WO2020215578A1 - 一种穿刺超声引导装置以及穿刺超声引导设备 - Google Patents

一种穿刺超声引导装置以及穿刺超声引导设备 Download PDF

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Publication number
WO2020215578A1
WO2020215578A1 PCT/CN2019/104001 CN2019104001W WO2020215578A1 WO 2020215578 A1 WO2020215578 A1 WO 2020215578A1 CN 2019104001 W CN2019104001 W CN 2019104001W WO 2020215578 A1 WO2020215578 A1 WO 2020215578A1
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WO
WIPO (PCT)
Prior art keywords
puncture
ultrasonic
puncture needle
array elements
needle
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PCT/CN2019/104001
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English (en)
French (fr)
Inventor
邱维宝
苏敏
张志强
蔡蕊琳
郑海荣
Original Assignee
深圳先进技术研究院
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Application filed by 深圳先进技术研究院 filed Critical 深圳先进技术研究院
Publication of WO2020215578A1 publication Critical patent/WO2020215578A1/zh
Priority to US17/506,705 priority Critical patent/US20220039832A1/en

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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
    • A61B17/3401—Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • 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
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • 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
    • A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
    • 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
    • A61B2017/3413—Needle locating or guiding means guided by ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound
    • A61B2090/3782—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument
    • A61B2090/3784—Surgical systems with images on a monitor during operation using ultrasound transmitter or receiver in catheter or minimal invasive instrument both receiver and transmitter being in the instrument or receiver being also transmitter

Definitions

  • the present invention relates to the field of medical equipment, and in particular to a puncture ultrasound guidance device and a puncture ultrasound guidance device.
  • Vertebral puncture technology has always been a technical problem in the field of medical applications. Due to the complex tissue environment near the human spine and lumbar vertebrae, fat, muscles, ligaments, hard bones, and cartilage make it more difficult for medical staff to puncture the vertebrae. Therefore, a real-time and effective method is needed to guide medical staff to perform puncture.
  • ultrasound is a real-time, portable, less painful, and side-effect imaging method. Therefore, ultrasound-guided vertebral puncture has attracted more and more attention.
  • the method of guiding puncture through ultrasound is mainly to perform imaging during puncture by fixing or not fixing an array ultrasound transducer on the surface of the human skin to guide the forward route of the needle tube.
  • this method is more difficult to operate. Medical staff need to operate the array transducer and needle tube at the same time, and the components near the vertebrae are complex. It is difficult for an external transducer to distinguish the nearby tissue cost, and some cartilage is The ligament is relatively small, and a high-frequency transducer is required to ensure the resolution of the imaging. When puncturing an obese patient, it is difficult for an imaging array transducer placed outside the body to ensure that it has sufficient imaging depth.
  • a puncture ultrasound guidance device that has good imaging effect, simple operation, and can distinguish the structure of the needle tube front end, and plan the best puncture route of the needle tube.
  • the purpose of the present invention is to provide a puncture ultrasound guiding device, which has good imaging effect and simple operation, and at the same time it can distinguish the tissue structure form of the front end of the needle tube and plan the best puncture route of the needle tube.
  • Another object of the present invention is to provide a puncture ultrasound guidance device, which can control the imaging range, while having good imaging effects and simple operation.
  • the present invention is realized by adopting the following technical solutions.
  • a puncture ultrasound guide device comprising a puncture needle tube and an ultrasonic transducer, one end of the puncture needle tube has a puncture needle, the ultrasonic transducer is accommodated in the puncture needle tube and extends to the puncture needle, and
  • the ultrasonic transducer includes a plurality of ultrasonic array elements for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements are arranged at the puncture needle.
  • the puncture needle is sharp and has a containing head, and a plurality of ultrasonic array elements are arranged on the containing head.
  • the puncture head has opposite needle tip and needle tail sides, and a plurality of the ultrasonic array elements are arranged between the needle tip side and the needle tail side.
  • a plurality of the ultrasonic array elements are distributed in an array.
  • a plurality of the ultrasonic array elements are distributed horizontally.
  • a plurality of the ultrasonic array elements are distributed in a staircase shape, and there is a height difference between the ultrasonic array elements distributed along the direction of the steps.
  • the end surface of the puncture needle has a puncture inclined surface
  • the array composed of a plurality of ultrasonic array elements has an array inclined surface matched with the puncture inclined surface.
  • the ultrasonic transducer further includes a flexible member and a tube shell, the tube shell is accommodated in the puncture needle tube and extends to the puncture needle, the flexible member is accommodated in the tube shell, A plurality of the ultrasonic array elements are arranged at one end of the flexible member close to the puncture needle, and the plurality of ultrasonic array elements are all electrically connected with the flexible member.
  • the end of the tube shell has a puncture head
  • the puncture head is accommodated in the puncture needle
  • the end surface of the puncture head is flush or clamped with the end surface of the puncture needle Angle setting.
  • a plurality of the ultrasonic array elements are arranged in the tube shell.
  • a puncture ultrasound guidance device includes an ultrasound electronic system and a puncture ultrasound guidance device.
  • the puncture ultrasound guidance device includes a puncture needle tube and an ultrasound transducer.
  • One end of the puncture needle tube has a puncture needle, and the ultrasound transducer is accommodated in the
  • the puncture needle tube is inside and extends to the puncture needle, and the ultrasonic transducer includes a plurality of ultrasonic array elements for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements are arranged at the puncture needle.
  • the ultrasonic electronic system is electrically connected with the ultrasonic transducer.
  • the puncture ultrasound guiding device arranges an ultrasound transducer in the puncture needle tube and extends to the puncture needle, and transmits and receives ultrasonic waves through a plurality of ultrasonic array elements arranged at the puncture needle.
  • electronic scanning imaging is performed based on multiple ultrasound array elements. The imaging range is wide. It can effectively distinguish the component shape of the puncture needle tip, so as to facilitate the planning of the best puncture path.
  • the ultrasound transducer Pull out from the puncture needle tube, and then release the anesthetic or extract body fluids from the puncture needle tube.
  • the puncture ultrasound guide device provided by the present invention is closer to the imaged tissue, the imaging is clearer, it is not easy to be blocked by other parts to affect the imaging, and the operation is convenient without requiring multiple medical staff Collaborative operation.
  • Fig. 1 is a schematic structural diagram of a puncture ultrasonic guiding device provided by a first embodiment of the present invention
  • FIG. 2 is a schematic diagram of the overall structure of the ultrasonic transducer in Figure 1;
  • Figure 3 is a sectional view of a partial structure of the ultrasonic transducer in Figure 1;
  • Figure 4 is a schematic diagram of a partial structure of the ultrasonic transducer in Figure 1;
  • FIG. 5 is a schematic structural diagram of an ultrasonic transducer provided by a second embodiment of the present invention.
  • FIG. 6 is a schematic diagram of a partial structure of a puncture ultrasonic guiding device provided by a third embodiment of the present invention.
  • Fig. 7 is a schematic diagram of a partial structure of a puncture ultrasonic guide device provided by a fourth embodiment of the present invention.
  • Icon 100- puncture ultrasound guide device; 110- puncture needle tube; 111- puncture needle; 113- needle tip side; 115- needle tail side; 130- ultrasonic transducer; 131- ultrasound array element; 1311-matching layer; 1313 Piezoelectric layer; 1315-backing layer; 133-flexible part; 135-tube shell; 150-handle.
  • orientation or positional relationship indicated by the terms “center”, “upper”, “vertical”, “horizontal”, “inner”, “outer”, etc. are based on the drawings shown
  • the orientation or positional relationship of the product, or the orientation or positional relationship usually placed when the product of the invention is used is only for the convenience of describing the invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, It is constructed and operated in a specific orientation, so it cannot be understood as a limitation to the present invention.
  • the terms “first”, “second”, etc. are only used for distinguishing description, and cannot be understood as indicating or implying relative importance.
  • CSF Spinal fluid
  • LP Lumbar puncture
  • Most lumbar punctures use anatomical landmarks to locate the intervertebral space between L3-L5, and then use a puncture needle to pass through several tissue layers between the vertebrae. Enter the subarachnoid space without encountering other obstacles (for example, blood vessels or bones) along the way.
  • Most lumbar punctures are performed "blindly" without the help of imaging or guidance mechanisms. Approximately 23.3% of people undergo lumbar puncture every year and fail.
  • Epidural injection is a new type of anesthesia technique that can effectively relieve lower body pain during surgery and childbirth, and can replace general anesthesia. It is currently very popular.
  • a needle needs to be inserted into the epidural space between the ligamentum flavum (LF) and the dura, and then a catheter is inserted to deliver the anesthetic.
  • epidural injections still use the blind insertion method of "reduced resistance” (LOR).
  • LOR reduced resistance
  • the method is that the anesthesiologist touches the patient’s vertebrae through manual palpation, and selects a suitable gap to insert along the midline of the spine. Depth means that the anesthesiologist feels constant resistance during insertion of the needle tube.
  • the present invention provides a puncture ultrasound guide device, which installs an ultrasound transducer containing multiple array elements at the front end of a needle tube, realizes ultrasound electronic scanning imaging through the ultrasound transducer, and obtains ultrasound images in the front end area of the transducer , So as to distinguish the organizational structure of the front end of the needle tube, plan the best puncture route, and the operation is very convenient, without the need for multiple people to operate.
  • this embodiment provides a puncture ultrasound guide device 100, including a puncture needle tube 110 and an ultrasonic transducer 130, one end of the puncture needle tube 110 has a puncture needle 111, the ultrasonic transducer 130 is accommodated in The puncture needle tube 110 extends to the puncture needle 111.
  • the ultrasonic transducer 130 includes a plurality of ultrasonic array elements 131 for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements 131 are arranged at the puncture needle 111.
  • ultrasound array elements 131 which has a wide imaging range and can effectively identify the component shape of the front end of the puncture needle 111, so as to facilitate the planning of the best puncture path.
  • the ultrasound is replaced.
  • the energy device 130 is pulled out from the puncture needle tube 110, and then anesthetic is released or the body fluid is extracted from the puncture needle tube 110, which is very convenient to operate.
  • the other end of the puncture needle tube 110 is provided with a handle 150, and the handle 150 is connected to the end of the ultrasonic transducer 130 away from the puncture needle 111.
  • the ultrasonic transducer 130 further includes a flexible member 133 and a tube shell 135, the tube shell 135 is accommodated in the puncture needle tube 110 and extends to the puncture needle 111, the flexible member 133 is accommodated in the tube shell 135, and a plurality of ultrasonic arrays
  • the element 131 is arranged at an end of the flexible member 133 close to the puncture needle 111, and a plurality of ultrasonic array elements 131 are electrically connected to the flexible member 133.
  • the bottom of each ultrasonic array element 131 is provided with electrodes, and the electrodes of multiple ultrasonic array elements 131 can be led out through the flexible member 133, which facilitates electrical connection with other external control devices.
  • the flexible member 133 may be a flexible board or a flexible cable, but any conductive structure capable of achieving flexible connection falls within the protection scope of the present invention.
  • the tube shell 135 is fitted in the puncture needle tube 110, and the tube shell 135 can withdraw outward along the puncture needle tube 110 under the action of external force, which facilitates the use of the puncture needle tube 110 to perform treatment operations after the puncture is in place.
  • the end of the tube shell 135 has a puncture head, the puncture head is accommodated in the puncture needle 111, and the end surface of the puncture head is flush with the end surface of the puncture needle 111.
  • the tube shell 135 is provided with a puncture head, and the puncture head is in the shape of a spike, which facilitates puncturing.
  • the tube shell 135 can also be confined in the puncture head without participating in the puncture action, and its specific structure will not be described here.
  • the puncture needle 111 has a spike shape and has a receiving head, and a plurality of ultrasonic array elements 131 are arranged in the receiving head.
  • the puncture needle 111 also has a needle tip side 113 and a needle tail side 115, a plurality of ultrasonic array elements 131 are arranged between the needle tip side 113 and the needle tail side 115, and the ultrasonic array element 131 near the needle tip side 113 is higher than that near the needle Ultrasonic array element 131 on the caudal side 115.
  • the heights of the multiple ultrasonic array elements 131 decrease in the direction away from the tip side 113, which can reduce the degree of shielding of the ultrasonic array elements 131 by the outer edge of the tube shell 135, so that each ultrasonic array element 131 can extend outward. Transmit and receive ultrasonic waves inside.
  • the pointed shape mentioned in this embodiment refers to the conventional needle tip shape.
  • the puncture needle 111 and the puncture head can also be other shapes that can also achieve the puncture effect.
  • a plurality of ultrasonic array elements 131 are distributed in an array, and an insulating barrier is provided between two adjacent ultrasonic array elements 131.
  • the ultrasonic transducer 130 in this embodiment is a stepped array transducer, a plurality of ultrasonic array elements 131 are distributed in a stepped manner, and the height difference between every two adjacent ultrasonic array elements 131 is equal, that is, the Each row of ultrasonic array elements 131 are arranged according to a gradient, the height difference between two adjacent rows of ultrasonic array elements 131 is equal everywhere, and the height and spacing are matched with the angle of the needle tube, and the two adjacent ultrasonic array elements 131 are isolated by insulating materials , For example through plastic insulation.
  • the installation orientations of the multiple ultrasonic array elements 131 are all set along the front of the puncture needle 111.
  • the installation orientations of the multiple ultrasonic array elements 131 here can also be slanted to the front of the puncture needle 111.
  • the multiple ultrasonic array elements 131 can also be installed independently of each other.
  • the installation orientation of the multiple ultrasonic array elements 131 can achieve the effect of transmitting and receiving ultrasonic waves toward the front of the puncture needle 111.
  • the end surface of the puncture needle 111 has a puncture slope
  • the outer edge of each ultrasonic array element 131 is flush with the puncture slope.
  • the outer edge of each ultrasonic array element 131 may also have a certain small angle with the puncture slope.
  • the top surface of each ultrasonic array element 131 forms a step surface with a stepped structure
  • the outer edge of each ultrasonic array element 131 is the outer edge of the step surface
  • the puncture slope is the slope where the slope end surface of the puncture needle 111 is located.
  • the outer edge of the ultrasonic array element 131 is coplanar with the end face of the puncture needle 111, so that the gradient of the step structure formed by the multiple ultrasonic array elements 131 is consistent with the inclination of the puncture slope, which reduces the ultrasonic array element 131 being punctured by the needle 111.
  • the degree of occlusion of the outer edge of each ultrasonic array element 131 can transmit and receive ultrasonic waves in a large range outwards.
  • each ultrasonic array element 131 does not protrude from the puncture slope, which also avoids the ultrasonic array element during the puncture process. Excessive contact of 131 with the tissues in the body ensures the maximum transmission and reception range of each ultrasound array element 131, and ultimately further improves the imaging effect.
  • each ultrasonic array element 131 includes a matching layer 1311, a piezoelectric layer 1313, and a backing layer 1315.
  • the number of each layer is not limited.
  • the backing layer 1315 is connected to the flexible member 133, and the piezoelectric layer 1313 is arranged on On the backing layer 1315, the matching layer 1311 is disposed on the piezoelectric layer 1313, and the outer edge of the matching layer 1311 of each ultrasonic array element 131 is coplanar with the puncture bevel to prevent the ultrasonic array element 131 from protruding from the puncture needle 111.
  • this embodiment provides a puncture ultrasound guide device 100.
  • Ultrasonic transducers 130 arranged in a stepped arrangement are installed on the puncture needle 111 at the front end of the puncture needle tube 110.
  • the element 131 performs electronic scanning imaging to select the optimal puncture route and accurately reach the puncture area during the puncture process.
  • the target area is anesthetized or the tissue and body fluid samples of the target area are obtained.
  • the present invention performs electronic scanning imaging by using interventional ultrasound transducers arranged in an array ladder, which can obtain more information, have a wide imaging range, and can effectively distinguish the component forms of the tip of the needle tube. At the same time, it is closer to the target tissue and the imaging is clearer. It is easy to be blocked by other parts and affect the imaging, and the operation is convenient without the coordination of multiple medical staff.
  • this embodiment provides a puncture ultrasound guide device 100. Its basic structure, principle and technical effect are the same as those of the first embodiment. For a brief description, the parts not mentioned in this embodiment can be referred to Corresponding content in the first embodiment.
  • This embodiment provides a puncture ultrasound guide device 100, which includes a puncture needle tube 110 and an ultrasonic transducer 130.
  • a puncture needle tube 110 One end of the puncture needle tube 110 has a puncture needle 111, and the ultrasonic transducer 130 is accommodated in the puncture needle tube 110 and extends to the puncture needle. Needle 111.
  • the ultrasonic transducer 130 includes a flexible member 133, a tube shell 135, and a plurality of ultrasonic array elements 131 for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements 131 are arranged at the puncture needle 111.
  • the tube shell 135 is accommodated in the puncture needle tube 110 and extends to the puncture needle 111
  • the flexible member 133 is accommodated in the tube shell 135, a plurality of ultrasonic array elements 131 are arranged at one end of the flexible member 133 close to the puncture needle 111, and a plurality of ultrasonic
  • the array elements 131 are electrically connected to the flexible member 133.
  • the bottom of each ultrasonic array element 131 is provided with electrodes, and the electrodes of multiple ultrasonic array elements 131 can be led out through the flexible member 133, which facilitates electrical connection with other external control devices.
  • a plurality of ultrasonic array elements 131 are ringed in the tube shell 135.
  • the multiple ultrasonic array elements 131 are arranged around the inside of the tube shell 135, and the multiple ultrasonic array elements 131 are arranged along the same plane.
  • the multiple ultrasonic array elements 131 here may also gradually decrease in height along the tip side 113 and the needle tail side 115 of the puncture needle 111, thereby also reducing the shielding effect of the edge of the puncture needle 111 to a certain extent.
  • the tube shell 135 is constricted in the puncture needle 111, and the end surfaces of the plurality of ultrasonic array elements 131 and the tube shell 135 are flush.
  • this embodiment provides a puncture ultrasound guide device 100, the basic structure and principle and the technical effects produced are the same as those of the first embodiment.
  • parts not mentioned in this embodiment can be referred to Corresponding content in the first embodiment.
  • This embodiment provides a puncture ultrasound guide device 100, which includes a puncture needle tube 110 and an ultrasonic transducer 130.
  • a puncture needle tube 110 One end of the puncture needle tube 110 has a puncture needle 111, and the ultrasonic transducer 130 is accommodated in the puncture needle tube 110 and extends to the puncture needle. Needle 111.
  • the ultrasonic transducer 130 includes a flexible member 133, a tube shell 135, and a plurality of ultrasonic array elements 131 for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements 131 are arranged at the puncture needle 111.
  • the tube shell 135 is accommodated in the puncture needle tube 110 and extends to the puncture needle 111
  • the flexible member 133 is accommodated in the tube shell 135, a plurality of ultrasonic array elements 131 are arranged at one end of the flexible member 133 close to the puncture needle 111, and a plurality of ultrasonic
  • the array elements 131 are electrically connected to the flexible member 133.
  • the bottom of each ultrasonic array element 131 is provided with electrodes, and the electrodes of multiple ultrasonic array elements 131 can be led out through the flexible member 133, which facilitates electrical connection with other external control devices.
  • the ultrasonic transducer 130 is an area array transducer, and a plurality of ultrasonic array elements 131 are arranged in the shell 135 along the same plane array. Specifically, the multiple ultrasonic array elements 131 and the tube shell 135 are all confined in the puncture needle 111, and the multiple ultrasonic array elements 131 are all flush with the end surface of the tube shell 135.
  • this embodiment provides a puncture ultrasound guide device 100, the basic structure and principle and the technical effects produced are the same as those of the first embodiment.
  • parts not mentioned in this embodiment can be referred to Corresponding content in the first embodiment.
  • This embodiment provides a puncture ultrasound guide device 100, which includes a puncture needle tube 110 and an ultrasonic transducer 130.
  • a puncture needle tube 110 One end of the puncture needle tube 110 has a puncture needle 111, and the ultrasonic transducer 130 is accommodated in the puncture needle tube 110 and extends to the puncture needle. Needle 111.
  • the ultrasonic transducer 130 includes a flexible member 133, a tube shell 135, and a plurality of ultrasonic array elements 131 for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements 131 are arranged at the puncture needle 111.
  • the tube shell 135 is accommodated in the puncture needle tube 110 and extends to the puncture needle 111
  • the flexible member 133 is accommodated in the tube shell 135, a plurality of ultrasonic array elements 131 are arranged at one end of the flexible member 133 close to the puncture needle 111, and a plurality of ultrasonic
  • the array elements 131 are electrically connected to the flexible member 133.
  • the bottom of each ultrasonic array element 131 is provided with electrodes, and the electrodes of multiple ultrasonic array elements 131 can be led out through the flexible member 133, which facilitates electrical connection with other external control devices.
  • the ultrasonic transducer 130 is a linear array transducer, each ultrasonic array element 131 is linear, and a plurality of ultrasonic array elements 131 are parallel to each other and arranged in the tube shell 135 in parallel along the same horizontal plane. Specifically, the multiple ultrasonic array elements 131 and the tube shell 135 are all confined in the puncture needle 111, and the multiple ultrasonic array elements 131 are all flush with the end surface of the tube shell 135.
  • This embodiment provides a puncture ultrasound guidance device, including an ultrasound electronic system (not shown) and a puncture ultrasound guidance device 100, wherein the basic structure and principle of the puncture ultrasound guidance device 100 and the technical effects produced are the same as those of the first embodiment
  • a puncture ultrasound guidance device including an ultrasound electronic system (not shown) and a puncture ultrasound guidance device 100, wherein the basic structure and principle of the puncture ultrasound guidance device 100 and the technical effects produced are the same as those of the first embodiment
  • parts not mentioned in this embodiment please refer to the corresponding content in the first embodiment.
  • the puncture ultrasound guide device 100 includes a puncture needle tube 110 and an ultrasound transducer 130.
  • One end of the puncture needle tube 110 has a puncture needle 111.
  • the ultrasound transducer 130 is accommodated in the puncture needle tube 110 and extends to the puncture needle 111, and the ultrasound transducer 130 includes a plurality of ultrasonic array elements 131 for transmitting and receiving ultrasonic waves, and the plurality of ultrasonic array elements 131 are arranged at the puncture needle 111.
  • the ultrasonic electronic system is electrically connected to the ultrasonic transducer 130 for exciting multiple ultrasonic array elements 131 and processing echo signals received by the ultrasonic transducer 130.
  • the ultrasound electronic system includes a controller and an imaging device.
  • the imaging device is electrically connected to the ultrasound transducer for performing image reconstruction corresponding to the anatomical tissue structure according to the echo signal and obtaining a tissue image in front of the puncture needle 111 .
  • the controller is electrically connected to the multiple ultrasonic array elements 131 of the ultrasonic transducer 130, and the angles of the multiple ultrasonic array elements 131 at which the multiple ultrasonic array elements 131 are transmitted and received are adjusted through the controller, so that the imaging range can be deflected at a certain angle. It is electrically connected to the controller for imaging.
  • the image generated by the imaging device may be a two-dimensional ultrasound image or a three-dimensional ultrasound image.

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Abstract

公开了一种穿刺超声引导装置（100）以及穿刺超声引导设备，涉及医疗器械领域。穿刺超声引导装置（100）包括穿刺针管（110）和超声换能器（130），穿刺针管（110）的一端具有穿刺针头（111），超声换能器（130）容置在穿刺针管（110）内并延伸至穿刺针头（111）处，且超声换能器（130）包括多个用于发射和接收超声波的超声阵元（131），多个超声阵元（131）设置在穿刺针头（111）处。在实际使用时，通过利用多个超声阵元（131）进行电子扫描成像，成像范围广，能够有效地识别穿刺针头（111）前端的组织结构，从而便于规划出最佳的穿刺路径。这种穿刺超声引导装置（100）距离所成像的组织更近，成像更清晰，不容易被其他部位遮挡影响成成像，并且操作方便，不需要多位医护人员协同操作。

Description

一种穿刺超声引导装置以及穿刺超声引导设备 技术领域
本发明涉及医疗器械领域，具体而言，涉及一种穿刺超声引导装置以及穿刺超声引导设备。
背景技术
椎骨穿刺技术在医学应用领域一直是一个技术难题。由于人体脊椎腰椎附近组织环境复杂，脂肪、肌肉、韧带、硬骨、软骨各种成分提高了医护人员对椎骨穿刺的难度。因此，需要一种实时有效的方法来引导医护人员来进行穿刺。
相对X射线，CT等，超声是一种实时，便携，痛苦小，无副作用的成像方法，因此超声引导椎骨穿刺越来越受到人们的关注。在现有技术中，通过超声引导穿刺的方法主要是通过在人体皮肤表面固定或不固定一个阵列超声换能器在穿刺时进行成像，引导针管的前进路线。但是这种方法操作难度比较大，医护人员需要同时对阵列换能器和针管进行操作，并且椎骨附近成分复杂，一个体外的换能器很难对其附近的组织成本进行区分，而且部分软骨和韧带比较小，需要频率比较高的换能器保证成像的分辨率。对一个肥胖患者进行穿刺时，一个放置在体外的成像阵列换能器很难保证其具有足够的成像深度。
有鉴于此，设计制造出一种成像效果好、操作简单，同时能够分辨出针管前端的组织结构形态，规划出针管的最佳穿刺路线的穿刺超声引导装置就显得尤为重要。
发明内容
本发明的目的在于提供一种穿刺超声引导装置，成像效果好、操作简单，同时能够分辨出针管前端的组织结构形态，规划出针管的最佳穿刺路线。
本发明的另一目的在于提供一种穿刺超声引导设备，能够控制成像范围，同时成像效果好、操作简单。
本发明是采用以下的技术方案来实现的。
一种穿刺超声引导装置，包括穿刺针管和超声换能器，所述穿刺针管的一端具有穿刺针头，所述超声换能器容置在所述穿刺针管内并延伸至所述穿刺针头，且所述超声换能器包括多个用于发射和接收超声波的超声阵元，多个所述超声阵元设置在所述穿刺针头处。
进一步地，所述穿刺针头呈尖刺状并具有容置头部，多个超声阵元设置在容置头部。
进一步地，穿刺头部具有相对的针尖侧和针尾侧，多个所述超声阵元设置在所述针尖侧与所述针尾侧之间。
进一步地，多个所述超声阵元呈阵列分布。
进一步地，多个所述超声阵元呈水平分布。
进一步地，多个所述超声阵元呈阶梯状分布，且沿阶梯方向分布的所述超声阵元之间存在高度差。
进一步地，所述穿刺针头的端面具有穿刺斜面，多个超声阵元组成的阵列具有与穿刺斜面相配合的阵列斜面。
进一步地，所述超声换能器还包括柔性件和管壳，所述管壳容置在所述穿刺针管内并延伸至所述穿刺针头，所述柔性件容置在所述管壳内，多个所述超声阵元设置在所述柔性件靠近所述穿刺针头的一端，且多个所述超声阵元均与所述柔性件电连接。
进一步地，所述管壳的端部具有穿刺头部，所述穿刺头部容置在所述穿刺针头内，且所述穿刺头部的端面与所述穿刺针头的端面相平齐或呈夹角设置。
进一步地，多个所述超声阵元环设在所述管壳内。
一种穿刺超声引导设备，包括超声电子系统和穿刺超声引导装置，穿刺超声引导装置包括穿刺针管和超声换能器，所述穿刺针管的一端具有穿刺针头，所述超声换能器容置在所述穿刺针管内并延伸至所述穿刺针头，且所述超声换能器包括多个用于发射和接收超声波的超声阵元，多个所述超声阵元设置在所述穿刺针头处。所述超声电子系统与所述超声换能器电连接。
本发明具有以下有益效果：
本发明提供的一种穿刺超声引导装置，将超声换能器设置在穿刺针管内并延伸至穿刺针头，通过设置在穿刺针头处的多个超声阵元发射和接收超声波。在实际使用时，基于多个超声阵元进行电子扫描成像，成像范围广，能够有效地分辨穿刺针头前端的成分形态，从而便于规划出最佳的穿刺路径，经过穿刺后，将超声换能器从穿刺针管中拔出，再从穿刺针管中释放麻药或者提取体液。相较于现有的体外阵列换能器，本发明提供的穿刺超声引导装置距离所成像的组织更近，成像更清晰，不容易被其他部位遮挡影响成像，并且操作方便不需要多位医护人员协同操作。
附图说明
图1为本发明第一实施例提供的穿刺超声引导装置的结构示意图；
图2为图1中超声换能器的整体结构示意图；
图3为图1中超声换能器的局部结构剖视图；
图4为图1中超声换能器的局部结构示意图；
图5为本发明第二实施例提供的超声换能器的结构示意图；
图6为本发明第三实施例提供的穿刺超声引导装置的局部结构示意图；
图7为本发明第四实施例提供的穿刺超声引导装置的局部结构示意图。
图标：100-穿刺超声引导装置；110-穿刺针管；111-穿刺针头；113-针尖侧；115-针尾侧；130-超声换能器；131-超声阵元；1311-匹配层；1313-压电层；1315-背衬层；133-柔性件；135-管壳；150-手柄。
具体实施方式
为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本申请进行进一步详细说明。应当理解，此处所描述的具体实施例仅用以解释本申请，并不用于限定本申请。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本发明的描述中，需要说明的是，术语“中心”、“上”、“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，或者是该发明产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本发明和简化描述，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”等仅用于区分描述，而不能理解为指示或暗示相对重要性。
在本发明的描述中，还需要说明的是，除非另有明确的规定和限定，术语“设置”、“相连”、“安装”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。
脊髓液(CSF)是一种重要的体液，可以用来诊断各种中枢神经系统疾病或病症，包括危及生命的疾病，如脑炎或脑膜炎，有的疾病诊断延迟几个小时都可能会引发严重的后果。腰椎穿刺(LP)是一种有效的获得脊髓液的方法，目前腰椎穿刺大多是通过解剖标志法来定位L3-L5之间的椎间隙，然后使用穿刺针穿过椎骨之间的几个组织层进入蛛网膜下腔，并且沿途不能碰到其他障碍物(例如，血管或骨骼)。大多数腰椎穿刺是在没有成像或引导机制的帮助下“盲目地”执行的。每年大约有近23.3％ 的人进行腰椎穿刺手术以失败告终。这些失误导致治疗延误，并造成不必要和危险的程序。一些肥胖患者的表皮和目标之间的脂肪组织过多，腰椎穿刺的失败率更高，由于腰椎穿刺导致的并发症率在肥胖患者中几乎增加到了50％。
硬膜外注射是一种新型麻醉技术，能够有效地缓解手术和分娩过程中的下半身疼痛，能够替代全身麻醉的方案，目前很受欢迎。在硬膜外注射过程中，需要将针插入位于黄韧带(LF)和硬脑膜之间的硬膜外腔中，然后插入导管以输送麻醉剂。现今，硬膜外注射多还是采用“阻力减弱”(LOR)的盲插入法，该方法是麻醉师通过手动触诊，即触摸患者的椎骨，选择合适的间隙沿着脊椎中线插入，至于插入的深度是麻醉师凭感觉在插入针管过程中感受到恒定的阻力，当针管插入硬膜外腔时阻力会变弱，则麻醉师认为已经找准位置。但是比较肥胖的患者很难找到合适的插入位置，而且患者之间的组织阻力存在差异，有时根本感觉不到，即使是经验丰富的麻醉师也会被误导。因此，往往要经过多次穿刺才能完成注射，给患者带来巨大痛苦，并且经验丰富的麻醉师和新手麻醉师在硬膜外注射的过程中会有1-3％和3-5％的概率产生硬脑膜穿刺的并发症，硬脑膜穿刺可导致暂时性或不可逆转的永久性并发症，如头痛，硬膜外血肿或神经损伤。综上，硬膜外注射仍然是麻醉师进行的最具挑战性的任务之一，需要更好的方法来引导麻醉师准确穿刺。
正如背景技术中所言，现有的穿刺引导方法多是通过体外阵列超声阵列换能器在穿刺时进行成型，引导针管的前进路线。但是这种方式操作难度较大且成像效果不佳。进一步地，出现了将单阵元换能器安置在针管的前端，能够对检测到的前方组织进行回波反射，但是获得的信息 过于抽象和单一很难通过一个个单独的回波判断出前方组织的成分和形态，同时由于单阵元换能器的安装结构不合理，导致取出时十分困难，仅仅只能作为探测手段，而无法作为治疗手段。本发明提供了一种穿刺超声引导装置，将包含有多个阵元的超声换能器安装在针管的前端，通过超声换能器实现超声电子扫描成像，获得换能器前端区域内的超声图像，从而分辨出针管前端的组织结构形态，规划出最佳穿刺路线，且操作十分方便，无需多人操作。
下面结合附图，对本发明的一些实施方式作详细说明。在不冲突的情况下，下述的实施例中的特征可以相互组合。
第一实施例
结合参见图1和图2，本实施例提供了一种穿刺超声引导装置100，包括穿刺针管110和超声换能器130，穿刺针管110的一端具有穿刺针头111，超声换能器130容置在穿刺针管110内并延伸至穿刺针头111。且超声换能器130包括多个用于发射和接收超声波的超声阵元131，多个超声阵元131设置在穿刺针头111处。
在实际使用时，通过多个超声阵元131进行电子扫描成像，成像范围广，能够有效地识别穿刺针头111前端的成分形态，从而便于规划出最佳的穿刺路径，经过穿刺后，将超声换能器130从穿刺针管110中拔出，再从穿刺针管110中释放麻药或者提取体液，操作十分方便。
在本实施例中，穿刺针管110的另一端设置有手柄150，手柄150与超声换能器130远离穿刺针头111的一端连接。
进一步地，超声换能器130还包括柔性件133和管壳135，管壳135容置在穿刺针管110内并延伸至穿刺针头111，柔性件133容置在管壳135内， 多个超声阵元131设置在柔性件133靠近穿刺针头111的一端，且多个超声阵元131均与柔性件133电连接。具体地，每个超声阵元131的底部均设置有电极，通过柔性件133可将多个超声阵元131的电极引出，方便与外部的其他控制器件电连接。
在本实施例中，柔性件133可以是柔性板，也可以是柔性线缆，但凡是能够实现柔性连接的导电结构均在本发明的保护范围之内。
需要说明的是，本实施例中管壳135配合设置在穿刺针管110内，在外力的作用下管壳135能够沿穿刺针管110向外退出，方便穿刺到位后利用穿刺针管110进行治疗操作。
在本实施例中，管壳135的端部具有穿刺头部，穿刺头部容置在穿刺针头111内，且穿刺头部的端面与穿刺针头111的端面相平齐。具体地，管壳135通过设置穿刺头部，且穿刺头部呈尖刺状，有利于进行穿刺。在本发明其他较佳的实施例中，管壳135也可以缩限在穿刺头部内不参与穿刺动作，其具体结构在此不过多描述。
结合参见图3和图4，穿刺针头111呈尖刺状并具有容置头部，多个超声阵元131设置在容置头部内。且穿刺针头111还具有相对的针尖侧113和针尾侧115，多个超声阵元131设置在针尖侧113与针尾侧115之间，且靠近针尖侧113的超声阵元131高于靠近针尾侧115的超声阵元131。具体地，多个超声阵元131沿远离针尖侧113的方向高度依次递减，能够降低超声阵元131被管壳135的外缘的遮挡程度，使得每个超声阵元131都能向外大范围内发射和接收超声波。
需要说明的是，本实施例中所提及的呈尖刺状，指的是常规的针尖形状，当然，此处穿刺针头111和穿刺头部也可以是其他同样能够达到穿刺效果的形状。
在本实施例中，多个超声阵元131呈阵列分布，且相邻两个超声阵元131之间设置有绝缘隔层。具体地，本实施例中超声换能器130为阶梯阵列换能器，多个超声阵元131呈阶梯状分布，且每相邻两个超声阵元131之间的高度差相等，即阵列的每排超声阵元131按照梯度排布，相邻两排超声阵元131的高度差处处相等，且高度和间距与针管的角度相配合，相邻两个超声阵元131之间通过绝缘材料隔绝，例如通过塑料隔绝。
在本实施例中，多个超声阵元131的安装朝向均沿穿刺针头111的正前方设置，当然，此处多个超声阵元131的安装朝向也可以是沿倾斜于穿刺针头111的正前方的其他方向，或者，此处多个超声阵元131也可以相互独立地设置安装朝向，但凡多个超声阵元131的安装朝向能够实现向着穿刺针头111前方发射接收超声波的效果均在本发明的保护范围之内。
在本实施例中，穿刺针头111的端面具有穿刺斜面，每个超声阵元131的外侧边缘与穿刺斜面相平齐。当然，此处每个超声阵元131的外侧边缘也可以与穿刺斜面具有一定的微小夹角。具体地，每个超声阵元131的顶面形成阶梯结构的台阶面，每个超声阵元131的外侧边缘即台阶面的外侧边缘，穿刺斜面为穿刺针头111的斜端面所在的斜面，每个超声阵元131的外侧边缘与穿刺针头111的端面共面设置，使得多个超声阵元131形成的阶梯结构的斜度与穿刺斜面的斜度保持一致，降低了超声阵元131被穿刺针头111的外缘的遮挡程度，使得每个超声阵元131都能向外大范围内发射和接收超声波，同时每个超声阵元131并未突出于穿刺斜面，也避免 了在穿刺过程中超声阵元131过多地与体内组织相接触，最大程度的保证了每个超声阵元131的发射和接收范围，最终进一步提高了成像效果。
在本实施例中，每个超声阵元131包括匹配层1311、压电层1313和背衬层1315，各层的数量不限定，背衬层1315与柔性件133连接，压电层1313设置在背衬层1315之上，匹配层1311设置在压电层1313之上，每个超声阵元131的匹配层1311的外侧边缘均与穿刺斜面共面，避免超声阵元131突出于穿刺针头111。
综上所述，本实施例提供了一种穿刺超声引导装置100，将呈阶梯排布的超声换能器130安装在穿刺针管110前端的穿刺针头111上，在穿刺过程中通过多个超声阵元131进行电子扫描成像，用以在穿刺过程中选择最优的穿刺路线并准确达到穿刺区域，穿刺引导后对目标区域进行麻醉或者获取目标区域组织和体液样本。本发明通过使用阵列阶梯排布的介入式超声换能器进行电子扫描成像，获取信息多，成像范围广，能够有效的分别针管前端的成分形态，同时距离目标组织更近，成像更清晰，不容易被其他部位遮挡影响成像，并且操作方便不需要多位医护人员协同操作。
第二实施例
参见图5，本实施例提供了一种穿刺超声引导装置100，其基本结构和原理及产生的技术效果和第一实施例相同，为简要描述，本实施例部分未提及之处，可参考第一实施例中相应内容。
本实施例提供了一种穿刺超声引导装置100，包括穿刺针管110和超声换能器130，穿刺针管110的一端具有穿刺针头111，超声换能器130容置在穿刺针管110内并延伸至穿刺针头111。
超声换能器130包括柔性件133、管壳135和多个用于发射和接收超声波的超声阵元131，多个超声阵元131设置在穿刺针头111处。管壳135容置在穿刺针管110内并延伸至穿刺针头111，柔性件133容置在管壳135内，多个超声阵元131设置在柔性件133靠近穿刺针头111的一端，且多个超声阵元131均与柔性件133电连接。具体地，每个超声阵元131的底部均设置有电极，通过柔性件133可将多个超声阵元131的电极引出，方便与外部的其他控制器件电连接。
在本实施例中，多个超声阵元131环设在管壳135内。具体地，多个超声阵元131设置在管壳135的内部的四周，多个超声阵元131沿同一平面设置。当然，此处多个超声阵元131也可以是沿穿刺针头111的针尖侧113和针尾侧115高度依次递减，从而也能够一定程度上降低穿刺针头111的边缘的遮挡效果。
在本实施例中，管壳135缩限在穿刺针头111内，多个超声阵元131与管壳135的端面相平齐。
第三实施例
参见图6，本实施例提供了一种穿刺超声引导装置100，其基本结构和原理及产生的技术效果和第一实施例相同，为简要描述，本实施例部分未提及之处，可参考第一实施例中相应内容。
本实施例提供了一种穿刺超声引导装置100，包括穿刺针管110和超声换能器130，穿刺针管110的一端具有穿刺针头111，超声换能器130容置在穿刺针管110内并延伸至穿刺针头111。
超声换能器130包括柔性件133、管壳135和多个用于发射和接收超声波的超声阵元131，多个超声阵元131设置在穿刺针头111处。管壳135容 置在穿刺针管110内并延伸至穿刺针头111，柔性件133容置在管壳135内，多个超声阵元131设置在柔性件133靠近穿刺针头111的一端，且多个超声阵元131均与柔性件133电连接。具体地，每个超声阵元131的底部均设置有电极，通过柔性件133可将多个超声阵元131的电极引出，方便与外部的其他控制器件电连接。
在本实施例中，超声换能器130为面阵换能器，多个超声阵元131沿同一平面阵列设置在管壳135内。具体地，多个超声阵元131和管壳135均缩限在穿刺针头111内，多个超声阵元131均与管壳135的端面相平齐。
第四实施例
参见图7，本实施例提供了一种穿刺超声引导装置100，其基本结构和原理及产生的技术效果和第一实施例相同，为简要描述，本实施例部分未提及之处，可参考第一实施例中相应内容。
本实施例提供了一种穿刺超声引导装置100，包括穿刺针管110和超声换能器130，穿刺针管110的一端具有穿刺针头111，超声换能器130容置在穿刺针管110内并延伸至穿刺针头111。
超声换能器130包括柔性件133、管壳135和多个用于发射和接收超声波的超声阵元131，多个超声阵元131设置在穿刺针头111处。管壳135容置在穿刺针管110内并延伸至穿刺针头111，柔性件133容置在管壳135内，多个超声阵元131设置在柔性件133靠近穿刺针头111的一端，且多个超声阵元131均与柔性件133电连接。具体地，每个超声阵元131的底部均设置有电极，通过柔性件133可将多个超声阵元131的电极引出，方便与外部的其他控制器件电连接。
在本实施例中，超声换能器130为线阵换能器，每个超声阵元131均呈线条状，多个超声阵元131相互平行且沿同一水平面并列设置在管壳135内。具体地，多个超声阵元131和管壳135均缩限在穿刺针头111内，多个超声阵元131均与管壳135的端面相平齐。
第五实施例
本实施例提供了一种穿刺超声引导设备，包括超声电子系统(图未示)和穿刺超声引导装置100，其中穿刺超声引导装置100的基本结构和原理及产生的技术效果和第一实施例相同，为简要描述，本实施例部分未提及之处，可参考第一实施例中相应内容。
穿刺超声引导装置100包括穿刺针管110和超声换能器130，穿刺针管110的一端具有穿刺针头111，超声换能器130容置在穿刺针管110内并延伸至穿刺针头111，且超声换能器130包括多个用于发射和接收超声波的超声阵元131，多个超声阵元131设置在穿刺针头111处。超声电子系统与超声换能器130电连接，用于激励多个超声阵元131并处理超声换能器130接收到的回波信号。
在本实施例中，超声电子系统包括控制器和成像装置，成像装置与超声换能器电连接，用于依据回波信号进行与解剖组织结构对应的图像重建并得到穿刺针头111前方的组织图像。控制器与超声换能器130的多个超声阵元131电连接，通过控制器来调节多个超声阵元131的发射和接收超声波的角度，从而能够使得成像范围实现一定角度的偏转，成像装置与控制器电连接，用于成像。
需要说明的是，此处通过成像装置产生的图像可以是二维超声图像，也可以是三维超声图像。虽然本发明参照当前的较佳实施方式进行了描述， 但本领域的技术人员应能理解，上述较佳实施方式仅用来说明本发明，并非用来限定本发明的保护范围，任何在本发明的精神和原则范围之内，所做的任何修饰、等效替换、改进等，均应包含在本发明的权利保护范围之内。

Claims (12)

  1. 一种穿刺超声引导装置，其特征在于，包括穿刺针管和超声换能器，所述穿刺针管的一端具有穿刺针头，所述超声换能器容置在所述穿刺针管内并延伸至所述穿刺针头，且所述超声换能器包括多个用于发射和接收超声波的超声阵元，多个所述超声阵元设置在所述穿刺针头处。
  2. 根据权利要求1所述的穿刺超声引导装置，其特征在于，所述穿刺针头呈尖刺状并具有容置头部，多个所述超声阵元设置在所述容置头部。
  3. 根据权利要求2所述的穿刺超声引导装置，其特征在于，所述穿刺针头具有相对的针尖侧和针尾侧，多个所述超声阵元设置在所述针尖侧与所述针尾侧之间。
  4. 根据权利要求2所述的穿刺超声引导装置，其特征在于，多个所述超声阵元呈阵列分布。
  5. 根据权利要求2或4所述的穿刺超声引导装置，其特征在于，多个所述超声阵元呈水平分布。
  6. 根据权利要求2或4所述的穿刺超声引导装置，其特征在于，多个所述超声阵元呈阶梯状分布，且沿阶梯方向分布的所述超声阵元之间存在高度差。
  7. 根据权利要求2或4所述的穿刺超声引导装置，其特征在于，所述穿刺针头的端面具有穿刺斜面，多个所述超声阵元组成的阵列具有与所述穿刺斜面配合的阵列斜面。
  8. 根据权利要求1所述的穿刺超声引导装置，其特征在于，所述超声换能器还包括柔性件和管壳，所述管壳容置在所述穿刺针管内并延伸至所述穿刺针头，所述柔性件容置在所述管壳内，多个所述超声阵元设置在所述柔性件靠近所述穿刺针头的一端，且多个所述超声阵元均与所述柔性件电连接。
  9. 根据权利要求8所述的穿刺超声引导装置，其特征在于，所述管壳的端部具有穿刺头部，所述穿刺头部容置在所述穿刺针头内，且所述穿刺头部的端面与所述穿刺针头的端面相平齐或呈夹角设置。
  10. 根据权利要求8所述的穿刺超声引导装置，其特征在于，多个所述超声阵元环设在所述管壳内。
  11. 一种穿刺超声引导设备，其特征在于，包括超声电子系统和如权利要求1-10任一项所述的穿刺超声引导装置，所述超声电子系统与所述超声换能器电连接，用于激励多个所述超声阵元并处理所述超声换能器接收到的回波信号。
  12. 根据权利要求11所述的穿刺超声引导设备，其特征在于，所述超声电子系统包括成像装置，所述成像装置与所述超声换能器电连接，用于依据所述回波信号进行与解剖组织结构对应的图像重建并得到所述穿刺针头前方的组织图像。
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