Systems, devices, and related methods for retracting tissue
By using an anchor and clamp to apply force to the tissue through a tissue retraction system, the problems of time-consuming solution injection and poor visibility in existing technologies are solved, and more efficient lesion resection is achieved.
Patent Information
- Application Number
- CN202210224902.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2016-08-05
- Filing Date
- 2017-08-04
- Publication Date
- 2026-01-13
- Estimated Expiration
- 2037-08-04
AI Technical Summary
Existing techniques for removing tissue lesions involve time-consuming solution injections that fail to provide sufficient tissue retraction, resulting in unclear vision and difficulty in effectively removing flat lesions.
A tissue retraction system is employed, comprising first and second anchors and elongated connecting members, which apply force to the tissue via the anchors and clamps to provide multidirectional retraction force to enhance visibility and exposure of the cutting plane.
It improves the visualization and precision of tissue lesion resection, reduces unwanted incision errors, and increases the efficiency of lesion removal.
Smart Images

Figure CN114652371B_ABST
Abstract
Description
[0001] This application is a divisional of Chinese Application No. 201780048903.9, filed August 4, 2017, entitled "Systems, Devices, and Related Methods for Retracting Tissue," which claims priority to U.S. Provisional Application No. 62 / 371,471, filed August 5, 2016, the entire contents of which are incorporated herein by reference.
[0002] Cross Reference to Related Applications
[0003] This application claims priority to U.S. Provisional Application No. 62 / 371,471, filed August 5, 2016, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD
[0004] Aspects of the present disclosure relate generally to tissue retraction. More specifically, the present disclosure relates to systems, devices, and related methods for retracting tissue. BACKGROUND
[0005] Technical developments have enabled users of medical systems, devices, and methods to perform increasingly complex procedures on subjects. Removing tissue in, for example, a subject's gastrointestinal tract is one procedure that can present difficulties. One such difficult area involves removing a lesion on tissue. To remove the lesion, a user can retract tissue at or around the lesion. This retraction can enable the user to clearly visualize a cutting plane for removing the lesion. Having this visualization can help prevent unwanted incision errors, such as cutting off a blood vessel. Visualization can also help ensure that as much or all of the lesion is removed.
[0006] To achieve retraction, a user can inject a solution into tissue at or around the lesion to lift the tissue in preparation for cutting. Reaching and lifting the lesion, particularly the base of the lesion, can require multiple injections. This can be time consuming. Moreover, the injections can not provide sufficient tissue retraction to provide the user with the desired line of sight or other access. These potential problems are exacerbated when the target lesion to be removed is a flat lesion.
[0007] Providing a solution that retracts tissue while reducing or eliminating the occurrence of the above-mentioned drawbacks can lead to better results for the user and the subject. SUMMARY
[0008] Aspects of the present disclosure relate to systems, devices, and methods for retracting tissue, among other things. Each of the aspects disclosed herein can include one or more of the features described in connection with any of the other disclosed aspects.
[0009] In one aspect of the application, a tissue retraction system can include a first anchor, a second anchor, and an elongate coupling member extending between the first anchor and the second anchor. The system can also include a holder for receiving the first anchor, the second anchor, and the elongate coupling member. The holder can include a proximal portion and a distal portion. The distal portion can have a smaller width than the proximal portion such that the distal portion exerts a force on a proximal end of the first anchor during placement of the first anchor from the holder. The force can cause the first anchor to move into an open configuration for receiving tissue.
[0010] Aspects of the tissue retraction system can include one or more of the following features. In the holder, the first anchor can be proximate to the second anchor. The first anchor can include a first jaw and a second jaw, and the first jaw can be pivotably attached to the second jaw. The first anchor can also include a biasing element that biases at least one of the first jaw and the second jaw to move toward the other of the first jaw and the second jaw. The second anchor can include a third jaw and a fourth jaw, and the third jaw can be pivotably attached to the fourth jaw. In the holder, distal ends of the third jaw and the fourth jaw can engage opposing surfaces of proximal ends of the first jaw and the second jaw.
[0011] In another aspect of the application, a repositionable clamping system for tissue can include a clip. The clip can include a fastening element having a first configuration for receiving tissue and a second configuration for engaging tissue. The clip can also include a base for receiving at least a portion of the fastening element. The fastening element can move to the first configuration when moved away from the base, and the fastening element can move to the second configuration when moved toward the base. The clip can also include an actuation element at least partially received within the base to move the fastening element between the first configuration and the second configuration. The actuation element can include an engagement element. The system can also include an implement. The implement can include a manipulation element for engaging the engagement element. The implement can also include a receiver for receiving at least a portion of the base to secure the base relative to the receiver. The manipulation element can be configured to position the base to be secured relative to the receiver. Moving the actuation element relative to the base when the base is secured on the receiver can move the fastening element between the first configuration and the second configuration.
[0012] Aspects of the repositionable clamping system can include one or more of the following features. The receiver can include a first coupling element. The base can include a second coupling element. The first coupling element can releasably couple to the second coupling element to secure the base relative to the receiver. The first coupling element can include one of a recess and a protrusion configured to be received in the recess. The second coupling element can include the other of the recess and the protrusion. The first coupling element can include an internal geometric feature. The second coupling element can include an external geometric feature that matches the internal geometric feature. The first coupling element and the second coupling element can form a snap connection. The manipulation element can include an arm having a curved distal end, and the engagement element can include a ferrule. The manipulation element can include a ball, and the engagement element can include a socket. The ball can releasably couple to the socket.
[0013] In yet another aspect of the disclosure, a method for retracting tissue can include anchoring a first element to tissue at a first location. The method can also include anchoring a second element to the tissue at a second location. The second location can be spaced apart from the first location. Anchoring the second element to the tissue can establish tension in a portion of a coupling element extending between the first element and the second element such that the first element, the coupling element, and the second element can exert a force on the tissue at the first location. The force can have a direction of application and a magnitude. The method can also include manipulating the tissue at the first location while the force is exerted on the tissue at the first location.
[0014] Aspects of the method for retracting tissue can include one or more of the following features. Releasing the second element from the tissue at the second location. Moving the second element toward the tissue at a third location, the third location being spaced apart from the second location. Anchoring the second element to the tissue at the third location. Adjusting the magnitude of the force by pulling the first element toward the second element using the coupling element. Ejecting the first element from the holder. Engaging the first element with the holder to move the first element to an open configuration to receive the tissue at the first location. Disengaging the first element from the holder to move the first element to a closed configuration to anchor the first element to the tissue at the first location.
[0015] It is to be understood that both the foregoing general description and the following detailed description are merely exemplary and explanatory and are not restrictive of the application as claimed. BRIEF DESCRIPTION OF DRAWINGS
[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the application and together with the description, serve to explain the principles of the application.
[0017] Figures 1A to 1H A retraction system in use according to aspects of the present disclosure is shown.
[0018] Figure 2 Another retraction system in use is shown in accordance with aspects of the present application.
[0019] Figures 3A to 3E Another retraction system in use is shown in accordance with aspects of the present application.
[0020] Figures 3F to 31 An assembly including a retainer, an anchor, and a pusher is shown in accordance with aspects of the present application. Figures 3A to 3E A retainer and anchor of a retraction system.
[0021] Figure 4 A cross-sectional view of an assembly including a retainer, an anchor, and a pusher is shown in accordance with aspects of the present application.
[0022] Figure 5 A cross-sectional view of another assembly including a retainer, an anchor, and a pusher is shown in accordance with aspects of the present application.
[0023] Figure 6 Exemplary engagement elements and fasteners arranged in columns are shown in accordance with aspects of the present application.
[0024] Figures 7A to 7C Another retraction system in use is shown in accordance with aspects of the present application.
[0025] Figure 8 An anchor is shown in accordance with aspects of the present application.
[0026] Figure 9 Another anchor is shown in accordance with aspects of the present application.
[0027] Figure 10 An end view of another retainer in accordance with aspects of the present application.
[0028] Figure 11 A cross-sectional view of a retainer and anchor is shown in accordance with aspects of the present application.
[0029] Figures 12A to 12F Another retraction system in use is shown in accordance with aspects of the present application.
[0030] Figure 13 A portion of a positioning appliance and an anchor is shown in accordance with aspects of the present application.
[0031] Figure 14 A portion of another positioning appliance and another anchor is shown in accordance with aspects of the present application.
[0032] Figure 15 A portion of another positioning appliance and another anchor is shown in accordance with aspects of the present application.
[0033] Figure 16A and 16B Portions of another positioning instrument and another anchor are shown in accordance with aspects of the present application.
[0034] Figure 17 A perspective view of another anchor in accordance with aspects of the present application is shown.
[0035] Figure 18 Portions of another positioning instrument and another anchor are shown in accordance with aspects of the present application.
[0036] Figures 19A to 19H Another retraction system in use in accordance with aspects of the present application is shown.
[0037] Figure 20A and 20B Another version of the retraction system of Figures 19A to 19H in use in accordance with aspects of the present application is shown.
[0038] Figure 21A and 21B Another version of the retraction system of Figures 19A to 19H in use in accordance with aspects of the present application is shown.
[0039] Figure 22 An auxiliary anchor in accordance with aspects of the present application is shown.
[0040] Figure 23A and 23B Another version of the retraction system of Figures 19A to 19H in use in accordance with aspects of the present application is shown.
[0041] Figure 24A and 24B Another version of the retraction system of Figures 19A to 19H in use in accordance with aspects of the present application is shown.
[0042] Figure 25A and 25B Another version of the retraction system of Figures 19A to 19H in use in accordance with aspects of the present application is shown. DETAILED DESCRIPTION
[0043] The present invention relates to systems, devices, and methods for retraction of tissue. Reference will now be made in detail to aspects of the present invention, examples of which are illustrated in the drawings. Wherever possible, the same or like reference numbers will be used throughout the drawings to refer to the same or like parts. The term "distal" refers to the portion of the device that is farthest from the user when the device is introduced into the patient. Conversely, the term "proximal" refers to the portion of the device that is closest to the user when the device is introduced into the patient. The term "retract" can refer, for example, to positioning tissue to expose and / or visualize a cutting plane for removal of tissue. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example," not "ideal."
[0044] Figures 1A to 1H A system 100 for retracting a portion of tissue 102 is shown. The tissue 102 can include, for example, a target region 104 to be removed, such as a region having a lesion. The system 100 can include an introducer 106 for providing access to the tissue 102. The introducer 106 can deploy anchors 108 and 110 into a portion of the tissue 102 that is opposite, or otherwise faces, the target region 104. Additionally or alternatively, the introducer can deploy the anchors 108 and 110 into a portion of the tissue that is spaced apart from the target region 104. Figure 1A and 1B The deployed anchors 108 and 110 are shown.
[0045] The introducer 106 can also deploy an anchor 112 into the target region 104, as shown in Figure 1C The tether 114, visible in Figure 1D , can be coupled to the anchor 112. A clip 116 can be coupled to the tether 114. The introducer 106 and a positioning instrument (not visible in Figure 1D ) herein can attach the clip 116 to the anchor 108 to retract the target region 104. A cutting instrument 120, shown in Figure 1E , can be used to cut the retracted target region 104.
[0046] Figure 1F and 1GThe introducer 106 and the positioning appliance 118 are shown removing the clip 116 from the anchor 108 and attaching the clip 116 to the anchor 110 to further distract the target region 104. The anchors 108 and 110 can act as a staged pull point for distracting the target region 104. The space between the anchors 108 and 110 can provide the user with the ability to achieve different distraction vectors (e.g., directions and / or magnitudes of distraction) for distracting the target region 104. This control over the distraction vector can provide the user with enhanced ability to expose and / or visualize a cutting plane that the user will use to guide cutting the target region 104 using the cutting appliance 120. Figure 1H The cutting appliance 120 is shown cutting the distracted target region 104 after adjusting the distraction vector.
[0047] The introducer 106 can include an elongated tubular member 122. The elongated tubular member 122 can include a plurality of lumens (not shown) that extend longitudinally through the interior of the elongated tubular member 122. The lumens can receive appliances, illumination elements (not shown), imaging elements (not shown), and / or fluid or other material flow (not shown) into or out of the target region 104.
[0048] An end cap 126 can cover the distal end of the elongated tubular member 122. The end cap 126 can include a plurality of ports 128 (see, e.g., Figure 1F and 1H ) that communicate with the lumens. The ports 130 can communicate with appliance lumens. Appliances inserted through the appliance lumens can extend out of the distal end of the introducer 106 via the ports 130. Other ports 128 can communicate with other lumens to receive illumination elements, imaging elements, and / or fluid or other material flow. The user of the introducer 106 can use the illumination elements and imaging elements to visualize the target region 104 and its surrounding environment. The introducer 106 can include, for example, any suitable type of endoscope, sheath, or catheter.
[0049] The introducer 106 can also include a handle (not shown) having a steering mechanism (not shown) mounted thereon. The steering mechanism can be coupled to one or more steering wires or cables that can extend longitudinally through the elongated tubular member 122. By manipulating the steering mechanism to exert tension and / or compression forces on the steering wires or cables, the user can control the deflection of the distal end of the introducer 106.
[0050] The anchor 108 can include a first end 132 (immediately proximal to the tissue 102 in Figure 1A ) that is configured to penetrate into the tissue 102. The first end 132 can include, for example, a sharp penetrating tip. The anchor 108 can also include a second end 134 (immediately distal to the tissue 102 in Figures 1B to 1HThe second end 134 can be used as an attachment point. For example, the second end 134 can include a loop, an eyelet, a hook, or any other suitable attachment element.
[0051] The middle portion of the anchor 108 between the first end 132 and the second end 134 can move between a contracted or resting configuration and an extended or stretched configuration. When stretched, the anchor 108 can exert a biasing force that tends to bring the first end 132 and the second end 134 toward each other. For example, the middle portion of the anchor 108 can include a helical tension spring 136.
[0052] In addition to providing a biasing force, the helical tension spring 136 can provide functionality. For example, rotating the helical tension spring 136 in one of a clockwise direction and a counterclockwise direction can facilitate the first end 132 penetrating deeper into the tissue 102, similar to the operation of a screwdriver. Rotating the helical tension spring 136 in the other of the clockwise direction and the counterclockwise direction can facilitate the first end 132 being moved back from the tissue 102. This can provide a user with the ability to control the depth of penetration of the anchor 108 into the tissue 102.
[0053] The anchor 110 can include one or more of the features of the anchor 108. In one example, the anchor 110 can be identical to the anchor 108. However, the anchor 110 can be disposed into the tissue 102 at a location spaced apart from the anchor 108. As will be explained in detail below, due to the spacing of the anchors 108 and 110, the anchors 108 and 110 can act as a tiered pull point that imparts different distraction vectors onto the target region 104.
[0054] The anchor 112 can also include one or more of the features of the anchor 108. For example, the anchor 112 can include a first end 138 configured to penetrate tissue at the target region 104 (as seen in Figure 1C the middle portion of the anchor 108), a second end 140 opposite the first end 138, and a helical tension spring 142 connecting the first end 138 to the second end 140 (as seen in Figures 1D to 1H In one example, the length of the anchor 112 can be greater than the length of the anchor 110. The depth of penetration of the anchor 112 into the target region 104 can be controlled by rotating the anchor 112 in either of a clockwise direction and a counterclockwise direction.
[0055] The tether 114 may include a line, rope, cable, elastic band (e.g., rubber band), spring (e.g., helical tension spring), suture thread, high-carbon spring thread, braided or wound filament, stainless steel, nitinol, spring steel, music wire, muscle wire, and / or any other suitable elongated component. The tether 114 may be metallic, polymeric, or a combination of metal and polymer. One end of the tether 114 may be attached to the second end 140 of the anchor 112 (e.g., ...). Figures 1D to 1H (As seen in the image). The other end of the tether 114 can be attached to the clip 116. The clip 116 may include a base element 144. One end of the base element 144 can be attached to an engaging element 146. The engaging element 146 can be configured to be releasably coupled to a second end of the anchors 108 and 110. The tether 114 can be attached to the clip 116 at the location where the base element 144 intersects with the engaging element 146. Alternatively, the tether 114 can be attached to the clip 116 at any other suitable location on the clip 116.
[0056] The outer surface of the base element 144 may include a shoulder or support 148. The shoulder 148 may include one or more protrusions projecting from the outer surface. The shoulder 148 may engage the anchor 112, as described below. In one example where the tether 114 includes a helical tension spring, the tether 114 may be integral with the helical tension spring 142 of the anchor 112.
[0057] One end of the base element 144, opposite to the end attached to the engaging element 146, may include an opening (not shown). The opening may receive the tip portion 150 of the positioning device 118, thereby allowing the tip portion 150 to be received within the base element 144 so that the clamp 116 can move together with the tip portion 150. Figure 1F The top portion 150 is shown before the insertion of the base element 144, and Figure 1G A tip portion 150 is shown within the base element 144 (where the tip portion 150 is concealed by the base element 144). A shaft portion (not shown) of the positioning device 118 can extend proximally through the device cavity. A user can manipulate the shaft portion to extend the tip portion 150 out of and retract it into the inlet 106, and / or otherwise move the tip portion 150. The shaft portion can be sufficiently flexible to deflect along with the inlet when the inlet 106 is deflected by the user.
[0058] Prior to deployment, the positioning instrument 118, anchors 108, 110, and 112, and tether 114 can be housed within the instrument lumen. This can, for example, prevent the anchors 108, 110, and 112 from prematurely engaging tissue as the distal end of the introducer 106 is navigated toward the target region 104. Within the instrument lumen, the tip portion 150 of the positioning instrument 118 can be received within the base element 144 of the clip 116. The anchor 112 can surround the clip 116. The second end 140 of the anchor 112 can engage the shoulder 148. The first end 138 of the anchor 112 can engage the second end of the anchor 110. The first end of the anchor 110 can engage the second end 134 of the anchor 108. The first end 132 of the anchor 110 can be recessed from the port 130.
[0059] Once the distal end of the introducer 106 is positioned relative to the target region 104, the user can deflect the distal end of the introducer 106 to prepare for deployment of the anchor 108 into the tissue 102. Deploying the anchor 108 can include moving the positioning instrument 118 distally to cause at least the first end 132 of the anchor 108 to extend out of the port 130 and into contact with the tissue 102 Figure 1A ). Deploying the anchor 108 can also include rotating the positioning instrument 118 about its central longitudinal axis. This rotation can rotate the clip 116, the anchor 112, the anchor 110, and the anchor 108, through the chain of engagements between these elements. As the first end 132 of the anchor 108 is rotated, the first end 132 can penetrate into the tissue 102 and can continue to rotate deeper into the tissue 102. When a desired penetration depth is reached, the positioning instrument 118 and the introducer 106 can be moved away from the anchor 108, leaving the anchor 108 in place in the tissue 102. The anchor 110 can be deployed into the tissue 102 in a similar manner at another location (see Figure 1B ). The anchor 112 can also be deployed into the target region 104 in a similar manner (see Figure 1C ).
[0060] The positioning instrument 118 and the clip 116 mounted thereon can be moved distally further and further during deployment and release of the anchors 108, 110, and 112. By the time the anchor 112 is deployed, the engagement element 146 can extend distally out of the instrument lumen and the port 130, as shown in FIG. 6B. The tether 114 can be cut at the port 130, and the clip 116 can be released from the positioning instrument 118. The clip 116 can be released by rotating the positioning instrument 118 about its central longitudinal axis. This rotation can rotate the clip 116, the anchor 112, the anchor 110, and the anchor 108, through the chain of engagements between these elements. As the clip 116 is rotated, the clip 116 can be released from the positioning instrument 118 and can continue to rotate deeper into the tissue 102. When a desired penetration depth is reached, the positioning instrument 118 and the introducer 106 can be moved away from the anchor 108, leaving the anchor 108 in place in the tissue 102. The anchor 110 can be deployed into the tissue 102 in a similar manner at another location (see Figure 1CUsing the first end 138 of the anchor 112 that is embedded in the target region 104, the user can move the introducer 106, the positioning instrument 118, and the clip 116 (which base element 144 can still be mounted on the tip portion 150 of the positioning instrument 118) toward the anchor 108. This movement can impart tension on the tether 114, which can pull the anchor 112 and the target region 104. The retraction can be along a vector that extends between the target region 104 and the anchor 108. This movement can also stretch the anchors 108 and 112 and / or the tether 114.
[0061] With the anchors 108, 110, and 112, the tether 114, and the clip 116 in place, the positioning instrument 118 can be removed from the instrument lumen to allow insertion of the cutting instrument 120. The cutting instrument 120 can be guided distally through the instrument lumen and extend distally out of the port 130 to a position as shown in Figure 1E The cutting instrument 120 can include a distal cutting element 154. The cutting element 154 can include, for example, a blade, an electrosurgical electrode, a heating element, and / or any other element suitable for cutting the tissue 102. A shaft 156 can extend proximally from the cutting element 154, through the instrument lumen, and to the proximal end of the introducer 106. The shaft 156 can be operably coupled to a power source, such as an electrosurgical unit or other suitable power source, to provide energy for cutting the tissue 102. Alternatively, the positioning instrument 118 can be left in place, and the cutting instrument 120 can be introduced through another lumen.
[0062] The user can remove the target region 104 by sweeping the distal end of the introducer 106 back and forth, thereby sweeping the cutting element 154 back and forth over the retracted target region 104 (as indicated by the double-headed arrow proximate the cutting element 154 in Figure 1E Other movements of the cutting element 154 can also be performed, including stabbing, twisting, lifting, lowering, etc. As the cutting element 154 cuts the target region 104, the target region 104 can form a flap that can be pulled toward the anchor 108 by tension and / or biasing forces in the anchor 112, the tether 114, and / or the anchor 108. This can result in a decrease in the retraction force applied to the target region 104. To increase the retraction force, the user can remove the cutting instrument 120 from the instrument lumen. The user can reintroduce the positioning instrument 118 into the instrument lumen and navigate the positioning instrument 118 until the tip portion 150 again extends distally out of the port 130, as in Figure 1FAs depicted in [the text]. The tip portion 150 can re-enter the base element 144 of the clip 116. The tip portion 150, with the aid of the inserter 106, can move the clip 116 to release the engaging element 146 from the second end 134 of the anchor 108. The tip portion 150 and the inserter 106 can then move the clip 116 to engage the engaging element 146 with the second end of the anchor 110, as [the text is incomplete]. Figure 1G As seen in the image. This movement can apply tension to the tether 114, which can pull the anchor 112 and thus further pull apart the target area 104. The pulling apart can occur along a vector extending between the target area 104 and the anchor 110. Movement of the clamp 116 to the anchor 110 can also stretch the anchors 110, 112 and / or the tether 114.
[0063] The positioning device 118 can be removed again from its internal cavity to make room for the cutting device 120. The user can then use the cutting device 120 to continue cutting the retracted target area 104, such as in... Figure 1H As shown in the diagram. Alternatively, the positioning device 118 and the cutting device 120 can be positioned in different cavities of the inlet 106, without needing to remove one to make way for the other. It should be understood that additional anchors may have been arranged into the tissue 102 along with anchors 108 and 110, allowing the user to further retract the target area 104 to aid in cutting. The above process steps can be repeated until the target area 104 is removed.
[0064] Figure 2 Another system 200 is shown for retracting tissue 202 in a target area or lesion 204. Like system 100, system 200 may include an inserter 206, a cutting instrument 220, anchors 208 and 210 for embedding in tissue 202 to act as graded pull points, an anchor 212 for embedding in the target area 204, a tether 214 for linking the anchor 212 to the anchors 208 and 210, and a clamp 216 at one end of the tether 214 for engaging the anchors 208 and 210.
[0065] System 200 may differ from system 100 in various ways. For example, anchor 208 may include a base element 244 having a fastener (not shown) attached to a first end. The fastener may be embedded in tissue 202 to secure anchor 208 to tissue 202. The fastener may include, for example, a helical through end similar to anchor 108. Engaging element 234 may be attached to a second end of base element 244. Engaging element 234 may include a ring or eyelet. Anchor 210 may be similar to or even identical to anchor 208.
[0066] Anchor 212 may include a base element 242 having a fastener 238 at a first end and a tether 214 at a second end 240. Fastener 238 may include, for example, a gripping element formed by jaws. It is contemplated that the jaws may move between an open position for receiving tissue and a closed position for gripping the received tissue. The fasteners of anchors 208 and 210 may also be similar to fastener 238. Any suitable positioning device (not shown) may be configured to actuate the jaws between the open and closed positions. Exemplary positioning devices are described below. Alternatively, a positioning device similar to positioning device 118 of system 100 may be used to position anchors 208, 210, and 212, tether 214, and clamp 216 from the inlet 206.
[0067] A first end of the tether 214 may be attached to a second end 240 of the anchor 212. The second end of the tether 214 may be attached to a clip 216. The clip 216 may include an engaging element 246 configured to be received in an engaging element 234 of the anchor 208 (and an engaging element of the anchor 210) to attach the clip 216 to the anchor 208. The clip 216 may also include a hole or eyelet 258 configured to receive a cutting tool 220.
[0068] Anchors 208, 210, and 212, tethers 214, and clips 216 can be positioned from within the instrument cavity of the inlet 206 using any suitable positioning device. With the anchors 208, 210, and 212, tethers 214, and clips 216 positioned and the positioning device removed from the instrument cavity, the cutting device 120 can be guided distally through the instrument cavity and extends distally from the inlet 206. Alternatively, the positioning device 118 and the cutting device 120 can occupy different cavities of the inlet 206 without requiring one to be moved to make way for the other.
[0069] The user can insert the distal end of the cutting tool 220 into the hole 258 of the clamp 216. Using the movement of the inserter 206 and the cutting tool 220, the user can pull the clamp 216 toward the anchor 208 (in...). Figure 2 (Shown in dashed lines). The user can attach the engagement element 246 of the clip 216 to the engagement element 234 of the anchor 208. These movements can apply tension to the tether 214, which can pull the anchor 212 and thus pull away the target area 204. Pulling away can occur along a vector extending between the target area 204 and the anchor 208. This movement can also stretch the tether 214.
[0070] With the target area 204 pulled back, the user can sweep the cutting element 254 of the cutting tool 220 across the pulled-back target area 204. As the cutting element 254 cuts the target area 204, the target area 204 can form a flap that can be pulled toward the anchor 208 by the tension and / or bias force in the tether 114. This may result in a decrease in the pulling force on the target area 204. To increase the pulling force, the user can reinsert the cutting tool 220 into the hole 258 of the clamp 216. The user can use the cutting tool 220 and the inserter 206 to move the clamp 216 to release the engagement element 246 from the engagement element 234 of the anchor 108. The cutting tool 220 can then move the clamp 216 to engage the engagement element 246 with the engagement element of the anchor 210 (in Figure 2 (Shown in solid lines). This movement can apply tension to the tether 214, which can pull the anchor 212 and thus further pull apart the target area 204. Pulling apart can occur along a vector extending between the target area 204 and the anchor 210. This movement can also stretch the tether 214.
[0071] The user can use cutting tool 220 to cut further retracted target area 204. It should be understood that additional anchors may have been placed into tissue 202 along with anchors 208 and 210, allowing the user to further retract target area 204 to aid in cutting by performing the steps described above. This process can be repeated until target area 204 is removed.
[0072] It should be understood that aspects of system 200 can be used interchangeably with aspects of system 100. For example, one or more of the anchors 208, 210, and 212, the tether 214, and the clip 216 of system 200 can be used in place of the anchors 108, 110, and 112, the tether 114, and the clip 116 of system 100. Conversely, one or more of the anchors 108, 110, and 112, the tether 114, and the clip 116 of system 100 can be used in place of the anchors 208, 210, and 212, the tether 213, and the clip 216 of system 200.
[0073] Figures 3A to 31 Another system 300 for retracting tissue is shown. Figures 3A to 3E The system 300 used in a subject is shown. Figures 3F to 31 A portion of the system 300 used is shown to illustrate certain aspects of the system 300 more clearly. The system 300 may include an inlet 306 (similar to inlet 106) for placing anchors 308 and 310 into tissue 302 to act as graded pull points. Prior to placement, anchors 308 and 310 may be received in the cavity 360 of retainer 362 (the cavity is in…)Figures 3F to 31 (As shown in the figure). The retainer 362 can slide within the instrument cavity (not shown) of the introducer 306 so that the user can retrieve the retainer 362 into the instrument cavity during navigation of the introducer 306 to the target area and extend the retainer 362 from the distal end of the introducer 306 to arrange the anchors 308 and 310 into the tissue 302. When within the cavity 360, the anchors 308 and 310 can be constrained by the surface of the retainer 362 forming the cavity 360 (see figure). Figures 3F to 31 For example, anchors 308 and 301 can be held in a straight shape by the inner surface of retainer 362.
[0074] Anchors 308 and 310 can be continuously arranged in the cavity 360. The first end 332 of anchor 308 can extend toward the distal end of retainer 362. The second end 334 of anchor 308 can engage the first end of anchor 310, as in... Figure 3H As seen in the image. In one example, anchor 308 may be integral with anchor 310, wherein anchors 308 and 310 are connected by a fragile portion. Alternatively, anchors 308 and 310 may be separate segments, wherein the second end 334 of anchor 308 is adjacent to the first end of anchor 310.
[0075] The second end of anchor 310 can engage the distal end of pusher or plunger 364. A user can move pusher 364 distally to push anchors 308 and 310 distally through cavity 360. With continued distal movement, pusher 364 can extend the first end 332 of anchor 308 out of retainer 362. The first end 332 can pass through tissue 302 (see...). Figure 3A , 3B (and 3F). As more of the anchor 308 extends out of the retainer, the exposed portion of the anchor 308 can begin to return to its unrestrained form (see 3F). Figure 3C , 3G And 3H). Unrestricted forms may include, for example, in Figure 3D , 3E And the ring shape shown in 3I, or alternatively, a triangle, hook, U-shaped pin, or any other suitable shape. Anchor 308 can be made of any suitable material, including wire, stainless steel, nitinol, high-carbon spring steel, polymeric materials including shape memory, and / or bioresorbable materials. Once anchor 308 is released from retainer 362, it can detach from anchor 310 and remain on tissue 302 (see [link to retainer]). Figure 3D and 3I The first end of the anchor 310 can extend from the retainer 362, and the placement process can be repeated to place the anchor 310 at a position spaced apart from the anchor 308.Figure 3E and 3I Although two anchors, 308 and 310, are depicted, it should be understood that any number of anchors can be received in retainer 362, depending on how many graded pull points the user wishes to set.
[0076] Figure 4 Another retainer 462 is shown. Retainer 462 may be similar to retainer 362 of system 300, except that anchors 408 and 410, and any additional anchors, may be stacked. Anchors 408 and 410 may partially overlap, rather than being arranged end-to-end as anchors 308 and 310. The cavity 460 of retainer 462 may be wider than the cavity 360 of retainer 362 to accommodate stacked anchors 408 and 410. Similar to plunger or pusher 364 of system 300, plunger or pusher 464 may push the proximal end 434 of anchor 408 distally to place anchor 408 into tissue. Plunger 464 may then be retracted and moved to engage the proximal end of anchor 410 to prepare for placement of anchor 410. This process may be repeated to place all anchors in retainer 462.
[0077] Figure 5 Retainer 562 is shown. Retainer 562 may be similar to retainers 362 and 462 of systems 300 and 400, respectively. In retainer 562, anchors 508 and 510, as well as any other anchors, may be arranged side-by-side in a bundle configuration within a cavity or chamber 560. Plungers or pushers 364 and 464, similar to those of systems 300 and 400, may be used to push the proximal ends of the anchors distally, one at a time, to place the anchors into the tissue. Between arrangements, plunger 564 may be retracted and positioned proximal to the next anchor in preparation for placement of the next anchor.
[0078] Figure 6 An arrangement or table 668 with three columns 670, 672, and 674 is shown. Column 670 shows various types of engaging elements, including, for example, a single hook 673 with a tip, a gripping element 674 with jaws, a multi-hook assembly 676 with a tip, a magnet 678, a first half 680 of a hook-and-loop fastener, a hook 682 with a bulbous end, and a ring 684. Any engaging element in column 670 can be used in systems 100 and 200, respectively, to replace engaging elements 146 and 246 in place of clips 116 and 216.
[0079] Column 672 illustrates various types of engagement elements that can engage the engagement elements of column 670. Column 672 includes, for example, rings or eyelets 686 (which are configured to attach to a single hook 673, gripping element 674, and multi-hook assembly 676), magnets 688 (which are configured to attract and attach to magnets 678), a second half 690 of a hook-and-loop fastener (which is configured to attach to the first half 680), and angled hooks 692 (which are configured to attach to hooks 682 and rings 684).
[0080] Column 674 illustrates various types of fasteners that can be used to secure objects to tissue, including, for example, T-tags 694, coils 696 with sharp tips, annular elements 698, and self-expanding hook assemblies 699. Any of the fasteners in column 674 can be used in conjunction with any of the engaging elements in column 672 to secure the engaging element in column 672 to tissue. Assemblies of fasteners from column 674 and engaging elements from column 672 can be used in systems 100, 200, and 300 as anchors 108, 110, 208, 210, 308, and 310, respectively. It is also conceivable that any of the fasteners in column 674 can be used in systems 100 and 200 to secure anchors 112 and 212 to target regions 104 and 204, respectively. The list in Table 668 illustrates exemplary aspects and is not an exhaustive list of all possibilities. For example, any of the engagement elements and / or fasteners of systems 100, 200, and 300 may form part of Table 668.
[0081] Figures 7A to 7C A system 700 for retracting tissue 702 is shown. Tissue 702 may include, for example, a target region 704 to be removed, such as a region with lesions. System 700 may include an introducer 706 for providing access to tissue 702. The introducer 706 may be provided with anchors 708 and 712 respectively to engage a portion of tissue 702 opposite to or otherwise facing the target region 704 and the target region 704 itself.
[0082] Figure 7A A system 700 is shown in a delivery configuration that facilitates navigation of the distal end of the infeeder 706 to the target area 704. Anchors 708 and 712 can be received within a retainer 762. A positioning device 718 can also be received within the retainer 762. By moving the positioning device 718 distally, a user can push the anchors 708 and 712 distally to position them. Figure 7B The diagram shows a retainer 762 extending distally from the inlet 706 during arrangement, and an anchor 712 being pushed distally from the retainer 762. As the anchor 712 disengages from the retainer 762, the distal end of the retainer 762 can move the anchor 712 into an open configuration (as shown in...).Figure 7B (As seen in the image). The open anchor 712 can receive the target area 704. When the anchor 712 is separated from the retainer 762, the anchor 712 can close on the target area 704, thereby gripping the target area 704. The tether 714 can be connected to the anchor 712 at one end and to the anchor 708 at the other end.
[0083] With anchor 712 gripping target area 704, the user can deflect inserter 706 to move retainer 762 and clamp 708 toward a portion of tissue 702 that may be facing or otherwise opposite target area 704. The user can use positioning device 718 to push anchor 708 out of retainer 762 so that anchor 708 grips tissue 702. These movements can apply tension to tether 714, which can pull anchor 712 and thus pull target area 704 away, as in... Figure 7C As shown in the diagram. The pull can be made along a vector extending between the target area 704 and the anchor 712. This movement can also stretch the tether 714.
[0084] The cutting instrument 720 can be used to cut the retracted target area 704. If the cutting affects the target area 704, causing slack in the tether 714, the position of the anchor 708 can be adjusted, for example using a positioning instrument 718, to release the anchor 708 from the tissue 702, reposition the anchor 708, and then release it again so that the anchor 708 can engage another portion of the tissue 702. This adjustment can provide the user with the ability to utilize different retraction vectors (e.g., the direction and / or magnitude of retraction) relative to the target area 704. This control over the retraction vector can provide the user with enhanced ability to expose and / or visualize the cutting plane, which the user uses to guide the cutting with the cutting instrument 704 to remove the target area 704.
[0085] The injector 706 can be, for example, similar to the injector 106 of system 100. The injector 706 may include an instrument cavity 701. The instrument cavity 701 is in... Figure 7A It is visible in the sectional view; and in Figure 7B The interior is also visible, with a portion of the injector 706 made transparent to reveal internal features. It is conceivable that additional cavities (not shown) could be provided for illumination, imaging, and / or material movement.
[0086] The retainer 762 can slide within the instrument cavity 701 of the inserter 706, allowing the user to pull the retainer 762 into the instrument cavity 701 while navigating the inserter 706 to the target region 704, and to extend the retainer 762 from the distal end of the inserter 706 to arrange the anchors 708 and 710 into the tissue 702. The retainer 702 may have a proximal portion 703 and a distal portion 705. The cavity 760 may extend through the proximal and distal portions 703 and 705. The proximal portion 703 may be wider than the distal portion 705. Additionally or alternatively, the inner diameter of the proximal portion 703 may be larger than the inner diameter of the distal portion 705. Therefore, the cavity 760 may be wider in the proximal portion 703 than in the distal portion 705. The transition from the proximal portion 703 to the distal portion 705 can be gradual, such that the retainer 702 and the cavity 760 can be tapered at the transition.
[0087] Anchor 708 may include fasteners 738 for attachment to tissue 702, such as gripping elements formed by jaws 707 and 709. Jaws 707 and 709 may be pivotally attached to each other at fulcrum 711. Bias element 713, such as a torsion spring member, may engage jaws 707 and 709 to bias jaws 707 and 709 into a closed configuration. When jaws 707 and 709 are moved into the closed configuration, the distal tips of jaws 707 and 709 at the first end 732 of anchor 708 may move toward each other. If unobstructed, the distal tips of jaws 707 and 709 may move to contact each other. At the second end 734 of anchor 708, on the other side of fulcrum 711, the proximal tips of jaws 707 and 709 may move away from each other when jaws 707 and 709 are moved into the closed configuration. When jaws 707 and 709 are moved to the open position (e.g., overcoming the biasing force applied by biasing element 713), the proximal tips of jaws 707 and 709 at the second end 734 can move toward each other, and the distal tips 707 and 709 at the first end 732 can move away from each other. Applying a force to one or more of jaws 707 and 709 at or near the proximal tips of jaws 707 and 709 can move jaws 707 and 709 to the open position, thereby allowing jaws 707 and 709 to receive tissue 702. Removing this force allows jaws 707 and 709 to move to the closed position to secure to tissue 702. Protrusions 715 and 717, such as inclined protrusions, curved protrusions, ramps, etc., can be provided at the proximal tips of jaws 707 and 709 to move jaws 707 and 709 to the open position, as described below. Anchor 712 can be similar to anchor 708. Anchors 708 and 712 can be connected by tether 714.
[0088] Prior to placement, anchors 708 and 712 may be continuously arranged within the cavity 760 at the proximal portion 703 of the retainer 762. A first end 732 of anchor 708 may extend toward the distal end of the retainer 762 and may engage a second end (e.g., the proximal end) of anchor 712. A second end 734 of anchor 708 may engage the distal end of positioning device 718. The cavity 760 at the proximal portion 703 may be sized such that anchors 708 and 712 are in their closed configuration. Alternatively, the cavity 760 may be sized such that anchors 708 and 712 are in a partially open configuration, for example, due to engagement between the inner surface of the retainer 762 and protrusions 715 and 717. A tether 714 may be included within the cavity 760 along with anchors 708 and 712. Alternatively, one or more of the anchors 708 and 712 can be flipped end-to-end in the cavity 760.
[0089] At or near the target area 704, with the inlet 706 in place, the user can move the positioning device 718 distally to push the anchors 708 and 712 from the proximal portion 703 of the retainer 762 through the cavity 760 to the distal portion 705. As the distal movement continues, the positioning device 718 can begin to push the anchor 712 out of the retainer 762. When the second end of the anchor 712 reaches the transition zone between the proximal portion 703 and the distal portion 705 of the retainer 762, the protrusions on the anchor 712 can engage the inner surface of the retainer 762 due to the reduced width of the retainer 762 at the distal portion. This engagement can apply a compressive force to the proximal tip of the jaws of the anchor 712, causing the distal tips of the jaws to move away from each other. Figure 7B The positioning device 718 is used to receive the target area 704. Continued distal movement of the positioning device 718 can completely remove the anchor 712 from the retainer 762. As the protrusion on the anchor 712 disengages from the retainer 762, the biasing element of the anchor 712 can force the jaws of the anchor 712 into a closed configuration, thereby securing the jaws to the target area 704. Through these steps, the anchor 712 (and anchor 708) can automatically open and close during deployment due to interaction with the retainer 762.
[0090] The user can move the inlet 706 to a position on the tissue 702 opposite to or otherwise facing the target area 704. This movement can retract the target area 704 due to the connection between the anchor 708 (still in the retainer 706) and the anchor 712 via the tether 714. Using the achieved desired retraction vector, the user can arrange the anchor 708 on the tissue 702 in a manner similar to how the anchor 712 is placed on the target area 704 to secure the retraction vector (see [link to product]). Figure 7CThen, the user can remove the retainer 762 from the appliance cavity 760.
[0091] With the target area 704 pulled open, the user can cut the target area 704 with a cutting tool 720 (which may be similar to any of the aforementioned cutting tools in this invention). During cutting, the target area 704 may form flaps that can be pulled toward the anchor 708 by the tension and / or bias force in the tether 714. This may result in a decrease in the pulling force on the target area 704. To increase the pulling force, the user can remove the cutting tool 720 and reinsert the positioning tool 718. The user can extend the positioning tool 718 from the inserter 706. The positioning tool 718 may include gripping elements 719, such as the jaws of pliers. The user can apply compressive force on the proximal tips of the jaws 707 and 709 to move the anchor 708 into an open position, thereby releasing the tissue 702. The positioning tool 718 and / or the inserter 706 can move the anchor 708 to another location on the tissue 702, which can apply a different pulling force on the target area 704. The user can then return to the cutting target area 704. This process can be repeated until the target area 704 is removed.
[0092] Other variations are also conceivable. For example, multiple tethers 714 can be used. Each of the tethers 714 can be attached to the same anchor 712 at its first end. Each of the tethers 714 can have its own anchor 708 at its second end. Each of the tether-anchor pairs can be attached to different locations on the tissue 702, thereby imparting multiple pulling forces with different vectors on the target area 704.
[0093] Alternatively, multiple anchor-tether-anchor assemblies (e.g., assemblies similar to anchor 708, tether 713, and anchor 712) can be used to pull apart the target area 704. For example, one anchor-tether-anchor assembly can be used to initially pull apart the target area 704 during the first cutting phase. Once slack is created in the anchor-tether-anchor assembly and the desired amount and / or direction of pull apart is not provided, another anchor-tether-anchor assembly can be inserted to increase the amount of pull apart and / or change the direction of pull apart. The anchor-tether-anchor assemblies can be identical or can have one or more differences. For example, one may have a shorter tether, a different tether construction, and / or a different type of anchor.
[0094] Alternatively, the tether 714 can be omitted. Anchors 708 and 710 can be arranged separately from each other to engage tissue, and are not necessarily used for tissue retraction. For example, anchors 708 and 710 can be used as clamps for closing holes in tissue, positioning tissue, clamping blood vessels, or performing any other suitable task.
[0095] Figure 8 and 9 Anchors 808 and 908 are shown. Anchors 808 and 908 can be used to replace anchors 708 and 712 of system 700. Anchors 808 and 908 may respectively include integrated jaws 807 and 809, and 907 and 909, which form the number 8.
[0096] Regarding anchor 808, biasing element 813 can engage opposing surfaces of the proximal portion of anchor 808. Biasing element 813 may include, for example, a compression spring. Figure 8 In the diagram, biasing element 813 is shown in a partially compressed state, indicating how biasing element 813 would appear when a compressive force is applied to the proximal portion of anchor 808. Without force, the distal tips of jaws 807 and 809 can move toward each other and / or engage.
[0097] Regarding anchor 908, biasing element 913 can engage the opposing surfaces of the distal portion of anchor 908. Biasing element 913 may include, for example, a tension spring. Figure 9 In the diagram, biasing element 913 is shown in a partially stretched state, indicating how biasing element 913 would appear when a compressive force is applied to the proximal portion of anchor 908. Without force, the distal tips of jaws 907 and 909 can move toward each other and / or engage.
[0098] Figure 10A distal view of retainer 1062 is shown. A cavity 1060 is shown within retainer 1062. Retainer 1062 may include an inner surface region at its distal end having a different inner diameter. For example, the inner surface of retainer 1062 may include opposing regions 1023 and 1025. Opposing regions 1023 and 1025 may be equidistantly spaced from the central longitudinal axis of retainer 1062. The inner surface of retainer 1062 may also include opposing regions 1027 and 1029. Opposing regions 1027 and 1029 may gradually slope toward the central longitudinal axis of retainer 1062. The inner surface of retainer 1062 may also include opposing regions 1031 and 1033. Opposing regions 1031 and 1033 may provide a transition between opposing regions 1023 and 1025 and adjacent regions 1027 and 1029. Relative regions 1031 and 1033 may be substantially coplanar, and / or may be straight portions of the inner surface of the retainer 1062. A portion of the inner surface of the retainer 1062 having relative regions 1023 and 1025, 1027 and 1029, 1031 and 1033 may be only the distal portion of the retainer 1062. The inner surface of the proximal portion of the retainer 1062 may be circular, and / or may have an inner diameter similar to the inner diameter defined between relative regions 1023 and 1025.
[0099] Retainer 1062 can be used instead of retainer 762 in system 700. Any of anchors 708, 712, 808, and 908 can be positioned within cavity 1060. A region of the inner surface of retainer 1062 can engage the anchor. Using anchor 708 as an example, anchor 708 can be positioned within cavity 1060 of the proximal portion of retainer 1062. Anchor 708 can be in its closed configuration or near its closed configuration, depending on the width of cavity 1060 in the proximal portion of retainer 1062. Positioning device 718 can move anchor 708 distally such that the distal portions of jaws 707 and 709 extend from retainer 1062 and engage the proximal portions of jaws 707 and 709 with opposing regions 1023 and 1025. The user can rotate the retainer 1062 clockwise relative to the anchor 708 to engage the proximal portions of jaws 707 and 709 with opposing regions 1027 and 1029. Continued clockwise rotation of the retainer 1062 compresses the proximal portions of jaws 707 and 709 as the distance between the diameter-opposing portions of opposing regions 1027 and 1029 decreases. The anchor 708 can achieve an open configuration when the proximal portions of jaws 707 and 709 are close to opposing regions 1031 and 1033. The open jaws 707 and 709 can receive tissue (not shown). Continued clockwise rotation of the retainer 1062 causes the proximal portions of jaws 707 and 709 to separate from opposing regions 1027 and 1029 and move radially outward along opposing regions 1031 and 1033 due to the biasing force applied to jaws 707 and 709 by the biasing element. Anchor 708 can be moved back toward its closed position, thereby securing jaws 707 and 709 to the tissue. Any of anchors 712, 808, and 908 can be arranged from retainer 1062 in a similar manner.
[0100] Figure 11A retainer 1162 similar to retainer 762 is shown. For example, retainer 1162 may include a proximal portion 1103, a distal portion 1105, and an inner cavity 1160, wherein the width of the inner cavity 1160 is greater in the proximal portion 1103 than in the distal portion 1105. In the figure, a portion of retainer 1162 has been removed to expose the interior of retainer 1162 and the anchors (e.g., anchors 1108, 1112, and 1121) housed therein. Anchors 1108, 1110, and 1121 may be similar to anchors 708 and 712. For example, anchor 1108 may include jaws 1107 and 1109 that pivot about fulcrum 1111, and jaws 1107 and 1109 may be biased toward a closed configuration by a biasing element 1113 (e.g., a torsion spring). In the closed configuration, the distal tips of jaws 1107 and 1109 may contact, or a compressive force may be applied to the tissue between jaws 1107 and 1109. Applying a compressive force to the proximal tips of jaws 1107 and 1109 can move jaws 1107 and 1109 to the open configuration by overcoming the biasing force applied by biasing element 1113. Anchors 1112 and 1121 may be similar to anchor 1108.
[0101] Before being positioned from retainer 1162, anchors 1108, 1112, and 1121 can be arranged end-to-end, with the distal tip of the jaws of anchor 1121 clamped onto the proximal tips of the jaws of anchor 1108, 1107 and 1109. Similarly, the distal tips of the jaws of anchor 1108, 1107 and 1109 can be clamped onto the proximal tips of the jaws of anchor 1112.
[0102] During placement, a positioning device (not shown, but similar to positioning device 718) can be used to push anchors 1108, 1112, and 1121 distally through the inner cavity 1160. Anchor 1112 can begin to move away from the distal end of retainer 1162. As the distal tips of the jaws 1107 and 1109 of anchor 1108 reach the transition between the proximal portion 1103 and the distal portion 1105 of retainer 1162, the reduction in the diameter of retainer 1162 allows the inner surface of retainer 1162 to apply a compressive force to the distal tips of the jaws 1107 and 1109 of anchor 1108. This compressive force can act on the proximal tips of the jaws of anchor 1112, thereby moving anchor 1112 to its open position. Anchor 1112 can receive tissue between its jaws.
[0103] As the positioning device further pushes the anchors 1108, 1112, and 1121 distally, the proximal tip of the jaws of anchor 1108 can be compressed by retainer 1162 (and the distal tip of the jaws of anchor 1121) at the transition between the proximal portion 1103 and the distal portion 1105 of retainer 1162. Anchor 1108 can release anchor 1112, thereby allowing anchor 1112 to move into its closed position to secure to tissue. Anchor 1108 can then be prepared to receive tissue. This process can be repeated to deploy additional anchors. Although three anchors are shown, it should be understood that any suitable number of anchors can be provided in retainer 1162. After deployment, the positioning device can be used to apply compressive force on the proximal tip of any of the jaws of anchors 1108, 1112, and 1121 to move the anchor into an open position to release tissue. Positioning device 1118 and / or importer 1106 can move any of the anchors 1108, 1112, and 1121 to another location.
[0104] It is conceivable that anchors 1108, 1112, and 1121 can be positioned to engage tissue without being secured by ropes, rather than necessarily engaging to retract tissue. For example, anchors 1108, 1112, and 1121 can be used as clamps to close holes in tissue, position tissue, clamp blood vessels, or perform any other suitable task. Alternatively, at least two of anchors 1108, 1112, and 1121 can be linked by tethers (not shown, but similar to tethers 114, 214, and 714) so that two or more of anchors 1108, 1112, and 1121 can be used for tissue retraction. Although system 1100 has been described above as having a retainer 1162 with a narrowed distal portion 1105, it is conceivable that... Figure 10 Retainer 1062 can replace retainer 1162. In such an example, the relative rotation of retainer 1062 with respect to anchors 1108, 1112 and 1121 can be used to open and close anchors 1108, 1112 and 1121.
[0105] Figures 12A to 12F A system 1200 for retracting tissue 1202 is shown. Tissue 1202 may include, for example, a target region 1204 to be removed, such as a region with a lesion. System 1200 may include an introducer 1206 for accessing tissue 1202. The introducer 1206 may facilitate the arrangement of anchors 1208 and 1212 on tissue 1202, such as the target region 1204 and a portion of tissue 1202 opposite to or otherwise facing the target region 1204. A tether 1214 that can engage the anchors 1208 and 1212 may also be arranged to aid in retracting the target region 1204.
[0106] Figure 12A An importer 1206 is shown in a delivery configuration that facilitates navigation of the distal end of the importer 1206 to the target area 1204. Anchors 1208 and 1212 can be received within a retainer 1262. A positioning device 1218 can also be received within the retainer 1262. The positioning device 1218 can be releasably coupled to the anchors 1212. By moving the positioning device 1218 distally, a user can push the anchors 1208 and 1212 and the tether 1214 distally to eject the anchors 1208 and 1212 and the tether 1214 from the retainer 1262 (see [link to image]). Figure 12B Anchor 1208 can be ejected in a closed configuration. Anchor 1212 can initially be ejected in a closed configuration, but once ejected, positioning device 1218 can be actuated to move anchor 1212 to an open configuration for receiving target area 1204. Positioning device 1218 can be actuated again to move anchor 1212 to a closed configuration to secure anchor 1212 to target area 1204, as shown. Figure 12C What we see in the video.
[0107] With anchor 1212 secured to target area 1204, the user can release positioning device 1218 from anchor 1212. The user can manipulate inlet 120 toward anchor 12086 and can releasably connect inlet 1206 to anchor 1208 (see [link]). Figure 12D and 12E Using the infeeder 1206 and the positioning device 1218, the user can move the anchor 1208 to a portion of the tissue 1202 opposite to or otherwise facing the target area 1204. This movement can apply tension to the tether 1214, which can pull the anchor 1212 and thus pull the target area 1204 away. Figure 12E When the desired pull-away vector is achieved, the user can actuate the positioning device 1218 to open the anchor 1208. This allows the anchor 1208 to receive tissue 1202, after which the positioning device 1218 can close the anchor 1208 to secure the anchor 1208 to the tissue 1202.
[0108] Cutting tool 1220 (similar to any of the cutting tools described above in this specification) can be used to cut the pulled-out target area 1204 (see... Figure 12F If cutting reduces the tension in the tether 1214 to the point that pulling away the target area 1204 is no longer sufficient, the position of the anchor 1208 can be readjusted. This can be achieved by releasably attaching the positioning device 1218 to the anchor 1208 (see [link to product]). Figure 12DThe positioning device 1218 is actuated to open the anchor 1208 to release the tissue 1202, move the anchor 1208 to another position on the tissue 1202 to achieve a new desired retraction vector, and actuate the positioning device 1218 to close the anchor 1208 to secure the anchor 1208 to the new position on the tissue 1202 to achieve readjustment. This readjustment can provide the user with the ability to utilize different retraction vectors (e.g., retraction direction and / or amplitude) relative to the target area 1204. This control over the retraction vector can provide the user with enhanced ability to expose and / or visualize the cutting plane, which the user uses to guide the cutting device 1220 to make cuts to remove the target area 1204. Additionally or alternatively, the positioning device 1218 can be used to move the anchor 1212 from the target area 1204 to another target area to retract and remove the new target area.
[0109] The injector 1206 may be similar to any of the aforementioned injectors described in this invention. The injector 1206 may include a cavity, one of which may be an instrument cavity 1260. The retainer 1262 may include a sleeve that can slide within the instrument cavity 1260 such that the distal end of the retainer 1262 may extend from the injector 1206 (e.g., during the placement of anchors 1208 and 1212) and be retracted into the injector 1206 (e.g., during the insertion and manipulation of the distal portion of the injector 1206 into the target region 1204).
[0110] Anchor 1208 may include a base 1244. Base 1244 may include a sleeve or capsule body having an inner cavity. Anchor 1208 may also include a fastener 1238 for attachment to tissue 1202, such as a gripping element formed by jaws 1207 and 1209. Fastener 1238 may extend distally from the distal end of base 1244. Jaws 1207 and 1209 may have a closed configuration (in... Figure 12A (as seen in) and the open form (similar to) Figure 12B (The open state of anchor 1212 in the middle).
[0111] Anchor 1208 may further include an actuating element 1235. Actuating element 1235 may include a collar 1237 and a shaft 1239. The collar 1237 may extend proximally from the proximal end of the base 1244. The collar 1237 may be coupled to fastener 1238 via the shaft 1239. The shaft 1239 may extend through the base 1244. When movement of the collar 1237 and shaft 1239 in the proximal direction pulls jaws 1207 and 1209 toward the base 1244, jaws 1207 and 1209 may be in a closed configuration. The distal end of the base 1244 may apply a restraining force to jaws 1207 and 1209, thereby holding them in the closed configuration. The movement of the collar 1237 and shaft 1239 in the distal direction allows the jaws 1207 and 1209 to extend distally away from the base, thereby removing the restraint on the jaws 1207 and 1209 and allowing them to move into an open position. Anchor 1212 can be similar to anchor 1208. Anchors 1208 and 1212 can be connected by a tether 1214, which can be similar to tethers 114, 214, and 714. The end of tether 1214 can be attached to the base of anchors 1208 and 1212. Alternatively, tether 1214 can be omitted. In such an example, anchors 1208 and 1212 can be used as individual repositionable surgical clamps.
[0112] Positioning device 1218 may include receiver 1241 and actuation element 1243. Receiver 1241 may include a cannula or capsule having an inner lumen (not shown). Actuation element 1243 may be movable within the lumen of receiver 1241 in proximal and distal directions such that actuation element 1243 may extend from the distal end of receiver 1241 and may be retracted to the distal end or into receiver 1241. Figure 12D A manipulator 1243 is shown extending distally from the distal end of receiver 1241. Manipulator 1243 may be configured to releasably engage a collar 1237 of actuation element 1235 of anchor 1208. For example, manipulator 1243 may include a curved distal end 1245.
[0113] Once the bent distal end 1245 engages the collar 1237, the actuating element 1243 can be retracted into the receiver 1241 to pull the anchor 1208 proximally into the receiver 1241. Initially, the proximal portions of the collar 1237 and the shaft 1239 can be pulled into the receiver 1241. Further retraction of the actuating element 1243 can pull the base 1244 into the receiver 1241 so that the receiver 1241 can receive the base 1244. The distal portion of the receiver 1241 and the proximal portion of the base 1244 may include mating coupling elements 1247 and 1249 for releasably coupling the receiver 1241 and the base, thereby allowing the receiver 1241 to temporarily capture the base 1244. When the coupling elements 1247 and 1249 are engaged, the receiver 1241 and the base 1244 can be secured relative to each other. The connecting elements 1247 and 1249 may include any suitable releasable mechanical connection, such as snap-fit connection, locking structure, magnetic coupling, etc.
[0114] With the connecting elements 1247 and 1249 engaged, the actuating element 1243 can extend distally to move the collar 1237, shaft 1239, and jaws 1207 and 1209 distally relative to the base 1244. This moves the jaws 1207 and 1209 to their open position, allowing the anchor 1208 to acquire tissue 1202 and / or release previously acquired tissue 1202. Proximal movement of the actuating element 1243 can move the jaws 1207 and 1209 back to their closed position to secure the anchor 1208 to the newly acquired tissue. After the anchor 1208 is secured to the tissue 1202, the connecting elements 1247 and 1249 can be released from each other, and the actuating element 1243 can be released from the collar 1237. The positioning device 1218 can move away from the anchor 1208, retaining the anchor 1208 in the appropriate position on the tissue. This process can be repeated whenever anchors 1208 and 1212 need to be arranged and / or rearranged onto the tissue.
[0115] Figure 13 A portion of another positioning element 1318 and another anchor 1308 is shown, which is similar to positioning element 1218 and anchor 1208 of system 1200. It is contemplated that portions of positioning element 1318 and anchor 1308 could be used in place of similar portions of positioning element 1218 and anchor 1208. Positioning element 1318 may include a receiver 1341 and an actuating element 1343 having a curved distal end 1245. Anchor 1308 may include a fastener 1338 having jaws 1307, 1309; an actuating element 1335 including a shaft (not shown) and a collar 1337; and a base 1344.
[0116] Receiver 1341 and base 1344 may include mating coupling elements 1347 and 1349. Coupling element 1347 may include a groove or channel extending proximally from the distal end of receiver 1341 and laterally forming an L-shaped chamber. Coupling element 1349 may include a protrusion projecting from the outer surface of base 1344. In use, actuating element 1343 may engage collar 1337 and pull base 1344 into receiver 1341. Coupling element 1349 may be aligned with coupling element 1347 such that when actuating element 1343 moves proximally, coupling element 1349 may move proximally through coupling element 1347. By twisting actuating element 1343, anchor 1308 may rotate about its central longitudinal axis, causing coupling element 1349 to travel laterally through coupling element 1347. This releasably engages positioning element 1318 to anchor 1308.
[0117] When the positioning element 1318 is releasably coupled to the anchor 1308, the receiver 1341 and the base 1344 can be secured relative to each other. The actuating element 1343 can be pulled proximally to close the jaws 1307, 1309 for securing the anchor 1308 to tissue. The actuating element 1343 can be pushed distally to open the jaws 1307, 1309 to allow the jaws 1307, 1309 to capture tissue, and / or release the jaws 1307, 1309 from previously captured tissue to reposition the anchor 1308.
[0118] Figure 14 In addition to portions of another positioning element 1418 and another anchor 1408, which are similar to positioning elements 1218 and 1318 and anchors 1208 and 1308 of systems 1200 and 1300, respectively, portions of positioning elements 1418 and anchors 1408 are conceivable to replace similar portions of other positioning elements and anchors. Positioning element 1418 may include a receiver 1441 and an actuating element 1443 having a bent distal end 1445. Anchor 1408 may include a fastener 1438 having jaws 1407 and 1409; an actuating element 1435 including a shaft 1439 and a collar 1437; and a base 1444.
[0119] Receiver 1441 and base 1444 may include mating coupling elements 1447 and 1449. Coupling elements 1447 and 1449 may include, for example, mating geometries, such as mating threads. Coupling element 1447 may include threads on the inner surface of receiver 1441. Coupling element 1449 may include threads on the outer surface of base 1444. In use, actuating element 1443 may engage collar 1437 and may pull the proximal end of base 1444 to the distal end of receiver 1441. By twisting actuating element 1443 (which can be assisted by pulling actuating element 1443 proximally), anchor 1408 may rotate about its central longitudinal axis, thereby facilitating engagement of coupling elements 1447 and 1448. Further twisting of actuating element 1443 may screw anchor 1408 into positioning element 1418. This releasably engages positioning element 1418 to anchor 1408.
[0120] When the positioning element 1418 is releasably coupled to the anchor 1408, the receiver 1441 and the base 1444 can be secured relative to each other. The actuating element 1443 can be pulled proximally to close jaws 1407 and 1409 for securing the anchor 1408 to tissue. The actuating element 1443 can be pushed distally to open jaws 1407 and 1409 to allow jaws 1407 and 1409 to access tissue, and / or release jaws 1407 and 1409 from previously accessed tissue for re-insertion of the anchor 1408.
[0121] Figure 15 A portion of the actuating element 1543 is shown, and in particular, the curved distal end 1545 of the actuating element 1543. The actuating element 1543 may be similar to actuating elements 1243, 1343, and 1443. The curved distal end 1545 may engage a collar 1537 of the actuating element 1535. The collar 1537 may be similar to collars 1237, 1337, and 1437. However, the collar 1537 may have a discontinuity 1551 formed therein. When sufficient force is applied at the discontinuity 1551 by the curved distal end 1545, the curved distal end 1545 may unfold the collar 1537, thereby allowing the curved distal end 1545 to enter or exit the collar 1537 via the discontinuity 1551. The collar 1537 may be used in place of any of the collars 1237, 1337, and 1437 to allow the actuating element to enter into and exit the collar.
[0122] Figure 16A and 16BA portion of another positioning element 1618 and another anchor 1608 is shown. It is contemplated that portions of positioning element 1618 and anchor 1608 can be used to replace similar portions of any of the other positioning elements described herein (such as positioning elements 1218, 1318, and 1418). Positioning element 1618 may include a receiver 1641 and an actuating element 1643 having an enlarged distal end 1645. The enlarged distal end 1645 may include a spherical ball, a circular plate, and / or any other suitable protrusion. Anchor 1608 may include a fastener with jaws (not shown); an actuating element 1635 including a shaft 1639 and a socket 1637; and a base 1644. The fastener may include, for example, aspects of fasteners 1238, 1338, and 1438.
[0123] Receiver 1641 and base 1644 may include mating coupling elements 1647 and 1649. Coupling elements 1647 and 1649 may include, for example, mating snap-fit elements. Coupling element 1647 may include one or more protrusions at the distal end of the inner surface of receiver 1641. Coupling element 1649 may include one or more notches or notches on the outer surface of the proximal end of base 1644, or through one or more holes on one or more sides of the proximal end of base 1644.
[0124] Figure 16A Connecting elements 1647 and 1649 are shown, which are releasably connected to each other to secure receiver 1641 relative to base 1644. The extended distal end 1645 of actuating element 1643 is also releasably connected to the socket 1637 of actuating element 1635. Moving the releasably connected actuating element 1643 and actuating element 1635 distally opens the fastener, while moving it proximally closes the fastener. Figure 16A In this configuration, the fastener is closed. Further proximal movement of the socket 1637 can be prevented by the engagement of the proximal end of the socket 1637 with the reduced-diameter portion 1653 of the base 1644. The closed fastener can be secured to the tissue. To retain the anchor 1608 in its proper position within the tissue, the actuating element 1643 can be pulled proximally to pull the enlarged distal end 1645 out of the socket 1637, as in... Figure 16B As shown in the diagram, continued proximal pulling of the actuating element 1643 can bring the enlarged distal end 1645 into contact with the reduced-diameter portion 1657 of the receiver 1641. As the enlarged distal end 1645 moves proximal past the reduced-diameter portion 1657, it can force the reduced-diameter portion 1657 to open, which can release the coupling element 1647 from the coupling element 1649, thereby allowing the positioning element 1618 to be released from the anchor 1608.
[0125] To remove anchor 1608 from the organization for rearrangement, the distal end of receiver 1641 can be moved toward the proximal end of base 1644. The inclined surface of coupling element 1647 can engage the proximal end of base 1644, allowing coupling element 1647 to move outward and onto the outer surface of base 1644. Receiver 1641 can be moved distally relative to base 1644 until coupling element 1647 snaps into engagement with coupling element 1649. Actuating element 1643 can be moved to engage the enlarged distal end 1645 with the reduced diameter portion 1657 to help push the reduced diameter portion 1657 outward, thereby facilitating coupling of receiver 1641 to base 1644. Actuating element 1643 can be moved distally to engage with socket 1637 to push socket 1637 distally, thereby opening the fastener. When socket 1637 is pushed distally, enlarged distal end 1645 can engage socket 1637. In one example, a protrusion, shoulder, or other support (not shown) may be provided on the inner surface of the base 1644 to engage the distal end of the socket 1637, thereby limiting further distal travel of the socket 1637 beyond the point where the fastener is fully open. When the socket 1637 contacts the protrusion, shoulder, or support, the proximal end of the socket 1637 forcibly pushes the enlarged distal end 1645, causing the enlarged distal end 1645 to engage within the socket 1637.
[0126] With the fastener open, the anchor 1608 can be released from one location on the tissue and moved to another. By moving the actuating element 1643 proximally, the fastener can be closed to the new location on the tissue, thereby moving the actuating element 1635 proximally due to the enlarged distal end 1645 being received into the socket 1637. The positioning element 1618 can then be released from the anchor according to the steps described above. This process can be repeated whenever repositioning is required.
[0127] Figure 17A perspective view of a portion of an actuating element 1735 is shown, which may be similar to actuating element 1635. Actuating element 1735 may be used instead of actuating element 1635. Actuating element 1735 may include a recess 1737 at its proximal end. However, the proximal portion of actuating element 1735 may extend proximally beyond the proximal end of base 1644, and the remainder of actuating element 1735 may be received in base 1644. A lateral protrusion 1757 at the proximal end of recess 1737 may be configured to abut against the proximal end of base 1644 when the fastener of anchor 1608 is fully open. The abutment of lateral protrusion 1757 against the proximal end of base 1644 may hold recess 1737 in place so that the enlarged distal end 1645 of actuating element 1643 may be inserted into recess 1737 for fastening closure. The socket 1737 may define a U-shaped recess so that the enlarged distal end 1645 enters the socket 1737 from the side. It is also conceivable that the base of the U-shaped recess may be enlarged to further facilitate the entry of the enlarged distal end 1645 from the side.
[0128] Figure 18 A portion of another positioning element 1818 and another anchor 1808 is shown, similar to positioning element 1618 and anchor 1608. Anchor 1808 may include a spring-biased fastener 1838 having jaws 1807 and 1809. Fastener 1838 may be spring-biased by a biasing element 1859, which may include a compression spring. The proximal end of biasing element 1859 may engage base element 1861 at the proximal ends of jaws 1807 and 1809. The distal end of biasing element 1859 may engage a stop 1863, which may be fixed relative to the distal end of base 1844 of anchor 1808. In the absence of a deforming force acting on biasing element 1859, biasing element 1859 may move base element 1861 away from stop 1863. This can pull jaws 1807 and 1809 toward the distal end of base 1844, and close jaws 1807 and 1809 due to engagement between jaws 1807 and 1809 and the inner surface of the distal end of base 1844 and / or engagement between jaws 1807 and 1809 and the outer surface of stop 1863.
[0129] Positioning element 1818 may be provided with actuating element 1843 having an enlarged distal portion 1845 similar to an enlarged distal end 1645. The enlarged distal portion 1845 may include a circular plate, a spherical ball, and / or any other suitable enlargement. The enlarged distal portion 1845 may be used to engage a receiver (not shown) of positioning element 1818, which may be similar to receiver 1641, to facilitate engagement of a coupling element (not shown) onto the receiver using a coupling element on base 1844. The coupling element may, for example, be similar to coupling elements 1647 and 1649. The enlarged distal portion 1845 may also facilitate disengagement of the coupling element.
[0130] When the connecting elements are engaged, the actuating element 1843 can be pushed distally via the base 1844. An extension 1865, extending distally from the enlarged distal portion 1845, can engage the base element 1861. The extension 1865 can apply a distal force to the base element 1861, resulting in compression of the biasing element 1859 and causing jaws 1807 and 1809 to move to the open position. When the distal force on the base element 1861 is removed or reduced, the biasing element 1859 can move jaws 1807 and 1809 back to the closed position.
[0131] Figures 19A to 19H A system 1900 for retracting tissue 1902 is shown. Tissue 1902 may include, for example, a target region 1904 to be removed, such as a region with a lesion. System 1900 may include an introducer 1906 for providing access to tissue 1902. The introducer 1906 may facilitate the placement of a tether 1914 through the target region 1904 and the placement of an anchor 1908 on a portion of tissue 1902 opposite to or otherwise facing the target region 1904.
[0132] Figure 19A An inlet 1906 located near the target area 1904 is shown, and an anchor 1908 extending distally from the distal end of the inlet 1906. Figure 19B An anchor 1908 is shown in its open configuration, with jaws 1907 and 1909 extended for receiving the target area 1904. A tether 1914 can be secured to the jaws 1907. Figure 19C An anchor 1908 is shown, which is moved to a closed configuration to penetrate the target area 1904 with jaws 1907 and 1909, and to allow the tether 1914 to pass through the target area 1904. The tether 1914 can be gripped by the jaws 1909. Figure 19D Anchor 1908 is shown moved back to the open position, with tether 1914 now passing through target area 1904. Anchor 1908 can be opened and closed by actuating positioning device (not shown).
[0133] The user can manipulate the infeeder 1906 and anchor 1908 onto a portion of tissue 1902 that is opposite to or otherwise faces the target area 1904. This movement can apply tension to the tether 1914, which can pull the tether 1914 and thus pull the target area 1904 away (in... Figure 19E (As seen in the image). When the desired pull-away vector is achieved, the user can close the anchor 1908 to fasten the anchor 1908 to the tissue 1202 at the desired location (as seen in the image). Figure 19F (As seen in the video).
[0134] Cutting instrument 1920 (similar to any of the aforementioned cutting instruments described in this specification) can be used to cut the pulled-out target area 1904 (see Figure 19G If cutting reduces the tension in the tether 1914, resulting in insufficient pull on the target area 1904, the length of the tether 1914 can be adjusted to enhance pull. This readjustment can be achieved by grasping the free end of the tether 1914 with tweezers or another gripping tool and pulling on the free end to tighten the portion of the tether 1914 connecting the anchor 1908 to the target area 1904. Figure 19H As shown in the image.
[0135] The infeeder 1906 may be similar to any of the other infeeders described in this invention. The infeeder 1906 may include a cavity, one of which may be an instrument cavity (not shown). An end cap 1926 may be disposed at the distal end of the infeeder 1906. The end cap 1926 may include a plurality of ports, one of which may be port 1930. Port 1930 may open into the instrument cavity. An anchor 1908 may slide within the instrument cavity such that the anchor 1908 may be received within the instrument cavity during delivery and may extend distally from the instrument cavity via a passage through port 1930 for arrangement. The insertion and removal of the anchor 1908 into and out of the infeeder 1906 may be caused by a positioning device (not shown) releasably coupled to the anchor 1908. The positioning device may, for example, be similar to any of the aforementioned positioning devices described in this invention.
[0136] Anchor 1908 may include jaws 1907 and 1909 and a base 1944. Jaws 1907 and 1909 can move between open and closed configurations by moving relative to the base 1944. For example, jaws 1907 and 1909 can move toward an open configuration when moved distally relative to the distal end of the base 1944. Jaws 1907 and 1909 can move toward a closed configuration when moved proximally relative to the distal end of the base 1944. The arrangement and operation of jaws 1907 and 1909 and the base 1944 can be similar to the arrangement and operation of similar components of anchors 1208, 1210, 1308, 1408, 1608, and 1808. Positioning devices for operating jaws 1907 and 1909 can be similar to positioning devices 1218, 1318, 1418, 1618, and 1818.
[0137] A tether 1914, which may include sutures, chains, or other suitable structures and / or materials, may extend along a portion of the jaws 1907 such that a gripping element 1967, extending laterally inward from the jaws 1909, can hook onto a portion of the tether 1914 when the anchor 1908 is closed. In use, the anchor 1908 may be positioned in an open configuration, wherein the jaws 1907 and 1909 are above the opposite sides of the target area 1904 (e.g., Figure 19B (As seen in the image). Then, the anchor 1908 can be closed so that when the jaws 1909 move toward the jaws 1907, the gripping element 1967 pierces the target area 1904 (as shown in the image). Figure 19C (As seen in the image). The hook feature 1969 at one end of the gripping element 1967 can be interfaced with the jaws 1907 to hook the loop 1971 of the tether 1914 extending along the first jaws 1907. The anchor 1908 can be reopened so that the gripping element 1967 with the tether 1914 hooked thereon can pass through the target area 1904, thereby anchoring the tether 1914 to the target area 1904.
[0138] Jaw 1907 may include a notch 1973 along the inner surface of the distal end of jaw 1907. Jaw 1907 may also include a slot 1975 extending laterally through its distal end and communicating with the notch 1973. When the loop 1971 of the tether 1914 is hooked onto the notch 1973, a portion of the loop 1971 may extend across the slot 1975. Gripping element 1967 may pass through the slot 1975 between opposite sides of the notch 1973 to hook the loop 1971. Jaw 1907 may also include an opening 1977 extending laterally therethrough, the opening 1977 being spaced apart from the slot 1975 by a certain distance. Alternatively, jaws 1907 may include rings, magnets, hook-and-loop fasteners, screws, or latches for engaging with hooks, magnets, hook-and-loop fasteners, threaded holes, or chucks on tether 1914 to secure tether 1914 to jaws 1907.
[0139] The length of the tether 1914 can extend through the base 1944 of the anchor 1908, with the proximal free end of the tether 1914 protruding from the proximal end of the base 1944. At its distal end, the tether 1914 can be fed through the opening 1977 so that the remaining distal length of the tether 1914 can extend along the inner surface of the jaws 1907. The loop 1971 of the tether 1914 can be hooked through the opposite side of the slot 1973 so that a portion of the loop 1971 extends across the slot 1975. Thus, when the gripping element 1967 passes through the slot 1975, the gripping element 1967 can pass through the loop 1971 to grip or hook a portion of it.
[0140] The gripping element 1967 can extend laterally from the inner surface of the jaws 1909. The gripping element 1967 may include a hook feature 1969, which may be defined by a J-shaped or L-shaped slot. The free end of the gripping element 1967 may have an angled surface 1979 configured such that when the gripping element 1967 is inserted through the slot 1975, a ferrule 1971 can be guided along the angled surface 1979 until the ferrule 1971 reaches and is received therein by the hook feature 1969. When the anchor 1908 is closed, at least a portion of the gripping element 1967 can be received within the slot 1975 such that the hook feature 1967 hooks the ferrule 1971.
[0141] When anchor 1908 is installed, the proximal free end of tether 1914 can extend from the proximal end of base 1944 (e.g., Figure 19G(As seen in the image). By pulling the free end, a portion of the tether 1914 between the target area 1904 and the anchor 1908 can be tightened. A one-way mechanism (not shown) may be provided in the base 1944. The one-way mechanism allows tightening of the tether 1914 while preventing it from loosening. The one-way mechanism may include, for example, a ratchet assembly. The tether 1914 may be similar to other tethers described above. Additionally or alternatively, the tether 1914 may include grooves and / or protrusions similar to zipper straps or chains for one-way movement to tighten. Alternatively, the tether 1914 may be omitted, and the anchor 1908 may be used alone as a surgical clamp.
[0142] Figure 20A and 20B A version of system 1900 is shown, in which tether 1914 extends proximally from anchor 1908, enters port 1930, passes through the instrument cavity, and extends proximally from the inlet 1906. The user can adjust the retraction of the proximal end of the inlet 1906 on the target area 1904 by pulling tether 1914. The step of grasping tether 1914 with tweezers or similar tools can be avoided.
[0143] Figure 20A and 20B Another difference is that the tether 1914 may not extend through the base 1944. In this respect, a one-way mechanism is not required in the base 1944. Instead, a one-way mechanism may be provided at the port 1930, within the instrument cavity, or proximal to the inlet 1906 to prevent the tether 1914 from loosening between the target area 1904 and the anchor 1908. As explained above, the one-way mechanism may include a ratchet assembly, a zipper tether feature, etc. Additionally or alternatively, the one-way mechanism may include a fastening at the proximal end of the inlet 1906 to prevent unnecessary distal migration of the tether 1914.
[0144] exist Figure 20A In this process, the cutting tool 1920 can cut the target area 1904 in a manner that produces blades. This can cause the portion of the tether 1914 between the anchor 1908 and the target area 1904 to become slack. Figure 20B The portion of the tether 1914 between the anchor 1908 and the target area 1904 is shown after tightening by pulling the proximal end of the tether 1914 from the proximal end of the inlet 1906.
[0145] Figure 21A and 21BA version of system 1900 is shown, wherein the pull vector acting on target region 1904 can be adjusted by arranging auxiliary anchors 1910. Auxiliary anchors 1910 can be manipulated by inserter 1906 (or another inserter) to engage with a portion of tether 1914 between anchor 1908 and target region 1904. Auxiliary anchors 1910 can be secured to tissue 1902 at another location while holding tether 1914, thereby adjusting the amplitude and / or direction of the pull force applied to target region 1904 via tether 1914 and anchor 1908. Additional auxiliary anchors can be inserted to further adjust the pull vector. It is also contemplated that auxiliary anchors 1910 can be used to adjust the pull vector of any of the other aforementioned tethers described in this invention.
[0146] Figure 22 Another exemplary version of auxiliary anchor 2210 is shown, which can be used to adjust the pull-away vector by engaging tether 1914 and organization 1902. Auxiliary anchor 2210 may include opposing jaws 2283 and 2285. Jaws 2283 and 2285 may include biasing elements 2287 and 2289, such as torsion springs, to bias jaws 2283 and 2285 into a closed configuration. Jaws 2283 and 2285 may be connected via spring member 2291. Spring member 2291 may include a tension spring that can be stretched to apply a pull-away force between jaws 2283 and 2285 and the material gripped by jaws 2283 and 2285. Opposite ends of spring member 2291 may be pivotally connected to jaws 2283 and 2285 via rotating links 2293 and 2295. In one example, jaws 2283 can open to receive tether 1914 and close to grip tether 1914. After the desired amount of pulling force is applied to tether 1914 via jaws 2283 and spring member 2291, jaws 2285 can be secured to tissue.
[0147] Figure 23A and 23B A version of system 1900 is shown, in which the pull-off vector acting on the target region 1904 can be adjusted by adjusting the angle of the rotating link 2393 of the base 1944, which is pivotally connected to the anchor 1908 by hinge 2395. Figure 23A In this configuration, rotating link 2393 can be positioned relative to base 1944 such that its central longitudinal axis is coaxial. Rotating link 2392 can pivot relative to base 1944 such that its central axis is angled, as shown below. Figure 23BAs shown in the diagram. A locking mechanism, such as a ratchet assembly, can be provided at hinge 2395 to maintain the angular orientation of the rotating link 2392 relative to the base 1944. The angle of the rotating link 2392 can change the direction of the pulling force applied to the target area 1904 and can increase the amplitude of the pulling force to cut the target area 1904. It is conceivable that, in this invention, the rotating link connection can be provided between any of the aforementioned tethers and anchors.
[0148] Figure 24A and 24B A version of the system 1900 is shown, wherein the pull vector acting on the target region 1904 can be adjusted by adjusting the distance between the legs of the tether 1914, which extends between the target region 1904 and the anchor 1908. Adjustment can be provided using a ring element 2397. The user can insert the ring element 2397 from... Figure 24A The position shown is slid downwards along the tether 1914 toward the target area 1904. The ring element 2397 continues to slide toward the target area 1904. Figure 24B The position shown reduces the length of the tether 1914 passing through the target area 1904, allowing the tether 1914 to tighten around the target area 1904. Tightening causes the target area 1904 to form an upward tent shape. It is conceivable that the annular element 2397 can be used with any version of the system 1900 described in this invention.
[0149] Figure 25A and 25B A version of system 1900 is shown, wherein the pulling force applied to target region 1904 by tether 1914 can be adjusted by heating tether 1914 and / or by directing electrical energy into tether 1914. In such an example, tether 1914 can be made of “muscle line,” which may include, for example, nitinol wire, configured to contract when heat or electrical energy is applied. The base 1944 of anchor 1908 may include port 2599, configured to receive, for example, the distal tip of cutting tool 1920. Cutting tool 1920 may be supplied with energy for contracting tether 1914 via port 2599. Figure 25A The diagram shows the tether 1914 before it retracts and the pulling force applied to the target area 1904. Figure 25B The diagram shows the tether 1914 after contraction and the increased pulling force. It is conceivable that either the aforementioned base and tether structure in this invention may include a muscle line and a port for directing energy into the muscle line to provide increased pulling force through the contraction of the muscle line.
[0150] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art based on consideration of the description and practice of the features disclosed herein. The description and examples are intended to be illustrative only.
Claims
1. A repositionable clamping system for an organization, comprising: The clip includes: Fastening element, the fastening element having a first form for receiving tissue and a second form for engaging tissue, A base for receiving at least a portion of the fastening elements, the fastening elements moving to a first configuration when moving away from the base, and moving to a second configuration when moving towards the base. An actuating element, partially received within the base to move the fastening element between a first configuration and a second configuration, the actuating element including a collar that can be contacted and engaged from the outside of the base to move the fastening element between the first configuration and the second configuration after deployment; and Appliance, the appliance comprising: An actuating element for engaging the collar, and A receiver is configured to receive at least a portion of the base to fix the base relative to the receiver, and the actuating element is configured to position the base to fix it relative to the receiver and to move the actuating element relative to the base when the base is fixed to the receiver, so that the fastening element moves between a first configuration and a second configuration; The actuating element has a discontinuity in its collar, and the operating element of the device can enter or exit the collar through this discontinuity, thereby engaging with the collar.
2. The repositionable clamping system of claim 1, wherein the receiver includes a first coupling element, the base includes a second coupling element, and the first coupling element is releasably coupled to the second coupling element to secure the base relative to the receiver.
3. The repositionable clamping system of claim 2, wherein the first coupling element includes a groove and one of a protrusion configured to be received in the groove, and the second coupling element includes the groove and the other of the protrusion.
4. The repositionable clamping system of claim 2, wherein the first coupling element and the second coupling element form a snap-fit connection.
5. The reconfigurable clamping system of claim 2, wherein the first coupling element includes internal geometry and the second coupling element includes external geometry that matches the internal geometry.
6. The repositionable clamping system according to any one of claims 1 to 5, wherein the actuating element comprises an arm having a curved distal end.
7. The reconfigurable clamping system according to any one of claims 1 to 5, wherein the first configuration is an open configuration and the second configuration is a closed configuration.
8. The reconfigurable clamping system according to any one of claims 1 to 5, wherein, The clamp includes a first clamp and a second clamp, and the clamping system further includes: A stretchable tether having a first end and a second end, wherein the first end of the stretchable tether is connected to the first clamp, and the second end of the stretchable tether is connected to the first clamp.
9. The repositionable clamping system of claim 8, wherein at least one of the first clamp and the second clamp has a first end engaged with one end of the stretchable tether and a second end engaged with tissue.
Citation Information
Patent Citations
Tissue hemostasis clamping device
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