Patent Description:
A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages.

<CIT> discloses an applicator tool particularly designed to remove a medical article from a tray receiving a plurality of said medical articles.

<CIT> discloses a surgical instrument suitable for microinvasive surgery.

<CIT> discloses a clip operable between an open configuration and a closed configuration.

<CIT> discloses a laparoscopic surgical device comprising a pair of jaws which are cantilevered off a single pivot which is individually coupled to first and second arms via first and second pivot couplings respectively, and by compressing the two arms towards one another, the pivot couplings move towards one another to effect a scissors opening of the jaws.

The invention is defined by the independent claim, the dependent claims concerning preferred embodiments.

This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example tissue engagement device includes a first actuation member including a body coupled to a first jaw and a second jaw at a pivot point, wherein the body is designed to shift between a first configuration and a first compressed configuration and a second actuation member coupled to the first actuation member at the pivot point and at a fixation point, wherein the second actuation member is designed to shift between a second configuration and a second compressed configuration. Further, shifting the first actuation member from the first configuration to the first compressed configuration, shifting the second actuation member from the second configuration to the second compressed configuration, or both, shifts the first jaw and the second jaw between a closed configuration and an open configuration.

Alternatively or additionally to any of the embodiments above, wherein the second actuation member is positioned substantially perpendicular to the first actuation member.

Alternatively or additionally to any of the embodiments above, wherein body, the first jaw and the second jaw are formed from a monolithic member.

Alternatively or additionally to any of the embodiments above, wherein the body, the second actuation member or both the body and the second actuation member include an arcuate portion.

Alternatively or additionally to any of the embodiments above, wherein the body, the second actuation member or both the body and the second actuation member are substantially circular.

Alternatively or additionally to any of the embodiments above, wherein the body, the second actuation member or both the body and the second actuation member are substantially ovular.

Alternatively or additionally to any of the embodiments above, wherein shifting the first actuation member, the second actuation member or both the first and second actuation members rotates the first jaw and the second jaw around the pivot point.

Alternatively or additionally to any of the embodiments above, further comprising a compression membrane positioned around at least a portion of the body, the second actuation member or both the body and the second actuation member.

Alternatively or additionally to any of the embodiments above, wherein the first jaw and the second jaw are biased in the closed configuration.

Another tissue engagement device includes:.

Alternatively or additionally to any of the embodiments above, wherein the second plane is positioned substantially perpendicular to the first plane.

Alternatively or additionally to any of the embodiments above, wherein first actuation member, the first jaw and the second jaw are formed from a monolithic member.

Alternatively or additionally to any of the embodiments above, wherein the first actuation member, the second actuation member or both the first and the second actuation members include an arcuate portion.

Alternatively or additionally to any of the embodiments above, wherein the first actuation member, the second actuation member or both the first and the second actuation members are substantially circular.

Alternatively or additionally to any of the embodiments above, wherein the first actuation member, the second actuation member or both the first and the second actuation members are substantially ovular.

Alternatively or additionally to any of the embodiments above, wherein actuation of the first actuation member, the second actuation member or both the first and second actuation members rotates the first jaw and the second jaw around the pivot point.

Alternatively or additionally to any of the embodiments above, further comprising a compression membrane positioned around at least a portion of the first actuation member, the second actuation member or both the first and the second actuation member.

Another tissue engagement member includes:.

Alternatively or additionally to any of the embodiments above, wherein the first actuation member, the second actuation member or both the first and the second actuation members includes an arcuate portion.

On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.

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

A number of medical procedures, including intravascular procedures, procedures along the digestive and/or biliary tract, thoracic procedures, etc. utilize medical devices to access tissue intended for removal (e.g., "target tissue") within the body. For example, in some current medical procedures (e.g., Endoscopic Submucosal Dissection (ESD), Peroral Endoscopic Myotomy (POEM), cholecystectomy, Video-Assisted Thoracoscopic Surgery (VATS)), physicians may utilize an endoscope or similar medical device to access and remove cancerous lesions. Further, as part of the procedure, the physician may utilize an endoscope capable of both accessing the target tissue site while also permitting a cutting device to be deployed therethrough to excise the target tissue. Additionally, in some instances, the endoscope may incorporate features which assist the physician in visualizing and performing the tissue dissection procedure. For example, some endoscopes may include a light and/or camera designed to illuminate the body lumen as the scope is navigated and positioned adjacent to the target tissue site. Additionally, some endoscopes may also include a lumen (e.g., a working channel) through which a cutting member or other accessory medical devices may be deployed and utilized.

While physicians are becoming more proficient at extracting cancerous lesions from within the body (e.g., within the digestive tract, abdominal cavity, thoracic cavity, etc.), the extraction methods continue to be inefficient and time-consuming. For example, in some instances poor visualization of the tissue dissection process may result in a prolonged tissue dissection procedure. In another example, the actual tissue that the physician is attempting to dissect may, itself, obstruct the pathway of the tools which the physician is using during the procedure. Therefore, in some instances it may be desirable to utilize a medical device which assists in improving the visualization of the target tissue while also mitigating the obstruction of dissection tools the physician is utilizing. Therefore, in some instances it may be desirable to utilize a tissue retraction device which lifts and retracts the region of tissue to be dissected by the physician. Disclosed herein are medical devices such as tissue retraction devices, tissue engagement devices and delivery systems that are designed to lift and retract the target tissue.

<FIG> is a plan view of an example tissue retraction device <NUM>. The tissue retraction device <NUM> may include a first engagement member 12a coupled to a second engagement member 12b. Each of the engagement members 12a and 12b may be referred to as a clip, clasp, fastener, clamp, etc. For simplicity purposes, the following description will describe the engagement member 12a, however, it can be appreciated that the engagement member 12b may include all of the features and functionality described with respect to engagement member 12a.

Additionally, <FIG> illustrates that the first engagement member 12a may be coupled to the second engagement member 12b by a tether member <NUM>. The tether member <NUM> may include a first end and a second end, wherein each of the first end and the second end is coupled to the engagement members 12a, 12b via a coupling member <NUM>. The tether <NUM> may be referred to as a band, rope, cord, leash, strap, strand, etc. The tether <NUM> may include a variety of cross-sectional geometries. For example, the tether <NUM> may be circular, rectangular, triangular, or the like. Further, the tether <NUM> may be bioabsorbable. Further, the tether <NUM> may be constructed from an elastomeric material such as latex, Nitrile® rubber, ethylene propylene diene rubber, silicone rubber, chloroprene, polychloroprene (e.g., Neoprene®), polyolefin, thermoplastic elastomer, polyisoprene, etc. The tether <NUM> may elongate from a first, unelongated (e.g., relaxed) position to a second, elongated position. It can be appreciated that when the tissue retraction device <NUM> is in an elongated position, the tissue retraction device <NUM> is in tension, and therefore, includes a retraction force which is pulling the first engagement member 12a toward the second engagement member 12b.

<FIG> illustrates a perspective view of the first engagement member 12a. The engagement member 12a may include a body portion <NUM>. The body portion <NUM> may be coupled to a first jaw <NUM> and a second jaw <NUM> at a pivot point <NUM>. The combination of the body <NUM>, the first jaw <NUM> and the second jaw <NUM> may be referred to as a first actuation member <NUM> herein. Each of the first jaw <NUM> and the second jaw <NUM> may include a curved region <NUM>. The curved regions <NUM> may be utilized to grasp and/or engage tissue adjacent to a target tissue site. In some examples, the curved regions <NUM> may be described as a "tooth. " Further, while <FIG> illustrates that the curved regions <NUM> may include a single, flat-faced tooth member, this is not intended to be limiting. Rather, the curved regions <NUM> may include one or more teeth. While not shown in <FIG>, it is contemplated that the teeth may be spaced from one another and/or interdigitate with one another. A variety of different combinations and orientations of teeth are contemplated.

<FIG> illustrates that the body portion <NUM> may be positioned between the first jaw <NUM> and the second jaw <NUM>. The body portion <NUM> may include an arcuate portion. In some instances, the body portion <NUM> may include a curve, loop, arc, etc. For example, the body portion <NUM> may be substantially circular-shaped. However, this is not intended to be limiting. Rather, it can be appreciated that the body <NUM> may include many different shapes. For example, the body <NUM> may be rectangular, ovular, square, hexagonal, polygonal, etc..

Additionally, as discussed above, the body portion <NUM> may include a first end region <NUM> from which the first jaw <NUM> extends away therefrom and a second end region <NUM> from which the second jaw <NUM> extends away therefrom. In some examples, the body <NUM>, the first jaw <NUM> and the second jaw <NUM> may be formed as a monolithic structure. In other words, the body <NUM>, the first jaw <NUM> and the second jaw <NUM> may be formed as a single, continuous piece of material. However, in other examples, the first jaw <NUM> and/or the second jaw <NUM> may be separate components from the body <NUM>, whereby each of the first jaw <NUM> and the second jaw <NUM> may be separately attached to the first end region <NUM> and the second end region <NUM> of the body <NUM>, respectively.

<FIG> further illustrates that the first engagement member 12a may include a pivot point <NUM> which may include a first attachment portion 24a positioned adjacent to a second attachment portion 24b (the attachment portion 24b is more clearly shown in <FIG>). In some examples, the geometry and/or shape of the first attachment portion 24a may mirror the geometry and/or shape of the second attachment portion 24b. Further, in some examples, the first attachment member 24a may extend away from the first end region <NUM> of the body while the second end region <NUM> may extend away from the second end region <NUM> of the body <NUM>.

Each of the first attachment member 24a may include a first aperture 26a while the second attachment member 24b may include a second aperture 26b (not shown in <FIG>, but shown in <FIG>). Each of the first aperture 26a and the second aperture 26b may extend through the wall thickness of each of the first attachment member 24a and the second attachment member 24b.

Additionally, <FIG> illustrates that the first engagement member 12a may include a second actuation member <NUM>. In some examples, the second actuation member may be coupled to the body <NUM> of the first actuation member <NUM> at the pivot point <NUM>. For example, <FIG> illustrates that the second actuation member <NUM> may include a projection <NUM> which includes a third aperture (not shown in <FIG>, but more clearly shown in <FIG>) which may be positioned adjacent to the first attachment portion 24a and the second attachment portion 24b. Further, <FIG> illustrates that the first attachment member 24a, the second attachment member 24b and the second actuation member <NUM> (via the projection <NUM>) may be coupled to one another via a first pin <NUM>. In other words, the first attachment member 24a, the second attachment member 24b and the second actuation member <NUM> may be aligned such that the pin <NUM> may extend through the first aperture 26a of the first attachment portion 24a, the second aperture 26b of the second attachment portion 24b and the third aperture of the second actuation member <NUM>.

However, in other examples, the first attachment member 24a, the second attachment member 24b and the second actuation member <NUM> (via the projection <NUM>) may be coupled to one another via other design configurations. Further, other design configurations may be utilized in place of the pin <NUM>. For example, design configurations including living hinges, interfering elements, trapped linkages and/or a pivot ball may be utilized.

Additionally, <FIG> illustrates that the second actuation member <NUM> may be coupled to the body <NUM> of the first actuation member <NUM> at a connection point <NUM>. For example, <FIG> illustrates that the second actuation member <NUM> may be coupled to the body <NUM> of the first actuation member <NUM> via a pin <NUM>. However, while <FIG> illustrates that the second actuation member <NUM> may be coupled to the body <NUM> of the first actuation member <NUM> via a pin <NUM>, this is not intended to be limiting. Rather, it is contemplated that a variety of attachment technique may be utilized to couple the second actuation member <NUM> to the body <NUM> of the first actuation member <NUM>. For example, it is contemplated that the second actuation member <NUM> may be welded, glued, etc. to the body <NUM> of the first actuation member <NUM>.

Additionally, it can be appreciated that the engagement member 12a may be designed such that the first actuation member <NUM> and/or the second engagement member <NUM> bias the first jaw <NUM> and the second jaw <NUM> in a closed position (e.g., a position in which the first jaw <NUM> and the second jaw <NUM> contact one another). For example, the ends of the first jaw <NUM> and the second jaw <NUM> may contact one another while in a closed position. Positioning the first jaw <NUM> and the second jaw <NUM> together while in a closed position may permit a preload force to be generated when in the closed position.

<FIG> illustrates a side view of the first engagement member 12a. As described above, <FIG> illustrates a pair of jaws (e.g., the first jaw <NUM> facing the second jaw <NUM>) extending away from the body portion <NUM> of the first actuation member <NUM>. <FIG> further illustrates the curved portion <NUM> of each of the first jaw <NUM> and the second jaw <NUM> curving inward toward one another. Additionally, <FIG> illustrates the first attachment portion 24a extending away from the first end region <NUM> of the body <NUM>. As discussed above, <FIG> illustrates that pin member <NUM> positioned within the first aperture 26a of the first attachment portion 24a. <FIG> further illustrates the second actuation member <NUM> coupled to the body <NUM> at the connection point <NUM> via the pin member <NUM>. It can be appreciated from <FIG> that, in some examples, the second actuation member <NUM> may be positioned substantially perpendicular to the body <NUM> of the first actuation member <NUM>.

In some instances it may be desirable to design the body <NUM> of the first actuation member <NUM> to include a specific aspect ratio. As described herein, the aspect ratio of the body <NUM> may be defined as the ratio of its length (approximately the distance from pin member <NUM> to the pin member <NUM>) to its "width" (approximately the width of the body <NUM> which is substantially perpendicular to a longitudinal line extending between the pin member <NUM> and the pin member <NUM>). In some examples, the aspect ratio of the body <NUM> should be at least <NUM>:<NUM> (e.g., the distance between the pin member <NUM> and the pin member <NUM> should be <NUM> times the "width" of the body <NUM>, as discussed above). Further, in some examples, the aspect ratio should be larger than <NUM>:<NUM>.

<FIG> illustrates another side view of the first engagement member 12a. It can be appreciated that the side view shown in <FIG> may be opposite to, and mirror, the side view illustrated in <FIG>. Therefore, like <FIG>, <FIG> illustrates the first jaw <NUM> facing the second jaw <NUM>, whereby the first jaw <NUM> and the second jaw <NUM> extend away from the body portion <NUM> of the first actuation member <NUM>. <FIG> further illustrates the curved portion <NUM> of each of the first jaw <NUM> and the second jaw <NUM> curving inward toward one another. Additionally, <FIG> illustrates the second attachment portion 24b extending away from the second end region <NUM> of the body <NUM>. As discussed above, <FIG> illustrates that pin member <NUM> positioned within the second aperture 26b of the second attachment portion 24b. <FIG> further illustrates the second actuation member <NUM> coupled to the body <NUM> at the connection point <NUM> via the pin member <NUM>. It can be appreciated from <FIG> that, in some examples, the second actuation member <NUM> may be positioned substantially perpendicular to the body <NUM> of the first actuation member <NUM>.

<FIG> illustrates an exploded view of the tissue engagement member 12a, including the first actuation member <NUM> and the second actuation member <NUM>. As described above, the first actuation member <NUM> including the body portion <NUM>, first jaw <NUM> and the second jaw <NUM>. Further, <FIG> more clearly illustrates the first aperture 26a extending through the first attachment member 24a. Additionally, <FIG> illustrates a fourth aperture <NUM> through which the pin <NUM> (described above) may extend. It can further be appreciated from <FIG> that the body <NUM>, the first jaw <NUM> and the second jaw <NUM> may lie within a single plane.

Additionally, <FIG> illustrates the second actuation member <NUM> including a projection <NUM> extending away therefrom. <FIG> further illustrates the third aperture <NUM> extending through the wall thickness of the projection <NUM>. Further, <FIG> shows that that the second actuation member <NUM> may include a fifth aperture <NUM> through which the pin <NUM> may extend. As described above, the fourth aperture <NUM> of the body <NUM> may be aligned with the fifth aperture <NUM>, thereby permitting the pin <NUM> to extend therethrough and couple the body <NUM> of the first actuation member <NUM> to the second actuation member <NUM>.

It can further be appreciated from <FIG> that the second actuation member <NUM> may lie within a single plane which is offset from the plane in which the first actuation member <NUM> lies within. As discussed above, in some examples, the plane in which the first actuation member <NUM> lies may be substantially perpendicular to the plane in which the second actuation member lies. However, this is not intended to be limiting. Rather, it is contemplated that the plane in which the first actuation member <NUM> lies may be substantially offset to the plane in which the second actuation member lies.

As discussed above, <FIG> illustrates the pin member <NUM> which may be utilized to couple the first attachment portion 24a, the second attachment portion 24b and the projection <NUM> of the second actuation member <NUM>. As will be discussed in greater detail below, the cylindrical design of the pin <NUM> may permit the first attachment portion 24a, the second attachment portion 24b and/or the second actuation member <NUM> to rotate therearound.

<FIG> and <FIG> illustrate that the engagement member 12b may be designed such that actuation of the first actuation member <NUM>, the second actuation member <NUM> or both the first actuation member <NUM> and the second actuation member <NUM> may shift the first jaw <NUM> and the second jaw <NUM> relative to one another. For example, the engagement member 12a may be designed such that a clinician may utilize a manipulator (not shown) to grasp and squeeze the first actuation member <NUM>, the second actuation member <NUM> or both the first actuation member <NUM> which may shift the first jaw <NUM> relative to the second jaw <NUM>.

For example, <FIG> shows the first jaw <NUM> and the second jaw <NUM> of the tissue retraction device 12a opened to an expanded configuration. Further, <FIG> illustrates that the first jaw <NUM> and the second jaw <NUM> may open to an expanded configuration when the body <NUM> of the first actuation member <NUM> is actuated (e.g. compressed, squeezed, etc.). The arrows <NUM> shown in <FIG> depict the actuation (e.g., compression) of the body <NUM> of the first actuation member <NUM>. Further, it can be appreciated from <FIG> that as the body <NUM> is actuated (e.g., compressed) it may deform from a first configuration (e.g., the substantially circular configuration shown in <FIG>) to a second configuration (e.g., the substantially ovular configuration shown in <FIG>). As described above, other configurations are contemplated. It can further be appreciated that release of the compressive force applied to the body <NUM> of the first actuation member <NUM> may allow the first jaw <NUM> and the second jaw <NUM> to close and return to the configuration described above with respect to <FIG>.

<FIG> illustrates that as the body <NUM> of the first actuation member <NUM> is compressed, the body <NUM> may lengthen. It can be appreciated that the lengthening of the body <NUM> may cause the first attachment portion 24a and the second attachment portion 24b to rotate (e.g., pivot) around the pin member <NUM>. It can be further appreciated that the rotation of the first attachment portion 24a and the second attachment portion 24b around the pin member <NUM> may result in the first jaw <NUM> shifting relative to the second jaw <NUM> (lengthening of the body <NUM> may result in the jaws shifting from a closed configuration to an open configuration).

Similar to <FIG>, <FIG> shows the first jaw <NUM> and the second jaw <NUM> of the tissue retraction device 12a opened to an expanded configuration. Further, <FIG> illustrates that the first jaw <NUM> and the second jaw <NUM> may open to an expanded configuration when the second actuation member <NUM> is actuated (e.g. compressed, squeezed, etc.). The arrows <NUM> shown in <FIG> depict the actuation (e.g., compression) of the second actuation member <NUM>. Further, it can be appreciated from <FIG> that as the actuation member <NUM> is actuated (e.g., compressed) it may deform from a first configuration (e.g., the substantially circular configuration shown in <FIG>) to a second configuration (e.g., the substantially ovular configuration shown in <FIG>). As described above, other configurations are contemplated. It can further be appreciated that release of the compressive force applied to the second actuation member <NUM> may allow the first jaw <NUM> and the second jaw <NUM> to close and return to the configuration described above with respect to <FIG>.

<FIG> illustrates that as the second actuation member <NUM> is compressed, it may lengthen. It can be appreciated that the lengthening of the second actuation member <NUM> may correspondingly lengthen the body <NUM> of the first actuation member <NUM> (as the second actuation member <NUM> is coupled to the first actuation member <NUM> at both the pivot point <NUM> and the connection point <NUM>), and therefore, may cause the first attachment portion 24a and the second attachment portion 24b to rotate (e.g., pivot) around the pin member <NUM>, as described above. It can be further appreciated that the rotation of the first attachment portion 24a and the second attachment portion 24b around the pin member <NUM> may result in the first jaw <NUM> shifting relative to the second jaw <NUM> (lengthening of the body <NUM> may result in the jaws shifting from a closed configuration to an open configuration).

Additionally, it can be appreciated from the above discussion that actuation of both the first actuation member <NUM> and the second actuation member <NUM> may lengthen the body <NUM>, thereby causing the jaws to shift from a closed configuration to an open configuration. This feature is important as it may permit a clinician to grasp the engagement member 12a from a variety of different angles, all of which may permit the jaws to open. Further, the ability to grasp the engagement member 12a from a variety of different angles may reduce the time a clinician may spend having to shift the tissue retraction device <NUM> to a specific orientation in order to grasp it at a specific angle.

To that end, <FIG> illustrates that in some examples, a portion of the engagement member 12a may include an actuation membrane (depicted by the dashed lines <NUM>). As illustrated in <FIG>, the membrane <NUM> may extend around a portion of the body <NUM> and/or the second actuation member <NUM>. For example, the membrane <NUM> may extending around the body <NUM> and the second actuation member <NUM> while not covering the first jaw <NUM> and the second jaw <NUM>. It can be appreciated that the membrane <NUM> may aid the actuation of the first actuation member <NUM>, the second actuation member <NUM> or both. For example, the membrane <NUM> may be secured to the first actuation member <NUM>, the second actuation member <NUM> or both the first actuation member <NUM> and the second actuation member <NUM> such that compressing/squeezing the membrane <NUM> may actuate the first actuation member <NUM>, the second actuation member <NUM> or both the first actuation member <NUM> and open the jaw members.

<FIG> illustrates another example tissue engagement device <NUM>. The tissue engagement device <NUM> may be similar in form and function to the tissue engagement device 12a described above. For example, the tissue engagement device <NUM> may include a first jaw <NUM> and a second jaw <NUM> coupled to one or more actuation members at a pivot location <NUM>. In some instances (such as the example shown in <FIG>), each of the first jaw <NUM> and the second jaw <NUM> may be directly attached to a first actuation member <NUM> and a second actuation member <NUM>, respectively. Further, <FIG> illustrates that in some examples the first jaw <NUM> may be formed as a monolithic structure with the first actuation member <NUM>. Similarly, <FIG> illustrates that in some examples the second jaw <NUM> may be formed as a monolithic structure with the second actuation member <NUM>. <FIG> further illustrates that the each of the first actuation member <NUM> and the second actuation member <NUM> transitions to the first jaw <NUM> and the second jaw <NUM>, respectively, at a first rotation point <NUM> and a second rotation point <NUM> formed within a framework <NUM>.

Additionally, <FIG> illustrates that the engagement member <NUM> may include a third actuation member <NUM> and a fourth actuation member <NUM>. As illustrated in <FIG>, one end of each of the third actuation member <NUM> and the fourth actuation member <NUM> may be coupled to the framework <NUM> at a third rotation point <NUM> and a fourth rotation point <NUM>, respectively. As will be described in greater detail below, the framework <NUM> may be designed to permit rotation of each end of the third actuation member <NUM> and the fourth actuation member <NUM> coupled to the framework <NUM>. Additionally, <FIG> illustrates that an end of each of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and the fourth actuation member <NUM> may be coupled to another at a connection point <NUM>. Similarly to that described above with respect to <FIG>, a variety of designs, arrangements, structures, etc. may be utilized to couple the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and the fourth actuation member <NUM> with one another at the connection point <NUM>.

<FIG> illustrates a perspective view of the framework <NUM> including the first rotation point <NUM>, the second rotation point <NUM>, the third rotation point <NUM> and the fourth rotation point <NUM>. Further, <FIG> illustrates that the first rotation point <NUM> may include the combined structure of the first actuation member <NUM> and the first jaw <NUM>, whereby that combined structure is coupled to the framework <NUM> via a pin connection <NUM>. Similarly, <FIG> illustrates that the second rotation point <NUM> may include the combined structure of the second actuation member <NUM> and the second jaw <NUM>, whereby that combined structure is coupled to the framework <NUM> via a pin connection <NUM>. Further, <FIG> illustrates that the third actuation member <NUM> may be coupled to the framework via a pin connection <NUM> and the fourth actuation member <NUM> may be coupled to the framework via a pin connection <NUM>. It can be appreciated that each of these pin connections <NUM>, <NUM>, <NUM>, <NUM> may permit a structure attached thereto to rotate. For example, pin connection <NUM> may permit rotation of an end region of both the first actuation member <NUM> and the first jaw <NUM>. Similarly, the pin connection <NUM> may permit rotation of an end region of both the second actuation member <NUM> and the second jaw <NUM>. Likewise, the pin connection <NUM> may permit rotation of the end region of the third actuation member <NUM> while the pin connection <NUM> may permit rotation of the end region of the fourth actuation member <NUM>.

Similar to that described above, it can be appreciated that the combined actuation of any combination of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and/or the fourth actuation member <NUM> may lengthen (e.g., elongate) one or more of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and/or the fourth actuation member <NUM>. In other words, actuation of any combination of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and/or the fourth actuation member <NUM> may lengthen the distance between the pivot point <NUM> and the connection point <NUM> (shown in <FIG>). Further, this lengthening may cause rotation of the end regions of one or more of the first actuation member <NUM> and/or the second actuation member <NUM> at the first pin connection <NUM> and/or at the pin connection <NUM>, respectively. It can be appreciated that rotation of the first actuation member <NUM> and/or the second actuation member <NUM> may cause rotation of the first jaw <NUM> and/or the second jaw <NUM>. The rotation of the first jaw <NUM> and the second jaw <NUM> may correspond to a shifting of the jaws from closed configuration to an open configuration (and from an open configuration to a closed configuration as the actuation force is removed).

Additionally, <FIG> illustrates that the engagement member <NUM> may include a third actuation member <NUM> and a fourth actuation member <NUM>. As illustrated in <FIG>, one end region of each of the third actuation member <NUM> and the fourth actuation member <NUM> may be coupled to the framework <NUM> at a third rotation point <NUM> and a fourth rotation point <NUM>, respectively. As will be described in greater detail below, the framework <NUM> may be designed to permit rotation of each end of the third actuation member <NUM> and the fourth actuation member <NUM> coupled to the framework <NUM>. Additionally, <FIG> illustrates that an end of each of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and the fourth actuation member <NUM> may be coupled to another at a connection point <NUM>. Similarly to that described above with respect to <FIG>, a variety of designs, arrangements, structures, etc. may be utilized to couple the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and the fourth actuation member <NUM> with one another at the connection point <NUM>.

Further, <FIG> illustrates that the first rotation point <NUM> may include the combined structure of the first actuation member <NUM> and the first jaw <NUM>, whereby that combined structure is coupled to the framework <NUM>. Similarly, <FIG> illustrates that the second rotation point <NUM> may include the combined structure of the second actuation member <NUM> and the second jaw <NUM>, whereby that combined structure is coupled to the framework <NUM>.

Similar to that described above, it can be appreciated that the combined actuation of any combination of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and/or the fourth actuation member <NUM> may lengthen (e.g., elongate) one or more of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and/or the fourth actuation member <NUM>. In other words, actuation of any combination of the first actuation member <NUM>, the second actuation member <NUM>, the third actuation member <NUM> and/or the fourth actuation member <NUM> may lengthen the distance between the pivot location <NUM> and the connection point <NUM>. Further, this lengthening may cause rotation of the end regions of one or more of the first actuation member <NUM> and/or the second actuation member <NUM> at the first pin connection <NUM> and/or the second actuation member <NUM>, respectively. It can be appreciated that rotation of the first actuation member <NUM> and/or the second actuation member <NUM> may cause rotation of the first jaw <NUM> and/or the second jaw <NUM>. The rotation of the first jaw <NUM> and the second jaw <NUM> may correspond to a shifting of the jaws from closed configuration to an open configuration (and from an open configuration to a closed configuration as the actuation force is removed).

It should be noted that the features of any of the tissue retraction systems, tissue engagement members or components thereof described with respect to particular figures and/or embodiments are not limited to that particular example. Rather, it is contemplated that all of the features or examples disclosed with respect to a single example may be incorporated into any other example disclosed herein.

The materials that can be used for the various components of tissue retraction system <NUM> and the various devices disclosed herein may include those commonly associated with medical devices. For simplicity purposes, to the extent the following discussion makes reference to tissue retraction system <NUM>, it is not intended to limit the devices and methods described herein only to tissue retraction system <NUM>, as the discussion may be applied to other similar devices disclosed herein.

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

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

In at least some embodiments, portions or all of tissue retraction system <NUM> and/or other components of tissue retraction system <NUM> may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of tissue retraction system <NUM> and/or other components of tissue retraction system <NUM> in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of tissue retraction system <NUM> and/or other components of tissue retraction system <NUM> to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into tissue retraction system <NUM> and/or other components of tissue retraction system <NUM>. For example, tissue retraction system <NUM> and/or other components of tissue retraction system <NUM>, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Tissue retraction system <NUM> and/or other components of tissue retraction system <NUM>, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.

Claim 1:
A tissue engagement device, comprising:
a first actuation member (<NUM>) including a body (<NUM>), a first jaw (<NUM>) and a second jaw (<NUM>), the body being coupled to the first jaw and the second jaw at a pivot point, wherein the body is designed to shift between a first configuration and a first compressed configuration; and
a second actuation member (<NUM>) coupled to the first actuation member at the pivot point and at a fixation point, wherein the second actuation member is designed to shift between a second configuration and a second compressed configuration;
wherein shifting the body from the first configuration to the first compressed configuration or shifting the second actuation member from the second configuration to the second compressed configuration shifts the first jaw and the second jaw between a closed configuration and an open configuration,
wherein the body (<NUM>), the first jaw (<NUM>) and the second jaw (<NUM>) lie within a first plane, and the second actuation member (<NUM>) lies within a second plane offset from the first plane.