CN119318513B - Under-lens positive negative pressure suction biopsy needle and biopsy system - Google Patents
Under-lens positive negative pressure suction biopsy needle and biopsy systemInfo
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- CN119318513B CN119318513B CN202411344575.5A CN202411344575A CN119318513B CN 119318513 B CN119318513 B CN 119318513B CN 202411344575 A CN202411344575 A CN 202411344575A CN 119318513 B CN119318513 B CN 119318513B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3478—Endoscopic needles, e.g. for infusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3413—Needle locating or guiding means guided by ultrasound
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- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Pathology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Sampling And Sample Adjustment (AREA)
Abstract
The invention provides a forward negative pressure suction rotary-cut biopsy needle under a lens and a biopsy system, wherein the biopsy needle comprises a distal pipeline part and a proximal hand-held part, the proximal hand-held part comprises a proximal shell and a rotary cutter tube transmission assembly, the proximal end of the rotary cutter tube is arranged in the proximal shell through the rotary cutter tube transmission assembly, a negative pressure interface is arranged on the proximal end wall of the proximal shell, the rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotation shaft sleeve, the mandrel assembly is fixedly sleeved on the rotary cutter tube, the rotation shaft sleeve is sleeved on the mandrel assembly, the rotation shaft sleeve is in dynamic sealing with the rotary cutter tube through a first dynamic sealing piece, the proximal end of the rotation shaft sleeve is fixedly communicated with a rotary joint tube through a second dynamic sealing piece in dynamic sealing communication with the negative pressure interface, and the rotation shaft sleeve is driven to rotate, so that the rotation shaft sleeve drives the mandrel assembly to rotate, and the rotary cutter tube is driven to rotate.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a forward negative pressure suction rotary-cut biopsy needle under a lens and a biopsy system
Background
Biopsies are a group of medical diagnostic test methods for determining the structure and composition of tissue or cells, for short "biopsy", also known as surgical pathology. In biopsy, cells or tissues are sampled from an organ or other body part and taken to a pathology department, standard pathological sections are prepared, and the changes of morphological structures are observed under a microscope, so that clear pathological diagnosis can be finally given, and the clinic targeted treatment is guided. Generally, if an abnormality is found by a superficial examination, such as palpation or radiographic imaging, a biopsy can be performed to determine the nature of the suspected abnormality.
Aspiration biopsy through a bronchoneedle under the guidance of an ultrasonic endoscope is a minimally invasive examination technology for aspiration biopsy of lung, peripulmonary tissues and lymph nodes under the guidance of ultrasonic in real time. The ultrasonic real-time monitoring device has the advantages that important parts such as large blood vessels and nerves can be avoided as much as possible under the ultrasonic real-time monitoring, the sampling accuracy is improved while the risks such as massive hemorrhage are reduced, the wound is small, the operation is simple, and the ultrasonic real-time monitoring device is relatively safe.
Traditional ultrasonic endoscope biopsy needles need repeated puncture sampling, and the tissue integrity of the extracted tissue is poor, so that the problems of low sampling efficiency and poor sample quality are caused.
The rotary-cut biopsy needle is different from the traditional biopsy needle, is provided with a rotary cutter tube, drives the rotary cutter tube to rotate through a motor, replaces traditional reciprocating puncture sampling through a rotary cutting mode, and improves sampling efficiency and sample quality.
However, due to the structural reasons, the rotary biopsy needle cannot realize the sealing problem of the rotary cutter tube on the basis of meeting the normal rotation, forward and backward movements of the rotary cutter tube, and further cannot realize the negative pressure suction of the rotary cutter tube.
Disclosure of Invention
In order to solve the technical problems, one embodiment of the invention provides an under-scope positive negative pressure suction rotary-cut biopsy needle, which comprises a distal pipeline part and a proximal handheld part, wherein the distal pipeline part comprises an outer sheath tube, a rotary-cut knife tube and a puncture needle which are movably sleeved in sequence from outside to inside;
a negative pressure interface is arranged on the proximal end wall of the proximal housing and is used for connecting a negative pressure device;
The rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, wherein the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are positioned in the proximal end shell, the mandrel assembly is fixedly sleeved on the rotary cutter tube, the rotary shaft sleeve is sleeved on the mandrel assembly and is in sliding connection with the mandrel assembly in the axial direction and is relatively and fixedly connected in the circumferential direction;
the axial movement transmission mechanism comprises a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal end shell and is in threaded engagement transmission with the transmission screw, the transmission screw is sleeved on the rotary shaft sleeve, is axially fixed relative to the mandrel assembly and is in relative rotation connection in the circumferential direction, and the screw sleeve is driven to rotate so that the rotary movement of the screw sleeve is converted into the axial movement of the transmission screw, and the transmission screw drives the mandrel assembly and the rotary cutter tube to axially move.
Optionally, a rotary gear is fixedly connected to the rotary shaft sleeve, and the rotary shaft sleeve drives the rotary gear to perform rotary motion through a rotary driving motor.
Optionally, the screw rod cover is fixed connection stroke gear, the screw rod cover passes through stroke driving motor drive stroke gear makes rotary motion.
Optionally, the proximal hand-held portion further includes a motor handle, the rotary driving motor and the travel driving motor are both mounted in the motor handle, and the motor handle is fixedly connected with the proximal housing.
Optionally, the mandrel assembly comprises a fixing tube and an inner cutter sleeve, the fixing tube is fixedly sleeved on the rotary cutter tube, the inner cutter sleeve is fixedly sleeved on the fixing tube, the rotary shaft sleeve is sleeved on the inner cutter sleeve, and the rotary shaft sleeve and the inner cutter sleeve are inserted into an axial guide groove through an axial bulge to realize axial sliding connection, and are fixedly connected in the circumferential direction;
the inner cutter sleeve and the transmission screw rod are connected in a circumferential rotation mode through the annular limiting clamping piece which is arranged in the circumferential direction and inserted into the annular limiting clamping groove, and are fixedly connected in the axial direction.
Optionally, a guide rail is further arranged on the inner wall of the proximal end housing, and the driving screw is slidably arranged on the guide rail.
Optionally, the proximal hand-held portion further comprises an endoscope fixing member and a distal housing, the endoscope fixing member comprises a sheath seat and a sheath seat locking member, and the sheath seat is movably sleeved on the outer sheath tube; the sheath seat is provided with a second luer connector which is matched with the first luer connector on the endoscope, and the sheath seat is connected with the second luer connector in an assembling way through the first luer connector so as to realize the fixed connection with the endoscope;
the sheath seat is axially and slidably connected with the distal end of the distal sheath tube, and can be locked with the distal end shell through the sheath seat locking piece, and the proximal end of the distal end shell is axially and slidably connected with the distal end of the proximal end shell.
Optionally, the proximal hand-held part further comprises a puncture depth adjusting device, the puncture depth adjusting device comprises an adjusting sleeve and a sleeve locking piece, the adjusting sleeve is movably sleeved on the distal end shell, when the puncture depth adjusting device is used, the puncture depth is set by adjusting the position of the adjusting sleeve on the distal end shell, then the adjusting sleeve is locked on the distal end shell through the sleeve locking piece, and finally the proximal end shell is slid distally to achieve puncture.
Optionally, the distal end housing is provided with a scale for penetration depth.
Optionally, the inner ring of the rotary shaft sleeve is provided with a first groove, and the first dynamic sealing element is fixedly installed in the first groove.
Optionally, a second groove is formed in the inner side of the proximal end wall of the proximal end housing, the second groove is communicated with the negative pressure interface, and the second dynamic sealing element is fixedly installed in the second groove.
Optionally, the first dynamic seal member or/and the second dynamic seal member is/are a seal ring.
Optionally, the sealing ring is a pan plug sealing or a silica gel sealing ring.
Optionally, the rotary cutter tube comprises a distal metal tube, a metal wire spring tube, a proximal metal tube and a polymer sealing tube, wherein the distal end of the distal metal tube is an annular blade, the proximal end face of the distal metal tube is fixedly connected with the distal end face of the metal wire spring tube, the polymer sealing tube is at least sealed and sleeved on the metal wire spring tube and the joint of the metal wire spring tube and the distal metal tube, and the proximal metal tube is fixedly sleeved on the proximal end of the polymer sealing tube.
The invention further provides a positive negative pressure suction biopsy system under a lens, which comprises the biopsy needle and the negative pressure device, wherein the negative pressure device is used for carrying out negative pressure suction on tissues in the rotary cutter tube through the negative pressure interface.
Optionally, the biopsy system further comprises an injector, and after sampling is completed, the injector injects physiological saline into the rotary cutter tube through the negative pressure interface to flush out the tissue sample in the rotary cutter tube.
Optionally, the biopsy system further comprises a host, wherein the host comprises a main control module, and the main control module is electrically connected with the negative pressure device through a negative pressure driving module and controls the negative pressure of the negative pressure device.
Compared with the prior art, the technical scheme of the embodiment of the invention has the following beneficial effects:
The rotary cutter tube can rotate and axially move relative to the proximal end shell, so that the seal of the rotary cutter tube is divided into axial seal and rotary seal, and the axial seal is realized in a specific scheme that the rotary cutter tube and the rotary cutter tube are dynamically sealed through the first dynamic seal member in the rotary shaft sleeve (the relative speed of the rotary cutter tube and the first dynamic seal member is low due to the fact that the axial movement speed of the rotary cutter tube is low, the requirement on the abrasion of the first dynamic seal member is low, the first dynamic seal member is beneficial to miniaturization, and the first dynamic seal member can be placed in a narrow space in the rotary shaft sleeve), the proximal end of the rotary shaft sleeve is fixedly communicated with the rotary cutter tube, and a proximal end port of the rotary cutter tube is always located in a space between a distal end port of the rotary cutter tube and the first dynamic seal member in the rotary shaft sleeve regardless of axial movement of the rotary cutter tube during sampling, so that a sealing space is formed between the proximal end of the rotary shaft sleeve and the first dynamic seal member to accommodate axial movement of the rotary cutter tube. The rotary sealing device has the specific implementation scheme that when sampling is carried out, the rotary pipe and the rotary shaft sleeve synchronously rotate, so that relative rotation can be generated between the rotary pipe and the negative pressure interface, and based on the rotary sealing device, the rotary pipe is in dynamic sealing communication with the negative pressure interface through the second dynamic sealing piece, so that the rotary sealing of the rotary cutter pipe is realized. Therefore, the invention solves the sealing problem of the rotary cutter tube, and further realizes the negative pressure suction of the rotary-cut biopsy needle.
Further, in the present invention, the negative pressure suction can raise the sampling amount of the rotary cutter tube. During sampling, as the tissue in the inner cavity of the rotary cutter tube increases, the friction force between the tissue and the rotary cutter tube can be continuously increased, and the friction resistance can influence the sample tissue to enter the deep part of the inner cavity of the rotary cutter tube, so that the obtained sample tissue cannot be increased. The suction provided by the negative pressure can overcome friction resistance, more sample tissues are sucked into the inner cavity of the rotary cutter, and the sampling amount is increased.
Furthermore, the negative pressure is finely controlled by the host, so that the negative pressure value can be gradually increased along with the continuous advance of the rotary cutter tube in the sampling process, and the damage to the integrity of a tissue sample due to the excessive high early negative pressure value is avoided.
Further, in the present invention, since the rotary cutter tube has a tubular structure and the distal end thereof has an annular blade, after sampling is completed, it is necessary to stretch the tissue at the blade to complete the sampling. For a tissue structure of which part is difficult to break, the problem of sampling failure due to insufficient breaking force can occur. The negative pressure suction can increase the breaking force of the rotary cutter tube when the rotary cutter tube retreats, so that the tissue can be successfully broken.
Further, in the invention, after sampling is completed, normal saline is injected into the rotary cutter tube through the negative pressure interface, positive pressure is provided by the injection of the normal saline, a tissue sample is flushed out of the rotary cutter tube, and sample damage caused by ejection by adopting a rigid needle is avoided.
Of course, it is not necessary for any one product to practice the invention to achieve all of the advantages set forth above at the same time.
Drawings
In order to more clearly illustrate the embodiments of the invention or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the invention, and that other drawings can be obtained according to these drawings without inventive faculty for a person skilled in the art.
FIG. 1 is a schematic view of a negative pressure aspiration rotary-cut biopsy needle (with a motor handle installed) according to one embodiment of the present invention;
FIG. 2 is a schematic view of a distal tubing section according to an embodiment of the present invention;
FIG. 3 is a schematic view of a rotary cutter tube according to an embodiment of the present invention;
FIG. 4 is a schematic view of a rotary cutter tube with an inner blade edge according to an embodiment of the present invention;
FIG. 5 is a schematic view of a rotary cutter tube with an outer blade edge according to an embodiment of the present invention;
FIG. 6 is a schematic view of a negative pressure aspiration rotary-cut biopsy needle (without a motor handle) according to one embodiment of the present invention;
FIG. 7 is a cross-sectional view of a negative pressure aspiration rotary-cut biopsy needle provided in one embodiment of the present invention;
FIG. 8 is a schematic view of the structure within the distal housing of a negative pressure aspiration rotary-cut biopsy needle provided in one embodiment of the present invention;
FIG. 9 is a schematic view of a rotary cutter tube axially moved to the most distal end according to an embodiment of the present invention;
fig. 10 is a schematic view showing a structure in which a rotary cutter tube is axially moved to the most advanced end according to an embodiment of the present invention.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
The terms "first," "second," "third," "fourth" and the like in the description and in the claims and in the above drawings, if any, are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used may be interchanged where appropriate such that the embodiments of the invention described herein may be implemented in sequences other than those illustrated or otherwise described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. The terms "upper" and "above" and any variations thereof are intended to describe positional relationships and are not meant to describe relationships that are direct contacts between objects.
As described in the background art, due to the structural reasons, the conventional rotary biopsy needle cannot realize the sealing problem of the rotary cutter tube on the basis of meeting the normal rotation, forward and backward movements of the rotary cutter tube, and further cannot realize the negative pressure suction of the rotary cutter tube.
In order to solve the technical problems, the invention provides an under-scope positive negative pressure suction rotary-cut biopsy needle, which comprises a distal pipeline part and a proximal handheld part, wherein the distal pipeline part comprises an outer sheath pipe, a rotary-cut knife pipe and a puncture needle which are movably sleeved in sequence from outside to inside;
a negative pressure interface is arranged on the proximal end wall of the proximal housing and is used for connecting a negative pressure device;
The rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, wherein the circumferential rotation transmission mechanism comprises a mandrel assembly and a rotary shaft sleeve which are positioned in the proximal end shell, the mandrel assembly is fixedly sleeved on the rotary cutter tube, the rotary shaft sleeve is sleeved on the mandrel assembly and is in sliding connection with the mandrel assembly in the axial direction and is relatively and fixedly connected in the circumferential direction;
the axial movement transmission mechanism comprises a screw sleeve and a transmission screw, wherein the screw sleeve is rotatably arranged in the proximal end shell and is in threaded engagement transmission with the transmission screw, the transmission screw is sleeved on the rotary shaft sleeve, is axially fixed relative to the mandrel assembly and is in relative rotation connection in the circumferential direction, and the screw sleeve is driven to rotate so that the rotary movement of the screw sleeve is converted into the axial movement of the transmission screw, and the transmission screw drives the mandrel assembly and the rotary cutter tube to axially move.
The rotary cutter tube can rotate and axially move relative to the proximal end shell, so that the seal of the rotary cutter tube is divided into axial seal and rotary seal, and the axial seal is realized in a specific scheme that the rotary cutter tube and the rotary cutter tube are dynamically sealed through the first dynamic seal member in the rotary shaft sleeve (the relative speed of the rotary cutter tube and the first dynamic seal member is low due to the fact that the axial movement speed of the rotary cutter tube is low, the requirement on the abrasion of the first dynamic seal member is low, the first dynamic seal member is beneficial to miniaturization, and the first dynamic seal member can be placed in a narrow space in the rotary shaft sleeve), the proximal end of the rotary shaft sleeve is fixedly communicated with the rotary cutter tube, and a proximal end port of the rotary cutter tube is always located in a space between a distal end port of the rotary cutter tube and the first dynamic seal member in the rotary shaft sleeve regardless of axial movement of the rotary cutter tube during sampling, so that a sealing space is formed between the proximal end of the rotary shaft sleeve and the first dynamic seal member to accommodate axial movement of the rotary cutter tube. The rotary sealing device has the specific implementation scheme that when sampling is carried out, the rotary pipe and the rotary shaft sleeve synchronously rotate, so that relative rotation can be generated between the rotary pipe and the negative pressure interface, and based on the rotary sealing device, the rotary pipe is in movable sealing communication with the negative pressure interface through the second movable sealing piece, so that the rotary sealing of the rotary cutter pipe is realized. Therefore, the invention solves the sealing problem of the rotary cutter tube, and further realizes the negative pressure suction of the rotary-cut biopsy needle.
And the negative pressure suction can increase the sampling amount of the rotary cutter tube. During sampling, as the tissue in the inner cavity of the rotary cutter tube increases, the friction force between the tissue and the rotary cutter tube can be continuously increased, and the friction resistance can influence the sample tissue to enter the deep part of the inner cavity of the rotary cutter tube, so that the obtained sample tissue cannot be increased. The suction provided by the negative pressure can overcome friction resistance, more sample tissues are sucked into the inner cavity of the rotary cutter, and the sampling amount is increased.
Meanwhile, the negative pressure is finely controlled by the host, so that the negative pressure value is gradually increased along with the continuous advance of the rotary cutter tube in the sampling process, the excessive high early negative pressure value is avoided, and the integrity of a tissue sample is damaged.
Because the rotary cutter tube is of a tubular structure, the far end of the rotary cutter tube is an annular blade, and after sampling is completed, tissues at the blade are required to be broken, so that sampling is completed. For a tissue structure of which part is difficult to break, the problem of sampling failure due to insufficient breaking force can occur. The negative pressure suction can increase the breaking force of the rotary cutter tube when the rotary cutter tube retreats, so that the tissue can be successfully broken.
After the sampling is completed, normal saline is injected into the rotary cutter tube through the negative pressure interface, positive pressure is provided by the normal saline injection, a tissue sample is flushed out of the rotary cutter tube, and sample damage caused by ejection of a rigid needle is avoided.
In order to make the above objects, features and advantages of the present invention more comprehensible, the following description of the embodiments of the present invention will be given in connection with the accompanying drawings in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
Referring to fig. 1 to 10, an embodiment of the present invention provides an under-scope positive negative pressure suction rotary-cut biopsy needle, which comprises a distal pipeline portion 1 and a proximal hand-held portion 2, wherein the distal pipeline portion 1 comprises an outer sheath tube 101, a rotary-cut knife tube 102 and a puncture needle 103 which are movably sleeved in sequence from outside to inside.
The outer sheath 101 serves as the outermost layer of the distal tube section 1 of the biopsy needle, and its lumen may fully accommodate the rotary cutter tube 102 and the needle 103, thereby avoiding damage to the endoscope by the needle 103 or the rotary cutter tube 102 during delivery of the outer sheath 101 into the working channel of the endoscope.
The material of the sheath tube 101 is not limited, and smooth polymer materials such as PTFE and PEEK are preferable, so that the endoscope is prevented from being damaged in the process of passing through a working channel of the endoscope, and the conveying performance of the endoscope is ensured.
The single-side wall thickness of the outer sheath tube 101 is not limited, and can be set according to actual use requirements. As an example, the sheath 101 has a single-sided wall thickness of greater than 0.15mm to ensure sufficient strength to provide support for the rotary cutter tube 102 so that the rotary cutter tube 102 can rotate at high speed internally.
The rotary cutter tube 102 is a tubular structure, which serves as an intermediate layer of the distal tube section 1 of the biopsy needle, for collecting tissue samples. The distal end of the rotary cutter tube 102 is provided with an annular blade to ensure that the rotary cutter tube 102 can cut tissue smoothly. The annular blade preferably adopts a flat structure for ensuring the integrity of the rotary-cut tissue, so that the rotary-cut tissue is not twisted and pathological analysis is not affected.
As an example, referring to fig. 4, the annular blade at the distal end of the rotary cutter tube 102 is an inner blade edge 1021 formed by removing an outer edge angle from the distal end surface of the rotary cutter tube 102, and the inner blade edge 1021 is used for cutting high-density tissue.
As another example, referring to fig. 5, the annular blade at the distal end of the rotary cutter tube 102 is an outer blade 1021 'formed by removing an inner edge from the distal end surface of the rotary cutter tube 102, and the outer blade 1021' is used for cutting low-density tissue.
In a specific embodiment, referring to fig. 3, the rotary cutter tube 102 includes a distal metal tube 1022, a wire spring tube 1023, a proximal metal tube 1025 and a polymer sealing tube 1024, where the distal metal tube 1022 and the proximal metal tube 1025 are both metal tubes, such as stainless steel tubes, the distal end of the distal metal tube 1022 is an annular cutting edge 1021, the distal metal tube 1022 is made of metal, so that the rotary cutter tube 102 can be ensured to cut a tissue smoothly, and the proximal metal tube 1025 is made of metal, so as to facilitate assembly and fixation thereof. The wire spring tube 1023 is a hollow tube woven from wires, the wires are of stainless steel or nickel titanium, and the wire spring tube 1023 can flexibly transmit rotational speed and torque in a bent state and effectively reduce vibration. The proximal end of the distal metal tube 1022 is connected to the distal end of the wire spring tube 1023 by an end-face welding process to ensure that the outer and inner diameters of the distal metal tube 1022 and the wire spring tube 1023 are substantially identical.
A layer of thin-wall polymer sealing tube 1024 is arranged on the outer side of the rotary cutter tube 102, the outer surface of the rotary cutter tube 102 is covered with the polymer sealing tube 1024, and the polymer sealing tube 1024 is at least sealed and sleeved on the wire spring tube 1023 and the connection part of the wire spring tube 1023 and the far-end metal tube 1022. For example, a thin-wall heat shrinkage pipe can be adopted, and the thin-wall heat shrinkage pipe is fixed on the outer side of the rotary cutter pipe 102 through a heat shrinkage process, so that the rotary cutter pipe 102 is sealed, negative pressure or positive pressure can be transmitted to an inner cavity, and leakage at welding positions, gaps among braided pipes and the like is avoided. Meanwhile, the thin-wall heat shrink tube can reduce friction force between the rotary cutter tube 102 and the puncture needle 103 during rotation, and avoid abrasion of braided wires of the rotary cutter tube 102.
The proximal metal tube 1025 is wrapped around the outer proximal side of the polymeric seal tube 1024, and the fixation of the proximal metal tube 1025 to the polymeric seal tube 1024 may be accomplished by adhesive bonding or other means. In this manner, a sealed lumen of only two outlets may be formed within the interior of the rotary shaver tube 102. And, the proximal metal tube 1025 is always in dynamic sealing connection with the first dynamic seal 208.
As one example, wire spring tube 1023, polymeric seal tube 1024 and proximal metal tube 1025 are flush at the proximal end face.
In order to increase the adhesion firmness after the tissue cutting and avoid the falling of the tissue after the cutting and sampling are completed, the inner wall surface of the rotary cutter tube 102 is provided with a rough surface, such as a thread-like surface, for increasing the friction coefficient.
In order to enhance the effect of ultrasonic development, the outer surface of the distal metal tube 1022 is provided with an ultrasonic reflection area, which is required to be an uneven texture, and the shape of the texture of the ultrasonic reflection area is not particularly limited, for example, the roughness of the outer surface of the distal metal tube 1022 is increased by a process such as threading, dotting, etc., so that the development effect of the rotary cutter tube 102 under ultrasound is enhanced.
During sampling, the shaver tube 102 may be axially advanced while rotating, while simultaneously cutting tissue, storing the cut tissue in the lumen of the annular blade. After cutting is completed, the rotary cutter tube 102 is axially retracted, and the tissue is pulled apart by negative pressure and friction to complete sampling.
The needle 103, which may be a nitinol needle, acts as the innermost layer of the distal tube section 1 of the biopsy needle. The needle 103 has a sharp tip that can assist the lance tube 102 in penetrating through the tissue wall to a designated sampling location. The annular blade at the distal end of the rotary cutter tube 102 is an inner blade edge 1021 formed by removing the outer edge angle from the distal end surface of the rotary cutter tube 102, so that the tracheal wall can be easily broken through. After the breakthrough is completed, the puncture needle 103 is withdrawn from the rotary cutter tube 102, and room is made for negative pressure transmission.
The proximal hand-held portion 2 includes a proximal housing 204 and a shaver tube drive assembly by which the proximal end of the shaver tube 102 is mounted within the proximal housing 204.
A negative pressure interface 2041 is provided on the proximal end wall of the proximal housing 204, and the negative pressure interface 2041 is used for connecting a negative pressure device. The invention does not limit the specific type of the negative pressure device, and the negative pressure device can be a negative pressure suction needle cylinder or a negative pressure pump.
The rotary cutter tube transmission assembly is mounted in the proximal housing 204, the rotary cutter tube transmission assembly is connected with the rotary cutter tube 102, and the rotary cutter tube 102 is driven by the rotary cutter tube transmission assembly to rotary cut tissues.
The rotary cutter tube transmission assembly can drive the rotary cutter tube 102 to rotate so as to cut tissues, and can also adjust the axial stroke of the rotary cutter tube 102 so as to adjust the cutting depth of the rotary cutter tube 102. Therefore, the rotary cutter tube transmission assembly comprises a circumferential rotation transmission mechanism and an axial movement transmission mechanism, wherein the circumferential rotation transmission mechanism and the axial movement transmission mechanism are both connected with the rotary cutter tube 102, the circumferential rotation transmission mechanism drives the rotary cutter tube 102 to rotate so that the rotary cutter tube 102 cuts tissues, and the axial movement transmission mechanism drives the rotary cutter tube 102 to axially move so as to adjust the axial stroke of the rotary cutter tube 102 and further adjust the cutting depth of the rotary cutter tube 102.
Referring to fig. 8, the circumferential rotation transmission mechanism includes a spindle assembly 209 and a rotation sleeve 207 disposed in the proximal housing 204, wherein the spindle assembly 209 is fixedly sleeved on the rotary cutter tube 102, and the rotation sleeve 207 is sleeved on the spindle assembly 209 and is slidably connected to the spindle assembly 209 in the axial direction and is relatively fixedly connected in the circumferential direction. The rotation shaft sleeve 207 is driven to rotate, so that the rotation shaft sleeve 207 drives the spindle assembly 209 to rotate, and further drives the rotary cutter tube 102 to rotate. The present invention does not limit the driving device for driving the rotation shaft sleeve 207 to rotate, and may be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a rotary driving motor, specifically, the rotary shaft sleeve 207 is coaxially and fixedly connected with a rotary gear 214, and the rotary gear 214 is driven by the rotary driving motor, so that the rotary shaft sleeve 207 drives the spindle assembly 209 to rotate.
Because the rotary shaft sleeve 207 and the mandrel assembly 209 which are sleeved with each other are in sliding connection in the axial direction and are in relative fixed connection in the circumferential direction, which belongs to the mature technical means in the mechanical field, the specific connection structure of the rotary shaft sleeve 207 and the mandrel assembly 209 is not limited in the invention.
As an embodiment, the mandrel assembly 209 includes a fixed tube and an inner cutter sleeve, the fixed tube is fixedly sleeved on the rotary cutter tube 102, the inner cutter sleeve is fixedly sleeved on the fixed tube, the rotating shaft sleeve 207 is sleeved on the inner cutter sleeve, and the rotating shaft sleeve 207 and the inner cutter sleeve are inserted into an axial guide groove through an axial protrusion to realize axial sliding connection, and are fixedly connected in the circumferential direction.
In a specific implementation manner, a plurality of protrusions are arranged on the inner wall of the rotary shaft sleeve 207 at intervals along the circumferential direction, the protrusions are all arranged along the axial direction of the rotary shaft sleeve 207, a plurality of guide grooves matched with the protrusions are arranged on the outer wall of the inner cutter sleeve at intervals along the circumferential direction, and the guide grooves are all arranged along the axial direction of the inner cutter sleeve. The plurality of protrusions are inserted into the plurality of guide grooves, so that the rotary shaft sleeve 207 is in axial sliding connection with the inner cutter sleeve, and is fixedly connected in the circumferential direction, namely, the rotary shaft sleeve 207 and the inner cutter sleeve can slide relatively in the axial direction and synchronously rotate in the circumferential direction. Of course, the projection may be provided on the outer wall of the inner hub, and the guide groove may be provided on the inner wall of the rotating hub 207. This embodiment is not particularly limited.
In the invention, the rotary shaft sleeve 207 and the rotary cutter tube 102 are in dynamic seal through a first dynamic seal piece 208, the proximal end of the rotary shaft sleeve 207 is fixedly communicated with a rotary joint tube 215 in a sealing way, and the rotary joint tube 215 is also in dynamic seal communication with the negative pressure interface 2041 through a second dynamic seal piece 206.
Because of the rotational movement and axial movement of the rotary cutter tube 102 relative to the proximal housing 204, the present invention breaks the seal of the rotary cutter tube 102 into an axial seal and a rotary seal:
The axial sealing is specifically implemented by dynamically sealing the rotary shaft sleeve 207 and the rotary cutter tube 102 through a first dynamic sealing element 208 in the rotary shaft sleeve 207, wherein the proximal end of the rotary shaft sleeve 207 is fixedly communicated with a rotary cutter tube 215, and the distal end port of the rotary cutter tube 102 is always positioned in a space 212 between the distal end port of the rotary cutter tube 215 in the rotary shaft sleeve 207 and the first dynamic sealing element 208 no matter how the rotary cutter tube 102 axially moves during sampling, so that a sealing space 212 is formed between the proximal end of the rotary shaft sleeve 207 and the first dynamic sealing element 208 to accommodate the axial movement of the rotary cutter tube 102. Referring to fig. 9, during sampling, the rotary cutter tube 102 is axially advanced while rotating, and when the rotary cutter tube 102 is axially moved to the most distal end, the rotary cutter tube 102 is still sealed with the rotary shaft sleeve 207 by the first movable seal 208, and the distal end port of the rotary cutter tube 102 is still located in the space 212' between the rotary tube 215 and the first movable seal 208 in the rotary shaft sleeve 207. Referring to fig. 10, after the cutting is completed, the rotary cutter tube 102 is axially retracted, and when the rotary cutter tube 102 is axially moved to the distal end, the rotary cutter tube 102 is still in dynamic seal with the rotary shaft sleeve 207 by the first dynamic seal 208, and the distal end port of the rotary cutter tube 102 is still located in the space 212 "between the rotary tube 215 in the rotary shaft sleeve 207 and the first dynamic seal 208".
The rotary sealing is specifically implemented in that during sampling, since the rotary pipe 215 rotates synchronously with the rotary shaft sleeve 207, relative rotation is generated between the rotary pipe 215 and the negative pressure interface 2041, and based on the rotary sealing, the rotary pipe 215 is in dynamic sealing communication with the negative pressure interface 2041 through the second dynamic sealing element 206 to realize rotary sealing of the rotary cutter pipe 102.
For ease of assembly and fixation, swivel tube 215 is a metal tube, such as a steel tube. The nipple 215 forms a rotary seal with the second dynamic seal 206, and at high rotational speeds (> 3000 RPM) no leakage occurs. The spin tube 215 has a surface roughness requirement, typically Ra <0.2.
Since the dynamic seal is a relatively mature technology in the field of mechanical fluid transmission, the specific structure of the first dynamic seal 208 and the second dynamic seal 206 is not limited by the present invention.
As an example, the first dynamic seal 208 and the second dynamic seal 206 are sealing rings, such as a flood seal or a silicone sealing ring.
The inner ring of the rotating shaft sleeve 207 is provided with a first groove, and the first dynamic seal 208 is fixedly installed in the first groove. The inner surface of the first dynamic seal 208 and the outer surface of the rotary cutter tube 102 should be as smooth as possible to reduce frictional resistance from the seal.
A second groove is provided on the inner side of the proximal end wall of the proximal housing 204, and is in communication with the negative pressure port 2041, and the second dynamic seal 206 is fixedly mounted in the second groove. The inner surface of the second dynamic seal 206 and the outer surface of the nipple 215 should be as smooth as possible to reduce the frictional resistance of the seal.
As an embodiment, a luer connector is provided on the negative pressure connector 2041, through which a negative pressure suction syringe or a negative pressure pump structure can be connected.
The axial movement transmission mechanism comprises a screw sleeve 210 and a transmission screw 211, wherein the screw sleeve 210 is rotatably arranged in the proximal end shell 204 and is in threaded engagement transmission with the transmission screw 211, the transmission screw 211 is sleeved on the rotary shaft sleeve 207 and is axially fixed relative to the mandrel assembly 209 in a relative rotation connection in the circumferential direction, the screw sleeve 210 is driven to rotate, so that the rotary movement of the screw sleeve 210 is converted into the axial movement of the transmission screw 211, and the transmission screw 211 drives the mandrel assembly 209 and the rotary cutter tube 102 to axially move. The driving device for driving the screw sleeve 210 to rotate is not limited in the present invention, and may be pneumatic, hydraulic or electric. As an embodiment, the driving device adopts a stroke driving motor, specifically, the screw sleeve 210 is coaxially and fixedly connected with a stroke gear 213, the stroke gear 213 is driven by the stroke driving motor to perform a rotational movement, the stroke gear 213 drives the screw sleeve 210 to rotate, and the rotational movement of the screw sleeve 210 is converted into an axial movement of the transmission screw 211. The drive screw 211 is mounted on the swivel sleeve 207 and is axially fixed relative to the spindle assembly 209 and is rotationally coupled relative to the spindle assembly in the circumferential direction.
As an embodiment, the proximal hand-held part 2 further comprises a motor handle 205, the rotation driving motor and the stroke driving motor are both installed in the motor handle 205, and the motor handle 205 is fixedly connected with the proximal housing 204. The rotation driving motor and the stroke driving motor respectively control the rotary cutting gear and the stroke gear 213 directly or through gear transmission, so that the rotation, the forward and the backward of the rotary cutter tube 102 are realized.
The screw sleeve 210 is only rotationally movable within the proximal housing 204 and does not move axially. To limit axial movement of the screw sleeve 210 within the proximal housing 204, positioning baffles are provided on the proximal and distal ends of the screw sleeve 210, on the proximal housing 204, to limit axial movement of the screw sleeve 210 between the two positioning baffles.
In this embodiment, the driving screw 211 is sleeved on the rotating shaft sleeve 207, and is fixedly connected with the spindle assembly 209 in an axial direction and is rotatably connected with the spindle assembly in a circumferential direction.
As an embodiment, the inner cutter sleeve and the driving screw 211 are inserted into the annular limiting clamping groove through the annular limiting clamping piece circumferentially arranged to realize circumferential rotation connection, and are fixedly connected in the axial direction.
In a specific implementation manner, the outer side of the inner cutter sleeve is circumferentially provided with an annular limiting clamping groove, the inner side of the driving screw 211 is circumferentially provided with an annular limiting clamping piece matched with the annular limiting clamping groove, the annular limiting clamping piece is inserted into the annular limiting clamping groove to realize circumferential rotation connection between the driving screw 211 and the inner cutter sleeve, and the driving screw 211 is fixedly connected in the axial direction, namely, the inner cutter sleeve and the driving screw 211 can relatively rotate, but cannot relatively displace in the axial direction. Of course, the inner side of the driving screw may be circumferentially provided with an annular limiting clamping groove, and the outer side of the inner cutter sleeve may be circumferentially provided with an annular limiting clamping piece adapted to the annular limiting clamping groove, which is not particularly limited in this embodiment.
The inner wall of the proximal housing 204 is axially provided with a guide rail, the driving screw 211 is slidably disposed on the guide rail, and the driving screw 211 is driven to rotate by the screw sleeve 210, so that the driving screw 211 moves along the guide rail, so as to limit the axial movement distance of the driving screw 211.
In one embodiment, the proximal hand-held portion 2 further includes an endoscope fixing member 201 and a distal end housing 203, the endoscope fixing member 201 includes a sheath holder 2011 and a sheath holder locking member 2012, and the sheath holder 2011 is movably sleeved on the outer sheath 101, so that the sheath holder 2011 can move axially on the outer sheath 101.
The sheath 2011 is provided with a second luer connector which is matched with the first luer connector on the endoscope, and the sheath 2011 is assembled and connected with the second luer connector through the first luer connector to realize the fixed connection with the endoscope.
The specific connection form of the first luer connector and the second luer connector is not limited in this embodiment, and the first luer connector and the second luer connector can be in threaded connection, clamping connection or other detachable fixed connection modes.
The distal housing 203 has a sleeve-type structure with two open ends, and the distal housing 203 is fixedly sleeved on the proximal end of the outer sheath 101. Distal housing 203 is located between sheath hub 2011 and proximal housing 204. The sheath 2011 is axially slidably connected to the distal end of the distal housing 203 and is lockable to the distal housing 203 by the sheath lock 2012, and the proximal end of the distal housing 203 is axially slidably connected to the distal end of the proximal housing 204.
The first luer connector on the endoscope is assembled and connected with the second luer connector on the sheath 2011, so that the fixed connection with the endoscope is realized. After the sheath holder 2011 is fixed with the endoscope, the relative position of the outer sheath 101 and the endoscope is adjusted by adjusting the relative position of the sheath holder 2011 and the distal end housing 203, and after the adjustment is completed, the outer sheath 101 and the endoscope are locked by the sheath holder locking piece 2012 and the distal end housing 203, so that the fixation of the outer sheath 101 and the endoscope is realized.
Since the technical solution of adjusting and locking between the two structures (the sheath seat 2011 and the distal end housing 203) by the locking member (the sheath seat locking member 2012) belongs to a relatively mature technology in the mechanical field, the invention is not particularly limited thereto, for example, the sheath seat locking member 2012 may be a locking cap structure, an internal thread is provided in the locking cap structure, an external thread adapted to the internal thread is provided on the sheath seat 2011, and the sheath seat 2011 is locked on the distal end housing 203 by the matching assembly of the internal thread and the external thread. When the locking cap structure is unscrewed, the sheath 2011 and the distal housing 203 are in an unlocked state, and an axial sliding operation can be performed. Of course, the sheath seat locking member 2012 of the present invention is not limited to a lock cap structure, but may be a threaded fastener, specifically, a side wall of the sheath seat 2011 is provided with a threaded hole, the sheath seat locking member 2012 is a threaded fastener adapted to the threaded hole, a first end of the threaded fastener passes through the threaded hole into the sheath seat 2011, a second end of the threaded fastener is located outside the sheath seat 2011, and the threaded fastener is screwed by manually screwing the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the distal housing 203, and further the proximal housing 204 is fixed with the sheath seat 2011. The threaded fastener may be a locking screw or the like.
Conventional biopsy needles are typically secured by a proximal housing and an endoscope, which is commonly operated by an endoscope operator. However, due to the motor, the rotary-cut biopsy needle has a large weight after the motor handle and the proximal housing are assembled, and if the proximal housing and the endoscope are fixed in a traditional fixing manner, the difficulty of endoscope operation and the difficulty of the endoscope operator can be greatly increased. According to the invention, the outer sheath tube is fixed with the endoscope through the endoscope fixing piece on the outer sheath tube, and the proximal end shell and the motor handle are held and operated by another special operator. Therefore, the holding and operation of the endoscope are distinguished from the holding and operation completion of the proximal housing, the operation difficulty is reduced, and the adjustment range of the intervention depth of the outer sheath is increased.
The proximal hand-held part 2 further comprises a puncture depth adjusting device 202, the puncture depth adjusting device 202 comprises an adjusting sleeve 2021 and a sleeve locking piece 2022, the adjusting sleeve 2021 is movably sleeved on the distal end housing 203, when in use, the puncture depth is set by adjusting the position of the adjusting sleeve 2021 on the distal end housing 203, then the adjusting sleeve 2021 is locked on the distal end housing 203 by the sleeve locking piece 2022, and finally the proximal end housing 204 is slid distally to realize puncture. Until the distal end of the proximal housing 204 contacts the adjustment sleeve 2021, i.e., the adjustment sleeve 2021 blocks the distal sliding of the proximal housing 204, at which point the penetration is complete.
Since the technical solution of adjusting and locking the two structures (the adjusting sleeve 2021 and the inlet housing) by the locking element (the sleeve locking element 2022) belongs to a relatively mature technology in the mechanical field, the invention is not limited thereto, for example, the sleeve locking element 2022 may be a locking cap structure, an internal thread is provided in the locking cap structure, an external thread adapted to the internal thread is provided on the adjusting sleeve 2021, and the adjusting sleeve 2021 is locked on the distal housing 203 by the matching assembly of the internal thread and the external thread. When the locking cap structure is unscrewed, the adjustment sleeve 2021 and the distal housing 203 are in an unlocked state, allowing for an axial sliding operation. Of course, the sleeve locking element 2022 of the present invention is not limited to a locking cap structure, but may be a threaded fastener, specifically, a threaded hole is formed on a side wall of the adjusting sleeve 2021, the sleeve locking element 2022 is a threaded fastener that is matched with the threaded hole, a first end of the threaded fastener passes through the threaded hole into the adjusting sleeve 2021, and a second end of the threaded fastener is located outside the adjusting sleeve 2021, and the threaded fastener is screwed by manually tightening the second end of the threaded fastener, so that the first end of the threaded fastener abuts against the distal housing 203, and further, the proximal housing 204 is fixed with the adjusting sleeve 2021. The threaded fastener may be a locking screw or the like.
Example 2
The embodiment provides a positive negative pressure suction biopsy system under a lens, which comprises the negative pressure suction rotary-cut biopsy needle and a negative pressure device according to the embodiment 1, wherein the negative pressure device performs negative pressure suction on tissues in the rotary-cut knife tube 102 through a negative pressure interface 2041.
As an embodiment, the biopsy system further comprises a syringe that injects saline into the shaver tube 102 through the negative pressure interface 2041 after sampling is completed, and flushes out the tissue sample in the shaver tube 102.
The negative pressure device and the syringe may share one port, or may be separate ports, and connected to the negative pressure port 2041.
As an embodiment, the negative pressure interface 2041 is further connected to a three-way connector, where the three-way connector includes a first interface, a second interface and a third interface, the first interface is used for communicating with the negative pressure interface 2041, the second interface is used for connecting with the negative pressure device, the third interface is used for connecting with the syringe, an adjusting switch is disposed in the three-way connector, and the first interface realizes the switching of the paths with the second interface and the third interface through the adjusting switch. If the regulating switch is in the I gear, the negative pressure suction of the negative pressure device can be transmitted to the far end of the rotary cutter tube 102 to realize the adsorption of tissues, and if the regulating switch is in the II gear, the injector can punch out and sample the tissues in the rotary cutter tube 102 so as to ensure the integrity of the tissues.
The present embodiment is not limited to a specific type of the negative pressure device, and may be, for example, a negative pressure suction cylinder or a negative pressure pump. The method for adjusting the negative pressure will be described below using a negative pressure device as a negative pressure pump.
In order to realize the regulation of negative pressure size, biopsy system still includes the host computer, and the host computer includes main control module, main control module passes through negative pressure drive module and is connected with the negative pressure pump electricity, and main control module control output DAC analog signal, and output adjustable pressure drive signal is because the drive voltage and the flow of negative pressure pump are linear relation to control negative pressure pump drive voltage, negative pressure pump flow size just can realize the regulation of negative pressure size promptly.
The host computer still has negative pressure sensor, monitors the real-time negative pressure size of negative pressure pump, and the accurate negative pressure value of feedback for main control module, main control module is based on the negative pressure value of feedback, adjusts the negative pressure value through adjusting the flow size of negative pressure pump.
The main control module is also electrically connected with the rotary cutting driving motor and the stroke driving motor respectively through the motor driving module. During sampling, the negative pressure is regulated in three stages:
(1) In the initial stage, the negative pressure value is smaller and is less than 10KPa, so that the annular cutting edge of the rotary cutter tube 102 can be close to tissues, and the annular cutting edge of the rotary cutter tube 102 can conveniently cut and separate the tissues.
(2) In the sampling stage, the negative pressure value is gradually increased based on the rotary cutting depth of the rotary cutter tube 102. If the screw is screwed by 1mm, the negative pressure value of 1KPa can be increased. When screwed in 20mm, the negative pressure value increased to 30KPa. If the host machine finds that the torque of the rotary driving motor is obviously reduced (identified by motor current), the situation that the tissue in the inner cavity of the rotary cutter tube 102 is blocked and cannot go deep is indicated, so that the annular blade of the rotary cutter tube 102 cannot cut and separate the tissue, at the moment, the negative pressure pump is controlled to increase the negative pressure value, so that the tissue in the inner cavity of the rotary cutter tube 102 moves to the deep of the inner cavity, a space is reserved at the distal end of the rotary cutter tube 102, and the sampling amount is increased.
(3) And (3) a sampling end stretch-break stage, wherein after the sampling is finished, the negative pressure pump provides a larger negative pressure value, such as >30KPa, so that the sample tissue is completely separated through superposition of the suction force and the friction force of the negative pressure.
(4) In the sample collection stage, the negative pressure is closed, the three-way joint is regulated, physiological saline is injected into the inner cavity of the rotary cutter tube 102, and the sample tissue is flushed out.
Although the present invention is disclosed above, the present invention is not limited thereto. Various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention, and the scope of the invention should be assessed accordingly to that of the appended claims.
Claims (16)
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| CN120130895B (en) * | 2025-05-16 | 2025-08-15 | 湖南省华芯医疗器械有限公司 | Front end component, insertion part, endoscope and front end component assembling method |
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| CN116831643A (en) * | 2023-08-10 | 2023-10-03 | 湖南峰恒晶医疗科技有限公司 | A closed continuous sampling breast biopsy needle |
| CN118648925A (en) * | 2024-06-18 | 2024-09-17 | 上海修能医疗器械有限公司 | Radiofrequency cutting biopsy needle and biopsy needle use method |
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| CN1655724A (en) * | 2002-03-19 | 2005-08-17 | 巴德都柏林Itc有限公司 | vacuum biopsy device |
| US7608048B2 (en) * | 2003-08-28 | 2009-10-27 | Goldenberg Alec S | Rotating soft tissue biopsy needle |
| CN217187394U (en) * | 2021-12-13 | 2022-08-16 | 上海英诺伟医疗器械股份有限公司 | Negative pressure guide sheath |
| CN115813454B (en) * | 2022-11-30 | 2025-07-25 | 重庆西山科技股份有限公司 | Control method of biopsy sampling device and biopsy sampling device |
| CN219270970U (en) * | 2022-12-29 | 2023-06-30 | 施爱德（厦门）医疗器材有限公司 | A biopsy puncture needle rotary cutting structure |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116831643A (en) * | 2023-08-10 | 2023-10-03 | 湖南峰恒晶医疗科技有限公司 | A closed continuous sampling breast biopsy needle |
| CN118648925A (en) * | 2024-06-18 | 2024-09-17 | 上海修能医疗器械有限公司 | Radiofrequency cutting biopsy needle and biopsy needle use method |
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