WO2017063382A1 - 一种执行器可弯转的外科器械 - Google Patents

一种执行器可弯转的外科器械 Download PDF

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Publication number
WO2017063382A1
WO2017063382A1 PCT/CN2016/087641 CN2016087641W WO2017063382A1 WO 2017063382 A1 WO2017063382 A1 WO 2017063382A1 CN 2016087641 W CN2016087641 W CN 2016087641W WO 2017063382 A1 WO2017063382 A1 WO 2017063382A1
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WO
WIPO (PCT)
Prior art keywords
actuator
rack
distal end
flexible member
extension tube
Prior art date
Application number
PCT/CN2016/087641
Other languages
English (en)
French (fr)
Inventor
聂红林
杨光
张析量
江洋
石秀凤
李安华
Original Assignee
逸思（苏州）医疗科技有限公司
上海逸思医疗科技有限公司
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 逸思（苏州）医疗科技有限公司, 上海逸思医疗科技有限公司 filed Critical 逸思（苏州）医疗科技有限公司
Priority to RU2018117902A priority Critical patent/RU2719947C2/ru
Priority to BR112018007509-4A priority patent/BR112018007509B1/pt
Priority to EP16854766.9A priority patent/EP3363372A4/en
Priority to JP2018538925A priority patent/JP7073600B2/ja
Priority to US15/768,608 priority patent/US20180289372A1/en
Publication of WO2017063382A1 publication Critical patent/WO2017063382A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B17/295—Forceps for use in minimally invasive surgery combined with cutting implements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00818—Treatment of the gastro-intestinal system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07221—Stapler heads curved
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07257—Stapler heads characterised by its anvil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07271—Stapler heads characterised by its cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072—Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214—Stapler heads
    • A61B2017/07285—Stapler heads characterised by its cutter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft

Definitions

  • the present invention relates to a medical device, and more particularly to a laparoscopic instrument.
  • a surgical stapler is a surgical instrument that functions by closing two corresponding actuators (typically including an anvil assembly and a cartridge assembly) to hold the tissue and then pushing the metal staples in the stapler cartridge Formed to stitch the tissue together.
  • a cutting knife is also provided for cutting the stitched tissue.
  • Endoscopic surgery is to make a small incision of 5 to 12 mm in diameter in different parts of the abdomen or chest. Through these small incisions, the camera lens and various special surgical instruments are inserted into the abdominal cavity of the camera inserted into the abdominal cavity. The image of the organ is transmitted to the television screen, and the surgeon performs the operation by observing the image and operating it in vitro with various surgical instruments. Among them, the endoscopic stapler plays the most important role in the operation.
  • the Endo GIA Universal cutting stapler and nail cartridge of Tyco Healthcare (later renamed Covidien) is a representative product to achieve the above functions.
  • the product structure of the U.S. Patent Application Publication No. US 2010/0237131 A1 utilizes the structure of a hinge + eccentric rigid link hinge to effect deflection of the actuator. Due to the structural design principle, the maximum bending angle of the nail actuator is only 45°. In the case where the actuator needs to be bent at a large angle to complete the operation, the actuator with a small bending angle cannot achieve the lesion resection in some parts.
  • the present invention is directed to a surgical instrument comprising an actuator, an extension tube and a controller, wherein: a proximal end of the extension tube is coupled to the controller, a distal end of the extension tube and the execution Connected, the actuator is rotatable relative to a distal end of the extension tube; the controller includes a bend control mechanism, the bend control mechanism being movable in at least one direction; the extension tube including a first flexible member, The first flexible member provides rotation of the actuator to at least one side relative to a distal end of the extension tube by the bending mechanism moving in at least one direction.
  • the extension tube further includes a second flexible member, the distal end of the first flexible member and the distal end of the second flexible member being respectively coupled to the sides of the actuator along a central axis;
  • the bending mechanism moves in the first direction, the first flexible member is driven to move proximally thereof, and the second flexible member is moved toward the distal end thereof to drive the actuator distally relative to the extension tube
  • the end is rotated toward the first side;
  • the bending mechanism is moved in the second direction, the first flexible member is driven to move to the distal end thereof, and the second flexible member is moved toward the proximal end thereof to drive the execution
  • the device rotates toward the second side relative to the distal end of the extension tube.
  • the bending mechanism includes a gear, a first rack, and a second rack; the gear is meshed with the first rack and the second rack; the first rack and the rack A proximal end of the first flexible member is coupled, and the second rack is coupled to a proximal end of the second flexible member.
  • the extension tube further includes a nail sleeve, a nail inner tube, a curved rod, a gear, a first rack, and a second rack, wherein: the nail inner tube and the nail sleeve a tube coaxially disposed; the gear is rotatably disposed on the inner tube of the magazine, the first rack and the second rack are disposed on both sides of the gear, and the gear and the first a rack and the second rack are in meshing assembly; the bending rod is disposed in the nail casing, and the proximal end of the bending rod is connected to the bending mechanism, and the distal end of the bending rod Fixedly coupled to the first rack, the first rack is also fixedly coupled to a proximal end of the first flexible member, and the second rack is fixedly coupled to a proximal end of the second flexible member; The control bending mechanism controls the movement of the bending rod: when the bending rod moves toward the proximal end thereof, the bending rod pulls the first
  • the inner tube of the nail includes a first inner tube and a second inner tube, and the first inner tube and the second inner tube are the same as the inner tube A shaft arrangement, the gear being rotatably disposed on the first inner tube or the second inner tube.
  • the actuator comprises an anvil assembly, a cartridge assembly, wherein the cartridge assembly comprises a staple cartridge, one or more staples, one or more pusher blocks, and a staple cartridge;
  • the instrument further includes a drive assembly including a cutting blade and a flexible knife bar; a proximal end of the anvil assembly is movably coupled to a proximal end of the staple cartridge seat, the drive assembly driving the actuator The conversion is performed between the first state and the second state.
  • the angle at which the actuator rotates towards at least one side with respect to the distal end of the extension tube is any value between 0° and 180°.
  • the distal end of the extension tube is coupled to the actuator by one or more hinges, the first flexible tab does not pass through the center of the one or more hinges, such that the at least one flexible pull
  • the sheet can be hinged to provide a rotational torque to the actuator that urges the actuator to rotate at least one side relative to the distal end of the extension tube.
  • the present invention also provides a bendable magazine comprising a magazine body, an intermediate connecting portion, and an actuator, the magazine body being coupled to the actuator by an intermediate connecting portion, wherein: the magazine body comprises a bend control mechanism, and a first flexible member; the bend control mechanism being movable in at least one direction, moving in at least one direction by the bend control mechanism, the first flexible member providing the actuator relative to the staple
  • the body of the crucible is rotated to at least one side.
  • the staple cartridge is adapted for use in a laparoscopic stapler.
  • the magazine further includes a second flexible member, a distal end of the first flexible member and a distal end of the second flexible member being respectively coupled to the actuators on both sides of the central axis;
  • the bending mechanism moves in the first direction
  • the first flexible member is driven to move proximally thereof
  • the second flexible member is moved toward the distal end thereof to drive the actuator relative to the magazine body
  • the distal end rotates toward the first side
  • the bending mechanism moves in the second direction
  • the first flexible member is driven to move distally thereof, and the second flexible member moves toward the proximal end thereof to drive the
  • the actuator rotates toward the second side relative to the distal end of the magazine body.
  • the bending mechanism of the magazine includes a gear, a first rack, and a second rack; Engaging with the first rack and the second rack; the first rack is coupled to the proximal end of the first flexible member, and the second rack is coupled to the second flexible member Near end connection.
  • the magazine body further includes a nail casing, a nail inner tube, a bending rod, a gear, a first rack, and a second rack, wherein: the nail inner tube and the nail file a sleeve coaxially disposed; the gear is rotatably disposed on the inner tube of the magazine, the first rack and the second rack are disposed on both sides of the gear, and the gear and the The first rack and the second rack are in meshing assembly; the bending rod is disposed in the nail casing, and the proximal end of the bending rod is connected with the bending mechanism, and the bending rod is far The end is fixedly coupled to the first rack, the first rack is also fixedly coupled to the proximal end of the first flexible member, and the second rack is fixedly coupled to the proximal end of the second flexible member; The bending mechanism controls the movement of the bending rod: when the bending rod moves toward the proximal end thereof, the bending rod pulls the first rack to further pull the first flexible
  • the inner tube of the nail includes a first inner tube and a second inner tube, and the first inner tube and the second inner tube are the same as the inner tube A shaft arrangement, the gear being rotatably disposed on the first inner tube or the second inner tube.
  • the angle at which the actuator is rotated toward at least one side with respect to the distal end of the magazine body is any value between 0° and 180°.
  • the surgical instrument of the present invention employs a flexible member to provide a bend of the actuator relative to the distal end of the extension tube, enabling the actuator to be bent at a greater angle, thereby adapting to medical treatment in more complex clinical conditions, such as being limited in space
  • the parts (such as the chest and pelvis) are more convenient to perform surgery to solve problems that other surgical instruments cannot solve.
  • the actuator of the present invention can bend a large angle surgical instrument to perform functions such as lesion resection, tissue cutting and suturing in various difficult positions, thereby benefiting more patients.
  • the actuator of the device of the present invention can still rotate to a perpendicular angle to the rectum at the lowest position of the rectum, so that more patients with low rectal cancer can also undergo minimally invasive surgery.
  • the surgical instrument of the present invention can be used not only in surgery but also in related therapeutic and diagnostic procedures.
  • the present invention can be applied not only to a cavity stapler but also to products such as a closure, an electric knife, and the like.
  • FIG. 1 is a schematic view of the design of a surgical instrument in accordance with an embodiment of the present invention.
  • FIG. 2 is a general schematic view of a magazine in a surgical instrument in accordance with an embodiment of the present invention.
  • FIG 3 is an exploded illustration of a staple cartridge in a surgical instrument in accordance with an embodiment of the present invention.
  • FIG. 4 is a schematic view of a straight line state of an actuator of a magazine in a surgical instrument in accordance with an embodiment of the present invention.
  • Figure 5 is a partial view of Figure 4.
  • FIG. 6 is a schematic illustration of the actuator of the magazine in the surgical instrument turned to the first side in accordance with an embodiment of the present invention.
  • Figure 7 is a partial view of Figure 6.
  • FIG. 8 is a schematic illustration of the actuator of the magazine in the surgical instrument turned to the second side in accordance with an embodiment of the present invention.
  • FIG. 9 is a schematic illustration of the use of a surgical instrument in accordance with an embodiment of the present invention.
  • the device of the present invention will be described by taking an anastomat as an example.
  • the surgical instrument with which the actuator of the present invention can be bent is not limited to a lenticular stapler.
  • the techniques of the present invention may also be employed in other products such as closures, electric knives, and the like.
  • FIG. 1 is a schematic view of the design of a surgical instrument in accordance with an embodiment of the present invention.
  • the surgical instrument shown in FIG. 1 includes an actuator 100, an extension tube 200, and a controller 300.
  • the extension tube 200 is movably coupled to the distal end of the controller 300 and coupled to the proximal end of the actuator 100, the extension tube 200 forming a connection channel for effecting the action by the controller 300 to the actuator 100.
  • Controller 300 is used to control the operation of the instrument.
  • the surgical instrument of the present invention may be of a unitary design, i.e., the extension tube 200 as a unit is coupled to the distal end of the controller 300 and to the proximal end of the actuator 100, respectively.
  • the length of the extension tube 200 can vary depending on the indication and the particular circumstances of the patient.
  • the surgical instrument of the present invention can also be of a split design, as shown in FIG.
  • the split design of the surgical instrument of the present invention can include a stapler 400 and a staple cartridge 500.
  • the stapler 400 and the staple cartridge 500 can be combined for use as a whole by a certain assembly relationship.
  • the same stapler can be adapted to various types of staples during surgery.
  • the controller 300 can include a bend control mechanism 312.
  • the bend control mechanism 312 can move in the first direction and the second direction.
  • the bend control mechanism 312 can employ a gear reversing mechanism.
  • the bend control mechanism 312 can include a gear 512, a first rack 510a, and a second rack 510b. It can be understood that the gear 512, the first rack 510a, and the second rack 510b can also be placed in the extension tube.
  • the controller 300 can employ a handle member.
  • the controller 300 may further include a curved bending wrench 313, a fixed handle 314, a movable handle 316 (eg, a firing trigger) that is movably coupled to the fixed handle, and a set of actions to move the handle 316.
  • the transmission that is transmitted to the actuator can be controlled to rotate at a distal end of the extension tube 200 at a distal end of the extension tube 200 in a plane perpendicular to the axis of rotation of the hinge by rotating the bend wrench 313.
  • the bender is rotated to each particular position and the actuator 100 is rotated a particular angle accordingly.
  • Actuator 100 can be rotated at different angles to accommodate different clinical applications.
  • the actuator By triggering the firing trigger, the actuator can continuously clamp, suture, and cut the human tissue.
  • the rotary bender is independent of the two functions of rotating the actuator and operating the firing trigger to drive the actuator.
  • the surgical procedure of the surgical instrument of the present invention may be as follows: first operating the bending wrench to control the rotation of the actuator to a suitable angle required by the clinic, then adjusting the position of the tissue in the actuator jaw, and then operating the firing trigger to implement the tissue Clamp, stitch, cut and other functions.
  • FIG. 2 there is shown a total of staples in a surgical instrument in accordance with an embodiment of the present invention.
  • Body map and explosion map there is shown a total of staples in a surgical instrument in accordance with an embodiment of the present invention.
  • a turnable magazine 500 is provided.
  • the magazine 500 can include a magazine body 501, an intermediate connection portion 502, an actuator 100, and a drive assembly 160.
  • the magazine body 501 may mainly include a nail casing 504, a first nail inner tube 506a, a second nail inner tube 506b, a bending rod 508, a first rack 510a, a second rack 510b, and a gear. 512.
  • the first staple inner tube 506a and the second inner nail tube 506b are coaxially disposed with the staple sleeve 504.
  • the gear 512 is rotatably disposed on the first inner tube 506a or the second inner tube 506b.
  • the intermediate connection portion 502 can include an intermediate connector 518 (two intermediate connectors are shown in FIG. 3), a rivet b 520.
  • the actuator 100 can include an anvil assembly 120, a cartridge assembly 140.
  • the actuator 100 can also include an anvil connector 180, a gland 182, and a rivet a 184.
  • the anvil assembly 120 can include a staple forming surface that includes a plurality of rows of staple forming grooves.
  • the cartridge assembly 140 can include a staple cartridge 142, staples 144, pusher blocks 146, and staple cartridge holders 148. There may be one or more staples 144 and pusher blocks 146.
  • the upper surface of the staple cartridge 142 is the tissue contacting surface and the staple cartridge 142 is mounted in the staple cartridge holder 148.
  • the anvil assembly 120 is movably coupled proximally to the proximal end of the cartridge housing 148 of the cartridge assembly 140 and is switchable between an open state and a closed state.
  • the drive assembly 160 is coupled to the transmission mechanism for converting, for example, the action of firing the trigger into a closing, firing, and opening action of the actuator 100.
  • the anvil assembly 120 and the staple cartridge holder 148 can include longitudinal slots 149a and 149b, respectively, for receiving the drive assembly 160 through.
  • the drive assembly 160 When the drive assembly 160 is moved toward the distal end of the actuator 100 through the longitudinal slots 149a, 149b, the anvil assembly 120 and the cartridge assembly 140 are driven to transition from a first state (eg, an open state) to a second state (eg, closed) State) and urges the pusher slider 162 and the pusher block 146 to eject the staples 144 and form in the staple forming grooves of the staple forming faces of the anvil assembly 120. vice versa.
  • the drive assembly drives the actuator to transition between the first state and the second state.
  • the drive assembly 160 can include a slider 162, a cutting blade 164, and a flexible knife bar 166.
  • the cutting blade 164 is used to cut tissue between rows of staple lines after the tissue is stitched by the staples 144.
  • the nail body 501, the intermediate connecting body 518, and the actuator 100 can pass one or more Rotating hinges such as hinges 522a, 522b are connected.
  • the two hinges 522a, 522b are spatially parallel to each other, perpendicular to the plane in which the actuator can be bent.
  • the first and second inner tube 506a and the second inner tube 506b are coaxially disposed with the magazine 504.
  • the curved lever 508 is disposed between the first inner tube 506a and the second inner tube 506b, and is fixedly coupled to the first rack 510a.
  • the first rack 510a and the second rack 510b are respectively placed on both sides of the first nail inner tube 506a, and are meshed and driven by a gear 512 placed on a rotating shaft on the first nail inner tube 506a.
  • the first rack 510a is fixedly coupled to the first flexible pull tab 514a
  • the second rack 510b is fixedly coupled to the second flexible pull tab 514b.
  • the first flexible pull tab 514a and the second flexible pull tab 514b respectively pass through the intermediate connecting body 518 and are connected to the right and left sides of the actuator 100 along the central axis.
  • the flexible shank 166 of the drive assembly 160 is partially disposed inside the magazine body 501 and passes through the intermediate connector 518.
  • the cutting blade 164 and the slider 162 are placed inside the actuator 100.
  • the bender 508 on the stapler 500 can be controlled to advance or retreat by the bend control mechanism 312 on the stapler 400.
  • FIG. 4 through 5 there is shown a schematic view of a straight line state of an actuator of a magazine in a surgical instrument and a partial view A thereof, in accordance with one embodiment of the present invention.
  • the actuator 100 is in line with the central axis of the attachment mechanism (e.g., the magazine body or extension tube).
  • the two flexible tabs 514a, 514b are fixedly mounted on the rivet a 184 of the actuator 100, respectively.
  • the attachment position of the flexible tabs 514a, 514b to the actuator is offset from the central plane of symmetry where the axes of rotation of the two hinges 522a, 522b are located, and the flexible tabs 514a, 514b do not pass through the center of the hinge.
  • the flexible pull tab is hinged as a rotating shaft to provide a certain rotational torque to the actuator to drive the actuator to rotate.
  • FIG. 6-7 there is shown a schematic view of the actuator of the magazine in the surgical instrument turned to the first side and a partial view thereof, in accordance with one embodiment of the present invention.
  • the bending lever 508 pulls the first rack 510a toward the proximal end of the magazine 500 (as indicated by the arrow), and the first rack 510a pulls the first flexible tab 514a.
  • the first rack 510a drives the gear 512 to rotate, thereby driving the second rack 510b to move toward the distal end of the magazine 500 (as indicated by the arrow), and the second flexible tab 514b is relaxed.
  • the stapled actuator 100 turns in a first side direction (eg, counterclockwise as shown). Actuator 100 relative to the nail
  • the rotation angle of the main body 501 is ⁇ .
  • the amount of rotation of the actuator 100 can be controlled by controlling the amount of feed of the bending lever 508 by the bending mechanism 312 on the stapler 400.
  • ⁇ may be any value between 0° and 180° (for example, 0°, 30°, 45°, 60°, 90°, 120°, 135°, 180°, etc.).
  • the first flexible tab is tightened and the second flexible tab is relaxed to drive the actuator to turn.
  • the two racks move in opposite directions, and the displacement of the first flexible pull tab and the displacement of the second flexible pull tab during the rotation of the actuator Equal, offset each other.
  • the displacement of the two flexible tabs in opposite directions can also be counteracted by other means.
  • FIG 8 there is shown a schematic view of the actuator of the magazine in the surgical instrument being turned to the second side in accordance with one embodiment of the present invention.
  • the curved lever 508 when the curved lever 508 is subjected to thrust, the curved lever 508 pushes the first rack 510a toward the distal end of the magazine 500 (as indicated by the arrow), and the first flexible tab 514a is relaxed.
  • the first rack 510a drives the gear 512 to rotate, thereby driving the second rack 510b to move toward the proximal end of the magazine 500 (as indicated by the arrow), and the second rack 510b pulls the second flexible tab 514b to make the actuator of the magazine 100 turns in the direction of the second side (for example, clockwise as shown), and the angle of rotation is ⁇ .
  • ⁇ may be any value between 0° and 180° (for example, 0°, 30°, 45°, 60°, 90°, 120°, 135°, 180°).
  • the principle of the actuator turning to the second side is similar to the principle of turning the first side direction described above, except that the second flexible tab is tightened and the first flexible tab is relaxed.
  • FIG. 9 a schematic illustration of the use of a surgical instrument in accordance with one embodiment of the present invention is shown.
  • the surgical instrument of the present invention can be applied to surgery in the lungs, digestive tract (including stomach, intestines). Pulmonary surgery generally involves the removal of the lesion. In digestive tract surgery, after the lesion is usually removed, the cut intestine tube needs to be re-docked.
  • the actuator of the nail that can bend the endoscope stapler can be bent, and the proximal end of the actuator and the bending mechanism inside the controller (such as the stapler handle) pass through the intermediate mechanism (for example, the curved control in the figure)
  • the rod 508 is connected, and the actuator can be controlled to bend a plurality of angles by adjusting the bending mechanism.
  • the actuator and the central axis of the connecting mechanism are in a straight line, and the actuator of the stapler passes through the puncturing device.
  • the actuator Extending into the chest or abdominal cavity, the actuator is controlled to bend a certain angle by controlling the bending mechanism on the external control handle, and a series of operations such as clamping, transverse, and anastomosis are performed on the surgical site.
  • the actuator is controlled to change to a straight state by the bending mechanism on the external control handle, and exits the body.
  • the position of the transverse cut line is usually about 5 cm from the tumor boundary.
  • the actuator of the stapler needs to be able to be placed in a lower position in the narrow pelvic cavity, affected by the position of the hip bone limiting stapler, and the stapler with a small turning angle
  • the actuator can't cut the rectum vertically and cross-cut, increasing the risk of incomplete surgical resection.
  • the surgical instrument with a small turning angle of the actuator cannot vertically traverse the rectum, and the stapler with a large turning angle of the actuator (without hatching) can.
  • surgical instruments with larger actuator turning angles can cope with lower-grade tumors (Tumor 2).
  • Tumor 2 When the actuator of the surgical instrument has a larger rotation angle, the tumor can be cut at a lower position, which can be better applied to low rectal cancer surgery, or other limited space in the body.
  • the surgical instrument according to the invention wherein the angle of rotation of the actuator can reach 90 or even 180 to accommodate extreme applications.
  • the flexible pull tabs 512a, 512b may alternatively be wire ropes.
  • a flexible member such as a single or multiple strands of filament.
  • the flexible pull tabs, wire ropes described above are by way of example only and not limitation, and those skilled in the art can contemplate more other similar flexible components to effect the bending of the actuator. Such implementations are not to be interpreted as causing a departure from the scope of the invention.
  • the surgical instrument of the present invention employs a flexible member to provide a bend of the actuator relative to the distal end of the extension tube, enabling the actuator to be bent at a greater angle, thereby adapting to medical treatment in more complex clinical conditions, such as being limited in space
  • the parts (such as the chest and pelvis) are more convenient to perform surgery to solve problems that other surgical instruments cannot solve.
  • the actuator of the present invention can bend a large angle surgical instrument to perform functions such as lesion resection, tissue cutting and suturing in various difficult positions, thereby benefiting more patients.

Abstract

一种外科器械，包括执行器（100）、延长管（200）和控制器（300），其中：所述延长管（200）的近端与所述控制器（300）连接，所述延长管（200）的远端与所述执行器（100）连接，所述执行器（100）能相对于所述延长管（200）的远端旋转；所述控制器（300）包括控弯机构（312），所述控弯机构（312）能向至少一个方向运动；所述延长管（200）包括第一柔性部件（514a），通过所述控弯机构（312）向至少一个方向运动，所述第一柔性部件（514a）提供所述执行器（100）相对于所述延长管（200）的远端向至少一侧旋转。一种可弯转钉匣（500），采用柔性部件（514a、514b）来提供执行器（100）相对于延长管（200）远端的弯转，使执行器（100）能够弯转更大的角度，从而适于更复杂临床条件下的医疗。

Description

一种执行器可弯转的外科器械 技术领域
本发明涉及一种医疗器械，更具体地涉及一种腔镜器械。
背景技术
外科吻合器是一种外科器械，它的作用原理是通过两个对应的执行器(通常包括钉砧组件和钉仓组件)闭合以夹持组织，然后将吻合器钉仓中的金属缝合钉推出成形，将组织缝合在一起。在有些吻合器中，还装有一把切割刀，用于将缝合好的组织切断开。
随着技术的进步，传统手术方式逐渐转向腔镜手术。腔镜手术就是在腹部或胸部的不同部位做数个直径5～12毫米的小切口，通过这些小切口插入摄像镜头和各种特殊的手术器械，将插入腹腔内的摄像头所拍摄的腹腔内各种脏器的图像传输到电视屏幕上，外科医生通过观察图像，用各种手术器械在体外进行操作来完成手术。其中，腔镜吻合器在手术中扮演最关键的角色。
但是，腔镜手术也有局限性。由于腹腔或者胸腔内空间的限制，传统的直线腔镜吻合器在一些极端情况下，不能有效地到达手术部位进行夹持、横断、吻合组织，所以催生了吻合器执行器可转弯的腔镜吻合器。
美国Tyco Healthcare公司(后改称为Covidien)的Endo GIA Universal切割吻合器和钉匣，是实现上述功能的有代表性的产品。公开号为US2010/0237131A1的美国专利申请中的产品结构采用铰链+偏心刚性连杆铰链的结构实现执行器的偏转。受该结构设计原理所限，该钉匣执行器最大弯转角度仅为45°。在需要执行器大角度弯转才能完成手术的情况下，采用该弯转角度小的执行器则无法实现某些部位的病灶切除。例如，在低位直肠切除术中，由于盆腔的空间限制了器械进入盆腔的角度，虽然钉匣执行器产生了转弯，但在部分手术中执行器仍然不能与直肠呈垂直角度缝合、切割，致使部分肿瘤位置较低的患者无法使用该器械进行手术治疗。
因此，本领域需要一种执行器可转弯更大角度的外科器械，以适于更复杂临床条件下的医疗。
发明内容
鉴于此，本发明旨在提供一种外科器械，包括执行器、延长管和控制器，其中：所述延长管的近端与所述控制器连接，所述延长管的远端与所述执行器连接，所述执行器能相对于所述延长管的远端旋转；所述控制器包括控弯机构，所述控弯机构能向至少一个方向运动；所述延长管包括第一柔性部件，通过所述控弯机构向至少一个方向运动，所述第一柔性部件提供所述执行器相对于所述延长管的远端向至少一侧旋转。
根据一方面，所述延长管还包括第二柔性部件，所述第一柔性部件的远端与所述第二柔性部件的远端分别连接在所述执行器沿中心轴的两侧；所述控弯机构向第一方向运动时，将驱动所述第一柔性部件向其近端运动，所述第二柔性部件向其远端运动，进而驱动所述执行器相对于所述延长管的远端向第一侧旋转；所述控弯机构向第二方向运动时，将驱动所述第一柔性部件向其远端运动，所述第二柔性部件向其近端运动，进而驱动所述执行器相对于所述延长管的远端向第二侧旋转。
根据一方面，所述控弯机构包括齿轮、第一齿条、第二齿条；所述齿轮与所述第一齿条、所述第二齿条呈啮合装配；所述第一齿条与所述第一柔性部件的近端连接，所述第二齿条与所述第二柔性部件的近端连接。
根据一方面，所述延长管还包括钉匣套管、钉匣内管、控弯杆、齿轮、第一齿条、第二齿条，其中：所述钉匣内管与所述钉匣套管同轴布置；所述齿轮可转动地设置在所述钉匣内管上，所述第一齿条与所述第二齿条布置在所述齿轮两侧，且所述齿轮与所述第一齿条、所述第二齿条呈啮合装配；所述控弯杆置于钉匣套管内，所述控弯杆的近端与所述控弯机构连接，所述控弯杆的远端与所述第一齿条固定连接，所述第一齿条还与所述第一柔性部件的近端固定连接，所述第二齿条与所述第二柔性部件的近端固定连接；所述控弯机构控制所述控弯杆的运动：当所述控弯杆向其近端运动时，所述控弯杆拉动所述第一齿条，进一步拉动所述第一柔性部件，通过所述第一柔性拉片拉动所述执行器相对于所述延长管的远端向所述第一侧旋转；当所述控弯杆向其远端运动时，所述控弯杆推动所述第一齿条，并通过所述齿 轮进一步驱使所述第二齿条向近端方向运动，进而拉动所述第二柔性部件，通过所述第二柔性拉片拉动所述执行器相对于所述延长管的远端向所述第二侧旋转。
根据一方面，所述钉匣内管包括第一钉匣内管和第二钉匣内管，所述第一钉匣内管、所述第二钉匣内管与所述钉匣套管同轴布置，所述齿轮可转动地设置在所述第一钉匣内管或所述第二钉匣内管上。
根据一方面，所述执行器包括钉砧组件、钉仓组件，其中所述钉仓组件包括钉仓、一个或多个缝合钉、一个或多个推钉块、以及钉仓座；所述外科器械还包括驱动组件，所述驱动组件包括切割刀、以及柔性刀杆；所述钉砧组件的近端与所述钉仓座的近端可动地连接，所述驱动组件驱使所述执行器在第一状态与第二状态之间进行转换。
根据一方面，所述执行器相对于所述延长管的远端向至少一侧旋转的角度是0°至180°之间的任意数值。
根据一方面，所述延长管的远端与所述执行器通过一个或多个铰链连接，所述第一柔性拉片不通过所述一个或多个铰链的中心，从而所述至少一个柔性拉片能以铰链为旋转轴，为所述执行器提供旋转扭矩，驱使所述执行器相对于所述延长管的远端向至少一侧旋转。
本发明还提供了一种可弯转的钉匣，包括钉匣主体、中间连接部分、执行器，所述钉匣主体通过中间连接部分与所述执行器连接，其中：所述钉匣主体包括控弯机构、以及第一柔性部件；所述控弯机构能向至少一个方向运动，通过所述控弯机构向至少一个方向运动，所述第一柔性部件提供所述执行器相对于所述钉匣主体向至少一侧旋转。
根据一方面，所述钉匣适用于腔镜吻合器。
根据一方面，所述钉匣还包括第二柔性部件，所述第一柔性部件的远端与所述第二柔性部件的远端分别连接在所述执行器沿中心轴的两侧；所述控弯机构向第一方向运动时，将驱动所述第一柔性部件向其近端运动，所述第二柔性部件向其远端运动，进而驱动所述执行器相对于所述钉匣主体的远端向第一侧旋转；所述控弯机构向第二方向运动时，将驱动所述第一柔性部件向其远端运动，所述第二柔性部件向其近端运动，进而驱动所述执行器相对于所述钉匣主体的远端向第二侧旋转。
根据一方面，所述钉匣的控弯机构包括齿轮、第一齿条、第二齿条；所述齿轮 与所述第一齿条、所述第二齿条呈啮合装配；所述第一齿条与所述第一柔性部件的近端连接，所述第二齿条与所述第二柔性部件的近端连接。
根据一方面，所述钉匣主体还包括钉匣套管、钉匣内管、控弯杆、齿轮、第一齿条、第二齿条，其中：所述钉匣内管与所述钉匣套管同轴布置；所述齿轮可转动地设置在所述钉匣内管上，所述第一齿条与所述第二齿条布置在所述齿轮两侧，且所述齿轮与所述第一齿条、所述第二齿条呈啮合装配；所述控弯杆置于钉匣套管内，所述控弯杆的近端与所述控弯机构连接，所述控弯杆的远端与所述第一齿条固定连接，所述第一齿条还与所述第一柔性部件的近端固定连接，所述第二齿条与所述第二柔性部件的近端固定连接；所述控弯机构控制所述控弯杆的运动：当所述控弯杆向其近端运动时，所述控弯杆拉动所述第一齿条，进一步拉动所述第一柔性部件，通过所述第一柔性拉片拉动所述执行器相对于所述钉匣主体的远端向所述第一侧旋转；当所述控弯杆向其远端运动时，所述控弯杆推动所述第一齿条，并通过所述齿轮进一步驱使所述第二齿条向近端方向运动，进而拉动所述第二柔性部件，通过所述第二柔性拉片拉动所述执行器相对于所述钉匣主体的远端向所述第二侧旋转。
根据一方面，所述钉匣内管包括第一钉匣内管和第二钉匣内管，所述第一钉匣内管、所述第二钉匣内管与所述钉匣套管同轴布置，所述齿轮可转动地设置在所述第一钉匣内管或所述第二钉匣内管上。
根据一方面，所述执行器相对于所述钉匣主体的远端向至少一侧旋转的角度是0°至180°之间的任意数值。
本发明的外科器械采用柔性部件来提供执行器相对于延长管远端的弯转，使执行器能够弯转更大的角度，从而适于更复杂临床条件下的医疗，例如可以在空间受限的部位(如胸腔和盆腔)更方便的实施手术，解决其他外科器械无法解决的问题。本发明的执行器可弯转大角度的外科器械能够完成各种疑难位置的病灶切除、组织切割和缝合等功能，使更多患者受益。例如，对于直肠癌患，本发明的器械的执行器在直肠的最低位仍能旋转到与直肠垂直的角度，从而更多低位直肠癌患者也可以接受微创手术。
此外，本发明的外科器械不仅可用于外科手术中，也可在相关治疗和诊断过程中使用。
此外，本发明不仅可应用于腔镜吻合器，还可应用于诸如闭合器、电刀等产品。
附图说明
纳入于此且构成本说明书一部分的附图示出了本发明的示例性实施例，并与以上给出的发明内容和下面给出的具体实施方式一起用来解释本发明的特征。
图1是根据本发明的实施例的外科器械的设计示意图。
图2是根据本发明的一个实施例的外科器械中钉匣的总体示意图。
图3是根据本发明的一个实施例的外科器械中钉匣的爆炸图示。
图4是根据本发明的一个实施例的外科器械中钉匣的执行器的直线状态示意图。
图5是图4的局部视图。
图6是根据本发明的一个实施例的外科器械中钉匣的执行器转向第一侧的示意图。
图7是图6的局部视图。
图8是根据本发明的一个实施例的外科器械中钉匣的执行器转向第二侧的示意图。
图9是根据本发明的一个实施例的外科器械的使用示意图。
具体实施方式
将参照附图详细描述各种实施例。在可能之处，相同附图标记将贯穿附图用于指代相同或类似部分。对特定示例和实现所作的引用是用于说明性目的，而无意限定本发明或权利要求的范围。
措辞“示例性”在本文中用于表示“用作示例、实例或示出”。本文中描述为“示例性”的任何实现不必然被解释为优于或胜过其他实现。
为简明起见，以吻合器为例来说明本发明的器械。本领域技术人员可以理解，本发明的执行器可弯转的外科器械不局限于腔镜吻合器。在诸如闭合器、电刀等其他产品中，也可采用本发明的技术。
图1是根据本发明的一个实施例的外科器械的设计示意图。图1所示的外科器械包括执行器100、延长管200以及控制器300。延长管200与控制器300的远端可动地连接，并与执行器100的近端连接在一起，延长管200构成一个连接通道，用于实现将通过控制器300作出的动作传递给执行器100。控制器300用于控制器械的操作。
本发明的外科器械可采用整体式设计，即延长管200作为一个整体分别与控制器300的远端和与执行器100的近端连接。根据不同的适应症以及患者的具体情况，延长管200的长度可以不同。
本发明的外科器械还可采用分体式设计，如图1所示。根据图1所示的该实施例，本发明的外科器械的分体式设计可以包括吻合器400和钉匣500。吻合器400和钉匣500可通过一定的装配关系，组合为一个整体使用。在分体式设计中，手术中同一吻合器可以适配各种类型的钉匣。
参考图1和图3，控制器300可以包括控弯机构312。例如，控弯机构312可以向第一方向和第二方向运动。作为示例，控弯机构312可以采用齿轮换向机构。控弯机构312可以包括齿轮512、第一齿条510a、第二齿条510b。可以理解，齿轮512、第一齿条510a、第二齿条510b也可以置于延长管中。控制器300可以采用手柄部件。在这种情况下，控制器300还可以包括控弯扳手313、固定手柄314、与固定手柄相对可动地连接的可移动手柄316(例如击发扳机)、以及一组将可移动手柄316的动作传递至执行器的传动机构。例如，操作时，可以通过旋转控弯扳手313来控制执行器100在延长管200远端、在与铰链旋转轴垂直的平面上旋转一定的角度。控弯扳手旋转到每个特定位置，执行器100相应地旋转一个特定角度。执行器100可以旋转不同的角度，以适应不同的临床应用情况。扳动击发扳机，就可实现执行器对人体组织的连续夹持、缝合、切割等功能。旋转控弯扳手以旋转执行器与操作击发扳机以驱动执行器工作的这两个功能相互独立。一般而言，本发明的外科器械的操作步骤可以如下：先操作控弯扳手控制执行器旋转到临床需要的合适角度之后，再调整组织在执行器钳口中的位置，然后操作击发扳机对组织实施夹持、缝合、切割等功能。
以下以分体式设计的腔镜吻合器为例予以详细说明。
参考图2至图3，其示出了根据本发明的一实施例的外科器械中钉匣的总 体图与爆炸图。
根据本发明的一个实施例，提供了一种可转弯的钉匣500。作为示例，钉匣500可以包括钉匣主体501、中间连接部分502、执行器100、驱动组件160。
作为示例，钉匣主体501主要可以包括钉匣套管504、第一钉匣内管506a、第二钉匣内管506b、控弯杆508、第一齿条510a、第二齿条510b、齿轮512、第一柔性拉片514a、第二柔性拉片514b、第一连接片516a、第二连接片516b等。在所示实施例中，第一钉匣内管506a、第二钉匣内管506b与钉匣套管504同轴布置。齿轮512可转动地设置在第一钉匣内管506a或所述第二钉匣内管506b上。尽管图中示出了钉匣内管可以分为多个部分，例如第一钉匣内管506a和第二钉匣内管506b，但可以理解，在另一些实施例中，钉匣内管可以是一个整体。
中间连接部分502可以包括中间连接体518(图3中示出两个中间连接体)、铆钉b 520。
执行器100可以包括钉砧组件120、钉仓组件140。执行器100还可以包括钉砧连接体180、压盖182、铆钉a 184。钉砧组件120可以包括钉成形面，钉成形面包含多排钉成形槽。钉仓组件140可以包括钉仓142、缝合钉144、推钉块146和钉仓座148。缝合钉144和推钉块146可以有一个或多个。钉仓142的上表面为组织接触面，钉仓142安装在钉仓座148中。钉砧组件120在近端与钉仓组件140的钉仓座148的近端可动地连接在一起，并可以在张开状态和关闭状态之间转换。驱动组件160与传动机构连接，用于把例如击发扳机的动作转换为执行器100的关闭、击发和张开动作。一般情况下，钉砧组件120和钉仓座148可分别包含纵向槽149a和149b，上述纵向槽149a、149b用于容纳驱动组件160通过。当驱动组件160通过上述纵向槽149a、149b向执行器100的远端运动时，会驱使钉砧组件120和钉仓组件140从第一状态(例如张开状态)转换为第二状态(例如关闭状态)，并且驱使推钉滑块162和推钉块146顶出缝合钉144并在钉砧组件120的钉成形面的钉成形槽中成形。反之亦然。因而，驱动组件驱使所述执行器在第一状态与第二状态之间进行转换。
一般情况下，驱动组件160可以包括滑块162、切割刀164、柔性刀杆166。切割刀164用于在组织被缝合钉144缝合后，在多排钉线之间切割组织。
钉匣主体501、中间连接体518、执行器100三者可以通过一个或多个可 转动铰链例如铰链522a、522b连接。作为示例，两个铰链522a、522b空间上相互平行，垂直于执行器可以弯转的平面。
根据本发明的一个示例，第一钉匣内管506a和第二钉匣内管506b与钉匣套管504同轴布置。控弯杆508置于第一钉匣内管506a和第二钉匣内管506b之间，与第一齿条510a固定连接。第一齿条510a与第二齿条510b分别置于第一钉匣内管506a的两侧，通过置于在第一钉匣内管506a上的旋转轴上的齿轮512啮合传动。第一齿条510a与第一柔性拉片514a近端固定连接，第二齿条510b与第二柔性拉片514b近端固定连接。第一柔性拉片514a和第二柔性拉片514b分别穿过中间连接体518，连接至执行器100沿中心轴的左右两侧。
根据本发明的一个示例，驱动组件160的柔性刀杆166部分置于钉匣主体501内部，并穿过中间连接体518。切割刀164和滑块162则置于执行器100内部。
当钉匣500安装在吻合器400上时，通过吻合器400上的控弯机构312，可以控制钉匣500上的控弯杆508前进或后退。
参考图4至图5，其示出根据本发明的一个实施例的外科器械中钉匣的执行器的直线状态示意图及其局部视图A。
如图4所示，根据本发明的一个实施例，执行器100与连接机构(例如，钉匣主体或延长管)的中心轴共线呈直线状态。在该实施例中，两个柔性拉片514a、514b分别固定安装在执行器100的铆钉a 184上面。在这样的设计中，柔性拉片514a、514b与执行器的连接位置偏离于两个铰链522a、522b旋转轴所在的中心对称平面，且柔性拉片514a、514b不通过铰链的中心。从而，使柔性拉片以铰链为旋转轴，为执行器提供一定的旋转扭矩，驱使执行器旋转。
参考图6至图7，其示出根据本发明的一个实施例的外科器械中钉匣的执行器转向第一侧的示意图及其局部视图。
如图所示，当控弯杆508受到拉力时，控弯杆508拉动第一齿条510a向钉匣500近端运动(如箭头所示)，第一齿条510a拉动第一柔性拉片514a。同时，第一齿条510a带动齿轮512转动，进而带动第二齿条510b向钉匣500远端运动(如箭头所示)，第二柔性拉片514b放松。这样，钉匣的执行器100向第一侧方向(例如，如图所示的逆时针方向)转弯。执行器100相对于钉匣 主体501的转动角度为α。通过吻合器400上的控弯机构312控制控弯杆508进给量，可以控制执行器100的转动角度α的大小。根据本发明的一个实施例，α可以是0°至180°之间的任意数值(例如0°、30°、45°、60°、90°、120°、135°、180°等等)。
从图中可以看出，第一柔性拉片收紧，第二柔性拉片放松，从而驱动执行器转弯。在该实施例中，通过齿轮和两个齿条的啮合，两个齿条运动方向相反，在执行器旋转时，第一柔性拉片的收紧与第二柔性拉片的放松所产生的位移相等，相互抵消。在本发明的设计中，还可通过其他方式抵消两个柔性拉片的相反方向的位移。
参考图8，其示出了根据本发明的一个实施例的外科器械中钉匣的执行器转向第二侧的示意图。
如图所示，当控弯杆508受到推力时，控弯杆508推动第一齿条510a向钉匣500远端运动(如箭头所示)，第一柔性拉片514a放松。第一齿条510a带动齿轮512转动，进而带动第二齿条510b向钉匣500近端运动(如箭头所示)，第二齿条510b拉动第二柔性拉片514b，使钉匣的执行器100向第二侧方向转弯(例如，如图所示的顺时针方向)，转动角度为β。通过吻合器400上的控弯机构312控制控弯杆508进给量，可以控制执行器的转动角度β的大小。根据本发明的一个实施例，β可以是0°至180°之间的任意数值(例如0°、30°、45°、60°、90°、120°、135°、180°)。
执行器转向第二侧方向原理与上述转向第一侧方向原理类似，区别是第二柔性拉片收紧，第一柔性拉片放松。
参考图9，其示出了根据本发明的一个实施例的外科器械的使用示意图。
本发明的外科器械可以应用于肺部、消化道(包括胃、肠)手术中。肺部手术一般是将病灶切除。消化道手术，一般将病灶切除后，需要将切断后的肠管重新对接。
一般情况下，可弯转腔镜吻合器的钉匣的执行器可以弯转，执行器的近端与控制器(例如吻合器手柄)内部的控弯机构通过中间机构(例如，图中控弯杆508)连接，通过调整控弯机构可以控制执行器弯转多个角度。在初始状态下，执行器与连接机构的中心轴共线呈直线状态，吻合器的执行器通过穿刺器 伸入胸腔或者腹腔，通过在体外控制手柄上的控弯机构控制执行器弯转一定的角度，并对手术部位进行夹持、横断、吻合等一系列操作。手术完成后，通过在体外控制手柄上的控弯机构控制执行器重新变为直线状态，退出体外。
举例而言，对于消化道手术，临床中为了彻底切除肿瘤并且防止肿瘤组织残留，通常横断切割线的位置距离肿瘤边界5cm左右。当直肠癌肿瘤位置靠近患者肛门的比较低的位置时，吻合器的执行器需要能够置入狭小的盆腔内更低的位置，受髋骨限制吻合器进入位置的影响，转弯角度小的吻合器的执行器就不能垂直横断切割直肠，增加肿瘤切除不完整的手术风险。
从图中可以看出，执行器转弯角度小的外科器械(带剖面线)不能对直肠进行垂直横断，而执行器转弯角度大的吻合器(无剖面线)则可以。并且，执行器转弯角度更大的外科器械，可以应对更低位置的肿瘤(肿瘤2)。当外科器械的执行器转动角度更大时，能够在更低的位置切割肿瘤，可以较好的应用于低位直肠癌手术，或者其他体内空间受限制的情况。
根据本发明的外科器械，其中执行器的旋转角度可以达到90°甚至180°，以适应极端应用的情况。
根据本发明的另一实施例，作为替代，上述柔性拉片512a、512b也可以是丝绳。例如，单股丝或多股缠绕丝之类的柔性部件。应当理解，上述柔性拉片、丝绳仅作为示例而非限制，本领域技术人员可以构想更多其他类似的柔性部件来实现执行器的弯转。这样的实现方式不应被解读成导致脱离了本发明的范围。
此外，还应当理解，以上所描述的各实施例还可在诸如整体式设计的腔镜吻合器之类的外科器械中实现。此外，各个实施例还可实现在诸如闭合器、电刀等其他产品中。
本发明的外科器械采用柔性部件来提供执行器相对于延长管远端的弯转，使执行器能够弯转更大的角度，从而适于更复杂临床条件下的医疗，例如可以在空间受限的部位(如胸腔和盆腔)更方便的实施手术，解决其他外科器械无法解决的问题。本发明的执行器可弯转大角度的外科器械能够完成各种疑难位置的病灶切除、组织切割和缝合等功能，使更多患者受益。
上述描述和图示仅作为说明性示例提供。对单数形式的权利要求元素的任 何引述，例如使用冠词“一”、“某”或“该”的引述不应解释为将该元素限定为单数。技术人员对于每种特定应用可用不同的方式来实现所描述的结构，但这样的实现方式不应被解读成导致脱离了本发明的范围。
提供所公开的实施例的先前描述是为了使本领域任何技术人员皆能制作或使用本发明。对这些实施例的各种修改对本领域技术人员来说将是显而易见的，且本文所定义的一般原理可被应用于其它实施例而不背离本发明的精神或范围。由此，本发明并非旨在限定于本文中示出的实施例，而是应被授予与所附权利要求和本文中公开的原理和新颖性特征一致的最广义的范围。

Claims (11)

  1. 一种外科器械，包括执行器、延长管和控制器，其中：
    所述延长管的近端与所述控制器连接，所述延长管的远端与所述执行器连接，所述执行器能相对于所述延长管的远端旋转；
    所述控制器包括控弯机构，所述控弯机构能向至少一个方向运动；
    所述延长管包括第一柔性部件，通过所述控弯机构向至少一个方向运动，所述第一柔性部件提供所述执行器相对于所述延长管的远端向至少一侧旋转。
  2. 如权利要求1所述的外科器械，其特征在于：
    所述延长管还包括第二柔性部件，所述第一柔性部件的远端与所述第二柔性部件的远端分别连接在所述执行器沿中心轴的两侧；
    所述控弯机构向第一方向运动时，将驱动所述第一柔性部件向其近端运动，所述第二柔性部件向其远端运动，进而驱动所述执行器相对于所述延长管的远端向第一侧旋转；
    所述控弯机构向第二方向运动时，将驱动所述第一柔性部件向其远端运动，所述第二柔性部件向其近端运动，进而驱动所述执行器相对于所述延长管的远端向第二侧旋转。
  3. 如权利要求2所述的外科器械，其特征在于：
    所述控弯机构包括齿轮、第一齿条、第二齿条；
    所述齿轮与所述第一齿条、所述第二齿条呈啮合装配；
    所述第一齿条与所述第一柔性部件的近端连接，所述第二齿条与所述第二柔性部件的近端连接。
  4. 如权利要求2所述的外科器械，其特征在于：
    所述延长管还包括钉匣套管、钉匣内管、控弯杆、齿轮、第一齿条、第二齿条，其中：
    所述钉匣内管与所述钉匣套管同轴布置；
    所述齿轮可转动地设置在所述钉匣内管上，所述第一齿条与所述第二齿条布置 在所述齿轮两侧，且所述齿轮与所述第一齿条、所述第二齿条呈啮合装配；
    所述控弯杆置于钉匣套管内，所述控弯杆的近端与所述控弯机构连接，所述控弯杆的远端与所述第一齿条固定连接，所述第一齿条还与所述第一柔性部件的近端固定连接，所述第二齿条与所述第二柔性部件的近端固定连接；
    所述控弯机构控制所述控弯杆的运动：当所述控弯杆向其近端运动时，所述控弯杆拉动所述第一齿条，进一步拉动所述第一柔性部件，通过所述第一柔性拉片拉动所述执行器相对于所述延长管的远端向所述第一侧旋转；当所述控弯杆向其远端运动时，所述控弯杆推动所述第一齿条，并通过所述齿轮进一步驱使所述第二齿条向近端方向运动，进而拉动所述第二柔性部件，通过所述第二柔性拉片拉动所述执行器相对于所述延长管的远端向所述第二侧旋转。
  5. 如权利要求4所述的外科器械，其特征在于：
    所述钉匣内管包括第一钉匣内管和第二钉匣内管，所述第一钉匣内管、所述第二钉匣内管与所述钉匣套管同轴布置，所述齿轮可转动地设置在所述第一钉匣内管或所述第二钉匣内管上。
  6. 如权利要求1所述的外科器械，其特征在于：
    所述执行器包括钉砧组件、钉仓组件，其中所述钉仓组件包括钉仓、一个或多个缝合钉、一个或多个推钉块、以及钉仓座；
    所述外科器械还包括驱动组件，所述驱动组件包括切割刀、以及柔性刀杆；
    所述钉砧组件的近端与所述钉仓座的近端可动地连接，所述驱动组件驱使所述执行器在第一状态与第二状态之间进行转换。
  7. 如权利要求1所述的外科器械，其特征在于：
    所述执行器相对于所述延长管的远端向至少一侧旋转的角度是0°至180°之间的任意数值。
  8. 如权利要求1所述的外科器械，其特征在于：
    所述延长管的远端与所述执行器通过一个或多个铰链连接，所述第一柔性拉片 不通过所述一个或多个铰链的中心，从而所述至少一个柔性拉片能以铰链为旋转轴，为所述执行器提供旋转扭矩，驱使所述执行器相对于所述延长管的远端向至少一侧旋转。
  9. 如权利要求1至8中任一项所述的外科器械，其特征在于：
    所述至少一个柔性部件是柔性拉片或丝绳。
  10. 一种可弯转的钉匣，包括钉匣主体、中间连接部分、执行器，所述钉匣主体通过中间连接部分与所述执行器连接，其中：
    所述钉匣主体包括控弯机构、以及至少一个柔性部件；
    所述控弯机构能向至少一个方向运动，通过所述控弯机构向至少一个方向运动，所述至少一个柔性部件提供所述执行器相对于所述钉匣主体向至少一侧旋转。
  11. 如权利要求10所述的钉匣，其特征在于：
    所述钉匣适用于腔镜吻合器。
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