Through-the-scope tissue closure device

Abstract

An exemplary medical device is disclosed. The exemplary medical device includes a tissue clipping device comprising a bushing having a distal end, a proximal end, and a lumen through the bushing. A clip comprising at least a first arm and a second arm is configured to be connected to the distal end of the bushing, and one of the first arm and the second arm includes a tissue gripping member. A control wire having a proximal end and a distal end is configured to be connected to the lumen of the bushing, and a helical member is configured to be connected to the distal end of the control wire. The control wire is configured to advance the helical member distally along the longitudinal axis of the tissue clipping device and to retract the helical member proximally along the longitudinal axis of the tissue clipping device.

Description

Technical Field

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[0003]

[0001] The present disclosure relates to medical devices and methods for manufacturing medical devices. More specifically, the present disclosure relates to full-thickness tissue closure devices.

Background Art

[0002] Pathologies of the gastrointestinal system, biliary system, vascular system, and other body lumens and hollow organs are often treated through endoscopic procedures, many of which require active and / or prophylactic hemostasis to control bleeding. Tools for deploying hemostatic clips via an endoscope are often used to stop internal bleeding by clamping together the edges of a wound or incision. Hemostatic clips hold the tissue surrounding a wound and apply pressure at that site to hold the edges of the wound together, allowing the natural healing process to close the wound. A dedicated endoscopic clipping device is used to deliver the clip to a desired location in the body, position the clip at the desired location, and after deployment, the clip delivery device is removed and the clip remains in the body. These clips may be left in place until they fall off through natural processes, or may be removed later through a separate procedure after the bleeding site has healed.

Summary of the Invention

[0003] This summary of the present disclosure is provided to aid understanding, and those skilled in the art will understand that each of the various aspects and features of the present disclosure can be advantageously used, in some cases separately, or in other cases in combination with other aspects and features of the present disclosure. The limitations regarding the scope of the claimed subject matter are not intended by the inclusion or non-inclusion of elements, components, etc. in this summary. Thus, it should be understood that the present disclosure is presented with respect to aspects or embodiments, but that individual aspects can be claimed separately or in combination with aspects and features of that embodiment or any other embodiment.

[0004] Several embodiments can be implemented as tissue closure devices. The tissue closure device may include a bushing having a distal end, a proximal end, and a lumen through the bushing; a clip including at least a first arm and a second arm, wherein the proximal end region of the clip is configured to connect to the distal end of the bushing; a control wire having a proximal end and a distal end, wherein the control wire is configured to pass through the lumen of the bushing; and a helical member configured to connect to the distal end of the control wire, wherein the control wire is configured to advance the helical member distally along the longitudinal axis of the tissue closure device and to retract the helical member proximally along the longitudinal axis of the tissue closure device, and one of the first arm and the second arm includes a tissue gripping member.

[0005] In a further embodiment of the tissue clipping device, the tissue gripping member is a hook. In a further embodiment of the tissue clipping device, the helical member is connected to a control wire via a cam member.

[0006] In a further embodiment of the tissue clipping device, when the control wire is retracted in the proximal direction, the cam member engages with the proximal end of the first arm and the proximal end of the second arm, thereby moving the first arm and the second arm toward each other to a closed position.

[0007] In a further embodiment of the tissue clipping device, when the control wire is retracted proximal, the cam member is positioned within the proximal end of the clip, thereby locking the first and second arms in the closed position.

[0008] In a further embodiment of the tissue clipping device, the proximal end of the control wire is connected to a handle. In a further embodiment of the tissue clipping device, when the clip is in the open position, the proximal end of the first arm and the proximal end of the second arm engage with each other to control the opening angle.

[0009] Some embodiments of the present disclosure can be implemented as a method for closing tissue using a tissue closure device. The method includes inserting a closure device into a target site in the body through a natural body columbar, wherein the closure device includes a bushing having a distal end, a proximal end, and a lumen through which the bushing passes; a clip including at least a first arm and a second arm, the proximal end of which the clip is configured to be connected to the distal end of the bushing; a control wire having a proximal end and a distal end, the control wire configured to pass through the lumen of the bushing; and a helical member configured to be connected to the distal end of the control wire. The procedure may include the steps of: advancing distally so that the first and second arms move radially away from each other with respect to the longitudinal axis of the clipping device and the helical member engages with the first tissue at the target site; rotating the control wire in a first direction so that the helical member rotates within the tissue; and retracting the control wire and helical member proximal to pull the first tissue proximal into the clip, wherein when the control wire and helical member are retracted proximal to the first arms, the first and second arms move toward each other so that the clip closes.

[0010] In a further embodiment of this method, one of the first arm and the second arm includes a tissue gripping member. In a further embodiment of this method, the tissue gripping member is a hook.

[0011] In a further embodiment of this method, the helical member is connected to a control wire via a cam member. In a further embodiment of this method, when the control wire is retracted proximally, the cam member engages with the proximal end of the first arm and the proximal end of the second arm, thereby moving the first arm and the second arm toward each other and closing the clip.

[0012] In further embodiments, the method may include the step of rotating the control wire in a second direction to rotate the helical member, thereby disengaging the helical member from the first structure.

[0013] In a further embodiment of this method, when the control wire is retracted proximally, the cam member is positioned within the proximal end of the clip, thereby locking the first and second arms in the closed position.

[0014] In further embodiments, the method may include the step of pulling the control wire proximal to disconnect the connection between the control wire and the clip, thereby allowing the control wire to be removed from the tissue clipping device.

[0015] In further embodiments, the method may include the step of advancing a control wire such that the first and second arms move radially away from each other with respect to the longitudinal axis of the clipping device, and the helical member engages with the second tissue at the target site.

[0016] In a further embodiment of this method, when the helical member engages with the second tissue, the first tissue is fixed to the tissue gripping member. Some embodiments of the present disclosure can be implemented as a tissue clip. The tissue clip may include a bushing having a distal end and a proximal end; a first arm including a first tissue gripping member positioned adjacent to the distal end of the first arm, the proximal end of the first arm connected to the distal end of the bushing; a second arm including a second tissue gripping member positioned adjacent to the distal end of the second arm, the proximal end of the second arm connected to the distal end of the bushing; and a helical member configured to be positioned between the first arm and the second arm, the helical member configured to advance distally along the longitudinal axis of the tissue clip, wherein the tissue clip is configured to move from a first closed position to a second open position.

[0017] In a further embodiment of the tissue clip, when the clip is in the second open position, the proximal ends of the first arm and the second arm engage with each other to control the opening angle. In a further embodiment of the tissue clip, one of the first tissue gripping member or the second tissue gripping member includes a hook.

[0018] The above summary of some embodiments is not intended to describe each disclosed embodiment or all implementations of the present disclosure. The following drawings and detailed description illustrate these embodiments more specifically.

[0019] The present disclosure can be more fully understood in consideration of the following detailed description in connection with the accompanying drawings.

Brief Description of the Drawings

[0020] [Figure 1] A diagram illustrating an exemplary tissue closure device in a first position. [Figure 2] A diagram illustrating the tissue closure device shown in FIG. 1 in a second position. [Figure 3] A diagram illustrating a part of the tissue closure device shown in FIG. 1. [Figure 4] A diagram illustrating an exemplary tissue closure device positioned near a target site. [Figure 5A] A diagram illustrating an enlarged portion of the tissue closure device showing the helical member, as shown in circle 5A of FIG. 4. [Figure 5B] A diagram illustrating the helical member shown in FIG. 5A engaged with the target tissue. [Figure 5C] A diagram illustrating the tissue closure device shown in FIG. 4 with the helical member retracted proximally. [Figure 5D] A diagram illustrating a cross-sectional view of the tissue closure device shown in FIG. 5C including the target tissue, and the tissue closure device is in the first position. [Figure 5E] A diagram illustrating the tissue closure device shown in FIG. 5D including the target tissue, and the tissue closure device is in the second position. [Figure 5F]An illustration of a tissue closure device shown in FIG. 5E, including a helical member engaged with a target tissue, the tissue closure device being in a first position. [Figure 5G] An illustration of a tissue closure device shown in FIG. 5F, including a target tissue, the tissue closure device being in a second position. [Figure 5H] A figure illustrating a partial cross-sectional view of the tissue closure device shown in FIG. 5G. [Figure 5I] A figure illustrating a part of the tissue closure device shown in FIG. 5H, where the control wire has been removed. [Figure 6] A figure illustrating an exemplary tissue closure device attached to a target site. [Figure 7A] A figure illustrating a partial cross-sectional view of an exemplary tissue closure device in a first position. [Figure 7B] A figure illustrating a partial cross-sectional view of an exemplary tissue closure device shown in FIG. 7A in a second position. [Figure 8A] A figure illustrating a partial cross-sectional view of an exemplary tissue closure device in a first position. [Figure 8B] A figure illustrating a partial cross-sectional view of an exemplary tissue closure device shown in FIG. 8A in a second position. [Figure 9A] A figure illustrating a partial cross-sectional view of an exemplary tissue closure device in a first position. [Figure 9B] A figure illustrating a partial cross-sectional view of an exemplary tissue closure device shown in FIG. 9A in a second position. [Figure 10] A figure illustrating an exemplary tissue closure device. [Figure 11A] A figure illustrating an exemplary tissue closure device in a first position. [Figure 11B] A figure illustrating an exemplary tissue closure device shown in FIG. 11A in a second position.

Best Modes for Carrying Out the Invention

[0021] This disclosure is open to various modifications and alternative forms, the details of which are illustrated by example in the drawings and described in detail. However, it should be understood that the intent is not to limit this disclosure to the embodiments described. Rather, the intent is to encompass all modifications, equivalents, and alternatives that fall within the spirit of this disclosure.

[0022] The terms defined below shall apply unless otherwise given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be qualified by the term “approximately,” whether expressly indicated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to (i.e., having the same function or result as) the stated value. Often, the term “approximately” may include numbers rounded to the nearest significant figure. Listing numerical ranges by endpoints includes all numbers within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0023] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless otherwise explicitly indicated. As used herein and in the appended claims, the term “or” generally refers to “and / or” unless otherwise explicitly indicated.

[0024] Please note that references in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include specific features, structures, and / or characteristics. In addition, when specific features, structures, and / or characteristics are described in relation to one embodiment, please understand that such features, structures, and / or characteristics may also be used in relation to other embodiments, whether explicitly described or not, unless otherwise explicitly stated.

[0025] The following detailed description should be read with reference to the drawings, where similar elements in different drawings are numbered the same. The drawings are illustrative embodiments and are not necessarily to a specific scale, and are not intended to limit the scope of the claims.

[0026] Conditions of body lumens and hollow organs are often treated through endoscopic procedures, many of which may require mechanisms to control bleeding. Endoscopically, tools for deploying tissue closure devices, such as hemostatic clips, are often used to stop internal bleeding by clamping together the edges of a wound or incision. Hemostatic clips (e.g., wound / tissue closure devices) can grasp the tissue surrounding a wound by applying pressure to a target tissue site, holding the edges of the wound together and allowing the natural healing process to close the wound. A dedicated endoscopic clipping device is used to deliver the clip to the desired location in the body, position the clip in the desired location, and after deployment, the clip delivery device is withdrawn, leaving the clip in the body. These clips may remain in place until removed through natural processes, or they may be removed later through separate procedures after the bleeding site has healed.

[0027] As those skilled in the art will understand, when the clip arm is deployed over the tissue surrounding a bleeding wound, it effectively pulls the edges of the wound together to stop bleeding at the target tissue site. However, as those skilled in the art will understand, these clips can be used for any application where portions of tissue need to be pulled together. As the control wire is pushed distally, the clip holder releases its grip on the proximal end of the clip, deploying the clip from the insertion device. The insertion device is then removed from the body, and the clip is left in place on the target tissue. Exemplary clips according to the present invention may be used to fix tissue layers together, to close an opening in one or more layers of tissue, for lung tissue compression, to compress bronchiolar / alveolar tissue in emphysema patients, for the treatment of chronic obstructive pulmonary disease ("COPD"), etc. For example, clipping devices may be used to close wounds and / or incisions for hemostasis of spontaneous or surgical bleeding, "suturing" wounds, occlusion of blood vessels or lumens, fold formation of hollow organs, tissue adhesion, tissue access, etc.

[0028] Figures 1 to 3 show an exemplary tissue closure device 10. Figure 1 illustrates an exemplary tissue closure device 10 in a first closure position 30. The tissue closure device 10 may include a bushing 12, which may include a distal end 13 and a proximal end 11. The bushing 12 may include a lumen 15 that penetrates the bushing. In some cases, the proximal end 11 of the bushing 12 may be configured to be connected to a shaft 50. In some cases, the shaft 50 may include an endoscope, laparoscope, catheter, guide tube, etc. The distal end 13 of the bushing 12 may be releasably connected to the proximal end region 33 of a clip 20. The clip 20 may include a diameter that allows the clip 20 and the bushing 12 to pass through the delivery device. The clip 20 may include at least a first arm 22 and a second arm 24. Although the clip 20 is shown to include a first arm 22 and a second arm 24, the clip 20 may be intended to include three, four, five, or any preferred number of arms as desired. The first arm 22 and the second arm 24 may be equidistant from each other, which may position the first arm 22 and the second arm 24 at 180 degrees from each other, but other angles may be used without departing from the scope of the disclosure. The first arm 22 and the second arm 24 may be formed with a curvature selected such that a tissue-receiving cavity 34 can be formed between the first arm 22 and the second arm 24 when the first arm 22 and the second arm 24 are in a first closed position 30 as shown in Figure 1.

[0029] The clip 20 may further include a helical member 26 that can be positioned between the first arm 22 and the second arm 24 within the tissue receiving cavity 34. Optionally, the helical member 26 may be connected to a washer 17 which can be connected to a cam member 16. Optionally, the washer 17 may be removed, and the helical member 26 may be directly connected to the cam member 16. The helical member 26 may be releasably connected to the distal end 18 of a control wire 14. Optionally, the control wire 14 may be releasably connected to the cam member 16. Optionally, the control wire 14 may be releasably connected to the washer 17. The control wire 14 may penetrate the lumen of the shaft 50 and the lumen 15 of the bushing 12 and extend beyond the distal end 13 of the bushing 12. The control wire 14 may be configured to actuate along the longitudinal axis L1 of the tissue closure device 10. The operation of the control wire 14 may include advancing the control wire 14 distally and / or retracting the control wire 14 proximal to the control wire. Furthermore, the control wire 14 may be configured to rotate clockwise and / or counterclockwise. The operation and / or rotation of the control wire 14 may then result in the operation and / or rotation of the helical member 26, since the helical member 26 is releasably connected to the control wire 14.

[0030] Figure 1 further illustrates that the proximal end 19 of the control wire 14 may be connected to a control member 52 (e.g., a handle, actuator, etc.). The control member 52 may be configured to control the operation of the control wire 14 (e.g., forward, backward, and rotation of the control wire 14). In some cases, the control member 52 may also be used as a grip to control the translation of the shaft 50. The control member 52 may be used by a clinician to advance the tissue closure device 10 to a position adjacent to the target tissue in order to perform a medical procedure. In addition, the control member 52 may include one or more actuators, gears, levers, etc., which enable the clinician to operate the shaft 50 in addition to other features or components of the tissue closure device 10, such as the control wire 14. As will be described in more detail below, the tissue closure device 10 may be advanced distally to a position adjacent to the target tissue, such as a lesion, within a portion of a body lumen, while the shaft 50 may extend from the body lumen to a position outside the body.

[0031] Figure 2 illustrates the tissue closure device 10 in a second open position 35. As shown in Figure 2, the proximal end 27 of the first arm 22 may include a first tab 31, which may include a size and shape configured to engage with a first notch 81 in the distal end 13 of the bushing 12. The second arm 24 may include a second tab 32, which may include a size and shape configured to engage with a second notch 82 in the distal end 13 of the bushing 12. The notches 81, 82 may be sized to allow the first and second tabs 31, 32 to move within the notches 81, 82 as the first arm 22 and the second arm 24 expand radially away from the longitudinal axis L1 of the tissue closure device 10. When the first arm 22 and the second arm 24 extend radially to the second open position 35, the first tab 31 and the second tab 32 come into contact with each other, thereby preventing further extension of the first arm 22 and the second arm 24 and controlling the open angle of the clip 20. In some cases, the full extension of the first arm 22 and the second arm 24 may include a range of about 25 to about 90 degrees from the longitudinal axis L1 of the tissue closure device 10. In some cases, the full extension of the first arm 22 and the second arm 24 may include a range of about 35 to about 60 degrees from the longitudinal axis L1 of the tissue closure device 10. In some cases, the full extension of the first arm 22 and the second arm 24 may include a range of 45 degrees from the longitudinal axis L1 of the tissue closure device 10.

[0032] As shown in Figure 2, the first arm 22 and the second arm 24 may include blunt or rounded ends to minimize tissue trauma. In some cases, the distal end 25 of the first arm 22 may include a first tissue gripping member 29, and the distal end 21 of the second arm 24 may include a second tissue gripping member 28. In some cases, the first tissue gripping member 29 may include a pyramidal point. In some cases, the second tissue gripping member 28 may include a hook. Although it has been shown that the first tissue gripping member 29 includes a pyramidal point and the second tissue gripping member 28 includes a hook, the first tissue gripping member 29 and / or the second tissue gripping member 28 may include a pyramidal point, a hook, multiple dentate-shaped ends, barbs, etc. In some cases, either the first arm 22 or the second arm 24 may include a recess within its distal end configured to receive a tissue gripping member (e.g., a first tissue gripping member 29, a second tissue gripping member 28). These are some examples.

[0033] Figure 3 shows a portion of the tissue closure device 10, showing the distal end 13 of the bushing 12 and the proximal ends 27 and 23 of the first arm 22 and the second arm 24, respectively. As shown in Figure 3, the tissue closure device 10 is in the second open position 35. When the tissue closure device 10 is in the second open position 35, the first tab 31 and the second tab 32 abut each other at their outer edges. The first tab 31 may include a first notch 86 and the second tab 32 may include a second notch 87, so that when the first tab 31 and the second tab 32 abut each other, they form an opening 88. The opening 88 is sized and shaped so that the control wire 14 can operate freely within the tissue closure device 10.

[0034] In some cases, the control wire 14 may be retracted proximally, thereby allowing the cam member 16 to engage (e.g., contact) with the first tab 31 and the second tab 32. The proximal retraction of the control wire 14 may provide a compressive force of the cam member 16 on the first tab 31 and the second tab 32, thereby compressing the first arm 22 and the second arm 24 radially toward the longitudinal axis L1 of the tissue closure device 10. This compressive force on the tabs 31 and 32 thereby moves the clip 20 from the second open position 35 to the first closed position 30. Furthermore, the proximal end 27 of the first arm 22 may include a first ledge 83, and the proximal end 23 of the second arm 24 may include a second ledge 84, both positioned inside each of the arms 22 and 24, respectively. The ledges 83 and 84 may be configured to receive and hold the cam member 16 when the control wire 14 is removed from the clip 20, thereby locking the first arm 22 and the second arm 24 in the first closed position 30 and preventing the cam member 16 from being removed from the clip 20. Removal of the control wire 14 may include the step of pulling the control wire 14 proximal to sever the connection between the control wire 14 and the clip 20 (e.g., the cam member 16), which allows the control wire 14 to be removed from the tissue closure device 10.

[0035] Figure 4 illustrates an exemplary tissue closure device 100 positioned near a target tissue site 150. The tissue closure device 100 may be considered an example of the tissue closure devices 10 shown in Figures 1 to 3. The tissue closure device 100 may include a bushing 112, which may include a distal end 113 and a proximal end 111. The bushing 112 may include a lumen 115 that penetrates the bushing. In some cases, the proximal end 111 of the bushing 112 may be configured to be connected to a shaft (e.g., shaft 50). In some cases, the shaft may include an endoscope, laparoscope, catheter, guide tube, etc. The distal end 113 of the bushing 112 may be releasably connected to the proximal end region 133 of a clip 120. The clip 120 may have a diameter that allows the clip 120 and the bushing 112 to pass through the delivery device. The clip 120 may include at least a first arm 122 and a second arm 124. Although the clip 120 is shown to include a first arm 122 and a second arm 124, the clip 120 may be intended to include three, four, five, or any preferred number of arms as desired. The first arm 122 and the second arm 124 may be equidistant from each other, which may position the first arm 122 and the second arm 124 at 180 degrees from each other, but other angles may be used without departing from the scope of the disclosure. The first arm 122 and the second arm 124 may be formed with a curvature selected such that a tissue-receiving cavity 134 can be formed between the first arm 122 and the second arm 124 when the first arm 122 and the second arm 124 are in a closed position (e.g., a first closed position 30).

[0036] The clip 120 may further include a helical member 126 that can be positioned between the first arm 122 and the second arm 124 within the tissue receiving cavity 134. Optionally, the helical member 126 may be connected to a washer 117 which can be connected to a cam member 116. Optionally, the washer 117 may be removed, and the helical member 126 may be directly connected to the cam member 116. The helical member 126 may be releasably connected to the distal end 118 of a control wire 114. Optionally, the control wire 114 may be releasably connected to the cam member 116. Optionally, the control wire 114 may be releasably connected to the washer 117. The control wire 114 may penetrate the lumen of the shaft and the lumen 115 of the bushing 112 and extend beyond the distal end 113 of the bushing 112. The control wire 114 may be configured to actuate along the longitudinal axis L2 of the tissue closure device 100. The operation of the control wire 114 may include advancing the control wire 114 distally and / or retracting the control wire 114 proximal to the control wire. Furthermore, the control wire 114 may be configured to rotate clockwise and / or counterclockwise. The operation and / or rotation of the control wire 114 may then result in the operation and / or rotation of the helical member 126, since the helical member 126 is releasably connected to the control wire 114.

[0037] Figure 4 shows the tissue closure device 100 in the second open position 35. As shown in Figure 4, the proximal end 127 of the first arm 122 may include a first tab 131, which may include a size and shape configured to engage with a first notch 181 in the distal end 113 of the bushing 112. The second arm 124 may include a second tab 132, which may include a size and shape configured to engage with a second notch 182 in the distal end 113 of the bushing 112. The notches 181, 182 may be sized to allow the first and second tabs 131, 132 to move within the notches 181, 182 as the first arm 122 and the second arm 124 expand radially away from the longitudinal axis L2 of the tissue closure device 100. When the first arm 122 and the second arm 124 extend radially to the open position 135, the first tab 131 and the second tab 132 come into contact with each other, thereby preventing further extension of the first arm 122 and the second arm 124. In some cases, the full extension of the first arm 122 and the second arm 124 may include a range of about 25 to about 90 degrees from the longitudinal axis L2 of the tissue closure device 100. In some cases, the full extension of the first arm 122 and the second arm 124 may include a range of about 35 to about 60 degrees from the longitudinal axis L2 of the tissue closure device 100. In some cases, the full extension of the first arm 122 and the second arm 124 may include a range of 45 degrees from the longitudinal axis L2 of the tissue closure device 100.

[0038] As shown in Figure 4, the first arm 122 and the second arm 124 may include blunt or rounded ends to minimize tissue trauma. In some cases, the distal end 125 of the first arm 122 may include a first tissue gripping member 129, and the distal end 121 of the second arm 124 may include a second tissue gripping member 128. In some cases, the first tissue gripping member 129 may include a pyramidal point. In some cases, the second tissue gripping member 128 may include a hook. Although it has been shown that the first tissue gripping member 129 includes a pyramidal point and the second tissue gripping member 128 includes a hook, the first tissue gripping member 129 and / or the second tissue gripping member 128 may include a pyramidal point, a hook, multiple dentate-shaped ends, barbs, etc. In some cases, either the first arm 122 or the second arm 124 may include a recess within its distal end configured to receive a tissue gripping member (e.g., first tissue gripping member 129, second tissue gripping member 128). These are some examples.

[0039] As shown in Figure 4, the tissue closure device 100 is positioned adjacent to the target tissue site 150. The control wire 114 may be advanced distally along the longitudinal axis L2 of the tissue closure device 100, thereby advancing the helical member 126 toward the target tissue site 150. The control wire 114 may advance the helical member 126 until it contacts the target tissue site 150, and the user may rotate the control wire 114 in a first direction, as further shown in Figures 5A to 6, to rotate the helical member 126 into the target tissue site 150.

[0040] Figures 5A to 6 illustrate the tissue closure method according to the present disclosure. Figure 5A shows a helical member 126 positioned near the target tissue site 150, as shown by circle 5A in Figure 4. As previously stated, the control wire 114 may be advanced distally along the longitudinal axis L2 of the tissue closure device 100, thereby advancing the helical member 126 toward the target tissue site 150. The control wire 114 may advance the helical member 126 until it contacts the target tissue site 150, and the user may rotate the control wire 114 in a first direction, as indicated by arrow 190, which rotates the helical member 126 into the target tissue site 150, as shown in Figure 5B. The control wire 114 may then be retracted proximally along the longitudinal axis L2 of the tissue closure device 100 until the cam member 116 engages with (e.g., contacts) the first tab 131 and the second tab 132, as shown in Figure 5C. The proximal retraction of the control wire 114 may provide a compressive force of the cam member 116 on the first tab 131 and the second tab 132, thereby radially compressing the first arm 122 and the second arm 124 toward the longitudinal axis L2 of the tissue closure device 100. This compressive force on the tabs 131 and 132 thereby moves the clip 120 from the open position 135 to the closed position 130, as shown in Figure 5D.

[0041] When the clip 120 is in the closed position 130, the first tissue gripping member 129 may push the target tissue portion 150 against the second tissue gripping member 128, as shown in Figure 5D. The second tissue gripping member 128 may include a “fishhook” type hook, which can be configured to hold tissue on the second arm 124. The control wire 114 may then be rotated in a second direction, as indicated by arrow 191, which rotates the helical member 126, thereby disengaging the helical member 126 from the target tissue portion 150. The control wire 114 may then be advanced distally, thereby advancing the helical member 126 distally. As the control wire 114 and the helical member 126 advance distally, the first arm 122 and the second arm 124 are biased to move from the closed position 130 to the open position 135, as shown in Figure 5E.

[0042] As shown in Figure 5E, the second tissue gripping member 128 can continue to grip the tissue of the target tissue site 150. This allows the helical member 126 to advance into the second target tissue site 155 and grip further tissue, as shown in Figure 5F. The control wire 114 may then be retracted proximal along the longitudinal axis L2 of the tissue closure device 100 until the cam member 116 engages (e.g., contacts) with the first tab 131 and the second tab 132. The proximal retraction of the control wire 114 provides a compressive force on the first tab 131 and the second tab 132 of the cam member 116, thereby compressing the first arm 122 and the second arm 124 radially toward the longitudinal axis L2 of the tissue closure device 100. This compressive force on the tabs 131 and 132 thereby moves the clip 120 from the open position 135 to the closed position 130. When the clip 120 is in the closed position 130, the second target tissue site 155 may be grasped by the second tissue grasping member 128, as shown in Figure 5G. The control wire 114 may then be rotated in a second direction, which rotates the helical member 126, thereby engaging and disengaging the helical member 126 from the second target tissue site 155. This process of grasping the target tissue may be repeated at a frequency desired by the clinician.

[0043] As shown in Figure 5H, the proximal end 127 of the first arm 122 may include a first ledge 183, and the proximal end 123 of the second arm 124 may include a second ledge 184, each positioned inside the respective arms 122 and 124. The ledges 183 and 184 may be configured to receive and hold a cam member 116 when the control wire 114 is removed from the clip 120, thereby locking the first arm 122 and the second arm 124 in a closed position 130 and preventing the cam member 116 from being removed from the clip 120. Removal of the control wire 114 may include the step of pulling the control wire 114 proximal to sever the connection between the control wire 114 and the clip 120 (e.g., the cam member 116), which allows the control wire 114 to be removed from the tissue closure device 100, as shown in Figure 5I. The tissue clip 120 is then detached from the bushing 112 via proximal force, and remains in place at a target tissue site in the body (e.g., target tissue site 150), as shown in Figure 6. The tissue clip 120 may remain in place until it is removed by natural processes, or it may be removed later through a separate procedure after the bleeding site has healed.

[0044] Figures 7A and 7B show partial cross-sectional views of an exemplary tissue closure device 100. As shown in Figures 7A and 7B, the tissue closure device 100 may include alternative mechanisms for radially expanding (e.g., opening) and radially compressing (e.g., closing) the tissue closure device 100. As shown in Figures 7A and 7B, the first actuating arm 141 and the second actuating arm 144 may be positioned within the bushing 112. The first actuating arm 141 and the second actuating arm 144 may each include a first tip 142 and a second tip 143. The first tip 142 may be connected to the first arm 122, and the second tip 143 may be connected to the second arm 124. During use, a user (e.g., a clinician) may use the actuating mechanism to advance the actuating arms 141 and 144, thereby moving the first tip 142 and the second tip 143, respectively. The distal advancement of the actuating arms 141 and 144 extends the first arm 122 and the second arm 124 radially. In some cases, the actuating arms 141 and 144 may be retracted proximally, thereby compressing the first arm 122 and the second arm 124 radially. In such cases, the movement of the control wire 114 is independent of the movement of the actuating arms 141 and 144.

[0045] Figures 8A and 8B show partial cross-sectional views of an exemplary tissue closure device 100. As shown in Figures 8A and 8B, the tissue closure device 100 may include alternative mechanisms for radially expanding (e.g., opening) and radially compressing (e.g., closing) the tissue closure device 100. As shown in Figures 8A and 8B, the outer sleeve 160 may be positioned around the outer diameter of the bushing 112 and may advance distally over the first arm 122 and the second arm 124. As shown in Figure 8A, when the outer sleeve 160 advances over the first arm 122 and the second arm 124, the tissue clip 120 is held in the closed position. When the outer sleeve 160 is retracted proximal, thereby releasing the first arm 122 and the second arm 124, a spring 162 within the tissue clip 120 biases the first arm 122 and the second arm 124 radially outward, thereby moving the tissue clip 120 to the open position.

[0046] Figures 9A and 9B show partial cross-sectional views of an exemplary tissue closure device 100. As shown in Figures 9A and 9B, the tissue closure device 100 may include alternative mechanisms for radially expanding (e.g., opening) and radially compressing (e.g., closing) the tissue closure device 100. As shown in Figures 9A and 9B, the tissue closure device 100 may include a locking component 170 that can be advanced distally through the lumen 115 of the bushing 112 and engage with ledges 183 and 184. The ledges 183 and 184 may be configured to receive the locking component 170 and hold the cam member 116 in place when the control wire 114 is removed from the clip 120, thereby locking the first arm 122 and the second arm 124 in a closed position 130 and preventing the cam member 116 from being removed from the clip 120.

[0047] Figure 10 shows an exemplary tissue closure device 100 including alternative tissue gripping members. As shown in Figure 10, the first tissue gripping member 229 may include one or more recesses that can be configured to receive one or more pyramidal points of the second tissue gripping member 228.

[0048] Figures 11A and 11B show an exemplary tissue closure device 100 including alternative tissue gripping members. As shown in Figures 11A and 11B, the first arm 122 may include a first tissue gripping member 329 which may include one or more pyramidal points. In some cases, the second arm 124 may include a second tissue gripping member 328 which may include a hook. In the embodiments of Figures 11A and 11B, the second arm 124 may include a smooth rod-shaped surface configured to allow the second arm 124 to grip and hold multiple segments of target tissue, such as target tissue 330, 335, 340, 345.

[0049] Materials that can be used for various components of the tissue closure device 10 disclosed herein and various other medical devices may be made from metals, metal alloys, polymers (some examples thereof are disclosed below), metal-polymer composites, ceramics, combinations thereof, and equivalents, or other suitable materials.Examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylenetetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® from DuPont), polyether block esters, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether esters (e.g., ARNITEL® from DSM Engineering Plastics), ether or ester copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® from DuPont), polyamides (e.g., DURETHAN® from Bayer, CRISTAMID® from Elf-Atochem), elastomer polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., PEBAX®), ethylene vinyl acetate copolymers (E VA), silicone, polyethylene (PE), Marex high-density polyethylene, Marex low-density polyethylene, linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly-p-phenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID® from EMS American Grillon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS) Examples include polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof.In some embodiments, the sheath can be blended with liquid crystal polymer (LCP). For example, the mixture may contain up to about 6% LCP.

[0050] Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels, mild steel, nickel-titanium alloys such as linear elastic and / or superelastic Nitinol, and nickel-chromium-molybdenum alloys (e.g., UNS:N06625, e.g., INCONEL® 625, UNS:N06022, e.g., HASTELLOY® C-22, UNS:N10276, e.g., HASTELLOY® C27). 6 (registered trademark), other HASTELLOY (registered trademark) alloys, etc.), nickel-copper alloys (e.g., UNS:N04400, e.g., MONEL (registered trademark) 400, NICKELVAC (registered trademark) 400, NICORROS (registered trademark) 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035, e.g., MP35-N (registered trademark)), nickel-molybdenum alloys (e.g., UNS:N10665, e.g., HASTELLOY (registered trademark) ALLOY Examples of suitable materials include B2(registered trademark), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, cobalt-chromium alloys, cobalt-chromium-molybdenum alloys (e.g., UNS:R30003, e.g., ELGILOY(registered trademark), PHYNOX(registered trademark), etc.), platinum-reinforced stainless steel, titanium, combinations thereof, or any other suitable material. In at least some embodiments, some or all of the tissue closure devices 10 and various other medical devices disclosed herein may also be doped with, fabricated from, or otherwise contain radiopaque materials. Radiopaque materials are understood to be materials that can produce a relatively bright image on a fluoroscopic screen or other imaging technique during a medical procedure. This relatively bright image helps users of the tissue closure devices 10 and various other medical devices disclosed herein to determine their location. Some embodiments of radiopaque materials, but not limited to, may include gold, platinum, palladium, tantalum, tungsten alloys, polymer materials loaded with radiopaque fillers, and equivalents. In addition, other radiopaque marker bands and / or coils may also be incorporated into the design of the tissue closure devices 10 and various other medical devices disclosed herein to achieve the same results.

[0051] It should be understood that this disclosure is, in many respects, merely illustrative. Modifications may be made in detail, particularly with respect to shape, size, and step arrangement, without exceeding the scope of this disclosure. This may include, to the appropriate extent, the use of any feature of one exemplary embodiment used in other embodiments. The scope of this disclosure is, of course, defined by the language in which the appended claims are expressed.

Claims

1. A tissue closure device A bushing having a distal end, a proximal end, and a lumen that penetrates the bushing. A clip comprising at least a first arm and a second arm, wherein the proximal end region of the clip is configured to be connected to the distal end of the bushing, and A control wire having a proximal end and a distal end, configured to penetrate the lumen of the bushing. A spiral member configured to be connected to the distal end of the control wire and Includes, The control wire is configured to advance the helical member distally along the longitudinal axis of the tissue closure device and to retract the helical member proximal along the longitudinal axis of the tissue closure device. A tissue closure device in which one of the first arm and the second arm includes a tissue gripping member.

2. The tissue closure device according to claim 1, wherein the tissue gripping member is a hook.

3. The tissue closure device according to claim 1 or claim 2, wherein the helical member is connected to the control wire via a cam member.

4. The tissue closure device according to claim 3, wherein when the control wire is retracted in the proximal direction, the cam member engages with the proximal end of the first arm and the proximal end of the second arm, thereby moving the first arm and the second arm toward each other to a closed position.

5. The tissue closure device according to claim 4, wherein when the control wire is retracted proximal, the cam member is positioned within the proximal end of the clip, thereby locking the first arm and the second arm in the closed position.

6. The tissue closure device according to any one of claims 1 to 5, wherein the proximal end of the control wire is connected to a handle.

7. The tissue closure device according to any one of claims 1 to 6, wherein when the clip is in the open position, the proximal end of the first arm and the proximal end of the second arm engage with each other to control the opening angle.

8. A method for closing down an organization The step of inserting a closure device into a target site in the body through a natural body cavity, wherein the closure device A bushing having a distal end, a proximal end, and a lumen that penetrates the bushing. A clip comprising at least a first arm and a second arm, wherein the proximal end of the clip is configured to be connected to the distal end of the bushing, and A control wire having a proximal end and a distal end, configured to penetrate the lumen of the bushing. A spiral member configured to be connected to the distal end of the control wire and Steps including, The first arm and the second arm move radially away from each other with respect to the longitudinal axis of the clipping device, and the control wire is advanced distally so that the helical member engages with the first tissue at the target site. The steps include rotating the control wire in a first direction and rotating the helical member within the tissue. The steps include: retracting the control wire and the helical member in the proximal direction, thereby drawing the first tissue proximal into the clip; A method including, A method wherein, when the control wire and the helical member are retracted to the proximal position, the first arm and the second arm move toward each other, thereby closing the clip.

9. The method according to claim 8, wherein one of the first arm and the second arm includes a tissue gripping member.

10. The method according to claim 9, wherein the tissue gripping member is a hook.

11. The method according to any one of claims 8 to 10, wherein the helical member is connected to the control wire via a cam member.

12. The method according to claim 11, wherein when the control wire is retracted to a proximal position, the cam member engages with the proximal end of the first arm and the proximal end of the second arm, thereby moving the first arm and the second arm toward each other and closing the clip.

13. It is an organizational clip. A bushing having a distal end and a proximal end A first arm, comprising a first tissue gripping member positioned adjacent to the distal end of the first arm, wherein the proximal end of the first arm is connected to the distal end of the bushing, and A second arm, comprising a second tissue gripping member positioned adjacent to the distal end of the second arm, wherein the proximal end of the second arm is connected to the distal end of the bushing, and A helical member configured to be positioned between the first arm and the second arm, and configured to advance distally along the longitudinal axis of the tissue clip, and Includes, The tissue clip is configured to move from a first closed position to a second open position.

14. The tissue clip according to claim 13, wherein when the clip is in the second open position, the proximal end of the first arm and the proximal end of the second arm engage with each other to control the open angle.

15. The tissue clip according to claim 13 or 14, wherein one of the first tissue gripping member or the second tissue gripping member includes a hook.

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