Tissue closure device through mirror

Abstract

An example medical device is disclosed. An example medical device includes a tissue clamping device including a bushing having a distal end, a proximal end, and a lumen extending therethrough. A clip including at least a first arm and a second arm is configured to be coupled to the distal end of the bushing, wherein one of the first arm and the second arm includes a tissue grasping member. A control wire having a proximal end and a distal end is configured to extend through the lumen of the bushing, and a helical member is configured to be coupled to the distal end of the control wire. The control line is configured to advance the helical member in a distal direction along a longitudinal axis of the tissue gripping device and retract the helical member in a proximal direction along a longitudinal axis of the tissue gripping device.

Description

Cross Reference to Related Applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 508,048, filed June 14, 2023, the disclosure of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present invention relates to medical devices and methods for manufacturing medical devices. More particularly, the present invention relates to full-thickness tissue closure devices. BACKGROUND

[0003] Conditions of the gastrointestinal system, biliary tree, vascular system, and other body cavities and hollow organs are often treated by endoscopic surgery, many of which require active hemostasis and / or prophylactic hemostasis to control bleeding. Tools that deploy hemostatic clips via an endoscope are often used to stop internal bleeding by clamping the edges of a wound or incision together. The hemostatic clips grasp the tissue around the wound and hold the edges of the wound together by applying pressure to the site to allow the natural healing process to close the wound. Specialized endoscopic clipping devices are used to deliver the clips to a desired location in the body and position and deploy the clips at that desired location, after which the clip delivery device is withdrawn, leaving the clips in the body. These clips can be left in place until they fall out by natural processes or are later removed by a separate procedure after the hemostatic site has healed. SUMMARY

[0004] The summary of the invention is presented to facilitate understanding of the present invention and to fully disclose the invention now contemplated. Those skilled in the art will understand that aspects and features of the present invention can be advantageously used independent of other aspects and features of the invention in some cases or in combination with other aspects and features of the invention in other cases. The inclusion of an element, component, etc. in the summary is not intended to have any limiting effect on the scope of the claimed subject matter. Thus, although the invention is presented in terms of various aspects or embodiments, it should be appreciated that individual aspects can be claimed either independently or in combination with various aspects and features of the embodiments or any other embodiments.

[0005] Some embodiments can be implemented as a tissue closure device. The tissue closure device can include a hub having a distal end, a proximal end, and a lumen extending therethrough; a clip comprising at least a first arm and a second arm, wherein a proximal region of the clip is configured to be coupled to the distal end of the hub; a control wire having a proximal end and a distal end, the control wire configured to extend through the lumen of the hub; and a helical member configured to be coupled to the distal end of the control wire; wherein the control wire is configured to advance the helical member in a distal direction along a longitudinal axis of the tissue closure device and to retract the helical member in a proximal direction along the longitudinal axis of the tissue closure device; and wherein one of the first arm and the second arm comprises a tissue grasping member.

[0006] In further embodiments of the tissue clamping device, the tissue grasping member is a hook.

[0007] In further embodiments of the tissue clamping device, the helical member is coupled to the control line via a cam member.

[0008] In further embodiments of the tissue clamping device, when the control line is retracted in the proximal direction, the cam member engages 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 the closed position.

[0009] In further embodiments of the tissue clamping device, when the control line is retracted proximally, 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.

[0010] In further embodiments of the tissue clamping device, the proximal end of the control line is coupled to a handle.

[0011] In further embodiments of the tissue clamping 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 each other to control the opening angle.

[0012] Some embodiments of the present application can be implemented as a method of closing tissue with a tissue closing device. The method can include inserting the closing device through a natural body lumen to a target site in the body, the closing device comprising: a hub having a distal end, a proximal end, and a lumen extending therethrough; a clip comprising at least a first arm and a second arm, wherein the proximal end of the clip is configured to be coupled to the distal end of the hub; a control line having a proximal end and a distal end, the control line configured to extend through the lumen of the hub; and a helical member configured to be coupled to the distal end of the control line; advancing the control line distally such that the first arm and the second arm move radially away from each other relative to a longitudinal axis of the clamping device and the helical member engages a first tissue at the target site; rotating the control line in a first direction, which rotates the helical member into the tissue; and retracting the control line and the helical member in the proximal direction, thereby pulling the first tissue proximally into the clip; wherein when the control line and the helical member are retracted proximally, the first arm and the second arm move toward each other, thereby closing the clip.

[0013] In further embodiments of the method, one of the first arm and the second arm comprises a tissue grasping member.

[0014] In further embodiments of the method, the tissue grasping member is a hook.

[0015] In further embodiments of the method, the helical member is coupled to the control line via a cam member.

[0016] In further embodiments of the method, when the control line is retracted proximally, the cam member engages 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 close the clip.

[0017] In another embodiment, the method may include rotating the control line in a second direction, which causes the helical member to rotate, thereby disengaging the helical member from the first tissue.

[0018] In another embodiment of the method, when the control line retracts proximally, the cam member is positioned within the proximal end of the clamp, thereby locking the first and second arms in the closed position.

[0019] In another embodiment, the method may include pulling the control line proximally to sever the connection between the control line and the clamp, thereby allowing the control line to be withdrawn from the tissue clamping device.

[0020] In another embodiment, the method may include a feed control line such that the first arm and the second arm move radially away from each other relative to the longitudinal axis of the clamping device, and the helical member engages the second tissue at the target location.

[0021] In another embodiment of the method, the first tissue is secured to the tissue gripping member when the helical member engages the second tissue.

[0022] Some embodiments of the present invention 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 grasping member positioned adjacent to the distal end of the first arm, wherein the proximal end of the first arm is coupled to the distal end of the bushing; a second arm including a second tissue grasping member positioned adjacent to the distal end of the second arm, wherein the proximal end of the second arm is coupled to the distal end of the bushing; and a helical member configured to be positioned between the first and second arms, wherein the helical member is 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.

[0023] In another 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.

[0024] In another embodiment of the tissue clip, one of the first tissue gripping member or the second tissue gripping member includes a hook.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation of the invention. The following drawings and detailed descriptions illustrate these embodiments in more particular terms. Attached Figure Description

[0026] The invention will be more fully understood by taking into consideration the following detailed description in conjunction with the accompanying drawings, wherein:

[0027] Figure 1 An example tissue closure device is shown in the first position;

[0028] Figure 2 shown in a second position Figure 1 the tissue closure device shown;

[0029] Figure 3 shown in a second position Figure 1 a portion of the tissue closure device shown;

[0030] Figure 4 shown positioned proximate a target site;

[0031] Figure 5A shown in a second position Figure 4 the helical member shown in circle 5A;

[0032] Figure 5B shown engaged with target tissue Figure 5A the helical member shown;

[0033] Figure 5C shown in a second position Figure 4 the tissue closure device shown, wherein the helical member is retracted proximally;

[0034] Figure 5D shown in a second position Figure 5C a cross-sectional view of the tissue closure device shown, wherein the tissue closure device is in a first position;

[0035] Figure 5E shown in a second position Figure 5D the tissue closure device shown, wherein the tissue closure device is in a second position;

[0036] Figure 5F shown in a second position Figure 5E the tissue closure device shown, wherein the tissue closure device is in a first position;

[0037] Figure 5G shown in a second position Figure 5F the tissue closure device shown, wherein the tissue closure device is in a second position;

[0038] Figure 5H shown in a second position Figure 5G a cross-sectional view of a portion of the tissue closure device shown;

[0039] Figure 5I shown in a second position Figure 5H a portion of the tissue closure device shown, wherein the control line has been removed;

[0040] Figure 6 shown attached to a target site;

[0041] Figure 7A A cross-sectional view of a portion of an example tissue closure device in a first position is shown;

[0042] Figure 7B Showing the second position Figure 7A The example shown is a cross-sectional view of a portion of an organization closure device;

[0043] Figure 8A A cross-sectional view of a portion of an example tissue closure device in a first position is shown;

[0044] Figure 8B A cross-sectional view of a portion of an example tissue closure device in the second position is shown;

[0045] Figure 9A A cross-sectional view of a portion of an example tissue closure device in a first position is shown;

[0046] Figure 9B Showing the second position Figure 9A The example shown is a cross-sectional view of a portion of an organization closure device;

[0047] Figure 10 An example tissue closure device is shown;

[0048] Figure 11A An example tissue closure device is shown in the first position; and

[0049] Figure 11B Showing the second position Figure 11A The example shown is a tissue closure device. Detailed Implementation

[0050] While the invention is adaptable to various modifications and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that the invention is not intended to limit its aspects to the described embodiments. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit of the invention.

[0051] For the purposes of the following definitions, unless otherwise specified in the claims or elsewhere in this specification, these definitions shall apply.

[0052] All numerical values ​​herein are assumed to be modified by the term "about," whether or not explicitly stated otherwise. The term "about" 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) the cited figures. In many cases, the term "about" may include numbers rounded to the nearest significant figure.

[0053] Notations representing a range of numbers by endpoints include all of the numbers within that range (for example, 1 to 5 includes, 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0054] As used in the specification and the appended claims, the singular forms“a,”“an” and“the” include plural referents unless the context clearly dictates otherwise. As used in the specification and the appended claims, the term“or” is generally employed in its sense of inclusive“and / or” unless the context clearly dictates otherwise.

[0055] It should be noted that references to“one embodiment,”“some embodiments,”“other embodiments,” etc. in this specification mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearances of the phrase“in one embodiment” in various places in the specification are not necessarily all referring to the same embodiment, however.

[0056] The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings depict only illustrative embodiments and are not necessarily drawn to scale. The detailed description and drawings provide examples of the disclosed subject matter.

[0057] Pathologies of body lumens and hollow organs are often treated by endoscopic surgery, many of which can require a mechanism to control bleeding. Tools that deploy tissue closure devices, such as hemostatic clips, via an endoscope are often used to stop internal bleeding by clamping the edges of a wound or incision together. Hemostatic clips (e.g., wound / tissue closure devices) can grasp tissue around a wound and hold the edges of the wound together by applying pressure to the target tissue site to allow the natural healing process to close the wound. Specialized endoscopic clip applier devices are used to transport the clips to a desired location in the body and position and deploy the clips at the desired location, after which the clip transport device is withdrawn, leaving the clip in the body. These clips can be left in place until they are removed via a natural process or after the bleeding site has healed by a separate surgery.

[0058] As will be appreciated by those skilled in the art, when deployed to the tissue surrounding a bleeding wound, the clip arms draw the wound edges together, thereby achieving hemostasis of the target tissue site. However, as will be appreciated by those skilled in the art, these clips can be used for any application where it is desirable to draw portions of tissue together. When the control line is pushed distally, the clip holder releases its grip on the proximal end of the clip, thereby deploying the clip from the insertion device. The insertion device can then be removed from the body, leaving the clip in place on the target tissue. Exemplary clips according to the present application can be used to fasten tissue layers together, close an opening in one or more tissue layers, lung tissue compression, compress bronchiole / alveolar tissue in a patient with emphysema, treat chronic obstructive pulmonary disease (COPD), etc. For example, the clip device can be used to close a wound and / or incision for hemostasis of natural or surgical bleeding, "suture" a wound, occlude a blood vessel or lumen, fold a hollow organ, attach tissue, tissue apposition, etc.

[0059] Figures 1-3 An example tissue closure device 10 is shown. Figure 1 An example tissue closure device 10 is shown in a first closed position 30. The tissue closure device 10 can include a hub 12, which can have a distal end 13 and a proximal end 11. The hub 12 can include a lumen 15 extending therethrough. In some cases, the proximal end 11 of the hub 12 can be configured to be coupled to a shaft 50. In some cases, the shaft 50 can include an endoscope, laparoscope, catheter, guide tube, etc. The distal end 13 of the hub 12 can be releasably coupled to a proximal end region 33 of a clip 20. The clip 20 can have a diameter that allows the clip 20 and the hub 12 to pass through a delivery device. The clip 20 can include at least a first arm 22 and a second arm 24. Although the clip 20 is shown as including a first arm 22 and a second arm 24, it is contemplated that the clip 20 can include three arms, four arms, five arms, or any suitable number of arms, as desired. The first arm 22 and the second arm 24 can be spaced equidistant from one another, which can position the first arm 22 and the second arm 24 180 degrees from one another, although other angles can be used without departing from the scope of the present application. The first arm 22 and the second arm 24 can be formed with a selected curvature such that when the first arm 22 and the second arm 24 are in the first closed position 30, as shown, a tissue receiving cavity 34 can be formed between the first arm 22 and the second arm 24. Figure 1 A tissue receiving cavity 34 can be formed between the first arm 22 and the second arm 24 when the first closed position 30 is shown.

[0060] The clip 20 can also include a helical member 26 that can be positioned within the tissue receiving cavity 34 between the first arm 22 and the second arm 24. In some cases, the helical member 26 can be coupled to a washer 17 that can be coupled to the cam member 16. In some cases, the washer 17 can be removed and the helical member 26 can be directly coupled to the cam member 16. The helical member 26 can be releasably coupled to the distal end 18 of the control line 14. In some cases, the control line 14 can be releasably coupled to the cam member 16. In some cases, the control line 14 can be releasably coupled to the washer 17. The control line 14 can extend through a lumen of the shaft 50 and a lumen 15 of the hub 12 and beyond the distal end 13 of the hub 12. The control line 14 can be configured to be actuated along the longitudinal axis LI of the tissue closure device 10. Actuating the control line 14 can include advancing the control line 14 in a distal direction and / or retracting the control line 14 in a proximal direction. In addition, the control line 14 can be configured to be rotated clockwise and / or counterclockwise. Actuation and / or rotation of the control line 14 can subsequently cause actuation and / or rotation of the helical member 26 because the helical member 26 is releasably coupled to the control line 14.

[0061] Figure 1 The proximal end 19 of the control line 14 is also shown coupled to a control member 52 (e.g., handle, actuator, etc.). The control member 52 can be configured to control actuation of the control line 14 (e.g., advancing, retracting, rotating the control line 14). In some cases, the control member 52 can also serve as a grip to control translation of the shaft 50. The control member 52 can be used by a clinician to advance the tissue closure device 10 to a position proximate to target tissue to perform a medical treatment. Additionally, the control member 52 can include one or more actuators, gears, levers, etc. that allow the clinician to manipulate the shaft 50 in addition to other features or components of the tissue closure device 10, such as the control line 14. As will be described in greater detail below, the tissue closure device 10 can be advanced distally within a portion of a body lumen to a position proximate to target tissue, such as a lesion, while the shaft 50 can extend out of the body lumen to a position outside of the body.

[0062] Figure 2 The tissue closure device 10 is shown in a second open position 35. As Figure 2As shown, the proximal end 27 of the first arm 22 may include a first lug 31, which may have the size and shape configured to engage with a first incision 81 within the distal end 13 of the bushing 12. The second arm 24 may include a second lug 32, which may have the size and shape configured to engage with a second incision 82 within the distal end 13 of the bushing 12. The incisions 81, 82 may be sized to allow the first and second lugs 31, 32 to move within the incisions 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 expand radially to the second open position 35, the first lug 31 and the second lug 32 are abutted against each other, thereby preventing further expansion of the first arm 22 and the second arm 24 and controlling the opening angle of the clamp 20. In some cases, full expansion of the first arm 22 and the second arm 24 may include a range of approximately 25 degrees to approximately 90 degrees from the longitudinal axis L1 of the tissue closure device 10. In some cases, full expansion of the first arm 22 and the second arm 24 may include a range of approximately 35 degrees to approximately 60 degrees from the longitudinal axis L1 of the tissue closure device 10. In some cases, full expansion 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.

[0063] like Figure 2 As shown, the first arm 22 and the second arm 24 may include blunt or rounded ends to reduce 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 cone point. In some cases, the second tissue gripping member 28 may include a hook. Although the first tissue gripping member 29 is shown to include a cone point and the second tissue gripping member 28 to include a hook, it is contemplated that the first tissue gripping member 29 and / or the second tissue gripping member 28 may include a cone point, a hook, multiple toothed ends, barbs, etc. In some cases, one of 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., the first tissue gripping member 29, the second tissue gripping member 28). These are some examples.

[0064] Figure 3 A portion of the tissue closure device 10 is shown, including the distal end 13 of the bushing 12 and the proximal ends 27, 23 of the first arm 22 and the second arm 24. Figure 3As shown, 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 lug 31 and the second lug 32 abut each other at the outer edges of the first lug 31 and the second lug 32. The first lug 31 can include a first notch 86 and the second lug 32 can include a second notch 87 such that when the first lug 31 and the second lug 32 abut each other, they form an opening 88. The opening 88 has a size and shape such that the control line 14 can be freely actuated within the tissue closure device 10.

[0065] In some cases, the control line 14 can be proximally retracted, thereby allowing the cam member 16 to engage (e.g., abut) the first lug 31 and the second lug 32. Proximally retracting the control line 14 can provide a compressive force of the cam member 16 onto the first lug 31 and the second lug 32, thereby causing the first arm 22 and the second arm 24 to radially compress toward the longitudinal axis LI of the tissue closure device 10. This compressive force on the lugs 31, 32 in turn causes the clip 20 to move from the second open position 35 to the first closed position 30. Additionally, the proximal end 27 of the first arm 22 can include a first flange 83 and the proximal end 23 of the second arm 24 can include a second flange 84, each positioned on the inside of each arm 22, 24. The flanges 83, 84 can be configured to receive the cam member 16 and hold the cam member 16 in place when the control line 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. Removing the control line 14 can include proximally pulling the control line 14 to sever the connection between the control line 14 and the clip 20 (e.g., the cam member 16), which allows the control line 14 to be withdrawn from the tissue closure device 10.

[0066] Figure 4 An example tissue closure device 100 is shown positioned proximate to a target tissue site 150. The tissue closure device 100 can be considered a Figures 1-3An example of a tissue closure device 10 is shown. The tissue closure device 100 can include a hub 112, which can have a distal end 113 and a proximal end 111. The hub 112 can include a lumen 115 extending therethrough. In some cases, the proximal end 111 of the hub 112 can be configured to be coupled to a shaft (e.g., shaft 50). In some cases, the shaft can include an endoscope, a laparoscope, a catheter, a guide tube, or the like. The distal end 113 of the hub 112 can be releasably coupled to a proximal end region 133 of a clip 120. The clip 120 can have a diameter that allows the clip 120 and the hub 112 to pass through a delivery device. The clip 120 can include at least a first arm 122 and a second arm 124. Although the clip 120 is shown as including a first arm 122 and a second arm 124, it is contemplated that the clip 120 can include three arms, four arms, five arms, or any suitable number of arms, as desired. The first arm 122 and the second arm 124 can be spaced equidistant from one another, which can position the first arm 122 and the second arm 124 180 degrees from one another, although other angles can be used without departing from the scope of the present disclosure. The first arm 122 and the second arm 124 can be formed with a selected curvature 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., first closed position 30).

[0067] The clip 120 can also include a helical member 126, which can be positioned between the first arm 122 and the second arm 124 within the tissue receiving cavity 134. In some cases, the helical member 126 can be coupled to a washer 117, which can be coupled to a cam member 116. In some cases, the washer 117 can be removed and the helical member 126 can be directly coupled to the cam member 116. The helical member 126 can be releasably coupled to a distal end 118 of a control line 114. In some cases, the control line 114 can be releasably coupled to the cam member 116. In some cases, the control line 114 can be releasably coupled to the washer 117. The control line 114 can extend through a lumen of a shaft and the lumen 115 of the hub 112 and beyond the distal end 113 of the hub 112. The control line 114 can be configured to be actuated along a longitudinal axis L2 of the tissue closure device 100. Actuating the control line 114 can include advancing the control line 114 in a distal direction and / or retracting the control line 114 in a proximal direction. In addition, the control line 114 can be configured to be rotated clockwise and / or counterclockwise. Actuation and / or rotation of the control line 114 can subsequently result in actuation and / or rotation of the helical member 126, as the helical member 126 is releasably coupled to the control line 114.

[0068] Figure 4 The tissue closure device 100 is shown in a second open position 35. As Figure 4As shown, the proximal end 127 of the first arm 122 may include a first lug 131, which may have the size and shape configured to engage with a first incision 181 within the distal end 113 of the bushing 112. The second arm 124 may include a second lug 132, which may have the size and shape configured to engage with a second incision 182 within the distal end 113 of the bushing 112. The incisions 181, 182 may be sized to allow the first and second lugs 131, 132 to move within each other 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 expand radially to the open position 135, the first lug 131 and the second lug 132 are abutted against each other, thereby preventing further expansion of the first arm 122 and the second arm 124. In some cases, full expansion of the first arm 122 and the second arm 124 may include a range of approximately 25 degrees to approximately 90 degrees from the longitudinal axis L2 of the tissue closure device 100. In some cases, full expansion of the first arm 122 and the second arm 124 may include a range of approximately 35 degrees to approximately 60 degrees from the longitudinal axis L2 of the tissue closure device 100. In some cases, full expansion of the first arm 122 and the second arm 124 may include a range of approximately 45 degrees from the longitudinal axis L2 of the tissue closure device 100.

[0069] like Figure 4 As shown, the first arm 122 and the second arm 124 may include blunt or rounded ends to reduce tissue trauma. In some cases, the distal end 125 of the first arm 122 may include a first tissue grasping member 129, and the distal end 121 of the second arm 124 may include a second tissue grasping member 128. In some cases, the first tissue grasping member 129 may include a cone point. In some cases, the second tissue grasping member 128 may include a hook. Although the first tissue grasping member 129 is shown to include a cone point and the second tissue grasping member 128 to include a hook, it is contemplated that the first tissue grasping member 129 and / or the second tissue grasping member 128 may include a cone point, a hook, multiple toothed ends, barbs, etc. In some cases, one of the first arm 122 or the second arm 124 may include a recess within its distal end configured to receive a tissue grasping member (e.g., the first tissue grasping member 129, the second tissue grasping member 128). These are some examples.

[0070] like Figure 4 As shown, the tissue closure device 100 is positioned near the target tissue site 150. A control line 114 can 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 line 114 can advance the helical member 126 until it abuts the target tissue site 150, and the user can rotate the control line 114 in a first direction, which rotates the helical member 126 into the target tissue site 150, as shown.Figures 5A-6 Further shown.

[0071] Figures 5A-6 A tissue closure method according to the present application is shown. Figure 5A A helical member 126 is shown positioned proximate to a target tissue site 150, as Figure 4 shown. As previously described, the control line 114 can 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 line 114 can advance the helical member 126 until it abuts the target tissue site 150, and the user can rotate the control line 114 in a first direction, as indicated by arrow 190, which rotates the helical member 126 into the target tissue site 150, as Figure 5B shown. The control line 114 can then be retracted proximally along the longitudinal axis L2 of the tissue closure device 100 until the cam member 116 engages (e.g., abuts) the first and second lugs 131, 132, as Figure 5C shown. Proximal retraction of the control line 114 can provide a compressive force of the cam member 116 onto the first and second lugs 131, 132, thereby causing the first and second arms 122, 124 to compress radially toward the longitudinal axis L2 of the tissue closure device 100. This compressive force on the lugs 131, 132 in turn moves the clip 120 from the open position 135 to the closed position 130, as Figure 5D shown.

[0072] When the clip 120 is in the closed position 130, the first tissue grasping member 129 can push the target tissue site 150 onto the second tissue grasping member 128, as Figure 5D shown. The second tissue grasping member 128 can include a "fish hook" type hook that can be configured to hold tissue on the second arm 124. The control line 114 can then be rotated in a second direction, as indicated by arrow 191, which rotates the helical member 126, thereby causing the helical member 126 to disengage from the target tissue site 150. The control line 114 can then be advanced distally, thereby advancing the helical member 126 distally. As the control line 114 and helical member 126 are advanced in the distal direction, the first and second arms 122, 124 are biased to move from the closed position 130 to the open position 135, as Figure 5E shown.

[0073] As Figure 5E shown, the second tissue grasping member 128 can continue to grasp tissue of the target tissue site 150. This allows the helical member 126 to advance into a second target tissue site 155, as Figure 5Fand grasp more tissue. Then, the control line 114 can be proximally retracted along the longitudinal axis L2 of the tissue closure device 100 until the cam member 116 engages (e.g., abuts) the first and second lugs 131, 132. Proximally retracting the control line 114 can provide a compressive force of the cam member 116 onto the first and second lugs 131, 132, thereby causing the first and second arms 122, 124 to radially compress toward the longitudinal axis L2 of the tissue closure device 100. This compressive force on the lugs 131, 132 in turn causes the clip 120 to move 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 can be clamped by the second tissue grasping member 128, as Figure 5G shown. Then, the control line 114 can be rotated in the second direction, which causes the spiral member 126 to rotate, thereby causing the spiral member 126 to disengage from the second target tissue site 155. The clinician can repeat this process of grasping target tissue as needed.

[0074] As Figure 5H shown, the proximal end 127 of the first arm 122 can include a first flange 183 and the proximal end 123 of the second arm 124 can include a second flange 184, each positioned on the inside of each arm 122, 124. The flanges 183, 184 can be configured to receive the cam member 116 and hold the cam member 116 in place when the control line 114 is removed from the clip 120, thereby locking the first and second arms 122, 124 in the closed position 130 and preventing the cam member 116 from being removed from the clip 120. Removing the control line 114 can include pulling the control line 114 proximally to sever the connection between the control line 114 and the clip 120 (e.g., the cam member 116), which allows the control line 114 to be withdrawn from the tissue closure device 100, as Figure 5I shown. Then, the tissue clip 120 is detached from the hub 112 via the proximally directed force, leaving the tissue clip 120 at the target tissue site (e.g., the target tissue site 150) in the body, as Figure 6 shown. The tissue clip 120 can remain in place until it is removed via a natural process or after the bleeding site has healed by a separate surgery.

[0075] Figures 7A-B shown. As Figure 7A and Figure 7B shown, the tissue closure device 100 can include alternative mechanisms for radially expanding (e.g., opening) and radially compressing (e.g., closing) the tissue closure device 100. As Figure 7A and Figure 7BAs shown, first actuation arm 141 and second actuation arm 144 can be positioned within hub 112. First actuation arm 141 and second actuation arm 144 can include first tip 142 and second tip 143, respectively. First tip 142 can be coupled to first arm 122, and second tip 143 can be coupled to second arm 124. In use, a user (e.g., a clinician) can utilize the actuation mechanism to advance actuation arms 141, 144, thereby moving first tip 142 and second tip 143, respectively. Advancing actuation arms 141, 144 distally causes first arm 122 and second arm 124 to radially expand. In some cases, actuation arms 141, 144 can be retracted proximally, thereby radially compressing first arm 122 and second arm 124. In such cases, movement of control wire 114 is independent of movement of actuation arms 141, 144.

[0076] Figures 8A-B A cross-sectional view of a portion of example tissue closure device 100 is shown. As shown, Figure 8A and Figure 8B Tissue closure device 100 can include alternative mechanisms for radially expanding (e.g., opening) and radially compressing (e.g., closing) tissue closure device 100. As shown, Figure 8A and Figure 8B Outer sleeve 160 can be positioned around the outer diameter of hub 112, and can be advanced distally over first arm 122 and second arm 124. When outer sleeve 160 is advanced over first arm 122 and second arm 124, tissue clip 120 remains in the closed position, as shown. Figure 8A When outer sleeve 160 is retracted proximally, thereby releasing first arm 122 and second arm 124, spring 162 within tissue clip 120 biases first arm 122 and second arm 124 radially outward, thereby moving tissue clip 120 to the open position.

[0077] Figures 9A-B A cross-sectional view of a portion of example tissue closure device 100 is shown. As shown, Figure 9A and Figure 9B Tissue closure device 100 can include alternative mechanisms for radially expanding (e.g., opening) and radially compressing (e.g., closing) tissue closure device 100. As shown, Figure 9A and Figure 9B Tissue closure device 100 can include a locking component 170 that can be advanced distally through lumen 115 of hub 112 and into engagement with ledges 183, 184. Ledges 183, 184 can be configured to receive locking component 170 and hold cam member 116 in place when control wire 114 is removed from clip 120, thereby locking first arm 122 and second arm 124 in closed position 130 and preventing removal of cam member 116 from clip 120.

[0078] Figure 10 An example tissue closure device 100 including alternative tissue grasping components is shown. Figure 10 As shown, the first tissue gripping member 229 may include one or more recesses that can be configured to receive one or more cone points of the second tissue gripping member 228.

[0079] Figures 11A-B An example tissue closure device 100 including alternative tissue grasping components is shown. (Example:) Figure 11A and Figure 11B As shown, the first arm 122 may include a first tissue gripping member 329, which may include one or more cone-shaped points. In some cases, the second arm 124 may include a second tissue gripping member 328, which may include hooks. Figure 11A and Figure 11B In the example, the second arm 124 may include a smooth, rod-shaped surface configured to allow the second arm 124 to grasp and hold target tissue, such as multiple segments of target tissue 330, 335, 340, 345, and hold them thereon.

[0080] Materials used for various components of the tissue closure device 10 disclosed herein and various other medical devices may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), and polyoxyethylene (POM, e.g., commercially available from DuPont). Polyether block esters, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), and polyether esters (e.g., commercially available from DSM Engineering Plastics) ), ether- or ester-based copolymers (e.g., butyl phthalate / poly(hydrocarbon ether) and / or other polyester elastomers, such as those commercially available from DuPont) ), polyamide (e.g., available from Bayer) Or it can be purchased from Elf Atochem. ), elastomer polyamide, block polyamide / ether, polyether block amide (PEBA, for example, can be traded as...) Commercially available), ethylene-vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low-density polyethylene (e.g., ), polyesters, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (e.g., ), polysulfone, nylon, nylon-12 (such as GRIVORY® SA available from EMS American Grilon ), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefins, polystyrene, epoxy, poly(vinylidene chloride) (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, and the like. In some embodiments, the sheath can be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

[0081] Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic and / or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276, other nickel-chromium alloys, other nickel- molybdenum alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium- molybdenum alloys (e.g., UNS: R30003 such as ELGILOY® and MAGNELOY®); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.

[0082] ​​​​​​​​​​​In at least some embodiments, portions or all of the tissue closure devices 10 and various other medical devices disclosed herein can also be doped with, made from, or otherwise include, radiopaque materials. Radiopaque materials should be understood to mean materials that are not translucent to x-rays or other imaging techniques. This relatively bright image helps users of the tissue closure devices 10 and various other medical devices disclosed herein determine the location of the devices. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque markers and / or coils can also be incorporated into the tissue closure devices 10 and various other medical devices disclosed herein to achieve the same result.

[0083] It will be appreciated that the present application is merely illustrative in nature. There can be many variations to the details, particularly with respect to the arrangement of steps, the number and size of the components employed, and the shapes, components, and sizes of the shapes employed in the drawings. Such variations are not to be regarded as a departure from the spirit and scope of the present application, and, to the extent there are any discrepancies between the language of the following claims and the disclosure presented herein, it is intended that the former be considered to be the more authoritative.

Claims

1. A tissue closure device comprising: a hub having a distal end, a proximal end, and a lumen extending therethrough; a clip comprising at least a first arm and a second arm, wherein a proximal region of the clip is configured to be coupled to the distal end of the hub; a control wire having a proximal end and a distal end, the control wire configured to extend through the lumen of the hub; and a helical member configured to be coupled to the distal end of the control wire; wherein the control wire is configured to advance the helical member in a distal direction along a longitudinal axis of the tissue closure device and retract the helical member in a proximal direction along the longitudinal axis of the tissue closure device; and wherein one of the first arm and the second arm comprises a tissue grasping member.

2. The tissue closure device of claim 1, wherein the tissue grasping member is a hook.

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

4. The tissue closure device of claim 3, wherein when the control wire is retracted in a proximal direction, the cam member engages a proximal end of the first arm and a proximal end of the second arm, thereby causing the first arm and the second arm to move toward one another to a closed position.

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

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

7. The tissue closure device of any one of claims 1 to 6, wherein proximal ends of the first arm and the second arm engage one another to control an opening angle when the clip is in an open position.

8. A method for tissue closure, the method comprising: inserting a closure device through a natural body lumen to a target site in a body, the closure device comprising: a hub having a distal end, a proximal end, and a lumen extending therethrough; a clip comprising at least a first arm and a second arm, wherein a proximal end of the clip is configured to be coupled to the distal end of the hub; a control wire having a proximal end and a distal end, the control wire configured to extend through the lumen of the hub; and a helical member configured to be coupled to the distal end of the control wire; advancing the control wire distally such that the first arm and the second arm move radially away from one another relative to a longitudinal axis of the clipping device and the helical member engages a first tissue at the target site; rotating the control wire in a first direction, which rotates the helical member into the tissue; and retracting the control wire and the helical member in a proximal direction, thereby pulling the first tissue proximally into the clip; wherein the first arm and the second arm move toward one another as the control wire and helical member are retracted proximally, thereby closing the clip.

9. The method of claim 8, wherein one of the first arm and the second arm comprises a tissue grasping member. ​ 10. The method of claim 9, wherein the tissue grasping member is a hook.

11. The method of any one of claims 8-10, wherein the helical member is coupled to the control line via a cam member.

12. The method of claim 11, wherein when the control line is retracted proximally, the cam member engages with a proximal end of the first arm and a proximal end of the second arm, thereby causing the first arm and the second arm to move toward each other to close the clip.

13. A tissue clip comprising: a hub having a distal end and a proximal end; a first arm comprising a first tissue grasping member positioned proximate a distal end of the first arm, wherein a proximal end of the first arm is coupled to the distal end of the hub; a second arm comprising a second tissue grasping member positioned proximate a distal end of the second arm, wherein a proximal end of the second arm is coupled to the distal end of the hub; and a helical member configured to be positioned between the first arm and the second arm, wherein the helical member is configured to be advanced distally along a longitudinal axis of the tissue clip; wherein the tissue clip is configured to move from a first closed position to a second open position.

14. The tissue clip of 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 each other to control an opening angle.

15. The tissue clip of claim 13 or 14, wherein one of the first tissue grasping member or the second tissue grasping member comprises a hook.

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