A laparoscopic stapler having a bioadhesive in a separate pocket to assist in anastomosis

Abstract

To provide an abdominoscope stapler for stapling a tissue for more preferable anastomosis with less leakage.SOLUTION: An abdominoscope stapler comprises: a staple housing assembly (20) which can operate so as to staple a tissue, by driving a staple (66) to an anvil assembly (30). The staple housing assembly (20) comprises a pocket (29) for storing a bio adhesive agent. Therefore, when stapling the tissue, the bio adhesive agent is discharged, and the bio adhesive agent is delivered to the tissue which is clamped between the staple housing assembly (20) and the anvil assembly (30) for tissue adhesion.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] The present invention generally relates to surgical staplers. More specifically, the present invention relates to a laparoscopic stapler having a bioadhesive in a separate pocket for assisting anastomosis.

Background Art

[0002] Depending on the situation, a surgeon may want to align a surgical instrument through an opening formed in a patient's body and use the instrument to adjust, align, attach, and / or otherwise interact with tissues within the patient. For example, in some surgical procedures, a portion of the digestive tract may be severed and removed to eliminate unwanted tissue or for other reasons. Once the desired tissue has been removed, it may be necessary to recombine the remaining portions of the tissue with each other. A circular stapler is one of the tools for achieving these anastomosis procedures.

[0003] Because laparoscopic procedures are minimally invasive, laparoscopic surgery is considered optimal for some patients. However, existing circular staplers are not a suitable option for modern minimally invasive laparoscopic surgery. Specifically, existing circular staplers are too large for the common 12 mm trocars required for laparoscopic surgery and can only be used in laparoscopic-assisted open surgery, not in fully laparoscopic open surgery.

[0004] In addition, surgeons prefer the possibility of end-to-end anastomosis in laparoscopic procedures because tissues heal better with end-to-end anastomosis than with side-to-side anastomosis or side-to-end anastomosis. However, there is no end-to-end anastomosis system available for today's fully laparoscopic open surgery. Moreover, unreliable anastomosis leads to bleeding and leakage. Therefore, surgeons need to reinforce the anastomosis with sutures after stapling to avoid leakage.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In view of the above, it is desirable to provide a new stapler that is compatible with both fully laparoscopic surgery and end-to-end anastomosis without leakage.

Means for Solving the Problems

[0006] Accordingly, an object of the present invention is to provide a laparoscopic stapler for better anastomosis with less leakage and improved tissue healing.

[0007] Accordingly, a laparoscopic stapler for stapling tissue is provided. The laparoscopic stapler includes a staple housing assembly operable to drive staples toward an anvil assembly to staple tissue, the staple housing assembly including a pocket for containing a bioadhesive, whereby when stapling tissue, the bioadhesive is released and delivered into the tissue clamped between the staple housing assembly and the anvil assembly for tissue adhesion.

[0008] In one embodiment, the staple housing assembly is a separate assembly selectively movable relative to the anvil assembly.

[0009] In one embodiment, both the staple housing assembly and the anvil assembly are substantially T-shaped assemblies.

[0010] In one embodiment, the pocket includes a plurality of pockets, each of which corresponds to one of a plurality of staple pockets disposed within the staple housing assembly.

[0011] In one embodiment, the plurality of pockets are arranged in a plurality of oval rows similar to the staple pockets.

[0012] In one embodiment, the staple housing assembly further includes a blade for tissue cutting.

[0013] In one embodiment, the staple housing assembly includes a step drive unit for sequentially extruding staples, a bioadhesive, and a blade.

Brief Description of the Drawings

[0014] This specification concludes with the claims that particularly point out and distinctly claim this technology. However, this technology is considered to be better understood by reading the description of certain specific embodiments below in conjunction with the accompanying drawings, in which like reference numerals identify the same elements.

Figure 1

Figure 2

Figure 3

Figure 4

Modes for Carrying Out the Invention

[0015] The following description of specific embodiments of the present technology should not be used for the purpose of limiting its scope. Other embodiments, features, aspects, embodiments, and advantages of the present technology will be apparent to those skilled in the art by the following description, which is one of the best modes contemplated for carrying out the present technology by way of example. Therefore, the drawings and description should be regarded as being of an illustrative nature rather than a limiting nature.

[0016] FIG. 1 illustrates an exemplary laparoscopic stapling instrument 10 having an anvil assembly 30, a shaft assembly 40, and an actuator handle assembly 50. A separate staple housing assembly 20 is configured to be operatively coupled to the closure system and the trigger system of the instrument. The staple housing assembly 20 is operable to drive staples toward the anvil assembly 30 to form staples when in a coupled position. The shaft assembly 40 extends distally from the actuator handle assembly 50, and the anvil assembly 30 is coupled to the distal end of the shaft assembly 40. In one embodiment, the actuator handle assembly 50 is operable to actuate a push trigger of the staple housing assembly 20 to drive a plurality of staples out from the staple housing assembly 20 coupled to the distal end of the instrument. The staples are bent by the anvil assembly 30 to form completed staples. Thus, tissue between the coupled and closed staple housing assembly 20 and the anvil assembly 30 can be stapled using the instrument 10.

[0017] As shown in FIG. 2, the staple housing assembly 20 is a separate deflectable T-shaped assembly. In one embodiment, the staple housing assembly 20 includes a staple housing 21 and a housing shaft 22 extending proximally from the staple housing 21. Unlike a normal circular stapling head, the staple housing 21 according to the present invention has a horizontally elongated or oval outer shape, such as an ovalized rectangular or elliptical outer shape. The staple housing 21 is linked to the housing shaft 22, for example, via a head pivot 23, and the housing shaft 22 is for selectively coupling the staple housing assembly 20 to a closure system of the instrument. In an embodiment, the staple housing assembly 20 is rotatable about the longitudinal axis of the head pivot 23 between a first linear configuration for delivery and a second vertical configuration as shown for coupling and stapling. In the linear configuration, the staple housing assembly 20 has a very low profile such that the entire assembly can pass through a 12 mm trocar commonly used in laparoscopic surgery, and in the vertical configuration, it will be appreciated that the staple housing 21 is pivotable relative to the housing shaft 22 to present a high profile. The staple housing assembly 20 is described as being selectively coupleable to a closure system in this context, but the proximal shaft may include a one-way coupling mechanism such that once attached, the staple housing assembly 20 cannot be removed from the instrument 10.

[0018] The anvil assembly 30 of this embodiment can also be substantially flipped up in a T-shape and is coupled to the distal end of the shaft assembly 40. As shown in FIG. 3, the anvil assembly 30 includes an anvil 31 and an anvil shaft 32 extending proximally from the anvil 31. The anvil 31 has a central opening and an oval staple forming surface at the distal end. The housing shaft 22 of the staple housing assembly 20 can pass through the opening so as to be coupled to the closing system of the instrument. The anvil 31 can also be linked to the anvil shaft 32 via, for example, a head pivot portion 33. Similar to the staple housing assembly 20, the anvil assembly 30 is configured to be rotatable about the longitudinal axis of the head pivot portion 33 between a first linear configuration and a second perpendicular configuration. Also, in the case of the linear configuration, the anvil assembly 30 has a very low profile so that the entire assembly can pass through a 12 mm trocar, and in the case of the perpendicular configuration, the anvil 31 pivots to be perpendicular to the anvil shaft 32, presenting a high profile in a T-shape.

[0019] Since the staple housing assembly 20 is a separate connectable component, the staple housing assembly 20 can be inserted into a part of the tissue in a linear configuration before being coupled to the instrument. As just one example, the staple housing assembly 20 may be inserted into a first tubular portion of the tissue such as the esophagus, while the instrument 10 is inserted into a second tubular portion of the tissue such as the jujune. And since both the staple housing assembly 20 and the anvil assembly 30 can pass through a 12 mm trocar in a linear configuration, the stapler according to the present invention can be used in a fully laparoscopic operation and thus can be called a laparoscopic stapler. Moreover, due to the high profile provided by the T-shaped staple housing assembly and the anvil assembly, the stapler according to the present invention can be adapted to join relatively large lumens, for example, lumens with diameters of 26 mm, 28 mm, 30 mm, 34 mm, 36 mm, 38 mm, 40 mm, or 42 mm.

[0020] As described above, the staple housing assembly 20 is operably coupleable to the closure system and the firing system of the instrument 10 for stapling material clamped between the staple housing assembly 20 and the anvil assembly 30. After the staple housing assembly 20 is coupled, the closure system is operable to translate the staple housing assembly 20 longitudinally relative to the anvil assembly 30 to clamp tissue therebetween. Once in the proper position, the firing system, including a trigger 54, can be actuated by the user to drive and fire staples from the staple housing assembly.

[0021] As shown in FIG. 4, the staple housing 21 of the present embodiment includes an outer casing 24 and an inner casing 25. A push trigger 26 is disposed within the staple housing 21 and configured to be driven proximally in response to actuation of the trigger 54 and can then drive a step drive 27 proximally. The staple housing 21 further includes a blade 28 configured to cut tissue when the step drive 27 is actuated proximally. A plurality of staples 66 housed within a staple pocket are also aligned proximal to the step drive 27 such that proximal actuation of the step drive 27 also drives the staples proximally.

[0022] According to the present invention, the staple housing 21 further includes a plurality of adhesive pockets 29 for accommodating a bioadhesive. The adhesive pockets are provided such that the step drive unit 27 drives the staples 66 to staple the tissue, and the bioadhesive can also be extruded from the staple housing 21 to the tissue by the same drive unit. As can be seen from FIG. 4, the adhesive pockets 29 and the staple pockets are arranged in a pair of concentric oval rows. The blade 28 is disposed distally with respect to the bioadhesive and the staples. Therefore, when the step drive unit 27 is actuated proximally, the staples are first extruded, and the bioadhesive is extruded from each pocket to the tissue to perform stapling and adhesion. Such delivery of the bioadhesive to the tissue can prevent leakage, promote tissue healing, and thus provide improved anastomosis. When the step drive unit 27 is further actuated proximally, the blade 28 is driven to achieve tissue cutting.

[0023] Here, the operation of the laparoscopic stapler according to the present invention will be described with respect to exemplary jejunojejunal anastomosis and esophagoanastomosis.

[0024] In this laparoscopic method, the anastomosis is performed in a prepared state using a delivery channel provided by a 12 mm trocar, and the ends of the jejunum and esophagus are closed, for example, with a linear stapler. In a first step, an opening is created in the prepared and closed end of the esophagus and can be stabilized with a grasping tool. A staple housing assembly, such as the staple housing assembly 20 described above, is inserted in a linear configuration through the created opening, and then the assembly 20 is actuated into a T-shaped configuration and the housing shaft is protruded out of the esophageal end from the opening to prepare for the staple housing assembly 20 to engage. Optionally, the assembly 20 can be stabilized, for example, with a grasping tool. In the next step, the instrument 10 is inserted in a linear configuration using the anvil assembly 30 through a 12 mm trocar surgical device and into the prepared opening of the jejunum, and then the instrument is actuated into a T-shaped configuration. The jejunal wall is here made oval by the T-shaped anvil. In the next step, the staple housing assembly 20 is coupled to the closure system of the instrument, and the staple housing assembly 20 is actuated proximally towards the anvil assembly 30 to close the gap distance therebetween. Once the instrument 10 is within the operating range, the user actuates the trigger 54 of the instrument 10 to drive the step drive 27 proximally. Actuation of the step drive 27 extrudes staples and a bioadhesive into the tissue for stapling and adhesion and also extrudes a blade to cut the overlapping tissue of the esophagus and jejunum. When the end-to-end anastomosis is thus completed, the surgeon can return the staple housing assembly 20 and the anvil assembly 30 to a linear configuration, and then the stapler can be removed from the patient through the 12 mm trocar.

[0025] Many modifications can be made to the described example. When the staple housing assembly 20 is coupled to the closure system, it is envisioned that the gap distance between the proximal surface of the staple housing assembly 20 and the distal surface of the anvil assembly 30 can be shortened. In this regard, the closure system can be longitudinally translatable relative to the anvil assembly 30 via an adjustment knob 58 located at the proximal end of the actuator handle assembly 50. Thus, when the staple housing assembly 20 is coupled to the closure system, rotation of the adjustment knob 54 shortens the gap distance by actuating the staple housing assembly 20 relative to the anvil assembly 30. For example, the staple housing 20 is actuated proximally relative to the anvil assembly 30 from an initial open position to a closed position, thereby shortening the gap distance and the distance between the two portions of tissue to be joined. Once the gap distance is within a predetermined range, the staple housing assembly 20 can be fired by the user pivoting the trigger 54 of the actuator handle assembly 50.

[0026] As described above, the gap distance corresponds to the distance between the staple housing assembly 20 and the anvil assembly 30. This gap distance may not be easily visible when the stapler is inserted into the patient. Accordingly, a movable indicator bar can be provided to be visible through an indicator window aligned with the top of the actuator handle assembly 50. For example, the indicator bar is operable to move in response to rotation of the adjustment knob 58 such that the position of the indicator bar represents the gap distance. Moreover, the indicator window 51 can further comprise a scale indicating that the gap is within a desired operating range and corresponding staple compression representations at each end of the scale. Thus, the user can visually observe the position of the coupled staple housing 20 relative to the anvil assembly 30 via the indicator bar and the scale.

[0027] In a further embodiment according to the present invention, as shown in FIG. 1, anvil control buttons 52, 53 corresponding to the actuation of the anvil assembly 30 to its T-shaped configuration and the deactivation of the anvil assembly 30 to its original linear configuration are provided on the actuator handle assembly 50. With this configuration, the user can easily return the stapler to a low profile for removal through the trocar channel.

[0028] Although the preferred embodiments have been shown and described, it is to be understood that such disclosure is not intended to limit the present invention, but rather is intended to cover all modifications and alternative configurations within the spirit and scope of the present invention.

[0029] 〔Embodiment〕 (1) A laparoscopic stapler for stapling tissue, comprising a staple housing assembly operable to drive staples towards an anvil assembly to staple the tissue, wherein the staple housing assembly comprises a pocket for accommodating a bioadhesive, whereby when stapling the tissue, the bioadhesive is released and delivered into the tissue clamped between the staple housing assembly and the anvil assembly for tissue adhesion. (2) The laparoscopic stapler according to Embodiment 1, wherein the staple housing assembly is a separate assembly movable relative to the anvil assembly. (3) The laparoscopic stapler according to Embodiment 2, wherein both the staple housing assembly and the anvil assembly are substantially T-shaped assemblies. (4) The laparoscopic stapler according to Embodiment 3, wherein the pocket includes a plurality of pockets, each of which corresponds to one of a plurality of staple pockets disposed within the staple housing assembly. (5) The laparoscopic stapler according to Embodiment 4, wherein the plurality of pockets are arranged in a plurality of oval rows similar to the staple pockets.

[0030] (6) The laparoscope stapler according to Embodiment 2, wherein the staple housing assembly further includes a blade for tissue cutting. (7) The laparoscope stapler according to Embodiment 6, wherein the staple housing assembly includes a step driving unit for sequentially pushing out the staples, the bioadhesive, and the blade.

Claims

1. 1. A laparoscopic stapler for stapling tissue comprising: a staple housing assembly operable to drive staples towards an anvil assembly to staple said tissue, said staple housing assembly comprising: an adhesive pocket for containing a bioadhesive; a staple pocket for receiving the staple; A blade for cutting tissue; a stepper drive for expelling the staples, the bioadhesive, and the blade; Equipped with 1. A laparoscopic stapler comprising: a step drive configured to drive a stapler having a distal end disposed distal to the bioadhesive and the staples; and a step drive configured to drive the blade to effect tissue cutting when the step drive is actuated proximally, the step drive first pushing the staples and the bioadhesive from their respective pockets into the tissue for stapling and adhering, and when the step drive is actuated further proximally, the step drive drives the blade to effect tissue cutting.

2. The laparoscopic stapler of claim 1 , wherein the staple housing assembly is a separate assembly movable relative to the anvil assembly.

3. 3. The laparoscopic stapler of claim 2, wherein the staple housing assembly comprises a staple housing and a housing shaft extending proximally from the staple housing, and the anvil assembly comprises an anvil and an anvil shaft extending proximally from the anvil.

4. The laparoscopic stapler of claim 3 , wherein said staple housing assembly includes a plurality of combinations of said adhesive pockets and corresponding said staple pockets.

5. 5. The laparoscopic stapler of claim 4, wherein said staple housing includes a surface facing said anvil, said surface being oval, and a plurality of said combinations are arranged to form a plurality of oval rows of pockets on said surface.

6. The laparoscopic stapler of claim 2 , wherein the step actuator sequentially ejects the staples, the bioadhesive, and the blade.

7. 4. The laparoscopic stapler of claim 3, wherein the staple housing assembly moves from an open position relative to the anvil assembly to a closed position in which the tissue is clamped between the staple housing assembly and the anvil assembly upon proximal movement of the staple housing assembly toward the anvil assembly.

8. 2. The laparoscopic stapler of claim 1, wherein the step drive includes a first portion aligned distal to the staple and adhesive pocket contained within the staple pocket and a second portion aligned distal to a distal end of the blade.

9. 10. The laparoscopic stapler of claim 1, wherein the bioadhesive is released when stapling the tissue and delivered into the tissue clamped between the staple housing assembly and the anvil assembly for tissue adhesion.

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