CN113559390A - Medical intervention catheter part, medical intervention catheter and medical intervention system - Google Patents

Medical intervention catheter part, medical intervention catheter and medical intervention system Download PDF

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Publication number
CN113559390A
CN113559390A CN202010275482.7A CN202010275482A CN113559390A CN 113559390 A CN113559390 A CN 113559390A CN 202010275482 A CN202010275482 A CN 202010275482A CN 113559390 A CN113559390 A CN 113559390A
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China
Prior art keywords
position sensor
needle assembly
needle
catheter
distal end
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CN202010275482.7A
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Chinese (zh)
Inventor
梁波
蒋佳强
梅莹
汤菁
奚云珠
孙毅勇
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Shanghai Microport EP MedTech Co Ltd
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Shanghai Microport EP MedTech Co Ltd
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Priority to CN202010275482.7A priority Critical patent/CN113559390A/en
Publication of CN113559390A publication Critical patent/CN113559390A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2051—Electromagnetic tracking systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided

Abstract

The invention provides a medical interventional catheter component, a medical interventional catheter and a medical interventional system, wherein the medical interventional catheter component comprises a catheter body, a needle assembly, a first position sensor and a second position sensor; the needle assembly is movably arranged along the axial direction of the catheter body, the first position sensor is fixedly arranged on the catheter body, and the second position sensor is fixedly arranged on the needle assembly. With the configuration, the distance between the second position sensor and the first position sensor can be obtained through the position relation between the two position sensors, and the length of the needle assembly axially extending out of the catheter body can be further known. Therefore, better treatment effect can be obtained by accurately controlling the extending length of the needle outlet assembly.

Description

Medical intervention catheter part, medical intervention catheter and medical intervention system
Technical Field
The invention relates to the technical field of medical instruments, in particular to a medical interventional catheter component, a medical interventional catheter and a medical interventional system.
Background
Interventional catheters with retractable needles play an increasingly important role in interventional procedures, particularly in the treatment of heart diseases, and are used primarily in two areas: 1. interventional catheters for injectable drugs and biologics (such as cell cultures, growth factors, therapeutic drugs); 2. an ablation interventional catheter for ablation with a retractable needle. The injection interventional catheter can be used for treating coronary heart disease, and the ablation interventional catheter can be used for treating hypertrophic cardiomyopathy and the like.
Coronary heart disease is a serious disease most easily causing death of patients, when coronary artery is seriously blocked, the long-term reduction of blood flow can cause myocardial function loss, because ischemia causes myocardial cell death, the dead myocardial cells cannot be replaced and regenerated, so scars can be formed after wound healing, the scar area cannot be normally contracted, and the load of other areas of the heart is increased, and further the heart gradually degenerates and fails. In the prior art, the far end of some interventional catheters with telescopic injection needles is provided with an adjustable bend, which is beneficial for the far end of the catheter to smoothly reach the region of the heart to be treated; when the retractable needle is in an extending state, the needle is inserted into the target area, and medicines or biological reagents are injected into the cardiac muscle, so that the treatment effect is achieved; the proximal end of the handle has a push button for controlling the length of the needle and a knob for controlling the extent of the needle.
Hypertrophic cardiomyopathy can reduce the amount of blood pumped from the heart to the whole body, and finally lead to heart failure; meanwhile, the focus in the hypertrophic myocardium may cause abnormal electrocardio-conduction, resulting in serious arrhythmia. Treatment with ablation modalities has been a new choice for surgeons in recent years, and ablation of such arrhythmias requires a larger and deeper lesion, and methods to increase the size of the lesion would include increasing the electrode diameter, increasing the electrode-to-tissue contact area, increasing tissue conductivity, and increasing the direct mechanical penetration of the needle/ablation electrode into the tissue. The needle electrode ablation is most effective, the depth of the traditional ablation focus can be increased by about 7mm, the needle electrode ablation is enough, and the conductive liquid injected into the needle can cool the needle electrode and increase the conductivity of the tissue, so that the ablation power is increased and the size of the ablation focus is increased. In the prior art, some catheters which can be inserted into an ablation needle are provided with a handle for controlling the extension and retraction of the needle and another handle for controlling the bending of the distal end of the catheter at the proximal end; the needle extending out of the catheter can be inserted into cardiac muscle for ablation, saline is filled in the needle to cool the ablation needle, and the conductivity of the cardiac muscle is increased at the same time, so that the ablation area of the cardiac muscle is enlarged; the other path of the saline is introduced between the outer wall of the needle and the catheter to wash the gap between the needle and the catheter and prevent the generation of thrombus.
Compared with other treatment means, the two devices can achieve certain treatment effect, but when the injection needle or the ablation needle is controlled to extend out at the near end or the needle is inserted into cardiac muscle, the extending length of the needle can fluctuate greatly, and the extending length is one of important factors influencing the treatment effect of the injection needle and the ablation needle. If the needle-out length can not be accurately controlled, the injection needle or the ablation needle can not reach the depth of the target position, the ablation focus with the required size can not be formed, and the ideal treatment effect can not be achieved.
Disclosure of Invention
The invention aims to provide a medical interventional catheter component, a medical interventional catheter and a medical interventional system, and aims to solve the problem that an interventional catheter with a telescopic needle in the prior art cannot accurately control the length of the needle.
In order to solve the above technical problem, the present invention provides a medical interventional catheter assembly, comprising: the catheter comprises a catheter body, a needle assembly, a first position sensor and a second position sensor;
the catheter body is provided with a hollow first inner cavity, the needle assembly is arranged along the axial direction of the catheter body, and the needle assembly can move along the axial direction of the catheter body between a retracted position and an extended position;
the first position sensor is fixedly arranged on the catheter body, and the second position sensor is fixedly arranged on the needle assembly; the position information of the first position sensor and the position information of the second position sensor are used for judging the axial distance of the needle assembly moving relative to the catheter body.
Optionally, the retracted position is set such that the needle assembly is fully threaded into the first lumen; the extended position is configured such that the distal end of the needle assembly extends beyond the distal end of the first lumen.
Optionally, the position information of the first position sensor and the position information of the second position sensor are used for calculating a spatial linear distance of the distal end of the needle assembly relative to the distal end of the catheter body, and the spatial linear distance and the radial distance of the first position sensor and the second position sensor are used for calculating an axial distance of the distal end of the needle assembly relative to the distal end of the catheter body.
Optionally, the needle assembly comprises a hollow needle and a syringe, the syringe is connected to the proximal end of the hollow needle; the second position sensor is fixed with the hollow needle or the injection tube.
Optionally, the second position sensor is fixedly disposed on an outer wall of the hollow needle and located at a connection position of the hollow needle and the syringe.
Optionally, the second position sensor and a lead of the second position sensor are disposed in a tube wall of the injection tube.
Optionally, the needle assembly further comprises a temperature sensor fixedly disposed in an outer wall of the hollow needle, an inner wall of the hollow needle, or a needle wall of the hollow needle, for sensing a temperature of the hollow needle.
Optionally, the needle assembly includes a wire protection tube, and the wire protection tube is inserted into the injection tube and is used for the wire of the second position sensor to be inserted.
Optionally, the needle assembly further comprises a solid ablation needle and an ablation lead, and the solid ablation needle is electrically connected with the ablation lead.
Optionally, the catheter body includes a guide tube, the guide tube is fixedly inserted into the first inner cavity along an axial direction of the catheter body, the guide tube has a second inner cavity, the second inner cavity is used for the needle assembly to be inserted, and the first position sensor is disposed outside the guide tube.
In order to solve the technical problem, the invention also provides a medical interventional catheter, which comprises a control handle and the medical interventional catheter component; the control handle is connected with the proximal end of the catheter body and comprises a knob for driving the needle assembly to move.
In order to solve the technical problem, the invention also provides a medical interventional system, which comprises the medical interventional catheter, the magnetic field generator, the reference electrode and the control device; the first position sensor, the second position sensor, the magnetic field generator and the reference electrode are respectively in communication connection with the control device, the first position sensor and the second position sensor are used for sensing a magnetic field of the magnetic field generator to obtain sensing signals, and the control device obtains position information of the first position sensor and position information of the second position sensor based on the sensing signals and the reference electrode and judges the axial distance of the needle assembly moving relative to the catheter body.
Optionally, the medical intervention system comprises: a display device communicatively coupled to the control device, the display device for displaying an axial distance of the distal end of the needle assembly relative to the distal end of the first lumen.
Optionally, the knob is in communication connection with the control device; the control device is configured to calculate an axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity based on the position information of the first position sensor and the position information of the second position sensor, and control the knob to drive the needle assembly to move according to the comparison result of the calculated axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity and a set value, so that the axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity is kept within a preset range.
Optionally, the medical interventional catheter further comprises a force sensor disposed on the needle assembly and/or the catheter body, the force sensor being in communication with the control device for sensing a feedback force of the catheter body and/or the needle assembly; the control device is configured to send out an alarm signal when the feedback force of the catheter body and/or the needle assembly sensed by the force sensor is larger than a preset threshold value.
In summary, in the medical interventional catheter component, the medical interventional catheter and the medical interventional system provided by the invention, the medical interventional catheter component comprises a catheter body, a needle assembly, a first position sensor and a second position sensor; the needle assembly is movably arranged along the axial direction of the catheter body, the first position sensor is fixedly arranged on the catheter body, and the second position sensor is fixedly arranged on the needle assembly. With the configuration, the distance between the second position sensor and the first position sensor can be obtained through the position relation between the two position sensors, and the length of the needle assembly axially extending out of the catheter body can be further known. Therefore, better treatment effect can be obtained by accurately controlling the extending length of the needle outlet assembly.
Drawings
It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:
FIG. 1 is a schematic view of a medical interventional catheter component provided in accordance with an embodiment of the invention;
FIG. 2 is a schematic view of a medical interventional catheter according to an embodiment of the present invention;
FIG. 3 is a schematic diagram illustrating a medical interventional system according to an embodiment of the present invention;
FIG. 4 is a schematic view of a needle assembly provided in accordance with an embodiment of the present invention;
FIG. 5 is a cross-sectional view of a medical interventional catheter component provided in accordance with an embodiment of the present invention;
FIGS. 6a and 6b are schematic views illustrating the telescoping of a medical interventional catheter component according to an embodiment of the invention;
FIGS. 7 a-7 c are schematic views of a needle assembly provided in accordance with a second embodiment of the present invention;
FIGS. 8 a-8 c are schematic views of a needle assembly provided in accordance with a third embodiment of the present invention;
FIG. 9 is a schematic view of a needle assembly provided in accordance with a fourth embodiment of the present invention;
FIG. 10 is a schematic view of a medical interventional catheter component provided in accordance with a sixth embodiment of the invention, wherein the catheter body includes a force sensor;
FIG. 11 is a schematic view of a needle assembly provided in accordance with a sixth embodiment of the present invention, wherein the needle assembly includes a force sensor.
In the drawings:
1-a medical interventional catheter; 3-a perfusion apparatus or an injection apparatus; 4-the heart; 5-an ablation device;
10-a catheter body; 11-a guide tube;
20-a needle assembly; 21-a hollow needle; 22-an injection tube; 23-a wire protection tube; 24-a temperature sensor; 25-a stationary tube; 31-a first position sensor; 32-a second position sensor; 320-a lead of a second position sensor; 36-a force sensor; 40-control the handle; 41-knob; 42-an electrical connector;
51-a magnetic field generator; 52-a reference electrode; 53-a control device; 54-a display device;
Detailed Description
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is to be noted that the drawings are in greatly simplified form and are not to scale, but are merely intended to facilitate and clarify the explanation of the embodiments of the present invention. Further, the structures illustrated in the drawings are often part of actual structures. In particular, the drawings may have different emphasis points and may sometimes be scaled differently.
As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally used in its sense including "and/or" unless the content clearly dictates otherwise, the term "proximal" is generally the end near the operator and the term "distal" is generally the end near the lesion near the patient.
The invention provides a medical interventional catheter component, a medical interventional catheter and a medical interventional system, and aims to solve the problem that an interventional catheter with a telescopic needle in the prior art cannot accurately control the length of a needle. The medical interventional catheter component comprises: the catheter comprises a catheter body, a needle assembly, a first position sensor and a second position sensor; the catheter body is provided with a hollow first inner cavity, the needle assembly is arranged along the axial direction of the catheter body, and the needle assembly can move along the axial direction of the catheter body between a retracted position and an extended position; the first position sensor is fixedly arranged on the catheter body, and the second position sensor is fixedly arranged on the needle assembly; the position information of the first position sensor and the position information of the second position sensor are used for judging the axial distance of the needle assembly moving relative to the catheter body. With the configuration, the distance between the second position sensor and the first position sensor can be obtained through the position relation between the two position sensors, and the length of the needle assembly axially extending out of the catheter body can be further known. Therefore, better treatment effect can be obtained by accurately controlling the extending length of the needle outlet assembly.
The following description refers to the accompanying drawings.
[ EXAMPLES one ]
Referring to fig. 1 to fig. 6b, fig. 1 is a schematic view of a medical interventional catheter component according to an embodiment of the present invention, fig. 2 is a schematic view of a medical interventional catheter according to an embodiment of the present invention, fig. 3 is a schematic view of a medical interventional system according to an embodiment of the present invention, fig. 4 is a schematic view of a needle assembly according to an embodiment of the present invention, fig. 5 is a cross-sectional view of a medical interventional catheter component according to an embodiment of the present invention, and fig. 6a and fig. 6b are schematic views of a telescopic structure of a medical interventional catheter component according to an embodiment of the present invention.
As described in the background, when the proximal control needle assembly of the medical interventional catheter with a retractable needle assembly is extended, or when the needle assembly is inserted into the myocardium, the length of the extended needle assembly may fluctuate greatly, and the inventors found that the main reasons are as follows: 1. the inner wall of the catheter and the needle assembly have friction force, and the friction force is increased when the catheter bends; 2. the push needle assembly is long and limited in rigidity, and cannot transmit the pushing force of the proximal end to the distal end of the needle assembly in a 1:1 manner; a certain gap is formed between the inner wall of the catheter and the outer wall of the needle assembly, the catheter is in different bending states, and the extending lengths of the needle assembly are different; 4. when the needle assembly is inserted into tissue, the pusher assembly is subjected to compressive forces which result in the needle assembly being inserted into the myocardium to a lesser extent than it was previously set without insertion. Thus, the needle-out length of the needle assembly cannot be precisely controlled.
To solve this problem, according to an embodiment of the present invention, there is provided a medical interventional catheter component, as shown in fig. 1, including: a catheter body 10, a needle assembly 20, a first position sensor 31 and a second position sensor 32; the catheter body 10 is provided with a hollow first inner cavity, the needle assembly 20 is arranged along the axial direction of the catheter body 10, and the needle assembly 20 can move along the axial direction of the catheter body 10 between a contraction position and an extension position; optionally, the retracted position is provided with the needle assembly 20 fully disposed through the first lumen; the extended position is such that the distal end of the needle assembly 20 extends beyond the distal end of the first lumen; the first position sensor 31 is fixedly arranged on the catheter body 10, and the second position sensor 32 is fixedly arranged on the needle assembly 20; the position information of the first position sensor 31 and the position information of the second position sensor 32 are used to determine the axial distance of the needle assembly 20 moving relative to the catheter body 10. With this arrangement, the distance between the second position sensor 32 and the first position sensor 31 can be obtained by the positional relationship between the two position sensors, and the length of the needle assembly 20 axially extending out of the catheter body 10 can be known. Thus, a better therapeutic effect can be obtained by precisely controlling the protruding length of the needle assembly 20.
As shown in fig. 2, a medical interventional catheter is further provided in an embodiment of the present invention, which includes a control handle 40 and the medical interventional catheter component as described above, the control handle 40 is connected to the proximal end of the catheter body 10, and the control handle 40 includes a knob 41, and the knob 41 is used for driving the needle assembly 20 to move. Further, the control handle 40 further includes an electrical connector 42, and the electrical connector 42 is connected to the first position sensor 31 and the second position sensor 32 through wires, respectively, and is used for electrically connecting to an external control device to transmit signals sensed by the first position sensor 31 and the second position sensor 32.
Referring to fig. 1 in combination with fig. 5, in some embodiments, the catheter body 10 includes a guide tube 11, the guide tube 11 is fixedly disposed in the first inner cavity along the axial direction of the catheter body 10, and the guide tube 11 has a second inner cavity through which the needle assembly 20 is disposed. Alternatively, the first inner cavity of the catheter body 10 is divided into a plurality of sub-cavities, and the guide tube 11 is fixed in one of the sub-cavities. The needle assembly 20 is driven by the knob 41 to advance and retract back and forth in the guide tube 11 (i.e., to move in the axial direction of the catheter body 10). Preferably, as shown in fig. 4, the needle assembly 20 includes a hollow needle 21 and an injection tube 22, the injection tube 22 is connected to the proximal end of the hollow needle 21, and the injection tube 22 is sleeved outside the proximal end of the hollow needle 21 to form a fixed connection; the second position sensor 32 is fixed to the hollow needle 21, for example, the second position sensor 32 is fixedly disposed on an outer wall of the hollow needle 21, an inner wall of the hollow needle 21, a needle wall of the hollow needle 21, an outer wall of the syringe 22, an inner wall of the syringe 22, or a tube wall of the syringe 22. Optionally, in some embodiments, the needle assembly 20 further includes a fixing tube 25, the hollow needle 21 and the second position sensor 32 are both inserted into the fixing tube 25 and sealed by glue, so as to fixedly connect the hollow needle 21 and the second position sensor 32, the fixing tube 25 is axially movably inserted into the second inner cavity of the guide tube 11, and the first position sensor 31 is disposed outside the guide tube 11.
Referring to fig. 4, in an exemplary embodiment of the needle assembly 20, the second position sensor 32 is fixedly disposed on an outer wall of the hollow needle 21 and is located at a connection position of the hollow needle 21 and the syringe 22. Optionally, the second position sensor 32 is connected to the proximal control handle 40 by a wire, and the wire 320 of the second position sensor is disposed in the syringe 22. Since the second position sensor 32 is disposed at the junction of the hollow needle 21 and the syringe 22, the lead wire 320 of the second position sensor can be directly inserted into the syringe 22 from the distal end of the syringe 22 and extend proximally. In some embodiments, the needle assembly 20 includes a wire protection tube 23, the wire protection tube 23 being disposed through the syringe tube 22 for passage of the wire 320 of the second position sensor. Since the injection solution passes through the injection tube 22, the wire protection tube 23 may be used to protect the wire 320 of the second position sensor from contact with the injection solution, and the distal end of the wire protection tube 23 may be sealed by injecting glue. Another protection tube can be preferably sleeved outside the second position sensor 32 and fixed by injecting glue. Optionally, the first position sensor 31 is fixedly disposed in another sub-cavity of the catheter body 10 and is injected with glue, so as to maintain the position of the distal end of the catheter body 10 unchanged. When the needle assembly 20 is advanced and retracted back and forth in the guide tube 11, the second position sensor 32 is changed in accordance with the position of the needle electrode 20, so that the second position sensor 32 is displaced in the axial direction with respect to the first position sensor 31 during the advance and retraction of the needle assembly 20. From the position information of the first position sensor 31 and the second position sensor 32, the axial distance of the distal end of the needle assembly 20 (i.e. the needle-out length) relative to the distal end of the first lumen can be calculated.
Referring to fig. 3, in order to realize sensing of the position information of the first position sensor 31 and the second position sensor 32, an embodiment of the present invention further provides a medical interventional system, which includes: the medical interventional catheter, the magnetic field generator 51, the reference electrode 52 and the control device 53 as described above; the first position sensor 31, the second position sensor 32, the magnetic field generator 51, andthe reference electrode 52 is respectively connected to the control device 53 in a communication manner, the first position sensor 31 and the second position sensor 32 are configured to sense the magnetic field of the magnetic field generator 51 to obtain a sensing signal, and the control device 53 obtains position information of the first position sensor 31 and position information of the second position sensor 32 based on the sensing signal and the reference electrode 52, and determines an axial distance that the needle assembly 20 moves relative to the catheter body 10. Preferably, the medical intervention system further comprises a display device 54, the display device 54 is in communication with the control device 53, and the display device 54 is configured to display an axial distance of the distal end of the needle assembly relative to the distal end of the first lumen. In one application example, join
Figure RE-GDA0002498415150000081
The three-dimensional cardiac electrophysiology mapping system can be used for an operator to observe the length of a needle after sensing two position sensors of a medical interventional catheter to obtain the length of the needle. Specifically, the medical intervention system comprises a medical intervention catheter 1, an ablation device 5 and a perfusion device or injection device 3, wherein the medical intervention catheter 1 is used for performing ablation or injection treatment on a heart 4 of a human body. The control device 53 comprises a positioning processing unit, a patient interface unit and a computer workstation, wherein the magnetic field generator 51 is positioned near the heart of the patient below the operating bed in the operation process, and the positioning processing unit controls the magnetic field generator 51 to work. The reference electrode 52 is attached to the back of the patient and connected to the patient interface unit, the proximal end of the medical interventional catheter enters the focal region of the heart of the patient in an interventional manner, the first position sensor 31 and the second position sensor 32 can sense the magnetic field of the magnetic field generator 51 to generate weak current signals, and the weak current signals are transmitted to the positioning processing unit and are collected and processed by combining the patient interface unit. Injecting or melting the medical interventional catheter at different positions of the heart, transmitting the three-dimensional position and direction information of the head end of the medical interventional catheter and the needle assembly and electrocardio signals to a computer workstation, constructing a three-dimensional heart cavity anatomical model by software, overlapping electrical physiological information to form an electroanatomical map, and displaying the electroanatomical map on a display deviceA three-dimensional image of the interventional catheter needle out and the needle out length are displayed at 54.
Preferably, the position information of the first position sensor 31 and the position information of the second position sensor 32 are used for calculating a spatial linear distance of the distal end of the needle assembly 20 relative to the distal end of the catheter body 10, and the spatial linear distance and the radial distance of the first position sensor 31 and the second position sensor 32 are used for calculating an axial distance of the distal end of the needle assembly 20 relative to the distal end of the catheter body 10. The principle of the calculation of the needle length is exemplarily explained below with reference to fig. 1, 5, 6a and 6 b.
The control device 53 can acquire the spatial coordinates of the two position sensors by acquiring current signals generated by the first position sensor 31 and the second position sensor 32 sensing the magnetic field of the magnetic field generator 51. The first position sensor 31 has coordinates of (x)1,y1,z1) The coordinates of the second position sensor 32 are (x)2,y2,z2) Then, the spatial linear distance L of the two position sensors is:
Figure RE-GDA0002498415150000091
the control device 53 may calculate the spatial linear distance L in real time according to the current signals of the two position sensors. The radial distance L between the first position sensor 31 and said second position sensor 322The control device 53 can be preset in advance, always unchanged during the movement of the needle assembly 20, while the spatial linear distance L of the two position sensors still satisfies:
Figure RE-GDA0002498415150000092
wherein L is1Is the axial distance of the first position sensor 31 and the second position sensor 32, and therefore, the axial distance of the first position sensor 31 and the second position sensor 32
Figure RE-GDA0002498415150000093
Further, as shown in FIG. 1In the illustrated example, the first position sensor 31 is located near the distal end of the catheter body 10 and the second position sensor 32 is located at the proximal end of the hollow needle 21, and since the hollow needle 21 has a certain length, the second position sensor 32 is located relatively on the proximal side of the first position sensor 31 when the distal end of the needle assembly 20 is flush with the distal end of the catheter body 10. Further, the retracted position is set at the maximum travel of the needle assembly 20 fully retracted into the catheter body 10 (i.e., the needle assembly 20 is at the most proximal end of its travel), when the axial distance between the two position sensors is LFirst stageOptionally, the distal end of the needle assembly 20 is located on the proximal side of the distal end of the catheter body 10 (this state is not shown). The axial distance of the two position sensors is L when the distal end of the needle assembly 20 is flush with the distal end of the catheter body 100It will be appreciated that since the length of the hollow needle 21 is constant, L is constant0Is constant, as shown in FIG. 6 a. The extended position is set to be at the maximum travel of the needle assembly 20 fully extended out of the catheter body 10 (i.e., the needle assembly 20 is at the most distal end of its travel), when the axial distance between the two position sensors is LmaxAs shown in fig. 6 b. Therefore, during the movement of the needle assembly 20 from the retracted position to the extended position (i.e., during needle withdrawal), the axial distance between the two position sensors is determined by LFirst stageDecrease to L0Then decreases to 0mm, and then gradually increases to L from 0mmmax。
Preferably, the control device 53 can determine the relative position of the first position sensor 31 and the second position sensor 32, and when the second position sensor 32 is determined to be located at the proximal end of the first position sensor 31, i.e. the axial distance between the two position sensors is determined by LFirst stageIn the process of reducing to 0mm, the length L of the needleNeedle outlet＝L0- L1Wherein L is0Is a constant value, L1Obtained according to the above formula (3) to obtain1As a variable, varies according to the movement of the needle assembly 20. It will be appreciated that when the second position sensor 32 is determined to be at the first position sensor distal end 31, i.e., the distance between the two position sensors increases from 0mm to LmaxIn the process, the length L of the needle outletNeedle outlet＝L0+L1。
Therefore, the axial distance (i.e. the needle-out length) of the distal end of the needle assembly 20 relative to the distal end of the catheter body 10 is calculated by first obtaining the spatial linear distance of the distal end of the needle assembly 20 relative to the distal end of the first lumen based on the position information of the first position sensor 31 and the position information of the second position sensor 32, and then calculating the axial distance (i.e. the needle-out length) of the distal end of the needle assembly 20 relative to the distal end of the catheter body based on the spatial linear distance and the radial distance between the first position sensor 31 and the second position sensor 32.
In some embodiments, referring to fig. 3 and 4, the medical interventional catheter is illustrated by way of example as an ablation needle catheter and an irrigated ablation needle catheter, wherein the hollow needle 21 is configured as an ablation electrode for insertion into a predetermined lesion and irrigation of saline distally through the injection tube 22, and the hollow needle 21 is electrically connected to an ablation wire and connected through the ablation wire to an electrical connector 42 of the proximal control handle 40 and further to an external ablation device.
The needle assembly 20 is not limited to the inclusion of a hollow needle 21, and in other embodiments, the needle assembly 20 includes a solid ablation needle (not shown) and an ablation lead wire, the solid ablation needle being electrically connected to the ablation lead wire.
Optionally, the needle assembly 20 further includes a temperature sensor 24, and the temperature sensor 24 is fixedly disposed on an outer wall of the hollow needle 21, an inner wall of the hollow needle 21, or a needle wall of the hollow needle 21, and is connected to the electrical connector 42 through a wire for sensing the temperature of the hollow needle 21. The wire protection tube 23 located in the injection tube 22 is also used for threading the wires of the temperature sensor 24 and/or the ablation wires. Of course, the wires of the temperature sensor 24 and/or the ablation wires may be independently threaded through the wire protection tube 23, or other protection tubes may be used separately. Further, a person skilled in the art can dispose a tip electrode, a ring electrode, etc. at the distal end of the catheter body 10 according to the prior art, and a description thereof will not be provided. Of course, in other embodiments, the medical intervention needle assembly may be other types of needle assemblies, such as an injection type needle assembly, and the needle of the medical intervention needle assembly may be a solid ablation needle, which is not limited in this respect.
In summary, by fixing the first position sensor 31 on the catheter body 1 and the second position sensor 32 on the movable needle assembly 20, the two position sensors are fixed in a way that on one hand, the position sensors can intervene in the human body and can freely move in a magnetic field without being limited by the magnetic field; meanwhile, the relative motion relationship can be measured, so that the important needle-out length can be calculated.
[ example two ]
Please refer to fig. 7a to 7c, which are schematic views of a needle assembly according to a second embodiment of the present invention.
The medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the second embodiment of the invention are basically the same as the medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the first embodiment of the invention, and the same parts are not described again, and only different points are described below.
As shown in fig. 7a to 7c, unlike the first embodiment, in the second embodiment, the second position sensor 32 is fixed to the syringe 22, for example, the second position sensor 32 is fixed to the outer wall of the syringe 22, the inner wall of the syringe 22, or the wall of the syringe 22. Fig. 7a shows an embodiment in which the second position sensor 32 is fixedly provided on the outer wall surface of the syringe 22, fig. 7b shows an embodiment in which the second position sensor 32 is fixedly provided on the inner wall surface of the syringe 22, and fig. 7c shows an embodiment in which the second position sensor 32 is fixedly provided in the wall of the syringe 22. The second position sensor 32 is disposed on the outer wall or inner wall of the injection tube 22, for example, by glue injection. The second position sensor 32 is disposed in the wall of the injection tube 22, and the second position sensor 32 and the injection tube 22 can be manufactured by composite molding.
Further, the needle assembly 20 includes a wire protection tube 23, the wire protection tube 23 is disposed through the injection tube 22, and optionally, the wire protection tube 23 is disposed at the proximal end of the second position sensor 32, through which the wire 320 of the second position sensor can pass. The installation mode of the sensor lead is convenient for protecting and installing the lead and is easy to realize process operation.
[ EXAMPLE III ]
Please refer to fig. 8a to 8c, which are schematic views of a needle assembly according to a third embodiment of the present invention.
The medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the third embodiment of the invention are basically the same as the medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the first embodiment of the invention, and the same parts are not described again, and only different points are described below.
As shown in fig. 8a to 8c, unlike the first embodiment, in the third embodiment, the second position sensor 32 is fixedly disposed on the outer wall of the injection tube 22, the inner wall of the injection tube 22, or the wall of the injection tube 22. Specifically, fig. 8a shows an embodiment in which the second position sensor 32 is fixedly disposed on the outer wall surface of the syringe 22, fig. 8b shows an embodiment in which the second position sensor 32 is fixedly disposed on the inner wall surface of the syringe 22, and fig. 8c shows an embodiment in which the second position sensor 32 is fixedly disposed in the wall of the syringe 22. Further, the lead 320 of the second position sensor is disposed in the wall of the injection tube 22 and extends to the proximal end, and in practice, the injection tube 22 may be formed by combining a tube and a lead. The installation mode of the sensor lead saves the installation space of the sensor lead, the inner cavity space of the injection tube 22 can be fully applied, space is provided for other leads and liquid to pass through, and the product performance is convenient to optimize. Particularly, as shown in fig. 8c, the inner wall and the outer wall of the injection tube 22 and the inner wall and the outer wall of the hollow needle 21 have no protrusions, the needle assembly 20 has a small moving resistance and a small flow resistance to the injection liquid or the perfusion liquid, and the lead wires are embedded in the tube wall by compounding, so that the lead wires do not contact the injection liquid or the perfusion liquid, and the reliability is high.
Furthermore, when the medical interventional catheter is configured as an ablation needle catheter and an irrigated ablation needle catheter, the temperature sensor wire and/or the ablation wire may also be co-molded with the second position sensor wire 320 in the wall of the injection tube 22.
[ EXAMPLE IV ]
Please refer to fig. 9, which is a schematic view of a needle assembly according to a fourth embodiment of the present invention.
The medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the fourth embodiment of the invention are basically the same as the medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the first embodiment of the invention, and the same parts are not described again, and only different points are described below.
As shown in fig. 9, in the fourth embodiment, the second position sensor 32 is fixedly disposed on the inner wall of the hollow needle 21. In this way, the installation space of the head end of the second position sensor 32 is saved, and the overall diameter of the needle assembly 20 can be reduced, so that the diameter of the whole medical interventional catheter can be reduced, and the interventional operation is facilitated. In addition, the protection of the second position sensor 32 and the implementation of the performance of ensuring the bending control of the product are facilitated.
In other embodiments, the second position sensor 32 may also be disposed in the needle wall of the hollow needle 21, for example, the hollow needle 21 may be made of a polymer material and combined with the second position sensor 32, and the second position sensor 32 is disposed in the needle wall of the hollow needle 21. Further, when the medical interventional catheter is configured as an ablation needle catheter and an irrigation ablation needle catheter, the outer wall of the hollow needle 21 may be formed with an electrode by plating or the like.
[ EXAMPLE V ]
The medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the fifth embodiment of the invention are basically the same as the medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the first embodiment of the invention, and the same parts are not described again, and only different points are described below.
Fifth, in the medical intervention system, the rotary knob 41 is communicatively connected to the control device 53; the control device 53 is configured to calculate an axial distance of the distal end of the needle assembly 20 relative to the distal end of the first lumen based on the position information of the first position sensor 31 and the position information of the second position sensor 32, and control the knob 41 to drive the needle assembly 20 to move according to the calculated axial distance of the distal end of the needle assembly 20 relative to the distal end of the first lumen compared with a set value, so that the axial distance of the distal end of the needle assembly 20 relative to the distal end of the first lumen is kept within a preset range. Wherein, the setting value and the preset range can be set differently according to the actual situation, and the selection of the setting value should meet the requirement that the needle assembly 20 enters the focus area with a set depth to achieve the treatment effect; the predetermined range is selected to ensure that the needle assembly 20 does not fluctuate too much in length when subjected to a counter force from body tissue. Preferably, the control device 53 compares the needle-out length of the needle assembly 20 with a set value in real time, and if the comparison result between the needle-out length and the set value exceeds a preset range, the control knob 41 is controlled in time to adjust the needle-out length of the needle assembly 20, so that the needle-out length of the needle assembly 20 is kept near the set value.
Optionally, the knob 41 is provided with a driving element, and the control device 53 can drive the knob 41 through the driving element, so as to adjust the needle-out length of the needle assembly 20. The skilled person can make a suitable choice of the drive element according to the prior art.
[ EXAMPLE six ]
Referring to fig. 10 and 11, fig. 10 is a schematic view of a medical interventional catheter component according to a sixth embodiment of the invention, wherein the catheter body comprises a force sensor, and fig. 11 is a schematic view of a needle assembly according to a sixth embodiment of the invention, wherein the needle assembly comprises a force sensor.
The medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the sixth embodiment of the invention are basically the same as the medical interventional catheter component, the medical interventional catheter and the medical interventional system provided in the first embodiment of the invention, and the same parts are not described again, and only different points are described below.
The medical interventional catheter 1 further comprises a force sensor 36 arranged on the needle assembly 20 and/or the catheter body 10, the force sensor 36 is in communication connection with the control device 53 for sensing a feedback force of the catheter body 10 and/or the needle assembly 20; the control device 53 is configured to send out an alarm signal when the feedback force of the catheter body 10 and/or the needle assembly 20 sensed by the force sensor 36 is greater than a preset threshold value.
Fig. 10 shows an exemplary embodiment, the distal end of the medical interventional catheter 1 comprises a force sensor 36, the force sensor 36 being arranged in the catheter body 10, preferably inside the tip electrode or between the tip electrode and the distal end of the catheter body 10. Preferably, the force sensor 36 is a ring-shaped or other shaped structure having a pressure strain gauge, and may be made of a pressure sensitive element or an electro-optical element. When the needle assembly 20 is inserted into a predetermined tissue and reaches a predetermined depth, the feedback force of the catheter body 10 sensed by the force sensor 36 is within a preset threshold. If the insertion force is continuously applied, the distal end of the catheter body 10 receives a feedback force (as shown by an arrow in fig. 10) from the tissue surface, and when the feedback force exceeds a preset threshold and reaches a dangerous limit, the control device 53 sends out a warning signal, such as triggering a workstation alarm, to prompt the operator to stop applying the insertion force to the catheter body 10, thereby avoiding adverse consequences such as myocardial perforation caused by too large force application to cause the distal end of the catheter body 10 to penetrate into the tissue.
Fig. 11 shows another exemplary embodiment, the distal end of the medical interventional catheter 1 comprises a force sensor 36, the force sensor 36 being arranged on the needle assembly 20, preferably in the inner surface, outer surface or wall of the hollow needle 21 or in the inner surface, outer surface or wall of the injection tube 22. Preferably, the force sensor 36 is a ring-shaped or other shaped structure having a pressure strain gauge, and may be made of a pressure sensitive element or an electro-optical element. When the needle assembly 20 is inserted into a predetermined tissue (such as myocardium), the feedback force sensed by the force sensor 36 should be within a preset threshold, and if the feedback force sensed by the force sensor 36 is too large to exceed the preset threshold, it indicates that the needle assembly 20 may stick into a wrong position (such as valve, tendon, etc.), which may not only fail to achieve the therapeutic effect but also aggravate the condition of the patient.
It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, similar parts between the embodiments may be referred to each other, and different parts between the embodiments may also be used in combination with each other, which is not limited by the present invention. For example, the second position sensor 32 may be fixed to the outer wall of the hollow needle 21 in the manner of the second position sensor 32 according to the first embodiment, while the lead of the second position sensor 32 may be arranged in the wall of the syringe 22 in the manner of the third embodiment, and the like, and those skilled in the art may use the above-mentioned arrangements in different combinations.
The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the appended claims.

Claims (15)

1. A medical intervention catheter component, comprising: the catheter comprises a catheter body, a needle assembly, a first position sensor and a second position sensor;
the catheter body is provided with a hollow first inner cavity, the needle assembly is arranged along the axial direction of the catheter body, and the needle assembly can move along the axial direction of the catheter body between a retracted position and an extended position;
the first position sensor is fixedly arranged on the catheter body, and the second position sensor is fixedly arranged on the needle assembly; the position information of the first position sensor and the position information of the second position sensor are used for judging the axial distance of the needle assembly moving relative to the catheter body.
2. The medical interventional catheter component of claim 1, wherein the retracted position is configured such that the needle assembly is fully disposed through the first lumen; the extended position is configured such that the distal end of the needle assembly extends beyond the distal end of the first lumen.
3. The medical interventional catheter assembly of claim 1, wherein the position information of the first position sensor and the position information of the second position sensor are used for calculating a spatial linear distance of the distal end of the needle assembly relative to the distal end of the catheter body, and wherein the spatial linear distance and the radial distance of the first position sensor and the second position sensor are used for calculating an axial distance of the distal end of the needle assembly relative to the distal end of the catheter body.
4. The medical interventional catheter component of claim 1, wherein the needle assembly comprises a hollow needle and a syringe connected to a proximal end of the hollow needle; the second position sensor is fixed with the hollow needle or the injection tube.
5. The catheter component of claim 4, wherein the second position sensor is fixedly disposed on an outer wall of the hollow needle at a junction of the hollow needle and the syringe.
6. The medical interventional catheter assembly of claim 4, wherein the second position sensor and a lead of the second position sensor are disposed in a wall of the syringe.
7. The medical interventional catheter component of claim 4, wherein the needle assembly further comprises a temperature sensor fixedly disposed in an outer wall of the hollow needle, an inner wall of the hollow needle or a needle wall of the hollow needle for sensing the temperature of the hollow needle.
8. The medical interventional catheter component of claim 4, wherein the needle assembly comprises a wire protection tube disposed through the syringe for passage of a wire of the second position sensor.
9. The medical interventional catheter component of claim 1, wherein the needle assembly further comprises a solid ablation needle and an ablation lead, the solid ablation needle being electrically connected with the ablation lead.
10. The medical interventional catheter assembly of claim 1, wherein the catheter body includes a guide tube fixedly disposed in the first lumen along an axial direction of the catheter body, the guide tube having a second lumen through which the needle assembly is disposed, the first position sensor being disposed outside the guide tube.
11. A medical intervention catheter, comprising: a control handle and a medical interventional catheter component according to any one of claims 1-10; the control handle is connected with the proximal end of the catheter body and comprises a knob for driving the needle assembly to move.
12. A medical intervention system, comprising: the medical interventional catheter of claim 11, a magnetic field generator, a reference electrode and a control device; the first position sensor, the second position sensor, the magnetic field generator and the reference electrode are respectively in communication connection with the control device, the first position sensor and the second position sensor are used for sensing a magnetic field of the magnetic field generator to obtain sensing signals, and the control device obtains position information of the first position sensor and position information of the second position sensor based on the sensing signals and the reference electrode and judges the axial distance of the needle assembly moving relative to the catheter body.
13. The medical intervention system of claim 12, comprising: a display device communicatively coupled to the control device, the display device for displaying an axial distance of the distal end of the needle assembly relative to the distal end of the first lumen.
14. The medical intervention system of claim 12, wherein the knob is communicatively coupled to the control device; the control device is configured to calculate an axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity based on the position information of the first position sensor and the position information of the second position sensor, and control the knob to drive the needle assembly to move according to the comparison result of the calculated axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity and a set value, so that the axial distance of the distal end of the needle assembly relative to the distal end of the first inner cavity is kept within a preset range.
15. The medical intervention system of claim 12, further comprising a force sensor disposed on the needle assembly and/or the catheter body, the force sensor communicatively coupled to the control device for sensing a feedback force of the catheter body and/or the needle assembly; the control device is configured to send out an alarm signal when the feedback force of the catheter body and/or the needle assembly sensed by the force sensor is larger than a preset threshold value.
CN202010275482.7A 2020-04-09 2020-04-09 Medical intervention catheter part, medical intervention catheter and medical intervention system Pending CN113559390A (en)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115569287A (en) * 2022-11-17 2023-01-06 上海微创电生理医疗科技股份有限公司 Medical catheter
CN116983074A (en) * 2023-09-25 2023-11-03 上海微创电生理医疗科技股份有限公司 Ablation auxiliary equipment and ablation system

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115569287A (en) * 2022-11-17 2023-01-06 上海微创电生理医疗科技股份有限公司 Medical catheter
CN116983074A (en) * 2023-09-25 2023-11-03 上海微创电生理医疗科技股份有限公司 Ablation auxiliary equipment and ablation system
CN116983074B (en) * 2023-09-25 2024-01-23 上海微创电生理医疗科技股份有限公司 Ablation auxiliary equipment and ablation system

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