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WO2016192037A1 - Instrument d'agrafage chirurgical doté de vis à verrouillage automatique - Google Patents

Instrument d'agrafage chirurgical doté de vis à verrouillage automatique Download PDF

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Publication number
WO2016192037A1
WO2016192037A1 PCT/CN2015/080568 CN2015080568W WO2016192037A1 WO 2016192037 A1 WO2016192037 A1 WO 2016192037A1 CN 2015080568 W CN2015080568 W CN 2015080568W WO 2016192037 A1 WO2016192037 A1 WO 2016192037A1
Authority
WO
WIPO (PCT)
Prior art keywords
pitch
drive screw
anvil
stapling instrument
surgical stapling
Prior art date
Application number
PCT/CN2015/080568
Other languages
English (en)
Inventor
Qianhong Yang
Hui Zhan
Original Assignee
Covidien Lp
Covidien (China) Medical Devices Technology Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Covidien Lp, Covidien (China) Medical Devices Technology Co., Ltd. filed Critical Covidien Lp
Priority to PCT/CN2015/080568 priority Critical patent/WO2016192037A1/fr
Publication of WO2016192037A1 publication Critical patent/WO2016192037A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis, e.g. in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like

Definitions

  • the present disclosure relates generally to a surgical stapling instrument for applying surgical fasteners to body tissue. More particularly, the present disclosure relates to a circular surgical stapling instrument for treating hollow tissue organs having a drive screw including a self-locking helical channel design.
  • Circular stapling instruments are known in the medical arts for facilitating performance of a variety of surgical procedures including circular anastomis procedures and hemorrhoid treatment procedures.
  • a circular anastomis procedure two hollow organ end sections are joined together by driving a circular array of staples through the organ end sections to join the organ end sections together while simultaneously coring any tissue interior of the driven circular array of staples to open a tubular passage within the joined organ end sections. Examples of instruments for performing circular anastomosis of hollow organs are described in U.S. Patent Nos.
  • hemorrhoid tissue or mucosal tissue adjacent the hemorrhoid tissue is dissected and sutured to remove the hemorrhoid and/or treat hemorrhoid prolapses.
  • Known circular stapling instruments include an elongated shaft having an anvil holding component disposed at a distal end of the elongated shaft.
  • An anvil assembly including an anvil rod and anvil head is releasably mounted to the distal end of the anvil holding component.
  • the anvil holding component is operably connected to a drive screw and is retractable within the elongated shaft of the stapling instrument to move the anvil assembly in relation to a cartridge assembly supported on a distal end of the elongated shaft between advanced and retracted positions.
  • the drive screw defines a helical channel and is supported for longitudinal movement within a handle assembly of the stapling instrument.
  • the helical channel is configured to receive a pin which is axially fixed to the handle assembly but rotatable about the drive screw such that rotation of the pin in relation to the drive screw effects longitudinal movement of the drive screw and corresponding longitudinal movement of the anvil assembly in relation to the cartridge assembly.
  • the force applied to the anvil holding component by the anvil assembly during attachment of the anvil assembly to the anvil holding component is translated through the instrument to the drive screw and onto the pin. This action can cause rotation of the drive screw and inadvertent proximal movement of the anvil holding component. Such inadvertent proximal movement of the anvil holding component may prevent the anvil assembly from being properly attached to the anvil holding component.
  • a surgical stapling instrument including a handle assembly having a housing supporting an approximation knob and a central body portion extending distally from the handle assembly.
  • a distal head portion is supported on a distal end of the central body portion and includes an anvil assembly and a cartridge assembly.
  • the anvil assembly includes an anvil shaft and an anvil head supported on a distal end of the anvil shaft.
  • the anvil assembly is movable in relation to the cartridge assembly between a spaced position and an approximated position.
  • a drive screw has a proximal end and a distal end and defines a helical channel. The drive screw is operatively connected to the anvil assembly and movable within the handle housing between an advanced position and a retracted position.
  • the approximation knob is operatively connected to the proximal end of the drive screw such that actuation of the approximation knob effects movement of the drive screw between retracted and advanced positions to move the anvil assembly between the spaced position and the approximated position.
  • the helical channel includes a first proximal portion having a first pitch and a second portion positioned immediately distal of the first proximal portion having a second pitch, wherein the first pitch is less than the second pitch.
  • the first pitch is less than. 160 cm [Is this centimeters or inches? ]
  • the surgical stapling instrument includes a firing mechanism having a firing trigger that is actuable to eject staples from the cartridge assembly.
  • the firing mechanism includes a pusher link.
  • the surgical stapling instrument includes a rotatable sleeve having a proximal end coupled to the approximation knob and a distal end positioned about the proximal end of the drive screw.
  • the distal end of the sleeve supports a pin that is received in the helical channel. The pin engages the drive screw in the proximal portion of the helical channel when the drive screw is in the advanced position.
  • a collar fixedly supported on the distal end of the sleeve and rotatably supported within the housing of the handle assembly supports the pin.
  • the collar is axially fixed within the housing.
  • a surgical stapling instrument including a handle assembly having a housing supporting an approximation knob.
  • a central body portion extends distally from the handle assembly and supports a distal head portion including an anvil assembly and a cartridge assembly.
  • the anvil assembly includes an anvil shaft and an anvil head supported on a distal end of the anvil shaft.
  • the anvil assembly is movable in relation to the cartridge assembly between a spaced position and an approximated position.
  • a drive screw has a proximal end and a distal end and defines a helical channel. The distal end of the drive screw is operatively connected to the anvil assembly and the drive screw is movable within the handle housing between an advanced position and a retracted position.
  • the approximation knob is operatively connected to the drive screw such that actuation of the approximation knob effects movement of the drive screw between the retracted and advanced positions to move the anvil assembly between the spaced position and the approximated position.
  • the helical channel includes a proximal-most portion having a first pitch, a distal-most portion having a second pitch and a central portion having a third pitch, the third pitch being greater than the first pitch and the second pitch.
  • the first pitch is less than. 160 cm. In certain embodiments, the second pitch is between. 160 cm and. 90 cm. In some embodiments, the third pitch is between. 520 cm and. 900 cm.
  • the central portion defines the third pitch and a fourth pitch, wherein the third and fourth pitches are greater than the first and second pitches.
  • the third pitch is positioned proximally of the fourth pitch and is greater than the fourth pitch.
  • the surgical stapling instrument includes a firing mechanism having a firing trigger that is actuable to eject staples from the cartridge assembly.
  • the firing mechanism includes a pusher link.
  • the surgical stapling instrument further includes a rotatable sleeve having a proximal end coupled to the approximation knob and a distal end positioned about the proximal end of the drive screw.
  • the distal end of the sleeve supports a pin that is received in the helical channel such that the pin engages the drive screw in the proximal-most portion of the helical channel when the drive screw is in the advanced position.
  • the surgical stapling instrument further includes a collar fixedly supported on the distal end of the sleeve.
  • the collar is rotatably supported within the housing of the handle assembly and supports the pin.
  • the collar is axially fixed within the housing.
  • Fig. 1 is a side, perspective view of one embodiment of the surgical stapling instrument of the present disclosure with the anvil assembly separated from the anvil assembly holding component;
  • Fig. 2 is an enlarged view of the indicated area of detail shown in Fig. 1;
  • Fig. 3 is a side, perspective view of the surgical stapling instrument of the present disclosure with the anvil assembly supported on the anvil assembly holding component;
  • Fig. 4 is an enlarged view of the indicated area of detail shown in Fig. 3;
  • Fig. 5 is a side, perspective view of the surgical stapling instrument shown in Fig. 3 with a handle housing half-section removed;
  • Fig. 6 is an enlarged view of the indicated area of detail shown in Fig. 5;
  • Fig. 7 is a cross-sectional view taken along line 7-7 of Fig. 5;
  • Fig. 7A is an enlarged view of the indicated area of detail shown in Fig. 7;
  • Fig. 8 is an enlarged view of the indicated area of detail shown in Fig. 7;
  • Fig. 9 is a perspective view from one side of the drive screw of the surgical stapling instrument shown in Fig. 7;
  • Fig. 10 is a side view of the drive screw of the surgical stapling instrument shown in Fig. 7.
  • the term “clinician” refers to a doctor, a nurse, or any other care provider and may include support personnel.
  • proximal refers to the portion of the device or component thereof that is closest to the clinician and the term “distal” refers to the portion of the device or component thereof that is farthest from the clinician.
  • the presently disclosed surgical stapling instrument includes an anvil assembly and an anvil holding component.
  • the anvil holding component releasably supports the anvil assembly and is connected to a drive screw of an approximation assembly of the surgical stapling instrument.
  • the drive screw defines a helical channel that is configured to receive a pin that is supported on an approximation knob and is rotatable about the drive screw to effect longitudinal movement of the drive screw and the anvil holding component.
  • the helical channel of the drive screw is configured to minimize inadvertent proximal movement of the anvil holding component caused by application of a force to the anvil holding component, such as during attachment of the anvil assembly to the anvil holding component.
  • surgical stapling instrument 10 includes a handle assembly 12, a central body portion 14 and a distal head portion 16.
  • the distal head portion 16 includes an anvil assembly 18 and a cartridge assembly 20.
  • the cartridge assembly 20 is supported on a distal end of the central body portion 14 and includes a cartridge body 20a that has a circular configuration and supports an annular array of staples (not shown) .
  • the anvil assembly 18 includes an anvil head 18a and an anvil shaft 18b.
  • the anvil head 18a is supported on the distal end of the anvil shaft 18b and defines an annular array of staple pockets (not shown) that are positioned to receive the staples.
  • the handle assembly 12 includes a housing 12a, a firing mechanism including a firing trigger 24, an approximation knob 26, an indicator assembly 28, and a lockout mechanism 30.
  • the approximation knob 26 forms part of an approximation mechanism that functions to retract and advance the anvil assembly 18 in relation to the cartridge assembly 20 as will be discussed in further detail below.
  • the firing mechanism functions to advance a pusher link 31 (Fig. 7) to eject staples from cartridge 20a of the cartridge assembly 20. Operation of the various components of the handle assembly 12 including the firing mechanism, the indicator assembly 28 and the lockout mechanism 30 are described in U.S. Patent No. 7, 303, 106, the contents of which are incorporated herein by reference in their entirety. Accordingly, these components and assemblies will not be described in further detail herein.
  • the approximation mechanism of the surgical stapling instrument 10 includes the approximation knob 26, a rotatable sleeve 34, a drive screw 36, and an anvil holding component or anvil retainer 38.
  • the rotatable sleeve 34 includes a substantially cylindrical hollow body portion 40 and a substantially cylindrical collar 42 which together define a central bore 42a (FIG. 6) .
  • the collar 42 defines an annular groove 44 (FIG. 6) that is dimensioned to receive an inwardly extending flange 46 formed on an inner wall of handle housing 12a of the handle assembly 12.
  • the receipt of the flange 46 within the groove 44 axially fixes sleeve 34 within handle housing 12a while permitting rotation of the sleeve 34 in relation to the housing 12a.
  • the proximal end of the body portion 40 of the rotatable sleeve 34 extends through an opening 47 (FIG. 7) in the proximal end of the housing 12a and is secured to the approximation knob 26 to rotatably fix the sleeve 34 to the approximation knob 26, such that rotation of the approximation knob 26 causes concurrent rotation of sleeve 34.
  • the drive screw 36 defines a helical channel 50 and is dimensioned to be slidably received within the central bore 42a (Fig. 8) of rotatable sleeve 34.
  • a pin 52 extends radially through the collar 42 on the distal end of the sleeve 34 into helical channel 50 of the drive screw 36. Since the sleeve 34 is axially fixed with respect to the housing 12a of the handle assembly 12, rotation of the sleeve 34 about the screw 36 causes the pin 52 to move along the channel 50 of the drive screw 36 to effect axial movement of the drive screw 36 within the housing 12a of the handle assembly 12.
  • the distal end 36a of the drive screw 36 defines a cylindrical recess 54 that is configured to receive a proximal end 38a of the anvil retainer 38.
  • Both the distal end 36a of the drive screw 36 and the proximal end 38a of the anvil retainer 38 define bores 56 (Fig. 9) that receive a pin 58 to fixedly secure the anvil retainer 38 to the drive screw 36.
  • the drive screw 36 and the anvil retainer 38 can be secured together using other known fastening techniques, e.g., welding, crimping, screw threads, etc.
  • longitudinal movement of the drive screw 36 is translated into longitudinal movement of the anvil retainer 38.
  • the distal end 38b (Fig. 7A) of the anvil retainer 38 includes a plurality of flexible, resilient fingers 60 (See, also, Fig. 4) that define a substantially cylindrical bore 62 that is dimensioned to receive the proximal end of the anvil shaft 18b of the anvil assembly 18.
  • each of the flexible fingers 60 defines a recess 64 having a proximally facing shoulder 66.
  • the recesses 64 are dimensioned to receive an annular abutment 68 formed on the anvil shaft 18b to releasably secure the anvil assembly 18 to the anvil retainer 38.
  • the annular abutment 68 has a diameter that is larger than the distal end of the bore 62 defined by the flexible fingers 60.
  • the anvil shaft 18b is inserted into the cylindrical bore 62 of the anvil retainer 38.
  • the annular abutment 68 of the anvil shaft 18b engages the distal end of the flexible fingers 60, the flexible fingers 60 are deformed or flex outwardly to allow the annular abutment 68 to pass into the cylindrical bore 62 and into the recesses 64 of the fingers 60.
  • the shoulder 66 defining each recess 64 engages the annular abutment 68 to secure the anvil assembly 18 to the anvil retainer 38.
  • the flexible fingers 60 are positioned distally of a cylindrical bearing 70 that is fixedly secured within the cartridge assembly 20 and defines a pathway for the anvil retainer 38 and the anvil shaft 18b as the anvil head 18a is moved from a position spaced from the cartridge assembly 20 to a position in approximation with the cartridge assembly 20.
  • the bearing 70 is dimensioned to limit outward deflection of the flexible fingers 60 as the anvil retainer 38 is withdrawn into the bearing 70 after the anvil assembly 18 has been secured to the anvil retainer 38 to lock the anvil assembly 18 to the anvil retainer 38.
  • the bearing 70 more securely couples the anvil assembly 18 to the anvil retainer 38 to prevent separation of the anvil assembly 18 from the anvil retainer 38 when a force is applied to the anvil assembly 18 in a direction to disengage the anvil assembly 18 from the anvil retainer 38, such as during firing of the stapling instrument 10.
  • a proximally directed force is applied to the anvil retainer 38 by the anvil assembly 18. This force is translated proximally along the anvil retainer 38 to the drive screw 36 and to the pin 52. As discussed above, the pin 52 is received in the helical channel 50 of the drive screw 36.
  • the pitch i.e., the distance between two corresponding points on a helix, at the proximal end of the helical channel 50, where the pin 52 engages the drive screw 36 when the drive screw is in an advanced position
  • the force of the drive screw 36 on the pin 52 has a lateral component that may cause the drive screw 36 to inadvertently rotate as the anvil assembly 18 is attached to the anvil retainer 38 or when another force is applied to the anvil retainer 38. If the drive screw 36 rotates during attachment of the anvil assembly 18 to the anvil retainer 38, the anvil retainer 38 may retract into the bearing 70.
  • the flexible fingers 60 of the anvil retainer 38 may be prevented from flexing outwardly by engagement with the bearing 70 to prevent full insertion of the anvil shaft 18b into the bore 62 of the anvil retainer 38. If full insertion of the anvil shaft 18b into the anvil retainer 38 is prevented, the annular abutment 68 will not be received within the recesses 64 of the flexible fingers 60 and the anvil assembly 18 will not be securely attached to the anvil retainer 38.
  • the pitch at the proximal end of the channel 50 of the drive screw 36 is reduced as compared to the pitch of the channel 50 immediately distally thereof.
  • the pitch of the channel 50 is higher at the proximal end of the channel 50 and decreases distally along the drive screw 36.
  • the greater pitch at the proximal end of the channel 50 allows the anvil assembly 18 to be approximated more quickly per turn of the approximation knob 26 when the anvil assembly 18 is spaced a large distance from the cartridge assembly 20.
  • the pitch decreases towards the distal end of the channel 50 to allow for fine approximation of the anvil assembly 18 and cartridge assembly 20 as tissue positioned between the anvil assembly 18 and the cartridge assembly 20 is being compressed.
  • the pitch “A” of the proximal end of the channel decreases towards pitch portion “B” .
  • the pitch of portion “B” at the proximal end of the helical channel 50 of the drive screw 36 is selected to minimize the lateral component of any force generated by contact between the pin 52 and the drive screw 36 such as during attachment of the anvil assembly 18 to the anvil retainer 38.
  • the pitch of portion “B” of the helical channel 50 of the drive screw 36 is less than about. 160 cm in the area where the pin 52 engages the drive screw 36 when the drive screw 36 is in its advanced position. In other embodiments, the pitch of portion “B” can be less than about. 250 cm.
  • the pitch of the helical channel 50 of the drive screw 36 varies along the length of the drive screw 36.
  • the pitch of portion “B” of the helical channel 50 immediately distal of the proximal portion “A” of the helical channel 50 may increase in the distal direction from about. 160 cm to about. 900 cm. This pitch allows the anvil assembly 18 to be retracted towards the cartridge assembly 20 at an advanced rate as the approximation knob 26 is rotated by a clinician.
  • the pitch of portion “C” of the helical channel 50 may decrease from the pitch in portion “B” from about. 900 cm to about. 520 cm.
  • the pitch of portion “D” of the helical channel 50 may remain constant at about. 520 cm.
  • the pitch of portion “E” of the helical channel 50 may be decrease even further at the distal end of the helical channel 50 from about. 520 cm to about. 160 cm to provide even finer approximation of the anvil assembly 18 and the cartridge assembly 20 as the anvil assembly 18 moves towards its fully approximated position.
  • the pitch of portion “F” of the helical channel 50 may be reduced even further at the distal-most end of the helical channel 50 from about. 160 cm to about. 090 cm to provide even finer control of approximation.
  • the pitch of the channel 50 need not continuously change along the length of the helical channel 50. More specifically, in some embodiments, the channel 50 of the drive screw 36 may have a pitch in portion “B” of less than about. 160 cm that increases to about. 520 cm, and the remaining portion of the channel 50 may have a pitch that remains constant for the remainder of the length of the channel 50. In other embodiments, the channel 50 of the drive screw 36 may have a pitch in portion “B” of less than about. 250 cm that increases to about. 520 cm and the remaining portion of the channel 50 may have a pitch that remains constant for the remainder of the length of the channel 50. Alternately, the remainder of the channel 50 may have a pitch that increases from, e.g., .
  • the pitch of the portion of channel 50 distally of portion “A” may be selected as desired to achieve any desired result, e.g., accelerated approximation or fine approximation.

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

Abstract

La présente invention concerne un instrument d'agrafage chirurgical comprenant un ensemble de rapprochement comprenant un bouton de rapprochement, un élément de retenue d'enclume, et une vis d'entraînement ayant une extrémité proximale et une extrémité distale et définissant un canal hélicoïdal. L'extrémité distale de la vis d'entraînement est reliée de façon fonctionnelle à l'élément de retenue d'enclume qui soutient un ensemble enclume. Le bouton de rapprochement est relié de façon fonctionnelle à la vis d'entraînement de telle sorte que l'actionnement du bouton de rapprochement entraîne un mouvement de la vis d'entraînement entre des positions rétractée et avancée pour déplacer l'ensemble enclume entre une position espacée et une position rapprochée par rapport à un ensemble cartouche. Le canal hélicoïdal comprend une partie proximale ayant un premier pas, une partie distale ayant un deuxième pas, et une partie centrale ayant un troisième pas. Le troisième pas est plus grand que le premier pas et le deuxième pas. Le premier pas est choisi de façon à réduire au minimum la probabilité de mouvement proximal involontaire de l'élément de retenue d'enclume.
PCT/CN2015/080568 2015-06-02 2015-06-02 Instrument d'agrafage chirurgical doté de vis à verrouillage automatique WO2016192037A1 (fr)

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PCT/CN2015/080568 WO2016192037A1 (fr) 2015-06-02 2015-06-02 Instrument d'agrafage chirurgical doté de vis à verrouillage automatique

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PCT/CN2015/080568 WO2016192037A1 (fr) 2015-06-02 2015-06-02 Instrument d'agrafage chirurgical doté de vis à verrouillage automatique

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112869811A (zh) * 2021-02-01 2021-06-01 苏州法兰克曼医疗器械有限公司 一种具有缝钉出仓自锁结构的吻合器

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5443198A (en) * 1991-10-18 1995-08-22 United States Surgical Corporation Surgical fastener applying apparatus
EP1576927A2 (fr) * 2004-03-19 2005-09-21 Tyco Healthcare Group Lp Agrafeuse chirurgicale
EP2163211A2 (fr) * 2008-09-10 2010-03-17 Tyco Healthcare Group LP Agrafeuse chirurgicale
US20130175318A1 (en) * 2012-01-05 2013-07-11 Kevin D. Felder Tissue stapler anvil feature to prevent premature jaw opening
US20140166728A1 (en) * 2012-12-17 2014-06-19 Ethicon Endo-Surgery, Inc. Motor driven rotary input circular stapler with modular end effector

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5443198A (en) * 1991-10-18 1995-08-22 United States Surgical Corporation Surgical fastener applying apparatus
EP1576927A2 (fr) * 2004-03-19 2005-09-21 Tyco Healthcare Group Lp Agrafeuse chirurgicale
EP2163211A2 (fr) * 2008-09-10 2010-03-17 Tyco Healthcare Group LP Agrafeuse chirurgicale
US20130175318A1 (en) * 2012-01-05 2013-07-11 Kevin D. Felder Tissue stapler anvil feature to prevent premature jaw opening
US20140166728A1 (en) * 2012-12-17 2014-06-19 Ethicon Endo-Surgery, Inc. Motor driven rotary input circular stapler with modular end effector

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112869811A (zh) * 2021-02-01 2021-06-01 苏州法兰克曼医疗器械有限公司 一种具有缝钉出仓自锁结构的吻合器
CN112869811B (zh) * 2021-02-01 2022-02-11 苏州法兰克曼医疗器械有限公司 一种具有缝钉出仓自锁结构的吻合器

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