SURGICAL STAPLER

Abstract

A surgical stapler is disclosed herein. The surgical stapler comprises a body having a distal end and a proximal end, and the body defines an interior space. A first knob and a second knob are configured adjacent the proximal end of the body. An anvil and trocar assembly is configured adjacent the distal end of the surgical stapler, wherein the anvil and trocar assembly is coupled to the first knob, and the first knob is configured to facilitate the extension and retraction of the anvil and trocar assembly at the distal end of the body. A staple and knife assembly is configured adjacent the anvil and trocar assembly within the body, wherein the staple and knife assembly is coupled to the second knob, and wherein the second knob is configured to facilitate firing of staples and actuation of a knife of the staple and knife assembly sequentially.

Claims

1. A surgical apparatus, comprising: (a) a body assembly, comprising: (i) a handle portion, and (ii) a shaft portion extending distally from the handle portion; (b) an end effector comprising a staple driver, wherein the staple driver is movable relative to the shaft portion of the body assembly between an unfired position and a fired position; (c) a staple firing actuator located on the handle portion of the body assembly; (d) a tissue cutting actuator located on the handle portion of the body assembly; (e) a staple containment housing that holds a plurality of unformed metal staples until the moment of dispensing the staples for forming in tissue; (f) an anvil assembly for receiving staple tips containing at least one contiguous uninterrupted staple-forming groove of at least the length of two unformed staple widths and which is substantially the same groove depth over its entire length, the at least one contiguous uninterrupted staple-forming groove configured for forming a plurality of staples during the same firing.

2. The surgical apparatus of claim 1, wherein the assembly comprises a circular-shaped distal end effector having at least one fully circular or arcuate groove, and wherein the at least one fully circular or arcuate groove is configured to form a plurality of staples during a single actuation, wherein the number of unformed (U-shaped) staples per linear centimeter of groove length is two or more.

3. The surgical apparatus of claim 1, wherein the anvil assembly comprises a linear distal end effector having at least one straight anvil groove, the at least one straight anvil groove oriented in a fixed or movable (articulable) mode, generally parallel with or up to an angle of 90 degrees to a shaft axis, and wherein the at least one straight anvil groove is configured to form a plurality of staples during a single actuation, wherein the number of unformed (U-shaped) staples per linear centimeter of groove length is two or more.

4. The surgical apparatus of claim 1, wherein the wherein the anvil assembly comprises an arcuate distal end effector having at least one circular or arcuate groove configured to form a plurality of staples during a single actuation, wherein the number of unformed (U-shaped) staples per linear centimeter of groove length is two or more.

5. A surgical apparatus, comprising: (a) a body assembly, comprising: (i) a handle portion, and (ii) a shaft portion extending distally from the handle portion; (b) an end effector comprising a staple driver, wherein the staple driver is movable relative to the shaft portion of the body assembly between an unfired position and a fired position; (c) a staple firing actuator located on the handle portion of the body assembly; (d) a tissue cutting actuator located on the handle portion of the body assembly; (e) a staple containment housing that holds a plurality of unformed metal staples until the moment of dispensing the staples for forming in tissue; (f) an anvil assembly for receiving staple tips containing at least one contiguous uninterrupted staple-forming groove of at least the length of two unformed staple widths and which is substantially the same groove depth over its entire length, the at least one contiguous uninterrupted staple-forming groove configured for forming a plurality of staples during the same firing; (g) a tissue release mechanism located within the handle portion of the body assembly, comprising; (i) a spring to store mechanical energy during closure of the anvil assembly; and (ii) a rotary knob operatively coupled to an elongated shaft and the anvil assembly; and (iii) a releasable shaft-engaging mechanism which operatively couples the rotary knob to the anvil during closure and the storage of mechanical energy; and (iii) a triggering mechanism to unleash the energy stored in the spring to allow a movable anvil of the anvil assembly to automatically move distally after completing the firing, enabling stapled tissue to easily be released.

6. The surgical apparatus of claim 2, further comprising: (h) a tissue compression limiter that is operatively connected to the movable anvil, and comprising at least one tension-limiting spring.

7. The surgical apparatus of claim 2, further comprising: (i) a high mechanical advantage staple firing mechanism comprising; (i) a slidable elongated driver shaft operatively connected to a staple driver, and containing a screw thread; (ii) an adjusting knob operatively connected to the slidable elongated driver shaft, and including a mating screw thread for engagement with the slidable elongated driver shaft;

8. The surgical apparatus of claim 2, further comprising: (j) a tactile feedback mechanism to emit a vibration and/or emit a clicking sound sufficient to be easily heard by a clinician, and wherein the tactile feedback mechanism is located on or within the handle portion, to alert the clinician of firing completion; and (k) a hardened stainless steel or ceramic knife sufficiently tough and sharp enough to cut through tissue and any of the softer metal staples from prior firings used to close tissues

9. The surgical apparatus of claim 2, wherein the anvil assembly further comprises: (l) an anvil mounted flat receiving substrate disc, wherein the anvil mounted flat receiving substrate disc is at least one of coating of polymer and rubber configured adjacent to the staple forming grooves, the anvil mounted flat receiving substrate disc configured to solidly back up the circular knife for effective cutting of the tissue and any prior staple lines encountered.

10. The surgical apparatus of claim 8, wherein the hardened stainless steel or ceramic knife imparts a rotational slicing action during tissue cutting.

11. The surgical apparatus of claim 2, wherein the movable anvil includes selectively serrated, machined, coated, or abrasive blasted surfaces, designed to grip tissue and prevent slippage during the stapling and/or cutting of tissues.

12. The surgical apparatus of claim 2, further comprising a clutching mechanism that effectively limits the torque which a clinician may input via turning the adjusting knob, and wherein the clutching mechanism is operatively connected to the slidable elongated shaft and anvil.

13. The surgical apparatus of claim 2, wherein the staple firing actuator and the tissue cutting actuator located on the handle portion of the body assembly are the same actuator operable in different operating modes.

14. The surgical apparatus of claim 1, wherein the staple firing actuator and the tissue cutting actuator located on the handle portion of the body assembly with both the staple firing and tissue cutting functions effectuated by the same actuator.

15. The surgical apparatus of claim 1, wherein: an anvil of the anvil assembly is constructed of at least one material selected from stainless steel and aluminum metal, wherein the at least one material is at least one of anodized, treated, oxidized, or tinted with colors; or the anvil of the anvil assembly is constructed of at least one metal selected from stainless steel or aluminum metal, wherein the at least one metal is coated or impregnated with at least one material selected from a group consisting of polytetrafluoroethylene (PTFE), stearate emulsions, or greases, wherein the at least one material, when interacting with the malleable metal staple, generates a coefficient of friction less than or equal to 0.5, whether static or sliding; or the anvil of the anvil assembly is constructed of a polymer and having a coating substantially hard enough to enable staples to form, wherein the coating is at least one of electro-plated coating of a metallic material.

16. The surgical apparatus of claims 1, further comprising unformed staples which include a pre-bend, to bias the buckling direction of the staple tips consistently toward each other during device actuation and staple forming, and to reduce the column strength of the staple legs to reduce the force required to form the staples.

17. The surgical apparatus of claim 1, wherein all the staples are fully formed prior to engagement of the knife to cut the tissue.

18. The surgical apparatus of claim 2, wherein an anvil shaft of the anvil assembly does not contain radial orientation means to provide radial positioning of the anvil to a plurality of cartridge pockets.

19. The surgical apparatus of claim 18, wherein the anvil shaft is configured to have an interference fit with a mating cartridge surface for at least a portion of shaft engagement with a mating surface of a staple cartridge.

20. The surgical apparatus of claims 1, wherein the staples are plated, coated or impregnated with at least one material selected from a group consisting of polytetrafluoroethylene (PTFE), stearate emulsions, and greases, wherein when the at least one material interacting with the malleable metal staple, generates a coefficient of friction less than or equal to 0.5, whether static or sliding.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The description of the illustrative embodiments can be read in conjunction with the accompanying figures. It will be appreciated that for simplicity and clarity of illustration, elements illustrated in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements are exaggerated relative to other elements. Embodiments incorporating teachings of the present disclosure are shown and described with respect to the figures presented herein, in which:

[0039] FIG. 1A through FIG. 1D illustrate views of a circular surgical stapler in unactuated states and actuated states, in accordance with embodiments of the present subject matter.

[0040] FIG. 2 illustrates a sectional view of the circular surgical stapler in the actuated state, in accordance with embodiments of the present subject matter.

[0041] FIG. 3A through FIG. 3C illustrate sectional views of the circular surgical stapler along section line A-A of FIG. 1C depicting the operation of actuation of the circular surgical stapler, in accordance with embodiments of the present subject matter.

[0042] FIG. 4A through FIG. 4H illustrate sectional views of the circular surgical stapler along section lines B-B and D-D depicting the operation of anvil and trocar assembly of the circular surgical stapler, in accordance with embodiments of the present subject matter.

[0043] FIG. 5A and FIG. 5C illustrate views of the anvil, in accordance with embodiments of the present subject matter.

[0044] FIG. 6A through FIG. 6C illustrate views depicting the bending of staple subsequent to firing the circular surgical stapler, in accordance with embodiments of the present subject matter.

[0045] FIG. 7A illustrates a perspective view of the anvil, in accordance with embodiments of the present subject matter.

[0046] FIG. 7B illustrates a perspective view of a staple cartridge used in the stapler, in accordance with an embodiment of the present subject matter.

[0047] FIG. 7C illustrates a perspective view of a staple, in accordance with an embodiment of the present subject matter.

[0048] FIG. 8A illustrates a perspective view of a conventional linear surgical stapler having a linear anvil installed thereon, in accordance with an embodiment of the present subject matter.

[0049] FIG. 8B and FIG. 8C illustrate different views of the linear anvil, in accordance with an embodiment of the present subject matter.

[0050] FIG. 9A illustrates a perspective view of a conventional curved surgical stapler having a curved anvil installed thereon, in accordance with an embodiment of the present subject matter.

[0051] FIG. 9B and FIG. 9C illustrate different views of the curved anvil, in accordance with an embodiment of the present subject matter.

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0052] For clarity of disclosure, the terms “proximal” and “distal” are defined herein relative to a surgeon, or other operator, grasping a surgical instrument having a distal surgical end effector. The term “proximal” refers to the position of an element arranged closer to the surgeon, and the term “distal” refers to the position of an element arranged closer to the surgical end effector of the surgical instrument and further away from the surgeon.

[0053] Moreover, to the extent that spatial terms such as “top,” “bottom,” “upper,” “lower,” “vertical,” “horizontal,” are used herein with reference to the drawings, it will be appreciated that such terms are used for exemplary description purposes only and not intended to be limiting or absolute. In that regard, it will be understood that surgical instruments such as disclosed herein may be used in orientations and positions not limited to those shown and described herein.

[0054] In addition, the term “endoscopic” is used generally to refer to surgical procedures performed through a small incision or a cannula inserted into a patient's body including endoscopic, laparoscopic and arthroscopic surgical procedures. Finally, the term clinician is used generally to refer to medical personnel including doctors, nurses, and support personnel.

[0055] FIG. 1A through FIG. 1D illustrate views of a circular surgical stapler 100 (hereinafter interchangeably referred to as stapler 100 or surgical stapler 100) in unactuated states and actuated states. FIG. 1A and FIG. 1B illustrate unactuated views of the stapler 100, while FIG. 1C and FIG. 1D illustrate actuated views of the stapler 100. Reference hereinafter is directed to FIG. 1A through FIG. 1D. In accordance with an embodiment of the present subject matter, the stapler 100 comprises a body 102 having a distal end 102A and a proximal end 102B. The body 102 defines an interior space. A first knob 104 and a second knob 106 are configured adjacent the proximal end 102B of the body 102. More specifically, the second knob 106 is fitted at the proximal end 102B, and the first knob 104 is coupled to the second knob 106. An anvil and trocar assembly 108 is configured adjacent the distal end 102A of the surgical stapler 100, wherein the anvil and trocar assembly 108 is coupled to the first knob 104. More specifically, the first knob 104 is configured to facilitate the extension and retraction of the anvil and trocar assembly 108 at the distal end of the body 102. A staple and knife assembly (not seen in FIG. 1A through FIG. 1D) is configured adjacent the anvil and trocar assembly 108 within the body 102, wherein the staple and knife assembly is coupled to the second knob 106, and wherein the second knob 106 is configured to facilitate firing of staples and actuation of a knife of the staple and knife assembly sequentially. The sequential actuation of the staples and the knife of the stapler 100 are discussed in detail in the subsequent sections of the present disclosure.

[0056] FIG. 2 illustrates a sectional view of the circular surgical stapler 100 in the actuated state, in accordance with embodiments of the present subject matter. Referring to FIG. 2, the staple and knife assembly 110 is configured concentric to the anvil and trocar assembly 108 at the distal end 102A of the body 102. The body 102 defines an interior space 102C for body all the different components for transmission of the movements of the first and second knobs 104, 106 to the anvil and trocar 108 and the staple and knife assembly 110.

[0057] Referring to FIG. 2, the stapler 100 comprises a variable threaded tube 112 disposed within and coupled to the first knob 104 and extending into the interior space 102C. The stapler 100 further comprises an adjustable shuttle 114 disposed within the interior space 102C such that a portion of the adjustable shuttle 114 is accommodated within the variable threaded tube 112 and extends therefrom into the interior space 102C. The stapler 100 further comprises a closure rod 116 disposed within the interior space 102C such that a portion of the closure rod 116 is accommodated within the adjustable shuttle 114 and extends therefrom up to a location in the interior space near the distal end 102A. The anvil and trocar assembly 108 is coupled to the closure rod 116. More specifically, the extension and retraction of the anvil and trocar assembly 108 required for the operation of the surgical stapler 100 is facilitated by the linear movement of the closure rod 116. The details of the operation of the closure rod 116 and the extension and retraction thereof are discussed in the subsequent sections of the present disclosure.

[0058] Referring to FIG. 2, the surgical stapler 100 further comprises the second knob 106, wherein the second knob 106 includes an extension 106A that extends into the interior space 102C. The surgical stapler 100 further comprises a threaded pusher 118 coupled to the extension 106A and extending into interior space 102C of the body 102 to a location near the distal end 102A. The rotation of the second knob 106 facilitates the linear movement of the threaded pusher 118, which in turn facilitates the firing of the staples and the actuation of the knife sequentially. The details of the sequential firing of the staples and the actuation of the knife via the rotation of the second knob 106 is discussed in more detail in the subsequent sections of the present disclosure.

[0059] Referring to FIG. 2, the surgical stapler 100 further comprises a firing safety assembly 120, wherein the firing safety assembly 120 includes a firing safety tab 120A configured on the second knob 106 within the body 102. The firing safety assembly 120 further comprises a firing safety link 120B disposed adjacent the extension 106A within the body 102. The firing safety link 120B is configured to abut the firing safety tab 120A, wherein the firing safety link 120B abuts the firing safety tab 120A on being displaced in the body 102 towards the proximal end 102B of the body. The displacement of the firing safety link 120B is facilitated by a guide pin 122 extending from the adjustable shuttle 114.

[0060] FIG. 3A through FIG. 3C illustrate sectional views of the circular surgical stapler 100 along section line A-A of FIG. 1C depicting the operation of actuation of the circular surgical stapler 100, in accordance with embodiments of the present subject matter. Referring to FIG. 3A, the first knob 104 is at its original rest position, i.e., the first knob 104 is at its initial position where it is yet to be rotated by a surgeon. In this position, the guide pin 122 is spaced apart from the firing safety link 120B. As such, the firing safety link 120B is also in an at-rest position where it does not apply any kind of force onto the firing safety tab 120A, and therefore, the firing safety tab 120A keeps the second knob 106 locked, thereby preventing any accidental actuation of the staple and knife assembly 110.

[0061] Reference is now directed to FIG. 3B. As seen in FIG. 3B, the guide pin 122 is displaced and is contacting the firing safety link 120B. More specifically, the guide pin 122 urges the firing safety link 120B against the firing safety tab 120A, which then allows the rotation of the second knob 106. The movement of the guide pin 122 is facilitated by the rotation of the first knob 104. More specifically, the variable threaded tube 112 is coupled to the first knob 104 such that the rotation of the first knob 104 facilitates the rotation of the variable threaded tube 112. In accordance with one embodiment of the present subject matter, the aforementioned rotatable coupling between the first knob 104 and the variable threaded tube 112 may be facilitated via a snap fit element 124 disposed operatively between the first knob 104 and the variable threaded tube 112 in a manner that the snap fit element 124 is pressed against the variable threaded tube 112 by an auto open button 126 configured on the first knob 104. More specifically, the first knob 104 includes the auto open button 126 and the snap fit element 124 placed between itself and the variable threaded tube 112.

[0062] The variable threaded tube 112 defines a variable thread 112A along an inner surface thereof. The adjustable shuttle 114 is configured for insertion and movement along a longitudinal axis of the variable threaded tube 112, wherein the adjustable shuttle 114 is coupled to the variable threaded tube 112 via a pin 114A configured to engage with the variable thread 112A to facilitate the linear movement of the adjustable shuttle 114 within the variable threaded tube 112. More specifically, the pin 114A is in engagement with the variable thread 112A, and when the first knob 104 is rotated, the variable threaded tube 112 rotates as well. The rotation of the variable threaded tube 112 causes the pin 114A to follow the variable thread 112A in accordance with the direction of rotation of the first knob 104. In one embodiment, the clockwise rotation of the first knob 104 may facilitate the movement of the adjustable shuttle 114 towards the distal end of the body for facilitating the extension of the anvil and trocar assembly from the distal end of the body. Similarly, the counterclockwise rotation of the first knob 104 may facilitate the retraction of the anvil and trocar assembly. The closure rod 116 extends from the adjustable shuttle 114 up to the distal end of the body for facilitating the extension or retraction of the anvil and trocar assembly in accordance with the rotation of the first knob 104.

[0063] Referring to FIG. 3B, while the guide pin 122 urges the firing safety link 120B to depress the firing safety tab 120A, the surgeon can now rotate the second knob 106 as the firing safety tab 120A is depressed and can no longer lock the rotational movement of the second knob 106. As the surgeon rotates the second knob 106, the extension 106A of the second knob 106 also rotates. The rotation of the extension 106A facilitates the linear movement of the threaded pusher 118 that is coupled to the extension 106A. More specifically, the threaded pusher 118 includes threads 118A that are configured to be in engagement with a threaded pusher pin 106B configured on the extension 106A. As the second knob 106 is rotated, the extension 106A and the threaded pusher pin 106B rotate in accordance with the direction of rotation of the second knob 106. In accordance with one embodiment, the second knob 106 and the threaded pusher 118 may be configured such that a clockwise rotation of the second knob 106 facilitates the linear movement of the threaded pusher 118 towards the distal end of the body, thereby facilitating the actuation of the staple and knife assembly.

[0064] Referring to FIG. 3C, the operation of the auto open button is depicted. The operation of the auto open button is explained in the subsequent sections of the present disclosure.

[0065] FIG. 4A through FIG. 4H illustrate sectional views of the circular surgical stapler 100 along section lines B-B and D-D depicting the operation of anvil and trocar assembly of the circular surgical stapler 100, in accordance with embodiments of the present subject matter. Referring to FIG. 4A, the anvil and trocar assembly 108, in accordance with an embodiment of the present subject matter, comprises a trocar 128 coupled to the closure rod 116, wherein rotation of the first knob 104 facilitates rotation of the variable threaded tube 112, which in turn facilitates linear movement of the adjustable shuttle 114 and the closure rod 116 to facilitate extension and retraction of the trocar at the distal end 102A of the body 102. In one embodiment, the anvil is configured for snap fitment onto the trocar. As seen in FIG. 4B, the snap fitment between trocar 128 and anvil 130 is facilitated via a clip 132 configured in a hollow extension 130A of anvil 130.

[0066] Referring back to FIG. 4A and FIG. 4B, the staple and knife assembly 110, in accordance with an embodiment of the present subject matter, comprises a knife pusher driver 134 disposed within the body 102 adjacent the distal end 102A and coupled to the threaded pusher 118. More specifically, the knife pusher driver 134 is configured to move linearly within the body in accordance with the movement of the threaded pusher 118. The staple and knife assembly 110 further comprises a staple driver 136 disposed adjacent the knife pusher driver 134 within the body 102, wherein the knife pusher driver 134 and the staple driver 136 are configured to facilitate firing of staples 138 by the staple driver 136 and actuation of a knife 140 by the knife pusher driver sequentially. More specifically, the staples 138 are configured in a more advanced position relative to the knife 140, and the knife pusher driver 134 that is pushed by the threaded pusher 118 in turn pushes the staple driver 136, thereby facilitating the firing of staples 138. Subsequent to the firing of staples 138, the knife pusher driver 134 facilitates the actuation of the knife 140.

[0067] Referring to FIG. 4C, the operational view of the stapler 100 at the distal end of the body 102, is illustrated. In operation, the anvil 130 is removed from the trocar 128. The anvil 130 and the trocar 128 have the tissues T that need to be joined purse stringed thereto.

[0068] Referring to FIG. 4D, trocar 128 and the anvil 130 are assembled together, wherein the clip 132 configured within the hollow extension 130A of the anvil 130 facilitates a snap fitment between the trocar 128 and the anvil 130.

[0069] Referring to FIG. 4E, the anvil 130 and the trocar 128 are retracted. In accordance with an embodiment of the present subject matter, the extension and retraction of the anvil 130 and the trocar 128 are affected via the rotation of the first knob. More specifically, the rotation of the first knob facilitates the rotation of the variable threaded tube, and the rotation of the variable threaded tube facilitates the linear movement of the adjustable shuttle and the closure rod, thereby causing the extension or retraction of the trocar 128. In accordance with one embodiment of the present subject matter, the clockwise rotation of the first knob facilitates retraction of the trocar 128, and the counterclockwise rotation of the first knob facilitates extension of the trocar 128. In this position, the tissues T are held securely under compression between the anvil 130 and the distal end 102A of the body.

[0070] Referring to FIG. 4F, the second knob is rotated clockwise direction for facilitate the linear movement of the driver pusher driver 134, which in turn facilitates the linear movement of the staple driver 136 towards the distal end for facilitating the firing of the staples 138. The clockwise rotation of the second knob facilitates the linear movement of the threaded pusher 118 towards the distal end, thereby pushing the knife pusher driver 134 and the staple driver 136 to facilitate the firing of the staples 138.

[0071] Referring to FIG. 4G, the second knob is rotated even more to facilitate the splaying of the tabs 136A of the staple driver 136 to facilitate easy movement of the knife pusher driver 134 by passing the staple driver 136, thereby pushing the knife 140 towards the tissues T that are held between the anvil 130 and the distal end 102A. At this stage, the stapling of the tissues T has already taken place in the previous step, and the knife 140 facilitates the cutting of the trapped tissue to obtain tissue doughnuts that are required to be inspected by the surgeon subsequent in whole operation. In one embodiment, an alert is provided to the surgeon once the stapling and cutting operations are completed via the stapler 100. In some embodiments, sensors may be used to sense the completion of the operation, and an alert in the form of an audio signal (e.g., a beep) or a visual signal (e.g., a light signal via an LED) may be provided to the surgeon. In some other embodiments a click sound is heard once the knife 140 contacts the anvil 130

[0072] Referring to FIG. 3C and FIG. 4H, the auto open button 126 is pressed subsequent to the completion of the stapling and tissue cutting operation. Once the auto open button 126 is pressed, the snap fit element 124 is spread apart, thereby releasing the variable threaded tube 112 from the being engaged to the first knob 104. A first biasing element 142, disposed between the first knob 104 and the variable threaded tube 112, urges the variable threaded tube 112 away from the first knob 104 subsequent to the disengagement of the variable threaded tube 112 with the first knob 104. Once the variable threaded tube 112 disengages with the first knob 104, the trocar 128 and the anvil 130 are also displaced beyond the distal end 102A a bit, thereby ensuring that the tissue doughnuts TD are entirely separated from the joined tissues subsequent to the completion of the stapling and tissue cutting operation of the stapler 100. As seen in FIG. 4H, the stapler is then removed out of the patient's body, and the anvil 130 is separated from the trocar 128 to obtain the tissue doughnuts TD for analysis by the surgeon.

[0073] A disadvantageous aspect of the conventional circular relates to opening and removing the device smoothly from the patient and knowing the position that is safe to open the device. The difficulty of removing a device after firing it or opening it to a position inadequate for safe removal can cause inadvertent tearing and undetected disruption of a portion of the staple line due to inability of the knife to cut completely through tissue and previous staple lines, and also due to the knife being retracted immediately after firing, and allowing the tissue to fall axially inward, causing it to snag on the edges of the cartridge and anvil. The present invention solves this problem by leaving the knife 140 distal until opened further following withdrawal from the patient, and then retracting the knife 140 sequentially thereafter, to prevent exposure to the clinicians during tissue doughnut inspection. Further, the present invention utilizes a hardened knife to effectively cut through prior staple lines, and an automatically opening anvil to ensure the device is adequately opened to remove it safely without disrupting the anastomotic staple line.

[0074] It is to be noted that the surgical stapler further comprises a second biasing element 144 disposed between the trocar 128 and the closure rod 116 for providing a biasing force against the downward movement of the trocar 128 to limit the compressive forces acting on the tissues T held between the anvil 130 and the distal end 102A to prevent any unwanted tissue injury.

[0075] FIG. 5A and FIG. 5B illustrate views of the anvil 130, in accordance with embodiments of the present subject matter. The anvil 130, in accordance with an embodiment of the subject matter, comprises a pair of grooves 130B for receiving staples therein subsequent to being fired for facilitating the stapling of required tissue. A knife abutment substrate 130C is radially configured on the anvil 130 spaced apart concentrically from the pair of grooves 130B. In accordance with one embodiment, the pair of grooves 130B are radially extending grooves. In accordance with a non-limiting embodiment of the present subject matter, the knife abutment substrate 130C is configured as a third groove. In another embodiment illustrated in FIG. 5C, the knife abutment substrate 130C is configured as a separate layer. In one embodiment, the knife abutment substrate 130C is made from a biocompatible material. In accordance with one embodiment of the present subject matter, the anvil is constructed of stainless steel or aluminum metal that is anodized, treated, oxidized, or otherwise tinted with colors that deviate from the natural machined metal-colored finish. In another embodiment, the anvil is constructed of stainless steel or aluminum metal coated or impregnated with materials such as polytetrafluoroethylene (PTFE), stearate emulsions, or greases, which when interacting with the malleable metal staple, generate a coefficient of friction less than or equal to 0.5, whether static or sliding. In yet another embodiment, the anvil is constructed of polymer and then electro-plated or otherwise conformably coated or shielded with a layer of metal that is substantially hard enough to enable staples to form.

[0076] FIG. 6A through FIG. 6C illustrate views depicting the bending of staple 138 subsequent to the firing of circular surgical stapler 100, in accordance with embodiments of the present subject matter. The bending of the staples 138 via the pair of grooves 130B can be seen in FIG. 6A through FIG. 6C. An advantageous factor of the anvil 130 is that its design is not pocketed, which is the case with the conventional anvils. The anvil 130 has grooves 130B instead of pockets for receiving the staples 138 therewithin. Such a design gives a lot of flexibility to the applicability of the anvil. More specifically, the design of the anvil 130 need not be changed according to the number of staples 138. Furthermore, the concept of configuring grooves 130B on the anvil 130 is not only limited to the circular staplers, and can be implemented on many the other kinds of surgical staplers which are not circular but may have, for example, a straight profile.

[0077] FIG. 7A illustrates another perspective view depicting the anvil 130 along with the arrangement of the staples 138 along the periphery of the distal end 102A. FIG. 7B illustrates a perspective view of a staple cartridge 138A used in the stapler 100, in accordance with an embodiment of the present subject matter. FIG. 7C illustrates a perspective view of a staple 138, in accordance with an embodiment of the present subject matter. One aspect of the staple 138 is that legs 138B of the staple 138 have a pre-bent configuration. The pre-bent configuration of the legs 138B allow the legs 138B to deformed in a predictable controlled manner when the stapler 100 is fired. The pre-bend assures the staples 138 will predictably form, without the need for pockets containing ramped angles for the tips to slide on. With proper anvil lubrication, the pre-bent leg 138B is fully sufficient to ensure the staple bends reliably every time. In accordance with one embodiment, the staples are plated, coated or impregnated with at least one material selected from a group consisting of polytetrafluoroethylene (PTFE), stearate emulsions, and greases, wherein when the at least one material interacting with the malleable metal staple, generates a coefficient of friction less than or equal to 0.5, whether static or sliding.

[0078] It is to be noted that one disadvantageous aspect of the conventional circular staplers is the difficulty of firing the device due to the high force to squeeze the firing lever to form the staples, and cut the knife backing washer and tissue. To this end, an improved actuation mechanism including the first knob 104, the second knob 106, and the associated components have been described herein. The actuation mechanism uses a combination of improvements including the use of a high mechanical advantage firing system comprising a drive screw, low coefficient of friction components, and pre-bent staples with smaller wire diameters, all combined. More specifically, the use of knobs instead of levers makes it very convenient to fire the staples. Furthermore, the unique pre-bent profile of the staple 138 described herein, in combination with first and second knobs 104, 106, and the use of low coefficient of friction components or adequately lubricated components provides an ease of usage not found in the conventional circular staplers having an actuation lever.

[0079] Another advantageous aspect of the stapler 100 is the simple configuration of the stapler. More specifically, the design of the stapler 100, in accordance with the present subject matter, includes very few components as compared to the designs of the conventional circular staplers, which is achieved by replacing the firing lever with a high mechanical advantage rotary firing mechanism and by combining multiple components into fewer components where sensible and were possible to accomplish this without sacrificing function. The reduced number of components also have an added advantage in terms being economical for manufacturing. It is important to note that the present invention is not limited to circular staplers, but can be included in various surgical staplers, e.g. linear or curved staplers, both open and laparoscopic, and whether or not they contain a cutter to subsequently transect tissue following the stapling. The reduced number of components also has an added advantage of ensuring that the surgical stapler 100 has a simple operation. Furthermore, the presence of a single rotary actuator for stapling, tissue cutting, as well as retraction of the trocar makes the stapler 100 intuitive and easy to use, while reducing the time required by the practitioner to familiarize himself with the stapler 100.

[0080] Yet another advantageous aspect of the stapler 100, in accordance with an embodiment of the present subject matter, is its sequential operation. Sequential operation refers to the feature of the stapler 100 in which the knife of the stapler is actuated only after the staples have been fired to join the required tissues. This means that knife of the stapler 100 is actuated only after the tissues that are required to be joined are stapled together. Such a feature eliminates the possibility of accidentally cutting the tissues that are required to be joined before they are stapled together.

[0081] Another advantageous aspect of the stapler 100, in accordance with the present subject matter, is that incomplete firing of the staples is eliminated due to the sequential firing of the staples as well as the simple and easy to use design of the stapler 100. Therefore, the conditions occurring from such incomplete firing such as poor hemostasis, leaky anastomosis, patient harm or death, are substantially prevented using the stapler 100, in accordance with an embodiment of the present subject matter.

[0082] A typical problem with the conventional staplers is that the clinicians don't open the device consistently to the same level prior to removal, which may result in the disruption of the anastomosis upon device removal and may cause immense harm or even death to the patient. The stapler 100, in accordance with an embodiment of the present subject matter, includes a specifically designed release mechanism that includes the auto-open button 126 and other components associated thereto to ensure fast, easy, and uniform opening of the stapler 100 prior to the removal of the stapler 100 from the patient's body.

[0083] FIG. 8A illustrates a perspective view of a conventional linear surgical stapler 800 having a linear anvil 802 installed thereon, in accordance with an embodiment of the present subject matter. FIG. 8B and FIG. 8C illustrate different views of the linear anvil 802, in accordance with an embodiment of the present subject matter. Referring to FIG. 8A through FIG. 8C, the linear anvil 802 may be configured on usage of any kind of linear surgical stapler, and the linear surgical stapler 800 is only one example of the surgical stapler on which the linear anvil 802 may be installed. The linear anvil 802 includes a plurality of staple grooves 804 configured thereon. The plurality of staple grooves 804 may be arranged in the form of two different sets of grooves that may be configured adjacent to one another depending upon the surgical requirements.

[0084] FIG. 9A illustrates a perspective view of a conventional curved surgical stapler 900 having a curved anvil 902 installed thereon, in accordance with an embodiment of the present subject matter. FIG. 9B and FIG. 9C illustrate different views of the curved anvil 902, in accordance with an embodiment of the present subject matter. Referring to FIG. 9A through FIG. 9C, the curved anvil 902 may be configured on usage of any kind of curved surgical stapler, and the curved surgical stapler 900 is only one example of the surgical stapler on which the curved anvil 902 may be installed. The curved anvil 902 includes a plurality of staple grooves 904 configured thereon. The plurality of staple grooves 904 may be arranged in the form of two different sets of grooves that may be configured adjacent to one another depending upon the surgical requirements. It is to be noted that the number of unformed (U-shaped) staples that can be stapled using the anvil of any of the aforementioned shapes per linear centimeter of groove length, in accordance with an embodiment of the present subject matter, is two or more

[0085] It is to be noted that configuration of the anvil having plurality of staple forming grooves is a novel feature of the anvil that simplifies the process of design as well as manufacturing the anvil, regardless of the shape of the anvil. The anvil may be circular, linear, or curved or arcuate. More specifically, the provision of the staple forming grooves eliminates the need of anvil having staple forming pockets. An advantageous aspect of the staple forming grooves over staple forming pockets is that the staple forming grooves even if the staples do get misaligned with respect to the staple forming grooves due to some reason, the staples will still deform as required subsequent to the firing. More specifically, in conventional surgical staplers, misalignment of the staple forming pockets with respect to the incoming staples may have disastrous implications, which are completely eliminated by the configuration of the staple forming grooves in the anvil, in accordance with the embodiments of the present subject matter.

[0086] In various embodiments, the anvil and trocar may be fabricated from, for example, 300 & 400 Series, 17-4 & 17-7 stainless steel, aluminum, or titanium.

[0087] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0088] Preferably, the invention described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK (DuPont de Nemours, Inc., Wilmington, Del.) bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility.

[0089] The foregoing description of the specific embodiments have been described herein above that a person having ordinary skill in the art can apply the current knowledge, readily modify, or adapt for various applications such specific embodiments without departing from the generic concept. All such adaptations and modifications are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments.

[0090] Further, it is to be understood that the terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, a person having ordinary skill in the art will readily recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

[0091] While the disclosure has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the disclosure. In addition, many modifications may be made to adapt a particular system, device or component thereof to the teachings of the disclosure without departing from the essential scope thereof. Therefore, it is intended that the disclosure is not limited to the particular embodiments disclosed for carrying out this disclosure, but that the disclosure will include all embodiments falling within the scope of the appended claims. Moreover, the use of the terms first, second, etc. do not denote any order or importance, but rather the terms first, second, etc. are used to distinguish one element from another.

[0092] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.

[0093] The description of the present disclosure has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosure in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope of the disclosure. The described embodiments were chosen and described in order to best explain the principles of the disclosure and the practical application, and to enable others of ordinary skill in the art to understand the disclosure for various embodiments with various modifications as are suited to the particular use contemplated.