Apparatus and method for applying a clamp member to a suture

Abstract

Medical devices for applying a clip member to a suture and methods for making and using such devices are disclosed. An exemplary medical device may include an elongate shaft including a proximal region and a distal region. The distal region defines a lumen having a lumen diameter, and a distally facing end surface. The medical device may also include an outer clip member defining an aperture and having an outer surface defining a shoulder. The elongate inner shaft may extend through and be longitudinally movable within the lumen and bore, and includes a distal end portion. An inner hoop member may be engaged with a distal end portion of the elongate inner shaft.

Description

This application is a divisional application of invention patent application number 201980034927.8 Cross-references to related literature

[0001] This application claims priority to U.S. Provisional Patent Application 62 / 848,787 filed on May 16, 2019 and U.S. Provisional Application Serial No. 62 / 676,548 filed on May 25, 2018, the disclosures of which are incorporated herein by reference in their entirety. Technical Field

[0002] The present invention relates to medical devices, and methods of making medical devices. More particularly, the present invention relates to devices for applying clamps to sutures, and methods of making and using such devices. Background Art

[0003] A variety of medical devices and methods have been developed for suturing tissue and securing and / or terminating the free ends of the suture relative to the tissue after it has been sutured in place. These devices are manufactured by any of a variety of different manufacturing methods and can be used according to any of a variety of methods. Each of the known devices and methods has certain advantages and disadvantages. There is a continuing need to provide alternative devices and alternative methods of manufacturing and using these devices. Summary of the invention

[0004] The present invention provides designs, materials, methods of manufacture and use alternatives for suture termination devices, for example, devices that apply clamps to sutures.

[0005] In some embodiments, the medical device includes: a slender shaft including a proximal region and a distal region, the distal region defining a cavity having a cavity diameter and a distally facing end surface; an outer clamp member defining a hole and having an outer surface defining a shoulder, the shoulder having a proximal-facing shoulder surface, and the shoulder having a shoulder diameter greater than the cavity diameter, wherein the outer clamp member includes a proximal portion proximal to the shoulder, the outer clamp member having a first structure, wherein the proximal portion is disposed in the cavity and engages with the distal region of the slender shaft, and a gap is defined between the proximal-facing shoulder surface and the distal-facing end surface; a slender inner shaft extending through the cavity and the hole and capable of longitudinal movement in the cavity and the hole, and the slender inner shaft includes a distal portion; and an inner clamp member engaged with the distal portion of the slender inner shaft, the inner clamp member being configured to engage with the outer clamp member and including at least one segment configured to fit within the hole.

[0006] In some embodiments, a medical device includes: an elongated shaft including a proximal region and a distal region, the distal region defining a lumen having a lumen diameter and a distally facing end surface; an outer clamp member defining a bore and having an outer surface defining a shoulder, the shoulder having a proximal facing shoulder surface, and the shoulder having a shoulder diameter greater than the lumen diameter, wherein the outer clamp member includes a proximal portion proximal to the shoulder, the outer clamp member having a first configuration, wherein the proximal portion is disposed within the lumen and is engaged with the distal region of the elongated shaft by a frangible bond, and a gap is defined between the proximal facing shoulder surface and the distal facing end surface. An elongated inner shaft extends through the lumen and the bore and is longitudinally movable within the lumen and the bore and includes a distal portion; and an inner clamp member engaged with the distal portion of the elongated inner shaft, the inner clamp member being configured to engage with the outer clamp member and including at least one segment configured to fit within the bore.

[0007] Alternatively or additionally to any of the above or following embodiments, the elongated inner shaft is designed such that proximal longitudinal movement of the elongated inner shaft moves the inner clamp member into engagement with the outer clamp member.

[0008] Alternatively or additionally to any of the above or following embodiments, wherein the outer clamp member is configured to switch toward a second configuration wherein the proximally facing shoulder surface engages a distally facing end surface of the elongated shaft.

[0009] Alternatively or additionally to any of the above or following embodiments, in the first configuration, the outer clamp member is engaged with the distal region of the elongated shaft via a bond; and in the second configuration, the bond is released.

[0010] Alternatively or additionally to any of the above or following embodiments, the elongated inner shaft is designed such that proximal longitudinal movement of the elongated inner shaft switches the outer clamp member from the first configuration toward the second configuration.

[0011] Alternatively or additionally to any of the above or following embodiments, the proximal portion of the outer clamp member is engaged with the distal region of the elongated shaft via a frangible bond.

[0012] Alternatively or additionally to any of the above or following embodiments, the outer clamp member is designed to switch toward a second configuration wherein a frangible bond between the outer clamp member and the distal region is broken.

[0013] Alternatively or additionally to any of the above or following embodiments, the outer clamp member is designed to switch toward a second configuration wherein the frangible bond between the outer clamp member and the distal region is broken and the proximally facing shoulder surface engages the distally facing end surface of the elongated shaft.

[0014] Alternatively or additionally to any of the above or following embodiments, when in the second configuration, the proximally facing shoulder surface engages a distally facing end surface of the elongated shaft.

[0015] Alternatively or additionally to any of the above or following embodiments, further comprising a suture cutting member disposed within the lumen of the distal region, and wherein the elongated inner shaft is designed to engage with the suture cutting member to cut the suture.

[0016] Alternatively or additionally to any of the above or following embodiments, the slender inner shaft is designed such that a first stage of proximal longitudinal movement of the slender inner shaft moves the inner clamp member to engage with the outer clamp member, and a second stage of proximal longitudinal movement of the slender inner shaft switches the outer clamp member toward a second structure in which the proximal-facing shoulder surface engages with the distal-facing end surface of the slender shaft.

[0017] Alternatively or additionally to any of the above or following embodiments, the slender inner shaft is designed such that a first stage of proximal longitudinal movement of the slender inner shaft causes the inner clamp member to move into engagement with the outer clamp member, and a second stage of proximal longitudinal movement of the slender inner shaft causes the frangible bond to be broken and the outer clamp member to be switched toward a second structure, wherein the proximally facing shoulder surface engages with the distally facing end surface of the slender shaft.

[0018] Alternatively or additionally to any of the above or following embodiments, 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 clamp member.

[0019] Alternatively or additionally to any of the above or following embodiments, further comprising a suture cutting member disposed within the cavity 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.

[0020] Alternatively or additionally to any of the above or following embodiments, further comprising an incision defined in a distal region of the elongated shaft, the incision defining a distally-facing shearing edge; and a suture cutting member disposed within the cavity and including a proximally-facing shearing edge, the suture cutting member having an open configuration, wherein the proximally-facing shearing edge is disposed distally of the distally-facing shearing edge to define an opening between the proximally-facing shearing edge and the distally-facing shearing edge, and wherein the suture cutting member is designed to switch toward a closed configuration, wherein the proximally-facing shearing edge has been moved proximally relative to the distally-facing shearing edge so that the opening is closed.

[0021] Alternatively or additionally to any of the above or following embodiments, further comprising: a shearing member fixed within the cavity and defining a distally facing shearing edge; and a suture cutting member disposed within the cavity and comprising a proximally facing shearing edge, the suture cutting member having an open structure, wherein the proximally facing shearing edge is disposed distally of the distally facing shearing edge to define an opening between the proximally facing shearing edge and the distally facing shearing edge, and wherein the suture cutting member is designed to switch toward a closed structure, in which the proximally facing shearing edge has been moved proximally relative to the distally facing shearing edge so that the opening is closed.

[0022] Alternatively or additionally to any of the above or following embodiments, the elongated inner shaft is designed such that proximal longitudinal movement of the elongated inner shaft switches the suture cutting member from the open configuration toward the closed configuration.

[0023] Alternatively or additionally to any of the above or following embodiments, the suture cutting member in the open configuration is engaged with the distal region of the elongated shaft with a frangible bond.

[0024] Alternatively or additionally to any of the above or following embodiments, the frangible bond between the suture cutting member and the distal region is broken when in the closed configuration.

[0025] Alternatively or additionally to any of the above or following embodiments, the shearing member is a tubular member defining a shearing member lumen having an inner diameter, and wherein the suture cutting member is a tubular member having an outer diameter sized to match the inner diameter of the shearing member lumen.

[0026] Alternatively or additionally to any of the above or following embodiments, the suture cutting member is a tubular member including a cutout portion forming a proximally facing shearing edge.

[0027] A medical device for applying a clamp to a suture is disclosed. In some embodiments, the medical device includes: a slender shaft including a proximal region and a distal region, the distal region defining a cavity, and a distally facing end surface; an outer clamp member defining a hole and a shoulder, the shoulder having a proximally facing shoulder surface, wherein the outer clamp member includes a proximal portion disposed in the cavity and releasably engaged with the distal region of the slender shaft so that the shoulder is distally spaced from the distally facing end surface; a slender inner shaft extending through the cavity and the hole and including a distal portion; an inner clamp member engaged with the distal portion of the slender inner shaft, the inner clamp member being configured to engage with the outer clamp member and including at least one section configured to fit into the hole; a distally facing shearing edge defined by the distal region of the slender shaft; and a suture cutting member disposed in the cavity and including a proximally facing shearing edge, the suture cutting member having an open structure, wherein the proximally facing shearing edge is disposed distally of the distally facing shearing edge to define an opening between the proximally facing shearing edge and the distally facing shearing edge.

[0028] In some embodiments, the medical device includes: a slender shaft comprising a proximal region and a distal region, the proximal region defining a cavity; an outer clamp member defining a hole, wherein the outer clamp member includes a proximal portion disposed in the cavity and releasably engaged with the distal region of the slender shaft; a slender inner shaft extending through the cavity and the hole and including a distal portion; an inner clamp member engaged with the distal portion of the slender inner shaft, the inner clamp member being configured to engage with the outer clamp member and including at least one section configured to fit into the hole; a distal-facing shearing edge defined by the distal region of the slender shaft; a shearing member secured in the cavity and defining the distal-facing shearing edge; and a suture cutting member disposed in the cavity and including a proximal-facing shearing edge, the suture cutting member having an open structure, wherein the proximal-facing shearing edge is disposed distally of the distal-facing shearing edge to define an opening between the proximal-facing shearing edge and the distal-facing shearing edge.

[0029] Alternatively or additionally to any of the above or following embodiments, the suture cutting member is designed to switch toward a closed configuration, wherein the proximally facing shearing edge has been moved proximally relative to the distally facing shearing edge such that the opening is closed.

[0030] Alternatively or additionally to any of the above or following embodiments, the elongated inner shaft is designed such that proximal longitudinal movement of the elongated inner shaft switches the suture cutting member from the open configuration toward the closed configuration.

[0031] Alternatively or additionally to any of the above or following embodiments, the suture cutting member in the open configuration is engaged with the distal region of the elongated shaft with a frangible bond.

[0032] Alternatively or additionally to any of the above or following embodiments, the frangible bond is broken when in the closed configuration.

[0033] Alternatively or additionally to any of the above or following embodiments, when in the open configuration, the suture cutting member is engaged with the distal region of the elongated shaft via a bond; and when in the closed configuration, the bond is released.

[0034] Alternatively or additionally to any of the above or following embodiments, the suture cutting member is a tubular member having an outer diameter sized to slidably fit within the lumen of the distal region of the elongated shaft.

[0035] Alternatively or additionally to any of the above or following embodiments, the shearing member is a tubular member defining a shearing member lumen, and wherein the suture cutting member is a tubular member having an outer diameter sized to fit within the shearing member lumen.

[0036] Alternatively or additionally to any of the above or following embodiments, the suture cutting member is a tubular member having a cutout portion forming a proximally facing shearing edge.

[0037] Methods of applying a clamp to a suture are disclosed. Some embodiments include a method of applying a clamp to a suture using a medical device, the medical device comprising: an elongated shaft having a distal region defining a lumen and a distally facing end surface; an outer clamp member defining a bore and including an outer surface defining a shoulder, the shoulder having a proximally facing shoulder surface, the outer clamp member having a first configuration, wherein the outer clamp member engages the distal region of the elongated shaft and defines a gap between the proximally facing shoulder surface and the distally facing end surface; an elongated inner shaft extending through the lumen and bore and being longitudinally movable within the lumen and bore and including a distal end portion; and an inner clamp member coupled to the elongated inner shaft and the method comprising: when the outer clamp member is in the first configuration and the inner clamp member is disengaged from the outer clamp member, passing a length of suture through the hole of the outer clamp member and between the outer clamp member and the inner clamp member; moving the slender inner shaft proximally through a first stage of proximal longitudinal movement so that the inner clamp member engages with the outer clamp member, thereby clamping a portion of the suture therebetween; and moving the slender inner shaft proximally through a second stage of proximal longitudinal movement so that the outer clamp member switches toward a second configuration, wherein the proximally facing shoulder of the outer clamp member engages with the distally facing end surface of the slender shaft.

[0038] A method of applying a clamp to a suture using a medical device, the medical device comprising: a slender shaft having a distal region defining a lumen and a distally facing end surface; an outer clamp member defining a bore and including an outer surface defining a shoulder having a proximally facing shoulder surface, the outer clamp member having a first configuration wherein the outer clamp member is engaged with the distal region of the slender shaft with a frangible bond and defines a gap between the proximally facing shoulder surface and the distally facing end surface. An elongated inner shaft extending through the cavity and the hole and being movable longitudinally therein and including a distal portion; and an inner clamp member engaged with the distal portion of the elongated inner shaft; the method comprising: passing a length of suture through the hole of the outer clamp member and between the outer clamp member and the inner clamp member when the outer clamp member is in a first configuration and the inner clamp member is disengaged from the outer clamp member; moving the elongated inner shaft proximally through a first stage of proximal longitudinal movement so that the inner clamp member engages with the outer clamp member, thereby trapping a portion of the suture therebetween; and moving the elongated inner shaft through a second stage of proximal longitudinal movement so that the outer clamp member switches toward a second configuration in which the frangible bond between the outer clamp member and the distal region is broken and a proximally facing shoulder of the outer clamp member engages with a distally facing end surface of the elongated shaft.

[0039] The above summary of some embodiments is not intended to describe every disclosed embodiment or every embodiment of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] A more complete understanding of the present invention may be obtained by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0041] Figure 1 is a partial side cross-sectional view of an exemplary medical device for applying a clamp to a suture.

[0042] Figure 2 yes Figure 1 Partial exploded view of medical equipment;

[0043] Figure 3 yes Figure 1 A perspective side view of a cutter member of a medical device;

[0044] Figure 4 yes Figure 1 a side cross-sectional view of a portion of a medical device of , wherein the inner and outer clamp members are longitudinally spaced (not directly engaged), the outer clamp member is in a first configuration, the cutter is in an open configuration, and a suture catheter and suture are loaded through the device in a side saddle arrangement;

[0045] Figure 5 Yes Figure 4a side cross-sectional view of a portion of a medical device shown with a suture catheter removed;

[0046] Figure 6 yes Figure 5 a side cross-sectional view of a portion of a medical device wherein the inner shaft has been moved proximally and the inner and outer clamp members are engaged to secure a suture therebetween;

[0047] Figure 7 yes Figure 6 a side cross-sectional view of a portion of a medical device wherein the inner shaft has been moved further proximally and the outer clamp member is in a second configuration;

[0048] Figure 8 yes Figure 7 a side cross-sectional view of a portion of a medical device wherein the inner shaft has been moved further proximally, disengaged from the outer clamp member, and engaged with the cutter;

[0049] Fig. 9 yes Figure 8 a side cross-sectional view of a portion of a medical device wherein the inner shaft has been further moved proximally and the inner shaft has been engaged with the cutter, causing the cutter to be moved proximally to cut the suture;

[0050] Fig.10 is a side cross-sectional view of a clamp member for anchoring a suture through tissue, including an inner clamp member and an outer clamp member engaged and securing the suture therebetween;

[0051] Fig.11 yes Figure 1 a side cross-sectional view of a portion of a medical device of , wherein the inner and outer clamp members are longitudinally spaced (not directly engaged), the outer clamp member is in a first configuration, the cutter is in an open configuration, and a suture catheter and suture are loaded in an arrangement throughout the device;

[0052] Fig.12 Yes Fig.11 a side cross-sectional view of a portion of a medical device shown with a suture catheter removed;

[0053] Fig.13 is a side cross-sectional view of a portion of another embodiment of a medical device for applying a clamp to a suture, the medical device including another cutter configuration and showing a suture extending therethrough in a through-device configuration;

[0054] Fig.14 yes Fig.13 A side view of a cutter member of a medical device;

[0055] Fig.15is a side cross-sectional view of a portion of another embodiment of a medical device for applying a clamp to a suture, the medical device being Fig.13 Similar to that shown in , which is a diagram showing the suture extending therethrough in a lateral saddle configuration;

[0056] Fig.16 is a side cross-sectional view of a portion of another embodiment of a medical device for applying a clamp to a suture, the medical device including another cutter configuration and showing a suture extending therethrough in a through-device configuration; and

[0057] Fig.17 is a side cross-sectional view of a portion of another embodiment of a medical device for applying a clamp to a suture, the medical device including another cutter configuration and showing a suture extending therethrough in a through-device configuration.

[0058] Fig.18 is a side cross-sectional view of a portion of another embodiment of a medical device for applying a clamp to a suture, the medical device including another cutter configuration and showing a suture extending therethrough in a side saddle configuration.

[0059] Fig.19 A side cross-sectional view of a portion of another embodiment of a medical device for applying a clamp to a suture, the medical device including another cutter configuration and showing a suture extending therethrough in a side saddle configuration.

[0060] Fig. 20 is a perspective view of an exemplary suture guide tab that may be used to load and / or pass suture through any embodiment of the medical device disclosed herein.

[0061] Fig.21 yes Fig.19 A side cross-sectional view of a portion of a medical device showing Fig. 20 The suture guide piece is inserted into the suture path through the medical device.

[0062] Fig. 22 Suture is shown being fed through the looped portion of the suture guide piece in preparation for pulling the suture through the path of the medical device.

[0063] Fig.23 The suture guide piece is pulled back through the medical device to pull the suture back through the path of the medical device.

[0064] Although the content of the present invention can be subjected to various modifications and alternative forms, its specific content has been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and alternative forms that belong to the spirit and scope of the present invention. DETAILED DESCRIPTION

[0065] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0066] All numerical values ​​herein are assumed to be modified by the term "about", whether or not explicitly stated. The term "about", in the context of numerical values, generally refers to a range of numbers that one skilled in the art considers to be equivalent to the stated numerical value (e.g., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant number.

[0067] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0068] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. The term "or" as used in this specification and the appended claims is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0069] It should be noted that references in the specification to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiments may include a particular characteristic, structure, and / or feature. However, such a description does not necessarily mean that all embodiments include the particular characteristic, structure, and / or feature. Additionally, when particular characteristics, structures, and / or features are described in conjunction with one embodiment, it should be understood that, unless expressly provided otherwise, these characteristics, structures, and / or features may also be used in conjunction with other embodiments, whether or not expressly described.

[0070] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings, which are not necessarily drawn to scale, depict exemplary embodiments and are not intended to limit the scope of the present disclosure.

[0071] Medical suturing is used for many different interventions. Some interventions may include suturing at remote locations within a patient's body and / or other locations that may be difficult to access. When the suturing process is completed, it may be necessary to terminate the suture in a manner that maintains the suture so that the suture does not easily unravel. This may include the use of devices such as clamps to maintain the suture. Disclosed herein are medical devices that can be used to suturing tissue and terminating sutures. At least some of these devices utilize clamps to maintain the suture. Some additional details of these devices are disclosed herein.

[0072] Figure 1 A partial side cross-sectional view of a medical device 10 for applying a clamp to a suture is shown, Figure 2 FIG. 1 is a partially exploded view of the medical device 10 , showing some components of the medical device 10 . The medical device 10 may include the elongated shaft 14 , the outer clamp member 34 , the elongated inner shaft 64 , and the inner clamp member 72 .

[0073] The elongated shaft 14 includes a proximal region 18 and a distal region 22. The proximal region 18 may include and / or may be made of an elongated tubular member that defines a lumen 20 having a lumen diameter. In the illustrated embodiment, the proximal region 18 is a coiled tubular shaft, however, other configurations may be envisioned. For example, the proximal region 18 may be a solid metal or polymer tubular member, a tubular member including a coil, braided and / or mesh material, and / or a tubular member made of a coil, braided and / or mesh material, and / or a tubular member reinforced with a coil, braided and / or mesh material, and the like. In addition, the proximal region 18 may, for example, include one or more slots and / or grooves and / or channels formed therein to enhance its flexible properties. The proximal region 18 may include or be made of one or more metals, polymers and / or composite or layered or reinforced structures thereof, including any disclosed herein.

[0074] The distal region 22 can be a tubular member including a tubular wall 24 defining a lumen 26 having a lumen diameter and including a distally facing end surface 30. The distal region 22, including the lumen 26, can be configured to function as a receiver and / or "socket" for receiving and retaining at least a portion of an outer clamp member 34 therein, which will be discussed below. In the illustrated embodiment, the distal region 22 is a generally solid metal tubular member, however, other configurations are also contemplated. For example, the distal region 22 can be a polymer tubular member, a tubular member including a coil and / or braided and / or mesh material, and / or a tubular member made of a coil and / or braided and / or mesh material, and / or a tubular member reinforced with a coil and / or braided and / or mesh material, and the like. In addition, the distal region 22 can include more than one slot and / or groove and / or channel formed therein, for example, to enhance its flexibility characteristics. The distal region 22 may include or be made of more than one metal, polymer, and / or composite or layered or reinforced structures thereof, including any of the structures disclosed herein.

[0075] The proximal region 18 and the distal region 22 may be one unitary piece, or may be separate parts connected, for example, in an end-to-end arrangement so that the cavity 26 communicates with the cavity 20. It is contemplated that the cavities 20, 26 may or may not be coaxial. In some embodiments, the cavity 20 and cavity 26 have the same or similar cavity diameters, while in other embodiments, they may be different.

[0076] The distal region 22 may optionally include a cutout 25 extending through the wall 24. The cutout 25 may provide access through the wall 24 to the cavity 26, for example, so that a suture may extend therethrough when the device 10 is used in a "side saddle" arrangement, wherein the suture extends from within the cavity 26 through the cutout 25, and the proximal portion of the suture extends outside the device 10 along the proximal region 18 of the shaft 14, as will be discussed in more detail below. However, as already noted, such a cutout 25 is optional. For example, it is also contemplated that the device 10 may be used with a suture in a "through-the-device" arrangement, wherein the suture does not extend outside the proximal region 18, but rather extends inside and through the cavity 20 of the proximal region 18 of the device 10, as discussed in more detail herein. In such an arrangement, the cutout 25 may be unnecessary.

[0077] The outer clamp member 34 can be a tubular member including an inner surface 44 and an outer surface 42, the inner surface 44 defining a hole 38 extending therethrough. As discussed herein, the hole 38 can be sized and / or configured to receive and / or engage a portion of the inner clamp member 72. The hole 38 can have a gradually decreasing or constant inner diameter. The outer clamp member 34 is constructed and / or designed to cooperate with the inner clamp member 72 to clamp and / or wedge a portion of the suture therein. Therefore, the outer clamp member 34 combines with the inner clamp member 72 to form a "clamp" to be applied to the suture.

[0078] The outer clamp member 34 includes a proximal portion 54 and a distal portion 56. The proximal portion 54 includes an outer diameter and is sized and / or configured to fit within the cavity 26 of the distal region 22 of the elongated shaft 14. The outer surface 42 defines a widened diameter portion and / or a shoulder 46 having a proximally facing shoulder surface 50. The widened diameter portion and / or the shoulder 46 and / or the entire distal portion 56 may include an outer diameter that is greater than the inner diameter of the cavity 26, and therefore may be configured such that they cannot fit within the cavity 26 of the distal region 22. In the illustrated embodiment, the shoulder 46 is defined by a generally stepped portion having an outer diameter that increases rapidly and / or increases in a stepped manner. However, in other embodiments, the outer surface 42 may taper and / or be angled and / or in a stepped manner so that the size of the outer diameter increases in a more gradual manner in the distal direction, and the shoulder 46 may be more slender. In such an embodiment, the widened diameter portion and / or shoulder 46 may be defined simply by a first portion along the outer surface 42 that includes an outer diameter that is sized such that it cannot fit within the cavity 26. Such an embodiment would still include a proximally facing shoulder surface 50, as the angle and / or taper would still provide a surface that faces in a proximal direction in a tapered and / or angled manner.

[0079] exist Figure 1, the outer clamp member 34 has a first configuration and / or is disposed in a first configuration, wherein the proximal portion 54 is disposed within the cavity 26 and engages the distal region 22 of the elongated shaft 14, thereby defining a gap 60 between the proximally facing shoulder surface 50 and the distally facing end surface 30. For example, the outer clamp member 34 may be fixedly engaged with the distal region 22 of the elongated shaft 14 with one or more frangible bonds. The frangible bond may be a connection and / or attachment between the outer clamp member 34 and the distal region 22 that is designed to temporarily and / or temporarily fixably 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 fixing of the components so that they can move relative to each other. For example, the one or more frangible bonds may include a frangible weld, such as an adhesive weld, a frangible adhesive, a frangible welding bond, a frangible mechanical interlock, a frangible friction contact, etc., between the outer surface 42 of the outer clamp member 34 and the surface of the distal region 22 (e.g., the cavity surface of the cavity 26). These frangible bonds can be selectively broken and / or overcome and / or released, for example, by applying a predetermined amount of relative longitudinal force between the outer clamp member 34 and the distal region 22. For example, when in the first configuration, the outer clamp member 34 can be releasably engaged and / or releasably coupled and / or releasably bonded and / or releasably connected and / or releasably attached to the distal region 22 such that the gap 60 is defined between the proximally facing shoulder surface 50 and the distally facing end surface 30. The releasable engagement and / or bonding and / or combining and / or connecting and / or attaching can be selectively overcome and / or released and / or broken, for example, by applying a predetermined amount of relative longitudinal force between the outer clamp member 34 and the distal region 22. The outer clamp member 34 can also include a second configuration in which the frangible bond between the outer clamp member 34 and the distal region 22 is broken and / or overcome and / or released, the outer clamp member 34 has been longitudinally moved relative to the distal region 22, and the gap 60 is closed. For example, the releasable engagement and / or coupling and / or bonding and / or connecting and / or attaching can be selectively overcome and / or released and / or broken, for example, by applying a predetermined amount of relative longitudinal force between the outer clamp member 34 and the distal region 22. For example, the proximally facing shoulder surface 50 can engage the distally facing end surface 30 in the second configuration.

[0080] The elongated inner shaft 64 can be a solid wire or ribbon, or can be a generally tubular member that defines a lumen along part or all of its length, or a combination of these structures. The elongated inner shaft 64 extends through the elongated shaft 14 and can move longitudinally within the elongated shaft 14 from the proximal end of the device 10, distally to the distal end of the device 10. For example, the inner shaft 64 extends into and through the lumen 20 of the proximal region 18, and extends into and through the lumen 26 of the distal region 22. The inner shaft 64 can also extend into and through the hole 38 of the outer clamp member 34 and can move longitudinally within the hole 38 of the outer clamp member 34. The elongated inner shaft 64 includes a distal portion 66 that is configured to engage with the inner clamp member 72. For example, the distal portion 66 can include an enlarged portion 68 that is configured to engage the inner clamp member 72 in an interference fit, as discussed in more detail herein. The enlarged portion 68 can be an integral part of the elongated inner shaft 64, or can be a separately attached component. For example, the enlarged portion 68 can be simply a rounded, spherical, and / or enlarged diameter portion of the inner shaft 64 itself, or can be a separately attached polymer or metal sleeve, tube, coil, braided wire, etc. to provide the enlarged diameter. In some embodiments, the enlarged portion 68 can be made of and / or include a deformable material such that it can temporarily or permanently expand radially when a predetermined axial compressive force is applied thereto.

[0081] The inner clamp member 72 can be a tubular member that defines a hole 78 extending therethrough. The hole 78 can be sized and / or configured to receive and / or engage a portion of the elongated inner shaft 64 that can extend at least partially therethrough. For example, the hole 78 can include a distal portion 80 and a proximal portion 82. The distal portion 80 can include an increased diameter relative to the proximal portion 82 and can be sized and / or configured to receive the enlarged portion 68 of the inner shaft 64 therein. In essence, the distal portion 80 has an enlarged diameter that forms a container for the enlarged portion 68 of the inner shaft 64. The proximal portion 82 can include a reduced diameter relative to the distal portion 80 and can be sized and / or configured to receive a portion of the shaft 64 proximal to the enlarged portion 68. This configuration can provide an interference fit and / or engagement between the inner clamp member 72 and the inner shaft 64. For example, an interference fit exists between the proximal portion 82 of the bore 38 and the enlarged portion 68 of the inner shaft 64, particularly when a proximal longitudinal force and / or movement is applied to the inner shaft 64. The size difference between the proximal portion 82 (which is narrower) and the enlarged portion 68 (which is wider) provides resistance to the enlarged portion 68 being pulled through the narrower proximal portion 82 of the bore 78. However, the inner clamp member 72 and / or the enlarged portion 68 of the inner shaft 64, or both, may be deformable and / or flexible such that application of a predetermined amount of longitudinal force may cause the interference fit to be overcome, thereby allowing the enlarged portion 68 to be pulled through the narrower proximal portion 82 of the bore 78.

[0082] The inner clamp member 72 includes a distal portion 74 and a proximal portion 76. The proximal portion 76 includes an outer diameter and is sized and / or configured to fit into the hole 38 of the outer clamp member 34. The proximal portion 76 can have a gradually decreasing or constant outer diameter. The outer diameter and / or surface of the proximal portion 76 can be configured to engage with the inner surface of the hole 38 of the outer clamp member 34 in an interference fit and / or frictional engagement manner to engage the inner clamp member 72 with the outer clamp member 34. The inner clamp member 72 is constructed and / or designed to cooperate with the outer clamp member 34 to clamp and / or wedge a portion of the suture therebetween. Therefore, the outer clamp member 34 combines with the inner clamp member 72 to form a "clamp" to be applied to the suture.

[0083] The distal portion 74 may include an outer diameter that is larger than the inner diameter of the hole 38 and, therefore, may be configured such that it cannot fit within the hole 38 of the outer clamp member 34. The transition between the diameters of the distal portion 74 and the proximal portion 76 may occur rapidly, defining a generally stepped shoulder portion having a rapidly increasing and / or stepwise increasing outer diameter. However, in other embodiments, the transition in diameter may be tapered and / or gradually angled and / or in a stepped manner such that the outer diameter increases in size in the distal direction in a more gradual manner and may define a thinner shoulder. In such embodiments, the widened diameter portion and / or shoulder may be defined only by a first portion along the inner clamp member 72 that includes an outer diameter that is sized such that it cannot fit within the hole 38 of the outer clamp member 34.

[0084] In at least some cases, the medical device 10 can include a suture cutting member 84. Figure 1-2 In the example described in , the suture cutting member 84 can be at least partially disposed within the lumen 26 of the distal region 22 of the elongated shaft 14. The inner shaft 64 can extend through the suture cutting member 84. Generally speaking, the suture cutting member 84 can be designed to terminate and / or otherwise cut the suture used with the device 10. However, in some cases, the device 10 can include different structural features or components for cutting sutures, and / or another device that can be used with the device 10 to cut sutures. In fact, some exemplary embodiments of the device 10 that do not include a suture cutting member 84 are contemplated.

[0085] Figure 3 A perspective view of a suture cutting member 84 is shown, illustrating some of its features. As can be seen here, the suture cutting member 84 can be a generally tubular member including a wall 79 having an outer diameter and defining a lumen having a distal opening 77 and a proximal opening 81. In at least some cases, the distal opening 77 can be designed so that the inner shaft 64 can pass therethrough. The proximal opening 81 can be designed so that the inner shaft 64 can at least partially extend therethrough. However, the proximal opening 81 can be narrower than the distal opening 77. For example, the proximal opening 81 can be sized so that the enlarged portion 68 of the inner shaft 64 may not pass through the proximal opening 81. This can provide an engagement mechanism between the inner shaft 64 and the suture cutting member 84, such that proximal retraction of the inner shaft 64 (e.g., relative to the suture cutting member 84) can include engagement of the enlarged portion 68 of the inner shaft 64 with the suture cutting member 84 (e.g., at a location adjacent the proximal opening 81), such that further proximal movement of the inner shaft 64 can cause the suture cutting member 84 to translate (e.g., proximally) within the lumen 26 of the shaft 14. This will be further described herein when use of the device 10 is discussed.

[0086] A cutout 85 can be formed in the wall 79. A shearing edge 83 can be defined along the cutout 85. In at least some cases, the shearing edge 83 can face in a generally proximal direction. As described in more detail below, the shearing edge 83 can be used to cut sutures.

[0087] return Figure 1-2 , the device 10 may also include a "joint" or shearing member 86. The shearing member 86 may be a generally tubular member that may be coupled to or otherwise secured within the shaft 14, such as within the lumen 20 of the proximal portion, or within the lumen 26 of the distal portion, or both. The shearing member 86 may be attached to the inner surface of the distal region 22 of the shaft, the inner surface of the proximal region 18 of the shaft 14, or both. In some cases, the shearing member 86 may extend through the junction of the proximal region 18 and the distal region 22 of the shaft 14. Other arrangements are also contemplated.

[0088] The shearing member 86 can define a lumen having an inner diameter and further define a distally facing shearing edge 87. In at least some cases, the shearing edge 87 of the shearing member 86 can be designed to work with the shearing edge 83 of the suture cutting member 84 so that when the shearing edges 87, 83 are brought together, the suture disposed between the shearing edges 87, 83 can be cut or sheared. In at least some embodiments, the shearing member 86 is configured to receive a portion of the suture cutting member 84 therein. For example, the shearing member 86 can include an inner diameter that is the same as or greater than the outer diameter of the suture cutting member 84, such that at least a portion of the suture cutting member 84 is configured to be disposed within at least a portion of the shearing member 86. In at least some embodiments, it may be desirable to have a close tolerance fit between the inner diameter of the shearing member 86 and the outer diameter of the suture cutting member 84 in order to provide a better suture cutting arrangement between the shearing edges 87, 83.

[0089] The suture cutting member 84 can be designed to be in a first configuration or an open configuration (e.g., Figure 4 , and wherein an opening 89 is defined between the shearing edge 83 of the suture cutting member 84 and the shearing edge 87 of the shearing member 86) and a second configuration or closed configuration (e.g., as Fig. 9, and wherein the shearing edge 83 of the suture cutting member 84 is adjacent to and / or engaged with the shearing edge 87 of the shearing member 86). In some cases, the suture cutting member 84 (e.g., the proximal portion of the suture cutting member 84) can be connected to the shearing member 86, for example, with a frangible bond. For example, the proximal portion of the suture cutting member 84 can be disposed within the distal portion of the shearing member 86, and the two structures can be fixed to each other with a frangible bond when in an open configuration. Therefore, in the original state with the frangible bond intact, the suture cutting member 84 may be in an open configuration. The proximal retraction of the inner shaft 64 can cause the enlarged portion 68 of the inner member 64 to contact the surface of the suture cutting member 84 (e.g., adjacent to the proximal opening 81), so that further proximal retraction of the inner shaft 64 can destroy or cut the frangible bond and allow the suture cutting member 84 to switch toward a closed configuration (e.g., move proximally).

[0090] Back to Figure 1 The medical device 10 also includes a handle and / or user interface 90 that can be designed and / or configured for user interaction to provide relative movement between the elongated shaft 14 and the inner shaft 64. Any of a variety of configurations of the user interface 90 are contemplated that can achieve this purpose. Figure 1 In the illustrated embodiment, the user interface 90 includes a distal portion 92, a proximal portion 94, and a slider portion 96 disposed around and / or along the proximal portion 94. The distal portion 92 is connected to the proximal end of the elongated shaft 14, and the proximal portion 94 is connected to the distal portion 92 and extends proximally from the distal portion 92. The slider portion 96 is connected to the proximal end of the inner shaft 64. The slider portion 96 is disposed on the proximal portion 94 and can move longitudinally and / or can slide on the proximal portion 94 and / or can slide along the proximal portion 94. Thus, the user interface can provide that the inner shaft 64 moves longitudinally relative to the elongated shaft 14 by actuating the slider 96 relative to the proximal portion 94. In some cases, the slider portion 96 can be designed to slide along a groove or slot 95 formed in the proximal portion 94. In other cases, the slider portion 96 can be replaced by one or more finger rings (not shown) that are designed to slide along the proximal portion 94. The finger ring may be designed to accommodate a user's finger (eg, index finger, middle finger, combination thereof, or other finger) such that the user may slide the finger ring along the proximal portion 96 to translate the inner shaft 64 relative to the elongated shaft 14 .

[0091] The proximal end of the proximal portion 94 can be configured for user engagement, and therefore, can include a structure or shape that can enhance user engagement, grip and / or comfort. For example, the proximal end of the proximal portion 94 can include a ring 98, such as a thumb ring, etc. The slider portion 96 can also be configured for user engagement, and therefore can also include a structure or shape that enhances user engagement, grip and / or comfort. For example, the slider portion 96 can include a scroll-like structure including an annular groove that can be configured to be engaged by more than one finger of the user. For example, the user can engage the user interface 90 by inserting the thumb into the thumb ring 98 and engaging the slider portion 96 with the index finger and middle finger (e.g., the finger is located in the annular groove of the slider portion 96).

[0092] The user interface 90 may include some additional features. For example, a reel stopper (not shown) may be provided along the channel 95, which may prevent unwanted movement of the reel member 96 (e.g., during transport and / or storage). Additionally or alternatively, the user interface 90 may include one or more stops, locks, spring members, detents, indexes, markings, etc., for visualizing, controlling, and / or limiting the longitudinal movement of the reel member 96.

[0093] The user interface 90 may also optionally include a suture exit port 93 disposed thereon and including a lumen communicating with the lumen 20 of the proximal portion 18. For example, as discussed herein, it is contemplated that the device 10 may be used with a suture in a "through-device" arrangement-wherein the suture does not extend along the exterior of the proximal region 18, but rather extends along the interior of the lumen 20 of the proximal region 18 of the device 10 and through the lumen. In such an arrangement, the suture will need to exit the device 10 near the proximal end. The suture exit port 93 may be used to provide this need. The suture exit port 93 may generally be configured as a Y-type adapter providing proximal access to the lumen 20. The user interface 90 described herein may include and / or be used with any of the various embodiments of the medical devices disclosed herein.

[0094] Figure 4-10 It may be used to illustrate and describe example methods of using device 10. For example, Figure 4The medical device is shown in an initial arrangement and ready for use. The inner clamp member 72 and the outer clamp member 34 are longitudinally spaced apart (and do not directly engage each other and / or clamp to the suture). The outer clamp member 34 is in a first configuration, wherein the proximal portion 54 of the outer clamp member 34 is disposed within the cavity 26 and can be engaged with the distal region 22 of the elongated shaft 14 with one or more frangible bonds. A gap 60 is defined between the proximally facing shoulder surface 50 of the outer clamp member 34 and the distally facing end surface 30 of the distal region 22 of the shaft 14. In essence, the distal region 22 acts as a "socket" for securely holding (e.g., frangibly bonding to) the outer clamp member 34 during delivery until it is needed to release it. The inner clamp member 72 is mounted on the elongated shaft 64, and the interference fit provided by the enlarged portion 68 holds the inner clamp member 72 thereon during delivery until it is needed to release it. In addition, the suture cutting member 84, if present, is in an open configuration, defining an opening 89 between the shearing edge 83 of the suture cutting member 84 and the shearing edge 87 of the shearing member 86. In addition, the suture cutting member 84 can be bonded with the shearing member 86 in one or more frangible bonds to keep the suture cutting member 84 in an open configuration until it is necessary to close it and cut the suture. At this stage, the device 10 is ready to load the suture and be used to clamp the suture. For example, after the suturing process, the open and / or free and / or proximal end of the suture 2 can be loaded and / or passed through the device 10. The proximal end of the suture can be fed into the distal end of the device 10 and passed through the device 10 along an appropriate path. This can be done with or without a tool or introducer, such as a tubular introducer, a silk thread, a loop, a needle, etc.

[0095] Figure 4An exemplary device and / or mechanism for loading suture 2 through medical device 10 is shown. Suture conduit 4 can be inserted into the desired path of suture 2 extending through device 10. In this example, suture 2 will be loaded in a "side saddle" arrangement - where suture 2 is loaded into the distal region of device 10, then extends from within device 10 through incision 25, and extends outside of device 10 along proximal region 18 of shaft 14. For example, suture conduit 4 can be arranged so that it extends from the proximal end of device 10 along the side of medical device 10 outward to distal region 22, and can then be inserted through device 10 along an appropriate path. For example, as shown, suture conduit 4 can be inserted through incision 25 of distal region 22, through incision 85 of suture cutting member 84 (e.g., through opening 89), through the lumen of suture cutting member 84 into and through lumen 26 of distal region 22, into and through hole 38 of outer clamp member 34, and out between outer clamp member and inner clamp member 34 and 72. The suture 2 can be returned through the suture conduit 4 so that it follows the same general path back through the suture conduit 4 and / or the device 10. The suture conduit 4 can be used to help guide and / or load the suture 2 through the device 10, and can help protect the suture from damage, such as damage from the cutting member 84 during loading of the suture. The suture conduit 4 can be similarly used with any of the embodiments of the medical devices disclosed herein. Figure 5 As shown, the suture guide tube 4 can be removed. The device 10 can be advanced over the suture 2 to the suture / defect site where it is best to clamp the suture 2. When doing so, the suture 2 is still inserted in the path through the device 10.

[0096] Once the device 10 is advanced to the desired location for applying the clamp 34 / 72 to the suture 2, the user can apply the appropriate and / or desired tension to the suture 2 and use the device 10 to apply the clamp to the suture 2. For example, using the user interface 90, the inner shaft 64 can be retracted proximally relative to the outer shaft 14. Figure 6 As shown, when doing so, the inner shaft 64 can move or otherwise translate the inner clamp member 72 proximally into engagement with the outer clamp member 34, thereby clamping a portion of the suture 2 therebetween. The inner clamp member 72 and the outer clamp member 34, once properly engaged on the suture 2, are combined to form a "clamp" applied to the suture 2. This can be described as the first stage of the proximal longitudinal movement of the elongated inner shaft 64 - which can apply the clamp to the suture.

[0097] Further proximal movement of the inner shaft 64 can move the outer clamp member 34 from the first configuration (e.g., Figure 5-6) moves toward a second configuration in which the frangible bond between the outer clamp member 34 and the distal region 22 of the shaft 14 is broken and / or released, and as shown Figure 7 As shown, the proximally facing shoulder surface 50 engages the distally facing end surface 30 of the elongated shaft 14. This movement of the inner shaft 64 can be described as moving the inner shaft 64 proximally through a second stage of proximal longitudinal movement to cause the outer clamp member 34 to switch toward a second configuration in which the frangible bond between the outer clamp member 34 and the distal region 22 of the shaft 14 is broken and / or released. This releases the outer clamp member 34 from fixed engagement with the shaft 14, thereby allowing the clamp to be released. In addition, engaging the proximally facing shoulder 50 of the outer clamp member 34 with the distally facing end surface 30 of the distal region 22 of the elongated shaft 14 can serve as a "stop" to allow the next stage of movement to disengage the inner clamp member 72 from the inner shaft 64.

[0098] like Figure 8 As shown, the inner shaft 64 can be designed to pass through the third stage of proximal movement, in which the inner shaft 64 is disengaged from the inner clamp member 72. In addition, the inner shaft 64 can be designed to engage the inner shaft 64 with the suture cutting member 84 in the fourth stage of proximal movement of the inner shaft 64. When doing so, the inner shaft 64 can switch the suture cutting member 84 from the open configuration to the closed configuration and cut the suture 2, as shown in FIG. Fig. 9 For example, moving the inner shaft 64 in the fourth stage of proximal movement can break and / or release the frangible bond between the suture cutting member 84 and the shearing member 86 so that the suture cutting member 84 can be switched toward the closed configuration to cut the suture.

[0099] A clamp (e.g., which may be defined as or otherwise include an inner clamp member 72 and an outer clamp member 34) is applied to the suture or otherwise holds the suture 2 in a clamp arrangement. As the frangible bond is broken and / or released, and the suture 2 is cut, the clamp may thereafter be detached from the shaft 14 and may be left in the anatomy to terminate and / or anchor the suture, such as Fig.10 A suture is shown extending through tissue T.

[0100] Fig.11 and 12 Another use and / or configuration of the device 10 relative to the suture 2 is shown, wherein the suture 2 is arranged in a "through the device" configuration. For example, Fig.11The catheter 4 is shown being used to deliver the suture 2 through the proximal portion 18 of the shaft 14 (rather than the outside), through the proximal portion of the suture cutting member 84, out through the incision 85 of the suture cutting member 84, along the outside of the distal portion of the suture cutting member 84, within and through the cavity 26, into and through the cavity 38, and out of the distal opening of the outer clamp member 34 (e.g., between the outer clamp member 34 and the inner clamp member 72). Fig.12 The catheter 4 is shown removed, while the suture 2 remains "through the device". At this point, the use of the device 10 can be the same as described above with reference to Figure 4-10 The use described is substantially the same. For example, the device 10 can be advanced over the suture 2 (which can also include tensioning the suture 2), and the inner shaft 64 can be retracted proximally to engage the inner clamp member 72 with the outer clamp member 34 and apply the clamp to the suture 2. This can include moving the inner shaft 64 through the first stage and / or the second stage of longitudinal movement. Additional longitudinal movement of the inner shaft 64 (e.g., through the third stage and / or the fourth stage) can cut the suture 2 and disengage the clamp from the device.

[0101] Fig.13 Another exemplary medical device 110 is shown, which may be similar in form and function to other devices described herein, wherein similar names and / or reference numerals indicate the same or similar structure and / or function as described elsewhere herein. While other components of the device / assembly remain substantially the same, in this example, the medical device 110 may include a suture cutting member 184, such as Fig.14 As shown, the suture cutting member includes an inner tube 197 and an outer tube 179 attached to the inner tube 197. In at least some examples, the inner tube 197 is attached in a non-coaxial or offset manner. The suture cutting member 184 may include a tube wall 179. A cutout 185 including or otherwise defining a shearing edge 183 may be formed in the tube wall 179. The cutout 185 and the shearing edge 183 are similar in structure and function to the cutout 85 and the shearing edge 83 discussed herein (e.g., the suture cutting member 184 may interact with the shearing member 86 to cut the suture 2).

[0102] Thus, the use of the device 110 can be similar to other embodiments of the device described herein. For example, the device 110 can start in a first configuration, wherein the proximal portion 54 of the outer clamp member 34 is disposed within the cavity 26 and engages with the distal region 22 of the elongated shaft 14, thereby defining a gap 60 between the proximally facing shoulder surface 50 and the distally facing end surface 30. As described herein, the inner shaft 64 can undergo a first, second, third, and fourth phases of proximal movement. When doing so, a clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be applied to the suture 2, the gap 60 between the proximally facing shoulder 50 and the distal end surface 30 can be closed to a second configuration, the suture cutting member 184 can be switched from an open configuration to a closed configuration to cut the suture 2, and the clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be released.

[0103] Although Fig.13 Suture 2 is depicted as being deployed in a "through-the-device" configuration, but other configurations are contemplated, including as Fig.15 The "side saddle" structure shown. Fig.15 As shown, when doing so, the wall of the distal region 22 of the shaft 14 may include a cutout 25 through which the suture 2 may be passed (e.g., similar to Figure 1 The cutout 25 shown in FIG.

[0104] Fig.16Another exemplary medical device 210 is described, which may be similar in form and function to other devices described therein, wherein similar names and / or reference numerals represent the same or similar structures and / or functions described elsewhere herein. Although the other components of the device / assembly remain substantially the same, this embodiment includes an alternative suture cutting member 284 having a different configuration from the cutter member 284. In this example, the suture cutting member 284 may include an inner tube 297, a middle tube 291, and an outer tube 279. As shown, the tubes 297, 291, and 279 may be arranged and / or fixed to each other on an axis (e.g., the tubes 297, 291, and 279 may be coaxial). However, other arrangements may be envisioned. The outer tube 279 defines a shearing edge 283 at its proximal end. The shearing edge 283 may be functionally similar to the shearing edge 83 discussed herein, because it interacts with the shearing edge 87 of the shearing member 86 in a similar manner to shear and / or cut the suture. The inner tube 297 receives the inner shaft 64 in a lumen therethrough, and its outer portion can be releasably engaged / fixed with the shearing member 86, for example, with a frangible bond. An opening can be defined between the shearing edge 283 and the shearing edge 87 of the shearing member 86. The intermediate tube 291 can serve as a spacer between the inner tube and the outer tubes 297, 291. The proximal retraction of the inner shaft 64 causes the distal portion 68 of the inner shaft 62 to engage with the inner tube 297 and release and / or destroy the frangible bond. Further proximal retraction of the inner shaft 64 can cause the shearing edge 283 and the shearing edge 87 to be combined together, switching them from an open configuration to a closed configuration, and they engage to shear / cut the suture 2.

[0105] Thus, the use of the device 210 can be similar to other embodiments of the device described herein. For example, the device 210 can start in a first configuration, wherein the proximal portion 54 of the outer clamp member 34 is disposed within the cavity 26 and engages with the distal region 22 of the elongated shaft 14, thereby defining a gap 60 between the proximally facing shoulder surface 50 and the distally facing end surface 30. As described herein, the inner shaft 64 can undergo a first, second, third, and fourth phases of proximal movement. When doing so, a clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be applied to the suture 2, the gap 60 between the proximally facing shoulder 50 and the distal end surface 30 can be closed to a second configuration, the suture cutting member 284 can be switched from an open configuration to a closed configuration to cut the suture 2, and the clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be released.

[0106] Although Fig.16 Suture 2 is depicted as being arranged in a "through-device" configuration, but other configurations are contemplated, including a "side saddle" configuration. When doing so, the wall of the distal region 22 of the shaft 14 may include a cutout (e.g., similar to Figure 1 The incision 25 shown in FIG. 2 ) is a through which the suture 2 can pass.

[0107] Fig.17 Another exemplary medical device 310 is described, which may be similar in form and function to other devices described therein, where similar names and / or reference numerals represent the same or similar structures and / or functions as described elsewhere herein. Although the other components of the device / assembly remain substantially the same, this embodiment includes different configurations of a shearing member 386 and a suture cutting member 384. The suture cutting member 384 can take the form of a tubular member on the axis of the inner shaft 64, and the suture cutting member 384 can be releasably engaged / fixed with the distal region 22, for example, with a frangible bond. The shearing edge 383 can be defined and / or disposed on the proximal end of the suture cutting member 384. The suture cutting member 384 can receive the inner shaft 64. In this example, the shearing member 386 is a blade and / or a blade-like member attached to a tubular member 397, which in turn can be attached to the shaft 14 (e.g., the distal region 22, the proximal region 18, or both). An opening can be defined between the shearing edge 383 of the cutting member 384 and the shearing edge 387 of the shearing member 386. The proximal retraction of the inner shaft 64 engages the distal portion 68 of the inner shaft 64 with the suture cutting member 384 and releases and / or destroys the frangible bond. Further proximal retraction of the inner shaft 64 can bring the shearing edge 383 and the shearing edge 387 together, switching them from an open configuration to a closed configuration, and they engage to shear / cut the suture 2.

[0108] Thus, the use of the device 310 can be similar to the use of other embodiments of the device described herein. For example, the device 310 can begin in a first configuration, wherein the proximal portion 54 of the outer clamp member 34 is disposed within the cavity 26 and engages the distal region 22 of the elongated shaft 14, thereby defining a gap 60 between the proximally facing shoulder surface 50 and the distally facing end surface 30. As described herein, the inner shaft 64 can undergo first, second, third, and fourth stages of proximal movement, and when doing so, the clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be applied to the suture 2, the gap 60 between the proximally facing shoulder 50 and the distal end surface 30 can be closed to the second configuration, the suture cutting member 384 can be switched from the open configuration to the closed configuration to cut the suture 2, and the clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be released.

[0109] Although Fig.17Suture 2 is depicted as being arranged in a "through-the-device" configuration, but other configurations are contemplated, including a "side saddle" configuration. When doing so, the wall of the distal region 22 of the shaft 14 may include a cutout (e.g., similar to Figure 1 25) through which the suture 2 can pass. In some cases, the suture 2 can pass through the suture cutting member 384 and then through the incision and / or opening (not shown) on the wall of the distal region 22 of the shaft 14. The proximal retraction of the inner shaft 64 can bring the shearing edge 383 and the shearing edge 87 together, which engage to shear / cut the suture 2.

[0110] Fig.18 Another example of a medical device 410 is described, which may be similar in form and function to other devices described therein, where similar names and / or reference numerals represent the same or similar structures and / or functions as described elsewhere herein. Although other components of the device / assembly remain substantially the same, this embodiment includes a different configuration of a suture cutting member 484. The suture cutting member 484 may include an inner tube 497 and an outer tube 479 attached to the inner tube 497. The inner tube 497 may be releasably engaged / fixed to the shearing member 86, for example, with a frangible bond. The outer tube 479 may be offset from the axis or otherwise arranged non-coaxially with the inner tube 497 so as to define an opening between the two tubes so that the suture 2 can pass therethrough. The suture cutting member 484 may also include, for example, a cut or shave 89 at its proximal end, which may help guide the suture toward and / or through the opening 25 in the tube wall 24 of the distal region 22 of the shaft 14 in a side saddle arrangement. In this example, the shearing member 86 may include a blade-shaped member 386 having a shearing edge 387. Proximal retraction of the inner shaft 64 may bring the shearing edge 83 and the shearing edge 387 together, which engage to shear / cut the suture 2. For example, the inner shaft 64 may be retracted until the enlarged portion 66 contacts the distal end of the inner tube 497. Further proximal retraction of the inner shaft 64 may break and / or release the frangible bond between the inner tube 497 and the shearing member 86, and allow the shearing edge 83 of the suture cutting member 484 to close with the shearing edge 387, from an open configuration to a closed configuration, and cut / cut the suture 2.

[0111] Thus, the use of the device 410 can be similar to other embodiments of the device described herein. For example, the device 410 can start in a first configuration, wherein the proximal portion 54 of the outer clamp member 34 is disposed within the cavity 26 and engages with the distal region 22 of the elongated shaft 14, thereby defining a gap 60 between the proximally facing shoulder surface 50 and the distally facing end surface 30. As described herein, the inner shaft 64 can undergo a first, second, third, and fourth phase of proximal movement. When doing so, a clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be applied to the suture 2, the gap 60 between the proximally facing shoulder 50 and the distal end surface 30 can be closed to a second configuration, the suture cutting member 484 can be switched from an open configuration to a closed configuration to cut the suture 2, and the clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be released.

[0112] Fig.19 Another exemplary medical device 510 is shown, which may be similar in form and function to other devices described therein, where similar names and / or reference numerals represent the same or similar structures and / or functions as described elsewhere herein. Although the other components of the device / assembly remain substantially the same, this embodiment includes a different configuration of a suture cutting member 584 and a shearing edge 583. Specifically, in this configuration, the device 510 does not include a separate "combination" and / or shearing member, as provided in some embodiments herein (e.g., a combination or shearing member 86, 386). Instead, in this embodiment, the structure of the distal region 22 of the shaft 14 defines a shearing edge 587 that works with the shearing edge 583 on the suture cutting member 584 to cut the suture 2. In some aspects, the distal region 22 of the shaft 14 is a shearing member and / or defines a shearing member in a cavity that defines a distally facing shearing edge 587 that works with the proximally facing shearing edge 583 on the suture cutting member.

[0113] For example, in the present embodiment, the distal region 22 of the shaft 14 includes a side opening and / or window and / or cutout 525 extending through its wall 24. As in some other embodiments, the cutout 525 can provide access through the wall 24 to the lumen 26, through which the suture 2 can extend when the device 510 is used in a "side saddle" arrangement, for example, wherein the suture extends from within the lumen 26 through the cutout 525, and as discussed herein, the proximal portion of the suture extends outside the device 510 along the proximal region 18 of the shaft 14. In addition, in the present embodiment, the cutout 525 defines a distally facing shearing edge 587. The shearing edge 587 defined by the cutout 525 in the distal region 22 of the shaft can be designed to work with the shearing edge 583 of the suture cutting member 584, so that the suture 2 located between the shearing edges 587 and 583 can be cut or sheared when the shearing edges 587 and 583 are brought together and / or closed.

[0114] The suture cutting member 584 can be substantially the same or similar in form and function to the suture cutting member 84 described herein. The suture cutting member 584 is disposed within the lumen 26 of the distal region 22 of the shaft 14, and the inner shaft 64 can extend through the suture cutting member 84. The suture cutting member 584 can be a generally tubular member, including a wall 579 having an outer diameter and defining a lumen having a distal opening 577 and a proximal opening 581. In at least some cases, the distal opening 577 can be designed so that the inner shaft 64 can pass therethrough. The proximal opening 581 can be designed so that the inner shaft 64 can at least partially extend therethrough. However, the proximal opening 581 can be narrower than the distal opening 577. For example, the proximal opening 581 can be designed so that the enlarged portion 68 of the inner shaft 64 may not pass through the proximal opening 581. This can provide an engagement mechanism between the inner shaft 64 and the suture cutting member 584 such that proximal retraction of the inner shaft 64 (e.g., relative to the suture cutting member 584) can include engagement of the enlarged portion 68 of the inner shaft 64 with the suture cutting member 584 (e.g., at a position adjacent to the proximal opening 81) such that further proximal movement of the inner shaft 64 can cause the suture cutting member 584 to translate (e.g., proximally) within the cavity 26 of the shaft 14.

[0115] In general, the suture cutting member 584, together with the shearing edge 583, can be designed to terminate and / or otherwise cut a suture used with the device 510. For example, a notch 585 can be formed in the wall 579 of the suture cutting member 584. The shearing edge 583 can be defined along the notch 585. In at least some cases, the shearing edge 583 can be oriented in a generally proximal direction. As described herein, the shearing edge 583, together with the shearing edge 587 defined in the distal region 22 of the shaft 14, can be used to cut the suture 2.

[0116] In this embodiment, the outer diameter of the suture cutting member 84 is determined to fit within the lumen 26 of the distal region 22 of the shaft 14 and optionally be movable and / or slidable therein. In at least some embodiments, it may be desirable to have a relatively close tolerance fit between the inner diameter of the distal region 22 of the shaft 14 (e.g., the lumen 26) and the outer diameter of the suture cutting member 84. This can provide a better and / or tighter suture cutting arrangement between the shearing edges 587, 583 as they move toward each other to cut the suture. The suture cutting member 584 can be designed to switch between a first configuration or open configuration and a second closed configuration. For example, in Fig.19 , wherein an opening is defined between the shearing edge 583 of the suture member 584 and the shearing edge 587 of the distal region 22 of the shaft 14. The suture 2 can extend through the opening between the edges 583 and 587 in this configuration. In the second or closed configuration, the shearing edge 583 of the suture cutting member 584 is brought adjacent and / or engaged and / or passed proximally by the shearing edge 587 to close the opening and cut the suture. In some cases, the suture cutting member 584 can be releasably engaged and / or coupled to the distal region 22 of the shaft 14, for example with a releasable and / or frangible bond. For example, as Fig.19 As shown, when in the open configuration, the two structures can be fixedly fixed to each other with a releasable and / or destructible combination. Therefore, in the original state, when the releasable and / or fragile combination is engaged and / or intact, the suture cutting member 584 can be in an open configuration. The proximal retraction of the inner shaft 64 can make the enlarged portion 68 of the inner shaft 64 contact the surface of the suture cutting member 584 (for example, adjacent to the proximal opening 581), so that the further proximal retraction of the inner shaft 64 can destroy and / or cut off and / or release and / or break away from the releasable and / or fragile combination, and allow the suture cutting member 84 to switch from the open configuration toward the closed configuration and / or switch to the closed configuration (for example, move proximally), and cut / shear the suture 2.

[0117] Thus, the use of the device 510 can be similar to other embodiments of the device described herein. For example, the device can start in a first configuration, wherein the proximal portion 54 of the outer clamp member 34 is disposed within the cavity 26 and engages with the distal region 22 of the elongated shaft 14, thereby defining a gap 60 between the proximally facing shoulder surface 50 and the distally facing end surface 30. As described herein, the inner shaft 64 can undergo a first, second, third, and fourth phase of proximal movement. When doing so, a clamp (e.g., including the outer clamp member 34 and the inner clamp member 72) can be applied to the suture 2, the gap 60 between the proximally facing shoulder 50 and the distal end surface 30 can be closed in the second configuration, the suture cutting member 584 can be switched from an open configuration to a closed configuration to cut the suture 2, and the clamp member (e.g., including the outer clamp member 34 and the inner clamp member 72) can be released.

[0118] Fig.19 The medical device 510 is also shown to include an alternative handle and / or user interface 590 that may be designed and / or configured for user interaction to provide relative movement between the elongated shaft 14 and the inner shaft 64. The user interface 590 is similar in many respects to the one described herein with reference to Figure 1 The user interface 90 shown and discussed above is similar to the user interface 90 shown and discussed above, but with some modifications. Fig.19 In the illustrated embodiment, the user interface 590 includes a distal portion 592, a proximal portion 594, and a slider portion 596 disposed around and / or along the proximal portion 594. The distal portion 592 is connected to the proximal end of the elongated shaft 14, and the proximal portion 594 is connected to and extends proximally from the distal portion 592. The slider portion 596 is connected to the proximal end of the inner shaft 64. The slider portion 596 is disposed on the proximal portion 594 and can be longitudinally moved and / or slidable on and / or along the proximal portion 594. Therefore, the user interface 590 can provide longitudinal movement of the inner shaft 64 relative to the elongated shaft 14 by actuating the slider 596 relative to the proximal portion 594. In some cases, the slider portion 596 can be designed to slide along a groove or slot formed in the proximal portion 594. In this embodiment, the slider portion 596 includes two finger rings that are designed to accommodate a user's fingers (e.g., an index finger, a middle finger, a combination thereof, or other fingers) so that the user can use the finger rings to engage the slider portion 596 and slide it along the proximal portion 596 to move the inner shaft 64 relative to the slender shaft 14.

[0119] The proximal end of the proximal portion 594 may also be configured for user engagement, and therefore, may include a structure or shape that may enhance user engagement, grip, and / or comfort. For example, the proximal end of the proximal portion 594 may include a ring 598, such as a thumb ring, etc. For example, a user may engage with the user interface 590 by inserting a thumb into the thumb ring 598 and inserting one or more fingers into one or more finger rings of the slider portion 596.

[0120] The user interface 590 may include additional features. For example, a movable slider stop (not shown) may be disposed along and / or within the channel 595 that may prevent unwanted movement of the slider member 596 (e.g., during transport and / or storage). Additionally or alternatively, the user interface 590 may include one or more stops, locks, spring members, stops, indicia, markings, etc., for visualizing, controlling, and / or limiting longitudinal movement of the slider member 596. Although not shown in this embodiment, the user interface 590 may also optionally include a suture outlet similar to the suture outlet, such as a suture outlet similar to that described above and in Figure 1 The suture outlet 93 is shown in FIG. The user interface 590 described herein may include and / or be used with any of the various embodiments of the medical device disclosed herein.

[0121] Fig. 20 Examples of suture guiding devices and / or mechanisms that may be used to load and / or pass suture 2 through any embodiment of the medical device disclosed herein are shown. Fig. 20 An exemplary embodiment of a suture guide sheet 600 is shown. The suture guide sheet 600 includes: a handle portion 610; a proximal shaft portion 612 extending distally from the handle portion 610; an annular portion 614 extending distally from the proximal shaft portion 612; and a distal shaft portion 620 extending distally from the annular portion 614. The suture guide sheet 600 may include or be made of one or more metals, polymers, and / or composite or layered or reinforced structures thereof, including any disclosed herein. In some exemplary embodiments, the structure of the suture guide sheet 600 may be cut from a sheet of polymer material and may be a unitary and / or unitary structure. For example, in some embodiments, the suture guide sheet 600 may be a unitary structure cut from a sheet of polyimide material.

[0122] Figure 21-23 Suture guide piece 600 is shown for loading and / or threading suture 2 through medical device 510 (eg, Fig.19 As a general suggestion, the suture guide piece 600 can be passed through the device 510 along a desired path and then used to pull the suture 2 back into the device along the desired path. Fig.21As shown, the suture guide piece 610 can be inserted into the desired path for the suture 2 to extend through the device 510. In this example, it would be desirable to load the suture in a "side saddle" arrangement - where the suture 2 is loaded into the distal region of the device 510, then extends from within the device 510 through the cutout 525, and extends outside the device 510 along the proximal region 18 of the shaft 14. For example, as shown, the suture guide piece 600 can be inserted and / or extended through a path in the device that extends through the cutout 525 of the distal region 22, through the cutout 585 of the suture cutting member 584, through the lumen of the suture cutting member 584, into and through the lumen 26 of the distal region 22, into and through the aperture 38 of the outer clamp member 34, and out between the outer clamp member 34 and the inner clamp member 72. The suture guide 600 can be disposed through a passage in the device 510 such that the handle 610 is disposed proximally and externally of the medical device 510 (e.g., adjacent and / or proximal to the incision 525). A proximal shaft 612 extends from the handle and is disposed within the path through the device 510. An annular portion 614 is disposed distally of the path and beside the exterior of the medical device 510 (e.g., adjacent and / or distally and / or between the outer clamp member 34 and the outer clamp member 72). A distal shaft portion 620 extends distally of the annular portion 614. The distal shaft portion 620 can assist in manipulating the path of the suture guide 600 through the medical device 510, particularly the annular portion 614.

[0123] like Fig. 22 As shown, the suture 2 can then be fed through the annular portion 614. Fig.23 As shown, the suture guide piece 600 can then be pulled back through the device 510 to pull the suture 2 back through the path of the device 510. Thus, the suture guide piece 610 can be used to help guide and / or load the suture 2 through the device 510. Once the suture 2 is pulled through the device 510 as desired, the suture guide piece 610 can be removed from the suture 2, and the device 510 can be advanced over the suture 2 to the suture / defect site, where the suture 2 is clamped and / or the suture is cut as needed. When doing so, the suture 2 remains inserted in the path through the device 510 until the clamp is applied and the suture is cut. It should be understood that the suture guide piece 600 described herein can include and / or be used with any of the various embodiments of the medical device disclosed herein to assist in passing the suture through the desired path of a particular device.

[0124] Materials that can be used for the various components of the medical devices disclosed herein may include those materials commonly associated with medical devices. Any device, component, and / or component or device component disclosed herein may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or the like, or other suitable materials or combinations of materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, available from DuPont, for example). ), ether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), ether esters (e.g., available from DSM Engineering Plastics) ), ether- or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers, such as those available from DuPont ), polyamides (e.g., available from Bayer Or can be purchased from Elf Atochem ), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA, for example, can be ), ethylene vinyl acetate copolymer (EVA), silicone resin, polyethylene (PE), Marex high-density polyethylene, Marex low-density polyethylene, linear low-density polyethylene (e.g. ), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyterephthalamide (e.g., ), polysulfone, nylon, nylon 12 (such as purchased from EMS American Grilon ), perfluoropropyl vinyl ether (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly (styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials or mixtures, combinations, copolymers thereof, polymer / metal composites, etc. In some embodiments, the polymer can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6% LCP.

[0125] Some examples of suitable metals and metal alloys include stainless steels, such as 304V, 304L, 316LV, and 17-7 stainless steel; low carbon steel; nickel titanium alloys, such as linear elastic and / or superelastic nitinol; other nickel alloys, such as nickel chromium molybdenum alloys (e.g., UNS: N06625 such as 625, UNS: N06022 such as UNS:N10276 other Alloys, etc.), nickel-copper alloys (such as UNS: N04400, such as 400, 400, 400, etc.), nickel-cobalt-chromium-molybdenum alloys (such as UNS: R30035, such as etc.), nickel-molybdenum alloys (such as UNS: N10665, such as ALLOY ), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0126] It should be understood that the present invention is illustrative in many respects. Changes may be made in detail, particularly in shape, size, and arrangement of steps without exceeding the scope of the present invention. This may include, within appropriate limits, using any feature of one embodiment in other embodiments. Of course, the scope of the present invention is defined in the language expressed in the appended claims.

Claims

1. A medical device for applying a clamp to a suture, the medical device comprising: an elongated shaft comprising a distal region and a distal end; an outer clamp member secured to a distal region of the elongated shaft with a frangible bond, the outer clamp member defining a shoulder; wherein the outer clamp member is configured to switch between a first configuration and a second configuration, wherein a gap is defined between the distal ends of the elongated shafts; an elongated inner shaft extending through the elongated shaft and the outer clamp member and movable longitudinally within the elongated shaft and the outer clamp member; as well as An inner clamp member is engaged with the distal end portion of the inner elongated shaft, the inner clamp member being configured to engage with the outer clamp member and to shift the outer clamp member from the first configuration toward the second configuration.

2. The medical device of claim 1, wherein the elongated inner shaft is configured such that proximal longitudinal movement of the elongated inner shaft moves the inner clamp member into engagement with the outer clamp member.

3. The medical device of claim 1, wherein the shoulder engages the distal end of the elongated shaft when the outer clamp member is in the second configuration.

4. The medical device of claim 3, wherein the elongated inner shaft is configured such that proximal longitudinal movement of the elongated inner shaft switches the outer clamp member from the first configuration toward the second configuration.

5. The medical device of claim 3, wherein the elongated inner shaft is configured such that proximal longitudinal movement of the elongated inner shaft releases the frangible bond between the outer clamp member and the distal end region of the elongated shaft.

6. The medical device of claim 1, wherein the frangible bond between the outer clamp member and the distal end region of the elongated shaft is released when the outer clamp member is in the second configuration.

7. The medical device of claim 1, further comprising a suture cutting member disposed within the distal region of the elongated shaft, and wherein the elongated inner shaft is configured to engage the suture cutting member to cut the suture.

8. The medical device of claim 1 , wherein the elongated inner shaft is configured such that a first stage of proximal longitudinal movement of the elongated inner shaft moves the inner clamp member into engagement with the outer clamp member, and a second stage of proximal longitudinal movement of the elongated inner shaft switches the outer clamp member toward the second structure in which the shoulder engages with the distal end of the elongated shaft.

9. The medical device of claim 8, wherein the elongated inner shaft is configured such that a third stage of proximal movement of the elongated inner shaft disengages the elongated inner shaft from the inner clamp member.

10. The medical device of claim 9, further comprising the suture cutting member disposed within the distal region, and the elongated inner shaft is configured such that a fourth stage of proximal movement of the elongated inner shaft engages the elongated inner shaft with the suture cutting member.

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