WO2022116448A1 - 一种导向器械盒及穿刺导向和释放机构 - Google Patents

一种导向器械盒及穿刺导向和释放机构 Download PDF

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Publication number
WO2022116448A1
WO2022116448A1 PCT/CN2021/084410 CN2021084410W WO2022116448A1 WO 2022116448 A1 WO2022116448 A1 WO 2022116448A1 CN 2021084410 W CN2021084410 W CN 2021084410W WO 2022116448 A1 WO2022116448 A1 WO 2022116448A1
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WO
WIPO (PCT)
Prior art keywords
guide
main body
life
puncture
depth
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Application number
PCT/CN2021/084410
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English (en)
French (fr)
Inventor
罗中宝
王海峰
张星光
Original Assignee
上海睿刀医疗科技有限公司
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Application filed by 上海睿刀医疗科技有限公司 filed Critical 上海睿刀医疗科技有限公司
Publication of WO2022116448A1 publication Critical patent/WO2022116448A1/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
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives

Definitions

  • the invention relates to the technical field of medical devices, in particular to a guide device box and a puncture guide and release mechanism.
  • Cancer is a major disease endangering human health.
  • electric field pulses have received extensive attention for their non-thermal and minimally invasive biomedical effects, and have been gradually applied in the clinical treatment of tumors.
  • Minimally invasive therapy often requires a puncture needle to reach the lesion area in the human body for treatment, and the puncture needle usually needs to be positioned with the puncture template under the guidance of ultrasound or other medical imaging equipment to reach the desired target position.
  • the existing multi-needle puncture guide system has an opening and closing mechanism for positioning the puncture needle, but since the opening and closing mechanism is fixedly installed on the puncture needle guide arm, the opening and closing mechanism cannot be disassembled and sterilized. Therefore, a detachable and sterile sheath tube needs to be arranged between the puncture needle and the puncture needle guide arm. During the operation, after each puncture needle is arranged, a sheath tube is left on the needle body of the puncture needle, which is inconvenient to use and increases the operation time. In addition, an independent driving device needs to be provided for the opening and closing mechanism, the structure is complicated, and the production cost is high.
  • the present invention provides a guide instrument box and a puncture guide and release mechanism.
  • the guide instrument case includes:
  • the guide opening and closing flap protruding from the side of the main body includes a first guide opening and closing flap and a second guide opening and closing flap connected by a guide flap rotation shaft, and the guide opening and closing flap is kept closed by an elastic member to form a A through hole for the puncture needle to pass through;
  • An inclined surface is formed on one side surface of the second guide opening and closing flap, and the inclined surface is configured to be able to abut with a release push rod inserted into the first depth range from the rear of the main body, so as to The opening degree of the guide flap is controlled based on the insertion depth of the release push rod.
  • the guiding instrument case further comprises: a first engaging portion for detachably mounting the main body to the control arm.
  • the first engaging portion includes a guide member and a locking member, wherein the guide member is a guide post protruding from the rear of the main body, and the locking member is a hook.
  • the main body is further provided with a dismounting button, the dismounting button is connected with the hook, and the locking between the hook and the control arm is released by pressing the dismounting button.
  • the elastic member is a tension spring between the bottom of the main body and the lower surface of the first side of the second guide flap.
  • the main body is further provided with a life indicating slider that can slide along the axial direction of the main body,
  • the life indicating slider is configured to be capable of abutting with a release push rod inserted into a second depth range from the rear of the main body to slide from a normal life position to an end of life position,
  • the depth of the first depth range is smaller than the depth of the second depth range.
  • a limit slide rail is provided in the main body, a raised one-way buckle is provided on the limit slide rail, and a side of the one-way buckle close to the rear of the main body has a an inclined slope, the one-way buckle forms a stop structure on the side close to the front of the main body,
  • the life indicating slider slides along the limit slide rail, and the reverse movement of the life indicating slider is restricted by the stop structure of the one-way buckle.
  • two one-way buckles are provided on one of the limit slide rails, and the distance between the two one-way buckles is the same as the distance between the sliding part of the life indicating slider along the axial direction of the main body. Same size.
  • the limit slide rail includes an upper rail and a lower rail, and the one-way buckles are respectively provided on the upper rail and the lower rail, respectively.
  • a friction-reducing groove is formed on an upper surface or a lower surface of the sliding portion of the life indicating slider.
  • the life indicating slider has a sliding portion and a life indicating portion disposed at the side end of the sliding portion, the life indicating portion has a normal life indicating portion located at the front and an end-of-life indicating portion located at the rear department,
  • a life indicating hole is opened on the main body corresponding to the life indicating portion.
  • the puncture guide and release mechanism comprises a control arm and the guiding instrument case according to one of claims 1-10, which is detachably mounted to the front end of the control arm,
  • the control arm includes a release push rod retractably inserted into the main body of the guide instrument box at the front end of the control arm.
  • control arm further includes a second engaging portion matching and engaging with the first engaging portion of the guiding instrument case.
  • control arm further includes a mounting seat, the release push rod is fixed on the mounting seat, and the mounting seat is driven by a motor.
  • the mounting seat is slidably arranged on a guide rail along the axial direction of the control arm,
  • the motor drives the lead screw to rotate, and the external thread of the lead screw engages with the internal thread in the through hole of the mounting seat, so that the mounting seat can reciprocate on the guide rail.
  • a depth control device is also fixed on the mounting seat, and the mounting seat slides within a third depth range to limit the penetration depth of the puncture needle by the depth control device.
  • the depth control device includes a baffle fixing seat and a puncture needle baffle, the baffle fixing seat protrudes from the side of the control arm, and a detachable detachable baffle fixing seat is on the baffle fixing seat.
  • a puncture needle baffle is provided, and the puncture needle baffle is provided with a non-closed perforation for the puncture needle to pass through, and the non-closed perforation is opposite to the through hole formed by the closure of the guide opening and closing flap.
  • the guiding instrument box has an opening and closing function
  • the guiding instrument box and the control arm can share the driving device, and the occupation of the operation space is smaller. , simple structure, convenient operation and low cost.
  • FIG. 1 is a schematic diagram of the use of the puncture guide and release mechanism proposed by an embodiment of the present invention
  • Fig. 2 is the rear side view of the puncture guide and release mechanism proposed by the embodiment of the present invention.
  • FIG. 3 is a front side view of the puncture guide and release mechanism proposed by an embodiment of the present invention.
  • Fig. 4 is the structure diagram of some parts inside the main body of the guiding instrument box A proposed by the embodiment of the present invention (sectional view of the second guiding opening and closing flap);
  • FIG. 5 is a front view of the internal parts of the main body of the guiding instrument box A proposed by the embodiment of the present invention.
  • FIG. 6 is a schematic diagram of the guide device box A proposed by the embodiment of the present invention in a released state under the control of the release push rod;
  • FIG. 7 is a schematic diagram of the guide device box A proposed by the embodiment of the present invention being in a closed state under the control of the release push rod;
  • FIG. 8 is a diagram of the internal parts of the main body of the guiding instrument box A proposed by the embodiment of the present invention (the life indicating slider is at the normal position of the life);
  • FIG. 9 is a longitudinal sectional view of the guide device box A proposed by the embodiment of the present invention (the life indicating slider is located at the normal position of the life);
  • Fig. 10 is a diagram of the internal parts of the main body of the guiding instrument box A proposed by the embodiment of the present invention (the life indicating slider is at the end of life position);
  • Fig. 11 is a longitudinal sectional view of the guide instrument box A proposed by the embodiment of the present invention (the life indicating slider is at the end of life position);
  • Fig. 12 is the assembly structure diagram of the life indicating slider of the guide device box A proposed in the embodiment of the present invention in the main body;
  • Fig. 13 is a longitudinal sectional view of the main body of the guide instrument box A proposed by the embodiment of the present invention.
  • FIG. 14 is a rear perspective view of the life indicator slider of the guide device box A proposed by the embodiment of the present invention.
  • 15 is a front perspective view of the life indicator slider of the guide device box A proposed by the embodiment of the present invention.
  • 16 is a schematic diagram of the internal structure of the puncture guide and release mechanism proposed by the embodiment of the present invention.
  • the term “including” and its various variants can be understood as open-ended terms meaning “including but not limited to”.
  • the term “based on” and similar expressions can be understood as “based on at least”.
  • the terms “first”, “second”, “third” and other expressions are only used to distinguish different features and have no substantive meaning.
  • the terms “left”, “right”, “center” and the like are used only to denote the positional relationship between opposite objects.
  • an embodiment of the present invention provides a guide instrument box A and a puncture guide and release mechanism.
  • the puncture guide and release mechanism of the embodiment of the present invention includes a control arm B and a guide instrument box A detachably mounted to the front end of the control arm B, the control arm B
  • the arm B includes a release push rod 3 telescopically inserted into the main body of the guide instrument box at the front end of the control arm B.
  • the puncture depth of the puncture needle C is limited by the depth control device on the control arm B, and the puncture needle C passes through the through hole 25 on the guide instrument box A, and further punctures.
  • the puncture template D Through the puncture template D, it is inserted into the lesion area, and the biological tissue is punctured.
  • the guide instrument case A of the embodiment of the present invention includes a main body 1 and a guide opening and closing flap 2 .
  • the guide flap 2 protruding from the side of the main body 1 includes a first guide flap 21 and a second guide flap 22 connected by a guide flap rotating shaft 23 , the guide opening and closing flap 2 is kept closed by the elastic member 24 to form a through hole 25 for the puncture needle C to pass through.
  • An inclined surface 221 is formed on one side surface of the second guide flap 22, and the inclined surface 221 is configured to be able to engage with a release push rod inserted from the rear of the main body 1 into a first depth range 3 abuts to control the opening degree of the guide flap 2 based on the insertion depth of the release push rod 3 .
  • the release push rod 3 When in use, the release push rod 3 is inserted into the main body 1 from the rear of the main body 1 , and as the release push rod 3 continues to extend in, it forms abutment with the inclined surface 221 and continues downward along the inclined surface 221 Overcoming the resistance of the elastic member 24 and pressing the second guide opening and closing flap 22, the second guide opening and closing flap 22 is gradually opened as the push rod 3 continues to extend, until the release push rod 3 reaches the first position along the inclined surface 221.
  • the release push rod 3 starts to form abutment with the inclined surface 221 until the release push rod 3 reaches the top of the second guide opening and closing flap 22 (the second guide opening and closing flap 22 is no longer open) in the process.
  • the insertion depth range of the release push rod 3 constitutes the first depth range.
  • the first guide opening and closing flap 21 is fixed on the main body 1 , and the middle portion of the second guide opening and closing flap 22 and the first guide opening and closing flap 21 pass through the guide flap
  • the rotating shaft 23 is rotatably connected, and the elastic member 24 is a tension spring, which is arranged between the bottom of the main body 1 and the lower surface of the first side of the second guide opening and closing flap 22, and is held by the tension spring.
  • the guide flap 2 is closed to form a through hole 25 for the puncture needle to pass through.
  • the inclined surface 221 in the embodiment is the bottom surface of a sliding groove on the upper surface of the second guide opening and closing flap 22 .
  • the main body 1 is further provided with a life indicating slider 4 that can slide along the axial direction of the main body 1 .
  • the life indication slider 4 is used to indicate the end of the service life of the guide tool box A by moving.
  • the life indicating slider 4 is configured to be able to abut with the release push rod 3 inserted into the second depth range from the rear of the main body 1 to slide from the normal life position to the end of life position, wherein the first The second depth range is the depth range in which the release push rod 3 pushes the life indicating slider 4 from the normal life position to the life end position, and the depth of the first depth range is smaller than the depth of the second depth range.
  • the release push rod 3 continuously protrudes into the interior of the main body 1, and makes the second guide opening and closing flap 22 open to the maximum extent. After that, if the guide instrument box A reaches the number of times of use or the duration of use, the control release push rod 3 continues to protrude into the main body 1 , and then abuts the life indicating slider 4 and pushes the life indicating slider 4 toward the main body 1
  • the front end moves from the first position to the second position, wherein the first position corresponds to the normal life position, the second position corresponds to the end of life position, and the life indicator slider 4 at the second position identifies the guide instrument box A end of life.
  • the life indicating slider 4 has a sliding portion 41 and a life indicating portion 42 disposed at the side end of the sliding portion 41 , and the life indicating portion 42 has a life indicating portion located at the front.
  • the normal indicating portion 421 and the end-of-life indicating portion 422 located at the rear are provided with a life indicating hole 43 on the main body 1 corresponding to the life indicating portion 4 .
  • the life indicator slider 4 is in the normal life position, and the life normal indicator portion 421 on the front is opposite to the life indicator hole 43 on the main body 1, as shown in Figures 8 and 9;
  • the life indicating slider 4 slides to the end of life position, and the end of life indicating portion 422 is opposite to the life indicating hole 43 on the main body 1, as shown in FIG. 10 and FIG. 11 .
  • the normal life indicator 421 and the end of life indicator 422 on the life indicator 42 can be marked with different colors. For example, the normal life indicator 421 is green, and the end of life indicator 422 is red. When the hole 43 sees red, it indicates that the guide tool box A cannot be used continuously, so as to remind the user to replace the guide tool box A with a new one.
  • a limit slide rail 44 is provided in the main body 1 , and a raised one-way card is provided on the limit slide rail 44 Buckle 45, one side of the one-way buckle 45 close to the rear of the main body 1 has an inclined slope, the side of the one-way buckle 45 close to the front of the main body 1 forms a stop structure, the life indicator
  • the sliding portion 41 of the slider 4 slides along the limit slide rail 44, and the life indicator slider 4 is restricted from moving in the reverse direction by the stop structure of the one-way buckle 45, so that the life indicator slider 4 cannot move toward the main body.
  • the rear part of 1 is disengaged, especially it cannot be returned from the end of life position to the normal position of life, preventing re-use.
  • the limiting slide rail 44 includes an upper rail and a lower rail, and the one-way buckles 45 are correspondingly provided on the upper rail and the lower rail, respectively. More preferably, two one-way buckles 45 are provided on one of the limit slide rails 44 , and the distance between the two one-way buckles 45 and the sliding portion 41 of the life indicating slider 4 are along the The axial dimensions of the main body 1 are the same, so that the upper rail and the lower rail can stably clamp the life indicating slider 4 without shaking, and can accurately indicate that the guide instrument box A has a normal life.
  • Antifriction grooves 411 are formed on the upper surface and/or the lower surface of the sliding part 41 of the life indicator slider 4 to reduce friction between the surface of the sliding part 41 and the end of the one-way buckle 45 and the sliding rail 44 . friction.
  • the guiding instrument box A further includes a first engaging portion 5 for detachably mounting the main body 1 to the control arm B.
  • the first engaging portion 5 can adopt various methods such as mechanical engaging or electromagnetic locking, so that the guide instrument box A can be installed on the end of the control arm B.
  • FIG. Due to the detachable arrangement of the guide instrument case A, it is easier to sterilize the guide opening and closing flap 2 or to replace the guide instrument case A as a whole.
  • the first engaging portion 5 is disposed at the rear of the main body 1 , and includes a guide member 51 and a locking member 52 , wherein the guide member 51 is protruded from the rear of the main body 1 .
  • the guide column, the locking member 52 is a hook.
  • the main body 1 is also provided with a disassembly button 53, the disassembly button 53 is supported by a spring in the button groove 54 on the main body 1, the disassembly button 53 is connected with the hook 52, and the disassembly button 53 is connected to the button groove 54. Pressing the dismounting button 53 releases the locking between the hook and the control arm B.
  • the control arm B includes a second engaging portion 6 that matches and engages with the first engaging portion 5 of the guiding instrument box A, and has a guide hole 61 for receiving the guide member 51 and a second engaging portion 61 for receiving the guide member 51.
  • the engaged hook fixing holes 62 are shown in FIG. 3 . Therefore, when the guide tool case A is attached to the end of the control arm B using the structure of the first engaging portion 5 and the second engaging portion 6, there are differences between the guide members 51 and 61 and the locking members 52 and 62. Double positioning, the guide box A does not rotate on the control arm B.
  • the release push rod 3 is fixed on the mounting seat 72, the mounting seat 72 is driven by a motor, and is slidably arranged along the The control arm B is placed on the axial guide rail, so that the release push rod 3 can be protruded from the release push rod hole 63 at the front end of the control arm B and inserted into the guide instrument box A.
  • the control arm B includes a motor 71 , a mounting seat 72 , a guide rail 73 and a screw rod 74 .
  • the motor 71 drives the screw rod 74 to rotate, and the external thread of the screw rod 74 engages with the internal thread in the through hole of the mounting seat 72 , and drives the mounting seat 72 to reciprocate on the guide rail 73 .
  • a depth control device 8 is also fixed on the mounting seat 72 , and the depth control device 8 follows the mounting seat 72 at a third depth Sliding within the range to limit the puncture depth of the puncture needle C by the depth control device 8 .
  • the depth of the third depth range is smaller than the depth of the first depth range.
  • the depth control device 8 includes a baffle fixing seat 81 and a puncture needle baffle 82 , and the baffle fixing seat 81 protrudes from the side of the control arm B, A puncture needle baffle 82 is detachably provided on the baffle fixing base 81 , and the puncture needle baffle 82 has a non-closed perforation 83 for the puncture needle C to pass through.
  • the non-closed perforation 83 is the same as the above-mentioned
  • the through holes 25 formed by the closure of the guide flap 2 are aligned, so that during puncture, the motor 71 drives the mounting seat 72 to move along the axial direction of the control arm B, sets the predetermined puncture depth of the puncture needle C, and then moves the needle shaft of the puncture needle C Fitting with the side wall of the non-closed hole 83 of the puncture needle baffle 82, the needle tip of the puncture needle C passes through the through hole 25 of the guide opening and closing flap 2, and further punctures the biological tissue.
  • the puncture needle baffle 82 is detachable, which is convenient for sterilizing the puncture needle baffle 82 or replacing the puncture needle baffle 82.
  • the motor 71 drives the screw rod 74 to rotate, and the mounting seat 72 on the screw rod 74 can reciprocate along the guide rail 73 .
  • the puncture guide and release mechanism works in three stroke intervals.
  • the first stroke interval for controlling the puncture depth of the puncture needle C according to the puncture position of the puncture needle C, the motor 71 drives the mounting seat 72 and drives the depth control device 8 on it to advance or retreat within the third depth range, and the puncture needle is moved forward or backward.
  • the baffle 82 is set to the corresponding position, and the predetermined puncture depth of the puncture needle C is set; then, the puncture needle C is passed through the non-closed through hole 83 of the puncture needle baffle 82 and the through hole 25 leading to the opening and closing flap 2 until the puncture needle handle The puncture is completed when it is pressed against the puncture needle baffle 82 .
  • the second stroke interval for controlling the opening and closing of the guide flap 2 of the guide instrument box A after the puncture is completed, the motor 71 continues to drive the mounting seat 72 and drives the release push rod 3 on it to move forward, and the release push rod 3 is in the first stroke. It abuts with the inclined surface 221 of the upper surface of the second guide flap 22 within the depth range, and presses the second guide flap 22 downward, causing the guide flap 2 to open and release the puncture needle C.
  • the puncture guide and release mechanism repeats operations in the first stroke interval and the second stroke interval for multiple times according to the subsequent puncture positions of the puncture needles C to complete the puncture of the plurality of puncture needles C.
  • the third stroke interval for controlling the state of the life indicator of the guide tool box A under normal conditions, the life indicator slider 4 of the guide tool box A is in the normal life position, the life normal indicator 421 on the front and the life indicator on the main body 1
  • the holes 43 are opposite, for example, shown in green.
  • the motor 71 drives the mounting seat 72 and drives the release push rod 3 on it to continue to move forward, and the release push rod 3 pushes the front of the life indicator slider 4 within the second depth range
  • the end-of-life indication portion 422 at the rear is opposite to the life indication hole 43 on the main body 1, for example, it displays red to indicate that the guide instrument box A cannot be used continuously and needs to be replaced.
  • the present invention realizes three different functions through the design of the motor 71 to drive the mounting seat 72 to reciprocate in the three-segment stroke interval without increasing the structural complexity, the structure is simplified, and the cost is saved.
  • the guiding instrument box has an opening and closing function
  • the guiding instrument box and the control arm can share the driving device, and the occupation of the operation space is smaller, the structure is simple, and the operation is convenient. ,low cost.

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Abstract

公开了一种导向器械盒(A)，包括主体(1)和从主体(1)侧部伸出的导向开合瓣(2)，导向开合瓣(2)包括通过导向瓣转轴(23)连接的第一导向开合瓣(21)和第二导向开合瓣(22)，导向开合瓣(2)通过弹性件(24)保持闭合，以形成供穿刺针(C)通过的过孔(25)；在第二导向开合瓣(22)的一侧表面上形成有倾斜面(221)，倾斜面(221)被配置为能够与从主体(1)后部插入到第一深度范围内的释放推杆(3)抵接，以基于释放推杆(3)的插入深度控制导向开合瓣(2)的张开程度。导向器械盒(A)具有开合功能，导向器械盒(A)和控制臂(B)能够共用驱动装置，对手术空间的侵占更小，结构简单、操作便捷，成本低。还同时公开了相应的穿刺导向和释放机构。

Description

一种导向器械盒及穿刺导向和释放机构 技术领域
本发明涉及医疗器械技术领域，具体涉及一种导向器械盒及穿刺导向和释放机构。
背景技术
癌症是危害人类健康的主要疾病。近年来，随着脉冲生物电学的不断发展，电场脉冲以其非热、微创的生物医学效用收到广泛的关注，并逐渐应用于肿瘤的临床治疗。微创疗法往往需要通过穿刺针到达人体内的病灶区域进行治疗，而穿刺针通常需要在超声或其他医学影像设备的引导下，配合穿刺模板进行定位，从而到达预期的目标位置。
现有多针穿刺引导系统具有定位穿刺针的开合机构，但由于开合机构固定安装在穿刺针导向臂上，而无法拆卸对开合机构消毒。因此，需要在穿刺针与穿刺针导向臂之间设置一个可拆卸消毒的鞘管。手术时，每布置完一根穿刺针后，均在穿刺针针体上留有鞘管，使用不便，同时也增加了手术时间。此外，还需要为开合机构设置独立的驱动装置，结构复杂，生产成本高。
发明内容
为了解决上述多针穿刺引导系统的开合机构不能拆卸以及系统结构复杂的技术问题，本发明提出了一种导向器械盒及穿刺导向和释放机构。
根据本发明的一个方面，所述导向器械盒包括：
主体；
从所述主体的侧部伸出的导向开合瓣，包括通过导向瓣转轴连接的第一导向开合瓣和第二导向开合瓣，所述导向开合瓣通过弹性件保持闭合，以形成供穿刺针通过的过孔；
在所述第二导向开合瓣的一侧表面上，形成有倾斜面，所述倾斜面被配置为能够与从所述主体后部插入到第一深度范围内的释放推杆抵接，以 基于所述释放推杆的插入深度控制所述导向开合瓣的张开程度。
在一个实施例中，所述导向器械盒还包括：用于将所述主体可拆卸的安装到控制臂的第一卡合部。
在一个实施例中，所述第一卡合部包括导向部件和锁定部件，其中所述导向部件为在所述主体后部凸出设置的导向柱，所述锁定部件为卡钩。
在一个实施例中，所述主体上还设置有拆卸按钮，所述拆卸按钮与所述卡钩连接，通过按压所述拆卸按钮解除所述卡钩与所述控制臂之间的锁合。
在一个实施例中，所述弹性件为在所述主体底部与所述第二导向开合瓣的第一侧的下表面之间的张紧弹簧。
在一个实施例中，在所述主体中还设置有能够沿所述主体的轴向滑动的寿命指示滑块，
所述寿命指示滑块被配置为能够与从所述主体后部插入到第二深度范围内的释放推杆抵接，以从寿命正常位置滑动到寿命终止位置，
其中，所述第一深度范围的深度小于第二深度范围的深度。
在一个实施例中，在所述主体中设置有限位滑轨，所述限位滑轨上设置有凸起的单向卡扣，所述单向卡扣靠近所述主体后部的一侧具有倾斜斜面，所述单向卡扣靠近所述主体前部的一侧形成止挡结构，
所述寿命指示滑块沿所述限位滑轨滑动，并由所述单向卡扣的止挡结构限制所述寿命指示滑块逆向移动。
在一个实施例中，一条所述限位滑轨上设置有两个单向卡扣，两个单向卡扣之间的距离与所述寿命指示滑块的滑动部沿所述主体轴向的尺寸相同。
在一个实施例中，所述限位滑轨包括上轨和下轨，在所述上轨和下轨上分别对应的设置有所述单向卡扣，
所述寿命指示滑块的滑动部的上表面或下表面形成有减摩凹槽。
在一个实施例中，所述寿命指示滑块具有滑动部和设置在所述滑动部侧端的寿命指示部，所述寿命指示部具有位于前部的寿命正常指示部和位于后部的寿命终止指示部，
与所述寿命指示部对应的主体上开设有寿命指示孔。
根据本发明的另一个方面，所述穿刺导向和释放机构包括控制臂和可拆卸的安装到所述控制臂前端的如权利要求1-10之一所述的导向器械盒，
所述控制臂包括在控制臂前端可伸缩的插入到所述导向器械盒主体中的释放推杆。
在一个实施例中，所述控制臂还包括与所述导向器械盒的第一卡合部匹配卡合的第二卡合部。
在一个实施例中，所述控制臂还包括有安装座，所述释放推杆固定所述安装座上，所述安装座由电机驱动。
在一个实施例中，所述安装座可滑动的设置在沿所述控制臂轴向的导轨上，
所述电机驱动丝杆转动，所述丝杆的外螺纹与所述安装座通孔中的内螺纹啮合，使得所述安装座能够在所述导轨上往复运动。
在一个实施例中，所述安装座上还固定有深度控制装置，所述安装座在第三深度范围内滑动以通过所述深度控制装置来限制穿刺针的穿刺深度。
在一个实施例中，所述深度控制装置包括挡板固定座和穿刺针挡板，所述挡板固定座从所述控制臂的侧部伸出，在所述挡板固定座上可拆卸的设置有穿刺针挡板，所述穿刺针挡板上具有供穿刺针通过的非闭合穿孔，所述非闭合穿孔与所述导向开合瓣闭合形成的过孔相对。
本发明的有益效果：本发明实施例提出的导向器械盒及穿刺导向和释放机构，其中的导向器械盒具有开合功能，导向器械盒和控制臂能够共用驱动装置，对手术空间的侵占更小，结构简单、操作便捷，成本低。
附图说明
图1是本发明实施例提出的穿刺导向和释放机构的使用示意图；
图2是本发明实施例提出的穿刺导向和释放机构的后侧视图；
图3是本发明实施例提出的穿刺导向和释放机构的前侧视图；
图4是本发明实施例提出的导向器械盒A的主体内部的部分零件结构 图(第二导向开合瓣的截面图)；
图5是本发明实施例提出的导向器械盒A的主体内部零件的正视图；
图6是本发明实施例提出的导向器械盒A在释放推杆控制下导向开合瓣2呈释放状态的示意图；
图7是本发明实施例提出的导向器械盒A在释放推杆控制下导向开合瓣2呈闭合状态的示意图；
图8是本发明实施例提出的导向器械盒A的主体内部零件图(寿命指示滑块位于寿命正常位置)；
图9是本发明实施例提出的导向器械盒A的纵向截面图(寿命指示滑块位于寿命正常位置)；
图10是本发明实施例提出的导向器械盒A的主体内部零件图(寿命指示滑块位于寿命终止位置)；
图11是本发明实施例提出的导向器械盒A的纵向截面图(寿命指示滑块位于寿命终止位置)；
图12是本发明实施例提出的导向器械盒A的寿命指示滑块在主体中的装配结构图；
图13是本发明实施例提出的导向器械盒A的主体的纵向截面图；
图14是本发明实施例提出的导向器械盒A的寿命指示滑块的后侧立体图；
图15是本发明实施例提出的导向器械盒A的寿命指示滑块的前侧立体图；
图16是本发明实施例提出的穿刺导向和释放机构的内部结构示意图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明白，以下结合具体实施例，并参照附图，对本发明进一步详细说明。但本领域技术人员知晓，本发明并不局限于附图和以下实施例。
如本文中所述，术语“包括”及其各种变体可以被理解为开放式术语，其意味着“包括但不限于”。术语“基于”及其类似表述可以被理解为“至 少基于”。术语“第一”、“第二”、“第三”等表述仅用于区分不同的特征，并无实质含义。术语“左”、“右”、“中间”及其类似表述仅用于表示相对物体之间的位置关系。
如图1-16所示，本发明实施例提出了一种导向器械盒A及穿刺导向和释放机构。参照图1-3、图6、图7、图16，本发明实施例的穿刺导向和释放机构包括控制臂B和可拆卸的安装到所述控制臂B前端的导向器械盒A，所述控制臂B包括在控制臂B前端可伸缩的插入到所述导向器械盒主体中的释放推杆3。
使用时，如图1所示，通过所述控制臂B上的深度控制装置限制穿刺针C的穿刺深度，穿刺针C从所述导向器械盒A上的过孔25中穿出，并进一步穿过所述穿刺模板D，插入到病灶区域，对生物组织进行穿刺。
本发明实施例的导向器械盒A包括主体1和导向开合瓣2。如图2-7所示，所述导向开合瓣2从所述主体1的侧部伸出的，包括通过导向瓣转轴23连接的第一导向开合瓣21和第二导向开合瓣22，所述导向开合瓣2通过弹性件24保持闭合，以形成供穿刺针C通过的过孔25。在所述第二导向开合瓣22的一侧表面上，形成有倾斜面221，所述倾斜面221被配置为能够与从所述主体1后部插入到第一深度范围内的释放推杆3抵接，以基于所述释放推杆3的插入深度控制所述导向开合瓣2的张开程度。使用时，释放推杆3从所述主体1后部插入到主体1中，随着释放推杆3的不断伸入而与所述倾斜面221形成抵接，并沿着倾斜面221继续向下克服弹性件24的阻力而抵压第二导向开合瓣22，第二导向开合瓣22随着推杆3的不断伸入而逐渐张开，直到释放推杆3沿着倾斜面221达到第二导向开合瓣22的顶部，如图6所示。此时，第二导向开合瓣22张开到最大程度。其中，从所述释放推杆3开始与倾斜面221形成抵接到所述释放推杆3达到第二导向开合瓣22的顶部(第二导向开合瓣22不再张开)的过程中，所述释放推杆3的插入深度范围构成所述第一深度范围。
具体的，如图4-7所示，所述第一导向开合瓣21固定在所述主体1上，所述第二导向开合瓣22的中部与第一导向开合瓣21通过导向瓣转轴23转动连接，所述弹性件24为张紧弹簧，设置在所述主体1底部与所述第二导 向开合瓣22的第一侧的下表面之间，由所述张紧弹簧保持所述导向开合瓣2闭合以形成供穿刺针通过的过孔25。在所述第二导向开合瓣22的关于导向瓣转轴23与所述过孔25相对的第一侧的上表面上，形成有朝向所述主体后部向下倾斜的倾斜面221，在本实施例中的倾斜面221为所述第二导向开合瓣22上表面的一个滑槽的底面。
如图8-15所示，在所述主体1中还设置有能够沿所述主体1的轴向滑动的寿命指示滑块4。所述寿命指示滑块4用于通过移动来指示导向器械盒A的使用寿命的终结。所述寿命指示滑块4被配置为能够与从所述主体1后部插入到第二深度范围内的释放推杆3抵接，以从寿命正常位置滑动到寿命终止位置，其中，所述第二深度范围为释放推杆3将所述寿命指示滑块4从寿命正常位置推到寿命终止位置的深度范围，所述第一深度范围的深度小于第二深度范围的深度。
如前所述，释放推杆3的不断伸入到主体1的内部，并使得第二导向开合瓣22张开到最大程度。此后，如果所述导向器械盒A达到使用次数或使用时长，则控制释放推杆3继续向主体1内部伸入，随后与寿命指示滑块4抵接，并推动寿命指示滑块4向主体1的前端运动，从第一位置运动到第二位置，其中第一位置对应于寿命正常位置，第二位置对应于寿命终止位置，位于第二位置处的寿命指示滑块4标识了导向器械盒A的寿命终结。
具体的，如图14、图15所示，所述寿命指示滑块4具有滑动部41和设置在所述滑动部41侧端的寿命指示部42，所述寿命指示部42具有位于前部的寿命正常指示部421和位于后部的寿命终止指示部422，与所述寿命指示部4对应的主体1上开设有寿命指示孔43。
正常使用的导向器械盒A，其寿命指示滑块4处于寿命正常位置，前部的寿命正常指示部421与主体1上的寿命指示孔43相对，如图8、图9所示；当导向器械盒A达到使用次数或使用时长，寿命指示滑块4滑动到寿命终止位置，寿命终止指示部422与主体1上的寿命指示孔43相对，如图10、图11所示。所述寿命指示部42上的寿命正常指示部421和寿命终止指示部422可以采用不同的颜色来标记，例如，寿命正常指示部421为 绿色，而寿命终止指示部422为红色，这样通过寿命指示孔43看到红色时，就表明导向器械盒A不能继续使用,以提醒使用人员更换新的导向器械盒A。
为了便于寿命指示滑块4在主体1内部滑动，如图8-13所示，在所述主体1中设置有限位滑轨44，所述限位滑轨44上设置有凸起的单向卡扣45，所述单向卡扣45靠近所述主体1后部的一侧具有倾斜斜面，所述单向卡扣45靠近所述主体1前部的一侧形成止挡结构，所述寿命指示滑块4的滑动部41沿所述限位滑轨44滑动，并由所述单向卡扣45的止挡结构限制所述寿命指示滑块4逆向移动，使得寿命指示滑块4不能向主体1的后部脱出，尤其是不能从寿命终止位置退回到寿命正常位置，防止再次使用。
在本发明的优选实施例中，所述限位滑轨44包括上轨和下轨，在所述上轨和下轨上分别对应的设置有所述单向卡扣45。更为优选的，一条所述限位滑轨44上设置有两个单向卡扣45，两个单向卡扣45之间的距离与所述寿命指示滑块4的滑动部41沿所述主体1轴向的尺寸相同，由此上轨和下轨能够稳定的夹持寿命指示滑块4，而不发生晃动，能够准确的指示导向器械盒A的寿命正常。所述寿命指示滑块4的滑动部41的上表面和/或下表面形成有减摩凹槽411，以减少滑动部41的表面与单向卡扣45端部、以及滑轨44之间的摩擦。
再次参照图2-5、图8-11，所述导向器械盒A还包括用于将所述主体1可拆卸的安装到控制臂B的第一卡合部5。所述第一卡合部5可以采用机械卡合或电磁锁合等多种方式，从而能够将导向器械盒A安装到控制臂B的端部。由于所述导向器械盒A的可拆卸设置，更易于对所述导向开合瓣2进行消毒或者对所述导向器械盒A进行整体更换。
在本发明实施例中，所述第一卡合部5设置在所述主体1后部，包括导向部件51和锁定部件52，其中所述导向部件51为在所述主体1后部凸出设置的导向柱，所述锁定部件52为卡钩。所述主体1上还设置有拆卸按钮53，所述拆卸按钮53有弹簧支撑在所述主体1上的按钮槽54中，所述拆卸按钮53与所述卡钩52连接，通过朝向按钮槽54按压所述拆卸按钮53解除所述卡钩与所述控制臂B之间的锁合。相应的，在所述控制臂B包括 与所述导向器械盒A的第一卡合部5匹配卡合的第二卡合部6，具有接受导向部件51的导向孔61和与所述卡钩卡合的卡钩固定孔62，如图3所示。由此，在使用上述第一卡合部5和第二卡合部6的结构将导向器械盒A安装到控制臂B的端部时，由于存在导向件51、61和锁定件52、62的双重定位，导向器械盒A不会在控制臂B上发生转动。
如图3、图4、图6、图7、图16所示，所述释放推杆3固定在所述安装座72上，所述安装座72由电机驱动，可滑动的设置在沿所述控制臂B轴向的导轨上，使得所述释放推杆3能够从控制臂B前端的释放推杆孔63中伸出并插入到所述导向器械盒A中。
如图6、图7、图16所示，在本发明的实施例中，所述控制臂B包括电机71、安装座72、导轨73和丝杆74。所述电机71驱动丝杆74转动，所述丝杆74的外螺纹与所述安装座72通孔中的内螺纹啮合，驱动所述安装座72在所述导轨73上往复运动。
此外，如图2、图3、图6、图7、图16所示，所述安装座72上还固定有深度控制装置8，所述深度控制装置8跟随所述安装座72在第三深度范围内滑动，以通过所述深度控制装置8来限制穿刺针C的穿刺深度。其中，所述第三深度范围的深度小于第一深度范围的深度。
具体的，如图2、图3所示，所述深度控制装置8包括挡板固定座81和穿刺针挡板82，所述挡板固定座81从所述控制臂B的侧部伸出，在所述挡板固定座81上可拆卸的设置有穿刺针挡板82，所述穿刺针挡板82上具有供穿刺针C通过的非闭合穿孔83，所述非闭合穿孔83与前述所述导向开合瓣2闭合形成的过孔25对齐，从而在穿刺时，电机71驱动安装座72沿控制臂B的轴向移动，设置穿刺针C的预定穿刺深度，随后将穿刺针C的针杆与所述穿刺针挡板82的非闭合穿孔83的侧壁贴合，穿刺针C的针尖穿过所述导向开合瓣2的过孔25，并进一步对生物组织进行穿刺。当穿刺针C的针柄与所述穿刺针挡板82的非闭合穿孔83的周缘接触时，达到预定穿刺深度，停止穿刺。本发明实施例的穿刺操作可用于单针治疗或活检，而通过多次重复操作，也能够实现多针治疗或活检。在本实施例中，所述穿刺针挡板82可拆卸的设置，便于对穿刺针挡板82进行消毒或者对 穿刺针挡板82进行更换。
本发明实施例的穿刺导向和释放机构工作时，电机71驱动丝杆74转动，丝杆74上的安装座72能够沿导轨73往复运动。在此过程中，所述穿刺导向和释放机构工作在三段行程区间之中。
控制穿刺针C的穿刺深度的第一行程区间：根据穿刺针C的穿刺位置，由电机71驱动安装座72并带动其上的深度控制装置8在第三深度范围内前进或后退，将穿刺针挡板82设置到相应位置，设置穿刺针C的预定穿刺深度；随后，将穿刺针C穿过穿刺针挡板82的非闭合穿孔83和导向开合瓣2的过孔25，直至穿刺针手柄抵持于穿刺针挡板82时完成穿刺。
控制导向器械盒A的导向开合瓣2开合的第二行程区间：穿刺完成后，电机71继续驱动安装座72并带动其上的释放推杆3往前移动，释放推杆3在第一深度范围内与第二导向开合瓣22的上表面的倾斜面221抵接，向下抵压第二导向开合瓣22，导致导向开合瓣2打开，释放穿刺针C。
此后，所述穿刺导向和释放机构根据后续的穿刺针C的穿刺位置，重复多次在第一行程区间和第二行程区间动作，完成多根穿刺针C的穿刺。
控制导向器械盒A的寿命指示器状态的第三行程区间：正常情况下，导向器械盒A的寿命指示滑块4处于寿命正常位置，前部的寿命正常指示部421与主体1上的寿命指示孔43相对，例如显示绿色。当导向器械盒A达到使用次数或使用时长时，电机71驱动安装座72并带动其上的释放推杆3继续往前移动，释放推杆3在第二深度范围内推动寿命指示滑块4前行到寿命终止位置，后部的寿命终止指示部422与主体1上的寿命指示孔43相对，例如显示红色，以标识导向器械盒A不能继续使用，需要更换。
本发明通过电机71驱动安装座72在三段行程区间往复运动的设计，在不增加结构复杂度的情况下实现了三种不同的功能，结构简化，节约了成本。
本发明实施例提出的导向器械盒及穿刺导向和释放机构，其中的导向器械盒具有开合功能，导向器械盒和控制臂能够共用驱动装置，对手术空间的侵占更小，结构简单、操作便捷，成本低。
在本说明书的描述中，参考术语“一个实施例”、“一些实施例”、“示 例”、“具体示例”、或“一些示例”等的描述意指结合该实施例或示例描述的具体特征、结构、材料或者特点包含于本发明的至少一个实施例或示例中。在本说明书中，对上述术语的示意性表述不一定指的是相同的实施例或示例。而且，描述的具体特征、结构、材料或者特点可以在任何的一个或多个实施例或示例中以合适的方式结合。
以上，对本发明的实施方式进行了说明。但是，本发明不限定于上述实施方式。凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (16)

  1. 一种导向器械盒，其特征在于，包括：
    主体；
    从所述主体的侧部伸出的导向开合瓣，包括通过导向瓣转轴连接的第一导向开合瓣和第二导向开合瓣，所述导向开合瓣通过弹性件保持闭合，以形成供穿刺针通过的过孔；
    在所述第二导向开合瓣的一侧表面上，形成有倾斜面，所述倾斜面被配置为能够与从所述主体后部插入到第一深度范围内的释放推杆抵接，以基于所述释放推杆的插入深度控制所述导向开合瓣的张开程度。
  2. 如权利要求1所述的导向器械盒，其特征在于，还包括：用于将所述主体可拆卸的安装到控制臂的第一卡合部。
  3. 如权利要求2所述的导向器械盒，其特征在于，所述第一卡合部包括导向部件和锁定部件，其中所述导向部件为在所述主体后部凸出设置的导向柱，所述锁定部件为卡钩。
  4. 如权利要求3所述的导向器械盒，其特征在于，所述主体上还设置有拆卸按钮，所述拆卸按钮与所述卡钩连接，通过按压所述拆卸按钮解除所述卡钩与所述控制臂之间的锁合。
  5. 如权利要求1所述的导向器械盒，其特征在于，所述弹性件为在所述主体底部与所述第二导向开合瓣的第一侧的下表面之间的张紧弹簧。
  6. 如权利要求1所述的导向器械盒，其特征在于，在所述主体中还设置有能够沿所述主体的轴向滑动的寿命指示滑块，
    所述寿命指示滑块被配置为能够与从所述主体后部插入到第二深度范围内的释放推杆抵接，以从寿命正常位置滑动到寿命终止位置，
    其中，所述第一深度范围的深度小于第二深度范围的深度。
  7. 如权利要求6所述的导向器械盒，其特征在于，在所述主体中设置有限位滑轨，所述限位滑轨上设置有凸起的单向卡扣，所述单向卡扣靠近所述主体后部的一侧具有倾斜斜面，所述单向卡扣靠近所述主体前部的一侧形成止挡结构，
    所述寿命指示滑块沿所述限位滑轨滑动，并由所述单向卡扣的止挡结构限制所述寿命指示滑块逆向移动。
  8. 如权利要求7所述的导向器械盒，其特征在于，一条所述限位滑轨上设置有两个单向卡扣，两个单向卡扣之间的距离与所述寿命指示滑块的滑动部沿所述主体轴向的尺寸相同。
  9. 如权利要求7或8所述的导向器械盒，其特征在于，所述限位滑轨包括上轨和下轨，在所述上轨和下轨上分别对应的设置有所述单向卡扣，
    所述寿命指示滑块的滑动部的上表面或下表面形成有减摩凹槽。
  10. 如权利要求6所述的导向器械盒，其特征在于，所述寿命指示滑块具有滑动部和设置在所述滑动部侧端的寿命指示部，所述寿命指示部具有位于前部的寿命正常指示部和位于后部的寿命终止指示部，
    与所述寿命指示部对应的主体上开设有寿命指示孔。
  11. 一种穿刺导向和释放机构，其特征在于，包括控制臂和可拆卸的安装到所述控制臂前端的如权利要求1-10之一所述的导向器械盒，
    所述控制臂包括在控制臂前端可伸缩的插入到所述导向器械盒主体中的释放推杆。
  12. 如权利要求11所述的穿刺导向和释放机构，其特征在于，所述控制臂还包括与所述导向器械盒的第一卡合部匹配卡合的第二卡合部。
  13. 如权利要求11所述的穿刺导向和释放机构，其特征在于，所述控 制臂还包括有安装座，所述释放推杆固定所述安装座上，所述安装座由电机驱动。
  14. 如权利要求13所述的穿刺导向和释放机构，其特征在于，所述安装座可滑动的设置在沿所述控制臂轴向的导轨上，
    所述电机驱动丝杆转动，所述丝杆的外螺纹与所述安装座通孔中的内螺纹啮合，使得所述安装座能够在所述导轨上往复运动。
  15. 如权利要求13所述的穿刺导向和释放机构，其特征在于，所述安装座上还固定有深度控制装置，所述安装座在第三深度范围内滑动以通过所述深度控制装置来限制穿刺针的穿刺深度。
  16. 如权利要求15所述的穿刺导向和释放机构，其特征在于，所述深度控制装置包括挡板固定座和穿刺针挡板，所述挡板固定座从所述控制臂的侧部伸出，在所述挡板固定座上可拆卸的设置有穿刺针挡板，所述穿刺针挡板上具有供穿刺针通过的非闭合穿孔，所述非闭合穿孔与所述导向开合瓣闭合形成的过孔相对。
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