Laparoscopic stapler having flippable staple housing assembly and flippable anvil assembly - Patents.com

Abstract

To provide a novel stapler that is adaptable to both of the complete laparoscopic surgery and the end-to-end anastomosis free of occurrence of leakage.SOLUTION: A laparoscopic stapler comprises: a reversible anvil assembly (30), and a reversible staple housing assembly (20) movable with respect to the reversible anvil assembly (30). The anvil assembly (30) and the staple housing assembly (20) are respectively configured to be operable in a first configuration and a second configuration. In the first configuration, the anvil assembly (30) and the staple housing assembly (20) both have a low profile. In the second configuration, the anvil assembly (30) and the staple housing assembly (20) have a high profile for performing tissue stapling.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates generally to surgical staplers, and more particularly to a laparoscopic stapler having a flippable staple housing assembly and a flippable anvil assembly. [Background technology]

[0002] In some situations, a surgeon may wish to position a surgical instrument through an opening formed in a patient's body and use the instrument to adjust, align, attach, and / or alternatively interact with tissue within the patient's body. For example, some surgical procedures may involve severing and removing a portion of the digestive tract to eliminate unwanted tissue or for other reasons. Once the desired tissue has been removed, it may be necessary to reattach the remaining portions of the tissue to one another. A circular stapler is one of the tools used to accomplish these anastomosis procedures.

[0003] Laparoscopic surgery is considered the best surgery for some patients because the laparoscopic approach is minimally invasive. However, existing circular staplers are not a suitable option for modern minimally invasive laparoscopic surgery. Specifically, existing circular staplers are too large for the typical 12 mm trocars required for laparoscopic surgery, so they can only be used in laparoscopically assisted surgery, not fully laparoscopic surgery.

[0004] Surgeons also prefer the possibility of end-to-end anastomosis in laparoscopic procedures because tissues heal better than side-to-end or side-to-side anastomosis. However, there is no end-to-end anastomosis system available for fully laparoscopic surgery today. 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 [Problem to be solved by the invention]

[0005] With the above in mind, it would be desirable to provide a new stapler that is adapted for both fully laparoscopic surgery and end-to-end anastomosis without leaks. [Means for solving the problem]

[0006] It is therefore an object of the present invention to provide a laparoscopic stapler that can be used in fully laparoscopic surgery and in which the desired end-to-end anastomosis can be achieved by using such a stapler.

[0007] Accordingly, a new laparoscopic stapler for stapling tissue is provided, the laparoscopic stapler according to the present invention comprising a flippable anvil assembly and a flippable staple housing assembly movable relative to the flippable anvil assembly, the anvil assembly and the staple housing assembly configured to be operable in a first configuration and a second configuration, in which both the anvil assembly and the staple housing assembly have a low profile such that they may be delivered separately through a 12 mm trocar, and in the second configuration, the anvil assembly and the staple housing assembly have a high profile for performing stapling of tissue.

[0008] In a preferred embodiment of the present invention, an anvil assembly is coupled to a distal end of a shaft assembly of the stapler, and a staple housing assembly is selectively coupleable to a closure and firing system of the stapler.

[0009] In another embodiment of the present invention, both the staple housing assembly and the anvil assembly have a substantially T-shaped configuration.

[0010] In a further embodiment of the present invention, a staple housing assembly includes an oval shaped staple housing and a housing shaft extending proximally from the staple housing.

[0011] In a further embodiment of the present invention, an anvil assembly includes an oval shaped anvil and a housing shaft extending proximally from the anvil.

[0012] According to another aspect, the laparoscopic stapler may further include a visual indicator to indicate the gap distance between the anvil assembly and the staple housing assembly when coupled.

[0013] According to another aspect, the laparoscopic stapler may further include a first anvil control button operative to move the anvil assembly from the first configuration to the second configuration, and a second anvil control button operative to move the anvil assembly from the second configuration to the first configuration.

[0014] According to another aspect, the laparoscopic stapler may further include a scale indicating when a gap between the staple housing assembly and the anvil assembly is within a desired range of operation and a corresponding staple compression representation at each end of the scale.

[0015] In a preferred embodiment of the present invention, the staple housing assembly further comprises a blade for cutting tissue. [Brief description of the drawings]

[0016] While this specification concludes with claims particularly pointing out and distinctly claiming the present technology, the technology will be better understood from the following description of certain embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which: [Figure 1] 1 is a perspective view of an exemplary laparoscopic stapler in accordance with the present invention; [Diagram 2] 2 illustrates a staple housing assembly for use in the laparoscopic stapler of FIG. 1; [Diagram 3] 2 illustrates an anvil assembly used in the laparoscopic stapler of FIG. 1; [Figure 4] 1 is a cross-sectional view of a staple housing assembly according to the present invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] The following description of a specific example of the present technology should not be used to limit its scope. Other examples, features, aspects, embodiments, and advantages of the present technology will become apparent to those skilled in the art from the following description, which is illustrative and is one of the best modes contemplated for carrying out the present technology. Therefore, the drawings and description should be regarded as illustrative in nature, and not restrictive.

[0018] 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 operably coupled to the closure and trigger systems 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 a 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 of the staple housing assembly 20 coupled to the distal end of the instrument. The staples are bent by the anvil assembly 30 to form a completed staple. Thus, tissue between the coupled and closed staple housing assembly 20 and the anvil assembly 30 may be stapled utilizing the instrument 10.

[0019] As shown in FIG. 2, the staple housing assembly 20 is a separate flippable T-shaped assembly. In one embodiment, the staple housing assembly 20 comprises a staple housing 21 and a housing shaft 22 extending proximally from the staple housing 21. Unlike a typical circular stapling head, the staple housing 21 according to the present invention has an elongated or oval profile, such as a rounded rectangular or elliptical profile. The staple housing 21 is linked to the housing shaft 22, for example, via a head pivot 23, which 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. It will be appreciated that in the linear configuration, staple housing assembly 20 has a very low profile to allow the entire assembly to pass through a 12 mm trocar commonly used in laparoscopic surgery, and in the vertical configuration, staple housing 21 is pivotable to be perpendicular to housing shaft 22 to present a high profile. Although staple housing assembly 20 is described in this context as being selectively coupleable to a closure system, the proximal shaft may include a one-way coupling mechanism such that staple housing assembly 20 cannot be removed from instrument 10 once attached.

[0020] The anvil assembly 30 of this embodiment is also flippable in a substantially 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 a distal end. The housing shaft 22 of the staple housing assembly 20 can pass through the opening to be coupled to the closure system of the instrument. The anvil 31 can also be linked to the anvil shaft 32 via, for example, a head pivot 33. Similar to the staple housing assembly 20, the anvil assembly 30 is also configured to be rotatable about the longitudinal axis of the head pivot 33 between a first linear configuration and a second vertical configuration. Also, in 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 vertical configuration, the anvil 31 pivots to be perpendicular to the anvil shaft 32, giving it a T-shape and a high profile.

[0021] Because the staple housing assembly 20 is a separate connectable component, the staple housing assembly 20 can be inserted into a portion of tissue in a linear configuration before being connected to the instrument. By way of example only, the staple housing assembly 20 may be inserted into a first tubular portion of tissue, such as the esophagus, while the instrument 10 is inserted into a second tubular portion of tissue, such as the jujune. And because 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 fully laparoscopic surgery and thus can be referred to as a laparoscopic stapler. Moreover, the high profile provided by the T-shaped staple housing assembly and anvil assembly allows the stapler according to the present invention to be adapted for joining relatively large lumens, for example, lumens having diameters of 26 mm, 28 mm, 30 mm, 34 mm, 36 mm, 38 mm, 40 mm, or 42 mm.

[0022] As described above, the staple housing assembly 20 is operably couplable to the closure and firing systems 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 longitudinally translate the staple housing assembly 20 relative to the anvil assembly 30 to clamp tissue therebetween. Once in the proper condition, the firing system, including trigger 54, can be actuated by the user to drive and fire the staples from the staple housing assembly.

[0023] As shown in FIGURE 4, the staple housing 21 of this 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, which in turn can drive the step driver 27 proximally. The staple housing 21 further includes a blade 28 configured to cut tissue when the step driver 27 is actuated proximally. A plurality of staples 66 contained within the staple pockets are aligned proximally of the step driver 27 such that proximal actuation of the step driver 27 also drives the staples proximally.

[0024] According to the present invention, the staple housing 21 further comprises a plurality of adhesive pockets 29 for containing a bioadhesive. The adhesive pockets are provided such that the step actuator 27 drives the staples 66 to staple the tissue, and the bioadhesive can also be extruded from the staple housing 21 into the tissue by the same actuator. As can be seen in 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 relative to the bioadhesive and the staples. Thus, when the step actuator 27 is actuated proximally, it first extrudes the staples and extrudes the bioadhesive from each pocket into the tissue for stapling and adhesion. Such delivery of the bioadhesive into the tissue may prevent leakage and promote tissue healing, thus providing an improved anastomosis. When the step actuator 27 is actuated further proximally, it drives the blade 28 to accomplish tissue cutting.

[0025] The operation of the laparoscopic stapler according to the present invention will now be described with respect to exemplary Jojun and esophageal anastomoses.

[0026] 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 esophagus and esophagus are closed, for example, with a linear stapler. In a first step, an opening is made in the prepared and closed end of the esophagus and can be stabilized with a grasper. A staple housing assembly, such as the staple housing assembly 20 described above, is inserted in a linear configuration through the made opening, and then the assembly 20 is actuated into a T-shaped configuration, causing the housing shaft to project out of the opening and out of the esophagus end, in order for the staple housing assembly 20 to be ready to be joined. Optionally, the assembly 20 can be stabilized, for example, with a grasper. In a next step, the instrument 10 is inserted with the anvil assembly 30 in a linear configuration through a 12 mm trocar surgical device and into the opening of the prepared esophagus, and then the instrument is actuated into a T-shaped configuration. The esophagus wall is now made into an oval shape 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 toward the anvil assembly 30 to close the gap distance therebetween. Once the instrument 10 is within operating range, the user actuates the trigger 54 of the instrument 10 to actuate the step actuator 27 proximally. Actuation of the step actuator 27 expels the staples and bioadhesive into the tissue for stapling and adhesion, and also expels the blade to cut the overlapping tissue of the esophagus and esophageal mucosa. With the end-to-end anastomosis thus completed, the surgeon may return the staple housing assembly 20 and the anvil assembly 30 to the linear configuration, and the stapler may then be removed from the patient through a 12 mm trocar.

[0027] Many modifications may be made to the described example. It is envisioned that when the staple housing assembly 20 is coupled to the closure system, the gap distance between the proximal surface of the staple housing assembly 20 and the distal surface of the anvil assembly 30 may be shortened. In this regard, the closure system may 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, once the staple housing assembly 20 is coupled to the closure system, rotation of the adjustment knob 58 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 may be fired by a user pivoting a trigger 54 of the actuator handle assembly 50.

[0028] As mentioned 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 a patient. Therefore, a movable indicator bar may be provided that is 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 a rotation of the adjustment knob 58 such that the position of the indicator bar represents the gap distance. Moreover, the indicator window 51 may further comprise a scale that indicates when the gap is within a desired range of motion and a corresponding staple compression representation at each end of the scale. Thus, a user can view the position of the coupled staple housing 20 relative to the anvil assembly 30 via the indicator bar and the scale.

[0029] In a further embodiment according to the invention, anvil control buttons 52, 53 are provided on actuator handle assembly 50 which correspond to actuation of anvil assembly 30 to its T-shaped configuration and deactuation of anvil assembly 30 to its original linear configuration, as shown in FIG 1. This configuration allows a user to easily return the stapler to a low profile for removal through the trocar channel.

[0030] While preferred embodiments have been shown and described, it will be understood that it is not intended to limit the invention by such disclosure, but rather to cover all modifications and alternative constructions within the spirit and scope of the invention.

[0031] [Embodiment] (1) A laparoscopic stapler for stapling tissue, comprising: a flippable anvil assembly; a flippable staple housing assembly movable relative to the flippable anvil assembly, 1. A laparoscopic stapler, wherein the anvil assembly and the staple housing assembly are each configured to be operable in a first configuration and a second configuration, wherein in the first configuration, both the anvil assembly and the staple housing assembly have a low profile such that the anvil assembly and the staple housing assembly can be delivered separately through a 12 mm trocar, and in the second configuration, the anvil assembly and the staple housing assembly have a high profile for performing stapling of tissue. (2) A laparoscopic stapler as described in embodiment 1, wherein the anvil assembly is coupled to a distal end of the stapler shaft assembly and the staple housing assembly is selectively coupleable to a closure and firing system of the stapler. (3) A laparoscopic stapler as described in embodiment 2, wherein both the staple housing assembly and the anvil assembly have a substantially T-shaped configuration. (4) A laparoscopic stapler according to embodiment 3, wherein the staple housing assembly comprises an oblong staple housing and a housing shaft extending proximally from the staple housing. (5) A laparoscopic stapler according to embodiment 3, wherein the anvil assembly comprises an oval anvil and a housing shaft extending proximally from the anvil.

[0032] (6) The laparoscopic stapler of embodiment 2, further comprising a visual indicator for indicating a gap distance between the anvil assembly and the staple housing assembly when coupled. (7) A laparoscopic stapler as described in embodiment 2, further comprising a first anvil control button operable to move the anvil assembly from the first configuration to the second configuration, and a second anvil control button operable to move the anvil assembly from the second configuration to the first configuration. (8) A laparoscopic stapler as described in embodiment 2, further comprising a scale indicating when a gap between the staple housing assembly and the anvil assembly is within a desired range of operation, and a corresponding staple compression representation at each end of the scale. (9) A laparoscopic stapler as described in embodiment 2, wherein the staple housing assembly further comprises a blade for cutting tissue.

Claims

1. 1. A laparoscopic stapler for stapling tissue comprising: an actuator handle assembly; a shaft assembly extending distally from the actuator handle assembly; an anvil assembly coupled to a distal end of the shaft assembly; and a staple housing assembly, at least a portion of which is located distal to the anvil assembly and movable relative to the anvil assembly, the staple housing assembly being capable of clamping tissue between the anvil assembly and the staple housing assembly, the staple housing assembly comprises a staple housing, a housing shaft extending proximally from the staple housing and along a longitudinal axis of the shaft assembly, and a head pivot portion rotatably supporting the staple housing relative to the housing shaft; the staple housing assembly is changeable between a first configuration and a second configuration, wherein in the first configuration of the staple housing assembly, the staple housing extends in a direction non-perpendicular to the housing shaft, and as the staple housing assembly changes from the first configuration to the second configuration, the staple housing rotates about the head pivot relative to the housing shaft, the staple housing extends in a lateral direction that is perpendicular to the housing shaft that extends along the longitudinal axis of the shaft assembly, and a length of the staple housing in the lateral direction in the second configuration is greater than a length of the staple housing in the lateral direction in the first configuration; the anvil assembly includes an anvil, an anvil shaft extending proximally from the anvil and along the longitudinal axis of the shaft assembly, and a second head pivot rotatably supporting the anvil relative to the anvil shaft; the anvil assembly is changeable between a first configuration and a second configuration, wherein in the first configuration of the anvil assembly, the anvil extends in a direction non-perpendicular to the anvil shaft, and as the anvil assembly changes from the first configuration to the second configuration, the anvil rotates about the second head pivot relative to the anvil shaft, the anvil extends in the lateral direction that is perpendicular to the anvil shaft that extends along the longitudinal axis of the shaft assembly, and a length of the anvil in the lateral direction in the second configuration is greater than a length of the anvil in the lateral direction in the first configuration; a stapler having a staple housing assembly that is adapted to be inserted through a trocar into tissue and then changed to the second configuration when the staple housing assembly is in the first configuration and spaced apart from portions of the laparoscopic stapler other than the staple housing assembly, and a staple housing assembly that is adapted to be inserted through a trocar into tissue and then changed to the second configuration when the anvil assembly is in the first configuration and capable of being coupled to portions of the laparoscopic stapler other than the staple housing assembly to perform stapling of tissue.

2. 10. The laparoscopic stapler of claim 1, further comprising a visual indicator for indicating a gap distance between the anvil assembly and the staple housing assembly when the staple housing assembly is coupled to the portion of the laparoscopic stapler other than the staple housing assembly.

3. 10. The laparoscopic stapler of claim 1, further comprising a first anvil control button operative to move the anvil assembly from the first configuration to the second configuration, and a second anvil control button operative to move the anvil assembly from the second configuration to the first configuration.

4. The laparoscopic stapler of claim 1 , wherein the staple housing assembly further comprises a blade for cutting tissue.

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