ENVIRONMENT SET FOR A SURGICAL STAPLING INSTRUMENT

专利摘要:
surgical stapling instruments. the present invention relates to circular stapling instruments and anvil assemblies. anvil assemblies may have flattenable anvil support members that can be inserted through an opening in a patient and then expanded to be attached to an anvil plate assembly that has a staple forming surface thereon. the anvil support member is fixable to the anvil plate assembly such that when the anvil assembly is attached to the stapling head of a circular stapler, the staple forming surface is substantially level with the supported staples on the stapling head. a variety of different anvil support members and anvil plate assemblies are presented.
公开号:BR112013023611B1
申请号:R112013023611-6
申请日:2012-03-13
公开日:2020-12-15
发明作者:Frederick E. Shelton Iv；Taylor W. Aronhalt；Chester O. Baxter Iii；Mark S. Ortiz；Kreena B. Modi；Ii William B. Weisenburgh；Jerome R. Morgan；Emily A. Heeb；Christopher J. Hess；Joseph E. Young；Barry C. Worrell；Christopher J. Schall；Andrew Yoo；Edward G. Chekan；Steven G. Hall；Gregory W. Johnson；Tamara Widenhouse；Katherine J. Schmid；Aron O. Zingman；Richard W. Timm；Jacob S. Gee；Daniel J. Mumaw；Michael J. Vendely；Andrew T. Beckman；James R. Janszen；Gary W. Knight；Karen N. Hagerty；Jason K. Rupert
申请人:Ethicon Endo-Surgery, Inc；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] The present invention relates, in general, to surgical procedures and surgical instruments to complete such procedures and, more particularly, to surgical stapling devices and methods of use. BACKGROUND
[0002] Obesity is one of the fastest growing health problems in the world. For example, the Center for Disease Control estimates that more than 20% of the US population is obese. Gastric bypass surgery was defined as one of the most effective treatments for morbid obesity.
[0003] There are several different gastric bypass operations. The most common gastric bypass surgery is Roux-en-Y gastric bypass. In a Roux-en-Y gastric bypass, the stomach becomes smaller by creating a small containment bag at the top of the stomach using surgical clips or a plastic band. The smaller stomach is connected to the median portion of the small intestine (jejunum), bypassing the rest of the stomach and the upper portion of the small intestine (duodenum). The procedure can be done by making a large incision in the abdomen (an open procedure) or by making a small incision and using small instruments and a camera to guide the surgery (a laparoscopic procedure). Laparoscopic procedures generally result in faster recoveries and shorter hospital stays. The risk associated with infection by injury is significantly reduced and patients generally report less pain and experience a faster return to normal activity.
[0004] When performing Roux-en-Y gastric bypass surgery laparoscopically, several conventional trocar devices are placed in various locations across the abdominal wall to provide passages through which surgical instruments, grasping devices and cameras can be inserted . As indicated above, this procedure involves creating a small stomach containment bag and attaching the jejunum to it by means of an anastomosis (commonly called G-J anastomosis). The jejunum portion is then fixed to the median portion of the jejunum by another anastomosis (commonly called the J-J anastomosis). Such an arrangement, therefore, diverts the separate portion of the stomach and duodenum.
[0005] The circular stapler is an essential tool for the construction of gastrointestinal anastomosis. Circular clips useful for performing such procedures are shown, for example, in US Patent Nos. 5,104,025; 5,205,459; 5,285,945; and 5,309,927 which are each incorporated herein by reference in their respective totalities. In general, a conventional circular stapler typically consists of an elongated rod that has a proximal drive mechanism and a distal stapling mechanism mounted on the elongated rod. The distal stapling mechanism commonly consists of a fixed stapling cartridge that contains a plurality of staples configured in a concentric circular assembly. A scalpel for round cutting is mounted inside the cartridge, concentrically in relation to the clamps, to obtain an axial path inside it. Extending axially from the center of the cartridge is a movable trocar shaft, adapted to have a staple anvil attached to it in a removable manner. The anvil is configured to form the ends of the clamps as they are guided to it. The distance between a distal face of the staple cartridge and the staple anvil is commonly controlled by an adjustment mechanism that is mounted on the proximal end of the staple rod to control the axial movement of the trocar. The tissues that are clamped between the staple cartridge and the staple anvil are simultaneously stapled and cut when the trigger mechanism is activated by the surgeon.
[0006] When using conventional circular staplers to perform Roux-en-Y gastric bypass surgery, the anvil of the device is placed transabdominally through an enlarged port site and passed through a gastrotomy in the anterior aspect of the stomach. The gastric containment bag is built around the anvil and the gastrotomy is closed. The staple head of the circular stapler is inserted through the upper portion of the jejunum portion and the anvil is connected to it. The stapler is then "fired" to create the anastomosis. Such a method has been adopted by many surgeons. However, there are some disadvantages, including the need to enlarge the trocar site to accommodate the anvil and the construction of the gastrotomy and its closure. Such additional steps undesirably increase the time required to complete the surgical procedure.
[0007] Thus, there is a need for a circular stapling device with an anvil arrangement that can pierce gastric walls in an unexpanded state and is then moved to an expanded state to facilitate the formation of the anastomosis when the stapler surgical procedure is performed.
[0008] Such circular stapling devices are also commonly used in diseased portions removed from the colon. The introduction and management of the circular stapler anvil in a conventional laparoscopic approach to colorectal surgery has been an ongoing limiter to employ laparoscopic procedures and techniques to complete such a procedure. For example, laparoscopic colorectal procedures can generally be impractical to perform due to the number of steps involved. Such procedures are also complicated by the need to avoid crossing staple lines. Other problems that can be encountered with such procedures involve seeding an individual's tissue removal, the need to create one or more doors for the introduction of anvils into the body cavity and the creation of colon defects that result from anvil placement challenges .
[0009] Another need remains for a circular stapling device with an anvil arrangement that can be inserted into the patient in a flattened state and then reconfigured in an expanded state to facilitate the formation of the anastomosis when the surgical stapler is acted upon.
[00010] The previously mentioned discussion is only intended to illustrate some of the disadvantages present in the field of the invention at the moment, and should not be taken as a denial of the scope of the claims. BRIEF SUMMARY
[00011] In conjunction with the general aspects of various embodiments of the present invention, an anvil set is provided for a surgical stapling instrument. In various forms, the anvil assembly comprises a plurality of anvil plates that are movably coupled for selective movement between a flattened and an expanded orientation. The plurality of anvil plates form at least a portion of a substantially flat anvil plate assembly when they are in the expanded orientation. An anvil expansion member is movably supported relative to the plurality of anvil plates and is selectively movable between a first unacted position to a second position where the anvil expansion member moves the plurality of anvil plates to the expanded orientation. The anvil set additionally has a tissue piercing tip portion.
[00012] In conjunction with yet another general aspect of a form of the present invention, a circular surgical stapling device is provided. In one form, the device comprises a staple cartridge that functionally supports a plurality of surgical staples therein. The device further comprises a trocar stem having a tissue-piercing tip formed therein. The trocar stem is selectively movable axially in relation to the staple cartridge. The device additionally includes an umbrella-type anvil assembly that is movably supported relative to the staple cartridge. The umbrella anvil set comprises a plurality of anvil plate segments that are movably supported relative to each other for selective movement from a flattened orientation to an expanded orientation in response to an applied actuating motion application. to that by the trocar stem. The plurality of anvil plate segments form an annular anvil plate assembly that is supported in substantial confronting relationship with the staple cartridge when the anvil assembly is in the expanded orientation.
[00013] In accordance with yet another general aspect of a form of the present invention, a surgical procedure is provided to form an anastomosis. In one form, the procedure comprises providing a circular stapler that has a staple cartridge end with an anvil attached to it that is selectively movable between a flattened configuration and an expanded configuration. The procedure further comprises orienting the anvil in a flattened orientation and inserting the staple cartridge end with the flattened anvil attached thereto through an opening in a patient. The procedure further comprises perforating target tissues through which the anastomosis must be formed with the staple cartridge end attached to it and expanding the anvil so that the target tissues are located between the expanded anvil and the cartridge end staple. In addition, the procedure comprises firing the stapler to conduct surgical staples supported on the staple cartridge for forming contact with the expanded anvil and removing the staple cartridge end with an anvil attached to it from the patient.
[00014] In accordance with a general aspect of a form of the present invention, an anvil plate is provided for a surgical stapling instrument. In various forms, the anvil plate comprises a plurality of anvil plate segments that are mobile interconnected and reconfigurable from a first orientation in which the anvil plate segments can be inserted through a cannula opening as a unit and then reconfigured in a second orientation in the form of a substantially flat anvil plate assembly that has a diameter that is larger than the cannula opening.
[00015] According to another general aspect of a form of the present invention, an anvil is provided for a surgical stapling instrument. In one form, the anvil comprises a plurality of anvil plates that are movably coupled for selective movement between the non-planar orientations and a substantially flat orientation in which the plurality of anvil plates form a set of annular anvil plate. The anvil additionally comprises an anvil support member which is configured for attachment to the anvil plate assembly to retain this in substantially flat orientation.
[00016] In accordance with a general aspect of a form of the present invention, an anvil is provided for a surgical stapling instrument. In one form, the anvil comprises an anvil plate assembly that has a staple forming surface therein and an anvil support member that is configured to move between a flattened position and an expanded position in which, when the anvil support is in the expanded position, the anvil support member is fixable to the anvil plate assembly. In various embodiments, the anvil support member is attachable to an actuator portion of the surgical stapling instrument.
[00017] According to another general aspect of a form of the present invention, an anvil support member is provided for a surgical stapling device. In one form, the anvil support member comprises a rod that is configured for attachment to an actuator portion of the surgical stapling device. The anvil support member further comprises a reconfigurable connection assembly which is coupled to the rod. The connection set is reconfigurable from a first configuration in which the connection set can be inserted through a cannula opening for a second expanded configuration adapted to support an anvil plate assembly.
[00018] In accordance with yet another general aspect of a form of the present invention, an anvil is provided for a surgical stapling instrument. In one form, the anvil comprises an anvil stem that is configured to attach to an actuator portion of the surgical stapling device. The anvil stem defines a stem axis. A reconfigurable anvil head assembly is coupled to the anvil stem and has an overall width measured along an axis that is substantially perpendicular to the stem axis. The anvil head is reconfigurable between a first orientation in which the general width has a first magnitude and a second orientation in which the general width has a second magnitude which is greater than the first magnitude.
[00019] In accordance with a general aspect of a form of the present invention, an anvil set is provided for a circular stapling instrument. In one form, the anvil assembly comprises an annular anvil plate assembly that has a staple forming surface thereon. An anvil support member is attachable to an actuator portion of the surgical stapling instrument and is configured to selectively move between a flattened and an expanded position. The anvil assembly further comprises structures for coupling the anvil support member to the anvil plate assembly when the anvil support member is in the expanded position so that when the anvil support member is coupled to the actuator of the stapling instrument surgical, the staple-forming surface of the annular anvil plate assembly is substantially level with the corresponding staples supported on the circular stapling instrument.
[00020] According to another general aspect of a form of the present invention, a circular stapling instrument is provided that includes a stapling head that supports a plurality of surgical staples therein. A firing system communicates in a functional way with the stapling head to apply a firing movement to the stapling head to thereby drive surgical staples from there. The instrument additionally includes an anvil adjustment system and an anvil set. In one form, the anvil assembly comprises an anvil stem that is configured to be attached to the anvil adjustment system in a predetermined orientation. An anvil support member is functionally coupled to the anvil stem and is configured to be selectively moved between a flattened and an expanded position. The anvil assembly further comprises an anvil plate assembly that has a staple forming surface thereon and structures configured for coupling the anvil support member to the anvil plate assembly when the anvil support member is in the expanded position of so that when the anvil stem is coupled to the anvil adjustment system in the predetermined orientation, the staple forming surface of the anvil plate assembly is substantially level with the corresponding surgical staples on the stapling head.
[00021] In accordance with yet another general aspect of a form of the present invention, a method for stapling tissue is provided which includes providing a circular stapling instrument comprising a stapling head that supports a plurality of surgical staples therein. The stapling instrument further comprises a firing system that communicates functionally with the stapling head to apply a firing movement to the stapling head to thereby drive the surgical staples from there and an anvil adjustment system. The method further includes providing an anvil support member that is selectively movable between a flattened and an expanded orientation and providing an anvil plate assembly that has a staple forming surface thereon. In addition, the method comprises coupling the anvil support member to the anvil adjustment system when the anvil adjustment system is in the flat orientation and inserting the stapling head and the anvil support member fixed through an opening in a patient. The method also includes inserting the anvil plate assembly through the opening or another opening in the patient and orienting the anvil support member in the expanded orientation. In addition, the method includes fixing the anvil plate assembly to the expanded anvil support member such that the staple forming surface is substantially level with the surgical staples on the stapling head and the stapled tissue is positioned between the staple forming surface and the stapling head and activating the trigger system to guide the surgical staples into the forming contact with the staple forming surface. BRIEF DESCRIPTION OF FIGS.
[00022] The attached drawings, which are incorporated into this specification and form part of it, illustrate modalities of the invention and, together with the general description provided above and the detailed description of the modalities provided below, serve to explain the principles of present invention.
[00023] FIG. 1 is a perspective view of a circular surgical stapling instrument with an anvil set of the present invention shown in broken lines;
[00024] FIG. 2 is a partial cross-sectional view of a stapling head and anvil assembly of the present invention in which the anvil assembly is in a flattened configuration for drilling through the fabric;
[00025] FIG. 3 is a partial cross-sectional view of the stapling head and the anvil assembly of FIG. 2 in which the anvil assembly is in an expanded or open configuration to form a substantially flat anvil plate from which the clamps on the stapling head can be released;
[00026] FIG. 4 is a top view of the expanded anvil assembly of FIG. 3;
[00027] FIG. 5 is an exploded perspective view of a portion of the circular stapling instrument of FIG. 1;
[00028] FIG. 6 is a cross-sectional view of the circular stapling instrument of FIG. 1;
[00029] FIG. 7 is a partial cross-sectional view of a portion of the rod of the circular stapling instrument and the stapling head with an anvil assembly mode of the present invention attached thereto and in an installed or expanded configuration;
[00030] FIG. 8 is a diagrammatic view showing the use of various modalities of circular stapling instrument of the present invention to perform a Roux-en-Y procedure;
[00031] FIG. 9 is a partial cross-sectional view of a portion of a circular stapling instrument rod and stapling head embodiment of a form of the present invention with another anvil assembly embodiment of the present invention attached thereto and in an expanded orientation or installed;
[00032] FIG. 10 is a partial cross-sectional view of another embodiment of the stapling head and anvil assembly in a form of the present invention in which the anvil assembly is in a flattened orientation;
[00033] FIG. 11 is a partial cross-sectional view of the stapling head and the anvil assembly of FIG. 10 in which the anvil assembly is in an expanded or installed orientation;
[00034] FIG. 12 is a partial cross-sectional view of another embodiment of the stapling head and anvil assembly of the present invention that is used to perforate the tissue;
[00035] FIG. 13 is a bottom perspective view of the stapling head and the anvil assembly of FIG. 12 with the anvil set in the flattened orientation;
[00036] FIG. 14 is a partial cross-sectional side view of the anvil assembly embodiment of FIGS. 12 and 13;
[00037] FIG. 15 is a partial perspective view of the stapling head and the anvil assembly of FIGS. 12 to 14 after being drilled through the fabric and having been moved to the expanded or installed orientation and in which some components of the same are shown in cross section;
[00038] FIG. 16 is a partial cross-sectional view of another embodiment of the stapling head and anvil assembly of a form of the present invention after the anvil assembly has been used to pierce adjacent target tissues;
[00039] FIG. 17 is another partial cross-sectional view of the staple head and anvil assembly of FIG. 16 before staple firing starts;
[00040] FIG. 18 is a top view of the anvil assembly embodiment of FIGS. 16 and 17 in an expanded or installed orientation;
[00041] FIG. 19 is a partial cross-sectional view of another embodiment of the circular stapling instrument of the present invention coupled to the anvil set embodiment shown in FIGS. 16 to 18;
[00042] FIG. 20 is a diagrammatic view of a portion of a patient's colon that has a diseased portion to be removed;
[00043] FIG. 21 is another diagrammatic view of the patient's colon revealed in FIG. 20 which discloses the use of a stapling instrument and anvil set of the present invention in conjunction with removing the diseased portion;
[00044] FIG. 22 is a partial side view of additional anvil assembly modalities of various forms of the present invention used to perforate the colon wall;
[00045] FIG. 23 is a side view of the colon of FIGS. 20 and 21, after the diseased portion has been removed and the colon ends have been reconnected using the stapling instrument of FIG. 21;
[00046] FIG. 24 is another diagrammatic view of the colon of FIGS. 21 and 22 illustrating the removal of the patient's diseased colon segment;
[00047] FIG. 25 is a bottom perspective view of another embodiment of anvil assembly of a form of the present invention in an expanded or installed orientation;
[00048] FIG. 26 is a diagrammatic view of an anvil plate assembly of FIG. 25 in a flattened orientation and is inserted through a cannula portion of a trocar device;
[00049] FIG. 27 is a bottom view of the anvil plate assembly of FIG. 26 in the expanded plane orientation;
[00050] FIG. 28 is a top view of the anvil plate assembly of FIG. 27;
[00051] FIG. 29 is a side elevation view of an anvil support member embodiment shown in FIG. 25 in a flattened orientation;
[00052] FIG. 30 is a side elevation view of the anvil support member embodiment of FIG. 29 in an expanded or installed orientation;
[00053] FIG. 31 is a partial cross-sectional view of an anvil plate embodiment of a form of the present invention attached to an anvil support member embodiment of a form of the present invention;
[00054] FIG. 32 is a perspective view illustrating the insertion of another anvil plate assembly embodiment of the present invention in a flattened orientation and inserted through a trocar cannula;
[00055] FIG. 33 is a view of a first anvil joint arrangement employed in the anvil plate assembly disclosed in FIG. 32 and in a flat or open orientation;
[00056] FIG. 34 is another view of the first anvil joint arrangement of FIG. 33 in expanded or closed orientation;
[00057] FIG. 35 is a view of a second anvil joint arrangement employed in the anvil plate assembly disclosed in FIG. 32 and in a flat or open orientation;
[00058] FIG. 36 is another view of the second anvil joint embodiment of FIG. 35 in expanded or closed orientation;
[00059] FIG. 37 is an enlarged view of an end of an anvil plate segment that forms the second anvil joint disclosed in FIG. 36;
[00060] FIG. 38 is a bottom view of the anvil plate assembly embodiment of FIGS. 32 to 37 in expanded / assembled orientation;
[00061] FIGS. 39A to F disclose various folded or flattened orientations of another anvil plate assembly embodiment of another form of the present invention;
[00062] FIG. 40 is a partial view of a hinge joint employed in the anvil plate assembly mode disclosed in FIGS. 39A to 39F;
[00063] FIG. 41 is a diagrammatic view illustrating the insertion of the anvil plate assembly mode of FIGS. 39 and 40 in a flattened orientation and inserted through a trocar cannula;
[00064] FIG. 42 is a diagrammatic view illustrating the insertion of another anvil plate assembly embodiment of another form of the present invention in a flattened orientation and inserted through a trocar cannula;
[00065] FIG. 43 is an exploded perspective view of another embodiment of anvil assembly of another form of the present invention;
[00066] FIG. 44 is a perspective view of another embodiment of anvil support member of another form of the present invention in a flattened orientation;
[00067] FIG. 45 is another perspective view of the anvil support member embodiment of FIG. 44 in an expanded or installed orientation;
[00068] FIG. 46 is a partial cross-sectional view of a stapling head and anvil assembly of a form of the present invention;
[00069] FIG. 47 is another partial cross-sectional view of the stapling head and anvil assembly of FIG. 46 with their connection set in a locked position;
[00070] FIG. 48 is a partial exploded assembly view of some of the components of the anvil assembly embodiment disclosed in FIGS. 46 and 47 and a trocar stem from a circular stapling instrument;
[00071] FIG. 49 is a perspective view of a locking sleeve and retaining ring of the anvil assembly embodiment of FIGS. 46 and 47;
[00072] FIG. 50 is a perspective view of a locking ring embodiment of the present invention before it is expanded;
[00073] FIG. 51 is a perspective view of the embodiment of the locking ring of FIG. 50 after being expanded;
[00074] FIG. 52 is another cross-sectional view of the anvil assembly embodiment of FIGS. 46 and 47 before triggering the circular stapling instrument;
[00075] FIG. 53 is a perspective view of another embodiment of the anvil supporting member of a form of the present invention in a flattened orientation and with the anvil cover shown in cross section;
[00076] FIG. 54 is another perspective view of the anvil support member embodiment of FIG. 53 in an open or expanded orientation;
[00077] FIG. 55 is a side view of a portion of the anvil support member of FIGS. 53 and 54 illustrating a range of movement of the connecting bars thereof;
[00078] FIG. 56 is a top view of the anvil support member of FIGS. 54 and 55 with the connection set thereof in the open or expanded position;
[00079] FIG. 57 is a partial cross-sectional view of a portion of the anvil cover and a connecting bar illustrating a latch configuration of at least one embodiment of a form of the present invention;
[00080] FIG. 58 is an exploded perspective view of an anvil support member arrangement and anvil plate assembly arrangement of various embodiments of the present invention;
[00081] FIG. 59 is another exploded perspective view of the anvil support member embodiment and the anvil plate assembly embodiment disclosed in FIG. 58;
[00082] FIG. 60 is a bottom perspective view of another embodiment of the anvil support member of a form of the present invention;
[00083] FIG. 61 is a top view of an embodiment of the anvil plate assembly of the present invention;
[00084] FIG. 62 is a partial cross-sectional view of a portion of a connecting bar and anvil plate assembly of FIGS. 60 and 61 before being coupled together;
[00085] FIG. 63 is another partial cross-sectional view of the connection bar and anvil plate of FIG. 62 after being coupled together;
[00086] FIG. 64 is a bottom perspective view of another embodiment of the anvil assembly of the present invention in an expanded orientation;
[00087] FIG. 65 is another perspective view of the embodiment of the anvil assembly of FIG. 64;
[00088] FIG. 66 is a top view of the anvil assembly embodiment of FIGS. 64 and 65;
[00089] FIG. 67 is another top view of the anvil assembly embodiment of FIGS. 64 to 66 in a flattened orientation;
[00090] FIG. 68 is a perspective view of the anvil assembly of FIGS. 64 to 67 in a flattened orientation;
[00091] FIG. 69 is a perspective view of a portion of the anvil assembly of FIGS. 64 to 68;
[00092] FIG. 70 is another perspective view of the anvil assembly of FIGS. 64 to 69 in a flattened orientation;
[00093] FIG. 71 is a side view of the anvil assembly of FIGS. 64 to 70 in expanded orientation; and
[00094] FIG. 72 is another side view of the anvil assembly of FIGS. 64 to 71 in the flat orientation. DETAILED DESCRIPTION
[00095] Certain exemplary embodiments will now be described to provide a general understanding of the principles of structure, function, manufacture and use of the devices and methods of the present invention presented. One or more examples of these modalities are illustrated in the attached drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are exemplary non-limiting modalities, and that the scope of the various modalities of the present invention is defined only by the claims. The characteristics illustrated or described in conjunction with an exemplary modality can be combined with the characteristics of other modalities. Such modifications and variations are designed to be included within the scope of the present invention.
[00096] The reference from the beginning to the end of the specification of "various modalities", "some modalities", "a modality", or "the modality", or similar, means that an attribute, structure, or characteristics described together with the modality is included in at least one modality. Therefore, the appearance of the phrases "in various modalities", "in some modalities", "in one modality", or "in modality", or similar, in places from beginning to end of the specification are not necessarily all referring to the same modality. In addition, the particular attributes, structures, or characteristics can be combined in any suitable way in one or more modalities. Therefore, the particular attributes, structures, or features illustrated or described in conjunction with a modality can be combined, in whole or in part, with the structures of the attributes, or features of one or more other modalities without limitation. Such modifications and variations are designed to be included within the scope of the present invention.
[00097] The terms "proximal" and "distal" are used in the present invention with reference to the manipulation that a clinician makes of the handle portion of the surgical instrument. The term "proximal" refers to the portion closest to the clinician, and the term "distal" refers to the portion located farthest from the clinician. It will also be understood that, for the sake of convenience and clarity, spatial terms such as "vertical", "horizontal", "up" and "down" can be used in the present invention with respect to the drawings. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and / or absolute.
[00098] FIG. 1 illustrates a circular stapling instrument 10 that can be used in conjunction with various anvil set modalities of the present invention. The construction and operation of circular surgical stapling instruments is well known in the art. These conventional components and features of such a circular stapler will not be discussed in detail in this document beyond what may be necessary to understand the construction and operation of the various embodiments of the present invention. As the present Detailed Description proceeds, those of ordinary skill in the art will understand that the various embodiments of the present invention can be effectively employed with a variety of different circular stapler configurations without deviating from the character and scope of the present invention. For example, various embodiments of the present invention can be employed with those circular staplers disclosed in US Patent No. 7,506,791, entitled "Surgical Stapling Instrument With Mechanical Mechanism For Limiting Maximum Tissue Compression", the disclosure of which is hereby incorporated by reference, in its entirety. Accordingly, the scope of protection provided to the various embodiments of the present invention should not be otherwise limited for use with the exemplary circular stapler shown in this document.
[00099] The circular stapling instrument 10 shown in FIG. 1 includes a stapling head 20, an anvil set 200, an adjustment knob set 40 and a handle set 60. The stapling head 20 is coupled to the handle set 60 by an arcuate shank set 80. A trigger 120 is pivotally supported by the handle assembly 60 and acts to operate the stapler 10 when a safety mechanism 62 is released. As will be discussed in further detail below, when trigger 120 is activated, a firing system (not shown in FIG. 1) operates within stem assembly 80 to cause the clips to be ejected from the staple head 20 into contact forming with the anvil set 200. Simultaneously, a scalpel functionally supported inside the stapling head 20 acts to cut the woven fabric within the circumference of the stapled fabric. Stapler 10 is then pulled through the fabrics, leaving the stapled fabrics in place.
[000100] FIGS. 2 and 3 illustrate a stapling head shape 20 that can be used in conjunction with various anvil assembly embodiments of the present invention. In various embodiments, the stapling head 20 may comprise a housing member 22 that supports a staple cartridge 26 therein. The housing member 22 additionally supports a circular staple conductor 24 which is adapted to interface with the staple cartridge 26 and guide the staples 28 supported thereon to the forming contact with the anvil assembly 200 as will be discussed in further detail below . A circular scalpel member 30 is also centrally disposed within the staple conductor 24. The proximal end of the compartment member 22 can be coupled to an outer tubular cover 82 of the arcuate stem assembly 80 by a distal ferrule member 83.
[000101] FIGS. 5-7 illustrate a shape of the arcuate shank assembly 80 that can be employed with various modalities of circular stapling instrument of the present invention. As can be seen in FIGS. 5 and 7, the arcuate rod assembly 80 may include a compression rod 84, a distal compression rod portion 85, an upper tension band 86, a lower tension band 87 and a spacer band 88 which are mounted within the outer tubular cover 82. Anvil stem 210 of anvil assembly 200 is attached to the upper tension band 86 and the lower tension band 87 by locks 89. The proximal ends of the upper tension band 86 and the lower tension band 87 are attached to the distal end of an adjustment rod 90. As can be seen in FIG. 7, the stapling head 20 includes a distally protruding central hub portion 100 that is centrally arranged within the stapling head 20 and attached to the stem housing 82 at point 101. The central hub portion 100 can be attached to the housing shank 82 by, for example, adhesive, welding, rivets, etc. The compression rod 84 is free to move axially with respect to the central hub portion 100 to drive the clamp conductor 24 distally. Thus, the axial movement of the compression rod 84 within the outer tubular cover 82 causes the clamp conductor 24 to move axially within the housing member 22. As will be discussed below, the trigger trigger 120 will cause the compression rod 84 moves in the distal direction (arrow "DD") thus leading the staple conductor 24 distally to fire the staples 28 into the forming contact with the anvil assembly 200. As the staple conductor 24 is guided distally this also leads the distal end 31 of the scalpel 30 through the tissue maintained within the circumference of the stapled tissue.
[000102] In various embodiments, the adjustment rod 90 is movably supported within the handle assembly 60 which may comprise two segments of handle compartment 61 which are interconnected together by suitable closing arrangements for ease of assembly. Trigger 120 is pivotally attached to handle assembly 60 by a pivot pin 121. A spring 122 is supported on pivot pin 121 and serves to tilt trigger 120 in the opposite direction to handle assembly 60 to an unacted position . A safety yoke 123 is pivotally coupled to handle 60 by pin 124 so that it can be pivoted between a safe position where trigger 120 cannot be lowered towards handle 60 and an off position where the safety yoke 123 does not inhibit the pivoting path of trigger assembly 120 towards handle assembly 60. As can be seen in FIG. 5, trigger 120 may have a pair of fins 125 that are sized to be received in grooves 132 on a firing clip 130 that is attached to the proximal end 133 of the compression rod 84 by a protrusion 134 or other suitable closing arrangements. Such an arrangement allows distal axial movement (arrow "DD") and proximal axial movement (arrow "PD") of the compression rod 84 through the trigger joint 120 as will be further discussed below.
[000103] As can be seen in FIGS. 5 and 6, the adjustment rod 90 has a distal portion 141 which is attached to the lower and upper tension bands 86, 87 and a proximal portion 142 which is joined to the distal portion 141 by a segment of reduced diameter 143. The proximal portion 142 is axially received within an axial passage 152 in a distal lock nut 150 which is fitted over or otherwise attached to a proximal lock nut 160 to form a lock nut assembly generally designated as 161 so that the nut distal lock 150 and proximal lock nut 160 can rotate together. The distal closing nut 150 may also have a distally extending hub portion 154 which is contiguous with an inwardly extending retaining flange formed within the handle assembly 60. Such an arrangement allows the distal closing nut 150 rotate freely within handle assembly 60, but are unable to move axially with it. Similarly, the end of the proximal portion 142 of the adjustment rod 90 is axially received within an axial passage within the proximal closing nut 160. Also in various embodiments, the closing button assembly 40 is attached to the proximal end of the adjusting nut. proximal closure 160 in the various ways described in US Patent No. 7,506,791, the disclosure of which has been incorporated herein by reference. The closing button assembly and adjustment rod and related components for adjusting the position of the anvil in relation to the stapling head are referred to in this document as "anvil adjustment system". Rotation of the closing knob assembly 40 results in the axial path of the anvil stem 210 in the proximal and distal directions depending on the direction in which the knob assembly 40 is rotated.
[000104] Turning to FIGS. 2 to 4, an implementation of an anvil set 200 is shown. As can be seen in these FIGS., The anvil assembly 200 includes the anvil stem 210 which has a tissue penetrating tip member 212 formed at the distal end thereof. In various embodiments, the tissue penetrating tip member 212 includes a substantially conical shaped tip portion 214 that ends at a sharp point 216. In various embodiments, the tissue penetrating tip member 212 can be integrally formed with the anvil stem 210. In various implementations, the anvil stem 210 and the tissue penetration tip member 212 are manufactured from metallic material.
[000105] Various shapes of the anvil set 200 additionally include a plurality of connection sets 220. In the embodiment disclosed in FIG. 4, four connection assemblies 220 are employed. Each connection set 220 includes a distal link 222 that is hingedly coupled to the tissue penetrating tip member 212. Each distal link 222 is hingedly coupled to a segment of primary anvil plate 224 that is hingedly coupled to a collar 230 which is movably supported on anvil stem 210. Each segment of primary anvil plate 224 has a primary staple forming surface 226 formed therein. In addition, anvil assembly 200 additionally includes a plurality of secondary anvil plate segments 227 that are pivotally coupled to collar 230. As can be seen in FIG. 4, for example, a secondary anvil plate segment 227 is disposed between adjacent primary anvil plate segments 224. In various embodiments, the primary anvil plate segments 224 and the secondary anvil plate segments 227 have shaped surfaces complementary in this, so that when the primary anvil plate segments 224 are pivoted to the open position (FIG. 3), they come into contact with the adjacent secondary anvil plate segments 227 and pivot them to the open position as well as to form a substantially flat anvil plate assembly 229. Each secondary anvil plate segment 227 has a primary staple forming surface 228 thereby cooperating with the primary staple forming surfaces 226 of the primary anvil segments 224.
[000106] FIG. 2 illustrates the anvil set 200 in a flattened orientation that allows the anvil set 200 to be inserted through a trocar cannula or other opening in the body. As the surgeon extracts the anvil stem 210 in the proximal direction "PD" by rotating the knob 40, collar 230 will eventually come into contact with the distal end 102 of the central hub portion 100 of the compression rod 85. Continuous movement of the anvil stem 210 in the proximal direction will cause the movable collar 230 to travel distally on the anvil stem 210 until it contacts a distal flange 232 on the anvil stem 210. See FIG. 3. When in this position, the anvil assembly 200 is in the installed or "expanded" orientation and the primary and secondary staple forming surfaces 226, 228 of the primary and secondary anvil plate segments 224, 227 form the substantially flat anvil 229 whose staple forming surface is in confronting relationship with staple cartridge 26 in the stapling head 20. The surgeon can then activate or "fire" the circular stapler 10 to drive the staples 28 to the surfaces clamp formation 226, 228.
[000107] The circular stapling instrument 10 can be used to perform a variety of different surgical procedures. FIG. 8 illustrates the use of the circular stapling instrument 10 in conjunction with the execution of a Roux-en-Y procedure. When performing laparoscopically Roux-en-Y gastric bypass surgery, several conventional 250 trocar devices are placed in various locations across the patient's abdominal wall to provide passages through which surgical instruments, grasping devices and / or cameras can be used. be inserted. As indicated above, this procedure involves creating a small stomach containment bag 260 and attaching the jejunum 262 to this by means of an anastomosis 264 (commonly called an G-J anastomosis). The stomach containment bag 260 can be formed by inserting a conventional endoscopic surgical instrument (not shown) through the appropriate trocar device 250 and by cutting and stapling a portion 268 of the stomach 266 at the esophageal-gastric junction. A conventional endoscopic surgical instrument can also be used to separate the jejunum 262 at a location 263 in addition to where it leaves the stomach 266. The separate end 265 of the jejunum 262 is then attached to the stomach containment bag 260 using the set of anvil 200 attached to a circular stapling instrument 10 that was inserted through the trocar device 250.
[000108] In particular, the circular stapling head 20 with the anvil assembly 200 coupled to it in a flattened orientation (FIG. 2) is inserted through the cannula portion 252 of the trocar device 250. The anvil assembly 200 is advanced through the separate end portion 265 of jejunum 262 by pushing the tissue penetrating tip member 212 through it and also through the wall of the stomach containment bag 260. Once the anvil set 200 has been inserted through the wall from the stomach containment bag 260, the surgeon can then extract the anvil assembly 200 towards the stapling head 20 of the circular stapling instrument 10 to capture the wall ("T") of the containment bag 260 and the wall ( "T1") from the separate end portion 265 of the jejunum 262 between the anvil assembly 200 and the stapling head 20. As the anvil assembly 200 is extracted in expansion contact with the distal end 102 of the d portion and central hub 100 of the compression rod 85, the anvil plate assembly 229 is formed. The stapling device 100 can then be triggered to create the G-J anastomosis. The circular stapling instrument 10 can then be removed from the trocar device 250.
[000109] A second circular stapling instrument 10 or the previous circular stapling instrument 10 with a new staple cartridge 26 installed thereon can then be inserted through the cannula portion 252 of a properly located trocar device 250 and the limb tissue penetration tip 212 can be used to penetrate through a portion 267 of the jejunum below the duodenum 269 and through a portion of the lower jejunum portion 270 as shown in FIG. 8. Once the anvil set 200 has been located within the lower jejunum portion 270, the surgeon can then extract the anvil set 200 towards the stapling head 20 which causes the anvil set 200 to move for expanded or installed orientation. The surgeon continues to extract the expanded anvil plate set 200 towards the stapling head set 20 to capture the walls ("T2" and "T3") of the jejunum portions 267, 270 in between and then fire the circular stapling instrument 10 to form anastomosis 272 in between (commonly called JJ anastomosis). Such an arrangement, therefore, diverts the separate portion of the stomach 266 and duodenum 269.
[000110] FIGS. 9 to 11 illustrate another circular stapling instrument 310 of the present invention. Various embodiments of the circular stapling instrument 310 have components that are substantially identical to the circular stapling instrument 10 described above and have been identified with the same element numbers in FIGS. 9 to 11. Those components that differ from or are additional to the components of the circular stapling instrument 10 will now be described. As can be seen in FIG. 9, the circular stapling instrument 310 includes an anvil assembly 320 that includes an anvil stem 321. The anvil stem 321 is attached to the upper tension band 86 and the lower tension band 87 on the circular stapling instrument 310 by locks. 89. The proximal ends of the upper tension band 86 and the lower tension band 87 can be attached to a distal end of the adjustment rod 90 as described above. In this embodiment, the distal compression rod portion 85 is configured to engage the clamp conductor assembly 24 which is functionally supported within the stapling head 20. Thus, the axial movement of the compression rod 84 within the tubular cover outer 82 causes the staple conductor assembly 24 to move axially within the housing member 22 of the staple head 20. As discussed above, the trigger trigger 120 (FIG. 1) will cause the compression 84 moves in the distal direction (arrow "DD") thus driving the staple conductor assembly 24 distally to fire the staples in the staple cartridge 26 into the forming contact with the anvil assembly 320. According to the conductor assembly of staple 24 is conducted distally, this also leads the distal end of the scalpel 30 through the tissue contained within the circumference of the stapled tissue.
[000111] Turning to FIGS. 10 and 11, an implementation of an anvil set 320 is shown. As can be seen in these FIGS., A tissue penetration tip member 322 is formed at the distal end of anvil stem 321. In various embodiments, the tissue penetration tip member 322 includes a substantially tapered tip portion 324 ending at a sharp point 326. In various embodiments, the tissue penetration tip member 322 can be integrally formed with the anvil stem 321. The anvil stem 321 and the tissue penetration tip member 324 are manufactured from metallic material.
[000112] Various shapes of the anvil set 320 further include an anvil connection set 330. In the embodiment disclosed in FIGS. 10 and 11, the anvil connection assembly 330 includes a plurality of (four) outer segments of anvil plate 332 that are pivotally coupled to the tissue penetration tip member 324 by first corresponding links 334. Each outer segment of anvil plate 332 has a staple forming surface 336 that has staple forming pockets 338 formed therein. When the anvil assembly 320 is in the expanded or installed position (FIG. 11), the staple forming pockets 338 correspond to the outermost row of staples within the staple cartridge 26 supported on the stapling head 20 of the circular stapling instrument 310 .
[000113] As can also be seen in FIGS. 10 and 11, the anvil connection assembly 330 additionally comprises a collection of inner segments of anvil plate 340. The internal segments of anvil plate 340 are pivotally coupled to an internal connection assembly 350 that is coupled to the stem of anvil 321. In at least one implementation, for example, the inner connection set 350 includes a center collar 352 that is attached to the anvil stem 321. Each inner segment of anvil plate 340 is pivotally coupled to the center collar 352 by a primary link 354. The inner link assembly 350 additionally includes a plurality of actuator blocks 356. Each inner segment of anvil plate 340 has a corresponding actuator block 356 attached thereto by a secondary link 358. Each inner segment of anvil plate 340 has a staple forming surface 342 that has staple forming pockets 344 therein. When the anvil assembly 320 is in the expanded or installed position (FIG. 11), the staple forming pockets 344 correspond to the innermost row of staples within the staple cartridge 36 in the circular stapling instrument 310.
[000114] In various embodiments, a central hub portion 360 extends centrally through the stapling head 20. A proximal end 361 of the central hub portion 360 is configured to slidably engage the inner wall of the tubular cover 82 as may be. seen in FIG. 11. The compression rod 84 is free to move axially with respect to the central hub portion 360 to drive the clamp conductor assembly 24 distally. Thus, the axial movement of the compression rod 84 within the tubular cover 82 causes the staple conductor assembly 24 to move axially within the compartment member 22 of the stapling head 20. As will be discussed below, the trigger action firing rod 120 will cause the compression rod 84 to move in the distal direction (arrow "DD") thus driving the clamp conductor assembly 24 distally to fire the clamps on the clamp cartridge 26 into the forming contact with the substantially flat anvil plate 346 formed by the outer segments of anvil plate 332 and the inner segments of anvil plate 340. As the staple conductor assembly 24 is guided distally, this also leads the distal end of the scalpel 30 through the tissue contained inside the circumference of the stapled fabric.
[000115] In various implementations, the central hub portion 360 is also configured to move axially within the stapling head 20. As can be seen in FIGS. 9 and 11, an actuator rod 363 is attached to the proximal end 364 of the central hub portion 360 and is attached to a slide switch 365 mounted on handle 60. Slide switch 365 can be configured to slide distally and proximally to move axially and retract the central hub portion 360. The slide switch can be configured with a series of detectors (not shown) or other structures (not shown) that define switching positions that correspond to the axial positions for the central hub portion 360. Thus, the slide switch 365 and finally the central hub portion 360 will be locked in position and unable to move axially when the slide switch 365 is moved to one of these switching positions.
[000116] FIG. 10 illustrates the anvil set 320 in a flattened orientation that allows the anvil set 320 to be inserted through a cannula portion of a trocar device or other opening in the body. Once the anvil set 320 has been drilled through the tissue to be cut and stapled, the surgeon extracts the anvil stem 321 in the "PD" proximal direction by rotating the knob 40. Once the flat anvil set 320 is extracted adjacent the staple cartridge 26, the surgeon can then advance the central hub portion 360 distally to cause the anvil assembly 320 to move to the expanded or installed orientation. As the distal end 362 of the central hub portion 360 moves distally, this comes in contact with the actuator blocks 356 of the internal connection assembly 350. The movement of the actuator blocks 356 distally facilitates the articulation movement of the inner segments of the anvil plate 340 for contacting the outer anvil plate segments 332 to tilt the outer anvil plate segments 332 radially outwardly to form a substantially flat anvil plate assembly 346 as shown in FIG. 11. When in that position, the anvil assembly 320 is in the "expanded" or installed orientation and the staple forming surfaces 336, 342 of the anvil plate segments 332, 340 are in confronting relationship with the staple cartridge 26 in stapling head 20 of the circular stapling instrument 310. The surgeon can then activate or "fire" the circular stapling instrument 310 to drive the staples into the staple forming pockets 338, 344 on the staple forming surfaces 336, 342, respectively. The circular stapling instrument 310 can, for example, be used to perform a Roux-en-Y procedure in the manner described above, as well as to perform other surgical procedures.
[000117] FIGS. 12 to 15 illustrate another embodiment of anvil expandable in various forms of the present invention that can be used in conjunction with a circular stapling instrument 410. Various embodiments of the circular stapling instrument 410 have components that are substantially identical to the circular stapling instrument 10 described above and, therefore, its construction and operation will not be repeated again, in addition to what is necessary to understand the construction and operation of the circular stapling instrument 410. As can be seen in FIGS. 12 to 15, the circular stapling instrument 410 includes an expandable and flattenable anvil assembly 420. In this implementation, the circular stapling instrument 420 includes a trocar stem 412 that can be attached to the upper tension band 86 and the tension band lower 87 of the circular stapling instrument 410 by locks 89. The proximal ends of the upper tension band 86 and the lower tension band 87 can be attached to a distal end of the adjustment rod 90 as described above.
[000118] FIGS. 13 and 14 illustrate a trocar rod shape 412 that can be used with various embodiments of the present invention. Those skilled in the art will also note that various embodiments of the present invention can also be employed with conventional trocar stem arrangements without departing from the spirit and scope of the present invention. As can be seen in FIGS. 13 and 14, the trocar stem 412 is provided with a plurality of (preferably four) outwardly extending fixing fins 414. Such an arrangement allows the trocar stem 412 to be fixed non-rotatively to a variety of different Tip sets that can be used in conjunction with different types of tip effector arrangements that are specifically configured to perform various procedures and surgical actions.
[000119] The circular stapling instrument 410 can be effectively employed with an anvil assembly 420 that serves to form the staples as they are conducted from the staple cartridge 26. As can be seen in FIG. 14, an anvil assembly form 420 includes a tissue penetrating tip member 430 that is fixable to the trocar shaft 412. In various embodiments, the tissue penetrating tip member 430 includes a substantially tapered tip portion 432 that ends at a sharp point 434 and has an anvil stem 436 attached to it. The proximal end 438 of the anvil stem 436 is substantially hollow and sized to receive the trocar tip 416 therein. The proximal end 438 has a pair of spaced-out fixing tabs 440 that protrude from there that extend between the trocar fins 414. Each fixing tab 440 has a hole or recess 442 in it that is oriented to receive a corresponding holder 418 formed on the trocar shaft 412. Thus, when the holders 418 fit into its corresponding orifice or recess 442, the tissue penetration tip member 430 is affixed to the trocar stem 412 to travel with it. In various embodiments, the tissue penetrating tip member 430 is manufactured from metallic material.
[000120] Various shapes of the anvil set 420 further include a plurality of anvil plates 450. In the embodiment disclosed in FIGS. 12 to 15, two anvil plates 450 are employed. In at least one embodiment, each anvil plate 450 has an arched shape and has at least one staple forming pocket therein. In a preferred embodiment, each anvil plate 450 has a first arched configuration 452 of staple forming pockets 454 therein and a second arched configuration 456 of staple forming pockets 458 therein that, when anvil assembly 420 is in expanded orientation or installed, corresponds to the circular arrangement of staples inside the staple cartridge 26. In various embodiments, anvil plates 450 have an anvil hub portion 460 that extends around a portion of anvil stem 436. The anvil plates anvil 450 are movably coupled by at least two spring-loaded clips 462 (shown in FIG. 15). The spring clips 462 are used to tilt the anvil cube portions 460 in friction engagement with the anvil stem 436 to retain the anvil plates 450 in the flattened orientation. Refer to FIGS. 12 and 13. Furthermore, in at least one implementation, each anvil plate 450 has a tapered inner wall portion 464 formed therein. When the anvil plates 450 are in flat orientation, a space 466 is provided between the tapered inner wall portions 464 of the facing anvil plates 450. See FIG. 13.
[000121] Various embodiments of the anvil assembly 420 additionally comprise an anvil expansion member 470 having a centrally arranged tapered tip portion 472 that is dimensioned to extend axially to the opening 466 when the anvil assembly 420 is moved in the direction proximal "PD" toward the stapling head 20. A hollow expansion rod 474 extends from the tapered tip portion 472 and is sized to allow anvil stem 436 to move axially within it. In addition, the anvil expansion member 470 additionally has a pair of diametrically opposed fixed plate claw sections 476 that project from there. The fixed plate claw sections 476 are dimensioned and shaped in relation to the anvil plates 450 so that when they are received between the facing anvil plates 450, they interweave with this to form a substantially flat annular plate assembly 480. See FIG. 15.
[000122] As can be seen in FIGS. 12 and 13, each of the fixed plate claw sections 476 has a first arched configuration 452 of staple forming pockets 454 therein and a second arched configuration 456 of staple forming pockets 458 therein where, when the anvil assembly 420 is in the expanded or installed orientation, corresponds to the circular arrangement of staples inside the staple cartridge 26. It will be understood that the staple forming pockets 454, 458 serve to form the staples as they are conducted through the "T" fabric to be stapled and on the anvil plate set 480.
[000123] In various embodiments, the expansion rod 474 extends through a hub rod centrally arranged (not shown) on the clamping head 20. The expansion rod 474 is dimensioned and shaped in relation to the hub rod to establish a sliding friction fitting with it. FIGS. 12 and 13 illustrate an initial position of the anvil expansion member 470 when the anvil assembly 420 is in the flattened position. When in this position, the anvil expansion member 470 is retained in that position by the friction fit established between the expansion rod 474 and the hub rod. When in the flattened orientation, the surgeon can then force the tissue penetrating tip member 432 through the "T" tissue to be stapled to allow the anvil assembly 420 to extend through it. Since the flat anvil assembly 420 is located on the opposite side of the "T" fabric, the substantially flat anvil plate assembly 480 is then extracted towards the stapling head 20 to capture the target tissues in between. The anvil assembly 420 is moved in the proximal direction "PD" by rotating the knob 40 on the handle portion 60 to extract the trocar shaft 412 towards the handle 60 as is known. As the anvil assembly 420 is moved in the proximal direction, the tip portion 472 of the anvil expansion member 470 enters the opening 466 between the anvil plates 450 and engages the tapered inner walls 464 of the anvil plates 450 to tilt the plates anvil 450 radially outward in the radial direction "RD" (FIG. 14) until the fixed plate claw sections 476 are received between the anvil plates 450. See FIG. 15. When in this expanded orientation, anvil plates 450 intertwine with fixed plate claw sections 476 to form an annular and substantially flat anvil plate assembly 480. Additional movement of anvil assembly 420 in the proximal "PD" direction causes the anvil expansion rod 474 to slide into the hub shank to allow the anvil assembly 420 to be moved to the desired position for stapling and cutting tissue. Once the anvil set 420 has been properly positioned in relation to the stapling head 20, the surgeon can then "fire" the device by activating the trigger trigger 60 that drives the scalpel 30 and drives the clamps into contact forming with the substantially flat annular anvil plate assembly 480. The expandable anvil assembly 420 can be in conjunction with the circular stapling instruments of the type described above or other circular stapling instruments can, for example, be used to perform a Roux-en-Y procedure as described above, how to perform other surgical procedures.
[000124] FIGS. 16 to 19 illustrate another expandable anvil assembly 520 that can be employed with the circular stapling instrument 510 to perform various stapling procedures such as the Roux-en-Y procedure described above. Various embodiments of the circular stapling instrument 510 have components that are substantially identical to the circular stapling instruments 310 described above and / or others described and, therefore, their construction and operation will not be repeated again beyond what is necessary to understand the construction and operation of the 510 circular stapling instrument.
[000125] In at least one implementation, the expandable anvil assembly 520 comprises an umbrella-type assembly that includes a plurality of selectively positionable first anvil links 530 having a distal end portion 532 that is hingedly attached to an anvil stem 540. Each first anvil link has an elongated body portion 534 and a proximal end 536 that has a first segment of anvil plate 538 formed therein. The first 530 anvil links can be manufactured from metallic material. The first anvil plate segments 538 have a first staple forming surface that has a first arcuate configuration of the first staple forming pockets 539 therein. See FIG. 18. In various embodiments, each of the first anvil links 530 has a lock ring holder 535 formed therein and is movably received within a lock ring 550.
[000126] In various embodiments, the expandable anvil assembly 520 additionally includes a second anvil link assembly 570 that includes a plurality of primary links 572 that are pivotally coupled to an intermediate harness ring 574. A plate segment secondary anvil 576 is hingedly coupled to each of the primary links 572. the secondary anvil plate segments 576 are hingedly coupled to an actuator ring 580. the intermediate harness ring 574 and the actuator ring 580 are seated movably on anvil shank 540. Each of the secondary anvil plate segments 576 has a staple forming bottom 577 therein that has staple forming pockets 579 therein. Refer to FIG. 18.
[000127] This modality additionally includes a centrally disposed actuator hub 590 which is movably supported within the stapling head 20 as shown in FIG. 19. The proximal end 592 of the actuator hub 590 is attached to the actuator rod 363 which is attached to the slide switch 365 on the handle 60. The movement of the slide switch 365 in the distal direction "DD" will drive the actuator hub 590 in the distal direction inside the clamping head 20. Such movement of the actuator hub 590 drives the second anvil link assembly 570 distally to cause the first anvil links 530 to be positioned open. As the first anvil links 530 are positioned open, the locking ring 550 is caused to slide upwards from the first anvil links 530. The surgeon will continue to advance the second set of anvil links 570 distally until the forming surfaces clip 577 of the secondary anvil plate segments 576 are in relation to the clamp cartridge 26 in the staple head 20. FIG. 16 illustrates the secondary anvil plate segments 576 in an intermediate position before reaching the confronting relationship to the staple cartridge 26. In various embodiments, the slide switch 365 can be configured with holders or other locking arrangements to define the position final "firing" of the second anvil link set in which the first anvil plate segments and the secondary anvil plate segments cooperate to form an annular and substantially flat anvil plate assembly generally designated as 595. See FIG . 18. Thus, when the slide switch 365 is locked in position, the actuator hub 590 is locked in a position where the intermediate harness ring 574 is in contiguous relationship with a locking flange 541 on the anvil stem 540. When in that position, the locking ring 550 is in contiguous relationship with the locking ring holders 535 in the first anvil links 530 to lock the first anvil links 530 in that positioned position.
[000128] In various implementations, the anvil stem 540 of the circular stapling instrument 510 has a trocar tip portion 542 that terminates at a pointed tissue penetration tip 544. See FIG. 17. In FIG. 17, the expandable anvil assembly 520 is in the flattened orientation. When in the flat orientation, the trocar tip portion 542 can be used to perforate the tissue. As can be seen in that FIG., For example, the trocar tip portion 542 is perforated through the "T" and "T1" fabrics that must be cut and stapled. Thereafter, the surgeon can activate the slide switch 365 to form the substantially flat annular anvil plate assembly 595. Since the anvil plate assembly 595 was formed in relation to the staple cartridge 26 supported on the stapling head 20, the surgeon can activate the trigger trigger 120 on the handle 60 to fire the clamps and the scalpel 30 as described above.
[000129] In the past, laparoscopic colectomies were impractical for execution due to the number of steps necessary to be performed to introduce the stapling instruments into the surgical site. Problems with crossed staple lines, seeding of individual tissue removal, creation of doors to introduce anvils into the body cavity and colon defects of anvil placement have been encountered frequently when using such procedures. The various embodiments of the present invention described above can be used effectively to perform a laparoscopic colectomy while avoiding many, if not all, of such problems.
[000130] FIGS. 20 and 21 illustrate a colon section 600 that has a diseased portion 602 that must be removed therefrom. As can be seen in FIG. 21, a circular stapling instrument 10 of the type and construction described above with a corresponding anvil set 420 of the type and construction described above is inserted into colon 600 through rectum 604. Anvil set 420 is used to pierce portions of the colon wall "T" and "T1" when the anvil assembly 420 is in the flattened position in the ways described above. FIG. 21 illustrates this process in general. As can be seen in that FIG., The conventional handles 610 can be employed through appropriately located trocars (not shown) to catch the diseased portion 602. Those skilled in the art will understand that any of the above described modalities can be employed to perform this procedure. FIG. 22 illustrates the anvil assembly 520 as well as a pointed anvil assembly 620 which has an auger tip formed therein to penetrate the colon wall. Once the anvil assembly has penetrated through the colon wall portions "T" and "T1", the circular stapling instrument 10 can be operated as described above to complete anastomosis 606. Thereafter, instrument 10 is removed through rectum 604.
[000131] FIG. 23 illustrates the use of conventional cutter devices 640 to separate the diseased colon portion 602. Again the cutter 640 can be inserted through a properly located trocar. FIG. 24 illustrates the removal of the diseased portion by inserting a conventional specimen recovery device 650 through the colon 600 to collect specimen 602 and remove it through rectum 604 or place it in a specimen recovery bag 660 inserted through another properly placed trocar.
[000132] As can be understood from the above, the various configurations of circular stapling instrument and anvil set configuration described here represent the vast improvements over the previous circular stapler arrangements. The use of the various modalities of circular stapling and anvil instrument of the present invention can eliminate the often time-consuming process of tying sutures around the anvil stem. In addition, the various anvil sets shown above can be used effectively with conventional circular stapling instruments. Such self-drilling and self-centering anvil arrangements can also eliminate the need to create the "side-by-side" anastomosis. Various anvil assembly embodiments of the present invention described above can also result in a reduction of the insertion and removal forces required to use the instruments. The need to create another defect to insert an anvil into the patient can also be eliminated when using various modalities of the present invention. Such embodiments of the present invention can also result in little or no staple line dilation which can lead to better hemostasis.
[000133] FIGS. 25 to 28 illustrate another expandable anvil set 700 that can be used with the circular stapling instrument 10 to perform various stapling procedures such as the Roux-en-Y procedure described above. In at least one implementation, the expandable anvil assembly 700 includes an anvil plate assembly 710 which, in at least one embodiment, includes a flexible ring member 712 that supports a plurality of metal segments of anvil plate 720 therein. The flexible ring member 712 can be manufactured from an elastomeric material that allows the ring member 712 to be flattened in a first configuration that allows it to be inserted through the cannula portion 181 of a trocar device 180 (FIG. 26) and then spring-open for a second configuration comprising a substantially flat annular anvil plate assembly 710 as shown in FIGS. 27 and 28. The metal segments of the anvil plate 720 are arched in shape and can be embedded or otherwise attached to the flexible ring member 712. Each segment of the anvil plate 720 has a clamp forming surface 722 in which it has a plurality of arched configurations of staple forming pockets 726 therein. In one embodiment, for example, the staple forming surface 722 has an internal configuration 724 and an external configuration 725 of staple forming pockets 726 therein. As can be seen in FIGS. 25 to 27, the internal configuration 724 of staple forming pockets 726 is misaligned with respect to the external configuration 725 of staple forming pockets 726 to match the concentric arrangement of staples in the staple head 20.
[000134] In various embodiments, the expandable anvil assembly 700 additionally includes an anvil support member 730 that is configured to attach to the anvil plate assembly 710 to guide and provide load support for this. As can be seen in FIGS. 25 and 29 to 31, in at least one implementation, the anvil support member 730 comprises a central rod 732 having a proximal end 734 which is configured to be attached to the end of the trocar stem of the circular stapling device. The proximal end 734 may have a cavity therein sized to receive the trocar tip therein. In other embodiments, the proximal end 734 is configured to releasably engage a trocar stem arrangement of the type shown in FIG. 14.
[000135] In at least one implementation, the anvil support member 730 includes a connection assembly 740 which is movably seated on the central stem 732 so that it is movable between a flattened orientation (FIG. 29) and an orientation expanded or installed (FIGS. 25 to 30). As can be seen in FIGS. 25, 29 and 30, connection set 740 comprises a plurality of joined links 742 which include a distal link 744 and a proximal link 746 which are articulated together (fixed). In other embodiments, however, each distal link 744 can be coupled to a corresponding proximal link 746 by a live hinge arrangement that includes a detent arrangement for locking links when in the anvil plate support position. Each of the distal links 744 is pivotally coupled to a distal end ring 750 which is mounted at the distal end of the central stem 732. Each of the proximal links 746 is pivotally coupled to a lock ring 752 which is seated movable mode on the central stem 732. A retaining collar 760, in the form of a plurality of spaced outwardly extending flanges 762, is provided on the central stem 732 to retainly engage the lock ring 752 when the connection assembly 740 is in the expanded or installed orientation as shown in FIG. 30. When locking ring 752 is engaged in a retaining manner with retaining collar 760, connection assembly 740 is locked in expanded orientation.
[000136] As can be seen in FIGS. 29 to 31, each of the proximal links 746 has a latch feature 748 formed therein. The latch feature 748 is adapted to engage a corresponding latch flap 728 formed on the underside 727 of each anvil plate 720. As can be seen in FIG. 28 in at least one embodiment, each anvil plate 720 has two latch tabs 728 therein. The latch flaps 728 are positioned so that when the corresponding latch features 748 engage the anvil support member 730 in a locked fashion, the clamp forming pockets 726 on the anvil plates 720 are aligned with the corresponding clamps on the anvil head. stapling of the circular stapling instrument, so that when the staples are fed to the anvil plates 720, the staples are appropriately formed by the corresponding staple forming pockets 726 therein. In alternative embodiments, the ends of the links can be configured to engage the corresponding holes in the anvil plates 720 in a retaining manner.
[000137] In use, the anvil plate assembly 710 is oriented in the flat orientation so that they can be passed through the cannula portion 181 of the trocar device 180 (FIG. 26) or another opening in the body (for example, through colon, etc.). Anvil support member 730 is similarly oriented in the flattened orientation (FIG. 29) so that it can also pass through the cannula portion 181 or another body opening. This can be attached to the trocar stem of the circular stapling instrument and inserted through the cannula portion 181 or body opening with the stapling head of the instrument. In other approaches, however, the flat anvil support member 730 can be separately inserted into the patient and then attached to the trocar shaft of the circular stapling instrument that has been inserted, for example, through a cannula portion of another trocar or other opening. Once the anvil plate assembly 730 has passed through the cannula portion 181, flexible ring 712 causes the plate assembly to flex in its flat orientation. If the anvil support member 730 is inserted through the cannula portion or the opening without being attached to the trocar shaft of the circular stapling instrument, with, for example, a grasping device, the surgeon can use the grasping device to move the connection set 740 to the expanded orientation so that the locking ring 752 is placed in locking engagement with the retaining collar 760. After that, the expanded anvil support member 730 is matched with the set of plate anvil 710. More specifically, the anvil plate assembly 710 is oriented with respect to the proximal links 746 of the connection assembly 740 so that the latch features 748 are first oriented adjacent the corresponding latch flaps 728 on the anvil plates 720 and then rotated in locking engagement therewith as illustrated in FIG. 31. The assembled anvil assembly 700 can then be attached to the trocar shaft of the circular stapling instrument. To ensure that the staple forming pockets 726 are not substantially level with the corresponding staples on the stapling head, the proximal end 734 of the stem 732 is attached to the trocar stem in an aligned manner. Such alignment can be accomplished using the trocar stem arrangement configured as shown in FIG. 14 or other suitable alignment arrangement (ie keys / locks, grooves, etc.). In applications where the anvil set 700 is introduced into the patient while it is attached to the trocar shaft of the circular stapling instrument, the surgeon can insert the anvil plate set 710 over the flat anvil support member 730. Since the anvil plate set 710 was inserted over the flat anvil support member 730, the surgeon can then move the anvil support member 730 to the expanded orientation and then the anvil plate set 710 can, then, be fixed to that in the manner discussed above.
[000138] FIGS. 32 to 38 illustrate another anvil plate assembly 810 that can be inserted through a cannula portion 181 of a trocar device 180 or another opening in the body in a flattened orientation (FIG. 26) and then opened to assume a substantially flat orientation or configuration (FIG. 38). In at least one implementation, the anvil plate assembly 810 includes a plurality of anvil plates 820 that are movably secured by a plurality of first and second spring clips 840, 860. Each anvil plate 820 has an arcuate shape so that when configured in the expanded orientation, the anvil plates 820 cooperate to form a substantially annular and flat anvil plate configuration as shown in FIG. 38.
[000139] In various embodiments, the ends of the anvil plates 820 are configured to intertwine to form the expanded anvil plate assembly shown in FIG. 38. When assembled, the anvil plate assembly 810 includes a pair of first fixing joints 821 which are opposite each other and a pair of second fixing joints 850 which are opposite each other. Refer to FIGS. 32 and 38. FIGS. 33 and 34 illustrate an exemplary first fixing joint 821. As can be seen in those FIGS., The first adjacent ends 822 of the anvil plates 820 forming a first fixing joint 821 have a first notch 823 therein. Each first end 822 additionally has a first flat fixing flap 824 which protrudes from that which is slidably extended to a first complementary shaped groove 825 formed at the first end 822 of the anvil plate 820. The first ends 822 are movably coupled by a first spring clip 840. The ends 842 of each first spring clip 840 are movably attached within the first spring grooves 843 formed at the first ends 822. When the plate plate assembly anvil 810 is in the flattened orientation, the first spring-loaded clips 840 retain the first ends as shown in FIGS. 32 and 33. When the anvil plate assembly 810 is in the expanded orientation, the ends 842 of the first spring clips 840 slide into their respective first spring grooves 843 to retain the first ends 822 of the anvil plates 820 in interlaced engagement as shown in FIGS. 34 and 38.
[000140] FIGS. 35 to 37 illustrate a second fastening joint 850. As can be seen in these FIGS., The second adjacent ends 852 of the fastening plates 820 forming a second fastening joint 850 have a second notch 853 therein. Each second end 852 also has a second flat fixing flap 854 projecting from there which is sized to extend into a second complementary shaped groove 855 formed at the second end 852 of the anvil joint plate 820. The second ends 852 they are movably coupled by a second spring clip 860. The ends 862 of each second spring clip 860 are movably attached within the second spring grooves 863 formed at the second ends 852. When the anvil plate assembly 810 is in the flattened orientation, the second clips with the spring 860 retain the second ends 852 as shown in FIGS. 32 and 35. When the anvil plate assembly 810 is in the expanded orientation, the ends 862 of the second spring clips 860 slide into their respective second spring grooves 863 to retain the second ends 852 of the anvil plates 820 in interlocking engagement as shown in FIGS. 36 and 38. In various embodiments, the fixing tabs 824, 854 are substantially parallel with the staple forming surfaces on the anvil plates 820 so that when the anvil plates 820 are assembled together in the expanded orientation, the fixing tabs 824, 854 provide additional support and rigidity for the anvil plate assembly 810 in the plane which is substantially perpendicular to the direction in which the clamps are to be fired.
[000141] Each anvil plate segment 820 has a staple forming surface 870 therein that has a plurality of arched configurations of staple forming pockets 876 therein. In one embodiment, for example, the staple forming surface 870 has an internal configuration 872 and an external configuration 874 of staple forming pockets 876 therein. When in expanded orientation, anvil plate assembly 810 can be attached to anvil support member 730 and used in the manner described above. In particular, each of the anvil plates 820 may have two latch tabs (not shown) formed on the underside thereof. The latch tabs are positioned so that when they lock in place with the corresponding latch features 748 on the anvil support member 730, the staple forming pockets 876 on the anvil plates 820 are aligned with the corresponding clamps on the stapling head of the circular stapling device, so that when the staples are fed to the anvil plates 820, the staples are appropriately formed by the corresponding staple forming pockets 876. As shown in FIG. 32, a handle 880 can be employed to retain the anvil assembly 810 in the flattened orientation during insertion into the patient. Thereafter, the handle 880 can be cut using a conventional cutting device 890 to allow the anvil assembly 810 to be moved to the expanded orientation.
[000142] FIGS. 39A to 39F, 40 and 41 illustrate another expandable anvil plate assembly 900 of the present invention. In one deployment, the anvil plate assembly 900 includes four arched anvil plate segments 910 that are coupled by hinges 912. FIGS. 39A and 39B illustrate the anvil plate assembly 900 in a completely flattened configuration. In the illustrated embodiment, the anvil plate assembly 900, when in the completely flat configuration, is sized to fit through the cannula portion 181 of a trocar device 180 that has an opening of 12 mm. Refer to FIG. 41. Once the anvil set 900 has been inserted through the trocar cannula 181 or other body opening, the anvil set 900 is unfolded as illustrated in FIGS. 39C to 39F to form a substantially flat anvil plate assembly. Each of the anvil plate segments 910, which can be manufactured from metallic material, has a staple forming surface 914 that has an internal configuration 916 of staple forming pockets 918 and an external configuration 920 of forming pockets of clip 918 on it.
[000143] FIG. 42 illustrates another expandable anvil plate assembly 930 of the present invention. In one deployment, the anvil plate set 930 includes four arched anvil plate segments 932 which are coupled by hinges 934. In the illustrated embodiment, a cable 940 is threaded through each of the 932 segments. The flat anvil set 930 it can be pulled through the trocar cannula 181 by a conventional 950 handle instrument that has been inserted through another trocar device (not shown). As the flat anvil set 930 is inserted through the cannula 181, the end 942 of the handle is threaded through the cannula 181 where it can be accessed outside the trocar device 180. Once the flat anvil set 930e has been inserted through from the cannula portion 181, the surgeon can then pull end 942 of handle 940 to extract the two anvil plate end segments 932 together to form the substantially flat annular anvil plate assembly. A releasable latch feature (not shown) is provided on each end segment to lock the 930 anvil assembly in the expanded configuration. As can be seen in FIG. 42, each of the anvil plate segments 932, which can be manufactured from metallic material, has a staple forming surface 936 which has an internal configuration 937 of staple forming pockets 938 and an external configuration 939 of pockets staple formation 938 therein.
[000144] Although anvil plate sets 900, 930 can be employed with any of the anvil support member arrangements shown in the present invention, FIG. 43 illustrates another anvil support member arrangement 950 of the present invention. An implementation of the anvil support member arrangement 950 includes an anvil support plate 960 that is seated on an anvil stem 970. Anvil assembly 900, 930 (as appropriate) is inserted through the cannula portion 181. The support plate 960 and the anvil stem 970 are also sized to be inserted through the cannula portion 181 or another body opening. Once all three components 900 or 930, 960, 970 have been inserted into the patient, they can be assembled as shown in FIG. 43. The support plate 960 can be adjusted on the anvil stem 970 to orient the support plate 960 in a desired orientation therein. The anvil stem 970 is configured to be attached to the trocar tip of the surgical stapling instrument in a desired orientation. Anvil stem 970 can, for example, be configured as shown in FIG. 14. Support plate 960 can also be configured to lock in position with the anvil stem 970 or lock with the end cap 972 of the anvil stem. As can also be seen in FIG. 43, the bottom side 962 of the support plate 960 is configured to lock with the particular anvil plate assembly 900, 930. In the disclosed embodiment, a series of grooves 964 is formed on the bottom side 962 of the support plate 960 to receive from a portion of the hinges 912, 934 in this way. In at least one implementation, one of the hinges 912, 934 is sized differently from the other hinges in the anvil plate assembly. Likewise, only one of the grooves is dimensioned / configured to interlock with this hinge to result in the proper orientation of the anvil plate assembly on the support plate. In this way, when the anvil has been completely assembled and attached to the trocar shaft, the staple forming pockets on the anvil plate assembly are correctly aligned (ie, not substantial leveling) with the staples on the stapling head of the stapling instrument Circular.
[000145] FIGS. 44 and 45 illustrate another flattenable anvil support member 980 that can be used to support any of the anvil plate assemblies shown in the present invention. As can be seen in these FIGS., The anvil support member 980 includes an anvil stem 982 that has a proximal end 984 that is configured to be attached to the tip of a trocar of a circular stapling instrument. Anvil stem 982 is configured to be attached to the trocar tip of the surgical stapling device in a desired orientation. Anvil stem 982 can, for example, be configured as shown in FIG. 14 to be attached to the trocar tip. In addition, anvil support member 980 additionally includes a plurality of anvil support arms 986 which are pivotally coupled to anvil stem 982. Anvil support arms 986 can be configured with a holder or other arrangement of latch so that when they are pivoted to the open position illustrated in FIG. 45, they are releasably locked in that position. In other embodiments, no latch arrangement is employed.
[000146] As can be seen in FIG. 45, each of the anvil support arms 986 has a latch tab 988 therein which is configured to lock with the anvil plate assembly when the anvil plate assembly is in the flat open position. A variety of latch flap arrangements can be employed. In one embodiment, the 988 tabs can be configured to be pressed into the openings in the anvil plate assembly. One of the flaps 988 can be sized or located so that they can only lock with a corresponding opening or latch flap on the anvil plate assembly to properly orient the anvil plate assembly with respect to the anvil stem. Such an arrangement serves to ensure that the staple forming pockets on the anvil plate assembly are correctly aligned with the staples on the stapling head when the anvil stem has been properly attached to the trocar stem in a desired orientation.
[000147] FIGS. 46 to 52 illustrate another expandable anvil support member 1000 that can be employed with the circular stapling device 10 or other circular stapling devices with the changes / modifications noted below to perform various surgical stapling procedures. In at least one implant, the expandable anvil support member 1000 that can be used in conjunction with an anvil plate assembly 1080 or any of the other anvil plate assembly embodiments of the present invention.
[000148] In various embodiments, the expandable anvil support member 1000 includes a central rod 1010 having a hollow proximal end 1012 that is sized to receive a tip 1102 of a trocar stem 1100 from the circular stapling instrument 10. A plurality locking tabs 1014 is provided at the proximal end 1012 and has a locking lug or protrusion 1016 formed therein that is designed to fit a lower cut 1104 on the trocar stem 1100. See FIGS. 46 to 48. Other latch arrangements can be employed to secure the central rod 1010 to the trocar shaft 1100. Furthermore, in various implementations, a plurality (for example, four) of articulation rods 1018 protrudes transversely from the central rod 1010 and define PAPA pivot geometric axes that are substantially transversal to the SA-SA stem axis. The distal end 1019 of the central stem 1010 is widened as shown.
[000149] An embodiment of the expandable anvil support member 1000 additionally includes a hollow locking sleeve 1020 which is movably seated on the central rod 1010. The locking sleeve 1020 has a plurality of grooves 1022 which are oriented to allow the pivot bars 1018 slide along this. The distal end 1024 of the locking sleeve 1020 has a deformable retaining ring 1030 attached thereto which is configured to interact with a centrally arranged hub portion 1031 extending through the stapling head 20 as shown. In its initial non-deformed configuration, the retaining ring 1030 is located at the distal end 1033 of the central hub 1031 and allows the trocar shaft 1100 to pass freely through it. As the trocar stem 1100 is extracted in the proximal direction, the articulation rods 1018 will come into contact with the bottom of the grooves 1022 in the locking sleeve 1020 thereby extracting the locking sleeve 1020 in the proximal direction. As the retaining ring 1030 is extracted from the central hub portion 1031, the retaining ring 1030 deforms to form a frictional contact with the inner wall of the central hub 1031 to hold locking sleeve 1020 in position as will be discussed in further detail below .
[000150] In various implementations, the anvil support member 1000 additionally includes a movable connecting set 1040 comprising two pairs (only a pair of connecting bars 1042 is shown in FIGS.) Of diametrically opposite connecting bars 1042 which are hingedly coupled to hinge rods 1018. For example, FIGS. 46, 47 and 52 disclose two diametrically opposed connecting rods 1042 which are pivotally coupled to the central rod 1010 around the pivot rods 1018. Each connecting rod 1042 has a notched distal end 1044 which is configured to engage retainer to a stem cap 1050 that is seated on the distal end 1019 of stem 1010. The stem cap 1050 is sized so that it can be inserted through a specific size of trocar cannula or other opening in the body. Each of the connecting bars 1042 has a proximal end 1046 that is configured to be locked in an anvil plate assembly 1080. Any of the latch arrangements shown in the present invention can be employed to lock the anvil plate assembly 1080 or any of the other anvil plate assemblies shown in the present invention for the proximal ends 1046 of the connecting bars 1042.
[000151] Various embodiments of the anvil support member 1000 further include a distal locking collar 1060 which is attached to the distal end 1022 of locking sleeve 1020. FIGS. 50 and 51 illustrate a method of fabricating the distal locking collar 1060. In various embodiments, the distal locking collar 1060 may comprise a hollow sleeve and having a plurality of longitudinal slits 1062 equally spaced around its circumference. Refer to FIG. 50. As can also be seen in FIG. 50 in its "unlocked" or "unformed" initial position, the center of sleeve 1060 may have a central outer diameter "D1" that is larger than its "DE" end diameters. When the axial forces "AF" are applied to the ends of the distal locking collar 1060, the collar is axially flattened thereby increasing the central outer diameter ("D2" is greater than "D1").
[000152] In use, the anvil support member 1000 and the expandable anvil plate set 1080 (or any of the other anvil plate sets shown in the present invention) can be separately introduced into the patient's body via, for example, example, a trocar cannula or other body opening. FIG. 46 illustrates the attachment of the anvil support member 1000 to the trocar shaft 1100. As can be seen in this FIG., The anvil plate assembly 1080 has been attached to the proximal ends 1046 of the connecting bars 1040. Since the central stem 1010 has been attached to the trocar shaft 1100, the surgeon can then begin to extract the anvil support member 1000 proximally ("PD") towards the stapling head 20 by rotating the button 40 of the stapling instrument Circular. As the stem 1010 is extracted proximally, the hinge rods 2018 will come into contact with the bottom of the respective groove 1022 from which they protrude into the locking sleeve 1020. Furthermore, as the central stem 1010 is extracted in a manner proximal, the distal locking collar 1060 will be flattened out between the distal end 1019 of the stem 1010 and the distal end 1022 of the locking sleeve 1020. As shown in FIG. 47, according to the distal locking collar 1060 slots into a retaining engagement with the notched ends 1044 of the connecting rods 1040 to retain them in engagement with the stem cap 1050. Such a configuration permanently holds the connecting rods 1040 in their orientation expanded or installed.
[000153] The surgeon can then continue to extract the trocar shaft 1100 proximally, which extracts the anvil support member 1000 and the anvil plate assembly 1080 towards the stapling head 20. Depending on the rod 1010 and the locking sleeve 1020 are extracted proximally, the retaining ring 1030 is tilted radially inward (arrows "R" in FIG. 47) towards the central hub portion 1031. As the retaining ring 1030 is extracted at central hub portion 1031, retaining ring 1030 deforms to form a frictional contact with the inner wall of the central hub portion 1031 to hold locking sleeve 1020 in position. This modality can be used to perform a variety of surgical procedures including those described above.
[000154] FIGS. 53 to 57 illustrate another expandable and flattenable anvil support member 1200 that can be effectively employed with any of the anvil plate assemblies described herein. In at least one implant, the anvil support member 1200 includes a central rod 1210 having a distal end 1212 and a proximal end 1214. The proximal end 1214 can be configured as illustrated in FIG. 14 to be releasably attached to a trocar stem of a circular stapling instrument. In other embodiments, the proximal end 1214 can be locked onto the tip of a trocar stem as described above. In still other arrangements, the proximal end 1214 can be adjusted on the trocar stem to properly orient the staple support member 1200 with respect to the staple cartridge supported within the stapling head of the circular stapling instrument. In each case, it is desirable to properly orient the staple support member 1200 with respect to the stapling head and staple cartridge therein so that when an anvil plate assembly is attached to it, the staple forming surface and the staple forming pockets in this are properly oriented to form staples as they are conducted to the anvil plate assembly.
[000155] As can also be seen in FIGS. 53 to 56, in at least one implant, an anvil cap 1220 is attached to the distal end 1212 of the central rod 1210. Anvil cap 1220 is sized to pass through a trocar cannula or other opening size in the body. The anvil cap 1220 can be configured with an arched dome-shaped surface 1222 to facilitate easy passage through the body without inadvertently injuring adjacent tissue. However, in other implementations, the anvil cap 1220 can be configured to perforate the tissue to allow the anvil support member to be used to perform certain procedures described above.
[000156] Various implementations of the anvil support member 1200 further include a connection set 1230 which is movably seated on the central rod 1210. In various embodiments, the connection set 1230 may include two pairs of connection bars which are attached to the distal end of the stem 1210. More specifically, as can be seen in FIG. 56, the connection set 1230 includes a first pair 1232 of diametrically opposed first connecting bars 1234 which are pivotally coupled to the central rod 1210 around a first pivot rod 1236 which defines a first pivot axis "PA1" - "PA1" which is substantially transversal to the "SA" - "SA" rod axis. The connection set 1230 additionally includes a second pair 1240 of second diametrically opposed connection bars 1242 which are pivotally coupled to the central rod 1210 around a second pivot axis 1244 which defines a second pivot axis "PA2" - " PA2 "which is substantially transversal to the stem axis" SA "-" SA ". Such an arrangement allows each of the connecting bars 1234, 1242 to articulate in a corresponding plane that is displaced from the center of the stem 1210. This arrangement allows the simple rotation of the connecting bars 1234, 1242 to cross when expanded (FIGS. 54 and 56), but to be rotated flat along the stem 1210 (FIG. 53) and able to fit under a trocar cannula for rotation. For example, in at least one implant, the diameter of the anvil cap 1220 is approximately slightly less than 15 mm in diameter. When in the flat or closed position (FIGS. 53 and 55), the anvil support member 1200 can pass under a trocar cannula which has a diameter that is approximately 15 mm. When in the expanded position, however, the proximal ends of the tie bars can open to a diameter "D" of approximately 35 mm. Refer to FIG. 56. Obviously, the anvil support member 1200 can be supplied in different sizes to accommodate different cannula and opening sizes without departing from the spirit and scope of the present invention.
[000157] In addition in various implementations, each of the first latch bars 1234 has a notched distal end 1235 that is configured for latch engagement with a corresponding first latch feature / cavity 1224 in anvil cover 1220 when the connection set 1230 is installed or expanded orientation. Refer to FIG. 57. Similarly, each of the second latch bars 1242 has a notched distal end 1244 that is configured for latch engagement with a corresponding second feature / latch cavity (not shown) on the anvil cap 1220 when the connection assembly 1230 is in the installed or expanded orientation.
[000158] As illustrated in FIGS. 53 and 54, each of the first connecting bars 1234 has a first proximal end 1237 which is configured to engage with a latch with an anvil plate assembly of any of the types described herein. In a deployment, for example, the first proximal ends 1237 may have a plurality of latch holders 1239 sized for latch engagement with the corresponding first openings or latch features in the anvil plate assembly. However, other latch arrangements of the types and construction described above can be employed. Similarly, each of the second connecting rods 1242 has a second proximal end 1246 which is configured for latch engagement with the anvil plate assembly. The second proximal end may have second detectors 1248 which are dimensioned for latch engagement with second openings or corresponding latch features in the anvil plate assembly. The first and second latch features can be configured to lock the anvil plate in such a way that the anvil plate assembly is properly oriented with respect to the instrument's stapling head when the 1210 stem was attached to the instrument's trocar stem .
[000159] As can also be seen in FIGS. 53 and 54, an elastomeric locking sleeve 1260 is received in connection assembly 1230. Locking sleeve 1260 may have a conical shape with an open end. The inclination of the locking sleeve 1260 forces the first and second connecting bars 1234 and 1242 to the open or expanded position when not constricted. When in that flattened or not installed position, the tilt force generated by the locking sleeve 1260 is not large enough to cause the first and second connecting bars 1234, 1242 to engage with latch on the anvil cap 1250. However, when the connecting bars 1234, 1242 are moved to their expanded or installed orientation, the locking sleeve forms a set of rigid triangles that lock the anvil support member 1200 and strong enough to support the formation clamp loads. This modality can be used to perform a variety of surgical procedures including those described above.
[000160] FIGS. 58 to 63 illustrate, diagrammatically, a method of attaching an anvil support member 1300 to an anvil plate assembly 1350. Those skilled in the art will understand that the capabilities of the anvil support plate 1350 can be employed together with any of the modalities of the anvil support member and any of the modalities of the anvil plate set shown in the present invention. As can be seen in FIGS. 58 to 60, the anvil support member 1300 has a connection assembly 1302 comprising a plurality of connection bars 1304. In the disclosed embodiment, connection bars 1304 are shown in the installed or open position. In the disclosed embodiment, an elastomeric locking sleeve 1311 is received at the connecting bars 1304 as shown in FIG. 58.
[000161] Each of the connecting bars 1304 has a magnet attached to its proximal end 1306. In particular, those connecting bars 1304 that are diametrically opposed to each other have a magnet with poles attached to it. As such, in at least one way, two opposing connecting bars 1304 have a positive pole magnet 1308 attached thereto and the other two opposite connecting bars 1304 have a negative pole magnet 1310 attached thereto. Refer to FIGS. 59 and 60. The anvil plate assembly 1350 has a staple forming surface 1352 therein that has staple forming pockets therein (not shown) that are configured to form staples as they are conducted from the stapling head of the instrument. stapling to which the anvil set is attached.
[000162] As with the various anvil support members described above, the stem portion 1312 of the anvil support member 1300 is configured to be attached to the trocar shaft of the circular stapling instrument. Various methods of fixing the anvil support member to the trocar in a specific orientation (keys, locking tabs, holders, etc.) have been presented. In at least one implant, the anvil plate assembly 1350 has a plurality of magnets attached to or embedded in it that are arranged to correspond to the magnets 1308, 1310 of the clip support member 1300. When the anvil plate assembly 1350 is attached to an anvil support member 1300 that has been properly attached to the trocar stem of a surgical stapling instrument, the staple forming surface 1352 of the anvil plate assembly 1350 is appropriately oriented in relation to the surgical staples inside the head stapling of the instrument. As such, the negative pole magnets 1354 are oriented within the anvil plate assembly 1350 to magnetically couple with the positive pole magnets 1308 attached to the anvil supporting member 1300 and the positive pole magnets 1356 are oriented to magnetically couple to the negative pole magnets 1310 on the anvil support member 1300.
[000163] FIGS. 64 to 70 illustrate another set of anvil 1400 that is configurable between a flattened configuration (FIGS. 67, 68 and 70) and an expanded configuration (FIGS. 64 to 66). The portions of the anvil set 1400 can be sized so that when in the flattened configuration, the anvil set 1400 can pass through a particular size of the trocar cannula or opening of a particular size. As can be seen in FIGS., The anvil assembly 1400 has an anvil head assembly 1410 that has an anvil stem 1460 attached thereto. FIGS. reveal the proximal end 1462 of the anvil stem with a square cross section. The proximal end 1462 of the anvil stem 1460 may have a circular cross section. In each arrangement, the proximal end 1462 of the anvil stem 1460 is configured to be attached to the trocar of a circular stapling instrument. In this way, the proximal end 1462 of the anvil stem 1460 can be configured as shown in FIG. 14. In other embodiments, the proximal end 1462 of the anvil stem 1460 may have a hollow portion sized to receive the tip of the trocar stem therein. Locking tabs, holders, etc. can be used to fix the anvil stem 1460 to the trocar stem. See, for example, the arrangements shown in FIG. 48. In addition or alternatively, the proximal end 1462 of the anvil stem 1460 can be adjusted on the trocar stem to properly orient the anvil head assembly 1410 with respect to the staple holder on the stapling head of the stapling instrument.
[000164] As can be seen in FIGS. 64 to 70, the anvil head assembly 1410 includes an anvil body portion 1412 to which the anvil stem 1430 is attached. In particular, the anvil stem 1460 is attached to the anvil body portion 1412 so that it projects from a bottom surface 1414 thereof. The anvil body portion 1412 has a first first side pair 1420 1422. Each first side 1422 tapers from the bottom surface 1414 to the top surface 1416 of the anvil body portion 1412 as shown. Each first side 1422 has a centrally arranged key 1424 as shown. A first anvil segment 1430 is slidably attached to each first side 1422. Each first anvil segment 1430 can be shaped as shown in FIGS. and has a lock 1432 which is sized to receive the first corresponding key 1424 therein. Each first anvil segment 1430 has a staple forming surface 1434 therein which has an inner line 1435 and an outer line 1436 of staple forming pockets 1438. See FIG. 70. As can be seen in FIGS. 68 and 70, each of the first anvil segments 1430 is configured to slide in the proximal direction "PD" relative to the anvil body portion 1412 when the anvil assembly 1400 is in the flat orientation.
[000165] As can be seen further in FIGS. 64 to 70, the anvil body portion 1412 has a second pair 1440 of second sides 1442. Each second side 1442 tapers from the bottom surface 1414 to the top surface 1416 of the anvil body portion 1412 as shown. Each second side 1442 has a second centrally arranged key 1444 as shown. A second anvil segment 1450 is slidably attached to each second side 1442. Each second anvil segment 1450 can be shaped as shown in FIGS. and has a lock 1452 which is sized to receive the second corresponding key 1444 therein. Each second anvil segment 1450 has a staple forming surface 1454 therein which has an inner line 1455 and an outer line 1456 of second staple forming pockets 1458. See FIG. 70. As can be seen in FIGS. 68 and 70, each of the second anvil segments 1450 is configured to slide in the "DD" distal direction relative to the anvil body portion 1412 when the anvil assembly 1400 is in the flattened orientation.
[000166] To install the anvil set 1400, the surgeon orientates the first anvil segments 1430 in a downward or proximal direction and the second anvil segments 1450 is oriented in an upward or distal direction in relation to the body portion 1412. Such first orientation flattened provides the anvil head 1410 with its less cross-sectional profile. That is, the anvil head assembly 1410 has an "overall width" that is measured along an axis that is substantially perpendicular to the "SA-SA" stem axis. When in the first flattened orientation, the overall width has a magnitude "D1" as shown in FIG. 71. When the anvil head assembly 1410 is in the second expanded orientation, the magnitude of the overall width (designated as D2 in FIG. 72) is greater than the magnitude of the overall width when the anvil head assembly is in the first flattened orientation . When in flattened orientation, the anvil head 1410 can pass through a particular opening size or trocar cannula. The anvil stem 1460 can be attached to the instrument's trocar stem prior to insertion into the patient or after the anvil assembly 1400 has been inserted into the patient. After that, the surgeon then moves the second anvil segments 1450 downward or in the proximal direction "PD" and the first anvil segments 1430 is moved upward or in the distal direction "DD". The movements can be misaligned so that the second anvil segments 1450 are moved downward in the first proximal direction and the first anvil segments 1430 are moved upward in the distal direction and locked in the second anvil segments 1450. Such an arrangement creates a single firing platform supported 1470 that clamps can react against. The instrument can then be triggered. After the instrument has been triggered, the second anvil segments 1450 can be moved upward in the distal direction and the first anvil segments 1430 can be moved downward in the proximal direction to return the anvil head 410 to the flattened configuration. When in the flattened configuration, the anvil set 1400 can be more easily removed from the target tissue.
[000167] The various embodiments of the present invention represent a vast improvement over the previous circular clamp arrangements and anvil assemblies thereof. Although various modalities of the invention have been described, it will be evident, however, that various modifications, alterations and adaptations to these modalities can occur to those skilled in the art, from obtaining part or all of the advantages of the present invention. For example, according to several modalities, a single component can be replaced by multiple components, and multiple components can be replaced by a single component, to perform one or more specific functions. This request is therefore intended to cover all these modifications, alterations and adaptations, without departing from the scope and spirit of the presented invention, as defined by the attached claims.
[000168] Any patent, publication or other description material, in whole or in part, which is said to be incorporated into the present invention for reference purposes, is incorporated into the present invention only to the extent that the incorporated materials do not come into effect. conflict with existing definitions, statements or other description material presented in this description. Accordingly, and to the extent necessary, the description as explicitly stated herein replaces any conflicting material incorporated herein by reference. Any material, or portion thereof, that is deemed to be incorporated by reference into the present invention, but which conflicts with definitions, statements, or other description materials existing herein will be incorporated here only to the extent that no conflict will appear between the embedded material and the existing description material.
[000169] The invention to be protected should not be interpreted as limited to the specific modalities presented. The modalities should therefore be considered illustrative rather than restrictive. Variations and changes can be made by others, without departing from the spirit of the present invention. Consequently, there is an express intention that all such equivalents, variations and alterations that fall within the spirit and scope of the present invention, as defined in the claims, are covered by it.

权利要求:
Claims (7)
[0001]
1. Anvil set (420) for a surgical stapling instrument, comprising: a tissue penetration tip member (430) including a tissue penetration tip portion (432) and an anvil stem (436) attached to him; a plurality of movable anvil plates (450) coupled together and to the tissue penetrating tip member (430) for selective movement between a flattened orientation and an expanded orientation in which the plurality of anvil plates (450) forms at least a portion of a flat anvil plate assembly (480) when in expanded orientation; and a movable anvil expansion member (470) supported on the anvil stem (436) in relation to the plurality of anvil plates (450) and which is selectively movable between a first unacted position and a second position in which the anvil expansion (470) moves the plurality of anvil plates (450) to the expanded orientation; and wherein the anvil expansion member (470) is supported for axial displacement along the anvil stem (436) with respect to the plurality of anvil plates (450), so that when the anvil expansion member (470) is moved from the first position to the second position, the anvil plates (450) move radially out of the flattened orientation to the expanded orientation; and characterized by the fact that the anvil expansion member (470) has at least two anvil plate sections (476) that form a portion of the flat anvil plate assembly (480) when the anvil plates (450) are in expanded orientation and the anvil expansion member (470) is in the second position.
[0002]
Anvil assembly (420) according to claim 1, characterized in that the plurality of anvil plates (450) comprises: a first arcuate anvil plate segment (450); and a second arcuate anvil plate segment (450) supported for movement relative to the first arcuate anvil plate segment (450).
[0003]
Anvil assembly (420) according to claim 2, characterized in that the anvil expansion member (470) has a pair of diametrically opposed anvil plate sections (476) that extend between the ends of confrontation of the first and second arcuate anvil plate segments (450) when the anvil expansion member (470) is in the second position.
[0004]
Anvil assembly (420) according to any one of claims 1 to 3, characterized in that the tissue-piercing tip portion (432) is attachable to a trocar for a circular surgical stapling instrument.
[0005]
Anvil assembly (420) according to any one of claims 1 to 4, characterized in that each of the anvil plates (450) has at least one first staple forming pocket (454) in it and at least a second staple forming pocket (458) in it.
[0006]
Anvil assembly (420) according to claim 5, characterized in that when the anvil plates (450) are retained in the expanded position, the first staple forming pockets (454) on the anvil plates ( 450) form at least a first annular configuration (452) of the first staple forming pockets (454) and the second staple forming pockets (458) form at least a second annular configuration (456) of the second staple forming pockets (458) on the anvil plate assembly (480).
[0007]
Anvil assembly (420) according to claim 6, characterized in that at least a second annular configuration (456) of the second staple forming pockets (458) are located radially outwardly from at least a first annular configuration (452) of the first staple forming pockets (454).

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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-15| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 13/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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