, the needle having a generally curved configuration extending through an arch of at least about 180 degrees, and wherein the needle is deformable from a first configuration to a second configuration.

2. The needle according to claim 1, further characterized in that the needle extends through an arc of at least about 270 degrees.

3. The needle according to claim 1, further characterized in that the needle is deformable from a first open configuration to a second closed configuration.

4. The needle according to claim 1, further characterized in that the needle comprises a plurality of sequentially deformable segments.

5. The needle according to claim 1, further characterized in that it comprises a plurality of circumferentially spaced notches extending from an inner circumferential portion of the needle.

6. The needle according to claim 1, further characterized in that it comprises a plurality of notches sized such that the slots are closed as the needle is deformed from the first configuration to the second configuration.

7. The needle according to claim 1, further characterized in that the needle comprises a first tip end and a second end.

8. The needle according to claim 1, further characterized in that the needle comprises a first end and a second open end.

9. The needle according to claim 1, further characterized in that it comprises a first tip end and a second open end, wherein the first tip end is received within the second open end when the needle of the first configuration is deformed. the second configuration.

10. A needle for use in suture, the needle comprising a generally curved tubular portion, wherein the generally curved tubular portion extends through an arch of at least about 180 degrees.

11. The needle according to claim 10, further characterized in that the generally curved tubular portion extends through an arc of at least about 270 degrees.

12. The needle according to claim 10, further characterized in that the needle is deformable from a first configuration to a second configuration.

13. The needle according to claim 10, further characterized in that it comprises a length of suture material disposed within the tubular portion of the needle.

14. The needle according to claim 10, further characterized in that it comprises a first tip end and a second open end communicating with an internal space within the tubular portion.

15. The needle according to claim 10, further characterized in that the needle is deformable from a first configuration to a second configuration.

16. The needle according to claim 10, further characterized in that the needle is deformable from an open configuration to a closed configuration.

17. The needle according to claim 10, further characterized in that it comprises a length of suture material extending from the tubular portion of the needle, and a suture anchor disposed at an end portion of the suture material.

18. A medical suture apparatus comprising: a generally arched needle; and a needle driver assembly for receiving the generally arcuate needle and urging the needle along a generally arcuate path, wherein the needle driver assembly comprises a support member for moving from a first position to a second position for deforming the needle .

19. - The medical device according to claim 18, further characterized in that the needle drive assembly comprises at least one rotating element for driving the needle along the generally arcuate path.