Patent Description:
A wide variety of medical devices and methods have been developed for suturing tissue, and securing and/or terminating the free end of a suture relative to the tissue once a suture is in place. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative devices as well as alternative methods for manufacturing and using such devices.

<CIT> relates to a two-part suture cinch including a collar and a plug. A cinch applicator is also provided, and includes an elongate tubular member, a plunger engaged within the distal end of the tubular member, a flexible shaft extending through the tubular member and plunger, and a proximal handle for moving the shaft longitudinally relative to the tubular member. The plunger includes a distal housing for the collar of the cinch, and the plug is coupled to the distal end of the flexible shaft. The suture is thread through the collar and a portion of the applicator. Operation of the applicator draws the plug into the collar and clamps the suture between the plug and collar. In addition, once the plug is coupled in to the collar, the plunger is displaced proximally to release the two-part cinch form the applicator. A method for applying the cinch is also provided.

This disclosure provides design, material, manufacturing method, and use alternatives for suture termination devices, for example, devices for applying a cinch to a suture.

The medical device comprises: an elongated shaft including a proximal region and a distal region, the distal region defining a lumen having a lumen dimeter, and a distally facing end surface; an outer cinch member defining a bore and having an outer surface defining a shoulder, the shoulder having a proximally facing shoulder surface and having a shoulder diameter greater than the lumen dimeter, wherein the outer cinch member includes a proximal portion that is proximal of the shoulder, the outer cinch member having a first configuration wherein the proximal portion is disposed within the lumen and is engaged with the distal region of the elongate shaft with a frangible bond and a gap is defined between the proximally facing shoulder surface and the distally facing end surface; an elongated inner shaft extending through and longitudinally movable within the lumen and the bore and including a distal end section; and an inner cinch member engaged with the distal end section of the elongated inner shaft, the inner cinch member configured to engage the outer cinch member and including at least a segment configured to fit within the bore.

Alternatively or additionally to any of the embodiments above or below, the elongated inner shaft is designed such that proximal longitudinal movement of elongated inner shaft moves the inner cinch member into engagement with the outer cinch member.

Alternatively or additionally to any of the embodiments above or below, wherein the outer cinch member is designed to shift toward a second configuration where the proximally facing shoulder surface engages the distally facing end surface of the elongated shaft.

Alternatively or additionally to any of the embodiments above or below, in the second configuration, the bond is released.

Alternatively or additionally to any of the embodiments above or below, the elongated inner shaft is designed such that proximal longitudinal movement of the elongated inner shaft shifts the outer cinch member from the first configuration toward the second configuration.

Alternatively or additionally to any of the embodiments above or below, the outer cinch member is designed to shift toward a second configuration where the frangible bond between the outer cinch member and the distal region is broken.

Alternatively or additionally to any of the embodiments above or below, the outer cinch member is designed to shift toward a second configuration where the frangible bond between the outer cinch member and the distal region is broken and the proximally facing shoulder surface engages the distally facing end surface of the elongated shaft.

Alternatively or additionally to any of the embodiments above or below, when in the second configuration the proximally facing shoulder surface engages the distally facing end surface of the elongated shaft.

Alternatively or additionally to any of the embodiments above or below, further including a suture cutting member disposed within the lumen of the distal region, and wherein the elongated inner shaft is designed to engage the suture cutting member for cutting the suture.

Alternatively or additionally to any of the embodiments above or below, the elongated inner shaft is designed such that a first stage of proximal longitudinal movement of the elongated inner shaft moves the inner cinch member into engagement with the outer cinch member, and a second stage of proximal longitudinal movement of the elongated inner shaft shifts the outer cinch member toward a second configuration in which the proximally facing shoulder surface engages the distally facing end surface of the elongated shaft.

Alternatively or additionally to any of the embodiments above or below, the elongated inner shaft is designed such that a first stage of proximal longitudinal movement of the elongated inner shaft moves the inner cinch member into engagement with the outer cinch member, and a second stage of proximal longitudinal movement of the elongated inner shaft breaks the frangible bond and shifts the outer cinch member toward a second configuration in which the proximally facing shoulder surface engages the distally facing end surface of the elongated shaft.

Alternatively or additionally to any of the embodiments above or below, the elongated inner shaft is designed such that a third stage of proximal movement of the elongated inner shaft disengages the elongated inner shaft from the inner cinch member.

Alternatively or additionally to any of the embodiments above or below, further including a suture cutting member disposed within the lumen of the distal region, and the elongated inner shaft is designed such that a fourth stage of proximal movement of the elongated inner shaft engages the elongated inner shaft with the suture cutting member.

Alternatively or additionally to any of the embodiments above or below, further including: a cutout defined in the distal region of the elongated shaft defining a distally facing shear edge; and a suture cutting member disposed within the lumen and including a proximally facing shear edge, the suture cutting member having an open configuration wherein the proximally facing shear edge is disposed distally of the distally facing shear edge to define an opening between the proximally facing shear edge and the distally facing shear edge, and wherein the suture cutting member is designed to shift toward a closed configuration where the proximally facing shear edge has moved proximally relative to the distally facing shear edge such that the opening is closed.

Alternatively or additionally to any of the embodiments above or below, further including: a shear member affixed within the lumen and defining a distally facing shear edge; and a suture cutting member disposed within the lumen and including a proximally facing shear edge, the suture cutting member having an open configuration wherein the proximally facing shear edge is disposed distally of the distally facing shear edge to define an opening between the proximally facing shear edge and the distally facing shear edge, and wherein the suture cutting member is designed to shift toward a closed configuration where the proximally facing shear edge has moved proximally relative to the distally facing shear edge such that the opening is closed.

Alternatively or additionally to any of the embodiments above or below, the elongated inner shaft is designed such that proximal longitudinal movement of elongated inner shaft shifts the suture cutting member from the open configuration toward the closed configuration.

Alternatively or additionally to any of the embodiments above or below, in the open configuration the suture cutting member is engaged with the distal region of the elongate shaft with a frangible bond.

Alternatively or additionally to any of the embodiments above or below, in the closed configuration, the frangible bond between the suture cutting member and the distal region is broken.

Alternatively or additionally to any of the embodiments above or below, the shear member is a tubular member defining a shear member lumen having an inner diameter, and wherein the suture cutting member is a tubular member having an outer diameter sized to fit within the inner diameter of the shear member lumen.

Alternatively or additionally to any of the embodiments above or below, the suture cutting member is a tubular member including a cutout portion forming the proximally facing shear edge.

A medical device for applying a cinch to a suture is disclosed. In some embodiments, the medical device comprises: an elongated shaft including a proximal region and a distal region, the distal region defining a lumen, and a distally facing end surface; an outer cinch member defining a bore, and a shoulder having a proximally facing shoulder surface, wherein the outer cinch member includes a proximal portion disposed within the lumen and is releasably engaged with the distal region of the elongate shaft such that the shoulder is spaced distally from the distally facing end surface; an elongated inner shaft extending through the lumen and the bore and including a distal end section; an inner cinch member engaged with the distal end section of the elongated inner shaft, the inner cinch member configured to engage the outer cinch member and includes at least a segment configured to fit within the bore; a distally facing shear edge defined by the distal region of the elongated shaft; and a suture cutting member disposed within the lumen and including a proximally facing shear edge, the suture cutting member having an open configuration wherein the proximally facing shear edge is disposed distally of the distally facing shear edge to define an opening between the proximally facing shear edge and the distally facing shear edge.

In some embodiments, the medical device comprises: an elongated shaft including a proximal region and a distal region, the distal region defining a lumen; an outer cinch member defining a bore, wherein the outer cinch member includes a proximal portion disposed within the lumen and is releasably engaged with the distal region of the elongate shaft; an elongated inner shaft extending through the lumen and the bore and including a distal end section; an inner cinch member engaged with the distal end section of the elongated inner shaft, the inner cinch member configured to engage the outer cinch member and includes at least a segment configured to fit within the bore; a shear member affixed within the lumen and defining a distally facing shear edge; and a suture cutting member disposed within the lumen and including a proximally facing shear edge, the suture cutting member having an open configuration wherein the proximally facing shear edge is disposed distally of the distally facing shear edge to define an opening between the proximally facing shear edge and the distally facing shear edge.

Alternatively or additionally to any of the embodiments above or below, the suture cutting member is designed to shift toward a closed configuration where the proximally facing shear edge has moved proximally relative to the distally facing shear edge such that the opening is closed.

Alternatively or additionally to any of the embodiments above or below, in the closed configuration, the frangible bond is broken.

Alternatively or additionally to any of the embodiments above or below, in the open configuration the suture cutting member is engaged with the distal region of the elongate shaft with a bond; and in the closed configuration, the bond is released.

Alternatively or additionally to any of the embodiments above or below, the suture cutting member is a tubular member having an outer diameter sized to slidably fit with a tight tolerance within the lumen of the distal region of the elongated shaft.

Alternatively or additionally to any of the embodiments above or below, the shear member is a tubular member defining a shear member lumen, and wherein the suture cutting member is a tubular member having an outer diameter sized to fit within the shear member lumen.

Alternatively or additionally to any of the embodiments above or below, the suture cutting member is a tubular member having a cutout portion forming the proximally facing shear edge.

A method for applying a cinch to a suture is disclosed which does not form part of the claimed invention. Some embodiments include a method for applying a cinch to a suture using a medical device, the medical device including: an elongated shaft having a distal region defining a lumen and a distally facing end surface; an outer cinch member defining a bore and including an outer surface defining a shoulder having a proximally facing shoulder surface, the outer cinch member having a first configuration where the outer cinch member is engaged with the distal region of the elongate shaft and a gap is defined between the proximally facing shoulder surface and the distally facing end surface; an elongated inner shaft extending through and longitudinally movable within the lumen and the bore and including a distal end section; and an inner cinch member which is engaged with the distal end section of the elongated inner shaft; and the method comprising: passing a length of the suture through the bore of the outer cinch member and between the outer cinch member and the inner cinch member while the outer cinch member is in the first configuration and the inner cinch member is disengaged from the outer cinch member; moving the elongated inner shaft proximally through a first stage of proximal longitudinal movement such that the inner cinch member engages the outer cinch member, thereby trapping a portion of the suture there between; and moving the elongated inner shaft proximally through a second stage of proximal longitudinal movement to shift the outer cinch member toward a second configuration where the the proximally facing shoulder of the outer cinch member engages the distally facing end surface of the elongated shaft.

A method for applying a cinch to a suture using a medical device, the medical device including: an elongated shaft having a distal region defining a lumen and a distally facing end surface; an outer cinch member defining a bore and including an outer surface defining a shoulder having a proximally facing shoulder surface, the outer cinch member having a first configuration where the outer cinch member is engaged with the distal region of the elongate shaft with a frangible bond and a gap is defined between the proximally facing shoulder surface and the distally facing end surface; an elongated inner shaft extending through and longitudinally movable within the lumen and the bore and including a distal end section; and an inner cinch member which is engaged with the distal end section of the elongated inner shaft; the method comprising: passing a length of the suture through the bore of the outer cinch member and between the outer cinch member and the inner cinch member while the outer cinch member is in the first configuration and the inner cinch member is disengaged from the outer cinch member; moving the elongated inner shaft proximally through a first stage of proximal longitudinal movement such that the inner cinch member engages the outer cinch member, thereby trapping a portion of the suture there between; and moving the elongated inner shaft proximally through a second stage of proximal longitudinal movement to shift the outer cinch member toward a second configuration where the frangible bond between the outer cinch member and the distal region is broken and the proximally facing shoulder of the outer cinch member engages the distally facing end surface of the elongated shaft.

Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used in connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.

Medical suturing is used in a number of different interventions. Some of the interventions may include suturing at remote sites within the patient and/or otherwise at sites that may be challenging to access. When the suturing process is complete, it may be desirable to terminate the suture in a way that maintains the suture so that the suture does not easily come undone. This may include using a device such as a cinch in order to maintain the suture. Disclosed herein are medical devices that may be used to suture tissue as well as to terminate the suture. At least some of these devices utilize a cinch to maintain the suture. Some additional details of such devices are disclosed herein.

<FIG> shows a partial cross-sectional side view of a medical device <NUM> for applying a cinch to a suture, and <FIG> is a partially exploded view of the medical device <NUM>, showing some of the components of the medical device <NUM>. The medical device <NUM> includes an elongated shaft <NUM>, an outer cinch member <NUM>, an elongated inner shaft <NUM>, and an inner cinch member <NUM>.

The elongated shaft <NUM> includes a proximal region <NUM> and a distal region <NUM>. The proximal region <NUM> may include and/or be made of an elongated tubular member defining a lumen <NUM> having a lumen diameter. In the embodiment shown, the proximal region <NUM> is coiled tubular shaft, however, other configurations are contemplated. For example, the proximal region <NUM> may be a solid metallic or polymer tubular member, a tubular member including and/or made of and/or reinforced with a coil, braid and/or mesh material, or the like. Further, the proximal region <NUM> may include one or more slots and/or grooves and/or channels formed therein, for example, to enhance the flexibility characteristics thereof. The proximal region <NUM> may include or be made of one or more metals, polymers, and/or composite or layered or reinforced structures thereof, including any of those disclosed herein.

The distal region <NUM> is a tubular member including tubular wall <NUM> defining a lumen <NUM> having a lumen diameter, and including a distally facing end surface <NUM>. The distal region <NUM>, including the lumen <NUM>, may be configured to function as a receiver and/or "socket" for receiving and maintaining at least a portion of the outer cinch member <NUM> therein, as will be discussed below. In the embodiment shown, the distal region <NUM> is a generally solid metallic tubular member, however, other configurations are contemplated. For example, the distal region <NUM> may be a polymer tubular member, a tubular member including and/or made of and/or reinforced with a coil and/or braid and/or mesh material, or the like. Further, the distal region <NUM> may include one or more slots or grooves or channels formed therein, for example, to enhance the flexibility characteristics thereof. The distal region <NUM> may include or be made of one or more metals, polymers, and/or composite or layered or reinforced structures thereof, including any of those disclosed herein.

The proximal region <NUM> and the distal region <NUM> may be one integral piece, or may be separate parts connected such that the lumen <NUM> is in communication with the lumen <NUM>, for example, in an end to end arrangement. Arrangements are contemplated where the lumens <NUM>, <NUM> may or may not be coaxial. In some embodiments, the lumen diameters of the lumen <NUM> and the lumen <NUM> are the same or similar, while in other embodiments they may differ.

The distal region <NUM> may optionally include a cutout <NUM> that extends through the wall <NUM>. The cutout <NUM> may provide access to the lumen <NUM> through the wall <NUM>, for example, such that a suture may extend there through when the device <NUM> is used in a "side saddle" arrangement- where the suture extends from within the lumen <NUM> through the cutout <NUM>, and a proximal portion of the suture extends external of the device <NUM> along the proximal region <NUM> of the shaft <NUM>, as will be discussed in more detail below. However, as indicated, such a cutout <NUM> is optional. For example, it is also contemplated that the device <NUM> may be used with a suture in a "through-the-device" arrangement - where the suture, rather than extending externally along the proximal region <NUM>, extends internally along and through the lumen <NUM> of the proximal region <NUM> of the device <NUM>, as discussed in more detail herein. In such an arrangement, the cutout <NUM> may not be necessary.

The outer cinch member <NUM> is a tubular member including an inner surface <NUM> defining a bore <NUM> extending there through, and an outer surface <NUM>. The bore <NUM> may be sized and/or configured to receive and/or engage a portion of the inner cinch member <NUM>, as discussed herein. The bore <NUM> may have a tapered or constant inner diameter. The outer cinch member <NUM> is configured and/or designed to mate with the inner cinch <NUM> to trap and/or wedge a portion of a suture there between. As such, the outer cinch <NUM>, in combination with the inner cinch <NUM>, make up the "cinch" that will be applied to the suture.

The outer cinch member <NUM> includes a proximal portion <NUM> and a distal portion <NUM>. The proximal portion <NUM> includes an outer diameter and is sized and/or configured to fit within the lumen <NUM> of the distal region <NUM> of the elongated shaft <NUM>. The outer surface <NUM> defines a widened diameter portion and/or shoulder <NUM> having a proximally facing shoulder surface <NUM>. The widened diameter portion and/or shoulder <NUM> and/or the entire distal portion <NUM> includes an outer diameter that is larger than the inner diameter of the lumen <NUM>, and as such may be configured such that they cannot fit into the lumen <NUM> of the distal region <NUM>. In the embodiment shown, shoulder <NUM> is defined by a generally stepped portion having a rapid and/or stepped increase in outer diameter. However, in other embodiments, the outer surface <NUM> may be tapered and/or angled gradually and/or in a stepwise fashion such that the outer diameter increases in size in a distal direction in a more gradual manner, and the shoulder <NUM> may be more subtle. In such embodiments, the widened diameter portion and/or shoulder <NUM> may simply be defined by a first part along the outer surface <NUM> that includes an outer diameter sized such that it cannot fit into the lumen <NUM>. Such embodiments will still include a proximally facing shoulder surface <NUM>, in that the angle and/or taper would still provide a surface that is facing in a proximal direction in a tapered and/or angled manner.

In <FIG>, the outer cinch member <NUM> has and/or is disposed in a first configuration, where the proximal portion <NUM> is disposed within the lumen <NUM> and is engaged with the distal region <NUM> of the elongated shaft <NUM> such that a gap <NUM> is defined between the proximally facing shoulder surface <NUM> and the distally facing end surface <NUM>. The outer cinch member <NUM> is fixedly engaged with the distal region <NUM> of the elongated shaft <NUM> with one or more frangible bond. The frangible bond is a connection and/or attachment between the outer cinch member <NUM> and the distal region <NUM> that is designed to temporarily and/or provisionally fixedly secure or engage the components together, and is also designed to be selectively broken and/or overcome and/or released when desired to release the fixable securement of the components such that they may be moved relative to one another. For example, the one of more frangible bonds may include a frangible weld, such as a tack weld, a frangible adhesive bond, a frangible solder bond, a frangible mechanical interlock, a frangible frictional engagement, or the like, between the outer surface <NUM> of the outer cinch member <NUM> and a surface (e.g. luminal surface of the lumen <NUM>) of the distal region <NUM>. These frangible bonds may be selectively broken and/or overcome and/or released, for example, by the application of a predetermined amount of relative longitudinal force applied between the outer cinch member <NUM> and the distal region <NUM>. For example, the outer cinch member <NUM> may be releasably engaged and/or releasably coupled and/or releasably bonded and/or releasably connected and/or releasably attached with the distal region <NUM> when in the first configuration, such that such that the gap <NUM> is defined between the proximally facing shoulder surface <NUM> and the distally facing end surface <NUM>. The releasable engagement and/or coupling and/or bond and/or connection and/or attachment may be selectively overcome and/or released and/or broken, for example, by the application of a predetermined amount of relative longitudinal force applied between the outer cinch member <NUM> and the distal region <NUM>. The outer cinch member <NUM> may also include a second configuration, where the frangible bond(s) between the outer cinch member <NUM> and the distal region <NUM> is broken and/or overcome and/or released, the outer cinch member <NUM> has moved longitudinally relative to the distal region <NUM>, and the gap <NUM> has closed. For example, the releasable engagement and/or coupling and/or bond and/or connection and/or attachment may be selectively overcome and/or released and/or broken, for example, by the application of a predetermined amount of relative longitudinal force applied between the outer cinch member <NUM> and the distal region <NUM>. For example, the proximally facing shoulder surface <NUM> may engage the distally facing end surface <NUM> in the second configuration.

The elongated inner shaft <NUM> may be a solid wire or ribbon, or may be a generally tubular member defining a lumen along a part or the entire length thereof, or a combination of these structures. The elongated inner shaft <NUM> extends through and is longitudinally movable within the elongated shaft <NUM> from the proximal end of the device <NUM>, distally, to the distal end of the device <NUM>. For example, inner shaft <NUM> extends into and through the lumen <NUM> of the proximal region <NUM> and into and through the lumen <NUM> of the distal region <NUM>. The inner shaft <NUM> also extends into and through and is longitudinally movable within the bore <NUM> of the outer cinch member <NUM>. The elongated inner shaft <NUM> includes a distal end section <NUM> configured to engage the inner cinch member <NUM>. For example, the distal end section <NUM> may include an enlarged section <NUM> configured to engage the inner cinch member <NUM> in an interference fit, as discussed in more detail herein. The enlarged section <NUM> may be an integral portion of the elongated inner shaft <NUM>, or may be a separately attached component. For example, enlarged section <NUM> may simply be a rounded, bulbous and/or enlarged diameter portion of the inner shaft <NUM> itself, or may be a separately attached polymer or metallic sleeve, tube, coil, braid, or the like, to provide an enlarged diameter. In some embodiments, the enlarged section <NUM> may be made of and/or include a deformable material, such that when a predetermined axial compressive force is applied thereto, it may expand radially, either temporarily or permanently.

The inner cinch member <NUM> may be a tubular member defining a bore <NUM> extending there through. The bore <NUM> may be sized and/or configured to receive and/or engage a portion of the elongated inner shaft <NUM>, which may extend at least partially there through. For example, the bore <NUM> may include distal section <NUM> and a proximal section <NUM>. The distal section <NUM> may include an increased diameter relative to the proximal section <NUM>, and may be sized and/or configured to receive the enlarged section <NUM> of the inner shaft <NUM> therein. In essence, the distal section <NUM> has an enlarged diameter that forms a pocket for the enlarged section <NUM> of the inner shaft <NUM>. The proximal section <NUM> may include a decreased diameter relative to the distal section <NUM>, and may be sized and/or configured to receive a portion of the shaft <NUM> that is proximal to the enlarged section <NUM>. This configuration may provide an interference fit and/or engagement between the inner cinch member <NUM> and the inner shaft <NUM>. For example, there is an interference fit between the proximal section <NUM> of the bore <NUM> and the enlarged section <NUM> of the inner shaft <NUM>, in particular when a proximal longitudinal force and/or movement is applied to the inner shaft <NUM>. The size difference between the proximal section <NUM> (which is narrower) and the enlarged section <NUM> (which is wider) provides resistance to the enlarged section <NUM> pulling through the narrower proximal section <NUM> of the bore <NUM>. However, either the inner cinch member <NUM> and/or the enlarged section <NUM> of the inner shaft <NUM>, or both, may be deformable and/or flexible, such that the application of a predetermined amount of longitudinal force allows the interference fit to be overcome, thereby allowing the enlarged section <NUM> to be pulled through the narrower proximal section <NUM> of the bore <NUM>.

The inner cinch member <NUM> includes a distal portion <NUM> and a proximal portion <NUM>. The proximal portion <NUM> includes an outer diameter and is sized and/or configured to fit within the bore <NUM> of the outer cinch member <NUM>. The proximal portion <NUM> may have a tapered or constant outer diameter. The outer diameter and/or surface of the proximal portion <NUM> may be configured to engage the inner surface of the bore <NUM> of the outer cinch member <NUM> in an interference fit and/or frictional engagement to engage the inner cinch member <NUM> with the outer cinch member <NUM>. The inner cinch member <NUM> is configured and/or designed to mate with the outer cinch member <NUM> to trap and/or wedge a portion of a suture there between. As such, the outer cinch <NUM>, in combination with the inner cinch <NUM>, make up the "cinch" that will be applied to the suture.

The distal portion <NUM> may include an outer diameter that is larger than the inner diameter of the bore <NUM>, and as such may be configured such that it cannot fit into the bore <NUM> of the outer cinch member <NUM>. The transition between the diameters of the distal portion <NUM> and a proximal portion <NUM> may occur rapidly, defining a generally stepped shoulder portion having a rapid and/or stepped increase in outer diameter. However, in other embodiments, the transition in diameters may be tapered and/or angled gradually and/or in a stepwise fashion such that the outer diameter increases in size in a distal direction in a more gradual manner, and a more subtle shoulder may be defined. In such embodiments, the widened diameter portion and/or shoulder may simply be defined by a first part along the inner cinch member <NUM> that includes an outer diameter sized such that it cannot fit into the bore <NUM> of the outer cinch member <NUM>.

In at least some instances, the medical device <NUM> may include a suture cutting member <NUM>. In the example depicted in <FIG>, the suture cutting member <NUM> may be disposed at least partially within the lumen <NUM> of the distal region <NUM> of the elongated shaft <NUM>. The inner shaft <NUM> may extend through the suture cutting member <NUM>. In general, the suture cutting member <NUM> may be designed to terminate and/or otherwise cut a suture used with the device <NUM>. However, in some instances, the device <NUM> may include a different structural feature or component for cutting the suture and/or another device may be used in conjunction with the device <NUM> in order to cut the suture. Indeed, some example embodiments of the device <NUM> are contemplated that do not include the suture cutting member <NUM>.

<FIG> shows a perspective view of the suture cutting member <NUM>, illustrating some of the features thereof. Here it can be seen that the suture cutting member <NUM> may be a generally tubular member including a wall <NUM> having an outer diameter and defining a lumen having a distal opening <NUM> and a proximal opening <NUM>. In at least some instances, the distal opening <NUM> may be designed so that the inner shaft <NUM> can pass there through. The proximal opening <NUM> may be designed so that the inner shaft <NUM> can extend at least partially there through. However, the proximal opening <NUM> may be narrower than the distal opening <NUM>. For example, the proximal opening <NUM> may be sized so that the enlarged section <NUM> of the inner shaft <NUM> may not be able to pass through the proximal opening <NUM>. This may provide an engagement mechanism between the inner shaft <NUM> and the suture cutting member <NUM> such that proximal retraction of the inner shaft <NUM> (e.g., relative to the suture cutting member <NUM>) may include engagement of the enlarged section <NUM> of the inner shaft <NUM> with the suture cutting member <NUM> (e.g., at a location adjacent to the proximal opening <NUM>) such that further proximal movement of the inner shaft <NUM> may result in the suture cutting member <NUM> translating (e.g., proximally) within the lumen <NUM> of the shaft <NUM>. This will be demonstrated further during the discussion of usage of the device <NUM> herein.

A cutout <NUM> may be formed in the wall <NUM>. A shear edge <NUM> may be defined along the cutout <NUM>. In at least some instances, the shear edge <NUM> may face in a generally proximal direction. The shear edge <NUM> may be used to cut a suture as described in more detail below.

Turning back to <FIG>, the device <NUM> may also include a "union" or shear member <NUM>. The shear member <NUM> may be a generally tubular member that may be coupled to or otherwise secured within the shaft <NUM>, for example within the lumen <NUM> of the proximal section, or the lumen <NUM> of the distal section, or both. The shear member <NUM> may be attached to an inner surface of the distal region <NUM> of the shaft, an inner surface of the proximal region <NUM> of the shaft <NUM>, or both. In some instances, the shear member <NUM> may extend across the junction of the proximal region <NUM> and the distal region <NUM> of the shaft <NUM>. Other arrangements are contemplated.

The shear member <NUM> may define a lumen having an inner diameter and also define a distally facing shear edge <NUM>. In at least some instances, the shear edge <NUM> of the shear member <NUM> may be designed to work with the shear edge <NUM> of the suture cutting member <NUM> such that a suture disposed between the shear edges <NUM>, <NUM> may be cut or sheared when the shear edges <NUM>, <NUM> come together. In at least some embodiments, the shear member <NUM> is configured to receive a portion of the suture cutting member <NUM> therein. For example, the shear member <NUM> may include an inner diameter that is the same as or larger than the outer diameter of the suture cutting member <NUM>, such that at least a portion of the suture cutting member <NUM> is configured to be disposed within at least a portion of the shear member <NUM>. In at least some embodiments, it may be desirable to have a tight tolerance fit between the inner diameter of the shear member <NUM> and the outer diameter of the suture cutting member <NUM> to provide for a better suture cutting arrangement between the shear edges <NUM>, <NUM>.

The suture cutting member <NUM> may be designed to shift between a first or open configuration (e.g., as depicted in <FIG> and where an opening <NUM> is defined between the shear edge <NUM> of the suture cutting member <NUM> and the shear edge <NUM> of the shear member <NUM>) and a second or closed configuration (e.g., as depicted in <FIG> and where the shear edge <NUM> of the suture cutting member <NUM> is brought adjacent to and/or engages the shear edge <NUM> of the shear member <NUM>). In some instances, the suture cutting member <NUM> (e.g., a proximal portion of the suture cutting member <NUM>) may be coupled to the shear member <NUM>, for example with a frangible bond. For example, a proximal portion of the suture cutting member <NUM> may be disposed within a distal portion of the shear member <NUM>, and the two structures may be fixedly secured to each other with a frangible bond while in the open configuration. Thus, in an original state where the frangible bond is intact, the suture cutting member <NUM> may be in the open configuration. Proximal retraction of the inner shaft <NUM> may bring the enlarged section <NUM> of the inner member <NUM> into contact with a surface of the suture cutting member <NUM> (e.g., adjacent to the proximal opening <NUM>) so that further proximal retraction of the inner shaft <NUM> may break or sever the frangible bond and allow the suture cutting member <NUM> to be shifted (e.g., moved proximally) toward the closed configuration.

Turning back to <FIG>, the medical device <NUM> also includes a handle and/or user interface <NUM> that may be designed and/or configured for user interaction to provide relative movement between the elongated shaft <NUM> and the inner shaft <NUM>. Any of a wide variety of configurations of the user interface <NUM> are contemplated that may achieve this purpose. In the embodiment shown in <FIG>, the user interface <NUM> incudes a distal portion <NUM>, a proximal portion <NUM>, and a slider portion <NUM> that is disposed about and/or along the proximal portion <NUM>. The distal portion <NUM> is connected to the proximal end of the elongated shaft <NUM>, and the proximal portion <NUM> is connected to and extends proximally from the distal portion <NUM>. The slider portion <NUM> is connected to the proximal end of the inner shaft <NUM>. The slider portion <NUM> is disposed on and longitudinally movable and/or slidable over and/or along the proximal portion <NUM>. As such, the user interface may provide for longitudinal movement of the inner shaft <NUM> relative to the elongate shaft <NUM> by actuation of the slider <NUM> relative to the proximal portion <NUM>. In some instances, the slider portion <NUM> may be designed to slide along a groove or slot <NUM> formed in the proximal portion <NUM>. In other instances, the slider portion <NUM> may be replaced by one or more finger loops (not shown) designed to slide along the proximal portion <NUM>. The finger loops may be designed to accommodate the fingers of a user (e.g., an index finger, a middle finger, combinations thereof, or other fingers) so that a user can slide the finger loops along the proximal portion <NUM> in order to shift the inner shaft <NUM> relative to the elongated shaft <NUM>.

The proximal end of the proximal portion <NUM> may be configured for user engagement, and as such, may include a structure or a shape that may enhance user engagement, grip and/or comfort. For example, the proximal end of the proximal portion <NUM> may include a loop <NUM>, such as a thumb loop or the like. The slider portion <NUM> may also be configured for user engagement, and as such may also include a structure or shape to enhance user engagement, grip and/or comfort. For example, the slider portion <NUM> may include a spool like configuration including an annular groove which may be configured to be engaged by one or more fingers of user. For example, a user may engage the user interface <NUM> by inserting a thumb into the thumb loop <NUM>, and engaging the slider portion <NUM> with an index and middle finger (e.g., with the fingers disposed in the annular groove of the slider portion <NUM>).

The user interface <NUM> may include a number of additional features. For example, a spool stop (not shown) may be disposed along the channel <NUM>, which may prevent undesired movement of the spool member <NUM> (e.g., during shipping and/or storage). In addition or in the alternative, the user interface <NUM> may include one or more stops, locks, spring members, detents, indexing, markings or the like for visualizing, controlling and/or limiting longitudinal movement of the spool member <NUM>.

The user interface <NUM> may also optionally include a suture exit port <NUM> disposed thereon, and including a lumen in communication with the lumen <NUM> of the proximal portion <NUM>. For example, as discussed herein, it is contemplated that the device <NUM> may be used with a suture in a "through-the-device" arrangement - where the suture, rather than extending externally along the proximal region <NUM>, extends internally along and through the lumen <NUM> of the proximal region <NUM> of the device <NUM>. In such an arrangement, the suture will need to exit the device <NUM> near the proximal end. The suture exit port <NUM> may be used to provide this. The suture exit port <NUM> may be generally configured as a Y-adapter that provides proximal access to the lumen <NUM>. The user interface <NUM> as described herein may be included and/or used with any of the various embodiments of medical devices disclosed herein.

<FIG> may be used to illustrate and describe an example method of using the device <NUM>. For example, <FIG> shows the medical device in an initial arrangement and ready for use. The inner cinch member <NUM> and the outer cinch member <NUM> are spaced longitudinally (and not directly engaged with each other and/or cinched onto the suture). The outer cinch <NUM> is in a first configuration, where the proximal portion <NUM> of the outer cinch member <NUM> is be disposed within the lumen <NUM> and may be engaged with the distal region <NUM> of the elongate shaft <NUM> with one or more frangible bond. A gap <NUM> is defined between the proximally facing shoulder surface <NUM> of the outer cinch member <NUM> and the distally facing end surface <NUM> of the distal region <NUM> of the shaft <NUM>. In essence, the distal region <NUM> is acting as a "socket" for securely holding (e.g. frangibly bonded to) the outer cinch member <NUM> during delivery, until it is desirable to release it. The inner cinch member <NUM> is mounted on the elongate shaft <NUM>, and the interference fit provided by the enlarged section <NUM> maintains the inner cinch member <NUM> thereon during delivery, until it is desirable to release it. Also, the suture cutting member <NUM>, if present, is in the open configuration, where an opening <NUM> is defined between the shear edge <NUM> of the suture cutting member <NUM> and the shear edge <NUM> of the shear member <NUM>. Further, the suture cutting member <NUM> may be engaged with the shear member <NUM> with one or more frangible bond, to maintain the suture cutting member <NUM> in the open configuration until it is desirable to close it and cut the suture. At this stage, the device <NUM> is ready to be loaded with a suture and be used to apply a cinch to the suture. For example, following a suturing procedure the open and/or free and/or proximal end of the suture <NUM> may be loaded into and/or through the device <NUM>. The proximal end of the suture may be fed into the distal end of the device <NUM> and along the appropriate pathway through the device <NUM>. This may be done with or without using a tool or guide, such as a tubular guide, wire, loop, needle, or the like.

<FIG> shows an example device and/or mechanism for loading the suture <NUM> through the medical device <NUM>. A suture guide tube <NUM> may be inserted in the desired pathway for the suture <NUM> to extend through the device <NUM>. In this example, the suture <NUM> will be loaded in a "side saddle" arrangement- where the suture <NUM> is loaded into the distal region of the device <NUM>, and then extends from within the device <NUM> through the cutout <NUM>, and extends external of the device <NUM> along the proximal region <NUM> of the shaft <NUM>. For example, the suture guide tube <NUM> may be disposed such that it extends externally alongside the medical device <NUM> from the proximal end of the device <NUM> (e.g. adjacent the user interface <NUM>) to the distal region <NUM>, and then may be inserted along an appropriate pathway through the device <NUM>. For example, as shown, the suture guide tube <NUM> may be inserted through the cutout <NUM> in the distal region <NUM>, through the cutout <NUM> of the suture cutting member <NUM> (e.g. through the opening <NUM>), through the lumen of the suture cutting member <NUM> into and through the lumen <NUM> of the distal region <NUM>, into and through the bore <NUM> of the outer cinch member <NUM>, and out between the outer and inner cinch members <NUM> and <NUM>. The suture <NUM> may be fed back through the suture guide tube <NUM> such that is follows the same general pathway back through the suture guide tube <NUM> and/or device <NUM>. The suture guide tube <NUM> may be used to help guide and/or load the suture <NUM> through the device <NUM> and may help protect the suture from damage, for example, from the cutter member <NUM> during loading of the suture. The suture guide tube <NUM> may be similarly used with used with any of the embodiments of medical devices disclosed herein. The suture guide tube <NUM> may be removed as shown in <FIG>. The device <NUM> may be advanced over the suture <NUM> down to the suturing/defect site where it is desirable to apply a cinch to the suture <NUM>. When doing so, the suture <NUM> remains inserted in the pathway through the device <NUM>.

Once the device <NUM> is advanced to the desired position for the application of the cinch <NUM>/<NUM> to the suture <NUM>, a user may apply appropriate and/or desired amount of tension to the suture <NUM>, and apply the cinch to the suture <NUM> using the device <NUM>. For example, using the user interface <NUM>, the inner shaft <NUM> may be proximally retraced relative to the outer shaft <NUM>. As shown in <FIG>, when doing so, the inner shaft <NUM> may move or otherwise proximally shift the inner cinch member <NUM> into engagement with the outer cinch member <NUM>, thereby trapping a portion of the suture <NUM> there between. The inner cinch member <NUM> and outer cinch members <NUM> are, once appropriately engaged on the suture <NUM>, in combination, the "cinch" applied to the suture <NUM>. This may be described as being a first stage of proximal longitudinal movement of the elongated inner shaft <NUM> - which may apply the cinch to the suture.

Further proximal movement of the inner shaft <NUM> may shift the outer cinch member <NUM> from a first configuration (e.g., as shown in <FIG>) toward a second configuration where the frangible bond between the outer cinch member <NUM> and the distal region <NUM> of the shaft <NUM> is broken and/or released, and the proximally facing shoulder surface <NUM> engages the distally facing end surface <NUM> of the elongated shaft <NUM> as shown in <FIG>. This movement of the inner shaft <NUM> may be described as moving the inner shaft <NUM> proximally through a second stage of proximal longitudinal movement to shift the outer cinch member <NUM> toward the second configuration where the frangible bond between the outer cinch member <NUM> and the distal region <NUM> of the shaft <NUM> is broken and/or released. This releases the outer cinch member <NUM> from fixed engagement with the shaft <NUM>, thereby allowing the cinch to be released. Additionally engaging the proximally facing shoulder <NUM> of the outer cinch member <NUM> with the distally facing end surface <NUM> of the distal region <NUM> of the elongated shaft <NUM> may act as a "stop" of sorts, to allow for the next stage of movement to disengage the inner cinch member <NUM> from the inner shaft <NUM>.

The inner shaft <NUM> may be designed to move through a third stage of proximal movement where the inner shaft <NUM> disengages from the inner cinch member <NUM> as shown in <FIG>. Further, the inner shaft <NUM> may be designed such that a fourth stage of proximal movement of the inner shaft <NUM> engages the inner shaft <NUM> with the suture cutting member <NUM>. When doing so, the inner shaft <NUM> may shift the suture cutting member <NUM> from the open configuration to the closed configuration and cuts the suture <NUM> as shown in <FIG>. For example, moving the inner shaft <NUM> through the fourth stage of proximal movement may break and/or release the frangible bond between the suture cutting member <NUM> and the shear member <NUM> so that the suture cutting member <NUM> can shift toward the closed configuration to cut the suture.

The cinch (e.g., which may be defined as or otherwise include the inner cinch member <NUM> and the outer cinch member <NUM>) is applied to or otherwise holds the suture <NUM> in a cinched arrangement. Due to frangible bonds being broken and/or released, and the suture <NUM> being cut, the cinch may then be disengaged from the shaft <NUM> and can remain in the anatomy to terminate and/or anchor a suture that extends through tissue T as depicted in <FIG>.

<FIG> and <FIG> show an alternative use and/or configuration of the device <NUM> relative to the suture <NUM> where the suture <NUM> is arranged in a "through the device" configuration. For example, <FIG> shows the guide tube <NUM> being used to feed the suture <NUM> through the proximal portion <NUM> of the shaft <NUM> (rather than external), through the proximal portion of the suture cutting member <NUM>, out through the cutout <NUM> of the suture cutting member <NUM>, along the outside of the distal portion of the suture cutting member <NUM>, within and through the lumen <NUM>, into and through the lumen <NUM>, out the distal opening of the outer cinch member <NUM> (e.g., between the outer cinch member <NUM> and the inner cinch member <NUM>). <FIG> shows the guide tube <NUM> removed, and suture <NUM> remains as "through the device". At this point, use of the device <NUM> may be substantially the same as use described above with reference to <FIG>. For example, the device <NUM> may be fed over the suture <NUM> (which may also include tensioning the suture <NUM>), the inner shaft <NUM> may be proximally retracted to engage the inner cinch member <NUM> with the outer cinch member <NUM> and apply the cinch to the suture <NUM>. This may include moving the inner shaft <NUM> through a first stage and/or a second stage of longitudinal movement. Additional longitudinal movement of the inner shaft <NUM> (e.g., through the third and/or fourth stage) may cut the suture <NUM> and disengage the cinch from the device.

<FIG> illustrates another example medical device <NUM> that may be similar in form and function to the other devices described therein, wherein like names and/or reference numbers indicate the same or similar structure and/or function as described elsewhere herein. While other components of the device/assembly remain largely the same, in this example, the medical device <NUM> may include a suture cutting member <NUM>, shown in <FIG>, that includes an inner tube <NUM> and outer tube <NUM> attached to the inner tube <NUM>. In at least some instances, the inner tube <NUM> is attached in a manner that is non-coaxial or could be described as being off axis. The suture cutting member <NUM> may include a tube wall <NUM>. A cutout <NUM> may be formed in the tube wall <NUM> that includes or otherwise defines a shear edge <NUM>. Cutout <NUM> and shear edge <NUM> are similar in structure and function to cutout <NUM> and shear edge <NUM> as discussed herein (e.g. the suture cutting member <NUM> may interact with the shear member <NUM> to cut the suture <NUM>).

As such, use of the device <NUM> may be similar to that of other embodiments of devices described herein. For example, the device <NUM> may start in a first configuration, where the proximal portion <NUM> of the outer cinch member <NUM> is disposed within the lumen <NUM> and is engaged with the distal region <NUM> of the elongated shaft <NUM> such that a gap <NUM> is defined between the proximally facing shoulder surface <NUM> and the distally facing end surface <NUM>. The inner shaft <NUM> may go through the first, second, third, and fourth stages of proximal movement, as described herein. When doing so, the cinch (e.g., including the outer cinch member <NUM> and the inner cinch member <NUM>) may be applied to the suture <NUM>, the gap <NUM> between the proximally facing shoulder <NUM> and the distal end surface <NUM> may close into a second configuration, the suture cutting member <NUM> may shift from the open to the closed configuration, to cut the suture <NUM>, and the cinch (e.g., including the outer cinch member <NUM> and the inner cinch member <NUM>) may be released.

While <FIG> depicts the suture <NUM> being arranged in a "through the device" configuration, other configurations are contemplated including a "side saddle" configuration as shown in <FIG>. As shown in <FIG>, when doing so, the wall of the distal region <NUM> of the shaft <NUM> may include a cutout <NUM> through which the suture <NUM> can be passed (e.g., similar to the cutout <NUM> as shown in <FIG>).

<FIG> depicts another example medical device <NUM> that may be similar in form and function to the other devices described therein, wherein like names and/or reference numbers indicate the same or similar structure and/or function as described elsewhere herein. While other components of the device/assembly remain largely the same, this embodiment includes an alternative suture cutting member <NUM> having a different configuration for the cutter member <NUM>. In this example, the suture cutting member <NUM> may include an inner tube <NUM>, an intermediate tube <NUM>, and outer tube <NUM>. As shown, the tubes <NUM>, <NUM>, and <NUM> may be arranged and/or affixed to one another on axis (e.g., the tubes <NUM>, <NUM>, and <NUM> may be coaxial). However, other arrangements are contemplated. The outer tube <NUM> defines a shear edge <NUM> on the proximal end thereof. Shear edge <NUM> may be similar in function to shear edge <NUM> as discussed herein, in that it interacts in a similar manner with the shear edge <NUM> of the shear member <NUM> to shear and/or cut the suture. The inner tube <NUM> receives the inner shaft <NUM> in the lumen there through, and an outer portion thereof may be releasably engaged/secured with the shear member <NUM>, for example, with a frangible bond. An opening may be defined between the shear edge <NUM> and the shear edge <NUM> of the shear member <NUM>. The intermediate tube <NUM> may act as a spacer between the inner and outer tubes <NUM>, <NUM>. Proximal retraction of the inner shaft <NUM> causes the distal portion <NUM> of the inner shaft <NUM> to engage the inner tube <NUM> and release and/or break the frangible bond. Further proximal retraction of the inner shaft <NUM> may bring together the shear edge <NUM> and shear edge <NUM>, shifting them from an open to a closed configuration, and which engage to shear/cut the suture <NUM>.

While <FIG> depicts the suture <NUM> being arranged in a "through the device" configuration, other configurations are contemplated including a "side saddle" configuration. When doing so, the wall of the distal region <NUM> of the shaft <NUM> may include a cutout (e.g., similar to the cutout <NUM> as shown in <FIG>) through which the suture <NUM> can be passed.

<FIG> depicts another example medical device <NUM> that may be similar in form and function to the other devices described therein, wherein like names and/or reference numbers indicate the same or similar structure and/or function as described elsewhere herein. While other components of the device/assembly remain largely the same, this embodiment includes a different configuration for the shear member <NUM> and the suture cutting member <NUM>. The suture cutting member <NUM> may take the form of a tubular member on axis with the inner shaft <NUM>, and the suture cutting member <NUM> may be releasably engaged/secured with the distal region <NUM>, for example, with a frangible bond. A shear edge <NUM> may be defined and/or disposed on the proximal end of the suture cutting member <NUM>. The suture cutting member <NUM> may receive the inner shaft <NUM>. In this example, the shear member <NUM> is a blade and/or blade like member affixed to a tubular member <NUM>, which may in turn be affixed to the shaft <NUM> (e.g. the distal region <NUM>, proximal region <NUM>, or both). An opening may be defined between the shear edge <NUM> of the cutting member <NUM> and the shear edge <NUM> of the shear member <NUM>. Proximal retraction of the inner shaft <NUM> causes the distal portion <NUM> of the inner shaft <NUM> to engage the suture cutting member <NUM>, and release and/or break the frangible bond. Further proximal retraction of the inner shaft <NUM> may bring together the shear edge <NUM> and shear edge <NUM>, shifting them from an open to a closed configuration, and which engage to shear/cut the suture <NUM>.

While <FIG> depicts the suture <NUM> being arranged in a "through the device" configuration, other configurations are contemplated including a "side saddle" configuration. When doing so, the wall of the distal region <NUM> of the shaft <NUM> may include a cutout (e.g., similar to the cutout <NUM> as shown in <FIG>) through which the suture <NUM> can be passed. In some instances, the suture <NUM> may pass through the suture cutting member <NUM> and then through the cutout and/or opening (not shown) in the wall of the distal region <NUM> of the shaft <NUM>. Proximal retraction of the inner shaft <NUM> may bring together the shear edge <NUM> and shear edge <NUM>, which engage to shear/cut the suture <NUM>.

<FIG> depicts another example medical device <NUM> that may be similar in form and function to the other devices described therein, wherein like names and/or reference numbers indicate the same or similar structure and/or function as described elsewhere herein. While other components of the device/assembly remain largely the same, this embodiment includes a different configuration for the suture cutting member <NUM>. The suture cutting member <NUM> may include an inner tube <NUM> and outer tube <NUM> attached to the inner tube <NUM>. The inner tube <NUM> may be releasably engaged/secured to a shear member <NUM>, for example, with a frangible bond. The outer tube <NUM> may be arranged off-axis or otherwise in a non-coaxial manner with the inner tube <NUM> so that an opening is defined between the two tubes so that a suture <NUM> may pass there through. The suture cutting member <NUM> may also include a cutout or skive <NUM>, for example at the proximal end thereof, that may help guide the suture toward and/or through an opening <NUM> in the tube wall <NUM> of the distal region <NUM> of the shaft <NUM> in a side saddle arrangement. In this example, the shear member <NUM> may include a blade like member <NUM> having a shear edge <NUM>. Proximal retraction of the inner shaft <NUM> may bring together the shear edge <NUM> and shear edge <NUM>, which engage to shear/cut the suture <NUM>. For example, the inner shaft <NUM> may be retracted until the enlarged section <NUM> contacts the distal end of the inner tube <NUM>. Further proximal retraction of the inner shaft <NUM> may break and/or release the frangible bond between the inner shaft <NUM> and the shear member <NUM>, and allow the shear edge <NUM> of the suture cutting member <NUM> to come together with the shear edge <NUM>, from an open to a closed configuration, and cut/shear the suture <NUM>.

<FIG> illustrates another example medical device <NUM> that may be similar in form and function to the other devices described therein, wherein like names and/or reference numbers indicate the same or similar structure and/or function as described elsewhere herein. While other components of the device/assembly remain largely the same, this embodiment includes a different configuration for a suture cutting member <NUM> and a shear edge <NUM>. In particular, in this configuration, the device <NUM> does not include a separate "union" and/or shear member, (for example, unions or shear members <NUM>, <NUM>) as provided in some of the embodiments herein. Rather, in this embodiment, structure of the distal region <NUM> of the shaft <NUM> defines a shear edge <NUM> that works in conjunction with a shear edge <NUM> on the suture cutting member <NUM> to cut the suture <NUM>. In some respects, the distal region <NUM> of the shaft <NUM> is and/or defines a shear member within the lumen that defines a distally facing shear edge <NUM> that works in conjunction with a proximally facing shear edge <NUM> on the suture cutter.

For example, in this embodiment, the distal region <NUM> of the shaft <NUM> includes a side opening and/or window and/or cutout <NUM> that extends through the wall <NUM> thereof. As in some other embodiments, the cutout <NUM> may provide access to the lumen <NUM> through the wall <NUM>, for example, such that a suture <NUM> may extend there through when the device <NUM> is used in a "side saddle" arrangement- where the suture extends from within the lumen <NUM> through the cutout <NUM>, and a proximal portion of the suture extends external of the device <NUM> along the proximal region <NUM> of the shaft <NUM>, as discussed herein. Additionally, in this embodiment, the cutout <NUM> defines a distally facing shear edge <NUM>. The shear edge <NUM> defined by the cutout <NUM> in the distal region <NUM> of the shaft may be designed to work with the shear edge <NUM> of the suture cutting member <NUM> such that a suture <NUM> disposed between the shear edges <NUM> and <NUM> may be cut or sheared when the shear edges <NUM> and <NUM> come together and/or close.

The suture cutting member <NUM> may be largely the same or similar in form and function to the suture cutting member <NUM> described herein. The suture cutting member <NUM> member is disposed within the lumen <NUM> of the distal region <NUM> of the shaft <NUM>, and the inner shaft <NUM> may extend through the suture cutting member <NUM>. The suture cutting member <NUM> may be a generally tubular member including a wall <NUM> having an outer diameter and defining a lumen having a distal opening <NUM> and a proximal opening <NUM>. In at least some instances, the distal opening <NUM> may be designed so that the inner shaft <NUM> can pass there through. The proximal opening <NUM> may be designed so that the inner shaft <NUM> can extend at least partially there through. However, the proximal opening <NUM> may be narrower than the distal opening <NUM>. For example, the proximal opening <NUM> may be sized so that the enlarged section <NUM> of the inner shaft <NUM> may not be able to pass through the proximal opening <NUM>. This may provide an engagement mechanism between the inner shaft <NUM> and the suture cutting member <NUM> such that proximal retraction of the inner shaft <NUM> (e.g., relative to the suture cutting member <NUM>) may include engagement of the enlarged section <NUM> of the inner shaft <NUM> with the suture cutting member <NUM> (e.g., at a location adjacent to the proximal opening <NUM>) such that further proximal movement of the inner shaft <NUM> may result in the suture cutting member <NUM> translating (e.g., proximally) within the lumen <NUM> of the shaft <NUM>.

In general, the suture cutting member <NUM>, in conjunction with the shear edge <NUM>, may be designed to terminate and/or otherwise cut a suture used with the device <NUM>. For example, a cutout <NUM> may be formed in the wall <NUM> of the suture cutting member <NUM>. A shear edge <NUM> may be defined along the cutout <NUM>. In at least some instances, the shear edge <NUM> may face in a generally proximal direction. The shear edge <NUM>, in conjunction with the shear edge <NUM> defined in the distal region <NUM> of the shaft <NUM> may be used to cut a suture <NUM> as described herein.

In this embodiment, the outer diameter of the suture cutting member <NUM> is sized to fit within, and selectively movable and/or slidable within the lumen <NUM> of the distal region <NUM> of the shaft <NUM>. In at least some embodiments, it may be desirable to have a relatively tight tolerance fit between the inner diameter (e.g. lumen <NUM>) of the distal region <NUM> of the shaft <NUM>, and the outer diameter of the suture cutting member <NUM>. This may provide for a better and/or tighter suture cutting arrangement between the shear edges <NUM>, <NUM> as they are moved toward one another to cut the suture. The suture cutting member <NUM> may be designed to shift between a first or open configuration and a second closed configuration. For example, a first open configuration is depicted in <FIG>, where an opening is defined between the shear edge <NUM> of the suture cutting member <NUM> and the shear edge <NUM> of the distal region <NUM> of the shaft <NUM>. A suture <NUM> may extend through this opening between the edges <NUM> and <NUM> in this configuration. In the second, or closed configuration, the shear edge <NUM> of the suture cutting member <NUM> is brought adjacent to and/or engages and/or passes proximally by the shear edge <NUM> to close the opening and cut the suture. In some instances, the suture cutting member <NUM> may be releasably engaged and/or coupled to the distal region <NUM> of the shaft <NUM>, for example with a releasable and/or frangible bond. For example, the two structures may be fixedly secured to each other with a releasable and/or frangible bond while in the open configuration as shown in <FIG>. Thus, in an original state, where the releasable and/or frangible bond is engaged and/or intact, the suture cutting member <NUM> may be in the open configuration. Proximal retraction of the inner shaft <NUM> may bring the enlarged section <NUM> of the inner member <NUM> into contact with a surface of the suture cutting member <NUM> (e.g., adjacent to the proximal opening <NUM>) so that further proximal retraction of the inner shaft <NUM> may break and/or sever and/or release and/or disengage the releasable and/or frangible bond and allow the suture cutting member <NUM> to be shifted (e.g., moved proximally) from the open configuration toward and/or into the closed configuration and cut/shear the suture <NUM>.

As such, use of the device <NUM> may be similar to that of other embodiments of devices described herein. For example, the device may start in a first configuration, where the proximal portion <NUM> of the outer cinch member <NUM> is disposed within the lumen <NUM> and is engaged with the distal region <NUM> of the elongated shaft <NUM> such that a gap <NUM> is defined between the proximally facing shoulder surface <NUM> and the distally facing end surface <NUM>. The inner shaft <NUM> may go through the first, second, third, and fourth stages of proximal movement, as described herein. When doing so, the cinch (e.g., including the outer cinch member <NUM> and the inner cinch member <NUM>) may be applied to the suture <NUM>, the gap <NUM> between the proximally facing shoulder <NUM> and the distal end surface <NUM> may close in a second configuration, the suture cutting member <NUM> may shift from the open to the closed configuration, to cut the suture <NUM>, and the cinch (e.g., including the outer cinch member <NUM> and the inner cinch member <NUM>) may be released.

The medical device <NUM> of <FIG> is also shown as including an alternative handle and/or user interface <NUM> that may be designed and/or configured for user interaction to provide relative movement between the elongated shaft <NUM> and the inner shaft <NUM>. The user interface <NUM> is similar in many respects to the user interface <NUM> shown and discussed herein with reference to <FIG>, with some modification. In the embodiment shown in <FIG>, the user interface <NUM> incudes a distal portion <NUM>, a proximal portion <NUM>, and a slider portion <NUM> that is disposed about and/or along the proximal portion <NUM>. The distal portion <NUM> is connected to the proximal end of the elongated shaft <NUM>, and the proximal portion <NUM> is connected to and extends proximally from the distal portion <NUM>. The slider portion <NUM> is connected to the proximal end of the inner shaft <NUM>. The slider portion <NUM> is disposed on and longitudinally movable and/or slidable over and/or along the proximal portion <NUM>. As such, the user interface <NUM> may provide for longitudinal movement of the inner shaft <NUM> relative to the elongate shaft <NUM> by actuation of the slider <NUM> relative to the proximal portion <NUM>. In some instances, the slider portion <NUM> may be designed to slide along a groove or slot <NUM> formed in the proximal portion <NUM>. In this embodiment, the slider portion <NUM> includes two finger loops designed to accommodate the fingers of a user (e.g., an index finger, a middle finger, combinations thereof, or other fingers) so that a user can use the finger loops to engage the slider portion <NUM> to slide it along the proximal portion <NUM> in order to shift the inner shaft <NUM> relative to the elongated shaft <NUM>.

The proximal end of the proximal portion <NUM> may also be configured for user engagement, and as such, may include a structure or a shape that may enhance user engagement, grip and/or comfort. For example, the proximal end of the proximal portion <NUM> may include a loop <NUM>, such as a thumb loop or the like. For example, a user may engage the user interface <NUM> by inserting a thumb into the thumb loop <NUM>, and inserting one or more fingers into one or more of the finger loops of the slider portion <NUM>.

The user interface <NUM> may include a number of additional features. For example, a removable slider stop (not shown) may be disposed along and/or within the channel <NUM>, which may prevent undesired movement of the slider member <NUM> (e.g., during shipping and/or storage). In addition or in the alternative, the user interface <NUM> may include one or more stops, locks, spring members, detents, indexing, markings or the like for visualizing, controlling and/or limiting longitudinal movement of the slider member <NUM>. While not shown in this embodiment, the user interface <NUM> may also optionally include a suture exit port similar to the suture exit port, for example similar to the suture exit port <NUM> described above and shown in <FIG>. The user interface <NUM> as described herein may be included and/or used with any of the various embodiments of medical devices disclosed herein.

<FIG> shows an example suture guide device and/or mechanism that may be used for loading and/or threading the suture <NUM> through any of the embodiments of the medical devices disclosed herein. <FIG> shows and example embodiment of a suture guide tab <NUM>. The suture guide tab <NUM> includes: a handle portion <NUM>; a proximal shaft portion <NUM> extending distally from the handle portion <NUM>; a loop portion <NUM> extending distally from the proximal shaft portion <NUM>; and a distal shaft portion <NUM> extending distally from the loop portion <NUM>. The suture guide tab <NUM> may include or be made of one or more metals, polymers, and/or composite or layered or reinforced structures thereof, including any of those disclosed herein. In some example embodiments, the structure of the suture guide tab <NUM> may be cut from a sheet of polymeric material, and may be of monolithic and/or unitary construction. For example, in some embodiments, the suture guide tab <NUM> may be a monolithic structure cut from a sheet of polyimide material.

<FIG> show an example of use of the suture guide tab <NUM> for loading and/or threading the suture <NUM> through the medical device <NUM> (e.g. of <FIG>). As a general proposition, the suture guide tab <NUM> may be threaded through the device <NUM> along a desired pathway, and then used to pull the suture <NUM> back through the device along that desired pathway. As shown in <FIG>, the suture guide tab <NUM> may be inserted in the desired pathway for the suture <NUM> to extend through the device <NUM>. In this example, it will be desirable to load the suture in a "side saddle" arrangementwhere the suture <NUM> is loaded into the distal region of the device <NUM>, and then extends from within the device <NUM> through the cutout <NUM>, and extends external of the device <NUM> along the proximal region <NUM> of the shaft <NUM>. For example, as shown, the suture guide tab <NUM> may be inserted and/or extend through a pathway in the device that extends through the cutout <NUM> in the distal region <NUM>, through the cutout <NUM> of the suture cutting member <NUM>, through the lumen of the suture cutting member <NUM> into and through the lumen <NUM> of the distal region <NUM>, into and through the bore <NUM> of the outer cinch member <NUM>, and out between the outer and inner cinch members <NUM> and <NUM>. The suture guide tab <NUM> may be so disposed through the pathway in the device <NUM> such that the handle <NUM> is disposed proximally and externally alongside the medical device <NUM> (e.g. adjacent and/or proximal of the cutout <NUM>). The proximal shaft <NUM> extends from the handle and is disposed within the pathway through the device <NUM>. The loop portion <NUM> is disposed distally of the pathway and externally alongside the medical device <NUM> (e.g. adjacent and/or distal and/or between the outer and inner cinch members <NUM> and <NUM>). The distal shaft portion <NUM> extends distally of the loop portion <NUM>. The distal shaft portion <NUM> may aid in navigating the suture guide tab <NUM>, and in particular, the loop portion <NUM>, through the pathway of the medical device <NUM>.

As shown in <FIG>, a suture <NUM> may then be fed through the loop portion <NUM>. As shown in <FIG>, the suture guide tab <NUM> may then be pulled back through the device <NUM> to pull the suture <NUM> back through the pathway through the device <NUM>. As such, the suture guide tab <NUM> may be used to help guide and/or load the suture <NUM> through the device <NUM>. Once the suture <NUM> is pulled through the device <NUM> as desired, the suture guide tab <NUM> can be removed from the suture <NUM>, and the device <NUM> may be advanced over the suture <NUM> down to the suturing/defect site where it is desirable to apply a cinch to the suture <NUM>, and/or cut the suture as desired. When doing so, the suture <NUM> remains inserted in the pathway through the device <NUM> until the cinch is applied and the suture is cut. It should be understood that the suture guide tab <NUM> as described herein may be included and/or used with any of the various embodiments of medical devices disclosed herein to aid in threading a suture through the desired pathway of the particular device.

The materials that can be used for the various components of the medical devices disclosed herein may include those commonly associated with medical devices. Any of the devices, members and/or components of members or devices disclosed herein may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material or composites of materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-<NUM> (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styreneb-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments polymers can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about <NUM> percent LCP.

Some examples of suitable metals and metal alloys include stainless steel, such as 304V, <NUM>, 316LV, and <NUM>-<NUM> stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® <NUM>, UNS: N06022 such as HASTELLOY® C-<NUM>®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® <NUM>, NICKELVAC® <NUM>, NICORROS® <NUM>, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickeltungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

Claim 1:
A medical device (<NUM>) for applying a cinch to a suture, the medical device comprising:
an elongated shaft (<NUM>) including a proximal region (<NUM>) and a distal region (<NUM>), the distal region (<NUM>) defining a lumen (<NUM>) having a lumen diameter, and a distally facing end surface (<NUM>);
an outer cinch member (<NUM>) defining a bore (<NUM>) and having an outer surface (<NUM>) defining a shoulder (<NUM>), the shoulder (<NUM>) having a proximally facing shoulder surface (<NUM>) and having a shoulder diameter greater than the lumen diameter, wherein the outer cinch member (<NUM>) includes a proximal portion (<NUM>) that is proximal of the shoulder (<NUM>), the outer cinch member (<NUM>) having a first configuration wherein the proximal portion (<NUM>) is disposed within the lumen (<NUM>) and is engaged with the distal region (<NUM>) of the elongate shaft (<NUM>) with a frangible bond and a gap (<NUM>) is defined between the proximally facing shoulder surface (<NUM>) and the distally facing end surface (<NUM>);
an elongated inner shaft (<NUM>) extending through and longitudinally movable within the lumen (<NUM>) and the bore (<NUM>) and including a distal end section (<NUM>); and
an inner cinch member (<NUM>) engaged with the distal end section (<NUM>) of the elongated inner shaft (<NUM>), the inner cinch member (<NUM>) configured to engage the outer cinch member (<NUM>) and including at least a segment configured to fit within the bore (<NUM>).