Patent Grant
12042143
This disclosure generally relates to surgical devices and procedures, and more specifically to surgical devices and procedures for passing and retrieving suture through tissue.
Suturing of tissue generally involves mounting suture to a needle, piercing the tissue with the suture-loaded needle, and passing the suture-loaded needle through the tissue. Multiple passes of the suture through the tissue are typically used to stitch the tissue together. Minimally invasive surgical procedures that involve suturing require the surgeon to pass the suture through the tissue using one or more tools inserted into the surgical cavity through small incisions and, thus, suturing during minimally invasive surgery can be challenging. Suture passers are tools that can be used during minimally invasive surgeries to pass suture through tissue within the surgical cavity. For example, suture passers loaded with suture may be positioned in the surgical cavity and used to complete a first pass of suture through tissue in the surgical cavity. Typically, after the first pass of suture through tissue, the suture passer is removed from the surgical cavity to reload the conventional suture passer with suture. Once reloaded with suture outside of the surgical cavity, the suture passer is repositioned back in the surgical cavity and then used to complete the second pass of suture through tissue. Such a reloading process, as described above, is cumbersome as it involves moving the suture passer in and out of the surgical site and also manually (for example, by hand) picking up the passed suture to reload the suture passer to stitch tissue.
According to an aspect, a suture passer is configured to repeatedly pass and retrieve a suture-loaded holder through tissue for continuous suturing without requiring the suture-loaded holder to be removed from the surgical cavity. The suture passer may include a tissue engaging recess that may be positioned around tissue to be sutured in the surgical cavity. The suture-loaded holder may be mounted on a moveable needle of the suture passer and passed through tissue positioned in the tissue engaging recess via distal movement of the needle. After passing distally through the tissue, the suture-loaded holder may be retained in a distal portion of the suture passer and may unmount from the needle as the needle retracts back through tissue away from the distal portion. The suture-loaded holder may be retained in the distal portion by a component of the suture passer in the distal portion that engages the suture-loaded holder. The suture passer may be repositioned on the tissue and the needle may then pass through a different portion of tissue to the distal portion and pick up the suture-loaded holder retained in the distal portion. For the needle to pick up the suture-loaded holder from the distal portion, a sheath of the suture passer which moves along with the needle to the distal portion, may move relative to the needle in the distal portion and thus releases the suture holder from the distal portion. After picking up the suture-loaded holder, the needle may then retract the suture-loaded holder back through tissue and away from the distal portion as the needle retracts once again away from the distal portion. The passing of the suture-loaded holder to the distal portion and picking up of the suture-loaded holder in the distal portion may be repeated as needed to suture together tissue in the surgical cavity without having to withdraw the suture passer from the surgical cavity.
According to an aspect, a suture passer includes a first shaft comprising a hollow tube and a distal portion located distally of a distal end of the hollow tube; a needle comprising a needle tip and a needle shaft translatably mounted in the hollow tube and having a distal portion that is extendable out of the distal end of the hollow tube for passing a suture loaded holder through tissue positioned between the distal end of the hollow tube and the distal portion of the first shaft via a stroke of the needle; an actuatable engagement located in the distal portion of the first shaft for retaining the suture loaded holder in the distal portion of the first shaft after the suture loaded holder has passed through the tissue; a sheath extending around an exterior of the needle shaft and translatable with the needle shaft for at least a portion of a stroke of the needle shaft, wherein the sheath is moveable relative to the needle shaft for actuating the engagement to an unlatched position to release the holder from the distal portion of the first shaft.
Optionally, relative movement of the sheath to the needle shaft may include a rotational movement of the sheath about a longitudinal axis of the needle shaft.
Optionally, relative movement of the sheath to the needle shaft may include a translational movement of the sheath along a longitudinal axis of the needle shaft.
Optionally, relative movement of the sheath to the needle shaft may be controlled by a cam directly connected to the sheath or operatively connected to the sheath via a cam follower attached to the sheath.
Optionally, the actuatable engagement may be moved to a latched position by movement of the holder into the distal portion via the stroke of the needle.
Optionally, the suture passer may include an arm that comprises the actuatable engagement at the distal portion of the first shaft and an actuating surface positioned proximal to the actuatable engagement.
Optionally, the sheath may be configured to actuate the actuatable engagement by interfacing with the actuating surface, and when the sheath interfaces the actuating surface via relative movement to the needle shaft, the actuatable engagement is pushed away from the holder from the latched position to an unlatched position.
Optionally, as the sheath moves to actuate the actuatable engagement to the unlatched position, the holder may be released from the distal portion and securely mounted to the needle shaft via movement of the one or more tabs of the holder towards a recess of the needle shaft by the sheath.
Optionally, the actuating surface of the arm may be positioned in the distal portion of the first shaft.
Optionally, the actuating surface of the arm may be positioned proximally of the distal portion.
Optionally, the arm may include a living hinge.
Optionally, the holder may be a ferrule.
Optionally, the needle tip may be removably attached to the needle shaft and the needle tip is the holder.
Optionally, the suture passer may include the suture loaded holder.
Optionally, the holder may include an inner portion configured to interface with the needle shaft for mounting the holder onto the needle shaft via a friction fit or may include an inner portion having one or more movable tabs configured to move into a slot of the needle shaft, and when the actuatable engagement is in the latched position, the holder is secured in the distal portion of the first shaft so that the holder can be unmounted from the needle shaft.
Optionally, the suture passer may include a first trigger operatively connected to the sheath and needle shaft and when the holder is mounted on the needle shaft and the first trigger is pressed, the holder is moved with the needle via a stroke of the needle to the distal portion of the first shaft.
Optionally, the holder may include: one or more tabs configured to secure suture to the holder, an inner portion configured for receiving the needle shaft within the inner portion, and an exterior portion configured to interface with the sheath.
Optionally, the holder may include a tab configured to deflect inwards towards the needle shaft inserted within the holder for retaining the needle shaft within the holder.
Optionally, the tab may be movable by a translational movement of the sheath.
Optionally, the tab may be movable by a rotational movement of the sheath.
Optionally, the suture passer may include a first trigger operatively connected to the sheath and the needle shaft, wherein pressing the first trigger causes the sheath to translate together with the needle shaft to the distal portion of the first shaft, and wherein releasing the pressed first trigger causes the sheath to translate together with the needle shaft away from the distal portion of the first shaft.
Optionally, the first trigger may include a lock for latching the first trigger in a pressed position.
Optionally, the first trigger may be operatively connected to the sheath and the needle shaft via a rotatable cam.
Optionally, movement of the first trigger in a first direction may cause the sheath to translate together with the needle shaft to the distal portion, and after or as the sheath and the needle shaft translate to the distal portion, the sheath is configured to rotate in a rotational direction about the needle shaft and movement of the first trigger in a second direction causes the sheath to translate together with the needle shaft away from the distal portion and after or as the sheath and the needle shaft translate away from the distal portion, the sheath is configured to rotate about the needle shaft in the rotational direction.
Optionally, the suture passer may include a second trigger configured to move the sheath relative to the needle shaft to actuate the actuatable engagement to an unlatched position and press one or more tabs of the ferrule into a recess of the needle for securing the holder to the needle shaft, and movement of the second trigger causes the first trigger to move to a pressed position.
Optionally, the first trigger and the second trigger may be operatively connected to the sheath and the needle shaft via a cam comprising a first track for a first follower attached to the sheath and a second track for a second follower attached to the needle.
Optionally, movement of the first trigger may cause the first follower and the second follower to move simultaneously, and movement of the second trigger subsequent to movement of the first trigger may cause the first follower to move relative to the second follower.
Optionally, the distal portion of the first shaft may include one or more holes configured to allow tissue to pass through to prevent jamming of tissue at the distal portion.
Optionally, the distal portion of the first shaft may include a second portion connected to the first portion, the second portion having a tapered internal diameter.
According to an aspect, a method for passing a suture through tissue may include: positioning the tissue between a distal end of a hollow tube of a first shaft of a suture passer and a distal portion of the first shaft positioned distally of the distal end of the hollow tube; translating a distal portion of a needle through the tissue to the distal portion of the first shaft to retrieve a suture loaded holder retained in the distal portion, the needle comprising a needle tip and a needle shaft, the needle shaft is translatably mounted in the hollow tube; translating a sheath extending around an exterior of the needle shaft with the needle through the tissue to the distal portion of the shaft; actuating a moveable engagement to an unlatched position to release the suture loaded holder from the distal portion of the first shaft via movement of the sheath relative to the needle shaft.
Optionally, movement of the sheath relative to the needle shaft may include rotating the sheath about a longitudinal axis of the needle shaft.
Optionally, movement of the sheath relative to the needle shaft may include translating the sheath along a longitudinal axis of the needle shaft.
Optionally, movement of the sheath relative to the needle may be controlled by a cam directly connected to the sheath or operatively connected to the sheath via a cam follower attached to the sheath.
Optionally, the suture passer may include an arm that comprises the moveable engagement at the distal portion of the first shaft and an actuating surface positioned proximal to the moveable engagement, wherein the sheath engages the actuating surface to actuate the moveable engagement.
Optionally, actuating the moveable engagement to release the holder from the distal portion of the first shaft may include interfacing the sheath with the actuating surface via relative movement to the needle shaft, and pushing away the moveable engagement from the holder from a latched position to the unlatched position.
Optionally, as the sheath moves to actuate the actuatable engagement to the unlatched position, the holder may be released from the distal portion and securely mounted to the needle shaft via movement of one or more tabs of the holder towards a recess of the needle shaft by the sheath.
Optionally, the actuating surface of the arm may be positioned in the distal portion of the first shaft.
Optionally, the actuating surface of the arm may be positioned proximally of the distal portion.
Optionally, the arm may include a living hinge.
Optionally, the method may include interfacing an inner portion of the holder with the needle shaft for mounting the holder onto the needle shaft via a friction fit or interfacing an inner portion of the needle shaft having one or more movable tabs configured to move into a slot of the needle shaft for mounting the holder onto the needle shaft, and securing the holder in the distal position of the first shaft so that the holder can be unmounted from the needle shaft when the moveable engagement is in a latched positioned.
Optionally, the method may include pressing a first trigger when the holder is mounted on the needle shaft to move the holder with the needle via translation of the needle to the distal portion of the first shaft, the first trigger being operatively connected to the sheath and needle.
Optionally, the holder may include: one or more first tabs configured to secure suture to the holder, an inner portion configured for receiving the needle shaft within the inner portion, and an exterior portion configured to interface with the sheath.
Optionally, the method may include deflecting a second tab of the holder inwards towards the needle shaft inserted within the holder for securing the holder to the needle shaft.
Optionally, deflecting the second tab may include translational movement of the sheath.
Optionally, deflecting the second tab may include rotational movement of the sheath.
Optionally, the method may include pressing a first trigger operatively connected to the sheath and the needle to translate the sheath with the needle through the tissue to the distal portion of the first shaft, and the method comprises releasing the pressed first trigger to translate the sheath together with the needle away from the distal portion of the first shaft.
Optionally, the method may include latching the first trigger in a pressed position via a lock.
Optionally, the first trigger may be operatively connected to the sheath and the needle shaft via a rotatable cam.
Optionally, the method may include moving the first trigger in a first direction to translate the sheath together with the needle shaft to the distal portion, moving the first trigger in a second direction to translate the sheath together with the needle shaft away from the distal portion of the first shaft, and rotating the sheath in a rotational direction about the needle shaft after or as the sheath and the needle shaft translate to and from the distal portion.
Optionally, the method may include moving a second trigger to a pressed positioned to actuate the moveable engagement to rotate the sheath in the rotational direction about the needle shaft.
Optionally, the first trigger and the second trigger may be operatively connected to the sheath and the needle via a cam comprising a first track for a first follower attached to the sheath and a second track for a second follower attached to the needle.
Optionally, moving the first trigger may cause the first follower and the second follower to move simultaneously, and moving the second trigger subsequent to moving of the first trigger causes the first follower to move relative to the second follower.
Optionally, the method may include: repositioning the tissue between the distal end of the hollow tube of the first shaft of the suture passer and the distal portion of the first shaft positioned distally of the distal end of the hollow tube; translating the distal portion of the needle shaft mounted in the hollow tube and the suture loaded holder mounted on the needle through the tissue to the distal portion of the first shaft; translating once again the sheath with the needle shaft through the tissue to the distal portion of the first shaft; and actuating the moveable engagement positioned in the distal portion of the first shaft for retaining the suture loaded holder in a latched position in the distal portion of the first shaft.
Optionally, the method may include allowing tissue to pass through one or more holes of the distal portion of the first shaft to prevent jamming of tissue at the distal portion.
Optionally, the distal portion of the first shaft may include a second portion connected to the first portion, the second portion having a tapered internal diameter.
The disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:
Reference will now be made in detail to implementations and examples of various aspects and variations of devices, systems, and methods described herein. Although several exemplary variations of the devices, systems, and methods are described herein, other variations of the devices, systems, and methods may include aspects of the devices, systems, and methods described herein combined in any suitable manner having combinations of all or some of the aspects described.
Disclosed herein are examples of devices, systems, and methods for repeatedly passing suture through tissue without requiring removal of the suture passer from the surgical cavity. An exemplary suture passer passes a suture-loaded suture holder back and forth through the tissue. The suture holder with its loaded suture is mounted on a needle of the suture passer and passed distally through the tissue via a distal movement of the needle. After passing through the tissue, the suture-loaded holder is moved into a distal portion of the suture passer through continued distal movement of the needle. The distal portion retains the suture-loaded holder as the needle retracts back through the tissue. After the needle retracts, the suture passer can be repositioned on the tissue and the needle can then be passed through a different portion of the tissue. The needle picks up the suture holder from the distal portion of the suture passer and pulls it back through the tissue. In this way, suture can be repeatedly passed back and forth through tissue without needing to withdraw the suture passer from the surgical cavity.
The suture holder may be retained in the distal portion of the suture passer on a first needle stroke and may be released from the distal portion of the suture passer on a second needle stroke. For example, on the first needle stroke towards the distal portion of the suture passer, the suture holder mounted to the needle is passed through tissue to the distal portion of the suture passer via distal movement of the needle and retained in the distal portion of the suture passer by a moveable component that engages the suture holder. The moveable component may engage the suture holder by snapping into a recess of the suture holder due to a bias of the moveable component. Engagement of the moveable component in the recess of the suture holder overcomes any frictional force between the suture holder and the needle (or any other retention feature) that would otherwise tend to retain the suture holder on the needle as the needle retracts back through tissue. Thus, engagement of the suture holder by the moveable component causes the suture holder to dismount from the needle as it remains retained in the distal portion of the suture passer upon retraction of the needle back through tissue.
On the second stroke of the needle to the distal portion of the suture passer, the moveable component may be moved out of engagement with the suture holder. For moving the moveable component out of engagement with the suture holder, the suture passer can include a sheath that passes through the tissue along with the needle. The sheath may be configured to extend concentrically about an exterior surface of the needle. When the needle and sheath reach the distal portion, the sheath causes the moveable component to move out of engagement with the suture holder and the needle re-engages the suture holder. Since the moveable component is not engaged with the suture holder, the suture holder can release from the distal portion and retract back through the tissue away from the distal portion of the suture passer via proximal movement of the needle.
The first trigger may actuate the first stroke of the needle and the second stroke of the needle. For example, for actuating the first stroke of the needle, a user may press the first trigger in a first direction which causes the needle, the suture holder mounted to the needle, and the sheath extending about the needle to move distally through tissue to the distal portion of the suture passer. Upon release of the first trigger subsequent the first stroke of the needle, the needle and the sheath can retract proximally through tissue away from the distal portion of the suture passer as the suture holder remains in the distal portion. After the needle and the sheath have retracted away from the distal portion, the user may press the first trigger again to actuate the second stroke of the needle which causes the needle and the sheath extending about the needle to move distally through tissue to the distal portion of the suture passer. In response to the second stroke actuated by user actuation of the first trigger, the sheath may move relative to the needle via a cam operationally connected to the first trigger and the sheath. As the sheath moves relative to the needle, the sheath releases the suture holder from the distal portion and the needle re-engages the suture holder. Upon release of the first trigger subsequent the second stroke, the needle, the suture holder remounted to the needle, and the sheath retract proximally through tissue away from the distal portion of the suture passer.
Optionally, a movable cam of the suture passer may control movement of the sheath relative to the needle. The movable cam may be operably connected to the first trigger and the sheath and may include a recessed track that is configured to engage a stationary pin of the suture passer. Engagement of the recessed track of the cam and the stationary pin of the suture passer may limit movement of the cam to a path of the recessed track. Thus, as the movable cam moves due to actuation of the first trigger, the movement of the cam follows a path of the recessed track due to the stationary pin engaged with the recessed track. The recessed track may include straight portions and curved portions. The recessed track may include a step to limit rotational movement of the cam to a first rotational direction. For every actuation and release of the first trigger, the cam operably connected to the first trigger may move a pre-determined amount of degrees in the first rotational direction, a pre-determined translational distance, or a combination thereof.
A position of the sheath based on a position of the movable cam may differentiate the second stroke of the needle from the first stroke of the needle. For example, the cam may move to a passing position as the needle completes the first stroke of the needle and may move to a retrieving position as the needle completes the second stroke of the needle. During the first stroke of the needle, the sheath moves along with the needle distally to the distal portion of the suture passer based on movement of the cam to the passing position. As the cam moves to the passing position, the sheath moves relative to the needle to a position in which a slot of the sheath accommodates an actuating surface operably coupled to the moveable component so that the movable component is not actuated by the sheath. With the slot of the sheath accommodating the actuating surface operably coupled to the moveable component, the suture-loaded holder is retained in the distal portion as described above and further below. During the second stroke of the needle, the sheath moves along with the needle distally to the distal portion of the suture passer based on movement of the cam to the retrieving position. As the cam moves to the retrieving position, the sheath moves relative to the needle to a position in which the sheath actuates the actuating surface coupled to the moveable component. In this position, the slot of the sheath is no longer positioned to accommodate the actuating surface coupled to the movable component. The actuation of the actuating surface coupled to the movable component by the sheath releases the suture-loaded holder from the distal portion of the suture passer as described above and further below. Movement of the cam from the passing position to the retrieving position and from the retrieving position to the passing position may include a rotational movement, a translational movement, or a combination thereof. Movement of the cam from the passing position to the retrieving position follows a first path of the recessed track and movement of the cam from the retrieving position to the passing position follows a second path of the recessed track. The first path and the second path may form a continuous path of the recessed track.
Movement of the sheath relative to the needle may cause the sheath to move the moveable component engaged with the suture holder in the distal portion out of engagement with the suture holder. Movement of the sheath relative to the needle may include rotation of the sheath, further distal translation of the sheath, or a combination thereof. The movement of the sheath relative to the needle may move an actuating surface of the sheath to a position in which the actuating surface of the sheath pushes against an actuating surface of an arm operably coupled to the moveable component causing the arm to move. Movement of the arm causes the moveable component of the distal portion of the suture passer to disengage from the suture-loaded holder and thus release the suture-loaded holder from retention in the distal portion of the suture passer. Optionally, the arm of the suture passer may include the moveable component.
The actuating surface of the arm may be located in the distal portion of the suture passer or in a portion of the suture passer that is proximal to the tissue engaging recess of the suture passer. In accordance with the actuating surface of the arm being located in the portion proximal to the tissue engaging recess, the actuating surface of the sheath may be located in the portion proximal to the tissue engaging recess such that the actuating surface of the sheath and the actuating surface of the arm may contact each other as a result of movement of the sheath relative to the needle. In accordance with the actuating surface of the arm being located in the distal position of the suture passer, the actuating surface of the sheath may be located in the distal portion of the suture passer such that the actuating surface of the sheath and the actuating surface of the arm may contact each other as a result of movement of the sheath relative to the needle. The arm may include a living hinge so that movement of the actuating surface (either in the distal portion or proximal portion of the suture passer) of the arm causes movement of the actuatable engagement in the distal portion of the suture passer.
Movement of the sheath relative to the needle may cause the sheath to move to a holding position in which the sheath holds the suture holder fixed against the needle. The sheath may hold the suture against the needle by pushing and holding one or more first tabs of the suture holder towards a recess of the needle. With the sheath holding the suture holder against the needle, the suture holder may be retracted through tissue away from the distal portion of the suture passer with proximal movement of the needle. Movement of the sheath to the holding position may include further distal translation of the sheath in the distal portion relative to the needle. Movement of the sheath to the holding position may include rotation of the sheath relative the needle.
The suture passer may include a movable cam configured to control movement of the sheath relative to the needle. The cam may be operationally connected to the first trigger so that release of the first trigger causes the sheath to move relative to the needle via the cam control. The cam may be rotational, translational, or both rotational and translational.
The suture passer may include a plurality of user actuatable triggers. The triggers may be actuated, for example, by a user pressing one or more triggers. User actuation of a first trigger of the plurality of triggers may cause the needle and the sheath to move distally to the distal portion of the suture passer and subsequent release of the user actuation of the first trigger may cause the needle and the sheath to retract proximally away from the distal portion of the suture passer. Similar to the above description regarding examples having a single trigger, a first user actuation of the first trigger may actuate a first stroke of the needle to the distal portion. During the first stroke, the suture holder may be mounted to the needle and move with the needle to the distal portion. As described above in reference to the single trigger, after the first stroke, the suture holder may be retained in the distal portion as the needle and the sheath retract proximally away from the distal portion. A second user actuation of the first trigger may actuate a second stroke of the needle and the sheath to the distal portion. Subsequent the second user actuation of the first trigger, the needle and the sheath are in the distal portion of the suture passer. While the first trigger remains actuated by the second user actuation, user actuation of a second trigger of the plurality of triggers causes the sheath to move relative to the needle in the distal portion of the suture passer. As described above and further below, movement of the sheath relative to the needle can move a movable component engaged with the suture holder in the distal portion out of engagement with the suture holder. Actuation of the second trigger may mechanically override one or more tracks of a cam configured to control movement of the sheath relative to the needle.
Optionally, the sheath may be operatively connected to the first trigger and to the second trigger via cam control. Subsequent actuation of the first trigger, the sheath may move via cam control in a distal direction to the distal portion and stop at a first distal position. When the second trigger is actuated after the first trigger is actuated, the sheath may move via the cam control relative to the needle to a second distal position located distal to the first distal position for retrieving the suture holder.
The suture passer may include a trigger lock for holding the first trigger in a pressed position. In the pressed position, the needle may be positioned in the distal portion of the suture passer. The first trigger may remain in the pressed position unless the second trigger is actuated or the trigger lock is moved to an unlocked position.
The suture-loaded holder may be mounted to the needle via a friction fit. That is, the suture holder may include one or more second tabs configured to contact the needle when the needle is positioned in the suture holder. The one or more second tabs of the suture holder in contact with the needle may be configured to hold the suture holder on the needle via friction. The friction force is not changed by sheath position.
Optionally, as the suture holder mounted to the needle is moved by movement of the needle to and from the distal portion of the suture passer, the sheath can be configured to cover at least a portion of the suture holder. That is, while the suture holder is mounted to the needle, the sheath can be configured to cover the portion of the suture holder. Accordingly, when the suture holder is released from the distal portion of the suture passer and remounted on the needle, the sheath covers the portion of the suture holder. The portion of the suture holder may be covered by the sheath during translation movement of the needle to and from the distal portion until the sheath moves relative to the needle. As the suture holder is unmounted from the needle and retained in the distal portion of the suture passer, the sheath is configured to uncover the portion of the suture holder. The portion of the suture holder may be a proximal portion of the suture holder.
The needle may include a needle tip and a needle shaft. The suture holder may be mounted and unmounted about an external surface of the needle shaft via movement of the moveable component as described above and further below. The needle tip and the needle shaft may be configured to pass through an interior of the suture holder during mounting and unmounting of the suture holder to the needle shaft. The needle tip may be fixed to the needle shaft.
The needle shaft may be hollow for receiving the suture-loaded holder. The hollow needle shaft may include an inwardly extending portion for engaging a corresponding recessed portion of the suture holder. When the suture holder is positioned in the hollow needle shaft, the suture-loaded holder may be mounted to the hollow needle shaft by engaging the inwardly extending portion of the needle shaft with the recessed portion of the suture-loaded holder. The recessed portion of the suture-loaded holder may be recessed from an external surface of the suture-loaded holder and the inwardly extending portion of the needle shaft may extend from an internal surface of the needle shaft.
Optionally, the suture holder may be a ferrule. The ferrule may have an annular shape and the ferrule may be configured to mount the needle shaft.
In addition, it is also to be understood that the singular forms “a”, “an,” and “the” used in the following description are intended to include the plural forms as well, unless the context clearly indicates otherwise. It is also to be understood that the term “and/or,” as used herein, refers to and encompasses any and all possible combinations of one or more of the associated listed items. It is further to be understood that the terms “includes,” “including,” “comprises,” and/or “comprising,” when used herein, specify the presence of stated features, integers, steps, operations, elements, components, and/or units, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, units, and/or groups thereof.
In the following description of the disclosure and examples, reference is made to the accompanying drawings in which are shown, by way of illustration, specific examples that can be practiced. It is to be understood that other examples and examples can be practiced, and changes can be made, without departing from the scope of the disclosure.
Suture passer 100 can be used for suturing tissue in a surgical cavity during minimally invasive surgeries. The surgical cavity may be in a joint which, due to the anatomy of the joint, is considered a “tight” joint in that the joint is anatomically more constricted than “spacious” joints like a shoulder or knee joint. During minimally invasive surgery, the tissue engaging recess 110 of the suture passer 100 loaded with suture may be inserted into the surgical cavity, either with or without a cannula, to position the suture passer 100 for suturing tissue. Tissue may be positioned in the tissue engaging recess 110 inserted into the surgical cavity. A surgeon may use the suture passer 100 to repeatedly pass suture through tissue positioned in the tissue engaging recess 110 without removing the suture passer 100 from the surgical cavity between suture passes. To pass suture through different portions of tissue, the surgeon may reposition tissue in the engaging portion 110 or reposition the suture passer 100 to reposition the tissue engaging recess 110 around a portion of tissue. The surgeon does not have to remove the suture passer 100 from the surgical cavity after each pass through tissue to reload the suture passer 100 with suture. In this way, suturing tissue in anatomically constricted spaces, just as a hip joint, can be performed without moving the suture passer 100 in and out of the surgical cavity, and thus facilitates more efficient and feasible suturing in “tight” joints.
The suture passer 100 may be used to suture physically tough tissue that is located in anatomically constrained spaces of the body. For example, the suture passer 100 may be used to suture fibrous capsule of a hip joint. The fibrous capsule is typically difficult for a surgeon to suture together by hand due to the toughness of the tissue and the location of the tough tissue in the hip joint. A needle having an appropriate piercing diameter for piercing through tough tissue may be loaded into the suture passer 100. The needle 140 may include a needle tip 140a, a needle shaft 140b, and a needle handle 140c. The needle 140 may pre-assembled as part of the suture passer 100.
The needle 140 may be replaceable and disposable and the suture passer 100 may be reusable. A surgeon may load the disposable needle 140 into the suture passer 140 by inserting the needle tip 140a into the shaft 130 of the suture passer and guiding the needle tip 140a to the tissue engaging recess 110 of the shaft 130. The needle handle 140c may be translatably locked in the handle portion 120 of the suture passer 100 via a needle latch 142.
A suture holder, which can be, for example, in the form of a ferrule 180, may be loaded with implantable suture.
The suture passer 100 may include a sheath 190. The sheath 190 may extend around an exterior of the needle 140 and may be translatable with the needle 140 for at least a portion of the needle movement towards and away from the distal portion 170. The sheath 190 may be configured to rotate or translate relative to the needle 140 based on pressing or releasing a trigger (such as trigger 150). The relative movement of the sheath 190 to the needle 140 may include a rotational movement of the sheath 190 about a longitudinal axis of the needle 140. The relative movement of the sheath to the needle may include a translational movement of the sheath along a longitudinal axis of the needle.
The suture passer 100 may include a moving jaw 200 configured to extend around the sheath 190 and move between the distal portion 170 and the distal end 165 of the hollow tube 160. The moving jaw 200 may move with the needle 140 for gripping tissue positioned in the tissue engaging region 110. Alternatively, the moving jaw 200 may move relative to the needle 140 upon user actuation of a trigger (such as trigger 150).
As shown in the example of
The distal portion 170 may include a distal end 174 and a proximal end 176. The distal end 174 may include a stopping surface 175a configured to prevent an inserted ferrule from moving further distally into the distal end 174. The distal end 174 may include an inner surface 175b configured to interface with an outer surface of the needle 140 so that tissue is prevented from entering the distal end 174 and interfering with a mechanism for retaining and releasing the ferrule in the distal portion 170. The stopping surface 175a may be located proximal to the inner surface 175b. The proximal end 176 of the distal portion 170 may include a tapered inner perimeter 177 to help prevent tissue from jamming at the proximal end 176 of the distal portion 170.
The ferrule 180 may be moved further distally from the first position to a second position in the distal portion 170 via distal movement of the needle 140 (as indicated by arrow 222b in
The sheath 190 may move along with the needle 140 distally to the distal portion of 170 as the needle 140 passes the ferrule 180 to the third position. The sheath 190 may include a slot 192 that accommodates an actuating surface 230 of an arm 240 of the suture passer 100 so that the sheath 190 does not actuate the actuating surface 230 when the needle 140 passes the ferrule 180 to the third position. The arm 240 may include the actuating surface 230 and the actuatable engagement 220.
After the ferrule 180 has been retained in the distal portion 170 and unmounted from the needle 140, the needle 140 is retracted away from distal portion back through tissue positioned in the tissue engaging region. When the needle 140 is retracted towards the hollow tube 160, a user of the suture passer 100 may reposition the tissue engaging region of the suture passer 100. In this way, user actuation of a trigger (such as trigger 150) may cause the needle 140 to move distally to the distal portion 170 through another portion of tissue to retrieve the ferrule 180 from the distal portion 170. The needle 140 may be re-inserted into the ferrule 180 by moving the needle 140 to distally to a distal-most position of the needle 140 in the distal portion 170 via actuation of a trigger (such as trigger 150). When the needle 140 is inserted in the ferrule 180, the ferrule 180 may be securely mounted to the needle 140 via a friction fit between the ferrule 180 and the needle 140. When the needle 140 is inserted in the ferrule 180, the ferrule 180 may be securely mounted to the needle 140 via one or more tabs of the ferrule 180 that are configured to snap into a recess of the needle 140, as discussed further below in reference to
The ferrule 180 may be released from the third position in the distal portion 170 via actuation of the actuating surface 230 of the arm 240 of the suture passer 100 by the sheath 190.
The motion of the sheath relative to the needle may be controlled by a cam attached to the sheath. Motion of the cam may be controlled by the trigger in the handle portion of the suture passer.
Actuation of the trigger 150 in the first direction 152a may cause the cam 250 to move such that the sheath 190 rotates by a pre-determined amount of degrees for every complete actuation of the trigger 150. The sheath 190 rotates in a same rotational direction for each actuation of the trigger 150. The pre-determined amount may be at least 45 degrees or at least 90 degrees. The pre-determined amount may be at most 270 degrees or at most 180 degrees. The pre-determined amount may be 45-270 degrees or 90-180 degrees.
The ferrule 180 may be retained in the distal portion of the suture passer (as shown in
The suture passer may include an arm that has an actuating surface located proximally of the distal portion of the suture passer so that the suture passer may be configured to retrieve a ferrule based on actuation of the actuating surface located proximally to the distal portion.
Moving the actuatable engagement 320 to the unlatched position releases the ferrule 380 from a distal portion 310. The ferrule 380 may be mounted to the needle 385 as the actuatable engagement 320 moves to the unlatched position. The ferrule 380 may be mounted to the needle 385 after the actuatable engagement 320 moves to the unlatched position. The ferrule 380 may be mounted to the needle 385 via a friction fit between the ferrule 380 and the needle 385 or by snapping one or tabs of the ferrule 380 into one or more recesses of the ferrule 380 (as discussed in reference to
Movement of the needle within the ferrule during retrieval of the ferrule from the distal portion may unlatch the ferrule from the distal portion and simultaneously securely mount the ferrule to the needle. The ferrule may be securely mounted to the translatable needle via a friction fit or via actuation of one or more tabs of the ferrule.
The one or more tabs 410 of the ferrule 400 may be configured to interface with the sheath 430. For example, when the needle 420 is inserted into the ferrule 400 to a position in which the one or more tabs 410 of the ferrule 400 are positioned over the recess 450, the sheath 430 may be translatable (as indicated by arrow 432a) relative to the needle 420 over an exterior surface 470 of the one or more tabs 410 based on user actuation of a trigger of the suture passer. The sheath 430 positioned over the one or more tabs 410 pushes the one or more tabs 410 to deflect towards the recess 450 of the needle 420 (as indicated by arrow 412b). As the sheath 430 interfaces with the exterior surface 470 of the one or more tabs 410, the one or more tabs 410 are held in a deflected or pressed position for holding the one or more tabs 410 within the recess 450. In this way, the ferrule 400 is held securely against the needle 420. Upon release of user actuation of a trigger or actuation of a second trigger of the suture passer, the sheath 430 may be retracted away from the ferrule to no longer interface the exterior surface 470 of the one or more tabs 410. When the sheath 430 no longer interfaces the exterior surface 470 of the one or more tabs 410, the one or more tabs 410 will no longer be held in the pressed position for the holding the one or more tabs 410 pressed within the recess 450 of the needle 420, thus the ferrule 400 will no longer be securely held against the needle 420. The relative movement of the sheath 430 may include one or more of a translational movement or a rotational movement.
The suture passer may include a first trigger for translating the needle to and from the distal portion and for passing a ferrule to the distal portion during translation of the needle to the distal portion. The suture passer may include a second trigger for retrieving the ferrule from the distal portion and mounting the ferrule onto the needle.
The second trigger may be operatively connected to the needle and the sheath via followers of a cam. For example, the handle portion 506 may include a first pin 505a of the sheath 530 and a second pin 505b of the needle 509. The second pin 505b may be attached to a base 513 of the needle 509. The handle portion 506 may include a spring 542 connected to the base 513 and a spring 544 connected to the first pin 505a. The spring 542 urges the base 513 and the second pin 505b on the base 513 in a direction away from the distal portion 501. The spring 544 urges the first pin 505a in a direction away from the distal portion 501 along a base track 546 of base 513. The first pin 505a may be configured to follow a first track 507a of a translatable cam 503 and the second pin 505b may be configured to follow a second track 507b of the translatable cam 503. The translatable cam 503 is connected to the second trigger 504 and operatively connected to the first trigger 502.
In the example of
Movement of the needle 509 relative to the sheath 530 is due to curvature of tracks 507a, 507b. For example, as the base 513 connected to the first trigger 502 moves with the fourth portion of the actuation of the first trigger 502, the pin 505b positioned on the base 513 moves with the base 513 towards the distal portion 501. The pin 505b pushes against track 507b of the cam 503 to pivot the cam 503 counterclockwise (with respect to the orientation of
With the needle 509 in its distal-most position as shown in
In the example of
Movement of trigger lock 535 to an unlock position (for example, as shown in
To initiate retrieval of the ferrule 520 retained in the distal portion 501, the first trigger 502 can be actuated again by a user to move the needle 509 and the sheath 530 back to the distal portion 501. This actuation repeats translation movements of the needle 509 and the sheath 530 as shown in
After the first trigger 502 has been locked in the pressed position and the needle 509 is in its distal-most position (as shown by the needle position of
Actuation of the second trigger 504 moves the sheath 530 relative to the needle 509, which results in the sheath 530 covering the one or more tabs 512 (as shown in the left inset of
Actuation of the second trigger 504 by the user moves the trigger lock 535 from a locked position to an unlocked positions. The right inset of
Upon release of the second trigger 504 by the user, the needle 509, the ferrule 520 mounted to the needle 509, and the sheath 530 move together away from the distal portion 501 under force of the bias of the spring 542 and the spring 544. The spring 544 urges pin 505a away from the distal portion 501 and the spring 542 urges the needle base 513 (and the pin 505b on the needle base 513) away from the distal portion 501. As the pins 505a, 505b move away from the distal portion 501, the pin 505a pushes the cam 503 connected to the second trigger 504 to pivot clockwise (with respect to the orientation of
As the second trigger 504 is released by the user, pins 505a, 505b move simultaneously, while maintaining the first distance 540d (540a) apart. For example, the pins 505a, 505b can move from the position shown in
During the release of the second trigger 504, pressure maintained on the second trigger 504 by the user prevents the second trigger 504 from reaching its maximum clockwise rotation. When the second trigger 504 is prevented by the user from reaching its maximum clockwise rotation, the second trigger 504 maintains pressure on the first trigger 502 which keeps the pins 505a, 505b spaced apart at the first distance 540d (540a) as the second trigger 504 is released. The second trigger 504 can maintain pressure on the first trigger 502 by pressing on surface 541 (shown in
In the example of
At step B, the needle 509 has moved to distal-most position of the distal portion 511b in which the needle is inserted into ferrule 520 in the distal portion 511b of the tissue engaging region 510. On the other hand, at step B, the sheath 530 has moved to a proximal position of the distal portion 511b. At step B, a second trigger 504 may be actuated for moving the sheath 530 relative to the needle 509 from the proximal position of the distal portion 511b in a direction towards the distal-most position of the distal portion 511b. The movement of the sheath 530 relative to the needle 509 may be configured to release the ferrule 520 from the actuatable engagement 550 in the distal portion 511b and securely mount the ferrule 520 to the needle 509. The ferrule 520 may be mounted to the needle 509 via movement described in
At step C, the needle 509 and sheath 530 are in a position for releasing the ferrule 520 from the actuatable engagement 550 in the distal portion 501 and mounting the ferrule 520 securely to the needle 509. The first trigger 502 and the second trigger 504 may be released so that the sheath 530 moves with the needle 509 away from the distal portion 511b towards the proximal portion 511a of the tissue engaging region 510.
At step D, the needle 509 and the sheath 530 are positioned in the proximal portion 511a of the tissue engaging region 510 and the ferrule 520 is mounted to the needle 509.
At step E, the needle 509 and the ferrule 520 mounted to the needle 509 are positioned in the distal end of the distal portion 511b and the sheath 530 is positioned in the proximal end of the distal portion 511b. In transitioning from step E to step F, the needle 509 and the ferrule 520 mounted to the needle 509 move relative to the sheath 530. At step F, the ferrule 520 may be retained in the distal portion 511b and unmounted from the needle 509. Steps D-F may be steps of movements described in
Between steps A and B, steps C and D, and steps D and E, the sheath 530 may cover at least a portion of the ferrule 520 and lock the ferrule 520 to the needle as described in
The suture holder may be the needle tip of the needle.
The needle tip 600 may include an aperture 670 configured for receiving an actuatable engagement 680 (such as actuatable engagement 220, 320) of the suture passer. As described in reference to ferrules 180, 400, 520 the needle tip 600 may be retained in the distal portion 602 when the actuatable engagement 680 (such as actuatable engagement 220, 320) of the suture passer is snapped into a latched position with the aperture 670 and the needle tip 600 may be released from the distal portion 602 when the actuatable engagement 680 is pushed away from the latched position to an unlatched position with the aperture 670 by a sheath 690. The sheath 690 may push the actuatable engagement 680 from the latched position to the unlatched position based on movement of the sheath 690 relative to the needle shaft 620. As the actuatable engagement 680 moves from the latched position with the aperture 670 to an unlatched position with the aperture 670, the needle tip 600 is released from the distal portion 602 and mounted to the needle shaft 620.
A distal portion 604 of the needle tip 600 and a distal portion 692 of the needle shaft 620 are configured to pierce through tissue to create a hole. A size of the hole created may be based on a size of the distal portion 604 of the needle tip 600 and a size of the distal portion 692 of the needle shaft 620. The distal portion 692 of the needle shaft 620 may be configured to create a hole having a larger size than a hole created by the distal portion 604 of the needle tip 600. The larger size hole created by the needle shaft 620 eases movement of the needle tip 600 through tissue during passing of the needle tip 600 to the distal portion 602 and during retrieval of the needle tip 600 from the distal portion 602.
The foregoing description, for the purpose of explanation, has been described with reference to specific examples. However, the illustrative discussions above are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The examples were chosen and described in order to best explain the principles of the techniques and their practical applications. Others skilled in the art are thereby enabled to best utilize the techniques and various examples with various modifications as are suited to the particular use contemplated.
Although the disclosure and examples have been fully described with reference to the accompanying figures, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the disclosure and examples as defined by the claims. Finally, the entire disclosure of the patents and publications referred to in this application are hereby incorporated herein by reference.
This application claims the benefit of U.S. Provisional Application No. 63/153,859, filed Feb. 25, 2021, the entire contents of which are hereby incorporated by reference herein.
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| Number | Date | Country | |
|---|---|---|---|
| 20220265267 A1 | Aug 2022 | US |
| Number | Date | Country | |
|---|---|---|---|
| 63153859 | Feb 2021 | US |
