WO2022247720A1 - 用于超声乳化手术的积液盒 - Google Patents

用于超声乳化手术的积液盒 Download PDF

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Publication number
WO2022247720A1
WO2022247720A1 PCT/CN2022/093803 CN2022093803W WO2022247720A1 WO 2022247720 A1 WO2022247720 A1 WO 2022247720A1 CN 2022093803 W CN2022093803 W CN 2022093803W WO 2022247720 A1 WO2022247720 A1 WO 2022247720A1
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WIPO (PCT)
Prior art keywords
main body
perfusion
chamber
communicates
passage
Prior art date
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PCT/CN2022/093803
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English (en)
French (fr)
Inventor
袁小鹤
骆威
颜忠余
刘振中
Original Assignee
以诺康医疗科技（苏州）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 以诺康医疗科技（苏州）有限公司 filed Critical 以诺康医疗科技（苏州）有限公司
Priority to EP22810447.7A priority Critical patent/EP4238541A4/en
Priority to US18/547,114 priority patent/US20240050275A1/en
Priority to BR112023013707A priority patent/BR112023013707A2/pt
Priority to JP2023544082A priority patent/JP2024503529A/ja
Publication of WO2022247720A1 publication Critical patent/WO2022247720A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61F9/00745—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/60—Containers for suction drainage, adapted to be used with an external suction source
    • A61M1/62—Containers comprising a bag in a rigid low-pressure chamber, with suction applied to the outside surface of the bag
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/77—Suction-irrigation systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0204—Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
    • A61M3/022—Volume; Flow rate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0612—Eyes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Definitions

  • the invention relates to the technical field of medical instruments, in particular to an effusion box used for phacoemulsification.
  • Clouding of the lens or cataracts are fairly common as we age. Cataracts can be treated by replacing the cloudy lens with an intraocular lens. Ophthalmic phacoemulsification surgery is the most advanced cataract treatment technology. The phacoemulsification system usually uses ultrasonic energy to break the lens and suction the lens from the capsular bag.
  • Precise control of fluid volume and intraocular pressure in the eye is important during cataract surgery and other treatments of the eye. While ultrasonic energy can fragment the cataract and allow it to be drawn into the treatment probe with suction, a corresponding irrigation fluid needs to be introduced into the eye so that the total volume of fluid in the eye does not change excessively. If the total volume of fluid in the eye is allowed to decrease (too little pressure) during this procedure, the eye may collapse and cause significant tissue damage. Similarly, excessive pressure in the eye can strain and damage the tissues of the eye.
  • a surgical box that can cooperate with the host is usually used to realize the perfusion and suction functions, but the existing technology usually uses the form of gravity perfusion to realize the perfusion function, and the perfusion pressure cannot be detected in real time; and the existing When a surge occurs, the technology mostly uses the fluid from the perfusion channel to flow into the suction channel. This method will cause the instability of the perfusion pressure and aggravate the change of the intraocular pressure.
  • the purpose of the present invention is to overcome the deficiencies in the prior art and provide a fluid collection box for phacoemulsification.
  • the purpose of the present invention is achieved through the following technical solutions:
  • the effusion box used for phacoemulsification surgery includes a box body composed of a front plate, a main body and a rear plate, the box body is connected with a waste liquid bag, and the main body has an independently set perfusion channel and a suction channel,
  • the perfusion passage is a sealed flow cavity defined by the cover and the main body, the flow cavity communicates with the first interface and the second interface on the main body for perfusion, and the gap between the cover and the main body There is a gap and the on-off of the perfusion passage is controlled by squeezing the cover; the suction passage is a pipeline that communicates with the third interface and the waste liquid bag and is sucked by a peristaltic pump.
  • the suction passage is also connected with a negative pressure regulating circuit to adjust the internal pressure.
  • the back of the cover is provided with ribs extending downward along its edge, and the main body is provided with a groove matching the ribs, and the ribs are in interference fit with the grooves And there is a gap between the two;
  • the wall of the flow chamber is jointly defined by the back of the cover and the surface of the main body, and the perfusion water outlet and the perfusion water inlet of the flow chamber are located on the main body, Moreover, the perfusion water outlet communicates with the first interface, and the perfusion water inlet communicates with the second interface.
  • the cover has an outer convex portion and an elastic portion, the outer convex portion is opposite to the pouring water outlet, the elastic portion is opposite to the pouring water inlet, in the first state, the There is a gap between the convex part and the pouring water outlet to keep the liquid flowing in the flow cavity; in the second state, the convex part is squeezed, and the convex part is in close contact with the pouring water outlet, to block the flow of liquid in the flow chamber; the elastic part can be deformed during perfusion, and the elastic part is provided with a sensor to detect the perfusion pressure in the flow chamber through the generated deformation.
  • the suction passage includes a first communication port and a second communication port on the main body, the third interface communicates with the first communication port, the waste liquid bag communicates with the second communication port,
  • the pump tube of the peristaltic pump communicates between the first communication port and the second communication port, and the pump tube is arranged on a limit mechanism on the main body, and the limit mechanism includes a The limiting groove on the main body and two fixing blocks are clamped at both ends of the limiting groove, each of the fixing blocks is fixedly connected to the pump tube, and the two sides of the extending direction of the pump tube are provided with stoppers. plate.
  • the suction passage includes an accommodating cavity arranged on the back of the main body, the accommodating cavity is a sealed cavity jointly formed by the main body, the rear plate and the sealing ring, and the entrance of the accommodating cavity
  • the liquid port is in communication with the second communication port, and the accommodating cavity is in communication with the waste liquid bag through a communication piece.
  • a partition is vertically arranged in the accommodating chamber, and is divided into a first chamber and a second chamber by the partition, the liquid inlet communicates with the first chamber, and the There is a gap at the top of the partition, and the liquid in the first chamber enters the second chamber through the gap.
  • the connecting member is two identical connecting pipes arranged vertically on the inner side of the rear plate, and the two connecting pipes are respectively arranged in the first chamber and the second chamber, and the The input port of the connecting pipe is located at the top thereof, and the output port is located at the bottom of the side connected with the rear plate, and the output port is arranged opposite to and communicated with the through hole on the waste liquid bag.
  • the negative pressure regulating circuit is arranged on the surface of the main body, and is composed of a backflow water inlet, a backflow water outlet and a sealing channel, the backflow water inlet is connected with the second chamber, and the backflow outlet is connected to the second chamber.
  • the water port is in communication with the third interface, the cavity wall of the sealed channel is jointly defined by the cover and the surface of the main body, when the suction passage detects blockage, the return water inlet is opened; when the When the suction passage is not blocked, the return water inlet is closed.
  • the negative pressure value in the suction passage is measured by a negative pressure sensor arranged on the surface of the main body, and the negative pressure sensor is a seal formed by a deformable metal sheet and the surface of the main body.
  • a cavity, the sealed cavity communicates with the third interface and the first communication port respectively.
  • a hand-held ring-shaped part is provided on the back of the rear plate.
  • the suction channel Independently set the perfusion channel and the suction channel so that they will not interfere with each other.
  • the suction channel is used to accommodate the liquid in the cavity to adjust the intraocular pressure, while ensuring the stability of the pressure inside the perfusion channel and reducing eye
  • the change of internal pressure improves the safety of use
  • the elastic part of the cover of the perfusion channel deforms and expands during perfusion.
  • its own elasticity can slow down the impact of perfusate entering, and on the other hand, it can use the size of its deformation to cooperate with the sensor on the host.
  • the convex part of the perfusion channel is set opposite to the position of the perfusion outlet.
  • the perfusate needs to be squeezed and disconnected, it can be positioned quickly; on the other hand, the gap between it and the perfusion outlet is increased. , which can ensure that the perfusion pathway has sufficient capacity;
  • the suction path uses a peristaltic pump to realize the suction function.
  • the peristaltic pump suction has better stability and safety.
  • a limit mechanism is set to fix the position of the pump tube, which can effectively prevent the pump tube from happening during work. Axial movement and twisting;
  • a negative pressure sensor on the suction channel, which uses the deformable properties of the metal sheet to reflect the negative pressure inside the suction channel in real time, and can monitor the negative pressure in real time through its deformation, and control it through the detected negative pressure.
  • the opening and closing of the negative pressure regulating circuit is used to improve the precise control of the internal pressure of the suction passage;
  • a baffle is vertically arranged in the accommodating cavity.
  • the setting of the baffle can block the large particles in the suction pipeline in the first chamber, and play a filtering role to prevent the suction pipeline from entering the suction pipeline through the backflow inlet. .
  • Fig. 1 Explosion schematic diagram of the embodiment of the present invention
  • Fig. 2 the side view of the embodiment of the present invention
  • Fig. 3 partial structural schematic diagram of main body in the present invention
  • Fig. 4 the sectional view of perfusion channel in the present invention
  • Figure 5 a partial schematic diagram of an embodiment of the present invention
  • Figure 6 a partial schematic diagram of an embodiment of the present invention.
  • FIG. 7 Partial schematic diagram of the rear plate back and waste liquid bag in the present invention.
  • Fig. 8 Partial schematic diagram of rear plate surface and waste liquid bag in the present invention.
  • Figure 9 Partial schematic diagram of an embodiment of the present invention.
  • the present invention discloses a effusion box for phacoemulsification surgery, which includes a box body composed of a front plate 1, a main body 2 and a rear plate 3, and the box body communicates with waste Liquid bag 4, the main body 2 has a perfusion passage and a suction passage independently arranged, the perfusion passage is a sealed flow cavity 100 defined by the cover body 5 and the main body 2, the flow cavity 100 is connected to the The first interface 201 and the second interface 202 on the main body 2 are connected for perfusion, there is a gap between the cover 5 and the main body 2, and the opening and closing of the perfusion passage is controlled by squeezing the cover 5;
  • the suction passage is a pipeline that communicates with the third interface 203 and the waste liquid bag 4 and is sucked by a peristaltic pump.
  • the suction passage is also connected with a negative pressure regulating circuit to adjust the internal pressure.
  • the irrigation channel and the suction channel are set independently so that they will not interfere with each other, so that when a surge occurs, the suction channel is used to suck the intraocular fluid to adjust the intraocular pressure, and at the same time, the internal pressure of the irrigation channel is guaranteed.
  • the pressure is stable, reducing the change of intraocular pressure and improving the safety of use.
  • the back of the cover body 5 is provided with a rib 501 extending downward along its edge, and the main body 2 is provided with a groove 204 matching the rib 501 , the rib 501 is interference fit with the groove 204 and there is a gap between them;
  • the cavity wall of the flow cavity 100 is jointly defined by the back of the cover 5 and the surface of the main body 2, so
  • the perfusion water outlet 101 and the perfusion water inlet 102 of the flow chamber 100 are both located on the main body 2, and the perfusion water outlet 101 communicates with the first interface 201, and the perfusion water inlet 102 communicates with the second interface 202 connected.
  • the perfusion liquid enters the perfusion water inlet 102 from the second interface 202 in turn, flows into the flow chamber 100 , and then flows out of the first interface 201 from the perfusion water outlet 101 .
  • the cover body 5 has an outer convex portion 502 and an elastic portion 503, the outer convex portion 502 is opposite to the pouring water outlet 101, and the elastic portion 503 is opposite to the pouring water inlet 102,
  • the first state there is a gap between the protruding part 502 and the pouring water outlet 101 to keep the liquid flowing in the flow chamber 100; in the second state, the protruding part 502 is squeezed, and the The protrusion 502 is in close contact with the perfusion outlet 101 to block the flow of liquid in the flow chamber 100 .
  • the outside of the protruding portion 502 may be provided with linear motion components for extrusion, such as solenoid valves and the like.
  • the protruding part 502 is set opposite to the perfusion outlet 101, on the one hand, when the perfusate needs to be squeezed and disconnected, it can be positioned quickly; on the other hand, the gap between it and the perfusion outlet 101 is increased, Sufficient capacity of the perfusion pathway can be ensured.
  • the elastic part 503 is preferably made of a soft sealing material, such as silica gel or rubber.
  • the elastic part 503 is a thin film with a thickness of 0.2-0.6 mm, which can be deformed during pouring.
  • the elastic part 503 is provided with a sensor (not shown in the figure) to detect the perfusion pressure in the flow chamber 100 through the generated deformation, and judge the height and water volume of the matching infusion bottle (not shown in the figure) according to the perfusion pressure. It is a prior art that the sensor obtains the pressure value by measuring the degree of deformation, and it is not the focus of the present invention, so it will not be repeated here.
  • the elasticity of the elastic part 503 itself can also reduce the impact generated when the perfusate enters.
  • the suction passage includes a first communication port 205 and a second communication port 206 on the main body 2, the third interface 203 communicates with the first communication port 205, the The waste liquid bag 4 communicates with the second communication port 206, and the pump tube 10 of the peristaltic pump is communicated between the first communication port 205 and the second communication port 206, and the pump tube 10 is arranged on the main body 2
  • the limiting mechanism includes a limiting groove 7 fixed on the main body 2 and two fixing blocks 701 clamped at both ends of the limiting groove 7, each of the fixing blocks 701 are fixedly connected with the pump tube 10 , and baffles 702 are provided on both sides of the extending direction of the pump tube 10 .
  • Such a structure can effectively prevent axial movement and twisting of the pump tube 10 during operation, so as to ensure the stability of the pump tube 10 .
  • the suction passage includes an accommodating cavity 9 arranged on the back of the main body 2 , and the accommodating cavity 9 is jointly formed by the main body 2 , the rear plate 3 and the sealing ring 8
  • the surface of the rear plate 3 can also be arranged on the back cover that matches the sealing ring 8 to further ensure the sealing of the sealing chamber 9 .
  • the liquid inlet 901 of the accommodating cavity 9 communicates with the second communication port 206 , and the accommodating cavity 9 communicates with the waste liquid bag 4 through a connecting piece.
  • a partition 902 is vertically arranged in the accommodating chamber 9, and is divided into a first chamber 903 and a second chamber 904 by the partition 902, and the liquid inlet 901 and the first The chambers 903 are connected, and the top of the partition 902 has a gap 9021 , and the liquid in the first chamber 903 enters the second chamber 904 through the gap 9021 .
  • the setting of the gap 9021 makes it necessary for the liquid in the first chamber 903 to reach a certain height before it can flow into the second chamber 904.
  • the partition 902 utilizes the notch 9021 to filter, and in other feasible embodiments, the partition 902 may also be provided with some filter holes on its top for filtering.
  • the notch 9021 is a straight line notch, and in other feasible embodiments, the notch 9021 may have any suitable shape.
  • the connecting member is two identical connecting pipes 301 vertically arranged on the inner surface of the rear plate 3, and the two connecting pipes 301 are respectively arranged in the first cavity In the chamber 903 and the second chamber 904, the input port 3011 of the connecting pipe 301 is located at its top, and its output port 3012 is located at the bottom of the side connected to the rear plate 3, and the output port 3012 is connected to the waste liquid
  • the through holes 401 on the bag 4 are oppositely arranged and communicated with each other.
  • the structure of the connecting pipe 301 is such that when the height of the liquid in the first chamber 903 and the second chamber 904 exceeds the input port 3011, the liquid in the first chamber 903 and the second chamber 904 will be input into the connecting pipe 301, and input into the waste liquid bag 4 through the output port 3012.
  • the inner side of the rear panel 3 has a set of buckles 302, and the main body 2 has a
  • the buckle 302 is matched with the buckle hole 207, and the buckle 302 can be buckled in the buckle hole 2017, so that the rear panel 3 is buckled with the host 2.
  • the edge of the rear plate 3 is provided with a set of claws 304 to engage with the main body 2, and the main body 2 and the rear plate 3 are also provided with matching positioning holes 208 and positioning columns 303 to engage with each other. To further strengthen the connection stability between the two.
  • a ring-shaped part 12 that can be held is provided on the back of the rear panel 3 .
  • the component 12 may not be ring-shaped, but may be in any suitable shape such as a circle, a square, an ellipse, or the like.
  • the negative pressure regulating circuit is arranged on the surface of the main body 2, and is composed of a backflow water inlet 601, a backflow water outlet 602 and a sealing channel 603.
  • the backflow water inlet 601 It communicates with the second chamber 904, the return water outlet 602 communicates with the third interface 203, and the chamber wall of the sealed channel 603 is jointly defined by the cover 6 and the surface of the main body 2, when When the negative pressure in the suction passage reaches the set value, it means that there is a blockage in the suction passage at this time, and the return water inlet 601 is opened; when the negative pressure in the suction passage is less than the set value , that is, there is no blockage in the suction passage at this time, and the return water inlet 601 is closed.
  • the setting of the negative pressure regulating circuit can quickly open the return water inlet 601, and the second chamber The liquid in the chamber 904 is sucked into the suction channel to achieve the purpose of quickly adjusting the negative pressure inside the suction channel, thereby avoiding rapid changes in intraocular pressure, preventing the collapse of the inside of the eye or the occurrence of significant tissue damage .
  • the negative pressure regulating circuit is normally closed, and is opened only when the negative pressure in the suction passage reaches a set value.
  • a A negative pressure sensor is used to monitor the negative pressure value in the suction passage in real time.
  • the negative pressure sensor is a sealed cavity 200 composed of a deformable metal sheet 11 and the surface of the main body 2, and the sealed cavity 200 communicates with the third interface 203 and the The first communication port 205 .
  • the metal sheet 11 is preferably made of stainless steel, so that it has better flexibility, and the metal sheet 11 can be fixed with the main body 110 through injection molding, bonding and other processes to ensure that the sealed cavity 200 of tightness.
  • the sealed cavity 200 is arranged between the third interface 203 and the first communication port 205, so that the sealed cavity 200 can reflect the negative pressure in the suction passage in real time through its deformation, and cooperate with Other detection mechanisms (not shown) arranged on the main body 2 detect the negative pressure value in the suction passage, so that the opening and closing of the negative pressure regulating circuit can be controlled according to the measured negative pressure value. closed to improve precise control of the pressure inside the suction passage.
  • the detection mechanism can be a pressure sensor, a laser detector, etc. It is a prior art to obtain the pressure value by measuring the degree of deformation, and it is not the focus of the present invention, so it will not be repeated here.

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  • Heart & Thoracic Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • External Artificial Organs (AREA)

Abstract

本发明揭示了一种用于超声乳化手术的积液盒，包括由前板、主体和后板共同组成的盒体，所述盒体连通有废液袋，所述主体上具有独立设置的灌注通路和抽吸通路，所述灌注通路为由盖体与所述主体共同限定的密封流通腔，所述流通腔与所述主体上的第一接口、第二接口连通进行灌注，所述盖体与所述主体之间存在间隙并通过挤压所述盖体来控制所述灌注通路的通断；所述抽吸通路为连通第三接口和所述废液袋并通过蠕动泵进行抽吸的管路，所述抽吸通路还连通有一负压调节回路，以调节其内部的压力。本发明独立设置灌注通路和抽吸通路，使得二者不会相互干扰，独立工作，同时保证了灌注通路内部的压力稳定，减少眼内压的变化，提高使用安全性。

Description

用于超声乳化手术的积液盒 技术领域
本发明涉及医疗器械技术领域，具体地涉及一种用于超声乳化手术的积液盒。
背景技术
随着年龄的增长，晶状体浑浊或白内障是相当常见的。白内障可通过人工晶状体替换浑浊晶状体来治疗，眼科超乳手术是目前较先进的白内障治疗技术，超声乳化系统通常使用超声能量来破碎晶状体并从囊袋内抽吸晶状体。
在白内障手术盒和眼睛的其他治疗过程中，精确控制眼睛内的液体体积和眼内压是十分重要的。虽然超声能量可以使白内障破碎并允许其被吸入具有抽吸的治疗探头中，但是需要将相应的冲洗液体引入眼睛中，使得眼睛中的流体的总体积不会过度变化。如果在该过程中允许眼睛中的液体总体积变小(过小的压力)，那么眼睛可能塌陷并导致显著的组织损伤。类似的，眼睛内的过大压力可能会拉伤和损伤眼睛的组织。
在手术过程中，当针头处的白内障突然被吸走时，常常会发生浪涌的现象，浪涌会造成眼内压快速变化，很容易对眼睛造成损伤。
在现有的眼科手术系统中通常使用能够与主机配合的手术盒，实现灌注与抽吸功能，但现有技术通常使用重力灌注的形式实现灌注功能，无法实时检测灌注压的大小；并且现有技术在发生浪涌时多采用从灌注通路将液体流入抽吸通路，此方式会造成灌注压的不稳定，会加剧眼内压的变化。
因此，如果在眼科手术中保证眼内液体体积和眼内压的平衡是目前急需解决的问题。
发明内容
本发明的目的是克服现有技术存在的不足，提供一种用于超声乳化手术的积液盒。本发明的目的通过以下技术方案来实现：
用于超声乳化手术的积液盒，包括由前板、主体和后板共同组成的盒体，所述盒体连通有废液袋，所述主体上具有独立设置的灌注通路和抽吸通路，所述灌注通路为由盖体与所述主体共同限定的密封流通腔，所述流通腔与所述主体上的第一接口、第二接口连通进行灌注，所述盖体与所述主体之间存在间隙并通过挤压所述盖体来控制所述灌注通路的通断；所述抽吸通路为连通第三接口和所述废液袋并通过蠕动泵进行抽吸的管路，所述抽吸通路还连通有一负压调节回路，以调节其内部的压力。
优选的，所述盖体的背面沿其边沿设置有向下延伸的凸筋，所述主体上设置有与所述凸筋相匹配的凹槽，所述凸筋与所述凹槽过盈配合且二者之间存在间隙；所述流通腔的腔壁由所述盖体的背面和所述主体的表面共同限定，所述流通腔的灌注出水口和灌注进水口均位于所述主体上，且所述灌注出水口与所述第一接口连通，所述灌注进水口与所述第二接口连通。
优选的，所述盖体上具有一外凸部和一弹性部，所述外凸部与所述灌注出水口相对，所述弹性部与所述灌注进水口相对，第一状态下，所述外凸部与所述灌注出水口之间存在间隙使所述流通腔内保持液体流动；第二状态下，挤压所述外凸部，所述外凸部与所述灌注出水口紧贴，以阻断所述流通腔内的液体流动；所述弹性部可在灌注时产生形变，所述弹性部设置有传感器来通过产生的形变检测所述流通腔内的灌注压。
优选的，所述抽吸通路包括所述主体上的第一连通口和第二连通口，所述第三接口连通所述第一连通口，所述废液袋连通所述第二连通口，所述第一连通口和第二连通口之间连通有所述蠕动泵的泵管，所述泵管设置于所述主体上的限位机构上，所述限位机构包括固设于所述主体上的限位槽和两个卡设于所述限位槽两端的固定块，每个所述固定块均与所述泵管固接，且所述泵管延伸方向的两侧设置有挡板。
优选的，所述抽吸通路包括设置于所述主体背面的容置腔，所述容置腔为由所述主体、后板和密封圈共同构成的密封腔室，所述容置腔的进液口与所述第二连通口连通，且所述容置腔通过连通件与所述废液袋连通。
优选的，所述容置腔内竖直设置有一隔板，并被所述隔板分隔成第一腔室和第二腔室，所述进液口与所述第一腔室连通，所述隔板的顶部具有一缺口，所述第一腔室内液体通过所述缺口进入所述第二腔室。
优选的，所述连通件为两个相同的且竖直设于所述后板内侧面的连接管，两个所述连接管分别设置于所述第一腔室和第二腔室内，所述连接管的输入口位于其顶部，其输出口位于其与所述后板连接的侧面底部，所述输出口与所述废液袋上的通孔相对设置并相连通。
优选的，所述负压调节回路设置于所述主体的表面，并由回流进水口、回流出水口和密封通道构成，所述回流进水口与所述第二腔室相连通，所述回流出水口与所述第三接口相连通，所述密封通道的腔壁由封盖与所述主体的表面共同限定，当所述抽吸通路检测到堵塞时，所述回流进水口打开；当所述抽吸通路没有堵塞时，所述回流进水口关闭。
优选的，所述抽吸通路内的负压值由设置于所述主体表面的负压传感器测得，所述负压传感器为一由可形变的金属薄片和所述主体的表面共同构成的密封腔体，所述密封腔体 分别连通所述第三接口和第一连通口。
优选的，所述后板的背面设置有一可手持的环形部件。
本发明的有益效果主要体现在：
1、独立设置灌注通路和抽吸通路，使得二者不会相互干扰，在发生堵塞时使用抽吸通路容置腔内液体来调节眼内压，同时保证了灌注通路内部的压力稳定，减少眼内压的变化，提高使用安全性；
2、灌注通路具有的盖体具有的弹性部，在灌注时形变膨胀，其自身的弹性一方面可以减缓灌注液进入时产生的冲击，一方面可以利用其形变的大小与主机上的传感器配合进行实时检测其灌注压的大小；
3、灌注通路具有的外凸部与灌注出水口的位置相对设置，一方面使得当需要挤压断开灌注液时，可以快速定位；另一方面增大了其与灌注出水口之间的间隙，可以保证灌注通路具有足够的容量；
4、抽吸通路采用蠕动泵来实现抽吸功能，蠕动泵抽吸具有更好的稳定性和安全性，同时设置了限位机构来固定泵管的位置，可以有效防止泵管在工作中发生轴向移动和扭动；
5、抽吸通路连通有一负压调节回路，来防止抽吸通路中发生堵塞导致内部负压过大，避免了眼睛的塌陷和不必要的组织损伤，保证了手术的安全性，降低了风险；
6、抽吸通路上还设置有负压传感器，利用金属薄片可形变的属性来实时反映抽吸通路内部的负压，并可通过其形变实时监测负压大小，并通过检测的负压来控制负压调节回路的开闭，来提高对所述抽吸通路内部压力的精准控制；
7、所述容置腔内竖直设置有一隔板，隔板的设置能够将抽吸管路的大颗粒物挡在第一腔室内，起到过滤作用，防止通过回流进水口进入抽吸管路。
附图说明
下面结合附图对本发明技术方案作进一步说明：
图1：本发明实施例的爆炸示意图；
图2：本发明实施例的侧视图；
图3：本发明中主体的部分结构示意图；
图4：本发明中灌注通路的剖视图；
图5：本发明实施例的部分示意图；
图6：本发明实施例的部分示意图；
图7：本发明中后板背面和废液袋的部分示意图；
图8：本发明中后板表面和废液袋的部分示意图；
图9：本发明实施例的部分示意图。
具体实施方式
以下将结合附图所示的具体实施方式对本发明进行详细描述。但这些实施方式并不限于本发明，本领域的普通技术人员根据这些实施方式所做出的结构、方法、或功能上的变换均包含在本发明的保护范围内。
在方案的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“前”、“后”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。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。并且，在方案的描述中，以操作人员为参照，靠近操作者的方向为近端，远离操作者的方向为远端。
如图1至图9所示，本发明揭示了一种用于超声乳化手术的积液盒，包括由前板1、主体2和后板3共同组成的盒体，所述盒体连通有废液袋4，所述主体2上具有独立设置的灌注通路和抽吸通路，所述灌注通路为由盖体5与所述主体2共同限定的密封流通腔100，所述流通腔100与所述主体2上的第一接口201、第二接口202连通进行灌注，所述盖体5与所述主体2之间存在间隙并通过挤压所述盖体5来控制所述灌注通路的通断；所述抽吸通路为连通第三接口203和所述废液袋4并通过蠕动泵进行抽吸的管路，所述抽吸通路还连通有一负压调节回路，以调节其内部的压力。独立设置所述灌注通路和抽吸通路，使得二者不会相互干扰，使得在发生浪涌时使用所述抽吸通路抽吸眼内液体来调节眼内压，同时保证了所述灌注通路内部的压力稳定，减少了眼内压的变化，提高使用安全性。
具体的如图3和图4所示，所述盖体5的背面沿其边沿设置有向下延伸的凸筋501，所述主体2上设置有与所述凸筋501相匹配的凹槽204，所述凸筋501与所述凹槽204过盈配合且二者之间存在间隙；所述流通腔100的腔壁由所述盖体5的背面和所述主体2的表面共同限定，所述流通腔100的灌注出水口101和灌注进水口102均位于所述主体2上，且所述灌注出水口101与所述第一接口201连通，所述灌注进水口102与所述第二接口202连通。当进行灌注时，灌注液依次从所述第二接口202进入所述灌注进水口102，并流入所述流通腔100内，再从所述灌注出水口101流出所述第一接口201。
进一步的，所述盖体5上具有一外凸部502和一弹性部503，所述外凸部502与所述灌注出水口101相对，所述弹性部503与所述灌注进水口102相对，第一状态下，所述外凸 部502与所述灌注出水口101之间存在间隙使所述流通腔100内保持液体流动；第二状态下，挤压所述外凸部502，所述外凸部502与所述灌注出水口101紧贴，以阻断所述流通腔100内的液体流动。所述外凸部502的外部可以设置直线运动部件来进行挤压，例如电磁阀等。结构上所述外凸部502与灌注出水口101相对设置，一方面使得当需要挤压断开灌注液时，可以快速定位；另一方面增大了其与灌注出水口101之间的间隙，可以保证灌注通路具有足够的容量。
所述弹性部503优选采用软性密封材质构成，例如硅胶、橡胶，所述弹性部503为厚度在0.2-0.6mm之间的薄膜，可在灌注时产生形变，所述弹性部503设置有传感器(图中未示出)来通过产生的形变检测所述流通腔100内的灌注压，并根据灌注压判断与之匹配的输液瓶(图中未示出)的高度和水量。传感器通过测量形变程度得出压力值大小是现有技术，不是本发明的重点，此处不做赘述。所述弹性部503自身的弹性还可以减缓灌注液进入时产生的冲击。
如图3、图5所示，所述抽吸通路包括所述主体2上的第一连通口205和第二连通口206，所述第三接口203连通所述第一连通口205，所述废液袋4连通所述第二连通口206，所述第一连通口205和第二连通口206之间连通有所述蠕动泵的泵管10，所述泵管10设置于所述主体2上的限位机构上，所述限位机构包括固设于所述主体2上的限位槽7和两个卡设于所述限位槽7两端的固定块701，每个所述固定块701均与所述泵管10固接，且所述泵管10延伸方向的两侧设置有挡板702。这样的结构可以有效防止所述泵管10在工作中发生轴向移动和扭动，以保证所述泵管10的稳定性。
进一步的，如图6所示，所述抽吸通路包括设置于所述主体2背面的容置腔9，所述容置腔9为由所述主体2、后板3和密封圈8共同构成的密封腔室，在其他可行的实施例中，所述后板3的表面还可以设置于所述密封圈8相匹配的后盖来进一步保证所述密封腔9的密封性。
所述容置腔9的进液口901与所述第二连通口206连通，且所述容置腔9通过连通件与所述废液袋4连通。具体的，所述容置腔9内竖直设置有一隔板902，并被所述隔板902分隔成第一腔室903和第二腔室904，所述进液口901与所述第一腔室903连通，所述隔板902的顶部具有一缺口9021，所述第一腔室903内液体通过所述缺口9021进入所述第二腔室904。所述缺口9021的设置使得所述第一腔室903内的液体需要达到一定的高度才能流入所述第二腔室904内，这样的结构设置使得所述隔板902可以过滤掉所述第一腔室903内的体积较大的杂质，防止杂质流入所述负压调节回路中，达到防止大颗粒杂质通过回 流进水口601进入抽吸通路内的目的，减少所述抽吸通路堵塞的发生。在本优选实施例中所述隔板902利用所述缺口9021来过滤，在其他可行的实施例中，所述隔板902也可以在其顶部设置一些过滤孔来进行过滤。在图示实施例中所述缺口9021为一直线缺角，其他可行的实施例中，所述缺口9021可以具有任意合适的形状。
如图7、图8所示，所述连通件为两个相同的且竖直设于所述后板3内侧面的连接管301，两个所述连接管301分别设置于所述第一腔室903和第二腔室904内，所述连接管301的输入口3011位于其顶部，其输出口3012位于其与所述后板3连接的侧面底部，所述输出口3012与所述废液袋4上的通孔401相对设置并相连通。所述连接管301的结构使得当所述第一腔室903和第二腔室904内的液体高度超过所述输入口3011时，所述第一腔室903和第二腔室904内的液体才会输入所述连接管301内，并由所述输出口3012输入所述废液袋4内。
如图7、图8所示，为了保证所述后板3和所述主机2之间的紧密连接，所述后板3的内侧面具有一组卡扣302，所述主体2上具有与所述卡扣302相匹配的卡孔207，所述卡扣302可卡设于所述卡孔2017内，使得所述后板3与所述主机2卡接。进一步的，所述后板3的边沿设置有一组卡爪304来与所述主体2卡接，所述主体2和后板3上还设置有相匹配的定位孔208和定位柱303向卡合来进一步加强二者之间的连接稳定性。
如图7所示，为了便于拿取，所述后板3的背面设置有一可手持的环形部件12。在其他可行的实施例中，所述部件12可以不是环形，可以是圆形、方形、椭圆形等任意合适的形状。
如图1、图3、图5所示，所述负压调节回路设置于所述主体2的表面，并由回流进水口601、回流出水口602和密封通道603构成，所述回流进水口601与所述第二腔室904相连通，所述回流出水口602与所述第三接口203相连通，所述密封通道603的腔壁由封盖6与所述主体2的表面共同限定，当所述抽吸通路内的负压达到设定值时，代表此时所述抽吸通路内发生了堵塞，所述回流进水口601打开；当所述抽吸通路内的负压小于设定值时，即此时所述抽吸通路内没有堵塞，所述回流进水口601关闭。当所述抽吸通路内发生堵塞或其他紧急情况造成所述抽吸通路内部负压过大时，所述负压调节回路的设置可以快速打开所述回流进水口601，将所述第二腔室904内的液体吸入所述抽吸通路中，来达到快速调整所述抽吸通路内部的负压的目的，从而避免眼内压的快速变化，防止眼睛内部的塌陷或显著的组织损伤的发生。
所述负压调节回路常态下为关闭状态，仅当所述抽吸通路内的负压达到设定值时打 开，为了控制所述负压调节回路的开闭，所述抽吸通路上设置有一负压传感器，来实时监测所述抽吸通路内的负压值。如图9所示，所述负压传感器为一由可形变的金属薄片11和所述主体2的表面共同构成的密封腔体200，所述密封腔体200分别连通所述第三接口203和第一连通口205。所述金属薄片11优选为不锈钢材质，使其具有较好的柔韧性，并且所述金属薄片11可通过注塑、粘接等工艺与所述主体110固定在一起，以保证所述密封腔体200的密封性。所述密封腔体200设置于所述第三接口203和第一连通口205之间，使得所述密封腔体200可以通过其形变来实时反映所述抽吸通路内的负压大小，并配合其他设置在所述主体2上的检测机构(图中未示出)来检测所述抽吸通路内的负压值，使得可以根据测得的负压值来控制所述负压调节回路的开闭，来提高对所述抽吸通路内部压力的精准控制。所述检测机构可以是压力传感器、激光检测器等，通过测量形变程度得出压力值大小是现有技术，不是本发明的重点，此处不做赘述。
应当理解，虽然本说明书按照实施方式加以描述，但并非每个实施方式仅包含一个独立的技术方案，说明书的这种叙述方式仅仅是为清楚起见，本领域技术人员应当将说明书作为一个整体，各实施方式中的技术方案也可以经适当组合，形成本领域技术人员可以理解的其他实施方式。
上文所列出的一系列的详细说明仅仅是针对本发明的可行性实施方式的具体说明，它们并非用以限制本发明的保护范围，凡未脱离本发明技艺精神所作的等效实施方式或变更均应包含在本发明的保护范围之内。

Claims (10)

  1. 用于超声乳化手术的积液盒，其特征在于：包括由前板(1)、主体(2)和后板(3)共同组成的盒体，所述盒体连通有废液袋(4)，所述主体(2)上具有独立设置的灌注通路和抽吸通路，所述灌注通路为由盖体(5)与所述主体(2)共同限定的密封流通腔(100)，所述流通腔(100)与所述主体(2)上的第一接口(201)、第二接口(202)连通进行灌注，所述盖体(5)与所述主体(2)之间存在间隙并通过挤压所述盖体(5)来控制所述灌注通路的通断；所述抽吸通路为连通第三接口(203)和所述废液袋(4)并通过蠕动泵进行抽吸的管路，所述抽吸通路还连通有一负压调节回路，以调节其内部的压力。
  2. 根据权利要求1所述的用于超声乳化手术的积液盒，其特征在于：所述盖体(5)的背面沿其边沿设置有向下延伸的凸筋(501)，所述主体(2)上设置有与所述凸筋(501)相匹配的凹槽(204)，所述凸筋(501)与所述凹槽(204)过盈配合且二者之间存在间隙；所述流通腔(100)的腔壁由所述盖体(5)的背面和所述主体(2)的表面共同限定，所述流通腔(100)的灌注出水口(101)和灌注进水口(102)均位于所述主体(2)上，且所述灌注出水口(101)与所述第一接口(201)连通，所述灌注进水口(102)与所述第二接口(202)连通。
  3. 根据权利要求2所述的用于超声乳化手术的积液盒，其特征在于：所述盖体(5)上具有一外凸部(502)和一弹性部(503)，所述外凸部(502)与所述灌注出水口(101)相对，所述弹性部(503)与所述灌注进水口(102)相对，第一状态下，所述外凸部(502)与所述灌注出水口(101)之间存在间隙使所述流通腔(100)内保持液体流动；第二状态下，挤压所述外凸部(502)，所述外凸部(502)与所述灌注出水口(101)紧贴，以阻断所述流通腔(100)内的液体流动；所述弹性部(503)可在灌注时产生形变，所述弹性部(503)设置有传感器来通过产生的形变检测所述流通腔(100)内的灌注压。
  4. 根据权利要求1-3任一所述的用于超声乳化手术的积液盒，其特征在于：所述抽吸通路包括所述主体(2)上的第一连通口(205)和第二连通口(206)，所述第三接口(203)连通所述第一连通口(205)，所述废液袋(4)连通所述第二连通口(206)，所述第一连通口(205)和第二连通口(206)之间连通有所述蠕动泵的泵管(10)，所述泵管(10)设置于所述主体(2)上的限位机构上，所述限位机构包括固设于所述主体(2)上的限位槽(7)和两个卡设于所述限位槽(7)两端的固定块(701)，每个所述固定块(701)均与所述泵管(10)固接，且所述泵管(10)延伸方向的两侧设置有挡板(702)。
  5. 根据权利要求4所述的用于超声乳化手术的积液盒，其特征在于：所述抽吸通路包括设置于所述主体(2)背面的容置腔(9)，所述容置腔(9)为由所述主体(2)、后板(3)和 密封圈(8)共同构成的密封腔室，所述容置腔(9)的进液口(901)与所述第二连通口(206)连通，且所述容置腔(9)通过连通件与所述废液袋(4)连通。
  6. 根据权利要求5所述的用于超声乳化手术的积液盒，其特征在于：所述容置腔(9)内竖直设置有一隔板(902)，并被所述隔板(902)分隔成第一腔室(903)和第二腔室(904)，所述进液口(901)与所述第一腔室(903)连通，所述隔板(902)的顶部具有一缺口(9021)，所述第一腔室(903)内液体通过所述缺口(9021)进入所述第二腔室(904)。
  7. 根据权利要求6所述的用于超声乳化手术的积液盒，其特征在于：所述连通件为两个相同的且竖直设于所述后板(3)内侧面的连接管(301)，两个所述连接管(301)分别设置于所述第一腔室(903)和第二腔室(904)内，所述连接管(301)的输入口(3011)位于其顶部，其输出口(3012)位于其与所述后板(3)连接的侧面底部，所述输出口(3012)与所述废液袋(4)上的通孔(401)相对设置并相连通。
  8. 根据权利要求7所述的用于超声乳化手术的积液盒，其特征在于：所述负压调节回路设置于所述主体(2)的表面，并由回流进水口(601)、回流出水口(602)和密封通道(603)构成，所述回流进水口(601)与所述第二腔室(904)相连通，所述回流出水口(602)与所述第三接口(203)相连通，所述密封通道(603)的腔壁由封盖(6)与所述主体(2)的表面共同限定，当所述抽吸通路检测到堵塞时，所述回流进水口(601)打开；当所述抽吸通路没有堵塞时，所述回流进水口(601)关闭。
  9. 根据权利要求8所述的用于超声乳化手术的积液盒，其特征在于：所述抽吸通路内的负压值由设置于所述主体(2)表面的负压传感器测得，所述负压传感器为一由可形变的金属薄片(11)和所述主体(2)的表面共同构成的密封腔体(200)，所述密封腔体(200)分别连通所述第三接口(203)和第一连通口(205)。
  10. 根据权利要求9所述的用于超声乳化手术的积液盒，其特征在于：所述后板(3)的背面设置有一可手持的环形部件(12)。
PCT/CN2022/093803 2021-05-26 2022-05-19 用于超声乳化手术的积液盒 WO2022247720A1 (zh)

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BR112023013707A BR112023013707A2 (pt) 2021-05-26 2022-05-19 Caixa de coleta de fluido para cirurgia de facoemulsificação
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