Clip device for endoscope

Abstract

The present disclosure relates to a clip device comprising a sheath comprising an internal cavity and at least one open end, a plurality of clip arms movable between a first configuration in which the plurality of clip arms are open to receive a target tissue and a second configuration in which the plurality of clip arms are closed to clamp the target tissue. A locking mechanism is provided on the plurality of clip arms to engage one another to maintain the second configuration. A restriction mechanism is optionally configured in association with the locking mechanism to prevent the target tissue from being pinched between the locking mechanism.

Description

[0001] Relevant application data

[0002] Pursuant to 35:119 of the United States Code, this application is based on and claims priority to U.S. Provisional Application No. 63 / 148,655, filed February 12, 2021, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention relates to a clamping device for an endoscope, and more particularly, to an endoscope clamping device having an improved mechanism for locking the clamping arms of the clamping device. Background Technology

[0004] Various endoscopic clip devices are known, and many require hemostatic clips to control internal bleeding. The hemostatic clip grasps the tissue around the wound and temporarily holds the wound edges together to allow the natural healing process to permanently close the wound. A specialized endoscopic clip device is used to deliver the hemostatic clip to the desired location within the body, and then the endoscopic clip delivery device is withdrawn, leaving the hemostatic clip in place. Such conventional endoscopic clip devices can be loaded onto the distal end of the applicator assembly prior to endoscopic manipulation. Once the hemostatic clip has been deployed at the desired target area within the body, the applicator assembly can be reloaded with a new clip unit.

[0005] A typical endoscopic clamp device includes a pair of clamping arms, the proximal ends of which are connected to a connector configured to releasably engage the distal end of the applicator's control member. Each clamping arm includes a locking mechanism to lock the arms when clamping target tissue, allowing the arms to be pulled toward each other until the locking mechanisms engage. Once the arms are locked, a proximal force exceeding a predetermined threshold can be applied to the control member, disengaging it from the connector and allowing the control member to be coupled to a new clamping unit.

[0006] However, the locking mechanisms of conventional endoscopic clamp devices have defects in one or more aspects. For example, when moving a conventional locking mechanism to lock the clamp arm, the target tissue may be squeezed between the locking mechanisms. In this case, the locking mechanism may not function properly, leading to undesirable hemostasis. Summary of the Invention

[0007] Therefore, the object of this disclosure is an endoscope clamping device and clamping unit that substantially eliminates one or more problems caused by the limitations and disadvantages found in conventional endoscope clamping devices and clamping units.

[0008] The purpose of this disclosure is to provide a clamping device comprising: a sheath including an inner cavity and at least one open end; a plurality of clamping arms movable between a first configuration in which the plurality of clamping arms are open to receive target tissue and a second configuration in which the plurality of clamping arms are closed to clamp the target tissue. Locking mechanisms are respectively disposed on the plurality of clamping arms to engage with each other to maintain the second configuration. A restraining mechanism is optionally configured to be associated with the locking mechanism to prevent the target tissue from being squeezed between the locking mechanisms.

[0009] Another object of the present invention is to provide an endoscopic clamp device system for disposing of tissue, comprising: a clamp unit including a pair of clamping arms, the proximal ends of the clamping arms being connected to a connector, the clamp unit being movable between a first configuration for receiving target tissue between the clamping arms and a second configuration in which the target tissue is held by the clamping arms, the clamp unit being displaced from the distal ends of the clamping arms; locking mechanisms respectively disposed on the clamping arms for locking the clamping arms in the second configuration; an applicator including a sheath and a control member extending through the sheath from the proximal end to the distal end and including an inner cavity extending therethrough, the control member being releasably coupled to the connector to move the clamp unit between the first and second configurations, the clamping arms being constrained toward the second configuration via a surface of the inner cavity when the clamping arms are pulled proximally into the inner cavity; and a restraining mechanism configured to operate in association with the clamp unit to prevent the target tissue from being squeezed between the locking mechanisms.

[0010] Another object of this disclosure is to provide a method for delivering an endoscopic clip device, the method comprising: loading a first clip unit onto an applicator by coupling a control member of an applicator to a connector at the proximal end of a clip arm of a first clip unit; inserting the first clip unit into a target site within a patient via a passageway of an endoscope; moving the first clip unit between a first configuration in which the distal ends of the clip arms are separated from each other and a second configuration in which the distal ends of the clip arms are pulled toward each other by longitudinally moving the control member until target tissue is grasped between the distal ends of the clip arms; locking the clip arms in the second configuration by further proximally pulling the control member until the clip arms engage with each other via their locking mechanisms; and releasing the first clip unit from the applicator by further proximally pulling the control member until a proximal force exerted by the control member on the connector exceeds a predetermined threshold causing the control member to disengage from the connector to release the clip assembly from the applicator, wherein, in the second configuration, a restraining mechanism is operated to prevent target tissue from being squeezed between the locking mechanisms when the clip arms are pulled toward each other.

[0011] Additional features and advantages will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practice of the invention. The objects and other advantages of the disclosed endoscope clip devices, systems, and methods will be realized and obtained through the written description and embodiments thereof, as well as the structures particularly pointed out in the drawings. Attached Figure Description

[0012] The following detailed description of the preferred embodiments can be read in conjunction with the accompanying drawings, in which the same numbers designate the same elements.

[0013] Figure 1 A perspective view of a system according to an exemplary embodiment of the present invention is shown.

[0014] Figure 2 It shows that according to Figure 1 A side view of the distal part of the system.

[0015] Figure 3 It shows that according to Figure 1 A side view of the system's applicator.

[0016] Figure 4 It shows Figure 3 A side view of the distal part of the applicator.

[0017] Figure 5 It shows Figure 4 Longitudinal cross-sectional view of the distal part.

[0018] Figure 6 It shows Figure 3 A three-dimensional view of a portion of the applicator.

[0019] Figure 7 It shows Figure 6 The longitudinal cross-sectional view of this part of the applicator.

[0020] Figure 8A This is a schematic front view of a clamping unit in a first configuration according to an exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 8B This is an enlarged cross-sectional view taken at line AA in Figure 8. Figure 8C This is a schematic front view of a clamping unit in a first configuration, according to an exemplary embodiment, where the limiting member is located closer to the locking member than on a pair of clamping arms. Figure 8D It is a perspective view schematically illustrating an exemplary structural configuration between the limiting member and the locking member, and Figure 8E This is a perspective view schematically illustrating another exemplary structural configuration between the limiting member and the locking member.

[0021] Figure 9AThis is a schematic front view of a clamping unit in a second configuration, according to an exemplary embodiment, in which a target tissue is held by a pair of clamping arms. Figure 9B Is Figure 9A An enlarged cross-sectional view taken at line BB.

[0022] Figure 10A This is a schematic front view of a clamping unit in a first configuration according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 10B Is Figure 10A An enlarged cross-sectional view taken at line CC.

[0023] Figure 11A This is a schematic front view of a clamping unit in a second configuration, according to another exemplary embodiment, in which a target tissue is held by a pair of clamping arms. Figure 11B Is Figure 11A The cross-sectional view taken at line DD.

[0024] Figures 12A to 12B A side view of the distal portion of another exemplary embodiment of the clamping device system associated with the first embodiment is shown.

[0025] Figure 13A This is a schematic front view of a clamping unit in a first configuration according to yet another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 13B This is a schematic front view of a clamping unit in a second configuration where a pair of clamping arms are closed and clamping the target tissue.

[0026] Figure 14A This is a schematic front view of a clamping unit in a first configuration according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 14B Is Figure 14A An enlarged cross-sectional view taken at line EE.

[0027] Figure 15A This is a schematic front view of a clamping unit in a first configuration according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 15B Is Figure 15A An enlarged cross-sectional view taken at line FF.

[0028] Figure 16 This is a schematic diagram illustrating a clamping unit with limiting tracks in the channel of an endoscope according to an exemplary embodiment.

[0029] Figure 17 This is a schematic diagram illustrating a clamping unit with a limiting track in a first configuration according to an exemplary embodiment.

[0030] Figure 18 A side view of the distal portion of another exemplary embodiment of the clamping device system related to the second embodiment is shown.

[0031] Figure 19A This is a schematic front view of a clamping unit in a first configuration according to an exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 19B It is a schematic diagram. Figure 19A Side view of the clamping unit. Figure 19C This is a schematic illustration of the action of pulling the clamping unit into the sheath towards the second configuration. Figure 19A The side view of the clamping unit, and Figure 19D This is a schematic illustration of the clamping unit in the second configuration. Figure 19A Side view of the clamping unit.

[0032] Figure 20A This is a schematic front view of a clamping unit in a first configuration according to an exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 20B This is a schematic front view of a clamping unit in a second configuration where a pair of clamping arms are closed to clamp the target tissue. Figure 20C It is a schematic diagram based on and Figure 20A A front view of the clamping unit in a first configuration, which is different from another exemplary embodiment.

[0033] Figure 21 A side view of the distal portion of another exemplary embodiment of the clamping device system related to the third embodiment is shown.

[0034] Figure 22A This is a schematic side view of a clamping unit in a first configuration with a pair of clamping arms open, according to yet another exemplary embodiment. Figure 22B It is a schematic diagram. Figure 22A Top view of the clamping unit. Figure 22C This is a schematic side view of a clamping unit in a second configuration with a pair of clamping arms closed. Figure 22D It is a schematic diagram. Figure 22C Top view of the clamping unit.

[0035] Figure 23 This is a perspective view schematically illustrating an applicator for an endoscope using a clamping unit according to an exemplary embodiment.

[0036] Figure 24 It is a schematic diagram and Figure 23 A three-dimensional view of the clamping unit associated with the applicator.

[0037] In all the accompanying drawings, the dimensions of the various components have been appropriately adjusted for clarity. For ease of viewing, in some cases, only named features are labeled with reference numerals. Detailed Implementation

[0038] In the following description, the accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate exemplary embodiments of the invention and, together with the general description given above and the detailed description of the exemplary embodiments given below, serve to explain the principles of the invention.

[0039] Additionally, it should be noted that the terms “proximal” and “towards proximal” as used herein refer to the direction toward the user of the device (proximal / towards proximal), while the terms “distal” and “towards distal” refer to the direction away from the user of the device (distal / towards distal). The term “patient” as used herein includes any and all living organisms and includes the term “subject.” A patient can be a human or an animal.

[0040] Figure 1 A perspective view of an exemplary clamping device system 100 is shown. Figure 2 A side view of the distal portion of an exemplary clamping device system 100 is shown. Figure 1 and Figure 2 As shown, the clamping device system 100 includes a clamping unit 102, an applicator 104, and a cartridge 106. Before the system 100 is inserted into a living body to clamp target tissue, the clamping unit 102 can be loaded into the distal portion of the applicator 104. The applicator 104 is configured such that after the clamping unit 102 has been deployed in the patient, a new clamping unit 102 can be loaded onto the applicator 104, allowing the same applicator 104 to be used to deliver a new clamping unit 102 to a second portion of the patient's target tissue. Each clamping unit 102 according to this embodiment can be stored in the cartridge 106, which facilitates loading the clamping unit 102 onto the applicator 104.

[0041] In particular, such as Figure 1As shown, before being loaded onto the applicator 104, the clamping unit 102 is stored in a case 106, which can be configured, for example, as a storage container, so that the clamping unit 102 can be securely stored in the case 106. In one embodiment, the clamping unit 102 can be stored in the case 106 in a first configuration (tissue receiving configuration). The case 106 includes a proximal opening 174 through which the distal portion of the applicator 104 (e.g., the distal end of the control member 110 and the distal end of the sheath 108) can be inserted into the case 106 to load the clamping unit 102 onto the distal portion of the applicator 104. Once the distal end 118 of the control member 110 has been coupled to the connector 116 of the clamping unit 102, the clamping unit 102 can be pulled toward a second configuration (tissue holding configuration) to remove the clamping unit 102 from the case 106.

[0042] The applicator 104 includes a sheath 108 at its distal end and a control member 110 extending through the sheath 108. The clamping unit 102 includes a pair of clamping arms 112, each including a proximal end 114 connected to a connector 116 configured to releasably engage the distal end 118 of the control member 110. Once the clamping unit 102 is connected to the control member 110, the clamping unit 102 can move relative to the sheath 108 between a first configuration and a second configuration: a tissue receiving configuration in which the pair of clamping arms 112 are open to receive target tissue, and a tissue holding configuration in which the target tissue is held by the pair of clamping arms 112.

[0043] like Figures 3 to 7 As shown, the applicator 104 includes a sheath 108, a flexible member 120 extending proximally from the sheath 108, and a control member 110 extending through the sheath 108 and the flexible member 120. The proximal end of the flexible member 120 is connected to a handle member 122, which includes an actuator such as a spool 124 coupled thereto. In one example, the spool 124 is connected to the proximal end 126 of the control member 110 such that once the clamping unit 102 is loaded onto the applicator 104, the spool 124 can slide longitudinally on the handle member 122 to move the clamping unit 102 between a first configuration (tissue receiving configuration) and a second configuration (tissue clamping configuration). Specifically, sliding the spool 124 on the handle member 122 moves the control member 110 relative to the sheath 108, thereby moving the clamping unit 102 relative to the sheath 108, thus moving the clamping unit 102 between the first and second configurations.

[0044] In one implementation, such as Figures 6 to 7As shown, the handle member 122 includes a positioning feature 128 that contacts the short tube 124 to provide tactile feedback to the user of the exemplary clamping device system 100 regarding the position of the connector 116 relative to the sheath 108. The positioning feature 128 may include a deformable protrusion extending laterally outward from the outer surface of the handle member 122. The protrusion is deformable such that the short tube 124 can slide over the protrusion when a force applied to the protrusion exceeds a predetermined threshold. During the initial loading of the clamping unit 102, the short tube 124 can slide over the protrusion. However, when the distal surface 130 of the short tube 124 abuts a portion of the protrusion, the positioning feature 128 provides the user with tactile feedback indicating that the connector 116 is in its most distal position relative to the sheath 108 without fully extending distally beyond it. In other words, the clamping unit 102 is in its most open configuration without fully extending distally beyond the sheath 108 (e.g., separated from it).

[0045] Furthermore, a portion of the handle member 122 can be cut away to form a recess, and a cover member 129, serving as a roof-shaped cover, can be detachably fitted into the handle member 122 to cover the recess. The cover member 129 has a protrusion 129a formed at its proximal end. The protrusion 129a is configured to engage with a positioning feature 128, thereby preventing the cover member 129 from detaching from the handle member 122.

[0046] Flexible component 120 (e.g. in) Figure 1 and Figure 3 The control member 110 can be formed as a coil, extending from the distal end 118 through the coil to the proximal end 126. As those skilled in the art will understand, in the prior art, the coil preferably has sufficient flexibility to pass through even tortuous paths of a living body, and in this exemplary embodiment, the size and shape of the coil are configured to allow it to pass through the passage of an endoscope or other insertion device. Although the flexible member 120 is shown and illustrated as a coil, those skilled in the art will understand that any other suitable flexible structure can be employed, as long as the flexible member 120 can provide a contractile force sufficient to counteract the tension exerted on the control member 110 by the clamping unit 102. Although the applicator 104 is illustrated as including a short tube 124, the applicator 104 can include any variation of the actuation mechanism for moving the control member 110 to control the movement of the clamping arm 112.

[0047] The control member 110 extends from the distal end 118, releasably coupled to the connector 116, to the proximal end 126, coupled to the short tube 124. The size and shape of the distal end 118 are configured to releasably engage with the corresponding features of the connector 116. In one embodiment, the distal end 118 may be shaped as an enlarged ball received within a correspondingly shaped receiving socket of the connector 116. However, those skilled in the art will understand that the distal end 118 can have any variation in shape and size, provided that it is releasably coupled to the connector 116.

[0048] like Figure 2 As shown, connector 116 includes a distal end 148 connected to a proximal end 114 and extending proximally from the distal end 148 to receive the distal end 118 of control member 110 therein. Connector 116 includes a longitudinal groove 160 defined via a reciprocating portion 162, which is expandable to receive the distal end 118 of control member 110. The longitudinal groove 160 extends from a proximal opening 164 to a space 166, the space 166 being sized and shaped to receive the distal end 118. In one exemplary embodiment, the distal end 118 may be configured to be received as a ball within a receiving socket of a corresponding size and shape in space 166. The proximal opening 164 of groove 160 has a cross-sectional area (e.g., diameter) smaller than the cross-sectional area of ​​space 166. The opposing portion 162 is expandable to receive the distal end 118 of the control member 110 and is biased toward each other such that once the distal end 118 enters the space 166 distally, the opposing portion 162 springs back to lock the distal end 118 within the space 166, thus coupling the control member 110 to the connector 116. Therefore, longitudinal movement of the control member 110 relative to the sheath 108 controls the movement of the clamp arm 112 between the tissue receiving configuration and the tissue holding configuration.

[0049] According to this embodiment, the distal end 118 of the control member 110 can be inserted into the connector 116 via the proximal opening 164. When the control member 110 is pushed distally into the connector 116 beyond a predetermined threshold, the proximal opening 164 of the longitudinal groove 160 deforms to allow the distal end 118 to pass through the proximal opening 164 into the space 166. In one embodiment, opposing portions 162 defining the longitudinal groove 160 can be separated from each other to allow the distal end 118 to pass through the proximal opening 164 into the space 166. Once the distal end 118 is received within the space 166, the longitudinal groove 160 returns to its initial size, retaining the distal end 118 of the control member 110 therein.

[0050] like Figure 4 and Figure 5As shown, the sheath 108 extends longitudinally from the proximal end 132 of the flexible member 120, which is connected to the distal end 134, to the distal end 136 and includes an inner cavity 138 extending through the sheath 108. The size and shape of the inner cavity 138 may be configured to receive at least a portion of the clamping unit 102 therein. The inner cavity 138 includes a shoulder 176 along its proximal portion, which reduces the cross-sectional area of ​​the inner cavity 138 proximally, thereby preventing the connector 116 from passing proximally through the shoulder 176. The sheath 108 may be configured to attach to the distal end 134 of the flexible member 120. The sheath 108 may be laser-cut to increase its flexibility. For example, the sheath 108 may include a helically extending slit along the sheath 108, such that the sheath 108 can flex along its length. Alternatively, the sheath 108 may be a coil sheath configured to include a PTFE tube disposed between the coil sheath and a stranded wire of multiple metal wires inserted through the sheath 108. The stranded wire of the multiple metal wires may be coated with silicone as a lubricant.

[0051] like Figure 2 As shown, clamping unit 102 includes a pair of clamping arms 112, each having a proximal end 114 connected to connector 116. In one embodiment, the pair of clamping arms 112 may be formed from a single piece of material, the single piece of material being bent in half at the proximal end 114 to form the two clamping arms 112. Connector 116 may be connected to the single piece of material at the point where the material is bent to form the two clamping arms 112 (e.g., the proximal end 114). Although the clamping arms 112 are illustrated and shown as being formed from a single piece of material, the pair of clamping arms 112 may be formed via two separate materials, the proximal ends of the two separate materials being connected to each other via connector 116.

[0052] In this embodiment, the clamping arms 112 are biased such that, when not pulled into the sheath 108, the distal ends 140 of the clamping arms 112 move apart to enter an open tissue receiving configuration. When pulled into the sheath 108, the sheath 108 constrains the clamping arms 112, holding the distal ends 140 of the clamping arms 112 together in a closed tissue holding configuration. The connector 116 is longitudinally slidable with the inner cavity 138 of the sheath 108 to allow the clamping arms 112 to move between the tissue receiving configuration and the tissue holding configuration. The distal ends 140 of each clamping arm 112 can extend laterally inward toward the distal end 140 of the other clamping arm 112 to facilitate clamping target tissue between the two distal ends 140. The distal ends 140 may also include, for example, other clamping features such as teeth and / or protrusions.

[0053] The clamping arms 112 may include a locking mechanism to lock the pair of clamping arms when the clamping unit 102 is in a closed tissue clamping configuration. In this exemplary embodiment, as Figure 2As shown, the locking mechanism includes corresponding mating features 150, 152 (a pair of locking members) for locking the clamp arm 112 in a closed tissue clamping configuration. The first clamp arm of the clamp arm 112 includes a male locking feature 150, while the second clamp arm of the clamp arm 112 includes a female locking feature 152. Specifically, the male locking feature 150 is disposed on and extends from the inner surface of the first clamp arm of the clamp arm 112 toward the second clamp arm of the clamp arm 112, and includes a pair of prongs. The female mating feature 152 is disposed on the inner surface of the second clamp arm of the clamp arm 112 and extends from the inner surface toward the first clamp arm of the clamp arm 112. The female mating feature 152 includes an opening sized and shaped to allow the pair of prongs to be received therein.

[0054] Furthermore, on each arm, the limiting and locking mechanisms extend by different distances in the direction away from the arm. For example, and as... Figure 2 As shown, the limiting member 181 of the limiting mechanism extends a first distance d1 in a first direction away from the first arm 112a, and the engaging feature 150 of the locking mechanism extends a second distance d2 in the first direction away from the first arm 112a, and the first distance d1 is greater than the second distance d2.

[0055] The pair of pins are deformable, and once the pair of pins pass through the opening, they return to their initial configuration, locking the male locking member 150 within the female locking member 152. The male locking member 150 and the female locking member 152 are specifically configured such that they only engage with each other when the pair of clamping arms 112 are pulled toward each other beyond a predetermined threshold distance. Therefore, the pair of clamping arms 112 can move multiple times as needed between the tissue receiving configuration and the tissue clamping configuration before locking the clamping unit 102 into the tissue holding configuration.

[0056] Although clamping unit 102 is described as including the above-described locking mechanisms 150 and 152, those skilled in the art will understand that the clamping unit of this disclosure may include any variation of the corresponding mating features for locking the clamping arms relative to each other.

[0057] The clamping unit 102 also includes a limiting mechanism that operates in association with the locking mechanism and is configured to prevent target tissue from being squeezed between the locking mechanisms when the clamping unit 102 is pulled into the sheath 108 to close a pair of clamping arms 112 toward a closed tissue clamping configuration. As will be described in detail below, the limiting mechanism may have different configurations and may be arranged in different positional relationships relative to the locking mechanisms, as long as the limiting mechanism is configured to prevent target tissue from being squeezed between the locking mechanisms.

[0058] First Implementation Method

[0059] Figure 8A The illustration schematically depicts a clamping unit in a first configuration according to a first exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 8B This is a cross-sectional view taken at line AA in Figure 8. In a first exemplary embodiment, the clamping unit 102 includes a restraining mechanism mounted on a pair of clamping arms 112. Specifically, the restraining mechanism includes a first restraining member 181 and a second restraining member 182. The first restraining member 181 is disposed on the inner surface of the first clamping arm 112 and extends from that inner surface toward the second clamping arm 112. The second restraining member 182 is disposed on the inner surface of the second clamping arm 112 and extends from that inner surface toward the first clamping arm 112. The first restraining member 181 and the second restraining member 182 may be disposed more distally than the locking members 150 and 152, respectively. Alternatively, the restraining members 181 and 182 may be attached to the distal ends of the locking members 150 and 152, respectively.

[0060] In addition, such as Figure 8C As shown, the first limiting member 181 and the second limiting member 182 may be located more proximal to the pair of clamping arms 112 than the locking members 150 and 152, respectively. In this case, the distal end of the first limiting member 181a and the distal end of the second limiting member 182a should be positioned more distally than the locking members 150 and 152, respectively. Figure 8D This is a perspective view schematically illustrating an exemplary structural configuration between limiting members 181 and 182 and locking members 150 and 152. Figure 8D As shown, both limiting members 181 and 182 may include an opening whose size and shape are configured to allow a corresponding locking member of locking members 150 and 152 to extend through the opening from the inner surface of one of the clamps of clamp 112 without interfering with the corresponding locking member of limiting members 181 and 182. Figure 8E This is a perspective view schematically illustrating another exemplary structural configuration between limiting members 181 and 182 and locking members 150 and 152. Figure 8E As shown, locking members 150 and 152 can be attached to the two sides of the corresponding clamping arm 112 respectively, such that limiting members 181 and 182 extend through the corresponding locking members 150 and 152 in the distal direction without interfering with the corresponding locking members 150 and 152.

[0061] As described above, when the clamping unit 102 is in the first configuration, a pair of clamping arms 112 open to receive the target tissue 200. As will be described in detail below, the dimensions and shapes of the first limiting member 181 and the second limiting member 182 are set such that when the pair of clamping arms 112 move to close and clamp the target tissue 200, the target tissue 200 is prevented from being squeezed between the locking mechanisms 150 and 152.

[0062] In this exemplary embodiment, both the first limiting member 181 and the second limiting member 182 are configured as bent rods, which may have a flat / circular front end surface that contacts the target tissue 200 without damaging it when a pair of clamping arms 112 move to receive and clamp the target tissue 200. The invention is not limited to the flat / circular shape of the front end surface. The front end surfaces of both limiting members 181 and 182 may have any suitable protective shape capable of minimizing or preventing unnecessary damage to the target tissue 200 by the limiting members 181 and 182. Furthermore, when the limiting members 181 and 182 are configured as bent rods, the curvature may allow the distal end of the limiting member (i.e., the end not attached to the clamping arms 181, 182) to face the distal end of the clamping unit 102 (i.e., towards the opening through which the target tissue 200 is received by the clamping unit 102) or to face the proximal end of the clamping unit 102 (i.e., towards the proximal end 114 connected to the connector 116).

[0063] The first limiting member 181 and the second limiting member 182 may be formed from the same single-piece material used to form the pair of clamping arms 112 as described above. Alternatively, the pair of limiting members 181 and 182 may be formed from a different material than the pair of clamping arms 112, and thus be attached to the pair of clamping arms 112 by an adhesive substance or welding during assembly.

[0064] The first limiting member 181 and the second limiting member 182 may be made of any suitable biocompatible material, such as, but not limited to, polymers and materials including fillers, such as metals, carbon fibers, glass fibers, or ceramics and combinations thereof. Metals may include cobalt-chromium alloys, nickel-titanium alloys, titanium, stainless steel, etc. Practical but non-limiting polymers include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene-propylene copolymers, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene dicarboxylic acid derivatives such as polyethylene naphthalate, polybutylene naphthalate, polypropylene naphthalate and propylene naphthalate, polyurethane, polyurea, silicone rubber, polyamide, polycarbonate, polyaldehyde, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers, wholly or partially halogenated polyethers, polyamide / polyether polyesters, and copolymers and combinations thereof, as well as ABS (acrylonitrile butadiene-styrene copolymer), PEEK (polyether ether ketone), etc.

[0065] Figure 9A This is a schematic front view of a clamping unit in a second configuration, according to a first exemplary embodiment, in which a target tissue is held by a pair of clamping arms. Figure 9B Is Figure 9A A cross-sectional view taken at line BB. Once the target tissue is 200... Figure 8A As shown, the clamping assembly 102 is received between the clamping arms 112, and by moving the control member 110 proximally relative to the clamping assembly 102, the clamping assembly 102 moves toward the target tissue 200 in a second configuration held by the pair of clamping arms 112. When the pair of clamping arms 112 close to each other, the first restraining member 181 and the second restraining member 182 move to contact each other and deform to extend distally, thereby pushing the target tissue away from the locking mechanisms 150 and 152. Figure 9B As shown, limiting members 181 and 182 are in contact with each other and form a stop bar in front of locking mechanisms 150 and 152. The stop bar formed by limiting members 181 and 182 can prevent the target tissue 200 from entering the area between locking mechanisms 150 and 150, thereby preventing the target tissue 200 from being squeezed between locking mechanisms 150 and 150.

[0066] Additionally, the restraining members 181 and 182 can be configured to be flexible and deformable (i.e., movable toward each other). For example... Figure 9A As shown, when a pair of clamping arms 112 further close to each other, the stop bar formed by the limiting members 181 and 182 moves further distally to keep the target tissue away from the locking mechanisms 150 and 152.

[0067] When it is confirmed that the desired portion of the target tissue 200 is clamped between the clamping arms 112 (e.g., the tissue portion on the opposite side of a bleeding wound), the control member 110 is further pulled proximally relative to the clamping assembly 102 (via the short tube 124) to lock the clamping assembly 102 in a closed configuration. That is, the clamping arms 112 are further pulled proximally into the sleeve 108 until the locking mechanisms 150, 152 engage with each other, locking the clamping arms 112 relative to each other.

[0068] Figure 10A This is a schematic front view of a clamping unit in a first configuration according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 10B Is Figure 10A The cross-sectional view taken at line CC. Figure 11A This is a schematic front view of a clamping unit in a second configuration, held by a pair of clamping arms, according to another exemplary embodiment, located in a target tissue. Figure 11B Is Figure 11A The cross-sectional view taken at line DD.

[0069] In an exemplary implementation of this variant, such as Figure 10B As shown, the restraining member 181 is positioned offset from the restraining member 182, which is positioned on the second clamping arm of the clamping arm 112. Therefore, even when the clamping unit 102 is pulled toward the second configuration where the pair of clamping arms 112 close to clamp the target tissue 200, the restraining members 182 and 182 will not come into contact with each other. Figure 11A and Figure 11B As shown, the limiting members 181 and 182 intersect each other in the second configuration, in which both limiting members 181 and 182 serve as stop bars (anti-intrusion mechanisms) to prevent the target tissue 200 from being squeezed between the locking mechanisms 150 and 152 when the locking mechanisms 150 and 152 move to engage each other.

[0070] Figure 12A and Figure 12B A side view of the distal portion of an additional exemplary embodiment of the clamping device system associated with the first embodiment is shown. The clamp delivery system 100 includes a clamping unit 102 attached to the distal end of an applicator 104. For example, the clamping unit 102 may be connected to a control member 110 via a connector 116. The control member 110 is movable within the cavity of the applicator 104, and manipulation of the control member 110 (e.g., retraction and extension) causes the clamping unit 102 to move to retract into at least a portion of the channel 10c or to extend from an opening at the distal end of the control member 110. A stop 56 is used to define the distance the clamping unit 102 may move in the retraction direction.

[0071] like Figure 12A and Figure 12B As shown, clamping unit 102 has two clamping arms 112a, 112b, and the bases of the two clamping arms 112a, 112b are pivotable relative to each other about pivoting connector 142a. In the illustrated embodiment, as the clamping arms 112a, 112b move from an open position (i.e., the first configuration) to a closed position (i.e., the second configuration), grooves or tracks 144 in the clamping arms 112a, 112b accommodate the movement of the clamping arms 112a, 112b. Additionally, clamping unit 102 can pivot and / or rotate relative to control member 110 about pivoting connector 142b.

[0072] As with other embodiments disclosed herein, each clamping arm 112a, 112b includes a locking mechanism to lock the pair of clamping arms when the clamping unit 102 is in a closed tissue clamping configuration. The locking mechanism includes corresponding mating features 150, 152 (e.g., a pair of locking members – male locking feature 150 and female locking feature 15) that lock the clamping arms 112 in the closed tissue clamping configuration. As with other embodiments disclosed herein, each clamping arm 112a, 112b also includes a limiting mechanism mounted on the pair of clamping arms 112a, 112b. Specifically, the limiting mechanism includes a first limiting member 181 and a second limiting member 182. Any embodiment of the locking and limiting mechanisms disclosed herein can be used for reference. Figure 12A and Figure 12B The clamping unit 102 is shown and described in the embodiments. In some embodiments, the clamping unit 102 includes only a restraining mechanism (such as... Figure 12B The first limiting member 181 and the second limiting member 182 shown herein function to inhibit tissue from entering the proximal side of the clamping unit 102 and to interfere with the pivoting of the clamping unit 102. In other aspects, such as other structural features, configurations, and operations, Figure 12A and Figure 12B The embodiments of clamping unit 102 and clamping arms 112a, 112b are the same as those described above. Figures 2 to 1 The structural features, configuration, and operation described in 1 are consistent with those of the first embodiment.

[0073] Second Implementation Method

[0074] Figure 13A This is a schematic front view of a clamping unit in a first configuration according to a second exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 13B This is a schematic front view of a clamping unit in a second configuration according to a second exemplary embodiment, in which a pair of clamping arms are closed and clamping a target tissue.

[0075] In a second exemplary embodiment, the limiting mechanism is a limiting rail 184 that connects the locking mechanism 150 to the locking mechanism 152. The limiting rail 184 may be shaped as a rod and serve as a stop between the locking mechanisms 150 and 152. The limiting rail 184 is capable of preventing the target tissue 200 from entering the area between the locking mechanisms 150 and 152, thereby preventing the target tissue 200 from being squeezed between the locking mechanisms 150 and 152.

[0076] like Figure 13AAs shown, clamping unit 102 includes a limiting rail 184, one end of which is attached to the end of locking mechanism 150, and the other end passes through a through hole (or slot) formed in locking mechanism 152. With this exemplary configuration, limiting rail 184 acts as a stop bar capable of preventing target tissue 200 from entering the area between locking mechanisms 150 and 152, thereby preventing target tissue 200 from being squeezed between locking mechanisms 150 and 152.

[0077] One end of the limiting track 184 can be joined to the end of the locking mechanism 150 by an adhesive, heating, or extrusion process. A through hole can be part of an opening in the locking mechanism 152, the size and shape of which are configured to allow the locking mechanism 150 to be received therein and also to allow the limiting track 184 to pass through it.

[0078] like Figure 13B As shown, when the clamping unit 102 is pulled proximally toward the second configuration where a pair of clamping arms 112 are closed to clamp the target tissue 200, the limiting rail 184 passes through the opening of the locking mechanism 152. During this time, the limiting rail 184 prevents the target tissue 200 from being squeezed between the locking mechanisms 150 and 152. Once the locking mechanisms 150 and 152 are engaged with each other, the limiting rail 184 moves to the outside of the clamping unit 102.

[0079] The confinement track 184 is made of a flexible and deformable material and can be formed of any suitable biocompatible material, such as, but not limited to, polymers and materials including fillers, such as metals, carbon fibers, glass fibers, or ceramics and combinations thereof. The metals may include cobalt-chromium alloys, nickel-titanium alloys, titanium, stainless steel, etc. Practical but non-limiting polymers include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene-propylene copolymers, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene dicarboxylic acid derivatives such as polyethylene naphthalate, polybutylene naphthalate, polypropylene naphthalate, and polyurethane, polyurea, silicone rubber, polyamide, polycarbonate, polyaldehyde, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers, wholly or partially halogenated polyethers, polyamide / polyether polyesters, and copolymers and combinations thereof, as well as ABS (acrylonitrile butadiene-styrene copolymer), PEEK (polyether ether ketone), etc.

[0080] Figure 14A This is a schematic front view of a clamping unit in a first configuration according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 14B Is Figure 14A The cross-sectional view taken at line EE.

[0081] In an exemplary implementation of this variant, such as Figure 14A and Figure 14B As shown, one end of each pair of limiting rails 186 is attached to the corresponding side of the locking mechanism 150, and the other end of each pair passes through the corresponding through hole of the locking mechanism 152. Alternatively, the other end of each pair of limiting rails 186 may pass through a groove formed on the corresponding side of the locking mechanism 152 and on the second clamping arm of the pair of clamping arms 112.

[0082] One end of each limiting track 186 can be engaged to the corresponding side of the locking mechanism 150 by an adhesive, heating, or extrusion process. The corresponding through-hole can be part of an opening in the locking mechanism 152, the size and shape of which are configured to allow the locking mechanism 150 to be received therein and also to allow the limiting track 186 to pass through it. Alternatively, the groove can be sized and shaped to allow the limiting track 186 to pass through the locking mechanism 152 and the second of a pair of clamping arms 112.

[0083] The present invention is not limited to having a pair of limiting rails 186. The present invention may have a single limiting rail 186, one end of which is attached to one side of the locking mechanism 150, and the other end of which passes through a through hole in the locking mechanism 152. Alternatively, the other end of the single limiting rail 186 may pass through a groove formed on one side of the locking mechanism 152 and on the second of a pair of clamping arms 112.

[0084] The confinement track 186 can be made of flexible and deformable materials and can be formed of any suitable biocompatible material, such as, but not limited to, polymers and materials including fillers, such as metals, carbon fibers, glass fibers, or ceramics and combinations thereof. The metals may include cobalt-chromium alloys, nickel-titanium alloys, titanium, stainless steel, etc. Practical but non-limiting polymers include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene-propylene copolymers, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene dicarboxylic acid derivatives such as polyethylene naphthalate, polybutylene naphthalate, polypropylene naphthalate, and polyurethane, polyurea, silicone rubber, polyamide, polycarbonate, polyaldehyde, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers, wholly or partially halogenated polyethers, polyamide / polyether polyesters, and copolymers and combinations thereof, as well as ABS (acrylonitrile butadiene-styrene copolymer), PEEK (polyether ether ketone), etc.

[0085] Figure 15A This is a schematic front view of a clamping unit in a first configuration, according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 15B Is Figure 15A The cross-sectional view taken at line EE.

[0086] In an exemplary implementation of this variant, such as Figure 15A and Figure 15B As shown, a groove 260 is formed on one side of each locking mechanism 150 and 152, and one end of the limiting track 188 is attached to the groove 260 of one locking mechanism 150, while the other end passes through the groove 260 of the other locking mechanism 152.

[0087] One end of the limiting track 188 can be engaged to the groove 260 of the locking mechanism 150 by an adhesive, heating, or extrusion process. The size and shape of the groove 260 are configured to allow the limiting track 188 to pass through the locking mechanism 152 and the second of a pair of clamping arms 112.

[0088] The confinement track 188 can be made of flexible and deformable materials and can be formed of any suitable biocompatible material, such as, but not limited to, polymers and materials including fillers, such as metals, carbon fibers, glass fibers, or ceramics and combinations thereof. The metals may include cobalt-chromium alloys, nickel-titanium alloys, titanium, stainless steel, etc. Practical but non-limiting polymers include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene-propylene copolymers, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene dicarboxylic acid derivatives such as polyethylene naphthalate, polybutylene naphthalate, polypropylene naphthalate, and polyurethane, polyurea, silicone rubber, polyamide, polycarbonate, polyaldehyde, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers, wholly or partially halogenated polyethers, polyamide / polyether polyesters, and copolymers and combinations thereof, as well as ABS (acrylonitrile butadiene-styrene copolymer), PEEK (polyether ether ketone), etc.

[0089] Figure 16 This is a schematic diagram illustrating a clamping unit with a limiting track in a channel for inserting an endoscope, according to an exemplary embodiment. Figure 17 This is a schematic diagram illustrating a clamping unit with a limiting track in a first configuration according to an exemplary embodiment. Figure 16 and Figure 17As shown, in use, after the clamping unit 102 has been loaded onto the applicator 104, the clamping unit 102, in a closed configuration, is positioned at the distal end of the sheath 108, and a pair of clamping arms 112 extending from the open end 222 of the sheath 108 are closed. In this configuration, the clamping unit 102 is inserted through the channel 230 of the insertion portion 240 of the endoscope (or any other insertion device) and into the body (e.g., through a natural body cavity) until it reaches a portion adjacent to the target tissue to be clamped. A restraining rail 184 is connected to locking mechanisms 150 and 152 and is deformed to be positioned between the clamping unit 102 and the inner surface of the channel 230. Once the insertion portion 240 reaches the side adjacent to the target tissue to be clamped, the clamping unit 102 is pushed out of the channel 230 through the endoscope tip 242, and the pair of clamping arms 112 open for use.

[0090] Figure 18 A side view of the distal portion of an additional exemplary embodiment of the clamping device system related to the second embodiment is shown. The clamp delivery system 100 includes a clamping unit 102 attached to the distal end of an applicator 104. For example, the clamping unit 102 may be connected to a control member 110 via a connector 116. The control member 110 is movable within the cavity of the applicator, and manipulation of the control member 110 (e.g., retraction and extension) moves the clamping unit 102 to retract into at least a portion of the channel 10c or to extend from an opening at the distal end of the control member 110. A stop 56 is used to define the distance the clamping unit 102 may move in the retraction direction.

[0091] like Figure 18 As shown, clamping unit 102 has two clamping arms 112a, 112b, and the bases of the two clamping arms 112a, 112b are pivotable relative to each other about pivoting connector 142a. In the illustrated embodiment, as the clamping arms 112a, 112b move from an open position (i.e., the first configuration) to a closed position (i.e., the second configuration), grooves or tracks 144 in the clamping arms 112a, 112b accommodate the movement of the clamping arms 112a, 112b. Additionally, clamping unit 102 can pivot and / or rotate relative to control member 110 about pivoting connector 142b.

[0092] As with other embodiments disclosed herein, each clamping arm 112a, 112b includes a locking mechanism to lock a pair of clamping arms when the clamping unit 102 is in a closed tissue clamping configuration, and the locking mechanism includes corresponding mating features 150, 152 (e.g., a pair of locking members – male locking feature 150 and female locking feature 15) that lock the clamping arms 112 in the closed tissue clamping configuration. As with other embodiments disclosed herein, one of the clamping arms 112a, 112b also includes a restraining mechanism mounted thereon. Specifically, the restraining mechanism includes a restraining track 184. Any embodiment of the locking and restraining mechanisms disclosed herein can be used as a reference. Figure 18 The clamping unit 102 is shown and described in the embodiments. In some embodiments, the clamping unit 102 includes a restraining mechanism (such as...). Figures 13A to 13B , Figures 14A to 14B as well as Figures 16 to 17 The limiting member 184 shown or Figures 15A to 15B The restricted track 188 is shown. In other aspects, such as other structural features, configurations, and operations, Figure 18 The embodiments of clamping unit 102 and clamping arms 112a, 112b described above are similar to those described above. Figure 13A and Figures 13B to 17 The structural features, configuration, and operation of the second embodiment are consistent.

[0093] Third Implementation Method

[0094] Figure 19A This is a schematic front view of a clamping unit in a first configuration according to a third exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 19B It is a schematic diagram. Figure 19A Side view of the clamping unit. Figure 19C This is a schematic illustration of when the clamping unit is pulled into the sheath towards the second configuration. Figure 19A Side view of the clamping unit. Figure 19D This is a schematic diagram illustrating the second configuration of the clamp unit. Figure 19A Side view of the clamping unit.

[0095] In the third exemplary embodiment, the locking mechanisms 150 and 152 are positioned such that they are arranged closer to each other than in the first and second exemplary embodiments, such that the locking mechanisms 150 and 152 engage with each other inside the sheath 108. This adjustment allows the open end 222 of the sheath 108 to function as a restraining mechanism, as the size and shape of the open end are configured to prevent the target tissue 200 from entering the sheath 108 through the opening, thereby preventing the target tissue 200 from being squeezed between the locking mechanisms 150 and 152.

[0096] like Figures 19A to 19D As shown, when the clamping unit 102 is pulled proximally into the sheath 108, a pair of clamping arms 112 move toward a closed configuration. Even if a portion of the target tissue 200 protrudes between the locking mechanisms 150 and 152, this portion of the target tissue 200 is also blocked outside the sheath 108 by the open end 222 because the locking mechanisms 150 and 152 are adjusted to engage with each other inside the sheath 108.

[0097] Figure 20A This is a schematic front view of a clamping unit in a first configuration according to another exemplary embodiment, with a pair of clamping arms open to receive target tissue. Figure 20B This is a schematic front view of a clamping unit in a second configuration where a pair of clamping arms are closed to clamp the target tissue.

[0098] like Figure 20A and Figure 20B As shown, the open end 222 of the sheath 108 includes a limiting member 190 (see reference). Figure 20A Box I and Figure 20B (See box II) The limiting member 190 is a separator that equally divides the opening end 222 into a first opening 222a for the first clamping arm of the pair of clamping arms 112 and a second opening 222b for the second clamping arm of the pair of clamping arms 112. The size and shape of the first opening 222a are configured to allow the first clamping arm of the pair of clamping arms 112 and the locking mechanism 150 to pass through, and the size and shape of the second opening 222b are configured to allow the second clamping arm of the pair of clamping arms 112 and the locking mechanism 152 to pass through. With this configuration, even if a portion of the target tissue 200 protrudes between the locking mechanisms 150 and 152, this portion of the target tissue 200 is blocked outside the sheath 108 by the limiting member 190 because the locking mechanisms 150 and 152 are adjusted to engage with each other inside the sheath 108.

[0099] Figure 20C This is a schematic front view of the clamping unit in a first configuration according to a modified embodiment of FIG20. Figure 20C As shown, the open end 222 of the sheath 108 includes two limiting members 191 and 192 (see reference). Figure 20C(See box III in the diagram). Restricting member 191 is a rod-shaped member extending inward from the opening end 222 toward the central axis "O" of the opening end 222. Restricting member 192 is also a rod-shaped member extending inward from the opening end 222 and faces the restricting member 191 without contacting it. With this configuration, even if a portion of the target tissue 200 protrudes between the locking mechanisms 150 and 152, this portion of the target tissue 200 can be blocked outside the sheath 108 by the restricting members 190 and 191 because the locking mechanisms 150 and 152 are adjusted to engage with each other inside the sheath 108.

[0100] The limiting member 190 may be integrally formed with the sheath 108, or it may be joined to the opening end 222 by means of an adhesive, heating or extrusion process. The limiting members 191 and 192 may also be integrally formed with the sheath 108, or they may be attached to the inner surfaces of the opening end 222 by means of an adhesive, heating or extrusion process.

[0101] The limiting member 190 can be made of any suitable biocompatible material, such as, but not limited to, polymers and materials including fillers, such as metals, carbon fibers, glass fibers, or ceramics and combinations thereof. The metals may include cobalt-chromium alloys, nickel-titanium alloys, titanium, stainless steel, etc. Practical but non-limiting polymers include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene-propylene copolymers, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene dicarboxylic acid derivatives such as polyethylene naphthalate, polybutylene naphthalate, polypropylene naphthalate, and polyurethane, polyurea, silicone rubber, polyamide, polycarbonate, polyaldehyde, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers, wholly or partially halogenated polyethers, polyamide / polyether polyesters, and copolymers and combinations thereof, as well as ABS (acrylonitrile-butadiene-styrene copolymer), PEEK (polyether ether ketone), etc.

[0102] Figure 21 A side view of the distal portion of an additional exemplary embodiment of the clamping device system related to the third embodiment is shown. The clamp delivery system 100 includes a clamping unit 102 attached to the distal end of an applicator 104. For example, the clamping unit 102 may be connected to a control member 110 via a connector 116. The control member 110 is movable within the cavity of the applicator 104, and manipulation of the control member 110 (e.g., retraction and extension) causes the clamping unit 102 to move back into at least a portion of the channel 10c or to extend from an opening at the distal end of the control member 110. A stop 56 is used to define the distance the clamping unit 102 may move in the retraction direction.

[0103] like Figure 21As shown, clamping unit 102 has two clamping arms 112a, 112b, and the bases of the two clamping arms 112a, 112b are pivotable relative to each other about pivoting connector 142a. In the illustrated embodiment, as the clamping arms 112a, 112b move from an open position (i.e., the first configuration) to a closed position (i.e., the second configuration), grooves or tracks 144 in the clamping arms 112a, 112b accommodate the movement of the clamping arms 112a, 112b. Additionally, clamping unit 102 can pivot and / or rotate relative to control member 110 about pivoting connector 142b.

[0104] As with other embodiments disclosed herein, each clamping arm 112a, 112b includes a locking mechanism to lock the pair of clamping arms when the clamping unit 102 is in a closed tissue clamping configuration, and the locking mechanism includes corresponding mating features 150, 152 (e.g., a pair of locking members—male locking feature 150 and female locking feature 15) that lock the clamping arms 112 in the closed tissue clamping configuration. Any embodiment of the locking mechanism disclosed herein can be used as a reference. Figure 21 The clamping unit 102 of the illustrated and described embodiments. In some embodiments, the clamping unit 102 includes... Figures 19A to 19D as well as Figures 20A to 20B The locking mechanism shown does not include a restraining mechanism. In other aspects, such as other structural features, configurations, and operations, Figure 18 The embodiments of clamping unit 102 and clamping arms 112a, 112b described above are similar to those described above. Figures 19A to 19D as well as Figures 20A to 20B The structural features, configuration, and operation are consistent with those used in the third embodiment.

[0105] Fourth Implementation Method

[0106] Figure 22A This is a schematic side view of a clamping unit in a first configuration with a pair of clamping arms open, according to a fourth exemplary embodiment. Figure 22B It is a schematic diagram. Figure 22A Top view of the clamping unit. Figure 22C This is a schematic side view of a clamping unit in a second configuration with a pair of clamping arms closed. Figure 22D It is a schematic diagram. Figure 22C Top view of the clamping unit.

[0107] In the fourth exemplary embodiment, such as Figure 22A and Figure 22BAs shown, clamping unit 102 includes locking mechanisms 154 and 156, which are disposed inside sheath 108 and positioned more proximally than the open end 222 of sheath 108. Sheath 108 includes a U-shaped notch (cutout) 224 extending proximally from the open end 222. The notch / cutout 224 of the present invention is not limited to a U-shape and can be of any shape and size suitable for receiving locking mechanisms 154 and 156. Locking mechanisms 154 and 156 engage with grooves 192 formed on each of a pair of clamping arms 112. Both locking mechanisms 154 and 156 include a locking pin P with a diameter greater than the width of the groove 192, such that locking mechanisms 154 and 156 can slide along the groove 192 without disengaging from the pair of clamping arms 112.

[0108] The groove 192 can be shaped as a narrow tapered section extending distally, and includes a diameter-reduced portion 194 at the distal end of the groove 192. With this configuration, as... Figure 22C and Figure 22D As shown, when the clamp unit 102 is pulled proximally, the locking pin P moves distally relative to the pair of clamping arms 112, bringing the locking mechanisms 154 and 156 closer together. When the locking pin P reaches the diameter reduction portion 194, the locking pin P locks at the diameter reduction portion 194 to prevent the locking mechanisms 154 and 156 from moving relative to the pair of clamping arms 112.

[0109] Because locking mechanisms 154 and 156 are located inside the sheath 108 and are positioned closer to the opening end 222 of the sheath 108, the target tissue 200 cannot enter the sheath 108 due to the structure of the opening end 222. Therefore, in the event that the target tissue 200 is blocked by the opening end 222 and cannot enter the sheath 108, the target tissue 200 can be prevented from being squeezed between locking mechanisms 154 and 156.

[0110] Exemplary methods

[0111] An exemplary method for loading a clamping unit 102 housed within a housing 106 into an applicator 104 includes inserting a control member 110 and / or a sheath 108 of the applicator 104 through a proximal opening 174 of the housing 106. For example, the distal end 118 of the control member 110 is moved relative to the housing 106 by moving a short tube 124 distally toward the connector 116 until the distal end 118 resists a distal force of the connector 116 exceeding a predetermined threshold, thereby deforming the proximal opening 164 of the slot 160 of the connector 116 to allow the distal end 118 to pass through the proximal opening 164 into the space 166 of the connector 116. As the distal end 118 moves distally relative to the sheath 108, the short tube 124 can slide distally over the positioning feature 128 of the handle member 122, providing the user with tactile feedback that the distal end 118 of the control member 110 has extended distally through the distal end 136 of the sheath 108 and is engaged with the connector 116. Once the distal end 118 is received within the space 166, the connector 116 returns to its initial shape, holding the distal end 118 within the space 166. After the connector 116 and the control member 110 are engaged, the clamping unit 102 is successfully loaded onto the applicator 104.

[0112] To remove the loaded clamping unit 102 from the box 106, pull the clamping arm 112 proximally relative to the sheath 108 of the applicator 104 so that the clamping arm 112 is oriented as shown. Figure 9A The limiting members 181 and 182 shown are in contact with each other and deform against each other, or as... Figure 11A The tissue clamping configuration shown is moved in an intersecting manner. The short tube 124 can be pulled proximally relative to the handle member 122 until it is pulled proximally to the positioning feature 128. As described above, when the clamping arm 112 is pulled into the sheath 108, the inner surface of the cavity 138 of the sheath 108 constrains the clamping arm 112 to move the clamping unit 102 toward the tissue clamping configuration. The clamping unit 102 can then be pulled out of the box 106 via the opening 174.

[0113] In use, after the clamp unit 102 is loaded onto the applicator 104, the clamp unit 102 passes through the channel 230 of the endoscope (or any other insertion device). Figure 16 The clamping unit 102 is inserted into the body (e.g., through a natural body cavity) until it reaches a site adjacent to the target tissue portion to be clamped. The clamping unit 102 is inserted in a closed configuration toward the target tissue 200 to facilitate passage of the clamping unit 102 through the channel 230. After reaching the site of the target tissue 200, the clamping unit 102 is pushed out from the distal end 42 of the channel 230 (in... Figure 17(in the middle), and by, for example, sliding the short axis 124 distally above the handle member 122, causing the clamp arm 112 to extend beyond the sheath 108 of the applicator 104, so that the clamp arm 112 moves toward the tissue receiving configuration. The distal surface 130 of the short tube 124 (in Figure 6 The contact between the clamp arm 112 and the positioning feature 128 provides tactile feedback to the user, indicating that the clamp arm 112 is in the maximum open configuration, and any further distal movement of the short tube 124 will cause the connector 116 to extend distally out of the sheath 108.

[0114] The clamping arms 112 can move repeatedly between a tissue receiving configuration and a tissue holding configuration (first and second configurations) until the target tissue is received between the distal ends 140 of the clamping arms 112 as needed. Once the target tissue is received between the clamping arms 112, the clamping unit 102 moves toward the tissue holding configuration by moving the control member 110 proximally relative to the clamping unit 102. At this time, as described in the first to fourth embodiments, the restraining member 180 is also actuated to prevent the target tissue from being squeezed between the locking mechanisms 150 and 152.

[0115] Once it is confirmed that the desired tissue portion is clamped between the clamping arms 112 (e.g., tissue portion on the opposite side of a bleeding wound), the control member 110 is further pulled proximally relative to the clamping unit 102 (via the short tube 124) to lock the clamping unit 102 in a closed configuration. That is, the clamping arms 112 are further pulled proximally into the sheath 108 until the locking mechanisms 150, 152 engage with each other, locking the clamping arms 112 relative to each other. The control member 110 is pulled proximally relative to the locking sheath 108 until the connector 116 contacts and abuts against the shoulder 176 of the inner cavity 138 of the sheath 108. The shoulder 176 prevents the connector 116 from moving proximally past the shoulder, while a continuous proximal force is applied to the control member 110.

[0116] When the distal end 118 of the control member 110 applies a force exceeding a predetermined threshold on the connector 116, the connector 116 deforms (e.g., the proximal opening 164 expands) to allow the distal end 118 to be released from the longitudinal slot 160. Once the distal end 118 is released from the connector 116, the applicator 104 can be withdrawn from the living body, leaving the clamping unit 102, including the restraining member 180, on the target tissue within the body. If necessary, a new clamping unit 102, including the restraining member 180, is then loaded onto the applicator 104 in the same manner as described above, so that the device can subsequently be used to clamp a second portion of the tissue. This process can be repeated multiple times as needed or desired, using the same applicator 104.

[0117] The present invention is not limited to the above-described embodiments that include a connection structure between the clamping unit 102 and the applicator 104. Figure 23This is a perspective view schematically illustrating another connection configuration of an applicator for use with an endoscope in combination with a clamping unit according to an exemplary embodiment. Figure 24 It is a schematic diagram and Figure 23 A three-dimensional view of the clamping unit used in the application device assembly.

[0118] like Figure 23 As shown, the applicator 10 is a unit (control unit) for insertion into the abdominal cavity and may include an insertion tube 20, a control line 30, and a control unit 40. For example, the applicator 10 is used in combination with a clamping unit 60 through a surgical instrument insertion channel (not shown) for inserting an endoscope. Therefore, the insertion tube 20 includes a distal end 21, a distal end coil 22, and a proximal end coil 24. The control line 30 includes a line 32 and a hook unit 31 at the distal end of the applicator 10. The control unit 40 includes a control unit body 41, a slider 42, a support 47, and a thumb ring 48. The body 41 includes a slit 41a and a gripping portion 41b. The slider 42 includes a first sliding member 51 and a second sliding member 52 having a slit 52b.

[0119] like Figure 24 As shown, clamp unit 60 can be assembled to hook unit 31. Clamp unit 60 may include clamp 61, connecting member 62, and restraint tube 63 as tightening member. Clamp 61 may have a ring (base) 61a, which is formed by bending a metal sheet such as a stainless steel leaf spring, for example, at approximately the central portion. Clamp 61 crosses near the ring 61a and extends into a pair of clamp arms 61b with an extended characteristic when separated at the distal ends. Organized gripping portions (clamping claws) 61c are formed at the ends of clamp 61.

[0120] The crossing portion of the arms 61b of the clamp 61 is made narrower than the distal end, and the tissue gripping portions 61c are opposite each other. When the clamp 61 is moved in the direction of pulling into the tube 63, the clamp 61 can slide on the inner surface of the restraint tube 63, but when the clamp 61 is moved in the opposite direction of pulling in, the clamp 61 disengages from the inner surface of the tube 63.

[0121] For example, the connecting member 62 is formed by injection molding of a robust resin such as a liquid crystal polymer and polyamide synthetic fiber. The connecting member 62 is a cylindrical rod and engages with the clamp 61 inside the restraint tube 63.

[0122] The connecting member 62 includes a stop protrusion 62i connected to the restraint tube 63, and the proximal end of the connecting member 62 forks into two branches, each including a cutout 62d and an elastic arm 62e. The two branches are configured to receive the ends of the arrow hook unit 31.

[0123] The restraint tube 63 is formed by injection molding of a rigid resin with suitable elasticity, such as a material more flexible than the clamp 61, for example, polyphthalamide (PPA) and polyamide (PA). The clamp 61 closes by fitting the tube 63 to the arm 61b of the clamp 61. The restraint tube includes a pair of wings 63d, which are formed to be resiliently retractable in the radial direction.

[0124] While preferred embodiments of the present invention have been illustrated and described above, it should be understood that these are exemplary embodiments and should not be considered limiting. Additions, omissions, substitutions, and other modifications may be made without departing from the spirit and scope of the invention. Therefore, the present invention should not be considered limited to the foregoing description, but only to the scope of the appended claims.

[0125] While various embodiments of the disclosed technology have been described above, it should be understood that these embodiments are presented as examples only and not as limitations. Similarly, the figures may depict exemplary schematic diagrams or other constructions of the disclosed technology, done to aid in understanding the features and functions that may be included in the disclosed technology. The disclosed technology is not limited to the illustrated exemplary schematic diagrams or constructions, but various alternative illustrations and constructions can be used to achieve the desired features. In fact, it will be apparent to those skilled in the art how alternative functions, logical or physical locations and constructions can be implemented to achieve the desired features of the technology disclosed herein.

[0126] Although the disclosed technology has been described above with reference to various exemplary embodiments and implementations, it should be understood that the various features, aspects, and functions described in one or more individual embodiments are not limited to their applicability to the particular embodiments in which they are described, but can be applied individually or in various combinations to one or more other embodiments of the disclosed technology, whether or not such embodiments are described and whether such features are presented as part of the described embodiments. Therefore, the breadth and scope of the technology disclosed herein should not be limited to any of the embodiments described in the foregoing exemplary embodiments.

[0127] The terms and phrases used in this document, and their variations thereof, should be considered open-ended rather than restrictive, unless otherwise expressly stated. As for the foregoing examples: the term “including” should be understood as “including, but not limited to”, etc.; the term “example” is used to provide exemplary instances of the items discussed, not an exhaustive or restrictive enumeration of them; the term “a” should be understood as “at least one,” “one or more,” etc.; and adjectives and terms of similar meaning such as “conventional,” “traditional,” “normal,” “standard,” “known,” etc., should not be considered as limiting the described items to a given era or to items available within a given era, but should be understood as encompassing conventional, traditional, normal, or standard techniques that are available or known now or in the future. Similarly, when this document relates to techniques that are obvious or known to a person skilled in the art, such techniques encompass those that are obvious or known to a person skilled in the art now or in the future.

[0128] In some cases, the presence of extended words and phrases such as “one or more,” “at least,” “but not limited to,” or other similar phrases should not be interpreted as a narrower case intended or required in situations where such extended phrases may not exist.

[0129] Furthermore, the various embodiments described herein are illustrated with reference to exemplary schematic diagrams, block diagrams, and other illustrations. As will become apparent to those skilled in the art upon reading this document, the illustrated embodiments and their various alternatives may be implemented without limitation from the illustrated examples. For example, the block diagrams and their accompanying descriptions should not be construed as imposing a particular construction.

Claims

1. A clamping device comprising: A sheath, comprising an inner cavity and at least one open end; Multiple clamping arms that are movable between a first configuration in which the multiple clamping arms are open to receive target tissue and a second configuration in which the multiple clamping arms are closed to hold the target tissue; A locking mechanism is provided on the plurality of clamping arms to engage with each other to maintain the second configuration; and A restraining mechanism is configured to be associated with the locking mechanism to prevent the target tissue from being squeezed between the locking mechanisms. The plurality of clamping arms includes a first arm and a second arm, and the locking mechanism includes a first locking member disposed on the first arm and a second locking member disposed on the second arm. The limiting mechanism includes a limiting track, one end of which is attached to the first locking member, and the other end of which passes through a through hole formed in the second locking member.

2. The clamping device according to claim 1, characterized in that, The through hole is part of the opening of the second locking member, and the opening of the second locking member is configured to receive the first locking member.

3. A clamping device, comprising: A sheath, comprising an inner cavity and at least one open end; Multiple clamping arms that are movable between a first configuration in which the multiple clamping arms are open to receive target tissue and a second configuration in which the multiple clamping arms are closed to hold the target tissue; A locking mechanism is provided on the plurality of clamping arms to engage with each other to maintain the second configuration; and A restraining mechanism is configured to be associated with the locking mechanism to prevent the target tissue from being squeezed between the locking mechanisms. The plurality of clamping arms includes a first arm and a second arm, and the locking mechanism includes a first locking member disposed on the first arm and a second locking member disposed on the second arm. The limiting mechanism includes a first limiting track and a second limiting track, and The first limiting track and the second limiting track have respective ends attached to the respective side surfaces of the first locking member, and the first limiting track and the second limiting track pass through a through hole formed in the second locking member.

4. The clamping device according to claim 3, characterized in that, The through hole is part of the opening of the second locking member, and the opening of the second locking member is configured to receive the first locking member.

5. A clamping device comprising: A sheath, comprising an inner cavity and at least one open end; Multiple clamping arms that are movable between a first configuration in which the multiple clamping arms are open to receive target tissue and a second configuration in which the multiple clamping arms are closed to hold the target tissue; A locking mechanism is provided on the plurality of clamping arms to engage with each other to maintain the second configuration; and A restraining mechanism is configured to be associated with the locking mechanism to prevent the target tissue from being squeezed between the locking mechanisms. The plurality of clamping arms includes a first arm and a second arm, and the locking mechanism includes a first locking member disposed on the first arm and a second locking member disposed on the second arm. The limiting mechanism includes at least one limiting track, and The at least one limiting track has an end attached to a first side surface of the first locking member, and the at least one limiting track is movable along a second side surface of the second locking member.

6. A clamping device comprising: A sheath, comprising an inner cavity and at least one open end; Multiple clamping arms that are movable between a first configuration in which the multiple clamping arms are open to receive target tissue and a second configuration in which the multiple clamping arms are closed to hold the target tissue; A locking mechanism is provided on the plurality of clamping arms to engage with each other to maintain the second configuration; and A restraining mechanism is configured to be associated with the locking mechanism to prevent the target tissue from being squeezed between the locking mechanisms. The plurality of clamping arms includes a first arm and a second arm, and the locking mechanism includes a first locking member disposed on the first arm and a second locking member disposed on the second arm. The limiting mechanism includes a limiting track, and One end of the limiting track is attached to a groove formed in the first locking member, and the limiting track is movable along a groove formed in the second locking member.

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