Suturing device and method

Abstract

The present invention is entitled "Suture Device and Method". The disclosed embodiments include devices, systems and methods for driving a needle to facilitate suturing, such as devices, systems and methods that can be performed in a surgical stapling procedure. In an exemplary embodiment, the device includes a frame that is configured to support two generally parallel rollers in a counter-rotatable manner. The first roller supported by the frame has a flat surface that is configured to rollably engage the first face of the shaft of a spiral needle. The second roller supported by the frame has a grooved surface defining a groove, and the grooved surface is configured to at least partially receive the second face of the shaft. The bottom of the groove has a bottom width that is at least as wide as the second face and is defined by the sides of the groove opening extending to the grooved surface, and the grooved surface has a surface width that is wider than the second face.

Description

Technical Field

[0001] The present disclosure relates to devices, systems, and methods for suturing an object, such as a junction of two passages. Background Art

[0002] The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.

[0003] Surgical anastomosis enables segments of one or more arteries, blood vessels, intestines, or any other passage to be connected or reconnected, such as in a coronary artery bypass graft (CABG) procedure. In a CABG procedure, for example, the saphenous vein may be harvested from a patient's leg and grafted to avoid blockage of a coronary artery. Such procedures are extremely useful and can regularly save and prolong lives.

[0004] However, CABG surgery and similar surgeries involve highly invasive surgical procedures. For example, a typical CABG surgery involves performing a median sternotomy, in which a vertical incision is made along the patient's sternum, after which the sternum itself is actually broken open to provide access to the heart and peripheral arteries. The median sternotomy provides space for the surgeon to insert the graft and suture the graft to the coronary arteries to complete the procedure. However, the considerable incision and disruption of the sternum may involve significant scarring, discomfort, and infection risk, and may require a significant amount of recovery time to heal the affected structures. Summary of the invention

[0005] The disclosed embodiments include devices, systems, and methods for actuating a needle to facilitate suturing, such as may be performed in surgical anastomosis procedures involving veins, arteries, or other passageways.

[0006] In an exemplary embodiment, an apparatus includes a frame. A first roller and a second roller are rotatably mounted in the frame parallel to each other and are configured to engage an axis of a needle formed into a spiral shape between them. The first roller and the second roller are configured to rotate in opposite directions. The needle can rotate around the first roller in response to the opposite rotation of the first roller and the second roller. A drive mechanism is fixed to the frame and is configured to move the frame.

[0007] In another embodiment, a system includes a needle formed into a spiral shape, wherein the needle includes an axis having a tail end configured to pull a filament and a leading end configured to pierce an object. A drive track can be positioned to guide the path of the needle. A needle drive mechanism includes a frame. A first roller and a second roller are rotatably mounted in the frame parallel to each other and are configured to engage the axis of the needle formed into a spiral shape between them. The first roller and the second roller are configured to rotate in reverse. The needle can rotate around the first roller in response to the reverse rotation of the first roller and the second roller. The drive mechanism is fixed to the frame and is configured to move the frame along the drive track.

[0008] In yet another exemplary embodiment, in an exemplary method, the opposite sides of the axis of the needle are engaged between the parallel surfaces of the first roller and the second roller, wherein the needle is formed into a spiral shape and is configured to pull the filament from its tail end. The first roller and the second roller are counter-rotated to rotate the spiral needle around the first roller positioned adjacent to the object so that the leading end of the needle pierces the object adjacent to the outside of the first roller. The first roller and the second roller are translated along the edge of the object. The first roller and the second roller are counter-rotated and the first roller and the second roller are translated so that the needle pulls the filament to sew the edge of the object adjacent to the outside of the first roller.

[0009] In another exemplary embodiment, an apparatus includes a frame configured to counter-rotatably support two generally parallel rollers. A first roller supported by the frame has a flat surface configured to rollably engage a first face of a shaft of a spiral needle. A second roller supported by the frame has a grooved surface defining a groove configured to at least partially receive a second face of the shaft. The bottom of the groove has a bottom width at least as wide as the second face and is defined by sides of the groove opening extending to the grooved surface, the grooved surface having a surface width wider than the second face.

[0010] In another embodiment, a system includes a spiral needle, wherein the needle includes an axle having a tail end configured to pull a filament and a leading end shaped to pierce an object. A needle drive mechanism includes a frame, which is configured to support two substantially parallel rollers in a counter-rotatable manner across a gap. The first roller has a flat surface, which is configured to rollably engage the first face of the axle of the spiral needle. The second roller supported by the frame has a grooved surface defining a groove, which is configured to at least partially receive the second face of the axle. The bottom of the groove has a bottom width at least as wide as the second face and is defined by the side of the groove opening extending to the grooved surface, and the grooved surface has a surface width wider than the second face. The drive mechanism is fixed to the frame and is configured to reversely rotate the roller and move the frame along the edge of the object to be sutured by the filament.

[0011] In yet another exemplary embodiment, in an exemplary method, the opposite face of the axis of the spiral needle is engaged between a first roller and a second roller parallel to the first roller. The first roller includes a flat surface that engages the first face of the axis, and the second roller includes a grooved surface that defines a groove, and the grooved surface at least partially receives the second face of the axis in the groove. The bottom of the groove has a bottom width that is at least as wide as the second face and is defined by the side of the groove opening extending to the grooved surface, and the grooved surface has a surface width wider than the second face. The first roller and the second roller are rotated in opposite directions so that the spiral needle rotates around the first roller positioned adjacent to the object so that the leading end of the needle pierces the object adjacent to the outside of the first roller. The first roller and the second roller are translated along the edge of the object. The first roller and the second roller are rotated in opposite directions and the first roller and the second roller are translated so that the needle pulls the filament to sew the edge of the object adjacent to the outside of the first roller.

[0012] In yet another embodiment, an apparatus includes a frame configured to support two substantially parallel rollers in a counter-rotatable manner. A first roller is supported by the frame, the first roller having a flat surface configured to rollably engage a first face of an axis of a spiral needle. A second roller is supported by the frame, the second roller having a grooved surface defining a spiral groove configured to at least partially receive a second face of the axis. The second roller further defines a correction recess defined by a lateral surface at the front end of the groove, the correction recess tapering to the width of the groove at the front end of the groove. When the leading end is received in the correction recess in response to counter-rotation of the first roller and the second roller, at least one of the lateral surfaces engages the leading end and guides the leading end into the front end of the groove.

[0013] In yet another embodiment, a system includes a spiral needle, wherein the needle includes an axis having a tail end configured to pull a filament and a leading end shaped to pierce an object. The frame is configured to support two substantially parallel rollers in a counter-rotatable manner. A first roller is supported by the frame, and the first roller has a flat surface configured to rollably engage the first face of the axis of the spiral needle. A second roller is supported by the frame, and the second roller has a grooved surface defining a spiral groove, and the spiral groove is configured to at least partially receive the second face of the axis. The second roller further defines a correction recess, which is defined by a lateral surface at the front end of the groove, and the correction recess tapers to the width of the groove at the front end of the groove. When the leading end is received in the correction recess in response to the reverse rotation of the first roller and the second roller, at least one of the lateral surfaces engages the leading end and guides the leading end into the front end of the groove. A drive mechanism is fixed to the frame and is configured to counter-rotate the rollers and move the frame along an edge of an object to be sewn by the filament.

[0014] In yet another embodiment, in an exemplary method, a spiral needle is counter-rotatably actuated between a grooved roller and an opposing flat roller. A leading end of the needle is received in a correction recess at a front end of a spiral groove defined by the grooved roller. The leading end of the needle is engaged by at least one lateral surface of the correction recess. The leading end of the needle is guided into the front end of the spiral groove along the at least one lateral surface.

[0015] In yet another embodiment, an apparatus includes at least one guide member configured to extend from a suturing mechanism, wherein the suturing mechanism is configured to rotate a spiral needle about an axis while advancing the needle around an object to be sutured. The guide track is configured to be positioned around the object and guide the suturing mechanism in an articulated path around the object. The guide track defines at least one guide channel configured to receive the guide member. The at least one guide channel is configured to direct movement of the guide member to pivot the suturing mechanism to realign the axis to be tangential to the curved guide track.

[0016] In yet another embodiment, a system includes a spiral needle configured to pull a filament from a trailing end. A suturing mechanism is configured to rotate the needle about an axis while rollingly advancing the suturing mechanism around an object to be sutured and supporting at least one guide member. A guide track is configured to position around an object and guide the suturing mechanism in an articulated path around the object. The guide track defines at least one guide channel configured to receive the guide member. The at least one guide channel is configured to direct movement of the guide member to pivot the suturing mechanism to realign the axis to be tangential to the curved guide track.

[0017] In yet another embodiment, in an exemplary method, a suturing mechanism is rollably advanced around a curved path, the suturing mechanism being configured to rotate a spiral needle around an axis. The needle is rotated so that the leading and trailing ends of the needle pass through a body. The suturing mechanism is guided along an articulated path so that the suturing mechanism pivots at a position around the curved path where the leading and trailing ends of the needle are disengaged from the body to realign the axis to be tangential to the curved path before the leading end of the needle next pierces the body.

[0018] The present disclosure also relates to another device, comprising:

[0019] a frame configured to counter-rotatably support two generally parallel rollers;

[0020] a first roller supported by the frame, the first roller having a planar surface configured to rollingly engage a first face of a shaft of a spiral needle; and

[0021] A second roller supported by the frame, the second roller having a grooved surface defining a spiral groove, the spiral groove being configured to at least partially receive the second face of the shaft, wherein the second roller further defines a correction recess, the correction recess being defined by lateral surfaces at a front end of the groove, the correction recess tapering to a width of the groove at the front end of the groove, and wherein when the leading end is received into the correction recess in response to counter-rotation of the first and second rollers, at least one of the lateral surfaces engages the leading end and guides the leading end into the front end of the groove.

[0022] In one embodiment of the device, at least one of the lateral surfaces of the correction recess is tangentially separated from the edge of the front end of the groove.

[0023] In one embodiment of the device, the correction recess is trapezoidal in shape.

[0024] In one embodiment of the device, the maximum width of the correction recess is sized to receive the leading end of the needle after deflection of the leading end, the deflection being caused by at least one of deflection of the leading end when the needle passes through an external object and deflection of the leading end caused by rotation of the gantry as the needle passes through the external object.

[0025] In one embodiment of the device, a first depth of the groove at the leading end of the groove is shallower than a second depth of the groove toward a trailing edge of the groove.

[0026] In one embodiment of the apparatus, the radius of the spiral needle is smaller than an integer multiple of the radius of the second roller.

[0027] In one embodiment of the apparatus, wherein said radius of said spiral needle is approximately 5% smaller than said integer multiple of said radius of said second roller.

[0028] In one embodiment of the apparatus, the apparatus further comprises a rotating mechanism configured to receive a rotating member imparting a rotating force and apply the rotating force to the rollers to counter-rotate the rollers along parallel rotation axes.

[0029] The present disclosure also relates to another system, comprising:

[0030] a helical needle, wherein the needle comprises a shaft having a trailing end configured to pull a filament and a leading end shaped to pierce a subject;

[0031] A needle drive mechanism, the needle drive mechanism comprising:

[0032] a frame configured to counter-rotatably support two generally parallel rollers;

[0033] a first roller supported by the frame, the first roller having a planar surface configured to rollingly engage a first face of a shaft of a spiral needle; and

[0034] a second roller supported by the frame, the second roller having a grooved surface defining a helical groove, the helical groove being configured to at least partially receive a second face of the shaft, wherein the second roller further defines a correction recess, the correction recess being bounded by lateral surfaces at a front end of the groove, the correction recess tapering to a width of the groove at the front end of the groove, and wherein at least one of the lateral surfaces engages the leading end and guides the leading end into the front end of the groove when the leading end is received into the correction recess in response to counter-rotation of the first and second rollers; and

[0035] A drive mechanism is fixed to the frame and is configured to counter-rotate the rollers and move the frame along an edge of an object to be sewn by the filaments.

[0036] In one embodiment of the system, at least one of the lateral surfaces of the correction recess is tangentially separated from an edge of the front end of the groove.

[0037] In one embodiment of the system, the correction recess is trapezoidal in shape.

[0038] In one embodiment of the system, the maximum width of the correction recess is sized to receive the leading end of the spiral needle after deflection of the leading end caused by at least one of deflection of the leading end when the needle passes through an external object and deflection of the leading end caused by rotation of the gantry as the needle passes through the external object.

[0039] In one embodiment of the system, a first depth of the groove at the leading end of the spiral groove is shallower than a second depth of the groove toward a trailing edge of the groove.

[0040] In one embodiment of the system, the radius of the spiral needle is less than an integer multiple of the radius of the second roller.

[0041] In one embodiment of the system, the radius of the spiral needle is approximately 5% smaller than the integer multiple of the radius of the second roller.

[0042] In one embodiment of the system, said shaft of said needle has a generally rectangular cross-section.

[0043] In one embodiment of the system, wherein the groove has one of a generally rectangular cross-section and a trapezoidal-shaped cross-section, the cross-section is configured to receive the generally rectangular square cross-section of the shaft of the needle.

[0044] The present disclosure also relates to another method comprising:

[0045] a spiral needle counter-rotatably actuated between a grooved roller and an opposing flat roller;

[0046] receiving the leading end of the needle in a correction recess at the front end of the helical groove defined by the grooved roller;

[0047] engaging the leading end of the needle with at least one lateral surface of the correction recess; and

[0048] The leading end of the needle is guided along the at least one lateral surface into the leading end of the helical groove.

[0049] In one embodiment of the method, the method further includes engaging the leading end of the needle within the correction recess after deflection of the leading end, the deflection being caused by at least one of deflection of the leading end when the needle passes through an external object and deflection of the leading end caused by rotation of the gantry as the needle passes through the external object.

[0050] In one embodiment of the method, further comprising selecting the needle to have a radius that is less than an integer multiple of the radius of the grooved roller.

[0051] The present disclosure also relates to yet another device, comprising:

[0052] at least one guide member configured to extend from a suturing mechanism, wherein the suturing mechanism is configured to rotate the helical needle about an axis while advancing the needle around an object to be sutured; and

[0053] A guide rail configured to be positioned about the object and to guide the suturing mechanism in an articulated path about the object, wherein the guide rail defines at least one guide channel configured to receive the guide member, wherein the at least one guide channel is configured to direct movement of the guide member to cause the suturing mechanism to pivot and thereby realign the axis to be tangential to the curved guide rail.

[0054] In one embodiment of the device, wherein the at least one guide channel includes a plurality of ridges formed on at least one side of the at least one guide channel, wherein each of the plurality of ridges is positioned to engage the at least one guide member to pivot the suturing mechanism.

[0055] In one embodiment of the apparatus, wherein the guide rail defines two guide channels, the guide channels include:

[0056] a uniformity guide channel configured to receive a first guide member extending from the suturing mechanism; and

[0057] An articulating guide channel includes the plurality of ridges and is configured to receive a second guide member extending from the suturing mechanism, wherein the articulating guide channel selectively engages the second guide member to pivot the suturing mechanism about the second guide member.

[0058] In one embodiment of the device, wherein:

[0059] The uniform guide channel includes an inner guide path adjacent to the object to be sutured; and

[0060] The articulation guide channel includes an outer guide path surrounding the inner guide path.

[0061] In one embodiment of the device, each of the plurality of ridges is configured to selectively restrict advancement of the second guide member through the articulating guide channel while the first guide member is advanced through the uniform guide channel to allow the suturing mechanism to pivot about the second guide member.

[0062] In one embodiment of the device, each of the plurality of ridges includes a pivot portion and a translation portion, wherein the pivot portion is configured to guide the second guide member to move outward from the object to pivot the suturing mechanism, and the translation portion is configured to direct the second guide member to advance through the articulated guide channel.

[0063] In one embodiment of the device, the guide rail further includes a drive track around the outer edge of the guide rail to receive a rollable drive mechanism, the rollable drive mechanism being configured to rollably advance the suturing mechanism around the curved guide rail.

[0064] In one embodiment of the apparatus, wherein the guide track comprises a geared track configured to receive a geared drive on the suturing mechanism.

[0065] In an embodiment of the apparatus, wherein the guide rail comprises a plurality of track sections, the plurality of track sections are connectable around the object to form a curved track.

[0066] The present disclosure also relates to a system device, the system device comprising:

[0067] a spiral needle configured to pull the filament from the trailing end;

[0068] a suturing mechanism configured to rotate the needle about an axis while rollably advancing the suturing mechanism about an object to be sutured and supporting at least one guide member; and

[0069] A guide rail configured to be positioned about the object and to guide the suturing mechanism in an articulated path about the object, wherein the guide rail defines at least one guide channel configured to receive the guide member, wherein the at least one guide channel is configured to direct movement of the guide member to cause the suturing mechanism to pivot and thereby realign the axis to be tangential to the curved guide rail.

[0070] In one embodiment of the system, the at least one guide channel includes a plurality of ridges formed on at least one side of the at least one guide channel, wherein each of the plurality of ridges is positioned to engage the at least one guide member to pivot the suturing mechanism.

[0071] In one embodiment of the system, wherein the guide rail defines two guide channels, the guide channels include:

[0072] a uniformity guide channel configured to receive a first guide member extending from the suturing mechanism; and

[0073] An articulating guide channel includes the plurality of ridges and is configured to receive a second guide member extending from the suturing mechanism, wherein the articulating guide channel selectively engages the second guide member to pivot the suturing mechanism about the second guide member.

[0074] In one embodiment of the system, wherein:

[0075] The uniform guide channel includes an inner guide path adjacent to the object to be sutured; and

[0076] The articulation guide channel includes an outer guide path surrounding the inner guide path.

[0077] In one embodiment of the system, each of the plurality of ridges is configured to selectively restrict advancement of the second guide member through the articulating guide channel while the first guide member is advanced through the uniform guide channel to allow the suturing mechanism to pivot about the second guide member.

[0078] In one embodiment of the system, each of the plurality of spines includes a pivot portion configured to guide the second guide member to move outward from the object to pivot the suturing mechanism and a translation portion configured to direct the second guide member to advance through the articulating guide channel.

[0079] In one embodiment of the system, the guide rail further includes a drive track around an outer edge of the guide rail to receive a rollable drive mechanism, the rollable drive mechanism being configured to rollably advance the suturing mechanism around the curved guide rail.

[0080] In one embodiment of the system, the guide track includes a geared track configured to receive a geared drive on the suturing mechanism.

[0081] In one embodiment of the system, wherein the guide rail comprises a plurality of track sections, the plurality of track sections are connectable around the object to form a curved track.

[0082] The present disclosure also relates to yet another method, comprising:

[0083] a suturing mechanism that is rollably advanced about a curved path, the suturing mechanism being configured to rotate the helical needle about an axis;

[0084] rotating the needle so that the leading and trailing ends of the needle pass through the body;

[0085] The suturing mechanism is guided along an articulated path so that the suturing mechanism pivots at a position about the curved path at which the leading and trailing ends of the needle disengage from the body to realign the axis to be tangential to the curved path before the leading end of the needle next pierces the body.

[0086] In one embodiment of the method, further comprising pausing said rotation of said needle while pivoting said suturing mechanism at said position about said curved path where said leading end and said trailing end of said needle are disengaged from said body.

[0087] Other features, advantages, and areas of applicability will become apparent from the description provided herein.It should be understood that the detailed description and specific examples are intended for illustrative purposes only and are not intended to limit the scope of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0088] The drawings described herein are for illustrative purposes only and are not intended to limit the scope of the present disclosure in any way. The components in the drawings are not necessarily drawn to scale, but emphasis is placed on illustrating the principles of the disclosed embodiments. In the drawings:

[0089] Figure 1 is a perspective view of an embodiment of an apparatus for suturing an object using a spiral needle;

[0090] Figure 2 yes Figure 1 A perspective view of a device in the form of a partial cross-section;

[0091] Figure 3 and Figure 4 They are Figure 1 A top perspective view and a bottom perspective view of a device positioned for guiding Figure 1 On the drive track of the equipment;

[0092] Figure 5 and Figure 6 yes Figure 1 The equipment is along Figure 3 and Figure 4 Views of the rails at different positions to illustrate the use of Figure 1 The suturing process of the device;

[0093] Figure 7 It has a motor to Figure 1 A perspective view of a system of devices for imparting rotational force;

[0094] Figure 8 is a flow chart of an illustrative method of stitching an object;

[0095] Fig. 9is a perspective view in partial cross-section of another embodiment of an apparatus for suturing an object using a spiral needle;

[0096] Fig.10 is with Fig. 9 A side view of a spiral needle used in conjunction with the device;

[0097] Fig.11 yes Fig.10 Cross-sectional view of the needle;

[0098] Fig.12 yes Fig. 9 Schematic view of the rollers of the device, the rollers engaging Fig.11 of needles;

[0099] Fig.13 yes Fig.12 A schematic view of a roller that engages a needle in a rectangular shaped groove;

[0100] Fig.14 is a schematic view of the side of a groove that impacts and applies a force to the shaft of the needle;

[0101] Fig.15 is a schematic view of a widened groove sized to prevent the sides of the groove from impacting the shaft of the needle;

[0102] Fig.16 is a schematic view of a groove having flared sides to prevent the sides of the groove from impacting the shaft of the needle;

[0103] Fig.17 yes Fig. 9 A schematic illustration of a roller of an apparatus of the type shown in FIG. 1 , which roller engages a needle that is subjected to a lateral force compressing the needle;

[0104] Figures 18 to 20 yes Fig. 9 A schematic illustration of a roller of a device of which the needle is received in a correction recess;

[0105] Figure 21 to Figure 23 is a side view of a needle received by the correction recess and guided into the groove;

[0106] Fig.24 yes Fig. 9 A schematic view of a grooved roller of an apparatus of the invention, wherein the roller adopts correction recesses of other shapes;

[0107] Fig.25 yes Fig. 9 Schematic view of a roller of a device of which the needle is received in another embodiment of the correction recess;

[0108] Fig.26A and Fig.26Bis a schematic axial view of a needle that may miss a correction recess on a grooved roller;

[0109] Fig.27A and Fig.27B is a schematic axial view of a needle having a decreasing helical radius;

[0110] Fig.28A and Fig.28B yes Fig.27A and Fig.27B A schematic illustration of a needle of FIG. 1 that strikes the surface of a grooved roller and is then received in a correction recess;

[0111] Fig.29 is a schematic illustration of a spiral needle pivoting as part of joining two channels during an anastomosis procedure;

[0112] Fig.30 It rotates around a curved orbit Fig. 9 A schematic view of a suturing mechanism;

[0113] Fig.31 is a schematic view of a representative articulated suture path;

[0114] Fig.32 is a top plan view of an exemplary guide rail;

[0115] Figure 33 to Figure 36 When the suture mechanism is around Fig.32 A schematic view of a guide member that pivots the suturing mechanism when the guide rail moves;

[0116] Fig.37 is a flow chart of an illustrative method of stitching an object;

[0117] Fig.38 is a flow chart of another illustrative method of stitching objects; and

[0118] Fig.39 is a flow chart of another illustrative method of stitching objects. DETAILED DESCRIPTION

[0119] It should be noted that the first digit of a three-digit reference number corresponds to the drawing number in which the element first appears.

[0120] The following description explains various embodiments of non-invasive devices, systems, and methods for suturing objects, such as passage junctions joined together in a surgical anastomosis procedure, by way of illustration only and not limitation.

[0121] By way of non-limiting overview and reference is made to Figure 1In various embodiments, the apparatus 100 includes a frame 110. Rollers 120 and 121 are rotatably mounted in the frame 110 in parallel with each other and are configured to engage a shaft 191 of a needle 190 formed in a spiral shape therebetween. The rollers 120 and 121 are configured to rotate in opposite directions. The needle 190 can rotate around the roller 120 in response to the opposite rotation of the rollers 120 and 121. The drive mechanism 150 is fixed to the frame 110 and is configured to move the frame 110.

[0122] Now that an overview has been given, details of various embodiments will be explained only by way of non-limiting examples given by way of illustration and not limitation.

[0123] Still reference Figure 1 In various embodiments, the apparatus 100 may be well suited for suturing channels or other objects together. In such embodiments, the frame 110 is adapted to support rollers 120 and 121. The rollers 120 and 121 are configured to drive the needle 190 to pull the filaments to sew one or more objects ( Figure 1 ). In the example of a CABG procedure, the object may include an end of a donor channel and an opening in a receiving channel, which may be joined together using sutures to complete the anastomosis procedure. In various embodiments, the device 100 is adapted to be compact for insertion into a body cavity, for example, by insertion into the patient's chest cavity via a subxiphoid incision (not shown) made below the patient's sternum. It should be appreciated that insertion of the device 100 through a relatively small incision for suturing may help reduce potential trauma, risks, and prolonged healing processes that may result from performing a median sternotomy (as may be commonly used to perform implantation and suturing of a donor vein in conventional CABG surgery).

[0124] However, it should be understood that the use of the device 100 is not limited to CABG surgery. Given by way of non-limiting example, the device 100 may be used for suturing in other procedures, such as, but not limited to, forming an arteriovenous fistula between a sutured artery and a vein for dialysis, suturing a colostomy formed between the intestine and the skin of the abdominal wall, or for joining the ends of a segment of intestine when a previous intervening portion has been removed. Therefore, it should be understood that such limitations are not intended and should not be inferred.

[0125] In various embodiments, the recesses in the frame 110 receive rollers 120 and 121, as described below with reference to Figure 2 As further described. The recesses in the frame enable rollers 120 and 121 to rotate and be driven by an external source of rotational force. Figure 1 Only roller 120 is exposed in FIG. 1 , but roller 121 may have a structure similar to roller 120, as described below with reference to FIG. Figure 2The roller 120 includes a cylindrical body 122 defining a plurality of grooves 124 that are sized and shaped to engage the shaft 191 of the needle 190. Specifically, the grooves 124 are formed to have a certain width and cross-sectional shape to at least partially receive the shaft 191 of the needle 190. The grooves 124 are also angled to accommodate the pitch of the needle 190. The width and pitch of the grooves 124 are described below with reference to Figure 2 In various embodiments, the cylindrical body 122 of the roller 120 may further define the features of the grooves 124 , while the roller 121 may have a generally smooth surface or a generally textured surface configured to press the needles 190 into the grooves 124 of the roller 120 .

[0126] In various embodiments, drive gears 126 and 127 are configured to engage rollers 120 and 121, respectively. In some embodiments, drive gears 126 and 127 may be coupled to rollers 120 and 121, respectively. In some other embodiments, drive gears 126 and 127 may be integrally formed as a part of rollers 120 and 121, respectively. Drive gears 126 and 127 are staggered so that rotation of roller 120 in a first direction causes roller 121 to reversely rotate in an opposite second direction. Thus, imparting a rotational force to roller 121 causes roller 121 to rotate in a first rotational direction (as indicated by arrow 128) and causes roller 120 to reversely rotate in a second rotational direction (as indicated by arrow 129, which is opposite to the first rotational direction). Rotatable member 130, such as a drive shaft or a drive cable, may be directly mechanically coupled to roller 120 or roller 121 to provide a rotational force to one of rollers 120 and 121 to reversely rotate rollers 120 and 121.

[0127] In various embodiments, the radius of needle 190 is greater than the radius of roller 120 about which needle 190 rotates. Thus, when shaft 191 of needle 190 is engaged between rollers 120 and 121, the axis of needle 190 and the axis of roller 120 are not co-linear. Thus, rotation of needle 190 (caused by counter-rotation of rollers 120 and 121) causes needle 190 to rotate about roller 120. The rotation of needle 190 about roller 120 enables rollers 120 and 121 to drive needle 190, thereby causing needle 190 to repeatedly pierce an object ( Figure 1 not shown).

[0128] In various embodiments, the apparatus 100 may be adapted to follow a drive track ( Figure 1 ), the driving track guide device 100 is along the object to be sutured ( Figure 1140). In such an embodiment, a guide bracket 140 may be disposed on the frame 110. The guide bracket 140 defines an internal guide 142 that is shaped to receive an edge of a drive rail so as to hold the frame 110 to the drive rail. The guide bracket 140 may also be configured to receive a drive mechanism 150 and hold the drive mechanism 150 against the drive rail so that the drive mechanism 150 can actuate the device 100 along the drive rail. The frame 110 may include one or more transverse rollers 146 that are configured to rollably engage the drive rail to hold the frame 110 to the drive rail. The transverse rollers 146 may be mounted on the guide bracket 140 on the frame 110 or adjacent to the guide bracket 140, such as Figure 1 as shown in .

[0129] In various embodiments, the drive mechanism 150 includes a worm gear 152 that is tilted so that rotation of the worm gear 152 moves the device 100 along the drive track. In some embodiments, the worm gear 152 is configured to engage a rotatable drive member 154 that provides a rotational force to the worm gear 152. In some other embodiments, the worm gear 152 may be driven by one or more gears ( Figure 1 120 and 121) engage with the rotatable member 130, or one or more of the rollers 120 and 121 to provide a rotational force to the worm gear 152.

[0130] Additional references Figure 2 In various embodiments, both rollers 120 and 121 include grooves 124 and 225, respectively, to engage the shaft 191 of the needle 190. Figure 2 As shown in FIG. 1 , the grooves 124 and 225 are inclined in opposite directions to gripably and rollably engage the shaft 191 of the needle 190. The width 247 of the grooves 124 and 225 is sized to releasably engage the width 290 of the shaft 191 of the needle 190. The pitch of the grooves 124 and 225 is The pitch θ of the matching needle 190. The corresponding widths 247 and 290 and the corresponding pitch and θ such that when rollers 120 and 121 rotate in opposite directions, rollers 120 and 121 can drive needle 190 to rotate about roller 120. Needle 190 itself includes a leading end 292 that is shaped to pierce one or more objects, such as but not limited to, a needle to be guided by device 100 ( Figure 1 ) The tissue of the edge of the donor channel and the receiving channel sutured together. The needle 190 may also include a tail end 294, which is configured to receive or attach to a filament 299 for suturing the object together.

[0131] Still reference Figure 2, rollers 120 and 121 include cylinders 122 and 223, respectively, rotatably received in the frame 110. At one end, the cylinders 122 and 223 can be rotatably received in a cylindrical opening 214 extending through the frame 110. At the opposite end, each of the cylinders 122 and 223 can be received in a circular recess 212 or cylindrical opening 214. In some embodiments, the cylindrical opening 214 can enable a drive shaft 229 that can be fixedly coupled to the roller 121 to extend through the frame 110. In such embodiments, the drive shaft 229 can thus engage the rotatable member 130, thereby providing a rotational force to the roller 121. The rotational force is also provided to the roller 120 via the staggered drive gears 126 and 127, thereby causing the rollers 120 and 121 to rotate in opposite directions. It should be understood that in some other embodiments, drive shaft 229 may be fixedly coupled to roller 120 such that interleaved drive gears 126 and 127 impart a rotational force to roller 121 , thereby causing rollers 120 and 121 to rotate in opposite directions.

[0132] In various embodiments, the rotatable member 130 can be mechanically coupled to the drive shaft 229 by a coupling 232 that can be secured and removed by an attachment device 234 (such as, but not limited to, an embedded screw). The rotatable member 130 can be driven by a motor ( Figure 2 The cylindrical opening 214 and / or the circular recess 212 may include a bushing ( Figure 2 ), to reduce friction and / or vibration between the rollers 120 and 121 and the frame 110 and / or between the drive shaft 229 and the frame 110.

[0133] Additional references Figure 3 In various embodiments, the drive track 300 is used to guide the device around the object to be sutured ( Figure 3 not shown). Figure 3 A donor channel 360 is shown having a distal edge 361 that will be joined to a receiving channel ( Figure 3304). The drive track 300 may include separate sections 302 and 303 that may be positioned around an object, such as a donor channel 360, and then mechanically coupled at a joint 304. The drive track 300 supports teeth 306 that are shaped and sized to be engaged by the worm gear 152. In various embodiments, the rotational force imparted by the rotating drive member 154 drives the worm gear 152, thereby causing the worm gear 152 to translate the device 100 along the guide rail 300. The interaction of the worm gear 152 and the drive track 300 thus causes the device 100 to translate along an edge of the object, such as the distal end 361 of the donor channel 360. In various embodiments, the drive track 300 includes an internal channel 308 defined along the object that causes the needle ( Figure 3 ) can extend from the device 100 to the object and through the object.

[0134] Additional references Figure 4 , the guide bracket 140 of the frame 110 guides the device 100 along the drive track 300. The receiving channel 362 defines an opening 363 below the drive track 300. The guide bracket 140 engages the drive track 300, and the drive track 300 is received in the internal guide 142 defined by the guide bracket 140. As previously described, the guide bracket 140 holds the worm gear 152 against the teeth 306 of the drive track 300. Therefore, when the needle 190 passes through the channel 308 in the drive track 300 to sew an object, the rotational force imparted to the worm gear 152 by the rotating drive member 154 causes the worm gear 152 to move the device 100 around the drive track.

[0135] Additional references Figure 5 and Figure 6 When the needle 190 is rotated to sew an object, the device 100 moves around the drive track 300. Figure 5 As shown in FIG. 1 , the device 100 is located at a first point 500 along the drive track 300 and the needle 190 extends through a first channel 501 in the drive track 300. Figure 6 , the rotation of the worm gear 152 has caused the device 100 to move along the guide track 300 to the second point 600, while the needle 190 has been rotated. Therefore, the needle 190 now extends through the second channel 603 in the drive track 300. As the needle 190 rotates through the object, the movement of the device 100 around the guide track 300 thereby suturing the object (in this non-limiting example, the object is the junction of the donor channel 360 and the receiving channel 362).

[0136] It should be understood that Figures 3 to 6As shown in , the drive track 300 is suitably a circular track configured to guide the device 100 around an object to sew the object, for example to join passages together. However, it should be understood that a linear drive track can be used to form a linear suture, for example to close a wound or incision. Therefore, it should be understood that the disclosed embodiments are not intended to be limited to any particular shape or size of drive track 300, and such limitation should not be inferred.

[0137] Additional references Figure 7 And in various embodiments, in the exemplary system 700, the drive track 300 is positioned around one or more objects to be sutured. The motor 780 provides a rotational force to cause the rollers 120 and 121 ( Figure 7 121 and the worm gear 152 of the drive mechanism 150. The motor 780 may include a gear box 782 so that, as desired, a single motor 780 can provide rotational forces of different speeds to the rotating member 130 coupled to the rollers 120 and 121 and the rotating drive member 154 coupled to the worm gear 152 of the drive mechanism 150. The system 700 may include drive links 784 and 786 to connect with the rotating member 130 and the rotating drive member 154. The drive links 784 and 786 may include flexible drive cables to provide rotational forces while accommodating the movement and positioning of the device 100.

[0138] In various embodiments and as Figure 7 , a gearbox 782 may be positioned at or adjacent to the motor 780, with a plurality of drive links 784 and 786 extending to the rollers 120 and 121 and the drive mechanism 150. In some other embodiments, the gearbox 782 may be positioned at the apparatus 100 so that a rotational force imparted to one of the rollers 120 and 121 may be mechanically transmitted to the drive mechanism 150, or vice versa. Thus, with only a single link extending from the motor 780 to the apparatus, in such embodiments, a rotational force may be provided to both the rollers 120 and 121 and the drive mechanism 150.

[0139] Additional references Figure 8, in various embodiments, an exemplary method 800 for suturing an object (such as in anastomosis) is provided. Method 800 starts at frame 805. At frame 810, the opposite sides of the axis of the needle are engaged between the parallel surfaces of the first roller and the second roller, wherein the needle is formed into a spiral shape and is configured to pull the filament from its tail end. At frame 820, the first roller and the second roller are rotated in the opposite direction so that the spiral needle rotates around the first roller positioned adjacent to the object. The opposite rotation of the first roller and the second roller causes the leading end of the needle to pierce the object adjacent to the outside of the first roller. At frame 830, the first roller and the second roller are translated along the edge of the object. The first roller and the second roller are rotated in the opposite direction and the first roller and the second roller are translated so that the needle pulls the filament to sew the edge of the object adjacent to the outside of the first roller. When the object is sutured, method 800 ends at frame 835.

[0140] Reference again Figure 2 In various embodiments, both rollers 120 and 121 include grooves 124 and 225, respectively, to engage the shaft 191 of the needle 190. In contrast, in other embodiments, only one roller may include grooves to engage the shaft 191 of the needle 190.

[0141] refer to Fig. 9 , the device 900 includes a plurality of reference Figure 2 The device 100 has the same components and operates in the same manner, with one exception. In the device 900, the roller 921 includes a groove 925 that wraps around the surface of the roller 121 to engage one side of the shaft 991 of the needle 990. Figure 2 As with the device 100, the pitch of the grooves 925 is angled to correspond to the pitch of the needles 990, as further described below. Figure 2 Compared to the device 100 , the surface 928 of the opposing roller 920 does not include or define a groove for receiving the needle 990 .

[0142] As in Figure 2 In the device 100, the shaft 991 of the needle 990 is again frictionally engaged on opposite sides by rollers 920 and 921. In contrast, in Figure 2 In the device 100, the shaft 191 of the needle 190 is engaged on both sides by the grooves 124 and 225 of the rollers 120 and 121, respectively. Fig. 9 In the device 900, the shaft 991 of the needle 990 is frictionally engaged by the surface 928 of the roller 920 on one side and frictionally engaged by the groove 925 of the roller 921 on the opposite side. Figure 2 As with the device 100, when rollers 921 and 920 rotate in opposite directions, frictional engagement of rollers 921 and 920 with opposite sides of shaft 991 of needle 990 causes needle 990 to rotate. Figure 2In the device 100 , rotation of the needle 990 causes the leading end 992 of the needle 990 to pierce the object to be sutured by the filament 299 , which is pulled by the trailing end 994 of the needle 990 .

[0143] As previously referenced Figure 2 As described above, the pitch of the groove 925 The pitch θ of the needle 990 is matched so that the needle 990 fits within the groove 921. It should be understood that the radius of the needle 990 around its axis is greater than the radius of the roller 921 around its axis, and as Fig. 9 As shown in FIG. 1 , roller 921 does not engage needle 990 in every turn of groove 925 at one time, and roller 921 may rotate multiple times for each rotation of needle 990. Thus, although the pitch of groove 925 is corresponds to the pitch θ of the needle 990 so as to receive the needle 990 when the needle 990 rotates back into the groove 925, but it should be understood that this does not mean that the pitch of the groove 925 Equal to the pitch θ of needle 990.

[0144] refer to Fig.10 , the spiral needle 990 has an axis 1001, when the rollers 920 and 921 ( Fig. 9 ) is actuated, the spiral needle rotates around the axis. Fig.12 As shown in Figure 2 For the device 100 of the present invention, the axis 1001 is not coaxially located with the axis of either of the rollers 920 and 921. Instead, the axis 1001 is parallel to the axes of the rollers 920 and 921, thereby enabling the needle 990 to be rotated by the rollers 920 and 921 while rotating about its own axis 1001 to engage the body to be sutured on the side of the needle 990 opposite to where the needle is engaged by the rollers 920 and 921 ( Fig. 9 ). In various embodiments, the shaft 991 of the needle 990 can have a rectangular or square cross-section, as further described below.

[0145] refer to Fig.11 , along Fig.10 In a cross-section of the shaft 991 of the needle 990 taken along the axis 10-10 of FIG. 1 , the shaft 991 of the needle 990 has opposing flat surfaces 1102 and 1104 defining opposing sides of a generally rectangular or square cross-section 1100. The opposing flat surfaces 1102 and 1104 may be engaged on one side within the groove 925 of the roller 921 and on the other side by the surface 928 of the roller 920.

[0146] refer to Fig.12, the shaft 991 of the needle 990 is received in the rectangular groove 925 of the roller 921. The rectangular groove 925 is defined by a generally flat bottom 1212, which is defined by generally flat sides 1216, which each extend to an opening 1214 at the grooved surface 1220 of the roller 921.

[0147] refer to Fig.13 , the shaft 991 of the needle 990 is received within the groove 925 in the roller 921. The shaft 991 of the needle 990 is received through the opening 1212 of the groove 925 of the roller 921. The flat surface 1102 on one side of the shaft 991 of the needle 990 is engaged by the generally flat bottom 1212 of the groove 925 between the generally flat sides 1216 of the groove 925. The surface 928 of the opposing roller 920 engages the opposite side of the shaft 991 of the needle 990 and presses the shaft 991 of the needle 990 into the groove 925 so that the shaft 991 of the needle 990 is frictionally engaged on both sides.

[0148] In various embodiments, the bottom 1212 of the groove 925 has a width W that is sized to be greater than the width of the flat surface 1102 on the side of the shaft 991. Because the needle 990 is spiral, the shaft 991 is angled away from the flat surface 1102 on the edge of the needle 990. The width W being greater than the width of the flat surface 1102 allows the spiral needle 990 to be received within the groove 925 without the side 1216 of the groove 925 impacting the side 993 of the shaft 991 of the needle 990.

[0149] refer to Fig.14 , without the groove 925 having a width W wider than the flat surface 1102 on the edge of the needle 990, the side 1216 of the groove 925 that strikes the side 993 of the shaft 991 of the needle 990 may cause the needle 990 to deform undesirably. o is equal to or only slightly larger than the flat surface 1102 on the edge of the needle 990, then when the needle 990 is moved by the opposing roller 920 ( Fig.14 When the needle 990 is pressed into the groove (not shown), the side 1216 of the groove 925 will apply a force 1401 to the side 993 of the shaft 991 of the needle 990. The force 1401 can compress the needle along the axis 1001 of the spiral needle 990, causing the realignment 1491 of the needle 990 to twist to match the groove 925. The compression of the needle 990 can cause the groove 925 and the needle 990 to be pitched relative to each other. and θ, respectively, no longer match, thereby impeding the ability of groove 925 to guide needle 990, or causing other undesirable effects.

[0150] refer to Fig.15, with the groove 925 having a width W, the shaft 991 of the needle 990 fits within the groove 925 without the sides 1216 of the groove 925 impacting the sides 993 of the shaft 991 of the needle 990. Thus, the widened width W of the groove 925 avoids undesirable effects, such as compression of the needle 990 along its axis 1001. In various embodiments, the shaft 991 of the needle 990 is properly accommodated within the groove 925 using a groove width W that is 20% greater than the width of the flat surface 1102 of the needle 990 on each side without the sides 1216 impacting the shaft 991 of the needle 990.

[0151] refer to Fig.16 , various embodiments of the grooved roller 1621 may include a groove 1625 having two flared sides 1650 to accommodate the shaft 991 of the needle 990. Thus, as Fig.16 As shown in FIG. , the groove 1625 has a generally trapezoidal cross-section, as previously described with reference to FIG. Figures 13 to 15 As described above, it is desirable to have a groove 925 with a width W to accommodate the shaft 991 of the needle 990 because the spiral shape of the needle 990 causes the shaft 991 of the needle to be angled toward (or angled into) the side 1216 of the groove 925. Because the shaft 991 of the needle 990 is angled away from the flat surface 1102 along the edge of the needle 990, the width W is used to accommodate the side 993 of the shaft 991 of the needle 990. Therefore, as Fig.16 , the bottom 1612 of the groove 1625 may be smaller than W, but the sides 1650 of the groove 1625 expand from the bottom 1612 of the groove 1625 to a width W at the opening 1614 at the surface 1620 of the grooved roller 1621. The expanded sides 1650 accommodate the shaft 990 of the needle 990 without impacting the shaft 991 to avoid applying a force to the needle 990 that can deform the needle 990, as previously described.

[0152] refer to Fig.17 , when the leading end 992 leaves the body being sutured ( Fig.17 The force 1702 on the needle 990 may also cause the leading end 992 of the needle 991 to miss the groove 225 when the needle 990 is rotated back toward the grooved roller 121. Instead of rotating into the groove 225, the leading end 992 of the needle 990 impacts the surface 1704 of the roller 121 outside of the groove 225. It should be understood that the force 1702 may act in either direction, thereby potentially causing the leading end 992 of the needle 990 to miss the groove 225 on either side.

[0153] refer to Fig.18, the correction recess 1810 can be located at the front end 1812 of the groove 1825 of the grooved roller 1821. The correction recess 1810 can be defined by the expanded lateral surfaces 1830 and 1831, which, as described below, will act as a funnel or guide to direct the leading end 992 of the needle 990 back into the groove 1825. The lateral sides 1830 and 1831 define a widened area to receive the leading end 992 of the needle 991. Therefore, the force 1702 does not act on the needle 990 (which would cause the leading end 992 of the needle 990 to miss the groove 1825 and impact the surface 1704 of the roller 121). Instead, the leading end 992 of the needle is received within the correction recess 1810. Then, as described below, reverse rotation of rollers 1821 and 920 will rotate correction recess 1810 relative to leading end 992 of needle 990 to guide needle 990 back into groove 1825 .

[0154] refer to Fig.19 , when rollers 1821 and 920 rotate in opposite directions, with grooved roller 1821 rotating in direction 1920, correction recess 1810 rotates toward opposite roller 920. Movement of correction recess 1810 causes lateral surface 1830 of correction recess 1810 to impact leading end 992 of needle 990. Lateral surface 1830 moves leading end 992 of needle 990 in direction 1940 to guide leading end 992 toward front end 1812 of groove 1825.

[0155] refer to Fig. 20 As grooved roller 1821 rotates further in direction 1920, leading end 992 of the needle is guided into front end 1812 of groove 1825. Correction recess ( Fig. 20 ) will be repeatedly rotated into position upon subsequent rotation of needle 990 after additional sutures are formed to receive leading end 992 of needle 990.

[0156] Still refer to Fig. 20 In various embodiments, the groove 1825 may have a reduced depth d1 at or near the front end 1812 of the groove 1825 as compared to the regular depth d2 of the remaining portion 2050 of the groove 1825. The reduced depth d1 at the front end 1812 may result in a reduced gap between the groove 1825 and the opposing roller 920 at the front end 1812. Such a reduced gap may result in the opposing roller 920 applying a higher pressure against the needle 990 at the front end 1812 of the groove 1825. The reduced depth d1 (and the resulting higher pressure) enables the rollers 920 and 1821 to firmly grip the needle 990 as it begins its next rotation after the needle 990 has been redirected into the groove 825 by the correction recess 1810.

[0157] refer to Figure 21 to Figure 23, the leading end 992 of the needle is directed by the lateral surface 1830 of the correction recess 1810 into the front end 1812 of the groove 1825 of the grooved roller 1821. Fig.21 , the leading end 992 of the needle 990 is received into the correction recess 1810, which is located between the lateral surfaces 1830 and 1831 that define the sides of the correction recess 1810. As previously described with reference Fig.18 As described above, the leading end 992 of the needle 990 will fall outside the groove 1825, the side of which is Figure 21 to Figure 23 Indicated by dotted line.

[0158] refer to Fig. 22 , when there is grooved roller 1821 as reference Fig.19 During the rotation, the lateral surface 1830 of the correction recess 1810 engages the leading end 992 of the needle 990. It should be understood that when the grooved roller 1821 is as shown in reference Fig.19 During such rotation, the correction recess 1810 becomes narrower between the lateral surfaces 1830 and 1831. Fig.23 , when there is grooved roller 1821 as reference Fig. 20 When the further rotation is performed, the correction recess 1810 ( Fig. 20 The lateral surfaces 1830 and 1831 (not shown) merge into the front end 1812 of the groove 1825. Therefore, the correction recess 1810 receives the leading end 992 of the needle 990 at a position outside the groove 1825 and guides the leading end 992 of the needle 990 into the groove 1825.

[0159] refer to Fig.24 and Fig.25 The grooved roller may include a correction recess having a shape different from the reference recess. Figures 17 to 23 The shape described. Fig.24 For example, the grooved roller 2421 may include a correction recess 2410 that is widened on only one side. For example, it may be expected that the only force acting on the needle 990 will cause the needle 990 to deflect in the direction 2502. Therefore, the correction recess 2410 may include one lateral surface 2431 extending straight from the front end 2412 of the groove 2425 and one expanded lateral surface 2430 to accommodate deflection of the leading end 992 of the needle 990 in the direction 2402. The single expanded lateral surface 2430 should accommodate any expected deflection of the leading end 992 of the needle 990.

[0160] It should be understood that the lateral surface of the correction recess is not limited to a straight flared shape. Fig.25For example, the correction recess 2510 may include one or more curved or otherwise non-straight surfaces 2530 and 2531 to engage the leading end 992 of the needle 990. The curved lateral surfaces 2530 and 2531 may also be used to impact the leading end 992 of the needle 990 to guide the leading end 992 into the front end 2512 of the groove 2525. The lateral surfaces of the correction recess are not limited to any particular geometry.

[0161] refer to Fig.26A and Fig.26B Based on forces that may affect the movement of the spiral needle 990, such as resistance encountered by the needle 990 or sliding of the needle 990 between the rollers 920 and 1821, the leading end 992 of the needle 990 may miss the correction recess 1810 when the leading end 992 rotates toward the correction recess 1810.

[0162] refer to Fig.26A , depicts a portion of needle 990 as it rotates around roller 920. It should be understood that Fig.26A , Fig.26B and Fig.27A An axial view of the needle 990 in FIG. Fig.27A and Fig.27B The axial view of needle 2790 in FIG. 1 shows a projection of needles 990 and 2790 that describes less than a complete arc of a circle about its axis. However, in practice, needles 990 and 2790 actually describe more than a complete arc of a circle about their axis so that rollers 920 and 1821 can engage the shafts of needles 990 and 2790 when needles 990 and 2790 are fully rotated about their axes to form sutures.

[0163] Needles 990 and 2790 describe more than a complete arc about their axis to partially illustrate the narrowed, pointed leading ends 992 and 2792 of needles 990 and 2790, respectively, which may be too narrow to be engaged by rollers 920 and 1821. Similarly, the trailing ends of needles 990 and 2790 (where needles 990 and 2790 may be narrowed or tapered to engage the suture they pull for forming a suture) FIG. 26A to FIG. 27B The filaments (not shown) may be too narrow to be engaged by rollers 920 and 1821. Therefore, needles 990 and 2790 describe more than a complete arc around their axis to allow for ends that may not be engaged by rollers 920 and 1821. In any case, FIG. 26A to FIG. 27B Needles 990 and 2790 in the drawings are represented as not depicting a complete arc about their axis so as to be able to show the position of the leading end 992 or 2792 of needle 990 or 2790, respectively, without the position of the leading end 992 or 2792 being potentially obscured by overlapping portions of needle 990 or 2790.

[0164] Continue to refer Fig.26A, when the needle 990 rotates in the direction 2601 due to the reverse rotation of the rollers 920 and 1821, the leading end 992 of the needle 990 approaches the correction recess 1810 formed in the surface of the grooved roller 1821. Fig.26B , when some of the forces described have hindered the movement of the needle 990, the grooved roller 1821 may have rotated so that the correction recess 1810 has rotated so that the leading end 992 of the needle 990 is not received by the correction recess 1810. Generally speaking, the radius R of the spiral needle 990 will be an integer multiple of the radius r of the grooved roller so that the movement of the correction recess 1810 is synchronized with the rotation of the needle 990 to receive the leading end 992 of the needle 990. In other words, the ratio between the radius R of the needle 990 (or the diameter of the needle) and the radius r of the roller 1810 (or the diameter of the needle 990) will be an integer greater than or equal to 2. However, the force acting on the needle 990 may impair the rotational synchronization of the needle 990 and the grooved roller 1810, indicating that the radius R of the needle 990 may be less than an integer multiple of the radius r of the roller 1810 (or the ratio of R to r should be less than 2 or another integer ratio of R to r).

[0165] refer to Fig.27A and Fig.28B , reducing the radius of the spiral needle 990 can compensate for the forces that may hinder the needle rotation to avoid synchronization problems with the grooved roller 1810. Fig.27A The radius R' of spiral needle 2790 is greater than that of needle 990 (for comparison with needle 2790, Fig.27A The radius R of the grooved roller 1810 is about 5% smaller than that of the needle 990 (shown in dashed form in FIG. 1 ). Thus, compared to the needle 990 having a radius R that is twice the radius r of the grooved roller 1810, the radius R' of the needle is about 1.9R or 5% smaller than R. With a shortened radius R', compared to the needle 990 having a radius R Fig.26A In contrast, leading end 2792 of needle 2790 is closer to grooved roller 1821 than leading end 992 of needle 990 at this point in the rotation of needle 2790. Fig.27B , when needle 2790 is rotated in direction 2701 , leading end 2792 of needle 2790 is received in correction recess 1810 .

[0166] refer to Fig.28A and Fig.28B, the leading end 2792 of the needle 2790 may reach the surface 2804 of the grooved roller 1821 before the correction recess 1810 has been rotated into position to receive the leading end 2792 of the needle 2790. Since the radius R' of the needle 2790 is less than an integer multiple of the radius r of the grooved roller 1810, as previously described, the needle 2790 may complete the rotation before the grooved roller having a radius r (which in this example is less than half the radius of the needle 2790) completes two rotations. Therefore, it is possible that the leading end 2792 of the needle 2790 may reach the surface 2804 of the grooved roller 1821 before the correction recess 1810 is in position to receive the leading end 2792 of the needle 2790. Reference Fig.28A , the leading end 2792 of the needle 2790 can therefore impact the surface 2804 of the grooved roller 1821 outside the correction recess 1810.

[0167] However, reference Fig.28B , as the grooved roller 1821 continues to rotate in the direction 2801 that is counter-rotating to the roller 920, the correction recess 1810 rotates under the leading end 2792 of the needle 2790. Therefore, even if the leading end 2792 of the needle 2790 having a radius R' should be in position to engage the correction recess 1810 before the correction recess 1810 is in position to receive the leading end 2792, the leading end 2792 will slide along the surface 2804 of the grooved roller 1821 until it can slide into the correction recess 1810.

[0168] Even though the leading end 2792 should reach the gap 2825 between the surface 2804 of the grooved roller 1821 and the surface 2821 of the opposing roller 920 before the leading end 2792 is received in the correction recess 1810, the needle 2790 cannot slide into the gap 2825 between the rollers 1821 and 920. It should be recalled and understood that the spiral needle 990 or 2790 is sized to fit between the rollers 920 and 1821 only when received in the groove 2425 of the grooved roller 1821. Therefore, the needle 2790 is too wide to fit into the gap 2825. Therefore, the leading end 2792 of the needle 2790 will slide along the surface 2804 of the grooved roller 1821 until the correction recess 2810 rotates under the leading end 2792 of the needle 2790. At this point, the leading end 2792 of the needle 2790 will be captured by the correction recess 1810 and guided into the channel 2425, as previously described with reference to Figures 18 to 25 described.

[0169] refer to Fig.29, the spiral needle 2910 moves around the anastomotic joint 2920 formed between the donor channel 2922 and the receiving channel 2924. It should be understood that as the needle 2910 moves around the joint 2920, the needle 2910 pivots to place the needle 2910 in position to suture the channels 2922 and 2924 to be joined as the needle 2910 rotates about its axis. (The suture pulled by the needle 2910 in a continuous strand along the path of the needle 2910 is not in the Fig.29 ) Specifically, the needle 2910 is pivoted so that its axis is generally tangential to the joint so that rotation of the needle 2910 causes the leading and trailing ends of the needle to pass through channels 2922 and 2924.

[0170] It should also be appreciated that in the first position 2930, the needle 2910 pierces the receiving channel 2924 at two points 2932 and 2934, and pierces the donor channel 2922 at a single point 2938. Because the needle 2910 pierces the tissue of the receiving channel 2924 at two points 2932 and 2934, attempting to pivot the needle 2910 in the first position 2930 would involve deforming and / or stretching the tissue of the receiving channel 2924, thereby potentially tearing the tissue of the receiving channel and / or deforming the needle 2910. In contrast, in the second position 2940, the needle 2910 is pivoted such that the needle 2910 pierces the tissue of the receiving channel 2924 at a single point 2942, and pierces the donor channel 2922 at a single point 2948. Because the needle 2910 pierces the tissue of each of the receiving channel 2924 and the donor channel 2922 at one point 2942 and 2948, respectively, pivoting the needle 2910 at the second position 2940 reduces or avoids deforming or stretching the tissue of the receiving channel 2924, tearing the tissue of the receiving channel, and / or deforming the needle 2910. Therefore, it is desirable to pivot the needle 2910 at a position where the needle 2910 pierces the tissue at a minimum number of points, preferably only one point.

[0171] refer to Fig.30 , system 3000 includes a method similar to that previously referenced Figure 1 The suturing mechanism 3010 described above. The suturing mechanism 3010 moves around the guide rail 3050, as previously described with reference to Figures 4 to 7 As previously described, the suturing mechanism 3010 drives the spiral needle 2910 through the tissue ( Fig.30 The guide rail 3020 defines an opening 3052 which will be located in the channel to be joined ( Fig.30 The guide rail 3020 may also include outwardly facing teeth or notches that will be driven by the drive mechanism (not shown) of the suturing mechanism 3010. Fig.303050 is formed by sections 3061 and 3063 that can be joined at a joint 3065 so that the guide rail 3010 can be located in a donor channel (such as Fig.29 ) around and / or removed from around the donor channel.

[0172] The suturing mechanism 3010 is depicted in three different positions 3020, 3030, and 3040, wherein the suturing mechanism moves and / or pivots about a guide rail 3050 to form a suture. In the first position 3020, the suturing mechanism 3010 is stationary and the needle 2910 pierces the tissue at a single point 3022 ( Fig.30 As shown in the reference Fig.29 As described above, this is the case where the suturing mechanism 3010 can pivot to reduce or avoid deformation or tearing of the tissue and / or deformation of the needle 2910. At the second position 3030, the suturing mechanism 3010 moves in direction 3031 and the needle 2910 pierces the tissue at a single point 3032 ( Fig.30 Because the suturing mechanism 3010 moves in the direction 3031, there may be a force 3034 between the needle 2910 and the tissue, which may deform the tissue and / or the needle 2910. At the third position 3040, the suturing mechanism 3010 moves in the direction 3031 and the needle 2910 pierces the tissue at a single point 3032 ( Fig.30 3041). The movement of the suturing mechanism 3010 moving in direction 3041 generates forces 3044 and 3048 between the needle 2910 and the tissue at points 3042 and 3046, respectively, where the needle pierces the tissue. Multiple non-parallel forces 3044 and 3048 can cause significant deformation of the tissue and / or needle 2910. Therefore, it should be understood that it is desirable to pivot the suturing mechanism 3010 when the suturing mechanism 3010 is stationary or at least when the needle 2910 pierces the tissue at only a single point to reduce the forces that can deform the tissue or the needle. Forming a guide 3050 to facilitate selective pivoting can facilitate this process.

[0173] refer to Fig.31 , a guide rail can be formed by determining the hinge path 3100 ( Fig.31 In various embodiments, the articulated path 3100 includes a path 3110 surrounding the object to be sutured. In various embodiments, the path 3110 includes a suturing mechanism ( Fig.31 3100) will pivot. These points 3120 may include locations spaced a certain distance apart around the path 3110, where, for example, the needle ( Fig.31 (not shown) pierces the tissue only at a single location. Fig.30As described above, it is desirable to minimize movement around the perimeter of the guide rail when pivoting the suturing mechanism, as described with reference to positions 2720, 2730, and 2740 and movements 2731 and 2741. Thus, the guide rail is planned by starting at the point 3120 where the suturing mechanism is to be pivoted, and then being directed along the segment 3130 between the points 3120. In practice, it may be desirable to use a stepper motor to rotate the needle ( Fig.31 3120) to form a suture, pause suturing, and then move the suturing mechanism to the next point 3120. The guide rail can be shaped to pivot the suturing mechanism at point 3120 and direct the suturing mechanism to the next point, as further described below.

[0174] refer to Fig.32 , the guide rail 3200 defines an articulated guide channel 3210. The articulated guide channel 3210 is configured to receive and engage a suture mechanism ( Fig.32 The first guide member 3250 may be fixedly extended directly from the suturing mechanism, or may be extended from a base (not shown) that is fixedly connected to the first guide member 3250 and can be connected to the suturing mechanism. Fig.32 The orientation of the suturing mechanism and / or the base is determined by Figure 32 to Figure 35 Object 3260 in is represented.

[0175] The articulated guide channel 3210 includes a plurality of ridges 3220 around the periphery of the guide rail 3200. The ridges 3220 are responsive to movement of the guide rail 3200 by the drive mechanism ( Fig.32 The guide member 3250 is alternately directed to move laterally and radially along the guide rail 3200 by imparting a tangential movement 3256 along the outer edge 3254 of the object 3260 (not shown), thereby actuating the object 3260 around the guide rail 3200.

[0176] In addition, the guide rail 3200 may also include a uniform guide channel 3280 configured to receive and engage a second guide member 3290. The second guide member 3290 may be fixedly extended directly from the suturing mechanism, or may be fixedly coupled to the second guide member 3250 and coupled to the suturing mechanism. Fig.32 The second guide member 3290 moves in an elliptical or other path around the object to be sutured. As further described below, the relative movement of the guide members 3250 and 3280 in their respective channels causes the object 3260 to translate and rotate to achieve the articulation path 3100 ( Fig.31 ) This movement along the articulated path 3100 allows a suturing mechanism (not shown) to form a suture at one point, pivot, move to the next point, and repeat the process until the joint is sutured around its perimeter.

[0177] The engagement of guide members 3250 and 3290 with respective guide channels 3210 and 3280 directs the pivoting and movement of object 3260 with tangential movement 3256 imparted by the drive mechanism along outer edge 3254 of object 3260. Figure 33 to Figure 36 As further described, the pivoting portion 3230 of the spine 3220 causes the object 3260 to pivot and the translating portion 3240 of the spine 3220 causes the object 3260 to move radially between the pivot points.

[0178] As the first guide member 3250 moves along one of the pivot portions 3230 of the spine 3220, the first guide member 3250 simultaneously moves radially along the articulated guide channel 3210 and outwardly from the center of the guide rail 3200. Because the first guide member 3250 moves partially outwardly along the pivot portion 3230 while it moves radially, the second guide member 3290 (which is rigidly connected to the first guide member 3250) is generally prevented from moving through the uniform guide channel 3280. Thus, as the first guide member 3250 moves along one of the pivot portions 3230 of the spine 3220, the object 3260 pivots about the generally stationary second guide member 3290.

[0179] In contrast, when the first guide member 3250 moves along one of the translational portions 3240 of the spine 3220, the first guide member 3250 does not move or moves only slightly radially along the articulated guide channel 3210 while moving inwardly toward the center of the guide rail 3200. Because the first guide member 3250 moves partially inwardly along the translational portion 3240, the object 3260 pivots about the first guide member 3250 as the second guide member 3290 advances through the uniform guide channel 3280. Thus, when the first guide member 3250 moves along one of the translational portions 3240 of the spine 3220, the object 3260 moves radially about the guide rail 3200. Thus, the alternating pivoting and translating of the object 3260 (which is or is coupled to a suturing mechanism) guides the suturing of the object while reducing deformation of the tissue or needle (neither of which is present in the present invention). Fig.32 ) Fig.31 The articulation path 3100.

[0180] refer to Figure 33 to Figure 36 , the engagement of guide members 3250 and 3290 with guide channels 3210 and 3280 provides ridge 3220 ( Fig.32 ) An example of how to direct the pivoting and translation of object 3260 about a guide rail. Figure 33 to Figure 36 In each of the figures, the tangential movement 3256 is driven by a drive mechanism ( Figure 33 to Figure 36 ) is applied to the object 3260, as previously referenced Fig.32 described.

[0181] refer to Fig.33 , the first guide member 3250 engages a ridge 3220 ( Fig.32 ). As the tangential movement 3256 is applied to the object 3260, while the first guide member 3250 is blocked from radial movement and directed inward by the first translation portion 3301, the second guide member 3290 pivots about the first guide member 3250 and moves through the uniform guide channel 3280 along the segment 3303. Thus, the object 3260 translates around the guide rail to the next pivot point.

[0182] refer to Fig.34 , the first guide member 3250 engages a ridge 3220 ( Fig.32 ). As the tangential movement 3256 is applied to the object 3260 while the first guide member 3250 is directed slightly outward and radially along the first pivot portion 3401, the second guide member 3290 is prevented from moving forward through the uniform guide channel 3280 and the object 3260 rotates through the arc 3405. The object 3260 thus pivots about the second guide member 3200.

[0183] refer to Fig.35 , the first guide member 3250 engages a ridge 3220 ( Fig.32 ). As the tangential movement 3256 is applied to the object 3260, while the first guide member 3250 is again blocked from radial movement and again directed inward by the first translational portion 3501, the second guide member 3290 pivots about the first guide member 3250 and moves through the uniform guide channel 3280 along the segment 3503. Thus, the object 3260 translates about the guide rail to the next pivot point.

[0184] refer to Fig.36 , the first guide member 3250 engages a ridge 3220 ( Fig.29 ). As the tangential movement 3256 is applied to the object 3260, while the first guide member 3250 is again directed slightly outward and radially along the first pivot portion 3601, the second guide member 3290 is again prevented from moving forward through the uniform guide channel 3280 and the object 3260 rotates through the arc 3605. The object 3260 is thus again pivoted about the second guide member 3290. The process is repeated as the first guide member 3250 successively engages each of the alternating translational portions 23240 and pivotal portions 3230 of the spine 3220 along the articulating guide channel 3210.

[0185] refer to Fig.37In various embodiments, an exemplary method 3700 is provided for suturing an object (such as in an anastomosis) using a grooved roller having a groove with at least one flared side. The method 3700 begins at box 3705. At box 3710, opposing faces of an axis of a spiral needle are engaged between a first roller and a second roller parallel to the first roller. The first roller includes a flat surface that engages a first face of the axis, and the second roller includes a grooved surface that defines a groove that at least partially receives a second face of the axis within the groove. As described in reference Fig.15 and Fig.16 The bottom of the groove has a bottom width at least as wide as the second face and is defined by the side of the groove opening extending to the grooved surface, which has a surface width wider than the second face. At frame 3720, the first roller and the second roller are rotated in the opposite direction. At frame 3730, the needle rotates around the first roller in response to the reverse rotation of the first roller and the second roller. At frame 3740, the leading end of the needle is pierced through the object in response to the reverse rotation of the first roller and the second roller. At frame 3750, the needle returns between the two first rollers and the second rollers in response to the reverse rotation of the first roller and the second roller. At frame 3760, the needle is received in the groove in response to the reverse rotation of the first roller and the second roller. Method 3700 ends at frame 3765.

[0186] refer to Fig.38 In various embodiments, an exemplary method 3800 is provided for capturing a needle in a correction recess and guiding it back into the groove of a counter-rotating roller. The method 3800 begins at block 3805. At block 3810, a spiral needle is counter-rotatably actuated between a grooved roller and an opposing flat roller. At block 3820, the leading end of the needle is received in a correction recess at the leading end of the spiral groove defined by the grooved roller, as previously described with reference to FIG. Fig.18 and Fig.24 At block 3830, the leading end of the needle is engaged by at least one lateral surface of the correction recess, as previously described with reference to Fig.19 and Fig. 22 At block 3740, the leading end of the needle is guided along at least one lateral surface into the front end of the spiral groove, as previously described with reference to Fig. 20 and Fig.23 Method 3700 ends at block 3845.

[0187] refer to Fig.39In various embodiments, an exemplary method 3900 for selectively pivoting and translating a suturing mechanism is provided. Method 3900 begins at block 3905. At block 3910, a suturing mechanism is actuated about a curved path, wherein the suturing mechanism is configured to rotate a spiral needle about an axis. At block 3920, the needle is rotated so that the leading and trailing ends of the needle pass through the body. At block 3930, the suturing mechanism is guided along an articulated path so that the suturing mechanism pivots at a position about the curved path, as previously described with reference to FIG. Figure 32 to Figure 36 The suturing mechanism pivots when the leading and trailing ends of the needle are disengaged from the body to realign the axis to be tangential to the curved path before the leading end of the needle next pierces the body. The method 3900 ends at block 3935.

[0188] It should be understood that the detailed description set forth above is merely illustrative in nature, and variations that do not depart from the gist and / or spirit of the subject matter protected by the claims are intended to be within the scope of the claims. Such variations should not be considered to depart from the spirit and scope of the subject matter protected by the claims.

Claims

1. A device for suturing, the device comprising: a frame configured to counter-rotatably support two generally parallel rollers; a first roller supported by the frame, the first roller having a planar surface configured to rollably engage a first face of a shaft of a spiral needle; and a second roller supported by the frame, the second roller having a grooved surface defining a groove, the groove being configured to at least partially receive a second face of the shaft, the groove having a bottom having a bottom width at least as wide as the second face and being defined by sides extending to a groove opening at the grooved surface, the grooved surface having a surface width wider than the second face; Wherein the second roller further defines a correction recess, which is defined by the lateral surface at the front end of the groove and gradually tapers to the width of the groove at the front end of the groove, and the leading end of the spiral needle is received in the correction recess and guided into the front end of the groove by the lateral surface of the correction recess. 2 . The apparatus of claim 1 , wherein a surface width of the trench opening is substantially the same as the bottom width of the bottom of the trench.

3. The apparatus of claim 2, wherein the surface width and the bottom width are approximately 40% wider than the second side.

4. The apparatus of claim 1, wherein the surface width is greater than the bottom width, and two sides of the groove expand outward from the bottom of the groove to the groove opening at the grooved surface. The apparatus of claim 4 , wherein the groove defines a generally trapezoidal cross-section.

6. The apparatus of claim 1, wherein a pitch of the grooves matches a pitch of the spiral needle in a ratio according to a ratio of a radius of the spiral needle to a radius of the second roller.

7. The apparatus according to claim 1, further comprising a rotation mechanism configured to impart a rotational force and further configured to apply the rotational force to the first roller and the second roller so that the first roller and the second roller can rotate in opposite directions along parallel rotation axes.

8. The apparatus of claim 1, further comprising a drive mechanism configured to translate the frame along an object adjacent the first roller.

9. The apparatus of claim 1, further comprising a guide mechanism configured to engage a track configured to guide the frame along an object adjacent the first roller.

10. A system for suturing, the system comprising: a spiral needle, wherein the spiral needle comprises a shaft having a trailing end configured to pull a filament and a leading end shaped to pierce a subject; A needle drive mechanism, the needle drive mechanism comprising: a frame configured to counter-rotatably support two generally parallel rollers across a gap; a first roller having a planar surface configured to rollably engage a first face of a shaft of the spiral needle; a second roller supported by the frame, the second roller having a grooved surface defining a groove, the groove being configured to at least partially receive the second face of the shaft, The bottom of the groove has a bottom width at least as wide as the second side and is defined by sides extending to the groove opening at the grooved surface, the grooved surface having a surface width wider than the second side; and a drive mechanism fixed to the frame and configured to cause the first roller and the second roller to rotate in opposite directions and to move the frame along an edge of an object to be sewn by the filament; Wherein the second roller further defines a correction recess, which is defined by the lateral surface at the front end of the groove and gradually tapers to the width of the groove at the front end of the groove, and the leading end of the spiral needle is received in the correction recess and guided into the front end of the groove by the lateral surface of the correction recess.

11. The system of claim 10, wherein a surface width of the trench opening is substantially the same as the bottom width of the bottom of the trench.

12. The system of claim 11, wherein the surface width and the base width are approximately 40% wider than the second side.

13. The system of claim 10, wherein the surface width is greater than the bottom width, and two sides of the groove expand outward from the bottom of the groove to the groove opening at the grooved surface.

14. The system of claim 13, wherein the groove defines a generally trapezoidal cross-section.

15. The system of claim 10, wherein a pitch of the grooves matches a pitch of the spiral needle in a ratio based on a ratio of a radius of the spiral needle to a radius of the second roller.

16. The system of claim 10, wherein the shaft of the helical needle has a generally rectangular cross-section.

17. The system of claim 16, wherein the shaft of the helical needle has a generally square cross-section.

18. The system of claim 10, further comprising a guide mechanism configured to engage a track to guide the frame along an object adjacent the first roller.

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