(19)
(11)EP 2 942 017 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
13.05.2020 Bulletin 2020/20

(21)Application number: 13866753.0

(22)Date of filing:  26.12.2013
(51)Int. Cl.: 
A61B 17/072  (2006.01)
(86)International application number:
PCT/CN2013/090561
(87)International publication number:
WO 2014/101794 (03.07.2014 Gazette  2014/27)

(54)

STAPLER-USE FIRING COMPONENT AND STAPLER

AUSLÖSEBAUTEIL ZUR VERWENDUNG MIT EINER KLAMMERVORRICHTUNG UND KLAMMERVORRICHTUNG

COMPOSANT DE DÉCLENCHEMENT D'UTILISATION D'UNE AGRAFEUSE ET AGRAFEUSE


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(30)Priority: 28.12.2012 CN 201210582075

(43)Date of publication of application:
11.11.2015 Bulletin 2015/46

(73)Proprietor: Touchstone International Medical Science Co., Ltd.
Suzhou, Jiangsu 215123 (CN)

(72)Inventors:
  • CHEN, Wangdong
    Suzhou Jiangsu 215123 (CN)
  • XU, Wei
    Suzhou Jiangsu 215123 (CN)

(74)Representative: dompatent von Kreisler Selting Werner - Partnerschaft von Patent- und Rechtsanwälten mbB 
Deichmannhaus am Dom Bahnhofsvorplatz 1
50667 Köln
50667 Köln (DE)


(56)References cited: : 
EP-A2- 1 785 098
CN-A- 101 534 725
CN-U- 203 029 297
US-A- 5 005 754
US-A1- 2008 110 958
CN-A- 101 305 928
CN-A- 103 142 269
US-A- 4 621 639
US-A- 5 395 030
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description


    [0001] This application claims the benefit of priority to Chinese Patent Application No. 201210582075.6 titled "FIRING ASSEMBLY FOR SURGICAL STAPLER AND SURGICAL STAPLERF", filed with the Chinese State Intellectual Property Office on Dec. 28, 2012.

    FIELD OF THE INVENTION



    [0002] The present application relates to a technical field of medical apparatus and instruments, especially relates to a firing assembly for a surgical stapler and a surgical stapler with the firing assembly.

    BACKGROUND OF THE INVENTION



    [0003] It has been nearly a century since the surgical stapler is used for alimentary tract anastomosis. Generally, the surgical staplers can be divided into many types, such as disposable surgical stapler, reusable surgical stapler, import surgical stapler or domestic surgical stapler. The surgical stapler is a device to replace a traditional manual suturing device in the medical field. With an improvement of manufacturing technology and a development of modern science and technology, the surgical stapler now in clinical use is high quality, easy to use, tight and snug fit, which especially has some advantages that fast suturing, easy operation and few side effects and complications, etc.. Sometimes, using the surgical staple can also resect a tumor that used to be impossible to be resected. So, the staples are highly favored by domestic and foreign clinical surgeons.

    [0004] Referring to FIG. 1, generally, the surgical stapler includes a body portion 10, a staple cartridge assembly 20, an anvil assembly 30 and a firing structure. The firing structure includes a firing handle/pushing button 41, a firing assembly 42 connected between the firing handle and the staple cartridge assembly 20. As the connection of the traditional firing assembly and the firing handle and the staple cartridge assembly is pure mechanical, in use, the firing force is lack of flexibility and with a hard feeling. Further, under a limitation of the structure of the surgical stapler, the deformation of each staple is almost equal to each other in once firing process. In fact, the thickness of the body tissue is not uniform. Especially, in a surgery that the anastomosis incision is longer, the thickness of the tissue is hard to estimate. Thus, if the deformation of the staples meets a need of hemostasis for a thick tissue, the need of hemostasis for a thin tissue will not be fully met, and will lead to a haemorrhage of the tissue. While, if the deformation of the staples meets a need of hemostasis for a thin tissue, an anastomosis of a thin tissue will be too tight, and a blood-supply and recovery of the anastomosis site will also be affected.

    [0005] Hence, it is desirable to provide a new firing assembly for a surgical stapler and a new surgical stapler which neither has the disadvantages of the traditional surgical stapler.

    [0006] EP 1 785 098 A2 discloses a surgical instrument having a hydraulically actuated end effector, wherein the end effector comprises a mechanism including a staple driving cylinder. The cylinder may include a piston. The staple may rest on the piston. A staple driver may or may not be present between the piston and the staple. A hydraulic line may provide pressurized hydraulic fluid, causing the piston to extend. In response, the piston may drive staple into contact with staple pocket. In various embodiments, the cylinder may drive one or a plurality of staples. It will be appreciated that the assembly may be incorporated into the end effector by placing one or more cylinders along the elongate channel of the surgical instrument.

    [0007] US 5,005,754 discloses a disposable mandrel and bladder where the mandrel is fabricated in order to be permanently incorporated within the driver bladder of a surgical stapling mechanism.

    [0008] US 5,395,030 discloses a surgical device for stapling and fastening body tissues.

    BRIEF SUMMARY OF THE INVENTION



    [0009] The subject matter of the invention is defined by independent claim 1.

    [0010] To solve the problems above, an object of the present application is to provide a firing assembly for a surgical stapler and a surgical stapler with the firing assembly, to solve the problems that the firing force applied to the staples is hard and the anastomosis of the staples is not uniform in the prior arts.

    [0011] To implement the above object, the firing assembly for a surgical stapler in accordance with the present invention is defined as given by the features of the independent claim. Preferred embodiments are defined in the dependent claims.

    [0012] Comparing with the prior arts, the firing assembly for a surgical stapler in accordance with the present invention has the advantages that the firing action is gentle, the anastomosis of the staples is uniform and the postoperative effect is good.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0013] 

    FIG. 1 is a partial perspective view of a surgical stapler for a prior art.

    FIG. 2 a schematic structural view of a firing assembly for a surgical stapler in accordance with an illustrated embodiment of the present application, when it is at its initial status;

    FIG. 3 is a partial perspective view of the firing assembly for the surgical stapler, the scaling factor for which is different from what for the FIG. 1;

    FIG. 4 a schematic structural view of the firing assembly for the surgical stapler when it is at its initial status, wherein the arrows show a force applied thereof;

    FIG. 5 is an enlarged view of structures in the circle A as shown in FIG. 4, to show the different formed heights of the staples.


    DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS



    [0014] Reference will now be made to the drawing figures to describe the embodiments of the present invention in detail.

    [0015] In the detailed description of the present embodiment, referring to the drawing figures and the brief description thereof will make an understanding of the embodiment easier. However, the embodiment will not limit the protection scope of the present invention. In the present invention, the main improvement is for the firing assembly and then the other parts of the surgical stapler will not be described in detail.

    [0016] Referring to FIGS. 2 to 5, the present application provides a firing assembly 100 for a surgical stapler. The firing assembly 100 has a shell 101 with a pair of guiding recesses 1012, 1014 defined in a pair of sidewalls 1011 thereof. The shell 101 has a pressure chamber 102 arranged therein to accommodate fluid. The fluid is liquid or gas. An assistor 103 is provided below the pressure chamber 102 and has a sealed connection with the pressure chamber 102. A pair of sidewalls of the assistor 103 are received in the guiding recesses 1012 and 1014 and moves therein. An ejector rod 104 is provided below the assistor 103 to push the assistor 103 moving upwardly and thereby compressing the fluid in the pressure chamber 102. Of course, easy to understand, if the assistor 103 and the ejector rod 104 are formed integrally, the purpose of the present invention can be also completed.

    [0017] The firing assembly 100 further has a plurality of piston holes 105 communicating with the pressure chamber 102 and a plurality of pistons 106 sealed in the piston holes 105. A gasket 107 is provided between the piston holes 105 and the pressure chamber 102, which is arranged at a bottom position of the piston holes 105. Corresponding to the position of the piston holes 105, the gasket 107 defines a plurality of through holes 1071 therethrough to ensure a communication of the pressure chamber 102 and the piston holes 105. Of course, the arrangement of the gasket 107 and the through holes 1071 can be modified to another means, such as a number of restriction members are provided in the piston holes 105. Of course, it is understood that, the restriction members are open in some way, and consequently a pressure of the fluid in the pressure chamber 102 is transmitted to a bottom surface of the pistons 106 and a force is applied on the pistons 106.

    [0018] A plurality of firing portions 108 are correspondingly provided above each pistons 106, each of which is movable in an axial direction of the pistons 106 independently. Of course, some of the firing portions 108 in independent or group settings are set with the same effect. To arrange the firing portions 108 in independent or group settings depends on the specific situation.

    [0019] When the firing assembly 100 in accordance with the present invention is at its initial status, the pressure of the fluid in the pressure chamber 102 is equal to that of the outside, and consequently the pistons 106 is in a stationary status. In the firing process, the ejector rod 104 is pushed to press the fluid in the pressure chamber 102 via the assistor 103, and consequently the pressure in the pressure chamber 102 increases and generates an upward pushing force (as shown by the arrows in FIG. [4]). As the pressure chamber 102 communicates with the piston holes 105 via the through holes 1071, the increased pressure in the piston holes 105 will push the pistons 106 moving upwardly, and consequently drives the firing portions 108 moves upwardly too. Now, the staples 3 arranged on the firing portions 108 will be ejected out and staple the anastomosed tissue 2. When the firing portions 108 move upwardly, the feet of the staples 3 is bent down to form a shape of "B" as they abut against the anvil 4.

    [0020] At a first stage of the deformation of the firing portions 108, the formed heights of the staples 3 are equal to each other. While, with the further bending of the feet of the staples 3, the anastomosed tissue 2 stapled by the staples 3 will also generate a downward reacting force after which is pressed by an acting force (as shown by the arrows in FIG. [4]). Now, for a part of the firing portions 108 located at an area where the anastomosed tissue 2 is thick, the reacting force applied thereto from the anastomosed tissue 2 is larger, which will first get a balance with the acting force applied to this part of the firing portions 108 from the pistons 106 since the pistons 16 are forced by the fluid. With the force balance, the deformation of staples 3 arranged at an area where the anastomosed tissue 2 is thick will be stopped. For another part of the firing portions 108 located at an area where the anastomosed tissue 2 is thin, another reacting force applied thereto from the anastomosed tissue 2 is smaller, which is still not smaller than the acting force applied to this part of the firing portions 108 from the pistons 106 since the pistons 16 are forced by the fluid. So, the staples 3 located at the area where the anastomosed tissue 2 is thin will be deformed further and the anastomosed tissue 2 will be stapled tightly, until the reacting force applying to the firing portions 108 form the anastomosed tissue 2 reaches a balance with the force applied to the firing portions 108 from the fluid.

    [0021] According to the basic properties that the fluid can transfer pressure, as long as the pistons 106 are with the same area, the acting force applied to the firing portions 108 from the pistons 106 will be equal to each other, and consequently a stapling effect for all the anastomosed tissues 2 will be same, even that the formed heights of the staples 3 are different from each other (referring to FIG. [5]).

    [0022] The firing assembly in accordance with the present invention can be used for various types of surgical stapler, including linear cutter, circular stapler, curved cutter stapler. Any type surgical staplers with the firing assembly in accordance with the present invention can implement the objects of the present invention. In the present invention, the fluid pressure is applied to adjust the formed heights of the staples, resulting that the firing action is gentle and accords with human body engineering principle. In addition, the formed heights of the staples vary due to a thickness of anastomosed tissues, which results that the ultimately stapling effect for the anastomosed tissues is uniform.

    [0023] In addition, it should be understood, although the specification is described in accordance with the implementation of the embodiment, but not every embodiment contains only an independent technical proposal. This kind of description for the specification is just for the sake of clarity. The person skilled in the art should consider the specification as a whole. The technical proposals of the every embodiment can also be combined in a proper way to form another embodiment that the person skilled in the art can understand.


    Claims

    1. A firing assembly (100) for a surgical stapler, comprising:

    a shell (101);

    a pressure chamber (102), which is arranged in the shell and accommodates fluid;

    an ejector rod (104), which is located below the shell to provide an actuated force and press the fluid in the pressure chamber;

    a plurality of piston holes (105), which communicate with the pressure chamber;

    a plurality of pistons (106), which are received in the piston holes; and

    a plurality of firing portions (108), which are adapted to be actuated by the pistons,

    a restriction member is provided between the piston holes (105) and the pressure chamber (102) to limit a movement of the pistons in the piston holes,

    wherein the restriction member is a gasket (107) arranged at a bottom position of the piston holes,

    and wherein the gasket defines a plurality of through holes (1071) corresponding to the piston holes.


     
    2. The firing assembly as claimed in claim 1, characterized in that, each of the firing portions is arranged over each of the pistons and wherein each of the firing portions is independent from each other.
     
    3. The firing assembly as claimed in claim 1, characterized in that, the fluid in the pressure chamber is liquid.
     
    4. The firing assembly as claimed in claim 1, characterized in that, the fluid in the pressure chamber is gas.
     
    5. The firing assembly as claimed in claim 1, characterized by an assistor (103) wherein a pair of guiding recesses (1012, 1014) are defined in sidewalls (1011) of the shell to receive said assistor (103) therein, and wherein the assistor is adapted to press the fluid in the pressure chamber via the movement of ejector rod.
     
    6. The firing assembly as claimed in claim 1, characterized by an assistor (103) wherein the shell defines a pair of guiding recesses (1012, 1014) in sidewalls (1011) thereof to receive said assistor (103) at a front end of the ejector rod therein, and wherein the assistor is adapted to press the fluid in the pressure chamber.
     
    7. The firing assembly as claimed in claim 5 or 6, characterized in that the assistor and the ejector rod are formed integrally.
     
    8. A surgical stapler, which comprises a body portion and a firing assembly according to one of claims 1 - 7.
     


    Ansprüche

    1. Auslöseanordnung (100) für eine chirurgische Klammervorrichtung, mit:

    einem Mantel (101);

    einer Druckkammer (102), die in dem Mantel angeordnet ist und Fluid enthält;

    einer Ejektorstange (104), die unter dem Mantel angeordnet ist, um eine Betätigungskraft bereitzustellen und das Fluid in der Druckkammer mit Druck zu beaufschlagen;

    mehreren Kolbenlöchern (105), die mit der Druckkammer in Verbindung stehen;

    mehreren Kolben (106), die in den Kolbenlöchern aufgenommen sind; und

    mehreren Auslöseteile (108), die zur Betätigung durch die Kolben geeignet sind,

    wobei ein Rückhalteelement zwischen den Kolbenlöchern (105) und der Druckkammer (102) vorgesehen ist, um eine Bewegung der Kolben in den Kolbenlöchern zu begrenzen,

    wobei das Rückhalteelement eine Dichtung (107) ist, die an einer unteren Position der Kolbenlöcher angeordnet ist,

    und wobei die Dichtung mehrere Durchgangslöcher (1071) definiert, die den Kolbenlöchern entsprechen.


     
    2. Auslöseanordnung nach Anspruch 1, dadurch gekennzeichnet, dass jedes der Auslöseteile über jedem der Kolben angeordnet ist, und wobei die Auslöseteile jeweils voneinander unabhängig sind.
     
    3. Auslöseanordnung nach Anspruch 1, dadurch gekennzeichnet, dass das Fluid in der Druckkammer eine Flüssigkeit ist.
     
    4. Auslöseanordnung nach Anspruch 1, dadurch gekennzeichnet, dass das Fluid in der Druckkammer Gas ist.
     
    5. Auslöseanordnung nach Anspruch 1, gekennzeichnet durch eine Hilfseinrichtung (103), wobei zwei Führungsausnehmungen (1012, 1014) in Seitenwänden (1011) des Mantels definiert sind, um die Hilfseinrichtung (103) darin aufzunehmen, und wobei die Hilfseinrichtung geeignet ist, das Fluid in der Druckkammer über die Bewegung der Ejektorstange mit Druck zu beaufschlagen.
     
    6. Auslöseeinrichtung nach Anspruch 1, gekennzeichnet durch eine Hilfseinrichtung (103), wobei der Mantel zwei Führungsausnehmungen (1012, 1014) in Seitenwänden (1011) desselben definiert, um die Hilfseinrichtung (103) an einem vorderen Ende der Ejektorstange darin aufzunehmen, und wobei die Hilfseinrichtung geeignet ist, das Fluid in der Druckkammer mit Druck zu beaufschlagen.
     
    7. Auslösemechanismus nach Anspruch 5 oder 6, dadurch gekennzeichnet, dass die Hilfseinrichtung und die Ejektorstange einstückig ausgebildet sind.
     
    8. Chirurgische Klammervorrichtung mit einem Körperteil und einer Auslöseanordnung nach einem der Ansprüche 1 - 7.
     


    Revendications

    1. Ensemble de déclenchement (100) pour une agrafeuse chirurgicale, comprenant:

    une coquille (101);

    une chambre à pression (102) qui est disposée dans la coquille et accueille le fluide;

    une tige d'éjection (104) qui est située sous la coquille pour fournir une force actionnée et pousser le fluide dans la chambre à pression;

    une pluralité de trous à piston (105) qui communiquent avec la chambre à pression;

    une pluralité de pistons (106) qui sont reçus dans les trous à piston; et

    une pluralité de parties de déclenchement (108) qui sont adaptées pour être actionnées par les pistons,

    un élément d'étranglement est prévu entre les trous à piston (105) et la chambre à pression (102) pour limiter un mouvement des pistons dans les trous à piston,

    dans lequel

    l'élément d'étranglement est un joint (107) disposé à une position inférieure des trous à piston,

    et dans lequel

    le joint définit une pluralité de trous traversants (1071) correspondant aux trous à piston.


     
    2. Ensemble de déclenchement selon la revendication 1, caractérisé par le fait que chacune des parties de déclenchement est disposée sur chacun des pistons et dans lequel chacune des parties de déclenchement est indépendante l'une de l'autre.
     
    3. Ensemble de déclenchement selon la revendication 1, caractérisé par le fait que le fluide dans la chambre à pression est du liquide.
     
    4. Ensemble de déclenchement selon la revendication 1, caractérisé par le fait que le fluide dans la chambre de pression est du gaz.
     
    5. Ensemble de déclenchement selon la revendication 1, caractérisé par un moyen d'assistance (103), dans lequel une paire d'évidements de guidage (1012, 1014) sont définis dans les parois latérales (1011) de la coquille pour y recevoir ledit moyen d'assistance (103), et dans lequel le moyen d'assistance est adapté pour pousser le fluide dans la chambre à pression par le mouvement de la tige d'éjection.
     
    6. Ensemble de déclenchement selon la revendication 1, caractérisé par un moyen d'assistance (103), dans lequel la coquille définit une paire d'évidements de guidage (1012, 1014) dans les parois latérales (1011) de cette dernière pour recevoir ledit moyen d'assistance (103) à une extrémité avant de la tige d'éjection de cette dernière, et dans lequel le moyen d'assistance est adapté pour pousser le fluide dans la chambre à pression.
     
    7. Ensemble de déclenchement selon la revendication 5 ou 6, caractérisé par le fait que le moyen d'assistance et la tige d'éjection sont formés de manière solidaire.
     
    8. Agrafeuse chirurgicale, qui comprend une partie de corps et un ensemble de déclenchement selon l'une des revendications 1 à 7.
     




    Drawing


















    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description