Suturing needles and related systems and methods

Abstract

Implementations of suturing needles, suturing devices, and related methods are provided. In accordance with some aspects of the present disclosure, a suturing needle is provided including a needle body having a leading end and a trailing end. The needle body can define at least one opening in the needle body. A distal end of a length of suturing material can be received through the at least one opening. The needle body further defines a deflectable tab in an outer surface of the needle body. The deflectable tab can be configured to be deflected to trap the distal end of the length of suturing material within the at least one opening.

Description

SUTURING NEEDLES AND RELATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present patent application claims the benefit of priority to U.S. Provisional Patent Application No. 63 / 584,214, filed September 21, 2023. The aforementioned patent application is incorporated by reference herein in its entirety for all purposes.TECHNICAL FIELD

[0002] Aspects of the present disclosure relate to devices, systems, and methods for performing a suturing procedure. For example, aspects of the present disclosure relate to needles for suturing devices in support of remote surgical, diagnostic, therapeutic, and other treatment procedures.INTRODUCTION

[0003] Sutures are used in a variety of surgical and other applications, such as closing ruptured or incised tissue, soft tissue attachment, attachment of grafts, etc. Additionally, sutures may have other medical and / or non-medical uses. Conventionally, suturing is accomplished by penetrating tissue with the sharpened tip of a suturing needle that has a thread of suturing material attached to the opposite blunt end of the needle. The needle is then pulled through the tissue, causing the attached thread of suturing material to follow the path of the needle. Typically, a knot is tied at the trailing end of the thread to anchor the first stitch. This action is performed repetitively with application of tension to the needle to pull a length of the threadthrough the tissue using subsequent stitches until the tissue is sutured as desired with one or more stitches.

[0004] While the above-described suturing process can be performed manually, automated suturing systems also exist. Such systems can include a needle driver device that has an open, C-shaped portion into which tissue segments are introduced. The C-shaped portion defines two arms, each with an entry / exit point for a curved needle. The curved needle is driven around a track (generally following the C-shaped portion) and across the opening in the C- shaped portion to draw a thread of suturing material into the needle driver device through the tissue segments, similar to the manual suturing process discussed above. It is desirable to provide improved suturing needles that are easier to use to facilitate such suturing procedures. The present disclosure addresses these, and other issues in the art, as set forth below.SUMMARY

[0005] Example embodiments of the present disclosure may solve one or more of the above-mentioned problems and / or may demonstrate one or more of the above-mentioned desirable features. Other features and / or advantages may become apparent from the description that follows.

[0006] In accordance with some aspects of the present disclosure, a suturing needle is provided. The suturing needle includes a needle body having a leading end and a trailing end. The needle body defines at least one opening in the needle body. A distal end of a length of suturing material can be received through the at least one opening. The needle body further defines a deflectable tab in an outer surface of the needle body proximate the at least oneopening. The deflectable tab is configured to be deflected to trap the distal end of the length of suturing material within the at least one opening.

[0007] In accordance with further aspects of the disclosure, the at least one opening in the needle body can be proximate at least one cavity defined within the needle body to receive the distal end of the length of suturing material therein. The deflectable tab can be defined in an outer surface of the needle body proximate the at least one cavity. The deflectable tab can be configured to be deflected into the at least one cavity to trap the distal end of the length of suturing material within the at least one cavity. The needle can define a single cavity along its length or a plurality of cavities along its length, each cavity being separated from an adjacent cavity by a wall. The wall can fully separate adjacent cavities, or may only partially separate the cavities. For example, the wall can initiate from a bottom of the cavity and terminate part way up the height of the cavity. In accordance with further aspects, the wall separating adjacent cavities can be porous or formed by a plurality of projections separating cavities sufficient to act as a stop to prevent the distal end of the length of suturing material to pass from a first cavity into a second, adjacent cavity.

[0008] In further implementations, if desired, the distal end region of the length of suturing material may include a stop, knot, or enlarged region located proximally with respect to the distal end of the length of suturing material to prevent the length of suturing material from passing into the cavity beyond a predetermined depth. In this manner, a needle with a single elongate cavity can be provided that is in communication with or adjacent to multiple openings and multiple deflectable tabs, wherein a single opening and adjacent tab or tabs can be used to trap a distal end region of a first length of suturing material in the needle. The stop or enlarged region that is immediately proximal to the distal end of the first length of suturing material canprevent the first length of suturing material from progressing into the cavity of the needle beyond a predetermined depth wherein it would overlap with further deflectable tabs or openings. When the first length of suturing material is exhausted it can be cut from the needle with a cutting catheter, and a second length of suturing material with a similar stop can be inserted through a second, different opening from the first opening by a suitable catheter, and held in place by depressing one or more tabs into the cavity to trap the second length of suturing material in place.

[0009] In accordance with further aspects of the disclosure, in some implementations, the at least one cavity can be defined along a majority of a length of the needle body. In some implementations, the needle body can define a plurality of deflectable tabs along the outer surface of the needle body adjacent the at least one cavity. Each deflectable tab can be configured to be deflected into the at least one cavity to trap the distal end of the length of suturing material within the at least one cavity. In some implementations, the at least one cavity can include a plurality of discrete cavities along a length of the needle body. The needle body can define a deflectable tab in the outer surface of the needle body proximate each cavity of the plurality of cavities, wherein each said deflectable tab can be configured to be deflected into a corresponding cavity to trap the distal end of the length of suturing material. A first cavity of the plurality of cavities and a corresponding deflectable tab can be configured to trap a distal end of a first length of suturing material within the first cavity. A second cavity of the plurality of cavities and a corresponding deflectable tab can be configured to trap a distal end of a second length of suturing material within the second cavity, for example, after the first length of suturing material has been used and detached from the suturing needle.

[0010] In some implementations in accordance with the present disclosure, the needle body can be straight. In other implementations, the needle body can be curved. For example, the needle body can be arcuate in shape. In some implementations, the needle body can define at least one flattened planar surface into which the at least one deflectable tab is formed. In some implementations, the needle body can be defined by a “D” shaped cross section, a circular cross section, a rectangular cross section, a triangular cross section, an oval cross section, a trapezoidal cross section, and the like.

[0011] In some implementations, the needle body can be formed from an additive manufacturing process. In accordance with still further aspects, the at least one tab and / or other structural features of the needle can be formed using a material removal process, such as a laser ablation process or chemical etching process, for example. In some implementations, the outer surface of the needle body can define at least one indentation therein formed by at least one facet, or two or more intersecting facets.

[0012] In accordance with further aspects of the disclosure, implementations of a suturing device are provided. An illustrative implementation of a suturing device can include a housing defining a needle track therein to slidably receive a suturing needle therein, a drive to advance the suturing needle along the needle track and through a tissue segment. The drive can be configured to engage and disengage from the suturing needle to advance the needle through the tissue segment. The suturing device can further include a suture delivery catheter to deliver a distal end portion of a length of suturing material to the suturing needle. The suture delivery catheter and the drive can cooperate to engage the distal end portion of the length of suturing material to the suturing needle.

[0013] In accordance with further aspects of the disclosure, the needle track can be an arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive the tissue segment therein to be sutured. The suturing needle can be an arcuate suturing needle, and the drive can be configured to releasably engage the arcuate suturing needle and advance the arcuate suturing needle along the arcuate needle track and across the gap from a starting position to an ending position during a drive stroke.

[0014] In accordance with some aspects of the suturing device, the suture delivery catheter and the drive can cooperate to trap the distal end portion of the length of suturing material into a cavity defined in the suturing needle. For example, the distal end portion can be trapped in the cavity defined in the suturing needle by deforming a portion of the suturing needle against the distal end portion of the length of suturing material. A distal end portion of the suture delivery catheter can be configured to engage the cavity defined in the suturing needle. In some implementations, the distal end portion of the suture delivery catheter can be pushed into the cavity as the drive advances the suturing needle along the needle track. For example, the drive can advance the distal end portion of the suture delivery catheter against a ramped surface to push the distal end portion of the catheter into the cavity as the suturing needle is advanced along the needle track. In some implementations, the suturing device can further include an endoscope. A distal end portion of the endoscope can be coupled to the housing of the suturing device. The suture delivery catheter can be slidably received inside of a passage defined along a length of the endoscope.

[0015] The disclosure further provides methods of suturing tissue. In accordance with some aspects, the method can include advancing a distal end portion of a suturing device asdescribed herein proximate tissue to be sutured, and advancing a suturing needle having a first length of suturing material attached thereto along the needle track through the tissue a plurality of times to form a plurality of stitches. The method can further include cutting the first length of suturing material to separate the first length of suturing material from the suturing needle. The method can further include advancing a suture delivery catheter to deliver a distal end portion of a second length of suturing material to the suturing needle, and engaging the distal end portion of the second length of suturing material to the suturing needle.

[0016] In accordance with some aspects, the engaging step can include advancing the suturing needle with the drive along the needle track to advance the suture delivery catheter against a ramped surface to push the distal end portion of the catheter against the suturing needle. In accordance with some aspects of the disclosure, the distal end portion of the second length of suturing material can be engaged with the suturing needle by fusing the distal end portion of the second length of suturing material to a suture receiving portion of the suturing needle.

[0017] Additional objects, features, and / or advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the present disclosure and / or claims. At least some of these objects and advantages may be realized and attained by the elements and combinations particularly pointed out in the appended claims.

[0018] It is to be understood that both the foregoing general description and the following detailed description are illustrative and explanatory only and are not restrictive of the claims; rather the claims should be entitled to their full breadth of scope, including equivalents.BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The present disclosure can be understood from the following detailed description, either alone or together with the accompanying drawings. The drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate one or more embodiments of the present teachings and together with the description explain certain principles and operation. In the drawings:

[0020] FIG. 1 depicts an upper isometric view of an illustrative suturing needle in accordance with some embodiments of the present disclosure.

[0021] FIG. 2 depicts a second upper isometric view of the suturing needle of FIG. 1.

[0022] FIG. 3 is a top plan view of a further implementation of a suturing needle in accordance with the present disclosure.

[0023] FIG. 4 is a cross section of the needle of FIG. 3 taken along the line indicated in FIG. 3, wherein a length of suturing material has been added held in place by two displaced securement tabs.

[0024] FIG. 5 is an isometric upper left side exploded view of an illustrative suturing device in accordance with the present disclosure showing relative positioning of the suturing needle of FIG. 1 and a suture delivery catheter.

[0025] FIG. 6 is a close-up isometric view of the device of FIG. 5 showing relative placement of a distal end portion of the suture delivery catheter with respect to the suturing needle and a guide surface disposed above the needle track to assist directing a distal end portion of a length of suturing material.

[0026] FIG. 7 is a further view showing relative positioning of components similar toFIG. 6.

[0027] FIG. 8 is a schematic view of a further implementation of a suturing device in accordance with the present disclosure.

[0028] FIG. 9 is a schematic view of a suturing system in accordance with the present disclosure.

[0029] FIG. 10 is a schematic diagram for a robotically -assisted manipulator system, according to some examples.

[0030] FIG. 11A is a schematic diagram of an instrument system according to examples described herein.

[0031] FIG. 1 IB illustrates a distal portion of the instrument system of FIG. 11A with an extended example of an instrument according to examples described herein.DETAILED DESCRIPTION

[0032] The present disclosure provides various embodiments of suturing needles and associated suturing devices and methods. Suturing needles according to various embodiments of the present disclosure include features that facilitate suturing operations, particularly in endoscopic procedures.

[0033] In accordance with some aspects of the present disclosure, a suturing needle is provided. For purposes of illustration, and not limitation, a first representative implementation of a suturing needle is presented in FIGS. 1-2.

[0034] As illustrated in FIGS 1-2, a suturing needle 100 is provided. The illustrated suturing needle 100 includes an arcuate body having a leading end 104 and a trailing end 102.As depicted, the needle body defines a plurality of openings (109A-109J) in an upper surface 114 the needle body. Each opening is in fluid communication with at least one cavity (110A-110J) defined within the needle body. The needle body can include a single cavity along the length of the needle body that openings (109A-109J) lead to, or the needle body can include a plurality of cavities therein, wherein each cavity is adjacent one or more of the openings 109. The cavity can extend along less or more than a majority of the length of the needle. A distal end 134 of a length of suturing material 130 can be received through the at least one opening 109 and into the at least one cavity 110. The needle body further defines one or more deflectable tabs 106A-106J, 108A-108J in the outer surface of the needle body proximate the at least one cavity. Each deflectable tab is configured to be deflected into the cavity (110, or 110A-J) to trap the distal end 134 of the length of suturing material 130 within the at least one cavity 110 against the floor of the cavity 110 such that the suturing needle can then be used in a suturing procedure to pull the suturing material 130 through one or more tissue segments in one or more stitches. The floor of the cavity may be any desired shape. In some implementations, the floor of the cavity is rounded to better match the profile of a length of suturing material.

[0035] In some implementations, the needle body can define at least one flattened planar surface (e.g., 114) into which one or more of the deflectable tabs are formed. In some implementations, the needle body can be defined by a “D” shaped cross section, a circular cross section, a rectangular cross section, a triangular cross section, an oval cross section, or a trapezoidal cross section, as desired. The needle of FIGS. 1-2 has a generally square cross section along its length, and defines a cavity, or cavities therein (if so configured) that have a “D” shaped cross section, wherein the floor of the cavity is curved. As further illustrated inFIGS. 1-2, needle 100 is defined by a generally toroidally shaped body that includes a tissuepiercing end 104 and a generally flat trailing end 102. It will be further appreciated that the trailing end 102 of the needle 100 can have differing shapes, including a flattened portion and a chamfered portion, or another suitable shape, as desired. With continuing reference to FIG. 1, needle 100 is further defined by a lower, generally planar “C” shaped face 116, a radially inner curved surface 118 and a radially outer curved surface 120. During a suturing procedure, the suturing needle is advanced along direction “A” as indicated. Direction “A” is referred to elsewhere herein as a “forward” direction or a “first” direction. Needle movement in the opposite direction is referred to herein as “backward” movement, movement along a “second” direction opposite the first direction, and the like.

[0036] For purposes of further illustration, FIG. 3 is a top plan view of a further implementation of a suturing needle 200 in accordance with the present disclosure. FIG. 4 is a cross section of the needle of FIG. 3 taken along the line indicated in FIG. 3, wherein a length of suturing material has been added held in place by two displaced securement tabs 206 and 208.

[0037] As illustrated in FIGS. 3-4, in some implementations, the body of the needle 200 can be straight. In other implementations as illustrated in FIGS 1-2, the needle body can be curved in shape, such as being arcuate in shape. FIG. 4 illustrates a longitudinal cross section of needle 200 along the direction indicated in FIG. 3. As illustrated in FIG. 4, a length of suturing material 130 has been introduced through opening 209B defined in an upper wall of the needle body. The length of suturing material passes into the cavity 210B, and is directed along a direction toward the leading edge of the needle 200. As illustrated in FIG. 4, needle 200 includes a plurality of discrete cavities 210A, 210B along a length of the needle body. Each cavity 210A, 210B is defined in part respectively by a lower wall 211 A, and an end wall 215A toward a forward end of the cavity 210A, 210B. As illustrated, the needle body defines deflectable tabs206A, 208A that are associated with cavity 210A and deflectable tabs 206B, 208B that are associated with cavity 210B. Each tab 206, 208, as illustrated as being formed by a “U”-shaped channel formed fully through the upper surface 214 of the needle 210. The channel can pass fully through the upper surface, or may be formed partway through the surface if desired. To actuate the tab, the tab is pushed inwardly into the cavity 210 within the needle 200 until a free end of the tab has contacted the suturing material 130 and has trapped the suturing material 130 between the free end of the tab 206, 208 and the floor of the cavity. Specifically, as illustrated in FIG. 4, the suturing material is trapped against floor 21 IB of cavity 210B by the free ends of deployed tabs 206B, 208B. After a suturing procedure has been performed using the suture 130 trapped in cavity 210B, the suturing material can be trimmed from the outside of the needle, and a second suture (not shown) can be introduced through opening 209A into cavity 210A and trapped in place using tabs 206A, 208A against floor 211A of cavity 210A. The proximal end wall 215A, 215B can serve as a “stop” against which a distal end 134 of the suture is pushed, after which the tabs 206, 208 can be pushed inwardly to lock the second suture into place. As discussed in further detail below, by providing a needle that can have more than one suture attached to it, this can remove a need to remove a suturing device from a patient to install a new needle and suture.

[0038] The needle (100, 200) can be formed from a variety of materials using a variety of manufacturing processes. For example, the needle can be formed from metallic materials as well as polymeric and / or composite materials. In some implementations, the needle body can be formed from an additive manufacturing process, such as three-dimensional (“3D”) printing. Alternatively, the needle 100, 200 can be formed at least on part from a length of hypotube material having a desired cross-sectional shape. The tabs 206, 208, opening 209 and cavity 210can be formed using a material removal process, such as a laser ablation process or chemical etching process, among others. In some implementations, the outer surface of the needle body can define at least one indentation therein (not shown) formed by at least one facet, or two or more intersecting facets, or alternative surfaces to interface with a needle advancement drive of a suturing device to advance the needle 100, 200 through a suturing procedure.

[0039] In accordance with further aspects of the disclosure, with reference to FIGS. 5-9 implementations of a suturing device are provided, or aspects thereof.

[0040] With reference to FIGS. 5-7, a first illustrative implementation of a suturing device 500 is provided that includes a housing 510 defining a needle track 520 therein to slidably receive a suturing needle (e.g., 100), a drive 530 to advance the suturing needle 100 along the needle track 520 across a gap 512 defined in the housing 510 through a tissue segment to be sutured (not shown). The drive 530 can be configured to engage and disengage from the suturing needle to advance the needle through the tissue segment. Any suitable drive 530 may be used to advance the needle, including but not limited to a drive pin 537 or drive pawl that can engage the trailing edge 102 of the needle and / or openings formed into the inner radial face 118, outer radial face 120, or lower surface 116 of the needle 100. The drive pin or drive pawl can be coupled to a reciprocating mechanism, such as a cable 533 or a band that reciprocates around pulleys 531 or bosses that follows the needle track 520 along an arcuate path. In the depicted illustrative implementation, a drive pin 537 is depicted that can move vertically into and out of engagement with an opening (not shown) in the needle 100. The drive pin can be spring loaded, for example, and constrained within a shuttle housing 535 that is crimped or otherwise fixedly attached to the cable 533. Shuttle housing 535 can ride in a shuttle track or raceway 539 that is arcuately shaped that is parallel to the needle track 520. The drive pin 537 can extend from theshuttle track 539 through an arcuately shaped slot (not shown) defined through in a wall or floor (not shown) that separate the needle track 520 from the shuttle track 539. The shuttle 535 is constrained to reciprocate in shuttle track 539 as the cable 533 is pulled in a first direction, and then in a second opposing direction to advance the needle 100 about the needle track 520 and across the gap 512 in a plurality of movements of the shuttle 535.

[0041] As further set forth in FIGS. 5-7, if desired the housing 510 of the suturing device 500 can terminate in a coupling 519 on a proximal end thereof to couple to an endoscope 300. Cables or other actuators (e.g., pushrods and the like) can be routed through conduits (not shown) that are directed alongside the endoscope to a proximal actuator, discussed in more detail with reference to FIG. 9. The endoscope can define a plurality of conduits along its length to receive various tools such as a camera having a lens located at a distal end of the endoscope to permit direct observation of tissue being sutured.

[0042] Further conduits may be defined along the endoscope 300 to perform aspiration procedures, to inject a beneficial agent into the region of the suturing site, to provide illumination, and / or to introduce one or more elongate tools into the region where suturing is occurring. For example, a tissue capture catheter 150 having a tissue anchor disposed at a distal end thereof can be slidably received within a passage defined along endoscope 300. The coupling 519 may be configured to orient the housing 510 of the suturing device and the endoscope 500 at an oblique respective angle to facilitate direct viewing of the suturing site through a visualization element / camera in the endoscope 300, and to permit use of the tissue capture catheter under direct visualization.

[0043] As further illustrated in FIGS. 5-7, the suturing device 500 can further include a suture delivery catheter 140 to deliver a distal end portion 134 of a length of suturing material130 to the suturing needle 100 while the suturing needle is disposed in the needle track 520.

[0044] The suture delivery catheter 140 and the drive 130 can cooperate to engage the distal end portion 134 of the length of suturing material to the suturing needle. Specifically, the components cooperate to deliver a length of suturing material to the needle, and to introduce the suturing material into the needle, and trap the suturing material in the needle. As illustrated in FIGS. 5-7, when the suturing needle 100 has used up all suture previously attached to the needle, the remaining suturing material can be cut from the needle, and a new length of suturing material can be delivered to the needle 100, preferably by way of a channel defined along the length of the endoscope 300.

[0045] As illustrated in FIGS. 6-7, distal end portion 160 of the suture delivery catheter 140 is configured to engage the suturing needle 110. More specifically, the distal end portion 160 of the suture delivery catheter includes a main body having an upper leading edge 161 and a plurality of downwardly depending projections 162, 164, 166 that engage respective locations of the suturing needle 100. A passageway 168 may be defined through the distal end portion that is in fluid communication with a lumen 142 (FIG .9) defined in the suture delivery catheter 140 that extends proximally to an actuator of the suturing system 500. Passageway 168 and lumen 142 cooperate to form a delivery channel along which suturing material 130 can be advanced distally, into the needle. Engagement of the projections 162, 164, 166 with respective locations and openings within the needle 110 provide alignment and registration between the suturing material 130 and the needle 100, and particularly passageway 168, with respect to the cavity 110J defined inside of the needle. Once projection 162 is received within the needle to providebasic alignment, the suturing material 130 may be advanced into the cavity 110 of the needle 100. In some implementations (See FIG. 7), the passageway can be provided as an angled passageway 168 A through component 160 to provide desired alignment with the cavity of the needle 100.

[0046] As depicted, projection 162 is configured to be received within opening 109J that leads to cavity 110J. The passageway 168 containing the suturing material 130 therein may be directed through projection 162. Once the suture has been advanced into cavity 110J via opening 109J, the drive 530 of the suturing device 500 may be actuated to pull the needle 100 along a forward direction until leading edge 161 of component 160 mechanically contacts downwardly ramped surface 182 of cleat 180. Urging the leading upper edge 161 of the foot component 160 against the downward angled surface 182 creates a downward force that pushes projections 166 against tabs 106J, 108J, forcing the tabs into cavity 110J, trapping the distal end 134 of the length of suturing material 130 against the lower surface of the cavity 110, thereby coupling the suture 130 to the needle 100. Projection 164 is similarly configured to be received within opening 1091 that leads to cavity 1101 defined in the suturing needle 110.

[0047] Once the suturing material 130 has been trapped within the needle 100, the drive 530 may be reversed to move needle 100 backward along the needle track 520. The suture delivery catheter 140 can then be pulled proximally off of the needle, and proximally into a lumen in endoscope 300 where the suture delivery catheter resides. The suture delivery catheter 140 can be removed, and replaced with a new suture delivery catheter and length of suture after the suturing material 130 has been used. Prior to introducing a new suture delivery catheter 140 into the endoscope, the length of suturing material 130 extends proximally through the endoscope, and preferably externally of the patient. When a desired number of stitches havebeen executed using the suturing device 520, a cinch or lock can be slid along the suture 130 down the passageway of the endoscope 300 and against the tissue be sutured. A cutting catheter (not shown) can then be advanced along the passageway previously occupied by the suture delivery catheter along the suturing material 130, and the remaining suturing material can be cut from the needle 100. After this, if more stitches are desired, a new suture delivery catheter 140’ can be advanced along the passageway through the endoscope 300 and coupled to a different opening 109 and respective cavity of the needle 100. As will be appreciated, each opening 109 can be used once. Once all cavities 109 have been used, the suturing device 500 is withdrawn from the patient, and the needle 100 is replaced with a new needle.

[0048] In accordance with further aspects of the disclosure, and with further reference to FIG. 4, the distal end region of the length of suturing material 130, including the distal end 134 and several millimeters (e.g., 2-8mm) of the suturing material may terminate at a proximal end in a stop, knot, taper, flattened section or enlarged region 133. The stop 133 is located proximally with respect to the distal end of the length of suturing material to prevent the length of suturing material from passing into a respective cavity of the needle beyond a predetermined depth. In this manner, a needle with a single elongate cavity can be provided that is in communication with or adjacent to multiple openings and multiple deflectable tabs, wherein a single opening and adjacent tab or tabs can be used to trap a distal end region of a first length of suturing material in the needle. The stop or enlarged region that is immediately proximal to the distal end of the first length of suturing material can prevent the first length of suturing material from progressing into the cavity of the needle beyond a predetermined depth wherein it would overlap with further deflectable tabs or openings. When the first length of suturing material is exhausted it can be cut from the needle with a cutting catheter, and a second length of suturing material with a similarstop can be inserted through a second, different opening from the first opening by a suitable catheter, and held in place by depressing one or more tabs into the cavity to trap the second length of suturing material in place.

[0049] FIG. 8 is a schematic view of a further implementation of a suturing device 600 in accordance with the present disclosure configured to utilize the straight needle 200 of FIGS. 3-4 discussed above. The suturing device includes a housing 610 that defines a needle track having a needle exit 624 and a needle entrance 622 on opposing sides of a tissue gap 612 to accommodate a plication 400 of tissue, or other tissue segment to be sutured, as desired. The housing 610 of device 600 may also include a suitable coupling (not shown) to couple device 600 to an endoscope (e.g., 300) as with implementation 500. The endoscope 300 can similarly include associated tissue capture catheters (e g., 150) and a suture delivery catheter 140 to deliver a suture to needle 200 in a manner similar to needle 100 as described above. The needle 200 can be advanced across the gap 612 using a drive (not shown) suitable to advance needle 200 along a linear direction.

[0050] The disclosure further provides methods of suturing tissue. In accordance with some aspects, the method can include advancing a distal end portion of a suturing device (e.g., 500, 600) as described herein proximate tissue to be sutured, and advancing a suturing needle (e g., 100, 200) having a first length of suturing material (e.g., 130) attached thereto along the needle track (e.g., 520, 620) through tissue a plurality of times to form a plurality of stitches. The method can further include cutting the first length of suturing material (e.g., 130) to separate the first length of suturing material from the suturing needle. The method can further include advancing a suture delivery catheter (e.g., 140) to deliver a distal end portion of a second lengthof suturing material to the suturing needle, and engaging the distal end portion of the second length of suturing material to the suturing needle.

[0051] In accordance with some aspects, the engaging step can include advancing the suturing needle (e.g., 100, 200) with the drive along the needle track (e.g., 520, 620) to advance the suture delivery catheter against a ramped surface (e.g., 180) to push the distal end portion of the suture delivery catheter against the suturing needle.

[0052] In accordance with some further aspects of the disclosure, with reference to FIG.4, the distal end portion 134 of the suturing material can instead be engaged with the suturing needle by fusing the distal end portion of the length of suturing material to a suture receiving portion 219 of the suturing needle. The suture receiving portion 219 may be located at any point of the suturing material, and the suturing material 130 may be coupled thereto by any suitable means, such as adhesive and welding. For example, the suture delivery catheter 140 can further be provided with a heating element on a distal face thereof (not shown) that can be used to apply mechanical pressure to press the suture material 130 against the suture receiving portion, wherein the heating element applies heat to melt the distal end 134 of the suturing material 130 to the suture receiving portion 219.

[0053] For purposes of further illustration, and not limitation, as depicted in FIG. 9, a suturing device (e.g., 500, 600) is provided in a schematic format to illustrate proximal components of the system. The suturing device 500, 600 contains a suturing needle (e.g., 100, 200) that can be coupled to a proximal device portion that terminates in an actuator 170 which may be a manual actuator, or an automated actuator, such as a surgical robot, discussed in detail below. The suturing device can be further coupled to an endoscope 300, as desired. The endoscope 300 can provide one or more working channels (not shown) and may include acamera to provide direct visualization of the working area. The endoscope 300 may provide a channel to receive a suture delivery catheter (e.g., 140, 160), a tissue capture catheter (e.g., 150), and if desired, the endoscope 300 may be oriented obliquely with respect to the suturing needle to provide enhanced visualization of a suturing procedure. This facilitates viewing the passage of the needle across the gap (e.g., 512, 612) using a camera(s) disposed in one (or more) of a plurality of passageways defined along the length of the endoscope 300. Endoscope 300 may be a conventional endoscope, or an endoscope that is specially configured for use with the suturing device.

[0054] With continuing reference to FIG. 9, as mentioned above, the system can include an actuator system 170, wherein drive 130 is coupled to an actuator 172. Suture delivery catheter 140 can similarly extend proximally to an actuator 174 that permits the suture delivery catheter to be slid and rotated within the endoscope, and the proximal end 132 of the suture 130 may extend to a separate actuator or tensioner, or may otherwise extend proximally out of the actuator 170. The tissue capture catheter 150 can similarly extend proximally to a respective actuator 176.

[0055] The disclosed suturing devices can be used to perform various suturing procedures, such as laparoscopic and other procedures. In some implementations, as mentioned above, it can be advantageous to provide an additional tool such as a tissue capture device (e.g., 150) to help capture and pull tissue into gap (e.g., 512, 612) to suture. The tissue capture catheter 150 can terminate distally in a tissue anchor, such as a helix having a sharpened distal tip, or other fastener, that can be removably anchored within tissue to be sutured. Use of a tissue capture catheter can be particularly useful when the tissue being sutured is not compliant, or when it is desired to grasp a planar surface that would not naturally fall into the tissue gap 512,612, and it is necessary to form a fold, or plication (e.g. 400, FIG. 8) of such a tissue structure to be pulled into gap 512, 612. Implementations of devices in accordance with the present disclosure can be used to perform an Endoscopic Sleeve Gastroplasty (“ESG”) procedure, wherein a device (e.g. 500, 600) can be deployed into a patient’s stomach, and an elongate tissue capture catheter (e.g., 150) can be used to grab portions of the stomach lining to form a plication (e.g., 400), and the plication cab then be held in place by passing needle (e.g., 100, 200) through the plication. This procedure can be repeated until all desired plications are formed. Tension can then be applied to the suture passing through the plications to reduce the volume of the stomach.

[0056] Aspects of this disclosure herein can be part of a computer-assisted teleoperational manipulator system, sometimes referred to as a robotically-assisted manipulator system or a robotic system. The manipulator system can include one or more manipulators that can be operated with the assistance of an electronic controller (e.g., computer) to move and control functions of one or more instruments when coupled to the manipulators.

[0057] FIG. 10 illustrates an embodiment of a robotically-assisted manipulator system for use with the tools described herein. The manipulator system can be used, for example, in surgical, diagnostic, therapeutic, biopsy, or non-medical procedures, and is generally indicated by the reference numeral 1100. As shown in FIG. 10, a robotically-assisted manipulator system 1100 can include one or more manipulator assemblies 1102 for operating one or more medical instrument systems 1104 in performing various procedures on a patient P positioned on a table T in a medical environment 1101. For example, the manipulator assembly 1102 can drive catheter or end effector motion, can apply treatment to target tissue, and / or can manipulate control members. The manipulator assembly 1102 can be teleoperated, non -teleoperated, or a hybridteleoperated and non-teleoperated assembly with select degrees of freedom of motion that can be motorized and / or teleoperated and select degrees of freedom of motion that can be nonmotorized and / or non-teleoperated. An operator input system 1106, which can be inside or outside of the medical environment 1101, generally includes one or more control devices for controlling manipulator assembly 1102. Manipulator assembly 1102 supports medical instrument system 1104 and can optionally include a plurality of actuators or motors that drive inputs on medical instrument system 1104 in response to commands from a control system 1112. The actuators can optionally include drive systems that when coupled to medical instrument system 1104 can advance medical instrument system 1104 into a naturally or surgically created anatomic orifice. Other drive systems can move the distal end of medical instrument in multiple degrees of freedom, which can include three degrees of linear motion (e.g., linear motion along the X, Y, Z Cartesian axes) and in three degrees of rotational motion (e.g., rotation about the X, Y, Z Cartesian axes). The manipulator assembly 1102 can support various other systems for irrigation, treatment, or other purposes. Such systems can include fluid systems (including, for example, reservoirs, heating / cooling elements, pumps, and valves), generators, lasers, interrogators, and ablation components.

[0058] Robotically-assisted manipulator system 1100 also includes a display system 1110 for displaying an image or representation of the surgical site and medical instrument system 1104 generated by an imaging system 1109 which can include an imaging system, such as an endoscopic imaging system. Display system 1110 and operator input system 1106 can be oriented so an operator O can control medical instrument system 1104 and operator input system 1106 with the perception of telepresence. A graphical user interface can be display able on the display system 1110 and / or a display system of an independent planning workstation.

[0059] In some examples, the endoscopic imaging system components of the imaging system 1109 can be integrally or removably coupled to medical instrument system 1104. However, in some examples, a separate imaging device, such as an endoscope, attached to a separate manipulator assembly can be used with medical instrument system 1104 to image the surgical site. The endoscopic imaging system 1109 can be implemented as hardware, firmware, software, or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of the control system 1112. It will be appreciated that either an integrated endoscopic device or a separate endoscope can serve as an endoscope that supports the suturing device (e.g., 500, 600) set forth herein.

[0060] Robotically-assisted manipulator system 1100 can also include a sensor system 1108. The sensor system 1108 can include a position / location sensor system (e.g., an actuator encoder or an electromagnetic (EM) sensor system) and / or a shape sensor system (e.g., an optical fiber shape sensor) for determining the position, orientation, speed, velocity, pose, and / or shape of the medical instrument system 1104. The sensor system 1108 can also include temperature, pressure, force, or contact sensors or the like.

[0061] Robotically-assisted manipulator system 1100 can also include a control system 1112. Control system 1112 includes at least one memory 1116 and at least one computer processor 1114 for effecting control between medical instrument system 1104, operator input system 1106, sensor system 1108, and display system 1110. Control system 1112 also includes programmed instructions (e.g., a non-transitory machine-readable medium storing the instructions) to implement a procedure using the robotically-assisted manipulator system including for navigation, steering, imaging, engagement feature deployment or retraction, applying treatment to target tissue (e g., via the application of energy), or the like.

[0062] Control system 1112 can optionally further include a virtual visualization system to provide navigation assistance to operator O when controlling medical instrument system 1104 during an image-guided surgical procedure. Virtual navigation using the virtual visualization system can be based upon reference to an acquired pre-operative or intra-operative dataset of anatomic passageways. The virtual visualization system processes images of the surgical site imaged using imaging technology such as computerized tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermography, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and / or the like. The control system 1112 can use a pre-operative image to locate the target tissue (using vision imaging techniques and / or by receiving user input) and create a pre-operative plan, including an optimal first location for performing treatment. The pre-operative plan can include, for example, a planned size to expand an expandable device, a treatment duration, a treatment temperature, and / or multiple deployment locations.

[0063] FIG. 11 A shows a medical instrument system 1200 according to some embodiments. In some embodiments, medical instrument system 1200 can be used in an image- guided medical procedure. In some examples, medical instrument system 1200 can be used for non-teleoperational exploratory procedures or in procedures involving traditional manually operated medical instruments, such as endoscopy. In some embodiments, medical instrument system 1200 is interchangeable with, or a variation of, medical instrument system 1104 of FIG. 10.

[0064] Medical instrument system 1200 includes elongate flexible device 1202, such as a flexible catheter or endoscope (e.g., gastroscope, bronchoscope), coupled to a drive unit 1204. Elongate flexible device 1202 includes a flexible body 1216 having proximal end 1217 and distalend, or tip portion, 1218. In some embodiments, flexible body 1216 has an approximately 14-20 mm outer diameter. Other flexible body outer diameters can be larger or smaller. Flexible body 1216 can have an appropriate length to reach certain portions of the anatomy, such as the lungs, sinuses, throat, or the upper or lower gastrointestional region, when flexible body 1216 is inserted into a patient's oral or nasal cavity. The suturing device (e.g., 500, 600) can be coupled to elongate flexible device 1202 as desired in lieu of endoscope 300.

[0065] Medical instrument system 1200 optionally includes a tracking system 1230 for determining the position, orientation, speed, velocity, pose, and / or shape of distal end 1218 and / or of one or more segments 1224 along flexible body 1216 using one or more sensors and / or imaging devices. The entire length of flexible body 1216, between distal end 1218 and proximal end 1217, can be effectively divided into segments 1224. Tracking system 1230 can optionally be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which can include the processors of control system 1112 in FIG. 10.

[0066] Tracking system 1230 can optionally track distal end 1218 and / or one or more of the segments 1224 using a shape sensor 1222. In some embodiments, tracking system 1230 can optionally and / or additionally track distal end 1218 using a position sensor system 1220, such as an electromagnetic (EM) sensor system. In some examples, position sensor system 1220 can be configured and positioned to measure six degrees of freedom, e.g., three position coordinates X, Y, Z and three orientation angles indicating pitch, yaw, and roll of a base point or five degrees of freedom, e.g., three position coordinates X, Y, Z and two orientation angles indicating pitch and yaw of a base point.

[0067] Flexible body 1216 includes one or more channels 1221 sized and shaped to receive one or more medical instruments 1226. In some embodiments, flexible body 1216 includes two channels 1221 for separate instruments 1226, however, a different number of channels 1221 can be provided. FIG. 1 IB is a simplified diagram of flexible body 1216 with medical instrument 1226 extended according to some embodiments. In some embodiments, medical instrument 1226 can be used for procedures and aspects of procedures, such as surgery, biopsy, ablation, mapping, imaging, illumination, irrigation, or suction. Medical instrument 1226 can be deployed through channel 1221 of flexible body 1216 and used at a target location within the anatomy. Medical instrument 1226 can include, for example, image capture devices, biopsy instruments, ablation instruments, catheters, laser ablation fibers, and / or other surgical, diagnostic, or therapeutic tools. Medical tools can include end effectors having a single working member such as a scalpel, a blunt blade, a lens, an optical fiber, an electrode, and / or the like. Other end effectors can include, for example, forceps, graspers, balloons, needles, scissors, clip appliers, and / or the like. Other end effectors can further include electrically activated end effectors such as electrosurgical electrodes, transducers, sensors, imaging devices and / or the like. Medical instrument 1226 can be advanced from the opening of channel 1221 to perform the procedure and then retracted back into the channel when the procedure is complete. Medical instrument 1226 can be removed from proximal end 1217 of flexible body 1216 or from another optional instrument port (not shown) along flexible body 1216. The medical instrument 1226 can be used with an image capture device (e.g., an endoscopic camera) also within the elongate flexible device 1202. Alternatively, the medical instrument 1226 can itself be the image capture device.

[0068] Medical instrument 1226 can additionally house cables, linkages, or other actuation controls (not shown) that extend between its proximal and distal ends to controllably the bend distal end of medical instrument 1226. Flexible body 1216 can also house cables, linkages, or other steering controls (not shown) that extend between drive unit 1204 and distal end 1218 to controllably bend distal end 1218 as shown, for example, by broken dashed line depictions 1219 of distal end 1218. In some examples, at least four cables are used to provide independent "up-down" steering to control a pitch motion of distal end 1218 and "left-right" steering to control a yaw motion of distal end 1218. In embodiments in which medical instrument system 1200 is actuated by a robotically-assisted assembly, drive unit 1204 can include drive inputs that removably couple to and receive power from drive elements, such as actuators, of the teleoperational assembly. In some embodiments, medical instrument system 1200 can include gripping features, manual actuators, or other components for manually controlling the motion of medical instrument system 1200. The information from tracking system 1230 can be sent to a navigation system 1232 where it is combined with information from visualization system 1231 and / or the preoperatively obtained models to provide the physician or other operator with real-time position information.

[0069] This description and the accompanying drawings that illustrate various embodiments should not be taken as limiting. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the scope of this description and the invention as claimed, including equivalents. In some instances, well-known structures and techniques have not been shown or described in detail so as not to obscure the disclosure. Like numbers in two or more figures represent the same or similar elements. Furthermore, elements and their associated features that are described in detail with reference toone embodiment may, whenever practical, be included in other embodiments in which they are not specifically shown or described. For example, if an element is described in detail with reference to one embodiment and is not described with reference to another embodiment, the element may nevertheless be claimed as included in the other embodiment.

[0070] For the purposes of this specification and appended claims, unless otherwise indicated, all numbers expressing quantities, percentages, or proportions, and other numerical values used in the specification and claims, are to be understood as being modified in all instances by the term “about,” to the extent they are not already so modified. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0071] It is noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the,” and any singular use of any word, include plural referents unless expressly and unequivocally limited to one referent. As used herein, the term “include” and its grammatical variants are intended to be non-limiting, such that recitation of items in a list is not to the exclusion of other like items that can be substituted or added to the listed items.

[0072] Further, this description’s terminology is not intended to limit the invention. For example, spatially relative terms — such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like — may be used to describe one element’s or feature’s relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions (i.e., locations) and orientations (i.e.,rotational placements) of a device in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as“below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the illustrative term “below” can encompass both positions and orientations of above and below. A device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0073] Further modifications and alternative embodiments will be apparent to those of ordinary skill in the art in view of the disclosure herein. For example, the devices and methods may include additional components or steps that were omitted from the diagrams and description for clarity of operation. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the present teachings. It is to be understood that the various embodiments shown and described herein are to be taken as illustrative. Elements and materials, and arrangements of those elements and materials, may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the present teachings may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of the description herein. Changes may be made in the elements described herein without departing from the spirit and scope of the present teachings and following claims.

[0074] It is to be understood that the particular examples and embodiments set forth herein are non-limiting, and modifications to structure, dimensions, materials, and methodologies may be made without departing from the scope of the present teachings.

[0075] Other embodiments in accordance with the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the inventiondisclosed herein. It is intended that the specification and examples be considered as illustrative and for example only, with the following claims being entitled to their fullest breadth, including equivalents, under the applicable law.

Claims

WHAT IS CLAIMED IS:

1. A suturing needle comprising a needle body having a leading end and a trailing end, the needle body defining at least one opening in the needle body to receive a distal end of a length of suturing material therethrough, the needle body further defining a deflectable tab in an outer surface of the needle body proximate the at least one opening, wherein the deflectable tab is configured to be deflected to trap the distal end of the length of suturing material within the at least one opening.

2. The suturing needle of Claim 1, wherein the at least one opening in the needle body is proximate at least one cavity defined within the needle body to receive the distal end of the length of suturing material therein, and further wherein the deflectable tab is defined in an outer surface of the needle body proximate the at least one cavity, and further wherein the deflectable tab is configured to be deflected into the cavity to trap the distal end of the length of suturing material within the at least one cavity.

3. The suturing needle of Claim 1, wherein the at least one cavity is defined along a majority of a length of the needle body.

4. The suturing needle of Claim 3, wherein the needle body defines a plurality of deflectable tabs along the outer surface of the needle body adjacent the at least one cavity, and further wherein each said deflectable tab is configured to be deflected into the at least one cavity to trap the distal end of the length of suturing material within the at least one cavity.

5. The suturing needle of Claim 1, wherein the at least one cavity comprises a plurality of discrete cavities along a length of the needle body, wherein the needle body defines a deflectable tab in the outer surface of the needle body proximate each cavity of the plurality of cavities, and further wherein each said deflectable tab is configured to be deflected into a corresponding cavity to trap the distal end of the length of suturing material.

6. The suturing needle of Claim 5, wherein a first cavity of the plurality of cavities and a corresponding deflectable tab is configured to trap a distal end of a first length of suturingmaterial with the first cavity, and further wherein a second cavity of the plurality of cavities and a corresponding deflectable tab is configured to trap a distal end of a second length of suturing material within the second cavity.

7. The suturing needle of Claim 1, wherein the needle body is straight.

8. The suturing needle of Claim 1, wherein the needle body is curved in shape or arcuate in shape.

9. The suturing needle of Claim 1, wherein the needle body is formed from an additive manufacturing process.

10. The suturing needle of Claim 1, wherein the needle body defines at least one flattened planar surface into which the at least one deflectable tab is formed.

11. The suturing needle of Claim 10, wherein the needle body is defined by a “D” shaped cross section.

12. A method of forming a needle of Claim 1 using an additive manufacturing process.

13. The method of Claim 12, further comprising forming the at least one deflectable tab in an outer surface of the needle using an ablation process.

14. The arcuate suturing needle of Claim 1, wherein the outer surface of the needle body defines at least one indentation therein formed by at least two intersecting facets.

15. A suturing device comprising: a housing defining a needle track therein to slidably receive a suturing needle therein; a drive to advance the suturing needle along the needle track and through a tissue segment, the drive being configured to engage and disengage from the suturing needle to advance the needle through the tissue segment; anda suture delivery catheter to deliver a distal end portion of a length of suturing material to the suturing needle, wherein the suture delivery catheter and the drive cooperate to engage the distal end portion of the length of suturing material to the suturing needle.

16. The suturing device of Claim 15, wherein: the needle track is an arcuate needle track having a first end and a second end, wherein the housing further defines a gap between the first end and second end of the arcuate needle track, and further wherein the gap is configured to receive the tissue segment therein to be sutured; the suturing needle is an arcuate suturing needle; and the drive is configured to releasably engage the arcuate suturing needle and advance the arcuate suturing needle along the arcuate needle track and across the gap from a starting position to an ending position during a drive stroke.

17. The suturing device of Claim 15, wherein the suture delivery catheter and the drive cooperate to trap the distal end portion of the length of suturing material into a cavity defined in the suturing needle.

18. The suturing device of Claim 17, wherein the distal end portion is trapped in the cavity defined in the suturing needle by deforming a portion of the suturing needle against the distal end portion of the length of suturing material.

19. The suturing device of Claim 17, wherein a distal end portion of the suture delivery catheter is configured to engage the cavity defined in the suturing needle.

20. The suturing device of Claim 19, wherein the distal end portion of the suture delivery catheter is pushed into the cavity as the drive advances the suturing needle along the needle track.

21. The suturing device of Claim 20, wherein the drive advances the distal end portion of the suture delivery catheter against a ramped surface to push the distal end portion of the catheter into the cavity.

22. The suturing device of Claim 15 further comprising an endoscope, a distal end portion of the endoscope being coupled to the housing of the suturing device, wherein the suture delivery catheter is slidably received inside of a passage defined along a length of the endoscope.

23. A method of suturing tissue, comprising: advancing a distal end portion of the suturing device of Claim 15 proximate tissue to be sutured; advancing a suturing needle having a first length of suturing material attached thereto along the needle track through the tissue a plurality of times to form a plurality of stitches; cutting the first length of suturing material to separate the first length of suturing material from the suturing needle; advancing the suture delivery catheter to deliver a distal end portion of a second length of suturing material to the suturing needle; and engaging the distal end portion of the second length of suturing material to the suturing needle.

24. The method of Claim 23, wherein the engaging step includes advancing the suturing needle with the drive along the needle track to advance the suture delivery catheter against a ramped surface to push the distal end portion of the catheter against the suturing needle.

25. The method of Claim 23, wherein the distal end portion of the second length of suturing material is engaged with the suturing needle by fusing the distal end portion of the second length of suturing material to a suture receiving portion of the suturing needle.

Images