CN117481617A

CN117481617A - Shock wave saccule device

Info

Publication number: CN117481617A
Application number: CN202311524037.XA
Authority: CN
Inventors: 闫小珅
Original assignee: Suzhou Xinling Meide Medical Technology Co ltd
Current assignee: Suzhou Xinling Meide Medical Technology Co ltd
Priority date: 2023-11-15
Filing date: 2023-11-15
Publication date: 2024-02-02
Anticipated expiration: 2043-11-15
Also published as: CN117481617B

Abstract

The invention provides a seismic balloon device, comprising: the balloon is arranged in the blood vessel, an inner cavity is formed in the balloon, a discharge electrode and a capacitance electrode are arranged in the inner cavity, and a conductive medium is filled in the inner cavity; the capacitive electrode comprises a first capacitive electrode and a second capacitive electrode; the sliding guide wire is arranged at the center of the balloon and is used for bearing the discharge electrode and the first capacitance electrode and pulling the discharge electrode and the first capacitance electrode to axially move along the balloon; the detection circuit comprises a plurality of groups of feedback circuits; the plurality of second capacitor electrodes are axially arranged along the inner wall of the balloon in a separated mode; each group of feedback circuits is respectively connected with a second capacitance electrode and a first capacitance electrode, and the blood vessel blocking position is determined by capacitance values measured by the plurality of groups of feedback circuits when the first capacitance electrode moves along with the axial direction of the sliding guide wire. By adopting the invention, the measuring mode of the blood vessel blocking position is changed, the detection operation is simplified, and the efficiency is improved.

Description

Shock wave saccule device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a shock wave saccule device.

Background

Coronary calcification lesions are very troublesome lesions in interventional therapy, called the "hardest bones" or the "hardest fort", and how to fully pretreat calcification lesions by more effective means is the focus of attention of clinicians at home and abroad. Traditional methods of treating calcified plaque, such as high pressure balloons, cutting balloons, spinous process balloons, and atherectomy/rotational atherectomy, each have limitations and tend to be "tricky" in mid-membrane calcification, eccentric calcified nodules, or severe calcification; inspired by urinary lithotripsy, the appearance of a shock wave lithotripsy system in coronary artery blood vessels provides a new thought for clinically treating calcified lesions, so that calcified plaques which cannot be treated in the past have a more efficient and safe solution.

The coronary shock wave lithotripsy is different from the traditional calcified lesion treatment technology in the working principle, and by perfectly combining the acoustic calcified fracturing technology with the balloon catheter, mechanical energy can be provided for lesions when the balloon is expanded at low pressure so as to efficiently and safely destroy superficial calcification and deep calcification, thereby obviously improving vascular compliance. The unique action mechanism ensures that the instrument not only has the effect on shallow calcification and deep calcification, but also has the treatment effect on non-eccentric lesions, and has the advantages of simple use, low treatment cost and almost no learning curve; in addition, the treatment pressure is lower and is only 4-6 atm, so that the soft tissue injury can be reduced, and the risks of complications such as interlayer and perforation and the like can be reduced.

In clinical application, after the balloon catheter enters a human blood vessel, an imaging device is needed to screen whether the balloon reaches a position of heavy calcification in the blood vessel, and the position of a discharge electrode is also needed to be placed in a calcified lesion section by the imaging device, wherein the needed imaging device is generally CT, X-ray machine, angiography machine and the like. The working process is that the balloon catheter is pushed in the blood vessel, the image equipment sends out rays, whether the balloon reaches the expected focus position is confirmed through the fed back image, if the balloon does not reach the expected position, the balloon continues to adjust the position in the blood vessel, the image equipment sends out rays again to form a position image of the balloon in the blood vessel, whether the balloon reaches the lesion section is confirmed again through the image, and whether the electrode position is the optimal discharge position is confirmed. As can be seen from the above description, the way of deploying the balloon by means of an imaging device such as a radiographic device is extremely cumbersome, requiring repeated movements of the balloon catheter multiple times, and multiple times of confirmation of whether the balloon reaches the lesion segment of the calcified stenosis. The method for positioning the balloon by using the imaging equipment such as the rays and the like has long operation time, the balloon moves in the blood vessel for multiple times, great pain is brought to the patient, and the patient and the doctor are subjected to longer X-ray injury time and larger injury.

Accordingly, there is a need to provide a seismic balloon apparatus that addresses the above-described issues.

Disclosure of Invention

The embodiment of the invention provides a vibration wave saccule device, which changes the detection mode of the blood vessel blocking position in principle, simplifies the detection operation and improves the efficiency.

The embodiment of the invention provides a seismic wave saccule device, which comprises:

the balloon is arranged in a blood vessel, an inner cavity is formed in the balloon, a discharge electrode and a capacitance electrode are arranged in the inner cavity, and a conductive medium is filled in the inner cavity; the capacitive electrode comprises a first capacitive electrode and a second capacitive electrode;

the sliding guide wire axially penetrates through the center of the balloon and is used for bearing the discharge electrode and the first capacitance electrode and pulling the discharge electrode and the first capacitance electrode to axially move along the balloon;

a detection circuit connecting the first and second capacitive electrodes to detect a capacitance value between the first and second capacitive electrodes;

the first capacitance electrodes are fixedly arranged on the sliding guide wire, the second capacitance electrodes are multiple, the second capacitance electrodes are axially separated along the inner wall of the balloon, and when the first capacitance electrodes axially move along the sliding guide wire to be opposite to the second capacitance electrodes, the second capacitance electrodes and the first capacitance electrodes form a capacitor;

the detection circuit comprises a plurality of groups of feedback circuits, and each group of feedback circuits is respectively connected with one second capacitance electrode and one first capacitance electrode; the feedback circuit is used for measuring the capacitance value between the connected second capacitance electrode and the first capacitance electrode, and the blood vessel blocking position is determined through a plurality of groups of capacitance values measured by the feedback circuit when the first capacitance electrode moves along with the sliding guide wire axially.

Optionally, the second capacitance electrode is formed by a plurality of etching lines which are formed by etching and are insulated by conductive metal coating coated on the inner wall of the balloon.

Optionally, the conductive metal coating is a silver coating.

Optionally, the second capacitor electrodes are arranged along the circumferential direction in an extending manner, and the surface area of each second capacitor electrode is equal.

Optionally, the second capacitive electrode is circumferentially divided into a plurality of second capacitive sub-electrodes, each of which has an equal surface area, and each of which is connected to a set of the feedback circuits.

Optionally, guide holes are coaxially arranged at two ends of the balloon, two ends of the sliding guide wire respectively penetrate out of the guide holes, and the sliding guide wire can axially move along the guide holes.

Optionally, the sliding guide wire is a metal wire, and the sliding guide wire is electrically connected with the first capacitor electrode.

Optionally, the feedback circuit is electrically connected with the second capacitor electrode through a first wire, and is electrically connected with the sliding guide wire through a second wire, so that the feedback circuit is electrically connected with a capacitor formed by the second capacitor electrode and the first capacitor electrode to form a closed loop.

Optionally, a wire layer is disposed on an inner wall of the balloon, and the first wires connected by the feedback circuits are laid on the wire layer to be respectively connected with the second capacitor electrodes.

Optionally, the feedback circuit includes power, adjustable capacitor, resistor, indicating device and electric capacity detection chip that connect in series, indicating device is pilot lamp or buzzer, adjustable capacitor is used for adjusting the electric capacity threshold value that the pilot lamp lights or buzzer sounded.

Optionally, the discharge electrode includes a positive electrode and a negative electrode, and the positive electrode and the negative electrode are respectively disposed at two ends of the first capacitor electrode.

Optionally, the conductive medium is a conductive liquid or a conductive gas.

Based on the same design thought, the invention also provides a detection method of the seismic wave saccule device, which comprises the following steps:

implanting the uninflated balloon into a blood vessel;

filling a conductive medium into the balloon to expand the balloon;

moving the sliding guide wire to enable the first capacitance electrode to move from one end of the balloon to the other end at a constant speed, and observing whether an indication device of a feedback circuit sends out an indication signal in the moving process of the sliding guide wire;

if the indicating device sends out an indicating signal, the position of the blood vessel blockage is indicated to be positioned on the outer wall of the saccule, and the position of the second capacitance electrode correspondingly connected with the feedback circuit of the indicating device sending out the indicating signal is the blood vessel blockage position;

if no indication device sends out an indication signal, indicating that the blood vessel blockage position is far away from the outer wall of the balloon, moving the balloon until the sliding guide wire is moved, and enabling the indication device with a feedback circuit to send out the indication signal when the first capacitance electrode is moved from one end of the balloon to the other end at a uniform speed; and confirming the blood vessel blocking position through the position of the second capacitance electrode correspondingly connected with the indicating device.

Compared with the prior art, the technical scheme of the invention has the beneficial effects.

For example, a first capacitance electrode and a plurality of second capacitance electrodes for detecting the blood vessel blocking position are arranged, the first capacitance electrode is arranged at the center of the balloon, the plurality of second capacitance electrodes are axially separated and arranged on the inner wall of the balloon, the distance between the first capacitance electrode and the plurality of second capacitance electrodes is fed back through the capacitance value of a capacitor formed between the first capacitance electrode and the plurality of second capacitance electrodes, and then the axial position of the blood vessel blocking is determined, so that the detection principle of the blood vessel blocking position is changed, the balloon can be deployed to the blood vessel blocking position without the assistance of image equipment, the detection operation process is simplified, the detection efficiency is effectively improved, and the discomfort of a patient in the detection process is relieved.

For example, the second capacitance electrode is circumferentially divided into a plurality of second capacitance sub-electrodes, and the intervals between the first capacitance electrode and the plurality of second capacitance sub-electrodes are fed back through the capacitance values of the capacitor formed between the first capacitance electrode and the plurality of second capacitance sub-electrodes, so that the circumferential position of the blood vessel blockage is determined, the blood vessel blockage position is more accurately determined, and the detection precision is improved.

For another example, a detection circuit is provided, and the feedback circuit indicating device connected with each second capacitance electrode sends out an indicating signal to directly indicate the second capacitance electrode positioned at the blood vessel blocking position, so that the test result is intuitively obtained.

Drawings

FIG. 1 is a schematic diagram of a seismic balloon apparatus in an embodiment of the invention;

FIG. 2 is a schematic diagram of the operation of a seismic balloon apparatus in an embodiment of the invention;

FIG. 3 is a schematic view of the structure of a balloon according to an embodiment of the present invention;

FIG. 4 is another schematic representation of the structure of a balloon in an embodiment of the present invention;

FIG. 5 is a schematic illustration of one attachment of a balloon in an embodiment of the present invention;

fig. 6 is a schematic diagram of a feedback circuit according to an embodiment of the invention.

Reference numerals illustrate:

1. a blood vessel; 11. calcified stenotic regions;

2. a balloon; 21. etching the line; 22. a guide hole; 23. and a wire layer.

3. Sliding the guide wire;

4. a capacitor electrode; 41. a first capacitor electrode; 42. a second capacitor electrode; 421. a second capacitor split electrode;

6. a discharge electrode; 61. a positive electrode; 62. a negative electrode;

7. a detection circuit; 71. a feedback circuit; 711. a power supply; 712. an adjustable capacitor; 713. a resistor; 714. an indication device; 715. a capacitance detection chip;

8. a first wire;

9. and a second wire.

Detailed Description

In order to make the objects, features and advantageous effects of the present invention more comprehensible, embodiments accompanied with figures are described in detail below. It is to be understood that the following detailed description is merely illustrative of the invention, and not restrictive of the invention. Moreover, the use of the same, similar reference numbers in the figures may indicate the same, similar elements in different embodiments, and descriptions of the same, similar elements in different embodiments, as well as descriptions of prior art elements, features, effects, etc. may be omitted. In the description of the present invention, radial, axial and circumferential refer to radial, axial and circumferential of the balloon 2.

Referring to fig. 1-6, an embodiment of the present invention provides a seismic balloon apparatus.

Specifically, the seismic balloon device comprises:

the balloon 2 is arranged in the blood vessel 1, the balloon 2 is provided with an inner cavity, a discharge electrode 6 and a capacitance electrode 4 are arranged in the inner cavity, and a conductive medium is filled in the inner cavity; the capacitive electrode 4 includes a first capacitive electrode 41 and a second capacitive electrode 42;

the sliding guide wire 3 axially penetrates through the center of the balloon 2 and is used for bearing the discharge electrode 6 and the first capacitance electrode 41 and pulling the discharge electrode 6 and the first capacitance electrode 41 to axially move along the balloon 2;

a detection circuit 7 that connects the first capacitance electrode 41 and the second capacitance electrode 42 to detect a capacitance value between the first capacitance electrode 41 and the second capacitance electrode 42;

the first capacitance electrode 41 is fixedly arranged on the sliding guide wire 3, a plurality of second capacitance electrodes 42 are arranged, the second capacitance electrodes 42 are axially separated along the inner wall of the balloon 2, and when the first capacitance electrode 41 moves along with the sliding guide wire 3 to be opposite to the second capacitance electrode 42, the second capacitance electrode 42 and the first capacitance electrode 41 form a capacitor;

the detection circuit 7 comprises a plurality of groups of feedback circuits 71, and each group of feedback circuits 71 is respectively connected with one second capacitance electrode 42 and one first capacitance electrode 41; the feedback circuit 71 is used to measure the capacitance between the connected second capacitive electrode 42 and the first capacitive electrode 41, and the position of the occlusion of the blood vessel 1 is determined by the capacitance measured by the multiple sets of feedback circuits 71 when the first capacitive electrode 41 moves axially with the sliding guide wire 3.

Since the capacitance value of a capacitor is proportional to the dielectric constant and the facing area between the two electrodes of the capacitor, and inversely proportional to the distance between the two electrodes of the capacitor. Since the diameter of the calcified stenosis 11 of the blood vessel 1 is smaller than that of the normal blood vessel 1 in the blood vessel 1, the diameter of the balloon 2 positioned in the calcified stenosis 11 of the blood vessel 1 is also smaller, the capacitance value of the capacitor formed by the first capacitance electrode 41 and the second capacitance electrode 42 is larger than that of the capacitor formed by the first capacitance electrode 41 and the second capacitance electrode 42 positioned at the normal position of the blood vessel 1, and each capacitance value of the capacitor array formed by a plurality of second capacitance electrodes 42 and the first capacitance electrode 41 which are arranged along the axial direction can be read by the detection circuit 7, and the limit value of the capacitance value is the calcified stenosis 11. When the calcified stricture 11 is identified, the discharge treatment of the balloon 2 can be performed by moving the first capacitance electrode 41 to this area.

The axial position of the blockage of the blood vessel 1 is determined by feeding back the capacitance value of the capacitor formed between the first capacitance electrode 41 and the plurality of second capacitance electrodes 42 and the distance between the first capacitance electrode 41 and the plurality of second capacitance electrodes 42, so that the calcified stenosis region 11 of the blood vessel 1 is marked, the image diagnosis by image equipment is not needed, the operation is efficient, safe and reliable, the operation time is short, the X-ray injury is avoided, and the calcified stenosis focus region can be detected while the balloon 2 is arranged.

Referring to fig. 3, in some embodiments, the second capacitive electrode 42 is insulated and separated by an etching line 21 formed by etching a conductive metal coating applied to the inner wall of the balloon 2.

In some embodiments, the conductive metal coating is a silver coating.

In a specific implementation, the etching is performed by laser irradiation, the silver coating is made of a photosensitive silver material, and the silver coating in the irradiated area is volatilized and removed by laser irradiation of a wavelength to which the photosensitive silver material is sensitive, so that an etching line 21 is formed. The grouped capacitor arrays of different sections can be formed by controlling the laser etching circuit, so that the different sections of the balloon 2 have different capacitance characteristics and can be selected for different blood vessel 1 environments.

In some embodiments, the second capacitive electrodes 42 are disposed in a circumferential extension, with each second capacitive electrode 42 having an equal surface area.

Referring to fig. 4, in some embodiments, the second capacitor electrode 42 is circumferentially divided into a plurality of second capacitor sub-electrodes 421, each second capacitor sub-electrode 421 has an equal surface area, and each second capacitor sub-electrode 421 is connected to a set of feedback circuits 71. The plurality of second capacitance sub-electrodes 421 are divided more finely in the circumferential direction, the intervals between the first capacitance electrode 41 and the plurality of second capacitance sub-electrodes 421 are fed back through the capacitance values of the capacitors formed between the first capacitance electrode 41 and the plurality of second capacitance sub-electrodes 421, the circumferential position of the blockage of the blood vessel 1 is further determined, the blockage position of the blood vessel 1 is more accurately determined, and the detection precision is improved.

In some embodiments, both ends of the balloon 2 are coaxially provided with guide holes 22, both ends of the sliding guide wire 3 respectively penetrate out of the guide holes 22, and the sliding guide wire 3 can axially move along the guide holes 22.

In some embodiments, the sliding guide wire 3 is a metal wire, and the sliding guide wire 3 is electrically connected to the first capacitive electrode 41.

In some embodiments, the feedback circuit 71 is electrically connected to the second capacitive electrode 42 through the first conductive wire 8 and electrically connected to the sliding guide wire 3 through the second conductive wire 9, so that the feedback circuit 71 is electrically connected to the capacitor formed by the second capacitive electrode 42 and the first capacitive electrode 41 to form a closed loop.

Referring to fig. 5, in some embodiments, a wire layer 23 is disposed on an inner wall of the balloon 2, and the first wires 8 connected by the plurality of feedback circuits 71 are laid on the wire layer 23 to be connected to the plurality of second capacitor electrodes 42 respectively.

Referring to fig. 6, in some embodiments, the feedback circuit 71 includes a power supply 711, an adjustable capacitor 712, a resistor 713, an indicator device 714, and a capacitance detection chip 715 connected in series, the indicator device 714 being an indicator light or a buzzer, the adjustable capacitor 712 being used to adjust a capacitance threshold at which the indicator light is on or the buzzer sounds. The capacitance detection chip 715 is used to measure capacitance values for conventional applications and will not be described here.

In some embodiments, the discharge electrode 6 includes a positive electrode 61 and a negative electrode 62, the positive electrode 61 and the negative electrode 62 being disposed at both ends of the first capacitive electrode 41, respectively.

In some embodiments, the conductive medium is a conductive liquid or a conductive gas, which is a material having a specific dielectric constant.

In the specific implementation, filling materials with different dielectric constants can be filled through multiple times of inflation or flushing to detect the same lesion, average values are obtained through multiple times of measurement, and the detection fault tolerance is improved by mutual comparison; suitable dielectric constant materials can also be selected for different patient conditions.

In order to better understand the technical scheme provided by the embodiment of the invention, the process of detecting the blocking position of the blood vessel 1 by using the seismic wave balloon device is further described below.

The method specifically comprises the following steps:

s1: implanting an unexpanded balloon 2 into the vessel 1;

s2: filling the balloon 2 with a conductive medium to expand the balloon 2;

s3: moving the sliding guide wire 3 to enable the first capacitance electrode 41 to move from one end of the balloon 2 to the other end at a uniform speed, and observing whether the indication device 714 of the feedback circuit 71 sends out an indication signal in the moving process of the sliding guide wire 3;

if the indication device 714 sends out an indication signal, it indicates that the blockage position of the blood vessel 1 is located on the outer wall of the balloon 2, and the position of the second capacitance electrode 42 corresponding to the feedback circuit 71 where the indication device 714 sends out the indication signal is located, namely the blockage position of the blood vessel 1;

if no indication device 714 sends out an indication signal, indicating that the blocking position of the blood vessel 1 is far away from the outer wall of the balloon 2, and moving the balloon 2;

s4: repeating the step S3 until the sliding guide wire 3 is moved, and when the first capacitance electrode 41 is moved from one end of the balloon 2 to the other end at a constant speed, the indication device 714 with the feedback circuit 71 sends out an indication signal; the position of the occlusion of the blood vessel 1 is confirmed by the position of the second capacitive electrode 42 to which the indicating means 714 is correspondingly connected.

In summary, in the seismic balloon device provided by the embodiment of the invention, the first capacitive electrode 41 and the plurality of second capacitive electrodes 42 for detecting the blocking position of the blood vessel 1 are provided, the first capacitive electrode 41 is arranged at the center of the balloon 2, the plurality of second capacitive electrodes 42 are axially separated and arranged on the inner wall of the balloon 2, the capacitance value of the capacitor formed between the first capacitive electrode 41 and the plurality of second capacitive electrodes 42 is used for feeding back the interval between the first capacitive electrode 41 and the plurality of second capacitive electrodes 42, so that the axial blocking position of the blood vessel 1 is determined, the detection principle of the blocking position of the blood vessel 1 is changed, the balloon 2 can be deployed to the blocking position of the blood vessel 1 without the assistance of an image device, the detection operation process is simplified, the detection efficiency is effectively improved, and discomfort in the patient detection process is reduced.

Further, in the embodiment of the present invention, the second capacitive electrode 42 is circumferentially divided into a plurality of second capacitive sub-electrodes 421, and the capacitance values of the capacitors formed between the first capacitive electrode 41 and the plurality of second capacitive sub-electrodes 421 are used to feed back the distances between the first capacitive electrode 41 and the plurality of second capacitive sub-electrodes 421, so as to determine the circumferential position of the blockage of the blood vessel 1, more accurately determine the blockage position of the blood vessel 1, and improve the detection accuracy.

Further, the detection circuit 7 is provided, and the feedback circuit 71 connected with each second capacitance electrode 42 indicates the device 714 to send out an indication signal to directly indicate the second capacitance electrode 42 at the blockage position of the blood vessel 1, so that the test result is intuitively obtained.

Although specific embodiments have been described above, these embodiments are not intended to limit the scope of the disclosure, even where only a single embodiment is described with respect to a particular feature. The characteristic examples provided in the present disclosure are intended to be illustrative, not limiting, unless stated differently. In practice, the features of one or more of the dependent claims may be combined with the features of the independent claims where technically possible, according to the actual needs, and the features from the respective independent claims may be combined in any appropriate way, not merely by the specific combinations enumerated in the claims.

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

1. A seismic balloon apparatus, comprising:

2. The seismic balloon device of claim 1, wherein the second capacitive electrode is insulated by etched lines of conductive metal coating applied to the balloon inner wall.

3. The seismic balloon device of claim 2, wherein the conductive metal coating is a silver coating.

4. The seismic balloon device of claim 1, wherein the second capacitive electrodes are disposed in a circumferentially extending manner, each of the second capacitive electrodes having an equal surface area.

5. The seismic balloon device of claim 1, wherein the second capacitive electrode is circumferentially separated into a plurality of second capacitive sub-electrodes, each of the second capacitive sub-electrodes having an equal surface area, each of the second capacitive sub-electrodes being coupled to a set of the feedback circuits.

6. The seismic balloon device of claim 1, wherein both ends of the balloon are coaxially provided with guide holes, both ends of the sliding guide wire respectively pass through the guide holes, and the sliding guide wire is axially movable along the guide holes.

7. The seismic balloon device of claim 1, wherein the sliding guidewire is a wire, the sliding guidewire being electrically connected to the first capacitive electrode.

8. The seismic balloon device of claim 7, wherein the feedback circuit is electrically connected to the second capacitive electrode via a first wire and to the sliding guidewire via a second wire such that the feedback circuit is electrically connected to a capacitor formed by the second capacitive electrode and the first capacitive electrode to form a closed loop.

9. The seismic balloon device of claim 1, wherein an inner wall of the balloon is provided with a wire layer, the first wires connected by the plurality of feedback circuits being laid on the wire layer to respectively connect the plurality of second capacitive electrodes.

10. The seismic balloon device of claim 1, wherein the feedback circuit comprises a power supply, an adjustable capacitor, a resistor, an indicator device and a capacitance detection chip connected in series, the indicator device being an indicator light or a buzzer, the adjustable capacitor being used to adjust a capacitance threshold at which the indicator light lights up or the buzzer sounds.

11. The shock balloon apparatus of claim 1, wherein the discharge electrode comprises a positive electrode and a negative electrode, the positive electrode and the negative electrode being disposed at respective ends of the first capacitive electrode.

12. The seismic balloon device of claim 1, wherein the conductive medium is a conductive liquid or a conductive gas.

13. A method of detecting a seismic balloon device according to any of claims 1-12, comprising the steps of:

implanting the uninflated balloon into a blood vessel;

filling a conductive medium into the balloon to expand the balloon;