surgical stapler

Abstract

To provide a surgical stapler, a cartridge for the surgical stapler, a cutting mechanism for the surgical stapler, and a method for applying surgical staples into a body of a patient.SOLUTION: A stapler may have an anvil coupled to a support jaw movably between a clamped configuration and a closed configuration. A cartridge may be configured to fit within an envelope diameter and to removably house a plurality of B-form staples, at least one of the plurality of B-form staples having a base length and a leg length, the leg length being at least 53% of the envelope diameter. The cartridge may have slots shaped to house at least a second one of the plurality of staples at an angle oblique to the first one of the plurality of staples.SELECTED DRAWING: Figure 5

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 159,191, filed May 8, 2015, and entitled "Surgical Stapler," the entire disclosure of which is incorporated herein by reference for all appropriate purposes. A surgical stapler is a medical device used to place surgical staples inside a patient's body to close wounds ranging from bowel resections to skin incisions and the like. [Background technology]

[0002] The staples to be applied to tissue must be selected based on the thickness of the tissue to be stapled. Generally, larger staples require the use of a similarly larger surgical stapler. For example, one 5 mm stapler sold under the trademark JustRight® has a nominal shaft diameter of approximately 5 mm and is currently labeled to apply staples with a nominal leg length of approximately 2 mm. In other words, the 5 mm JustRight® surgical stapler is labeled for use in procedures in which tissue can be clamped between the jaws of the stapler to a depth of approximately 1 mm or less. JustRight® is a trademark owned by the assignee of the present application.

[0003] Cardica® MicroCutter Xchange R Some currently available staplers, such as those sold under the trademark 30, do not use staples defined by leg length, but these staplers are similarly limited in that if the tissue cannot be clamped to a certain thickness, the stapler will not staple the tissue. If a physician needs to clamp tissue to, for example, 2 mm, the physician needs to use a stapler that is approximately 12 mm in diameter.

[0004] Some manufacturers have attempted to provide relatively small staplers capable of stapling relatively thick tissue, such as the Cardica® stapler mentioned above. However, these staplers use what are known as D-shaped staples, shown in Figures 35A-35B, instead of the more common B-shaped staples shown in Figures 35C-35D. The D-shaped staples have relatively thick legs, one of which lacks a specific shape for penetration, and have not been subject to widespread field use. The inventors believe that for a given tissue thickness, D-shaped staples introduce more trauma to the patient than B-shaped staples. Summary of the Invention [Problem to be solved by the invention]

[0005] While it is often acceptable to use a large stapler to place large staples, in certain medical procedures, such as procedures performed on small or fragile patients, such as small children or patients with physical or medical trauma, it may be preferable to use a smaller shaft surgical device to staple thicker tissue with B-type staples.

[0006] Furthermore, it is known that even if a physician clamps onto tissue that is too large for a given staple leg length or indicated use, currently available staplers can still fire the staples and improperly cut the tissue. That is, currently available staplers can fire the staples and then cut the tissue, leaving the site open. Therefore, it would be desirable to provide a stapler that does not leave the site open or unsealed if the staples are not properly placed.

[0007] It may also be desirable to provide the physician with the ability to create a wider cuff (i.e., a larger tissue allowance between the staple and the transection line) for a given clamped tissue thickness that is possible with currently available surgical devices.

[0008] Therefore, there is a need for a smaller surgical stapler that can staple thicker tissue using B-shaped staples and / or that can provide wider sleeves with less impact on the patient, as well as other new and innovative features. [Means for solving the problem]

[0009] The present disclosure relates generally to surgical instruments and, more particularly, to intracorporeal surgical staplers and / or methods for placing surgical staples within a patient's body.

[0010] In some embodiments, a cartridge for a surgical stapler is provided. The exemplary cartridge has an elongated body configured to fit within an envelope diameter and to removably house a plurality of B-shaped staples. At least one staple of the plurality of B-shaped staples has a base length and a leg length, the leg length being at least 53% of the envelope diameter. The exemplary cartridge also has a tissue clamping interface, a first slot configured to receive a translating cutting mechanism, and a second slot configured to house at least a first staple of the plurality of staples. The exemplary cartridge also has a third slot configured to house at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples.

[0011] In some embodiments, a surgical stapler is provided. The exemplary surgical stapler includes an anvil coupled to a support jaw for movement between a clamped configuration and a closed configuration in which a tissue clamping interface on the anvil abuts a tissue clamping interface on a cartridge. The exemplary support jaw includes a cartridge having an elongated body configured to removably receive a plurality of B-shaped staples, at least one of the plurality of B-shaped staples having a base length and a leg length. The exemplary cartridge further includes a first slot configured to receive a translating cutting mechanism, a second slot configured to receive at least a first staple of the plurality of staples, and a third slot configured to receive at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples. The anvil and the support jaws comprising the cartridge are configured to fit within an envelope diameter when in the closed configuration. The leg length of the at least one staple of the plurality of B-shaped staples, in some embodiments, is at least 53% of the envelope diameter.

[0012] In certain embodiments, a method of placing surgical staples within a patient is provided. An exemplary method includes deploying a surgical stapler in a closed configuration, the stapler including an anvil coupled to a support jaw for movement between a clamping configuration and a closed configuration in which a tissue clamping interface on the anvil abuts a tissue clamping interface on the cartridge. The exemplary support jaw includes a cartridge configured to removably receive a plurality of B-shaped staples, at least one of the plurality of B-shaped staples having a base length and a leg length. The exemplary cartridge includes a first slot configured to receive a translating cutting mechanism, a second slot configured to receive at least a first staple of the plurality of staples, and a third slot configured to receive at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples. An exemplary anvil and the support jaws including the cartridge are shaped to fit within the envelope diameter when in the closed configuration. The leg length of at least one of the plurality of B-shaped staples is at least 53% of the envelope diameter. An exemplary method also includes passing at least a portion of the stapler through the envelope diameter in the closed configuration and positioning tissue between the anvil and the support jaws. An exemplary method also includes moving the anvil to the clamping configuration in which the anvil and the support jaws clamp the tissue. An exemplary method also includes forming a plurality of staples around the tissue with the stapler.

[0013] In some embodiments, a surgical stapler is provided. An exemplary stapler includes a translating cutting mechanism having a first member with a cutting portion and a second member. The exemplary cutting mechanism is movable between a collapsed configuration in which the cutting mechanism is shaped to fit within the envelope diameter and an expanded configuration in which the cutting mechanism does not fit within the envelope diameter. [Brief explanation of the drawings]

[0014] [Figure 1A] FIG. 1 is a perspective view of a surgical stapler coupled to an actuator. [Figure 1B] FIG. 1B is a perspective view of the surgical stapler in FIG. 1A. [Figure 2] FIG. 1C is an exploded perspective view of the surgical stapler in FIG. 1B. [Figure 3] FIG. 1C is a perspective view of a cartridge of the stapler in FIG. 1B. [Figure 4] FIG. 4 is a cross-sectional view of the cartridge in FIG. 3. [Figure 5] 4 is another cross-sectional view of the cartridge in FIG. 3. FIG. [Figure 6] FIG. 4 is a plan view of the cartridge in FIG. 3. [Figure 7] FIG. 4 is a rotated plan view of the cartridge in FIG. 3. [Figure 8] FIG. 1C is a perspective view of the anvil of the stapler of FIG. 1B. [Figure 9] FIG. 9 is a plan view of the anvil in FIG. 8. [Figure 10] FIG. 9 is a bottom view of the anvil in FIG. 8. [Figure 11] FIG. 9 is a rear view of the anvil in FIG. 8. [Figure 12] FIG. 9 is a perspective view of a specific structure in the anvil in FIG. 8. [Figure 13] FIG. 9 is a perspective view of a specific structure in the anvil in FIG. 8. [Figure 14]FIG. 1C is a cross-sectional view of a cartridge and anvil suitable for the stapler of FIG. 1B. [Figure 15] FIG. 1C is a side view of a specific structure of the stapler in FIG. 1B. [Figure 16] FIG. 1C is a side view of a specific structure of the stapler in FIG. 1B. [Figure 17] FIG. 1C is a side view of a specific structure of the stapler in FIG. 1B. [Figure 18] FIG. 1C is a perspective view of a cutting mechanism in the stapler in FIG. 1B. [Figure 19] FIG. 1C is a perspective view of a cutting mechanism in the stapler in FIG. 1B. [Figure 20A] FIG. 1C is a perspective view of the stapler in FIG. 1B. [Figure 20B] FIG. 1C is a perspective view of the stapler in FIG. 1B. [Figure 20C] FIG. 1C is a perspective view of the stapler in FIG. 1B. [Figure 21] 1 is a cross-sectional view of a clamp suitable for a stapler. [Figure 22] FIG. 1C is a perspective view of a staple pusher in the stapler of FIG. 1B. [Figure 23] FIG. 23 is a first side view of the staple pusher of FIG. 22; [Figure 24] FIG. 23 is a second side view of the staple pusher of FIG. 22. [Figure 25] FIG. 1C is a perspective view of the lower anvil positioner of the stapler of FIG. 1B. [Figure 26] FIG. 1C is a perspective view of some components of the stapler in FIG. 1B. [Figure 27] FIG. 2 is a side cross-sectional view of some components of the stapler. [Figure 28] FIG. 1 is a perspective view of an integrated housing. [Figure 29] FIG. 10 is a cross-sectional view of a cartridge, staple pusher, and staples. [Figure 30] FIG. 30 is a detailed view of the components in FIG. 29. [Figure 31]FIG. 10 is a cross-sectional view of a cartridge, staple pusher, and staples. [Figure 32] FIG. 32 is a detailed view of the components in FIG. 31. [Figure 33] FIG. 10 is a cross-sectional view of the clamp and other components. [Figure 34] FIG. 1 is a cross-sectional perspective view of a clamp and other components. [Figure 35A] FIG. 1 is a side view of a surgical D-shaped staple prior to deployment. [Figure 35B] FIG. 35B is a side view of the D-shaped staple of FIG. 35A in a laid-down configuration. [Figure 35C] FIG. 1 is a side view of a surgical B-shaped staple prior to deployment. [Figure 35D] FIG. 35D is a side view of the B-shaped staple of FIG. 35C in a laid-down configuration. [Figure 36] 1 is a flowchart of an exemplary method. DETAILED DESCRIPTION OF THE INVENTION

[0015] To satisfy the foregoing needs and / or provide other new and useful features, a surgical stapler and method may be provided, and this paragraph is intended as a conceptual overview to provide the reader with a better understanding of the detailed description that follows. In some instances, a surgical stapler is provided that has a relatively small size and is configured to place relatively large staples within a patient. This may be achieved by housing the staples at an oblique angle relative to each other or a common reference point, such as a longitudinal axis or a line of transection. That is, instead of housing the staples parallel to each other (and / or perpendicular to a flat tissue clamping interface), as is known in the art, the inventors provide a system in which, in some instances, the staples are housed at a non-zero angle relative to each other or a common reference point and oriented to staple tissue clamped between a curved jaw / cartridge and a curved anvil. This configuration gives the physician the previously unavailable option of using a relatively small stapler to place relatively large staples. In other words, this configuration gives the physician the previously unavailable option of using a 5 mm stapler (nominal) to staple tissue with a device gap of greater than 1.0 mm.

[0016] For purposes of this specification, the term "nominal" refers to a range of dimensions common in the medical device and / or surgical stapler industry, regardless of which range is larger at the time of invention or at the time of manufacture. For example, currently available 5 mm staplers (nominal) are known to vary from 5.0 to 6.0 mm, or 5.5 ± 0.5 mm, depending on the manufacturer. As another example, cannulas having a 5.5 mm nominal inner diameter are known to have actual inner diameters of at least 5.59 mm as of this writing, but may be larger at the time of manufacture. Staples having a 3.5 mm nominal leg length are known to have actual leg lengths that vary by approximately ± 0.08 mm as of this writing. Furthermore, for purposes of this specification, all absolute terms, such as flat, parallel, orthogonal, circular, etc., as well as all dimensions, are understood to encompass the limitation "within reasonable manufacturing tolerances at the time of invention or at the time of manufacture, regardless of which range is larger." For purposes of this specification, the term "proximal" shall refer to the portion or region of the device located closer to the intended user, such as a physician, and the term "distal" shall refer to the end or region away from the user or physician.

[0017] Turning now to FIG. 1 , a representative endosurgical stapler 100 is shown passing through a cannula 400 and coupled to a stapler actuator 800 in a known manner. The cannula 400 may have a nominal inner diameter of 5.0 mm or 5.5 mm, which may be 6.0 mm or less with manufacturing tolerances known in the art. Those skilled in the art will appreciate that the cannula 400 is placed within a patient's body to provide a port through which a physician can access the patient's body using the stapler 100. The stapler 100 may have an anvil 102 configured to open or close against a support jaw 103. The support jaw 103 may include a cartridge housing 104 that houses a cartridge 106. In some embodiments, the housing 104 and cartridge 106 may be a unitary structure referred to as the support jaw 103. The anvil 102 and support jaw 103 may be coupled to or operated at the proximal region by a shaft 116 that houses an actuator and / or other control mechanism in a manner substantially known in the art.

[0018] An upper anvil positioner 110 and a lower anvil positioner 112 may be provided to actuate the anvil 102. The anvil positioners 110, 112 may operate to move the anvil 102 between open, clamped, and closed positions in a coordinated manner and are described in more detail in subsequent paragraphs herein (see, e.g., FIGS. 15-17).

[0019] Continuing with FIG. 1, a cutting mechanism 108 is disposed and movable toward the distal end of stapler 100 to cut the stapled tissue held between anvil 102 and support jaw 103 in a manner to be described in more detail in subsequent paragraphs.

[0020] 1 can be manufactured from any type of suitable material, and more particularly, the material should be selected with appropriate strength to withstand the forces required to clamp and staple relatively large swaths of tissue using relatively small specific structures. For example, and without limitation, any type of engineered material can be selected, such as high-strength surgical steel, ceramics, and / or polymers.

[0021] In some embodiments, surgical stapler 100 can have housing 104, a portion of which has an envelope diameter of approximately 5.5 millimeters or is configured to pass through a 5.5 mm cannula 400.

[0022] In some embodiments, a 5.5 mm nominal housing 104 can house or carry staples having a nominal leg length of 3.0 mm in the manner previously described herein. In some embodiments, the staples have a nominal leg length of 4.8 mm. In some embodiments, the staples have a nominal leg length of 2.0 mm. In some embodiments, the staples have a nominal leg length of 2.5 mm.

[0023] 2, further details of stapler 100 in FIG. 1 are shown in an exploded perspective view. As can be seen, cartridge 106 can be configured to accommodate one or more staple pushers 132 (not shown in FIG. 2) that, upon actuation by one or more cams 128, 130, can guide one or more staples outward from cartridge 106 and toward anvil 102 so that the staples are formed around tissue clamped between anvil 102 and cartridge 106 / support jaw 103.

[0024] Cams 128, 130 may be actuated in a manner known to those skilled in the art. That is, in some embodiments, standard staple pusher and stapler drive concepts currently available are used. In some embodiments, an extended cam and a reduced-size staple pusher may be provided. An extended cam is a cam that is taller than traditionally used with a comparable sized surgical stapler. Thus, the extended cam is taller to drive relatively large staples, such as staples having leg lengths of 3.0 mm or greater, while the staple pusher size is reduced, such that the staple leg length is greater than the pusher height, as shown in FIG. 5. Those skilled in the art will understand that when staple 150 or staple pusher 132 are housed at an oblique angle θ relative to each other or to the line of transection, cams 128, 130 are at a similarly defined angle.

[0025] 2, the cutting mechanism 108 can have a first member 118 and a second member 120 that are movable or spreadable relative to one another and configured to move from a proximal region of the stapler 100 toward a distal region of the stapler 100 to cut tissue clamped by the stapler 100. The first member 118 of the cutting mechanism 108 can be actuated, controlled, and / or retracted by a first actuator 122, and the second member 120 of the cutting mechanism 108 can be actuated, controlled, and / or retracted by a second actuator 124.

[0026] The upper anvil positioner 110 can be actuated using an upper anvil actuator 126, and the lower anvil positioner 112 can be actuated using a lower anvil actuator (not shown). The lower anvil positioner 112 can have one or more flanges 112 a, 112 b configured to engage multiple surfaces of the anvil 102 to cooperate with the upper anvil positioner 110 to open, clamp, or close the anvil 102.

[0027] A spring 113 may be provided to bias and maintain the anvil 102 in a closed position even if the physician inverts and rotates the stapler 100. That is, the spring 113 may prevent the anvil 102 from opening prior to intentional activation, and may do so in a manner substantially known in the art.

[0028] Referring now to FIG. 3, cartridge 106 has an elongate body 134 having a distal end 136 and a proximal end 138. Cartridge 106 can be configured to removably house a plurality of staples (not shown in FIG. 3). A first slot 140 can be provided and shaped to receive a cutting mechanism (such as cutting mechanism 108 in FIG. 2) and / or to connect or receive a clamping or translating mechanism. Referring briefly to FIGS. 1B and 21, the clamping mechanism can include a first member 118 or upper flange 506 configured to apply a fulcrum force to the anvil 102 as the clamping mechanism 502 is advanced distally. In some embodiments, clamping mechanism 502 is the cutting mechanism 108 or includes the cutting portion 206. A second slot 142 shaped to accommodate at least a first staple of the plurality of staples and a third slot 144 shaped to accommodate at least a second staple of the plurality of staples may also be provided.

[0029] As shown in FIG. 4, second and third slots 142, 144 can be shaped, configured, or positioned to receive a first staple at an oblique angle θ relative to the second slot or staple. In some embodiments, the angle θ between slot 142 and third slot 144 is between about 4° and about 30°. In some embodiments, the angle θ is between about 10° and about 20°. In some embodiments, the angle θ is between about 10° and about 15°. In some embodiments, the angle θ is between about 15° and about 20°. In some embodiments, the angle θ is about 15° plus or minus appropriate manufacturing tolerances. In some embodiments, the angle θ is between about 12° and about 18°.

[0030] 5, in some embodiments, second slot 142 is shaped to translatably receive at least first staple pusher 146, and third slot 144 is shaped to translatably receive at least second staple pusher 148. Second slot 142 and third slot 144 can be configured to limit translation of first staple pusher 146 at an oblique angle θ relative to the translation of second staple pusher 148.

[0031] 5, in some embodiments, staple pusher 146 can be configured to support first staple 150 and third staple 154, while second staple pusher 148 can be configured to support second staple 152 and fourth staple 156. First and third staples 150, 154 can be held substantially parallel to one another, while second and fourth staples 152, 156 can be held substantially parallel to one another. First and second staple pushers 146, 148 can be housed at an oblique angle θ relative to one another, and cartridge 106 can be configured to limit translational movement of staple pushers 146, 148 along relative paths that are oblique to one another.

[0032] The housing 104 or support jaw 103 can have an envelope diameter D of 5.6 mm or 5.5 mm and can house or carry staples having a nominal leg length of 3.0 mm. As shown in FIG. 5, in some embodiments, the housing 104 or support jaw 103 can house or carry a plurality of staples 150, 152, 154, 156 having a nominal leg length of 3.5 mm. The staples 150, 152, 154, 156 can be housed such that the first staple 150 and the second staple 152 are carried on opposing sides of a longitudinal axis defined by the slot 140 in the housing 104, cartridge 106, or support jaw 103, or the cutting mechanism 108, as shown in FIG. 5. The first and second staples 150, 152 can be angled relative to one another such that the legs of the first staple 150 and the legs of the second staple 152 form an angle θ with respect to one another. The angle θ can be an acute angle θ in some embodiments. In some embodiments, the angle θ can be from about 4° to about 30°. In some embodiments, the staples 150, 152 can be arranged mirror-image on either side of the longitudinal axis or slot 140 such that the first staple 150 can be rotated from a vertical orientation or from the slot 140 by about 2° to about 15°, and the second staple 152 can be rotated in the opposite direction from the vertical orientation or from the slot 140 by about 2° to about 15°. In some embodiments, the angle θ between the first staple 150 and the second staple 152 can be up to about 90°. The third staple 154 can be parallel to the first staple 150, and the fourth staple 156 can be parallel to the second staple 152. The third and fourth staples 154, 156 can be closer to the longitudinal axis than the first and second staples 150, 152.

[0033] It should be understood that surgical stapler 100 can carry or accommodate more than four staples. First and second staples (and third and fourth staples, if applicable) 150, 152, 154, 156 can be near the distal or working end of surgical stapler 100, while another group of staples can be further proximal to the user. Staples 150, 152, 154, 156 can include a plurality of B-shaped staples in an interleaved configuration to provide proper closure of tissue. That is, the staples can be configured such that some of the proximal and distal staples are adjacent to one another and some are not, with the distal legs of the proximal staples positioned distally of the proximal legs of the distal staples. Any suitable number of groups of staples can be deployed.

[0034] 5-7 simultaneously, in some embodiments, one or more of the staples 150, 152, 154, 156 are partially received or supported by corners or feature 166, 168, 170 in the second or third slots 142, 144. That is, the receiving areas 158, 160, 162, 164 in the staple pushers 146, 148 may partially support the staples 150, 152, 154, 156. In some embodiments, first staple pusher 146 can act in concert with wall 170 and receiving areas 166, 168 in elongated body 134 of cartridge 106 to substantially limit translation of first staple 150 when first staple 150 is pressed by a cam (such as cam 128 in FIG. 2) and first staple pusher (such as first staple pusher 146 in FIG. 5). In other words, in some embodiments, wall 170 and receiving areas 166, 168 in cartridge 106 can provide essential support or guidance for staples 150, 152, 154, 156.

[0035] It should be understood that when referring to staples 150, 152, 154, 156 as being limited to translational movement, some lateral or rotational play or movement is generally acceptable. Although only two staple pushers 146, 148 are described herein, one skilled in the art will understand that any number of staple pushers 146, 148 may be disposed generally along two paths, such as two slots 142, 144 on opposite sides of the slot 140 along which tissue is cut, to ensure that tissue is stapled together on both sides of the cut. The staple pushers 146, 148, slots 142, 144, and cartridge 106 can be configured to place the staples 150, 152, 154, 156 in two rows of interleaved staples 150, 152, 154, 156 to ensure that the stapled portion of tissue is properly clamped and stapled closed throughout the entire transection length.

[0036] Continuing to generally refer to Figures 3 through 7, cartridge 106 and / or stapler 100 can be configured to house or place staples 150, 152, 154, 156 within a patient's body, where at least one of staples 150, 152, 154, 156 has a leg length of 3.42 mm or greater, or a nominal leg length of 3.5 mm or greater, and anvil 102 and support jaw 103 are configured to pass through a cannula 400 having an inner diameter of 5.6 mm or less, or a nominal inner diameter of 5 mm or less. In some embodiments, at least one of staples 150, 152, 154, 156 has a nominal leg length of 4.8 mm or greater, or a leg length of 4.72 mm or greater, and anvil 102 and support jaw 103 are configured to pass through cannula 400 having a nominal inner diameter of 8 mm or less, or an inner diameter of 8.6 mm or less.

[0037] In some embodiments, stapler 100 is configured to pass through a cannula 400 having an inner diameter 402, and stapler 100 is configured to simultaneously carry at least first and second staples 150, 152 for placement within a patient, at least one of staples 150, 152 having a leg length L that is at least 53% of the inner diameter 402 of cannula 400 or at least 53% of the envelope diameter D of stapler 100 when the stapler is in a closed configuration (see, e.g., FIG. 1B ).

[0038] In some embodiments, the leg length L is at least 58% of the inner diameter 402 or envelope diameter D. In some embodiments, the leg length L is at least 60% of the inner diameter 402 or envelope diameter D of the cannula 400. In some embodiments, the leg length L is at least 61% of the inner diameter 402 or envelope diameter D of the cannula 400. For example, a staple 150 having a nominal leg length of 4.8 mm and a cannula 400 having a nominal inner diameter of 8.0 may have a ratio of 4.72 / 8.6 after accounting for manufacturing tolerances. For example, a staple 150 having a nominal leg length of 4.8 mm and a cannula 400 having a nominal inner diameter of 8.0 may have a ratio of 4.88 / 8.0 with less-than-ideal tolerance stackup.

[0039] In some embodiments, leg length L is up to 62% of the inner diameter, or envelope diameter, D, of cannula 400. In some embodiments, leg length L is up to 66% of the inner diameter, or envelope diameter, D, of cannula 400. For example, a staple 150 having a nominal leg length of 3.5 mm and a cannula 400 having a nominal diameter of 5 mm may have a ratio of 3.58 / 5.0, with less-than-ideal tolerance stackup. In some embodiments, leg length L is between 55% and 67% of inner diameter 402.

[0040] In some embodiments, stapler 100 is configured to (a) pass through cannula 400 having inner diameter 402, (b) place at least first and second staples 150, 152 within the patient, each having a first leg length L1 that is between 55% and 67% of inner diameter 402 of cannula 400, and (c) place at least third and fourth staples 154, 156 within the patient, each having a second leg length L2 that is different from the first leg length L1 of first and second staples 150, 152. In some embodiments, first leg length L1 is at least 57% of inner diameter 402. In some embodiments, the first leg length L1 is at least 58% of inner diameter 402. In some embodiments, the first leg length L1 is at least 61% of inner diameter 402.

[0041] In some embodiments, stapler 100 is configured to place a first staple 150 having a first leg length L1 and another staple 156 having a different leg length L2. In some embodiments, stapler 100 is configured to place a staple having a first leg length L1 on a first side of a tissue incision and a staple having a second leg length L2 on a second side of the tissue incision. In some embodiments, stapler 100 is configured to place a first staple having a first leg length L1 and a second staple having a second leg length L2 on the same side of a tissue incision.

[0042] In some embodiments, stapler 100 is configured with an outer envelope diameter D (see, e.g., FIG. 1B ) sized to pass through a cannula having an inner diameter 402 when stapler 100 is in a closed configuration with curved interfaces 202, 204 abutting one another (see, e.g., FIG. 15 ). Stapler 100 can be configured to clamp tissue positioned between anvil 102 and support jaw 103 to compress the tissue to a particular thickness and / or to confine tissue to a particular maximum thickness, referred to herein as device gap G, between anvil 102 and cartridge 106 (see, e.g., FIG. 14 ). Those skilled in the art will appreciate that surgical stapler 100 and associated staples are generally sized according to the intended thickness of the tissue to be stapled.

[0043] For purposes of this specification, device gap G is defined as the maximum spacing allowed between support jaw 103 or cartridge 106 and anvil 102 at the point when the device fires staples 150 into tissue.

[0044] In one example, stapler 100 may be configured or allowed to “float” toward contact between anvil 102 and support jaw 103 when positioned around very thin tissue, and then, as staples 150 are fired into tissue, stapler 100 may be configured to allow staples 150 to urge or press anvil 102 away from cartridge 106 to maximum device gap G. Maximum device gap G may be limited to a distance defined by translating cutting mechanism 108 (see, e.g., FIGS. 14, 20C ). Cutting mechanism 108 may move distally substantially simultaneously or nearly simultaneously with, or in coordination with, one or more cams 128, 130 to prevent stapler 100 from opening beyond maximum device gap G, such as when staples 150 are fired.

[0045] Relatedly, and as another example, stapler 100, when positioned around relatively thick tissue, can be configured to compress the tissue to the maximum device gap G as translating cutting mechanism 108 moves distally. For example, if stapler 100 is configured to clamp tissue at a device gap G of 2.0 mm, and the tissue positioned between stapler 100 is greater than 2.0 mm, stapler 100 and / or cutting mechanism 108 can adequately compress the tissue. Notably, if the tissue positioned between anvil 102 and support jaw 103 is so thick that it is not compressible to the appropriate device gap G, cutting mechanism 108 can be configured to cease or stop translation into the tissue that is not adequately clamped.

[0046] For example, the most currently available 5 mm (nominal) staplers are labeled to staple tissue that can be clamped to less than 1.0 mm, while Cardica's 5 mm staplers (nominal; actual size is greater than 5 mm, approximately 5.8 mm or greater) are labeled to staple tissue that can easily be clamped to 1.5 mm or less and use D-shaped staples. In both cases, if the physician intends to staple tissue with a greater thickness, a larger stapler must be used. Relatedly, currently available B-shaped staples with a nominal leg length of 3.5 mm are labeled to staple tissue that can be clamped to 1.5 mm to 2.0 mm. Currently available B-shaped staples with a nominal leg length of 4.8 mm are labeled to staple tissue that can be clamped to 2.0 mm.

[0047] In some embodiments, the envelope diameter D is about 5.5 mm or about 5.6 mm, and the device gap G is about 0.75 mm to about 1.0 mm. In some embodiments, the envelope diameter D is about 5.5 mm or about 5.6 mm, and the device gap G is about 1.0 mm to about 1.5 mm. In some embodiments, the envelope diameter D is about 5.5 mm or about 5.6 mm, and the device gap G is greater than about 1.5 mm to about 2.0 mm. In some embodiments, the envelope diameter D is about 8.5 mm or about 8.6 mm, and the device gap G is about 2.0 mm or greater.

[0048] In some embodiments, the device gap G is 13% or more of the envelope diameter D. In some embodiments, the device gap G is 17% or more of the envelope diameter D. In some embodiments, the device gap G is 20% or more of the envelope diameter D. In some embodiments, the device gap G is 22% or more of the envelope diameter D. In some embodiments, the device gap G is 26.8% or more of the envelope diameter D. In some embodiments, the device gap G is 27.3% or more of the envelope diameter D. In some embodiments, the device gap G is 37% or less of the envelope diameter D. In some embodiments, the device gap G is about 18% to about 37% of the envelope diameter D. In some embodiments, the device gap G is about 22% to about 37% of the envelope diameter D. In some embodiments, the device gap G is about 26.8% to about 35.7% of the envelope diameter D. In some embodiments, the device gap G is between 27.3% and about 36.4% of the envelope diameter D.

[0049] In some embodiments, the stapler 100 is modular, as shown in FIG. 2 or FIG. 6 . That is, one or more interchangeable cartridge kits 105 can be provided. For example, a first cartridge kit 105 having a cartridge 106, one or more staple pushers 132, and one or more staples (not shown) having a first leg length can be interchangeable with a second cartridge kit 105 having a cartridge 106, one or more staple pushers 132, and one or more staples (not shown) having a second leg length different from the first leg length. In some embodiments, the cartridge kit 105 is removable from the housing 104 or the support jaw 103. In some embodiments, the housing 104, the support jaw 103, and / or the cartridge 106 are provided with alignment features to ensure proper alignment. In some embodiments, the cartridge kit 105 is removable from the support jaw 103 without the use of tools. In some embodiments, locking features may be provided within cartridge kit 105 to prevent removal without the use of a tool. In some embodiments, cartridge kit 105, housing 104, anvil 102, cutting mechanism 108, upper and / or lower anvil positioners 110, 112, and shaft 116 are removable as a unit from stapler actuator 800.

[0050] 8-11, as shown in FIG. 1, stapler 100 can have an anvil 102. Anvil 102 can be shaped or configured to be movable relative to support jaw 103, for example, by a linkage mechanism 172. Linkage mechanism 172 can include one or more recesses or passages 174 in one of anvil 102 or support jaw 103 (or housing 104 in support jaw 103) configured to engage one or more corresponding protrusions 176 (see FIG. 2) in the other of anvil 102 or support jaw 103 (or housing 104 in support jaw 103). Linkage mechanism 172 can be configured to limit anvil 102 to rotational and translational movement relative to support jaw 103 or housing 104. Linkage mechanism 172 may be configured to adjust the pivot point of anvil 102 when anvil 102 is rotated relative to support jaw 103 or housing 104. Figures 8A and 8B show how linkage mechanism 172 may include one or more recesses or passages 174 in support jaw 103 and one or more protrusions 176 on anvil 102.

[0051] Linkage mechanism 172 may act in coordination with upper and / or lower anvil positioners 110, 112 to effectuate, enable, and / or limit movement of anvil 102 between open, clamped, and closed positions (see, e.g., FIGS. 15-17). Those skilled in the art will appreciate that although linkage mechanism 172 is shown as having a passageway 174 in anvil 102 and a protrusion 176 in support jaw 103 or housing 104, any number of linkage mechanisms 172 may be employed.

[0052] In some embodiments, the linkage mechanism 172 includes a resilient fit between a resilient region of the anvil 102 and the support jaw 103 or the housing 104. For example, the anvil 102 may have slight protrusions on one or both sides that correspond to pits, passages, or recesses in the support jaw 103 or the housing 104. During assembly, the anvil 102 may be slightly flexed to resiliently fit against the support jaw 103 or the housing 104. In some embodiments, the resilient region may be comprised of a thin-walled section in the anvil 102.

[0053] In some embodiments, the anvil 102 and / or support jaw 103 may be provided with one or more detents (not shown) that may be configured to engage one or more recesses or passages in the other of the anvil 102 and / or support jaw 103 to allow assembly with a tight fit between the anvil 102 and support jaw 103. The detents / recesses / passages may be configured to allow a user, recycler, and / or manufacturer to remove the anvil 102 from the support jaw 103.

[0054] Continuing with FIG. 8 , in some embodiments, the anvil 102 or linkage mechanism 172 can include a tissue stop mechanism 178. The tissue stop mechanism 178 can be a structure on the anvil 102 and / or support jaw 103 (or cartridge 106 or housing 104) configured to prevent tissue from being positioned beyond the stapling area between the anvil 102 and support jaw 103. That is, the tissue stop mechanism 178 is configured to prevent the stapler 100 from cutting unstapled tissue. In some embodiments, the tissue stop mechanism 178 includes a surface 180 on the anvil 102 that engages a surface 182 on the cartridge 106 (see, e.g., FIGS. 14-15 ) when the anvil is moved from the open position toward the clamping position and is selected and shaped to avoid damaging tissue clamped between the support jaw 103 and the anvil 102.

[0055] The anvil 102 may also have a slot 184 shaped and configured to receive or guide the cutting mechanism 108 or the members 118, 120 of the cutting mechanism 108 as the cutting mechanism 108 advances distally to cut tissue clamped between the support jaw 103 and the anvil 102. The slot 184 may extend from a proximal region 186 of the anvil 102 to a location that does not extend to the distal end 188 of the anvil 102. The slot 184 may be shaped to limit the translational movement of the cutting mechanism 108 or its members 118, 120 and / or to prevent the cutting mechanism 108 or members 118, 120 from extending beyond the distal end 188 of the anvil 102.

[0056] In some embodiments, the anvil 102 has one or more guide features 190 (see, e.g., FIG. 9 ) configured to guide the cutting mechanism 108 or members 118, 120 of the cutting mechanism 108 as the cutting mechanism 108 advances down the anvil 102 (see, e.g., FIGS. 20A-20C ). The guide features 190 on the anvil 102 may correspond to or engage with guide features 192 on the cutting mechanism 108. In some embodiments, the guide features 190 on the anvil 102 may be one or more recesses 190 that engage with corresponding one or more ridges or protrusions 192 on the upper member 118 of the cutting mechanism 108, as shown.

[0057] In some embodiments, the guides 192 on the cutting mechanism 108 may be protrusions that do not extend the entire length of the cutting mechanism 108 or members 118, 120 to reduce friction between the cutting mechanism 108 or members 118, 120 and the anvil 102.

[0058] In some embodiments, the guide portion 192 on the cutting mechanism 108 can be a recess (not shown). In some embodiments, the guide portion 190 on the anvil 102 can be a protrusion (not shown) on the anvil 102. In some embodiments, the anvil 102 can have a first guide portion 190 that is a recess or groove and a second guide portion 190 that is a protrusion or flange (not shown). One of ordinary skill in the art can readily envision any number of means for providing first and / or second guide portions 190 to guide the cutting mechanism 108 as it advances toward the distal end region of the stapler 100, and all of these means are contemplated herein.

[0059] In some embodiments, the anvil 102 is sized to through-fit a cannula 400 having a nominal inner diameter of 8.0 mm. In some embodiments, the anvil 102 is sized to through-fit a cannula 400 having an inner diameter of 8.6 mm or less. In some embodiments, the anvil 102 is sized to through-fit a cannula 400 having a nominal inner diameter of 5.5 mm. In some embodiments, the anvil 102 is sized to through-fit a cannula 400 having an inner diameter of 5.6 mm or less.

[0060] Continuing with Figures 9 through 13, the anvil 102 can have first and / or second cam guides 194, 196. The cam guides 194, 196 can be slots in portions of the anvil 102 configured to guide one or more cams 128, 130 (see Figure 2) as the cams 128, 130 move longitudinally or translate into the support jaw 103 or housing 104 to cause movement of the staple pusher 132 and / or staples 132, 146, 148. The cam guides 194, 196 can help maintain the cams 128, 130 positioned at an angle θ relative to one another, for example, the second and / or third slots 142, 144 in the cartridge 106 and the cam guides 194, 196 can guide the translating cams 128, 130 at an inclined angle θ relative to one another to achieve movement of the staple pushers 132, 146, 148 at the inclined angle θ relative to one another. In other words, the cam guides 1974, 196 can achieve a first path of travel on the first staple pusher 146 and a second path of travel on the second staple pusher 148, the first path of travel being at an inclined angle θ relative to the second path of travel.

[0061] 11 and 13, the anvil 102 can have a curved tissue clamping interface 202, and the cartridge 106 can have a curved tissue clamping interface 204 (see, e.g., FIG. 3) configured to oppose the curved tissue clamping interface 202 of the anvil 102 when the stapler 100 is in a clamped or closed configuration (see, e.g., FIGS. 15 and 17). That is, in some embodiments, the anvil 102 can be curved to provide a curved beam and utilize the compressive strength of the material to resist opposing staple-forming forces. More specifically, the curved beam can protect the anvil 102 from undesirable deformation, while also assisting in proper staple formation. Those skilled in the art will appreciate that the phrase "curved tissue clamping interface" is intended to refer to a clamping surface that is generally curved, which may or may not be interrupted by one or more recesses, protrusions, and / or flat areas.

[0062] Cooperatively, the curved tissue clamping interfaces 202, 204 can be configured to clamp tissue therebetween when the anvil 102 is in the clamping position (shown in FIG. 17). The curved tissue clamping interfaces 202, 204 can be configured to abut or overlap one another when the anvil 102 is in the closed position (shown in FIG. 15). In some embodiments, a portion of one or both of the curved tissue clamping interfaces 202, 204 can have a radius of curvature R that is 40% to 60% of the envelope diameter D. For example, for a 5.6 mm envelope diameter, the radius of curvature R can be 2.24 mm to 3.36 mm. In some embodiments, the envelope diameter D can be about 5.6 mm and the radius of curvature R can be about 2.6 mm to about 2.8 mm. In some embodiments, the radius of curvature may be about 48% of the envelope diameter D, or about 2.69 mm when the envelope diameter D is 5.6 mm.

[0063] A portion of the curved tissue clamping interface 202 on the anvil 102 can have a radius of curvature R that is less than half the envelope diameter D of the stapler 100. A portion of the curved tissue clamping interface 204 on the cartridge 106 can have a corresponding or similarly constrained radius of curvature to mate with or clamp tissue therewith the anvil 102. In some embodiments, a portion of one or both of the curved tissue clamping interfaces 202, 204 has a radius of curvature that is 45% to 55% of the envelope diameter. In some embodiments, the radius of curvature is 47% to 52% of the envelope diameter.

[0064] The curved tissue clamping interfaces 202, 204 can be configured to provide larger cuffs than those typically achieved with staplers of similar nominal size (e.g., envelope diameter). Those skilled in the art will appreciate that the cuff in stapled and transected tissue is defined as the distance from the edge of the transected tissue to the first inner staple row. The cuff width is important because a larger cuff reduces the likelihood of tissue slipping through the staples or of the staples falling out. In some embodiments, the cuff width W is greater than 0.5 mm. In some embodiments, the cuff width W is greater than 0.6 mm. In some embodiments, the cuff width W is about 0.7 mm or greater. In some embodiments, the cuff width W is 0.8 mm or greater. In some embodiments, the cuff width W is 0.9 mm or greater. In some embodiments, the cuff width W is about 1.6 mm. In some embodiments, the sleeve width W is greater than 0.5 mm to about 1.6 mm. In some embodiments, the envelope diameter D is 5.6 mm or less and the sleeve width W is greater than 0.5 mm. In some embodiments, the envelope diameter D is 5.6 mm or less and the sleeve width W is about 0.7 mm. In some embodiments, the sleeve width W is a function of the angle θ, the radius of curvature of the curved tissue clamping interfaces 202, 204, and the size of the staple 150. The staple 150 and angle θ can be configured based on currently known standard leg sizes or on standard sizes yet to be developed, such as, for example, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 3.8 mm, 4.1 mm, 4.8 mm, etc.

[0065] 12 , the anvil 102 can have one or more forming pockets 198 configured to form and / or fold the staples 150, 152, 154, 156 as they are forced outward from the cartridge 106, through tissue, and into the anvil 102. The forming pockets 198 can be configured in a substantially known manner, except that in embodiments in which the staples 150, 152, 154, 156 and the staple pusher 132 translate at an angle θ relative to one another, or in embodiments in which the anvil 102 and cartridge 106 have curved tissue clamping interfaces 202, 204, the forming pockets 198 can be angled or positioned in a manner suitable to properly form the staples 150, 152, 154, 156. The forming pockets 198 can interrupt engagement of tissue by the curved tissue clamping interface 202.

[0066] 14 , in some embodiments, stapler 100 can provide a substantially consistent and fixed maximum device gap G across a transverse cross-section of tissue and / or a longitudinal cross-section of tissue during staple firing and / or tissue clamping. In some embodiments, shaped pockets 184 in anvil 102 are shaped and positioned to assist in guiding or driving staples 150, 152, 154, 156 perpendicular to the tissue clamped between anvil 102 and cartridge 106 or support jaw 103. In some embodiments, stapler 100 has an envelope diameter D of 5.6 mm or less in the closed configuration and is configured to allow a maximum device gap G of greater than 1.5 mm up to 2.0 mm between curved tissue clamping interfaces 202, 204. In some embodiments, stapler 100 has an envelope diameter D of 8.6 mm or less in the closed configuration and is configured to allow a maximum device gap G of 2.0 mm or greater.

[0067] In some embodiments, stapler 100 is configured, in the closed configuration, to through-fit a cannula 400 having an inner diameter 402 of 5.6 mm or less and to place staples having a nominal leg length L of 3.5 mm within a patient while allowing a maximum device gap G of more than 1.5 mm between curved tissue clamp interfaces 202, 204. In some embodiments, stapler 100 is configured, in the closed configuration, to through-fit a cannula 400 having an inner diameter 402 of 8.6 mm or less and to place staples having a nominal leg length L of 4.8 mm within a patient while allowing a maximum device gap G of at least 2.0 mm between curved tissue clamp interfaces 202, 204.

[0068] In some embodiments, the angle θ between the first set of staples 150, 154 and the second set of staples 152, 156 provides a relatively wide sleeve, as previously described herein. The wider sleeve achieved using a stapler 100 configured for a 5.5 mm cannula 400 may be comparable to the sleeve achieved using a standard stapler configured for a 12 mm diameter cannula 400 and may be approximately 0.7 mm or less. In some embodiments, the curved cartridge 106 and rotated or angled staples increase the width of the tissue “sleeve” created following staple formation and tissue transection by creating additional space between the cutter / cutting mechanism and the inner staple row.

[0069] Continuing with FIG. 14, lead-in features 185 of forming pockets 184 can correspond to the rotation angle θ of the staples within cartridge 106. See also FIG. 10. That is, lead-in features 185 can be from about 4° to about 30° from each other, or in some embodiments, less than or up to about 90° from each other. Lead-in features 185 can include any lead-in means such as bevels, chamfers, reliefs, or any other feature known in the art and configured to assist in guiding staples into forming pockets 184.

[0070] 15 through 17, as previously described, the anvil 102 may be movable relative to the support jaw 103 between a closed position shown in FIG. 15, an open position shown in FIG. 16, and a clamped position shown in FIG. 17. In the closed position, the anvil 102 and the support jaw 103 may have a compressed envelope size or diameter D. That is, the anvil 102 and the support jaw 103 may be cooperatively configured to pass through a passageway having a particular nominal size interior dimension. For example, the closed envelope size may have a closed envelope diameter D configured to pass through a cannula 400 having a particular nominal size interior dimension or diameter 402, such as 8.6 mm or 5.6 mm, in some embodiments.

[0071] In some embodiments, stapler 100 can be tip-biased. That is, anvil 102 and / or support jaws 103 can be shaped to favor contact of the distal ends of stapler 100 first as stapler 100 is moved to the closed configuration. Tip-biased stapler 100 can be configured such that slight flexing of anvil 102 and / or support jaws 103 allows for full compression to the closed configuration in which anvil 102 and cartridge 106 contact along a substantial or majority of clamp interfaces 202, 204.

[0072] After penetrating or partially penetrating the cannula 400, the anvil 102 can be actuated to move to an open position, such as the open position shown in FIGURE 16. In the open position, the anvil 102 can be pivoted, pivoted and translated, or moved such that the distal portion 188 of the anvil 102 is positioned further away from the proximal portion 186 of the support jaw 103. With the stapler 100 in the open configuration, a physician can place tissue between the support jaw 103 and the anvil 102 in preparation for surgically cutting and / or stapling the tissue.

[0073] As shown in FIG. 17 , the anvil 102 can be movable to a clamping position. The clamping position can be selected or designed to achieve a substantially consistent maximum device gap G (see, e.g., FIGS. 10 , 14 ) between the anvil 102 and the cartridge 106 or support jaw 103, or their clamping interfaces 202, 204, during firing and as previously described herein. In some embodiments, the clamping position can be selected or designed such that the anvil 102 and support jaw 103 have an envelope size or diameter D2 in the clamped configuration that is larger than the compressed envelope size or diameter D in the closed configuration. In some embodiments, the clamping configuration results in an envelope size or diameter D that is larger than the inner diameter 402 or size of the cannula 400 through which the stapler 100 is passed.

[0074] In some embodiments, an upper anvil positioner 110 and a lower anvil positioner 112 may be provided and configured to effect movement of the anvil 102 relative to the support jaw 103. That is, the upper anvil positioner 110 and / or the lower anvil positioner 112 may be configured to manipulate or move the pivot point of the anvil 102 as the anvil 102 is moved between the closed and / or clamped positions.

[0075] 18 through 20C, as previously described, stapler 100 can have an expandable cutting mechanism 108 and / or clamping members configured to move between a folded configuration and a spread configuration. Figure 18 shows cutting mechanism 108 in the folded configuration, and Figure 19 shows the cutting mechanism in the spread configuration.

[0076] In the collapsed configuration (e.g., FIG. 18), the cutting mechanism 108 can have a height H or envelope diameter that is less than the combined height of the anvil 102 and support jaw 103 (or generally, the remainder of the stapler 100) or less than the envelope diameter D. In the spread configuration (e.g., FIG. 19), the cutting mechanism 108 can have a height H that is greater than or approaches the combined height of the anvil 102 and support jaw 103 when the anvil 102 is in the clamping configuration. In other words, the height H of the cutting mechanism 108 in the collapsed configuration can be less than the envelope diameter D of the stapler 100 when the stapler 100 is in the closed and / or clamping configuration. In some embodiments, the height H of the cutting mechanism 108 in the collapsed configuration can be less than the combined envelope diameter of the anvil 102 and the support jaw 103 when the stapler 100 or the anvil 102 is in a closed and / or clamping configuration or position. In some embodiments, the height H of the cutting mechanism 108 in the spread configuration can be greater than the combined envelope diameter D of the anvil 102 and the support jaw 103 when the stapler 100 or the anvil 102 is in a closed and / or clamping configuration or position. The height H of the cutting mechanism 108 in the collapsed configuration can be less than the inner diameter 402 of the cannula 400. The height H of the cutting mechanism 108 in the spread configuration can be greater than the inner diameter 402 of the cannula 400.

[0077] The expandable cutting mechanism 108 can include a first member 118 and a second member 120 that are expandable, translatable, or movable relative to one another. In some embodiments, the first of the members 118, 120 can move both longitudinally and transversely relative to the support jaw 103 or cartridge 106, and the second of the members 118, 120 is limited to longitudinal movement relative to the support jaw 103 or cartridge 106. In some embodiments, both of the members 118, 120 can move both longitudinally and transversely relative to the support jaw 103 or cartridge 106. In some embodiments, the first of the members 118, 120 can pivot relative to the second of the members 118, 120. That is, for example, the first member 118, 120 can pivot slightly as the cutting member 108 expands and rides up onto the anvil 102 and support jaw 103. Slight rotational movement may be limited by flanges and / or legs on members 118,120.

[0078] One of the members 118, 120 may have a cutter blade or cutting portion 206 and may be configured to advance through or partially through the slot 140 in the cartridge 106 and / or the slot 184 in the anvil 102 to cut tissue clamped between the anvil 102 and the support jaw 103. The other of the members 118, 120 may be configured to advance with the first member 118, 120 such that, in cooperation, the first and second members 118, 120 may provide a strengthening effect to the stapler 100. More particularly, as shown in FIG. 20C , the cutting mechanism 108 may be configured to apply a supportive clamping force to tissue clamped between the anvil 102 and the support jaw 103 when the cutting mechanism 108 is in a distal position and / or moved distally and spread about the anvil 102 and the support jaw 103.

[0079] In some embodiments, the upper anvil positioner 110 is configured to rotate relative to the support jaw 103 to assist in guiding the cutting mechanism 108 .

[0080] In some embodiments, the expandable cutting mechanism 108 is coupled to or includes a first actuator 122 coupled to one of the members 118, 120, such as the first member 118, and a second actuator coupled to the other of the members 118, 129, such as the second member 120. In some embodiments, one or both of the actuators 122, 124 are flexible. In some embodiments, the first actuator 122 is configured to apply a retraction force when activated (e.g., pulling the cutting mechanism 108 toward a user or a proximal region of the stapler 100), and the second actuator 124 is configured to apply an extension force when activated (e.g., pushing the cutting mechanism 108 away from a user or toward a distal region of the stapler 100). In some embodiments, the flexible actuators 122, 124 can be configured with appropriate stiffness to maintain the member 118, 120 to which the actuator 122, 124 is coupled oriented relative to the other member 118, 120. In other words, an actuator 122, 124, such as the first actuator 122, can provide the cutting mechanism 108 with limited pushing or extending force and a large retracting force when retraction is required.

[0081] In some embodiments, the cutting mechanism 108 is configured to move between a folded configuration in which the cutting portion 206 is not aligned with the tissue cutting area defined by the anvil 102 and the support jaw 103, and an unfolded configuration in which the cutting portion 206 is aligned with the tissue cutting area, which is defined by the device gap G between the anvil 102 and the support jaw 103 (see, e.g., Figures 19 and 20A-20C).

[0082] One or both of the actuators 122, 124 (as shown, the first actuator 122) can be configured to be flexible enough to allow the expandable cutting mechanism 108 to expand as it advances distally (i.e., the first member 118 can move upward and / or the second member 120 can move downward), and rigid enough to exert a force strong enough to move the member 118, 120 to which it is attached distally, or at least keep it oriented relative to the other member. Thus, in some embodiments, the first actuator 122 can orient the first member 118 relative to the second member 120, while the second actuator 124 essentially moves the cutting mechanism 108 distally.

[0083] It should be understood that the first and second actuators 122, 124 may be coupled to the first and second members 118, 120 using any means known in the art that is suitable for ensuring reliable control of the first and second members 118, 120. In some embodiments, one or both actuators 122, 124 may have multiple layers fused together or comprise a laminated beam. For example, multiple layers 122a, 122b, 122c, 122d may be provided that comprise high-strength steel and are interconnected using an adhesive to achieve appropriate flexibility in the actuators 122, 124 and tension in the members 118, 120. In some embodiments, neither actuator 122, 124 may comprise a laminated beam, but may comprise a material selected for flexibility and strength suitable for positioning the cutting mechanism 108 or members 118, 120. That is, the actuators 122, 124 should be selected to be rigid enough to urge the cutting mechanism 108 or members 118, 120 distally, yet flexible enough to move with the cutting mechanism 108 or members 118, 120 as the cutting mechanism 108 expands outside the envelope diameter D.

[0084] 18-19, those skilled in the art will appreciate that the cutting mechanism 108 can be made of any suitable material known in the art that is suitable for cutting tissue clamped between the anvil 102 and the support jaws 103 or cartridge 106. For example, the first member 118 can be formed of surgical steel and ground or machined to have a sharp cutting portion 206. In some embodiments, the first member 118 has one or more legs 208 with flange portions 210 configured to engage one or more flanges 214 on one or more legs 212 on the second member 120 to limit the amount of spread between the first and second members 118, 120. In some embodiments, the legs 208, 212 are configured to allow one member 118, 120 to rotate a predetermined amount relative to the other member 118, 120. In some embodiments, the cartridge 106, slot 140, and / or anvil 102 are configured to maintain a vertical orientation of the cutting mechanism 108.

[0085] The cutting mechanism 108 can include means for limiting the expansion between the first and second members 118, 120 to a predetermined expansion height H, such that, at maximum expansion, the cutting mechanism 108 is configured to help prevent the anvil 102 from deforming while clamping tissue. In some embodiments, the cutting mechanism 108 is configured to limit a tissue clamping gap between the anvil 102 and the support jaw 103 to a device gap G suitable for clamping, cutting, and / or stapling tissue. For example, in some embodiments, the cutting mechanism 108 is configured to compress the anvil 102 toward the support jaw 103 a predetermined amount as the cutting mechanism 108 advances from a proximal position toward a distal position. 19 , in some embodiments, the leading end portion 119 of the first member 118 and / or the leading end portion 121 of the second member 120 can be positioned on the cutting mechanism 108 in an area that is more distal to the user than the cutting surface 206. The leading end portions 119, 121 can be configured to apply a compressive force to the anvil 102 and support jaw 103 to ensure that the device gap G is reached prior to tissue cutting and / or to ensure that the maximum device gap G is not exceeded during tissue cutting.

[0086] In some embodiments, the cutting mechanism 108 is configured to jam or not advance into areas where the maximum device gap G is not achieved. For example, if the stapler 100 is configured to achieve a maximum device gap G of 2.0 mm, but a portion of the tissue cannot be compressed to 2.0 mm, the cutting mechanism 108 will not advance into the area of ​​tissue that is too thick. In this case, even if the stapler 100 accidentally fires staples into the tissue and those staples are not properly formed, the cutting member 108 will not cut the portion of the tissue that is not properly stapled. The physician can then manually retract the cutting mechanism 108 and pull the improperly formed staples from the tissue.

[0087] 19, one skilled in the art will appreciate that any portion of the first member 118 or second member 120 may be unitary, or any portion may be a separate component connected to other components of the cutting mechanism 108. In some embodiments, the legs 208, 212 of the members 118, 120 may be separate structures connected to the curved guide portions 118a, 120a of the members 118, 120.

[0088] 21 , in some embodiments, a surgical stapler 500 can have an anchored clamping mechanism 502 with a cutting surface 206, as previously described herein. The anchored clamping mechanism 502 can include a modified I-beam having a first or lower flange 504 and a second or upper flange 506 interconnected such that the modified I-beam does not extend through the entire diameter of the end effector, as is the case in currently available designs. Instead, the I-beam can be anchored at the first flange 504 within a cartridge 508, for example, in the space created by the angle of the staple. In some embodiments, the I-beam can include the first flange 504 shaped to slidingly engage a flange or recess in the cartridge 508. The I-beam can include a surface on one or more of the flanges 504, 506 shaped to slidingly engage an outer surface of the clamp or end effector of the surgical stapler 500.

[0089] In some embodiments, the tethered clamping mechanism 502, cutting mechanism 108, or I-beam may be configured to slide and track the cams 128, 130 and act as a fulcrum in a manner substantially as described above with respect to the cutting mechanism 108. In some embodiments, the tethered clamping mechanism 502, cutting mechanism 108, or I-beam may be configured to slide or advance distally.

[0090] As shown in FIG. 21, the first flange 504 may allow the tethered clamping mechanism to slide through a recess or channel cutout in the cartridge while allowing or limiting the maximum device gap G in a manner substantially as described above with respect to the cutting mechanism 108.

[0091] 22-24, staple pusher 148 is shown in further detail. Staple pusher 148 can include a first receiving area 160 and a second receiving area 164 configured to support two staples, substantially as previously described herein. In some embodiments, receiving areas 160, 164 are configured to support the staples in a staggered but parallel orientation to ensure that the stapled tissue is sealed. As shown in FIG. 22, the staple pusher 148 can have a first camming surface 216 and / or a second camming surface 218 that are configured to cooperate with the translational cams 128, 130 and the cartridge 106 to convert longitudinal motion of the translational cams 128, 130 into transverse motion, such as at an oblique angle θ relative to the staple pusher 132, to drive staples into tissue clamped between the anvil 102 and the support jaw 103.

[0092] 25 shows lower anvil positioner 112 having flanges 112a, 112b, as previously described, to assist in positioning anvil 102, although one skilled in the art will appreciate that a single flange 112a, 112b may be suitable or implemented. In some embodiments, flanges 112a, 112b are interconnected by bridge 112c, allowing a single actuator (not shown) to accomplish movement of lower anvil positioner 112 and / or flanges 112a, 112b. In some embodiments, lower anvil positioner 112 has bridge 112d connecting flanges 112a, 112b.

[0093] FIG. 26 shows the relationship between the cutting mechanism 108, spring 113, and upper anvil positioner 110.

[0094] As shown in FIGS. 27-28 , in some embodiments, the cartridge housing is not deployed. That is, the cartridge 106 and cartridge housing 104 are integrated into a single piece, i.e., the integrated staple housing 107, to form the outer casing. The integrated staple housing 107 can have specific structure to properly guide the staples outward from the housing 107 as they are driven by the cams 128, 130 (and staple pusher 132). In embodiments with an integrated staple housing 107, an insert 109 can be coupled, seated, or resiliently fitted into the center of the integrated housing 107 to complete the medical specific structure of the staple pocket 111. Additionally, the staple pusher 132 can be modified (trimmed) or appropriately sized to create space to increase the wall thickness of the housing for strength.

[0095] In some embodiments, an integrated staple housing providing staples guided by the housing wall, as shown in Figure 5 and / or Figures 29-30, may allow for increased wall thickness of the cartridge 508 or housing, thereby allowing for greater strength of the surgical stapler compared to staplers in which the pusher can accept the staples. Contrast Figures 29-30 with Figures 31-32.

[0096] In some embodiments, the stapler disclosed herein can be used within a flexible catheter. In some embodiments, the stapler 100 disclosed herein is configured to be coupled to or used with an articulation joint.

[0097] 20A-20C and / or 33-34, the tethered clamping mechanism 502 or cutting mechanism 108 may provide a safety lock feature. In some embodiments, the mechanism 502, 108 may advance such that if too much tissue is clamped (thereby not achieving the required clearance as previously described herein), the mechanism 502, 108 cannot advance downwardly relative to the anvil 102 and self-locks, preventing the firing sequence from continuing.

[0098] 36, in some embodiments, a method 3600 of performing a stapling procedure on a patient is provided. The method 3600 can include deploying 3602 a surgical stapler in a closed position, inserting 3604 at least a portion of the stapler through a cannula, and moving 3606 the stapler from the closed position to a clamping position.

[0099] Deploying 3602 the surgical stapler in a closed configuration can include deploying a surgical stapler having any of the features described hereinabove with respect to Figures 1 through 35B. In some embodiments, deploying 3602 includes deploying a stapler including an anvil movably coupled to a support jaw, where the support jaw includes a cartridge having an elongate body with a distal end and a proximal end, the cartridge configured to removably house a plurality of staples. The elongate body can have a first slot configured to receive a cutting mechanism, a second slot configured to house at least a first staple of the plurality of staples, and a third slot configured to house at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples.

[0100] Passing at least a portion of the surgical stapler through a cannula 3604 can include passing at least a portion of the stapler through a cannula having an inner diameter, which can be substantially as described herein above with respect to Figures 1 through 35B.

[0101] Moving the surgical stapler from the closed configuration to the clamping configuration 3606 can include moving the stapler to a clamping configuration in which the stapler maintains a gap between the anvil and the support jaws and the stapler cannot pass through the cannula. Moving the stapler to the clamping configuration 3606 can be accomplished with the staplers described above with respect to Figures 1 through 35B.

[0102] The method 3600 can include stapling tissue using staples having a leg length of 3.0 mm or greater with a stapler configured to pass through a cannula 400 having an inner diameter of 5.6 mm or less. The method 3600 can include stapling clamped tissue to a thickness of greater than 1.5 mm with a stapler having an envelope diameter of 5.6 mm or less in a closed position.

[0103] In some embodiments, the method 3600 further includes longitudinally translating at least one cam to bias at least one of the first staple presser or the second staple presser in an oblique direction relative to the other of the first staple presser or the second staple presser.

[0104] In some embodiments, the method 3600 further includes replacing a first cartridge kit in the surgical stapler with a second cartridge kit. The method 3600 may further include using a stapler having the first cartridge kit to place a first group of staples having a first leg length in a patient, replacing the cartridge kit, and using the stapler having the second cartridge kit to place a second group of staples having a second leg length different from the first leg length in a patient. In some embodiments, the same patient receives both groups of staples.

[0105] In addition to the above description, various specific examples are disclosed herein.

[0106] Example 1: A cartridge for a surgical stapler comprising: an elongated body configured to fit within an envelope diameter and to removably house a plurality of B-shaped staples, at least one staple of the plurality of B-shaped staples having a base length and a leg length, the leg length being at least 53% of the envelope diameter; a first slot configured to receive a translating cutting mechanism; a second slot configured to house at least a first staple of the plurality of staples; and a third slot configured to house at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples.

[0107] Example 2: The cartridge of Example 1, wherein the cartridge further comprises a curved tissue clamping interface, and the angle of inclination is from about 4° to about 30°.

[0108] Example 3: The cartridge of Example 1 or 2, wherein the second slot is configured to translate at least a first staple presser, the third slot is configured to translate at least a second staple presser, and the second slot and the third slot are configured to limit the translation of the first staple presser to an oblique angle relative to the translation of the second staple presser.

[0109] Example 4: The cartridge of Example 1, wherein the second slot is configured to translateably receive at least a first staple pusher configured to support at least a first staple of the plurality of staples and a third staple of the plurality of staples parallel to the first staple of the plurality of staples, and the third slot is configured to translateably receive at least a second staple pusher obliquely relative to the first staple pusher, the second staple pusher being configured to support at least a second staple of the plurality of staples and a fourth staple of the plurality of staples parallel to the second staple of the plurality of staples.

[0110] Example 5: A cartridge of any one of the preceding examples, wherein at least one staple of the plurality of staples has a nominal leg length of 3.42 mm or more and the envelope diameter is 5.6 mm or less, or at least one staple of the plurality of staples has a nominal leg length of 4.72 mm or more and the envelope diameter is 8.6 mm or less.

[0111] Example 6: The cartridge of Example 3 or 4, wherein the second slot is configured to slidably receive a first longitudinal translation cam to effect sliding movement of the first staple presser, and the third slot is configured to slidably receive a second longitudinal translation cam to effect sliding movement of the second staple presser that is inclined relative to the sliding movement of the first staple presser.

[0112] Example 7: The cartridge of any one of the preceding examples, wherein the cartridge includes a curved tissue clamping interface and the cartridge is configured to position at least one staple of the plurality of staples at a perpendicular angle relative to the curved tissue clamping interface.

[0113] Example 8: The cartridge of Example 7, wherein the curved tissue clamping interface is curved about a longitudinal axis extending between the proximal and distal ends of the elongate body, and wherein the curved tissue clamping interface has a radius that is approximately 40% to 60% of the envelope diameter.

[0114] Example 9: The cartridge of Example 8, wherein the envelope diameter is 5.6 mm or less and at least the first staple of the plurality of staples has a leg length of 3.42 mm or more, or at least the first staple of the plurality of staples is configured to be formed around clamped tissue to a thickness of greater than 1.5 mm.

[0115] Example 10: The cartridge of Example 1, wherein at least the first staple of the plurality of staples has a leg length of 3.42 mm or more and the envelope diameter is 5.6 mm or less, or at least the first staple of the plurality of staples has a leg length of 4.72 mm or more and the envelope diameter is 8.6 mm or less.

[0116] Example 11: The cartridge of any one of the preceding examples, wherein at least the first staple of the plurality of staples is configured to staple around the clamped tissue up to a tissue thickness, and the tissue thickness is at least 20% of the envelope diameter.

[0117] Example 12: The cartridge of Example 11, wherein the tissue thickness is about 22% to about 36% of the envelope diameter.

[0118] Example 13: The cartridge of Example 1, wherein the cartridge further comprises a recess for coupling to a cartridge support jaw, and the cartridge and the support jaw are shaped to fit within an envelope diameter of 5.6 mm or less, or the cartridge and the support jaw are shaped to fit within an envelope diameter of 8.6 mm or less.

[0119] Example 14: The cartridge of Example 1, further comprising a curved tissue clamping interface.

[0120] Example 15: The cartridge of any one of the preceding examples, wherein at least one staple of the plurality of staples has a leg length that is at least 61% of the envelope diameter.

[0121] Example 16: A surgical stapler comprising an anvil coupled to a support jaw for movement between a clamping configuration, in which the anvil and support jaw are configured to clamp tissue positioned therebetween, and a closed configuration, in which a tissue clamping interface on the anvil abuts a tissue clamping interface on a cartridge, the support jaw comprising a cartridge having an elongated body configured to removably receive a plurality of B-shaped staples, at least one staple of the plurality of B-shaped staples having a base length and a leg length, the cartridge further comprising a translating cutter. a first slot shaped to receive a staple having an enlarged length, a second slot shaped to accommodate at least a first staple of the plurality of staples, and a third slot shaped to accommodate at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples, wherein the anvil and support jaws with the cartridge are shaped to fit within an envelope diameter when in the closed configuration, and the leg length of at least one staple of the plurality of B-shaped staples is at least 53% of the envelope diameter.

[0122] Example 17: The stapler of Example 16, wherein the third slot is shaped to accommodate the second staple of the plurality of staples at an angle of about 4° to about 30° relative to the first staple of the plurality of staples.

[0123] Example 18: The stapler of Example 16 or 17, wherein the second slot is configured to translate at least a first staple presser, the third slot is configured to translate at least a second staple presser, and the second slot and the third slot are configured to limit the first staple presser to translational movement at an oblique angle relative to the translational movement of the second staple presser.

[0124] Example 19: The stapler of Example 16, wherein the second slot is configured to translateably accommodate at least a first staple pusher configured to support at least a first staple of the plurality of staples and a third staple of the plurality of staples parallel to the first staple of the plurality of staples, and the third slot is configured to translateably accommodate at least a second staple pusher oblique to the first staple pusher, the second staple pusher configured to support at least the second staple of the plurality of staples and a fourth staple of the plurality of staples.

[0125] Example 20: The stapler of any one of Examples 16 to 19, wherein at least one staple of the plurality of staples has a leg length of 3.42 mm or more and the envelope diameter is 5.6 mm or less, or at least one staple of the plurality of staples has a leg length of 4.72 mm or more and the envelope diameter is 8.6 mm or less, or the envelope diameter is 5.6 mm or less, and the stapler is configured to staple and cut tissue resulting in a sleeve width of more than 0.5 mm.

[0126] Example 21: The stapler of Example 19, further comprising a first longitudinal translation cam and a second longitudinal translation cam positioned at an angle relative to the first longitudinal translation cam, wherein the second slot is configured to slidably receive the first longitudinal translation cam to achieve sliding movement of the first staple presser, and the third slot is configured to slidably receive the second longitudinal translation cam to achieve sliding movement of the second staple presser at an angle relative to the sliding movement of the first staple presser.

[0127] Example 22: The stapler of any one of Examples 16 to 21, further comprising an expandable cutting mechanism configured to move between a folded configuration in which the cutting mechanism is shaped to fit within the envelope diameter and an expanded configuration in which the cutting mechanism has a dimension larger than the envelope diameter.

[0128] Example 23: The stapler of Examples 16 to 21, further comprising an expandable cutting mechanism having a first member with a cutting portion and a second member, the cutting mechanism configured to move between a folded configuration in which the cutting portion does not intersect with the longitudinal axis defined by the tissue clamping interface of the cartridge, and an expanded configuration in which the cutting portion intersects with the longitudinal axis defined by the tissue clamping interface of the cartridge.

[0129] Example 24: A stapler according to any one of Examples 16 to 23, wherein at least the first staple of the plurality of staples has a leg length of 3.42 mm or more and the envelope diameter is 5.6 mm or less, or at least the first staple of the plurality of staples has a leg length of 4.72 mm or more and the envelope diameter is 8.6 mm or less.

[0130] Example 25: The surgical stapler of Examples 16 or 24, wherein the surgical stapler is configured to staple and cut tissue up to a predetermined tissue thickness, the tissue thickness being defined as the distance between the anvil and the cartridge between staples, and the tissue thickness being at least 20% of the envelope diameter when the stapler is in the closed configuration.

[0131] Example 26: The stapler of any one of Examples 16 to 25, wherein the anvil has a curved tissue clamping interface and the cartridge has a curved tissue clamping interface configured to engage the curved tissue clamping interface of the anvil when the stapler is in the closed configuration.

[0132] Example 27: The stapler of any one of Examples 16 to 26, wherein at least one staple of the plurality of staples has a leg length that is at least 61% of the envelope diameter.

[0133] Example 28: Deploying a surgical stapler in a closed configuration, the stapler comprising: an anvil coupled to a support jaw for movement between a clamping configuration, wherein the anvil and support jaw are configured to clamp tissue positioned therebetween, and a closed configuration, wherein a tissue clamping interface on the anvil abuts a tissue clamping interface on a cartridge, the support jaw comprising a cartridge configured to removably receive a plurality of B-shaped staples, at least one staple of the plurality of B-shaped staples having a base length and a leg length, the cartridge further comprising: a first slot configured to receive a translating cutting mechanism; a second slot configured to receive at least a first staple of the plurality of staples; and a second slot configured to receive at least a second staple of the plurality of staples. a third slot shaped to receive a second staple at an oblique angle relative to the first staple of the plurality of staples, wherein the anvil and support jaws with the cartridge are shaped to fit within an envelope diameter when in the closed configuration, and the leg length of at least one staple of the plurality of B-shaped staples is at least 53% of the envelope diameter; passing at least a portion of the stapler through the envelope diameter in the closed configuration; positioning tissue between the anvil and the support jaws; moving the anvil to the clamping configuration where the anvil and the support jaws clamp the tissue; and forming a plurality of staples around the tissue with the stapler.

[0134] Example 29: The method of Example 28, further comprising the steps of: inserting a third staple of the plurality of staples parallel to the first staple of the plurality of staples; and inserting a fourth staple of the plurality of staples parallel to the second staple of the plurality of staples; and wherein the surgical stapler has an envelope diameter of 5.6 mm or less; or wherein the surgical stapler has an envelope diameter of 8.6 mm or less.

[0135] Example 30: The method of Example 28, further comprising clamping tissue between a curved tissue clamping interface on the support jaw and a curved tissue clamping interface on the anvil.

[0136] Example 31: A translating cutting mechanism having an anvil coupled to a support jaw so as to be movable between a clamping configuration, in which the anvil and support jaw are configured to clamp tissue positioned therebetween, and a closed configuration, in which a tissue clamping interface on the anvil abuts a tissue clamping interface on a cartridge, the anvil and the support jaw defining an envelope diameter when the anvil is in the closed configuration; a first member having a cutting portion; and a second member, the cutting mechanism extending upward. a translating cutting mechanism movable between a collapsed configuration shaped to fit within the envelope diameter and an expanded configuration in which the cutting mechanism does not fit within the envelope diameter, wherein the support jaw includes a cartridge having a first slot shaped to receive the translating cutting mechanism, a second slot shaped to accommodate at least a first staple of the plurality of staples, and a third slot shaped to accommodate at least a second staple of the plurality of staples.

[0137] Example 32: The surgical stapler of Example 31, wherein at least one of the first member or the second member has at least one guide portion configured to engage with a corresponding guide portion on the anvil to limit the cutting mechanism to translational movement relative to the corresponding guide portion.

[0138] Example 33: A surgical stapler according to Example 31 or 32, wherein the envelope diameter is 5.6 mm or less, or the envelope diameter is 8.6 mm or less.

[0139] Example 34: The surgical stapler of any one of Examples 31 to 33, further comprising: a first actuator connected to the first member, the first member configured to move the first member in a distal direction and onto the anvil; and a second actuator connected to the second member, the actuator configured to move the second member in a distal direction and onto the support jaw.

[0140] Example 35: The surgical stapler of Example 34, wherein the first actuator comprises a flexible member.

[0141] Example 36: A surgical stapler according to any one of Examples 31 to 35, wherein the first member has at least one leg having a first flange, and the second member has at least one leg having a second flange, and the first flange and the second flange are shaped to limit the expansion of the cutting mechanism.

[0142] Example 37: The surgical stapler of any one of Examples 31 to 36, wherein the cutting mechanism is configured to compress the anvil and the support jaws toward each other and into the clamping configuration as the cutting mechanism translates toward the distal end of the surgical stapler.

[0143] Example 38: The surgical stapler of any one of Examples 31 to 37, wherein the stapler has an envelope diameter of 5.6 mm in the closed configuration and the stapler is configured to staple and cut tissue clamped between the anvil and the support jaws so that the cut tissue has a sleeve width of greater than 0.5 mm.

[0144] Each of the various elements disclosed herein can be achieved in a variety of ways. The present disclosure should be understood to encompass each such variation, whether it be a variation of any apparatus embodiment, method, or process embodiment, or merely a variation of any of these elements. In particular, it should be understood that the terms for each element may be expressed by equivalent apparatus or method terms, even if only the function or result is the same. Such equivalent, broader, or even more inclusive terms should be considered to be encompassed in the description of each element or operation. Such terms can be substituted, if desired, to make clear the implicitly broad scope to which the invention is entitled.

[0145] It should be understood that, by way of example only, any action can be expressed as a means for performing that action or as an element that causes that action. Similarly, each disclosed physical element should be understood to encompass the disclosure of the action that it facilitates. With respect to this last aspect, and by way of example only, a disclosure of a clamp, whether explicitly discussed or not, should be understood to encompass the disclosure of the operation of the clamp, and conversely, if there is only a disclosure of the operation of the clamp, such disclosure should be understood to encompass the disclosure of a "clamping mechanism." Such variations and alternative terms should be understood to be expressly included in the above description.

[0146] The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein. The invention disclosed in this specification includes the following aspects. [Aspect 1] an elongated body configured to fit within an envelope diameter and to removably house a plurality of B-shaped staples, at least one staple of the plurality of B-shaped staples having a base length and a leg length, the leg length being at least 53% of the envelope diameter; a first slot configured to receive a translating cutting mechanism; a second slot configured to receive at least a first staple of the plurality of staples; a third slot configured to receive at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples; A cartridge for a surgical stapler comprising: [Aspect 2] the cartridge further comprising a curved tissue clamping interface; 2. The cartridge according to aspect 1, wherein the inclination angle is about 4° to about 30°. Aspect 3 the second slot is configured to translationally receive at least a first staple pusher; the third slot is configured to translationally receive at least a second staple pusher; Aspect 3. The cartridge of aspect 1 or 2, wherein the second slot and the third slot are configured to limit the first staple pusher to translational movement at an oblique angle relative to the translational movement of the second staple pusher. Aspect 4 the second slot is configured to translationally receive at least a first staple pusher configured to support at least the first staple of the plurality of staples and a third staple of the plurality of staples parallel to the first staple of the plurality of staples; 2. The cartridge of claim 1, wherein the third slot is configured to translateably accommodate at least a second staple pusher angled relative to the first staple pusher, the second staple pusher being configured to support at least a second staple of the plurality of staples and a fourth staple of the plurality of staples parallel to the second staple of the plurality of staples. Aspect 5 At least one staple of the plurality of staples has a leg length of 3.42 mm or more and the envelope diameter is 5.6 mm or less; or At least one staple of the plurality of staples has a nominal leg length of 4.72 mm or more and an envelope diameter of 8.6 mm or less. 10. The cartridge of any one of the preceding aspects, Aspect 6 the second slot is configured to slidably receive a first longitudinal translation cam to effectuate sliding movement of the first staple pusher; A cartridge according to aspect 3 or 4, wherein the third slot is configured to slidably receive a second longitudinal translation cam to achieve sliding movement of the second staple pusher that is inclined relative to the sliding movement of the first staple pusher. Aspect 7 the cartridge includes a curved tissue clamping interface; A cartridge according to any one of the preceding aspects, wherein the cartridge is configured to position at least one staple of the plurality of staples at a perpendicular angle relative to the curved tissue clamping interface. Aspect 8 the curved tissue clamping interface is curved about a longitudinal axis extending between the proximal and distal ends of the elongate body; 8. The cartridge of claim 7, wherein the curved tissue clamping interface has a radius that is about 40% to 60% of the envelope diameter. Aspect 9 The envelope diameter is 5.6 mm or less, (a) at least the first staple of the plurality of staples has a leg length of 3.42 mm or greater; or (b) at least the first staple of the plurality of staples is configured to form around clamped tissue to a thickness of greater than 1.5 mm; 9. The cartridge of embodiment 8, wherein the cartridge is at least one of: Aspect 10 At least the first staple of the plurality of staples has a leg length of 3.42 mm or more and an envelope diameter of 5.6 mm or less; or At least the first staple of the plurality of staples has a leg length of 4.72 mm or more and an envelope diameter of 8.6 mm or less. The cartridge of embodiment 1, wherein the cartridge is one of the following: Aspect 11 at least the first staple of the plurality of staples is configured to staple around clamped tissue up to a tissue thickness;

[0023] A cartridge according to any one of the preceding aspects, wherein the tissue thickness is at least 20% of the envelope diameter. Aspect 12 Aspect 12. The cartridge according to aspect 11, wherein the tissue thickness is about 22% to about 36% of the envelope diameter. Aspect 13 the cartridge further comprising a recess for coupling to a cartridge support jaw; the cartridge and the support jaws are shaped to fit within an envelope diameter of 5.6 mm or less; or the cartridge and the support jaws are shaped to fit within an envelope diameter of 8.6 mm or less; The cartridge of embodiment 1, wherein the cartridge is one of the following: Aspect 14 10. The cartridge of embodiment 1, further comprising a curved tissue clamping interface. Aspect 15 10. The cartridge of any one of the preceding aspects, wherein at least one staple of the plurality of staples has a leg length that is at least 61% of the envelope diameter. Aspect 16 1. A surgical stapler comprising an anvil coupled to a support jaw so as to be movable between a clamping configuration, in which the anvil and support jaw are configured to clamp tissue positioned therebetween, and a closed configuration, in which a tissue clamping interface on the anvil abuts a tissue clamping interface on a cartridge, the support jaw comprises a cartridge having an elongated body configured to removably receive a plurality of B-shaped staples; At least one staple of the plurality of B-shaped staples has a base length and a leg length; the cartridge further comprises a first slot configured to receive a translating cutting mechanism, a second slot configured to accommodate at least a first staple of the plurality of staples, and a third slot configured to accommodate at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples; the anvil and the support jaws with the cartridge are shaped to fit within an envelope diameter when in the closed configuration; and the leg length of the at least one staple of the plurality of B-shaped staples is at least 53% of the envelope diameter; Surgical stapler. Aspect 17 17. The stapler of claim 16, wherein the third slot is shaped to accommodate the second staple of the plurality of staples at an angle of about 4° to about 30° relative to the first staple of the plurality of staples. Aspect 18 the second slot is configured to translationally receive at least a first staple pusher; the third slot is configured to translationally receive at least a second staple pusher; 18. The stapler of claim 16 or 17, wherein the second slot and the third slot are configured to limit the first staple pusher to translational movement at an oblique angle relative to the translational movement of the second staple pusher. Aspect 19 the second slot is configured to translationally receive at least a first staple pusher configured to support at least the first staple of the plurality of staples and a third staple of the plurality of staples parallel to the first staple of the plurality of staples; 17. The stapler of claim 16, wherein the third slot is configured to translateably accommodate at least a second staple pusher angled relative to the first staple pusher, the second staple pusher being configured to support at least the second staple of the plurality of staples and a fourth staple of the plurality of staples. Aspect 20 At least one staple of the plurality of staples has a leg length of 3.42 mm or more and the envelope diameter is 5.6 mm or less; or At least one staple of the plurality of staples has a leg length of 4.72 mm or more and the envelope diameter is 8.6 mm or less; or the envelope diameter is 5.6 mm or less, and the stapler is configured to staple and cut tissue resulting in a sleeve width of greater than 0.5 mm. 20. The stapler of any one of aspects 16 to 19, wherein the stapler is one of: Aspect 21 The stapler is a first longitudinal translation cam; a second longitudinal translation cam positioned at an angle relative to the first longitudinal translation cam; the second slot is configured to slidably receive the first longitudinal translation cam to effect sliding movement of the first staple pusher; A stapler as described in aspect 19, wherein the third slot is configured to slidably receive the second longitudinal translation cam to achieve sliding movement of the second staple pusher that is inclined relative to the sliding movement of the first staple pusher. Aspect 22 22. The stapler of any one of aspects 16 to 21, further comprising an expandable cutting mechanism configured to move between a folded configuration in which the cutting mechanism is shaped to fit within the envelope diameter and an expanded configuration in which the cutting mechanism has a dimension larger than the envelope diameter. Aspect 23 The stapler further includes an expandable cutting mechanism having a first member with a cutting portion and a second member; A stapler described in any one of aspects 16 to 21, wherein the cutting mechanism is configured to move between a folded configuration in which the cutting portion does not intersect with the longitudinal axis defined by the tissue clamping interface of the cartridge, and an expanded configuration in which the cutting portion intersects with the longitudinal axis defined by the tissue clamping interface of the cartridge. Aspect 24 At least the first staple of the plurality of staples has a leg length of 3.42 mm or more and an envelope diameter of 5.6 mm or less; or At least the first staple of the plurality of staples has a leg length of 4.72 mm or more, and the envelope diameter is 8.6 mm or less. 24. The stapler of any one of aspects 16 to 23, wherein the stapler is one of: Aspect 25 the surgical stapler is configured to staple and cut tissue up to a predetermined tissue thickness; the tissue thickness is defined as the distance between the anvil and the cartridge between staples; 25. The surgical stapler of claim 16 or 24, wherein the tissue thickness is at least 20% of the envelope diameter when the stapler is in the closed configuration. Aspect 26 the anvil having a curved tissue clamping interface; A stapler described in any one of aspects 16 to 25, wherein the cartridge has a curved tissue clamping interface shaped to engage the curved tissue clamping interface of the anvil when the stapler is in the closed configuration. Aspect 27 27. The stapler of any one of claims 16 to 26, wherein at least one staple of the plurality of staples has a leg length that is at least 61% of the envelope diameter. Aspect 28 Deploying a surgical stapler in a closed configuration, the stapler including an anvil coupled to a support jaw for movement between a clamping configuration, in which the anvil and support jaw are configured to clamp tissue positioned therebetween, and a closed configuration, in which a tissue clamping interface on the anvil abuts a tissue clamping interface on the cartridge, the support jaw including a cartridge configured to removably receive a plurality of B-shaped staples, at least one of the plurality of B-shaped staples having a base length and a leg length, the cartridge further including a translational movement mechanism. a first slot configured to receive a dynamic cutting mechanism, a second slot configured to accommodate at least a first staple of the plurality of staples, and a third slot configured to accommodate at least a second staple of the plurality of staples at an oblique angle relative to the first staple of the plurality of staples, wherein the anvil and the support jaws including the cartridge are configured to fit within an envelope diameter when in the closed configuration, and the leg length of the at least one staple of the plurality of B-shaped staples is at least 53% of the envelope diameter; passing at least a portion of the stapler through an envelope diameter in the closed configuration; positioning tissue between the anvil and the support jaws; moving the anvil to the clamping configuration in which the anvil and the support jaws clamp the tissue; forming a plurality of staples around the tissue with the stapler; 1. A method of placing a surgical staple within a patient, comprising: Aspect 29 The method comprises: receiving a third staple of said plurality of staples parallel to said first staple of said plurality of staples; receiving a fourth staple of the plurality of staples parallel to the second staple of the plurality of staples; and the surgical stapler has an envelope diameter of 5.6 mm or less; or The surgical stapler has an envelope diameter of 8.6 mm or less. 29. The method of embodiment 28, wherein Aspect 30 30. The method of embodiment 28, further comprising clamping tissue between a curved tissue clamping interface on the support jaw and a curved tissue clamping interface on the anvil. Aspect 31 an anvil coupled to the support jaws so as to be movable between a clamping configuration in which the anvil and the support jaws are configured to clamp tissue positioned therebetween and a closed configuration in which a tissue clamping interface on the anvil abuts a tissue clamping interface on the cartridge, the anvil and the support jaws defining an envelope diameter when the anvil is in the closed configuration; a translating cutting mechanism having a first member having a cutting portion and a second member, the translating cutting mechanism being movable between a folded configuration in which the cutting mechanism is shaped to fit within the envelope diameter and an expanded configuration in which the cutting mechanism does not fit within the envelope diameter; A surgical stapler comprising: the support jaw comprises a cartridge having a first slot configured to receive the translating cutting mechanism, a second slot configured to accommodate at least a first staple of the plurality of staples, and a third slot configured to accommodate at least a second staple of the plurality of staples. Surgical stapler. Aspect 32 A surgical stapler as described in aspect 31, wherein at least one of the first member or the second member has at least one guide portion configured to engage with a corresponding guide portion on the anvil to limit the cutting mechanism to translational movement relative to the corresponding guide portion. Aspect 33 The envelope diameter is 5.6 mm or less; or The envelope diameter is 8.6 mm or less. 33. A surgical stapler according to claim 31 or 32, wherein the stapler is one of the above. Aspect 34 a first actuator coupled to the first member, the first actuator configured to move the first member distally and onto the anvil; a second actuator coupled to the second member, the second actuator configured to move the second member distally and onto the support jaw; 34. The surgical stapler of any one of aspects 31 to 33, further comprising: Aspect 35 35. The surgical stapler of claim 34, wherein the first actuator comprises a flexible member. Aspect 36 the first member includes at least one leg having a first flange; A surgical stapler described in any one of aspects 31 to 35, wherein the second member has at least one leg portion having a second flange, and the first flange and the second flange are shaped to limit expansion of the cutting mechanism. Aspect 37 A surgical stapler according to any one of aspects 31 to 36, wherein the cutting mechanism is configured to compress the anvil and the support jaws toward each other and into the clamping configuration as the cutting mechanism translates toward the distal end of the surgical stapler. Aspect 38 38. A surgical stapler according to any one of aspects 31 to 37, wherein the stapler has an envelope diameter of 5.6 mm in the closed configuration and the stapler is configured to staple and cut tissue clamped between the anvil and the support jaws such that the cut tissue has a sleeve width of greater than 0.5 mm.

Claims

1. A component of a surgical stapler, comprising: a support jaw having a cartridge containing a plurality of B-shaped staples; an anvil coupled to the support jaws, the anvil movable relative to the support jaws to form a closed configuration in which a first tissue clamping interface on the anvil abuts a second tissue clamping interface on the cartridge; a cutting mechanism having a first member and a second member, the first member being longitudinally movable relative to the support jaws, the first member being movable relative to the second member to vary the height of the cutting mechanism, and the cutting mechanism being movable between an expanded configuration having a dimension greater than an envelope diameter when the anvil and support jaws are in the closed configuration, and a collapsed configuration having a dimension less than the envelope diameter; Equipped with the cartridge further comprising a first slot configured to receive at least a portion of the cutting mechanism, a second slot configured to accommodate at least a first staple of the plurality of B-shaped staples, and a third slot configured to accommodate at least a second staple of the plurality of B-shaped staples. Components of a surgical stapler.

2. a leg length of at least one staple of the plurality of B-shaped staples is at least 53% of the envelope diameter; 10. A component of the surgical stapler of claim 1.

3. The surgical stapler component of claim 2 , wherein the leg length is 3.42 mm or greater.

4. The surgical stapler component of claim 2 , wherein the leg length is 4.72 mm or greater.

5. The surgical stapler component of claim 1 , wherein the envelope diameter is 5.6 mm or less.

6. The surgical stapler component of claim 1 , wherein the envelope diameter is 8.6 mm or less.

7. 2. The surgical stapler component of claim 1, wherein the third slot is configured to receive a second staple of the plurality of B-shaped staples at an oblique angle relative to the first staple of the plurality of B-shaped staples.

8. The surgical stapler component of claim 7, wherein the angle is between 4° and 30°.

9. The surgical stapler component of claim 1 , wherein a first member of the cutting mechanism is configured to engage an outer surface of the anvil.

10. The surgical stapler component of claim 1 , wherein the cutting mechanism includes a cutter blade between the first member and the second member.

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