Fastening device

Abstract

To navigate a tortuous anatomy without causing trauma to the tissue.SOLUTION: A fastening mechanism includes an actuator, a stapler, and a device coupler. The device coupler includes a proximal support connected to a distal support by a coupler arm, and the distal support is coupled to the proximal end of the stapler by a pivot connection part. The pivot connection part comprises: a distal support link arm including a distal support link arm pin hole; a pair of stapler link arms including a pair of stapler link arm pin holes; and a pivot pin which extends through the distal support link arm pin hole and the pair of stapler link arm pin holes and couples the stapler with the device coupler in a swingable manner.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates generally to tissue stapling. More specifically, at least some embodiments of the present invention relate to fastening mechanisms for medical devices, such as endoscopic staplers, and to associated methods of using the fastening mechanisms. [Background technology]

[0002] Stapling is used in many medical procedures, such as laparoscopic surgery. These procedures often involve the removal of a portion or section of tissue and the use of staples to close it. An exemplary procedure is colorectal anastomosis. In hybrid surgery, where a physician uses laparoscopic and endoscopic platforms to perform the procedure, rigid staplers are often used. Linear staplers may include long, rigid members and may not be able to navigate tortuous anatomical structures without causing trauma to the tissue. Summary of the Invention

[0003] According to one example, the fastening mechanism includes an actuator, a fastening device attached to a distal end of the actuator, and a device coupler. The fastening device is pivotally attached to the device coupler.

[0004] In another example, the actuator can move longitudinally to pivot the fastener relative to the device coupler. The fastening mechanism can further include a sheath. The sheath covers a portion of the actuator, and the actuator is longitudinally movable relative to the sheath. The actuator can include at least one inner drive mechanism that actuates the fastener to open and close the fastener and / or deploy the fastener. The fastener can be a stapler including a head and an anvil. The head includes a stapler cartridge in which the staples are retained and deployed. The stapler cartridge can include a plurality of longitudinal slots in which the staples are deployed. The stapler head can be constructed of a flexible material that allows the head to bend laterally. The proximal end of the actuator can be connected to a controller that operates the fastening mechanism. The controller can be operative to move the actuator longitudinally in either direction to open the fastener and / or close the fastener while simultaneously deploying the fastener. The actuator can be constructed of a flexible material. The device coupler can include a proximal support secured to a distal support. The proximal support is fixed to the sheath. The fastening device may be pivotally attached to a distal support of the device coupler. The proximal support may include at least one flexible arm. The distal support may define a lumen having a transparent barrier at an open distal end or end of the lumen.

[0005] According to one example, the fastening mechanism includes an actuator, a stapler attached to a distal end of the actuator, a sheath along which the actuator moves longitudinally, and an apparatus coupler for attaching the stapler to an outer surface of the distal end of the medical device, the apparatus coupler including a proximal support and a distal support, the proximal support fixedly coupled to the sheath and the stapler pivotally attached to the distal support of the apparatus coupler.

[0006] In another example, the medical device can be an endoscope and the proximal support and the distal support can be secured to a distal end of the endoscope. The actuator can be moved longitudinally relative to the sheath to oscillate the stapler relative to the device coupler. The actuator can include at least one inner drive mechanism that actuates the stapler to open and close the stapler and / or deploy the staples.

[0007] According to one example, a method of fastening tissue includes inserting an endoscope and a stapling mechanism secured to an exterior surface of the endoscope into a natural orifice of a subject, delivering the endoscope and stapling mechanism to a target tissue, oscillating the stapling mechanism relative to a distal end of the endoscope, positioning tissue between a head and an anvil of the stapling mechanism, and deploying staples from the stapler mechanism to fasten the target tissue.

[0008] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief description of the drawings]

[0009] [Figure 1] 1 is a perspective view of an endoscope according to one embodiment. [Diagram 2] FIG. 2 is a perspective view of a stapling mechanism according to one embodiment. [Diagram 3] 1 is a perspective view of a stapling mechanism coupled to an endoscope, according to one embodiment. [Figure 4] 4 is a perspective view of an alternative stapling mechanism and the endoscope of FIG. 3; FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, same or like reference numbers are used in the drawings to refer to the same or like parts. The term "distal" refers to the portion of the device that is furthest from a user when introducing the device into a subject (e.g., a patient). Conversely, the term "proximal" refers to the portion of the device that is closest to a user when placing the device into a subject.

[0011] The foregoing general description and the following detailed description are exemplary and explanatory only and are not intended to limit the features as set forth in the claims. As used herein, the terms "comprises / consists of", "comprises / consists of", "has", "includes" or other variations thereof are intended to be non-exclusively inclusive, such that a process, method, article, or device making up a list of elements may include other elements not expressly listed or elements inherent to such process, method, article, or device, rather than only those elements. In the present invention, relative terms such as, for example, "about", "substantially / generally", "generally" and "approximately" are used to indicate a possible variation of ±10% of a stated value or characteristic.

[0012] Endoscopic stapling may be particularly useful in endoscopic outpatient surgery. The present invention may solve one or more problems in the art. However, the scope of the disclosure is defined by the appended claims, not the ability to solve a particular problem. The present invention is directed to systems and devices for stapling mechanisms of medical devices, and related methods, among other aspects. Referring to FIG. 1, an endoscope 10 according to one embodiment is shown. The endoscope 10 includes a flexible shaft 20, a tip 30 at the distal end of the endoscope 10, and an articulation joint 50 disposed between and connecting the flexible shaft 20 and the tip 30. A handle 40 or some other device for operating or controlling the endoscope 10, as well as any tools or devices associated with the endoscope 10, are connected to the proximal end of the flexible shaft 20.

[0013] A number of actuation elements (not shown), such as cables or wires suitable for a medical procedure (e.g., medical grade plastic or metal), may extend distally from the proximal end of the endoscope 10 (such as the handle 40) to the articulation joint 50 and / or tip 30. For example, the articulation / actuation wires may be indirectly coupled to first and second actuators 42, 43 that control the articulation of the articulation joint 50 in a number of directions, such as up, down, left, right, etc. The actuators 42, 43 may be, for example, rotatable knobs that rotate about their axes to push or pull the actuation elements.

[0014] Alternatively or additionally, a user may operate the actuating elements independent of the handle 40. The distal ends of the actuating elements extend through the flexible shaft 20 and terminate at the articulation joint 50 and / or the tip 30. For example, one or more actuating elements may be connected to the articulation joint 50 and one or more other actuating elements may be attached to the tip 30. Actuation of the actuating elements may control the articulation joint 50, the tip 30, and / or elements attached to the tip 30, such as an end effector (not shown). Additionally, one or more electrical cables (not shown) may extend from a proximal end of the endoscope 10 (such as the handle 40) to the tip 30. The one or more electrical cables may provide electrical control for imaging, lighting, and / or other electrical devices within and outside the tip 30. The one or more electrical cables may transmit imaging signals from the tip 30 proximally for processing and / or display on a display. The handle 40 may also include a port 44 for introducing and / or removing tools, fluids, or other materials to and / or from the patient. A strain relief 46 is attached to the umbilicus for introduction of fluids, suction, and / or electrical wiring. Endoscope 10 is an exemplary endoscope to which a stapling mechanism may be attached. The present invention is not limited to stapling mechanisms for use in connection with endoscope 10. Any other medical scopes (e.g., colonoscopes, ureteroscopes, duodenoscopes, etc.), catheters, sheaths, etc. may be used in combination with the stapling mechanism of the present invention.

[0015] 2, there is shown an embodiment of a stapling mechanism 100 for a medical device, including but not limited to an endoscope, such as endoscope 10. Stapling mechanism 100 includes an actuator 104, a sheath 102, a device coupler 108, and a stapler 114.

[0016] The actuator 104 is a flexible tube made of plastic or other suitable biocompatible flexible material. The actuator 104 is of sufficient length to extend along the entire length of an endoscope, such as the flexible shaft 20 of the endoscope 10. The actuator 104 is sufficiently flexible to traverse the tortuous anatomy of a patient. The distal end of the actuator 104 is attached to the proximal end of the stapler 114 via a stapler connector 122. At least a portion of the proximal end of the actuator 104 is covered by the sheath 102. The proximal end of the actuator 104 may connect to any suitable controller or handle known in the art, represented by box 200, at the proximal end of the stapling mechanism 100.

[0017] The sheath 102 is also a flexible tube made of plastic or other suitable biocompatible flexible material. The sheath 102 is long enough in each embodiment to extend along the entire length of an endoscope, such as the flexible shaft 20 of the endoscope 10. The sheath 102 is flexible enough to traverse the tortuous anatomy of a patient. The distal end of the sheath 102 is fixedly attached to a sheath connector 106 with a coupler 123. The sheath 102 may be concentric with the actuator 104. Similar to the actuator 104, the proximal end of the sheath 102 may also be connected to any suitable controller or handle known in the art, such as a box 200, at the proximal end of the stapling mechanism 100 in a manner that allows longitudinal sliding of the actuator 104 within the sheath 102. The controller may operate the stapling mechanism to perform various operations. Such manipulation may include, but is not limited to, longitudinally moving the actuator 104 in either direction (distal or proximal) by extending or retracting the actuator 104 relative to the sheath 102. The controller may also control the stapling operation of the stapler 114 to staple the intended target tissue.

[0018] 2, the device coupler 108 includes a proximal support 108a, a distal support 108b, and a coupler arm 110 connecting the proximal support 108a and the distal support 108b. The proximal support 108a includes a sheath connector 106 and two arms 109 that can wrap around a medical device, including, for example, an endoscope shaft or an articulation joint. In some embodiments, the arms 109 can be flexible, for example, to elastically deflect or bend away from each other. The arms 109 define an opening 108c that receives the medical device. Each arm 109 can be deflected or bent radially outward to receive the medical device. Each arm 109 can be biased radially inward to rigidly couple to the medical device, for example, to engage circumferentially around the endoscope 10. In other embodiments, the proximal support 108a can be of different configurations. The different configurations can also hold and support the medical device. The medical device may include, but is not limited to, a single flexible arm or a single ring. The sheath connector 106 fixedly attaches the proximal support 108a to the sheath 102. This may ensure a more stable connection between the device coupler 108 and the sheath 102.

[0019] As shown in FIG. 2, the distal support 108b is an annular cap-like ring that defines a lumen 108d therein. The distal support 108b can hold and support a distal end of a medical device, including but not limited to an endoscope tip. The distal support 108b can have an open distal end. In other embodiments, the distal support 108b can have a distal end that is transparent and has a transparent cover or barrier that acts as a cap over the distal face of the medical device tip. The open distal end or transparent cap at its distal end allows the endoscope 10 to continue to perform its various functions, such as providing a light source and imaging via its camera, unhindered. In other embodiments, the distal support 108b can be substituted with various other supports embodying different configurations that can also hold and support a medical device.

[0020] The proximal support 108a is connected to the distal support 108b via a coupler arm 110. The coupler arm 110 is grooved or curved to accommodate the shape of the medical device that will rest on the coupler arm 110. The distal support 108b is attached to a proximal end of a stapler 114 via a pivot connection 112. The pivot connection 112 includes a distal support link arm 112a, a stapler link arm 112b, and a pivot pin 112c that pins the distal support link arm 112a and the stapler link arm 112b together. The distal support link arm 112a is fixedly attached to and extends from the distal support 108b, while the stapler link arm 112b is fixedly attached to and extends from a proximal location of the stapler 114. Both the distal support link arm 112a and the stapler link arm 112b have pin holes. At the pivot connection 112, the distal support link arm 112a and the stapler link arm 112b overlap each other such that the distal support link arm 112a is between the arms of the stapler link arm 112b and the pin holes of each are aligned, thereby allowing the pivot pin 112c to be inserted and pinned. The pivot connection 112 allows the rotation of the stapler 114 relative to the device coupler 108 about the pivot pin 112c by the longitudinal movement of the actuator 104 relative to the sheath 102. For example, the actuator 104 can be extended distally, for example, by operation of a controller, e.g., box 200, to which the actuator 104 is attached. In another example, the actuator 104 can be pulled proximally relative to the sheath 102. As a result, the stapler 114 rotates or swings in the opposite direction about the longitudinal axis of the pivot pin 112c.

[0021] 3, a proximal support 108a is secured to the endoscope 10 at a distal location relative to the endoscope 10, such as relative to the articulation joint 50 (see FIG. 1), via two arms 109. As shown, the arms 109 receive the endoscope 10, thereby coupling the endoscope 10 to the stapling mechanism 100. Securing the stapling mechanism 100 to a distal location of the endoscope 10 via the proximal support 108a provides a base from which the actuator 104 extends towards the stapler 114 to rotate the stapler 114 in a clockwise or counterclockwise direction.

[0022] FIG. 4 is another perspective view of the embodiment shown in FIG. 3. As shown, the actuator 104 extends distally, thereby causing the stapler 114 to swing counterclockwise about the pivot connection 112. As is evident from FIG. 4, the degree to which the stapler 114 can be rotated clockwise or counterclockwise can be adjusted based on the degree to which the actuator 104 moves longitudinally in either direction. For example, the more the actuator 104 extends distally, the more the stapler 114 will pivot counterclockwise about the pivot connection 112 until the presence of the device coupler 108 stops the stapler 114 from pivoting. Similarly, the more the actuator 104 is pulled proximally, the more the stapler 114 will pivot clockwise about the pivot connection 112 until the presence of the device coupler 108 stops the stapler 114 from pivoting.

[0023] 4 also shows the stapler 114 in an open position. In the open position, the distal end of the anvil 116 and the head 118 of the stapler 114 are spaced apart, thereby forming a gap through which material, including but not limited to tissue, can be held together and stapled. In the closed position, the inner surfaces of the anvil 116 and head 118 are in closest proximity to one another, so that there is little or no gap between the inner surfaces of the anvil 116 and head 118, as shown in FIG. 3. The stapler 114 can be opened and closed by the anvil 116 swinging about a stapler pivot 120 that holds the anvil 116 and head 118 together in a proximal position of the stapler 114.

[0024] Actuation of the drive mechanism opens and closes the stapler 114. With reference to FIGURE 4, a wire 124 resides within the lumen of the actuator 104 and a distal end of the wire 124 connects to a proximal end of the anvil 116. The proximal end of the wire 124 may connect to a controller (not shown) at the proximal end of the stapling mechanism 100. When the wire 124 is pulled proximally, the anvil 116 rotates about the stapler pivot 120 to open the stapler 114. Pushing the wire 124 distally causes the anvil 116 to rotate about the stapler pivot to close the stapler 114.

[0025] FIG. 4 further illustrates that the head 118 can include a stapler cartridge 126 from which it can hold and deploy one or more staples. The mechanism for deploying the staples can be actuated by a separate drive mechanism (not shown), such as a second internal drive mechanism within the lumen of the actuator 104. The form of this second internal drive mechanism is not limited and can be in the form of another wire (not shown) within the actuator 104. The distal end of this second inner wire can be connected to a mechanism with the head 118 that deploys one or more staples. The proximal end of the second inner wire can be connected to a controller (not shown), which, by its operation, can cause the second inner wire to actuate the deployment of the staples from the head 118. The inner wire 124 and the second inner wire (for deploying the staples) work in conjunction to simultaneously deploy the staples and close the stapler by operation of the controller, thereby securely stapling the intended target, e.g., tissue. In some embodiments, the wire 124 that opens and closes the stapler 114 and the second drive mechanism for deploying one or more staples can be operated by the same controller. In other embodiments, different drive mechanisms can be operated by different controllers.

[0026] In one embodiment, the head 118 can house staples in the stapler cartridge 126. The staples can be deployed from the stapler cartridge 126 under the influence of a driving force exerted by an actuation sled (not shown), as disclosed in U.S. Patent Application No. 62 / 812,538, entitled "Systems, Apparatuses, and Related Methods for Fastening Tissue," filed March 1, 2019, the contents of which are incorporated herein by reference in their entirety. The head 118 can have a longitudinal slot (not shown), which can allow the staples to pass through the stapler cartridge 126 and penetrate the intended target, e.g., tissue. In some embodiments, the actuation mechanism can be configured, when actuated, to move proximally in a longitudinal direction from a distal end of the stapler cartridge 126 toward a proximal end of the cartridge 128, contact the staples in the stapler cartridge 126, and actuate the staples through the longitudinal slot or surface of the stapler cartridge to attach the staples to the target tissue. Alternatively, in some embodiments, the actuation mechanism may be configured to move distally in a longitudinal direction from a proximal end of the stapler cartridge 126 toward a distal end of the stapler cartridge 126 when actuated. Either way, the actuation mechanism may be actuated via a second drive mechanism, as described above. For example, actuation of a second inner wire in the actuator 104 via a controller may deploy staples into the target tissue. In some examples, a single staple may extend through each slot. Each staple may be partially within the slot prior to deployment to aid in alignment of the staple with the slot. In some embodiments, two (or more) actuation mechanisms (not shown) may be required to actuate two (or more) different longitudinal staple rows in the stapler cartridge 126.

[0027] In some embodiments, the head 118 including the stapler cartridge 126 may be constructed from any suitable biocompatible material, including flexible materials that may allow the head 118 to bend sideways during insertion or positioning into a subject's body. Such flexibility may further allow the stapler 114 to be carefully navigated through tortuous anatomical structures without causing trauma to the surrounding tissue.

[0028] The anvil 116 may include longitudinally disposed grooves (not shown) that may align with longitudinal slots in the head 118 when the stapler 114 is in the closed position (see FIG. 3). When the head 118 is actuated to deploy the staples and the legs of the deployed staples penetrate the intended target, the grooves may act as a base that effectively bears against and receives the legs of the staples when the stapler 114 is closed, such that the deployed staples are securely secured to the target tissue.

[0029] With reference to Figures 2-4, an example method of stapling an intended target, e.g., tissue, using the embodiment of the stapling mechanism shown in Figures 2-4 is further described below. A user may couple or attach the stapling mechanism 100 to a medical device, e.g., an endoscope 10, and deliver the mechanism 100 and endoscope 10 into the subject's body, e.g., through a natural orifice (e.g., the mouth or anus) and through the subject's tortuous natural body lumen, e.g., the esophagus, stomach, colon, etc. The user may direct the mechanism 100 and endoscope 10 to the intended target site by various means, including imaging. Once at the target site, the user may open the stapler 114, if it is closed, by operation of a controller (not shown) which actuates the wire 124 and swings the anvil 116 about the stapler pivot 120. The user may then rotate the stapler 114 in a clockwise or counterclockwise direction by operation of the same or a different controller (not shown) attached to the actuator 104, which may be moved in either direction in the longitudinal direction via the controller. It should be noted that the user may also choose to rotate the stapler 114 first and then open the stapler 114 after the rotation. The order of the stapler rotation and opening steps may be reversed and is not limited to any particular order. After positioning the stapler 114 by rotating it, the user may manually manipulate the stapler such that the intended target is positioned between the head 118 and the anvil 116 of the stapler 114, or may employ mechanical means (not shown) including, but not limited to, graspers, suction, etc., that aid in placing the intended target, e.g., tissue, within the stapler. The user may then staple the intended target by operating the same or a different controller that activates another drive mechanism, such as a wire, to actuate the deployment of staples from the stapler cartridge 126. Actuation of the controller may simultaneously deploy the staples and close the stapler. Thereby stapling the intended target.The various mechanisms of stapling mechanism 100, including but not limited to rotating stapler 114, opening and closing stapler 114, and deploying staples from stapler cartridge 126, may be actuated by the operation of the same controller or different controllers.

[0030] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed stapling mechanism without departing from the scope of the invention. For example, the configuration of the coupler, actuator, and stapler can be changed to suit any medical device and are not limited to the examples set forth herein. Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. An actuator; a fastening device attached to a distal end of the actuator; Device coupler and wherein the fastening device is pivotally attached to the device coupler. Fastening mechanism.

2. The fastening mechanism of claim 1 , wherein the actuator moves longitudinally to pivot the fastening device relative to the device coupler.

3. Further comprising a sheath; The fastening mechanism of claim 1 or 2, wherein the sheath covers a portion of the actuator, and the actuator is longitudinally movable relative to the sheath.

4. 4. The fastening mechanism of claim 1, wherein the actuator includes at least one inner drive mechanism that causes the fastening device to do one or both of the following: (1) open or close the fastening device; (2) deploy a fastener.

5. The fastening mechanism of claim 1 , wherein the fastening device is a stapler including a head and an anvil, the head including a stapler cartridge in which staples are held and deployed.

6. The fastening mechanism of claim 5 , wherein the stapler cartridge includes a plurality of longitudinal slots into which a plurality of staples are deployed.

7. 7. The fastening mechanism of claim 5 or 6, wherein the head is constructed from a flexible material that allows the head to bend sideways.

8. The fastening mechanism of claim 1 , wherein a proximal end of the actuator is connected to a controller that operates the fastening mechanism.

9. 9. The fastening mechanism of claim 8, wherein the controller controls at least one of: (1) moving the actuator in either longitudinal direction; (2) opening the fastening device; and (3) simultaneously deploying fasteners and closing the fastening device.

10. The fastening mechanism of claim 1 , wherein the actuator is constructed from a flexible material.

11. The fastening mechanism of any one of claims 3 to 10, wherein the device coupler includes a proximal support secured to a distal support, the proximal support being secured to the sheath.

12. The fastening mechanism of claim 11 , wherein the fastening device is pivotally mounted to the distal support of the device coupler.

13. The fastening mechanism according to claim 11 or 12, wherein the proximal support comprises at least one flexible arm.

14. The fastening mechanism of any one of claims 11 to 13, wherein the distal support defines a lumen having an open distal end or a transparent barrier at an end of the lumen.

15. The fastening mechanism of claim 1 , wherein the device coupler removably attaches the fastening device to an exterior surface of a distal end of a medical device.

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