REPOSIBLE TISSUE ENGAGING MEMBERS AND ASSOCIATED SYSTEMS AND METHODS - Patent application

Abstract

The tissue engaging member has a pair of jaws movable between a closed configuration and an open configuration, an actuator movable to shift the jaws between the closed configuration and the open configuration, and a biasing element biasing the jaws to the closed configuration. The biasing element may be provided over a portion of the tissue engaging member. A cam mechanism may be provided operatively associated with at least one of the jaws and / or the actuator. The biasing element may operatively engage at least one of the jaws and / or the actuator to actuate the cam mechanism to return the jaws from the open configuration to the closed configuration. A manipulator having an actuator engaging element may be provided to engage an actuating element operatively associated with the actuator. The actuator engaging element may operatively engage the actuating element in a range of orientations.

Description

[Technical field]

[0001] The present disclosure relates generally to the field of tissue engaging members and associated systems and methods. More particularly, the present disclosure relates to the field of repositionable tissue engaging members and associated systems and methods. [Background technology]

[0002] Physicians are becoming more skilled in endoscopic procedures that use transluminally inserted instruments to perform various procedures without the need for open surgery. However, with currently available technology, performing more complex procedures such as endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR), which may be used to remove lesions from the gastrointestinal tract, can be difficult and time-consuming. Manipulating the device to clamp tissue can require procedures to be complicated and / or time-intensive techniques to position, orient, and reorient the device and associated medical instruments. In addition, non-ideal visualization and lack of tissue tension also make procedures difficult and time-consuming. Having a means to generate greater traction on the tissue is desirable to improve visualization of the cut surface. The use of repositionable clips is important to improve the ability to re-tension a tether that has lost tension as a procedure (e.g., cutting) is performed on the grasped tissue. Repositionable clips also allow for adjustments during the procedure and facilitate device retrieval. However, current repositionable clips present challenges related to factors such as cost, usability, and the cognitive load required to operate / actuate them.

[0003] It should be noted that improvements of the present disclosure may be useful with the above considerations in mind. Summary of the Invention

[0004] This Summary of the disclosure is provided to aid in understanding, as those skilled in the art will appreciate that each of the various aspects and features of the disclosure may be used advantageously separately in some cases, or in combination with other aspects and features of the disclosure in other cases. No limitation as to the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary.

[0005] In accordance with various principles of the present disclosure, the tissue engaging member includes a pair of jaw members coupled to one another and movable between a closed configuration and an open configuration. The pair of jaw members also includes an actuator operably engaged with the pair of jaw members for shifting the plurality of jaw members between the closed configuration and the open configuration. The pair of jaw members also includes a biasing element disposed to bias the plurality of jaw members toward the closed configuration. The pair of jaw members also includes a cam mechanism operably associated with at least one of the actuator, the biasing element, or at least one of the plurality of jaw members.

[0006] In some embodiments, the actuator is shiftable against a force of a biasing element to shift the plurality of jaw members from a closed configuration to an open configuration. In some embodiments, the biasing element operably engages at least one of the actuator or at least one of the plurality of jaw members. In some embodiments, the biasing element is disposed about a portion of one of the actuator or at least one of the plurality of jaw members.

[0007] In some embodiments, the cam mechanism includes a cam surface on one of the actuator or at least one of the plurality of jaw members. In some embodiments, the cam mechanism further includes a cam follower on the other of the actuator or at least one of the plurality of jaw members. In some embodiments, a biasing element operably engages one of the actuator or at least one of the plurality of jaw members to actuate the cam mechanism to return the plurality of jaw members from the open configuration to the closed configuration.

[0008] In some embodiments, the tissue engaging member further includes a housing, a jaw member, and an actuator disposed within a portion of the housing, hi some embodiments, a biasing element is operably engaged to one of the actuator, or the housing, or at least one of the plurality of jaw members to bias the plurality of jaw members into the closed configuration.

[0009] In some embodiments, the jaw members are coupled together and biased away from one another, the actuator is movable between a position that holds the jaw members in a closed configuration and a position that allows the jaw members to move apart towards an open configuration, and a biasing element biases the actuator to a position that holds the jaw members in the closed configuration.

[0010] In some embodiments, the tissue engaging member further includes an actuating element coupled to the actuator, the actuating element being graspable for moving the actuating element to shift the plurality of jaw members between the closed and open configurations.

[0011] In accordance with various principles of the present disclosure, the tissue engaging member includes a pair of jaw members coupled together and movable between a closed configuration and an open configuration, an actuator operatively engaging the pair of jaw members to shift the plurality of jaw members between the closed configuration and the open configuration, and a biasing element disposed over a portion of the actuator or at least one of the plurality of jaw members to bias the plurality of jaw members into the closed configuration.

[0012] In some embodiments, the biasing element is a resilient element disposed about the plurality of jaw members. In some embodiments, the biasing element is disposed about a portion of the actuator.

[0013] In some embodiments, the tissue engaging member further comprises a cam mechanism operably associated with at least one of the actuator, the biasing element, or at least one of the plurality of jaw members. In some embodiments, the cam mechanism comprises a cam surface on one of the actuator or at least one of the plurality of jaw members. In some embodiments, the cam mechanism further comprises a cam follower on the other of the actuator or at least one of the plurality of jaw members.

[0014] In accordance with various principles of the present disclosure, a tissue engagement system includes a tissue engaging member having a distal end and a proximal end, the tissue engaging member including a plurality of jaws along the distal end, an actuator along the proximal end, and a biasing element, the plurality of jaws shiftable between closed and open configurations, the actuator operatively engaging the plurality of jaws to move the plurality of jaws between the closed and open configurations, and the biasing element biasing the plurality of jaws to the closed configuration. The tissue engagement system further includes a tissue engaging member manipulator having a distal end operatively engaging the tissue engaging member and configured to move the actuator to shift the plurality of jaws between the closed and open configurations, and a manipulator deployment system configured to deliver and manipulate the tissue engaging member manipulator to move the actuator.

[0015] In some embodiments, the actuating element is operably coupled to a proximal end of the actuator along the proximal end of the tissue engaging member, and the actuator engaging element is provided on the distal end of the tissue engaging member manipulator and configured to engage the actuating element at a range of orientations relative to the actuating element.

[0016] In some embodiments, the manipulator deployment system further includes a flexible tubular element having a lumen defined therethrough and a sheath, wherein the tissue engaging member manipulator is movable proximally into the lumen defined through the flexible tubular element to abut a proximal end of the tissue engaging member with a distal end of the flexible tubular element, and the sheath is movable over the distal end of the flexible tubular element and over the tissue engaging member to hold the tissue engaging member in alignment with the manipulator deployment system.

[0017] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. [Brief description of the drawings]

[0018] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, the device may be enlarged so that details are discernible, but is intended to be reduced in relation to fitting, for example, into a working channel of a delivery catheter or endoscope. In each figure, elements that are identical or nearly identical or equivalent may generally be labeled with the same reference numerals, and similar elements may generally be labeled with similar reference numerals that differ by 100, and duplicate descriptions will be omitted. For purposes of clarity and conciseness, not all elements are labeled in every figure, and not all elements of each embodiment are shown unless illustration is necessary to enable a person skilled in the art to understand the present disclosure.

[0019] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference numerals indicate like elements and in which: [Figure 1] 1 illustrates a perspective view of an example of an embodiment of a tissue engaging member and associated system according to various aspects of the present disclosure. [Diagram 2] 2 shows a perspective view of a tissue engaging member as in FIG. 1; [Diagram 3] FIG. 3 illustrates an elevational view of a tissue engaging member as in FIG. 2, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in a closed configuration. [Figure 4] FIG. 4 illustrates an elevational view of a tissue engaging member such as that of FIGS. 2 and 3, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in an open configuration. [Diagram 5] 2 shows a perspective view of another embodiment of a tissue engaging member that may be used with a system such as that shown in FIG. 1. [Figure 6] FIG. 6 illustrates an elevational view of a tissue engaging member as in FIG. 5, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in a closed configuration. [Figure 7] FIG. 7 illustrates an elevational view of a tissue engaging member such as that of FIGS. 5 and 6, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in an open configuration. [Figure 8] 2 shows a perspective view of another embodiment of a tissue engaging member that may be used with a system such as that shown in FIG. 1. [Figure 9] FIG. 9 illustrates an elevational view of the tissue engaging member as in FIG. 8, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in a closed configuration. [Figure 10] FIG. 10 illustrates an elevational view of a tissue engaging member such as that of FIGS. 8 and 9, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in an open configuration. [Figure 11] 2 shows a perspective view of another embodiment of a tissue engaging member that may be used with a system such as that shown in FIG. 1. [Figure 12]FIG. 12 illustrates an elevational view of the tissue engaging member as in FIG. 11, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in a closed configuration. [Figure 13] FIG. 13 illustrates a perspective view of a tissue engaging member such as that of FIGS. 11 and 12, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in a closed configuration. [Figure 14] 2 shows a perspective view of another embodiment of a tissue engaging member that may be used with a system such as that shown in FIG. 1. [Figure 15] 15 shows a cross-sectional view of an embodiment of a tissue engaging member as in FIG. 14 taken along line XV-XV in FIG. 14. [Figure 16] FIG. 16 illustrates a perspective view of a tissue engaging member such as that of FIGS. 14 and 15, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in a closed configuration. [Figure 17] FIG. 17 illustrates a perspective view of a tissue engaging member as in FIGS. 14-16, with outer portions shown in phantom to reveal internal components, showing the tissue gripping portion in an open configuration. [Figure 18] 18 shows a perspective view of a variation of the tissue engaging member of FIGS. 14-17 that may be used with a system such as that shown in FIG. [Figure 19] 11 illustrates successive positions of the tissue engaging member and tissue engaging member manipulator from a tissue engaging member closed configuration to a tissue engaging member open configuration. [Figure 20] 11 illustrates successive positions of the tissue engaging member and tissue engaging member manipulator from a tissue engaging member closed configuration to a tissue engaging member open configuration. [Figure 21] 11 illustrates successive positions of the tissue engaging member and tissue engaging member manipulator from a tissue engaging member closed configuration to a tissue engaging member open configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It should be understood that the disclosure is not limited to the specific embodiments described, and may therefore vary. All devices and systems and methods discussed herein are examples of devices and / or systems and / or methods implemented according to one or more principles of the disclosure. Each example of an embodiment is provided for illustration purposes, and is merely an example, not the only way to implement these principles. Thus, references to elements or structures or features in the drawings should be recognized as references to example embodiments of the disclosure, and should not be understood as limiting the disclosure to the specific elements, structures or features illustrated. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the subject matter. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. Thus, it is intended that the subject matter encompasses such modifications and variations as fall within the scope of the appended claims and their equivalents.

[0021] It will be understood that the present disclosure is described in this application at various levels of detail. In certain instances, details that are not necessary for a person skilled in the art to understand the present disclosure or that would make it difficult for one to appreciate other details may be omitted. The terminology used herein is for the purpose of describing certain embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by those skilled in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0022] As used herein, "proximal" refers to a direction or location closest to a user (such as a medical professional or clinician or technician or operator or physician, such terms are used interchangeably herein without any limiting intent and include automated controller systems, etc.) when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery), and "distal" refers to a direction or location furthest from a user when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery). "Longitudinal" means extending along the longer or greater dimension of an element. "Center" means at least generally bisecting a center point, and "center axis" refers to, with respect to an opening, a line that at least generally bisects a center point of the opening and that extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or bore.

[0023] In accordance with various principles of the present disclosure, the tissue engaging member has a first tissue engaging element and a second tissue engaging element that are movably coupled relative to one another to engage, contact, hold, grasp, etc., body tissue. For convenience, and without any limitation, reference will be made to jaws rather than tissue engaging elements. The jaws of a tissue engaging member formed in accordance with various principles of the present disclosure may include a pair of jaw members that are movable relative to one another between a closed configuration in which the jaw members contact or substantially contact one another (e.g., tissue is grasped therebetween) and an open configuration in which the jaw members are spaced apart (e.g., allowing tissue to be placed therebetween or removed or released from between the jaw members). It will be understood that a tissue engaging member formed in accordance with various principles of the present disclosure may also be referred to as a clip, clasp, fastener, clamp, etc., without any limitation. For simplicity, and without any limitation, reference may be made herein to simply jaws rather than jaw members.

[0024] In accordance with various principles of the present disclosure, a biasing element is provided to maintain the jaws of the tissue engaging member in a closed configuration. In some embodiments, the jaws are in a closed configuration when the biasing element is in a rest position. It will be understood that terms such as rest, neutral, unbiased, undeformed, etc. may be used interchangeably herein to indicate a state of no stored or preserved potential energy. It will be further understood that terms such as form and position (and conjugations thereof and other grammatical forms) may be used interchangeably herein without any limiting intent. The biasing element may be formed as a separate element (e.g., separate from the jaws of the tissue engaging member). The biasing element may be in the form of a rubber band or a spring-biased metal element.

[0025] In embodiments where the biasing element maintains the jaws in the closed configuration when the biasing element is in a rest position, the biasing element must be shifted to another configuration or position, such as a potential energy stored configuration, to allow the jaws to shift to the open configuration. In some embodiments, an actuator may be provided to move the jaws to the open configuration, such as by moving the biasing element to the potential energy stored configuration. In some embodiments, the actuator moves the jaws against the force of the biasing element. In some embodiments, the actuator moves against the force of the biasing element.

[0026] In some embodiments, the jaws of the tissue engaging member are pivotally coupled together and a biasing element maintains the jaws in the closed configuration. An actuator may be provided in such embodiments to move the jaws to the open configuration against the biasing force of the biasing element and to hold the jaws in the open configuration. When the actuator is released, the biasing element may be positioned and / or configured to return the jaws to the closed configuration.

[0027] In some embodiments, the cam mechanism is associated with at least one of the actuator, the biasing element, or at least one of the plurality of jaw members. The cam mechanism may include a cam surface and a cam follower. In some embodiments, the cam surface is provided on either the actuator or the jaw member (one or both of the plurality of jaw members) and the cam follower is provided on the other of the actuator or the jaw member (one or both of the plurality of jaw members). Movement of the actuator relative to the plurality of jaw members causes the cam follower to move along the cam surface to move the plurality of jaw members between a closed configuration and an open configuration.

[0028] In some embodiments, the jaws are biased toward the open configuration and a biasing element maintains the jaws in the closed configuration. For example, the biasing element may bias the actuator to a jaw closed position to hold the jaws of the tissue engaging member in the closed configuration. In some embodiments, the actuator is positionable over the jaws to hold the jaws in the closed configuration. The actuator may be shifted to allow the jaws to shift to the open configuration, such as by being shifted relative to the biasing element. When the actuator is released, the biasing element may be positioned and / or configured to return the actuator to the jaw closed position and shift the jaws back to the closed configuration.

[0029] In some embodiments, the biasing element is provided over a portion of the tissue engaging member. In some embodiments, the biasing element contacts an outer surface of the tissue engaging member. In some embodiments, the biasing element contacts the jaws of the tissue engaging member. In some embodiments, an actuator is operatively associated with the jaws to move the jaws between the closed and open configurations, and the biasing element contacts the actuator. In some embodiments, the biasing element surrounds a portion of the tissue engaging member. In some embodiments, the biasing element surrounds the jaws of the tissue engaging member. In some embodiments, the actuator is operatively associated with the jaws to move the jaws between the closed and open configurations, and the biasing element surrounds the actuator. In some embodiments, the biasing element contacts and / or surrounds at least one of the jaws or the actuator of the tissue engaging member.

[0030] As discussed above, in some embodiments, an actuator is provided to shift the multiple jaws between the closed and open configurations. The actuator may be coupled or in conjunction with the multiple jaws to move the multiple jaws between the open and closed configurations, or may be operatively engaged with the multiple jaws without being in conjunction with the multiple jaws. The actuator may be positioned relative to the multiple jaws such that linear motion of the actuator shifts the multiple jaws between the closed and open configurations.

[0031] The actuating element may be provided, arranged, and configured to facilitate operable engagement of the actuator to shift the tissue engaging member between the open and closed configurations. The actuating element may be an actuator engaging element configured to facilitate operable engagement with the actuator. However, other configurations of the actuating element are within the scope and spirit of the present disclosure. Reference may be made herein to provided, associated, coupled, engaged, and the like to describe a physical relationship between the actuating element and at least one portion or component of the tissue engaging member, and such terms are used interchangeably herein without any intended limitation, unless otherwise indicated. The actuating element is configured to be operably engaged with the actuator engaging element by the instrument. It will be understood that terms such as associated, coupled, engaged, contacted, coupled, interlocked, and the like (including conjugations thereof and other grammatical forms) may be used interchangeably herein without any intended limitation, unless otherwise indicated. In some embodiments, the actuating element is configured to facilitate operable engagement with the actuator engaging element regardless of the orientation of the tissue engaging member relative to the tissue being grasped by the multiple jaws of the tissue engaging member. In some embodiments, the actuator engaging element may be operably engaged with the actuating element in two or more orientations relative to the actuating element. In some embodiments, the actuating element is configured to facilitate operably engagement with the actuator engaging element when the actuator engaging element is disposed within a range of angular positions relative to the actuating element. For example, the actuating element may be configured to enable operably engagement with the actuator engaging element when the actuator engaging element is disposed up to about 90° from an aligned (e.g., ideally aligned) position relative to the actuating element. In accordance with various principles of the present disclosure, a tissue engaging member manipulator includes an actuator engaging element configured to operably engage with the actuating element.

[0032] In accordance with various principles of the present disclosure, one or more tissue engaging members are provided in a tissue engaging system. The system may also include a tissue engaging member manipulator configured to actuate at least one of the tissue engaging members to shift the jaws of the tissue engaging member between a closed configuration and an open configuration. The tissue engaging member manipulator may be preloaded into operative engagement with the tissue engaging member to facilitate rapid deployment of the tissue engaging member. The system may further include a deployment system configured to deliver and manipulate the tissue engaging member manipulator to deploy and / or manipulate the tissue engaging member.

[0033] Various embodiments of tissue engaging members will now be described with reference to examples illustrated in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. indicate that one or more particular features, structures, and / or characteristics according to the principles of the present disclosure may be included in association with the embodiments. However, such references do not necessarily mean that all embodiments include the particular feature, structure, and / or characteristic, or that an embodiment includes all features, structures, and / or characteristics. Some embodiments may include one or more such features, structures, and / or characteristics in various combinations thereof. Moreover, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc. are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive separate or alternative embodiments with other embodiments. It should be understood that when a particular feature, structure, and / or characteristic is described in association with one embodiment, such feature, structure, and / or characteristic may also be used in association with other embodiments, whether or not expressly described, unless expressly stated to the contrary. Further, it is to be understood that such features, structures, and / or characteristics may be used or presented alone or in various combinations with each other to create alternative embodiments that are considered part of this disclosure, as it would be too burdensome to describe all of the many possible combinations and subcombinations of features, structures, and / or characteristics. Furthermore, various features, structures, and / or characteristics are described that may be exhibited by some embodiments but not by other embodiments. Similarly, various features, structures, and / or characteristics or requirements are described that may be a feature, structure, and / or characteristic or requirement of some embodiments but may not be a feature, structure, and / or characteristic or requirement of other embodiments. Thus, the present invention is not limited to only the embodiments specifically described herein.

[0034] In the following description, it will be understood that similar elements or components among various illustrated embodiments are generally designated with the same reference numbers incremented by 100, and duplicate descriptions are omitted. Descriptions of similar elements having similar descriptions may be omitted for brevity, and the description of one element is referenced as applicable to another similar element. Common features are identified by common reference elements, and descriptions of common features are generally not repeated for brevity. For clarity, not all components having the same reference numbers are numbered.

[0035] Referring now to the drawings, an example of an embodiment of a tissue engaging member 100 formed according to various principles of the present disclosure is shown gripping tissue T. Another example of an embodiment of a tissue engaging member 100 formed according to various principles of the present disclosure is shown in FIG. 1 , operatively engaged by a tissue engaging member manipulator 170. The tissue engaging members 100 in the view of FIG. 1 may be used to apply traction to tissue by use of a tether 160 extending between (and joining) the tissue engaging members 100 in a known or previously known manner. The tether 160 may be a traction band, a rubber band, an elastic elongation member, a wire, a cord, a cable, a spring, a suture, and / or any other suitable elongation member that is optionally elastic or elongate. It is understood that other uses of tissue engaging members formed according to various principles of the present disclosure are within the scope and spirit of the present disclosure. Additionally, while FIG. 1 illustrates one of the embodiments of tissue engaging member 100 disclosed herein, it is understood that any of the other tissue engaging members 200, 300, 400, 500, 500' may be illustrated in a similar environment for use and operation in a similar manner.

[0036] The tissue engaging member 100 shown in FIG. 1 has a plurality of tissue engaging jaws 110 along a distal end 101 of the tissue engaging member 100. The plurality of jaws 110 are movable between a closed configuration (shown in FIG. 3 and shown in FIG. 1 with tissue T grasped between the plurality of jaws 110) and an open configuration (shown in FIG. 4). An actuator 120 (shown in more detail in FIGS. 2-4) is operatively associated with the plurality of jaws 110 and moves the plurality of jaws 110 between the open and closed configurations. In the illustrated embodiment, a biasing element 130 maintains the plurality of jaws 110 in the closed configuration. The biasing element 130 may be in the form of a rubber band, O-ring, or other resilient element that may be operatively associated with, for example disposed about, the plurality of jaws 110. A casing or housing 140 (hereinafter, for convenience and without intended limitation, housing), such as in the form of a clevis, may be disposed about the plurality of jaws 110 and the actuator 120. In the illustrated embodiment, the biasing element 130 extends about the housing 140. The housing 140 may be formed by a relatively simple stamping process, facilitating manufacture of the tissue engaging member 100 and reducing manufacturing costs.

[0037] In accordance with various principles of the present disclosure, the actuating element 122 is operatively associated with the proximal end 103 of the tissue engaging member 100 to facilitate actuation of the tissue engaging member 100 to shift between the closed and open configurations. In the illustrated embodiment, the actuating element 122 is in the form of a loop that can be easily engaged by an actuator engaging element 172 of the tissue engaging member manipulator 170, as discussed in further detail below. However, other configurations of the actuating element 122 that allow for such easy engagement are within the scope and spirit of the present disclosure. In accordance with various principles of the present disclosure, the actuating element 122 can be moved longitudinally along the longitudinal axis LA of the tissue engaging member 100 to actuate the actuator 120 to shift the plurality of jaws 110 between the open and closed configurations. In the example embodiment of the tissue engaging member 100 shown in FIG. 1, the manner in which the tissue engaging member 100 operates and the mechanism by which the actuator 120 and the plurality of jaws 110 interact can be better understood with reference to FIGS. 2-4.

[0038] To clarify the arrangement of the elements of the tissue engaging member 100 that results in the desired operating characteristics of the tissue engaging member 100, a perspective view of one embodiment of the tissue engaging member 100 is shown in FIG. 2 with its housing 140 in phantom.

[0039] The jaws 110 of the tissue engaging member 100 include a pair of jaw members 110a, 110b each including a tissue engaging end 112 (functionally, an end between which an element, e.g., tissue, is grasped) along a distal end 111 of the jaws 110. The tissue engaging distal ends 111 of the jaws 110 are illustrated as including interengaging teeth 115, although other configurations are within the scope and spirit of the present disclosure. A shank 114 (which may be referred to without limitation as a shaft or wing) extends proximally from each tissue engaging end 112 along a proximal end 113 of the jaw members 110a, 110b. As can be seen by the phantom line depiction of the housing 140, the shanks 114 of the jaws 110 extend between prongs or legs or arms 142 (hereinafter referred to as arms for convenience and without limitation) of the generally clevis-shaped housing 140. The jaw members 110a, 110b of the multiple jaws 110 are pivotable about a pivot pin 116 to pivot relative to one another between a closed configuration and an open configuration. The pivot pin 116 may be attached to a distal end 141 of the housing 140 to maintain the multiple jaws 110 attached to the housing 140. It will be appreciated that the pivot pin 116 may extend through both of the jaw members 110a, 110b, or each jaw member 110a, 110b may have a respective outwardly extending pivot pin 116 attached toward an arm 142 of the housing 140. It is noted that the tether 160 may be coupled to the tissue engaging member 100, for example, via the pivot pin 116, and optionally via a hinge or other extension coupled to or formed with the pivot pin 116, as illustrated in the embodiment of FIG. Other configurations, such as coupling via housing 140, are within the scope and spirit of the present disclosure.

[0040] The actuator 120 is operatively associated with the plurality of jaws 110 for shifting the plurality of jaws 110 between a closed configuration and an open configuration, as described in further detail below, such as with reference to Figures 3 and 4. The actuator 120 is disposed adjacent the plurality of shanks 114 of the plurality of jaws 110 and between the plurality of arms 142 of the housing 140. The actuator 120 may be larger in at least one dimension than the diameter of the housing 140, and thus may extend through a window 145 provided in the housing 140 to allow the actuator 120 to slide proximally to actuate the plurality of jaws 110.

[0041] A cam mechanism 150 is operatively associated with the actuator 120 and the plurality of jaws 110 of the tissue engaging member 100. As can be seen by the phantom line depiction of the housing 140, the cam mechanism 150 of the example embodiment of the tissue engaging member 100 shown in FIG. 2 generally associates the actuator 120 with the proximal ends 113 of the plurality of jaws 110 within a window 145 of the housing 140 between the plurality of housing arms 142. The cam mechanism 150 is configured and arranged such that movement of the actuator 120 shifts the plurality of jaws 110 between a closed configuration shown in FIG. 3 and an open configuration shown in FIG. 4. More specifically, the cam mechanism 150 includes a cam surface 152 and a cam follower 154 that moves along the cam surface 152. It will be understood that various terms such as move, slide, extend, translate, shift, etc. may be used interchangeably herein to describe the movement of the cam follower 154 without any intention of limitation. In the illustrated embodiment, the cam surfaces 152 are in the form of slots in the respective shanks 114 along the proximal ends 113 of each of the plurality of jaw members 110a, 110b, and the cam followers 154 are in the form of pins extending from either side of the actuator 120 facing the jaw members 110a, 110b to slide within the respective slots. It will be understood that an inverse configuration of the cam mechanism 150 (having respective slots for inwardly facing, actuator-facing pins on the plurality of shanks 114, and pins on the outwardly facing, shank-facing side of the actuator 120) or other configurations are within the scope and spirit of the present disclosure.

[0042] The operation of the cam mechanism 150 may be more readily understood with reference to Figures 3 and 4. The biasing element 130 is operatively associated with the plurality of jaws 110 and interacts with the plurality of jaws 110 to hold the plurality of jaws 110 in a closed configuration with the cam mechanism 150 in the closed configuration, as shown in Figure 3. In the illustrated embodiment, the biasing element 130 is disposed about the plurality of shanks 114 of the plurality of jaws 110 along the proximal end 103 of the plurality of jaws 110 such that it surrounds or encircles the plurality of shanks 114 such that the biasing element 130 operatively engages the plurality of jaws 110. However, other locations and configurations of the biasing element 130 are within the scope and spirit of the present disclosure. As discussed above, the tissue engaging member 100 includes an actuating element 122 arranged and configured to act on the actuator 120 (by moving or shifting the actuator 120 relative to the plurality of jaws 110 and / or the cam mechanism 150) to shift the plurality of jaws 110 between the closed and open configurations. Longitudinal shifting of tissue engaging member 100 along longitudinal axis LA and generally longitudinally along a deployment system 180 (as in FIG. 1 ) is considered to be one of the simpler motions to perform within the body, e.g., transluminally.

[0043] In the embodiment of the tissue engaging member 100 shown in FIGS. 2-4, the actuating element 122 is coupled to the actuator 120 via a shaft 124. The shaft 124 extends proximally from the actuator 120 through an axial opening 147 in the proximal end 143 of the housing 140 toward the proximal end 103 of the tissue engaging member 100 to couple with the actuating element 122. The coupling of the actuating element 122 may be accomplished in any known or conventional manner, such as brazing or welding (e.g., of metallic materials), mechanical deformation and coupling (e.g., crimping), or co-molding or other coupling (of polymeric materials). In some embodiments, at least the actuating element 122 and the shaft 124 are formed as a single, unitary piece (e.g., the actuating element 122 is bent from or co-molded with an element forming the shaft 124). In other embodiments, such as those described below, the actuating element and the shaft are formed as separate elements coupled to each other in any desired manner known or heretofore known in the art. Retracting actuating element 122 proximally (towards proximal end 103 and away from distal end 101 of tissue engaging member 100, as seen by comparing movement from the position shown in FIG. 2 to the position shown in FIG. 3 ) moves shaft 124 proximally, which in turn moves actuator 120 proximally. Proximal movement of actuator 120 causes cam follower 154 extending therefrom to move along cam surfaces 152 on shanks 114 of jaws 110, for example, from the position shown in FIG. 2 to the position shown in FIG. 3 . As cam follower 154 moves along cam surface 152, jaws 110 move from a closed position (shown in FIG. 2 ) to an open position (shown in FIG. 3 ) against the biasing force of biasing element 130.

[0044] The biasing element 130 may be held in place relative to the shanks 114 of each of the jaw members 110a, 110b and may apply a closing force to the jaw members 110a, 110b to return the jaws 110 to the closed configuration. In the example embodiment of the tissue engaging member 100 shown in Figures 2 and 3, at least one of the shanks 114 of the jaw members 110a, 110b is provided with grooves and / or shoulders 118 to hold the biasing element 130 in place relative to the shanks 114 and the cam mechanism 150. However, other configurations are within the scope and spirit of the present disclosure. When the proximal force is no longer applied to the actuating element 122 (e.g., when the actuating element 122 is released), the biasing force of the biasing element 130 is applied to the jaws 110 to return them to the closed configuration and the cam follower 154 moves along the cam surface 152 to move the actuator 120 proximally (e.g., from the position of Figure 3 to the position of Figure 2).

[0045] Although the example embodiment of the tissue engaging member 100 shown in Figures 2-4 has a cam mechanism 150, multiple jaws 110, and a biasing element 130 formed separately from the actuator 120 of the tissue engaging member 100 and disposed around or around the exterior of the multiple jaws 110, other configurations and positions and locations of the cam mechanism and / or the multiple jaws and / or the biasing element used in conjunction with the actuator of the tissue engaging member are within the scope and spirit of the present disclosure. Additionally, other mechanisms for coupling the multiple jaws of the tissue engaging member to the actuator to move the multiple jaws between the open and closed configurations are within the scope and spirit of the present disclosure. Various alternative embodiments are shown in Figures 5-18, as described in further detail below.

[0046] An alternative embodiment of tissue engaging member 200 is shown in Figures 5-7 in which the configuration of cam mechanism 250 and biasing element 230 differs from the configuration of cam mechanism 150 and biasing element 130 shown in tissue engaging member 100 of Figures 2-4. For simplicity and convenience, and without any intention of limitation, common elements having common functions in tissue engaging member 200 shown in Figures 5-7 as in tissue engaging member 100 shown in Figures 2-4 are designated with like reference numerals differing in value by 100, with it being understood that reference is made to the above descriptions of similar elements and operation.

[0047] In general, the cam mechanism 250 of the tissue engaging member 200 of Figures 3-5 can be considered similar to the cam mechanism 150 of the tissue engaging member 200 of Figures 3-5 in that both cam mechanisms include a cam surface and a cam follower. However, the location of such cam mechanism elements relative to the plurality of jaws and actuator in the tissue engaging member 200 is opposite to the location of such elements in the tissue engaging member 100. As can be seen with reference to Figure 7, the cam surface 252 of the cam mechanism 250 is in the form of a slot formed in the actuator 220. The cam follower 254 is in the form of a pin that extends inwardly from the plurality of shanks 214 of the plurality of jaws 210 toward the actuator 220, as shown partially in Figure 5 and in phantom in Figures 6 and 7.

[0048] Similar to the embodiment of the tissue engaging member 100 shown in FIGS. 2-4, the biasing element 230 is used in conjunction with the cam mechanism 250 of the example tissue engaging member 200 shown in FIGS. 5-7 to facilitate opening and closing of the plurality of jaws 210. In contrast, however, instead of operably engaging the plurality of jaws 210 (as with the biasing element 130 of the tissue engaging member 100 shown in FIGS. 2-4), the biasing element 230 operably engages the actuator 220. Additionally, the biasing element 230 may be operably engaged with (e.g., may be mounted or formed as part of) the housing 240 such that the biasing element 230 extends from the proximal end 243 of the housing 240 toward the cam mechanism 250. In the example embodiment shown in FIGS. 5-7, the biasing element 230 extends distally from the proximal end 243 of the housing 240 toward the distal end 201 of the tissue engaging member 200. The proximal end 233 of the biasing element 230 may be coupled to or integrally formed with the proximal end 243 of the housing 240. A spring arm 232 may be formed along the distal end 231 of the biasing element 230 for interacting with the actuator 220, as described in further detail below. It will thus be appreciated that the housing 240 of the tissue engaging member 100 shown in Figures 3-5 differs somewhat from the housing 140 of the tissue engaging member 100 shown in Figures 2-4.

[0049] Other than the differences noted above, other elements of the example embodiment of tissue engaging member 200 shown in Figures 5-7 are similar to the corresponding elements of the example embodiment of tissue engaging member 100 shown in Figures 2-4. Moreover, the operation of these tissue engaging members is similar in that actuation of the tissue engaging member to shift between the closed and open configurations can be accomplished by generally longitudinal pulling on an actuating element that can be easily grasped by a medical instrument. In particular, a medical instrument (such as that shown in Figures 1 and 19-21, as described in more detail below) can be used to move the actuating element 222 proximally and longitudinally (towards the proximal end 203 and away from the distal end 201 of the tissue engaging member 200) along the longitudinal axis LA. The actuating element 222 is coupled to an actuator 220 through a shaft 224. Optionally, shaft extension 226 (e.g., in the form of wire 226) may couple actuating element 222 to shaft 224 (by brazing, welding, crimping, co-molding, passing shaft extension 226 through a passage in shaft 224, or the like, in any known or previously known manner). In some embodiments, actuating element 222 and shaft extension 226 are formed from a common element (e.g., a wire with a proximal loop forming actuating element 222). Shaft 224 (and / or shaft extension 226, if provided) extends proximally through axial opening 247 at proximal end 243 of housing 240 to couple with actuating element 222. Shifting actuating element 222 and shaft 224 proximally causes proximal movement of actuator 220. Proximal movement of the actuator 220 causes cam followers 254 (on the shanks 214 along the proximal ends 213 of the jaws 210) to move along cam surfaces 252 (formed in the actuator 220) and pivot the jaw members 210a, 210b relative to one another about the pivot pin 216, shifting the tissue engaging ends 212 from a closed configuration (FIG. 6) to an open configuration (FIG. 7). As the actuator 220 moves proximally to actuate the jaws 210, the actuator 220 also moves proximally relative to the biasing element 230.A shoulder 228 on the actuator 220 facing the proximal end 223 of the actuator 220 may engage the biasing element 230 to shift the biasing element 230 to a biased configuration in which the spring arms 232 are biased to an open configuration that stores potential energy, as shown in Figure 7. Thus, when the actuation element 222 is released, the potential energy stored in the biasing element 230 causes the spring arms 232 to release the stored potential energy and shift the actuator 220 distally, returning the plurality of tissue engaging ends 212 to a closed configuration (e.g., with the distal ends 211 of the plurality of jaws 110 positioned to engage or hold tissue therebetween, as shown in Figures 1 or 6).

[0050] In another example of tissue engaging member 300 shown in FIGS. 8-10, a cam mechanism 350 similar to the cam mechanism 250 of tissue engaging member 200 shown in FIGS. 5-7 may be provided with a variation of the biasing element 330 that interacts therewith. The biasing element 330 of tissue engaging member 300 shown in FIGS. 5-7 operably engages actuator 320 and housing 340 (similar to biasing element 230 of tissue engaging member 200 operably engaging actuator 220 and housing 240), but biasing element 330 is formed separately from housing 340. More specifically, biasing element 330 is disposed between housing 340 and actuator 320, for example, at window 345 in housing 340. In the illustrated embodiment, biasing element 330 is disposed about shaft 324 that extends proximally from actuator 320 (towards proximal end 303 of tissue engaging member 300) and may be in the form of a coil spring.

[0051] The example embodiment of tissue engaging member 300 shown in FIGS. 8-10 is actuated to shift its multiple jaws 310 between a closed configuration and an open configuration in a manner similar to the manner in which tissue engaging member 200 shown in FIGS. 5-7 is actuated. Actuating element 322 may be shifted proximally (toward the proximal end 303 and away from the distal end 301 of tissue engaging member 300) along a longitudinal axis LA of tissue engaging member 300. Actuating element 322 is coupled to actuator 320 through a shaft 324 extending proximally from actuator 320. Optionally, a shaft extension 326 (e.g., in the form of a wire 326 as in the embodiment of FIGS. 5-7) extends through an axial opening 347 in the proximal end 343 of housing 340 to couple shaft 324 and actuating element 322. Shifting the actuation element 322 and shaft 324 (and optional shaft extension 326) proximally causes proximal movement of the actuator 320. Proximal movement of the actuator 320 causes cam followers 354 (on the shanks 314 along the proximal ends 313 of the jaws 310) to move along cam surfaces 352 (formed on the actuator 320) to pivot the jaw members 310a, 310b relative to one another about pivot pin 316 and shift the tissue engaging ends 312 away from a closed configuration (FIGS. 8 and 9) to an open configuration (FIG. 10). Proximal movement of the actuator 320 also causes the actuator 320 to compress the biasing element 330, storing potential energy therein, as shown in FIG. 10. More specifically, as shown in FIG. 8 , the distal end 331 of the biasing element 330 abuts a shoulder 328 along the actuator 320 facing toward the proximal end 303 of the tissue engaging member 300, and the proximal end 333 of the biasing element 330 abuts a shoulder 348 on the housing 340 facing toward the distal end 301 of the tissue engaging member 300 as the actuator 320 is shifted proximally.Releasing the actuating element 322 causes the potential energy stored in the biasing element 330 to return the biasing element 330 to its uncompressed configuration (as in FIG. 9 ), shifting the actuator 320 distally and returning the tissue engaging ends 312 to a closed configuration (e.g., as shown in FIG. 1 or FIG. 9 , with the distal ends 311 of the jaws 310 positioned to engage or hold tissue therebetween).

[0052] Yet another modification to a biasing element 430 that may be used with tissue engaging members having similar elements to the tissue engaging members 200, 300 of Figures 5-7 and 8-10, respectively, is shown in the example tissue engaging member 400 of Figures 11-13. Instead of being operatively engaged with an actuator 420 (as in the tissue engaging members 200, 300 of Figures 5-7 and 8-10), the biasing element 430 of the tissue engaging member 400 shown in Figures 11-13 is operatively engaged with a plurality of jaws 410 of the tissue engaging member 400. The illustrated biasing element 430 may be similar to the biasing element 130 of the tissue engaging member 100 shown in Figures 2-4, with other elements being similar to the elements of the tissue engaging members 200, 300 of Figures 5-7 and 8-10, respectively. For simplicity and convenience, and without any intended limitation, common elements having common functions in the tissue engaging member 400 shown in Figures 11-13 as in the tissue engaging members 200, 300 shown in Figures 5-7 and 8-10, respectively, are designated by the same reference numerals differing by 100, and reference is made to the above descriptions of similar elements and operation.

[0053] As discussed above, the biasing element 430 of the tissue engaging member 400 shown in Figures 11-13 operably engages the multiple jaws 410 of the tissue engaging member 400 to hold the multiple jaws 410 in a closed configuration, similar to the biasing element 130 of the tissue engaging member 100 shown in Figures 2-4. However, instead of being operably engaged with the multiple jaw shanks and / or housing (as in the tissue engaging member 100 of Figures 2-4), the biasing element 430 is operably engaged with the multiple tissue engaging ends 412 of the multiple jaws 410. More specifically, the biasing element 430 may be disposed about (e.g., surrounding) the multiple tissue engaging ends 412 of the multiple jaws 410 to apply a biasing force to hold the multiple jaws 410 in a closed configuration, as shown in Figures 11 and 12. 11-13, at least one of the tissue engaging ends 412 of the jaw members 410a, 410b includes a groove and / or shoulders 418 to hold the biasing element 430 in place relative to the jaws 410. However, other configurations are within the scope and spirit of the present disclosure.

[0054] Actuation of the example embodiment of the tissue engaging member 400 shown in Figures 11-13 is similar to the actuation of the tissue engaging members 200, 300 shown in Figures 5-7 and 8-10, except for the location of the biasing force that returns the plurality of jaws 410 to the closed configuration. An actuating element 422 along the proximal end 403 of the tissue engaging member 400 may be shifted proximally (toward the proximal end 403 and away from the distal end 401 of the tissue engaging member 400) along the longitudinal axis LA of the tissue engaging member 400 to shift an actuator 420 operatively associated with the plurality of jaws 410 to shift the plurality of jaws 410 between a closed configuration (as in Figures 11 and 12) and an open configuration (as in Figure 13). The actuating element 422 is coupled to the actuator 420 through a shaft 424 extending proximally from the actuator 420. Optionally, a shaft extension 426 (e.g., in the form of a wire 426 as in the embodiment of FIGS. 5-7) extends proximally through an axial opening 447 in the proximal end 443 of the housing 440 to couple the shaft 424 and the actuating element 422. Shifting the actuating element 422 proximally causes a proximal shift of the actuator 420. Proximal movement of the actuator 420 causes cam followers 454 (on the shanks 414 along the proximal ends 413 of the jaws 410) to move along cam surfaces 452 (formed on the actuator 420) to pivot the jaw members 410a, 410b relative to one another about pivot pin 416 and shift the tissue engaging ends 412 away from a closed configuration (FIGS. 11 and 12) to an open configuration (FIG. 13). Opening of the multiple jaws 410 causes the biasing element 430 to expand, storing potential energy therein, as shown in Figure 13. Releasing the actuation element 422 causes the potential energy stored in the biasing element 430 to return the biasing element 430 to its uncompressed configuration (as in Figure 12) and move the multiple tissue engaging ends 412 to a closed configuration (e.g., with the multiple distal ends 411 of the multiple jaws 410 positioned to engage or hold tissue therebetween, as shown in Figure 1 or 11 or 12).

[0055] In another embodiment of a tissue engaging member 500 formed according to various principles of the present disclosure, as shown in FIGS. 14-18, the plurality of jaws 510 may be configured or formed to be naturally biased to an open configuration (as in FIGS. 14, 15, 17, and 18). The actuator 520 may be in the form of a retaining member or fillet that is shiftable to hold the plurality of jaws 510 in a closed configuration (as in FIG. 16) or to allow the plurality of jaws 510 to expand to an open configuration (as in FIGS. 14, 15, 17, and 18). The biasing element 530 may be in the form of a spring biased collet or boss or solid spring (e.g., a conical solid spring) having a spring opening 532 that operably engages the actuator 520 to bias the actuator 520 back to a configuration that closes the plurality of jaws 510. Details of the example embodiment of the tissue engagement member 500 shown in FIG. 14 can be understood by reference to the cross-sectional view shown in FIG. 15 taken along line XV-XV in FIG. 14 and the elevational views shown in FIGS. 16 and 17, in which the actuator 520 is shown in phantom.

[0056] 15, the jaws 510 of the tissue engaging member 500 are illustrated having jaw members 510a, 510b adjacent a distal end 511 of the jaws 110 (between which tissue may be grasped when the jaws 510 are in a closed configuration) and shanks 514 extending proximally towards a proximal end 513 of the jaws 510 where the shanks 514 are coupled by a jaw ball joint 516. The shanks 514 are configured to bias the jaw members 510a, 510b apart when unconstrained. An actuator 520 is positioned relative to the jaws 510 and relative to a biasing element 530 to hold the jaws 510 in a closed configuration, as shown in FIG. To open the multiple jaws 510, an actuating element 522, which may be similar to actuating elements 122, 222, 322, 422 described above (reference is made to details of such actuating elements described above as optionally applicable to actuating element 522), is shifted proximally (toward the proximal end 503 of the tissue engaging member 500 and away from the distal end 501 of the tissue engaging member 500) along the longitudinal axis LA. The actuating element 522 is coupled to the actuator 520 via a shaft 524 that is coupled to a proximal end 523 of the actuator 520 (and extends through an opening 537 in the proximal end 533 of the biasing element 530 and an opening 517 through the jaw ball joint 516 of the multiple jaws 510). Shifting the actuation element 522 and shaft 524 proximally shifts the actuator 520 proximally along the distal end 531 of the biasing element 530 toward the spring opening 532, which causes the actuator 520 to bias the spring opening 532 into an extended, tensioned configuration that stores potential energy. The interaction between the actuator 520 and the spring opening 532 of the biasing element 530 may be considered a camming action, such that the tissue engaging member 500 may be considered to have a cam mechanism operatively associated with the actuator 520 and the biasing element 530.Releasing the actuating element 522 causes the potential energy stored in the spring opening 532 of the biasing element 530 to return the spring opening 532 to its resting configuration and shifts the actuator 520 distally on the shank 514 of the multiple jaws 510 to return the multiple tissue engaging ends 512 to a closed configuration (e.g., with the multiple distal ends 511 of the multiple jaws 510 positioned to engage or hold tissue therebetween), as shown in FIG. 1 or FIG. 16.

[0057] A variation of a tissue engaging member 500 as in FIGS. 14-17 is shown in FIG. 18. The modified tissue engaging member 500' of FIG. 18 has a modified biasing element 530' in which a spring opening 532' includes a cut or slit 535' along its distal end 531' to facilitate expansion of the spring opening 532' by extending the actuator 520 proximally into the spring opening 532' upon shifting the actuator 520 and shaft 524 proximally (toward the proximal end 503 and away from the distal end 501 of the tissue engaging member 500) along the longitudinal axis LA. It will be understood that the remaining elements of the tissue engaging member 500' shown in FIG. 18 are substantially the same as the similarly labeled elements of the tissue engaging member 500 shown in FIGS. 14-17, and reference is made to the above description of such elements that are applicable to the embodiment of FIG. 18.

[0058] With reference to FIG. 1 and FIGS. 19-20, the deployment of tissue engaging members formed according to various principles of the present disclosure will be described. In view of the above, it will be understood that any of the tissue engaging members 200, 300, 400, 500, 500' described above may be similarly deployed. In the example shown in FIG. 1, two or more tissue engaging members 100 may be similarly deployed with a tether 160 extending between the tissue engaging members 100. The tether 160 may be a tissue traction element configured to apply a traction force to tissue T engaged by a first deployed tissue engaging member 100 (left side of FIG. 1) upon engaging a second deployed tissue engaging member 100 (right side of FIG. 2) with tissue spaced from the first engaged tissue engaging member 100. It will be understood that other uses and environments for tissue engaging members formed according to various principles of the present disclosure are within the scope and spirit of the present disclosure.

[0059] In accordance with aspects of the present disclosure, the tissue engagement system includes one or more tissue engaging members 100 and a tissue engaging member manipulator 170 configured to actuate at least one of the tissue engaging members 100, as shown in FIG. 1. The one or more tissue engaging members 100 may be optionally deployed to a deployment site together with the manipulator 170 (e.g., in the same delivery device). Optionally, the manipulator 170 is deployed using a manipulator deployment system 180 configured to deliver and manipulate the manipulator 170 to actuate the tissue engaging members 100. It will be understood that the term manipulate and its variants are used for convenience without any limitation and may be used interchangeably herein with the term manipulate, move, control, actuate, steer, navigate, and various variants thereof. For simplicity, the deployment system in which the tissue engaging members 100 and / or the manipulator 170 and the deployment system 180 are deployed is not shown. It should be understood that any known or previously known deployment system may be used, such as any of a variety of flexible tubular elements, typically with optical / visualization capabilities (e.g., an endoscope or other introducer), and the details of such systems are not important to the principles of the present disclosure. Multiple tissue engagement members 100 and manipulators 170 and deployment systems 180 may be navigated / deployed to the deployment site via separate systems (e.g., separate delivery systems) or separate multiple working channels within a common system. The present disclosure is not limited in this context.

[0060] As shown in FIG. 1 , the manipulator 170 extends outwardly from a distal end 181 of the manipulator deployment system 180 to engage the actuating element 122 of the tissue engaging member 100. An actuator engaging element 172 is provided along the distal end 171 of the manipulator 170 to operably engage the actuating element 122 such that shifting the manipulator 170 proximally pulls the actuating element 122 proximally, actuating the tissue engaging member 100 to open in the manner described above. In accordance with aspects of the present disclosure, the actuator engaging element 172 is configured to operably engage the actuating element 122 of the tissue engaging member 100 within a range of angular orientations relative to the actuating element 122. In other words, the configuration of the actuating element 122 and the actuator engaging element 172 allow a range of relative positions relative to one another such that they still allow for operable engagement therebetween. In some embodiments, the actuator engaging element 172 is in the form of a hook (e.g., formed along the distal end of a pull wire) that engages with the actuation element 122, such as by being inserted into an opening 125 in the actuation element 122. As can be understood by one of ordinary skill in the art, the hook (generally along the major surface on which the majority of the hook resides) need only be transverse (i.e., not parallel) to the actuation element 122 (generally the major surface on which the actuation element 122 resides, or at least the portion of the actuation element 122 that is grasped by the actuator engaging element 172 of the manipulator 170). Thus, a range of relative orientations of the actuator engaging element 172 and the actuation element 122 allow for operable engagement therebetween, allowing movement of the manipulator 170 to result in movement of the actuation element 122.More specifically, to enable the actuator engaging element to grip and remain engaged with the actuator element 122, the actuator engaging element 172 may be angled from an ideally aligned position in which the hook is substantially perpendicular to the actuator element 122 and the open side of the hook is oriented to hook over a portion of the actuator element 122, up to a few degrees less than 90° (as can generally be determined by the thickness of the actuator engaging element 172, such as about 5°), or up to a few degrees less than 270° (as can generally be determined by the thickness of the actuator engaging element 172, such as about 5°).

[0061] In the example embodiment of the deployment system 180 shown in FIG. 1, the flexible extension element 174 of the manipulator 170 extends proximally along the flexible tubular element 182, for example, through a lumen 185 (shown partially in phantom) in the flexible tubular element 182, as controlled at the proximal end 183 of the deployment system 180 by a medical professional, for example, via a control handle 190. The flexible tubular element 182 may preferably be a catheter or other element having a lumen 185 therein that is capable of being navigated through a body passageway or lumen (e.g., through the gastrointestinal system) as known or heretofore known in the art. The flexible tubular element 182 may include a coil portion (having a lumen 185 extending therethrough) to facilitate transluminal navigation through tortuous paths as known in the art. The sheath 184 may extend the length of the flexible tubular element 182.

[0062] In the example embodiment of the control handle 190 shown in FIG. 1, a rotation knob 192 coupled to the flexible extension element 174 of the manipulator 170 may be used to rotate the actuator engagement element 172 of the manipulator 170 to position it relative to and operably engage the actuation element 122.

[0063] Once the actuator engagement element 172 and actuation element 122 are operatively engaged (as shown in FIG. 1 ), the manipulator 170 may be retracted proximally to retract the actuator 120 of the tissue engagement member 100 proximally. For example, the control handle 190 may include a translation knob 194 axially translatable (in a direction between the proximal end 183 and the distal end 181 of the deployment system 180) along the control handle 190 to move the manipulator 170 distally or proximally. In the embodiment shown in FIG. 19 (showing the tissue engagement system enlarged relative to the depictions of FIGS. 20 and 21 , but not showing the control handle 190), the tissue engagement member 100 is retracted proximally by the manipulator 170 to engage the proximal end 143 of the housing 140 of the tissue engagement member 100 with the distal portion 186 at the distal end 181 of the flexible tubular element 182. In some embodiments, the flexible tubular element 182 is flexible, such as formed from a coil element (as described above), and the distal portion 186 is less flexible than a proximal portion of the flexible tubular element 182. For example, the distal portion 186 may be a tubular element, such as a bushing, that does not have the spring resilience and potential axial mobility of the portion of the flexible tubular element 182 extending proximally therefrom. As can be seen with reference to FIG. 19 , the manipulator 170 may be retracted into the lumen 185 of the flexible tubular element 182 and the distal portion 186, but the tissue engagement member 100 does not enter the lumen 185. Instead, the distal end of the distal portion 186 provides a shoulder 188 against which the proximal end 143 of the housing 140 of the tissue engagement member 100 abuts when it is moved proximally toward the deployment system 180. Such a configuration allows for relative longitudinal movement of the manipulator 170 with respect to the housing 140 of the tissue engaging member 100 .

[0064] 20, the alignment sheath 184 can be extended distally (e.g., by axial shifting at its proximal end, either manually or via an associated controller, such as a control handle or control knob) over the housing 140 of the tissue engaging member 100 to hold the tissue engaging member 100 in place relative to the deployment system 180. With the housing 140 held against relative movement relative to the flexible tubular element 182, the manipulator 170 is retracted proximally relative to the flexible tubular element 182, allowing the manipulator 170 to pull the actuator 120 against the housing 140 of the tissue engaging member 100. The translation knob 194 can be moved proximally relative to the flexible tubular element 182 to move the flexible extension element 174 (shown in phantom extending through the flexible tubular element 182 and the sheath 184) proximally. The actuation element 122 and shaft 124 (which extends proximally from the actuator 120) are configured to extend beyond the flexible tubular element 182 to allow the actuator 120 to move proximally relative to the housing 140. Lumens 185. As discussed above, the actuator 120 is shifted proximally relative to the plurality of jaws 110 (which is pivotally coupled to the housing 140 and thus held therewith against proximal movement) to move the plurality of jaws 110 to the open configuration as shown in FIG. 21. Further details of the shifting of the actuator 120 which causes the cam followers 154 on the actuator 120 to move along the cam surfaces 152 on the shanks 114 of each of the plurality of jaws 110 to move the plurality of jaws 110 to the open configuration are referenced above, and associated reference numbers are provided in FIGS. 19-21 for reference with respect to the above description of the actuation of the plurality of jaws 110.

[0065] It will be understood that the various structures and features of the embodiments described herein and shown in the figures have several separate and independent inherent advantages. Thus, the various structures and features described herein need not all be present to achieve at least some of the desired properties and / or advantages described herein. Furthermore, the various features described herein may be used alone or in any combination. It will be understood that various features described with respect to one embodiment may be applied to another embodiment, whether or not explicitly indicated. Thus, it should be understood that one or more of the features described with reference to one embodiment can be combined with one or more of the features of any of the other embodiments described herein. That is, any of the features described herein can be mixed and matched to create hybrid designs, and such hybrid designs are within the scope of the present disclosure. Thus, the present invention is not limited to only the embodiments specifically described herein. The above descriptions are merely illustrative examples of embodiments and are not intended as limiting the broader aspects of the present disclosure.

[0066] The foregoing discussion has broad application and is presented for purposes of illustration and explanation, and is not intended to limit the present disclosure to one or more forms disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, ratios, and with other elements, materials, and components without departing from the concept, spirit, or scope or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the present disclosure may be combined in alternative aspects, embodiments, or configurations. Although the present disclosure is presented with respect to embodiments, it should be understood that various separate features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter or such individual features. Those skilled in the art will appreciate that the present disclosure may be used with many modifications or variations of the structure, arrangement, proportions, materials, components, and the like used in the implementation of the present disclosure that are specifically adapted to a particular environment and operational requirements without departing from the principles or spirit or scope of the present disclosure. For example, elements shown as integrally formed may be comprised of multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise altered, and sizes or dimensions of elements may be altered. Similarly, although operations or acts or steps are described in a particular order, this should not be construed as requiring such a particular order to achieve desired results, or that all operations or acts or steps should be performed. Additionally, other implementations are within the scope of the following claims. In some cases, the operations recited in the claims can be performed in a different order and still achieve desirable results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, and the scope of the claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or to the specific embodiments or configurations described or illustrated herein. In view of the foregoing, individual features of any embodiment may be used and may be claimed separately or in combination with the features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the foregoing description.

[0067] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the phrases "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. The terms "a," "an," "the," "first," "second," etc. do not exclude a plurality. For example, the term "a" or "an" entity as used herein indicates one or more of that entity. Thus, the terms "a" (or "an"), "one or more," and "at least one" can be used interchangeably herein. All directional references (e.g., proximal, distal, upper, lower, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, up, down, vertical, horizontal, radial, axial, clockwise, counterclockwise, etc.) are used for identification purposes only to aid in the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another, and do not limit the related elements with respect to position, orientation, or use, particularly in this disclosure. Connection references (e.g., attached, coupled, connected, and joined) should be interpreted broadly and may include intermediate members between and relative movement between elements of a collection of elements, unless otherwise indicated. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to one another. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0068] The following claims are incorporated by reference into this detailed description, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the term "comprises / comprising" does not exclude the presence of other elements or steps. In addition, although individual features may be included in different claims, they may in some cases be advantageously combined, and their inclusion in different claims does not imply that the combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be interpreted as limiting the scope of the claims in any way.

Claims

1. a pair of jaw members coupled together and movable between a closed configuration and an open configuration; an actuator operatively engaging the pair of jaw members to shift the jaw members between the closed and open configurations; a biasing element positioned to bias the plurality of jaw members toward the closed configuration; a cam mechanism operatively associated with at least one of the actuator, the biasing element, and at least one of the plurality of jaw members; Equipped with the jaw members are coupled together and biased away from one another; the actuator is shiftable to shift the plurality of jaw members from the closed configuration to the open configuration against a force of the biasing element; the actuator is movable between a position that retains the jaw members in the closed configuration and a position that allows the jaw members to move apart to the open configuration; The biasing element biases the actuator into a position that retains the plurality of jaw members in the closed configuration.

2. The tissue engaging member of claim 1 , wherein the biasing element is disposed about a portion of one of the actuator and at least one of the plurality of jaw members.

3. 2. The tissue engaging member of claim 1, wherein the cam mechanism comprises a cam surface on one of the actuator and at least one of the plurality of jaw members and a cam follower located on the other of the actuator and at least one of the plurality of jaw members.

4. The tissue engaging member of claim 1 , further comprising a housing, the plurality of jaw members and the actuator disposed within a portion of the housing.

5. The tissue engaging member of claim 4 , wherein the biasing element is operatively engaged with one of the actuator, the housing, and at least one of the plurality of jaw members to bias the plurality of jaw members into a closed configuration.

6. a pair of jaw members coupled together and movable between a closed configuration and an open configuration; an actuator operatively engaging the pair of jaw members to shift the jaw members between the closed and open configurations; a biasing element disposed over a portion of the actuator or at least one of the plurality of jaw members and biasing the plurality of jaw members into the closed configuration; Equipped with the jaw members are coupled together and biased away from one another; the actuator is shiftable to shift the plurality of jaw members from the closed configuration to the open configuration against a force of the biasing element; the actuator is movable between a position that retains the jaw members in the closed configuration and a position that allows the jaw members to move apart to the open configuration; The biasing element biases the actuator into a position that retains the plurality of jaw members in the closed configuration.

7. The tissue engaging member of claim 6 , wherein the biasing element is a resilient element disposed about the plurality of jaw members.

8. The tissue engaging member of claim 6 , wherein the biasing element is disposed about a portion of the actuator.

9. The tissue engaging member of claim 6 , further comprising a cam mechanism operatively associated with at least one of the actuator, the biasing element, and at least one of the plurality of jaw members.

10. 10. The tissue engaging member of claim 6, wherein the cam mechanism comprises a cam surface located on one of the actuator and at least one of the plurality of jaw members, and a cam follower located on the other of the actuator and at least one of the plurality of jaw members.

11. a tissue engaging member manipulator having a distal end configured to operatively engage the tissue engaging member and move the actuator to shift the plurality of jaws between the closed and open configurations; a manipulator deployment system configured to deliver and manipulate the tissue engaging member manipulator to move the actuator; 7. A tissue engaging system comprising the tissue engaging member of claim 6, further comprising:

12. an actuation element is operably coupled to a proximal end of the actuator along a proximal end of the tissue engaging member; The tissue engagement system of claim 11 , wherein an actuator engagement element is provided at a distal end of the tissue engagement member manipulator and is further configured to engage the actuation element at a range of orientations associated with the actuation element.

13. 13. The tissue engagement system of claim 11 or claim 12, wherein the manipulator deployment system comprises a flexible tubular element having a lumen defined therethrough and a sheath, the tissue engaging member manipulator being movable proximally into the lumen defined by the flexible tubular element to abut a proximal end of the tissue engaging member against a distal end of the flexible tubular element, and the sheath being movable over the distal end of the flexible tubular element and over the tissue engaging member to hold the tissue engaging member in alignment with the manipulator deployment system.

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