WO2017192438A1 - Agrafeuse/découpeuse chirurgicale et contrefort étendu - Google Patents

Agrafeuse/découpeuse chirurgicale et contrefort étendu Download PDF

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Publication number
WO2017192438A1
WO2017192438A1 PCT/US2017/030383 US2017030383W WO2017192438A1 WO 2017192438 A1 WO2017192438 A1 WO 2017192438A1 US 2017030383 W US2017030383 W US 2017030383W WO 2017192438 A1 WO2017192438 A1 WO 2017192438A1
Authority
WO
WIPO (PCT)
Prior art keywords
tissue
buttress
cartridge
surgical stapler
anvil
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2017/030383
Other languages
English (en)
Inventor
Nir I. Nativ
Sridevi Dhanaraj
Leo B. Kriksunov
Charles J. Scheib
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ethicon Inc
Ethicon LLC
Original Assignee
Ethicon Inc
Ethicon LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US15/147,942 external-priority patent/US10265091B2/en
Application filed by Ethicon Inc, Ethicon LLC filed Critical Ethicon Inc
Priority to BR112018072661A priority Critical patent/BR112018072661A2/pt
Priority to CN201780027879.0A priority patent/CN109069154B/zh
Priority to JP2018558231A priority patent/JP7010844B2/ja
Publication of WO2017192438A1 publication Critical patent/WO2017192438A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07292—Reinforcements for staple line, e.g. pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge

Definitions

  • the present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to apply a buttress material to enhance the properties of repaired or adjoined tissue at a target surgical site.
  • suturing was the accepted technique for rejoining severed tissues and closing wounds. Suturing is achieved with a surgical needle and a suturing thread, with the intended function of sutures to hold the edges of a wound or tissue against one another during the healing process. Staples are used to replace suturing when joining or anastomosing various body structures, such as, for example, the bowel.
  • the surgical stapling devices employed to apply staples are generally designed to simultaneously cut and seal an extended segment of tissue in a patient.
  • Linear or annular surgical stapling devices are employed by surgeons to sequentially or simultaneously apply one or more rows of surgical fasteners, e.g., staples, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of an anastomosis.
  • Linear surgical stapling devices generally include a pair of jaws or finger-like structures between which body tissue to be joined is placed. When the surgical stapling device is actuated, firing bars move longitudinally and contact staple drive members in one of the jaws, and surgical staples are pushed through the body tissue and into and against an anvil in the opposite jaw thereby crimping the staples closed.
  • a knife blade may be provided to cut between the rows/lines of staples.
  • a number of surgical staplers for use in open and endoscopic procedures are known. Some such staplers are operable to clamp down on layers of tissue, cut through the clamped layers of tissue, and drive staples through the layers of tissue to substantially seal the severed layers of tissue together near the severed ends of the tissue layers.
  • Some such staplers are operable to clamp down on layers of tissue, cut through the clamped layers of tissue, and drive staples through the layers of tissue to substantially seal the severed layers of tissue together near the severed ends of the tissue layers.
  • Merely exemplary surgical staplers are disclosed in U.S. Pat. No. 4,805,823, entitled "Pocket Configuration for Internal Organ Staplers," issued Feb. 21, 1989; U.S. Pat. No. 5,415,334, entitled “Surgical Stapler and Staple Cartridge,” issued May 16, 1995; U.S. Pat. No. 5,465,895, entitled “Surgical Stapler Instrument,” issued Nov. 14, 1995; U.S. Pat. No. 5,597,107, entitled "Surgical
  • Multistroke Firing Mechanism Having a Rotary Transmission issued May 6, 2008; U.S. Pat. No. 7,380,695, entitled “Surgical Stapling Instrument Having a Single Lockout Mechanism for Prevention of Firing,” issued Jun. 3, 2008; U.S. Pat. No. 7,380,696, entitled “Articulating Surgical Stapling Instrument Incorporating a Two-Piece E-Beam Firing Mechanism,” issued Jun. 3, 2008; U.S. Pat. No. 7,404,508, entitled “Surgical Stapling and Cutting Device,” issued Jul. 29, 2008; U.S. Pat. No. 7,434,715, entitled “Surgical Stapling Instrument Having Multistroke Firing with Opening Lockout,” issued Oct. 14, 2008; U.S. Pat. No.
  • a surgical stapler may be inserted through a thoracotomy, and thereby between a patient's ribs, to reach one or more organs in a thoracic surgical procedure that does not use a trocar as a conduit for the stapler.
  • Such procedures may include the use of the stapler to cut and close a vessel leading to a lung. For instance, the vessels leading to an organ may be severed and closed by a stapler before removal of the organ from the thoracic cavity.
  • Surgical staplers may be used in various other settings and procedures. Examples of surgical staplers that may be particularly suited or use through a thoracotomy are disclosed in U.S. Pat. No. 9,186, 142, entitled “Surgical Instrument End Effector Articulation Drive with Pinion and Opposing Racks", the disclosure of which is incorporated by reference herein.
  • Tissue thickness compensator for a surgical stapler
  • U.S. Patent No. 8,746,535 Tissue thickness compensator comprising detachable portions
  • U.S. Patent No. 8,864,009 Tissue thickness compensator for a surgical stapler comprising an adjustable anvil
  • U.S. Patent No. 9, 113,865 Staple cartridge comprising a layer
  • U.S. Patent No. 9,168,038 Staple cartridge comprising a tissue thickness compensator
  • U.S. Patent No. 9, 198,662 Tissue thickness compensator having improved visibility
  • U.S. Patent publication No. 2014/0239047 ADHERENCE CONCEPTS FOR NON- WOVEN ABSORBABLE FELT BUTTRESSES discloses a surgical stapling apparatus, comprising: a housing; a handle supported by the housing; an elongated body extending distally from the housing; a tool assembly at the distal end of the elongated body, the tool assembly including: a cartridge assembly including a staple cartridge having a tissue facing surface, a plurality of staple retaining pockets and a knife slot formed in the tissue facing surface thereof; a plurality of surgical fasteners loaded one each in the staple retaining pockets; and
  • an anvil assembly in juxtaposed relation to the cartridge assembly, the anvil assembly including an anvil plate having a tissue facing surface defining a plurality of staple forming pockets and a knife slot therein, at least one of the cartridge assembly or the anvil assembly being movable in relation to the other of the cartridge assembly and the anvil assembly;
  • a surgical buttress attached to the tissue facing surface of at least one of the cartridge assembly or the anvil assembly, the surgical buttress conforming to the tissue facing surface such that the surgical buttress is deformed locally into the staple retaining pockets and the knife slot of the cartridge assembly or the staple forming pockets and the knife slot of the anvil assembly to which the surgical buttress is attached, thereby increasing the contact area between
  • U.S. Patent publication No. 2013/0062391 SURGICAL INSTRUMENT WITH FLUID FILLABLE BUTTRESS discloses an apparatus, comprising: (a) a surgical cutter comprising a distal end and a proximal end, wherein the proximal end comprises a handle, wherein the distal end comprises an anvil and a lower jaw, wherein the anvil and the lower jaw are configured to clamp tissue, wherein the surgical cutter is configured to sever tissue clamped by the anvil and the lower jaw; and (b) a buttress filled with a liquid, wherein the buttress is configured to be placed between the anvil and the lower jaw, wherein the buttress comprises a compressive portion and a pressure portion, wherein the compressive portion is configured to be squeezed by the distal end of the surgical cutter by the anvil and the lower jaw clamping the compressive portion, wherein the pressure portion is configured to be pressurized with the liquid in response to clamping on the compression portion, wherein the buttress is configured to be
  • U.S. Patent No. 6,325,810 FOAM BUTTRESS FOR STAPLING APPARATUS discloses apparatus for hemostasis or pneumostasis of tissue comprising a staple cartridge containing a plurality of surgical staples provided in two spaced apart lines having an upper surface with an opening through which said staples may be ejected, said upper surface having releasably attached thereto a compliant bioabsorbable open cell foam, wherein the open cell foam has at least one surface that has been substantially sealed that is in contact with the upper surface of the cartridge.
  • the present invention relates to surgical instruments and methods for enhancing properties of tissue repaired or joined by surgical staples and, more particularly to surgical instruments and methods designed to apply a therapeutic material to enhance the properties of repaired or adjoined tissue at a target surgical site.
  • the present invention in one embodiment, relates to a surgical stapler for joining and resecting tissue comprising: a body, a shaft assembly, and an end effector, wherein the end effector comprises a lower jaw configured to receive a staple cartridge, an anvil pivotable toward and away from the lower jaw, and a translatable knife member; a disposable cartridge installed in the lower jaw, said cartridge containing a plurality of deployable staples in arrays separated by a tissue resection channel through which the knife member can translate; said anvil having a plurality of staple forming pockets aligned with said deployable staples; a surgical buttress at least partially disposed on a tissue facing surface of at least one of the cartridge or the anvil, said buttress having width substantially larger than width of said tissue facing surfaces; said buttress comprising a first portion positioned over the deployable staples or over the staple forming pockets, and at least one flap portion not positioned over the deployable staples or over the staple forming pockets; said flap portion folded or rolled on itself and configured
  • the present invention in another embodiment, relates to methods of joining tissue using the surgical stapler, comprising the steps of: inserting the staple cartridge into the lower jaw; capturing tissue between the anvil and the staple cartridge; translating the knife member distally from a proximal position to a distal position; substantially simultaneously cutting the captured tissue forming a resected tissue edge and driving the plurality of staples of the staple cartridge through the captured tissue, substantially simultaneously attaching said first portion of said buttress to a first tissue surface with staples and cutting said buttress in two halves while not attaching said flap portions to said tissue with said staples; removing said surgical stapler from contact with tissue leaving said buttress attached to the first tissue surface; unfurling at least one of said flap portions and wrapping said at least one flap portion around the resected tissue edge and optionally bringing said at least one flap portion in contact with a second tissue surface opposing the first tissue surface.
  • Figure 1 depicts a perspective view of an exemplary articulating surgical stapling instrument
  • Figure 2 depicts a side elevational view of the instrument of Figure 1;
  • Figure 3 depicts a perspective view of an end effector of the instrument of Figure 1, with the end effector in a closed configuration;
  • Figure 4 depicts a perspective view of the end effector of Figure 3, with the end effector in an open configuration
  • Figure 5 depicts an exploded perspective view of the end effector of Figure 3;
  • Figure 6 depicts a cross-sectional end view of the end effector of Figure 3, taken along line 6-6 of Figure 4;
  • Figure 7 depicts a perspective view of an exemplary cartridge that may be incorporated into the end effector of Figure 3;
  • Figure 8 shows an exploded perspective view of an alternative exemplary surgical stapling instrument
  • Figure 9 shows a perspective view of an exemplary cartridge with a buttress in a flat unfolded configuration placed on top of tissue facing surface of the cartridge;
  • Figure 10 shows a perspective view of an exemplary anvil with a buttress in a flat unfolded configuration placed on top of tissue facing surface of the anvil;
  • Figure 11 shows a schematic top view of an exemplary cartridge with a buttress in a flat unfolded configuration placed on top of tissue facing surface of the cartridge;
  • Figures 12-17 show a simplified cross-sectional view of cartridge with buttress disposed on tissue facing surface with flaps folded or rolled;
  • Figure 18 shows a schematic top view of an exemplary cartridge having grooves in tissue facing surface for storing buttress flaps;
  • Figure 19 shows a simplified cross-sectional view of cartridge with buttress disposed on tissue facing surface with flaps stored in the grooves;
  • Figures 20-22 show cross sectional view of an exemplary cartridge within end-effector with a buttress shown schematically installed on the cartridge with flaps folded;
  • Figure 23 shows a simplified cross-sectional view of tissue positioned prior to stapling and resection between anvil and cartridge installed in the end effector;
  • Figure 24 shows the view of Figure 23 after resection and stapling
  • Figures 25-28 show schematic cross-sectional views of tissue and buttress after stapling and removal of the surgical stapler, illustrating unfurling and wrapping flaps around resected surface and opposing tissue surface;
  • Figures 29A-F show schematic cross-sectional views of embodiments of single layer and multi-layer buttress on a cartridge
  • Figures 30A-E shows schematic cross-sectional views of tissue and two-layer buttress after stapling and removal of the surgical stapler, illustrating unfurling and wrapping flaps around resected surface and opposing tissue surface;
  • Figures 31 and 32 show a simplified cross-sectional view of cartridge with two-layer buttress disposed on tissue facing surface with flaps folded;
  • Figures 33-35 show several configurations of buttress positioned on the anvil
  • Figures 36A-D shows schematic top views of buttress with peripheral flaps and buttress with central flaps, with flaps shown in flat planar view and also in folded view;
  • Figures 37-39 show schematic cross sectional views of cartridge with a buttress having central flaps
  • Figures 40 and 41 show schematic cross sectional views of anvil with a buttress having central flaps
  • Figure 42 shows a simplified cross-sectional view of tissue positioned between anvil and cartridge installed in the end effector, after resection and stapling, with a buttress having central flaps;
  • Figures 43A-C show a schematic cross-sectional views of tissue and buttress having central flaps after stapling and removal of the surgical stapler, illustrating unfurling and wrapping flaps around resected surface and opposing tissue surface;
  • Figures 44A-C show simplified cross-sectional views of cartridge with two-layer buttress disposed on tissue facing surface with flaps folded;
  • Figures 45A and 45B show schematic top views of buttress with peripheral flaps and buttress with central flaps, with flaps having pores or apertures and shown in flat planar view.
  • Typical surgical stapling instruments such as surgical linear stapling instruments have a staple-containing component and an opposing anvil component, between which at least two tissue layers to be joined are compressed prior to delivery of staples from the staple-containing component, whereby staples are piercing both tissue layers and are bent, deformed, or closed against the opposing anvil component.
  • a disposable stapling cartridge is the staple-containing component, the cartridge typically installed in a jaw of the device, such as in a lower jaw adapted to hold the cartridge, and the opposing or upper jaw is the anvil component.
  • the cartridge has a slot disposed between adjacent, parallel rows of staples and extending substantially the entire length of the rows of staples.
  • the stapler includes firing means for the staples and a cutting means that is movable along the slot.
  • FIG. 1-6 a surgical stapling instrument or stapler is shown, with the figures taken from the U.S. Patent Publication No. 2015/0374373A1 "METHOD OF USING LOCKOUT FEATURES FOR SURGICAL STAPLER CARTRIDGE" which is incorporated by reference herein in its entirety.
  • FIG. 1 depicts an exemplary surgical stapling and cutting instrument (10) that includes a handle assembly (20), a shaft assembly (30), and an end effector (40).
  • End effector (40) and the distal portion of shaft assembly (30) are sized for insertion, in a nonarticulated state as depicted in FIG. 1, through a trocar cannula to a surgical site in a patient for performing a surgical procedure.
  • a trocar may be inserted in a patient's abdomen, between two of the patient's ribs, or elsewhere.
  • instrument (10) is used without a trocar.
  • end effector (40) and the distal portion of shaft assembly (30) may be inserted directly through a thoracotomy or other type of incision.
  • terms such as “proximal” and “distal” are used herein with reference to a clinician gripping handle assembly (20) of instrument (10).
  • end effector (40) is distal with respect to the more proximal handle assembly (20).
  • spatial terms such as “vertical” and “horizontal” are used herein with respect to the drawings.
  • surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute.
  • handle assembly (20) of the present example comprises pistol grip (22), a closure trigger (24), and a firing trigger (26). Each trigger (24, 26) is selectively pivotable toward and away from pistol grip (22).
  • Handle assembly (20) further includes an anvil release button (25), a firing beam reverse switch (27), and a removable battery pack (28).
  • Handle assembly (20) may have a variety of other components, features, and operabilities, in addition to or in lieu of any of those noted above.
  • shaft assembly (30) of the present example comprises an outer closure tube (32), an articulation section (34), and a closure ring (36), which is further coupled with end effector (40).
  • Closure tube (32) extends along the length of shaft assembly (30).
  • Closure ring (36) is positioned distal to articulation section (34). Closure tube (32) and closure ring (36) are configured to translate longitudinally relative to handle assembly (20). Longitudinal translation of closure tube (32) is communicated to closure ring (36) via articulation section (34).
  • Articulation section (34) is operable to laterally deflect closure ring (36) and end effector (40) laterally away from the longitudinal axis (LA) of shaft assembly (30) at a desired angle (a). End effector (40) may thereby reach behind an organ or approach tissue from a desired angle or for other reasons.
  • articulation section (34) enables deflection of end effector (40) along a single plane.
  • articulation section (34) enables deflection of end effector along more than one plane.
  • articulation is controlled through an articulation control knob (35) which is located at the proximal end of shaft assembly (30).
  • Knob (35) is rotatable about an axis that is perpendicular to the longitudinal axis (LA) of shaft assembly (30).
  • Closure ring (36) and end effector (40) pivot about an axis that is perpendicular to the longitudinal axis (LA) of shaft assembly (30) in response to rotation of knob (35).
  • rotation of knob (35) clockwise may cause corresponding clockwise pivoting of closure ring (36) and end effector (40) at articulation section (34).
  • Articulation section (34) is configured to communicate longitudinal translation of closure tube (32) to closure ring (36), regardless of whether articulation section (34) is in a straight configuration or an articulated configuration.
  • shaft assembly (30) of the present example further includes a rotation knob (31).
  • Rotation knob (31) is operable to rotate the entire shaft assembly (30) and end effector (40) relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30).
  • rotation knob (31) is operable to selectively lock the angular position of shaft assembly (30) and end effector (40) relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30).
  • rotation knob (31) may be translatable between a first longitudinal position, in which shaft assembly (30) and end effector (40) are rotatable relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30); and a second longitudinal position, in which shaft assembly (30) and end effector (40) are not rotatable relative to handle assembly (20) about the longitudinal axis (LA) of shaft assembly (30).
  • shaft assembly (30) may have a variety of other components, features, and operabilities, in addition to or in lieu of any of those noted above.
  • end effector (40) of the present example includes a lower jaw (50) and a pivotable anvil (60).
  • Anvil (60) includes a pair of integral, outwardly extending pins (66) that are disposed in corresponding curved slots (54) of lower jaw (50). Pins (66) and slots (54) are shown in FIG. 5.
  • Anvil (60) is pivotable toward and away from lower jaw (50) between an open position (shown in FIGS. 2 and 4) and a closed position (shown in FIGS. 1, 3).
  • lower jaw (50) of the present example defines a channel (52) that is configured to receive a staple cartridge (70).
  • Staple cartridge (70) may be inserted into channel (52), end effector (40) may be actuated, and then staple cartridge (70) may be removed and replaced with another staple cartridge (70).
  • Lower jaw (50) thus releasably retains staple cartridge (70) in alignment with anvil (60) for actuation of end effector (40).
  • staple cartridge (70) of the present example comprises a cartridge body (71) and a tray (76) secured to the underside of cartridge body (71).
  • the upper side of cartridge body (71) presents a deck (73), against which tissue may be compressed when anvil (60) is in a closed position.
  • Cartridge body (71) further defines a longitudinally extending channel (72) and a plurality of staple pockets (74).
  • a staple (77) is positioned in each staple pocket (74).
  • a staple driver (75) is also positioned in each staple pocket (74), underneath a corresponding staple (77), and above tray (76).
  • Staple drivers (75) are operable to translate upwardly in staple pockets (74) to thereby drive staples (77) upwardly through staple pockets (74) and into engagement with anvil (60).
  • Staple drivers (75) are driven upwardly by a wedge sled (78), which is captured between cartridge body (71) and tray (76), and which translates longitudinally through cartridge body (71).
  • Wedge sled (78) includes a pair of obliquely angled cam surfaces (79), which are configured to engage staple drivers (75) and thereby drive staple drivers (75) upwardly as wedge sled (78) translates longitudinally through cartridge (70).
  • staple cartridge (70) may be varied in numerous ways.
  • staple cartridge (70) of the present example includes two longitudinally extending rows of staple pockets (74) on one side of channel (72); and another set of two longitudinally extending rows of staple pockets (74) on the other side of channel (72).
  • staple cartridge (70) includes three, one, or some other number of staple pockets (74) on each side of channel (72).
  • anvil (60) of the present example comprises a longitudinally extending channel (62) and a plurality of staple forming pockets (64).
  • Channel (62) is configured to align with channel (72) of staple cartridge (70) when anvil (60) is in a closed position.
  • Each staple forming pocket (64) is positioned to lie over a corresponding staple pocket (74) of staple cartridge (70) when anvil (60) is in a closed position.
  • Staple forming pockets (64) are configured to deform the legs of staples (77) when staples (77) are driven through tissue and into anvil (60).
  • staple forming pockets (64) are configured to bend the legs of staples (77) to secure the formed staples (77) in the tissue.
  • a knife member (80) is configured to translate through end effector (40). As seen in FIG. 5, knife member (80) is secured to the distal end of a firing beam (82). As seen in FIGS. 4 and 6, knife member (80) is positioned in channels (62, 72) of anvil (60) and staple cartridge (70). Knife member (80) includes a distally presented cutting edge (84) that is configured to cut tissue that is compressed between anvil (60) and deck (73) of staple cartridge (70) as knife member (80) translates distally through end effector (40).
  • end effector (40) includes lockout features that are configured to prevent knife member (80) from advancing distally through end effector (40) when a staple cartridge (70) is not inserted in lower jaw (50).
  • end effector (40) may include lockout features that are configured to prevent knife member (80) from advancing distally through end effector (40) when a staple cartridge (70) that has already been actuated once (e.g., with all staples (77) deployed therefrom) is inserted in lower jaw (50).
  • end effector (40) may simply omit such lockout features.
  • anvil (60) is driven toward lower jaw (50) by advancing closure ring (36) distally relative to end effector (40).
  • Closure ring (36) cooperates with anvil (60) through a camming action to drive anvil (60) toward lower jaw (50) in response to distal translation of closure ring (36) relative to end effector (40).
  • closure ring (36) may cooperate with anvil (60) to open anvil (60) away from lower jaw (50) in response to proximal translation of closure ring (36) relative to end effector (40).
  • handle assembly (20) includes a pistol grip (22) and a closure trigger (24).
  • anvil (60) is closed toward lower jaw (50) in response to distal advancement of closure ring (36).
  • closure trigger (24) is pivotable toward pistol grip (22) to drive closure tube (32) and closure ring (36) distally.
  • suitable components that may be used to convert pivotal movement of closure trigger (24) toward pistol grip (22) into distal translation of closure tube (32) and closure ring (36) relative to handle assembly (20) will be apparent to those of ordinary skill in the art in view of the teachings herein.
  • closure trigger (24) When closure trigger (24) reaches a fully pivoted state, such that anvil (60) is in a fully closed position relative to lower jaw (50), locking features in handle assembly (20) lock the position of trigger (24) and closure tube (32), thereby locking anvil (60) in a fully closed position relative to lower jaw (50). These locking features are released by actuation of anvil release button (25).
  • Anvil release button (25) is configured and positioned to be actuated by the thumb of the operator hand that grasps pistol grip (22).
  • the operator may grasp pistol grip (22) with one hand, actuate closure trigger (24) with one or more fingers of the same hand, and then actuate anvil release button (25) with the thumb of the same hand, without ever needing to release the grasp of pistol grip (22) with the same hand.
  • closure trigger (24) with one or more fingers of the same hand
  • anvil release button (25) with the thumb of the same hand
  • Other suitable features may be used to actuate anvil (60).
  • surgical stapler 11 comprises an upper piece 300, a firing means 400, a lower piece 500 and a staple cartridge 600.
  • Staple cartridge 600 fits within the lower piece 500. Specifically, the front part of staple cartridge 600 fits into lower jaw channel 540. More specifically, the parallel side walls 610 of the staple cartridge 600 fit within the lower jaw channel 540. The back part of staple cartridge 600 has a breakable transverse member 660. This breakable transverse member 660 is placed on top of cartridge locking means 470 of firing means 400. At the same time two legs 650 within rearwardly extending surfaces 620 secure staple cartridge 600 to lower piece 500.
  • upper piece 300 has a rear upper handle portion 310 and a front upper jaw portion or anvil 320.
  • lower piece 500 includes a rear movable lower handle portion 510 and a front lower jaw portion 530.
  • the embodiment of the surgical stapler as illustrated in Figure 8 incorporates firing means 400, leaf spring 570, and staple cartridge 600 into lower piece 500. Yet, these elements may be placed in upper piece 300 instead of lower piece 500.
  • Lower handle portion 510 illustrated in Figure 8 is movable, more specifically, pivotable between two locking positions.
  • movable lower handle portion 510 In the first locking position, movable lower handle portion 510 is positioned at an oblique angle to lower jaw portion 530.
  • a C- shaped member 520 of lower handle 510 is disengaged from a stationary locking pin 330.
  • the upper and lower pieces, 300 and 500, respectively may be separated before or after operation of stapler 11 in the first locking position.
  • the C- shaped member 520 of movable lower handle 510 locks the upper and lower pieces 300 and 500 together.
  • the movable lower handle portion 510 In the second locking position the movable lower handle portion 510 is parallel to lower jaw portion 520. This second locking position occurs by engaging stationary locking pin 330 with C-shaped member 520.
  • This movable handle portion design may be on the upper or lower handle portions, 310 and 510, respectively.
  • Firing knob 590 activates firing means 400.
  • Firing means 400 also includes a roof assembly 700 and also contains a cutting means such as a knife blade assembly 440.
  • a cutting surface 450 is included in knife blade assembly 440.
  • tissue may be cut in many ways besides knife or razor blade cutting.
  • firing knob 590 is manually pushed towards staple cartridge 600. Pushing firing knob 590 moves knife blade assembly 440 forward toward the staple cartridge 600. Then knife cutting surface 450 is moved through slot 640 of staple cartridge 600 simultaneously advancing staples from staple cartridge 600 through longitudinal slots 630. In some staple cartridge 600 embodiments, knife blade assembly is incorporated into the staple cartridge 600.
  • FIG. 10 Other versions and modifications of the surgical staplers 10, 11 are known to a skilled artisan, all including a staple cartridge 70 or 600 having a plurality of staple pockets 74 or longitudinal slots 630 containing staples 77 (staples are not shown in Figure 8), with staple pockets 74 or longitudinal slots 630 typically arranged in one or several rows on both sides of longitudinally extending channel 72 or slot 640. There are typically at least two and frequently at least three rows of staple pockets 74 or longitudinal slots 630 on each side of longitudinally extending channel 72 or slot 640, with staple pockets 74 or longitudinal slots 630 in each row typically staggered or offset relative to pockets or slots in the adjacent row, to improve the sealing and prevent leakage along the stapling line.
  • a buttress 100 or 100a comprising absorbable or non-absorbable substantially flat and flexible material such as fabric, cloth, knit, felt, non-woven, foam, mesh, and the like, that is at least partially disposed on the tissue facing surface 170 of cartridge 70 or on tissue facing surface 160 of anvil 60 prior to stapling.
  • Buttress 100 or 100a is shown for clarity semi-transparent, but it can be also opaque. In some embodiments, buttress 100 or 100a is substantially wider than the width of cartridge 70 tissue facing surface 170 or anvil 60 tissue facing surface 160, with the excess width of buttress 100 or 100a comprising a peripheral flap 110 or 110a.
  • Buttress 100 or 100a is at least partially covering staple pockets 74 and preferably fully covering staple pockets 74.
  • a simplified top view of cartridge 70 is presented with two rows of staple pockets 74 on each side of channel 72 and buttress 100 (shown for clarity semi- transparent) disposed on tissue facing surface 170, with essentially symmetrical arrangement of buttress 100 on top and around channel 72, with peripheral flaps 110 symmetrically extending on both sides of cartridge 70.
  • Peripheral flaps 110 are schematically indicated by arrows showing the width of peripheral flaps 110, and showing a portion of buttress 100 that is foldable after deployment of staples.
  • FIG. 12 a simplified front cross-sectional view of cartridge 70 is presented with two rows of staple pockets 74 on each side of channel 72 and buttress 100 disposed on tissue facing surface 170, with peripheral flaps 110 stored folded at least once back onto buttress 100 with no peripheral flap 110 being over any staple pockets 74, preventing stapling of peripheral flaps 110 upon deployment of staples (staples not shown for simplification) from staple pockets 74.
  • Peripheral flap 110 is shown stored folded back twice onto buttress 100 and onto itself.
  • peripheral flap 110 is shown stored folded back four times onto buttress 100 and onto itself, or folded in an accordion-like shape. Any number of folds can be utilized to achieve necessary width of the buttress peripheral flap.
  • peripheral flap 110 is shown stored rolled on itself in a roll positioned below or above tissue facing surface 170, or at about the level of tissue facing surface 170.
  • peripheral flap 110 is shown stored bent alongside cartridge body 71.
  • FIG. 18 an embodiment of cartridge 70 is shown with a longitudinal cavities or grooves or recesses 172 formed in cartridge 70 tissue facing surface 170, and running parallel to channel 72 on both sides of channel 72 on the periphery of tissue facing surface 170, with rows of staple pockets 74 being between longitudinal cavities or grooves 172 and channel 72.
  • Figure 18 shows no buttress 100 for simplification, but as can be seen in Figure 19, buttress 100 peripheral flaps 110 are packed into cavities or grooves 172.
  • FIG. 20-22 representing, similarly to FIG. 6, a cross-sectional end view of the end effector of FIG. 3, taken along line 6-6 of FIG. 4, with the knife member 80 assembly not shown for simplification and buttress 100 with peripheral flaps 110 schematically shown.
  • Fig. 20 is showing an embodiment similar to that of Figs. 15 or 17.
  • Fig 21 is showing an embodiment similar to that of Figs. 12 or 13.
  • Fig 22 is showing an embodiment similar to that of Fig. 19.
  • peripheral flaps 110 are stored outside of staple pockets 74 to prevent stapling of peripheral flaps 110 during staple deployment.
  • Peripheral flaps 110 are stored distal to channel 72 and opposite channel 72, on the periphery of cartridge 70, with staple pockets 74 being between peripheral flaps 110 and channel 72.
  • Peripheral flap 110 is stored prior to the deployment/folding over tissue resected edge by being rolled on itself in one or more turns; folded in an accordion-like shape in one or more layers, folded onto cartridge 70 in one or more layers, or similarly packed for ease of later unfurling.
  • FIG. 23 a simplified cross-sectional view is presented of to be resected and stapled tissue layers Tl and T2 compressed between lower jaw 50 with cartridge 70 and anvil 60.
  • Cartridge 70 is shown with buttress 100 disposed on cartridge 70 and in contact with tissue T2, with peripheral flaps 110 packed into grooves 172 as was shown in the embodiment of Fig 19.
  • any other arrangement of peripheral flaps 110 outside of staple pockets 74 can be utilized.
  • the arrangement in Fig. 23 is corresponding to position immediately prior to deploying staples 77 (not shown in Fig. 23) and driving staples 77 through tissues Tl and T2 into anvil 60 and also prior to the knife member 80 (not shown in Fig. 23) translating through channel 72 and resecting stapled tissues Tl and T2.
  • FIG. 24 a simplified cross-sectional view is presented of the position after deployment of staples 77 and resecting tissue layers Tl and T2. Buttress 100 is stapled to the tissues Tl and T2 by staples 77 and is cut into two halves by the action of knife member 80 (not shown in Fig. 23) as knife member 80 resects/cuts tissue.
  • FIG. 25 a simplified cross-sectional view is presented of the position after opening of stapler 10 i.e. separation of lower jaw 50 and anvil 60 after stapling and removal of stapler 10.
  • Buttress 100 remains attached to stapled and resected tissues Tl and T2 by staples 77.
  • Buttress 100 with peripheral flap 110 has separated from cartridge 70, with peripheral flap 110 moving from its storage position within groove 172. Only one side of resected tissue layers Tl and T2 is shown for simplification. Tissue layers Tl and T2 have formed an exposed resection edge 120.
  • Peripheral flap 110 is then unfurled from its folded storage position and flipped over or folded back and is wrapped around the resected edge 120, as schematically indicated by arrows in Fig. 25, resulting in the position of the peripheral flap 110 shown in Fig. 26A. As can be seen, peripheral flap 110 starts folding at stapled area of buttress 100, i.e. at staples 77 row farthest away from edge 120.
  • Peripheral flap 110 is covering the stapled area of buttress on tissue T2, edge 120, and at least a portion of tissue Tl .
  • peripheral flap 110 of buttress 100 is covering the resected edge 120 which will help hemostasis and tissue sealing, improve healing, prevent adhesions.
  • Buttress 100 is contacting tissue T2 with one surface of the buttress, and is contacting edge 120 and tissue Tl with an opposite surface of buttress 100.
  • peripheral flap 110 is covering the stapled area of tissue Tl and beyond.
  • peripheral flap 110 is covering only a small portion of tissue Tl and not covering the stapled area of tissue Tl .
  • Peripheral flap 110 is contacting tissue edge 120 and opposing tissue Tl with the side of buttress 100 that is not in contact with tissue Tl, in other words with the side of buttress 100 that is opposite to the side of the buttress in contact with tissue Tl .
  • Peripheral flap 110 is manipulated by the surgeon using any available tools such as surgical grasper, or manually.
  • FIG. 26B a position similar to Fig. 26A is presented, with the difference being that only one tissue layer, designated as T and having surfaces SI and S2 in Fig 26B, is being resected and stapled, with surface S2 corresponding to tissue T2 and surface SI corresponding to tissue Tl .
  • optional fixating means are provided for peripheral flap 110 fixating on edge 120, and/or, on tissue Tl .
  • peripheral flap 110 has means for fixation on at least tissue Tl .
  • an adhesive coating or adhesive layer 130 on buttress 100 side facing away from tissue T2 with at least adhesive layer 130a on periphery of peripheral flap 110 which is in contact with tissue Tl .
  • adhesive layer 130b on area of peripheral flap 110 in contact with edge 120.
  • adhesive layer 130c on area of peripheral flap 110 in contact with stapled area of buttress 100.
  • all buttress 100 side facing away from tissue T2 can be covered by adhesive layer (not shown).
  • peripheral flap 110 As peripheral flap 110 is folded over the resected edge and brought into contact with tissue Tl, peripheral flap 110 is secured to tissue edge 120 and/or to tissue Tl by the action of the adhesive layer 130.
  • tissue adhesives and sealants which are activated by moisture, blood, and/or by contact with wet tissue are known and can be utilized.
  • biocompatible adhesives include, for example, fibrin glue, various cross-linking agents, alone or in combination with additional agent such as a protein and are known to a skilled artisan.
  • U.S. Patent No. 6,458,147 discloses biocompatible and biodegradable hydrogel compound applied to arrest the flow of blood or fluid from body tissue.
  • the compound preferably includes a protein comprising albumin, which is mixed with a polymer that comprises poly(ethylene) glycol (PEG), and, most preferably, a multi-armed PEG polymer.
  • PEG poly(ethylene) glycol
  • Biocompatible hydrogel compositions discloses biocompatible synthetic electrophilic component mixed with a nucleophilic component.
  • the electrophilic component can include a functionalized electrophilic poly (anhydride ester) material.
  • the nucleophilic material can include a protein. The components can react by cross- linking when exposed to moisture.
  • poly(ethylene glycol) (PEG) succinimidyl glutarate is mixed with a biocompatible, synthetic, nucleophilic polymer component essentially free of albumin and other biological molecules, containing, e.g., a polypeptide moiety having a number of active surface lysines of at least twenty per 5000 M/W, which can also be blended with a multi-arm poly(ethylene glycol) (PEG) amine.
  • U.S. Patent Publication No. 2014/0369991 Al “Formulations for Wound Therapy” discloses formulations comprising a dry powder fibrin sealant comprised a mixture of fibrinogen and/or thrombin, for use in the treatment of wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention.
  • adhesive is formed from dry protein such as albumin and a crosslinking agent.
  • the cross-linking agent is exemplified by 4 arm polyethylene glycol succinimidyl glutarate (also referred to as PEG-SG4, succinimidyl PEG NHS, tetra functional poly (ethylene glycol) succinimidyl glutarate).
  • Protein and cross-linking agent are disposed on or impregnated into peripheral flap 110 forming adhesive layer 130a, 130b, 130c, or adhesive layer on all buttress 100 side facing away from tissue T2 upon exposure to moisture or blood.
  • Adhesive is activated upon exposure to moisture or blood resulting in adhesive attachment of peripheral flap 110 to edge 120 and/or tissue Tl .
  • adhesive is formed from dry precursors to fibrin glue, such as fibrinogen and thrombin, which are disposed on or impregnated into peripheral flap 110 forming adhesive layers 130a, 130b, 130c, or adhesive layer on all buttress 100 side facing away from tissue T2 upon exposure to moisture or blood. Upon contact with moisture, fibrin is formed resulting in adhesive attachment of peripheral flap 110 to edge 120 and/or tissue Tl .
  • fibrin glue such as fibrinogen and thrombin
  • one or more miniature anchors such as barbed pins 135 are provided on peripheral flap 110 in the area on periphery of peripheral flap 110 which is in contact with tissue Tl and corresponds to area 130a in Fig. 27.
  • peripheral flap 110 is made of a material that is self- adhering to wet tissue surfaces, such as dry collagen foam, ORC sheet, PEG-SG coated bio- absorbable sheet, fibrinogen and or thrombin coated sheet, natural or natural synthetic composite material such as gelatin, chitosan, etc., and combinations thereof. Other materials can be utilized.
  • peripheral flap 110 is coated by a moisture activated composition having high adherence to wet tissues, such as a mucoadhesive composition.
  • FIG. 29 A a schematic cross-sectional view of buttress 100 is presented disposed in unfurled and straightened configuration on cartridge 70.
  • the width of peripheral flaps 110 of buttress 100 located on the periphery of buttress 100, which peripheral flaps 110 are not stapled, is designated by arrows "PF” and indicates peripheral flap width.
  • PF peripheral flap width
  • Peripheral flap 110 width PF is defined as area of buttress 100 distal to channel 72 that is not stapled and can be folded over stapled portion of buttress.
  • the width of central stapled portion of buttress 100, 100a is configured so that this portion is covering stapled area or covering staple pockets 74 or staple forming pockets 64.
  • the width of central stapled portion of buttress 100, 100a is from about 0.5 to about 1.0 times the width of tissue facing surface 170 or 160, such as 0.7, 0.8, 0.9, 1.0 times the width of tissue facing surface 170 or 160.
  • peripheral flaps 110, 110a is configured so that peripheral flaps can be folded backwards and wrapped around resected tissue edge 120.
  • the width of each peripheral flap is at least equal to or larger than one half of the width of tissue facing surface 170 or 160, such as 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.5, 2 times the width of tissue facing surface 170 or 160.
  • buttress 100 comprises a single layer of uniform thickness material.
  • buttress 100 comprises a multilayer material or single layer material of non-uniform thickness.
  • buttress 100 comprises a two-layer construct, with peripheral flaps 110 facing cartridge 70 and adapted to be wrapped around tissue edge, while second layer 111 of buttress 100, optionally less flexible, and optionally thicker material, is optimized for tissue support and/or staple line reinforcement, is adapted to remain opposite tissue T2.
  • Figure 30A shows embodiment of Figure 29B after stapling and resection, with peripheral flap 110 wrapped around tissues and positioned on tissue Tl, with second layer 111 remaining in contact with tissue T2 after stapling.
  • tissue support and/or staple line reinforcement by layer 111 and simultaneously coverage of resected edge 120 by peripheral flap 110.
  • buttress 100 comprises a two-layer construct, with peripheral flaps 110 facing cartridge 70 and adapted to be wrapped around tissue edge, while second layer 112 of buttress 100, optionally less flexible and optionally thicker material, is optimized for staple line reinforcement and/or tissue thickness compensation, and is adapted to be stapled and remain opposite tissue T2.
  • Figure 30B shows embodiment of Figure 29C after stapling and resection, with peripheral flap 110 wrapped around tissues and positioned on tissue Tl, with second layer 112 remaining in contact with tissue T2 after stapling.
  • second layer 112 is used to reinforce the stapled tissue.
  • the width of second layer 112 is as shown, at least wide enough to cover the stapled area i.e. area between outermost rows of staple pockets 74. Alternatively (not shown), the width of second layer 112 is equivalent or slightly wider than cartridge 70.
  • buttress 100 comprises a two-layer construct, with second layer 113 of buttress 100, facing cartridge 70 and optimized for staple line reinforcement and/or tissue thickness compensation, is adapted to be stapled and remain opposite tissue T2.
  • Second layer 113 is positioned between cartridge 70 and peripheral flaps 110, which are adapted to be wrapped around tissue edge.
  • Figure 30C shows embodiment of Figure 29D after stapling and resection, with peripheral flap 110 wrapped around tissues and positioned on tissue Tl, with second layer 112 remaining in contact with tissue T2 after stapling.
  • second layer 113 is as shown, is substantially equivalent to width of cartridge 70. Alternatively (not shown), the width of second layer 113 is at least wide enough to cover the stapled area i.e. area between outermost rows of staple pockets 74.
  • buttress 100 comprises a construct made of the same material and having a central thicker area 114 optimized for staple line reinforcement and/or tissue thickness compensation, adapted to be stapled and remain opposite tissue T2.
  • Peripheral flaps 110 positioned on two sides of central thicker area 114, are adapted to be wrapped around tissue edge.
  • Figure 30D shows embodiment of Figure 29E after stapling and resection, with peripheral flap 110 wrapped around tissues and positioned on tissue Tl, with central thicker area 114 remaining in contact with tissue T2 after stapling.
  • staple line reinforcement and/or tissue thickness compensation by area 114 and simultaneously coverage of resected edge 120 by peripheral flap 110.
  • the width of central thicker area 114 is as shown, substantially equivalent to width of cartridge 70. Alternatively (not shown), the width of central thicker area 114 is at least wide enough to cover the stapled area i.e. area between outermost rows of staple pockets 74.
  • buttress 100 comprises a construct having a central thicker area 115 made of a first material, optimized for staple line reinforcement and/or tissue thickness compensation, adapted to be stapled and remain opposite tissue T2.
  • Peripheral flaps 110 positioned on two sides of central thicker area 115, are made of a second material joined to the first material, and are adapted to be wrapped around tissue edge.
  • Figure 30E shows embodiment of Figure 30E after stapling and resection, with peripheral flap 110 wrapped around tissues and positioned on tissue Tl, with central thicker area 115 remaining in contact with tissue T2 after stapling.
  • staple line reinforcement and/or tissue thickness compensation by area 115 and simultaneously coverage of resected edge 120 by peripheral flap 110.
  • the width of central thicker area 115 is as shown, substantially equivalent to width of cartridge 70.
  • the width of central thicker area 115 is at least wide enough to cover the stapled area i.e. area between outermost rows of staple pockets 74.
  • FIG. 31 a simplified frontal cross-sectional view of an embodiment of cartridge 70 is presented with two rows of staple pockets 74 on each side of channel 72 and buttress 100 of embodiment shown in Fig. 29C disposed on tissue facing surface 170, with peripheral flaps 110 stored folded onto buttress 100 and onto itself.
  • Buttress 100 comprises a two-layer construct, with peripheral flaps 110 facing cartridge 70 and adapted to be wrapped around tissue edge, while second layer 112 of buttress 100, optionally less flexible material, is optimized for staple line reinforcement and/or tissue thickness compensation.
  • buttress 100 of embodiment shown in Fig. 29C is disposed on tissue facing surface 170, with peripheral flaps 110 packed into grooves 172.
  • Buttress 100 comprises a two-layer construct, with peripheral flaps 110 adapted to be wrapped around tissue edge, while second layer 112 of buttress 100, optionally less flexible material, is optimized for staple line reinforcement and/or tissue thickness compensation.
  • a buttress 100a supported on anvil 60.
  • FIG. 33 a simplified cross-sectional view of anvil 60 is sown, with buttress lOOd, in one embodiment, supported on anvil 60 in addition to buttress 100 supported on cartridge 70 described above.
  • buttress lOOd has no flaps and has a width substantially the same as width of anvil 60.
  • Buttress lOOd has adhesive 140 is disposed on the side of buttress lOOd facing anvil 60 and staple forming pockets 64. Upon deployment of both buttress lOOd and buttress 100 onto stapled tissues Tl and T2, adhesive 140 can be used to adhesively fixate buttress 100 peripheral flap 110 on buttress lOOd.
  • FIG. 34 a simplified cross-sectional view of anvil 60 is shown, with buttress 100a, in one embodiment, supported on anvil 60 as optional alternative to or
  • buttress 100a has peripheral flaps 110a which are wrapped around anvil 60 prior to deployment.
  • FIG. 35 a simplified cross-sectional view of anvil 60 is shown, with buttress 100a, in one embodiment, supported on anvil 60 as optional alternative to or
  • buttress 100a has peripheral flaps 110a which are packed into longitudinal cavities or grooves 172a formed in anvil 60, and running parallel to channel 62 on both sides of channel 62 on the periphery of anvil 60 as shown, with rows of staple forming pockets 64 being between longitudinal cavities or grooves 172a and channel 62.
  • buttress 100a is stapled to tissues Tl and T2 and is cut into two halves by the action of knife member 80 as knife member 80 resects/cuts tissue. After stapling and removal of stapler 10, buttress 100a remains attached to stapled and resected tissues Tl and T2, with peripheral flaps 110a separating from anvil 60. Peripheral flap 110a is then unfurled from its folded storage position and flipped over or folded back and is wrapped around the resected edge.
  • peripheral flaps 110, 110a of buttress 100 and 100a positioned on the periphery of buttress 100 or 100a and surrounding central stapled portion CSP of buttress, with peripheral flaps stored distal to longitudinally extending channels 72 or 62, on the periphery of tissue facing surface 170 of cartridge 70 or 160 or anvil 60.
  • central flaps (CF) 105 or 105a portions of buttress 100 or 100a are positioned proximal to channel 72, i.e. between channel 72 and rows of staple pockets 74 or channel 62 and rows of staple forming pockets 62.
  • Figure 36A a schematic top view of buttress 100 or 100a with peripheral flaps 110, 110a.
  • Figure 36A shows buttress 100, 100a in flat, unpacked/unwrapped view prior to stapling and resection, with peripheral flaps 110 or 110a forming a peripheral portion of buttress 100 or 100a, with also schematically shown line of resection 720 and stapling lines 740.
  • Figure 36B shows schematic top view of buttress 100 or 100a presented in
  • peripheral flaps 110 or 110a folded and packed in the peripheral area outside of stapling lines 740 and distal to line of resection 720. Folds 106 of peripheral flaps 110, 110a are schematically shown.
  • FIGS 36C, 36D embodiments of the present invention are shown where central flaps (CF) 105 or 105a are forming central portion of buttress 100 or 100a, while peripheral stapled portion (PSP) of buttress 100 or 100a is located on the periphery of buttress 100 or 100a.
  • Figures 36C, 36D are also schematically presenting line of resection 720 and stapling lines 740.
  • Figure 36C shows a schematic top view of buttress 100 or 100a in unpacked/unwrapped view.
  • Figure 37D shows a schematic top view of buttress 100 or 100a in packed/wrapped configuration prior to stapling and resection, with buttress central flaps 105 or 105a folded and packed in the area between line of resection 720 and stapling lines 740. Folds 106 of central flaps 105 or 105a are schematically shown.
  • Figure 37 shows a schematic cross-sectional view of cartridge 70 with buttress 100, with central flaps 105 folded and packed into grooves 172 which are proximal to channel 72 on both sides of channel 72, i.e. between channel 72 and rows of staple pockets 74.
  • Fig. 38 shows an alternative embodiment whereby grooves 172 are open on one side to channel 72.
  • Fig. 39 shows an alternative embodiment whereby buttress 100 is pre-cut into two halves positioned on both sides of channel 72.
  • FIG. 40-41 present schematic cross-sectional views of anvil 60 with buttress 100a, central flaps 105a of buttress 100a are positioned proximal to channel 62, i.e. between channel 62 and rows of staple forming pockets 64. Central flaps 105a of these embodiments are formed in the central portion of buttress 100a.
  • Fig 40 shows central flaps 105a folded and packed into grooves 172a which are proximal to channel 62 on both sides of channel 62, i.e. between channel 62 and rows of staple forming pockets 64.
  • Fig. 41 shows an alternative embodiment whereby grooves 172a are fully cutting though anvil 60 and are longitudinal open channels starting on tissue facing surface 160 and terminating on anvil 60 side opposing tissue facing side 160, with central flaps 105a partially exposed on side of anvil 60 opposite tissue facing side of anvil 60.
  • grooves 172a are fully cutting though anvil 60 and are longitudinal open channels starting on tissue facing surface 160 and terminating on anvil 60 side opposing tissue facing side 160, with central flaps 105a partially exposed on side of anvil 60 opposite tissue facing side of anvil 60.
  • buttress 100a is pre-cut into two halves positioned on both sides of channel 62.
  • embodiments with central flaps 105, 105A of Figures 36C, 36D, and 37-41 operate in a similar fashion to the embodiments with peripheral flaps 110, 110a, whereby upon deployment of staples and resecting of tissue T or tissue layers Tl and T2, buttress 100, 110a is stapled to the tissue and is cut into two halves by the action of knife member. Buttress 100, 100a remains attached to stapled and resected tissue and is separated from cartridge 70 or anvil 60, with central flaps 105 and/or 105a moving from storage position within grooves 172, 172a. Central flaps 105 and/or 105a are then unfurled from the folded storage position and wrapped around the resected tissue edge.
  • peripheral flaps 110 or 110a are positioned on the periphery of buttress 100 or 100a is that central flaps 105 and 105a do not need to be flipped over or folded back, but can be directly wrapped around tissue edge 120.
  • FIG. 42 a simplified cross-sectional view is presented of the position after deployment of staples 77 and resecting tissue T.
  • tissue T As shown, but several layers, such as tissues Tl and T2 as presented above can be stapled.
  • Buttress 100 is shown stapled to tissue T by staples 77 and cut into two halves by the action of knife member 80 (not shown in Fig. 42) as knife member 80 resects/cuts tissue.
  • FIG. 43 A a simplified cross-sectional view is presented of the position after opening of stapler 10 i.e. separation of lower jaw 50 and anvil 60 after stapling and removal of stapler 10. Buttress 100 remains attached to stapled and resected tissue T by staples 77.
  • Buttress 100 with central flap 105 has separated from cartridge 70, with central flap 105 moving from its storage position within groove 172. Only one side of resected tissue T is shown for simplification. Tissue T has formed an exposed resection edge 120.
  • Central flap 105 is then unfurled from its folded storage position and wrapped around the resected edge 120, as schematically indicated by arrow in Fig. 43B, resulting in the position of the central flap 105 shown in Fig. 43C.
  • central flap 105 is covering tissue edge 120 and at least a portion of tissue surface SI which is opposite to tissue surface S2.
  • Peripheral Stapled Portion PSP of buttress 100 is stapled to tissue surface S2, and central flap 105 wraps around tissue T starting at surface S2, goes over tissue edge 120, and covers at least a portion of tissue surface SI, which will help hemostasis and tissue sealing, improve healing, prevent adhesions.
  • central flaps 105, 105a for anvil 60 mounted buttress 100a
  • buttress 100a is stapled to tissues Tl and T2 or single layer tissue T and is cut into two halves by the action of knife member 80 as knife member 80 resects/cuts tissue.
  • knife member 80 As knife member 80 resects/cuts tissue.
  • central flaps 105a separating from anvil 60.
  • Central flap 105a is then unfurled from its folded storage position and wrapped around the resected edge 120.
  • central flaps 105, 105a are contacting tissue edge 120 and opposing tissue side SI with the same side of buttress 100 that is in contact with tissue T, in other words with the side of buttress 100 that is in contact with tissue T surface S2.
  • embodiments with central flaps 105, 105a may have optional fixating means are provided for fixating on edge 120, and/or, on tissue surface SI .
  • fixating means are provided for fixating on edge 120, and/or, on tissue surface SI .
  • peripheral stapled portion PSP of buttress 100 comprises two peripheral portions of buttress 100, 100a separated by two central flaps 105, 105a.
  • the width of PSP is configured to ensure there is a portion of buttress 100, 100a covering stapled area or covering stapling lines 740 or covering staple pockets 74 or staple forming pockets 64.
  • the width of peripheral stapled portion PSP of buttress 100 comprises is from about one half of tissue facing surface 170 or 160 width to about 0.9 times tissue facing surface 170 or 160 width, such as 0.6; 0.7; 0.8 times tissue facing surface width.
  • the width of central flaps 105, 105a is configured so that central flaps can be wrapped around resected tissue edge 120.
  • the width of each central flap 105, 105a is at least equal to or larger than the thickness of tissue T or combined thicknesses of tissues Tl and T2, such as 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4.5, 4, 4.5, 5, 8, 10, 15 times the thickness of tissue, most preferably 2-5 times thickness of tissue.
  • embodiments with central flaps 105, 105a may have buttress 100, 100a comprising single layer of uniform thickness material or a multilayer material or single layer material of non-uniform thickness.
  • an additional layer 112 is disposed on top of buttress 100, distal to surface 170, wherein layer 112 can be optionally less flexible and/or thicker than material of central flap 105.
  • Layer 112 can be configured for tissue support and/or staple line reinforcement, and is configured to remain opposite tissue T surface S2.
  • Layer 112 can be integrated into buttress 100.
  • an additional layer 113 is disposed between buttress 100 and surface 170 of cartridge 70.
  • Layer 113 can be optionally less flexible and/or thicker than material of central flap 105.
  • Layer 113 can be configured for tissue support and/or staple line reinforcement and can be integrated into buttress 100.
  • FIG. 44C showing a schematic cross-sectional view of cartridge 70 with buttress 100 having central flaps 105
  • buttress 100 is shown having thicker peripheral stapled portions 114, or PSP, and thinner central flaps 105.
  • Portions 114 can be optionally less flexible and/or thicker than material of central flap 105.
  • Portions 114 can be configured for tissue support and/or staple line reinforcement and are integrated into buttress 100.
  • Layers 112, 113, 114 can be made of the same material as buttress 100, or of a different material.
  • the width of layers 112, 113, 114 can be substantially equivalent to width of cartridge 70.
  • the width of layers 112, 113, 114 is at least wide enough to cover the stapled area i.e. area between outermost rows of staple pockets 74.
  • buttress 100 is deployed on cartridge 70, and buttress 100a is deployed on anvil 60, with peripheral flaps 110 and 110a and/or central flaps 105 and 105a wrapped over / folded over the resected edge (from one surface of tissue and another from opposing surface of tissue in overlapping configuration, and secured to each other by Velcro-like entanglement, adhesive or any other securement mechanism.
  • buttress 100 or 100a comprises both central flaps 105, 105a and peripheral flaps 110, 110a. After stapling and resection, peripheral flaps 110 or 110a and central flaps 105 or 105a wrapped over / folded over the resected edge from the same surface of tissue and in overlapping configuration.
  • peripheral flaps 110 and 110a and/or central flaps 105 and 105a are shape memory material, which upon exposure to moisture unfurls to cover edge 120 and opposing tissue surface.
  • the mechanisms of unfurling are for instance a bi-layer flap (not shown) with a high shrinkage coefficient upon exposure to moisture of layer of flap facing opposite of tissue T2 and/or high expansion coefficient upon exposure to moisture of layer of peripheral flap 110 facing tissue T2. Shrinkage and/or expansion upon absorbing moisture will result in automatic unfurling of flaps and wrapping of flaps over edge 120 and opposing tissue Tl .
  • Buttress 100, 100a and/or flaps 110, 110a, 105, 105a can optionally be coated with or impregnated with biomedically useful agents, such as agents promoting healing and preventing inflammation and infections.
  • biomedically useful agents are then into the surrounds over time, such time ranging from a few hours to several days to several weeks, such as 12 hours, 24 hours, 48 hours, 1 week, 2 weeks, 4 weeks, 12 weeks, with such medicant release referred to as sustained release of biomedically useful agents.
  • Biomedically useful agents or therapeutic material refers to any medically useful substance or combination of substances, which can improve tissue viability, including drugs, enzymes, growth factors, peptides, proteins, nutrients, excipients, antimicrobial agents, and any other injectable pharmaceutical agents.
  • tissue viability including drugs, enzymes, growth factors, peptides, proteins, nutrients, excipients, antimicrobial agents, and any other injectable pharmaceutical agents.
  • hemostatic agents such as thrombin and or fibrinogen.
  • Other examples of therapeutic agents are autologous cells.
  • Buttress 100, 100a and/or flaps 110, 110a, 105, 105a are preferably made of any suitable biocompatible material or composite in a form of non-woven, felt, knit, woven, molded sheet, and the like.
  • Buttress 100, 100a and/or flaps 110, 110a, 105, 105a of the present invention may be fabricated from any biodegradable and/or nonbiodegradable material, including polymers, that can be used in surgical procedures.
  • biodegradable is defined to include both bioabsorbable and bioresorbable materials. Materials include natural, synthetic, bioabsorbable, and/or nonabsorbable materials, and combinations thereof.
  • Natural biodegradable polymers which may be used to form Buttress 100, 100a and/or flaps 110, 110a, 105, 105a include native materials or derivatives of: polysaccharides such as chitosan, cellulose, collagen, gelatin, alone or in combination with biologic materials and/or synthetic polymers.
  • polysaccharides such as chitosan, cellulose, collagen, gelatin, alone or in combination with biologic materials and/or synthetic polymers.
  • cellulose derivatives include carboxymethyl cellulose, oxidized cellulose, oxidized regenerated cellulose, and the like, and combinations thereof.
  • Synthetic biodegradable polymers which may be utilized to form medical devices include various known bioerodible/bioresorbable polymers, such as poly(lactide co- glycolide) and more generally polymers and co-polymers made from glycolide, lactide, ⁇ -caprolactone, trimethylene carbonate, p-dioxanone, and the like, and combinations thereof.
  • Non-degradable materials can include polyethylene, polypropylene,
  • the thickness of buttress 100 is from about 0.05 mm to about 3 mm, more preferably from 0.1 mm to 2 mm, such as 0.2, 0.5, 0.8, 1.0, 1.5 mm.
  • the width of buttress 100 including flaps is at least 1.3 the width of tissue facing surface 170 of cartridge 70, more preferably at least 1.5; 2; 3 times the width of tissue facing surface 170 of cartridge 70.
  • the width of buttress 100 including flaps 110 is from 15 mm to 60 mm, such as 20, 25, 30, 35, 40 mm.
  • each flap has a width that is equal to or larger than the 0.5 times the width of tissue facing surface 160, 170, such as 0.75, 1, 1.5, 2 times the width of tissue facing surface 160, 170. [0152] In some embodiments each flap has a width that is larger than the sum of the distance between channel 72 and farthest row of staple pockets 74 and the thickness of tissues Tl and T2 being stapled, such as larger by 5 mm, 10 mm, 15 mm, 20 mm, 30 mm.
  • the length of buttress 100, 100a is from about 0.5 to about 1.3 times the length of tissue facing surface 170 or 160, such as 0.75; 1.0; 1.2 times the length of tissue facing surface 170 or 160. In some embodiments, the length of buttress 100, 100a is equal or 5-20% larger than the length of stapled area or length of staples lines 740.
  • tissue Tl and T2 are joined and resecting two or more layers of tissue Tl and T2 or single layer of tissue T.
  • tissue layer such as for instance pleura or lung tissue, liver tissue, kidney tissue, etc.
  • T and having surfaces SI and S2 can be resected and stapled, with surface S2 corresponding to tissue T2 of and surface SI corresponding to tissue Tl of Figs. 23-28, 30.
  • flap portions have a plurality of pores or apertures 118.
  • pores or apertures can provide for better tissue healing.
  • peripheral flaps 110 or 110a have apertures 118 or pores 118.
  • central flaps 105 or 105a have apertures 118.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne des agrafes chirurgicales pour agrafage et résection de tissu comprenant un contrefort chirurgical au moins partiellement disposé sur une surface tournée vers le tissu d'au moins la cartouche ou l'enclume, ledit contrefort ayant une largeur sensiblement supérieure à la largeur desdites surfaces tournées vers le tissu ; ledit contrefort comprenant une première partie positionnée par-dessus les agrafes déployables ou par-dessus les poches de formation d'agrafe, et au moins une partie de rabat non positionnée par-dessus les agrafes déployables ou par-dessus les poches de formation d'agrafe ; ladite partie de rabat étant pliée ou enroulée sur elle-même et conçue pour être déroulée et enroulée autour du tissu réséqué. La présente invention concerne également des procédés d'utilisation de tels dispositifs d'ensemble d'agrafeuse.
PCT/US2017/030383 2016-05-06 2017-05-01 Agrafeuse/découpeuse chirurgicale et contrefort étendu Ceased WO2017192438A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
BR112018072661A BR112018072661A2 (pt) 2016-05-06 2017-05-01 grampeador/cortador cirúrgico e reforço estendido
CN201780027879.0A CN109069154B (zh) 2016-05-06 2017-05-01 外科缝合器/切割器和延伸支撑物
JP2018558231A JP7010844B2 (ja) 2016-05-06 2017-05-01 外科用ステープラー／カッター及び拡張バットレス

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15/147,942 US10265091B2 (en) 2016-04-20 2016-05-06 Surgical stapler/cutter and extended buttress
US15/147,942 2016-05-06

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WO2017192438A1 true WO2017192438A1 (fr) 2017-11-09

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EP3909523A1 (fr) * 2020-05-12 2021-11-17 Covidien LP Dispositif d'agrafage chirurgical comportant une cartouche d'agrafes remplaçable
US11678928B2 (en) 2019-01-10 2023-06-20 Atricure, Inc. Surgical clamp

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US5769892A (en) * 1996-10-22 1998-06-23 Mitroflow International Inc. Surgical stapler sleeve for reinforcing staple lines
EP1795213A2 (fr) * 2005-12-02 2007-06-13 Xylos Corporation Matériaux implantables à base de cellulose microbienne pour applications médicales diverses
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EP2742872A1 (fr) * 2012-12-13 2014-06-18 Covidien LP Renfort plié destiné à être utilisé avec un appareil chirurgical
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* Cited by examiner, † Cited by third party
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US11678928B2 (en) 2019-01-10 2023-06-20 Atricure, Inc. Surgical clamp
EP3909523A1 (fr) * 2020-05-12 2021-11-17 Covidien LP Dispositif d'agrafage chirurgical comportant une cartouche d'agrafes remplaçable
US11406387B2 (en) 2020-05-12 2022-08-09 Covidien Lp Surgical stapling device with replaceable staple cartridge

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JP2019523026A (ja) 2019-08-22
CN109069154A (zh) 2018-12-21
JP7010844B2 (ja) 2022-01-26
BR112018072661A2 (pt) 2019-02-19
CN109069154B (zh) 2022-01-18

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