Tissue engagement device

Abstract

Medical devices and methods of using medical devices are provided.SOLUTION: The tissue engagement device includes a first drive member including a body portion coupled to the first jaw and the second jaw at a pivot point, wherein the body portion is moved between a first position and a first compressed position, and a second drive member coupled to the first drive member at a pivot point and a fixed point, wherein the second drive member is moved between a second position and a second compressed position. Further, moving the first drive member from the first position to the first compressed position and / or moving the second drive member from the second position to the second compressed position moves the first jaw and the second jaw between the closed position and the open position.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to medical devices and methods for manufacturing medical devices. More particularly, the present invention relates to tissue manipulation devices. [Background technology]

[0002] A wide variety of intracorporeal medical devices have been developed for medical applications, such as intravascular applications. These devices include guidewires, catheters, and the like. These devices are manufactured by a variety of different manufacturing methods and are used according to a variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. Summary of the Invention

[0003] The present disclosure provides medical device designs, materials, manufacturing methods, and alternative uses. An exemplary tissue engagement device includes a first drive member including a body portion coupled to first and second jaws at a pivot point, the body portion configured to move between a first position and a first compressed position, and a second drive member coupled to the first drive member at the pivot point and a fixed point, the second drive member configured to move between a second position and a second compressed position. Further, moving the first drive member from the first position to the first compressed position, moving the second drive member from the second position to the second compressed position, or both, moves the first and second jaws between a closed position and an open position.

[0004] Alternatively or additionally to any one of the above embodiments, the second drive member is arranged substantially perpendicular to the first drive member. Alternatively or additionally to any one of the above embodiments, the body portion, the first jaw and the second jaw are formed of a unitary member.

[0005] Alternatively or additionally to any one of the above embodiments, at least one of the body portion and the second drive member includes an arcuate portion. Alternatively or additionally to any one of the above embodiments, at least one of the body portion and the second drive member is generally circular.

[0006] Alternatively or additionally to any one of the above embodiments, at least one of the body portion and the second drive member is generally oval-shaped. Alternatively or additionally to any one of the above embodiments, movement of at least one of the first drive member and the second drive member rotates the first jaw and the second jaw about a pivot point.

[0007] Alternatively or additionally to any one of the above embodiments, further comprising a compression membrane disposed around at least a portion of at least one of the body portion and the second drive member. Alternatively or additionally to any one of the above embodiments, the first jaw and the second jaw are biased in a closed position.

[0008] Another tissue engagement device includes a first drive member including a first end having a first jaw, a second end having a second jaw, and a loop region located between the first and second jaws, wherein the first jaw, the second jaw, and the loop region lie in a first plane; and a second drive member pinned to the first drive member at a pivot point and a fixed point, the second drive member lying in a second plane offset from the first plane, wherein actuation of at least one of the first drive member and the second drive member moves the first and second jaws between a closed position and an open position.

[0009] Alternatively or additionally to any one of the above embodiments, the second plane is disposed substantially orthogonal to the first plane. Alternatively or additionally to any one of the above embodiments, the first drive member, the first jaw and the second jaw are formed of a unitary member.

[0010] Alternatively or additionally to any one of the above embodiments, at least one of the first drive member and the second drive member includes an arcuate portion. Alternatively or additionally to any one of the above embodiments, at least one of the first drive member and the second drive member is substantially circular.

[0011] Alternatively or additionally to any one of the above embodiments, at least one of the first drive member and the second drive member is generally oval-shaped. Alternatively or additionally to any one of the above embodiments, driving at least one of the first drive member and the second drive member rotates the first jaw and the second jaw about a pivot point.

[0012] Alternatively or additionally to any one of the above embodiments, further comprising a compressible membrane disposed around at least a portion of at least one of the first drive member and the second drive member. Alternatively or additionally to any one of the above embodiments, the first jaw and the second jaw are biased in a closed position.

[0013] Another tissue engaging member is a drive assembly coupled to a pair of jaws, the pair of jaws extending away from the drive assembly, the drive assembly including a first drive member coupled to a second drive member at a first connection point, the first drive member lying in a first plane and the second drive member lying in a second plane offset from the first plane, and actuation of the drive assembly moves the pair of jaws between the first position and the second open position.

[0014] Alternatively or additionally to any one of the above embodiments, at least one of the first drive member and the second drive member includes an arcuate portion. The above summary of some embodiments is not intended to describe each embodiment or every implementation of the present invention. The figures and detailed description that follow more particularly exemplify these embodiments.

[0015] The present disclosure can be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which: [Brief explanation of the drawings]

[0016] [Figure 1] 1 is a perspective view of an exemplary tissue retraction device. [Figure 2] FIG. 1 is a perspective view illustrating an exemplary tissue engagement device. [Figure 3] FIG. 2 is a side view of the tissue engagement device shown in FIG. 1. [Figure 4] FIG. 2 is a side view of the tissue engagement device shown in FIG. 1. [Figure 5] FIG. 2 is a perspective view of the exemplary tissue engagement device shown in FIG. 1. [Figure 6] FIG. 2 is a perspective view of the exemplary tissue engagement device shown in FIG. 1. [Figure 7] FIG. 2 is an exploded view of the exemplary tissue engagement device shown in FIG. 1. [Figure 8] FIG. 10 is a perspective view of another example tissue engaging device. [Figure 9] FIG. 12 is a perspective view of another tissue engagement device. [Figure 10] FIG. 10 is a perspective view of the tissue engagement device shown in FIG. 9. [Figure 11] FIG. 10 is a perspective view of another example tissue engaging device. DETAILED DESCRIPTION OF THE INVENTION

[0017] While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and described in detail. It is to be understood, however, that the intention is not to limit the invention to the particular embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

[0018] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​herein, whether expressly stated or not, are assumed to be modified by the term "about." The term "about" generally refers to a range of numerical values ​​that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" will include numerical values ​​that are rounded to the nearest significant figure.

[0019] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise.

[0020] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment includes one or more particular elements, structures, and / or characteristics. However, such listing does not necessarily mean that all embodiments include the particular elements, structures, and / or characteristics. Furthermore, if a particular element, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such element, structure, and / or characteristic may also be used in connection with other embodiments, whether explicitly stated or not, unless expressly stated to the contrary.

[0021] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0022] In many medical procedures, including endovascular procedures, procedures along the gastrointestinal and / or biliary tract, thoracic procedures, etc., medical devices are used to access tissue within the body to be removed (e.g., "target tissue"). For example, in current medical procedures (e.g., endoscopic submucosal dissection (ESD), peroral endoscopic myectomy (POEM), cholecystectomy, video-assisted thoracoscopic surgery (VATS)), physicians use endoscopes or similar medical devices to access and remove cancerous lesions. Furthermore, as part of the procedure, physicians use endoscopes that can access the target tissue site and deploy a resection device therethrough to resect the target tissue. In addition, in some instances, endoscopes incorporate elements to assist the physician in visualizing and performing the tissue resection procedure. For example, some endoscopes include lights and / or cameras configured to illuminate the body lumen when the scope is advanced and positioned adjacent to the target tissue site. Furthermore, some endoscopes include a lumen (e.g., a working channel) through which a cutting member or other accessory medical device can be deployed and used.

[0023] Although physicians have become more adept at removing cancerous lesions from within the body (e.g., the gastrointestinal tract, abdominal cavity, thoracic cavity, etc.), removal methods remain inefficient and time-consuming. For example, in some cases, poor visualization of the tissue resection procedure results in lengthy tissue resection procedures. In other instances, the actual tissue the physician is attempting to resect may obstruct the path of instruments used by the physician during the procedure. Therefore, in some instances, it is desirable to utilize medical devices that assist in improving visualization of the target tissue and reducing obstruction of the resection instruments used by the physician. Thus, in some instances, it is desirable to use tissue retraction devices that lift and retract the tissue area that the physician is resecting. Disclosed herein are medical devices, such as tissue retraction devices, tissue engagement devices, and delivery systems, configured to lift and retract target tissue.

[0024] 1 is a plan view illustrating an exemplary tissue retraction device 10. Tissue retraction device 10 includes a first engagement member 12a coupled to a second engagement member 12b. Engagement members 12a, 12b may each be referred to as a clip, clasp, fastener, clamp, etc. For simplicity, the following description will be directed to engagement member 12a, although it will be understood that engagement member 12b includes all of the elements and functionality described for engagement member 12a.

[0025] FIG. 1 further illustrates that the first engaging member 12a is connected to the second engaging member 12b by a tether member 14. The tether member 14 includes a first end and a second end, each of which is connected to the engaging members 12a and 12b via a connecting member 15. The tether member 14 may be referred to as a band, rope, cord, string, strap, strand, or the like. The tether member 14 may have various cross-sectional shapes. For example, the tether member 14 may be circular, rectangular, triangular, or the like. Furthermore, the tether member 14 may be bioabsorbable. Furthermore, the tether member 14 may be formed of an elastomeric material, such as latex, nitrile rubber, ethylene propylene diene rubber, silicone rubber, chloroprene, polychloroprene (e.g., Neoprene), polyolefin, thermoplastic elastomer, polyisoprene, or the like. The tether member 14 can be extended from a first, unextended (e.g., relaxed) position to a second, extended position. It can be seen that when the tissue retraction device 10 is in the extended position, the tissue retraction device 10 is taut and therefore provides a traction force that pulls the first engaging member 12a toward the second engaging member 12b.

[0026] FIG. 2 shows a perspective view of the first engagement member 12a. The engagement member 12a includes a body portion 16. The body portion 16 is coupled to a first jaw 18 and a second jaw 20 at a pivot point 22. The combination of the body portion 16, first jaw 18, and second jaw 20 is referred to herein as the first drive member 13. The first jaw 18 and second jaw 20 each include a curved portion 30. The curved portion 30 is used to grasp and / or engage tissue adjacent to the target tissue site. In some examples, the curved portion 30 is described as a "tooth." Furthermore, while FIG. 2 illustrates the curved portion 30 as including a single, flat-surfaced tooth member, this is not intended to be limiting. Rather, the curved portion 30 may include one or more teeth. Although not shown in FIG. 2, it is contemplated that the teeth can be spaced apart or interdigitated. Various different combinations and orientations of teeth are contemplated.

[0027] 2 shows that the body portion 16 is disposed between the first jaw 18 and the second jaw 20. The body portion 16 includes an arcuate portion. In some cases, the body portion 16 includes a curved portion, a looped portion, an arcuate portion, or the like. For example, the body portion 16 is generally circular. However, this is not intended to be limiting. Rather, it is understood that the body portion 16 can include many different shapes. For example, the body portion 16 can be rectangular, oval, square, hexagonal, polygonal, or the like.

[0028] Additionally, as noted above, body portion 16 includes a first end region 21 from which first jaw 18 extends and a second end region 23 from which second jaw 20 extends. In some examples, body portion 16, first jaw 18, and second jaw 20 are formed as a unitary structure. In other examples, body portion 16, first jaw 18, and second jaw 20 are formed as a single, continuous piece of material. However, in other examples, first jaw 18 and / or second jaw 20 are separate components from body portion 16, with first jaw 18 and second jaw 20 separately attached to first end region 21 and second end region 23 of body portion 16, respectively.

[0029] 2 further illustrates that first engagement member 12a comprises pivot point 22 including first mounting portion 24a disposed adjacent second mounting portion 24b (mounting portion 24b is more clearly shown in FIG. 4). In some examples, the shape of first mounting portion 24a mirrors the shape of second mounting portion 24b. Furthermore, in some examples, first mounting member 24a extends away from first end region 21 of body portion 16, and second end region 23 extends away from second end region 23 of body portion 16.

[0030] First mounting member 24a includes a first opening 26a, and second mounting member 24b includes a second opening 26b (not shown in FIG. 2, but shown in FIG. 3). First opening 26a and second opening 26b extend through the respective wall thicknesses of first mounting member 24a and second mounting member 24b, respectively.

[0031] 2 further illustrates that first engagement member 12a includes second drive member 32. In some examples, second drive member 32 is coupled to body portion 16 of first drive member 13 at pivot point 22. For example, FIG. 2 illustrates that second drive member 32 includes protrusion 34 including a third opening (not shown in FIG. 2 but shown more clearly in FIG. 5) disposed adjacent first mounting portion 24a and second mounting portion 26b. FIG. 2 further illustrates that first mounting member 24a, second mounting member 24b, and second drive member 32 (via protrusion 34) are coupled to one another via first pin 28. In other words, the first mounting member 24a, the second mounting member 24b, and the second drive member 32 are aligned so that the pin 28 extends through the first opening 26a of the first mounting member 24a, the second opening 26b of the second mounting member 24b, and the third opening of the second drive member 32.

[0032] However, in other examples, first mounting member 24a, second mounting member 24b, and second drive member 32 (via protrusion 34) may be coupled to one another using other designs. Additionally, other designs may be used in place of pin 28. For example, designs including living hinges, interference elements, encapsulated connections, and / or pivot balls may be used.

[0033] Additionally, FIG. 2 illustrates that the second drive member 32 is coupled to the body portion 16 of the first drive member 13 at connection point 35. For example, FIG. 2 illustrates that the second drive member 32 is coupled to the body portion 16 of the first drive member 13 via pin 36. While FIG. 2 illustrates that the second drive member 32 is coupled to the body portion 16 of the first drive member 13 via pin 36, this is not intended to be limiting. Rather, it is contemplated that a variety of attachment techniques may be used to couple the second drive member 32 to the body portion 16 of the first drive member 13. For example, it is contemplated that the second drive member 32 may be welded, glued, etc. to the body portion 16 of the first drive member 13.

[0034] It will further be appreciated that the engagement member 12a is designed such that the first drive member 13 and / or the second engagement member 32 bias the first jaw 18 and the second jaw 20 into a closed position (e.g., a position in which the first jaw 18 and the second jaw 20 contact each other). For example, the ends of the first jaw 18 and the second jaw 20 contact each other while in the closed position. By placing the first jaw 18 and the second jaw 20 together while in the closed position, a preload force can be generated when in the closed position.

[0035] FIG. 3 shows a side view of the first engagement member 12a. As noted above, FIG. 3 shows a pair of jaws (e.g., first jaw 18 facing second jaw 20) extending away from the body portion 16 of the first drive member 13. FIG. 3 further shows that the curved regions 30 of the first jaw 18 and the second jaw 20 each curve inward toward each other. Additionally, FIG. 3 shows that the first mounting portion 24a extends away from the first end region 21 of the body portion 16. As noted above, FIG. 3 shows that the pin member 28 is disposed within the first opening 26a of the first mounting portion 24a. FIG. 3 further shows that the second drive member 32 is coupled to the body portion 16 at connection point 35 via the pin member 36. It can be seen from FIG. 3 that in some examples, the second drive member 32 is disposed substantially perpendicular to the body portion 16 of the first drive member 13.

[0036] In some cases, it may be desirable to design body portion 16 of first drive member 13 to have a particular aspect ratio. As described herein, the aspect ratio of body portion 16 can be defined as the ratio of the length of the body portion (approximately the distance from pin member 36 to pin member 28) to the “width” of the body portion (approximately the width of body portion 16, measured approximately perpendicular to the longitudinal axis extending between pin member 36 and pin member 28). In some instances, the aspect ratio of body portion 16 should be at least 3:2 (e.g., the distance between pin member 36 and pin member 28 should be 1.5 times the “width” of body portion 16, as described above). Furthermore, in some instances, the aspect ratio should be greater than 3:2.

[0037] FIG. 4 shows the other side of the first engagement member 12a. FIG. 4 shows the opposite side of the side view shown in FIG. 3 and mirrors the side view shown in FIG. 3. Thus, similar to FIG. 3, FIG. 4 shows the first jaw 18 facing the second jaw 20, with the first jaw 18 and second jaw 20 extending away from the body portion 16 of the first drive member 13. FIG. 4 further illustrates that the curved portions 30 of the first jaw 18 and second jaw 20 curve inward toward each other. Furthermore, FIG. 4 illustrates that the second mounting portion 24b extends from the second end region 23 of the body portion 16. As noted above, FIG. 4 illustrates that the pin member 28 is disposed within the second opening 26b of the second mounting portion 24b. FIG. 4 illustrates that the second drive member 32 is coupled to the body portion 16 at connection point 35 via the pin member 36. It can be seen from FIG. 4 that in some instances, the second drive member 32 is positioned substantially perpendicular to the body portion 16 of the first drive member 13 .

[0038] FIG. 5 shows an exploded view of tissue engaging member 12a, including first drive member 13 and second drive member 32. As noted above, first drive member 13 includes body portion 16, first jaw 18, and second jaw 20. Additionally, FIG. 5 more clearly shows first opening 26a extending through first mounting member 24a. Additionally, FIG. 5 shows fourth opening 38, through which pin 36 (described above) extends. It can be seen from FIG. 5 that body portion 16, first jaw 18, and second jaw 20 are coplanar.

[0039] 5 further shows that the second drive member 32 includes a protrusion 34 extending therefrom. FIG. 5 further shows that a third opening 37 extends through the wall thickness of the protrusion 34. FIG. 5 further shows that the second drive member 32 includes a fifth opening 50 through which the pin 36 extends. As noted above, the fourth opening 38 of the body portion 16 is aligned with the fifth opening 40, thereby allowing the pin 36 to extend therethrough to couple the body portion 16 of the first drive member 13 to the second drive member 32.

[0040] 5, it can be further seen that the second drive member 32 lies in a single plane that is offset from the plane in which the first drive member 13 lies. As noted above, in some instances, the plane in which the first drive member 13 lies is generally orthogonal to the plane in which the second drive member lies. However, this is not intended to be limiting. Rather, the plane in which the first drive member 13 lies can be considered to be generally offset from the plane in which the second drive member lies.

[0041] 5 illustrates the pin member 42 used to connect the first mounting portion 24a, the second mounting portion 24b, and the protrusion 34 of the second drive member 32. As will be explained in more detail below, the cylindrical design of the pin 42 allows the first mounting portion 24a, the second mounting portion 24b, and / or the second drive member 32 to rotate about the pin.

[0042] 6 and 7 show that engagement member 12b is designed so that at least one of first drive member 13 and second drive member 32 moves first jaw 18 and second jaw 19 relative to each other. For example, engagement member 12a is designed so that a clinician can use a manipulator (not shown) to grasp and squeeze first drive member 13, second drive member 32, or both, thereby moving the first jaw relative to the second jaw.

[0043] For example, FIG. 6 illustrates the first jaw 18 and the second jaw 20 of the tissue retraction device 12a opened to an expanded position. Furthermore, FIG. 6 illustrates that the first jaw 18 and the second jaw 20 are opened to the expanded position when the body portion 16 of the first drive member 13 is actuated (e.g., compressed, squeezed, etc.). The arrow 17 illustrated in FIG. 6 indicates actuation (e.g., compression) of the body portion 16 of the first drive member 13. It can be further understood that when the body portion 16 is actuated (e.g., compressed), the body portion transforms from a first position (e.g., the substantially circular position illustrated in FIG. 2) to a second position (e.g., the substantially oval position illustrated in FIG. 6). As noted above, other positions are also contemplated. It can be further understood that release of the compressive force applied to the body portion 16 of the first drive member 13 can close the first jaw 18 and the second jaw 20, returning them to the positions described with respect to FIGS. 2-5.

[0044] 6 illustrates that when the body portion 16 of the first drive member 13 is compressed, the body portion 16 extends. It can be seen that the extension of the body portion 16 causes the first and second mounting portions 24a, 24b to rotate (e.g., pivot) about the pin member 28. It can further be seen that the rotation of the first and second mounting portions 24a, 24b about the pin member 28 causes the first jaw 18 to move relative to the second jaw 20 (extending the body portion 16 moves the jaws from a closed position to an open position).

[0045] FIGS. 6 and 7 show the first jaw 18 and the second jaw 20 of the tissue retraction device 12a opened to an expanded position. Additionally, FIG. 7 illustrates that the first jaw 18 and the second jaw 20 open to an expanded position when the second drive member 32 is actuated (e.g., compressed, squeezed, etc.). Arrow 19 in FIG. 7 indicates actuation (e.g., compression) of the second drive member 32. Furthermore, from FIG. 7, it can be seen that when the drive member 32 is actuated (e.g., compressed), the drive member 32 transforms from a first position (e.g., the substantially circular position shown in FIG. 2) to a second position (e.g., the substantially oval position shown in FIG. 7). As noted above, alternative configurations are contemplated. It can be further seen that releasing the compressive force applied to the second drive member 32 closes the first jaw 18 and the second jaw 20, returning them to the configuration described with respect to FIGS. 2-5.

[0046] 7 illustrates that when the second drive member 32 is compressed, the second drive member 32 extends. Extending the second drive member 32 correspondingly extends the body portion 16 of the first drive member 13 (because the second drive member 32 is coupled to the first drive member 13 at both the pivot point 22 and the connection point 35), thereby allowing the first and second mounting portions 24 a, 24 b to rotate (e.g., pivot) about the pin member 28, as described above. It can further be seen that the rotation of the first and second mounting portions 24 a, 24 b about the pin member 28 moves the first jaw 18 relative to the second jaw 20 (extending the body portion 16 moves the jaws from a closed position to an open position).

[0047] Furthermore, from the above description, it can be seen that actuation of both first drive member 13 and second drive member 32 extends body portion 16, thereby moving the jaws from a closed position to an open position. This feature is important because it allows a clinician to grasp engaging member 12a from a variety of different angles, all of which allow the jaws to open. Furthermore, being able to grasp engaging member 12a from a variety of different angles reduces the time a clinician spends having to orient tissue retraction device 10 in a particular way in order to grasp tissue retraction device 10 at a particular angle.

[0048] To that end, FIG. 8 illustrates that, in some examples, a portion of the engagement member 12a includes a drive membrane (shown by dashed lines 70). As shown in FIG. 8, the membrane 70 extends around a portion of the body portion 16 and / or the second drive member 32. For example, the membrane 70 extends around the body portion 16 and the second drive member 32 without covering the first jaw 18 and the second jaw 20. It can be appreciated that the membrane 70 assists in driving the first drive member 13, the second drive member 32, or both. For example, the membrane 70 can be secured to the first drive member 13, the second drive member 32, or both the first drive member 13 and the second drive member 32, and compressing / squeezing the membrane 70 can drive the first drive member 13, the second drive member 32, or both, to open the jaw members.

[0049] FIG. 9 illustrates another exemplary tissue engaging device 112. The tissue engaging device 112 is similar in form and function to the tissue engaging device 12a described above. For example, the tissue engaging device 112 includes a first jaw 118 and a second jaw 120 coupled to one or more drive members at a pivot location 122. In some examples (such as the example illustrated in FIG. 9 ), the first jaw 118 and the second jaw 120 are directly attached to a first drive member 132 and a second drive member 133, respectively. Furthermore, FIG. 9 illustrates that in some examples, the first jaw 118 is formed as a unitary structure with the first drive member 132. Similarly, FIG. 9 illustrates that in some examples, the second jaw 120 is formed as a unitary structure with the second drive member 133. FIG. 9 further shows that the first drive member 132 and the second drive member 133 transition to the first jaw 118 and the second jaw 120, respectively, at a first rotation point 150 and a second rotation point 152 formed within the framework 166.

[0050] 9 further illustrates that the engagement member 112 includes a third drive member 116 and a fourth drive member 117. As shown in FIG. 9, one end of each of the third drive member 116 and the fourth drive member 117 is coupled to a framework 166 at a third rotation point 154 and a fourth rotation point 156, respectively. As will be explained in more detail below, the framework 166 is designed to allow rotation of each end of the third drive member 116 and the fourth drive member 117 coupled to the framework 166. Furthermore, FIG. 9 illustrates that the ends of the first drive member 132, the second drive member 133, the third drive member 116, and the fourth drive member 117 are each coupled to another member at a connection point 136. Similar to that described with respect to FIG. 2, the first drive member 132, the second drive member 133, the third drive member 116 and the fourth drive member 117 can be coupled to each other at connection point 136 using various designs, configurations, structures, etc.

[0051] FIG. 10 shows a perspective view of a framework 166 including a first rotation point 150, a second rotation point 152, a third rotation point 154, and a fourth rotation point 156. Additionally, FIG. 10 illustrates that the first rotation point 150 includes a mating structure between the first drive member 132 and the first jaw 118, which is coupled to the framework 166 via a pin connection 158. Similarly, FIG. 10 illustrates that the second rotation point 152 includes a mating structure between the second drive member 133 and the second jaw 120, which is coupled to the framework 166 via a pin connection 160. Additionally, FIG. 10 illustrates that the third drive member 116 is coupled to the framework via a pin connection 162, and the fourth drive member 117 is coupled to the framework via a pin connection 164. It can be appreciated that these pin connections 158, 160, 162, and 164 each allow the structure attached thereto to rotate. For example, pin connection 158 allows for rotation of the end regions of both first drive member 132 and first jaw 118. Similarly, pin connection 160 allows for rotation of the end regions of both second drive member 133 and second jaw 120. Similarly, pin connection 162 allows for rotation of the end region of third drive member 116, and pin connection 164 allows for rotation of the end region of fourth drive member 117.

[0052] Similar to the above, any combination of the first drive member 132, the second drive member 133, the third drive member 116, and / or the fourth drive member 117 can be combined and driven to extend (e.g., lengthen) one or more of the first drive member 132, the second drive member 133, the third drive member 116, and / or the fourth drive member 117. In other words, any combination of the first drive member 132, the second drive member 133, the third drive member 116, and / or the fourth drive member 117 can be driven to extend the distance between the pivot point 122 and the connection point 136 (shown in FIG. 9 ). Furthermore, this extension can rotate one or more end regions of the first drive member 132 and / or the second drive member 133 at the first pin connection 158 and / or the pin connection 160, respectively. It can be appreciated that rotation of first drive member 132 and / or second drive member 133 causes rotation of first jaw 118 and / or second jaw 120. Rotation of first jaw 118 and second jaw 120 corresponds to movement of the jaws from a closed position to an open position (and from an open position to a closed position when the drive force is removed).

[0053] FIG. 11 illustrates another exemplary tissue engaging device 212. The tissue engaging device 212 is similar in form and function to the tissue engaging device 12a described above. For example, the tissue engaging device 212 includes a first jaw 218 and a second jaw 220 coupled to one or more drive members at a pivot location 222. In some examples (such as the example illustrated in FIG. 11 ), the first jaw 118 and the second jaw 120 are attached directly to a first drive member 232 and a second drive member 233, respectively. Furthermore, FIG. 11 illustrates that in some examples, the first jaw 218 is formed as a unitary structure with the first drive member 232. Similarly, FIG. 11 illustrates that in some examples, the second jaw 220 is formed as a unitary structure with the second drive member 233. FIG. 11 further illustrates that the first drive member 232 and the second drive member 233 transition to the first jaw 218 and the second jaw 220, respectively, at a first rotation point 250 and a second rotation point 252 formed within the framework 266.

[0054] 11 shows that the engagement member 212 includes a third drive member 216 and a fourth drive member 217. As shown in FIG. 11 , one end region of each of the third drive member 216 and the fourth drive member 217 is coupled to a framework 266 at a third rotation point 254 and a fourth rotation point 256, respectively. As will be explained in more detail below, the framework 266 is designed to allow each end of the third drive member 216 and the fourth drive member 217 coupled to the framework 266 to rotate. Furthermore, FIG. 11 shows that each end of the first drive member 232, the second drive member 233, the third drive member 216, and the fourth drive member 217 is coupled to another member at a connection point 236. Similar to that described in FIG. 2, the first drive member 232, the second drive member 233, the third drive member 216 and the fourth drive member 217 can be coupled to each other at connection point 236 using various designs, configurations, structures, etc.

[0055] 11 also shows that the first rotation point 250 includes the mating structure of the first drive member 232 and the first jaw 218, which is coupled to the framework 266. Similarly, FIG. 11 shows that the second rotation point 252 includes the mating structure of the second drive member 233 and the second jaw 220, which is coupled to the framework 266.

[0056] Similar to the above, it can be appreciated that driving any combination of the first drive member 232, the second drive member 233, the third drive member 216, and / or the fourth drive member 217 can extend (e.g., lengthen) one or more of the first drive member 232, the second drive member 233, the third drive member 216, and / or the fourth drive member 217. In other words, driving any combination of the first drive member 232, the second drive member 233, the third drive member 216, and / or the fourth drive member 217 can extend the distance between the pivot location 222 and the connection point 236. Furthermore, this extension can rotate one or more end regions of the first drive member 232 and / or the second drive member 233 with the first pin connection 258 and / or the second drive member 260, respectively. It can be understood that rotation of first drive member 232 and / or second drive member 233 causes rotation of first jaw 218 and / or second jaw 220. Rotation of first jaw 218 and second jaw 220 corresponds to movement of the jaws from a closed position to an open position (and from the open position to the closed position when the drive force is removed).

[0057] It should be noted that features of a tissue retraction system, tissue engaging member, or components thereof described with respect to a particular figure and / or embodiment are not limited to that particular example. Rather, it is contemplated that all elements or examples disclosed with respect to a single example may be incorporated into any other example disclosed herein.

[0058] Materials that can be used for the various elements of the tissue retraction system 10 and the various devices described herein may include those generally associated with medical devices. For purposes of brevity, the following description will be made with reference to the tissue retraction system 10, but this is not intended to limit the devices and methods described herein to only the tissue retraction system 10, as the description may also apply to other similar devices described herein.

[0059] The tissue retraction system 10 and / or other components of the tissue retraction system 10 may be fabricated from a metal, a metal alloy, a polymer (some examples of which are described below), a metal-polymer composite, a ceramic, a combination thereof, or another suitable material. Examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyetheresters (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalates and / or other polyester elastomers (e.g., HYTREL® available from DuPont)), polyamides (e.g., DURETHAN® or Elf® available from Bayer), and the like. CRISTAMID® available from Atochem), elastomeric polyamides, block polyamide / ethers, polyether block amides (PEBA available under trade names such as PEBAX®), ethylene vinyl acetate copolymers (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (such as REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (EMS AmericanSuitable materials include, but are not limited to, GRILAMID® available from Grillon, Inc., perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxies, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, and other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath can be blended with a liquid crystal polymer (LCP).

[0060] Examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, 316LV, 17-4, and 400 series stainless steels; mild steel; nickel-titanium alloys such as linear elastic and / or superelastic Nitinol; nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.). , other nickel alloys such as nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP-35N®), nickel-molybdenum alloys (e.g., UNS:N10665, such as HASTELLOY® ALLOYB2®), 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; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®); platinum-strengthened stainless steel; titanium; combinations thereof, etc.; or another suitable material.

[0061] In at least some embodiments, some or all of the tissue retraction system 10 and / or other components of the tissue retraction system 10 may be doped with, fabricated of, or contain a radiopaque material. A radiopaque material is understood to be a material capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image assists a user of the tissue retraction system 10 and / or other components of the tissue retraction system 10 in determining their location. Examples of radiopaque materials include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, and the like. Additionally, other radiopaque marker bands and / or coils may also be incorporated into the design of the tissue retraction system 10 and / or other components of the tissue retraction system 10 to achieve the same results.

[0062] In some embodiments, a degree of magnetic resonance imaging (MRI) compatibility is imparted to the tissue retraction system 10 and / or other components of the tissue retraction system 10. For example, the tissue retraction system 10 and / or other components of the tissue retraction system 10, or portions thereof, are fabricated from materials that do not substantially distort images or create substantial artifacts (e.g., gaps in images). For example, certain ferromagnetic materials are unsuitable because they may create artifacts in MRI images. The tissue retraction system 10 and / or other components of the tissue retraction system 10, or portions thereof, may also be fabricated from materials that can be imaged by MRI machines. Some materials that exhibit these properties include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, such as ELGILOY®, PHYNOX®, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, such as MP35-N®), nitinol, etc.

[0063] It should be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, the use of any element of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined in the language expressed by the appended claims.

[0064] (Addendum) (Appendix 1) a first drive member including a body portion extending between a pivot point and a fixed point and coupled to the first jaw and the second jaw at the pivot point, the body portion being moved between a first position and a first compressed position; a second drive member coupled to the first drive member at the pivot point and the fixed point and adapted to be moved between a second position and a second compressed position; Equipped with a tissue engagement device configured to apply a compressive force to the body portion to move the body portion from the first position to the first compressed position, thereby moving the first jaw and the second jaw from a closed position to an open position, and to apply a compressive force to the second drive member to move the second drive member from the second position to the second compressed position, thereby moving the first jaw and the second jaw from the closed position to the open position.

[0065] (Appendix 2) 2. The tissue engagement device of claim 1, wherein the first jaw and second jaw are moved from the closed position to the open position by moving the body portion from the first position to the first compressed position and moving the second drive member from the second position to the second compressed position.

[0066] (Appendix 3) 3. The tissue engagement device of claim 1 or 2, wherein when moved from the first position to the first compressed position and when moved from the second position to the second compressed position, the body portion and the second drive member are extended between the pivot point and the fixed point, respectively.

[0067] (Appendix 4) 4. The tissue engagement device of any one of appendixes 1 to 3, wherein the second drive member is disposed orthogonal to the first drive member.

[0068] (Appendix 5) 5. The tissue engagement device of any one of claims 1 to 4, wherein the body portion, the first jaw, and the second jaw are integrally formed.

[0069] (Appendix 6) 6. The tissue engagement device of any one of clauses 1 to 5, wherein at least one of the body portion and the second drive member comprises a curved portion.

[0070] (Appendix 7) 7. The tissue engagement device of any one of clauses 1-6, wherein at least one of the body portion and the second drive member is circular.

[0071] (Appendix 8) 8. The tissue engagement device of any one of appendixes 1-7, wherein at least one of the body portion and the second drive member has an oval two-dimensional shape.

[0072] (Appendix 9) 9. The tissue engagement device of claim 1, wherein the first jaw and the second jaw can be rotated about the pivot point by moving the main body portion from the first position to the first compressed position, and the first jaw and the second jaw can be rotated about the pivot point by moving the second drive member from the second position to the second compressed position.

[0073] (Appendix 10) 10. The tissue engagement device of any one of clauses 1-9, further comprising a compression membrane disposed around at least a portion of at least one of the body portion and the second drive member.

[0074] (Appendix 11) 11. The tissue engagement device of any one of claims 1 to 10, wherein the first jaw and the second jaw are biased in the closed position.

Claims

1. a first drive member including a body portion extending between a pivot point and a fixed point and connected to the first jaw and the second jaw at the pivot point, the body portion being moved between a first position and a first compressed position; a second drive member coupled to the first drive member at the pivot point and the fixed point, the second drive member being movable between a second position and a second compressed position; Equipped with a tissue engagement device, wherein moving the first drive member from the first position to the first compressed position and moving the second drive member from the second position to the second compressed position moves the first jaw and the second jaw between a closed position and an open position.

2. The tissue engagement device of claim 1 , wherein the second drive member is positioned substantially perpendicular to the first drive member.

3. The tissue engagement device of claim 1 or 2, wherein the body portion, the first jaw, and the second jaw are formed from a unitary member.

4. The tissue engagement device of any one of claims 1 to 3, wherein at least one of the body portion and the second drive member comprises an arcuate portion.

5. The tissue engagement device of any one of claims 1 to 4, wherein at least one of the body portion and the second drive member is generally circular or generally oval.

6. 6. The tissue engagement device of claim 1, wherein movement of at least one of the first drive member and the second drive member causes the first jaw and the second jaw to rotate about the pivot point.

7. The tissue engagement device of any one of claims 1 to 6, further comprising a compression membrane disposed around at least a portion of at least one of the body portion and the second drive member.

8. The tissue engagement device of any one of claims 1 to 7, wherein the first jaw and the second jaw are biased in the closed position.

9. a first drive member including a first end having a first jaw, a second end having a second jaw, and a loop region disposed between the first jaw and the second jaw, the first jaw, the second jaw, and the loop region lying in a first plane; a second drive member pinned to the first drive member at a pivot point and a fixed point, the second drive member lying in a second plane intersecting the first plane; Equipped with wherein at least one of driving the first drive member along the first plane and driving the second drive member along the second plane moves the first jaw and the second jaw between a closed position and an open position.

10. The tissue engagement device of claim 9 , wherein the second plane is disposed substantially perpendicular to the first plane.

11. 11. The tissue engagement device of claim 9 or 10, wherein the first drive member, the first jaw, and the second jaw are formed from a unitary member.

12. The tissue engagement device of any one of claims 9 to 11, wherein at least one of the first drive member and the second drive member includes an arcuate portion.

13. The tissue engagement device of any one of claims 9 to 12, wherein at least one of the first drive member and the second drive member is generally circular or generally oval.

14. 14. The tissue engagement device of any one of claims 9 to 13, wherein movement of at least one of the first drive member and the second drive member causes the first jaw and the second jaw to rotate about the pivot point.

15. The tissue engagement device of any one of claims 9 to 14, further comprising a compressible membrane disposed around at least a portion of at least one of the first drive member and the second drive member.

16. The tissue engagement device of any one of claims 9 to 15, wherein the first jaw and the second jaw are biased in the closed position.

17. The tissue engagement device of claim 1 , wherein the first position of the first drive member and the second position of the second drive member extend from the pivot point to the fixed point.

18. 2. The tissue engagement device of claim 1, wherein the distance between the pivot point and the fixed point increases when the first drive member is moved to the first compressed position or when the second drive member is moved to the second compressed position.

Images