Patent Description:
This disclosure relates generally to tissue fastening. More particularly, the present disclosure includes fastening mechanisms for medical devices and related methods of using the fastening mechanisms.

Interventional and therapeutic procedures oftentimes require closure of a tissue site, e.g., the gastrointestinal tract wall, as part of the procedure. Closure may be accomplished via the use of a fastening component, e.g., a clip or staple. The fastening component may be delivered to a site through a channel of a medical device, e.g., an endoscope, or may be attached over the scope. An issue with common over-the-scope fastening components is the quick deployment of the fastener to the targeted tissue site, without the ability unfasten and reposition the fastener to a more desired or correct site. <CIT> relates to a system for delivering a surgical clip to a surgical site within a patient' s body to compress body tissue. <CIT> relates to methods, devices, and systems for the endovascular, percutaneous or minimally invasive surgical treatment of bodily tissues, such as tissue approximation or valve repair. <CIT> relates to an apparatus for applying clips to tissue, comprises a plurality of clips, each of the clips including a proximal end having a pair of opposed jaws and a distal end including a linking feature. Wo <CIT> relates to a system for compressing body tissue including a clip having first and second tissue contacting surfaces. <CIT> relates to a tissue clip application fitting set or retrofitting set with a cap attachment for placement on the distal head of a medical endoscope of the shaft type. <CIT> relates to a resection device for resection of a tissue, for instance a stomach wall or a colon.

The invention is specified by the independent claim. In the following description, although numerous features may be designated as optional, it is nevertheless acknowledged that all features comprised in the independent claim are not to be read as optional. According to an example, a medical device may comprise a fastening assembly, wherein the fastening assembly includes an adapter defining an opening therethrough, a fastener releasably coupled to the adapter, wherein the fastener includes at least two jaws pivotable relative to one another, the fastener having a first configuration wherein the jaws are open and a second configuration wherein the jaws are closed, and at least one cable coupled to the fastener and the adapter, the at least one cable being configured to apply tension to the fastener to transition between the first configuration and the second configuration while the fastener is coupled to the adapter, and to control release of the fastener from the adapter.

In another example, the adapter may be a tubular shape configured to receive a distal end of a shaft. The adapter may include a resistance element coupled to the fastener, wherein the resistance element biases the fastener towards the first configuration, and wherein a tension force applied to the at least one cable transitions the fastener towards the second configuration against the bias of the resistance element. In the second configuration, the jaws of the fastener may extend along planes parallel to each other. The fastener may be biased towards the second configuration. Each of the at least two jaws may include at least one edge configured to grip or penetrate tissue. The fastener may include a first jaw coupled to a second jaw at each of a first pivot and a second pivot.

In another example, the at least one cable may include a first cable and a second cable. The first cable may be coupled to the first pivot and the second cable is coupled to the second pivot, wherein tensioning the first cable and the second cable pivots the first jaw relative to the second jaw. The at least one cable may include a frangible portion, the frangible portion being attached to the fastener and the adapter, and wherein breaking the frangible portion by tensioning the at least one cable releases the fastener from the adapter. A tensioning force sufficient to break the frangible portion may be greater than a tensioning force sufficient to transition the fastener between the first configuration and the second configuration.

In another example, the medical device may further include a shaft and a handle operably coupled to a proximal end of the shaft, wherein the adapter is coupled to a distal portion of the shaft and the at least one cable extends through the shaft from the adapter to the handle.

According to another example, a medical device may comprise a fastening assembly, wherein the fastening assembly includes an adapter, a fastener releasably coupled to the adapter, wherein the fastener includes a first jaw pivotable relative to a second jaw, the first jaw and the second jaw being open in a first configuration of the fastener and closed in a second configuration of the fastener, a first cable coupled to the fastener, wherein tensioning the first cable transitions the fastener between the first configuration and the second configuration, and a second cable coupled to the fastener or the adapter, wherein tensioning the second cable releases the fastener from the adapter. Tensioning the second cable may translate the fastener distally relative to the adapter. The medical device may further comprise a shaft, a connector, and a handle operably coupled to a proximal end of the shaft, wherein the adapter is coupled to a distal portion of the connector, the connector is coupled to a distal portion of the shaft, and the first and second cables extend proximally through the connector from the adapter to the handle. The medical device may further comprise a spring within the lumen of the connector adjacent to the adapter. Tensioning the second cable may move the adapter proximally, against a resistance of the spring. The proximal movement of the adapter may shear the first cable from the fastener, thereby releasing the fastener from the adapter. The connector may include an opening and a tube fixed to a proximal surface of the connector, wherein the tube is configured to receive the first cable and the second cable extending through a lumen of the connector and the opening.

According to an example, a method of fastening tissue may comprise inserting a medical device into a natural orifice of a subject, wherein the medical device includes a fastening assembly coupled to a distal portion of a shaft of the medical device, the fastening assembly including a fastener, an adapter, and at least one cable coupled to the fastener and the adapter, positioning the fastening assembly adjacent to a target site, applying tension to the at least one cable to close the fastener onto tissue at the target site while the fastener is coupled to the adapter, and applying further tension to the at least one cable to release the fastener from the adapter.

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the present disclosure through exemplary embodiments.

Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term "distal" refers to a portion farthest away from a user when introducing a device into a subject (e.g., a patient). By contrast, the term "proximal" refers to a portion closest to the user when placing the device into the subject.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, "about," "substantially," "generally," and "approximately," are used to indicate a possible variation of ±<NUM>% in a stated value or characteristic.

Embodiments of this disclosure may address one or more of the limitations in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem. The disclosure is drawn to medical devices including fastening mechanisms, and related methods, among other aspects.

An exemplary medical system may include, as an example, a suitable scope (e.g., bronchoscope, duodenoscope, endoscope, colonoscope, ureteroscope, etc.), catheter, tool, instrument, or the like, having a shaft/catheter that extends distally from a handle to a distal portion of the device. The shaft of such medical devices may be any suitable flexible shaft configured to traverse bodily lumens during a medical procedure. The shaft may include at least one lumen for receiving additional devices, e.g., scopes, tools, instruments, cables, or the like. Thus, the shaft may serve as a sheath or a guide for the aforementioned additional devices, which may extend distally through the shaft. Similarly, the handle may be any suitable medical device handle. The handle may include components for actuating or otherwise controlling the medical device, tools or devices associated with medical device, and/or the fastening mechanism(s) of the medical device.

The fastening mechanism may include an adapter, a fastener, and control members or elements (e.g., control cables or wires, etc.). The adapter is any suitable component that may be coupled to a distal end of the shaft. The adapter may comprise any suitable biocompatible material or combination of materials. The manner by which the adapter may be coupled to a distal end of a shaft of a scope or other suitable medical device may depend on the shape of the adapter. For example, in some examples, the adapter may be generally cylindrical or tube-shaped, including a longitudinal opening. The dimensions may be selected so that the adapter may be fitted over a distal portion of the shaft/scope, e.g., wherein the opening may be of such a diameter so that the adapter is fitted tightly/snugly over said shaft. In another example, the dimensions of a generally cylindrical or tube shaped adapter may be selected so that the adapter may be securely fitted within a distal opening of a shaft. Thus, the adapter may be any suitable shape that may couple to a distal portion of a shaft. The adapter may further include additional components and features that may assist in holding a fastener, in its pre-deployed state, as further discussed below.

The fastener may be configured as a clip or staple, for example. Exemplary materials suitable for the fastener include biocompatible metals and metal alloys such as, e.g., stainless steel, nitinol, etc. The fastener may include at least one jaw, e.g., two, three, or more jaws, etc., which may include features for grasping or otherwise securing tissue. For example, the fastener may include two jaws, each of which may include one or more edges or teeth, e.g., one two, three, etc., configured to penetrate the targeted tissue. In some examples, the fastener includes two jaws that are separate components coupled to one another, via a pair of suitable pivots/hinges. In some examples, the fastener includes two jaws formed from a single piece, wherein the single piece is further molded or shaped to form pivots between the two jaws, e.g., in the manner of a living hinge. In such examples wherein the fastener includes two jaws, the two jaws may pivot relative to one another, individually or simultaneously, and the fastener may be in an open (e.g., pre-deployed) state or a closed (e.g., deployed) state.

Thus, for example, the fastener may be capable of transitioning between different configurations in order to deploy the fastener in tissue and reposition the fastener before complete deployment, as further discussed below. The fastener may be configured to adopt a flat state wherein the jaw(s) are closed, and an arched state wherein the jaw(s) may be either open or closed. The jaw(s) of the fastener may be biased to adopt a closed, flat state. In the default flat state of a fastener having two jaws and two pivots at respective junctions between the jaws, the fastener may be relatively linear from one pivot to the other pivot, so that the fastener extends along a plane that includes both pivots. In the arched state, the fastener, regardless of the jaws being open or closed, may be bent or arched at a mid-point between the pivots so that the pair of pivots face one another. Such fasteners may comprise a flexible, elastic material, e.g., nitinol, to allow the fastener to adopt the arched shape, while having sufficient strength to fasten on to tissue. The fastener, in the arched state, may be mounted onto an adapter so that the pivots are secured or coupled onto a distal portion of the adapter. Thus, the arched state may represent a pre-deployment state of the fastener, whereas the flat state may represent a deployed state of the fastener. The fastener, which may comprise an elastic material, may transition from the arched state to its pre-deployment, default state, such that the pivots rotate from being perpendicular to the jaws to being co-planar with the jaws.

The control members may be any suitable cables or wires, e.g., steel cables, coupling the fastener to the handle of the medical device. For example, control cables may connect the fastener to features or aspects of the handle that may be actuated to apply tension onto the control cables. The tensioning and relaxation of the control cables may transition the fastener between an open and closed state.

Control cables may also assist in maintaining the fastener onto the adapter, prior to the fastener's deployment. For example, one pair, two pairs, or three or more pairs of control cables may be used to actuate the fastener during deployment. In some examples, to deploy the fastener, the portions of the control cables holding the fastener may be shearable or frangible, so that the fastener may be released when sufficient tension is applied to the cables.

Referring to an exemplary system shown in <FIG>, a medical device <NUM>, e.g., an endoscope, is shown. Medical device <NUM> includes a sheath <NUM>, a handle <NUM> coupled to a proximal portion of sheath <NUM>, and a shaft <NUM>, shaft <NUM> extending through sheath <NUM>, and fastening component <NUM> mounted over a distal portion of scope <NUM>. It is noted that fastening component <NUM> is not limited to being mounted over shaft <NUM>, as shown in the examples of <FIG>. In some embodiments, fastening component <NUM> may be mounted over other devices extending through shaft <NUM>, or may be mounted on sheath <NUM> itself. It is also noted, the device <NUM> may be without sheath <NUM>.

Handle <NUM> may include at least one aspect for actuating or controlling medical device <NUM>, e.g., shaft <NUM>, and for transitioning a fastener <NUM> between open and closed states in order to deploy fastener <NUM>. Sheath <NUM> may be flexible and cover at least a portion of shaft <NUM>. Shaft <NUM> may extend from handle <NUM> to a distal portion or end of medical device <NUM>. As discussed above, shaft <NUM> may be any suitable biocompatible and flexible shaft. As shown in <FIG>, shaft <NUM> includes a lumen defining a working channel <NUM>, through which accessory devices or instruments may be introduced. Shaft <NUM> further includes an imager <NUM> at a distal end <NUM> of shaft <NUM>. Imager <NUM> may be any suitable imaging component.

Fastening component <NUM> includes an adapter <NUM>, fastener <NUM>, e.g., a clip, and a pair of cables 300a, 300b. Adapter <NUM> as shown is tubular in shape, including a longitudinal opening with suitable dimensions for receiving a distal portion of scope, so that adapter <NUM> may be fitted over the distal portion of shaft <NUM>. Adapter <NUM> may include an opening of any suitable diameter that allows adapter <NUM> to have a snug or friction fit over shaft <NUM>, and minimize the displacement of adapter <NUM> with respect to shaft <NUM>.

The proximal portion of adapter <NUM> may be segmented circumferentially, and each segment, e.g., segments <NUM>, <NUM>, may be flexible and biased radially inwards. Thus, the proximal opening of adapter <NUM> may be of a smaller diameter than that of shaft <NUM>, but still be able to receive shaft <NUM>, as each of the segments (e.g., <NUM>, <NUM>) flex outwards to receive shaft <NUM>. Adapter <NUM> also includes a pair of projections, shown as pegs 110a, 110b (shown in <FIG>), extending outwards from a distal portion of adapter <NUM>. Pegs 110a, 110b are on directly opposite sides of adapter <NUM>, and are configured to assist in maintaining fastener <NUM> onto adapter <NUM>.

Adapter <NUM> further includes a resistive feature, e.g., a hoop <NUM>, as shown in <FIG>. Hoop <NUM> may comprise two wires or cables <NUM>, <NUM> formed of any suitable material providing sufficient flexibility. For example, cables <NUM>, <NUM> may comprise a nickel based alloy, a titanium based alloy, nitinol, medium to high carbon steels, spring steel, stainless steel, Inconel, and/or Elgiloy. As illustrated, hoop <NUM> is coupled to pegs 110a, 110b. Cable <NUM> extends between pegs 110a, 110b in a curved, semi-circular manner. Cable <NUM> also extends between pegs 110a, 110b in the same manner as cable <NUM>, but towards the opposite direction. Thus, cable <NUM> and cable <NUM> collectively form a hoop-like shape. Hoop <NUM> is biased towards a first, open state, in which cables <NUM>, <NUM> are transverse, e.g., perpendicular, to a longitudinal axis of adapter <NUM>. However, hoop <NUM> may flex when a sufficient force is applied against cables <NUM> and <NUM>. For example, cables <NUM> and <NUM> may be flexed towards a distal direction so that cables <NUM>, <NUM> pivot towards one another, thereby transitioning into a second, closed state. Hoop <NUM> may be coupled to fastener <NUM> and bias fastener <NUM> in an arched, open state, as shown in <FIG> and described in further detail below.

As discussed above, fastener <NUM> may transition between an arched state and a default, flat state. <FIG> and <FIG> illustrate fastener <NUM> mounted onto adapter <NUM> while in an open, arched state. Fastener <NUM> includes a first jaw <NUM> and a second jaw <NUM>. First jaw <NUM> and second jaw <NUM> each include a single tooth 220a, 220b, both of which are configured to penetrate a targeted site. It is noted that the shape of teeth 220a and 220b illustrated in the figures is exemplary only. For example, teeth 220a, 220b are shows as truncated ridges positioned proximate a mid-point of each jaw <NUM>, <NUM>. In other examples, the ridges may be pointed and/or may have multiple peaks that are truncated or pointed. Further, each jaw <NUM>, <NUM> may include a single tooth 220a, 220b as shown, or one or both jaw <NUM>, <NUM> may include two or more teeth, e.g., two, three, or four or more teeth.

As shown, the ends of first jaw <NUM> are coupled to corresponding ends of second jaw <NUM> by a pair of pivots/hinges 210a and 210b. Thus, pivot 210a and pivot 210b enable jaws <NUM>, <NUM> to pivot relative to each other, when fastener <NUM> is in an arched state. Pivot <NUM> and pivot 210b may each include a central opening 230a and 230b (shown in <FIG>). Central openings 230a, 230b may be configured to receive corresponding projections of adapter, e.g., pegs 110a, 110b, thereby allowing fastener <NUM> to be mounted onto adapter <NUM>.

A proximal portion of the inner surfaces of jaws <NUM> and <NUM> may respectively include hooks 240a, 240b. Hooks 240a and 240b protrude radially inwards towards adapter <NUM>. Hooks 240a, 240b are of a curved shape or rounded shape, e.g., c-shaped, so that they may grasp onto hoop <NUM>. The open or receiving ends of hooks 240a, 240b may be proximal facing so that the distal facing surface of hoop <NUM> is adjacent to hooks 240a, 240b. In some examples, hooks 240a, 240b may approach the open or receiving ends from an edge of adapter <NUM>, e.g., a proximal or distal edge, or an intermediate portion of adapter <NUM>. In some examples, hooks 240a, 240b may be more rigidly shaped, e.g., square-shaped, L-shaped, or angled than as depicted in <FIG>.

Hooks 240a, 240b may assist in further securing fastener <NUM> onto adapter <NUM> while fastener <NUM> is in an open, arched state. Moreover, hooks 240a, 240b couple fastener <NUM> to hoop <NUM> so that fastener <NUM> is biased towards an arched and open state. By application of a sufficient force onto jaws <NUM>, <NUM>, fastener <NUM> may transition towards a closed state, against the resistance provided by hoop <NUM>, and eventually a flat, deployed state. Such force may be applied onto fastener <NUM> by cables 300a, 300b, described in further detail below.

The default, flat state of fastener <NUM> is shown in <FIG>. In the flat state, fastener <NUM> is closed so that jaws <NUM> and <NUM> cross and are adjacent to one another. Furthermore, fastener <NUM> is relatively linear in shape, from one pivot 210a, 210b, to the other pivot 210a, 210b. The surfaces of pivots 210a, 210b may be co-planar in this configuration. In the flat state, fastener <NUM> is deployed and released from adapter <NUM> and cables 300a, 300b. An example of deploying fastener <NUM> is discussed below. It is noted that a flat fastener <NUM> may provide one or more benefit during a medical procedure including, but not limited to, serving as a tamponade to active bleeding, providing a low profile closure of a defect to pass a medical device (e.g., endoscope) beyond the repaired area without disruption to fastener <NUM> and the site , a constant closure force, and/or having a low delivered profile thereby allowing navigation past the area of tissue being clipped or otherwise fastened.

Cables 300a and 300b may be any suitable tensioning control elements, e.g., steel cables, each including both a first end and second end coupled to handle <NUM>. As shown in <FIG> and <FIG>, cables 300a and 300b may respectively be routed around pivots 210a, 210b so both ends of cables 300a and 300b return proximally to handle <NUM>, through a lumen of sheath <NUM>. The first and second ends of both cables 300a and 300b may connect to components of handle <NUM> such as control knobs, levers, or other control features, which may be actuated to apply tension onto cables 300a and 300b.

Cables 300a and 300b may be routed so that the tension applied to cables 300a, 300b causes jaws <NUM>, <NUM> to pivot relative to one another, thereby transitioning fastener <NUM> towards a closed state. For example, cables 300a and 300b may wrap around features of fastener <NUM> configured to pivot jaws <NUM>, <NUM> relative to one another. Said features may be, for example, pulley cams that are formed into jaws <NUM>, <NUM> of fastener <NUM>. Cables 300a and 300b may return to a proximal location (e.g., coupled to components of handle <NUM>) that allows application of a tensioning force on cables 300a, 300b, and said features of fastener <NUM> may translate the applied tension into torque/radial motion of jaws <NUM>, <NUM>. Therefore, by tensing or relaxing cables 300a, 300b, fastener <NUM> may be opened or closed as desired by the user. This may allow the user to repeatedly readjust the positioning of fastener <NUM>, even after fastener <NUM> has been closed onto tissue and before completely releasing fastener <NUM> from adapter <NUM>.

Cables 300a and 300b further include, respectively, frangible portions 310a and 310b. For example, the portions of cables 300a and 300b that are routed around pivots 210a, <NUM>0b that are thinner or otherwise configured to break upon application of force may represent frangible portions 310a, 310b. Frangible portion 310a, 310b may pull against fastener <NUM>, thereby causing jaws <NUM>, <NUM> to pivot relative to one another. In some examples, frangible portions 310a, 310b may be thinner portions of cables 300a and 300b more susceptible to breaking than other portions of cables 300a, 300b. Additionally or alternatively, frangible portions 310a, 310b may include linkages, e.g., welded and/or bonded connections, that are configured to break at a specified force or threshold force. It is noted that one or more portions of fastener <NUM> around which cables 300a, 300b are routed may be frangible as well.

The presence of frangible portions 310a and 310b enables a user to release and deploy fastener <NUM> from adapter <NUM> by applying a sufficient tension force to cables 300a and 300b. The amount of tension force sufficient to break frangible portions 310a, 310b from cables 300a, 300b may be greater than the tension force used to transition fastener <NUM> to a closed state. Thus, frangible portions 310a and 310b remain intact while fastener <NUM> is in an open state, and fastener <NUM> transitions to a closed state prior to it being deployed. Once frangible portions 310a and 310b of cables 300a, 300b are broken, pivots 210a, 210b translate radially outwards and away from pegs 110a, 110b of adapter <NUM>. Simultaneously, cables <NUM>, <NUM> of hoop <NUM> may translate proximally and revert to a biased position, thereby releasing themselves from hooks 240a, 240b of fastener <NUM>. Thus, fastener <NUM> reverts to its default, flat state and is released and deployed from adapter <NUM>.

Referring to <FIG>, an example of a method of applying a fastener, e.g., fastener <NUM>, is further discussed. A user may couple or mount fastening component <NUM> to a distal end of sheath <NUM> or shaft <NUM> of medical device <NUM>. Fastening component <NUM> may include fastener <NUM> mounted onto adapter <NUM> in an arched and open state. A user may deliver component <NUM> into the body of a subject, e.g., via a natural orifice (such as a mouth or anus) and through a tortuous natural body lumen of the subject, such as an esophagus, stomach, colon, etc. A user may direct fastening component <NUM> to an intended target site of tissue, optionally guided by imaging provided by imager <NUM>. Once the target site is reached, a user may engage actuators of handle <NUM> to apply tension to cables 300a, 300b, thereby closing fastener <NUM> onto tissue at the target site. A user may also reposition fastener <NUM> by releasing tension on cables 300a, 300b, thereby re-opening fastener <NUM> in order to move component <NUM> to a different position relative to the target site. The user then may re-apply tension onto cables 300a, 300b to close fastener <NUM> onto the new site. Once secured onto the desired target tissue, the user may apply increased tension onto cables 300a, 300b until frangible portions 310a, 310b are broken, and fastener <NUM> is released from adapter <NUM> and deployed onto the site in its default, flat (closed) state.

Referring to <FIG>, another example of a fastening component <NUM>' including fastener <NUM>' is shown. In this example, like reference numerals refer to similar features described above in connection to fastening component <NUM>, wherein fastening component <NUM>' and medical device <NUM>' may include any of the features of fastening component <NUM> and medical device <NUM>. Medical device <NUM>' includes shaft <NUM> coupled to fastening component <NUM>'. Shaft <NUM> may be any suitable biocompatible and flexible shaft. Shaft <NUM> includes a lumen, which may serve as a working channel through which any suitable accessory device or imager may extend therethrough. As shown, shaft <NUM> includes a protrusion, e.g., lip <NUM> that extends circumferentially and protrudes radially inward, towards a central axis of shaft <NUM>'. Lip <NUM> is configured to engage and secure a proximal portion of adapter <NUM>', as discussed in further detail below.

Fastening component <NUM>' includes a connector <NUM>, adapter <NUM>', fastener <NUM>', and cables <NUM>, <NUM>, and <NUM>. In some examples, fastening component <NUM>' also includes a tube <NUM>, as discussed below. Connector <NUM> as shown is tubular in shape, and includes a lumen <NUM> between its proximal and distal openings. Connector <NUM> includes an opening <NUM> (e.g., in a side of connector <NUM>), which may provide fluid communication between lumen <NUM> and the external environment. The opening <NUM> have any suitable shape that provides a passage for cables <NUM>, <NUM>, and <NUM> to pass through, for example to enter a lumen <NUM> of a tube <NUM> as further discussed below. Connector <NUM> optionally may include guiding components configured to hold and maintain cables <NUM>, <NUM>, and <NUM> along the inner wall of connector <NUM>.

Tube <NUM> may be flexible and comprise a biocompatible material. Further, tube <NUM> may be integrated into connector <NUM> or coupled to an external surface of connector <NUM> (e.g., fixed to connector <NUM> or detachable from connector <NUM>). For example, connector <NUM> and tube <NUM> may be a single, integral piece, or may be a separate attachment to connector <NUM>. Tube <NUM> maybe positioned proximal to opening <NUM>, and the distal end of tube <NUM> may be adjacent to opening <NUM>. Thus, tube <NUM> may be positioned relative to opening <NUM> so that cables <NUM>, <NUM>, and <NUM> may extend proximally through opening <NUM> and into lumen <NUM> of tube <NUM>, towards a handle (further discussed below). In some examples, tube <NUM> may extend proximally until it reaches a handle component.

It is noted that in some examples, fastening component <NUM>' does not include tube <NUM> and/or connector does not include opening <NUM>. In such cases, for example, cables <NUM>, <NUM>, and <NUM> may extend proximally, through the lumen of shaft <NUM>, towards a handle.

Referring again to <FIG>, the proximal opening of connector <NUM> receives shaft <NUM> and the distal opening of connector <NUM> receives adapter <NUM>'. The proximal opening of connector <NUM> may have as cross-sectional size (e.g., a diameter) configured to receive a distal portion of shaft <NUM> so that shaft <NUM> may be securely fitted onto connector <NUM>. For example, connector <NUM> may be secured onto shaft <NUM> via a frictional fit. The distal end of connector <NUM> as shown includes a protrusion, e.g., a lip <NUM>, that extends circumferentially and protrudes radially inward, towards a central axis of connector <NUM>. Thus, connector <NUM> may be coupled to adapter <NUM>' via lip <NUM> engaging with a proximal portion of adapter <NUM>', as further discussed below.

Adapter <NUM>' as shown is tubular in shape with a lumen extending along its longitudinal axis. A proximal portion of adapter <NUM>' includes a recess <NUM> that extends circumferentially about the outer surface of adapter <NUM>'. Recess <NUM> may be of sufficient depth to receive and engage with lip <NUM> of connector <NUM>. Thus, adapter <NUM>' may be secured onto shaft connector <NUM> via the engagement between recess <NUM> and lip <NUM>. Adapter <NUM>' further includes a first opening <NUM> and a second opening <NUM>. Openings <NUM>, <NUM> are on opposite sides of a proximal portion of adapter <NUM>', distal to shaft <NUM>'. Openings <NUM>, <NUM> are in at least partial alignment with corresponding openings 234a, 234b of fastener <NUM>', and are configured to receive cables <NUM> and <NUM>, as discussed in further detail below.

The outer surface of adapter <NUM>' further includes a recessed portion defining a channel <NUM>, and a distal edge <NUM> curved proximally defining a distal passage <NUM>. Channel <NUM> extends distally from opening <NUM> to distal passage <NUM>. Distal edge <NUM> may be a distal portion of adapter <NUM>' onto which cable <NUM> may rest and apply tension against. Thus, cable <NUM> may translate or ride on edge <NUM>, similar to a pulley configuration, as cable <NUM> is pulled proximally. It is noted that the distal portion of adapter <NUM>' may further include a pin, a pulley cam, or another similarly functioning component for cable <NUM> to ride on, instead of edge <NUM>. Adapter <NUM>' may also further include a pair of projections, e.g., pegs 120a, 120b, protruding radially outwards from a distal portion of adapter <NUM>', e.g., opening 120a. Pegs 120a, 120b are on directly opposite sides of adapter <NUM>', and assist in maintaining fastener <NUM>' onto adapter <NUM>'.

Like fastener <NUM> of <FIG> and <FIG>, fastener <NUM>' is also configured to adopt an arched state (as shown in <FIG>) and a default, flat state (similar to <FIG> for fastener <NUM>). <FIG> illustrate fastener <NUM>' mounted onto adapter <NUM>' while in an open, arched state. However, unlike fastener <NUM>, fastener <NUM>' is a single piece. The two jaws <NUM>', <NUM>' of fastener <NUM>' may be formed from a single piece of material, wherein the material is molded or shaped to form pivots 210a', 210b' between jaws <NUM>', <NUM>'. In some examples, jaws <NUM>', <NUM>' may comprise a first material, e.g., stainless steel, and pivots 210a', 210b', may comprise a second, different material, e.g., nitinol. In some examples, spring members, e.g., torsional springs, in place of pivots 210a', 210b', may be coupled to jaws <NUM>', <NUM>',.

Each jaw <NUM>', <NUM>' include a plurality of teeth <NUM>' configured to penetrate tissue of a target site. Teeth <NUM>' may be any suitable shape, e.g., pointed, tapered, rounded, straight edged, and/or may include needle pins to anchor to issue. Both pivots 210a', 210b' include central openings 230a', 230b' configured to receive the aforementioned pegs 120a, 120b of adapter <NUM>', thereby allowing fastener <NUM>' to be mounted onto adapter <NUM>'. Fastener <NUM>' may comprise any suitable flexible material, e.g., nitinol, and fastener <NUM>' may be manipulated or adjusted so that fastener <NUM>' is biased to a flat, closed state. Thus, fastener <NUM>' may be held in an arched, open state, against its bias, with the assistance of cables <NUM>, <NUM>, <NUM>, as further described below.

Furthermore, both jaws <NUM>', <NUM>' include respective protrusions 233a and 233b. Protrusions 233a, 233b extend proximally from the proximally facing edges of jaws <NUM>', <NUM>' at the midpoint between pivots 210a' and 210b', while fastener <NUM>' is in an arched, open state. Both protrusions 233a, 233b include cable openings 234a and 234b, respectively, and cable passages 235a and 235b, respectively. Openings 234a, 234b are positioned centrally on protrusions 233a, 233b. Passages 235a, 235b may be defined by the proximal edges of protrusions 233a, 233b, which curve distally), towards openings 234a, 234b. Openings 234a, 234b and passages 235a, 235b are configured to receive cables <NUM>, <NUM>, <NUM>, as discussed below.

Cables <NUM>, <NUM>, and <NUM> may be any suitable control elements, e.g., sutures including braided sutures, treads, ropes, etc., and may comprise any suitable material(s), including synthetic materials. For example, cables <NUM>, <NUM>, <NUM> may comprise polyglycolic acid, polylactic acid, monocryl and polydioxanone, nylon, polyester, polyvinylidene fluoride (PVDF), polypropylene, Kevlar, or the like. Cable <NUM> includes a crimp <NUM>, or any other suitable feature, joining the strands and also the ends of the cable, thereby defining a first loop 301a and a second loop 301b on opposite ends of crimp <NUM>. Cable <NUM> is routed so that first loop 301a passes through both cable opening 234a, and passage 235a of jaw <NUM>', so that the remaining portion of cable <NUM>, e.g., crimp <NUM> and second loop 301b, returns proximally towards the handle via opening <NUM> of adapter <NUM>', lumen <NUM> of connector <NUM>, and lumen <NUM> of tube <NUM>.

Likewise, cable <NUM> includes a crimp <NUM>, which joins both strands and ends of the cable, thereby defining a first loop 303a and a second loop 303b on opposite ends of crimp <NUM>. Cable <NUM> is also routed so that first loop 303a passes through cable opening 234b and passage 235b of jaw <NUM>', so that the remaining portion of cable <NUM>, e.g., crimp <NUM> and second loop 303b, returns proximally towards the handle via opening <NUM> of adapter <NUM>', lumen <NUM> of connector <NUM>, and lumen <NUM> of tube <NUM>. Because of such cable routing, proximal tension, e.g., a pulling force, applied to cables <NUM>, <NUM> causes jaws <NUM>', <NUM>' to pivot relative to one another, thereby transitioning fastener <NUM>' towards an open state. It is noted that jaws <NUM>', <NUM>' may pivot relative to one another simultaneously, but also separately and independently as well by independently controlling the respective cables <NUM>, <NUM> via actuators of the handle of medical device <NUM>'.

Cable <NUM> also includes a crimp <NUM>, which joins both strands and ends of the cable, thereby defining a first loop 302a and a second loop 302b, on opposite ends of crimp <NUM>. Cable <NUM> is routed so that first loop 302a passes through cable opening 234a and passage 235a of jaw <NUM>'. First loop 302a is also routed towards a distal end of adapter <NUM>' via passage through channel <NUM>, over edge <NUM>, and through distal passage <NUM>, before the remaining portion of cable <NUM>, e.g., crimp <NUM> and second loop 302b, returns proximally towards the handle. The remaining portion of cable <NUM> may return via a lumen of adapter <NUM>', lumen <NUM> of connector <NUM>, and lumen <NUM> of tube <NUM>. Because of such routing, fastener <NUM>' may be deployed from adapter <NUM>' by applying sufficient force and tension onto cable <NUM>. Tension applied to cable <NUM> (e.g., via a force pulling proximally) results in first loop 302a translating distally along passage <NUM>, while riding against edge <NUM>, which in turn causes first loop 302a to pull on and translate fastener <NUM>' distally relative to adapter <NUM>'. In other examples, fastening component <NUM>' may further include a fourth cable opposite of cable <NUM>, routed through adapter <NUM>' in a similar manner as cable <NUM>. This may provide a more balanced, distal translation of fastener <NUM>' off adapter <NUM>' when both cable <NUM> and the fourth cable are pulled proximally.

Fastening component <NUM>' of device <NUM>' may be utilized in a similar manner, as discussed above in connection to fastening component <NUM>. For example, after the desired target site is reached, a user may utilize the features of the handle of medical device <NUM>' (similar to features of handle <NUM> of medical device <NUM> shown in <FIG>) to provide slack onto cables <NUM>, <NUM>, thereby closing fastener <NUM>' onto the intended target site. However, prior to providing slack on cables <NUM>, <NUM>, a user may first apply tension onto cable <NUM> to translate fastener <NUM>' distally along adapter <NUM>', and allow jaws <NUM>', <NUM>' to have a full range of pivoting motion, and avoid obstruction by adapter <NUM>'. A user may re-open or re-close fastener <NUM>' by cycling tension or slack onto cables <NUM>, <NUM>. The user may then apply tension onto cable <NUM> to release fastener <NUM>' from adapter <NUM>', and deploy fastener <NUM>' onto the site in its default, flat (closed) state. By applying tension to cable <NUM>, cable <NUM> may assist in translating fastener <NUM>' distally, off adapter <NUM>', via distal surface <NUM> acting as a pulley or a surface on which force can be applied. It is also noted that a user may apply tension onto cable <NUM> prior to closing fastener <NUM>' onto tissue for positioning purposes. To release cables <NUM>, <NUM>, and <NUM> from fastener <NUM>', any portion of first loops 301a, 302a, and 303a may be cut. The user may then pull cables <NUM>, <NUM>, and <NUM> proximally, resulting in the cut first loops 301a, 302a, and 303a unthreading from the various openings, e.g., opening 234a and passage 235a, of fastener <NUM>'.

Referring to <FIG>, another example of fastening component <NUM>" according to the present disclosure is shown. In this example, like reference numerals refer to similar features described above in connection to fastening component <NUM> and fastening component <NUM>', wherein fastening component <NUM>" and medical device <NUM>" may include any of the features of fastening components <NUM>, <NUM>' and medical devices <NUM>, <NUM>', <FIG> illustrate fastener <NUM>' in a closed position while mounted onto adapter <NUM>". Adapter <NUM>" is tubular in shape, including a longitudinal opening. A proximal portion of adapter <NUM>" includes an edge <NUM> that protrudes radially outwards relative to the remainder of adapter <NUM>". Edge <NUM> extends circumferentially about the outer surface of adapter <NUM>". A proximal portion of adapter <NUM>" may be fitted within the distal opening of connector <NUM>', and edge <NUM> may abut against lip <NUM> of connector <NUM>'.

Adapter <NUM>" further includes a tab <NUM> that protrudes radially inward from an inner surface of adapter <NUM>". Table <NUM> includes a tab opening <NUM> configured to receive first loop 302a of cable <NUM>, as discussed in further detail below.

As shown in <FIG>, a spring <NUM> may be positioned between a distal facing surface of edge <NUM> and a base <NUM> residing within lumen <NUM> of connector <NUM>'. Base <NUM> protrudes radially inward, along an inner surface of connector <NUM>', towards a central axis of connector <NUM>'. However, base <NUM> does not protrude to the extent in which it would inhibit or barricade any accessory devices or imagers from extending towards a distal end of connector <NUM>'. Base <NUM> provides a proximal surface for spring <NUM> to compress against, when a force is applied against spring <NUM>. Base <NUM> also defines a proximal opening <NUM> that is configured to receive a distal portion of a shaft. In some examples, the inner surface of base <NUM>, i.e., the surface facing a central axis of connector <NUM>', may provide friction against a shaft, thereby securing said shaft onto connector <NUM>'. It is noted that <FIG> depict an example of connector <NUM>' without opening <NUM> or tube <NUM> (compare to <FIG>).

In fastening component <NUM>", first loop 302a of cable <NUM> is routed around tab <NUM> of adapter <NUM>", via opening <NUM>. As a result, when tension or pulling force is applied to cable <NUM>, via an actuator of the handle, adapter <NUM>" translates proximally, thereby compressing spring <NUM>. Adapter <NUM>" may be translated proximally until first loops 301a and 303a are caught between shaft <NUM>" and adapter <NUM>", which results in the shearing of first loops 301a and 303a. A distal surface of connector <NUM>' and proximal surfaces of openings <NUM>, <NUM> may be shearing surfaces.

Fastening component <NUM>" of device <NUM>" may be utilized in a similar manner, as discussed above for fastening component <NUM>'. For example, a user may provide slack onto cables <NUM>, <NUM>, thereby closing fastener <NUM>' onto the intended target site. The user may re-open or re-close fastener <NUM>' by cycling tension or slack onto cables <NUM>, <NUM>. The user may then apply tension onto cable <NUM>, resulting in the proximal retraction of adapter <NUM>" into connector <NUM>', which in turn shears first loops 301a, 303a and releases fastener <NUM>' from fastening component <NUM>".

Referring to <FIG>, an example of a handle configured to operate a fastening component according to this disclosure is shown. For example, handle <NUM> may be used in conjunction with fastening component <NUM>' shown in <FIG> and/or fastening component <NUM>" shown in <FIG> and <FIG>.

Handle <NUM> includes a base <NUM> and a wheel <NUM>. Base <NUM> includes a platform <NUM> and a clip <NUM>. Platform <NUM> is planar and circular in shape in the example shown, but may have any other suitable (non-circular) shape. The platform <NUM> includes an axle <NUM> that extends perpendicularly from a central part of a planar surface of the platform <NUM>. Axle <NUM> is configured to receive and hold wheel <NUM> as shown in <FIG>. For example, axle <NUM> may be a split fastener axle. It is noted that platform <NUM> optionally may include a plurality of slots and/or tabs, wherein axle <NUM> may be maneuvered and positioned within said slots and/or tabs. This may allow various positioning of wheel <NUM> relative to base <NUM>.

Platform <NUM> further includes a hub <NUM> proximate an edge portion of the platform <NUM>. Hub <NUM> as shown is tubular in shape with lumen <NUM>. Hub <NUM> may be configured to receive second loops 301b, 302b, and 303b of cables <NUM>, <NUM>, and <NUM> (see, e.g., <FIG>and <FIG>) via lumen <NUM>, and route said second loops to wheel <NUM>, as further discussed below. In some examples, hub <NUM> may engage with an external tube, e.g., tube <NUM>, that provides passage for the aforementioned cables to handle <NUM>. For example, the distal opening of hub <NUM> may be of a sufficient cross-sectional size (e.g., diameter) to receive or fit within the proximal opening of said external tube (e.g., tube <NUM>). In examples without such an external tube, hub <NUM> may engage with a proximal port of a shaft, for example, through which second loops 301b, 302b, and 303b may proximally extend. It is noted that in instances when hub <NUM> is at a distance from an external tube, a secondary tube may be used to bridge the gap between hub <NUM> and the external tube. Alternatively, second loops 301b, 302b, and 303b may remain exposed until received by hub <NUM>.

Clip <NUM> may extend from platform <NUM>. Clip <NUM> may have any suitable features configured to clasp or otherwise hold onto a scope shaft or a scope handle. As shown in <FIG>, clip <NUM> may be a c-shaped clip defining a space <NUM> that may receive a shaft, e.g., shaft <NUM> (see <FIG>).

Wheel <NUM> is configured to be rotatably coupled to base <NUM>. Wheel <NUM> includes a knob <NUM> that extends perpendicularly from a planar surface <NUM> of wheel <NUM>. Knob <NUM> is fixed to said planar surface <NUM>, such that rotation of knob <NUM> results in simultaneous rotation of wheel <NUM>, relative to platform base <NUM>. Knob <NUM> includes a crank <NUM> that extends perpendicularly relative to a longitudinal axis of knob <NUM>. Crank <NUM> may be any suitable, user-operable handle that assists in rotating knob <NUM>. Wheel <NUM> also includes a passage <NUM> extending throughout a length of knob <NUM> to the surface opposite of planar surface <NUM>. Passage <NUM> is configured to receive and remain secured onto axle <NUM>, so that wheel <NUM> is rotatably coupled to base <NUM>.

Wheel <NUM> further includes a first post <NUM> and a second post <NUM>, both of which extend perpendicularly from said planar surface <NUM>. First post <NUM> and second post <NUM> may be about <NUM> degrees apart from one another, and each post may be about <NUM> degrees counter-clockwise/clockwise from hub <NUM> and crank <NUM>. First post <NUM> and second post <NUM> include, respectively, a first protrusion <NUM> and a second protrusion <NUM>. Protrusions <NUM> and <NUM> may extend perpendicularly relative to lengths of respective first post <NUM> and second post <NUM>. In some instances, protrusions <NUM>, <NUM> may be configured to receive and secure second loops 301b, 302b, and 303b. However, it is also noted that second loops 301b, 302b, and 303b may be secured onto posts <NUM> and <NUM> by any suitable manner, without the assistance of protrusions <NUM> and <NUM>.

Wheel <NUM> further includes a first barrier <NUM> and a second barrier <NUM>. As shown in <FIG>, barriers <NUM> and <NUM> may be curved. Barriers <NUM> and <NUM> may assist in guiding second loops 301b, 302b, and 303b, along an edge of surface <NUM>, and towards posts <NUM>, <NUM>. Moreover, barriers <NUM>, <NUM> may define finite lengths or paths, indicated by dashed and dotted lines in <FIG>, in which second loops 301b, 302b, and 303b will be displaced when cables <NUM>, <NUM>, and <NUM> are tensioned. When cables <NUM>, <NUM>, and <NUM> are slacked, the cables may bow away from barriers <NUM>, <NUM>.

Referring to <FIG>, an example of a manner in which cables <NUM>, <NUM>, <NUM> are routed around wheel <NUM>, and an exemplary method of using handle <NUM> is further discussed. While wheel <NUM> is oriented in the position shown in <FIG>, second loop 302b (and a fourth cable loop, if present) may be secured to first post <NUM> and/or first protrusion <NUM>, via the first dotted path. Second loops 301b and 303b may be secured to second post <NUM> and/or second protrusion <NUM>, via the second dashed path. In such configuration, wheel <NUM> does not rotate counter-clockwise, or in the direction of arrow K, since the inner or proximal surfaces of jaws <NUM>', <NUM>' of fastener <NUM>' (see, e.g., <FIG> and <FIG>) are mounted and abutted to an outer surface of respective adapter <NUM>' or adapter <NUM>". Rotating wheel <NUM> via knob <NUM> clockwise, or in the direction of arrow D, pulls second loop 302b proximally and translates fastener <NUM>' distally, relative to adapter <NUM>' or <NUM>". Given that fastener <NUM>' is biased towards its closed state, this results in fastener <NUM>' closing and providing slack to second loops 301b and 303b. After rotation in direction D, rotating wheel <NUM> via knob <NUM> in direction K pulls second loops 301b and 303b, and translates fastener <NUM>' proximally, relative to adaptor <NUM>' or <NUM>". This will also transition fastener <NUM>' towards an open state, and slack the tension of second loop 302b. It is noted that the above-described cable routing may also be reversed, such that second loop 302b is secured to post <NUM>/protrusion <NUM>, and second loops 301b, 303b are secured to post <NUM>/protrusion <NUM>, thereby also reversing the directions of knob rotation. Once fastener <NUM>' is in a desired tissue area, and first loops 301a, 302a, 303a are cut or sheared, knob <NUM> may be rotated in direction K or D, to take up cables <NUM>, <NUM>, <NUM>.

Claim 1:
A medical device (<NUM>), comprising:
a fastening assembly (<NUM>), wherein the fastening assembly (<NUM>) includes:
an adapter (<NUM>) defining an opening therethrough, wherein the adapter (<NUM>) has a tubular shape configured to receive a distal end of a shaft;
a fastener (<NUM>) releasably coupled to the adapter (<NUM>), wherein the fastener (<NUM>) includes at least two jaws (<NUM>, <NUM>) pivotable relative to one another, the fastener (<NUM>) having a first configuration wherein the jaws are open and a second configuration wherein the jaws are closed; and
at least one cable (300a, 300b) coupled to the fastener (<NUM>) and the adapter (<NUM>), the at least one cable (300a, 300b) being configured to apply tension to the fastener (<NUM>) to transition between the first configuration and the second configuration while the fastener (<NUM>) is coupled to the adapter (<NUM>), and to control release of the fastener (<NUM>) from the adapter (<NUM>),
characterised in that the adapter (<NUM>) includes a resistance element coupled to the fastener (<NUM>), wherein the resistance element biases the fastener (<NUM>) towards the first configuration, and wherein a tension force applied to the at least one cable (300a, 300b) transitions the fastener (<NUM>) towards the second configuration against the bias of the resistance element, wherein the resistance element is a hoop (<NUM>) coupled to an inner surface of the fastener (<NUM>).