WO2021012719A1 - 超声抽吸注液一体化器械 - Google Patents

超声抽吸注液一体化器械 Download PDF

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Publication number
WO2021012719A1
WO2021012719A1 PCT/CN2020/084407 CN2020084407W WO2021012719A1 WO 2021012719 A1 WO2021012719 A1 WO 2021012719A1 CN 2020084407 W CN2020084407 W CN 2020084407W WO 2021012719 A1 WO2021012719 A1 WO 2021012719A1
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WO
WIPO (PCT)
Prior art keywords
liquid injection
suction
sleeve
housing
needle tube
Prior art date
Application number
PCT/CN2020/084407
Other languages
English (en)
French (fr)
Inventor
颜忠余
汪辉
程春节
骆威
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.)
Filing date
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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 EP20843381.3A priority Critical patent/EP4005542A4/en
Priority to US17/628,855 priority patent/US20220249282A1/en
Priority to KR1020217041764A priority patent/KR20220011166A/ko
Priority to JP2021575067A priority patent/JP7313731B2/ja
Priority to BR112022000987A priority patent/BR112022000987A2/pt
Publication of WO2021012719A1 publication Critical patent/WO2021012719A1/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
    • A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • A61M1/0023—
    • 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
    • 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
    • A61M1/774—Handpieces specially adapted for providing suction as well as irrigation, either simultaneously or independently
    • 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
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/85—Drainage tubes; Aspiration tips with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants
    • 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
    • A61M1/84—Drainage tubes; Aspiration tips
    • A61M1/86—Connectors between drainage tube and handpiece, e.g. drainage tubes detachable from handpiece
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0093—Ultrasound system, e.g. for inducing coagulation during eye surgery
    • 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

Definitions

  • the invention relates to the field of medical devices, in particular to an ultrasonic suction and liquid injection integrated device.
  • the human eye can transmit light through the cornea and focus on the image through the lens, and then focus through the vitreous to display the image on the back retina.
  • the quality of focus is determined by many factors, including the size and shape of the eye, and the transparency of the cornea, lens, and vitreous.
  • the vitreous body is a gelatinous transparent tissue located at the back of the eye. When diseases of the eye, such as fundus bleeding, retinal detachment, etc., need to be removed by vitrectomy, the removal of the vitreous body can relieve the application to the retina and other tissues of the eye Tension.
  • Commonly used instruments for vitrectomy include vitrectomy handles, lighting tubes, and liquid injection tubes.
  • FIG. 1 For example, Chinese patent CN104640522B "Vibratory surgical device for removing vitreous and other tissues" discloses an ultrasonic-driven suction needle (cannula) instrument, which uses an ultrasonic handle to drive the suction needle; such as conventional ophthalmic suction needles Similarly, the cross-sectional area of the suction port at its distal end is smaller than the cross-sectional area of the lumen. According to the patent publication, this device is used to remove the vitreous body by using suction pressure and needle tube vibration to form a periodic bidirectional flow of tissue through the side port, and no cavity is generated outside the distal tip.
  • the amplitude of ultrasonic vibration is expected to be limited to a small range to reduce turbulence or tissue damage. In practical applications, this appropriate amplitude limit is difficult to grasp; ultrasonic vibration and the heat generated can damage delicate tissues such as the retina. Without proper cooling and protection of the jacket, it will be a problem for medical equipment. There are security issues. However, the addition of the jacket will affect the performance of the ultrasound and increase heat generation.
  • the patent mentions several sheaths attached to the distal end of the cannula to reduce the damage caused by turbulence none of them provide a technical solution that affects the ultrasonic performance and heating effect; and the suction function and infusion function of the device are It is implemented separately by two different devices.
  • the present invention provides an integrated ultrasonic suction and liquid injection device, which uses the distal front opening of the inner needle tube to contact the perfusion liquid, and generates cavitation and blasting by ultrasonic vibration, that is, breaks, liquefies, and sucks through cavitation.
  • ultrasonic vibration that is, breaks, liquefies, and sucks through cavitation.
  • it reduces the damage of ultrasonic vibration to the tissue surrounding the needle, reduces the heat generation and its influence, and provides perfusion liquid to improve the efficiency of the vitreous body liquefaction and suction.
  • the technical solution of the present invention is:
  • An ultrasonic suction and liquid injection integrated instrument comprising a housing, an horn placed inside the housing, an inner needle tube and an outer needle sleeve extending at the distal end of the housing, and the outer needle sleeve is sleeved on the inner needle tube
  • the hollow interior of the inner needle tube is a suction pipeline
  • the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube is a liquid injection pipeline. The far end forms an intersection.
  • the liquid injection pipeline further includes a filling connector and a filling pipe provided on the housing, and the filling pipe can be configured as a pipeline externally attached to the housing or a channel placed in the housing .
  • the outer needle sheath includes a closed flat top surface at the distal end surface, a liquid injection side hole and a suction side hole respectively located at both ends of the outer needle sheath.
  • the gap is in communication with the suction side hole.
  • the proximal end of the inner needle tube is provided with a connecting body, and the inner needle tube is fixed on the horn through the connecting body.
  • the connecting body includes a tapered proximal end with a split, a middle section with an external thread structure, and a distal end for force locking, and the outer diameter of the middle section is greater than the maximum outer diameter of the tapered proximal end
  • the horn is provided with a matching internal thread
  • the inside of the connecting body includes a central hole, the central hole includes a large diameter area and a small diameter area, the small diameter area is located at the tapered proximal end
  • the inner diameter of the middle section is equivalent to the outer diameter of the inner needle tube, and the large diameter zone is located inside the distal end and has a diameter larger than the outer diameter of the outer needle sleeve.
  • the large diameter area has a stepped surface, and the proximal surface of the outer needle sheath abuts the stepped surface.
  • the distal end of the housing is connected with a soft shoulder sleeve for liquid injection
  • the distal end of the soft shoulder sleeve for liquid injection has a needle sleeve clamping hole
  • the inner diameter of the needle sleeve clamping hole is It is smaller than the outer diameter of the outer needle sleeve.
  • liquid injection soft shoulder sleeve there is a threaded connection between the liquid injection soft shoulder sleeve and the housing.
  • the liquid injection soft shoulder sleeve is fixed to the housing to form a liquid injection circulation space sealed from the outside, the liquid injection circulation space forms a part of the liquid injection pipeline, and the liquid injection circulation space is a One side passes through the liquid injection side hole of the outer needle sleeve to communicate with the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube, and the other side communicates with the perfusion connector and the perfusion tube on the outer shell.
  • the liquid injection side hole is located in the liquid injection circulation space.
  • the present invention also discloses in more detail another ultrasonic suction and liquid injection integrated instrument, which includes a housing, an horn placed inside the housing, an inner needle tube and an outer needle sleeve extending at the distal end of the housing, so The outer needle sleeve is sleeved on the outside of the inner needle tube, the proximal end of the inner needle tube is fixed to the distal end of the horn through a connecting body, and the proximal end of the outer needle sleeve is passed through a liquid injection soft shoulder sleeve Fixed at the distal end of the housing, the ultrasonic suction and liquid injection integrated instrument includes a suction pipe and a liquid injection pipe.
  • the suction pipe includes the hollow interior of the inner needle tube, the central channel of the connecting body, and the The inner hole of the horn and the suction joint
  • the liquid injection pipeline includes the gap between the inner wall of the outer needle sleeve and the outer wall of the inner needle tube, and the liquid injection between the liquid injection soft shoulder sleeve and the housing
  • the circulation space, the gap between the housing and the horn, the perfusion joint, the perfusion tube, and the distal end of the suction pipeline and the liquid injection pipeline form an intersection.
  • the outer needle sheath includes a suction side hole and a liquid injection side hole respectively provided at both ends thereof, the inlet of the suction line is a distal opening of the inner needle tube, and the distal opening is located at the The side of the suction side hole.
  • the outer needle sleeve includes a closed flat top surface at the distal end surface, a gap is provided between the distal opening of the inner needle tube and the inner wall of the flat top surface of the outer needle sleeve, and the gap is The suction side holes are connected.
  • the liquid injection soft shoulder sleeve is screwed to the housing to form a liquid injection circulation space sealed from the outside, and the liquid injection side hole is located in the liquid injection circulation space.
  • the connecting body includes a tapered proximal end with a split, a middle section with an external thread structure, and a distal end for force locking, and the outer diameter of the middle section is greater than the maximum outer diameter of the tapered proximal end
  • the horn is provided with a matching internal thread
  • the inside of the connecting body includes the central hole, the central hole includes a large diameter area and a small diameter area, the small diameter area is located in the tapered proximal
  • the inside of the end and the middle section and its diameter is equivalent to the outer diameter of the inner needle tube, the large diameter area is located inside the distal end and its diameter is greater than the outer diameter of the outer needle sleeve; the large diameter area has a Step surface, the proximal end surface of the outer needle sleeve abuts the step surface.
  • the proximal end of the inner needle tube is flush with or protrudes from the proximal end of the tapered proximal end, but the protruding length does not exceed one-eighth of the wavelength of the ultrasonic working frequency of the instrument.
  • the proximal end of the inner needle tube is glued into the central hole of the tapered proximal end of the connecting body through high-strength glue.
  • the intersection formed by the distal end of the suction pipe and the liquid injection pipe of the present invention has the ultrasonic vibration of the inner needle tube, and since the front opening of the inner needle tube is in contact with the perfusion liquid, cavities are easily generated at the intersection , Cause cavitation, and then break, liquefy, and absorb the vitreous body through cavitation;
  • the cavitation produced by the invention has the effect of liquefying and breaking the viscous vitreous body, making it easier to be sucked;
  • the front side of the inner needle tube of the present invention has a natural opening, which has a larger flow rate and lower resistance than a smaller opening on the side, which further facilitates suction and improves suction efficiency.
  • Figure 1 is a schematic diagram of an integrated ultrasonic suction and liquid injection device provided by a preferred embodiment of the present invention
  • FIG. 2 is a partial cross-sectional view of an integrated ultrasonic suction and liquid injection device provided by a preferred embodiment of the present invention
  • Figure 3 is an exploded schematic diagram of Figure 2;
  • Fig. 4 is a schematic structural diagram of a connector provided by a preferred embodiment of the present invention.
  • the present invention discloses an integrated ultrasonic suction and liquid injection device, which includes a housing 101, an horn 105 placed inside the housing, and an inner needle tube extending at the distal end of the housing 101 201 and an outer needle sleeve 301, the outer needle sleeve 301 is sleeved on the outer side of the inner needle tube 201.
  • the proximal end of the inner needle tube 201 is fixed to the distal end of the horn 105 through a connecting body 203 (the specific structure is shown in FIG. 4, which will be described in detail later), and the three are fixed to each other.
  • the proximal end of the outer needle sleeve 301 is fixed to the distal end of the housing 101 through a soft shoulder sleeve 102 for liquid injection.
  • the outer needle sleeve 301 and the connecting body 203 have a clearance fit, and the specific structure is as follows:
  • the proximal end of the housing 101 is provided with a perfusion connector 103 and a suction connector 108, which are respectively connected to a source of infusion fluid and a suction source that generates negative pressure.
  • the filling connector 103 and the suction connector 108 respectively serve as the proximal ports of the liquid injection pipeline and the suction pipeline.
  • a liquid injection soft shoulder sleeve 102 is fixed at the distal end of the housing 101. In a preferred embodiment of the present invention, the two are connected by threads, and the liquid injection soft shoulder sleeve 102 has a tapered structure.
  • the liquid injection soft shoulder sleeve 102 has a needle sleeve holding hole 106.
  • the inner diameter of the needle sleeve holding hole 106 is smaller than the outer diameter of the outer needle sleeve 301 under unstressed conditions, so that when the outer needle After the sleeve 301 passes through the needle sleeve clamping hole 106, it can be fixed in a certain position by the needle sleeve clamping hole 106 and sealed to prevent leakage.
  • the horn 105 adopts the existing technology and includes an inner hole 1051 inside, and the distal end of the inner hole 1051 is an internal thread structure.
  • the connecting body 203 includes a tapered proximal end 2032 with a split 2031, a middle section 2033 with an external thread structure, and a distal end 2034 for force locking.
  • the outer diameter of the middle section 2033 is greater than the maximum outer diameter of the tapered proximal end 2032, and its external thread matches the internal thread on the horn 105.
  • the inside of the connecting body 203 includes the central hole 2035.
  • the central hole 2035 includes a large diameter area 2036 and a small diameter area.
  • the small diameter area is located inside the tapered proximal end 2032 and the middle section 2033 and has the same diameter.
  • the outer diameter of the inner needle tube 201 is equivalent, and the large diameter area 2036 is located inside the distal end 2034 and its diameter is larger than the outer diameter of the outer needle sleeve 301.
  • the large-diameter region 2036 has a stepped surface 2037, and the proximal end surface of the outer needle sleeve 301 abuts the stepped surface 2037. Of course, a slight gap is also possible.
  • the proximal end of the inner needle tube 201 When the proximal end of the inner needle tube 201 extends into the central hole 2035 of the connecting body 203, the proximal end of the inner needle tube 201 is flush with or protrudes from the proximal end of the tapered proximal end 2032. It does not exceed one-eighth of the wavelength of the ultrasonic working frequency of the instrument, so as not to affect the ultrasonic characteristics of the system.
  • the inner diameter of the small diameter area of the central bore 2035 is slightly larger than the outer diameter of the inner needle tube 201.
  • the central bore 2035 of the tapered proximal end 2032 shrinks to reduce the inner needle tube 201 and the connecting body 203 are locked together.
  • the stress of the inner needle tube 201 in the locking part is gradually reduced from the proximal end to the distal direction, so the stress concentration caused by ultrasonic vibration is reduced during operation.
  • the connecting body 203 is threaded into the horn 105.
  • the length of the inner threaded area of the horn is shorter than the screw-in length of the connecting body.
  • the diameter of the inner hole 1051 of the horn is smaller than the outer diameter of the tapered proximal end 2032 of the connecting body, so that when the connecting body 203 continues to be screwed into the connecting body 203, the cone of the connecting body is close to The end 2032 will hit the inner hole of the horn, and the chamfer at the contact point will compress and shrink the split 2031.
  • the inner needle tube 201, the connecting body 203 and the horn 105 are well coupled together.
  • the inner needle tube 201 is a straight steel needle, which includes a hollow interior 202 and a distal opening 204.
  • the outer needle sleeve 301 is sleeved on the outer side of the inner needle tube 201, and the outer needle sleeve 301 includes a suction side hole 304 and a liquid injection side hole 303 respectively provided at both ends thereof.
  • the outer needle sheath 301 also includes a closed flat top surface 302 located at the distal end surface, and the distal opening 204 of the inner needle tube 201 is located at the side of the suction side hole 304 and is connected to the outer needle sheath 301 There is a gap 305 between the inner walls of the flat top surface 302, and the gap 305 communicates with the suction side hole 304.
  • the outer needle sleeve 301 is sleeved on the inner needle tube from the distal end of the inner needle tube 201, and then continues to be inserted until it reaches the step surface 2037 of the large diameter region 2036 of the connecting body 203.
  • the inner diameter of the large diameter area 2036 is greater than the outer diameter of the outer needle sheath 301 and is in the range of 50 microns. In this way, the proximal end of the outer needle sleeve 301 and the connecting body 203 have a clearance fit (that is, a loose fit) for controlling the centering of the outer needle sleeve 301.
  • the liquid injection soft shoulder sleeve 102 is sleeved on the outer side of the outer needle sleeve 301 from the distal end through the needle sleeve clamping hole 106, thus forming a liquid injection circulation space 107 sealed from the outside, and the liquid injection side of the outer needle sleeve 301
  • the hole 303 is located in the liquid injection circulation space 107.
  • One side of the liquid injection circulation space 107 passes through the liquid injection side hole 303 of the outer needle sleeve 301 and communicates with the gap between the inner wall of the outer needle sleeve 301 and the outer wall of the inner needle tube 201, and the other side is connected to the housing 101
  • the perfusion connector 103 and the perfusion tube 104 are connected.
  • the ultrasonic suction and liquid injection integrated instrument forms a suction pipe and a liquid injection pipe.
  • the suction pipeline includes the suction side hole 304 of the outer needle sleeve 301, the distal opening 204 of the inner needle tube 201, the hollow interior 202 of the inner needle tube 201, the central channel 2035 of the connecting body 203, and the horn The inner hole 1051 of 105 and the suction joint 108.
  • the liquid injection pipeline includes the gap between the inner wall of the outer needle sleeve 301 and the outer wall of the inner needle tube 201, the liquid injection circulation space 107 between the liquid injection soft shoulder sleeve 102 and the housing 101, and the The gap between the housing 101 and the horn 105, the pouring joint 103, and the pouring tube 104.
  • the filling tube 104 may be configured as a pipeline externally attached to the housing 101 or a channel placed in the housing 101.
  • the inner diameter of the outer needle sleeve 301 is greater than the outer diameter of the inner needle tube 201 in the range of 20-200 microns, so that the gap between them is controlled within a certain range to control the injection speed, so that the suction
  • the speed is higher than the speed of liquid injection to ensure that the vitreous tissue can approach the distal opening 204 of the inner needle tube 201.
  • the front side of the inner needle tube 201 of the present invention has a natural opening, which has a larger flow rate and lower resistance than a smaller opening on the side of the prior art, which further facilitates suction and improves the efficiency of suction.
  • the ultrasonic vibration is transmitted to the distal end of the inner needle tube 201 through the handle horn 105. Because the distal end of the suction line and the injection line form an intersection, the perfusion fluid near the distal end is empty. Cavitation causes local vitreous liquefaction and is pumped away together with the perfusate.
  • the principle of sucking the vitreous body is to use two-way flow. Cavitation is not needed or desired. It is believed that the cavitation caused by the cavity will damage the fine tissues of the eye; therefore, the amplitude of the needle must be controlled to be small.
  • the principle of the suction glass body of the present invention is to use cavitation. Only when a non-viscous liquid such as water exists on the ultrasonic vibration surface, cavitation is more likely to be generated and cause cavitation.
  • the intersection formed by the distal end of the suction pipeline and the injection pipeline of the present invention has the ultrasonic vibration of the inner needle tube, and because the front opening of the distal end of the inner needle tube is in contact with the perfusion fluid (such as water), the intersection is easy to produce Cavitation causes cavitation, which has the effect of liquefying and breaking the viscous vitreous body, making it easy to be sucked.
  • the perfusion fluid such as water
  • the ideal mode that does not produce cavitation is difficult to control in many cases, such as the presence of liquid from another injection needle, and the amplitude of the ultrasonic-driven suction needle exceeds A certain threshold, etc.; the jets, blasting, and vibration of the suction needle generated by such cavities may cause damage to the eye tissue. Therefore, the prior art proposes to put a protective cover on the suction needle, that is, attach an elastomer cover to the suction needle. On the suction needle, the ultrasonic vibration at the suction needle is large and sensitive, so it will affect the ultrasonic performance. There is a gap between the outer needle sleeve and the inner needle tube that is vibrated by ultrasonic vibration and the liquid is perfused.
  • the loosely-fitted connecting body 203 and the liquid injection soft shoulder sleeve 102 make the outer needle sleeve 301 centrally positioned, so the connecting body 203 and the inner needle tube 201 Ultrasonic vibrations of the outer needle cover 301 will not be transmitted to the outer needle cover 301, and the outer needle cover 301 will not affect the ultrasonic performance of the inner needle 201, and it can also reduce the ultrasonic or mechanical damage caused by the ultrasonic vibration to the tissue surrounding the needle to protect the delicate Tissues such as the retina.
  • Ultrasonic vibration itself can cause heat. Compared with the prior art, the vibration and friction between the elastomer sleeve and the suction needle can also cause friction and heat generation.
  • the vitreous body is thick and slow in circulation, and will not effectively remove heat.
  • the suction tube in the present invention At the junction formed by the distal end of the pipeline and the injection pipeline, the perfusion fluid passes through, which effectively plays a cooling role. At the same time, the perfusion fluid also plays a role in lubricating the suction pipeline, reducing the frictional resistance of the pipeline, and making the suction flow rate. Speed up and improve efficiency.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Surgery (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Surgical Instruments (AREA)
  • External Artificial Organs (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种超声抽吸注液一体化器械包括外壳（101），置于外壳（101）内部的变幅杆（105），延伸设置在外壳（101）远端的内针管（201）和外针套（301），外针套（301）套接在内针管（201）的外侧，内针管（201）的中空内部为抽吸管路，外针套（301）的内壁与内针管（201）的外壁之间的间隙为注液管路，抽吸管路和注液管路的远端形成交汇。本装置利用内针管（201）远端正面开口与灌注液接触，由超声振动产生空穴、爆破，即通过空化来破碎、液化、并吸除玻璃体，减少超声振动对针头周围组织的损伤、降低热量的产生及其影响、提供灌注液体来提升对玻璃体液化和抽吸的效率。

Description

超声抽吸注液一体化器械 技术领域
本发明涉及一种医疗器械领域，尤其涉及一种超声抽吸注液一体化器械。
背景技术
人眼可通过经由角膜使光透过并且通过晶状体进行图像汇聚聚焦，再经过玻璃体聚焦在后面的视网膜上显示图像。聚焦的质量由很多因素决定，包括眼睛的尺寸和形状，以及角膜，晶状体，玻璃体的透明度等。玻璃体为位于眼睛后端的凝胶状透明组织，当眼睛发生疾病，如眼底出血、视网膜脱落等，需要用玻切手术将玻璃体吸除，玻璃体被去除也可以便缓解施加到视网膜和眼睛其它组织上的张力。常用的玻切手术器械包括有玻切手柄、照明管、注液管等。
如中国专利CN104640522B“用于去除玻璃体及其它组织的振动外科手术装置”公布了一种超声驱动抽吸针管(套管)的器械，它利用超声手柄来驱动抽吸针管；如常规眼科抽吸针管一样，其远侧末端的抽吸端口横截面面积小于管腔的横截面面积。根据该专利公布，该种装置用于去除玻璃体是利用抽吸压力和针管的振动一起形成通过侧端口的组织的周期性双向流动造成，而在远侧末端的外部不产生空穴。这样的装置，超声振动的幅度希望限制在很小的范围来减小湍流或组织损伤。在实际的应用中，这种合适的振幅限制是难把握的；超声的振动及其产生的热量会损伤精细的组织如视网膜，如果没有合适的冷却和外套的保护，对医疗设备来说就会有安全性的问题。但外套的加入又会影响超声的性能和增加发热。虽然该专利提到附接到套管远端的几种护套来减少湍流造成的损伤，但都没有给解决影响超声性能和发热效果的技术方案；而且该装置中抽吸功能与输液功能是由两个不同的设备来分开实现的。
发明内容
有鉴于此，本发明提供一种超声抽吸注液一体化器械，利用内针管远端正面开口与灌注液接触，由超声振动产生空穴、爆破，即通过空化来破碎、液化、并吸除玻璃体，减少超声振动对针头周围组织的损伤、降低热量的产生及其影响、提供灌注液体来提升对玻璃体液化和抽吸的效率。
为解决以上技术问题，本发明的技术方案为：
一种超声抽吸注液一体化器械，包括外壳，置于外壳内部的变幅杆，延伸设置在所述外壳远端的内针管和外针套，所述外针套套接在所述内针管的外侧，所述内针管的中空内部为抽吸 管路，所述外针套的内壁与内针管的外壁之间的间隙为注液管路，所述抽吸管路和注液管路的远端形成交汇。
优选的，所述注液管路还包括设置在所述外壳上的灌注接头、灌注管，所述灌注管可配置成外附于所述外壳上的管路或者置于所述外壳内的通道。
优选的，所述外针套包括位于远端端面的封闭的平缓顶面，分别位于所述外针套的两端侧向的注液侧孔、及抽吸侧孔。
优选的，所述内针管的远端端面与所述外针套的平缓顶面的内壁之间具有间隙，所述间隙与所述抽吸侧孔连通。
优选的，所述内针管的近端设置有连接体，所述内针管通过所述连接体固定在所述变幅杆上。
优选的，所述连接体包括具有劈口的锥形近端，具有外螺纹结构的中段，以及用于施力锁紧的远端，所述中段的外径大于所述锥形近端的最大外径且所述变幅杆上设置有与之相配的内螺纹，所述连接体的内部包括一中央孔道，所述中央孔道包括大径区和小径区，所述小径区位于所述锥形近端和中段的内部且其直径与所述内针管的外径相当，所述大径区位于所述远端的内部且其直径大于所述外针套的外径。
优选的，所述大径区具有一台阶面，所述外针套的近端面抵住所述台阶面。
优选的，所述外壳的远端连接有一注液软肩套，所述注液软肩套的远端具有一个针套夹持孔，所述针套夹持孔在不受力条件下其内径小于所述外针套的外径。
优选的，所述注液软肩套与所述外壳之间为螺纹连接。
优选的，所述注液软肩套与所述外壳固定后形成一与外界密封的注液流通空间，所述注液流通空间形成所述注液管路的一部分，所述注液流通空间一侧经过外针套的注液侧孔与所述外针套的内壁与内针管的外壁之间的间隙连通，另一侧与所述外壳上的灌注接头、灌注管连通。
优选的，所述注液侧孔位于所述注液流通空间内。
本发明还更为详细地揭示了另一种超声抽吸注液一体化器械，包括外壳，置于外壳内部的变幅杆，延伸设置在所述外壳远端的内针管和外针套，所述外针套套接在所述内针管的外侧，所述内针管的近端通过一连接体固定在所述变幅杆的远端，所述外针套的近端通过一注液软肩套固定在所述外壳的远端，所述超声抽吸注液一体化器械包括抽吸管路和注液管路，所述抽吸管路包括内针管的中空内部、连接体的中央孔道、变幅杆的内孔和抽吸接头，所述注液管路包括所述外针套的内壁与内针管的外壁之间的间隙、所述注液软肩套与所述外 壳之间的注液流通空间、所述外壳与变幅杆之间的缝隙、灌注接头、灌注管，所述抽吸管路和注液管路的远端形成交汇。
优选的，所述外针套的近端与所述连接体之间为间隙配合。
优选的，所述外针套包括分别设置在其两端的抽吸侧孔和注液侧孔，所述抽吸管路的入口为所述内针管的远端开口，所述远端开口位于所述抽吸侧孔一侧。
优选的，所述外针套包括位于远端端面的封闭的平缓顶面，所述内针管的远端开口与所述外针套的平缓顶面的内壁之间具有间隙，所述间隙与所述抽吸侧孔连通。
优选的，所述注液软肩套与所述外壳螺纹固定并形成一与外界密封的注液流通空间，所述注液侧孔位于所述注液流通空间内。
优选的，所述连接体包括具有劈口的锥形近端，具有外螺纹结构的中段，以及用于施力锁紧的远端，所述中段的外径大于所述锥形近端的最大外径且所述变幅杆上设置有与之相配的内螺纹，所述连接体的内部包括所述中央孔道，所述中央孔道包括大径区和小径区，所述小径区位于所述锥形近端和中段的内部且其直径与所述内针管的外径相当，所述大径区位于所述远端的内部且其直径大于所述外针套的外径；所述大径区具有一台阶面，所述外针套的近端面抵住所述台阶面。
优选的，所述内针管的近端与所述锥形近端的近端平齐或突出但突出长度不超过器械超声工作频率的波长的八分之一。
优选的，所述内针管的近端通过高强度胶粘于所述连接体的锥形近端的中央孔道中。
本发明的有益效果主要体现在：
1、本发明抽吸管路和注液管路的远端形成的交汇处既有内针管的超声振动，而且由于内针管远端正面开口与灌注液接触，因此该交汇处很容易产生空穴，引起空化，进而通过空化来破碎、液化、并吸除玻璃体；
2、本发明的外针套与超声振动的内针管之间有间隙且通灌注液体，外针套与连接体是松配合，所以连接体、内针管的超声振动不会传到外针套上，也就不会影响内针管的超声性能，而且也能减少超声振动对针头周围组织的损伤；
3、超声振动本身会引起发热，相较于现有技术的针头上的弹性体套子也会引起摩擦生热，玻璃体粘稠且流通慢，不会有效地带走热量，本发明中抽吸管路和注液管路的远端形成的交汇处有灌注液的通过，有效地起到了冷却作用，同时灌注液也起到润滑抽吸管路的作用，降低管道摩擦的阻力，使抽吸流速加快；
4、本发明产生的空化有液化、破碎粘稠玻璃体的作用，使其更容易被抽吸；
5、本发明的内针管正面自然开口，比侧面的较小的开口流量大、阻力小，进一步有助抽吸，提升抽吸的效率。
附图说明
图1是本发明优选实施例提供的超声抽吸注液一体化器械的示意图；
图2是本发明优选实施例提供的超声抽吸注液一体化器械的局部剖视图；
图3是图2的爆炸示意图；
图4是本发明优选实施例提供的连接体的结构示意图。
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3所示，本发明揭示了一种超声抽吸注液一体化器械，包括外壳101，置于外壳内部的变幅杆105，延伸设置在所述外壳101远端的内针管201和外针套301，所述外针套301套接在所述内针管201的外侧。
所述内针管201的近端通过一连接体203(具体结构如图4所示，后文详述)固定在所述变幅杆105的远端，三者相互固定。所述外针套301的近端通过一注液软肩套102固定在所述外壳101的远端。所述外针套301与连接体203之间为间隙配合，具体结构如下：
所述外壳101的近端设置有灌注接头103和抽吸接头108，分别与输注流体源及产生负压的抽吸源相接通。所述灌注接头103和抽吸接头108分别作为注液管路和抽吸管路的近端接口。所述外壳101的远端固定有一注液软肩套102，本发明优选实施例中两者通过螺纹连接，且所述注液软肩套102呈锥形结构。所述注液软肩套102具有一个针套夹持孔106，所述针套夹持孔106在不受力条件下其内径小于所述外针套301的外径，这样当所述外针套301穿过所述针套夹持孔106后，可被所述针套夹持孔106固定在一定位置且密封防漏。
所述变幅杆105采用现有技术，其内部包括内孔1051，且该内孔1051的远端为内螺纹结构。
所述连接体203包括具有劈口2031的锥形近端2032，具有外螺纹结构的中段2033，以及用于施力锁紧的远端2034。所述中段2033的外径大于所述锥形近端2032的最大外径，其外螺纹与所述变幅杆105上的内螺纹相匹配。
所述连接体203的内部包括所述中央孔道2035，所述中央孔道2035包括大径区2036和小径区，所述小径区位于所述锥形近端2032和中段2033的内部且其直径与所述内针管201的外径相当，所述大径区2036位于所述远端2034的内部且其直径大于所述外针套301的外径。所述大径区2036具有一台阶面2037，所述外针套301的近端面抵住所述台阶面2037，当然稍有间隙也是可以的。
当所述内针管201的近端伸入到所述连接体203的中央孔道2035中后，所述内针管201的近端与所述锥形近端2032的近端平齐或突出但突出长度不超过器械超声工作频率的波长的八分之一，这样不至于影响系统的超声特性。
本优选实施例中，所述中央孔道2035的小径区的内径比所述内针管201的外径略微大一点，当劈口2031收紧时，锥形近端2032的中央孔道2035缩小将内针管201和连接体203锁定在一起。通过这种设计，使内针管201处于锁紧部分的应力自近端向远端方向渐进减小，因此在工作时，由超声振动引起的应力集中就减小了。为了提高内针管201与连接体203的耦合，进一步降低应力集中，推荐用高强度的胶把这两者在锁紧处粘在一起。具体的，当内针管201插在连接体203内后，把连接体203通过螺纹拧入变幅杆105。变幅杆内螺纹区的长度短于连接体旋入长度，变幅杆内孔1051直径小于连接体锥形近端2032的外径，这样当继续拧入连接体203，连接体的锥形近端2032就会碰到变幅杆的内孔，在接触处的倒角就压紧收缩劈口2031，最后内针管201、连接体203与变幅杆105就很好地耦合到一起了。
本优选实施例中，所述内针管201为直线型钢针，其包括中空内部202和远端开口204。
所述外针套301套接在所述内针管201的外侧，所述外针套301包括分别设置在其两端的抽吸侧孔304和注液侧孔303。所述外针套301还包括位于远端端面的封闭的平缓顶面302，所述内针管201的远端开口204位于所述抽吸侧孔304一侧，且与所述外针套301的平缓顶面302的内壁之间具有间隙305，所述间隙305与所述抽吸侧孔304连通。
所述外针套301从内针管201的远端套在内针管上，然后继续插入一直到达到连接 体203的大径区2036的台阶面2037。所述大径区2036的内径大于所述外针套301的外径，在50微米范围内。这样所述外针套301的近端与所述连接体203之间为间隙配合(即松配合)，用于控制外针套301的居中性。所述注液软肩套102通过针套夹持孔106从远端套在外针套301的外侧，这样形成了一与外界密封的注液流通空间107，所述外针套301的注液侧孔303位于所述注液流通空间107内。所述注液流通空间107一侧经过外针套301的注液侧孔303与所述外针套301的内壁与内针管201的外壁之间的间隙连通，另一侧与所述外壳101上的灌注接头103、灌注管104连通。
如上所述，所述超声抽吸注液一体化器械就形成了抽吸管路和注液管路。
所述抽吸管路包括所述外针套301的抽吸侧孔304、所述内针管201的远端开口204、内针管201的中空内部202、连接体203的中央孔道2035、变幅杆105的内孔1051和抽吸接头108。
所述注液管路包括所述外针套301的内壁与内针管201的外壁之间的间隙、所述注液软肩套102与所述外壳101之间的注液流通空间107、所述外壳101与变幅杆105之间的缝隙、灌注接头103、灌注管104。所述灌注管104可配置成外附于所述外壳101上的管路或者置于所述外壳101内的通道。
本优选实施例中，所述外针套301的内径大于所述内针管201的外径在20-200微米范围，使之间的缝隙控制在一定范围来控制注液的速度，使抽吸的速度大于注液的速度，保证有玻璃体组织能够接近内针管201的远端开口204。本发明的内针管201正面自然开口，比现有技术侧面的较小的开口流量大、阻力小，进一步有助抽吸，提升抽吸的效率。
在超声工作的情况下，超声振动通过手柄变幅杆105传递到内针管201的远端，由于所述抽吸管路和注液管路的远端形成交汇，引起远端附近的灌注液空化，空化造成局部玻璃体液化而连同灌注液被一起抽走。
相较于现有技术中抽吸玻璃体的原理是利用双向流动，不需要也不希望产生空穴，认为空穴引起空化会损坏眼睛精细组织；所以起针头振幅要控制的很小。本发明抽吸玻璃体的原理是利用空化，在超声振动面有非粘稠的液体如水的存在，才更容易产生空穴，引起空化。本发明抽吸管路和注液管路的远端形成的交汇处既有内针管的超声振动，而且由于内针管远端正面开口与灌注液(例如水)接触，因此该交汇处很容易产生空穴，引起空化，产生的空化有液化、破碎粘稠玻璃体的作用，使其容易被抽吸。
更为重要的是，现有技术中，不产生空穴的理想模式，在许多情况下是很难控制的，比如有从另外注液针头来的液体的存在，超声驱动的抽吸针头振幅超过一定阈值等；这 样的空穴产生的射流、爆破和抽吸针头的振动都有可能对眼组织造成损伤，所以现有技术提出在抽吸针头上套上保护套，即将弹性体套子附着在抽吸针头上，而抽吸针头处的超声振动大且敏感，所以会影响超声性能。本发明的外针套与超声振动的内针管之间有间隙且通灌注液体，松配合的连接体203以及注液软肩套102使外针套301居中定位，所以连接体203、内针管201的超声振动不会传到外针套301上，外针套301也就不会影响内针201的超声性能，而且也能减少超声振动对针头周围组织产生的超声或机械损伤，来保护精细的组织如视网膜。
超声振动本身会引起发热，相较于现有技术的弹性体套子与抽吸针头振动摩擦也会引起摩擦生热，玻璃体粘稠且流通慢，不会有效地带走热量，本发明中抽吸管路和注液管路的远端形成的交汇处有灌注液的通过，有效地起到了冷却作用，同时灌注液也起到润滑抽吸管路的作用，降低管道摩擦的阻力，使抽吸流速加快，效率提升。
以上仅是本发明的优选实施方式，应当指出的是，上述优选实施方式不应视为对本发明的限制，本发明的保护范围应当以权利要求所限定的范围为准。对于本技术领域的普通技术人员来说，在不脱离本发明的精神和范围内，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (19)

  1. 一种超声抽吸注液一体化器械，其特征在于，包括外壳(101)，置于外壳内部的变幅杆(105)，延伸设置在所述外壳(101)远端的内针管(201)和外针套(301)，所述外针套(301)套接在所述内针管(201)的外侧，所述内针管(201)的中空内部(202)为抽吸管路，所述外针套(301)的内壁与内针管(201)的外壁之间的间隙为注液管路，所述抽吸管路和注液管路的远端形成交汇。
  2. 根据权利要求1所述的超声抽吸注液一体化器械，其特征在于，所述注液管路还包括设置在所述外壳(101)上的灌注接头(103)、灌注管(104)，所述灌注管(104)可配置成外附于所述外壳(101)上的管路或者置于所述外壳(101)内的通道。
  3. 根据权利要求1所述的超声抽吸注液一体化器械，其特征在于，所述外针套(301)包括位于远端端面的封闭的平缓顶面(302)，分别位于所述外针套(301)的两端侧向的注液侧孔(303)、及抽吸侧孔(304)。
  4. 根据权利要求3所述的超声抽吸注液一体化器械，其特征在于，所述内针管(201)的远端端面与所述外针套(301)的平缓顶面(302)的内壁之间具有间隙(305)，所述间隙(305)与所述抽吸侧孔(304)连通。
  5. 根据权利要求1所述的超声抽吸注液一体化器械，其特征在于，所述内针管(201)的近端设置有连接体(203)，所述内针管(201)通过所述连接体(203)固定在所述变幅杆(105)上。
  6. 根据权利要求5所述的超声抽吸注液一体化器械，其特征在于，所述连接体(203)包括具有劈口(2031)的锥形近端(2032)，具有外螺纹结构的中段(2033)，以及用于施力锁紧的远端(2034)，所述中段(2033)的外径大于所述锥形近端(2032)的最大外径且所述变幅杆(105)上设置有与之相配的内螺纹，所述连接体(203)的内部包括一中央孔道(2035)，所述中央孔道(2035)包括大径区(2036)和小径区，所述小径区位于所述锥形近端(2032)和中段(2033)的内部且其直径与所述内针管(201)的外径相当，所述大径区(2036)位于所述远端(2034)的内部且其直径大于所述外针套(301)的外径。
  7. 根据权利要求6所述的超声抽吸注液一体化器械，其特征在于，所述大径区(2036)具有一台阶面(2037)，所述外针套(301)的近端面抵住所述台阶面(2037)。
  8. 根据权利要求1所述的超声抽吸注液一体化器械，其特征在于，所述外壳(101)的远端连接有一注液软肩套(102)，所述注液软肩套(102)的远端具有一个针套夹持孔(106)，所述针套夹持孔(106)在不受力条件下其内径小于所述外针套(301)的外径。
  9. 根据权利要求8所述的超声抽吸注液一体化器械，其特征在于，所述注液软肩套(102) 与所述外壳(101)之间为螺纹连接。
  10. 根据权利要求8所述的超声抽吸注液一体化器械，其特征在于，所述注液软肩套(102)与所述外壳(101)固定后形成一与外界密封的注液流通空间(107)，所述注液流通空间(107)形成所述注液管路的一部分，所述注液流通空间(107)一侧经过外针套(301)的注液侧孔(303)与所述外针套(301)的内壁与内针管(201)的外壁之间的间隙连通，另一侧与所述外壳(101)上的灌注接头(103)、灌注管(104)连通。
  11. 根据权利要求10所述的超声抽吸注液一体化器械，其特征在于，所述注液侧孔(303)位于所述注液流通空间(107)内。
  12. 一种超声抽吸注液一体化器械，其特征在于，包括外壳(101)，置于外壳内部的变幅杆(105)，延伸设置在所述外壳(101)远端的内针管(201)和外针套(301)，所述外针套(301)套接在所述内针管(201)的外侧，所述内针管(201)的近端通过一连接体(203)固定在所述变幅杆(105)的远端，所述外针套(301)的近端通过一注液软肩套(102)固定在所述外壳(101)的远端，所述超声抽吸注液一体化器械包括抽吸管路和注液管路，所述抽吸管路包括内针管(201)的中空内部(202)、连接体(203)的中央孔道(2035)、变幅杆(105)的内孔(1051)和抽吸接头(108)，所述注液管路包括所述外针套(301)的内壁与内针管(201)的外壁之间的间隙、所述注液软肩套(102)与所述外壳(101)之间的注液流通空间(107)、所述外壳(101)与变幅杆(105)之间的缝隙、灌注接头(103)、灌注管(104)，所述抽吸管路和注液管路的远端形成交汇。
  13. 根据权利要求12所述的超声抽吸注液一体化器械，其特征在于，所述外针套(301)的近端与所述连接体(203)之间为间隙配合。
  14. 根据权利要求12所述的超声抽吸注液一体化器械，其特征在于，所述外针套(301)包括分别设置在其两端的抽吸侧孔(304)和注液侧孔(303)，所述抽吸管路的入口为所述内针管(201)的远端开口(204)，所述远端开口(204)位于所述抽吸侧孔(304)一侧。
  15. 根据权利要求14所述的超声抽吸注液一体化器械，其特征在于，所述外针套(301)包括位于远端端面的封闭的平缓顶面(302)，所述内针管(201)的远端开口(204)与所述外针套(301)的平缓顶面(302)的内壁之间具有间隙(305)，所述间隙(305)与所述抽吸侧孔(304)连通。
  16. 根据权利要求14所述的超声抽吸注液一体化器械，其特征在于，所述注液软肩套(102)与所述外壳(101)螺纹固定并形成一与外界密封的注液流通空间(107)，所述注液侧孔(303)位于所述注液流通空间(107)内。
  17. 根据权利要求12所述的超声抽吸注液一体化器械，其特征在于，所述连接体(203)包括具有劈口(2031)的锥形近端(2032)，具有外螺纹结构的中段(2033)，以及用于施力锁紧的远端(2034)，所述中段(2033)的外径大于所述锥形近端(2032)的最大外径且所述变幅杆(105)上设置有与之相配的内螺纹，所述连接体(203)的内部包括所述中央孔道(2035)，所述中央孔道(2035)包括大径区(2036)和小径区，所述小径区位于所述锥形近端(2032)和中段(2033)的内部且其直径与所述内针管(201)的外径相当，所述大径区(2036)位于所述远端(2034)的内部且其直径大于所述外针套(301)的外径；所述大径区(2036)具有一台阶面(2037)，所述外针套(301)的近端面抵住所述台阶面(2037)。
  18. 根据权利要求17所述的超声抽吸注液一体化器械，其特征在于，所述内针管(201)的近端与所述锥形近端(2032)的近端平齐或突出但突出长度不超过器械超声工作频率的波长的八分之一。
  19. 根据权利要求17所述的超声抽吸注液一体化器械，其特征在于，所述内针管(201)的近端通过高强度胶粘于所述连接体(203)的锥形近端(2032)的中央孔道(2035)中。
PCT/CN2020/084407 2019-07-23 2020-04-13 超声抽吸注液一体化器械 WO2021012719A1 (zh)

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