Surgical stapler with partial pockets
By adopting flat anvil and tilt slider design in surgical staples, the adaptability problem of traditional surgical staples in small incisions and pipes is solved, achieving smaller incisions and higher reliability staple operation.
Patent Information
- Application Number
- JP2024194367
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2013-03-14
- Filing Date
- 2024-11-06
- Publication Date
- 2025-02-06
AI Technical Summary
Surgical staples used in traditional laparoscopic surgery need to be used in larger incisions, making it difficult to adapt to smaller incisions and pipe diameters, resulting in inconvenience in operation and increased manufacturing complexity.
A surgical staple is designed with a flat anvil that does not require grooves on the surface of the anvil, combined with an inclined nail legs and slider design that pushes the staple directly through the slider to reduce assembly number and space requirements, adapting to smaller cuts and pipe diameters.
Effective operation within a 5-10mm pipe is achieved, reducing manufacturing complexity and cost, while improving operation reliability and simplicity, reducing the size and recovery time of surgical incisions.
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Figure 2025019074000001_ABST
Abstract
Description
[Technical field]
[0001] SUMMARY OF THE DISCLOSURE The present disclosure relates to surgical instruments and, more particularly, to surgical stapling instruments and staples for sequentially applying a plurality of surgical staples to body tissue.
[0002] Description of Related Applications This application claims priority to and the benefit of U.S. Provisional Patent Application No. 61 / 785,100, filed March 14, 2013, entitled "Surgical stapler with partial pockets," which is incorporated herein by reference in its entirety. [Background technology]
[0003] A typical surgical stapler-type instrument has two elongated jaw members joined together at a handle at a proximal end and a hinge at a distal end. The jaw members are articulated to open and close to capture tissue between the jaw members. A user controls the instrument from the handle to open and close the jaw members to deploy the staples, and generally operates and controls the instrument. One of the jaw members supports a disposable cartridge containing two or more rows of staples. The other jaw member has an anvil against which the staples are struck to deform the legs of the staples. The staples are driven out of the cartridge by a camming surface or slider that moves longitudinally against a plurality of laterally positioned pushers that individually push each staple out of the cartridge. The camming surfaces of the slider are angled to complement the angled surfaces of the pushers. Cooperation of the inclined surfaces of the pusher and slider with each other is a critical step in the surgical stapling process. Misalignment can cause the staples to jam the instrument. Some staplers have a blade that follows a camming surface to cut tissue between two or more rows of deployed staples.
[0004] Surgical staplers are used in a variety of surgical techniques, including laparoscopic and / or endoscopic or other minimally invasive surgical procedures, in which the stapler is inserted through a cannula or tube positioned within a small incision made in the patient's body. In laparoscopic, endoscopic or minimally invasive surgery, a trocar or cannula is inserted across the patient's body tissue to access the body cavity and create a channel for the insertion of a camera, e.g., a laparoscope. The camera provides a live video feed capturing image, which is then displayed to the surgeon on one or more monitors. Additional trocars are inserted to create additional pathways, and surgical instruments, including surgical staplers, are inserted into the additional pathways to perform the procedure as viewed on the monitor. The location of the target tissue, e.g., the abdomen, typically pumps carbon dioxide gas into the body cavity to create a working space large enough to accommodate the scope and instruments used by the surgeon. Insufflation pressure within the body cavity is maintained through the use of specialized trocars equipped with seals that prevent insufflation gases from escaping and collapsing the surgical working space. Laparoscopic surgery offers many advantages over open procedures, including reduced pain and bleeding and shorter recovery times. Summary of the Invention [Problem to be solved by the invention]
[0005] As laparoscopic surgery progresses to become less invasive with smaller incisions and smaller cannula diameters, surgical staplers used in laparoscopic / endoscopic procedures must be designed to fit within the small diameter lumen of the cannula. Typically, a surgical stapler is inserted into a cannula with its jaws oriented in a closed position relative to the patient's body where they open to grasp and staple tissue. The handle of the stapler is located outside the patient's body under the control of a surgeon user. The portion of the stapler shaft between the jaws and the handle is long enough to extend from outside the patient's body into the patient's body. During a surgical procedure, the elongated shaft of the stapler is located inside the cannula through which it is inserted. The distal jaw includes many components, such as an anvil for forming the staples, a staple cartridge with a plurality of staples, camming surfaces, such as sliders, pushers, blades, and other components, all of which must be small enough to fit through a small diameter cannula and be made to function reliably and repeatedly from outside the patient's body. Conventional laparoscopic staplers are approximately 12 millimeters in diameter, whereas the present invention provides a surgical stapler designed to fit inside a cannula as small as about 5-10 mm in diameter. [Means for solving the problem]
[0006] According to one aspect of the present invention, a surgical stapler is provided. The surgical stapler includes a handle assembly and a cartridge assembly removably coupled to the handle assembly. The cartridge assembly includes a proximal end and a distal end, the cartridge assembly including a jaw assembly at the distal end. The jaw assembly includes a first jaw and a second jaw. The first jaw has an anvil surface and the second jaw has a top surface. The second jaw is movable relative to the first jaw, the jaw assembly having a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface. The second jaw has first and second surfaces that are substantially parallel to each other and perpendicular to the top surface. A first slot is formed between the first and second surfaces and extends along the length of the second jaw. The first slot has a slot width. A plurality of recesses are formed in the first surface. Each recess has a recess wall, a front sidewall, and a rear sidewall. The second jaw has a plurality of staple pockets. Each staple pocket is defined by a recessed wall, a front sidewall, a rear sidewall, a bottom wall of the second jaw, a second surface, and an opening in the top surface of the second jaw. The bottom wall is formed as part of the first surface, the second surface, or the other surface. An actuator is coupled to the handle assembly. The cartridge assembly includes a first camming surface having a thickness. The first camming surface is movable by the actuator within the first slot and along the length of the second jaw. A plurality of staples are contained within the plurality of staple pockets. Each staple has a staple width, and each staple is disposed within the pocket such that a portion of the staple width is located within the first slot and a portion of the slot width is located within and supported by the recess in the first surface. The bottom wall is formed as part of the first surface, the second surface, or the other surface, and is configured such that the first camming surface contacts a portion of the staple.Translation of the first camming surface within the first slot causes the first camming surface to pass through one or more staple pockets and contact the aforementioned portion of the staple width located within the first slot, thereby forcing the staple out of the opening and against the anvil surface.
[0007] In accordance with another aspect of the present invention, a surgical stapler is provided. The surgical stapler includes a handle assembly and a cartridge assembly removably coupled to the handle assembly. The cartridge assembly includes a proximal end and a distal end. A jaw assembly is disposed at the distal end of the cartridge assembly. The jaw assembly has a longitudinal axis and includes a first jaw coupled to a second jaw. The first jaw has an anvil surface that is a smooth, flat surface without staple forming pockets. The second jaw has a top surface. The second jaw is movable relative to the first jaw and has a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface. The second jaw includes a plurality of staple pockets. Each staple pocket has an opening located at the longitudinal axis and the top surface. An actuator is coupled to the handle assembly. At least one camming surface is movable within and along the length of the second jaw by the actuator. A plurality of staples are positioned within the staple pocket. Each staple has at least a first leg and a second leg connected to one another by a base, and each staple has an open configuration for penetrating tissue and a closed configuration for retaining tissue. The plurality of staples are disposed within the staple pocket in the open configuration. With the jaw assembly in the closed position, translation of the camming surface along the second jaw ejects the staples from the staple pocket toward the anvil surface of the first jaw, thereby transforming the staples from the open configuration to the closed configuration against the anvil surface.
[0008] In accordance with another aspect of the present invention, a surgical stapler is provided. The surgical stapler includes a handle assembly and a cartridge assembly removably coupled to the handle assembly. The cartridge assembly includes a proximal end and a distal end. A jaw assembly is disposed at the distal end of the cartridge assembly. The jaw assembly has a longitudinal axis and includes a first jaw coupled to a second jaw. The first jaw has an anvil surface that is a smooth, flat surface without staple forming pockets. The second jaw has a top surface. The second jaw is movable relative to the first jaw and has a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface. The second jaw includes a plurality of staple pockets. Each staple pocket has an opening located at the longitudinal axis and the top surface. An actuator is coupled to the handle assembly. At least one camming surface is movable within and along the length of the second jaw by the actuator. A plurality of staples are positioned inside the staple pocket. Each staple has an open configuration for penetrating tissue and a closed configuration for retaining tissue. The plurality of staples are disposed within the staple pocket in the open configuration. With the jaw assembly in the closed position, translation of the camming surface along the second jaw ejects the staples from the staple pocket toward the anvil surface of the first jaw, thereby transforming the staples from the open configuration against the anvil surface to the closed configuration.
[0009] In accordance with another aspect of the present invention, a surgical stapler is provided. The surgical stapler has a handle assembly and a cartridge assembly removably coupled to the handle assembly. The cartridge assembly includes a proximal end, a distal end, and a jaw assembly located at the distal end. The jaw assembly includes a first jaw having a longitudinal axis and coupled to a second jaw. The first jaw has an anvil surface and the second jaw has a top surface. The second jaw is movable relative to the first jaw and has a closed position in which the anvil surface is adjacent to the top surface and a gap is defined between the top surface and the anvil surface. The second jaw has a plurality of staple pockets with a plurality of openings located at the top surface. The staple pockets are arranged in at least three substantially parallel rows along the top surface of the second jaw. The stapler has an actuator coupled to the handle assembly and at least one camming surface movable along a length of the second jaw by the actuator. A blade is provided and configured to be movable within a gap formed between the top surface and the anvil surface when the first and second jaws are in a closed position. The blade is configured to sever tissue disposed between the first and second jaws defining a cut line. A plurality of staples are disposed within the plurality of staple pockets. A camming surface is configured to eject the staples from the staple pockets against the anvil surface, where translation of the camming surface along the second jaw deforms the staples. The second jaw has a number of rows of staple pockets on one side of the blade, the number of rows being different than the number of rows of staple pockets on the other side of the blade cut line.
[0010] In accordance with another aspect of the present invention, a surgical stapler is provided. The surgical stapler includes a handle assembly removably connected to a cartridge assembly. The cartridge assembly includes a jaw assembly located at a distal end. The jaw assembly has a longitudinal axis, the jaw assembly including a first jaw connected to a second jaw. The first jaw has a longitudinal axis and an anvil surface. The anvil surface has a series of parallel channels. Each channel has a length and each channel may be of any shape, e.g., semi-cylindrical, curved, concave, square or rectangular, and has a surface configured to assist in closing the staples in a desired orientation. The length of the channels is perpendicular to the longitudinal axis of the jaw assembly. The second jaw has a top surface and is movable relative to the first jaw. The jaw assembly has a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface. The second jaw has a plurality of staple pockets. Each staple pocket has an opening located at the top surface. An actuator is provided coupled to the handle assembly. The stapler has at least one camming surface movable within and along the length of the second jaw by the actuator. A blade is provided and configured to be movable within a gap formed between the top surface and the anvil surface when the first and second jaws are in a closed position. The blade is configured to sever tissue disposed between the first and second jaws defining a cut line. A plurality of staples are disposed within the plurality of staple pockets. Each staple has an open configuration that penetrates tissue and a closed configuration that retains tissue. The plurality of staples are received within the staple pockets in the open configuration. A channel extends across the anvil surface on each side of the cut line. With the jaw assembly in the closed position, translation of the camming surface along the second jaw ejects the staples from the staple pockets toward the anvil surface of the first jaw, thereby transforming the staples from an open configuration against the anvil surface to a closed configuration.The channels are configured to allow for the formation of the staples into a closed configuration.
[0011] According to another aspect of the present invention, a surgical stapler is provided. The surgical stapler has a handle assembly removably connected to a cartridge assembly. The cartridge assembly includes a proximal end, a distal end, and a jaw assembly located at the distal end. The jaw assembly has a longitudinal axis, the jaw assembly including a first jaw connected to a second jaw. The first jaw has a longitudinal axis and an anvil surface. The anvil surface has a series of parallel channels. Each channel has a length, and each channel may be of any shape, for example, curved, concave, semi-cylindrical, square or rectangular, and has a surface configured to aid in closing the staples in a desired direction. The length of each channel is parallel to the longitudinal axis of the jaw assembly and is movable relative to the anvil surface. The second jaw has a top surface. The second jaw is movable relative to the first jaw. The jaw assembly has a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface. The second jaw has a plurality of staple pockets with a plurality of openings located at a top surface. The staple pockets are arranged in parallel rows along a top surface of the second jaw. An actuator is provided, the actuator being coupled to the handle assembly. At least one camming surface is movable within the second jaw and along a length of the second jaw by the actuator. The surgical stapler further has a plurality of staples positioned inside the staple pockets. Each staple has an open configuration for penetrating tissue and a closed configuration for retaining tissue. The plurality of staples are disposed within the staple pockets in the open configuration. With the jaw assembly in the closed position, translation of the camming surface along the second jaw ejects the staples from the staple pockets toward the anvil surface of the first jaw, whereby the staples transform from the open configuration against the anvil surface to the closed configuration. The channel is configured to permit formation of the staples into the closed configuration.
[0012] In accordance with another aspect of the present invention, a surgical stapler is provided. The surgical stapler includes a handle assembly removably coupled to a cartridge assembly. The cartridge assembly includes a proximal end, a distal end, and a jaw assembly located at the distal end. The jaw assembly includes a first jaw coupled to a second jaw. The first jaw has an anvil surface and the second jaw has a top surface. The first jaw is coupled to the second jaw such that the second jaw is movable relative to the first jaw. The jaw assembly has a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface. The second jaw has first and second surfaces that are substantially parallel to each other and perpendicular to the top surface. The first surface has a plurality of recesses formed therein. Each recess has a recess wall, a front sidewall, a rear sidewall, and a bottom wall. The second jaw has a plurality of staple pockets. Each staple pocket is defined by a respective recess that includes an opening that opens into the top surface of the second jaw. The first surface has a plurality of longitudinally extending grooves formed therein. The surgical stapler further includes an actuator coupled to the handle assembly. A first camming surface is also provided. The first camming surface has a plurality of protrusions sized and configured to fit within and translate within the longitudinally extending grooves of the first surface. The first camming surface is movable along the length of the second jaw by the actuator. The surgical stapler has a plurality of staples positioned within a plurality of staple pockets. Each staple has a staple width, and each staple is positioned within and supported by the staple pocket. Translation of the first camming surface along the jaw assembly causes the protrusions of the first camming surface to pass through one or more staple pockets and contact a portion of the staple width, thereby forcing the staples out of the opening and against the anvil surface. [Brief description of the drawings]
[0013] [Figure 1] 1 is a perspective view of a surgical stapler of the present invention; [Diagram 2] FIG. 2 is a side view of the stapler cartridge assembly of the present invention; [Diagram 3] FIG. 2 is a semi-transparent side view of the proximal end of the stapler cartridge assembly of the present invention. [Figure 4] FIG. 2 is a side view of the actuator shaft and I-beam of the present invention. [Diagram 5] FIG. 2 is a perspective view of the distal end of the actuator shaft and I-beam of the present invention. [Figure 6] FIG. 2 is a perspective view of an I-beam of the present invention. [Figure 7] FIG. 2 is a side view of an I-beam of the present invention. [Figure 8] FIG. 2 is an end view of an I-beam of the present invention. [Figure 9] FIG. 2 is a perspective view of an end effector with the jaws in an open position in accordance with the present invention; [Figure 10] FIG. 2 is a bottom perspective view of the upper jaw of the present invention; [Figure 11] FIG. 2 is an end view of the upper jaw of the present invention; [Figure 12] FIG. 13 is a bottom perspective view of an upper jaw with a curved channel in accordance with the present invention. [Figure 13] FIG. 13 is an end view of an upper jaw with a curved channel of the present invention. [Figure 14] FIG. 2 is a top perspective view of the lower jaw of the present invention; [Figure 15] FIG. 2 is a side view of the lower jaw of the present invention. [Figure 16] FIG. 2 is a rear top perspective view of the lower jaw of the present invention; [Figure 17] FIG. 1 is a top perspective view of a staple cartridge of the present invention; [Figure 18] FIG. 1 is a top perspective view of a staple cartridge of the present invention; [Figure 19] FIG. 2 is an exploded top perspective view of the staple cartridge of the present invention; [Figure 20] FIG. 2 is a side view of a first plate of the staple cartridge of the present invention; [Figure 21] FIG. 2 is a top cross-sectional perspective view of the staple cartridge of the present invention; [Figure 22] FIG. 2 is a cross-sectional top perspective view of the staple cartridge, I-beam and slider of the present invention; [Figure 23] 1 is a schematic representation of tissue in an ejected state having an asymmetric staple cartridge of the present invention applied thereto; [Figure 24] 1 is a schematic diagram of an asymmetric stapler gripping tissue in accordance with the present invention. [Diagram 25] 1 is a schematic diagram of an asymmetric stapler with a curved end effector in accordance with the present invention. [Figure 26] FIG. 2 is a top perspective view of the slider of the present invention. [Figure 27] FIG. 2 is an end view of the slider of the present invention. [Figure 28] FIG. 2 is a side view of the slider of the present invention. [Figure 29] FIG. 2 is a plan view of the slider of the present invention. [Diagram 30] FIG. 2 is a rear top perspective view of the slider of the present invention. [Diagram 31] FIG. 2 is a top perspective view of the staple of the present invention; [Diagram 32] FIG. 2 is a side view of the staple of the present invention. [Diagram 33] FIG. 2 is an end view of the staple of the present invention; [Diagram 34] FIG. 2 is a plan view of the staple of the present invention. [Diagram 35] FIG. 2 is a top perspective view of a staple in a closed configuration in accordance with the present invention; [Diagram 36] FIG. 2 is a side view of a staple in a closed configuration in accordance with the present invention. [Figure 37] FIG. 2 is an end view of a staple in a closed configuration in accordance with the present invention. [Figure 38] FIG. 2 is a side view of a staple with barbs in accordance with the present invention; [Figure 39] FIG. 2 is a side view of a staple with barbs in accordance with the present invention; [Diagram 40]FIG. 13 is a cross-sectional top perspective view of four pronged staples and a slider positioned within a staple pocket in accordance with the present invention; [Diagram 41] FIG. 2 is a semi-transparent cross-sectional top perspective view of a slider and a lower jaw and a plurality of four-pronged staples loaded within the slider in accordance with the present invention; [Figure 42A] FIG. 1 is a top perspective view of a four pronged staple of the present invention. [Figure 42B] FIG. 2 is a side view of a four-pronged staple of the present invention. [Figure 42C] FIG. 2 is a plan view of a four-pronged staple of the present invention. [Fig.42D] FIG. 2 is an end view of a four pronged staple of the present invention. [Figure 43A] FIG. 1 is a top perspective view of a four pronged staple of the present invention. [Figure 43B] FIG. 2 is a top perspective view of the staple of the present invention; [Figure 44A] FIG. 1 is a top perspective view of a four pronged staple of the present invention. [Figure 44B] FIG. 2 is a side view of a four-pronged staple of the present invention. [Figure 44C] FIG. 2 is a plan view of a four-pronged staple of the present invention. [Fig.44D] FIG. 2 is an end view of a four pronged staple of the present invention. [Figure 45A] FIG. 1 is a top perspective view of a four pronged staple of the present invention. [Figure 45B] FIG. 2 is a side view of a four-pronged staple of the present invention. [Figure 45C] FIG. 2 is a plan view of a four-pronged staple of the present invention. [Figure 45D] FIG. 2 is an end view of a four pronged staple of the present invention. [Figure 46A] FIG. 1 is a top perspective view of a six-pronged staple of the present invention. [Figure 46B] FIG. 1 is a side view of a six-pronged staple of the present invention. [Figure 46C]FIG. 1 is a plan view of a six-pronged staple of the present invention. [Figure 46D] FIG. 2 is an end view of a six-pronged staple of the present invention. [Figure 47A] FIG. 13 is a cross-sectional side view of staples positioned within staple pockets of the lower and upper jaws of the present invention. [Figure 47B] FIG. 13 is a cross-sectional side view of the staple of the present invention contacting the upper jaw. [Figure 47C] 11 is a cross-sectional side view showing a staple being deformed against an upper jaw in accordance with the present invention; FIG. [Figure 48] FIG. 2 is a plan view of a plurality of staples connected to a spine in accordance with the present invention; [Figure 49] FIG. 13 is a top perspective view of a staple cartridge inserted into a lower jaw in accordance with the present invention; [Figure 50] FIG. 13 is a top perspective view of a staple cartridge inserted into a lower jaw in accordance with the present invention; [Figure 51] FIG. 13 is a top perspective view of a staple cartridge being inserted into a lower jaw in accordance with the present invention; [Figure 52] FIG. 13 is a top perspective view of a staple cartridge being inserted into a lower jaw in accordance with the present invention; [Figure 53] 1 is a transparent cross-sectional view of a handle assembly of the present invention; [Figure 54] FIG. 2 is a top rear perspective view of the end effector with the upper jaw in an open position in accordance with the present invention; [Figure 55] FIG. 2 is a top rear perspective view of the end effector with the upper jaw in a closed position in accordance with the present invention. [Figure 56] FIG. 1 is a side view of an end effector with the jaws in an open position in accordance with the present invention. [Figure 57] FIG. 2 is a side view of an end effector with the upper jaw in a closed position in accordance with the present invention. [Figure 58] FIG. 2 is a cross-sectional top perspective rear view of the surgical stapler of the present invention; [Figure 59] FIG. 2 is a semi-transparent cross-sectional perspective view of the handle assembly of the present invention as viewed from above and behind. [Figure 60] FIG. 2 is a cross-sectional side view of the handle assembly of the present invention. [Figure 61] FIG. 2 is a semi-transparent cross-sectional side view of an end effector of the present invention. [Figure 62] FIG. 2 is a semi-transparent cross-sectional side view of an end effector of the present invention. [Figure 63] FIG. 2 is a semi-transparent cross-sectional top perspective view of the end effector of the present invention. [Figure 64] FIG. 2 is a semi-transparent cross-sectional side view of a handle assembly of the present invention. [Figure 65] FIG. 2 is a semi-transparent cross-sectional top perspective view of the handle assembly of the present invention; [Figure 66] FIG. 2 is a semi-transparent side view of an end effector with the upper jaw in an open position in accordance with the present invention. [Figure 67] FIG. 2 is a semi-transparent end view of the end effector of the present invention. [Figure 68] FIG. 2 is a cross-sectional top perspective view of the plate, slider and staple of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0014] 1, a perspective view of a surgical stapler 10 of the present invention is shown. Stapler 10 is comprised of a handle assembly 12 that is removably coupled to a stapler cartridge assembly 14. Handle assembly 12 is configured to control the instrument and effect deployment of staples disposed within the distal end of stapler cartridge assembly 14. After the staples are extended from stapler 10, stapler cartridge assembly 14 is removed from handle assembly 12 and a new stapler cartridge assembly 14 is coupled to handle assembly 12 to continue stapling.
[0015] The stapler cartridge assembly 14 will now be described in detail with reference to FIG. 2. The stapler cartridge assembly 14 includes a connector 16 at a proximal end and an end effector 18 at a distal end. An outer tube 20 is connected to the end effector 18 at a distal end and to the connector 16 at a proximal end. An actuator shaft 22 is disposed within the lumen of the outer tube 20. The outer tube 20 is substantially cylindrical and has an outer diameter of approximately 5-10 mm. The actuator shaft 22 is configured to slide longitudinally relative to the outer tube 20. Details of the distal end of the stapler cartridge assembly 14 are shown in FIG. 3.
[0016] Referring to FIG. 3, the distal end of the stapler cartridge assembly 14 is shown. The connector 16 has a bolt 24 extending laterally outward from an outer surface of the connector 16. A similar bolt 24 extends on the opposite side of the connector 16, which is not visible in FIG. 3. The bolt 24 is configured for bayonet connection with the handle assembly 12 of the stapler, which has a complementary slot to receive the bolt 24 to secure the cartridge assembly 14 to the handle assembly 12. FIG. 3 also shows the actuator shaft 22 moved proximally relative to the outer tube 20, as compared to FIG. 2, which shows the actuator shaft 22 moved distally relative to the outer tube 20. As can be seen in FIG. 3, the proximal end of the actuator shaft 22 has a bolt 26 extending laterally outward from the actuator shaft 22. The bolt 26 is configured for bayonet connection with the actuator shaft of the handle assembly 12, which has a complementary slot to receive the bolt 26. The bolt 24 of the connector 16 is coupled to the handle assembly 12, at the same time that the bolt 26 of the actuator shaft 22 is coupled to the actuator shaft of the handle assembly 12. When connected to the handle assembly 12, the handle assembly 12 is used to move the actuator shaft 22 back and forth within the outer tube 20 to open and close the distal jaws and deploy staples.
[0017] The actuator shaft 22 will now be described with reference to FIG. 4. The actuator shaft 22 is an elongated shaft having a substantially cylindrical proximal portion 28 at its proximal end with an actuator bolt 26 connectable to an actuator of the handle assembly 12. The substantially cylindrical portion 28 is sized to fit snugly within the lumen of the outer tube 20. The cylindrical portion 28 is connected by a pin to an extended I-beam portion 30 towards the distal end of the actuator shaft 22. The distal end of the actuator shaft 22 has an I-beam 32 connected to the extended I-beam portion 30. The I-beam 32 is connected to the extended I-beam portion 30 as shown in FIG. 5.
[0018] The I-beam 32 will now be described with reference to Figures 6-8. The I-beam 32 has a top portion 34 and a bottom portion 36 connected to each other by a middle portion 38. The top portion 34 has a beveled front end 40 and a curved top. The middle portion 38 has a blade 42 and a beveled portion 44 at its front end. The middle portion 38 has an extension 46 at its rear end that can be connected to the extended I-beam portion 30 as shown in Figure 5. The bottom portion 36 is connected to the front end of the I-beam 32 and has a curved bottom. A front view of the I-beam is shown in Figure 8, which shows the profile shape in the shape of a capital letter "I".
[0019] The end effector 18 will now be described with reference to FIG. 9. The end effector 18 has an upper jaw 48 hinged to a lower jaw 50. At least one staple cartridge 52 containing a plurality of staples 54 is disposed within the lower jaw 50. The at least one staple cartridge 52 is configured to receive a plurality of staples 54, which are not visible in FIG. 9. The end effector 18 also has a slider 56 configured to push the staples 54 out of the cartridge 52. The slider 56 is not visible in FIG. 9.
[0020] The upper jaw 48 will now be described with reference to Figures 10 and 11. The upper jaw 48 has a flat anvil surface 58 or plate with a central slot 60. The central slot 60 is elongated with an open proximal end. The central slot 60 is sized and shaped to receive at least a portion of the intermediate portion 38 of the I-beam 32 therein so that the I-beam 32 slides therethrough relative to the upper jaw 48. The outer surface of the upper jaw 48 is substantially semicircular in shape to match the cylindrical lumen of the cannula through which the upper jaw is inserted. The upper jaw 48 has a top cover 62. The top cover 62 forms a part of the outer periphery of the upper jaw 48 and together with the anvil surface 58 defines a passage 64 therebetween for receiving the top portion 34 of the I-beam 32 therebetween so that the top portion 34 slides therethrough relative to the upper jaw 48. The upper jaw 48 further has a flange at its proximal end having a hole for receiving a pin and which is connected to a lower jaw 50 .
[0021] A typical anvil in a conventional surgical stapler has staple forming pockets on its surface designed to receive the legs of the staples and guide, tilt, and bend the staple legs as they are pressed against the anvil. These surface features of the typical anvil aid in the deformation of the staples when the anvil is deployed to achieve proper staple formation. Misalignment between the staple forming pockets and the staples can result in the staples failing to enter the staple forming pockets, resulting in catastrophic failure of the staple line. Careful staple forming pockets pose significant manufacturing challenges and increase manufacturing costs. Advantageously, the present invention does not utilize staple forming pockets on the anvil surface. The anvil surface is smooth and / or flat. By eliminating the need to redesign the staples to form anvil pockets, the anvil pockets are eliminated entirely, simplifying the design while advantageously providing an additional level of reliability to the stapler 10. If misalignment is minor, it is no longer a concern, especially with flat plate designs. The simplified design is also a great advantage to manufacturing as the costs associated with the anvil are reduced and there is no longer a need for ultra-precise parts to maintain perfect alignment. In one form, the anvil surface 58 is completely flat as shown in FIG. 10. In another form, shown in FIG. 12, the anvil surface has a series of curved channels 66 with a substantially smooth surface that allows the staples to be applied and deformed into the proper configuration. The length of the channels 66 is perpendicular to the longitudinal axis of the upper jaw 48. The wavy configuration of the channels 66 forms a central slot 60 in the anvil surface and alleviates the need for critical side-to-side alignment. Critical alignment of the staples is not necessary as the channels 66 are wide enough to easily accept the staple legs. The curvature of the channels 66 helps to deflect the staple legs in the proper direction. In another form, the anvil surface has two or more longitudinal curved channels 68 extending along the axis of the instrument as shown in FIG.The elongated curved channels 66, 68 allow for the formation of staples 54 without the worry and expense of proper alignment of each staple with each staple forming pocket. Although the channels 66, 68 are shown curved, the channels may have a square or rectangular cross section which aids in closing the staples in a desired orientation.
[0022] The lower jaw 50 will now be described with reference to Figures 14-16. The lower jaw 50 is an elongated piece sized and shaped to complementarily fit with the upper jaw 48. The lower jaw 50 has an open top and a curved outer surface. The cross section of the lower jaw 50 is substantially semicircular in shape except at the proximal end where the cross section of the lower jaw is substantially circular. The depending flange of the upper jaw 48 is attached to the lower jaw 50 by a pin inserted into a hole in the lower jaw 50 near the proximal end. When attached together, the upper jaw 48 and the lower jaw 50 create a substantially cylindrical profile. The distal end of the lower jaw 50 is angled and the cylindrical proximal end includes a vertically oriented slot 70 visible in Figure 16. The slot 70 is sized and shaped to receive the extended I-beam portion 30 of the actuator shaft 22, which itself is located within the lower jaw 50 distal to the slot 70. The cylindrical proximal end is adapted to be attached to the outer tube 20. The lower jaw 50 further includes a staple cartridge receiving portion 72. When one or more staple cartridges 52 are inserted into the staple cartridge receiving portion 72 of the lower jaw 50, a passageway is formed between the one or more staple cartridges 52 and a bottom cover 74. The passageway is sized and shaped to receive the bottom portion 36 of the I-beam 32, which slides longitudinally within the passageway relative to the lower jaw 50. A shelf 76 is provided within the staple cartridge receiving portion 72 at a distal end thereof to secure a front end of the one or more staple cartridges 52. A tongue 78 is formed at the proximal end of staple cartridge 52 for mating with a groove in staple cartridge 52 to secure the proximal end of staple cartridge 52 in lower jaw 50. A cartridge retainer 80, shown in FIG. 9, covers the tongue on the distal end of staple cartridge 52 after staple cartridge 52 is inserted into lower jaw 50.
[0023] The staple cartridge 52 will now be described with reference to Figures 17-22. The staple cartridge 52 includes a first plate 82, a second plate 84, and a third plate 86 connected to one another. The plates 82, 84, and 86 are made of any polymeric material, metal, such as aluminum or stainless steel, or glass-filled nylon. The first plate 82 is elongated and substantially rectangular in shape, and includes an outer surface 88 and an inner surface 90. The outer surface 88 is smooth, and the inner surface 90 includes a plurality of staple retaining locations 92. The staple retaining locations 92 are recesses formed in the inner surface 90 of the first plate 82. Each staple retaining location 92 is substantially U-shaped, and each staple retaining location is defined by a front sidewall 94 formed opposite and substantially parallel to a rear sidewall 96. The rear sidewall 96 is interconnected to the bottom wall 98 to form an L-shaped continuous wall defining a gap 100 between the bottom wall 98 and the front sidewall 94. In one form, the gap 100 is not formed. Instead, the bottom wall 98 is interconnected to both the front sidewall 94 and the rear sidewall 96 to form a complete U-shaped staple retaining location 92. The U-shaped staple retaining location is angled at approximately 30° to 90°, with 90° being a vertical orientation with no angle. The recessed wall 99 is recessed relative to the inner surface 90. The first plate is approximately 0.020 to 0.025 inches (0.508 to 0.635 mm) thick and the depth of each recess or thickness of each sidewall 94, 96, 98 is approximately 0.005 to 0.008 inches (0.127 to 0.203 mm). The staple retaining location 92 is configured to partially receive and retain a complementary substantially U-shaped staple having a thickness greater than the thickness of the side walls 94, 96, 98. The distal end of the first plate 82 includes a tongue 102 and the proximal end of the first plate 82 includes a groove 104 interlockable with the shelf 76 and tongue 78 of the lower jaw 50. The distal and proximal ends of the first plate 82 further include spacers 103, 105, respectively, that extend inwardly and are configured to space the inner surface 90 from the second plate 84. The first plate 82 is made of metal or plastic.
[0024] The second plate 84 or middle shim 84 is a thin, elongated, substantially rectangular plate of metal or plastic with a smooth exterior surface. The second plate 84 is approximately 0.01-0.02 inches (0.254-0.508 mm) thick. The distal end has a tongue 106 and the proximal end has a groove 108 configured to couple with the shelf 76 and tongue 78 of the lower jaw 50. In another embodiment, two second plates 84a, 84b are provided, each second plate having a thickness of approximately 0.005 inches (0.127 mm). One second plate 84a is flexed such that it exerts a force toward the first plate 82, and the other second plate 84b is flexed such that it exerts a force toward the third plate 86.
[0025] The third plate 86 is substantially identical to and a mirror image of the first plate 82. The third plate 86 is elongated and substantially rectangular in shape, the third plate having an outer surface 110 and an inner surface 112. The outer surface 110 is smooth and the inner surface 112 includes a plurality of staple retaining locations 92 that are substantially identical to and mirror images of the plurality of staple retaining locations 92 of the first plate 82. The staple retaining locations 92 are recesses formed in the inner surface 112 of the third plate 86. Each staple retaining location 92 is substantially U-shaped and is defined by two opposed, substantially parallel side walls, a front side wall 94 and a rear side wall 96. The rear side wall 96 forms an L-shaped continuous wall interconnected to a bottom wall 98 defining a gap 100 between the bottom wall 98 and the front side wall 94. In one form, the gap 100 is not formed. Alternatively, bottom wall 98 is interconnected to both front sidewall 94 and rear sidewall 96 to form a complete U-shaped staple retaining location 92. Recessed wall 99 is recessed relative to inner surface 112. The U-shaped staple retaining location is angled at approximately 30°-90°, with 90° being a vertical orientation with no angle. The third plate is approximately 0.020-0.025 inches (0.508-0.635 mm) thick and the depth of each recess or thickness of each sidewall 94, 96, 98 is approximately 0.005-0.008 inches (0.127-0.203 mm). Staple retaining location 92 is configured to partially receive and retain a complementary substantially U-shaped staple that is thicker than the thickness of sidewalls 94, 96, 98. The distal end of the third plate 86 includes a tongue 114 and the proximal end of the third plate 86 includes a groove 116 interlocking with the shelf 76 and tongue 78 of the lower jaw 50. The distal and proximal ends of the third plate 86 further include spacers 115, 117, respectively, that extend inwardly and are configured to space the inner surface 112 of the third plate 86 from the second plate 84.
[0026] The first plate 82, the second plate 84 and the third plate 86 are connected or sandwiched together to form a staple cartridge 52 having two rows of staggered staple pockets 118 positionable on one side of the blade 42 of the I-beam 32. The staple pockets 118 are staggered to form a complete closed line of staples. The second staple cartridge 52 is positioned on the other side of the blade 42 of the I-beam 32 and forms two rows of staple pockets 118 on the other side of the blade 42, thereby forming a total of four rows of staple pockets 118. The cartridge 52 may be modified with additional plates to create more than two rows of staples, and the cartridge 52 may have three or four rows of staples on each side of the I-beam 32. The staple pockets 118 are formed by the recessed wall 99, the front sidewall 94, the rear sidewall 96, the bottom wall 98 and the exterior surface of the second plate 84. Each pocket 118 has an open top and a partially open bottom. In one form, the bottom is closed. The spacers 103, 105 of the first plate 82 space the inner surface 90 of the first plate 82 from the second plate 84 to form a first slot 120 between the first plate 82 and the second plate 84. The first slot 120 is configured to receive a first angled camming surface of the slider 56, which will be described in more detail herein below. The first slot 120 intersects with the first row of staple pockets 118. The spacers 115, 117 of the third plate 86 space the inner surface 112 of the third plate 86 from the second plate 84 to form a second slot 122 between the third plate 86 and the second plate 84. The second slot 122 is configured to receive a second angled camming surface of the slider 56, which will be described in more detail herein below. A second slot 122 intersects the second row of staple pockets 118. An identical configuration appears in the staple cartridge located on the other side of the I-beam 32.The staple cartridge 52 may be considered to be a single unit that holds all of the staples on each side of the I-beam 32, or alternatively, two staple cartridge units are provided, one on each side of the I-beam 32.
[0027] 22, an alternative configuration of staple cartridge 52 is shown in which second plate 84 is not smooth and further includes a plurality of staple retaining locations 124 substantially similar to staple retaining locations 92 of first and third plates 82, 86. In this configuration, both of the opposing outer surfaces of second plate 84 include a recess formed by recessed wall 126 recessed from the outer surface, front sidewall 128, rear sidewall 130, and a bottom wall (not shown). The bottom wall may or may not include a gap. Staple retaining locations 124 of the first outer surface of second plate 84 are positioned opposite staple retaining locations 92 of first plate 82, which together form staple pockets 118. Additionally, the staple retaining locations 124 formed on the second outer surface of the second plate 84 are positioned opposite the staple retaining locations 92 of the third plate 86, which together define a staple pocket 118. The staple retaining locations 124 are angled the same as the opposing staple retaining locations 92 of the first and third plates 82, 86. Each pocket 118 formed by the staple retaining locations 92, 124 is configured to receive a substantially U-shaped staple 54 that is supported by the side walls but has an unsupported portion of the staple 54 located within the first and second slots 120, 122. This unsupported portion of the staple 54 located within either the first slot 120 or the second slot 122 is exposed for contact with the angled camming surface of the slider 56, which passes through the slots to push the staple 54 upwardly from the pocket 118.In this configuration in which the second plate 84 has the staple retaining locations 124, the depth of the staple receiving portions 92, 124 is each approximately 0.005 inches (0.127 mm), the width of each slot 120, 122 is approximately 0.005-0.006 inches (0.127-0.152 mm), the overall thickness of the staples 54 is approximately 0.015 inches (0.381 mm), and approximately 0.005 inches (0.127 mm) of the staples are located within the slots 120, 122, approximately 0.005 inches (0.127 mm) of the staples are located within and supported by the staple retaining locations 92 of the first plate 82, and approximately 0.005 inches (0.127 mm) of the staples are located within and supported by the staple retaining locations 124 of the third plate 86. 22 shows a standard configuration in which two rows of staggered staple pockets 118 are located on each side of the blade 42 of the slider I-beam 32 to deliver a total of four lines of staggered staples 54. In another form, the staple cartridge 52 is configured with an additional fourth plate (not shown) sandwiched together to form a third row of staple pockets 118 on each side of the blade 42 to deliver a total of six rows of staggered staples 54. Any number of staple rows is within the scope of the present invention achieved by the addition of additional plates.
[0028] 23-25, in one form of the present invention, an asymmetric staple cartridge is provided. The asymmetric staple cartridge utilizes a different number of rows of staple pockets on each side of the blade 42 of the I-beam 32. In one form, the staple cartridge has two or three rows of staple pockets on one side of the blade 42 of the I-beam 32 and only one row of staple pockets on the other side of the blade 42 of the I-beam 32, thereby creating a total of three or four rows of staples, with one row of staples delivered on either side of the cut line. The staple cartridges may be a single, integral part, or may be comprised of two cartridges, one having two or three rows of staple pockets for delivering two or three rows of staples located on one side of the blade 42, and a second staple cartridge having only one row of staple pockets for delivering only one row of staples on the other side of the blade 42. The use of an asymmetric stapler advantageously results in a smaller instrument with a reduced diameter of the end effector 18. Alternatively, the saved space within the end effector 18 can be utilized advantageously to provide additional structural support within an instrument of the same diameter. While two or three rows of staples on both sides of the blade 42 may be preferred to hold viable tissue, the specimen to be removed may require only one row of staples on one side of the cut line designed for short-term retention on the tissue to be removed. The resulting smaller instrument diameter is beneficial in certain procedures, such as the removal of endoluminal polyps. In such procedures, an endoluminal polyp removal stapler is provided on one side of the blade and has two or three rows of staple pockets delivering two or three rows of staples into the colon side of the cut line and one row of staples into the polyp side of the cut line. Different numbers of staple rows are used on each side of the cut line, and staplers can be customized for these specific surgical applications.The result is a dramatic reduction in instrument size, particularly the diameter of the end effector 18, or an instrument of the same size but with enhanced instrument behavior and reliability. FIG. 23 shows a cut resulting from using an asymmetric stapler of the present invention. FIG. 23 shows three lines 132 of staggered staples delivered into the organ side 134 and one line 136 of staples delivered into the removed tissue 138. To provide the surgeon as a user with a visual indication as to which side of the stapler 10 delivers fewer rows, the end effector 18 of the stapler 10 is colored such that the side of the stapler 10 having fewer rows of staples is a different color than the side of the stapler having two or more rows of staples as shown in FIG. 24. For example, the side of the stapler with a single line of staples is colored red and the other side of the blade is colored green. Other markings on the stapler 10 are possible. 25, the stapler end effector 18 is curved so that the surgeon knows to place the concave portion of the curvature against or on the side of the polyp 138, for example, and the convex side of the curved end effector against the colon side 134. The curved jaws aid the surgeon user in properly orienting the stapler with the concave side of the curvature having fewer rows of staples compared to the concave side of the blade having more rows of staples. In another configuration, the concave side of the stapler blade has fewer rows of staples relative to the convex side of the stapler blade.
[0029] The slider 56 will now be described with reference to Figures 26-30. The slider 56 has a slider base 140 with a bottom surface 142 and a top surface 144. At least a portion of the bottom surface 142 toward the distal end is curved to match the curved bottom 74 of the lower jaw 50. At the proximal end of the slider 56, the bottom surface 142 has a recessed portion 146 sized and shaped to receive the bottom portion 36 of the I-beam 32. A slot 148 is formed in the slider base 140 that opens at the proximal end and extends toward the distal end of the slider base 140. The slot 148 is sized and shaped to receive at least the lower intermediate portion 38 of the I-beam 32. In one form, the front end of the slider 56 that directs distal translation has a beveled or angled front surface that aids in pushing the staples out of the instrument. At least two angled camming surfaces 150 upstand from the top surface 144 of the slider base 140. FIGS. 26-30 show a slider 56 having four upstanding angled camming surfaces 150a, 150b, 150c, 150d. The asymmetric staple cartridge of the present invention has a slider 56 corresponding to the number of rows of staples on each side of the I-beam blade 42. The two angled camming surfaces 150a, 150b are separated from the two angled camming surfaces 150c, 150d by an I-beam receiving portion 152. The I-beam receiving portion 152 is sized and shaped to receive the intermediate portion 38 of the I-beam 32. Each camming surface 150 is approximately 0.005 inches (0.127 mm) thick and has an angled distal end. The angle of the camming surface 150 corresponds to the angle of the staple retaining locations 92, 124 which ranges from about 30° to about 90°, with 90° being a vertical camming surface 150. The slider 56 is disposed inside the lower jaw 50 within a lower passage formed between the one or more staple cartridges 52 and the bottom cover 74. The slider 56 is retained within the lower jaw 50 between the one or more staple cartridges 52 and the bottom cover 74, but is free to translate longitudinally distally and proximally relative to the lower jaw 50.Upwardly extending camming surfaces 150a, 150b each extend upwardly through slots 120, 122 of staple cartridge 52 on one side of blade 42 of I-beam 32. The other two upwardly extending camming surfaces 150c, 150d each extend upwardly through slots 120, 122 of the other side of staple cartridge 52 or a second staple cartridge 52 on the other side of blade 42 of I-beam 32. Slider camming surfaces 150 are configured to contact staples located within staple pockets 118 and sequentially urge the staples toward anvil surface 58 of upper jaw 48 as slider 56 translates along end effector 18.
[0030] The staple 54 of the present invention will now be described with reference to Figures 31-34. The staple 54 is shown in its undeformed or open state. The staple 54 has a first leg 154 and a second leg 156 connected to each other by a base 158. The first leg 154 intersects with the base 158 at an angle of approximately 90° to form a first intersection 160. The second leg 156 intersects with the base 158 at an angle of approximately 90° to form a second intersection 162. The first leg 154 is longer than the second leg 156. The staple 54 has an inner surface 164 and an outer surface 166 connected to each other by a first side wall 168 and a second side wall 170. The inner surface 164 intersects with the outer surface 166 at a first location 172 on the first leg 154 and at a second location 174 on the second leg 156. The first location 172 and the second location 174 are shown in FIG. 31 as intersections perpendicular to the length of the staple 54. In another embodiment, the intersections are parallel to the length of the staple 54. In another embodiment, the first location 172 and / or the second location 174 are intersections. In another embodiment, the first location 172 and / or the second location 174 are flat surfaces or any other geometric shape suitable for puncturing and penetrating tissue through which the staple is delivered. The first leg 154 has a first tip 176 located at a free distal end of the first leg 154, and the second leg 156 has a second tip 178 located at a free distal end of the second leg 156. The first and second tips 176, 178 begin where the first leg 154 and second leg 156 begin to taper or reduce in cross-sectional area in a distal direction along the legs 154, 156.
[0031] With particular attention to Figures 32-34, the first leg 154 is approximately 0.097 inches (2.464 mm) long and the second leg 156 is approximately 0.050 inches (1.270 mm) long. The ratio of the shorter second leg 156 to the longer first leg 154 is approximately 1 / 2. The overall length of the base 158 is approximately 0.080 inches (2.032 mm) and each leg 154, 156 is perpendicular to the base 158. The radius of curvature of the outer surface 166 at the first and second intersections 160, 162 is approximately 0.009 inches (0.229 mm). The distance between the first side wall 168 and the second side wall 170 or the thickness of the staple is approximately 0.015 inches (0.381 mm). The distance between the inner surface 164 and the outer surface 166 or the width of the first and second legs 154, 156 is approximately 0.010 inches (0.254 mm). The distance between the inner surface 164 and the outer surface 166 or the width of the base 158 is also approximately 0.010 inches (0.254 mm). The first tip 176 has a curved outer surface 166 with a radius of curvature of approximately 0.034 inches (0.864 mm). This curve forms a concave outer surface 166 at the location of the first tip 176. The inner surface 164 at the first tip 176 is perpendicular to the base 158 and intersects with the curved outer surface 166 at a line of intersection that defines the first point 172. The second tip 178 has a sloped outer surface 166. The portion of the outer surface 166 where the second tip 178 is located is angled from the vertical toward the inner surface 164 by approximately 10°. The portion of the inner surface 164 where the second tip 178 is located is angled from the vertical toward the outer surface 166 by approximately 30°. The angled outer surface 166 and the angled inner surface 164 where the second tip 178 is located together form an angle of approximately 40° between each other and define an intersection at the second point 174.
[0032] With particular attention to Figures 35-37, the staple 54 is shown in its deformed or closed configuration in which the first leg 154 is angled toward the second leg 156 to create a triangular shape or a delta or D-shaped configuration. The triangular shape results when the first leg 154 is deformed as a result of the undeformed staple 54 being pushed out of the staple pocket 118 of the lower jaw 50 and against the anvil surface 58 of the upper jaw 48 of the stapler 10 of the present invention. In this delta-shaped configuration, the second leg 156 remains upright and substantially perpendicular to the base 158 and the first leg 154 is deflected toward the second leg 156 until the first and second tips 176, 178 meet or are in a substantially juxtaposed relationship to one another. The resulting angle of the deflected first leg 154 relative to the base 158 is approximately 29°. In one configuration, the staple has a circular cross-section. In another configuration of the staple 54, a stress concentration is created in the first leg 154, which creates a weak spot in the first leg 154, which results in deformation, bending or deflection of the first leg 154 at the stress concentration location. One example of a stress concentration is at least one notch formed in the inner surface 164 at a location along the first leg 154 to cause bending of the first leg 154 to occur at the stress concentration. An example of a stress concentration in the form of a notch 188 is shown in Figures 44A and 44B. In another configuration, the stress concentration, e.g., one or more notches, are strategically positioned to create a variety of closed staple shapes. For example, the closed staple shapes are not limited to triangular staples, but include rectangular, square, diamond, and trapezoidal shapes. Additionally, in another configuration, a notch is formed to capture one leg within a notch formed in the opposite staple leg, thereby creating a locking configuration that includes first and second interlocked legs such that the closed staple configuration is configured to resist forces that would open the staple from the closed and interlocked configuration.
[0033] 38 and 39, the staple 54 is shown as having at least one barb 180. In the configuration shown in FIG. 38, a single barb 180 is formed on the inner surface 164 of the staple 54 near the distal end of each leg 154, 156. The barbs help provide enhanced mechanical retention of the staple in tissue and may be formed on the inner surface 164 or outer surface 166 on either or both legs. Multiple barbs 180 along one of the legs are shown in FIG. 39. In FIG. 39, four barbs 180 are formed on the inner surface of the first leg 154 and one barb 180 is formed on the inner surface of the second leg 156. Small barbs 180, such as macro- or nano-sized barbs, are also within the scope of the present invention.
[0034] 40 and 41, there is shown a four-pronged staple 182. The four-pronged staple 182 has a long first leg 154a interconnected to a short second leg 156a by a base 158a and a second long first leg 154b interconnected to a short second leg 156b by a base 158b. Each pair of staple legs 154a, 156a and 154b, 156b and their interconnecting bases 158a, 158b are substantially identical to the staple 54 described with reference to FIGS. 31-37, except that in the four-pronged staple 182, the two pairs of legs are interconnected to each other by an enlarged base 184 having the same thickness as the staple bases 158a, 158b, which is about 0.010 inches (0.254 mm) thick. An enlarged base 184 is connected to bases 158a and 158b and serves as a camming surface engageable with slider 56, which has an enlarged, angled slider camming surface 186. Staple cartridge 52 is still configured in substantially the same manner as described with reference to Figures 17-22, except that it is adapted to receive wide staples with wide four-pronged staples 182 and wide slots 120, 122 corresponding to wide slider 56. Cartridge 52 configured for four-pronged staples 182 is preferably substantially the same as that described with reference to Figure 22, except that first plate 82 and second plate 84 have angled staple retaining locations 92, 124 formed oppositely, respectively. At least a portion of the first leg 154a, the second leg 156a and the base 158a are disposed within the staple retaining location 92 of the first plate 82, and at least a portion of the first leg 154b, the second leg 156b and the base 158b are disposed within the staple retaining location 124 of the second plate 84. An additional third plate 86 may retain another row of four pronged staples 182 between the third plate 86 and the second plate 84, with another slider camming surface 186 located within the second slot 122.The four pronged staple 182 is angled to match the angle of the camming surface 186 of the slider 56 so that when the slider 56 is pushed forward by the translating I-beam 32, the angled slider camming surface 186 contacts the enlarged base 180 of the staple 182 and urges the staple 182 upwardly and out of the cartridge 52 and against the anvil surface 58 of the upper jaw 48 where the staple 182 is deformed into tissue. The deformed staple has two triangular shaped closures where the first legs 154a, 154b are bent toward the second legs 156a, 156b, respectively.
[0035] Figures 42A-42D show various views of a four-pronged staple 182 having a wider base 184 that provides additional strength to the staple 182. The first and second tips 176a, 176b, 178a, 178b have first and second side walls 168a, 168b, 170a, 170b that are angled to form an intersection line parallel to the length of the staple 182. A four-pronged staple 182 is shown in Figure 43A having first tips 176a, 176b and second tips 178a, 178b that are flat and blunt. The four-pronged staple 182 of FIG. 43A may be cut along the dotted lines to form two single staples 54 each having only two legs 154, 156 with first and second tips 176, 178 as shown in FIG. 43B.
[0036] 44A-44D, a four-pronged staple 182 is shown having notches 188 formed in the inner surface of the first legs 154a, 154b. The notches 188 are curved semi-cylindrical indentations that create stress centers in the legs 154a, 154b such that during deformation, the legs 154a, 154b tend to bend at the notches 188. In the four-pronged staple 182 configuration of FIGS. 44A-44D, the first ends 176a, 176b have curved outer surfaces 166a, 166b that intersect with straight inner surfaces 164a, 164b to form an intersection perpendicular to the length of the staple 182. Second tips 178a, 178b are formed by the intersection of angled outer surfaces 166a, 166b with straight inner surfaces 164a, 164b forming an intersection line perpendicular to the length of staple 182. Upon deformation, first legs 154a, 154b are bent at notches 188 such that first tips 176a, 176b contact tips 178a, 178b forming two interlocking triangular closures.
[0037] 45A-45D, a four-pronged staple 190 with staggered legs is shown. A first two-pronged staple having a long first leg 154a interconnected by a base 158a to a shorter second leg 156a is connected by an inclined enlarged flat base 184 to a second two-pronged staple having a long first leg 154b interconnected by a base 158b to a shorter second leg 156b, the first two-pronged staple being offset or staggered relative to the second two-pronged staple. The first and second two-pronged staples are substantially identical to the staples described above with reference to FIGS. 31-37. An angled base 184 interconnecting the first and second two-pronged staples allows the first two-pronged staples to be offset from the second two-pronged staples, resulting in a four-pronged staple 190 with alternating legs 154a, 154b, 156a, 156b. The enlarged base 184 serves as a camming surface that cams against the angled camming surface 150 of the slider 56. When actuated, the two long first legs 154a, 154b deform toward the second legs 156a, 156b, respectively, against the anvil surface 58, thereby forming two triangular closures that capture tissue between them. When an entire row of four-pronged staples 190 is deployed, the result is two effective rows of alternating staples.
[0038] 46A-46D, a six-pronged staple 192 is shown having a first two-pronged staple 194 connected in a staggered manner to a second two-pronged staple 196 connected in a staggered manner to a third two-pronged staple 198. The first, second and third two-pronged staples 194, 196, 198 are substantially identical to the two-pronged staple 54 of FIGS. 31-37 described above. The first two-pronged staple 194 has a long first leg 154a interconnected by a base 158a to a shorter second leg 156a. The second two-pronged staple 196 has a long first leg 154b interconnected to a short second leg 156b by a base 158b. The third two-pronged staple 198 has a long first leg 154c interconnected to a short second leg 156c by a base 158c. Each of the two-pronged staples 194, 196, 198 is interconnected to each other at its base 158a, 158b, 158c, respectively. The first two-pronged staple 194 is interconnected to the second two-pronged staple 196 by an inclined extension base located therebetween, and the first two-pronged staple 194 is offset from the second two-pronged staple 196. The second two branched staple 196 is connected to a third two branched staple 198 by an angled extension base located therebetween, with the second two branched staple 196 being offset from the third two branched staple 198. The three two branched staples 194, 196, 198 are connected to one another such that the first and third two branched staples 194, 198 are in alignment with one another and the intermediate second two branched staple 196 is offset with respect to the first and third two branched staples 194, 198.The six pronged staples 192 are loaded in an angled manner into the cartridge as described above with reference to Figures 22 and 40-41, where a first two pronged staple 194 is at least partially disposed within the staple holding location 92 of the first plate 82, a third two pronged staple 198 is at least partially disposed within the staple holding location 124 of the second plate 84, and a middle or second two pronged staple 196 is positioned within the first slot 120 together with a slider 56 having an enlarged slider camming surface 186 as described above with reference to Figures 40-41, with the angled enlarged base engaging such slider for deployment. Of course, the third plate 86 with the staple holding location 92 is loaded with staples 192 in a similar manner so as to be engageable with a second slider 56 positioned within the second slot 122. After the six pronged staple 192 is pressed against the anvil surface 58 by the slider, the first legs 154a, 154b, 154c are deflected toward the second legs 156a, 156b, 156c, respectively, thereby forming three triangular closures that capture tissue. The three triangular closures are staggered relative to each other, but are interlocked together to form a wide and strong stapled portion of tissue.
[0039] 47A-47C, another form of staple is shown. In this form, staple 204 has a first leg 154 interconnected to a second leg 156 by a base 158. The first leg 154 is substantially straight when undeformed, and the first leg has a first tip 176 with an angled or chamfered outer surface. The second leg 156 is slightly longer than the first leg 154. The second leg 156 further has an elbow 206 at which the second leg 156 is bent slightly toward the first leg 154 while in the undeformed state as shown in FIGS. 47A and 47B. The second leg 156 has a second tip 178 which, in one form, begins to taper from the elbow 206. Because the staples 204 are positioned within the cartridge at an angle as described above, when the staples 204 are pushed upward by an advancing slider (not shown), both the first tip 176 and the second tip 178 contact the flat anvil surface 58 substantially simultaneously as shown in FIG. 47B. Continued pushing of the staples 204 into the anvil surface 58 results in the first leg 154 bending toward the second leg 156 and the second leg 156 bending toward the first leg 154 as shown in FIG. 47C. The bevel or chamfered surface at the first tip 176 helps to orient the first leg 154 toward the second leg 156. The elbow 206 and the angled second leg 156 help to orient the second leg 156 toward the first leg 154. Because the staple pocket 118 holds the staple 204 at an angle relative to the flat anvil surface 58, the second leg 156 must be slightly longer and angled so that when the second tip 178 contacts the flat anvil surface 58, the portion of the second leg 156 distal to the elbow 206 is substantially perpendicular to the flat anvil surface 58.This configuration advantageously does not require anvil pockets formed in the anvil surface and does not require precise alignment of the staple legs 154, 156 with the anvil pockets to effect biasing of the staple legs 154, 156 toward one another. Such biasing is accomplished by striking the flat anvil surface 58.
[0040] Referring to FIG. 48, a plurality of staples 54 are shown connected to a spine 200, with the formation of the staples 54 being fishbone shaped for ease of manufacture, assembly and handling. A sheet of metal, such as surgical steel, stainless steel or titanium, is provided and the plurality of staples 54 are cut into the sheet of metal with a wire electrical discharge machining (EDM) machine. The staples 54 can also be formed using a micro water jet, photo etching or by stamping. The staples 54 remain connected to the spine 200 by the narrow connecting tabs 202 until the staples 54 are broken at the narrow connecting tabs 202 and loaded into a staple cartridge. After breaking off the staples 54, a portion of the connecting tabs 202 remains attached to the staples 54. The remaining tabs 202 serve as barbs 180 that enhance the mechanical hold on the tissue captured within the closed staples 54 after deployment. Thus, the staples 54 are manufactured without the need for post-processing, such as bending or sharpening. The spine 200 may also be an aid in the storage of the staples 54 and in the assembly of a staple cartridge.
[0041] 49 and 50, a staple cartridge 52 in the form of a single unit is inserted into the staple cartridge receiving portion 72 of the lower jaw 50. The staple cartridge 52 may be in the form of two units 52a, 52b, each unit having two slots 120, 122 with two rows of staples 54 positioned within the staple pockets 118. The asymmetric cartridge described above may also be employed. The staple cartridge 52 is inserted such that the grooves 104, 108, 116 of the first, second and third plates 82, 84, 86, respectively, engage the tongues 78 at the proximal end of the lower jaw 50 and the tongues 102, 106, 114 of the first, second and third plates 82, 84, 86, respectively, engage the shelves 76 at the distal end of the lower jaw 50. A cartridge retainer 80 is engaged over the tongues 102, 106, 114 as shown in FIG. 50 to secure the cartridge in place. Each cartridge 52 may have a paper cover slip (not shown) that covers the staple pockets 118 to hold the staples 50 inside the pockets 118 during storage and handling. The cover slip is then removed by peeling it off just before or just after installation of the cartridge 52. Each cartridge 52 further includes a slider 56 disposed within the cartridge 52 such that angled camming surfaces 150a, 150b of the slider 56 respectively locate within the slots 120, 122 on one side of the I-beam receiving portion 152 and angled camming surfaces 150c, 150d of the slider 56 respectively locate within the slots 120, 122 on the other side of the I-beam receiving portion 152. One side of cartridge 52a is spaced from the other side of cartridge 52b to define a central passage 208 through which the I-beam 32 in translation can pass.
[0042] Another mounting configuration for the cartridge 52 is shown in Figures 51 and 52. In this configuration, the front or distal end of the lower jaw 50 is open and the cartridge 52 has rails 212 that mate with tracks 210 formed in the staple cartridge receiving portion 72 of the lower jaw 50. The cartridge 52 slides through the open distal end of the lower jaw 50, which is then closed with a cap or latch (not shown). The cartridge 52 is shown as having a top plate 214 that provides additional strength across the width of the instrument. After the staples 54 are depleted, the staple cartridge 52 can be removed and disposed of and a new cartridge can be inserted to continue stapling. In another configuration, the staple cartridge 52 is pre-mounted within the stapler cartridge assembly 14 and, after the staples 54 are depleted, the entire stapler cartridge assembly 14 can be removed and disposed of and a new stapler cartridge assembly 14 can be coupled to the handle assembly 12 to continue stapling.
[0043] With the stapler cartridge assembly 14 connected to the handle assembly 12, the actuator shaft 22 is connected to an actuator shaft 216 within the handle assembly 12. The handle assembly 12 is then used to operate the stapler 10 in three different functions or modes of operation. The first mode allows a user to open and close the jaws 48, 50 of the end effector 18. The second mode fires the staples and the third mode of operation returns the I-beam 32 to its original proximal position following the firing of the staples.
[0044] 53, the handle 218 is connected to a forward drive 220 which engages forward teeth on the actuator shaft 216. When the handle 218 is pressed, the actuator 216 is moved slightly forward, which in turn moves the actuator shaft 22 of the stapler cartridge assembly 14 forward. Because the actuator shaft 22 is connected to the I-beam 32, the I-beam 32 is advanced forward by pushing the handle 218. As the I-beam 32 advances, the beveled front end 40 of the top portion 34 of the I-beam 32 enters the passage 64 of the upper jaw 48, which causes the open and spring-loaded upper jaw 48 to deflect downwardly from the open position to the closed position as shown in FIGS. 54 and 55. The upper jaw 48 is connected to the lower jaw 50 by a pin such that the upper jaw 48 can pivot relative to the lower jaw 50. A spring (not shown) is provided to provide a spring biasing force to urge the upper jaw 48 in an open position relative to the lower jaw 50. The top portion 34 of the I-beam 32 is shown in the passage 64 in FIG. 54 with the jaws biased in an open position. In FIG. 55, the top portion 34 of the I-beam 32 is shown in the passage 64 moving the upper jaw 48 in a closed orientation relative to the lower jaw 50. When the handle 218 is released, the actuator shafts 216, 22 move proximally to also pull the I-beam 32 proximally, thereby allowing the spring biasing force to open the jaws as the top portion 34 exits the passage 64. By pushing and releasing the handle 218, a user can open and close the jaws of the end effector 18, thereby positioning target tissue between the upper and lower jaws of the stapler 10. The end effector 18 is shown in an open position in FIG. 56 and in a closed position in FIG. 57, with the end-to-end distance of the gap between the upper jaw 48 and the lower jaw 50 being approximately 0.040 inches (1.016 mm) when in the closed position.
[0045] After the jaws are closed in place at the target tissue location, the stapler 10 is switched to operate in a firing mode by pressing a fire button 224 on the handle assembly 12 as shown in FIG. 58. The fire button 224 disengages the release driver 226 from the actuator shaft 216 as shown in FIGS. 59 and 60, thereby freeing the actuator shaft 216 for longitudinal movement. The release driver 226 is shown engaged with teeth on the actuator shaft 216 in FIG. 60. In FIG. 59, the release driver 226 is shown disengaged from the teeth on the actuator shaft 216 with the fire button 224 pressed. With the release driver 226 disengaged, the trigger handle 218 swings wide and the forward driver 220 engages forward teeth on the actuator 216. Pressing the handle 218 advances the actuator shaft 216 forward. 2, the I-beam 32 is advanced completely to the distal end of the cartridge 52. The handle 218 is pulled multiple times to advance the I-beam 32 fully to the distal end of the cartridge 52. The handle assembly 12 may further include a rotatable rack as described in pending U.S. Provisional Patent Application entitled "Surgical stapler having actuation mechanism with rotatable shaft," which is incorporated by reference in its entirety.
[0046] 61, the end effector 18 is shown with the jaws 48, 50 in a closed position. As the I-beam 32 is advanced distally, the upper portion 34 of the I-beam 32 travels within the upper passageway 64 and the bottom portion 36 of the I-beam 32 enters the slot 148 of the slider 56 to engage and push it distally. As the angled camming surface 150 is advanced, it contacts the staples (not shown) and pushes them out of the staple holding location 92. The blade 42 of the I-beam 32 sits within the gap 228 between the upper and lower jaws 48, 50 to cut tissue captured between the jaws or asymmetrically cut tissue with two or more rows of staples on each side of the blade 42 between the rows of staples.
[0047] 62 and 63 illustrate how the staples 54 are deployed as the slider 56 and I-beam 32 advance in a distal direction. The staples 54 are positioned within the staple pockets 118 with at least a portion of the staples 54 positioned against the U-shaped staple retaining location 92 such that the longer first legs 154 are positioned proximally relative to the shorter second legs 156. As the slider 56 advances, the inclined camming surfaces 150 sequentially contact the staples. In one form, the beveled front end 230 of the slider 56 contacts that portion of the outer surface 166 of the staples 54, such as the base 158 of the staples 54 that is located within the gap 100 in the bottom wall 98 of the U-shaped staple retaining location 92, to push the staples 54 upward. As the slider 56 advances, the inclined camming surface 150 of the slider 56 contacts the staples 54 and continues to urge the staples sequentially upward with the distal translation of the slider 56. Upon reaching a full deployment height, the long first leg 154 of the staple 54 contacts the flat anvil surface 58 of the upper jaw 48. In particular, the first tip 176 contacts the flat anvil surface 58. Because the first tip 176 has a curved, chamfered or beveled outer surface 166, the contact of the curved outer surface with the flat anvil surface 58 assists in bending the first leg 154 towards the second leg 156. The curved outer surface 166 of the first tip 176 slides against the flat anvil surface 58 as the first leg 154 bends into the configuration of a closed triangle. The short second leg 156 does not bend or deform. Unlike conventional staples in which the staple legs are fired perpendicular to the forming anvil, the staples of the present invention are fired at an angle relative to the flat anvil surface 58. The anvil surface of the present invention does not include staple forming pockets.When the long legs 154 contact the flat anvil surface 58, the tips 176 of the long legs 154 slide freely along the anvil surface while the staples 54 are gradually pushed perpendicular to the staple base 158 as the staples are at the same angle as the inclined camming surface 150 of the slider 56 until the tips 176 of the long legs 154 meet the tips of the shorter second legs 156 and the staples are closed capturing the tissue in a triangular closure. Advantageously, the closing force of the staples 54 of the present invention is relatively low as compared to conventional staples since only one leg, the long first leg 154, is deformed, whereas in conventional staples both legs of the staple are deformed simultaneously. Additionally, the closing force is further reduced by the fact that the long legs are merely bent rather than buckled and forced into the anvil pocket. The beam buckling force is significantly greater than the bending force, which requires simultaneous buckling of two staple legs in conventional staples. Conventional stapling instruments require a large firing force to apply a staple line. The staple legs are forced perpendicular to the anvil pocket, which causes the staple legs to buckle. Such large forces can impose significant stresses on the instrument components, which can cause fatigue for the user. Thus, the stapler 10 of the present invention significantly reduces the force required to deploy or deform a staple. The staple forming force of the present invention is relatively low compared to conventional staple designs. Because only one leg bends in contact with the anvil surface, the user and the instrument benefit from reduced forces on the instrument components and reduced actuation forces for the user.
[0048] The staple deployment method of the present invention drives an angled slider forward along the jaws of the stapling instrument. The slider 56 directly contacts the staples 54 as it passes through the same space in which the staples are deployed. The staples are held in place in part by pockets 118 provided in the inner jaw or cartridge 52 of the stapling instrument. These pockets provide guides for the staples as they are forced out of the stapling instrument and formed into tissue. The staples are held in the cartridge such that only a portion of the staple thickness is located within the pockets and another portion is located within an open channel that is flush with the slider 56. One side of the staple is held against the first plate in the staple receiving location 92 and the other side of the staple is held against the smooth wall of the second plate or alternatively within a staple holding location 124 also formed in the second plate. Each slider camming surface 150 moves forward along the center of the staple in its respective slot 120, 122. As the slider 56 is pushed distally along the length of the jaws, the angled slider ramps eject the staples from the guided cartridge pockets. The slider's angled camming surfaces 150 push perpendicularly against the staple bases 158. The slider contacts only a portion of the staples, while the remainder of the staples are held against the staple retaining locations 92, which act as guides to direct the staples out of the cartridge.
[0049] 64 and 65, after firing the staples, the handle assembly 12 is switched to a third mode of operation in which the I-beam 32 is returned proximally to its starting position. The gear switch button 232 is pressed, which rotates the actuator shaft 216 90 degrees so that the retraction teeth of the actuator 216 contact the retraction driver 234. The retraction driver 234 is connected to the handle 218 by a series of gears. When the handle 218 is pulled, the retraction driver 234 retracts the actuator 216 and the I-beam 32. The trigger handle 218 is pulled multiple times to return the I-beam 32 to its original position. The I-beam 32 is returned to its original proximal position to open the jaws 48, 50. With the I-beam 32 returned, the slider 56 is left in its distal firing position. 66 shows the I-beam 32 returned to its fully retracted position, allowing the spring loaded upper jaw 48 to open while the slider 56 is left in its distal location, thereby allowing the stapled tissue to be released from the jaws. Once the actuator shaft 216 and I-beam 32 are returned, the stapler cartridge assembly 14 can be removed from the handle assembly 12 and a new stapler cartridge assembly 14 can be installed to continue stapling.
[0050] Conventional laparoscopic staplers currently have a diameter of approximately 12 millimeters, which requires a large size cannula for insertion and therefore a large incision to be made in the patient. The laparoscopic stapler 10 of the present invention has a diameter of approximately 0.271 inches (6.883 mm), as shown in FIG. 67, which advantageously fits into a small diameter cannula that requires a smaller incision to be made in the patient. Smaller incisions result in less pain, faster recovery time for the patient, and less visible scarring after surgery. FIG. 67 shows that the I-beam 32 substantially defines the diameter of the end effector 18. Approximately just less than half the diameter of the stapling instrument is consumed by the upper jaw, leaving approximately half the diameter of the stapling instrument, or approximately 0.130 inches (3.302 mm), as the gap between the upper and lower jaws to accommodate the staple deployment mechanism including the staples and slider.
[0051] The problem presented with traditional staplers is that they require large diameters and large incisions as well as large firing forces to deploy the staples. This is because traditional staples require a pusher to deploy the staples. The pusher is an intermediate camming surface located between each staple and the slider. Typically, each pusher is flush with the staple and sits directly below it. The height of the pusher must be approximately equal to the height of the staple to fully push the staple out of the staple pocket and into the gap between the upper and lower jaws. The pusher typically has a sloped lower surface that cams against the sloped slider. The upper surface of the pusher is typically flat and horizontal and cams perpendicularly to the base of the staple. Essentially, the pusher takes up space that is useful when trying to achieve a small stapler that fits into a small size cannula, typically referred to as a 5 millimeter cannula. The present invention eliminates the need for a pusher altogether due to the angled positioning of the staples, where the base of the staple is parallel to the inclined camming surface of the slider. The staples of the present invention are positioned at an angle, so that the horizontally moving slider directly contacts the staples during deployment, in which case no additional pusher is provided between the staples and the slider. Since no pusher is required in the present invention, a lot of space is saved, resulting in a very small diameter instrument.
[0052] Not only is it important to reduce staple size, but it is also important to effectively deploy staples that form a closed staple configuration that can hold tissue in a manner that is as strong as conventional staplers and reliably and repeatably hold tissue in this manner, which is a key factor achieved by the stapler of the present invention. Another problem with conventional staplers that the present invention addresses and successfully avoids relates to the anvil surface. Traditional anvil surfaces have carefully crafted anvil pockets formed in the anvil surface. These anvil surface features are necessary to reliably and repeatedly form staples in conventional staplers. The anvil surface is particularly important because conventional staples are positioned perpendicular to the anvil surface, and without the anvil surface features to guide the buckling staple legs, the staple legs would splay in any direction and not form a good closure, which is important in securing tissue. Additionally, the anvil pockets of traditional staplers require the anvil of the upper jaw to be perfectly aligned with the staple pockets, and particularly the staples located within the pockets, in order to achieve full staple formation. Although anvil surface formations or pockets are a prerequisite for reliable staple formation, they also increase manufacturing costs that arise from creating a carefully crafted surface formation as well as ensuring that the anvil surface formation aligns with the staple track. The present invention advantageously eliminates the anvil surface formations and provides a smooth, flat anvil surface against which the staple legs rest and deform. Typically, without the anvil surface formations, the staple legs would splay in any direction and would not form a complete closure. However, the present invention provides an angled staple holding location that holds the staple at an angle to the anvil surface. Additionally, the staple has one long leg and a short leg. As a result of this design, when the staple is ejected from the lower jaw, it is the long leg that leads the staple ejection.Since the long leg leads, it is the first leg to contact the anvil surface and the first leg is ensured to bend towards the second leg rather than splaying out in any direction. The misalignment of the staple tips ensures that the remainder of the staple, including the short legs, remain substantially trapped and guided within the staple pocket or staple holding location as the long leg is being deformed against the flat anvil surface and are not displaced laterally resulting in a poorly formed staple. The tips of the long legs are also curved or beveled, which provides a tendency for the staple to bend towards the second leg. The curved tips also allow the tips of the long legs to slide against a smooth anvil surface as the long legs of the staple are being deformed. Thus, the present invention not only reduces the overall diameter of the end effector, but does so without sacrificing the repeatability and reliability of the staple formation.
[0053] The problem of fitting a surgical stapler into a 5mm cannula is solved by not having an intermediate camming portion, also called a "pusher," between the slider and the staple. Typically, the legs of the staple are placed into the receiving pocket so that they are initially perpendicular to the anvil. The angled slider contacts the pusher, which in turn contacts the staple and drives it out of the staple pocket. Without the intermediate camming portion or pusher, the slider would have to contact the staple directly, which could apply an oblique force to the staple, tilting the staple legs out of alignment with the anvil surface formations, resulting in poorly formed staples, or tilting the staple legs against the pocket, resulting in the staple hitting the pocket and becoming jammed. Typically, the staples are stacked on top of the pusher. Thus, the elimination of the pusher saves a great deal of space in the design, with the angled staples directly contacting the angled slider. Eliminating the pusher also further reduces manufacturing costs by reducing the number of components, and also simplifies manufacturing since the pusher no longer needs to be assembled. The angled orientation of the staples themselves also saves a great deal of space, as opposed to the staples being oriented vertically as in traditional staplers. Since there is no target pocket or anvil surface formation for the staple legs to contact, the certainty of staple formation is greatly improved, as the staples are free to deform against a smooth anvil surface without risking misalignment with the anvil pocket as in traditional staplers. Also, useful space is saved by the slider passing through the same space or slot where the stapler is located.
[0054] 68, there is shown another form of staple cartridge 52 which is substantially similar to the staple cartridge described above with reference to FIGS. 17-21, with like numerals being used to designate like parts. As described above, cartridge 52 has at least two plates sandwiched together to form a single row of staple receiving pockets, with additional plates being added to increase the desired number of staple rows. The outer surface 88 of first plate 82 is smooth and the inner surface 90 includes a plurality of staple retaining locations 92. The staple retaining locations 92 are recesses formed in the inner surface 90 of first plate 82. Each staple retaining location 92 is substantially U-shaped, with each staple retaining location 92 defined by a front sidewall 94 formed opposite and substantially parallel to a rear sidewall 96. The rear sidewall 96 is interconnected to a bottom wall 98, with an L-shaped wall defining a gap 100 between the bottom wall 98 and the front sidewall 94. In one form, the gap 100 is not formed. Alternatively, the bottom wall 98 is interconnected to both the front sidewall 94 and the rear sidewall 96 to form a complete U-shaped staple retaining location 92. The U-shaped staple retaining locations are angled at approximately 30° to 90°, with 90° being the vertical, non-tilted orientation. FIG. 68 illustrates the U-shaped staple retaining locations at a 90° angle or substantially vertical. The recessed walls 99 are recessed relative to the inner surface 90. The segments of the inner surface 90 located between the staple retaining locations 92 include a plurality of horizontal grooves 236 extending between the staple receiving locations 92. The grooves 236 are rectangular and may be square or rectangular in cross section. The grooves 236 have a depth equal to the depth of the recessed walls 99. The grooves 236 are separated from one another by lands 238 which define the inner surface 90 and are therefore flush with the inner surface 90. The grooves 236 extend the entire length of the first plate intersecting each side wall 94, 96 and the bottom wall 98 of the staple retaining location 92. The staple retaining location 92 is configured to partially receive and retain a complementary substantially U-shaped staple that is thicker than the thickness of the grooved side walls 94, 96, 98.In one form, the staple holding locations 92 receive the full thickness of a complementary U-shaped staple as shown in FIG. 68, so that there is no portion of the staple 54 located outside of the staple holding locations 92. The slider 56 also has an inclined camming surface 150 with sides having a plurality of horizontal grooves 240 that form channels to receive the upstanding lands 238 located between the staple holding locations 92. Although a second plate 84 or shim is not shown in FIG. 68, such second plate 84 or shim, together with the first plate 82, forms a slot 120 therebetween within which the inclined camming surface 150 of the slider 56 can translate with the sides having interlocking grooves 240 and lands 238. Because the staples 54 are located within the grooved staple receiving portion 92, the inclined camming surface 150 of the slider 56 can still contact the outer surface 166 of the staple as the inclined camming surface 150 translates through the grooves 136 to drive the staples 54 upwardly. The grooved inner surface 90 of the first plate 82 advantageously allows for the use of very thin staples, e.g., staples having a thickness equal to the same depth as the staple pocket depth or the depth of the staple holding locations 92. The depth of the staple pocket is approximately 0.0085 inches (0.216 mm), which is also the thickness of the staples 54 that may be used in this form of the invention. Thus, the grooved plate 82 not only allows for very thin staples, but also allows for additional space for structures that reduce staple size or strengthen the end effector.
[0055] Although the stapler of the present invention is particularly suited for laparoscopic procedures, the invention is not so limited and the stapler of the present invention can be used equally effectively in open surgical procedures, in which the stapler of the present invention can be used, for example, for closure and anastomosis of tissue, such as the colon, small intestine and stomach.
[0056] As will be understood, various modifications of the embodiments of the surgical stapler disclosed herein can be made. Thus, the above description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments. Those skilled in the art will recognize other modifications that fall within the scope and spirit of the invention.
Claims
1. 1. A surgical stapler comprising: A handle assembly is provided. a cartridge assembly coupled to the handle assembly, the cartridge assembly including a proximal end and a distal end, the cartridge assembly comprising: a jaw assembly disposed at the distal end of the cartridge assembly, the jaw assembly comprising: a first jaw having an anvil surface; a second jaw having a top surface, the second jaw movable relative to the first jaw, the second jaw having a closed position with the anvil surface adjacent the top surface and a gap formed between the top surface and the anvil surface, the second jaw having a first surface and a second surface substantially parallel to one another and perpendicular to the top surface, the first surface and the second surface defining a first slot extending along a length of the second jaw, the first slot having a slot width, a plurality of recesses formed in the first surface, each recess having a recess wall, a front sidewall, and a rear sidewall, the second jaw having a plurality of staple pockets, each staple pocket defined by an opening through the recess wall, the front sidewall, the rear sidewall, a bottom wall of the second jaw, a second surface, and the top surface of the second jaw; an actuator coupled to the handle assembly; a first camming surface having a thickness, the first camming surface movable by the actuator within the first slot and along a length of the second jaw; a plurality of staples contained within said plurality of staple pockets, each staple having a staple width, each staple contained within a pocket such that a portion of said staple width is located within said first slot and a portion of said staple width is located within said recess in said first surface; translation of the first camming surface within the first slot causes the first camming surface to pass through one or more staple pockets and contact the portion of the staple width located within the first slot, thereby forcing the staple out of the opening and against the anvil surface.
2. 2. The surgical stapler of claim 1, wherein the first camming surface is inclined relative to the top surface, and the front and rear sidewalls are perpendicular to the inclined first camming surface.
3. each staple having a first leg interconnected to a second leg by a base, said staples being substantially U-shaped in an open configuration, said first leg having a distal tip and said second leg having a distal tip, said first leg being shorter in length than said second leg which is longer, said staples being received within said recesses such that said first leg is adjacent said front sidewall and said second leg is adjacent said rear sidewall; the anvil surface is a smooth surface without pockets, and the second leg deforms toward the first leg into a closed configuration when pressed against the anvil surface by the translating first camming surface; The surgical stapler of claim 1 or 2, wherein the distal tip of the second leg slides along the anvil surface from the open configuration to the closed configuration.
4. 4. The surgical stapler of claim 1, wherein the second surface has a plurality of recesses formed in the second surface opposite the plurality of recesses formed in the first surface, each recess in the second surface having a recess wall, a front side wall, a rear side wall and a bottom wall, each staple pocket defined by the recess wall, the front side wall, the rear side wall and the bottom wall formed in the first surface and the recess wall, the front side wall, the rear side wall and the bottom wall formed in the second surface, and the plurality of staples are disposed in the plurality of staple pockets such that a portion of each staple is disposed within the recess in the first surface and a portion of each staple is disposed within the recess in the second surface.
5. The surgical stapler of any one of claims 1 to 4, wherein the bottom wall is formed in the first surface, and a gap is provided between the bottom wall and the front side wall.
6. 6. The surgical stapler of claim 1, wherein the first surface is one side of an elongated first plate and the second surface is one side of an adjacent elongated second plate, the first plate being positioned adjacent to the second plate.
7. The surgical stapler of any one of claims 1 to 6, wherein the first plate has at least one spacer extending from the first surface toward the second surface.
8. the second jaw has a third surface and a fourth surface substantially parallel to one another and perpendicular to the top surface, the third surface and the fourth surface being disposed between the third surface and the fourth surface to define a second slot extending along a length of the second jaw, the fourth surface defining a plurality of recesses, each recess having a recess wall, a front sidewall, and a rear sidewall, the second jaw having a plurality of second slot staple pockets, each second slot staple pocket defined by the recess wall, the front sidewall, the rear sidewall, a bottom wall of the second jaw, the third surface, and an opening through the top surface of the second jaw; a second camming surface having a thickness, the second camming surface movable by the actuator within the second slot along a length of the second jaw; 8. The surgical stapler of claim 1, further comprising a plurality of staples contained within the plurality of second slot staple pockets, a portion of the staple width located within the second slot and a portion of the staple width located within the recess in the fourth surface.
9. 9. The surgical stapler of claim 8, further comprising a blade movable along the length of the jaw assembly and within the gap formed between the top surface and the anvil surface when the first jaw and the second jaw are in the closed position, the blade being disposed between the first camming surface and the second camming surface.
10. 9. The surgical stapler of claim 8, further comprising a blade movable along the length of the jaw assembly and within the gap formed between the top surface and the anvil surface when the first jaw and the second jaw are in the closed position, the first camming surface and the second camming surface being disposed on one side of the blade.
11. The surgical stapler of claim 8 , wherein the first camming surface and the second camming surface are coupled to one another to define a unitary slider, the slider being coupled to the actuator.
12. The surgical stapler of claim 8 , wherein the second surface and the third surface are opposing sides of a single elongated plate.
13. 9. The surgical stapler of claim 8, wherein the first surface is one side of an elongated first plate, the second surface and the third surface are opposing sides of an elongated second plate, and the fourth surface is one side of an elongated third plate.
14. 1. A surgical stapler comprising: A handle assembly is provided. a cartridge assembly coupled to the handle assembly, the cartridge assembly including a proximal end and a distal end, the cartridge assembly comprising: a jaw assembly disposed at the distal end of the cartridge assembly; The jaw assembly has a longitudinal axis, the jaw assembly comprising: a first jaw having an anvil surface, the anvil surface being a smooth, flat surface without pockets; a second jaw having a top surface, the second jaw movable relative to the first jaw, the second jaw having a closed position in which the anvil surface is adjacent to the top surface and a gap is formed between the top surface and the anvil surface, the second jaw having a plurality of staple pockets, each staple pocket having a longitudinal axis and an opening at the top surface; an actuator coupled to the handle assembly; at least one camming surface movable within and along a length of the second jaw by the actuator; a plurality of staples contained within the staple pockets, each staple having an open configuration for penetrating tissue and a closed configuration for retaining tissue, the plurality of staples being disposed within the staple pockets in the open configuration; with the jaw assembly in a closed position, translation of the camming surface along the second jaw ejects the staples from the staple pockets toward the anvil surface of the first jaw causing the staples to transform from an open configuration to a closed configuration against the anvil surface.
15. Each staple has at least a first leg and a second leg connected to one another by a base; the first leg has a distal end and the second leg has a distal end, the first leg of each staple having a length shorter than the second leg; The surgical stapler of claim 14 , wherein the second leg is transformed toward the first leg into a closed configuration when forced against the anvil surface by the translating first camming surface.
16. 16. The surgical stapler of claim 15, wherein the longitudinal axis of the staple pocket is inclined relative to the top surface, the second leg contacts the anvil surface before the first leg, the distal tip of the second leg slides along the anvil surface, and the second leg deforms while a portion of the staple having the first leg remains substantially contained within the staple pocket.
17. 16. The surgical stapler of claim 15, wherein the second distal end is beveled or curved toward the first leg to provide a tendency for the staple to bend toward the first leg.
18. 1. A surgical stapler comprising: A handle assembly is provided. a cartridge assembly coupled to the handle assembly, the cartridge assembly including a proximal end and a distal end, the cartridge assembly comprising: a jaw assembly disposed at the distal end of the cartridge assembly; The jaw assembly has a longitudinal axis, the jaw assembly comprising: a first jaw having an anvil surface; a second jaw having a top surface, the second jaw movable relative to the first jaw, the second jaw having a closed position with the anvil surface adjacent the top surface and a gap formed between the top surface and the anvil surface, the second jaw including a plurality of staple pockets having a plurality of openings at the top surface, the staple pockets being arranged in at least three substantially parallel rows along the top surface of the second jaw; an actuator coupled to the handle assembly; at least one camming surface movable along a length of the second jaw by the actuator; a blade movable within the gap defined between the top surface and the anvil surface when the first jaw and the second jaw are in the closed position, the blade configured to sever tissue located between the first jaw and the second jaw defining a cut line; a plurality of staples disposed within said plurality of staple pockets; the camming surface is configured to erupt staples from the staple pockets against the anvil surface such that the staples are deformed by translation of the camming surface along the second jaw; a second jaw including a number of rows of staple pockets on one side of the blade, the number of rows being different than the number of rows of staple pockets on the other side of the blade.
19. 20. The surgical stapler of claim 18, further comprising visual indicators on the outer surface of the jaw assembly to indicate to a user which side of the jaw assembly delivers the fewer rows of staples.
20. The surgical stapler of claim 18 , wherein the jaw assembly is curved.