Suture apparatuses and methods

Abstract

As may be implemented in accordance with one or more embodiments herein, methods and / or apparatuses may be implemented using a shaft and an expandable and collapsible net coupled to the shaft for insertion into an opening in a tubular sidewall of vascular tissue. A plurality of needles are coupled to the shaft, and a suture is coupled to each needle and to another one of the needles. An actuator is used to deploy the needles and the sutures through the sidewall and into the net, with the net inserted within the vascular tissue. The actuator is retracted, leaving the needle extending through the sidewall and into the net. The net is retracted, with the needles embedded therein, from the vascular tissue and used to draw the needles out of the vascular tissue along with ends of the sutures coupled to the needles, therein closing the opening in the vascular tissue.

Description

SUTURE APPARATUSES AND METHODSOVERVIEW

[0001] In surgery, a tissue opening, in particular a tissue opening provided by cutting the tissue, can be manually closed by a surgeon using a needle and a suture thread. To close an opening caused by arteriotomy, an automated surgical apparatus may be used for feeding the needle with the suture thread through the edge area of the tissue opening and bringing the needle together with the suture out of the tissue opening again in order to close the opening.

[0002] While useful, it can be challenging to close sutures in vascular surgery requiring the closure of a blood vessel in general, and to close an artery in particular. Due to blood vessels being filled with blood, any insertion or retraction of a surgical apparatus from a vessel causes some blood to exit from the vessel. Where needle capture portions of a surgical apparatus have netting or mesh, blood flow between the tissue and the surgical apparatus, and through the mesh itself, may lead to loss of blood.

[0003] These and other aspects can present challenges to surgery, and in particular to closing sutures in vascular surgery.

[0004] Accordingly, various embodiments are directed to addressing challenge involving sutures, such as may address challenges noted above.

[0005] As may be implemented in accordance with one or more embodiments, an apparatus comprises a shaft, an expandable and collapsible net coupled to the shaft for insertion into an opening in a tubular sidewall of vascular tissue, and a plurality of needles coupled to the shaft. For each needle, a suture is coupled to the needle and to another one of the needles. For each needle, an actuator is to deploy the needle and the suture coupled to the needle through the sidewall and into the net, with the net inserted within the vascular tissue. The actuator is further to retract, leaving the needle extending through the sidewall and into the net. The net is configured and arranged with the shaft to, with the needles embedded in the net, retract from the vascular tissue and, via the retraction, draw the needles out of the vascular tissue along with ends of the sutures coupled to the needles, therein closing the opening in the vascular tissue.

[0006] Various embodiments are directed to methods as may be implemented in accordance with one or more apparatus-based aspects as characterized herein. For instance, a shaft having an expandable and collapsible net coupled thereto may be utilized for inserting the net into an opening in a tubular sidewall of vascular tissue. A plurality of needles are coupled to the shaft, each needle having a suture coupled thereto and to another one of theneedles. An actuator is used to deploy the needles and sutures through the sidewall and into the net, with the net inserted within the vascular tissue. The net is configured and arranged with the shaft to, with the needles embedded in the net, retract from the vascular tissue and, via the retraction, draw the needles out of the vascular tissue along with ends of the sutures coupled to the needles, therein closing the opening in the vascular tissue. The sutures may then be cut or tied, for example using a clip and clip delivery apparatus as characterized herein.

[0007] The above discussion / summary is not intended to describe each embodiment or every implementation of the present disclosure. The figures and detailed description that follow also exemplify various embodiments.BRIEF DESCRIPTION OF THE FIGURES

[0008] Various example embodiments may be more completely understood in consideration of the following detailed description and in connection with the accompanying drawings, in which:

[0009] Figure 1 shows a suture apparatus, as may be implemented in accordance with one or more embodiments;

[0010] Figure 2 shows a distal portion of the suture apparatus of Figure 1 at an introduction stage, as may be implemented in accordance with one or more embodiments;

[0011] Figure 3 shows the distal portion of the suture apparatus of Figure 1 at a net expansion stage, as may be implemented in accordance with one or more embodiments;

[0012] Figure 4 shows the distal portion of the suture apparatus of Figure 1 with the net expanded and needles pushed, as may be implemented in accordance with one or more embodiments;

[0013] Figure 5 shows the distal portion of the suture apparatus of Figure 1 with the needle pusher retracted, as may be implemented in accordance with one or more embodiments;

[0014] Figure 6 shows the distal portion of the suture apparatus of Figure 1 with the needles captured, as may be implemented in accordance with one or more embodiments;

[0015] Figure 7 shows a distal shaft and capture net of the suture apparatus of Figure 1, as may be implemented in accordance with one or more embodiments; SLIDE 127

[0016] Figure 8 shows the net and sleeve of the suture apparatus of Figure 1, as may be implemented in accordance with one or more embodiments; SLIDE 128

[0017] Figure 9 shows the distal portion of the suture apparatus of Figure 1 with the needle pushers advanced, as may be implemented in accordance with one or more embodiments;

[0018] Figure 10 shows the distal portion of the suture apparatus of Figure 1 with the needle pushers retracted, as may be implemented in accordance with one or more embodiments;

[0019] Figure 11 shows the distal portion of the suture apparatus of Figure 1 with the capture cage with needles collapsed, as may be implemented in accordance with one or more embodiments;

[0020] Figures 12-16 shows a suture apparatus inserted into vascular tissue in respective steps in which:

[0021] Figure 12 shows a suture apparatus inserted into a vessel wall, as may be implemented in accordance with one or more embodiments;

[0022] Figure 13 shows the suture apparatus of Figure 12 with its net expanded, as may be implemented in accordance with one or more embodiments;

[0023] Figure 14 shows the suture apparatus of Figure 12 with needles penetrating the net, as may be implemented in accordance with one or more embodiments;

[0024] Figure 15 shows the suture apparatus of Figure 12 with needle pushers retracted, as may be implemented in accordance with one or more embodiments; and

[0025] Figure 16 shows the suture apparatus of Figure 12 with the net relaxed, as may be implemented in accordance with one or more embodiments;

[0026] Figures 17-21 show respective suture patterns that may be implemented in accordance with one or more embodiments, in which:

[0027] Figure 17 shows a suture pattern along vascular tissue;

[0028] Figure 18 shows a suture pattern along vascular tissue;

[0029] Figure 19 shows a suture pattern along vascular tissue;

[0030] Figure 20 shows a suture pattern across vascular tissue; and

[0031] Figure 21 shows a suture pattern across vascular tissue;

[0032] Figure 22 shows a handle for a suture apparatus, as may be implemented in accordance with one or more embodiments;

[0033] Figures 23 A-23C show respective components of the handle of Figure 22 as may be implemented in accordance with one or more embodiments, in which

[0034] Figure 23A shows the components to pull the net;

[0035] Figure 23B shows the components to pull the net sleeve; and

[0036] Figure 23C shows the pushing of needles;

[0037] Figure 24 shows a single layer net, as may be implemented in accordance with one or more embodiments;

[0038] Figure 25 shows a double layer net, as may be implemented in accordance with one or more embodiments;

[0039] Figure 26 shows needles coupled to sutures and needle pushers, as may be implemented in accordance with one or more embodiments;

[0040] Figure 27 shows blunt tapered vertically separated needle pushers, in accordance with one or more embodiments;

[0041] Figure 28 shows blunt tapered horizontally separated needle pushers, in accordance with one or more embodiments;

[0042] Figure 29 shows beveled horizontally separated needle pushers, in accordance with one or more embodiments;

[0043] Figure 30 shows a distal shaft having a tapered end, as may be implemented in accordance with one or more embodiments;

[0044] Figure 31 shows a distal shaft having a blunt end, as may be implemented in accordance with one or more embodiments;

[0045] Figure 32 shows a distal shaft having a beveled end, as may be implemented in accordance with one or more embodiments;

[0046] Figure 33 shows a clip delivery apparatus, as may be implemented in accordance with one or more embodiments;

[0047] Figure 34 shows the clip delivery apparatus of Figure 33 with a threader pulling sutures through the clip, as may be implemented in accordance with one or more embodiments;

[0048] Figure 35 shows the clip delivery apparatus of Figure 33 with sutures being cut, as may be implemented in accordance with one or more embodiments;

[0049] Figure 36 shows the clip delivery apparatus of Figure 33 with the clip released, as may be implemented in accordance with one or more embodiments;

[0050] Figure 37 shows a suture threader for the clip delivery apparatus of Figure 33, as may be implemented in accordance with one or more embodiments;

[0051] Figure 38 shows a clip and plug, as may be implemented in accordance with one or more embodiments;

[0052] Figure 39 shows the clip and plug of Figure 38 with the plug inserted into the clip, as may be implemented in accordance with one or more embodiments;

[0053] Figure 40 shows a clip deployment apparatus, as may be implemented in accordance with one or more embodiments;

[0054] Figure 41 shows the clip deployment apparatus of Figure 40 with sutures hooked and fed through the clip, as may be implemented in accordance with one or more embodiments;

[0055] Figure 42 shows the clip deployment apparatus of Figure 40 with plug and plug pusher rod, as may be implemented in accordance with one or more embodiments;

[0056] Figure 43 shows the clip deployment apparatus of Figure 40 with the pusher rod withdrawn, as may be implemented in accordance with one or more embodiments;

[0057] Figure 44 shows the clip deployment apparatus of Figure 40 with sutures being cut, as may be implemented in accordance with one or more embodiments;;

[0058] Figure 45 shows the clip deployment apparatus of Figure 40 with the clip released, as may be implemented in accordance with one or more embodiments; and

[0059] Figure 46 shows the clip deployment apparatus of Figure 40 with the outer sleeve pulled back and the clip allowed to remain engaged with tissue, as may be implemented in accordance with one or more embodiments.

[0060] While various embodiments discussed herein are amenable to modifications and alternative forms, aspects thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure including aspects defined in the claims.DETAILED DESCRIPTION

[0061] Aspects of the present disclosure are believed to be applicable to a variety of different types of articles of manufacture, apparatuses, systems and methods involving medical apparatuses and approaches. In certain implementations, aspects of the present disclosure have been shown to be beneficial when used in the context of suturing tissue, such as for closing openings made in vascular tissue walls. While not necessarily so limited, various aspects may be appreciated through a discussion of examples using such exemplary contexts.

[0062] Various aspects of the present disclosure are directed to methods and apparatuses as depicted in underlying Provisional Patent Application Serial No. 63 / 612,135, filed on December 19, 2023 and including the appendices therein that form part of the application. For instance, certain embodiments are directed to a suture delivery apparatus and approach, and other embodiments are directed to further utilizing a suture clip apparatus and system, as respectively depicted in Appendix A. Other aspects are directed to a suture delivery apparatus and approach as characterized in Appendix B. Moreover, each of the embodiments and respective components therein may be combined, to suit particular applications. For instance, the suture delivery apparatus may be utilized with the suture clip apparatus for a particular application.

[0063] In accordance with a particular embodiment, an apparatus comprises a shaft, an expandable and collapsible net coupled to the shaft, and a plurality of needles coupled to the shaft. For each needle, a suture is coupled to the needle and to another one of the needles. For each needle, an actuator is to deploy the needle and the suture coupled to the needle into the net. The actuator is further to retract, leaving the needle extending into the net. The net is configured and arranged with the shaft to, with the needles embedded in the net, retract and withdraw the needles along with ends of the sutures coupled to the needles.

[0064] Such an approach may involve inserting the net into an opening in a tubular sidewall of vascular tissue, with the sutures inserted through the sidewall and into the net. When the actuator retracts, the needles are left extending through the sidewall and into the net. Further, the net may be retracted from the vascular tissue and used to draw the needles out of the vascular tissue along with ends of the sutures coupled to the needles, therein closing the opening in the vascular tissue. Closing the opening in the vascular tissue may involve pulling the sutures to close an arteriotomy opening in a circular fashion and / or tightening a clip against the sidewall.

[0065] The apparatus may further include a retractable sleeve configured to extend over the net in a collapsed state, and to retract to allow the net to expand in an expanded state.

[0066] In a particular implementation, the apparatus includes an access wire via which the net and plurality of needles are inserted into the vascular tissue, and an elongated support structure through which the access wire, shaft and net extend. A distal tip of the elongated support structure has a lumen to pass blood and the access wire, and the shaft is configured to follow guide wire for placement of the needles.

[0067] The net may be implemented in a variety of manners, and using a variety of materials. For instance, the net may include a woven or a flexible structure that allows penetration of a needle without being destroyed. The net may lock in place within the vascular tissue via expansion therein and engagement with the tubular sidewall. The net may include a double layer configured to capture the needles between the respective layers of the net.

[0068] A handle may be utilized at a proximal end of the apparatus and coupled to the net at a distal end of the apparatus, in which the handle expands the net in response to actuation of the handle in a first direction. The net may move toward the handle in response to the actuation, to provide the expansion. The handle may collapse the net in response to actuation of the handle in a second direction that is different than the first direction.

[0069] In a more detailed implementation, the apparatus includes an elongated support structure extending distally from the handle, and a guide for the needles to guide the needles in a direction parallel to the support structure. The apparatus further includes a pushing component slidably movable with respect to the elongated support structure and to push the needles in a distal direction away from the handle, and a sheath movable relative to the net. The needles are arranged at a first radial distance from a center of the elongated support structure, and in an expanded state, the net has an outer contour having a second radial distance with respect to the center of the support structure that is equal or larger than the first radial distance. In a collapsed state, the net has an outer contour having a third radial distance with respect to the center of the support structure that is smaller than the second radial distance. Further, the sheath covers at least part of a section of the net in the collapsed state and exposes the net in the expanded state.

[0070] The sheath may include an opening to allow blood flow into the sheath. The opening may be located at a longitudinal position in the sheath such that when the sheath is in its closed state, blood flow through the opening indicates that the net and needles arelocated in an operating position. A seal may be implemented between the support structure and the sheath to prevent blood flow from the in a proximal direction.

[0071] The pushing component may be implemented in a variety of manners. For instance, it may push all needles simultaneously, push pairs of the needles separated vertically relative to one another, push pairs of the needles separated horizontally relative to one another, or push pairs of the needles separated horizontally and offset relative to one another with a first pair of the needles positioned forward relative to a second pair of the needles.

[0072] The handle may include step indicators that change color in response to respective steps involving the deployment of the apparatus and closing of the opening in the vascular tissue. The step indicators may include visual windows located on the apparatus body, for instance as may change color when a specific procedural step has been successfully completed. For instance, different colors may be applied to confirm that the net has fully expanded to enable needle capture, that the needles have advanced through the vessel wall and into the net, that the needle pushers have been completely retracted, and that the net has contracted to securely complete the closure process. In a particular implementation, the handle includes an internal spiral mechanism to deploy the shaft for positioning the net and to withdraw a sleeve from around the net.

[0073] The distal end of the shaft may be tapered, blunt or beveled. The blunt end to facilitates deployment of the needles at the same level relative to the tubular sidewall. The beveled end facilitates delivery of the shaft at an angle relative to the tubular sidewall. Further, the distal tip / end of the shaft may have a width that transitions from a narrower width to a wider width along a length of the shaft.

[0074] Aspects of the present invention relate to a surgical apparatus for feeding a suture thread fastened to a needle through an edge area of a tissue opening, the surgical apparatus having a handle portion having a distal end and a proximal end, an elongated support structure extending distally from the handle portion, and a guiding unit for the needle. The guiding unit is arranged to guide the needle in a direction parallel to the support structure such that the needle has a first radial distance from a center of the support structure, a pushing element for the needle being slidably movable with respect to the support structure and being arranged to engage the needle and to push the needle in a distal direction, and a needle capture portion having a perforated structure circumferentially surrounding the support structure and having a collapsed state and an expanded state, wherein the surgical apparatus is arranged such that the perforated structure can be transferred from the collapsed state into the expanded state and vice versa, wherein in the expanded state theperforated structure has an outer contour having a second radial distance with respect to the center of the support structure being equal or larger than the first radial distance, and wherein in the collapsed state the perforated structure has an outer contour having a third radial distance with respect to the center of the support structure being smaller than the second radial distance.

[0075] Certain embodiments relate to a method for operating a surgical apparatus, wherein the surgical apparatus includes a handle portion having a distal end and a proximal end, an elongated support structure extending distally from the handle portion, and a needle capture portion having a perforated structure surrounding the support structure, wherein the method includes the steps guiding a needle with a suture thread attached thereto in a direction parallel to the support structure such that the needle has a first radial distance from a center of the support structure, transferring the perforated portion from its collapsed state into an expanded state, wherein in the expanded state an outer contour of the perforated structure has a second radial distance from the center of the support structure being equal or larger than the first radial distance, and pushing the needle in a distal direction into the perforated portion in its expanded state, transferring the perforated portion from its expanded state into a collapsed state, wherein in the collapsed state the outer contour of the perforated structure has a third radial distance with respect to the center of the support structure being smaller than the second radial distance, whereby the needle is captured by the perforated portion.

[0076] Various aspects are directed to a surgical apparatus for feeding a suture thread fastened to a needle through the edge area of a tissue opening reducing the blood flow from a vessel when inserting the surgical apparatus through a tissue opening into the vessel or when retracting the surgical apparatus through the tissue opening from the vessel.

[0077] Specific embodiments are directed to a surgical apparatus for feeding a suture thread fastened to a needle through an edge area of a tissue opening. The surgical apparatus includes a handle portion having a distal end and a proximal end, an elongated support structure extending distally from the handle portion, a guiding unit for the needle. The guiding unit is arranged to guide the needle in a direction parallel to the support structure such that the needle has a first radial distance from a center of the support structure, a pushing element for the needle being slidably movable with respect to the support structure and being arranged to engage the needle and to push the needle in a distal direction. A needle capture portion has a perforated structure circumferentially surrounding the support structure and has a collapsed state and an expanded state. The surgical apparatus is arranged such that the perforated structure can be transferred from the collapsed state into theexpanded state and vice versa. In the expanded state, the perforated structure has an outer contour having a second radial distance with respect to the center of the support structure being equal or larger than the first radial distance. In the collapsed state, the perforated structure has an outer contour having a third radial distance with respect to the center of the support structure being smaller than the second radial distance. The needle capture portion has a sheath and the surgical apparatus is arranged such that the perforated structure and the sheath are moveable to one another from a closed state to an open state and vice versa, wherein in the closed state the sheath covers at least part of a section of the perforated structure transferable from the collapsed state into the expanded state, and wherein in the open state the sheath exposes the perforated structure.

[0078] In certain embodiments, a needle capture portion has a perforated structure, which is covered by a sheath when inserting the surgical apparatus through the tissue opening or when retracting the surgical apparatus from the tissue opening. When inserting or retracting a surgical apparatus e.g. from an artery, the perforated structure of the needle capture portion may be located in the tissue opening allowing a blood flow from the interior space of the artery through the perforated structure out of the artery. By covering the perforated structure by a sheath at least when inserting the surgical apparatus into the vessel or retracting the surgical apparatus from the vessel, an undue amount of blood flow out of the vessel during insertion or retraction can be avoided.

[0079] In some implementations, the handle portion is not only used in order to hold the surgical apparatus, but also to provide one or a plurality of mechanical operating elements such as push buttons, slide buttons or operating wheels for manually operating the different elements of the surgical apparatus.

[0080] The terms “distal” and “proximal,” as used in the present application, denote opposite ends of an apparatus or a part thereof, wherein the “distal” end or “distal” direction during operation of the apparatus may refer to a location or direction away from the handle or external end, and the “proximal” end or “proximal” direction refers to a location or direction closer to the handle.

[0081] In some embodiments, an elongated support structure as characterized herein extends in a needle capture portion providing a stable core of the apparatus. While the elongated support structure may be shown extending distally from the handle portion, it may be provided in the handle portion itself. When operating the surgical apparatus the elongated support structure carrying other elements may be at least partly inserted into the tissue opening and fed through the tissue opening. The elongated support structure may be hollow,such as a hollow cylinder of bendable material, allowing the surgical apparatus to be a guide wire which is inserted into and fed through the support structure from a distal end of the support structure. Further, the support structure as well as the handle portion may be arranged such that the guide wire can be fed through the support structure and part of the handle portion in order to exit the handle portion, for example through a blood indicator port.

[0082] The surgical apparatus may feed a suture thread fastened to a needle through the edge area of the tissue opening and bring the needle together with the suture thread fastened thereto back out of the tissue opening in order to form a knot closing the tissue opening or to close the tissue opening otherwise, e.g. by use of a clip or clamp on the suture thread, afterwards. In order to do so, the needle may be guided such that is penetrates the tissue in an edge area of the tissue opening when the surgical apparatus is inserted through the tissue opening. A guiding unit may be used for the needle guiding the needle in a direction parallel to the support structure, for example in a distal direction, in which the guiding unit holds the needle in a distance from a center of the support structure such that the needle penetrates the tissue instead of being inserted through the tissue opening.

[0083] A radial distance from the center of the support structure may denote a distance in a direction perpendicular to the support structure measured from the center of the support structure. In a support structure having a radial symmetry, e.g. a hollow cylinder, this center may be formed by the axis of symmetry of the support structure.

[0084] In order to penetrate the edge area of the tissue opening, the needle may be slidably movable in a distal direction with respect to the support structure. The surgical apparatus may include a pushing element for the needle, to drive a sliding motion of the needle with respect to the support structure, and which itself is slidably movable with respect to the support structure and which is arranged to engage the needle and to push the needle in a distal direction.

[0085] After the needle has been pushed through the edge area of the tissue opening, it may be captured, moved to a radial position being closer to the center of the support structure than the first radial distance and moved through the tissue opening and out of the vessel together with the surgical apparatus. In an embodiment it is not only the needle that is captured by the perforated structure in the needle capture portion but also part of the suture thread fastened to the needle is captured by the perforated structure.

[0086] Certain embodiments involving a needle capture portion utilize a perforated structure circumferentially surrounding the support structure and having a collapsed state and an expanded state. In the expanded state, the perforated structure has an outer contourhaving a second radial distance with respect to the center of the support structure being equal or larger than the first radial distance. The outer contour of the perforated structure in its expanded state is at least as large as the first radial distance allowing the needle after having penetrated through the edge area of the tissue opening to enter into the perforated structure by a simple linear movement in a distal direction.

[0087] When collapsing the outer contour of the perforated structure reduces such that the outer contour of the perforated structure has a third radial distance with respect to the center of the support structure being smaller than the second radial distance. Thus, the needle captured in the perforated structure after the perforated structure is brought back into its collapsed state can be withdrawn together with the needle capture portion of the surgical apparatus out of the tissue opening. In certain embodiments, in the collapsed state the third radial distance of the outer contour is smaller than the first radial distance.

[0088] A “net” such as a perforated structure as implemented herein may include netting, a knitted fabric or a grid made of metal or plastic material. The perforated structure may be manufactured by forming meshes out of a strand of material or by cutting a grid into such a material, e.g. a hollow cylinder of metal or plastic material.

[0089] In a particular embodiment, the perforated structure includes a shape-memory alloy or a shape-memory polymer. Examples for shape-memory alloys are copper-based or NiTi- based shape-memory alloys. A shape-memory alloy is commercially available under its common name Nitinol.

[0090] The expanded state of the perforated structure may be stored by the shape-memory alloy or the shape-memory polymer, for instance as a perforated hollow cylinder. For instance, the shape-memory material may be pre-shaped or shaped by weaving the shapememory material into the required shape such that the shape is stored by the particular manufacturing of the perforated structure. In both cases, the perforated structure in an nontensioned condition may assume the shape of the perforated structure in its expanded state. A force may be applied when transferring the perforated structure from its expanded state to its collapsed state.

[0091] In a particular embodiment, the needle capture portion of the surgical apparatus includes a distal mounting component mounting a distal end of the perforated structure and a proximal mounting component mounting a proximal end of the perforated structure. The surgical apparatus may be arranged such that the distal mounting component and the proximal mounting component are movable to one another to vary a distance between the distal mounting component and the proximal mounting component, for example to movebetween a closed state and an open state. As such, altering the distance between the distal mounting component and the proximal mounting component of the perforated structure may transfer the structure between its collapsed state and its expanded state. Further, either the distal mounting component or the proximal mounting component may be fixed with respect to the support structure and the other mounting component is movable with respect to the support structure,

[0092] In a particular implementation, an operating component located at the handle portion moves the perforated structure and the sheath one another in order to alter the apparatus from the closed state to the open state and vice versa. There may be a single operating element for opening or closing the sheath and for transferring the perforated structure from its expanded state to its collapsed state or vice versa. For instance, when the perforated structure is in the collapsed state the sheath may be in the closed state. Further, the sheath may be arranged to cover the perorated structure in the closed state such that the perforated structure is not exposed to the outside environment of the surgical apparatus.

[0093] In another embodiment, the needle capture portion includes a distal mounting component and a proximal mounting component, one of the mounting components being fixed with respect to the support structure and the other mounting component fixed with respect to the support structure and the sheath are movable to one another to transfer the perforated structure and the sheath from the closed state to the exposed state.

[0094] When used in vascular surgery, the needle capture portion may be located at a position with respect to the wall of the vessel before the needle is distally pushed in order to penetrate the edge area of the tissue opening. To facilitate, the sheath may include a hole connecting the outside environment of the surgical apparatus with an interior space of the sheath to allow a blood flow from the outside environment into the interior space of the sheath. The onset of blood flow through the hole into the interior space of the sheath indicates that the hole must have been inserted through the tissue opening into the vessel such that blood from the vessel may flow through the hole. Thus the hole may be located at a longitudinal position of the sheath such that when the sheath is in its closed state a blood flow through the hole only onsets when the apparatus is in the correct position in order for the needle to penetrate the tissue in an edge area of the tissue opening.

[0095] In an embodiment a seal is located between the support structure and the sheath distally from the needle capture portion in order to prevent an unwanted or uncontrolled flow of blood from the perforated structure in a proximal direction of the apparatus.

[0096] One or more of the above aspects may be addressed utilizing a method for operating a surgical apparatus, wherein the surgical apparatus includes a handle portion having a distal end and a proximal end, an elongated support structure extending distally from the handle portion, and a needle capture portion having a perforated structure surrounding the support structure and a sheath, wherein the method includes the steps guiding a needle with a suture thread attached thereto in a direction parallel to the support structure such that the needle has a first radial distance from a center of the support structure, exposing the perforated portion by bringing the sheath into an exposed state, transferring the perforated portion from its collapsed state into an expanded state, wherein in the expanded state an outer contour of the perforated structure has a second radial distance from the center of the support structure being equal or larger than the first radial distance, and pushing the needle in a distal direction into the perforated portion in its expanded state, transferring the perforated portion from its expanded state into a collapsed state, wherein in the collapsed state the outer contour of the perforated structure has a third radial distance with respect to the center of the support structure being smaller than the second radial distance, whereby the needle is captured by the perforated portion, and covering at least part of the perforated portion in its collapsed state by the sheath.

[0097] As far as embodiments have been discussed with respect to a surgical apparatus or apparatus, they may also apply with respect to a method for operating such an apparatus or apparatus and vice versa. In particular, embodiments of the apparatus or apparatuses herein are suitable for carrying out a corresponding method for operating the apparatus.

[0098] Turning now to the figures, Figure 1 shows a suture apparatus 1, as may be implemented in accordance with one or more embodiments. The suture apparatus 1 includes a handle portion 2 having a proximal end 3 and a distal end 4, as well as a needle capture portion 5. The handle portion 2 includes a plurality of operating elements 6, 7, which when operated, i.e. pressed or slid by an operator of the surgical apparatus 1 drives the different elements of the suture apparatus 1. Furthermore, the handle portion 2 may include a plurality of indicator elements 8, 9, 10, 11 provided by windows in the outer shell 12 of the handle portion 2 and sliding elements in the windows indicating the state of operation of the suture apparatus 1. The outer contour of the handle portion 2 is designed under ergonomic considerations, to close a tissue opening, in particular an artificial tissue opening in a blood vessel, e.g. an artery.

[0099] The suture apparatus 1 may use over the wire (OTW) technology, in which a guide wire 15 is inserted in a blood vessel during a very early stage of a surgery. The sutureapparatus 1 has a hollow core that may be fed over the guide wire 15. To introduce the apparatus 1 into the blood vessel, the guide wire 15 is inserted into the distal tip 35 of the suture apparatus 1 and the apparatus automatically follows the guide wire. The guide wire 15 is further fed through the hollow support structure 16 into the handle portion 2. It exits the handle portion 2 through an indicator port 14.

[0100] The operation of the suture apparatus 1 starts when needle capture portion 5 is introduced to vascular tissue, such as a sidewall of an artery to be closed. An indicator hole 13 is connected by an internal tubing to indicator port 14 at the handle portion. Once the hole 13 is inserted into the artery, an onset of blood flow through the hole 13, through the internal tubing and out of the indicator port 14 indicates that the needle capture portion 5 of the suture apparatus 1 has been correctly placed in the artery and the actual operation of the suture apparatus 1 can commence.

[0101] Figure 2 shows a distal portion of the suture apparatus 1 of Figure 1 at an introduction stage, as may be implemented in accordance with one or more embodiments. An introducer shaft 101 is shown with a net cover shaft 102, needles 103 and a dilator shaft 104, which may include a hemostatic valve.

[0102] Figure 3 shows the distal portion of the suture apparatus of Figure 1 at a net expansion stage, as may be implemented in accordance with one or more embodiments. Net 105 has been expanded, via retraction of the net cover shaft 102.

[0103] Figure 4 shows the distal portion of the suture apparatus of Figure 1 with the net expanded and needles pushed, as may be implemented in accordance with one or more embodiments. Needle pushers, including needle pusher 106, operate to push needle tips with sutures attached (including suture 107). Figure 5 shows the distal portion of the suture apparatus of Figure 1 with the needle pusher 106 retracted, and Figure 6 shows the distal portion of the suture apparatus with the needles captured, as may be implemented in accordance with one or more embodiments. As shown in Figure 6, the net cover shaft 102 is within the introducer shaft 101.

[0104] Figure 7 shows a distal shaft portion of the introducer shaft 101 and capture net 105 of the suture apparatus of Figure 1 , as may be implemented in accordance with one or more embodiments. A blood indicator hole 108 is provided in the net cover shaft (or sleeve) 102, for flowing blood in response to the needles and net being introduced to an opening in a vessel wall.

[0105] Figure 8 shows the net 105 and sleeve 102 of the suture apparatus of Figure 1 , as may be implemented in accordance with one or more embodiments. Pulling back a capturehandle (e.g., as may be implemented with 7) simultaneously pulls back the net sleeve and the net, exposing the net and the expansion thereof (e.g., in an artery). This expanded net forms a “stabilizing foot” thereby providing stability when the needles are deployed. An artery wall may be held between the expanded capture net and the distal end of the outer sheath.

[0106] Figure 9 shows the distal portion of the suture apparatus of Figure 1 with the needle pushers advanced, as may be implemented in accordance with one or more embodiments. For reference, needle pusher 106 is shown pushing a needle 109. Four needle pushers (which are located inside the shaft) are shown, and move towards the distal end of the shaft. Each needle pusher has a needle with a suture attached at its distal tip end. The needle pushers have a pointed tip that slots into the base of a needle, and ensures that the needle doesn’t slip off during deployment. The needle pushers may push the needles through an artery wall at an adequate separation (e.g., 16Fr) to provide sufficient distance from the edge of the arteriotomy hole to prevent the sutures tearing through but not too much to result in deformation of the closed arteriotomy (which could cause vessel constriction and restrict blood flow). Operation of the needle pushers may be carried out via operating element 6.

[0107] Figure 10 shows the distal portion of the suture apparatus of Figure 1 with the needle pushers retracted, as may be implemented in accordance with one or more embodiments. The needle pushers may be withdrawn by sliding the operating element 6 away from the distal end, towards the back of the handle to its original position. This leaves the four needles (including needle 109) inside the capture net 105 with sutures attached.

[0108] Figure 11 shows the distal portion of the suture apparatus of Figure 1 with the capture net 105 with needles collapsed, as may be implemented in accordance with one or more embodiments. The capture net 105 with needles (including needle 109) is collapsed back to its original shape by pushing the capture handle (e.g., 7) and securely traps the needles inside with the attached sutures. The net 105 may be implemented with holes of about 0.7 mm in size, and the needles may be sized accordingly such that they are unable to be pulled out of the net.

[0109] Figures 12-16 shows the suture apparatus 1 inserted into vascular tissue in respective steps in which Figure 12 shows the apparatus inserted into a vessel wall 110, and Figure 13 shows the suture apparatus with its net 105 expanded. Figure 14 shows the needles penetrating the net 109 with sutures 107 attached, as being pushed by pushers 106. Figure 15 shows the needles retracted, and Figure 16 shows the net relaxed, as may be implemented in accordance with one or more embodiments.

[0110] The following example may be implemented with the apparatus 1 for suturing an opening in a vessel. A net forms a hollow cylinder around a support structure having a rather small outer contour in order to be introduced and retracted into and from an artery. In a collapsed state, the net is protected by a sheath formed by a hollow cylinder. The sheath is slideable with respect to the support structure such that it can be moved from a closed state to an open state. When the sheath is retracted from the net, the net provides a bridge between the inner space of the vessel and its outside environment, e.g., muscle tissue or subcutaneous layer. In this position the wall of the vessel would be located somewhere between the distal and proximal mounting aspects of the net. The sheath may be closed when the needle capture portion is inserted into the vessel or retracted out of the vessel to mitigate blood flow through the net. The net may be manufactured of a shape-memory alloy, which facilitates expansion of the net to an expanded state corresponding to the shape-memory alloy.

[0111] Accordingly, the net may capture needles attached to suture threads. Needles may be located in a guiding unit formed by a slot between the outer sheath and a guiding portion of the sheath. This guiding unit may hold needles in a first radial distance from the center of the support structure. When the needle capture portion is inserted into an artery such that the wall of the artery is located slightly distally from the distal end of the outer sheath, the needles can penetrate the outer wall of the artery to be closed. In order to drive the needles in a distal direction, a pushing element may engage and move the needles in the distal direction and the needles penetrate through an edge area of the wall surrounding the opening in the vessel.

[0112] Once the needles have fully entered the net in its expanded state, the net may be collapsed by stretching the net while capturing the needles, which may move radially inward relative to one another. With the net in a collapsed state, the sheath may be closed and the apparatus can be retracted from the vessel. Suture threads attached to the needles form an open loop entering the artery through the walls and exiting the artery through the opening in the wall.

[0113] Figures 17-21 show respective suture patterns that may be implemented in accordance with one or more embodiments. Each figure shows two sutures A and B in a sidewall of vascular tissue 201. The sutures may be implemented using the apparatus 1 as characterized in the figures above, to form patterns 202-206 as depicted in a top view for Figures 17-21, respectively.

[0114] Figure 22 shows a handle 300 for a suture apparatus, as may be implemented in accordance with one or more embodiments (and including those discussed with the otherfigures herein). The handle 300 may be implemented, for example, with the apparatus 1 of Figure 1 (and ensuing figures). The handle 300 includes a spiral transmission 301 to pull the distal end of a capture net via wire / connector 305, causing the net to expand while simultaneously pulling a net sleeve that covers the net (which may mitigate or prevent potential blood loss via the capture net) via wire / connector 306, allowing it to expand. The spiral transmission 301 has teeth that engage with teeth 302 and, as actuator 303 is moved, moves forward or backward to retract or expand the capture net. For instance, when the connected end is pulled back, the capture net may be pulled back and shortened, thereby expanding the capture net to a predetermined shape and size (nitinol memory). The spiral the transmission may be implemented with a variety of transmission ratios, for example from 3 / 1 to 2 / 1.

[0115] Figures 23 A-23C show respective positions of the handle 300 of Figure 22 as may be implemented in accordance with one or more embodiments. Figure 23A shows the position of components when pulling the net via 305, Figure 23B shows the position of components when pulling the net sleeve, and Figure 23C shows the pushing of needles via slider 304 as used to push needle pushers via 307, as characterized herein.

[0116] Figure 24 shows a single layer net, as may be implemented in accordance with one or more embodiments. The net is depicted in a relaxed state 400, and in an expanded state 401. Figure 25 shows a double layer net, as may be implemented in accordance with one or more embodiments. The double layer net is depicted in a relaxed state 410, and in an expanded state 411. Each net may be utilized in connection with various embodiments as depicted herein.

[0117] Figure 26 shows needles coupled to sutures and needle pushers, as may be implemented in accordance with one or more embodiments. Needles 500 and 501 are respectively pushed by pushers 510 and 511. Sutures 520 and 521 are respectively coupled to the needles.

[0118] Figures 27-28 show apparatuses with needle pushers and shafts having different distal end shapes, as may be implemented in accordance with one or more embodiments as depicted herein. Figure 27 shows vertically separated needle pushers 600 and a blunt shaft, in accordance with one or more embodiments. Figure 28 shows horizontally separated needle pushers 601, with a blunt shaft as may be implemented in accordance with one or more embodiments. Figure 29 shows a beveled shaft 612 with horizontally separated needle pushers 602, in accordance with one or more embodiments.

[0119] Figures 30-32 show distal shafts with respective end shapes, as may be implemented in accordance with one or more embodiments. Figure 30 shows a tapered shaft 620 and a haft 630 extending therefrom. Figure 31 shows a distal shaft 621 having a blunt end and shaft 631 extending therefrom, as may be implemented in accordance with one or more embodiments. Figure 32 shows a distal shaft 622 having a beveled end and with shaft 632 extending therefrom, as may be implemented in accordance with one or more embodiments.

[0120] Figures 33-36 show a clip delivery apparatus 700, as may be implemented in accordance with one or more embodiments. The apparatus 700 includes a handle 701, shaft 702, preloaded clip 703, suture threader 704 and suture hook 705, as well as buttons (1-3) 706, 707 and 708. Figure 34 shows the clip delivery apparatus of Figure 33 with the suture threader 704 hooked into sutures 709 for threading through the clip 703, as may be implemented in accordance with one or more embodiments. Figure 35 shows the clip delivery apparatus of Figure 33 with sutures being cut (portions 710) in response to movement of button 2 (707), as may be implemented in accordance with one or more embodiments. Figure 36 shows the clip delivery apparatus of Figure 33 with the clip 703 released via button 3 (708), as may be implemented in accordance with one or more embodiments. Movement of button 3 pulls back outer sleeve 711 allowing spring clamps 712 to open and release the clip 703.

[0121] Figure 37 shows a suture threader 720 as may be implemented for the clip delivery apparatus of Figure 33, in accordance with one or more embodiments. The threader 720 includes a hook end to capture sutures, for example to facilitate pulling through a clip. The threader may snap onto an underlying shaft 722 via coupler 723, for example as depicted in Figure 34.

[0122] Figure 38 shows a cross-sectional view of a clip 730 and plug 731, as may be implemented in accordance with one or more embodiments. The plug 731 may be inserted into a center region of the clip 730, for securing a suture 732 therein. The plug may include a notch 733 for receiving a pusher rod, implemented for pushing the plug into the opening of the clip for a desired fit (e.g. a friction and / or shape fit, in instances where the shape of the outer surface of the plug may match an inner surface of the opening in the clip). Figure 39 shows the clip and plug of Figure 38 with the plug inserted into the clip, securing the suture 732. Deformable materials of the clip and / or the plug and / or the sutures may be used to additionally provide form fixation

[0123] Figures 40-46 show a clip deployment apparatus 800, as may be implemented in accordance with one or more embodiments. Referring to Figure 40, which shows cross- sectional and side views A and B respectively, the apparatus includes a suture trimmer tube 801 and plug pusher rod 802 within an outer sleeve 803. A plug 804 is coupled to the end of the plug pusher rod 802. A suture threader having a hook 805 engages with sutures 806 for pulling them through clip 807, which his held and released via a spring based holder 808.

[0124] Figure 41 shows the clip deployment apparatus 800 shows the sutures hooked and fed through the clip 807, as may be implemented in accordance with one or more embodiments. In Figure 42, the clip deployment apparatus 800 with plug 804 and plug pusher rod 802 having inserted the plug into the clip 807 (e.g., using button 1), as may be implemented in accordance with one or more embodiments.

[0125] Figure 43 shows the clip deployment apparatus 800 with the pusher rod withdrawn, as may be implemented in accordance with one or more embodiments. The plug 804 remains in the clip 807, securing the sutures therein. Figure 44 shows the clip deployment apparatus 800 with sutures being cut (portions 809), as may be implemented in accordance with one or more embodiments.

[0126] Figure 45 shows the clip deployment apparatus of Figure 40 with the clip released, as may be implemented in accordance with one or more embodiments. The clip may be released by sliding a button (e.g., button 3 as shown in Figure 36) backwards, which pulls back the outer sleeve allowing spring clamps 810 to open and release the clip 807.

[0127] Figure 46 shows the clip deployment apparatus of Figure 40 with the outer sleeve 803 pulled back and the clip 807 allowed to remain engaged with tissue, as may be implemented in accordance with one or more embodiments.

[0128] Based upon the discussion and illustrations herein, those skilled in the art will readily recognize that various modifications and changes may be made to the various embodiments without strictly following the exemplary embodiments and applications illustrated and described herein. For example, various embodiments referring to insertion into an artery or other vascular tissue may be implemented for insertion into other tubular structures, for example such as flexible tubing. Such modifications do not depart from the true spirit and scope of various aspects of the invention, including aspects set forth in the claims.

Claims

What is Claimed is:

1. An apparatus comprising: a shaft; an expandable and collapsible net coupled to the shaft for insertion into an opening in a tubular sidewall of vascular tissue; a plurality of needles coupled to the shaft; for each needle, a suture coupled to the needle and to another one of the needles; for each needle, an actuator to: deploy the needle and the suture coupled to the needle through the sidewall and into the net, with the net inserted within the vascular tissue; and retract, leaving the needle extending through the sidewall and into the net; and the net being configured and arranged with the shaft to, with the needles embedded in the net, retract from the vascular tissue and, via the retraction, draw the needles out of the vascular tissue along with ends of the sutures coupled to the needles, therein closing the opening in the vascular tissue.

2. The apparatus of claim 1, further including a retractable sleeve configured to extend over the net in a collapsed state, and to retract to allow the net to expand in an expanded state.

3. The apparatus of claim 1, further including: an access wire via which the net and plurality of needles are inserted into the vascular tissue; and an elongated support structure through which the access wire, shaft and net extend, a distal tip of the elongated support structure having a lumen to pass blood and the access wire, wherein the shaft is configured to follow guide wire for placement of the needles.

4. The apparatus of claim 1 , wherein the net is configured to lock in place within the vascular tissue via expansion therein and engagement with the tubular sidewall.

5. The apparatus of claim 4, further including a handle at a proximal end of the apparatus and coupled to the net at a distal end of the apparatus, the handle being configured to expand the net in response to actuation of the handle in a first direction.

6. The apparatus of claim 5, wherein the net is configured to move toward the handle in response to the actuation.

7. The apparatus of claim 5, wherein the handle is configured to collapse the net in response to actuation of the handle in a second direction that is different than the first direction.

8. The apparatus of claim 5, further including: an elongated support structure extending distally from the handle; a guide for the needles to guide the needles in a direction parallel to the support structure; a pushing component slidably movable with respect to the elongated support structure and to push the needles in a distal direction away from the handle; and a sheath movable relative to the net, wherein: the needles are arranged at a first radial distance from a center of the elongated support structure, and in an expanded state, the net has an outer contour having a second radial distance with respect to the center of the support structure that is equal or larger than the first radial distance; in a collapsed state, the net has an outer contour having a third radial distance with respect to the center of the support structure that is smaller than the second radial distance; and the sheath covers at least part of a section of the net in the collapsed state and exposes the net in the expanded state.

9. The apparatus of claim 8, wherein the sheath includes an opening to allow blood flow into the sheath, the opening being located at a longitudinal position in the sheath such that when the sheath is in its closed state blood flow through the opening indicates that the net and needles are located in an operating position, further including a seal between the support structure and the sheath to prevent blood flow from the in a proximal direction.

10. The apparatus of claim 8, wherein the pushing component is configured to push all needles simultaneously.

11. The apparatus of claim 8, wherein the pushing component is configured to push pairs of the needles separated vertically relative to one another.

12. The apparatus of claim 8, wherein the pushing component is configured to push pairs of the needles separated horizontally relative to one another.

13. The apparatus of claim 8, wherein the pushing component is configured to push pairs of the needles separated horizontally and offset relative to one another, with a first pair of the needles positioned forward relative to a second pair of the needles.

14. The apparatus of claim 5, wherein the handle includes step indicators that change color in response to respective steps involving the deployment of the apparatus and closing of the opening in the vascular tissue.

15. The apparatus of claim 5, wherein the handle includes an internal spiral mechanism to deploy the shaft for positioning the net and to withdraw a sleeve from around the net.

16. The apparatus of claim 1, wherein closing the opening in the vascular tissue includes pulling the sutures to close an arteriotomy opening in a circular fashion.

17. The apparatus of claim 1, wherein closing the opening in the vascular tissue includes tightening a clip against the sidewall.

18. The apparatus of claim 1, wherein the shaft has a distal end selected from the group of: a tapered end; a blunt end to facilitate deployment of the needles at the same level relative to the tubular sidewall; and a beveled end to facilitate delivery of the shaft at an angle relative to the tubular sidewall.

19. The apparatus of claim 1, wherein a distal tip of the shaft has a width that transitions from a narrower width to a wider width along a length of the shaft.

20. The apparatus of claim 1, wherein the net is a double layer net configured to capture ones of the needles between the respective layers of the net.

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