WO2023065118A1 - 一种超声手术器械 - Google Patents

一种超声手术器械 Download PDF

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Publication number
WO2023065118A1
WO2023065118A1 PCT/CN2021/124742 CN2021124742W WO2023065118A1 WO 2023065118 A1 WO2023065118 A1 WO 2023065118A1 CN 2021124742 W CN2021124742 W CN 2021124742W WO 2023065118 A1 WO2023065118 A1 WO 2023065118A1
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WO
WIPO (PCT)
Prior art keywords
surgical instrument
ultrasonic surgical
inner sleeve
sleeve
instrument according
Prior art date
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PCT/CN2021/124742
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English (en)
French (fr)
Inventor
杨强
郑凤贤
雷焱阳
樊晓云
李三东
Original Assignee
天津瑞奇外科器械股份有限公司
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Application filed by 天津瑞奇外科器械股份有限公司 filed Critical 天津瑞奇外科器械股份有限公司
Priority to PCT/CN2021/124742 priority Critical patent/WO2023065118A1/zh
Publication of WO2023065118A1 publication Critical patent/WO2023065118A1/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
    • A61B17/32—Surgical cutting instruments

Definitions

  • the invention relates to the field of surgical instruments, in particular to an ultrasonic surgical instrument.
  • Ultrasonic surgical instruments also known as ultrasonic soft tissue cutting/hemostasis systems, are configured to achieve tissue cutting and coagulation during surgical operations. By setting different output power gears, the high power gear can cut tissue more quickly, and the low power gear can coagulate tissue better, so as to minimize the damage to the patient. It is mostly used in open surgery, laparoscopic or endoscopic surgery, and robot-assisted surgery.
  • Ultrasonic surgical instruments include handles, cutting heads, inner and outer sleeves, and a central rod for transmitting ultrasonic energy.
  • the distal end of the central rod is a knife.
  • the blades of ultrasonic surgical instruments tend to be slender, but the slender blades tend to be deformed when the scissors act on them due to the deterioration of strength, and eventually As a result, the consistency of the loading force acting on the tissue is poor, and it is prone to the problem that some tissues are not cut or coagulated.
  • the technical problem to be solved by the present invention is that the existing ultrasonic surgical instruments act on the tissue with poor consistency of loading force, and the problem that some tissues are not cut or coagulated easily occurs.
  • the present invention provides following technical scheme:
  • An ultrasonic surgical instrument comprising: a central rod for transmitting ultrasonic energy, the distal end of which is connected to a cutting head; a shear head pivotable relative to the cutting head, the cutting head having an open position and a closed position position, in the open position, at least a portion of the shear head is spaced from the knife head, and in the closed position, the shear head is adjacent to the knife head and is used to cut between the shear head and the knife head Tissue; an inner sleeve and an outer sleeve, the inner sleeve is sleeved on the central rod, the outer sleeve is sleeved on the inner sleeve, and the cutting head is pivotally connected to the outer sleeve on the distal end of the inner sleeve, the distal end of the inner sleeve acts on the shear head, the inner sleeve slides relative to the outer sleeve and drives the shear head to pivot relative to the cutter
  • the inner side of the first abutting portion abuts against the outer wall of the inner sleeve or is integrally formed with the outer wall of the inner sleeve, and the outer side of the first abutting portion abuts against the outer wall of the inner sleeve.
  • the first conflicting portion is at least one clip disposed between the inner sleeve and the outer sleeve.
  • grooves are provided on the outer wall of the inner sleeve and/or the inner wall of the outer sleeve, and the clips are located in the grooves.
  • the clip is elongated and extends along the axial direction of the inner sleeve and the outer sleeve.
  • the clamping piece is circular, and surrounds the annular space between the inner sleeve and the outer sleeve.
  • the first interference portion is integrally formed on the tube wall of the inner sleeve and is at least one first protrusion protruding outward.
  • the first protrusion is shaped as a long strip extending along the axial direction of the inner sleeve.
  • the first protrusions are uniformly arranged along the circumferential direction of the inner sleeve.
  • the first protrusion is formed in a ring shape, a spiral ring shape or an arc shape arranged along the circumference of the inner sleeve.
  • the first protrusions are shaped as arc-shaped protrusions distributed in a matrix along the axial direction of the inner sleeve and its circumferential direction.
  • the first interference portion is integrally formed on the tube wall of the outer tube and is at least one second protrusion protruding inward.
  • the second protrusion is shaped as a long strip extending along the axial direction of the outer sleeve.
  • the second protrusions are uniformly arranged along the circumference of the outer sleeve.
  • the second protrusion is formed into a circular ring, a spiral ring or an arc shape surrounding the inner wall of the outer sleeve.
  • the second protrusions are shaped as arc-shaped protrusions distributed in a matrix along the axial direction of the inner sleeve and its circumferential direction.
  • At least one sealing support part is provided between the inner sleeve and the central rod, and the sealing support part is located at a node of the central rod.
  • the first interference portion is located at a corresponding support position of the most distal sealing support portion.
  • the distal end of the first interference part is located at the distal end of the most distal sealing support part, and the proximal end of the first interference part is located at the most distal end of the sealing support part. the distal or proximal side of the sealing support.
  • the proximal end of the first interference part is located at the proximal end of the most distal sealing support part, and the distal end of the first interference part is located at the most distal end of the sealing support part. the distal or proximal side of the sealing support.
  • the first interference part is placed between the most distal end of the inner and outer sleeves and the proximal 50 mm of the sealing support part.
  • the first interference part is placed between the distal 5 mm of the sealing support part and the proximal 5 mm of the sealing support part.
  • the axial length of the first conflicting portion and the conflicting support surface of the inner sleeve or the outer sleeve is no more than 30 mm.
  • the axial length of the first conflicting part and the conflicting support surface of the inner sleeve or the outer sleeve is no more than 15 mm.
  • the length of the first conflicting part and the conflicting support surface of the inner sleeve or the outer sleeve along the circumference of the inner and outer sleeves does not exceed 50% of the inner circumference of the outer sleeve or the outer circumference of the inner sleeve 50% of.
  • the gap between the inner sleeve and the outer sleeve is further reduced by setting the first conflicting part on the distal side of the outer sleeve, so that the cutting head pivots toward the direction of the cutting head.
  • the position offset of the cutter head along its radial direction is almost zero under the support of the distal end of the inner sleeve and the outer sleeve, so that the force on the cutter head from the distal end to the proximal end gradually increases.
  • the ultrasonic energy of the head is gradually reduced from the distal end to the proximal end, and finally the loading of the end effector is more consistent from the proximal end to the distal end, so that the tissue is cut or coagulated at one time.
  • Fig. 1 is a schematic structural view of a specific embodiment of the ultrasonic surgical instrument of the present invention
  • Fig. 2 is an exploded view of a specific embodiment of the ultrasonic surgical instrument of the present invention
  • Fig. 3 is an exploded view of an end effector in a closed state in a specific embodiment of the ultrasonic surgical instrument of the present invention
  • Fig. 4 is an exploded view of an end effector in an open state of a specific embodiment of the ultrasonic surgical instrument of the present invention
  • Fig. 5 is a cross-sectional view of a specific embodiment of the ultrasonic surgical instrument of the present invention.
  • Fig. 6 is a force comparison diagram of the cutter head under the condition of different central rod diameters of the existing common ultrasonic instruments
  • Fig. 7 is a schematic structural view of the first structural form of the first interference part in the present invention.
  • Fig. 8 is a structural schematic diagram of a specific embodiment of the second structural form of the first interference part in the present invention.
  • Fig. 9 is a structural schematic diagram of a specific embodiment of the second structural form of the first interference part in the present invention.
  • Fig. 10 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 11 is a schematic structural view of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 12 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 13 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 14 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 15 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 16 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 17 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 18 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 19 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 20 is a structural schematic diagram of a specific embodiment of the third structural form of the first interference part in the present invention.
  • Fig. 21 is a force diagram of the cutter head of the ultrasonic surgical instrument of the present invention.
  • Fig. 22 is a comparison diagram of the deformation of the ultrasonic surgical instrument in the prior art and the present invention when the end actuator assembly is clamped.
  • distal side/end refers to a part or part of a component, instrument and/or device that is farther away from the user (for example, a doctor using the instrument), and
  • proximal/end refers to that part of the component, instrument and/or device, or part thereof, that is closer to the user.
  • first, second, and “third” are used for descriptive purposes only, and should not be construed as indicating or implying relative importance.
  • connection should be understood in a broad sense, for example, it can be fixed connection, detachable connection, or integral connection; it can be directly connected or indirectly connected through an intermediary, is the connection between two components.
  • connection should be understood in a broad sense, for example, it can be fixed connection, detachable connection, or integral connection; it can be directly connected or indirectly connected through an intermediary, is the connection between two components.
  • the present application relates generally to a medical device, and in particular to an ultrasonic surgical instrument, sometimes referred to as ultrasonic scissors, that can be used to cut tissue, coagulate tissue, and/or clamp tissue during a surgical procedure, whether in In open surgery or in laparoscopic surgery or endoscopic surgery.
  • an ultrasonic surgical instrument sometimes referred to as ultrasonic scissors
  • the surgical instruments described herein can also be used to grasp and manipulate tissue without the use of ultrasonic vibration of the end effector.
  • the surgical instrument can be used to clamp tissue to coagulate tissue as well as cut tissue depending on the amount of pressure applied by the clamp arms.
  • Clamping arms also referred to as shear heads, may be selectively deployable so that end effector assembly 40 may be used without clamping to apply ultrasonic energy to tissue.
  • the ultrasonic surgical instrument is used in open surgery, laparoscopy or surgical operation of cutting action; the ultrasonic surgical instrument includes an ultrasonic transducer 10, a handle assembly 20, a transmission assembly 30 and an end arranged in sequence from the proximal end to the distal end Execution component 40.
  • the ultrasonic transducer 10 is connected with the ultrasonic generator through a cable, and the electric power input by the ultrasonic generator is converted into mechanical power, that is, ultrasonic waves are transmitted, and the transmission assembly 30 transmits the ultrasonic energy to the end effector assembly 40, and the handle assembly 20 is suitable for the operator to manipulate the ultrasonic surgical instrument, and the handle assembly 20 can control the movement of the end effector assembly 40 through the transmission assembly 30 to perform cutting/hemostasis operations.
  • the shape of the handle assembly 20 can be held by the user in a conventional manner.
  • the ultrasonic surgical instrument controls the closure of the end effector assembly 40 through a trigger-shaped arrangement.
  • the handle assembly 20 includes a main housing 21 and a handle 22 extending downward from the main housing 21 .
  • the handle assembly 20, and in particular the handle 22 of the handle assembly 20, is adapted, in use, to be held by a medical practitioner to facilitate the grasping and manipulation of the surgical instrument while isolating the medical practitioner from ultrasonic vibrations.
  • a trigger 23 is mounted on the handle assembly 20 for pivotal movement towards and away from the handle 22 to cause a closing action of the end effector assembly 40 .
  • the handle assembly 20 is also provided with a button 24 for pressing toward the handle to induce the action of ultrasonic energy on the end effector assembly 40 .
  • the handle assembly 20 may have any of various alternative forms, such as a scissor handle arrangement.
  • the proximal end of the main housing 21 is open so that the transducer can be inserted into the main housing 21 , and the ultrasonic transducer 10 is inserted into the main housing 21 .
  • the handle assembly 20 includes first and second half shells 21A, 21B that cooperate with each other, the first half shell 21A and the second half shell 21B are welded, glued, , snap connection, etc. are connected together along the seam. It is understood that the handle assembly 20 may be a one-piece structure, or a structure in which more than two mating parts are connected together in various ways.
  • the handle assembly 20 and the trigger 23 can be made of suitable sterilizable plastic materials or other sterilizable materials such as various metal materials.
  • the end effector assembly 40 of the ultrasonic surgical instrument includes a cutter head 41 and a shear head 42 (also called a clamping arm) capable of pivoting relative to the cutter head 41.
  • the shear head 42 has an open position and a closed position. In the open position, at least a part of the cutting head 42 is spaced apart from the cutting head 41. In the closed position, the cutting head 42 is close to the cutting head 41 and used for cutting The tissue between the cutter heads 41 is described.
  • the instrument can have the transmission assembly 30 configured as an elongated tubular body with an outer diameter of 5.45-5.55 mm, and the transmission assembly 30 extends distally from the instrument handle assembly 20 .
  • the transmission assembly 30 includes a central rod 31 for transmitting the ultrasonic energy of the ultrasonic transducer 10 to the cutter head 41, an inner sleeve 32 sleeved on the central rod 31, and an inner sleeve sleeved on the inner sleeve.
  • the outer sleeve 33 is axially fixed relative to the handle assembly 20
  • the shear head 42 is pivotally connected to the outer sleeve 33
  • one end of the inner sleeve 32 is connected to
  • the operating mechanism of the handle assembly 20 is connected, and the other end acts on the shearing head 42.
  • the operating mechanism triggers the inner sleeve 32 to reciprocate axially relative to the outer sleeve 33 to drive the shearing head 42 around the pivot on the outer sleeve 33.
  • the shaft pivots.
  • the central rod 31 can be made of various materials, especially various medically or surgically acceptable metal materials, such as titanium, titanium alloy (eg Ti6Al4V), aluminum, aluminum alloy or stainless steel.
  • various medically or surgically acceptable metal materials such as titanium, titanium alloy (eg Ti6Al4V), aluminum, aluminum alloy or stainless steel.
  • the bit 41 and the central rod 31 are integrally formed, for example milled from a metal rod, to provide the desired characteristics.
  • the distal end of the cutter head 41 is arranged close to the anti-node anti-node to adjust the acoustic assembly to a preferred resonance frequency when the acoustic assembly is not loaded with tissue.
  • the distal end of the cutter head 41 The tip is configured to move longitudinally, for example, in a peak-to-peak range of about 10 to 100 microns, eg at a predetermined vibration frequency f0 of 55,500 Hz, the cutter head 41 preferably moves longitudinally in a range of about 20 to about 90 microns.
  • the cutting head 42 is connected with a cutting pad 43 , and the cutting head 42 and the cutting pad 43 are connected to the distal ends of the outer casing 33 and the inner casing 32 .
  • the shear pad 43 is made of a low coefficient of friction polymer material, or may be formed of any other suitable low friction material.
  • a shear pad 43 is mounted on the shear head 42 for cooperation with the cutting head 41, pivotal movement of the cutting head 42 positions the shear pad 43 substantially parallel to and in contact with the cutting head 41, thereby defining the tissue treatment area. With such a structure, the tissue is caught between the shear pad 43 and the cutter head 41 .
  • the scissor pad 43 may be provided with a non-smooth surface, such as a serration, in combination with the knife head 41 to enhance grip on tissue.
  • the serration or teeth may provide traction against knife movement.
  • the teeth can also provide opposing pull on the movement of the knife and jaws.
  • the serrations are only one of a variety of tissue engaging surfaces used to prevent movement of tissue relative to the knife head 41 Example.
  • Other exemplary embodiments include protrusions, cross-shaped patterns, tread patterns, shot or sand blasted surfaces, and the like.
  • the pivotal movement of the shearing head 42 relative to the cutting head 41 is realized by providing a pair of pivot points on the shearing head 42 , and the pair of pivot points are respectively engaged with the outer sleeve 33 and the inner sleeve 32 .
  • the outer sleeve 33 is fixedly connected with the handle assembly 20 .
  • the shear head 42 is pivotally connected to the outer sleeve 33 via the first through hole 421 on the shear head 42 and the corresponding second through hole 331 on the outer sleeve 33 .
  • a fastening pin or rivet slides through the first through hole 421 and said second through hole 331 to pivotally connect the shear head 42 to the outer sleeve 33 .
  • the inner sleeve 32 moves along the longitudinal axis of the outer sleeve 33.
  • Pivot pin 422 on shear head 42 engages pivot hole 321 at the distal end of inner sleeve 32 .
  • the reciprocating movement of the inner sleeve 32 relative to the outer sleeve 33 causes the shear head 42 to pivot relative to the cutting head 41 .
  • the central rod 31, the outer sleeve 33 and the inner sleeve 32 are connected to each other through a male bayonet connector assembly 34, so that it can be rotated as a whole with the ultrasonic transducer 10 relative to the handle assembly 20 by means of a knob 35, the central rod 31 extends into the main housing 21 of the handle assembly 20 through the knob 35 .
  • the outer casing 33 and the central rod 31 can be rotated by the knob 35, and then the end effector assembly 40 and the shearing head 42 connected thereto can be adjusted to a desired direction.
  • knob 35 During use, rotation of knob 35 relative to handle assembly 20 causes rotation of outer sleeve 33 , central rod 31 , and ultrasonic transducer 10 operably connected thereto relative to handle assembly 20 .
  • the knob 35 also serves to retain a portion of the bayonet connector assembly 34 within the handle assembly 20, and thereby, maintain the surgical instrument in an assembled state.
  • the reciprocating motion of the inner sleeve 32 drives the shear head 42 to open or close, and the force limiting mechanism 36 is operably connected to the inner sleeve 32, which includes a sleeve ring cap 361 that connects the distal gasket 362, distal Wave spring 363 , proximal washer 364 and proximal wave spring 365 are secured to collar 366 .
  • Collar 366 includes axially extending lugs that engage suitable openings in the proximal portion of tubular inner sleeve 32 .
  • a circumferential groove of the inner sleeve 32 receives an O-ring 367 for engagement with the inner surface of the outer sleeve 33 .
  • Tubular inner sleeve 32 includes an elongated slot through which connector pin 37 extends to provide reciprocating movement of inner sleeve 32 relative to outer sleeve 33 and central rod 31 .
  • the pivoting movement of the shear head 42 is effected by the reciprocating movement of the inner sleeve 32 .
  • the transmission assembly also includes a drive yoke 38 operatively connected to the trigger 23 whereby the trigger 23 and the reciprocatable inner sleeve 32 are connected to each other via the drive yoke 38 and the force limiting mechanism 36 .
  • Trigger 23 is rotatably connected to drive yoke 38 via a pin and link, and is rotatably connected to drive yoke 38 and main housing 21 via a post.
  • Movement of trigger 23 toward the handle moves inner sleeve 32 proximally, thereby pivoting shear head 42 toward knife head 41 .
  • the pulling action provided by the trigger 23 and cooperating handle 22 facilitates efficient manipulation and positioning of the instrument as well as pivoting of the scissor head 42 at the distal end of the instrument to the side of the knife head 41 whereby tissue is effectively driven against the knife head 41 on.
  • Movement of the trigger 23 away from the handle 22 moves the inner sleeve 32 distally, thereby pivoting the shear head 42 in a direction away from the cutting head 41 .
  • the end effector 40 acts on a thicker tissue, it is necessary to manipulate the trigger 23 with greater force to strengthen the tissue, and the force of the cutting head 42 in the Z direction is relatively large, so that the cutter head 41 tends to move in the Z direction, and the inner
  • the assembly gap between the outer sleeves can allow the cutter head 41 to move in the Z direction.
  • the central rod 31 fastened or integrated with the cutter head 41 abuts against the inner sleeve 32 through the sealing support portion 39 without gap, and there is an assembly gap between the inner and outer sleeves.
  • the above-mentioned pair of pivot points forms a straight line that is inclined to the left (it can also be considered that the formed line is inclined to the right).
  • the far end B of the end effector assembly 40 Closed, but there is still a large gap at the proximal end C.
  • There is a large gap at the proximal end C which is like clamping tissue, and the pressure is relatively small.
  • the ultrasonic energy on the cutter head 41 tends to increase gradually from the proximal end to the distal end, in order to make the loading of the cutter head 41 from the proximal end to the distal end of the cutter head 41 consistent when the end effector 40 cuts/hemostasis tissue, it is necessary to make the blade
  • the force on the head 41 tends to decrease gradually from the proximal end to the distal end.
  • the inner sleeve 32 and the outer sleeve 33 are provided with a first interference portion on the distal side of the two, and the first interference portion forms a support between the inner sleeve 32 and the outer sleeve 33, so that The gap at the distal end of the inner and outer sleeves is close to zero, which can prevent the radial gap between the inner and outer sleeves from changing without affecting the relative sliding movement of the inner and outer sleeves, that is, the cutter head is affected by the cutting head along the Z direction
  • the offset distance of the inner sleeve 32 along the Z direction is close to zero, which avoids the change of the radial gap between the inner and outer sleeves.
  • the inner side of the first conflicting portion abuts against the outer wall of the inner sleeve 32 or is integrally formed with the outer wall of the inner sleeve 32 , and the outer side of the first conflicting portion contacts the inner wall of the outer sleeve 33 integrally formed or abutted against the inner wall of the outer sleeve 33 .
  • the gap between the inner sleeve 32 and the outer sleeve 33 is further reduced by providing the first interference portion on the distal end side. As shown in FIG.
  • the shear head 42 approaches the knife
  • the head 41 is pivoted in the direction of tissue cutting/hemostasis, under the support of the distal ends of the inner sleeve 32 and the outer sleeve 33, the displacement of the cutter head 41 along its radial Z direction is reduced, which is almost zero.
  • the distal end B of the end effector assembly 40 is closed, and the gap at the proximal end C is small, so that the force on the cutter head 41 gradually increases from the distal end to the proximal end.
  • Fig. 6 (a) shows that the first existing common ultrasonic surgical instrument with a central rod diameter of D1 is a stress situation diagram of the cutter head when performing tissue cutting
  • Fig. 6 (b) shows that the central rod diameter is D1
  • Figure 6 (c) shows that the first existing common ultrasonic surgical instrument with a central rod diameter of D2 is performing tissue cutting
  • Figure 6(d) shows the stress situation diagram of the cutter head when the second conventional ultrasonic surgical instrument with a central rod diameter of D2 performs tissue cutting.
  • D2 ⁇ D1 the first conventional ultrasonic surgical instrument and the second conventional ultrasonic surgical instrument have different specific structures or different manufacturers, but none adopt the above-mentioned embodiment of the present invention.
  • the force on the cutter head basically presents a trend of gradually decreasing from the proximal end to the distal end;
  • the force on the cutter head fluctuates greatly, and there is no trend of gradually decreasing from the proximal end to the distal end.
  • Figure 21 shows the stress on the cutter head of the ultrasonic surgical instrument with a central rod diameter of D2 that adopts the above-mentioned embodiment of the present invention when performing tissue cutting, and the force on the cutter head shows a gradual decrease from the proximal end to the distal end the trend of.
  • At least one sealing support portion 39 is provided between the inner sleeve 32 and the central rod 31; in a specific embodiment, a plurality of grooves for installing the sealing support portion 39 are formed in the outer periphery of the central rod 31 Or the notch, the groove is located at the node of the central rod 31, since the ultrasonic amplitude at the node of the central rod 31 is zero, the sealing support part 39 is set at this position, and the effective support of the central rod 31 can be realized without affecting the center rod 31. Ultrasonic transmission.
  • the sealing supporting part 39 is specifically a sealing rubber ring arranged in the groove, and the sealing rubber ring is made of flexible materials such as silica gel.
  • the sealing support part 39 arranged at the most distal node is closest to the end effector assembly 40 , and the seal can also prevent tissue residual fluid generated when the end effector assembly 40 cuts from passing between the central rod 31 and the inner sleeve 32 Enter the interior of the transmission assembly 30 in the area.
  • the first interference portion extends proximally to the position of the sealing support portion 39 on the most distal side.
  • the central rod 31 is effectively supported on the distal side of the inner and outer sleeves 33 .
  • the first interference part is placed between the most distal end of the inner or outer sleeve 33 and 50 mm from the proximal side of the sealing support part 39, preferably, It is placed between 5 mm from the far side of the sealing support part 39 and 5 mm from the near side thereof, so as to realize a more stable support for the central rod 31 .
  • the length of the first conflicting part and the conflicting support surface of the inner sleeve 32 or the outer sleeve 33 along the circumference of the inner and outer sleeves does not exceed 50% of the inner circumference of the outer sleeve or 50% of the outer circumference of the inner sleeve.
  • the first interference portion is located at a support position corresponding to the most distal sealing support portion 39 . That is, the axial position and length of the first interference portion correspond to the axial position and length of the sealing support portion 39 , respectively.
  • the distal end of the first conflicting portion is located at the distal end of the most distal sealing support portion 39, and the proximal end of the first conflicting portion is located at the distal end of the sealing support portion 39.
  • the seal support portion 39 is distal or proximal.
  • This embodiment includes two cases. In one case, the first interference part is located at the distal end of the most distal sealing support part 39 as a whole, and in another case, the first interference part is partially located at the most distal end of the sealing support part 39. The distal end of the sealing support part 39 is partially located at the proximal end of the most distal sealing support part 39 .
  • the proximal end of the first conflicting portion is located at the proximal end of the most distal sealing support portion 39, and the distal end of the first conflicting portion is located at the distal end of the sealing support portion 39.
  • the seal support portion 39 is distal or proximal.
  • This embodiment also includes two cases. In one case, the first interference portion is entirely located at the proximal end of the most distal sealing support portion 39 , and in another case, the first interference portion is partially located at all of the most distal end. The proximal end of the sealing support portion 39 is partially located at the distal end of the most distal sealing support portion 39 . Three main structural forms of the first conflicting portion are introduced respectively below.
  • the first conflicting portion is at least one clip A disposed between the inner sleeve 32 and the outer sleeve 33 .
  • the processing difficulty of the inner and outer sleeves 33 can be reduced by arranging the clip A independent of the inner sleeve 32 and the outer sleeve 33 .
  • the surface of the clip A is shaped to match the arc surface of the tube wall of the inner and outer sleeves 33, so that the clip A has a larger distance from the outer tube wall of the inner tube 32 and the inner tube wall of the outer tube 33. contact area to achieve stable support for the central rod 31 .
  • the clips A are uniformly distributed along the circumferential direction. The length of the clip A arranged along the circumference of the inner and outer sleeves does not exceed 50% of the inner circumference of the outer sleeve 33 or 50% of the outer circumference of the inner sleeve 32 .
  • the outer wall of the inner sleeve 32 and/or the inner wall of the outer sleeve 33 are provided with grooves, and the clip A is located at the In the above-mentioned groove, the position of clip A is limited.
  • the clip A is elongated and extends along the axial direction of the inner sleeve 32 and the outer sleeve 33, and the clip A extends to the most distal sealing support portion 39 at the location.
  • the clip A is in the shape of a ring, which surrounds the annular gap between the inner sleeve 32 and the outer sleeve 33 .
  • the length of the clip A along the axial direction is not more than 30mm, and the distal end of the clip A is located at the distal end of the most distal sealing support part 39, and the proximal end of the clip A is The portion is located on the proximal side of the most distal sealing support portion 39 .
  • the first interference part is integrally formed on the outer wall of the inner sleeve 32 and protrudes outwards from the first protrusion 322, and the convex surface of the first protrusion 322 resists Connected to the inner wall of the outer sleeve 33.
  • the first interference portion in this structural form can be integrally formed by the inner sleeve 32, and the manufacturing cost is reduced.
  • the first protrusion 322 is shaped as a long strip extending along the axial direction of the inner sleeve 32 . More specifically, the first protrusions 322 are evenly arranged along the circumference of the inner sleeve 32, and the first protrusions 322 are from the most distal end of the inner or outer sleeve to the proximal side of the sealing support portion 39 Preferably, it is placed between 5 mm from the far side of the sealing support part 39 and 5 mm from the proximal side thereof, so as to achieve a more stable support for the central rod 31 .
  • the length of the first protrusion 322 against the supporting surface of the inner sleeve 32 or the outer sleeve 33 along the circumferential direction of the inner sleeve and the outer sleeve does not exceed 50% of the inner circumference of the outer sleeve or 50% of the outer circumference of the inner sleeve.
  • the first protrusion 322 is shaped like a circular ring, and may also be shaped like a spiral ring or an arc.
  • first protrusions 322 in the shape of an annular or circular arc can be arranged side by side, and the plurality of first protrusions 322 are arranged at intervals along the axial direction of the inner sleeve 32 until the seal near the farthest end Where the support part 39 is located.
  • the first protrusions 322 are shaped as arc-shaped protrusions distributed in a matrix along the axial direction of the inner sleeve 32 and its circumferential direction, for example, along the inner sleeve 32
  • One arc-shaped protruding point is provided at an interval of 3-5 mm in the axial direction of the inner sleeve 32
  • one arc-shaped protruding point is provided at an interval of 20-30 degrees along the circumferential direction of the inner sleeve 32 .
  • the first interference part is integrally formed on the inner wall of the outer sleeve 33 and protrudes inwardly to the second protrusion 332, and the convex surface of the second protrusion 332 abuts against the On the outer wall of the inner casing 32.
  • the second protrusion 332 is integrally formed on the outer sleeve 33 , and the manufacturing cost is reduced.
  • the second protrusion 332 is shaped as a strip extending along the axial direction of the outer sleeve 33, and the second protrusion 332 is formed along the axis of the outer tube 33.
  • the circumferential direction of the outer sleeve 33 is uniformly arranged, the distal end of the second protrusion 332 is located at the distal end of the most distal sealing support portion 39, and the proximal end of the clip A is located at the most distal end.
  • the near side of the sealing support part 39 is uniformly arranged, the distal end of the second protrusion 332 is located at the distal end of the most distal sealing support portion 39, and the proximal end of the clip A is located at the most distal end.
  • the sealing support part 39 is placed between 5 mm from the far side of the sealing support part 39 and 5 mm from the proximal side thereof, so as to achieve more stable support for the central rod 31 .
  • the length of the contact support surface between the second protrusion 332 and the inner sleeve or the outer sleeve along the circumference of the inner and outer sleeves does not exceed 50% of the inner circumference of the outer sleeve 33 or 50% of the outer circumference of the inner sleeve 32 .
  • the second protrusion 332 is formed into a circular ring, a spiral ring or an arc shape surrounding the inner wall of the outer sleeve.
  • several arc-shaped second protrusions 332 can be arranged side by side, and several second protrusions 332 are arranged at intervals along the axial direction of the outer sleeve 33 until it is close to the most The location of the sealing support part 39 at the distal end.
  • the spiral ring-shaped second protrusion 332 is located close to the sealing support portion 39 .
  • the annular second protrusion 332 is located at the distal end of the outer sleeve 33, wherein the second protrusion 332 in Fig. 16 and Fig. 17
  • the second protrusion 332 in FIG. 18 is formed by bending the end of the outer sleeve 33 inwards.
  • the integral molding method of the outer sleeve 33 and the second protrusion 332 is not limited to the above two methods, and forming the second protrusion 332 with the above structural features by other mechanical processing methods falls within the protection scope of the present application.
  • the second protrusions 332 are shaped as arc-shaped protruding points distributed in a matrix along the axial direction of the outer sleeve 33 and its circumferential direction, for example, along the One arc-shaped protruding point is arranged at an interval of 3-5 mm in the axial direction of the outer sleeve 33 , and one arc-shaped protruding point is arranged at an interval of 20-30 degrees along the circumferential direction of the outer sleeve 33 .

Abstract

一种超声手术器械，属于手术器械领域。包括：用于传递超声能量的中心杆(31)，中心杆(31)的远端连接刀头(41)；能够相对于刀头(41)枢转的剪头(42)，剪头(42)具有打开位置和闭合位置；内套管(32)与外套管(33)，内套管(32)套设于中心杆(31)上，外套管(33)套设于内套管(32)上，剪头(42)枢转地连接于外套管(33)的远端上，内套管(32)的远端作用于剪头(42)上，内套管(32)相对外套管(33)滑动并带动剪头(42)相对刀头(41)枢转；还包括设置于内套管(32)与外套管(33)远端侧的第一抵触部，第一抵触部在内套管(32)和外套管(33)之间形成支撑，以在不影响内外套管(33)相对滑动运动的前提下，防止内外套管(32,33)之间的径向间隙变化。解决了现有超声手术器械作用在组织上加载力一致性较差，部分组织未被切断或凝结的问题。

Description

一种超声手术器械 技术领域
本发明涉及外科器械领域，特别涉及一种超声手术器械。
背景技术
超声手术器械，又称超声软组织切割/止血系统，其被构造为在外科手术中实现组织切割、凝结。通过设置不同的输出功率档位，高功率档位可更快速地切割组织，低功率档位可更好地凝闭组织，从而使对患者的损伤最小。多用在开放式外科手术、腹腔镜或内窥镜手术以及机器人辅助的外科手术中。
超声手术器械的切割动作通常是通过位于器械远端处的端部执行组件来实现的，超声手术器械包括手柄、剪头、内外套管、传递超声能量的中心杆，中心杆的远端为刀头；医生通过挤压手柄或者把手来致动剪头，以使其压靠刀头；刀头则将超声能量传到患者的组织上，摩擦产生的热量导致与刀头接触的组织细胞内水汽化，蛋白质氢键断裂，细胞崩解重新融合，组织凝固后被切开；在切割血管时，刀头与组织蛋白接触，通过机械振动产生热量，导致组织内胶原蛋白结构被破坏，造成蛋白凝固，进而封闭血管，达到止血目的。为了使被切割的组织损伤面更小，超声手术器械的刀头具有向细长化发展的趋势，但是细长的刀头容易因强度变差而使剪头作用在其上时发生形变，最终导致作用在组织上加载力一致性较差，易出现部分组织未被切断或凝结的问题。
发明内容
本发明要解决的技术问题是现有超声手术器械作用在组织上加载力一致性较差，易出现部分组织未被切断或凝结的问题。
针对上述技术问题，本发明提供如下技术方案：
一种超声手术器械，包括：用于传递超声能量的中心杆，所述中心杆的远端连接刀头；能够相对于所述刀头枢转的剪头，所述剪头具有打开位置和闭合位置，在打开位置，所述剪头的至少一部分与所述刀头间隔开，在闭合位置，所述剪头靠近所述刀头并用于切割位于所述剪头与所述刀头之间的组织；内套管与外套管，所述内套管套设于 所述中心杆上，所述外套管套设于所述内套管上，所述剪头枢转地连接于所述外套管的远端上，所述内套管的远端作用于所述剪头上，所述内套管相对所述外套管滑动并带动所述剪头相对所述刀头枢转；还包括设置于所述内套管与所述外套管远端侧的第一抵触部，所述第一抵触部在内套管和外套管之间形成支撑，以在不影响内外套管相对滑动运动的前提下，防止内外套管之间的径向间隙变化。
本发明的部分实施方式中，所述第一抵触部的内侧抵接于所述内套管外壁上或与所述内套管外壁一体成型，所述第一抵触部的外侧抵接于所述外套管内壁上或与所述外套管内壁一体成型。
本发明的部分实施方式中，所述第一抵触部为设置于所述内套管与所述外套管之间的至少一个夹片。
本发明的部分实施方式中，所述内套管的外壁和/或所述外套管的内壁设有凹槽，所述夹片位于所述凹槽内。
本发明的部分实施方式中，所述夹片为长条形，其沿所述内套管与所述外套管的轴线方向延伸。
本发明的部分实施方式中，所述夹片为圆环形，其环绕于所述内套管与所述外套管之间的环形空隙内。
本发明的部分实施方式中，所述第一抵触部为一体成型于所述内套管的管壁上并向外侧突出的至少一个第一凸起。
本发明的部分实施方式中，所述第一凸起成型为沿所述内套管轴线方向延伸的长条形。
本发明的部分实施方式中，所述第一凸起沿所述内套管的周向均匀排布。
本发明的部分实施方式中，所述第一凸起成型为沿所述内套管周向设置的圆环形、螺旋环形或圆弧形。
本发明的部分实施方式中，所述第一凸起成型为沿所述内套管轴线方向及其周向矩阵分布的圆弧形凸点。
本发明的部分实施方式中，所述第一抵触部为一体成型于所述外套管的管壁上并向内侧突出的至少一个第二凸起。
本发明的部分实施方式中，所述第二凸起成型为沿所述外套管轴 线方向延伸的长条形。
本发明的部分实施方式中，所述第二凸起沿所述外套管的周向均匀排布。
本发明的部分实施方式中，所述第二凸起成型为环绕于所述外套管内壁上的圆环形、螺旋环形或圆弧形。
本发明的部分实施方式中，所述第二凸起成型为沿所述内套管轴线方向及其周向矩阵分布的圆弧形凸点。
本发明的部分实施方式中，所述内套管与所述中心杆之间设置至少一个密封支撑部，所述密封支撑部位于所述中心杆的节点处。
本发明的部分实施方式中，第一抵触部位于最远端的所述密封支撑部对应支撑位置。
本发明的部分实施方式中，所述第一抵触部的远端端部位于最远端的所述密封支撑部的远端，所述第一抵触部的近端端部位于最远端的所述密封支撑部远侧或近侧。
本发明的部分实施方式中，所述第一抵触部的近端端部位于最远端的所述密封支撑部的近端，所述第一抵触部的远端端部位于最远端的所述密封支撑部远侧或近侧。
本发明的部分实施方式中，所述第一抵触部，在内外套管最远端至所述密封支撑部的近侧50mm之间放置。
本发明的部分实施方式中，所述第一抵触部，在所述密封支撑部的远侧5mm至所述密封支撑部的近侧5mm之间放置。
本发明的部分实施方式中，所述第一抵触部与内套管或外套管的抵触支撑面，沿轴向设置的长度不超过30mm。
本发明的部分实施方式中，所述第一抵触部与内套管或外套管的抵触支撑面，沿轴向设置的长度不超过15mm。
本发明的部分实施方式中，所述第一抵触部与内套管或外套管的抵触支撑面，沿内外套管周向设置的长度不超过外套管内周长的50％或内套管外周长的50％。
本发明的技术方案相对现有技术具有如下技术效果：
本发明提供的超声波手术器械中，通过在内套管与外套管的远端 侧设置第一抵触部使两者之间的间隙进一步减小，这样，在剪头向接近刀头的方向上枢转以对组织进行切割时，刀头在内套管与外套管远端的支撑下沿其径向的位置偏移几乎为零，使刀头由远端至近端的受力逐渐增大，由于刀头的超声能量由远端至近端逐渐减小，最终使端部执行组件由近端至远端加载一致性较好，使组织被一次性切断或凝结。
附图说明
下面将通过附图详细描述本发明中优选实施例，将有助于理解本发明的目的和优点，其中:
图1为本发明的超声手术器械的一种具体实施方式的结构示意图；
图2为本发明的超声手术器械的一种具体实施方式的爆炸图；
图3为本发明的超声手术器械的一种具体实施方式中端部执行部件关闭状态下的爆炸图；
图4为本发明的超声手术器械的一种具体实施方式中端部执行部件打开状态下的爆炸图；
图5为本发明的超声手术器械的一种具体实施方式的剖视图；
图6为现有普通超声器械在不同中心杆杆径情况下的刀头受力对比图；
图7为本发明中第一抵触部的第一种结构形式的结构示意图；
图8为本发明中第一抵触部的第二种结构形式的其中一种具体实施方式的结构示意图；
图9为本发明中第一抵触部的第二种结构形式的其中一种具体实施方式的结构示意图；
图10为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图11为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图12为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图13为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图14为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图15为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图16为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图17为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图18为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图19为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图20为本发明中第一抵触部的第三种结构形式的其中一种具体实施方式的结构示意图；
图21为本发明超声手术器械的刀头受力图；
图22为现有技术与本发明的超声手术器械在端部执行组件夹持作用时的变形对比图。
具体实施方式
下面将结合附图对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
在本发明的描述中，需要说明的是，术语“远侧/端”是指零部件、仪器和/或装置的较远离使用者(例如，使用该仪器的医生)的部分或其部件，而术语“近侧/端”是指所述零部件、仪器和/或装置的较接近使用者的部分或其部件。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可 以是可拆卸连接，或一体地连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
此外，下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
本申请总体涉及一种医疗器械，特别涉及一种超声外科手术器械，有时也被称为超声手术剪，可以用于在外科手术过程中切割组织、凝结组织和/或夹持组织，无论是在开放手术中还是在腹腔镜手术或者内窥镜手术中。由于端部执行组件可选择性地进行超声振动，因此在本文中所描述的手术器械也可以在不使用端部执行组件的超声振动的情况下用于夹持和操作组织。当端部执行组件由超声振动时，可以用此手术器械夹持组织以凝结组织以及切割组织取决于夹持臂施加的压力的大小。夹持臂(也称剪头)，可以是可选择性地展开的，从而使得端部执行组件40可以不进行夹持而使用，以便将超声能量施加到组织上。
图1-图5是本发明的超声手术器械的一种具体实施方式的结构示意图。该超声手术器械用在开放式外科手术、腹腔镜或切割动作的外科手术；上述超声手术器械包括由近端至远端依次设置的超声换能器10、手柄组件20、传输组件30以及端部执行组件40。其中，超声换能器10通过电缆与超声发生器连接，将超声发生器输入的电功率转换成机械功率即超声波传递出去，传输组件30将所述超声能量传输至端部执行组件40上，手柄组件20则适于使操作者操控该超声手术器械，手柄组件20可通过传输组件30控制端部执行组件40的运动，以进行切割/止血操作。手柄组件20的形状可以为能够由使用者以传统的方式握持，一种具体的实施方式中，此超声手术器械通过扳机状设置来操纵端部执行组件40闭合。通过将超声换能器10插入到手柄组件20中，超声手术器械的近端接收超声换能器10的远端并与该远端装配在一起。
手柄组件20包括主壳体21和手柄22，手柄22从主壳体21向下延伸。手柄组件20，尤其是手柄组件20的手柄22，适于在使用中被 医疗从业者握持，以便于其抓持和操作手术器械，同时将医疗从业者与超声振动隔离开。扳机23安装在手柄组件20上，用于朝向手柄22枢转移动和远离手柄22枢转移动进而引起端部执行组件40的闭合动作。手柄组件20上还设有按钮24，用于朝向手柄按动进而引起端部执行组件40的超声能量作用。端部执行器在闭合动作下夹持组织(也就是给组织压力)，同时在超声能量的作用下，进行组织的切割/止血；上述作用在组织上的力及超声能量，可称为加载力。作为附图所示的枪式手柄22的替代实施方式，手柄组件20可以具有任何不同的替代形式，例如剪式手柄布置。主壳体21的近端是开放的，从而使得换能器可以被插入到主壳体21的内部，超声换能器10被插入主壳体21。
手柄组件20包括相互配合的第一半壳体21A和第二半壳体21B，第一半壳体21A和第二半壳体21B以多种现有技术中已知的方式例如，焊接、胶结、卡扣连接等沿着接缝连接到一起。可以理解的是，手柄组件20可以为一体成型结构，或者为多于两个相配合的部分以多种方式连接到一起的结构。手柄组件20以及扳机23，可以由合适的即可消毒的塑性材料或者其它可消毒的材料例如多种金属材料制成。
该超声手术器械的端部执行组件40包括刀头41以及能够相对于所述刀头41枢转的剪头42(也称夹持臂)，所述剪头42具有打开位置和闭合位置，在所述打开位置，所述剪头42的至少一部分与所述刀头41间隔开，在所述闭合位置，所述剪头42靠近所述刀头41并用于切割位于所述剪头42与所述刀头41之间的组织。
当该器械被构造用于内窥镜使用时，该器械可以将传输组件30设置为外径为5.45～5.55mm的细长管体，传输组件30从器械手柄组件20向远侧延伸。传输组件30包括用于传递所述超声换能器10的超声能量传递至刀头41上的中心杆31、套设于中心杆31上的内套管32，以及套设于所述内套管32上的外套管33；其中，所述外套管33相对所述手柄组件20在轴向上固定，所述剪头42枢转连接于所述外套管33上，所述内套管32一端与所述手柄组件20的操纵机构连接，另一端作用在剪头42上，操纵机构触发内套管32相对所述外套管33 沿轴向往复运动，以驱动剪头42绕外套管33上的枢转轴枢转。
部分实施方式中，中心杆31可以由多种材料制成，尤其是多种医学上或者外科手术上可接受的金属材料，例如钛、钛合金(例如Ti6Al4V)、铝、铝合金或者不锈钢。在一些实施方式中，例如附图所示的实施方式，刀头41和中心杆31一体成型，例如由一个金属杆铣削制成以提供期望的特征。刀头41的远端设置为靠近反节点anti-node,以在没有用组织加载声学组件时将声学组件调节到优选的共振频率，当超声换能器10被供给能量时，刀头41的远端被构造为例如在大约10至100微米的峰一峰范围内纵向运动，例如在55,500Hz的预定振动频率f0下，刀头41优选在大约20至大约90微米的范围内纵向运动。
剪头42上连接剪头垫43，剪头42与剪头垫43一起连接到外套管33和内套管32的远端。在实施方式的一种形式中，剪头垫43由低摩擦系数的聚合物材料制成，或者可以由仟何其他合适的低摩擦材料形成。剪头垫43安装在剪头42上用于与刀头41协作，剪头42的枢转运动将剪头垫43定位为基本平行于刀头41并与刀头41接触，由此限定组织处理区域。通过这样的结构，组织被抓在剪头垫43和刀头41之间。如图所示，剪头垫43可以设置有不平滑的表面(例如锯齿状结构，以与刀头41结合来增强对组织的夹持。锯齿状结构或者齿可以提供抵抗刀运动的牵拉。齿还可以对刀和夹钳运动提供相反的牵拉。如本领域技术人员可理解的，锯齿状结构仅是用于防止组织相对于刀头41的运动的多种组织接合表面中的一种示例。其他示例性的实施方式包括突起、交叉形图案、胎面花纹、喷丸或喷沙处理的表向等。
剪头42相对刀头41的枢转运动是通过在剪头42上设置一对枢转点来实现的，这一对枢转点分别与外套管33和内套管32接合。外套管33与手柄组件20固定连接。剪头42经由剪头42上的第一通孔421以及外套管33上对应的第二通孔331枢转地连接至外套管33。紧固销或铆钉滑动穿过第一通孔421与所述第二通孔331以将剪头42枢转地连接到外套管33上。内套管32沿着外套管33的纵向轴线移 动。剪头42上的枢轴销422接合内套管32远端处的枢轴孔321。由此，内套管32相对于外套管33的往复运动使剪头42相对刀头41进行枢转运动。
中心杆31、外套管33和内套管32通过凸型卡口连接器组件34彼此连接，从而利用旋钮35可以使得其作为一个整体与超声换能器10一起相对于手柄组件20旋转，中心杆31通过该旋钮35延伸入手柄组件20的主壳体21内。在使用过程中，利用旋钮35可以旋转外套管33和中心杆31，进而将端部执行组件40和与之相连的剪头42调整至所需的方向。在使用过程中，旋钮35相对于手柄组件20的旋转引起外套管33、中心杆31以及与之可操作地连接的超声换能器10相对于手柄组件20的旋转。在所描述的实施方式中，旋钮35也用于将卡口连接器组件34的一部分保持在手柄组件20内，并由此，使得手术器械保持在装配状态。
内套管32的往复运动驱动剪头42打开或闭合，力限制机构36可操作地连接到内套管32，其包括管套环帽361，管套环帽361将远侧垫圈362、远侧波形弹簧363、近侧垫圈364和近侧波形弹簧365紧固到套环366上。套环366包括轴向延伸的凸耳，凸耳与管状内套管32的近侧部分中的合适开口接合。内套管32的圆周槽接收O形环367，用于与外套管33的内表面接合。
管状内套管32包括细长槽，连接器销37延伸穿过细长槽,以提供内套管32相对于外套管33和中心杆31的往复运动。通过内套管32的往复运动而影响剪头42的枢转运动。传输组件还包括驱动轭形件38，驱动轭形件38可操作地连接扳机23，由此，扳机23与可往复运动的内套管32经由驱动轭形件38和力限制机构36彼此相连。扳机23经由销和以及连接件可旋转地连接至驱动轭形件38，并经由柱可旋转地连接至驱动轭形件38和主壳体21。
扳机23朝向手柄的运动使内套管32向近侧移动，由此使剪头42向刀头41枢转。由扳机23和协作的手柄22提供的扳动动作帮助方便有效地操纵并定位器械以及操作器械远端的剪头42向刀头41侧枢转，由此组织被有效地驱动推靠到刀头41上。扳机23远离手柄22 的运动使内套管32向远侧移动，由此使剪头42朝向远离刀头41的方向枢转。
当端部执行组件40作用于较厚的组织时，需要较大力度操纵扳机23以加持组织，剪头42向Z向的力较大，进而使刀头41有向Z向移动的趋势，内外套管间的装配间隙可允许刀头41向Z向移动。具体的，与刀头41紧固或一体的中心杆31通过密封支撑部39与内套管32抵接没有间隙，内外套管间具有装配间隙。如图22(f)所示，上述一对枢转点形成的直线上方向左倾斜(也可以认为是，形成的直线下方向右倾斜)，这时，端部执行组件40的远端B处已闭合，而其近端C处还存在很大的缝隙。近端C处存在缝隙很大，其如夹持组织，压力较小，这时容易出现远端夹持的组织在压力和能量的作用下已完成切割/止血，而近端夹持的组织还未完成切割/止血。也就是，端部执行组件40作用在组织上加载力一致性较差，易出现部分组织未被切断或凝结的问题。
由于刀头41上的超声能量由近端至远端呈逐渐增大的趋势，为了使端部执行组件40切割/止血组织时刀头41近端至远端的加载情况一致，则需要使刀头41的受力大小由近端至远端呈逐渐减小的趋势。为此，所述内套管32与所述外套管33在两者的远端侧设置第一抵触部，所述第一抵触部在内套管32和外套管33之间形成支撑，以使内外套管的远端的间隙接近于零，其可以在不影响内外套管相对滑动运动的前提下，防止内外套管之间的径向间隙变化，即刀头受到剪头沿Z方向的作用力时，内套管32沿Z向的偏移距离接近于零，避免了内外套管之间的径向间隙变化。更具体地，所述第一抵触部的内侧抵接于所述内套管32外壁上或与所述内套管32外壁一体成型，所述第一抵触部的外侧与所述外套管33内壁一体成型或抵接于所述外套管33内壁上。这样，通过在远端侧设置第一抵触部使得所述内套管32与所述外套管33之间的间隙进一步减小，如图22(e)所示，所述剪头42向接近刀头41的方向上枢转对组织进行切割/止血时，刀头41在内套管32与外套管33远端的支撑下沿其径向Z向的位置偏移减小，其几乎为零，这时，端部执行组件40的远端B处已闭合， 而其近端C处缝隙较小，以实现刀头41的受力由远端至近端逐渐增大。
图6(a)中示出中心杆杆径为D1的第一现有普通超声手术器械在进行组织切割时刀头的受力情况图，图6(b)示出了中心杆杆径为D1的第二现有普通超声手术器械在进行组织切割时刀头的受力情况图，图6(c)中示出中心杆杆径为D2的第一现有普通超声手术器械在进行组织切割时刀头的受力情况图，图6(d)示出了中心杆杆径为D2的第二现有普通超声手术器械在进行组织切割时刀头的受力情况图。其中，D2<D1，第一现有普通超声手术器械和第二现有普通超声手术器械其具体结构不同或厂家不同，但均未采用本发明上述实施方式。根据图6的四幅刀头受力图比对可以看出，由刀头的近端(即图中坐标原点位置)至远端(图中横坐标15mm位置处)，在杆径较大的情况下第一和第二现有普通超声手术器械中的刀头受力基本呈现了由近端至远端逐渐降低的趋势；而杆径较小的情况下，采用第一和第二现有普通超声手术器械时，刀头受力波动较大，并没有呈现出由近端至远端逐渐降低的趋势。图21中示出中心杆杆径为D2的采用本发明上述实施方式的超声手术器械在进行组织切割时刀头的受力情况图，其刀头受力呈现了由近端至远端逐渐降低的趋势。
为此，当中心杆的杆径较小的情况下，采用上述具体实施方式的超声手术器械由近端至远端切割/止血的一致性较好。
所述内套管32与所述中心杆31之间设置至少一个密封支撑部39；一种具体实施方式中，所述中心杆31的外周中形成有多个用于安装密封支撑部39的槽或凹口，槽位于中心杆31的节点处，由于中心杆31的节点处的超声波振幅为零，将此位置设置密封支撑部39，能够实现中心杆31有效支撑的同时不影响中心杆31的超声波传递。所述密封支撑部39具体为设置于所述槽内的密封胶圈，所述密封胶圈为硅胶等柔性材料制成。设置在最远侧的节点处的密封支撑部39最靠近端部执行组件40，该密封件还可以避免端部执行组件40切割时产生的组织残液经过中心杆31与内套管32之间的区域中进入传输组件30内部。
一种具体的实施方式中，所述第一抵触部向近端延伸至位于最远端侧的所述密封支撑部39的位置。这样，中心杆31则在内外套管33的远端侧得到了有效的支撑。更具体地，以最远端的密封支撑部39作为参照点，所述第一抵触部，在内或外套管33最远端至距离密封支撑部39的近侧50mm之间放置，优选的，是在距离密封支撑部39的远侧5mm至其近侧5mm之间放置，以实现对中心杆31更加稳定的支撑。所述第一抵触部与内套管32或外套管33的抵触支撑面，沿内外套管周向设置的长度不超过外套管内周长的50％或内套管外周长的50％。
更具体地，一种方式中，所述第一抵触部位于最远端的所述密封支撑部39对应的支撑位置处。即，第一抵触部的轴向位置及长度与所述密封支撑部39的轴向位置及长度分别对应。
另一种方式中，所述第一抵触部的远端端部位于最远端的所述密封支撑部39的远端，所述第一抵触部的近端端部位于最远端的所述密封支撑部39远侧或近侧。这种实施方式包括两种情况，一种情况下第一抵触部整体位于最远端的所述密封支撑部39的远端，另一种情况下第一抵触部部分位于最远端的所述密封支撑部39的远端，部分位于最远端的所述密封支撑部39的近端。
另一种方式中，所述第一抵触部的近端端部位于最远端的所述密封支撑部39的近端，所述第一抵触部的远端端部位于最远端的所述密封支撑部39远侧或近侧。这种实施方式同样包括两种情况，一种情况下第一抵触部整体位于最远端的所述密封支撑部39的近端，另一种情况下第一抵触部部分位于最远端的所述密封支撑部39的近端，部分位于最远端的所述密封支撑部39的远端。以下分别介绍第一抵触部的三种主要结构形式。
<第一种结构形式>
如图7所示，所述第一抵触部为设置于所述内套管32与所述外套管33之间的至少一条夹片A。通过设置独立于内套管32与外套管33的夹片A可以降低内、外套管33的加工难度。更具体地，夹片A的表面成型为与内外套管33的管壁匹配的弧形表面，以使夹片A与 内套管32的外管壁及外套管33的内管壁具有较大的接触面积以实现对中心杆31进行稳定地支撑。更具体地，所述夹片A沿周向均匀分布。夹片A沿内外套管周向设置的长度不超过外套管33内周长的50％或内套管32外周长的50％。
为了使上述独立的夹片A安装更加稳定，一种具体的实施方式中，所述内套管32的外壁和/或所述外套管33的内壁设有凹槽，所述夹片A位于所述凹槽内，以对夹片A进行位置限定。
一种具体实施方式中，所述夹片A为长条形，其沿所述内套管32与所述外套管33的轴线方向延伸，所述夹片A延伸至最远端的密封支撑部39所在位置处。
另一种具体实施方式中，所述夹片A为圆环形，其环绕于所述内套管32与所述外套管33之间的环形空隙内。圆环形的所述夹片A可以若干个，其沿所述内套管32与所述外套管33的轴向间隔排布，直至接近最远端的密封支撑部39所在位置处。
所述夹片A沿沿轴向设置的长度不超过30mm，且，所述夹片A的远端位于最远端的所述密封支撑部39的远端，所述夹片A的近端端部位于最远端的所述密封支撑部39的近侧。
<第二种结构形式>
如图8、图9所示，所述第一抵触部为一体成型于所述内套管32外壁上并向外侧突出的第一凸起322，所述第一凸起322的凸起表面抵接于所述外套管33内壁上。该结构形式的第一抵触部可以通过内套管32一体成型，制造成本降低。
更具体地，一种实施方式中，如图8所示，所述第一凸起322成型为沿所述内套管32轴线方向延伸的长条形。更具体地，所述第一凸起322沿所述内套管32的周向均匀排布，所述第一凸起322，在内或外套管最远端至距离密封支撑部39的近侧20mm之间放置，优选的，是在距离密封支撑部39的远侧5mm至其近侧5mm之间放置，以实现对中心杆31更加稳定的支撑。所述第一凸起322与内套管32或外套管33的抵触支撑面，沿内外套管周向设置的长度不超过外套管内周长的50％或内套管外周长的50％。
更具体地，另一种实施方式中，如图9所示，所述第一凸起322成型为圆环形，还可以成型为螺旋环形或圆弧形。圆环形或圆弧形的所述第一凸起322可以并列地设置若干个，若干个第一凸起322沿所述内套管32的轴向间隔排布，直至接近最远端的密封支撑部39所在位置处。
更具体地，另一种实施方式中，所述第一凸起322成型为沿所述内套管32轴线方向及其周向矩阵分布的圆弧形凸点，例如，沿所述内套管32的轴线方向间隔3-5mm设置一个所述圆弧形凸点，沿所述内套管32的周向间隔20-30度设置一个所述圆弧形凸点。
<第三种结构形式>
如图10-图20所述第一抵触部为一体成型于所述外套管33内壁上并向内侧突出的第二凸起332，所述第二凸起332的凸起表面抵接于所述内套管32的外壁上。该结构形式中第二凸起332一体成型于所述外套管33上，制造成本降低。
一种更具体的实施方式中，如图10、图11所示，所述第二凸起332成型为沿所述外套管33轴线方向延伸的长条形，所述第二凸起332沿所述外套管33的周向均匀排布，所述第二凸起332的远端位于最远端的所述密封支撑部39的远端，所述夹片A的近端端部位于最远端的所述密封支撑部39的近侧。优选的，是在距离密封支撑部39的远侧5mm至其近侧5mm之间放置，以实现对中心杆31更加稳定的支撑。所述第二凸起332与内套管或外套管的抵触支撑面，沿内外套管周向设置的长度不超过外套管33内周长的50％或内套管32外周长的50％。
另一种具体实施方式中，所述第二凸起332成型为环绕于所述外套管内壁上的圆环形、螺旋环形或圆弧形。如图12、图13所示，圆弧形的所述第二凸起332可以并列地设置若干个，若干个第二凸起332沿所述外套管33的轴向间隔排布，直至接近最远端的密封支撑部39所在位置处。如图14、图15所示，螺旋环形的所述第二凸起332位于接近所述密封支撑部39的位置处。如图16、图17、图18所示，圆环形的所述第二凸起332位于所述外套管33的远端端部，其中， 图16、图17的所述第二凸起332是由所述外套管33经过缩口处理形成，图18的所述第二凸起332是由所述外套管33的端部向内折弯形成。所述外套管33与所述第二凸起332的一体成型方式不限于以上两种方式，通过其他机械加工方式形成具有上述结构特征的第二凸起332均属于本申请的保护范围。
另一种实施方式中，如图19、图20所示，所述第二凸起332成型为沿所述外套管33轴线方向及其周向矩阵分布的圆弧形凸点，例如，沿所述外套管33的轴线方向间隔3-5mm设置一个所述圆弧形凸点，沿所述外套管33的周向间隔20-30度设置一个所述圆弧形凸点。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明的保护范围之中。

Claims (25)

  1. 一种超声手术器械，包括：
    用于传递超声能量的中心杆，所述中心杆的远端为刀头；
    能够相对于所述刀头枢转的剪头，所述剪头具有打开位置和闭合位置，在打开位置，所述剪头与所述刀头分离张开，可容纳组织；在闭合位置，所述剪头靠近所述刀头并用于切割位于所述剪头与所述刀头之间的组织；
    内套管与外套管，所述内套管套设于所述中心杆上，所述外套管套设于所述内套管上，所述剪头枢转地连接于所述外套管的远端上，所述内套管的远端作用于所述剪头上，所述内套管相对所述外套管滑动并带动所述剪头相对所述刀头枢转；
    其特征在于，还包括设置于所述内套管与所述外套管远端侧的第一抵触部，所述第一抵触部在内套管和外套管之间形成支撑，以在不影响内外套管相对滑动运动的前提下，防止内外套管之间的径向间隙变化。
  2. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部的内侧抵接于所述内套管外壁上，或与所述内套管外壁一体成型，所述第一抵触部的外侧抵接于所述外套管内壁上或与所述外套管内壁一体成型。
  3. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部为设置于所述内套管与所述外套管之间的至少一个夹片。
  4. 根据权利要求3所述的一种超声手术器械，其特征在于，所述内套管的外壁和/或所述外套管的内壁设有凹槽，所述夹片位于所述凹槽内。
  5. 根据权利要求3或4所述的一种超声手术器械，其特征在于，所述夹片为长条形，其沿所述内套管与所述外套管的轴线方向延伸。
  6. 根据权利要求3或4所述的一种超声手术器械，其特征在于，所述夹片为圆环形，其环绕于所述内套管与所述外套管之间的环形空 隙内。
  7. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部为一体成型于所述内套管的管壁上并向外侧突出的至少一个第一凸起。
  8. 根据权利要求7所述的一种超声手术器械，其特征在于，所述第一凸起成型为沿所述内套管轴线方向延伸的长条形。
  9. 根据权利要求8所述的一种超声手术器械，其特征在于，所述第一凸起沿所述内套管的周向均匀排布。
  10. 根据权利要求7所述的一种超声手术器械，其特征在于，所述第一凸起成型为沿所述内套管周向设置的圆环形、螺旋环形或圆弧形。
  11. 根据权利要求7所述的一种超声手术器械，其特征在于，所述第一凸起成型为沿所述内套管轴线方向及其周向矩阵分布的圆弧形凸点。
  12. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部为一体成型于所述外套管的管壁上并向内侧突出的至少一个第二凸起。
  13. 根据权利要求12所述的一种超声手术器械，其特征在于，所述第二凸起成型为沿所述外套管轴线方向延伸的长条形。
  14. 根据权利要求13所述的一种超声手术器械，其特征在于，所述第二凸起沿所述外套管的周向均匀排布。
  15. 根据权利要求12所述的一种超声手术器械，其特征在于，所述第二凸起成型为环绕于所述外套管内壁上的圆环形、螺旋环形或圆弧形。
  16. 根据权利要求12所述的一种超声手术器械，其特征在于，所述第二凸起成型为沿所述内套管轴线方向及其周向矩阵分布的圆弧形凸点。
  17. 根据权利要求1所述的一种超声手术器械，其特征在于，所述内套管与所述中心杆之间设置至少一个密封支撑部，所述密封支撑部位于所述中心杆的节点处。
  18. 根据权利要求17所述的一种超声手术器械，其特征在于，所述第一抵触部位于最远端的所述密封支撑部对应支撑位置。
  19. 根据权利要求17所述的一种超声手术器械，其特征在于，所述第一抵触部的远端端部位于最远端的所述密封支撑部的远端，所述第一抵触部的近端端部位于最远端的所述密封支撑部远侧或近侧。
  20. 根据权利要求17所述的一种超声手术器械，其特征在于，所述第一抵触部的近端端部位于最远端的所述密封支撑部的近端，所述第一抵触部的远端端部位于最远端的所述密封支撑部远侧或近侧。
  21. 根据权利要求17所述的一种超声手术器械，其特征在于，所述第一抵触部，在内外套管最远端至所述密封支撑部的近侧50mm之间放置。
  22. 根据权利要求21所述的一种超声手术器械，其特征在于，所述第一抵触部，在所述密封支撑部的远侧5mm至所述密封支撑部的近侧5mm之间放置。
  23. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部与内套管或外套管的抵触支撑面，沿轴向设置的长度不超过30mm。
  24. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部与内套管或外套管的抵触支撑面，沿轴向设置的长度不超过15mm。
  25. 根据权利要求1所述的一种超声手术器械，其特征在于，所述第一抵触部与内套管或外套管的抵触支撑面，沿内外套管周向设置的长度不超过外套管内周长的50％或内套管外周长的50％。
PCT/CN2021/124742 2021-10-19 2021-10-19 一种超声手术器械 WO2023065118A1 (zh)

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040147945A1 (en) * 2002-09-09 2004-07-29 Gernod Fritzsch Ultrasonic instrument
CN106175848A (zh) * 2016-08-31 2016-12-07 南京市鼓楼医院 一种基于实心针的超声乳化机头及超声乳化设备
CN108354652A (zh) * 2018-02-08 2018-08-03 南昌元合泽众科技有限公司 一种可重复使用的超声手术刀
CN108366813A (zh) * 2015-12-17 2018-08-03 伊西康有限责任公司 具有清洁端口的超声外科器械
CN109431578A (zh) * 2017-12-25 2019-03-08 上海逸思医疗科技有限公司 一种套管组件可拆卸的超声手术器械
CN110403672A (zh) * 2019-05-01 2019-11-05 杭州康基医疗器械股份有限公司 超声医疗外科器械
CN212213827U (zh) * 2019-11-13 2020-12-25 上海圣哲医疗科技有限公司 一种超声切割止血刀的刀尖结构

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040147945A1 (en) * 2002-09-09 2004-07-29 Gernod Fritzsch Ultrasonic instrument
CN108366813A (zh) * 2015-12-17 2018-08-03 伊西康有限责任公司 具有清洁端口的超声外科器械
CN106175848A (zh) * 2016-08-31 2016-12-07 南京市鼓楼医院 一种基于实心针的超声乳化机头及超声乳化设备
CN109431578A (zh) * 2017-12-25 2019-03-08 上海逸思医疗科技有限公司 一种套管组件可拆卸的超声手术器械
CN108354652A (zh) * 2018-02-08 2018-08-03 南昌元合泽众科技有限公司 一种可重复使用的超声手术刀
CN110403672A (zh) * 2019-05-01 2019-11-05 杭州康基医疗器械股份有限公司 超声医疗外科器械
CN212213827U (zh) * 2019-11-13 2020-12-25 上海圣哲医疗科技有限公司 一种超声切割止血刀的刀尖结构

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